Page 1

2017


Prevention is the name of the game. We have to bet on that and cultivate it from a young age. JosĂŠ Narro, Minister of Health of Mexico


2017 As 2016 turned the corner into a new year, macroeconomic uncertainty kept the world – and the global business community – on tenterhooks. The Mexican health industry cast a wary eye on events north of the border that were impacting the local exchange rate while also focusing treatment efforts on obesity and diabetes, which continued to top the country’s major health concerns. Considered as epidemics by the government, steps are being taken to eradicate these diseases in the country, especially through prevention. However, universal access to health, a key to promoting prevention in an increasingly aging population that is not accustomed to continuous medical checkups, remains an illusive ideal in the face of a fractured Mexican health system and the large number of people who continue to work informally, which complicates their access to a system marked by budget cuts. In this context, collaboration between the public and private sectors is vital for improving quality of life.

In the private sector, global economic uncertainty, and the election of US President Donald Trump, led large pharmaceutical companies to begin 2017 with some misgivings about peso volatility versus the two major currencies: the dollar and the euro, although initial fears faded as stability returned to the domestic currency. In fact, most continue to report growth and show a commitment to the development of health in Mexico through investments in areas such as clinical research, an area in which the country aspires to become a referent.

The health sector, which represents around 6 percent of the country’s GDP, continues to be a strategic industry for Mexico, a country blessed by an ideal geographical location, neighbor to the US and gateway to Latin America for many companies, and a diverse population. Mexico Health Review 2017 offers key insight into the challenges and the opportunities the industry continues to face, providing top-shelf interviews, analyses, insights and infographics. Mexico Health Review 2017 is essential to understanding the state of the health industry in Mexico today and for the path ahead.


ALL RIGHTS RESERVED Š Mexico Business Publications S.A. de C.V., 2017. This annual publication contains material protected under International, United States and Mexican Laws and international Treaties. Any unauthorized reprint or use of this material is prohibited. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system without express written permission from Mexico Business Publication S.A. de C.V. Mexico Health Review is a registered trademark.

The publisher has made all reasonable efforts to provide accurate information, and the information contained in this publication is derived from sources believed to be true and accurate. However, the information in this publication should not be considered to be complete or definitive, and may contain inaccuracies or typographical errors. The publisher accepts no responsibility regarding the accuracy of information and use of such information is at your own risk. The publisher will not be liable to any party for any direct, indirect, special or other consequential damages arising out of any use of information in this publication. The publisher provides no representations or warranties, express or implied, including any implied warranties of fitness for a particular purpose, merchantability or otherwise in relation to any information provided by the publisher in this publication.

ISBN: 978-0-9993108-0-9


TABLE OF CONTENTS

1

YEAR IN REVIEW

8

BIOELECTRONICS & BIOTECH

2

HEALTHCARE SYSTEMS

9

NUTRITION & WELLNESS

3

BIG PHARMA

4

GENERICS & BIOSIMILARS

11

HEALTH CONCERNS

5

MEDICAL DEVICES

12

INSURANCE

6

BIG DATA & HEALTH APPS

13

ATTRACTING & RETAINING TALENT

7

CLINICAL RESEARCH & TESTING

14

DOING BUSINESS IN MEXICO

10

LOGISTICS & SUPPLY CHAIN


Downtown, Mexico City, Mexico Tourism Board


YEAR IN REVIEW

1

As public institutions face shrinking budgets, they are struggling to cover a larger number of patients who are increasingly suffering from preventable disorders such as type 2 diabetes (T2D), obesity and conditions such as cardiac insufficiency that ensue. These have also worsened due to poor lifestyle habits such as a lack of exercise, smoking and alcohol consumption. External factors are also worrying. The Mexican peso has dropped against many currencies, pushing up the cost of importing goods and parts. This has hit the bottom line of companies in all sectors of the industry. Many are so far reluctant to pass on those added expenses to consumers, but for how long? An uncertain security environment in Mexico and the persistent problem of access to healthcare for many add to the question marks surrounding the sector.

This chapter will provide an overall review of the healthcare industry, featuring insights from the most prominent and important figures in the sector. It includes interviews from pertinent health and industry associations, government institutions and health-related agencies while discussing the state of the Mexican health system, the changes in regulation that occurred over the year, the progress made and the challenges to come.

5


7

CHAPTER 1: YEAR IN REVIEW 8

ANALYSIS : Despite Headwinds, Optimism Reigns

12

VIEW FROM THE TOP: José Narro, Ministry of Health

14

VIEW FROM THE TOP: Julio Sánchez y Tépoz, COFEPRIS

16

VIEW FROM THE TOP: Rafael Gual, CANIFARMA

18

VIEW FROM THE TOP: Cristóbal Thompson, AMIIF

20

VIEW FROM THE TOP: Edgar Romero, AMID

22

VIEW FROM THE TOP: José Campillo, FUNSALUD

24

INSIGHT: Patricia Uribe, CENSIDA

 Carlos Magis, CENSIDA 26

INFOGRAPHIC: COFEPRIS Breaks Down Barriers

27

VIEW FROM THE TOP: Ana Güezmes, UN Women

28

VIEW FROM THE TOP: Pressia Arifin-Cabo, UNICEF

30

ANALYSIS: Air Pollution World’s Fourth-Biggest Killer


ANALYSIS

DESPITE HEADWINDS, OPTIMISM REIGNS Despite geopolitical and economic pressures both at home and

epidemics, the first noncontagious diseases to

abroad, Mexico’s health industry is pulling together to improve

be considered as such. Although many private

access, raise awareness of the need for prevention and taking

and public-sector initiatives are afoot to combat

steps to position itself as global hub for clinical research

the diseases and related complications, to make true progress personal habits need change, says

8

Global economic and geopolitical uncertainty marked the

José Narro, the Minister of Health of Mexico. “The population

latter part of 2016 and the first half of 2017 and sparked

is not fully conscious about the dimension of the problem.

concern for many companies worried that currency

Secondly, although there has been a deceleration of the death

fluctuations would negatively impact their bottom line. The

rate, there is no decline. The number of deaths due to diabetes

peso yo-yoed in line with US polling predictions in the run-up

multiplied by about seven times between 1980 and 2015, from

to the November 2016 US elections and further depreciated

around 14,600 in 1980 to 98,500 in 2015. In the 21st century

against the US dollar post-elections as newly elected President

so far, there have been 1.1 million Mexican deaths directly due

Donald Trump maintained his nationalistic rhetoric, much of it

to diabetes. This is a grave problem. We must ensure that

directed against Mexico. The dollar appreciated against many

the measures that appear to be effective are maintained. We

other currencies, including the euro, against which the peso

also must act to protect young children and teenagers. For

faltered, negatively impacting many European-based health

this reason, in May 2017 we began the Salud en tu Escuela

companies. As 2017 rolled out, the Mexican peso stabilized

(Health in your School) program, which will send doctors to

and saw its best quarter in decades. The health sector plans

over 1,700 primary and middle schools to talk about key health

for the long-term and most companies reported growth and

topics,” Narro says.

plans to continue investing in Mexico, despite their initial fears. “Teva has drawn up a list of countries with growth markets

The government’s measures include raising awareness

and Mexico is among those,” says Guillermo Ibarra, Director

through various publicity campaigns but it remains hampered

General of Teva Mexico, a unit of the world’s largest generics

by access issues with the public health system and a shrinking

company, which produces 120 billion tablets and capsules

government budget. With less money to spend, government

per year. “One of my jobs has been to internally sell Mexico to

institutions have placed a priority on generics, pressuring Big

our global headquarters. It is a country that has industrialized

Pharma companies. On the other side of the ledger, both the

greatly and is not reliant on commodities; it has steady

public and private spheres have penciled in clinical research

economic growth of around 2-2.5 percent per year, which

as a strategic segment that could provide a windfall to

in the long term makes Global want to continue investing

companies, government institutions and ultimately, patients.

in the country. We have invested many millions of dollars in

A FRACTURED SYSTEM

improving, updating and raising the bar for our plants.”

The theme of access to health remained a significant topic Aside from the economic headwinds that buffeted the

in 2016/2017. The many Mexicans working in the informal

sector before tailing off, two diseases loomed over the health

sector are denied access to the main public healthcare

industry: obesity and diabetes, both of which were declared

institutions and are obliged to pay out-of-pocket for

EXCHANGE RATES ON THE FIRST DAY OF THE MEXICAN PESO EXCHANGE RATESWORKING AT THE BEGINNING OFMONTH THE MONTH 3Q16 TO 4Q17

25

2016 20.36

21.04

21.02

21.71

2017 22.04 21.09

20

18.30

15

20.96 20.74

July

18.85

18.85

Aug

Sept

——US Dollar

19.32

Oct

21.89

20.73

Nov

19.95

20.77

20.49

20.87

19.90

19.13

Dec

Jan

——Euro

Source: Ministry of Economy

Peso to Dollar

22.43

Peso to Euro

Feb

March

18.73

18.77

18.59

April

May

June


MEXICO’S PHARMACEUTICAL MARKET treatment or use Seguro Popular. This encourages the

MEXICO'S PHARMACEUTICAL MARKET (US$ billion)

population to delay seeking diagnosis and treatment, as

3.3

many prefer to live in blissful ignorance of a condition than to have it formally diagnosed. Not beginning treatment causes diseases to worsen and the effects cost dearly. “In most countries, pharmaceuticals represent only 10

Generics

11.2

Total value

percent of the total cost of diabetes. If people can invest that first 10 percent or even a little more to get access to better products, a big part of the other 90 percent of costs

9

can hopefully be avoided. In Mexico, this is critical, because the system is now treating the complications of people that

Sources: BMI Research, Seale & Associates

began suffering from diabetes 15 years ago. Since then, the diabetic population has more than doubled,” says Yiannis

35 percent. Like glaucoma, macular degeneration must be

Mallis, Vice President and General Manager of Novo Nordisk

detected early because the impact is irreversible. Diabetic

Mexico, the market leader for diabetes pharmaceuticals.

retinopathy is common due to the big diabetes problem in Mexico and occurs in both T1D and T2D. It also requires

Faced with shrinking budgets, public institutions are

early diagnosis to stop the progression of problems in the

struggling to cover a larger number of patients who are

retina,” he says. However, the theme of access remains. To

increasingly suffering from preventable illnesses such as

carry out checkups and catch conditions and diseases early,

type 2 diabetes (T2D), obesity and the ensuing conditions

the population must have access to healthcare services.

from these diseases such as cardiac insufficiency. These are worsened by poor lifestyle habits such as a lack of

Amid belt-tightening, public-sector institutions are

exercise, smoking and alcohol consumption. Dealing with

stretching budgets to cover more people. The Seguro

the complications is keeping the hospital sector busy.

Popular, for instance, has started eliminating duplicate

While public institutions are bursting, private hospitals

registrations with other institutions. “We have cleaned

have capacity to spare. The two are working on a more

up our database and no longer have 9 million duplicate

efficient way of collaborating to alleviate the public sector

registrations. We will continue to work on this in 2017 and we

burden and improve access. Several PPPs were announced

expect to reflect this in a higher quality service for patients

during the year for the construction of hospitals, most of

because there will be more resources per policyholder.

which will be operated by ISSSTE. However, many argue

Seguro Popular has been sharing information with other

that increasing the number of hospitals is not the key to

health systems since 2016, a year in which we lowered the

improving the health of Mexicans. “Health is a process, not

number of policyholders by 3 million,” says Gabriel O’Shea,

a state. Health ranges from the complete state of physical

National Commissioner for Social Protection in Health of

and mental wellbeing as defined by the WHO, to a second

Seguro Popular.

before death, when health is basically lost. In between there are many states, some better than others. If people see

PRIVATE SECTOR UNDER PRESSURE

health this way, prevention can be put in place. We want to

Companies are also feeling the pressure to make their

promote education so that more people can take control of

products available to a larger proportion of the population.

their health. We must begin to build processes for healthy

Big Pharma companies are often the only producers of a

aging,” says Narro.

certain treatment and therefore have a responsibility to ensure it is as widespread as possible. In recent years, as the

This is vital with any disease but it is especially important

government tender process has consolidated and amplified,

for diabetes and cancer given their impact, related

budget requirements often mean generics are favored over

ailments and high number of sufferers, which big and small

patented brands and some brands have even been liberated in

companies have recognized. Janssen, part of giant Johnson

Mexico so that generics companies can create less expensive

& Johnson, for example, is working on early diagnosis

versions of the products. This has pushed some Big Pharma

methods for prostate cancer while young Mexican startup

companies out, and some have created their own generics

Higia Technologies is developing early detection methods

lines to remain competitive. “In 2016, the Mexican health

for breast cancer. Rogelio Villarreal, Director General of

industry saw one of its toughest years, achieving single-digit

Centro de Oftalmología Monterrey and Ojos Para México

growth in terms of value due to the introduction of new

Foundation, says the problem runs across many afflictions.

products and price increases,” says Raúl Camarena, General

“Although the prevalence of glaucoma is 5 percent at

Manager of Aspen Labs Mexico. Despite a difficult year, the

40, at 70 it is 18 percent and above that it rises to 30-

Mexican pharmaceutical market remains the second largest in


ANALYSIS NUMBER OF ELDERLY ADULTS PER 100

NUMBER OF ELDERLY ADULTS IN MEXICO (per 100 CHILDREN AND YOUTHS children and youths) 38

40 35

20

10

16

18.5

sector, Perrigo, is confident in the Mexican market. “Our operations. Not only do we share a very similar business

26.4

25

chains and retailers. The world’s largest company in this business in Mexico is extremely important to Perrigo’s global

30.9

30

branded generic products available from large pharmacy

model with the US branch of Perrigo but we service many

21.3

of the same strategic customers that have presence on both sides of the border. We have identified Mexico as

15

the country in Latin America with the greatest potential

10

for growth as the economic and demographic conditions

5

are very promising for our industry. We believe that each

0

day there will be more opportunities to develop significant 1990

1995

2000

2005

2010

2015

NAFTA,” says Ricardo Ganem, Vice President and General

AVERAGE AGE IN MEXICO

AVERAGE AGE IN MEXICO (years)

Manager of Perrigo Mexico. “Each retailer is different, with distinct formats and specific strategies. Our job is to work

30 26 25 21

22

27

24

with them in developing products and brands that best fit each of their strategies. Even smaller pharmacies have varying strategies. Some sell from behind a counter like

20

traditional pharmacies, whereas others are more like minisupermarkets where you could even buy groceries and

15

other convenience items. This is a model more often seen in the US but it is a growing trend in Mexico,” he adds.

10 5 0

supply-chain partnerships between our countries due to

Medical device manufacturers face some of the same issues as Big Pharma companies, as some devices have high price

1995

2000

2005

2010

2015

Source: INEGI

points and suffer if budgets remain too low to invest in new equipment. In addition, specialized devices are facing tough competition from more generic, cheaper and older models. “The prices are also low, so they are not sustainable

Latin America and among the top 15 worldwide, according to

in the long term. We can offer those prices for one year, but

KPMG. BMI Research reports that the Mexican pharmaceutical

not several years running, especially with the depreciation

market as a whole was worth US$11.2 billion in 2015, of which

of the Mexican peso against other currencies. This is not

Seale & Associates estimate US$3.3 billion was attributable to

sustainable and endangers quality,” said Martín Ferrari,

generics. Generics producers are keen to make sure their more

Director General of Dräger Mexico.

affordable alternatives are available in as many points of sale as possible. Releasing packets of innovative medicines so that

One method that can be used to find ways to improve

generics companies can create options and increase access

healthcare is Big Data. Although the collection of Big Data

has been one of the greatest weapons in the government’s

in healthcare has been slow in the past due to the lack of

plan to offer increased access. However, price pressures have

digitalization, with the penetration of smartphones and the

begun impacting companies that are unwilling or unable to

increased number of startups it is taking off in 2017 with

go as low as requested. “We hardly sell to the government

giants such as Grupo PLM, Google and even Facebook.

because it has adopted an aggressive price-reduction policy.

“Many healthcare organizations use incredibly sophisticated

This policy erodes income at companies like pharmaceuticals,

technology in diagnostics and treatment but substantial parts

which need to earn money to continue reinvesting in research.

of their workforce use only rudimentary or no technology.

For companies like us, selling to the government is not

Less than 20 percent of payments to healthcare providers and

viable. We have decided to only sell particular products to

their suppliers are done digitally, for example,” states a 2016

state hospitals, so 95 percent of our sales are to the private

McKinsey article in Harvard Business Review. These gaps are

market,” says Felipe Espinosa, CEO of Mexican pharmaceutical

huge opportunities to digitalize and implement Big Data tools

Laboratorios Collins.

in Mexico, as with the right push the country could leapfrog.

As a result, many companies have begun turning to the

TESTING … TESTING

private sector for growth, looking for other streams of

The first half of 2017 also saw a push for clinical research as

revenue such as manufacturing for private labels, the

the authorities stepped in to help make Mexico the clinical


research hub many have been predicting for years. “In

is a hot topic that requires care. We are a low-margin

January 2017, we signed an agreement to promote clinical

industry, so all additional costs immediately impact

research that simplifies processes and integrates them. To

our profitability. We need to be prudent about how we

meet all requirements and obtain all permits used to take

manage additional expenses, which, ideally, we should

365 days but we are reducing this to 45 days. Our goal is

not have. The health industry in Mexico is also a complex

to triple the investment in clinical research in Mexico and

and fragmented one that requires different skillsets.

we hope to see US$600 million over the next two years,

I truly believe that Mexico is one of the most complex

up from under US$200 million. An agreement has been

healthcare markets,” says José Alberto Peña, Director

reached with IMSS and ISSSTE will soon join the program.

General of Grupo Marzam, one of the country’s big four

We are working on another agreement with the national

wholesalers/distributors of the health sector.

11

health institutions and with UNAM. This will no doubt happen by the end of 2017,” says Julio Sánchez y Tépoz,

Then there is the black market and the issue of

Commissioner of COFEPRIS. Medicines that are released

counterfeit medicine. To render faking medicine less

by companies cannot be sold immediately in the Mexican

appealing, pharmaceuticals are enhancing security at

market, as regulation stipulates that they must undergo

their warehousing facilities, as well as working to provide

testing by COFEPRIS, in addition to the clinical trials they

security features on their packaging. Holograms, braille

underwent either in Mexico or elsewhere, to first ensure

and QR codes are just some of the methods used to prove

their safety and efficiency. The backlog COFEPRIS saw in

authenticity. The medical devices sector suffers less from

this area led the regulatory agency to create the authorized

counterfeiting but more from the illegal importation and

third-party figure which can perform testing on its behalf.

sale of devices that are not stored in adequate conditions

“Speeding up processes through authorized third parties

to ensure patient safety. Herbal products have also faced

helped make the regulatory procedures more efficient

shake-ups recently, with many being removed from sale

and thus increased the attractiveness of Mexico as an

after COFEPRIS inspection. Ensuring the authenticity of

investment destination for health,” says Geraldine Rangel,

claims on packaging has been a main goal for this sector.

Director General of Healthlinks, a Mexican firm that provides

However, IMSS has been looking into including herbal

market analysis to companies wishing to enter Mexico.

medicine, a Mexican tradition, as the public institution is in desperate need of safe, cost-effective alternatives.

SECURING PRODUCTS The flip side of improving access is maintaining security, a

LOOKING FORWARD

challenge logistics companies are up to. The distribution

Although challenges remain in the Mexican healthcare

of essential medicines in Mexico is complicated by the

system, there are also opportunities for companies to

tough geographical terrain and the uncertain security

bridge gaps, the most notable of which is set to remain

environment. Many employ distinct methods to prevent

access to healthcare as both sectors seek to increase

vehicle theft, such as using dual GPS to circumvent

treatment options for a growing number of people, at a

jammers, employing electromagnetic locks and distinct

price that does not break the bank. Companies will need to

route planning. “One of the greatest challenges we face

balance this with providing innovative solutions, as well as

is Mexico’s size, so we must ensure the provision ofan

ensuring they can be amplified to suit the needs of Mexico’s

effective, efficient and continuous service. Security

121 million inhabitants.

T2D, BREAST AND PROSTATE CANCER DEATHS IN MEXICO (thousands) DEATH IN MEXICO

60

98,521

94,029

89,469

85,055

80,788

80

82,964

100

0

2010

„„ T2DT2D „„Prostate Cancer Source: INEGI

Prostate Cancer Breast Cancer

2011

2012

„„Breast Cancer

2014

2015

6,273

6,447

5,997

6,296

6,023 2013

5,548

5,613

5,911

5,222

5,666

5,508

20

5,062

40


VIEW FROM THE TOP

A 121 MILLION PEOPLE CHALLENGE JOSÉ NARRO Minister of Health of Mexico

12

Q: In 2016, you declared diabetes and obesity a crisis.

Young people are generally healthy, although they must

However, FUNSALUD’s José Campillo has said that rates

look after themselves. The elderly are another issue

are leveling off. Is this a success?

altogether: the idea of being ill frightens them. They

A: I cannot yet say that we have had success because the

prefer not to go for check-ups for fear some condition

population is not fully conscious about the dimension of the

will be discovered, but prevention is the name of the

problem. Secondly, although there has been a deceleration

game. We have to bet on prevention and this has to be

of the death rate, there is no decline. The number of deaths

cultivated from a young age. We used to think that a

due to diabetes multiplied by about seven times between

chubby child was happy and healthy but they must have

1980 and 2015, from around 14,600 in 1980 to 98,500 in

a healthy weight. We must all act.

2015. In the 21 century so far, there have been 1.1 million st

Mexican deaths directly due to diabetes. This is a grave

Q: Life expectancy is increasing. What challenges are

problem. We must ensure that the measures that appear

arising for healthcare as a result?

to be effective are maintained. We also must act to protect

A: Mexico’s population, like many around the world, is going

young children and teenagers. For this reason, in May 2017

through a demographic transition. Population pyramids

we began the Salud en tu Escuela (Health in your School)

have changed from 20 years ago when there was a strong

program, which will send doctors to over 1,700 primary and

base of young people. Now, the number of old people is

middle schools to talk about key health topics.

increasing. Forty-five years ago, the median age was 17.8. Now, it is 27, so we can say that the population is maturing.

Q: How do you control the various media campaigns

Children and the elderly are dependents and there are

aimed at children and what is the key to promoting

just over five million people aged over 70 but that figure

healthier habits?

will increase to over 17 million in 2050. Today, a regular

A: There is increased control over advertising campaigns

infection can be cured while chronic, nontransmissible,

that target children, such as for candy, food and drinks.

nonparasitic infections can be controlled. Health is a

I agree with President Peña Nieto that health begins at

process, not a state. Health ranges from the complete

home. It begins with topics such as hygiene, nutrition

state of physical and mental wellbeing as defined by the

and lifestyle. We need to work with parents because they

WHO, to a second before death, when health is basically

must understand that a child of four should not have food

lost. In between there are many states, some better than

portions equal to that of the father. School is the second-

others. If people see health this way, prevention can be

most important place where children develop good or

put in place. We want to promote education so that more

bad health habits. The Ministry of Health and the Ministry

people can take control of their health. We must begin to

of Public Education have an excellent relationship and the

build processes for healthy aging.

Education Reform will enable us to further improve this. Q: Pollution is an ongoing issue in Mexico that directly Q: How effective have public information campaigns been?

impacts health. What is the Ministry of Health doing in

A: There is an important link between public campaigns

this regard?

and health but we have to keep pushing. There have been

A: We have serious problems in Mexico City, but both

great marketing campaigns to raise social awareness in

local and federal governments are taking action. We now

this country. Going back several decades, there were

have much better ways of measuring pollution levels and

intelligent, wonderful campaigns that were strong for

better instruments to measure the impact that polluting

their time concerning reproductive health, family planning

particles have. Some actions taken include the restriction

and nutrition. We are continuing this tradition and in 2017

of vehicles and industrial activity, which limit mobility. The

our focus is on diabetes.

Environmental Commission of the Metropolis (CAMe) is a


coordinating mechanism that includes local, state and federal

Q: To what extent will the Ministry of Health be working

levels of government. President PeĂąa Nieto requested that

on reforming medical degrees for young doctors?

the commission includes the Ministry of Health.

A: We are working on a revision at the moment and in early May we attended the ANFEM assembly. The number

Q: What challenges arise in ensuring the continuity of

of schools, programs and students has increased greatly.

projects after the 2018 presidential elections?

The number of specialists, however, has not increased

A: There has been much done in terms of health over the

greatly, because there is neither need nor space for

past few years. Under the current government, maternal

a greater number to train as specialists. We have not

mortality has fallen by over 18 percent, infant mortality has

valued the role of the general practitioner. If there are

decreased by 6 percent, mortality due to accidents has

no positions for general doctors, how can they be hired?

also dropped and the frequency of dengue fever has been

There are organizational aspects of health that must be

reduced by two-thirds. In addition, there have been many

reviewed, so we must be clear. The reality of rural Mexico,

new medicines incorporated into the healthcare system.

where we need doctors, is not attractive to them. We

Since 1948, the change has been phenomenal. Infant

are speaking only of doctors but there are many other

mortality has decreased by over 90 percent. Back then, 132

professions in healthcare. The topic of human resources

of every 1,000 children died before their first birthday. Now,

is obviously central and so we are working on this.

the rate is 12 of every 1,000. This country has been lucky with public policy in several programs, otherwise we would not

Q: What are your priorities for 2017?

have been able to achieve what we have. A clear example is

A: Diabetes is one of our highest priorities, but it is difficult

vaccination. For over 40 years we have been dedicated to

to tell which is the most important because there are

vaccinating the population. There is no rubella or congenital

many, such as cancer and heart disease. When speaking

rubella in Mexico, we have controlled diphtheria and tetanus

of priorities, I often speak of diabetes because it generates

and neonatal tetanus has been eliminated.

the most deaths as a single cause. Cardiovascular disease may cause more deaths when grouped together, but the

Since 1974, there has been a program for family planning

causes are many and can be split into three main groups:

and now for reproductive health. Thanks to these

heart attacks, hypertension and others.

programs, Mexico has 121 million inhabitants instead of over 150 million. There has been an extremely successful

Another great issue is pregnancy in girls and teenagers.

campaign running since the 1980s to protect children

Children of 10-14 years old are having babies. There were

against diseases caused by dehydration. I trust that

400,000 births in 2015 and almost one in every five births

even with political changes, current health policies will

is to a teenage mother. The government has implemented

be maintained.

a national strategy aimed at preventing teenage pregnancies, which are often unwanted and unplanned.

Q: What is the Ministry of Health doing to spread its

The consequences are many: families are ruptured, studies

message on reproductive health to all of Mexico,

are abandoned, the young girl often has to work and often

including rural areas?

the father of the baby disappears and leaves her with the

A: We have to make the problems visible or they will

child or children. We have been working with different

not be solved. We are providing information and

structures since January 2015 on this strategy, which is

education and we must also provide services. In the rural

being coordinated by the National Council of Population

environment, we have two mechanisms to spread health

(CONAPO). Prevention and education are fundamental.

awareness, the first being state governments. Programs are defined nationally but implemented by the states.

Regarding cancer, the Chamber of Deputies and the Chamber of Senators in the Mexican Congress has

We must also ensure the service is available. IMSS-

approved the establishment of the National Register

Prospera, for example, has services for teenagers in

of Cancer, which will be a powerful tool for delineating

rural and indigenous environments. We must guarantee

public policies on how to allocate resources and where

that services to provide condoms, pills and other anti-

the focus should be. Cancer is the third highest cause of

contraceptive methods such as salpingo-ophorectomy

death in Mexico.

or a vasectomy can be offered. Some are more adequate for young people than others, but for someone that has already had many children, one of these methods may

Dr. JosĂŠ Narro is a surgeon from the Faculty of Medicine at

be more appropriate. We must guarantee access to

UNAM, with a master's in communitarian medicine from the

information and to these services for all so that people

University of Birmingham, England. Narro was head of UNAM

can make their own, informed decisions.

from 2007 to 2015 and in 2016 was named Minister of Health

13


VIEW FROM THE TOP

DYNAMIC CHANGES PROPEL MEXICO TO WORLD STAGE JULIO SÁNCHEZ Y TÉPOZ Commissioner of COFEPRIS

14

Q: What are the most important advances COFEPRIS has

working on this idea around two years ago with the aim

made in the past year?

of closing the knowledge gap because knowledge is not

A: We have made great strides on ethics and transparency,

shared in the pharmaceutical sector. Those that have money,

we have become an institution that is much closer to

like large companies with the capacities to invest in R&D,

citizens and we have put 10 catalogues of open data at

do so in specific areas. But there is a gigantic difference

their disposal. These are registers of licenses, permissions

between the amount of R&D that goes on in developed

and other types of information that was previously

countries compared to less developed economies. A first

requested of us. We have also installed a telephone

gap is created here. A second gap occurs because of the

service that receives 16,000 calls per month.

difference in technical knowledge. They want to protect knowledge and for this reason it is not transmitted. Secondly,

COFEPRIS regularly removes patents from groups of

knowledge only reaches those countries that collaborate and

medicines to allow for the production of generics. In 2016,

that offer assurances.

we released Group #14 because in February 2016 there was an issue with influenza and the active substance to treat

As an example, it is doubtful that Brazilian research

it, oseltamivir, was only produced by one laboratory and

centers share their knowledge quickly, efficiently and

manufactured in Switzerland. In May 2016, we liberated

transparently with Nigeria because standards are

Group #14 and there are now three generics available for

asymmetrical. We need to improve the flow so that

oseltamivir. In total, 37 active substances have been liberated

every country can benefit quickly and efficiently from

through our generics strategy, producing 491 generics, which

knowledge. We aim to contribute to reducing these gaps

represent MX$25 billion (US$1.4 billion) in savings while an

as much as possible through a center of excellence. This

extra two million people can be treated thanks to these

was an idea of the WHO and APEC and they should

savings. In 2017, we will continue with this strategy and more

compile information and generate joint public and private

than 40 new molecule authorizations will be announced. Last

actions so that knowledge can be shared. Our center has

year, Mexico was named Vice President of the International

several research and training projects underway in areas

Coalition of Medicines Regulatory Authorities (ICMRA), an

in which it is difficult to find an expert. There are few other

international association that unites the 14 most important

centers but those that exist are linked. Japan, the US and

regulatory agencies, for two years. We are a leader due to

Brazil each have one.

our generics strategy, innovation, reduced processing times for protocols and special pathways for administrative forms,

Q: According to ProMéxico, Mexico carries out only 1

which can now be obtained in 15 days instead of two years

percent of global clinical trials. How will you boost this

as it was five years ago.

number? A: In January 2017, we signed an agreement to promote

Q: How is COFEPRIS working on bringing more knowledge

clinical research that simplifies processes and integrates

to Mexico?

them. To meet all requirements and obtain all permits

A: One of the most important themes internationally is the

used to take 365 days but we are reducing this to 45 days.

creation of the COFEPRIS Center of Excellence. We began

Our goal is to triple the investment in clinical research in Mexico and we hope to see US$600 million over the next two years, up from under US$200 million. An agreement

The Federal Commission for the Protection against Sanitary

has been reached with IMSS and ISSSTE will soon join the

Risks (COFEPRIS) is a regulating authority responsible for 44

program. We are working on another agreement with the

cents of every peso spent by Mexican households, 9.8 percent

national health institutions and with UNAM. This will no

of GDP and 10.9 percent of foreign trade

doubt happen by the end of 2017.


Q: How do you evaluate which areas should be the main

A: My mandate is to protect public health. If I had one

focus for sanitary authorities?

dream for 2017 it would be for the population to be closer

A: We evaluate which conditions have the greatest

to us, to consult us, to give us a chance and to call us. It

prevalence in Mexico through reports such as ENSANUT,

would be wonderful if before citizens took a decision of any

which was released in late 2016 and covers NCDs. We

kind, they first looked after themselves and consulted us.

use these results to assign resources and generate

To ensure this message reaches all of Mexico, we have an

biotechnology to solve the most prevalent health

amazing program called Seis Pasos de la Salud (Six Steps

problems in Mexico. We were the first country in the

of Health) that is translated into 17 indigenous languages.

world to authorize the dengue vaccine and we are in

It will see a new component with the Ministry of Public

the process of establishing a protocol for its application.

Education through which we will soon reach schools.

Q: What results have you seen and what do you expect from the new pharmacovigilance NOM?

COFEPRIS REGULATES

COFEPRIS RESULTS (2012-2016)

44¢

152.4 million vaccines

A: NOM-220, which was published in March 2017, represents a paradigm shift. It implies that many more players are responsible for pharmacovigilance: the patient, the doctor, the laboratory, the pharmacy and the distributor. This change generates more reports that help COFEPRIS to provide a more punctual and strategic follow-up on the effects and quality of these medicines. With few reports, all we can do is check manufacturing plants but with pharmacovigilance we have more information and this propels change.

of every peso spent in Mexican households

approved and analyzed to ensure their quality in the National System of Vaccination

Q: What process does the commission use to identify areas of overregulation and resolve them?

+250 innovators

A: We will be working on the third phase of deregulation of medical devices and we are considering removing regulation from 10 percent of the devices currently on the market, perhaps more. This has been presented in international forums where we have been identified as innovators. We base our decision on analyses of sanitary risks. Scientific advances in medical devices means that the

9.8%

74%

of gross domestic product

cheaper than in the US

21

therapeutic areas covered

sanitary risks are lowered or eliminated as faster and more effective solutions are discovered. The sanitary risk

+6,300 medical devices

of technology in medical treatment and medical devices changes depending on technological advances and the same happens with medicine. There are combinations that do not generate increased secondary side-effects. Another element is that we realize that there are delayed administrative processes. We are digitalizing processes to

10.9%

2,242

of Mexican trade

deregulated devices

6,307

new registrations

avoid unnecessary costs in transport, paperwork and time. This is part of COFEPRIS Digital, implemented in December 2016, which has taken 99 forms and administrative processes online. With the extra 50 that we are adding,

+500 generics 42

1,998,202

additional patients treated

we will save 600 tons of paper in a year. All these simplified processes will help bring us closer to citizens and to provide a much more agile service. In addition to being based on reviews, we also perform an audit biyearly, one of which is focused on our internal quality-management system. Q: What is the single most important area COFEPRIS will be focusing on in 2017?

41 40

61%

price reduction 2012

2014

% of out-of-pocket expenditure of total health spending Source: COFEPRIS

71%

of mortality causes covered

15


VIEW FROM THE TOP

SIMPLIFIED REGISTRATION BOOSTS MEXICO PHARMA MARKET RAFAEL GUAL Director General of CANIFARMA

16

Q: How has the pharmaceutical industry evolved in the

those countries. Existing regulations and laws in Mexico are

past two years?

not insufficient; all that is lacking is evidence that they are

A: I think it has evolved well and regulation has continued to

being followed. Having them written is one thing, ensuring

advance. The structure of registration has been simplified so

compliance is another. The recognition from the WHO and

that time targets set out in the law are met for any process

PAHO of Mexico in terms of vaccines provides certainty that

involving the sanitary authorities. This is an important advance

the role is being fulfilled. COFEPRIS has to report evidence

that has allowed the pharmaceutical industry to be more

of verifications and certainty of reports. Tracking may be

competitive in Mexico and in international markets. Being

different in the US and Europe, but we are still missing an

recognized as a regulatory agency has allowed COFEPRIS

agreement with the FDA and the EMA on a bi-dimensional

to be much more agile in registering products in Central and

code that can be applied worldwide.

South America. Q: What advantages does Mexico present for clinical In terms of R&D, we have authorized a series of third parties

research, other than its large population?

to be much faster in clinical authorizations, which will allow

A: In Mexico, most R&D is carried out in private centers. The

Mexico to become a center of clinical research. In economic

main issue is researchers being paid to carry out the studies.

terms, the market has maintained 3-4 percent yearly growth

There is a promising environment in IMSS to incentivize

over the past decade, a rate that will probably not increase as

clinical research in Mexico, sponsored by the industry as

the market is mature and grows in line with the population. The

there were issues with IP. This has been changed. Previously,

export market has grown in double digits and will continue

if IMSS found a second use then the IP belonged to the

to do so thanks to COFEPRIS, which has been recognized as

agency. But an agreement has been reached so that the

a national regulatory reference agency in Central and South

IP does indeed belong to the industry sponsoring the

America. Companies have this advantage in addition to GMPs.

research. The advantage is that there are 50 million patients

Thanks to economies of scale, the Mexican economy is more

in IMSS with varying stages of disease because in Mexico

competitive and can export to these other regions.

there is no culture of prevention, which means diseases are available for study at advanced stages that may be hard to

Q: How has the new pharmacovigilance NOM affected

find in other countries.

companies and how easy or difficult is it for companies to adapt to it?

Q: What other steps are being taken to boost clinical

A: The new norm offers patients security and provides faster

research in Mexico?

product registration. If a drug does not have any reports

A: IMSS, COFEPRIS and CANIFARMA are on the verge

of major adverse effects caused by the pharmacovigilance

of signing a contract to facilitate the path to clinical

NOM, then registration can be renewed quickly. The NOM

research. During our CANIFARMA Awards 2016 we

also commits other parties such as doctors and patients to

announced that a research fair would be held during

reporting adverse effects. It is no longer the sole responsibility

which companies will be able to have direct contact

of the industry. It will cost the industry more but we think

with the companies that won the awards in 2016 and

we will reach an agreement with the authorities on what is

2015, to allow the research to be taken to market. Julio

necessary and what is desirable.

SĂĄnchez, Commissioner of COFEPRIS, has announced he will support this with a certificate and the research

Q: How is CANIFARMA helping the industry homogenize

will be followed by COFEPRIS from the beginning. This

its regulation with the FDA and EMA?

will contribute to further improving the relationship with

A: They are already homogenized. There is not much

the industry. Brazil and Argentina are Mexico’s biggest

difference between the regulation that exists in Mexico and

competitors in clinical research in the region. The fact


that we have a large number of patients to register in a

Q: What area will you focus on in the future?

clinical trial aids our competitiveness worldwide. Mexico

A: Previously, a product had to be registered every five

can increase patient numbers greatly if we make the most

years. We are working on a scheme that will allow changes

of IMSS. Brazil and Argentina are more agile.

in a product to be recorded before its five years are up, as the current process created bottlenecks at the end of

Q: What are the biggest challenges in the human pharma

five years. Many products are modified slightly and this

industry?

will allow companies to reregister it as soon as it happens.

A: We need to become an important center for clinical research because its potential is underused and we have to consolidate COFEPRIS’ recognition to open new markets for the industry. There is great quality in the products manufactured in Mexico and they are competitive. In addition, we need to continue consolidating regulations. I would add access, which is one of the main issues in the country, including new technologies which, despite having a greater cost, can bring increased benefits to the population.

CANIFARMA ACHEIVEMENTS Two new NOMs established: NOM - 059 for GMPs for medicinal products and NOM - 164 for GMPs for pharmaceutical products

Changed regulation on advertising

We need to facilitate this access in IMSS, ISSSTE, CSG and the National Formulary and I personally believe that opening clinical research in IMSS will facilitate the inclusion of new technologies, because having done the trials will shed light on the benefits they can provide in comparison

Established an institutional relationship with COFECE

2013-2018 development program for the pharmaceutical industry - results so far

Processing times shortened

NOM - 241 on GMPs was revised for medical devices

to current medicine. Q: What are the biggest challenges in the veterinary

Created the CANIFARMA Award to encourage research on the most significant causes of mortality

pharmaceutical industry?

JOBS CREATED BY COMPANIES AFFILIATED TO CANIFARMA (thousands)

A: They are extremely different. First, because there is no animal social-security system and there is no worry of incorporating new technologies. Challenges are more

the Mexican market. There are many multinationals here that are growing. The main issue is the topic of pure salts in food mixes. If a farmer administers pure salts instead of the correct medication it will cause problems. There are also issues with antibiotic resistance due to residue in food. There is no pure clenbuterol medicine for example, only

MX$200 billion

250 200

is the current value market of the Mexican pharmaceutical industry

150 100

79,000

as the market has been conservative in worrying only about

300,000

300

related to competitivity and access to international markets,

50 0

Direct

Indirect

medicine that contains traces of it. Sadly, we do not have the muscle in Mexico to create a regulation around this. Q: What role do you play in investigations such as that of COFECE? A: We give COFECE the information it requests but we do not have a proactive role. We clarify the panorama of the pharma industry. There are topics such as prices that

50%

of CANIFARMA employees have higher education degrees

are forbidden for discussion during any of the chamber’s meetings. In every act it says that it is forbidden to exchange

The market has maintained 3 to 4 percent yearly growth over the past decade

commercial information. This legally binds the chamber and its members to avoid these issues, so we provide requested

Sources: COFEPRIS, CANIFARMA

information. We are asked for example why all expired patented products do not have generic alternatives. It may not be commercially viable, it may be a difficult product to

The National Chamber of the Pharmaceutical Industry

create or the ingredient source may be unique, and this is a

(CANIFARMA) works toward developing the industry in Mexico

worldwide condition. If the patented product is interesting

with three main objectives: sanitary regulation, research and

enough for a generic to exist, it will.

innovation and economic development and industry policies

17


VIEW FROM THE TOP

COLLABORATE TO INNOVATE CRISTÓBAL THOMPSON Executive Director of AMIIF

18

Q: Research, development and innovation are AMIIF’s top

epidemiological impact of the main therapeutic areas to be

three core values. Which is the most important for 2017?

prioritized in this project (potentially: diabetes, cancer and

A: Innovation is always at the top of the agenda. It is the

cardio-vascular diseases). The objective of the second group

reason why we exist and we have been working on this. The

is to analyze new performance indicators and criteria to align

goal of AMIIF’s 2024 vision, its midterm plan for innovation,

patients and institutional needs in said therapeutic areas.

is to contribute to improving Mexico’s productivity and

The third group is a legal team discussing how and when the

competitiveness through pharmaceutical innovation. That

government could be able to implement innovative access

is our key goal. As President Peña Nieto has said, we are

models, aligned with the proper legal framework. Financial

experiencing a renaissance for innovation. For example,

and legal experts and doctors also attend these meetings.

hepatitis C products, which have a 95 percent rate of cure, have just been approved for inclusion in the public health

We are also looking at how we can bring in more resources

system, which is an incredible breakthrough. There are new

via clinical research. In January 2017, there was an agreement

treatments in HIV and patients are living almost as long as

made between all parties with President Peña Nieto present.

nonpatients and with minimum side-effects. There are also

Its objective is to increase investment in the sector from

new innovations in cancer treatments.

around US$250 million to above US$600 million. A meeting in early May 2017 brought together COFEPRIS, IMSS, ISSSTE, the

The objective of the agreement is to increase annual investment in clinical research from around US$250 million to above US$600 million

decentralized institutions, ProMéxico, the Ministry of Economy, SAT, Customs and the industry. We will have monthly meetings to provide updates on each area, understanding that by the end of 2017 we should have a better process for getting protocols approved to bolster the amount of funds coming into Mexico. A pillar of increasing access to innovation is to make understood its potential impact on productivity and competitiveness. Last year, we presented a study with the automotive industry in Guanajuato, which tried to show the impact of lost productivity on a sector. In the case of the auto industry, the impact of lost value was around 7.3 percent of the industry’s value, of which 1.3 percent was absenteeism and

One issue for pharmaceutical innovation is how to finance

6 percent was due to presenteeism. We are close to the big

it. We sat down with IMSS and now we have three teams

employers such as the Business Coordinating Council (CCE),

working with the institution to establish innovative access

COPARMEX and CONCAMIN to make sure that everyone has

models based on patient health outcomes. The project

a voice in making sure our health system, social security and

began between February and March 2017. Our first group

Seguro Popular deliver a better job.

is working on the analysis of the cost to the system and the Q: How much awareness remains to be raised among governors? Research

A: At the beginning of May 2017, Dr. Narro, Minister of Health,

Industries (AMIIF) encompasses over 40 of the leading

attended our board meeting for the first time. He said that

pharmaceutical and biotechnological research companies in

health and education are the two highest social equalizers. At

Mexico and aims to promote innovation in the health sector

the federal level, we have done a great job and awareness is

The

Mexican

Association

of

Pharmaceutical


19

Hemophilia research

higher than it was three years ago. Having said this, budgets

A: We hear a different version every day, from modernization

were cut last year, showing that although there is awareness,

of NAFTA, which is something we want and that the

this does not correspond to action yet.

government is clear about in its position, to removing it completely. Although we do not know what will happen, we

At the governor’s level, we have to improve awareness.

are prepared for various scenarios. The chairman of GE was

Investment must be holistic: people must be healthy and with

here in May 2017. He made it clear that NAFTA was very good

a good level of education. They must have infrastructure and

and he said that the big employers need to start speaking up.

public services, but there must be a good health system too.

I think they will start coming out and saying that yes there

We have been asked by the Ministry of Economy to undertake

are areas for improvement but overall commerce is highly

another study like the one we did in Guanajuato, a state that

integrated. How can it be disintegrated? Impossible. The

is growing at 6-7 percent per year. If employment continues

companies here have been present for many years and they

to grow but the health system does not keep pace, there will

will not go back. It the treaty collapses, we will not see major

be a bottleneck, a problem of too much success too quickly

issues, unless a tax is imposed on imported products, but

but with a gap in these kinds of public services for workers

we do not think that will happen. Overall, NAFTA has been

and their families. Again, investment usually goes to places

beneficial for all three countries and I am sure renegotiation

with good infrastructure. If this is not addressed, there will be

will center on optimization and on areas that did not exist

limitations in economic development.

when it began, such as e-commerce.

In May 2017, Mikel Arriola, Director General of the IMSS,

Q: How does the Accelerated Access initiative decided in the

announced tests in Nuevo Leon in which IMSS would follow

WEF in Davos this year complement AMIIF’s 2024 vision?

up on company employees to see who was at high risk and

A: This is a huge initiative. Top pharmaceutical companies are

to begin taking preventive measures early on. The more

joining together to develop a common framework that will

information we can give the government, the better.

help patients and countries battling NCDs in low and middle income countries. The industry is talking about looking for

Access to innovation is low, as only 10 percent of innovative

a full, holistic approach to the health system, trying to find

medicines approved by COFEPRIS are in the public health

ways to make overall improvements and enabling medicines

institutions. Early diagnosis and secondary prevention is much

to patients. For example, 300 billion units of medicine

less expensive than waiting five years for patients to get out

are donated every year to Africa, but it lacks distribution

of control. Then, by the time you give them innovation, the

infrastructure. What we are implementing in Mexico is already

cost will still be too high. In Guanajuato, we asked companies

a step ahead of what my colleagues in other countries tell me.

what they were given from the government: land and tax incentives. They did not think to ask about health. Getting

Q: What will AMIIF focus on in 2017?

the big employers onboard is a big part of the agenda and

A: Our main focus is how we can grant greater access to more

this will resonate when we hold events. Investment will come

patients. We will be finalizing steps to attract more investment

but states have to look at how to maximize that investment.

to clinical research, to keep working with COFEPRIS to continue improving timings and processes for approvals of

Q: A renegotiation of NAFTA is likely. What will AMIIF’s top

new molecules and finally to maintain the current standards

priorities be?

of IP protection.


VIEW FROM THE TOP

PROMOTING THE MEDICAL DEVICES SECTOR EDGAR ROMERO President of AMID

20

Q: AMID was created to eliminate “regulatory challenges”

two or three years and the evaluation system for new

in the industry. What are the biggest problems?

products is not used to working with such short time

A: AMID was indeed created for regulatory reasons to

frames. Medical devices account for 70-80 percent of

bring products to Mexico. COFEPRIS was the main focus

sanitary registrations in Mexico. How to evaluate them

of our efforts for around eight years. Our agenda is now

and the cost/benefit over time is a new challenge for any

broader and our main focus is access: how to collaborate

government, including Germany and the US. The main

with authorities to gain advances for patients and be a

challenge is bringing these devices to the country.

more productive country based on investment in health. We also have an ethics and compliance committee because

Q: What is the impact of the black market, which is

we must ensure these practices are the best they could

usually associated with pharmaceuticals, on medical

possibly be in Mexico while trying to establish the same

devices companies?

rules as in Europe and the US. We are also working against

A: The impact of the black market may not be as large

the black market. We want products to be controlled and

in medical devices as in pharma but there are medical

traced from the point they leave the manufacturing site to

devices that cross borders illegally without the proper

the point they are implanted in a patient. Finally, we are

temperature controls and distribution procedures.

working on being known as a reference in healthcare in

Appropriate techno-vigilance needs to be implemented.

the same way as the pharma industry.

It is not that devices are copied like in other industries; for example, many are bought abroad and brought

Medical devices account for 70-80 percent of sanitary registrations in Mexico

across the border without the correct quality protocol and temperature control, or a hospital may throw away devices and they are fished out from the trash. We have an agreement with COFEPRIS: if we find out about the sale of illegal products, they act immediately to remove them from the market. Q: How are AMID members impacted by COFEPRIS’ deregulation of medical devices?

Q: How have medical device trends evolved since 2015?

A: We have always had good channels of communication

A: Products now have a shorter innovation cycle than 15-

with COFEPRIS, but in 2016 and 2017 AMID planned a

20 years ago. There is an increasing number of players

full schedule with them. They are working on the third

with new technological processes, including Big Data.

package of deregulated medical devices. The first came

Consequently, the government faces the challenge of how

through in 2011 and the second in 2014. This deregulation

to evaluate them and ensure that the most innovative

is simply recognizing that certain products used in medical

medical devices reach patients. Now, from releasing a

practice are not medical devices and as such should not

product to releasing its next generation, there are only

be regulated by COFEPRIS. There are some companies that are part of AMID that commercialize these products, but they are merely components of medical devices per

The Mexican Association of Innovative Industries of Medical

se. This causes a problem as the number of devices in

Devices (AMID) aims to promote efficient and transparent

the market is multiplied by the number of side products

regulatory and procurement processes and to ensure safety,

that are produced. COFEPRIS was saturated by regulating

quality and effectiveness of solutions in healthcare services

these products they never needed to. These deregulation


packages are a list we share with the authorities of these

designed before the corresponding regulation. At this

accessories that can be deregulated. We are responsible

moment, the challenge is how to evaluate innovation

for 80 percent of COFEPRIS’ sanitary registers and as

faster. We are behind when compared to similar countries

innovation cycles decrease, their workload increases.

such as Colombia, Chile, Brazil and Argentina.

Deregulating these items is good because COFEPRIS can use its time to check true technological innovations

Q: How are global economic conditions impacting

instead of regulating these other products. This will

imports and exports of medical devices?

increase investment in innovation because less time

A: Since the Mexican peso depreciated against the dollar,

needs to be spent on other things.

it has been an industrywide worry but companies plan on a long-term basis. The peso appreciated against the

Q: What regulatory points are you lobbying for to

dollar in the first three months of 2017, strengthening

improve access?

from MX$22 to the dollar to MX$19. There has been an

A: The toughest part of gaining access is going through

impact on profitability but we need to think long-term

the CSG. We are asking them to make their processes

and see this trend through. No company has shown

simpler and to implement the most adequate rules

genuine concern or considered leaving the country.

possible for medical devices as the current rules were designed for pharma. If we followed pharma’s rules,

AMID associates are projecting growth above 9 percent

we would have to innovate at the same rhythm as that

in sales during 2017 and expectations for 2018 remain in

industry, which is much slower. We have been working

a good health. In addition, AMID is ensuring its presence

with the CSG since 2016 and we have just begun our first

in free-trade negotiations such as NAFTA. We are

efforts with the IMSS on a process level. They have the

being present as an industry to ensure the continuation

ability to define whether or not a product will reach a

of adequate conditions. We generate US$8 billion in

patient through public hospitals. We are looking at how

medical devices exports but we export 92 percent of

we can help make this process faster.

that to the US. The medical-devices sector is considered an emerging economic area for Mexico, along with IT and

Of the three stages of approval (COFEPRIS, CSG and the

pharmaceuticals.

institution), CSG is always the hardest for us. The process can take up to four years, while an ideal process takes

Q: What will be AMID’s main focus for 2017?

two to three years. We want to implement this time frame

A: During the second half of my presidency, we will

for everyone, regardless of their product, and we want to

focus on finishing our work with the CSG to improve

make the approval process predictable so that everyone

patient access to medical devices for better diagnostics,

follows the same steps. This is an additional challenge.

treatment, prognosis and the patient’s quality of life.

If the innovation cycle shortens but approval still takes

AMID will also continue promoting ethics and compliance

the same amount of time, it becomes unprofitable to

in the healthcare industry. We grew from 23 to 30

create new products; by the time a product is approved

companies last year thanks to a broader agenda and we

a second generation is already available, so we have to

now run several agenda items in parallel, which enables

try and gain general approval. In summary, innovation is

us to get more done.

21


VIEW FROM THE TOP

DIABETES AND OBESITY: HEALTHCARE PRIORITIES JOSÉ CAMPILLO Executive President of FUNSALUD

22

Q: In 2016, FUNSALUD established diabetes, breast

prevalence to increase. FUNSALUD has corroborated this

cancer, obesity and mental illnesses as priorities. Have

number with its own studies. In 2013, we estimated that

these changed in 2017?

the cost of diabetes would be MX$362 billion (US$20.1

A: Our priorities remain the same because these

billion) per year or 2.3 percent of national GDP. This figure

conditions have a high incidence and involve a great cost

will continue to grow and there may come a time when

to society and the country’s finances. At the end of 2016,

the public sector does not have the economic, technical

Minister of Health José Narro declared diabetes a health

and human resources capacity to deal with this tsunami.

emergency. It was an atypical statement because there was intention to take drastic action but only to emphasize

Q: Which countries can Mexico look to for a way to

that diabetes is a serious national public health problem.

attack this epidemic?

At the end of 2016, the ENSANUT survey was released.

A: Chile and Costa Rica are seeing good results, although

It measures obesity, overweight and diabetes prevalence

the comparison in terms of population is different.

among the Mexican population. In some segments, which

European countries like the UK also have good models.

vary between urban and rural communities, rates begin

However, we are seeing the problem in all countries,

to stagnate rather than continue shooting upward.

which is due to urbanization, lifestyle changes and

However, there is another hypothesis: we are reaching

consumption habits. I think Mexico, the country with the

saturation levels where things cannot get any worse. In

highest obesity rate after the US, could be the place to

2017, emphasis should be placed on the prevention of

experiment with immediate action. One action should

diabetes and its complications. Data from this survey

be to increase clinical research, especially for economic

show there has been a 175 percent increase in diabetic

reasons. It is a gigantic global market in which Mexico

foot amputations.

does not even reach 0.1 percent and needs to be improved. Mikel Arriola, Director of IMSS, is convinced

Q: Are citizens more aware now than before of this type

of this. The industry is also ready and COFEPRIS is at

of complication?

the best moment in its history, with great international

A: I do not think the population has that information and

recognition. Mexico can be an important crucible to start

if it does, it has not resulted in a lifestyle change. This

doing scientific research on diabetes that provides us a

is the main challenge of a problem that is multifactorial

favorable cost/benefit ratio. In 2017, it would be desirable

and that depends not only on food but on life habits. A

for the Ministry of Health to take the lead to carry out a

change in the population’s mentality is required.

concerted policy with the Ministry of Economy and the Presidency of the Republic. Ties with the industry exist

Q: The IMSS estimates that in the next 35 years the

thanks to the great work carried out by COFEPRIS.

number of patients with diabetes in the country will double. Do you agree?

Q: What has changed in the last 12 months in relation

A: There are many possibilities. In addition to the 6.5

to conditions such as breast cancer or mental illness?

million diabetics diagnosed it is thought there is almost

A: The capacity of care for these diseases has increased.

the same number undiagnosed, so the logical thing is for

However, budgetary or political considerations have meant that these are no longer priorities for the federal government. In terms of breast cancer, much progress

The Mexican Foundation for Health (FUNSALUD) is a private

has been made in perception and detection. The

institution that aims to contribute to the improvement of

pharmaceutical industry is shielded from any political

health in Mexico by being a reference point for the discussion

aggression by the current president of the US and the

of the health agenda

Ministry of Health is at the core of the solution. By


23

The Pulmovista 500, an electrical impedance tomography system performing respiratory monitoring

improving the health of the working population, great

everything, appears in none of them. It is an element

savings will be made.

that is systematically forgotten but without a healthy population there can be no healthy economy. The priority

Q: Universal access to health is a goal of FUNSALUD.

for 2017 should be to place health at the heart of any

How is the Ministry of Health working toward that goal?

strategy, which is not easy.

A: Universality is not a utopia but an obligation. Family wealth should not be affected by healthcare. It is an

Q: To what extent are doctor ’s consultancies in

inalienable universal right that cannot be postponed.

pharmacies a solution or an externalization of the

The conditions of the country in 2017, and perhaps for

problem of health access?

the next five years, are going to be very adverse, so we

A: Their existence tells us many things. It is a phenomenon

have to rethink proposals to reinterpret the reality and

that appeared spontaneously to solve problems that

be precise in our aspirations. The most important part is

should have been resolved by the government. However,

to ensure prevention and first-level care. One of the main

waiting times are shorter and care is personalized,

problems is that the model we followed was seen from

inexpensive and close. They are a tool that depends on

the perspective of the disease and not from health; we

us to make them favorable or harmful. There are about

have been curing and not conserving health. We need a

15,000 offices and they must be taken into account.

policy of prevention.

Now, ethical principles have to be established as well as a register of patients and greater communication, among

Q: How will budget cuts affect the goal of achieving

other elements. FUNSALUD wants to make a substantive

universal access to health?

proposal in this regard in 2017 in which we will try to

A: Recently, an agreement for the protection of the family

bring together government, academia and industry to

economy was signed and four strategies were proposed

conclude a document in 2018. Emphasis should be placed

but the health sector, which should be the beginning of

on the first level of care.


INSIGHT

FIGHTING HIV EPIDEMIC MEANS FIGHTING DIVERSITY 24

Patricia Uribe Director General of CENSIDA

Carlos Magis Integral Care Director of CENSIDA

The concentrated nature of the HIV epidemic in Mexico

“There is a challenge for Mexico and other Latin American

creates unique challenges for the agency tasked with

countries that have concentrated epidemics,” she says.

eradicating the disease, the National Center for Prevention

“We must develop different approaches for each group

and Control of HIV and AIDS (CENSIDA). While the country

and control all of them at the same time. It is easier to

continues to mark milestones in control and treatment, the

fight generalized epidemics because we can offer a blanket

disease's 'very diversity hinders progress.

service to the entire population.”

“The infection has different dynamics depending on

According to CENSIDA statistics, one out of every 1,500

every state’s heterogeneity and social habits,” says Carlos

women lives with HIV. Other affected groups include

Magis, Integral Care Director of CENSIDA. This diversity is

0.07 percent of pregnant women, 15 percent of men who

a wakeup call for health institutions because even though

have sex with men, 18 percent of transgender people and

it seems to be generally in control, there are concerns

6 percent of people who inject themselves with drugs.

in specific areas.

Two years ago, CENSIDA started developing a National Detection Campaign in alliance with civil organizations with

CENSIDA has three main objectives: eradicate perinatal

the objective of reducing the number of people infected

HIV, control HIV via sexual transmission and reduce new

with HIV. “We are one of the areas of the Ministry of Health

infections through intravenous drug use. The institution

that works the most with civil society, as well as working

has implemented plans for each type of transmission. The

with hospitals and managing the treatment of the majority

center is the main governing body for the management

of the patients in the country,” says Magis.

of the epidemic in Mexico and is in charge of providing treatment to patients. According to the institution, in

The institution is in charge of purchasing and distributing

Mexico HIV blood transmission is eradicated and perinatal

drugs for 66 percent of patients with HIV and it receives

transmission is almost eliminated. Health institutions

MX$3 billion (US$166 million) every year from the Fund

have also reached 63 percent detection, a reduction in

for Prevention of Catastrophic Expenses (FPGC) to buy

new infections and they are close to achieving UNAids’

medication. There are 138 Prevention and Attention Clinics

treatment goal of 90 percent by 2020.

for AIDS and Sexually Transmitted Infections (CAPASITS) across the country that provide treatment to 85,000

There are 138 Prevention and Attention Clinics for AIDS and Sexually Transmitted Infections (CAPASITS) across the country

patients who are living with HIV but who do not have social security. CENSIDA finances the social projects awarded in the tenders, which cost around MX$100 million (US$5.6 million) per year to improve HIV detection and prevention among key populations. In an effort to eliminate the HIV epidemic, UNAids declared a 90-90-90 treatment target by 2020: 90 percent diagnosis, 90 percent treatment and 90 percent viral suppression. Regarding perinatal transmission, healthcare institutions

Patricia Uribe, Director General of CENSIDA, says Mexico

began offering the HIV test to every pregnant woman, which

has a concentrated incidence among certain social groups:

has helped reduce newborn transmissions to 46 percent. In

gay men and other men who have sex with men (SMS),

2015 there were only 71 cases but the aspiration is to follow

transgender people, sex workers and their clients, prisoners,

in Cuba’s footsteps as the only country in Latin America

migrants and people who inject themselves with drugs.

that has successfully eradicated perinatal transmission. The


challenge is in targeting states with more women. “It is an issue in states that are demographically more female

MEXICO'S CENSIDA PROGRESS ON MEETING THE UNAIDS 2020 GOAL (thousands)

such as Chiapas, Guerrero or Veracruz, while in Morelos estimated total of people with HIV by 2015

eradication was accomplished in 2011,” says Magis. In terms of sexual transmission, Uribe says this is one of

diagnosed

the biggest challenges as many people do not use or have access to effective prevention methods and comprehensive in treatment

harm-reduction services. CENSIDA has created campaigns against sexual transmission with different focuses

25

depending on the social group. “Our most critical are

viral supression

teenagers because they are becoming sexually active and they do not have all the information they need,” she says. For this campaign, the main message is usually to avoid

0

50

unprotected sexual relationships but that is not always

„„2015

effective because strategies for women and vulnerable

Source: CENSIDA

100

150

200

„„UNaids Goal 90%

populations are different, explains Uribe. “There are women who are infected by having sex with their partner

were not covered before, like sexual diversity, sex work and

so targeting for the test demands us to consider gender-

intravenous drug use,” she says. “Society sees us as an open

inequality issues and to address social determinants such

window to promote other aspects besides HIV.”

as access to health services, education, employment and gender violence.”

The specialized Clinica Condesa in Mexico City is a clinic for transgender patients that not only treats HIV but it also

In the case of transmission through intravenous drug

helps in the process of undergoing sexual reassignment.

use, CENSIDA has designed specific projects for this

CONASIDA was also established to discuss HIV and AIDS-

demographic. However, as Uribe explains, it is a challenge

related topics with representatives of civil society who

to provide these patients with safety measures because it

provide ideas to deal with problems.

may be mistaken for promotion of drug use. “This type of transmission is not an issue across the country, it is focused

Paradoxically, keeping up with all these improvements

in the north, in cities like Tijuana and Juarez City, and it has

becomes a threat as patients’ life expectancy increases

started to spread to Guadalajara,” says Magis.

at the same rate as treatment prices. According to CENSIDA, in 1985 survival was one year but today a patient

The efficacy of these programs and CENSIDA’s access,

diagnosed with HIV and who begins treatment can survive

coverage and treatment-quality care can be measured

for approximately 44 years. Right now, 91 percent of HIV

by mortality rates. There are peaks in certain parts of the

treatments are ambulatory and patients frequently receive

country such as south of Veracruz, Tabasco and Campeche.

vaccines and odonatological, nutritional and psychological

These states have 10 deaths per 100,000 infections, while

care, which has improved their life quality.

in the center of the country there are four per 100,000. “Every year, our detection rates increase, meaning we have Magis says that many AIDS deaths occur because of late

more patients and the MX$3 billion (US$166 million) budget

treatment. “This infection has a lot to do with addictions

rises by MX$500 million (US$27.7 million) every year,” says

and sexual diversity, which is directly related to a

Magis. He says HIV is one of the most expensive diseases

discrimination stigma, so many people are reluctant to ask

covered by the FPGC because it has no cure, which means

for help,” he says. The results from the most recent national

patients require lifetime treatment. The high cost of HIV

discrimination survey held by CENSIDA in 2010 showed

is also due to the antiretroviral patent scheme. There is

the biggest discrimination in Mexico is against those with

no control over drug prices in Mexico, explains Uribe, due

HIV and AIDS and members of the LGBT community. “It

to the Mexican acquisition law that protects patents. “The

is particularly important to eliminate discrimination and

pharmaceutical price for the most used drug for HIV in

gender inequality because this prevents us from achieving

Mexico is four times higher than the manufacturing price,

the impact we need,” says Uribe.

at MX$2,500 (US$138) per month for every patient,” he continues. “In Africa, the drugs are sourced from generics

The CENSIDA Director General acknowledges that HIV and

labs and the cost is MX$200 (US$11) per month. We have

AIDS have forced healthcare institutions to innovate their

to create a dialogue between COFEPRIS and the authorities

approach to health issues. “We have to deal with topics that

that negotiate the treaties.”


INFOGRAPHIC

COFEPRIS BREAKS DOWN BARRIERS Since being recognized as a regulatory agency by the WHO,

regulatory agency, COFEPRIS, is recognized

over the past five years several Central and South American

by the WHO and by other Central and South

countries have followed suit, increasing Mexico’s attractiveness

American countries. A product that has

as a Latin American base of operations

successfully obtained registration in Mexico is much easier to launch in Costa Rica, Colombia,

26

One of the reasons Mexico is such an attractive destination

Ecuador, El Salvador, Chile, Panama, Belize and Peru. This

for foreign companies, other than the size of its population

makes Mexico an ideal springboard from which to begin a

and its growing economy, is the fact that its main sanitary

Latin American expansion for big multinationals.

COFEPRIS AGREEMENTS MILLIONS OF INHABITANTS

REGULATORY AGENCY

Belize

0.4

Caribbean Public Health Agency (CARPHA)

El Salvador

6.1 MEXICO Part of the Pacific Alliance

121 million Home regulatory agency: Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)

Costa Rica

4.8

Mexico

US$11.2 billion

Ecuador El Salvador

National Administration of Pharmacies and Drugs (DNFD)

Ecuador

16.1

Recognizes COFEPRIS since

2012

Sanitary Product Regulation Administration (DRPIS)

Panama

3.9 PHARMA MARKET IN 2015

Medicine and Sanitary Product Administration

National Agency of Regulation, Control and Sanitary Vigilance (ARCSA)

US$1.6 billion US$527 million

PART OF THE PACIFIC ALLIANCE Colombia

2013

Costa Rica

US$835 million

Colombia

US$3.3 billion

Chile

US$3.3 billion

Peru

US$1.6 billion

2014

Panama

2015

Belize

48.3

National Institute of Vigilance of Medicines and Food (INVIMA)

Chile

18

Institute of Public Health

US$1.18 billion Peru

Data not available 0 1 2 3 4 5 6 7 8 9 10 11

Sources: World Bank and BMI Research

31.4

General Administration of Medicines, Consumables and Drugs


VIEW FROM THE TOP

THE COMPLICATED ROAD TO EQUALITY ANA GĂœEZMES Mexico Representative of UN Women

Q: What are the main priorities for UN Women Mexico?

Q: What has the campaign HeForShe achieved in Mexico?

A: We have three priority areas. The first is the participation

A: HeForShe is a platform that seeks the commitment of

of women in government and in leadership roles. Mexico is

men in the struggle for equality and already has more than

one of only eight countries worldwide with electoral parity;

110,000 individual memberships in Mexico. In addition, many

in fact, 42 percent of parliamentarians are women. However,

universities have integrated the platform. For example,

there is only one female governor and in the private sector

UNAM has committed to imbue their health faculties with

the percentage of female CEOs is only 5 percent.

a stronger gender perspective on public and individual health. IMSS has also proposed more in-depth training for

The second area of priority is economic empowerment.

their health professionals to closely monitor compliance

According to INEGI, in 2016 only 43 percent of women in

to NOM-046, a regulation that obligates health services to

Mexico participated in the workforce, compared with 78

detect and prevent violence against women and to offer

percent of men, so we need to increase the number of

safe and legal abortions for victims of sexual violence.

employed women, promote formal jobs and end the wage gap. UN Women projects that it will take around 80 years

Q: #noesdehombre (#notamanthing) was the first

for women to achieve workforce equality.

campaign directed at men to raise awareness of sexual violence. How effective was it?

Our third priority is to increase women’s autonomy

A: It was a campaign in collaboration with Mexico City that

regarding health by providing universal access to sexual

focused on preventing violence on public transport. The

and reproductive care and by ending gender violence.

elaboration of the campaign was based on a study done by the Mexican college that showed that most men who

Q: What are the main health concerns for women in

perform violent actions in public spaces do not consider

Mexico?

it violence.

A: PAHO and UN Women's health division are mainly worried about three situations. The first is teenage pregnancy. We

Q: What needs to be done achieve more impact of the

are working on a campaign with 12 UN agencies called De

awareness against gender violence?

la A a la Z (From A to Z), from Aguascalientes to Zacatecas.

A: When we talk about gender sexual violence, something

The campaign promotes awareness of freedom of choice

very perverse happens, which is to say that women are

regarding marriage, because in Mexico one in every five

blamed for it and sometimes rape is justified because

women marries before the age of 18. Another priority in

of the way the woman was dressed or because she

terms of public health is the lack of access to healthcare

was alone. We worked with the government to create

and pension funds for women who work in the informal

a public program that ends impunity. There is a feeling

sector. This is also the situation for all those women who

that violence is not an issue because not many cases

have to stay at home to take care of family members. In

become public. However, we are working with the Ministry

Mexico, more and more people are living longer while

of Interior to get more answers from the media. Most of

suffering from chronic diseases and women are usually

the attention on the topic comes from campaigns on

responsible for their care. According to the census, in

social networks.

Mexico around 30 million people need permanent care, 3.5 million have a chronic disease, 1.2 million have a disability and a large percentage of the 10 million adults aged over

UN Women was created by the United Nations to promote

75 require special care. Our third health concern regarding

gender equality and the empowerment of women. In Mexico

women is gender violence, which is the clearest expression

it focuses on the promotion of women's access to healthcare,

of inequality.

participation in government and eradication of violence

27


VIEW FROM THE TOP

CAMPAIGNS, BETTER HABITS NEEDED TO FIGHT CHILD OBESITY PRESSIA ARIFIN-CABO Deputy Representative of UNICEF in Mexico

28

Q: What is UNICEF’s approach to combating child obesity?

are only allowed to bring to school the foods that appear

A: Figures demonstrate that 95 percent of obesity cases

in a healthy food chart, which has obliged parents to make

are attributed to poor nutritional patterns, therefore, the

healthier choices.

main priority to fight childhood overweight and obesity lies in campaigning and advocating good habits, but

Q: How can UNICEF fight dietary misinformation in Mexico?

also in promoting breastfeeding, water consumption and

A: There are several myths regarding breastfeeding. For

physical activity.

example, some women start feeding their child with formula when they cannot pump milk because they believe

In Mexico, 60 percent of adolescents do not do any physical

they have an issue. The truth is that they do not know how

activity and although it is a compulsory subject in schools,

to breastfeed.

it is not enough to compensate for their calorie intake. We are developing strategies to promote physical activity. For

Good nutrition starts in the womb so providing timely and

example, a new social media project will strengthen the

accurate information to pregnant and lactating mothers

importance of physical activity alongside good nutritional

is vital. Although one of UNICEF’s main priorities is the

habits among adolescents. We are also working on

prevention of teenage pregnancy, we also work to make

another initiative that advocates water consumption and

sure adolescent mothers get the right information to

accessibility. Several bad nutritional habits can be traced to

provide their babies with the best nutrition and the best

the sugary drinks consumed by many children just because

beginning to life.

their schools do not have potable water. Q: What has changed regarding low breastfeeding rates Besides diabetes and cardiovascular problems, there are

in Mexico and the impact on child obesity?

also many psychosocial effects associated with obesity.

A: Tackling obesity is a priority for UNICEF and

The way obesity is perceived in Mexico can incite bullying,

breastfeeding is vital in combating obesity. Women are

which can also lead to children losing motivation, eating

getting more and more information about the positive

more or suffering other nutritional diseases such as

impacts of breastfeeding; however, awareness is only

anorexia or bulimia.

slightly increasing and there is still much work to do. UNICEF works closely with strategic partners such as

Q: How effective have measures such as the sugar tax or

governments, academia, NGOs and the private sector

the ban on salt-shakers on restaurants tables been?

to support public health and advocacy campaigns. We

A: The sugar tax has contributed to fighting obesity but

participate in high-profile events like breastfeeding day,

it is still low (about MX$1 or US$0.05). More investment is

while also working locally with partners such as IMSS and

needed to change children’s behavior and even more so

the Ministry of Health.

that of their parents. Working with children as agents of change could be promising because they can inform their

It is not only about encouraging breastfeeding per se,

parents and prevent them from buying food that is not

it is also about making sure breastfeeding is a cross-

permitted in their schools. In Yucatan, for example, children

cutting and integrated element of other programs. The main issue with breastfeeding lies not only in how people perceive it, also in how people experience it. For

UNICEF is the UN agency in charge of promoting children’s

example, working mothers lack adequate breastfeeding

rights and wellbeing. Its local agency works with the Mexican

spaces in their workplaces and must leave their child at

government, NGOs and private companies to combat issues

home under a relative’s care. If a teenage mother does

that harm children’s quality of life

not receive the right information on how to take good


care of her child, which has a lot to do with lack of sex

practices and combating childhood overweight and obesity.

education in schools, then it is easier for her to believe

It is not just about working at the policy level but also at

in myths. Nutritional education for adolescents is crucial,

the budget level. This is a worthwhile investment because

particularly for adolescent girls because they might

what is invested in early childhood will pay off in the next 20

become mothers one day. If these girls receive adequate

years. Investing in combating overweight and obesity will

and timely information, they could influence whether the

save the government MX$64 billion (US$3.5 billion) yearly,

next generation will be obese or not.

the amount that public health spends on treating diseases

associated with overweight and obesity.

Q: What are UNICEF’s plans for indigenous communities in terms of nutrition? A: The main challenges associated with reaching indigenous communities are poverty, remote locations, lack of access to market choices and the media. Due to poverty, they buy high-calorie food with low nutritional value just to get through the day. In addition, we cannot lose sight of the chronic malnutrition that today continues to affect 1.5 million children, especially in rural and indigenous communities. The rural health centers have benefited from interventions via text messages with

In Mexico, 60 percent of adolescents do not do any physical activity”

Q: How can you demonstrate to the government what works and what does not? A: We gather data and look at different ECD indicators such as health and nutrition as well as government

information on topics like breastfeeding, Early Childhood

spending. We place a monetary value on each investment

Development (ECD), water and sanitation in schools and

to know the rate at which prevention expenditure reduces

good nutritional practices.

correction expenditure.

Q: How can UNICEF make these programs sustainable?

Q: What will be the main priorities for UNICEF in Mexico

A: UNICEF and other UN agencies work closely with national

in the next two years?

and local governments and other partners to support their

A: In 2019, we will embark on a new six-year country program

efforts. Program sustainability is tied to the government’s

in which obesity will continue to be a main priority. We will

empowerment to launch and continue these programs, while

increase our efforts to keep doing research and gather

funding them with sufficient resources. In middle-income

evidence to support health systems to prevent overweight

countries, UNICEF’s work is focused on supporting the

and obesity from an early age. UNICEF will also work with

government on upstream work. All of these initiatives are

adolescents to champion physical activity through innovation.

pilots and part of the process to generate evidence to show

We will tailor interventions to reach children and provide

the success a program may have: the costs and the benefits.

basic public services that will help combat overweight and obesity, including access to safe and potable water. We have

For example, part of UNICEF’s work is to encourage

been firefighting the symptoms and consequences but we

public investment in ECD, which includes good nutritional

really need to work together on the causes.

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29


ANALYSIS

AIR POLLUTION WORLD’S FOURTHBIGGEST KILLER

30

Low-quality air covers many of the world’s biggest cities

obstructive pulmonary disease (COPD),

and Mexico is no exception. This creates a variety of health

ischemic heart disease (IHD) and stroke and

problems but initiatives are beginning to emerge to improve

lung cancers in adults. Other associated

or solve the problem

health effects include adverse birth outcomes, childhood respiratory disease, diabetes,

Ninety-two percent of the world’s population lives in areas

atherosclerosis and neurodevelopment and cognitive

that do not meet World Health Organization (WHO) safety

function, according to the WHO. A study published in 2016

guidelines, according to a WHO study from September

in the National Academy of Sciences examined patients in

2016. Mexico City is one of the most polluted cities in the

the UK and Mexico and showed links between air pollution

world, and according to government data, saw only 78 days

and Alzheimer’s disease. The exact link between pollution

of clean air in 2016 according to WHO guidelines.

and allergies is yet to be established but the WAO forecasts that as air pollution and the ambient temperature increases,

“Today, climate change and pollution are realities,” says

so will problems related to allergies.

José Narro, Mexico’s Minister of Health. “We have serious problems in Mexico City but both local and federal

The organization measures air pollution in PM 10 and

governments are taking action. We now have much better

PM2.5, which is particulate matter of less than 10 and 2.5

ways of measuring pollution levels and better instruments

micrometers. The measures are an average taken between

to measure the impact that polluting particles have.

2010 and 2015, unless the latest available data precedes

Mexico City is in a valley and pollutants do not disperse.

this. It recommends no more than an annual mean of 20µg/

Some actions taken include the restriction of vehicles and

m3 for PM10 and 10µg/m3 for PM2.5. With the annual mean

industrial activity, which limit mobility. The Environmental

in Mexico varying between 11-35 PM2.5 µg/m3, it sits well

Commission of the Metropolis (CAMe) is a coordinating

above the recommended guideline.

mechanism that includes local, state and federal levels of government. President Peña Nieto requested that the

In addition, pollution plays a role in other diseases and

commission include the Ministry of Health. We all have to

conditions, such as depression and cardiovascular health.

realize that we have to do things for our own health. There

“Urbanization and depression go hand in hand. As an

are several dimensions to health, one of which is individual

economy develops, the population is weighed down with

and another is collective.”

heavier workloads, we spend more time in traffic and produce more pollution, all of which are stress factors

Poor air quality accounted for one in nine deaths in

that can lead to depression,” explains Oscar Parra,

2012, according to the report. This translates to 3 million

Managing Director of Mexico, Central America and the

deaths globally for 2012 related to outdoor air pollution

Andes of Lundbeck.

and 4.3 million related to indoor pollution. Of the total deaths, 93,000 occurred in low-middle income countries

Pollution in Mexico has long been a known-issue and its

in the Americas. Around 87 percent of the deaths linked

capital, Mexico City, was one of the first cities in the world

to outdoor air pollution occurred in low-middle income

to implement measures such as the license-plate-based

countries, where 82 percent of the world’s population

restrictions Hoy No Circula (No-Drive Day) in 1989. The

live. According to the World Allergy Organization (WAO),

restrictions have evolved over the years and now prohibit

common outdoor pollutants composed of particulate

drivers with cars that are not granted a 00 or 0 hologram

matter include vehicular traffic and fuels such as coal and

(linked to car age and MOT results) and registered to

gas for heating and industry. Indoor sources include wood

Mexico City from driving on one of the weekdays. Since

and coal used for heating and cooking and tobacco smoke.

2008, the measure has been extended to Saturdays.

Air pollution was responsible for 10 percent of deaths,

Cars with a 1 hologram are forbidden to be used on

the fourth biggest killer behind metabolic risks, dietary

two Saturdays per month, and 2 holograms and cars

factors and tobacco smoke, according to a 2013 World

not registered to the megalopolis are prohibited every

Bank infographic.

Saturday. There is an additional contingency, initiated when pollution in Mexico City reaches 150 IMECA points,

Causes of death linked to air pollution include acute

a measurement based on six types of pollutants. However,

lower respiratory infections in children under five, chronic

despite the extra Saturday measure, a paper published


in Nature by Lucas Davis, Faculty Director of the Energy

are posted across the city and throughout the media,

Institute at Haas, finds it has had “virtually no discernable

encouraging workers to cycle or take public transport and

effect on air quality.” The main reason attributed to this

urging bosses to allow employees to work from home.

is that the expected increase in public transportation did not occur.

In high-income countries, 56 percent of cities with over 100,000 inhabitants do not meet WHO air-quality

Still, the Global Alliance on Health and Pollution ranks

guidelines, nor do 98 percent in low-middle income

Mexico among the top 10 countries worldwide turning

countries. This prevalence of pollution costs the global

the corner on toxic pollution in 2014, due to its efforts in

economy dearly. The World Bank estimates premature

turning a contaminated oil refinery in Mexico City into an

deaths due to air pollution to have cost US$225 billion in

urban park with over a million visitors per year. Two other

2013 in forgone labor income, up from US$162 billion in

Latin American countries, Peru and Uruguay, were also

1990. “The respiratory health of children is at higher risk

among the top 10.

since they inhale a higher volume of air per body weight than adults and their immune defense mechanisms are

On March 1, 2017, the Ministry of the Environment and

still developing,” says the WAO.

Natural Resources launched a new National Strategy of Air Quality (ENCA). ENCA aims to “control, mitigate and

With pollution so deadly, many are creating alliances to help

prevent the emission and concentration of pollutants in

clean up the air. The World Bank partners with the Climate

the atmosphere in rural and urban areas by 2030” through

and Clean Air Coalition (CCAC) and the Global Alliance

five main lines, 21 strategies and 69 lines of action. The

on Health and Pollution and the WHO has established a

five main lines are: integral management to improve

campaign with the CCAC and the government of Norway

air quality, efficient and result-focused institutions,

called BreatheLife, which has identified a number of ways to

companies committed to air quality, atmospheric

clear the air, including sustainable transportation, industrial

policies based on scientific bases and a responsible

emissions reduction, solid-waste management, renewable

and participative society. Action in the responsible and

power and energy-efficient homes. For true change to occur

participative society line has already begun as photos

however, a push for clean air needs to come not only from

of children who cannot play outside due to dirty air

concerned NGOs but also from an involved population.

AIR POLLUTION OVER MEXICO

1

Annual mean ambient PM2.5 (µg/m3) < 10 11 - 15 16 - 25 26 - 35 Source: WHO

8

4

3 5 6

7

2

LOCATION

MEAN PM2.5 (µg/m3)

1

Monterrey

36

2

Toluca

33

3

Salamanca

28

4

Leon

27

5

Iraputo

26

6

Mexico City

20

7

Puebla

20

8

Guadalajara

19

31


Anesthetic machine Perseus A500 with IACS monitoring, mounted on a Movita arm with infusion pumps


HEALTHCARE SYSTEMS

2

The greatest challenge of 2016/2017 for the healthcare system is granting access to improved services to a larger percentage of the population. That task falls on the shoulders of the related public institutions, such as the Mexican Social Security Institute (IMSS) and the Seguro Popular. Less than half of the Mexican population has access to public healthcare and facilities, with 62.5 percent of the national workforce informally employed according to El Economista in an October 2016 report. INEGI figures show that only 62.2 million people, or about 48 percent of the population, had access to IMSS services as of July 2016. Despite government efforts, this figure represents only a 33.3 percent increase since 2006.

This chapter will offer an overview of the countryâ&#x20AC;&#x2122;s healthcare systems both public and private. Alongside the main social institutions and hospitals in Mexico, it will feature interviews from regional health ministries and it will cover the systemâ&#x20AC;&#x2122;s advantages and flaws, as well as the obstacles to overcome. This section will also review how the public and private sectors can work hand in hand to improve access to healthcare, notably through public-private partnerships. Investment in the Mexican healthcare system and its promotion abroad, including infrastructure projects such as new, innovative health facilities, will also be in focus.

33


CHAPTER 2: HEALTHCARE SYSTEMS 36

ANALYSIS : Access to Healthcare: An Ongoing Mission

37

INFOGRAPHIC: Mexico's Healthcare System

38

VIEW FROM THE TOP: Armando Ahued, Ministry of Health

40

VIEW FROM THE TOP: Gabriel O’Shea, Seguro Popular

42

VIEW FROM THE TOP: Marco Navarrete-Prida, PEMEX

44

VIEW FROM THE TOP: José Reyes, ISSSTE

45

VIEW FROM THE TOP: Roberto Bonilla, Hospitales San Ángel Inn

46

ANALYSIS: Public-Private Collaborations Boost Sector

47

VIEW FROM THE TOP: Alejandro Alfonso, ABC Medical Center

48

VIEW FROM THE TOP: Misael Uribe, Médica Sur

49

VIEW FROM THE TOP: Juan Galindo, Christus Muguerza Sistema de Salud

50

INSIGHT: Rafael Espino, Amerimed

51

VIEW FROM THE TOP: Miguel Castillo, Hospital Sedna

52

INFOGRAPHIC: National Health System Under the Spotlight

54

INSIGHT: Francisco Villarreal, Swiss Hospital

55

INSIGHT: Ricardo Bojalil, AsMed

56

VIEW FROM THE TOP: Jaime Cervantes, Grupo Vitalmex

57

VIEW FROM THE TOP: Ángela Spatharou, McKinsey & Company

58

VIEW FROM THE TOP: Lucas Olmedo, Fligoo

35


ANALYSIS

ACCESS TO HEALTHCARE: AN ONGOING MISSION The Mexican healthcare system is fragmented, although

announced during 2017,” says Julio Sánchez y

the government is striving to improve access, its foremost

Tépoz, Commissioner of COFEPRIS.

challenge. That task falls mostly on the shoulders of public institutions, such as the IMSS and the Seguro Popular

According to the OECD, in 2015 privately financed health expenditure represented 48.5

36

Less than half of the Mexican population has access to

percent of total sector expenses in Mexico. In addition,

IMSS, the largest public healthcare institution, and its

few have private insurance to fall back on. Analysts peg

facilities, with 62.5 percent of the national workforce

the number at under 10 percent of the population. In

informally employed, according to an El Economista report

2016, Moses Dodo, General Manager of Bupa Global Latin

published in October 2016. INEGI figures show that only

America, explained that corporate clients are driving the

62.2 million people, about 48 percent of the national

medical insurance market in Mexico and many young start-

population, had access to IMSS services as of July 2016.

ups are targeting the corporate insurance market. Others

Despite government efforts, this figure represents a 33.3

are spotting opportunities to create innovative business

percent increase since 2006.

models, targeting the middle class.

Institutions have made an effort to stretch budgets and

A final challenge is the demographic transition Mexico is

cover more people. The Seguro Popular, for instance,

facing amid a declining fertility rate and as the population

has started eliminating duplicate registrations with other

ages. According to the OECD, the country’s fertility rate has

institutions. “We have cleaned up our database and no

dropped from 5.9 children per woman in 1975 to 2.2 in 2015.

longer have 9 million duplicate registrations. We will

“Mexico’s population, like many around the world, is going

continue to work on this in 2017 and we expect to reflect

through a demographic transition,” says Mexico Minister of

this in a higher quality service for patients because there

Health José Narro. “Population pyramids have changed from

will be more resources per policyholder. The Seguro

20 years ago, when there was a strong base of young people.

Popular has been sharing information with the other

Now, the number of old people is increasing. Forty-five years

health systems since 2016, a year in which we lowered

ago, the median age was 17.8. Now, it is 27, so we can say

the number of policyholders by 3 million,” says Gabriel

that the population is maturing. Children and the elderly are

O’Shea, National Commissioner for Social Protection in

dependents and there are just over five million people aged

Health of the Seguro Popular.

over 70, but that figure will increase to over 17 million in 2050 thanks in part to medical advances. Today, a regular infection

However, the Mexican population pays a significant amount

can be cured while chronic, nontransmissible, nonparasitic

of their healthcare expenditure out-of-pocket, even in

infections can be controlled. Health is a process, not a state.

proportion to other countries. According to OECD figures,

Health ranges from the complete state of physical and

only 5.8 percent of GDP in 2015 in Mexico was spent on

mental wellbeing as defined by the WHO, to a second before

healthcare, almost half of which was out-of-pocket. Canada,

death, when health is basically lost. In between, there are

for example, spent 10.1 percent of GDP on healthcare in

many states, some better than others. If people see health

2015, only 30 percent of which was out-of-pocket. In a

this way, prevention can be put in place. We want to promote

country with a minimum wage of MX$80.04 (US$4.4) per

education so that more people can take control of their

day, paying for medical treatment out-of-pocket is simply

health. We must begin to build processes for healthy aging.”

unaffordable for many. In addition, when medicine is out of stock in the public sector, it forces workers that should be

Although the system faces a great deal of challenges,

covered to fork over money for their treatments. To make

globally it does not fare so badly and has been mentioned

medicine more affordable, COFEPRIS has been encouraging

as a model that, with some tweaks, could inspire others.

the production of generics by liberating patents. “In total,

The Bloomberg Healthcare Efficiency Index 2016 places

37 active substances have been liberated in our generics

Mexico 17th out of 55 countries, weighing up factors such

strategy, forming 491 generics. This represents MX$25

as life expectancy (60 percent of the grade) and relative

billion (US$1.4 billion) in savings and 2 million extra people

and absolute health expenditure (30 percent and 10 percent

can be treated thanks to these savings. In 2017, we will

respectively). Mexico’s life expectancy has increased in

continue with this strategy and in that of innovative

recent years despite high levels of obesity and diabetes,

medicine. Over 40 new molecule authorizations will be

which certainly boosted its ranking.


INFOGRAPHIC

MEXICO'S HEALTHCARE SYSTEM For everyone who is

For those who

formally employed and is

work at the oil

Institutions of state governments,

and gas company

not covered by another

for those who belong to

public institution

the state in question

37

For state

Others, such as police

INSTITUTIONS OF HEALTH AND SOCIAL SECURITY

workers

medical services

For those who belong

For those who belong

to the military

to the navy

Seguro Popular

IMSS-Prospera For those who do not have social security and

A type of public insurance for Mexican residents not covered through

live in rural or marginalized urban zones in

another institution

extreme poverty

The Ministry of Health

PUBLIC HEALTH INSTITUTIONS

OTHER TYPES OF INSTITUTIONS AND PROGRAMS IN PUBLIC HEALTH OR SOCIAL SECURITY

SNDIF National System for the Integral Development of Families. Social assistance for Mexican families Others

providing family planning, childcare and fighting

Such as university medical services

drug absuse

Private health institutions that offer subrogated services public sector workers

Insurers that offer medical protection services

Private health institutions open to the general public

Banks that offer health

PRIVATE INSTITUTIONS

services Others, such as private doctorâ&#x20AC;&#x2122;s consultancies in pharmacies

to their employees

INSURERS, BANKS & OTHER INSTITUTIONS OF PREPAID MEDICAL SERVICES

Medical units that belong to a charitable organization and offer services to general public, such as the Red Cross Source: INEGI

Other prepaid services such as NGOs or not-for-profit organizations


VIEW FROM THE TOP

HEALTH CHALLENGES IN ONE OF THE WORLD’S BIGGEST CITIES ARMANDO AHUED Minister of Health of Mexico City 38

Q: What steps is the Ministry of Health taking to quash

Q: Why has health education not been integrated into

disinformation and spread knowledge on health issues?

school curriculums?

A: Mexico City has spearheaded the promotion of health

A: It is a political decision that has not been made. What

information. We have launched campaigns on every topic

could be more important than children learning how their

imaginable and we have also printed 1.4 million copies of

body works, the risks they face and what needs to be done

a book on health for distribution to children in elementary

to preserve their health and life? This needs to be done

schools. It covers such topics as dental health, nutrition and

today, but it may take years. Still, the seeds need to be sown

general hygiene. We have a second book on sexual health

or in years to come we will continue to face the same issues.

with over a million copies in print. It touches on all related

Our children can lose 10 years of life due to overweight and

topics. A third book covers addictions: alcohol, tobacco,

obesity. At home, children are given portions to eat that are

drugs, myths and truths.

the same size as those the parents eat. We need to change the consciousness of parents. We also need to seek help

In winter of 2016-2017, Mexico City saw 23.6 percent fewer cases of pneumonia and bronchopneumonia than in 2015/2016

from teachers. When I was studying medicine, I was taught to cure sick people, not to keep people healthy. This is good but doctors should also know how to look after people and point them in the right direction to staying healthy. The healthcare system cannot handle the number of sick people who did not look after themselves and did not go for regular checkups. In addition, care becomes extremely expensive.

We must incorporate health as a subject in schools. I am

Stents cost MX$25,000 (US$1,389) and some people may

convinced that the only way to make people co-responsible

require three or four. Dialysis costs MX$2,000 (US$111) per

for looking after their health is to empower them through

session and sufferers may need three sessions per week

knowledge and understanding. If the information is

for the rest of their life. There is no wallet or public budget

provided to children, they will have it when they in turn

that can withstand this.

become parents. For example, children do not brush their teeth properly because their parents cannot show them

Q: How has the Ministry of Health promoted a preventive

how. This is why nine out of 10 children in primary school

health culture and what is its view on vaccinations?

have cavities and in secondary school they all have cavities.

A: In the swine flu pandemic that took place in Mexico City

On average, adults loose seven to nine teeth after the

in 2009 I had to make a historic decision: to close the city

age of 60; they cannot chew or bite, they begin to have

to protect residents. This taught us that we were vulnerable.

gastrointestinal problems and become malnourished, so

When the vaccine arrived, there was much confusion and

they get osteoporosis and they fall and break a bone. This

fear of the vaccine because the Minister of Health of

is why it is so important to teach dental hygiene and the

another state had commented that it caused Guillain-Barré

same goes for sexual health.

Syndrome. We refuted this, but the fear was terrible. Even health personnel did not want to get vaccinated.

Armando Ahued is a surgeon from the UAM. He became

To set an example and prove the vaccine was safe, I was the

the capital’s Minister of Health in 2007 and is known for

first to be vaccinated. Thankfully, former Minister of Health

successful programs such as Médico en tu Casa (Doctor in

José Ángel Córdova negotiated with Sanofi and distributed

your House)

stocks of the vaccine to all the states of the country. One


day, he called me and told me that, despite the Ministry

VaccinationsVACCINATIONS IN WINTER 2016-2017 INFLUENZA

of Health’s investment, people refused to be vaccinated. He asked me to find a way to get it done. I had the idea to place the vaccination stands in the city’s metro, which sees foot traffic of around five and a half million people per day. We put stands in the biggest stations and offered free vaccinations. As a result, people were lining up. I took Minister Córdova to visit the stands along with the press and

2,447,344 is the Mexico City vaccination goal

„„98.8% vaccinations acheived

word got out that the people of Mexico City were getting

„„1.2% vaccinations

the vaccination. This created a domino effect. Vaccination

not completed

stands were placed in public areas throughout the country. This was the start of a culture of care and prevention.

people ho haven been vaccinated Source: Mexico City Ministry of Health Vaccinations in cdmx

From 2009 to the present, we have been vaccinating

of protection. The best time to get vaccinated is in

without a problem. In winter of 2016-2017, Mexico

September or October. The aim of the Ministry of Health

City saw 23.6 percent fewer cases of pneumonia and

was to vaccinate 2,447,344 people in Mexico City,

bronchopneumonia than in 2015/2016, the number of

1,003,426 of which belong to my ministry. Mexico City

acute respiratory infections remained stable while there

met 98.8 percent of that goal.

were 56.6 percent fewer cases of influenza. There were only 10 deaths this winter, compared with eight last winter in a

In addition to influenza, we have vaccinated against

city of millions of people. The virus we expected to be most

rotavirus and pneumococcus. Everyone in a risk group

prevalent was H3N2 but it was actually H1N1.

should get vaccinated including pregnant women, children, elderly, diabetes sufferers and those who suffer from

From 2016, two oseltamivir generics have been available

chronic respiratory illnesses.

but people continue to associate the active ingredient oseltmavir with the brand Tamiflu and refuse to buy generic

Q: What will the Ministry’s priorities be in 2017? How will

versions. Now, we have enough oseltamivir in stock to

it distribute resources to achieve them?

cover both this winter and the next. One issue is that when

A: The greatest priorities will be to consolidate the

a family member gets influenza, everyone in the family

infrastructure that we already have, to improve the

takes some of the medicine as if it were preventive, which it

equipment, to prepare and train our professionals and

is not. There is also the issue of rapid testing, which results

to launch a campaign on dignified treatment. In addition,

in false positives or false negatives 50 percent of the time.

we will continue to promote health and prevention and

My recommendation is to seek out a clinical diagnosis only.

early diagnosis. Without a doubt, the Médico en tu Casa (Doctor in your House) program, which has sent doctors

In addition, it is pointless getting vaccinated in February

and nurses to knock on doors to seek out sick people, has

or March, as the influenza season ends in March and

been a successful experience and we will consolidate the

the vaccine takes 45 days to reach the maximum level

strategy by making free health services a reality.

39


VIEW FROM THE TOP

CARING FOR HALF OF MEXICANS GABRIEL O’SHEA National Commissioner for Social Protection in Health of the Seguro Popular 40

Q: The Seguro Popular registered over 8,000 migrants

Siglo XXI, which is aimed at children. To face these cuts,

returning to Mexico in early 2017. How is it reaching

we have lowered duplicate registrations and we have

these people?

cut some programs. We have also reduced trips to other

A: This has become quite a theme since President Trump

states to check on how things are going and employees

announced he would repatriate 3 million Mexicans. We have

no longer have company cellphones. A program I

created 50 booths in the 50 consulates in the US managed by

would have liked to implement but have not been able

the Ministry of Health from where we distribute information

to is the milk bank in hospitals to encourage exclusive

to our citizens about what the Seguro Popular is. We tell

breastfeeding for the first six months.

them that it is free, what it covers and what it does not, so that when they return to Mexico they can sign up. In addition,

Q: Of all the Seguro Popular’s programs, which is your

we placed 24 sign-up centers in the five Mexican border

favorite?

states solely aimed at reaching those being repatriated.

A: My favorite program is probably the cataract one

However, we have not seen an increase in deportations and

because I am an ophthalmologist. However, the program

the number of people registered in the first three months of

that has had the most impact is that which cares for

2017 was the same as the first three months of 2016.

children with cancer. In 15 years we have managed to reduce by 11 points the out-of-pocket expenditure of

Q: The Seguro Popular expects millions of people to renew

Mexicans, although we still remain the country in the OECD

their policies this year. How do you cope with such volume?

with the highest rate of out-of-pocket expenditure. I am

A: As of March 2017, there were 54.9 million Mexicans

certain that with the modifications to the law we have

affiliated with the Seguro Popular. The policies of 17 million

made we will achieve a reduction of 15 points within the

Mexicans will expire in 2017, although there is a tendency

next few years. We expect that from 2017 onwards this will

to leave things to the last minute, and so on the last day

help state health services carry larger stocks of medicine,

we see huge queues of people. Therefore, we expect only

which is what is most hitting the wallets of Mexicans.

50 percent of those 17 million to re-affiliate. We had 57 million policyholders last time we spoke with Mexico Health

Q: The Seguro Popular now has bariatric surgery among

Review in 2016. We have since cleaned up our database and

its services. What has been the result of that?

no longer have 9 million duplicate registrations. The Seguro

A: This is happening in Mexico City mostly, but it is hard to

Popular has been sharing information with the other health

implement in other states because there may not be as many

systems since 2016, a year in which we lowered the number

bariatric surgeons. It is aimed at cases of obesity in which the

of policyholders by three million.

patient is incapacitated in his or her daily activities. I believe everything should be tried before resorting to surgery:

Q: How have public-sector budget cuts impacted the

dieting and exercise or even taking medicine. Unless we

Seguro Popular? How is it ensuring patients are not

Mexicans change our diet and exercise, it will be difficult to

negatively affected?

justify resorting to bariatric surgery because we have done

A: The Seguro Popular has suffered from budget cuts

nothing to try and fight the root cause. It is all well and good

to programs such as catastrophic expenses or Médico

for the public sector to instill healthy habits in schools, but what good is it if parents undo this work once the child gets home? This is a complex theme that requires engagement

The Seguro Popular is a public-sector institution of health

from all sides: municipalities and mayors, but the largest

and social security that operates through medical facilities

commitment is that of parents. We have made great strides

belonging to the Ministry of Health. It covers almost half the

through the Prospera program in teaching people to eat well,

Mexican population

which does not cost a lot of money.


Oxylog 300 plus

41

Emergency ventilator Oxylog 300 plus and patient relocation with the Infinity M540 monitor

Q: You are an ophthalmologist. What trends in Mexican

a healthcare system and we see this increase every day.

ocular health are most concerning?

There are 12 million diabetics in Mexico, of which only 38

A: Cataract is the first reversible cause of eyesight loss in

percent have their condition under control. The others

the world and in Mexico the first cause of non-reversible

are suffering from side-effects.

sight loss is glaucoma. The main problems I see when giving consultations and operating are diabetes and

We have seen a decrease in the costs of cancer patients

obesity. They are our nightmare. If I could, I would focus

due to generic medicine. Today, a patient with breast

resources on fighting these two conditions, which would

cancer costs less than three years ago and we have seen

have a huge ripple effect on other health costs.

the same effect with HIV patients. The Seguro Popular monitors 81,000 HIV patients, each costing MX$37,600

In consolidated purchasing, we have saved MX$11 billion

(US$2,089) per year. This is a great burden for healthcare

(US$611 million) over the past three years. We want health

systems because they now live longer. HIV is not a death

centers to be on the lookout for these things and be

sentence as it was in the 1980s.

testing for them. In addition, it angers me if centers are lacking tests because I send the states money to buy test

Q: How will the Seguro Popular continue to face the

strips for them. Now, instead of sending money, I buy

diabetes and obesity epidemic in 2017?

material and send that to them. The same thing happens

A: It is no longer about building large hospitals. We have

with condoms. Twenty percent of pregnancies in Mexico

to continue what we have started: the interchange of

are in girls under the age of 19, so now we buy condoms

services. The theme of universality we all dreamed of is

directly and ship them to the states.

surely not so. It has steps, each of which can take years. We began interchanging during this six-year presidential

Q: In which areas has the Seguro Popular seen the

term, meaning patients can be treated where there is

largest increase and decrease in costs in 2016?

room, even if the facilities belong to another health

A: The largest increase has been in NCDs, mostly cardio-

system. We need to make the most of infrastructure that

pathologies and diabetes mellitus, and treatment of

is already in place. There are 35 private medical providers

ensuing complications like hemodialysis, amputations,

that offer services to the Seguro Popular. We need to

laser surgery for diabetic retinopathy and implanting

increase this number and we should reach 50 by the end

an Ahmed valve. All of this is extremely expensive for

of the year.


VIEW FROM THE TOP

SIMULTANEOUS TARGETS, POSITIVE RESULTS MARCO NAVARRETE-PRIDA Deputy Director of Health Services for PEMEX 42

Q : W h a t a r e P E M E X ’s h e a l t h p ri o ri t i e s f o r i t s

we have many elderly patients; 56 percent of PEMEX’s

beneficiaries in 2017?

beneficiaries are over 65 years old.

A: As a healthcare provider, we have to focus on simultaneous targets. However, we began as a medical

Q: What challenges does PEMEX face in retaining workers

services company, so labor health is our main concern. We

when faced with many new market entrants?

have doctors at every work site to deliver preventive care

A: We need to offer the best benefits to our workers so

and promote health, hygiene, risk detection and to evaluate

they do not need to look for other employers. This year, we

the compatibility of employees with the jobs they do. For

are also negotiating our collective bargaining agreement.

example, some employees work 35-60 meters above a

We work closely with the union and it is committed to

platform or land. They cannot suffer from vertigo, have

our focus on prevention and health promotion. We want

the flu or a high BMI because that would be risking their

both employer and employee to take responsibility for

life. At PEMEX Health Services we are further ahead in

employee health. The paternalistic scheme in which

health services than other industries such as automotive,

the state or PEMEX provides everything to a passive

pharmaceutical and aerospace. Our priority is to have our

beneficiary does not work. There should be a commitment

workers operating under the best conditions possible.

from the employees, too. To this end, we have integrated

Instead of building more hospitals, we want to focus our

a health bonus, which is given to workers with a BMI of

efforts on promoting preventive care. In fact, PEMEX has

less than 25 or for those who lose 10 kilos in a year. Their

41 health centers, including 10 first-class clinics, 24 hospitals

cholesterol and lipoproteins also must be in normal ranges

and 168 preventive centers of labor health. Our hospitals are

and if they are already diabetic their glycohemoglobin

operating on average at 70 percent capacity.

must be under seven. If they comply they get the bonus.

Q: What are the main health concerns of PEMEX’s

Q: What relationship do you have with other public

beneficiaries?

healthcare institutions?

A: They are similar to Mexico’s main health issues: diabetes,

A: President Peña Nieto and Minister Narro are working

cardiovascular diseases, obesity and systemic arterial

on the universalization of health services, which means

disease. Our rates of diseases are low and the most

that each institution has to be open to providing and

common are usually hearing problems. We are a high-risk

receiving support from other institutions. We have an

company, but we experience less than 0.2 accidents per

agreement with all the National Institutes of Health and

million hours worked. There are many myths about PEMEX

we hire subrogated services in some other locations.

but we have one of the lowest sick leave rates among

We have partnerships with health institutions in Sonora,

companies. Our workers take less than four sick days per

Aguascalientes, Tamaulipas and Veracruz. In cases of

year thanks to our preventive initiatives, our efficiency in

industrial emergencies, we receive a lot of support from

setting appointments and the workers own commitment.

IMSS. In 2016, when there was an emergency at our plant

The life expectancy of petroleum workers is 80 years,

at Pajaritos, Veracruz, we received patients from IMSS

higher than Mexico’s average, which is 78. This is because

because we had the largest coverage in the area. We also

they have increased access to health services. Therefore,

share successful experiences among institutions. In fact, every year we do a course on treating burn patients and we invite professionals from IMSS, SEDENA and SEMAR to

Petroleros Méxicanos (PEMEX) is a state-created oil and gas

take part because we are all part of the same ecosystem.

company and is the largest company in Mexico. It runs its own

We also have an agreement with the Ministry of Health to

healthcare system for its workers, which is also one of the

fumigate work areas to prevent vector-borne diseases and

largest in the country

we provide them with fuel for their trucks.


Q: How did you manage the delegation of part of your

of Health’s priorities on prevention of vector-borne

services to a private insurance company?

diseases and teenage pregnancy. In addition, we have

A: There are smaller locations in which we have fewer than

vaccinated almost 100 percent of 1-year olds. During

120 workers but we are still obligated to provide health

pregnancy, we perform syphilis and HIV screenings as

services. It would be very expensive for us to build a PEMEX

well as promoting contraceptive methods. We are also

hospital in those locations. From the beginning, we have

conducting an analysis of patients with hepatitis C to

hired private services to support those PEMEX locations

offer them new treatments.

that lack a health facility but which have active workers, or a total 104,000 beneficiaries. Two years ago, PEMEX’s

Q: What are the benefits of digitalizing patient

supply department designed a strategy to have one health

information?

administrator instead of 95 providers. Unfortunately, the

A: We hold universal electronic records for direct and

results were disappointing and we are now in the process

subrogated systems. The software was created by PEMEX

of returning to our previous system.

10 years ago for direct services and won the Innova award. Three years ago, we integrated it to the subrogated health

Q: What opportunities do you offer students who want

services. When a doctor receives a patient, he has a

to do medical residencies in PEMEX hospitals? Which

password to access the patient’s data. The software is also

specialties are available to them?

linked to the labor health department and to a diabetes

A : T h ro u g h P E M E X H e a l t h S e r v i c e s ’s re s i d e n t

website on which doctors can create an alert when they

program we have trained high-quality and specialized

recognize a diabetic patient. All this clinical information

professionals. We have schools at Hospital Central

and laboratory data is also gathered to elaborate Big

Sur de Alta Especialidad and Hospital Central Norte in

Data, which can be analyzed and presented in graphics

Azcapotzalco, Mexico City; Hospital Regional Ciudad

to identify which patients, in which areas and in which

Madero, Tamaulipas and Hospital Regional de Salamanca,

positions have which diseases and find correlations.

Guanajuato. There are 18 specialty and five subspecialty programs available for 388 students in the country. We

Q: What is PEMEX’s contribution to Mexico’s growing

are focused on the specialties we treat the most and for

clinical research industry?

10 years we have integrated successful students into the

A: We perform clinical trials to see which type of drugs

positions we need to fill.

and medical devices are best. In fact, two years ago we launched our molecular biology laboratory at the Hospital

Q: What are PEMEX’s main current health campaigns?

Central Sur de Alta Especialidad in Mexico City, where

A: We have permanent programs to promote health,

we are carrying out bacterial studies and soon will start

focused on child obesity, cervical and breast cancer

a genetic study of the PEMEX population. We have an

for women and prenatal care. We also perform chronic

agreement with INMEGEN to know which diseases our

degenerative diseases screenings, even in the workplace.

beneficiaries are prone to and to identify the best drugs to

We run a constant campaign on HIV and we treat around

treat them. In addition, we have a medical journal in which

700 cases, some of whom are active workers not on sick

PEMEX health professionals publish articles and research

leave. We also run campaigns aligned with the Ministry

papers. It is all part of our effort in preventive medicine.

43


VIEW FROM THE TOP

CAMPAIGNING FOR BETTER HEALTH JOSÉ REYES Director General of ISSSTE 44

Q: In addition to health services, ISSSTE works on

is to triple the number of mammographies from between

prevention through public awareness campaigns. Which

110,000 and 115,000 to 350,000. ISSSTE is raising awareness

areas are key targets?

among women between 25 and 69 years old. Although we

A: We have a number of ongoing campaigns. One such

have reduced the prevalence of cervicouterine cancer and

campaign relates to addiction prevention, particularly

the related mortality rate, the same cannot be said for breast

smoking, and targets young people through courses,

cancer. We named February Men’s Health Month because

conferences, personnel training, graphic information and

men are less likely to visit a physician than women: 63

social media. We are also drafting several campaigns against

percent of first-time doctor’s appointments are women.

overweight and obesity and their related conditions, which have a profound effect on quality of life and on the federal

Q: On the business side, what are the advantages of

budget. Twenty percent of ISSSTE’s health-allocated funds

building hospitals through PPP schemes?

were used to raise awareness of diabetes, overweight and

A: ISSSTE has an infrastructure program and fiscal resources

obesity, hypertension and cervicouterine, breast, prostate

but, due to budget adjustments, we have had to vary our

and colon cancer. ISSSTE’s annual budget amounts to MX$45

financing to continue building and expanding hospitals and

billion (US$2.5 billion) and we are spending MX$10 billion

clinics. We needed to migrate to a new scheme involving the

(US$555 million) or more just on these diseases.

private sector. ISSSTE invested over MX$4 billion (US$222 million) last year in building and expanding a number of clinics

Among specific programs, the Salud en tu Escuela (Health in

and hospitals. We have analyzed several new hospital projects

your School) campaign is focused on young people and on

in Tampico, Acapulco, Oaxaca and Mexico City and there are

the children of beneficiaries who suffer from overweight and

also some requests for new hospitals in San Luis Potosi and

obesity. This is a joint effort between players in the public

Sonora. There is a PPP hospital being built in Merida and three

health and educational spheres, such as the Ministry of

others to be tendered: Mexico City-Tlahuac, Villahermosa

Public Education (SEP) and the National Education Workers’

and Tepic. We estimate that in this federal government

Union (SNTE). Integrating teachers as health promoters and

administration’s remaining time, investments from PPP

developing permanent awareness and physical exercise

schemes could total about MX$14 billion (US$777 million).

campaigns are key objectives that will enable ISSSTE to evaluate the results at each school in the program. The

Q: What criteria helps ISSSTE to decide where a new

effort will include physicians, nurses and some students

hospital or clinic will be built?

from ISSSTE’s School of Nutrition and Dietetics. The ISSSTE

A: The location of beneficiaries and public health

en tu Dependencia (ISSSTE in your District) program is

infrastructure are the key criteria. The Ministry of Health,

focused on monitoring the health of employees. ISSSTE has

ISSSTE and IMSS have developed a strategy that prevents

identified about 570,000 diabetics among its beneficiaries.

duplication, so if there is an IMSS hospital in a community

Another campaign targets breast cancer across public health

with an ISSSTE clinic and someone at the latter needs

institutions. We integrated 25 new mammography machines

surgery, hemodynamics or cardiovascular services, these

into our facilities and we are finishing a new diagnosis center

will be subrogated to the IMSS hospital. Services will also

in one of our hospitals. Between 2016 and 2018, ISSSTE’s goal

be subrogated from IMSS to ISSSTE, which does not mean implementing a universalization program but exchanging services and prioritizing cities and states according to

The Institute of Safety and Social Services for State Workers

the demand for health services and the existing public

(ISSSTE) is the second largest of Mexico's public health

infrastructure. All public-sector agencies need to maintain

institutions, providing health and social services to almost 13

a close relationship. We also have collaboration and service-

million government workers

exchange schemes between both public and private entities.


VIEW FROM THE TOP

GOOD INFRASTRUCTURE, QUALITY CARE, LOWER PRICES ROBERTO BONILLA Director General of Hospitales San Ángel Inn 45

Q: What makes San Ángel Inn different from its

with a new business model backed up by other hospitals

competitors?

if complex treatments are needed. We opened this clinic

A: Our management model, which allows us to provide

because our customers asked us for a location where minor

patients with less costly services while delivering a long-

surgery could be performed.

term return on investment. We offer good infrastructure with quality care at substantially lower prices than our

Q: What are the main challenges and concerns for San

competitors. That is why we are the preferred hospital for

Ángel Inn?

closed-network patients and companies that manage their

A: Our main concern for the next four or five years is the

own healthcare benefits. Other hospitals target individual

patient’s access to healthcare, which mutual health insurance

patients while we want to attract businesses that will direct

coverage could solve. In Mexico, people have access to diverse

their employees to our hospitals.

health services through IMSS, ISSSTE, PEMEX and other public entities, while private coverage is scarce, with only about 7

Q: How does the hospital group keep up-to-date with

percent of the population under such plans. This percentage

technological advancements?

has not grown in the last 10 years despite an expanding middle

A: San Ángel Inn makes an effort to be up-to-date but our

class. Moreover, our main institutional clients are changing.

strategy does not require having the latest technologies. We

Banks do not want to continue using reverse quota schemes

make sure we have the modern and functional technology

and prefer to pay for social security while some insurance

to resolve 97 percent of the cases we encounter, so having

companies are considering dropping high medical-expense

state-of-the-art technology does not make sense with our

insurance on which they lose money. We need to learn to

business model. The only treatments we cannot perform

collaborate with other industry players to improve access to

because of technological limitations are radiotherapy, PET/

health. Our main challenge is in understanding how to increase

CT and some oncological treatments. We have a capable

access to private and public medical insurance.

medical team, enough technology and good infrastructure. Q: What impact do you expect to see from the model of Q: What challenges do you encounter when hiring and

chronic disease insurance?

retaining nursing staff?

A: It could improve the access to health services. Diabetes,

A: The issue is not in retention but in recruitment. The nurses

cardiovascular diseases and cancer are the main causes of

working at San Ángel Inn must have at least an undergraduate

death in Mexico. A person who has corresponding coverage

degree. Our competition regarding human talent are not

has a 30 percent chance of access to a good hospital in case

private hospitals but public, because nurses in the public

something serious happens. San Ángel Inn is creating a product

sector work only five days a week and receive better benefits

specifically for cardio-metabolic and cardiovascular disease.

than we can offer. We attempt to create a pleasant, patient-

This low-cost premium scheme is far more accessible. However,

oriented work atmosphere where nurses can grow. Within this

there is no insurance or prevention culture in Mexico. Hospitals

model, a nurse’s satisfaction does not derive from the benefits

do not focus their marketing on creating awareness about the

the hospital provides but from gratified patients. When a

need for health coverage because the existing demand for

patient has a good experience, the whole team is pleased.

their services is enough for most to perform relatively well.

Q: What plans does San Ángel Inn have to expand? A: We will finish consolidating our presence in Mexico City.

Hospitales San Ángel Inn is a hospital chain with four

We have a new hospital in Patriotismo and we are about

installations in Mexico City. It offers a wide variety of

to open a new short-stay and ambulatory clinic in Mier y

treatments and specialties, specializing in gynecology and

Pesado. This project is an opportunity to enter a new niche

obstetrics and cardiology and hemodynamics


ANALYSIS

PUBLIC-PRIVATE COLLABORATIONS BOOST SECTOR

46

The Mexican healthcare system is fragmented and many industry

is the difficulty of selling services to Seguro

experts believe that increased collaboration between the public

Popular. Hospitals have to undergo several

and private sector and within the industry could increase cost-

time-consuming registration processes so the

efficiency and lower waiting times at busy institutions

patient stream is initially slow.”

The public sector has made great advances in recent years

Alfonso additionally explains that unlike IMSS patients,

in dealing with the country’s large volume of patients

Seguro Popular patients can expect treatment in any

and in improving quality of care, but there is still room

participating hospital, which results in many patients

to improve. According to the OECD, 5.3 percent of the

traveling in from city outskirts or from more rural or less

Mexican population spent at least one night in hospital in

developed states to the big cities. “Seguro Popular was

2014, equivalent to around 6.4 million people. In addition,

created with the theory that ‘money will follow the patient,’

it reports that in the same year, an average of 2.6 doctor

so the belief is that wherever he or she goes there is a budget

consultations were carried out per capita, equaling 312

to pay for the service. The actual situation is that the federal

million visits. Outsourcing services, used in the right way, may

government gives each entity a budget targeted as money

benefit both institutions and patients, hospital operators say.

for Seguro Popular, but a given entity may not necessarily be equipped with the services specific patients need. Therefore,

Seguro Popular, one of the country’s main social security

there is a large migration of patients to Mexico City, where

institutions, does not own any hospitals itself. It outsources to

large hospitals, specialized clinics and good services can

public and private hospitals the services needed by its insured

be found. When those patients arrive at hospitals in the

patients. The agency has a catalogue of required services that

city, the center’s administrator must find a way of covering

private hospitals can address according to their capabilities

each patient’s costs because the state to which the patient

and for which they can seek accreditation. Once a hospital is

belongs will not pay,” he says.

certified, Seguro Popular can begin referring patients. IMSS does have hospital infrastructure but it is often “[The relationship] is important because of the volume of

overwhelmed with demand because it is responsible for

patients the government brings but also as a contribution

the health of over 70 million Mexicans. In this case, the

to balancing the health offering in different segments of

construction of hospitals and clinics in conjunction with the

the population,” says Miguel Castillo, Director General of

private sector may be a better option.

Hospital Sedna, which offers oncology services to Seguro Popular to treat breast, colon and prostate cancer. Due to

“What IMSS has done is take advantage of new legislation

the high incidence of those cancers in Mexico, these services

to facilitate the construction of new infrastructure, clearly

are in high demand. According to the WHO, in 2014 there

without medical care being in the hands of the private sector

were 20,444 cases of breast cancer, 14,016 cases of prostate

at any point, which is a legal impossibility,” says Mikel Arriola,

cancer and 8,651 cases of colorectal cancer in Mexico. The

Director General of IMSS. “We are having facilities built at

relationship with Seguro Popular is so fruitful that the

a faster pace, more efficiently and without the hurdles

hospital hopes to expand the number of services it offers to

associated with direct public investment. We have had

the government, looking to add general surgery and high-

bidding processes for four hospitals. We are looking to be

risk pregnancies to its list. Castillo hopes that these further

more efficient. We want to build more hospitals with less

accreditations will increase the number of patients seeking

money. We have MX$20 billion (US$1.1 billion) to build 12

treatment at the hospital.

hospitals and four of those will be through PPPs.”

Despite the many benefits for the health system, there are

The relationship between public and private entities will

still some kinks to be worked out. “Our relationship (with

continue and even expand for the foreseeable future.

the Seguro Popular) is strong but there are certain rules

Obesity, for example, is one treatment area that will benefit

that keep us from offering it more products and services,”

from the relationship. The OECD reports that more than one

says Alejandro Alfonso, CEO of ABC Medical Center.

in three people in Mexico are obese. To help alleviate the

“For every MX$1 it pays us, we have to give MX$0.19 to

issue, in 2016, Seguro Popular announced that due to the

the government. Seguro Popular does not pay VAT but

high obesity rates bariatric surgery would be offered through

as a private hospital we are not exempt. Another issue

the public sector.


VIEW FROM THE TOP

DISPARITY A CHALLENGE IN PUBLIC-PRIVATE COOPERATION ALEJANDRO ALFONSO CEO of ABC Medical Center 47

Q: How is ABC Medical Center cooperating with the

every MX$1 it pays us, we have to give MX$0.19 to the

public sector?

government. Seguro Popular does not pay VAT but as a

A: The healthcare situation in Mexico demands private

private hospital we are not exempt.

hospitals work together with the government because it is not economically viable for the government to meet healthcare

Another issue is the difficulty of selling services to

service demands by itself. The key is to find the right way

Seguro Popular. Hospitals have to undergo several time-

to make this happen to avoid the perverse incentives in the

consuming registration processes so the patient stream is

private and public sectors that pollute association. ABC

initially slow. Seguro Popular was created with the theory

Medical Center has been working with public healthcare

that “money will follow the patient,” so everywhere he or

through Seguro Popular and by offering occasional services to

she goes there will be a budget to pay for the service. The

other government institutions. As a not-for-profit organization,

actual situation is that the federal government gives each

we can afford to treat patients below cost and this is important

entity a budget targeted as money for Seguro Popular

because helping those who do not have enough resources is

but a given entity may not necessarily be equipped with

a part of our founder’s legacy. The challenge is to determine

the services specific patients need. Therefore, there is a

the price the government can pay for these services and how

large migration of patients to Mexico City, where large

economically and clinically efficient we can be as a private

hospitals, specialized clinics and good service can be

hospital when providing this aid. If there are no clear rules

found. When those patients arrive at the hospitals in the

about quality and affordability, we may find ourselves in a

city, the center’s administrator must find a way of covering

situation wherein we can no longer help the population.

patient costs because the state to which the patient belongs will not pay.

I am concerned about the decision to create general hospitals without a structured business plan. The word “general” by

The truth is that money does not follow the patient

itself might be counterproductive because it suggests the

because security systems for patient care in Mexico are

hospital can treat any manner of illness and it does not

sectored. With IMSS coverage, a patient can only go to

highlight the public’s true needs. A general hospital is not

IMSS facilities. Mexico operates a vertical system, so there

built based on a study of the population and popular diseases.

are many patients for whom there is no budget. We see

For its construction, rent is paid to a private company, which

teenagers with high-risk pregnancies camping outside

fulfils its construction and installation contract, at which point

hospitals, waiting for care without a place to sleep, and

the government takes operational control of that hospital. The

most of these are helped by civil organizations.

little money this general hospital receives is spent paying the private company and there is not enough left to treat patients,

Q: What approach could help solve the health system’s

which indebts the government. Instead, to improve existing

current situation?

services there should be an inventory of the country’s hospital

A: The solution is not easy and is not short term. First, we

capacity and an analysis of how they could be better used.

have to discuss which healthcare model we want to follow

There are empty surgical theaters at certain times of the day

with the participation of many social agents. Once the

in private hospitals that could be used by the lines of people

model is established, we can decide our course of action.

in public hospitals. Q: What is the thrust of ABC Medical’s relationship with

ABC Medical Center is a private institution in Mexico City

Seguro Popular?

that offers treatment in the fields of oncology, neurology,

A: Our relationship is strong but there are certain rules that

transplants, OB-GYN, pediatrics, traumatology, preventive

keep us from offering it more products and services. For

medicine and nutrition


VIEW FROM THE TOP

CREATING ACCESS TO TOP-FLIGHT SERVICES MISAEL URIBE President of Médica Sur 48

Q: What is Médica Sur’s strategy to ensure growth?

Q: What is your added value proposition regarding

A: Médica Sur’s growth stems from two points. First, we seek

medical tourism?

internal growth through the optimization of our processes.

A: Many people come to Mexico for plastic surgery but

This growth must be guided by a code of ethics to ensure

we want to provide even more services. We performed a

that we can provide quality service. Belonging to the JCI and

liver transplant for a 7-month-old girl who weighed 8kg

Mayo Clinic Care Network provides us a standard; however,

using 200 grams of her aunt’s liver. She is alive and she will

that is not enough because in healthcare we experience

recover. This is the kind of news we want other countries

changes every day. One major change is the increase

to hear to attract patients. More than medical tourism,

in ambulatory procedures in hospitals, which opens up

what we offer is an efficient use of resources that leads

new opportunities and leads us to the second priority for

to affordable prices. A knee or hip transplant might cost

Médica Sur: implementing external growth through a larger

US$100,000 in the US. Here it is US$40,000. We must

investment in diagnosis. Unfortunately, in Mexico there is a

follow the example of India, which has already become a

lack of confidence in diagnoses and unethical practices are

medical tourism destination for Americans. The cultural

common. There are many opportunities in this area. We will

difference and the actual distance between India and the

be able to provide tools that will lead professionals to the right

US are bigger than with Mexico, but India has talent and it

diagnoses and in doing so, open access to a top-flight service

is open to promoting it.

that is now privatized. Q: What are Mexico’s main requirements in terms of talent? Q: Which values guide Médica Sur in an increasingly

A: We need higher academic standards. Our future

competitive environment?

generations will compete with future generations from South

A: We have to work in a very competitive environment, but

Korea, India and Japan, where the pressure for excellence

we will never sacrifice the safety of a patient to economic

is part of everyday life. Mexican students should demand

profitability. In our facilities, the average stay is two days, while

more rigorous programs from their academic institutions

in public hospitals it is approximately 10 days. We are also the

to compete with the rest of the world. At Médica Sur, the

only hospital in Mexico that publicly reports deaths that occur

requirements to get into our program are very high, so our

in our facilities as well as infections and accidents.

residents are increasingly better. Only students with a GPA above 9.5 can apply and we choose only 20 percent of those.

Q: How are you delivering this message to the industry?

We have around 120 residents and interns and every year we

A: We created the Médica Sur Network to share our

admit between 30 to 40 students. We also believe that the

ideal of making things better in Mexico. So far, we

learning experience and academic results are better when

have seven members and we have allies in Los Cabos,

physicians work with a small group of students.

Queretaro, San Miguel de Allende and Merida. They pay a membership fee and we share our knowledge with them.

Q: What role does Médica Sur want to play in the Mexican

This network allows us to build a common front, nurture

health industry?

better relationships with insurance companies, consolidate

A: We do not want to fit into a role; we want to become

purchases and share expenses.

an example of good processes in the national and international health industry. We want to show the industry that a health service focused on the patient is

Médica Sur is a private hospital complex. With 31 laboratories

the most profitable model and that a sense of humanity

in Mexico City, one women’s clinic and two hospitals, it is a

and responsibility are the main drivers of return. We will

member of the JCI and the Mayo Clinic Care Network. Médica

also continue moving forward with technology and social

Sur also has a Pharmacovigilance Center

developments. We are an institution, not a business.


VIEW FROM THE TOP

WHEN GENEROSITY, GROWTH GO HAND-IN-HAND JUAN GALINDO Medical Director of Christus Muguerza Sistema de Salud 49

Q: How does Grupo Christus Muguerza differ from other

per year and a two-month salary bonus at the end of the

hospital groups?

year. This creates unequal working conditions. Some choose

A: We are the only healthcare system to operate in Mexico as

to stay at Christus Muguerza because of our work ethic.

a nonprofit organization, although fiscally we still pay taxes because we are a large group. However, no partner takes any

There are also 158 postgraduate residents studying a

of the profit for themselves and profit is entirely reinvested

specialty in our hospitals. This costs the group MX$50 million

in infrastructure and community service.

(US$2.7 million) annually and it bears the full cost. Although the government pays for medical residencies throughout the

Reaching those most in need is fundamental in our day-to-

country, private hospitals receive no subsidiary.

day. Christus Muguerza works with Operation Smile and has already operated on around 500 children with cleft lips free

Q: What steps is Grupo Christus Muguerza taking to expand

of charge. In 2016, Hospital Alta Especialidad operated on 12

its reach and what are its priority areas?

children with congenital heart disease. These patients reach

A: Surgical centers are moving away from hospitals, often

our hospital through the charity Cardio Chavitos. A North-

due to costs. We have acquired an ambulatory center in

American pediatric cardiology hospital helps us with the

San Luis Potosi and there is a center being remodeled in

equipment and teams are mixed Mexican-American.

Irapuato that will begin operating as a Christus Muguerza surgical ambulatory center in August 2017. One of the largest

Hospital Conchita in Monterrey is about to start a program

primary-care centers in Monterrey will also become a surgical

in laparoscopic gynecology surgery for women with

ambulatory center and will most likely open in 2018.

gynecological problems. There will be four groups of around 16 patients. This program does not only help people in need,

In September 2017, we will begin constructing a fifth

it also enables the head gynecologist to teach others how

hospital in Monterrey, It will be the first hospital in Mexico

to operate laparoscopically. Also, Hospital Del Parque, in

to follow a lean design, built with Perkins & Will. We

Chihuahua, has five years of experience providing free spinal

created an initial design and the firm is now drawing up

surgery for children with scoliosis or deformities.

architectural plans based on our needs. I want it to be the first sustainable hospital, with a water treatment plant,

Q: How has the hospital’s nursing program developed?

energy sourced from solar panels and we are evaluating

A: Christus Muguerza is involved in two nursing programs:

whether to integrate oxygen processing, a common

one with UDEM and one with the University of Chihuahua

practice in France and Canada.

as part of its community service program. The nursing school has grown in recent years and now has around 600

In the next six months, we will begin performing complete

students, whereas in previous years it saw averages of 120-

transplants in Hospital Alta Especialidad, the largest

140. UDEM contributes to the program with its academic

hospital in our system. We will begin transplanting

value. It has long been a partner of ours as it used to own

pancreases, for which so far in Mexico there have only

the Clínica Conchita before we acquired it. We also send

been isolated efforts. This will be in partnership with the

bachelor’s and master’s students to train in the US. We

Northwestern University Hospital in the US.

understand that not all the students will return to work at one of Christus Muguerza’s hospitals but that does not matter. Nursing is rewarded unfairly in Mexico because a

Christus Muguerza Sistema de Salud is a hospital group that

company has to take charge of hiring, taxes and insurance,

operates in Mexico and the south of the US. The group opened

and is thus not able to offer the same benefits as the public

its first hospital in Monterrey in 1934, and now manages nine

sector. IMSS, however, offers nurses three months’ holiday

hospitals and 18 medical centers across the country


INSIGHT

INTERNATIONALIZATION ESSENTIAL FOR MEXICAN HOSPITALS RAFAEL ESPINO Director General of Amerimed 50

A boost in federal government support would bolster and

sick. “With more than 20 years of experience, our network has

expand Mexico’s medical tourism, creating jobs and helping

received the majority of foreign patients in the country,” says

to keep doctors from leaving for greener pastures, says Rafael

Espino. The hospital, which is focused on providing quality

Espino, Director General of Amerimed, a hospital network

services in strategic locations, has a patient profile that breaks

focused on treating tourists. “We need a coherent medical

down to 70 percent Mexican tourists and 30 percent foreign.

tourism policy. The Ministry of Health and the Ministry of Tourism should work together to promote the country’s

According to Espino, Amerimed services are mainly delivered

advantages through federal funding, better financing and

to the private sector but as one of the few well-equipped

business promotion.”

hospitals in its chosen locations, it frequently supports IMSS and ISSSTE with X-rays, CT scans, MRIs and laboratory

The lack of a cohesive policy is keeping the hospital on the

services. The hospital network also participates every year in

fringes of the medical tourism industry despite the low prices

government tenders.

and top-notch doctors and nurses that make Mexico an attractive destination to receive medical care. “The country has

To ensure its growth ambitions, Amerimed is working to

access to state-of-the-art equipment from the US or Europe at

improve quality and the number of specialties available at its

a good price, because Mexico has trade agreements with most

hospitals. It is also obtaining JCI certification for both facilities

western countries,” says Espino. “We are more focused on

in Cozumel and in Cancun. “The JCI has good recognition

emergencies or consultancies. Medical tourism, which consists

abroad and it is important for us as an international health

of programmed surgeries or treatment, represents only 3 or

service provider to be certified by the most important

4 percent of our activities,” he says.

international agencies,” Espino says. Amerimed already is certified by the General Health Council in Mexico and the

Espino says better policies could increase employment

Canadian Accreditation Council. “We are the only hospital in

and keep doctors in the country, giving Mexican cities an

Cozumel that is internationally certified. This is important since

aggregated value. He also cites changes in US healthcare

the island is a frequent destination for the main world cruise

policies such as the current US administration’s rebuttal of

lines, which like to have quality medical facilities available on

the Affordable Care Act, that could increase the number of

land,” says Espino.

US tourists traveling abroad for medical care. That number, according to Patients Without Borders, reached 1.4 million in

Amerimed is also looking forward to branching into other

2016. “If healthcare prices do not drop with the suspension

tourism locations. The company is building a boutique hospital

of the Affordable Care Act (Obamacare), Mexico will be the

in Playa del Carmen, which will have a variety of medical

first option for Americans due to proximity, the number of

specialties, an intensive care area and two surgery rooms.

facilities near the border and low prices further favored by

There also are plans to open a small hospital in Acapulco.

the peso’s depreciation.”

“This will be a new direction for the business model because 97 percent of the tourists in Acapulco are Mexicans, so the

The exchange rate, however, might favor his business. “Mexico

business will be focused on national patients instead of

could become cheaper for foreigners, therefore more tourists

international ones,” Espino says.

will be attracted to the country and the demand for hospital services will increase.”

To execute this growth, Amerimed has partnered with a private equity fund in the US and is looking for additional

Amerimed has branches in two of Mexico’s main tourist

funding to increase its infrastructure and services. “We are

destinations: Cancun and Cozumel. Most of its patients are

open to working with other private equity funds that want to

vacationers who have been in an accident or have gotten

invest in the Mexican healthcare sector,” Espino says.


VIEW FROM THE TOP

VARIETY OF SPECIALTIES SPURS GENERAL HOSPITAL AMBITION MIGUEL CASTILLO Director General of Hospital Sedna 51

Q: In which areas have you been investing?

Q: How do you work with the public sector?

A: We have been working on updating our diagnostic

A: We do work with the government and tend to many

imaging equipment. We use German machines in this area

patients through the Seguro Popular, mostly with breast

and next year we want to renew our surgical equipment

cancer. Our partner’s oncological center is also accredited

and to invest in an advanced laparoscopic surgical theater

to tend to rectal, colon and prostate cancer. We are the first

so we can offer this service. The hospital is 10 years old

hospital in El Bajio to be accredited to offer recto-colon

already and in the health industry you have to be constantly

cancer treatment. When working with the Seguro Popular,

updating. Equipment becomes obsolete and there are

a hospital must be accredited in certain specialties from

constantly new inventions to help diagnose and care for

the institution’s catalogue of services. Once accredited, the

patients. We want to offer the best service to our patients

hospital tells the institution what space it has available and

and stay up to date.

based on that, patients are sent to the hospital. We provide the same service when working through the government

Q: To what capacity does the hospital operate and what

as we do with private patients.

are your expansion plans? A: We are operating at around 60 percent of our capacity.

Q: What is the strategy behind offering high-risk pregnancy

The hospital has been expanding significantly since we

services over normal pregnancy services?

changed our focus from women to become a general

A: High-risk pregnancies are in the Seguro Popular catalogue.

hospital. From 2015-2016, we grew 50 percent and we are

There are many institutions that offer services for general

looking at growth of 30-40 percent for 2016-2017. We have

pregnancies but very few offer a high-risk specialty. Given

achieved this goal through our various client segments,

our history in gynecology, we have the experience and the

our quality of service and by seeking out doctors and

expertise, so we are confident we can offer this service. We

insurance companies that do business with us because we

do not want to open specialties in which we cannot offer the

offer much transparency. We also see doctors as clients

required service.

and we want them to enjoy their time here. They are treated with a super-personalized service and we want

Q: What are the hospital’s short-term plans?

them to know that there are many people available to help

A: We would like to continue building on our vision of

them with anything they need.

humane treatment. This begins with our people and so in 2017 we will be investing greatly in them. We also have

Q: How do you attract patients and what are the advertising

areas ready for growth and we could increase our capacity

rules surrounding hospitals?

by 40 percent. We have the space to grow and we have

A: Customer service is one of our main values and safety

140 doctor’s offices that could also grow by 20 percent. We

is our top priority, followed by service. We mostly attract

want to focus on obesity and bariatric surgery, one of the

patients with our service. We firmly believe that by providing

country’s main challenges — epidemiological alerts have

a service that is humane and friendly, patients will come back

been issued for diabetes and overweight in the country. We

to us time and time again and will recommend us. There

are building an obesity clinic at the hospital for the integral

is also the patient’s family, doctors and insurers, for whom

treatment of this condition and metabolic disorders.

we have different lines of appeal. COFEPRIS’ advertising regulations cover the entire health industry. Within that, there are rules that cover the advertising of services. As a hospital,

Hospital Sedna is a private hospital located in Mexico City

we can advertise; it is not very restrictive. More than a legal

that originally focused on female health but has expanded

restriction, we have a moral obligation to tell the truth so

to offer over 30 specialties and aims to become a general

that the business can be sustainable.

hospital offering integral services


INFOGRAPHIC

NATIONAL HEALTH SYSTEM UNDER THE SPOTLIGHT Born in the early 20th century, Mexico’s National Health

boosting competition among providers and

System has evolved through the years. Besides the widely

promoting the effectiveness of hospitals.

popular IMSS, the system now includes state oil giant PEMEX and military facilities

KPMG agrees with this needed coordination and goes even further. According to the financial services company, “a population’s health is an indispensable

faces. OECD recommendations to strengthen the Mexican

value for economic development and social welfare.” This is

health system include expanding coordination between

why better coordination between financial services firms,

institutions, aligning the standardization of processes,

suppliers, associations and institutions is required.

121 million Mexicans

POPULATION ACCORDINGAS OF AFFILIATES OF DISTRIBUTION EACH HEALTH INSTITUTION TO HEALTH INSTITUTION (DEC. 2015 IN MILLIONS) DEC. 2015 (millions)

0

and 49 percent are men. • 1 percent: The annual growth rate of the population

Population aged over 65 will grow, impacting health services

| IM

S

|

2

• OECD average:

2030

80 years

m

2020

ily

2017

IMSS affiliated population

75 years

lders

74,032,437

• Life expectancy:

t s ho

10%

7%

6

IMSS IN IN 2015 IMSSAFFILIATES AFFILIATED PERCENTAGE (2015) RA SPE RO P S-

gh Ri

10

1,824,595

10

Other public institutions

1,893,946

20

PEMEX, SEDENA, SEMAR

• 51 percent of Mexicans are women

30

Seguro Popular

Mexico in 2015

12,973,731

• 2,353,596 births were recorded in

40

IMSS

2.2 children per woman

2,189,514

50

Private institutions

60

57,105,622

70

2050 projection

ISSSTE

• 150 million:

74,032,437

80

• Implies making sure people have access to health services without affecting their finances • Upholds quality and effectiveness in promoting healthcare, as well as prevention, diagnosis, treatment, physical therapy and palliative care

Universal health coverage is a concept established by the World Health Organization.

Fa

GOING “UNIVERSAL”

|

52

As the system has grown, so too have the challenges it

Insured Workers

Insured Pensioned

Nonworkers Pensioned non-IMSS „„4.69% Pensioned „„24.16% Workers Pensioned IMSS „„0.36% Non-Affiliated non-IMSS Nonworkers „„10.71% Pensioned 30.02% Insured „ „ AffiliatedPensioned IMSS IMSS-PROSPERA „„3.41% Pensioned „„16.44% IMSSPROSPERA „„10.22% Non-Affiliated


THE STORY STARTED 112 YEARS AGO

1905

6%

Founding of Mexico's

of Mexico's GDP is attributed to the health sector

Hospital General

1917

Founding of the General Health Council (CSG) and the Public Health Department

PERCENTAGE OF POPULATION THAT WORKED IN THE INFORMAL SECTOR PER STATE IN Q416

1922

Founding of the Public Health School of Mexico

Aguascalientes Baja California

1931

Baja California South

Rural hygiene program. Vaccination, school hygiene

Campeche

and mother-child services

Coahuila Colima

1937

Chiapas Chihuahua

Founding of the Ministry of Public Assistance after the merger of the

Durango

Department of Child

Guanajuato Guerrero Hidalgo Jalisco

Social Assistance and the Board of Public Welfare

Increase in health spending

1943

US$500

Michoacan

per capita in 2016

Mexico City Morelos

Salubrity and Assistance

US$570

Nayarit Nuevo Leon Oaxaca

Founding of the Ministry of

(today the Ministry of

per capita in 2020

Health), after a merger between the Department

Puebla

of Public Salubrity and

Queretaro

the Ministry of Public

Quintana Roo

Assistance

San Luis Potosi Sinaloa

1944

Sonora State of Mexico

IMSS started providing services in Mexico City. In 1952, construction began

Tabasco

on Hospital La Raza; today,

Tamaulipas

the first IMSS Hospital

Tlaxcala

Center is among the most

Veracruz

important of the country

Yucatan Zacatecas 0

20

40

60

80

100

1960 Founding

of ISSSTE

——57.2% National average

1987 2003

Founding of the National Institute of Public Health

Founding of the Seguro Popular

CHALLENGES TO FACE The Mexican Health System has many challenges. Chief among them is a lack of infrastructure.

The bad: Rising obesity, tobacco use and chronic illness (*)

The good: Steady reduction in infectious diseases

*Cardiovascular disease, cancer and diabetes are the most frequent Sources: IMSS, KPMG, INEGI, OECD, WEF, Economist Intelligence Unit

For every 1,000 patients who need magnetic resonance imaging, there are: OECD average 3.3 medics 4.8 hospital beds

In Mexico 2.5 medics 1.6 hospital beds

53


INSIGHT

FOCUSED GROWTH TAKING MONTERREY FORWARD FRANCISCO VILLARREAL Medical Director of Swiss Hospital 54

With declining fertility rates and increased life expectancy,

or implant valves. In addition, patient recuperation after

Mexico’s population is slowly but surely aging. With a

hemodynamics is immediate as there is no surgical

more advanced age comes a host of health issues not

opening and no need to stay in intensive care,” explains

experienced in younger years, including dementia, a

Villarreal, adding that he hopes the hospital will soon be

degeneration in ocular health and a weaker heart, all of

approved to perform these surgeries.

which require care. Transplantations are also high on the hospital’s list. “After The increased need for heart care has not escaped the

hemodynamics, we would like to begin offering organ

notice of surgical hospital Swiss Hospital in Monterrey, run

and tissue transplants, mainly kidneys as they are most in

by Medical Director Francisco Villarreal. Villarreal noted

demand in Mexico and are not overly complicated,” says

an increase in the number of elderly patients in their

Villarreal. In addition to offering this further specialty,

emergency and intensive care units toward the end of 2016

Villarreal says that by 2018-2019 Swiss Hospital would

and the beginning of 2017. “Over recent months, we have

become a teaching hospital, having already reached an

been asked to offer hemodynamics.

agreement with Del Valle University

There have been so many patients

in the State of Mexico.

that we have had to channel them to other hospitals. We are now working on a business plan with investors to offer these services,” says Villarreal. The advance of the technology has

101,600 people are admitted to hospital yearly for congestive heart failure in Mexico

led to a reduction of open heart

“The number of places available in the National Medicine Exam versus the number of students is a problem, mostly of planning. We cannot create so many medical faculties if there is nowhere to train

surgeries thanks to techniques such as heart valves or

the students. Around 40,000 students graduate annually,

through hemodynamics. The Hemodynamics Society

yet there are only 7,000-8,000 places. Those 32,000

defines the science as “an important part of cardiovascular

students that do not make it go to pharmacies and open

physiology dealing with the forces the pump (the heart) has

a consultancy, earning MX$50 (US$2.8) per appointment

to develop to circulate blood through the cardiovascular

after studying medicine because there are not enough

system. Adequate blood circulation (blood flow) is a

hospitals,” says Villarreal, adding that private hospitals

necessary condition for adequate supply of oxygen to

opening up to teaching may be a type of salvation that

all tissues.” Two of the main issues in hemodynamics are

allows more doctors to specialize. In addition, he explains

hypertension and congestive heart failure and, according

that while some areas are high in demand, others are

to ENSANUT 2016, 25.5 percent or 32 million Mexican

forgotten. “Everyone wants to be a general surgeon, a

adults are hypertensive. The OECD estimates that 101,600

pediatrician, oncologist or anesthetist heart surgeon. No

people are admitted to hospital yearly for congestive heart

one wants to be a pathologist or a geneticist, for example.

failure in Mexico.

Students want the adventurous specialties like birthing. They want to see blood,” he adds.

Despite the number of hemodynamic issues, treatment has simplified greatly over the past 30 years. “By inserting a

Ultimately, the problem lies with the high number of

catheter and injecting a substance a blockage is cleared

students accepted to study medicine and the few

and the patient goes home. The process is simple and

residencies available in hospitals. “We need to reduce

easy but bears a high cost. The number of heart surgeries

the number of students accepted to study medicine. Why

has been drastically reduced, as many use hemodynamics

produce more doctors than the country needs?”


INSIGHT

QUICK TURNAROUND FOR SIMPLE SURGERIES RICARDO BOJALIL Director General of AsMed 55

The conundrum of receiving medical care in Mexico is

ambulatory accreditation. “It is a daily commitment to

this: the public sector has long wait times but the private

patient safety and security measures. We are making

sector is expensive. Mexico City clinic AsMed believes the

some changes to the plans of the building but processes

answer lies in its business model of providing ambulatory

are continually improved upon.”

and short-stay care. In addition, the clinic maintains low costs for medical AsMed’s model relies on alliances with doctors, explains

devices, buying only the equipment needed to perform

Ricardo Bojalil, Director General of AsMed. When these

the services it offers and looking for machines that have

doctors recommend a minor surgery to a patient, they

several functions. “In this way, the same machine or

both go to AsMed’s clinic to perform the procedure in

laparoscopic instrument can be used to perform different

a high-tech environment and in a short amount of time.

surgeries, especially since those we offer are not very

For the patient, the procedure is offered at a lower price

complicated,” Bojalil says. “We offer the best technology

than in most hospitals, which is also an attractive model

at affordable prices.”

for insurance companies because they would then have

There are 340 doctors registered with AsMed in Mexico City

fewer costs to reimburse. “We are continually trying to make our operations more efficient, so we can lower our prices even further, while maintaining quality, processes and certification,” says Bojalil, adding that although the clinic’s target is not the public sector, indirectly it is involved in that sphere because it works with the third party that performs hemodialysis for IMSS. “We take care of part of its

Although still small, the company is already giving back

contract, performing hemodialysis here in the clinic and

to the community. Since 2016, it has participated in

taking care of vascular access,” says Bojalil.

Cinépolis’ ophthalmological charity program Del Amor Nace la Vista (Sight is Born from Love), performing

This is a market with great potential. According to 2014

around 15-20 monthly surgeries for the beneficiaries of

INEGI figures, the value of ambulatory care services

the program. “We dedicate one or two days per month

represents almost 21 percent of paid health services in

to performing these procedures for Del Amor Nace la

Mexico, which means a monetary value of MX$190.6 billion

Vista,” Bojalil specifies.

(US$10.6 billion), 0.9 percent of GDP. This is only slightly less than the value of hospital services, representing 28

The company is validating its business model and then

percent of paid health services, MX$254.2 billion (US$14.1

hopes to scale across Mexico. “We have made some

billion) or 1.2 percent of GDP. Patients can be assured

adjustments from the first model, moving from a fully

they are receiving top-of-the-range care, says Bojalil.

ambulatory model to short-stay surgeries.” In 2016, AsMed

AsMed continuously works to maintain its accreditations;

saw around 30 percent growth. This is much lower than

the clinic will need to renew its CGS certification at the

the growth rate of 100 percent seen in past years. Bojalil

end of 2017 but Bojalil says no extra effort will be needed

explains that the clinic focused on making adjustments

because the clinic strives to maintain high standards year

and maintaining quality rather than expanding. Currently

in and year out, regardless of whether the hospital is

operating at 60 percent capacity, its target is to reach

under audit. It is also looking to receive international

80 percent by the end of 2017. It will also expand: Bojalil

validation, having recently decided to aim for JCI

says the clinic will open two new operating rooms in 2017.


VIEW FROM THE TOP

MEXICAN COST-REDUCING TECHNIQUES TO HIT EUROPE JAIME CERVANTES CEO of Grupo Vitalmex 56

Q: Which of your products differentiate you from your

In parallel, we are extending our capabilities to the private

competition?

market through focused investments.

A: The first product we offer to public institutions are personalized solutions based on specific health needs and

Another growth strategy we are analyzing is the

challenges. This product has worked well in Mexico because

development of our own clinics and hospitals with a focus on

it offers flexibility for public healthcare providers. We are

the treatment of noncommunicable diseases and minimally

working with three imaging clinics in the north and south

invasive surgery. The primary causes of death worldwide

regions of Mexico, where we are looking to improve access

are cardiovascular diseases, followed by cancer. Vitalmex is

to diagnoses for local communities. The second product we

an expert in treating these ailments and that is where our

offer is integrated services, a pay-per-procedure strategy

development plans also focus. This is a high-growth area

for elective surgeries and procedures. The hospital or

in healthcare and we are carrying out market research to

clinic pays us for completed procedures, which means

analyze possibilities in that segment.

the customer does not need to invest in fixed assets and inventories to offer health services. It is a win-win situation

Finally, we believe there are opportunities to export our

because we profit through the correct management of

business model. We are successful in Mexico and the

economies of scale in the procurement of medical devices,

healthcare challenges that we face and the given services

high logistics efficiency and high productivity with our

are similar in many countries.

latest-generation equipment. Our third product is inventory management. We are experts in transporting medical items

Q: Why expand to Europe when many exalt the

and devices. Because of the volume that we manage in 210

opportunities to be found in Mexico?

hospitals in the public sector, we offer this service to private

A: I believe that our business model is replicable in many

hospitals as well with significant reductions in variable

countries because healthcare challenges and trends are

costs and permanent availability of materials. Our fourth

similar to those in Mexico. We already have a great deal

product is the management of health centers and hospitals.

of knowledge of integrated services and believe there

Our vision focuses on three segments: infrastructure

are many opportunities to create efficiencies for existing

development for the public health system, working with

hospitals in other countries. What we offer is a proven

insurance companies to reduce the cost of premiums

model to help them reduce their capital investment

and satisfying the needs of patients at the bottom of the

costs, increase their productivity, optimize their installed

socioeconomic pyramid through micro-credits.

capacity and improve quality indicators, as well as treatment techniques.

Q: What are your expansion plans over the next several years? A: Our plans detail three strategic lines of development and

Mexico is a market with a great deal of potential. However,

growth from two main sources. The first line is to maintain

there are also many opportunities abroad, in both emerging

business with our public sector clients. The main products

and mature markets. In places like Germany, Switzerland,

we offer to public institutions are personalized solutions

the UK, France, the US and Austria, the cost of medical

designed to address the national health coverage challenge.

devices and disposables is increasingly high. In those countries, hospitals and insurance companies are looking to reduce costs and we believe that our integrated solutions

Vitalmex is a consultant that helps clients improve their business

are an attractive and proven way to do so. For example, the

model. It has three main lines of business: imaging diagnostics,

owner of 12 hospitals in Switzerland invited us to evaluate

surgery and the treatment of chronic diseases. Originally

their operations. It turned out that we could reduce their

established in Mexico, it has now set its sights abroad

costs by around 15 percent through integrated services.


VIEW FROM THE TOP

LITTLE, BUT PROMISING, CHANGE ÁNGELA SPATHAROU Partner at McKinsey & Company 57

Q: Last year, you told MHR that companies were not making

basic care. For example, access to primary care in doctors’

drastic changes in the face of global economic challenges.

offices located in pharmacies out-of-pocket. The theme of

What is your view now?

effective and timely access is vital for Mexico.

A: In both the public and private sectors, we have seen more significant efforts to reduce costs, which have taken different

Quality remains another priority issue. Different systems

forms. Organizations are delivering more consistently against

in Mexico recognize there is a lot of internal variation and

programs they have developed in previous years and are

even more variation across systems. If this is not addressed

looking forward to a tangible impact by 2018.

within the next few years, it should become a clear priority for any next administration. This is one of the important topics

In the private health provider and insurance sectors, many

people will put on the table. Leaving quality aside, there

organizations are looking more drastically to leverage digital

has been progress in cost reductions and efficiency efforts.

and advanced analytics tools. In some cases, this is generated

Many initiatives have been in the media like the consolidated

by the local market environment and led locally; in others,

purchases but there is still ground to cover.

this may be an area of focus led by headquarters that are abroad. There is definitely a step-change, meaning it is not just

Innovation is emerging, often through interesting startups, but

business as usual but quite often a part of a comprehensive

there has been much less investment in Mexico to-date than

effort to revolutionize core processes and improve customer

in other geographies. Start-ups at different levels of maturity

experience and retention. This is where digital has diverse

need to undergo different rounds of financing and access to

functionality, supporting cost reduction, growth and customer

funds for innovation in Mexico remains an issue. While there is

experience improvements.

more access to funding now than before, it is still not enough to sustain a robust market. The startup market is particularly

Q: To what extent are digital advances penetrating hospitals?

difficult on the retail side. If a model relies on consumers

A: It differs between the public and private sectors. In the

signing up and paying a small amount each month, investors

public sector, there seems to be an issue of “bottlenecking”

often find between two and three years down the line that

in many organizations in how much can be done to improve

the numbers may not materialize. The quickest avenue to

information-management systems or to introduce analytics

market is still through an institutional buyer. Recently, we were

and digital platforms on a national scale. There are often

talking to a start-up that offers micro-insurance to individual

small, grass-roots innovative initiatives in individual hospitals

consumers for healthcare services but it is now morphing

or regions, but these can only be scaled up through the

into a company providing care management products to

center. There are still problems around digitalization,

institutional buyers interested in capping their employee or

with frequent delays in core programs that go back a few

insured risk – a B2B model. Speaking broadly, there is a large

years. In the private sector, the situation is a little different.

amount of insecurity in the Mexican labor force. Consumers

Particularly, the problems of health insurance businesses in

with poor job security may not want to commit to regular

Mexico within international firms that are faced locally have

installments. The percentage of people in the private health

often been addressed in other geographies and solutions

insurance market is still relatively small; typically the largest

can be deployed at speed.

part is sponsored through employer coverage.

Q: What are the most prominent issues you have noticed? A: There is still a general issue of access through the systems,

McKinsey & Company is a global management consulting firm

both in terms of specialized care, where there are many

that serves leading businesses, governments, NGOs and not-for-

delays, and in basic access to primary care. What we have

profits. It is the largest and longest-established management-

seen is consumers finding other avenues to secure access to

consulting firm in Mexico, working in every major sector


VIEW FROM THE TOP

REAL DATA ANALYSIS IMPACTS RESULTS LUCAS OLMEDO CEO of Fligoo 58

Q: What makes Fligoo different from its competitors in

A: We often go to a warehouse and find boxes of paper,

terms of added value?

which is not organized; it is hard to find a person’s file.

A: We compete directly with IBM Watson Health. We

Fligoo strives to show impact and results in one quarter,

have close relations with the company in San Francisco

to show clients that, although they may have nothing

as we share an office. However, it did not create the

today, in one quarter they will have some data and some

algorithms or technology it uses. IBM Watson Health’s

analysis. We have scanned millions of sheets and forms.

focus is mostly consulting, so they implement a solution and then sell another and another. It will cost millions

It is true that companies see challenges in digitalizing.

and take years. Fligoo delivers a much faster impact and

They struggle to think about data when they do not even

identifies a client’s exact needs. Finally, we built all the

have digital processes. We explain we can do it all for

technology in-house. All our employees are engineers

them and structure the data. We explain it is not a huge

with a strong background in data and a lot of experience.

investment and does not take a lot of time. Thinking of Big Data, ArtificiaI Inteligence (AI) and analytics can

Q: What are the first steps to be taken in a hospital that

seem complicated for those who do not have a tech

does not have electronic medical records?

background but we can implement it easily.

A: The first step is data collection. This can be challenging in places with no digital records or prescriptions, so we

Q: How adaptable are your solutions to clients?

must analyze where the information should be taken from.

A: That is our main focus when we create a product.

Most times it is a mess, so we must recognize and identify

We know that our solutions have to be easy to integrate

the information that is available and make it digital. The

and without taking a long time to implement. A client

second step is to identify what will help a client or the

does not want to spend a year implementing a piece of

industry from the information available. Many companies

software, paying for engineers and hoping it will work.

try to begin analyzing data as soon as possible but first

Our solutions are therefore very tweakable, ad-hoc for

we must understand the company’s vision and which

each client. We ask them what they want to accomplish,

elements will help them get there, as well as identify

what is most important for them and then adjust the

patterns and key factors in the data. The third step is to

algorithm accordingly to make it work for that client.

develop the solution, the algorithm or technology that can

Technology must be able to adapt to clients that have

process millions of pieces of data and extract the most

had a system in place for 10-15 years and are reluctant to

important information to come to conclusions must faster.

change. We must make it as easy as possible for them.

Many companies say they do data analysis and that they are innovative but we truly impact a company’s results; we

Q: What is your strategy to grow the company?

try to decrease their costs, increase revenue and profits,

A: We have plans to open an office in Mexico City, another

accelerate processes and save employee claim costs.

in Barcelona and in 2018 we would like to go to Asia, perhaps to Singapore, Hong Kong or Tokyo. We will be

Q: What are the main challenges you have encountered in

investing a lot in expansion in 2017-2018 and trying to

implementing solutions? How have you overcome them?

show how good we are and how we can solve problems globally. We work in other sectors too, such as finance and banking, although healthcare represents 60-70

Fligoo is a US-based company that provides data solutions.

percent of our business. Expanding across countries and

It aims to solve complex problems and provide extraordinary

sectors simultaneously is a big challenge. We have also

results, and has the mission of democratizing world opportunities

just confirmed we will be opening new business units

through technology and innovation

for education.


FLIGOO CASE STUDIES

IMPROVING ELECTRONIC HEALTH/MEDICAL RECORDS USABILITY THROUGH SEARCH AND DICTIONARY SYNONYM DATABASES CHALLENGE

The company was able to improve the usability of all its

The client needed to improve the search

products through search speed, and reduced the number

component for all its products since it would

of mistakes in health records in less time than expected.

not deliver an accurate result unless the user

We adapted our search engine to its platforms in a way

typed the exact name, which was unusual,

that is optimized for health vocabulary, we built a database

especially for non-technicians. A mistake in

that relates the synonyms that each name has across all

a record can have an impact on a patient’s

health dictionaries and we applied machine learning based

life. The health system has a large and

on the specific user and the population to provide the most

complex vocabulary. The name of conditions,

accurate results.

medications, immunizations and diagnoses are difficult to learn and even more to spell

SOLUTION

for most people. The search engine would not

Fligoo has a proprietary search engine that combines

understand typos, partial words, words in a

phonetic, spelling and machine-learning algorithms that

different order or synonyms. The probability of

understand typos, words that have a similar phonetic

not finding the desired result was high.

composition and it is optimized to search for partial words or sentences. The expected time for development was two

OUTCOME

months, with under 80 percent accuracy, but we delivered

In three weeks we were able to predict what the user was

it in three weeks with 99 percent accuracy at 34 percent

looking for with 99 percent accuracy with three letters.

of the cost expected.

REDUCING REVENUE CYCLE MANAGEMENT COSTS WITH MACHINE LEARNING CHALLENGE

improved progressively as the machine learned about cases

The client needed to significantly reduce costs

and the company saved millions in useless billing costs.

and improve its complex and expensive health revenue cycle that employs multiple channels

SOLUTION

to collect from all payers regardless of the

A mixed in-house and nearshore Fligoo team composed

case. The management platform works with

of eight senior engineers worked on this project, applying

the cycle of claims submission, medical coding,

their expertise in the industry and with Big Data. The project

charge capturing, payment posting, denial

kicked off on-site in the client’s office for four weeks and

management services and account receivables.

was continued remotely from San Francisco and Argentina,

Even though it is a core initiative, people from

with the leaders traveling to the company’s site every four

other projects cannot be relocated and building

weeks to keep the project going almost as if on-site while

a new internal team is too expensive and would

being efficient on budget as well.

delay the process for months of useless billing costs.

We mined the company’s complete history of cases with machine learning to identify patterns among customers,

OUTCOME

cases and response behavior in the past to each stage

The solution catalogued cases into categories using data

of the cycle (answered, partially paid, completely paid,

on treatments, insurance, bill amounts and credit scores,

appealed, etc.). We were able to understand the different

among others, identified the optimum channels and

kinds of cases the company usually dealt with and built a

timing for communication and determined the maximum

model that analyzed every situation in real time to define

investment that should be made per case. Conversion rates

the optimum collection procedure.

59


The manufacturing of prolonged liberation capsules


BIG PHARMA

3

Besides better services, patients also require access to new innovative medicines, which in Mexico can take years. Due to increasingly constrained public sector budgets, the pace of purchasing expensive, innovative or new medicines is gradually slowing. As a result, Big Pharma companies have been turning ever more to the private sector for sales and growth. However, many Big Pharma companies have also been impacted by world events such as the election of US President Donald Trump, the pesoâ&#x20AC;&#x2122;s depreciation and worldwide economic and political uncertainty. Caution has become the rule of thumb for many companies.

This chapter will provide an overview of the largest pharmaceutical companies in Mexico, focusing on the economic challenges they face and how to overcome them, how they are ensuring patients have access to their products, their recently released drugs and the medicines they have in the pipeline. Interviews held with the CEOs and Director Generals of the sectorâ&#x20AC;&#x2122;s biggest players reveal how important Mexico is to their Latin American and global strategy. Insightful Q&As, informative articles and original analyses bring this key segment into focus.

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CHAPTER 3: BIG PHARMA 64

ANALYSIS: Uncertainty for the Present, Hope for the Future

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VIEW FROM THE TOP: Pedro Galvis, Merck

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VIEW FROM THE TOP: Félix Scott, Sanofi

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VIEW FROM THE TOP: Raúl Camarena, Aspen Labs

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VIEW FROM THE TOP: Rodrigo Puga, Pfizer

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INSIGHT: Mario Sturion, Janssen

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VIEW FROM THE TOP: Karel Fucikovsky, Pierre Fabre Médicament

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ROUNDTABLE: What are the Greatest Challenges Pharmaceutical Companies Face?

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VIEW FROM THE TOP: Alexis Serlin, Novartis

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ANALYSIS: Pharmaceutical Deals Completed in 3Q16 Through 2Q17 over US$1 Billion

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VIEW FROM THE TOP: Oscar Parra, Lundbeck

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VIEW FROM THE TOP: Vincenzo D’Elia, Alfa Wassermann

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INSIGHT: David López, BioMarin


ANALYSIS

UNCERTAINTY FOR THE PRESENT, HOPE FOR THE FUTURE A tough regulatory environment and the impact of a weaker

“In 2016, the Mexican health industry saw

peso are among the hurdles Big Pharma companies face in

one of its toughest years, achieving single-

Mexico but the general landscape provides optimism and

digit growth in terms of value due to the

suggests strong growth ahead

introduction of new products and price increases,” says Raúl Camarena, General

Big Pharma knows there is a growing market in Mexico 64

Manager of Aspen Labs Mexico.

– 20 of the world’s 25 top pharmaceutical companies are already here, according to ProMéxico – and they are

This situation has led some companies with interests

hungry to improve market share, introduce innovative

in Mexico to take precautions, according to Vincenzo

products and expand the country’s blossoming generics

D’Elia, Director General of Alfa Wassermann. “We have

markets. But they remain hampered by strict regulations

seen significant currency devaluation, which has lifted the

while dealing with a weakened Mexican currency that is

cost to import products and increased our operational

driving up prices.

costs. There are many services we have to cover in foreign currencies. In some cases, we have to take the loss, but

“We are a heavily regulated industry and even more so

we must also reduce and relocate resources. For example,

due to our internal compliance with government policies.

if we had three projects planned for next year, we would

In Mexico and Latin America, our time-to-market for

only go ahead with two.”

drugs is getting slower,” says Karel Fucikovsky, Director General of Pierre Fabre Médicament LATAM. He points

Despite the headwinds, the industry overall remains

to the registration process for new products as among

optimistic, partly because of the diversity of investment

the hardest hurdles with which to comply, even with

in the country. Speaking to El Universal in February

recent moves to simplify processes and time frames.

2017, Cristóbal Thompson, Executive Director of AMIIF,

“Unfortunately, we have examples of novel drugs that have

downplayed Trump’s impact on the pharmaceutical over

been in the registration process for almost six years and

the long run. “Trump has talked about repatriating plants

there is still no answer as to when market authorization

but in the case of the pharmaceutical industry it does not

will be granted. This obviously generates financial and

apply because [our industry does] clinical research. In

business forecasting issues for us, plus big questions from

addition, we attract investment from Japanese, European

our partners in Europe trying to understand the situation.”

or Latin American companies,” he said.

The companies understand the necessity for strict

THE BRIGHT SIDE

oversight but point to the need to improve access to

There is good reason to be hopeful. According to the

innovative medicines in a country that is aging and hence,

report The Mexican Pharmaceutical Industry, News,

seeing greater prevalence of chronic diseases. Further

published by KPMG, Mexico’s pharmaceutical market is

hampering their efforts is a government that has tightened

in a good position. KPMG says the segment is among

its purse strings and curbed the purchase of these drugs

the top 15 in the world and second in Latin America,

and treatments. At the same time, more substances

impacting 161 national economic sectors and providing

have been liberated, helping spur growth in the generics

74,000 direct jobs and more than 300,000 indirect jobs.

segment. “Thirty-seven active substances have been

In addition, Mexico accounts for 1 percent of the global

liberated through our generic strategy, which represent

Big Pharma market, with an impact on the country’s GDP

MX$25 billion (US$1.4 billion) in savings while an extra two

of about 6 percent.

million people can be treated thanks to these savings,” says Julio Sánchez y Tépoz, Commissioner of COFEPRIS.

Transnational companies are banking on Mexico’s industry potential and working together with public institutions

EXTERNAL IMPEDIMENTS

to empower growth in the sector. Novartis established a

Outside factors are also pressuring the sector. US President

five-year plan in agreement with the Ministry of Health to

Donald Trump, elected in November 2016, has publicly

increase clinical research. Also, the company is confident

called for lower drug prices and also targeted companies

enough about Mexico´s leadership in the industry that

doing business in Mexico, leading directly to the weakening

it is building the Novartis Center of Operations for Latin

of the Mexican peso.

America in Mexico. “This project is a great opportunity


for Mexico. Once completed, the team will grow by 1,000 associates and in two years we will reach the 500 mark,”

PHARMA CONSUMPTION PROJECTION (US$ billions) 21 5.5% compound annual growth rate

says Novartis Director General, Alexis Serlin.

20.02 On the regulatory side, there is also room for optimism, despite complaints of a snail-like pace, because companies do see progress being made in many areas. COFEPRIS, the national regulatory agency, has positioned

18.98

19

itself in recent years as one of the most influential in the 17.99

world and its international relevance is becoming more noticeable. Its processes, essential for the development of drugs such as generics, are slower than in other Latin American countries but there is one distinct advantage:

17.05

65

17

the lack of price controls. 16.16 “One of the main differences is getting products into the government healthcare system. New technology is

15.32

more easily accepted into the National Formulary in other countries. However, Mexico enjoys price freedom. This is a positive benefit for us because price controls and caps

15

2015

2016

2017

2018

2019

2020

Fuente: INEGI

in other countries have been a challenge,” says D’Elia. “With 121 million inhabitants, excellent professionals and a Many factors come into play before launching a product,

decent level of infrastructure, there should be much more

such as initial investment, research and paperwork to

clinical research in Mexico,” says Rodrigo Puga, President

achieve the patent. According to KPMG, of every 10,000

and Country Manager of Pfizer Mexico. “This does not

investigated substances, only one is produced. Given this

happen because administrative processes and institutions

situation COFEPRIS is working to speed up its processes.

delay procedures more than they should. The company

“COFEPRIS has done a fantastic job accelerating

has over 400 research centers in Mexico, although it is

processes and reducing bureaucracy,” says Oscar Parra,

still an incipient process. According to AMIIF, Mexico

Managing Director of Mexico, Central America and Andes

could be looking at a US$500 million investment in

of Lundbeck.

clinical research in the near future. Pfizer will invest US$16 million in Mexico in research in 2017.” US-based Pfizer is

INCENTIVES FOR RESEARCH

one of the world’s leading biopharmaceutical businesses.

Another major challenge Mexico is facing – but which is an opportunity for Big Pharma – is that Mexicans

Mexico’s public health sector is also extremely cognizant

are living longer. A longer life expectancy gives way to

of the urgent need to encourage people to see doctors

the chronic diseases that have become national health

earlier in the disease cycle. Its approach is to conduct

antagonists. Part of the blame for this sits with the

clinical research, speed up bureaucratic processes,

country’s population, which mostly shuns prevention and

improve transparency in the public procurement of

refuses to undergo periodic checkups.

medicines and to promote prevention programs. However, according to Sturion, there is still much work

Big Pharma companies, such as Janssen, have identified

to be done. “For Mexican healthcare, prevention is still a

this problem and are already working on solutions. “Our

hope but it is a challenging area to move in. The actions,

vision is to have a world without disease, including

resources, programs and initiatives are still limited across

cancer,” says Mario Sturion, Director General of Janssen.

the country,” he says.

“With that mindset, we created an area for disease interception. This looks at how we can intervene in the

According to KPMG, Mexico has 2.5 doctors per 1,000

pathway of the disease before it even becomes a disease.”

inhabitants, close to the average of the OECD member countries, while the projections presented by the firm on

To this end, research and development has become a key

the consumption of pharmaceutical products in Mexico

target area for many top pharmaceutical companies that

are encouraging. By 2020, total spending will be slightly

see Mexico has having the right mix of demographics and

above US$24 billion, compared to just over US$16 billion

economic incentive. But, again, regulations are a barrier

spent in 2016. Although the industry is weathering a

to what many believe should be a prosperous area.

tough period now, the future looks bright.


VIEW FROM THE TOP

WITHSTANDING THE TEST OF TIME PEDRO GALVIS General Manager of Merck Mexico

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Q: What role will personalized medicine play in

A: The structure we have implemented allows us to focus

biopharma?

on each business sector and especially on our patients’

A: This is critical. We have been working on personalized

needs and those of our customers. This latter point is

medicine for some years and we were one of the first to

key to differentiating our products and services offer. We

do so in oncological treatments. For example, Erbitux is

continuously adapt our strategy to the local environment

a product approved for treating metastatic colorectal

and work closely with our team to take advantage of

cancer and locally advanced and recurrent metastatic

existing opportunities. We have high-quality, innovative

head and neck cancer. We were among the first to

products and a truly motivated and engaged team.

implement and generate know-how of genomic testing in colorectal cancer. Depending on the mutational

Q: How up-to-speed is regulation of personalized

status of specific genes in a patient’s DNA, a doctor

medicine in Mexico?

can decide on the best treatment for that individual. It

A: There are not many challenges in the area of regulation. It

has been interesting yet challenging because it entails

has not been a critical issue. The authorities have been open

much research, education and work with physicians and

to discussing this and to integrating personalized medicine

specialists.

into treatments. It is also in the guidelines for most specialists.

Now, personalized medicine is part of our daily life. Many

Q: If regulation is not an issue, what are the main

of the products in our pipeline will also be related to

challenges that need to be overcome?

personalized medicine. Avelumab, recently approved

A: The biggest challenge we face as an industry is market

in the US for an aggressive form of skin cancer, will be

access, as our innovative products must be available to

launched in the field of immuno-oncology.

the patients who need them. Unfortunately, this situation is not good enough at the moment and is definitely below

Q: Merck is working with the Seguro Popular. To what

the international standards set for a country with the

extent is personalized medicine widely available?

size and population of Mexico. When compared to other

A: It is starting to be increasingly available. Metastatic

OECD countries and those in the region, Mexico has one

colorectal cancer was included in the Seguro Popular’s

of the lowest access indexes, so we are working on this

catalogue three years ago. It has taken some time for

through AMIIF. First we collaborated with COFEPRIS to

hospitals to get accreditation but now there are around

try to speed up the regulatory process for registration and

13-14 hospitals in Mexico that are accredited to provide

approval. Then, we worked with the CSG and together we

this treatment on behalf of the Seguro Popular. We expect

managed to improve processes. Finally, our next step will

that very soon other catastrophic diseases like multiple

be to work with IMSS and ISSSTE. There is limited access

sclerosis and Turner syndrome will also be included in the

to innovative products. There have been several budget

Seguro Popular catalogue to cover those patients in need.

cuts, the institutions were not financially viable and they were really struggling, but this is improving. While we

Q: Merck operates in many areas, some highly

understand the issues, the country needs to push for

competitive. What is its strategy to stand out in each?

health to improve productivity. Mexico’s economic situation is not that different to that of

Merck is the oldest pharmaceutical and chemical company in

other countries, as budget constraints are an issue all over

the world, founded in 1668 in Germany. It works in biopharma,

the world. We have been looking at alternative contracting

OTCs, allergen immunotherapy, high-tech chemicals and life

models and risk-sharing options, among others ideas, to

sciences. Merck has been present in Mexico since 1930

increase access to innovation.


Q: Generics have faced resistance in Mexico but

may be a lot but we continuously innovate and every year

are gaining ground. What are the advantages and

we bring out new products and technologies. Innovation

disadvantages of selling a branded OTC?

is at Merck’s core.

A: In Mexico, generics are a large part of the Mexican pharmaceutical market. Merck had a generics division

Q: What role do your chemicals play in healthcare?

that was divested due to strategic reasons, but we

A: What used to be the chemical division is now the

understand it is an option to guarantee access to some

life-sciences division. Most pharmaceutical research

products. However, the big issue continues to be the

companies and academia use our portfolio of over

quality of these products. We believe in the value of our

300,000 products, reagents, lab equipment and

brands. Our growth hormone is one of several options in

devices to solve the most difficult problems in the

the market. Ours is differentiated through the quality of

industry. We also supply raw materials, water systems,

the product and because of the devices we use, such as

biopharmaceutical manufacturing systems and regulatory

our electronic auto-injector that keeps track of patient

advice to our most important customers. The acquisition

adherence and of past doses by recording the size and

of Sigma Aldrich in 2015 significantly extended our

time of injections. Doctors can later use this device to

portfolio and our e-commerce platform.

know whether the patient is actually using the prescribed dose and how often.

Q: What will your priorities be for 2017 and for the Mexican market?

Q: What is the company’s strategic advantage over other

A: We have achieved aggressive growth over the past

companies?

four years, growing at double-digit rates, which is around

A: One of our board members once said: “We do not think

three times that of the market. The challenge after four

in quarters, we think in generations.” That says a lot about

years is to continue this growth; we are having a positive

the long-term approach this company takes in each of its

year so far and so we hope to deliver on this expectation.

businesses. Compared to other companies that are more

We are doing this through our core products, but we will

focused on quarterly results for shareholders, for Merck,

also launch new products in general medicine and cardio-

which is mostly a family company, this has been key. We

metabolic care. In 2017, it is vital to prepare for new

are in each business for the long run and decisions are

strategic launches in specialty care, such as Avelumab

not made based on immediate results but for the long

in immuno-oncology and Cladribine, a new product for

term. We say Merck is 350 years new, because 350 years

multiple sclerosis.

The size of Mexico's economy represents a potentially attractive market to pharmaceutical companies, but selling to the public institutions, some of the largest purchasers, is increasingly difficult due to budget restrictions and drug prices. With 121 million inhabitants, Mexico is the second-biggest market in Latin America. For pharmaceuticals, however, capturing that potential business is not always simple, especially in the public sector. Pharmaceutical regulations are renowned for being strict in the country and to sell a drug to the public sector it must pass three stages. First, it must be tested and approved by the regulatory body COFEPRIS; secondly, it must be approved by the CSG, which adds it to the National Formulary; and finally, it must be accepted onto a list of medicines by a public institution. After the third step is accomplished, the medicine can then be sold to that particular institution. However, institutions face shrinking budgets and an increasingly fat, sicker population, meaning they spend less on innovative or new medicines. “In the last 18 months, Seguro Popular cut around MX$10 billion (US$555 million) from its catastrophic fund, which is the budget for rare diseases and other expensive diseases such as cancer, and at the same time IMSS has not been accepting any new molecules for rare diseases in the last five years,” says David López, Country Manager Mexico of niche pharmaceutical company BioMarin. Pharmaceutical companies are finding other ways to do business by focusing on preventive solutions, selling to a different segment, creating generic versions of their products or by creating solutions so niche there are no generic or cheaper alternatives available. “Pfizer has launched its first biosimilar, a product for rheumatoid arthritis that IMSS is providing, and we are developing biosimilar versions of its five most-sold biotech medicines to be launched over the next four or five years,” says Rodrigo Puga, President & Country Manager of Pfizer Mexico.

BUDGET CUTS FORCE BIG PHARMA TO GET CREATIVE

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VIEW FROM THE TOP

INNOVATION A KEY TO PATIENT-CENTRIC CARE FÉLIX SCOTT Director General and Country Chair of Sanofi

68

Q: How does Sanofi approach patient-centric care in terms

provide patients with a solution that can return them to an

of products and therapies?

active lifestyle, especially those with conditions like multiple

A: We are convinced that products by themselves are not

sclerosis. An oral therapy might be cheaper than our solution

enough. A holistic approach that includes pathology and

but it causes more hospitalizations and is more expensive

solutions is required. It is essential to always take into

over the course of a lifetime, while an innovative solution will

account that beyond every product there is a patient. This

result in expenditures for only three years. We have patients

is very important in healthcare, especially with therapies for

who were treated with our therapies 20 years ago and have

chronic diseases. Sanofi has a broad portfolio and we are

not needed further treatments, although we continue to

Mexico’s number one pharmaceutical company in number of

follow their progress and symptoms. There is an opening in

drugs. Chronic diseases are a social concern that are related

the healthcare system to include more innovative drugs but

to lifestyle, which is why we are redefining treatment.

we must accelerate the process for chronic diseases. Many of our products are already included in the public system but we

Q: How much of Sanofi’s R&D is conducted in Mexico?

need to provide access to high-tech products and treatments.

A: We have a clinical research unit here that does research for Mexico and for some countries in the Latin American region.

Q: How does Sanofi provide healthcare professionals with

Mexico plays an important role in the implementation of

access to innovation and how does that talent benefit the

Sanofi’s clinical studies and is top-of-mind when it comes to

company?

allocating those studies. The country is among Sanofi’s top

A: We offer a continuous education platform (PAEC) that

five emerging economies and the Mexico branch ranks 10th

is the result of a cooperation agreement between Sanofi

among all global subsidiaries. Today, there are more than

and the Ministry of Health. Many Ministry of Health doctors

35 active phase III and IV studies in Mexico. The country is

are certified in the programs offered through this platform.

one of Sanofi’s most important clinical research units for

For example, we offer certification for treating diabetes. We

emerging countries. We also have a program with the Aspen

do not promote any of our brands through this platform

Institute and UNAM that is focused on native research, in

because our main objective is to increase the number of

which we sponsor research by local professionals who are

trained doctors. We have certified around 16,000 doctors

venturing into projects focused on local needs.

through PAEC in just three years. There are about 14,500 family doctors actively participating in the platform. We

Q: What pharma-economic solutions can you offer the

want to continue developing talent in Mexico and we

market to provide more access to innovative therapies?

want to increase our team’s diversity. We are interested in

A: We developed a monoclonal antibody to treat cholesterol.

nurturing talent in indigenous communities and we have

This innovative therapy is more efficient than statins, which

developed a scholarship that helps train that talent. We

are the usual treatment provided by public institutions.

also want to export talent from Mexico to Sanofi’s global

Patients treated with statins are still prone to heart attacks,

subsidiaries.

which in the end will be more expensive than any therapy. We are seeing this purchasing behavior start to change and

Q: What are Sanofi’s priorities in Mexico?

we hope that decisions begin to target innovation. We can

A: We want to continue redefining health for Mexican patients, which means making the most of all the opportunities we have to promote significant change in

Sanofi is a pharmaceutical group founded in 2004 after the

patient health through the private or public sectors with

merger of Sanofi-Sythelabó and Aventis. It is the world’s

innovation in drugs, training, support for doctors and

third-largest pharmaceutical group and a leader in research in

through scientific research. For us it is important to bring

Mexico with over 35 active studies

Sanofi’s global innovation to Mexico.


VIEW FROM THE TOP

CAST-OFFS PROVIDE OPPORTUNITY, BENEFIT RAÚL CAMARENA General Manager of Aspen Labs Mexico

69

Q: What makes Aspen Labs stand out from other companies

Aspen has bought from other labs have allowed us to revive

in the industry in Mexico? What is its main added-value?

products well known by doctors.

A: Our business model is different from that of a typical Big Pharma company. Big Pharma companies carry out R&D,

Q: What were the reasons for which 2016 was a difficult

through which they offer innovative products for certain

year for the industry?

pathologies. In Aspen’s pharma business we do not carry

A: There was a lack of innovation in 2016. Innovation in the

out R&D. What we do is buy products or brands that other

industry often causes products for high specialty needs

companies no longer want to invest in. In this way, we can

to become increasingly expensive, but we have not seen

keep costs at an accessible level for patients because we

important advances in the health sector in accessibility.

do not experience pressure to reinvest in these areas. Of course, we are a public company listed on the Johannesburg

In the private sector, access has been effective in lowering

Stock Exchange and release our financial results.

the cost and prices for patients. At the same time, it has shifted market dominance from manufacturers and the

For example, the Infacare formula was developed in South

main providers of the sector to commercialization and

Africa and we transferred that technology to our facilities in

sale points. We are seeing changes in the way clients are

Vallejo, Mexico City. As that plant produces for Mexico, Latin

approached, client convenience and of course access at

America and we are beginning to produce for Australia and

better prices. This means the industry that did not adapt

the US, the additional volume added to that plant helps

to this new model has run into problems. In Mexico, there

us reduce our costs. This means we can offer high quality

are no instruments to evaluate with certainty the value of

products to Mexican patients.

the public market. We have information from some of the big institutions, but not an overall picture.

Q: What growth have you seen in 2016 and what internal and external factors are the drivers of this?

Q: To what extent do you plan on further expanding from

A: In 2016, the Mexican health industry saw one of its

your two existing plants? What other ambitions do you

toughest years. In that year it achieved single digit growth

have for Mexico?

in terms of value due to the introduction of new products

A: Over the next three or five years, we plan on further

and price increases. At Aspen, we are seeing growth at

expanding our manufacturing capacity in Mexico in the

twice the audited market growth.

pharmaceutical segment. In 2017, we will transfer products to be manufactured in our Vallejo plant and we will export

Our pharma business is witnessing healthy organic growth

them globally.

in both private and public sectors. This is driven by our lines in thrombosis, hormones and cytokines for women’s health

Commercially, we are launching several products that

and men’s health.

will satisfy market opportunities we have detected, more specifically in pharmaceutical combinations. In the nutrition

In addition, we have a line of products that are traditionally

segment we will continue to innovate with new formulas

used in the public sector and that were not taken privately

and we will launch a new product.

in the past, such as our low weight molecular heparin. Since the end of 2015, we have been taking this product to the private sector, where it has been well received. We have also

Aspen Labs is a South African pharmaceutical company, the

launched Fondaparinux, a product used in the ER when a

largest listed on the Johannesburg Stock Exchange. Present in

patient has a heart attack and needs products like this one

over 150 countries, it specializes in OTCs, infant nutrition, male

immediately to avoid complications. Other mature brands

and female health and cardiology


VIEW FROM THE TOP

DIVERSE PORTFOLIO ENSURES GROWTH RODRIGO PUGA President and Country Manager of Pfizer Mexico

70

Q: Generic medicines are becoming more popular in

IMSS, ISSSTE and decentralized agencies. A new drug has a

Mexico and innovator patents are expiring. What is Pfizer’s

patent with 15 years of exclusivity from when the molecule

strategy to deal with this?

is discovered. It takes eight to 10 years to gain approval and

A: Access to health services is an important challenge.

introduce the drug into a market and in Mexico four to five

Mexico spends 6 percent of its GDP on health, the lowest

years for the product to be available to the public sector.

expenditure of all OECD member countries, as others spend an average of 9 percent on health. Pfizer has launched its

Q: What is Pfizer’s approach to personalized medicine?

first biosimilar, a product for rheumatoid arthritis that IMSS

A: Pfizer already has some personalized products in the

is providing, and we are developing biosimilar versions of

market; for example, our therapy for patients with ALK-

its five most-sold biotech medicines to be launched over

positive non-small cell lung cancer. In immunotherapy,

the next four or five years. Pfizer’s strategy is to participate

especially oncology, the objective is to strengthen the

in attractive segments and to target growth above the

immune system to combat cancer. Most cancer treatments

market rate. To achieve that goal, we must compete in

use biological and chemical compounds but this Pfizer

innovation. The company has 90 projects globally and over

treatment could help the immune system target tumor

US$7 billion invested in R&D. It also has a business base of

cells directly. In oncology, it is difficult to decide when to

patent-expired drugs that are still successful due to our

launch a product because it does not follow the same cycle

quality prestige. We are successful in emerging markets

as other products. Pfizer’s acquisition of Medivation will

because, although regulations have improved, physicians

enable us to strengthen our clinical research into prostate,

and patients do not trust all generics. However, we have also

breast and blood cancer.

launched a generics line, a segment in which Pfizer enjoys an average growth of 35 to 40 percent annually.

Q: What are Pfizer Mexico’s priorities for the rest of 2017 and 2018?

Q: On what pathologies is your pipeline going to focus?

A: Along with Brazil, Pfizer Mexico is a priority subsidiary.

A: The five main areas in which Pfizer is working are oncology,

Pfizer Mexico’s commercial objective is growing above the

central nervous system, cardiovascular, rare diseases and

market growth of 5 percent. The company will continue

biosimilar drugs. It is hard to say where the best results will

launching innovative medicines, biosimilars and high-quality

be, because out of every 100 projects that start in the clinical

generics. We want to continue working closely with AMIIF

phase, only one will reach the market. We invest about US$7-8

to demonstrate that investing in health is one of the best

billion per year and launch one or two new products per year.

investments in terms of economic impact. We also want to work on innovative access strategies.

Q: What is Pfizer’s strategy to sell innovative drugs to the Mexican public sector?

Pfizer Mexico will also continue innovating in clinical

A: The arthritis biotech product Pfizer introduced to IMSS

research. With 121 million inhabitants, excellent professionals

already existed and we developed the biosimilar version. In

and a decent level of infrastructure, there should be much

innovators, the challenge is showing public health institutions

more clinical research in Mexico. This does not happen

the cost/effectiveness ratio of products, starting with the CSG,

because administrative processes and institutions delay procedures more than they should. The company has over 400 research centers in Mexico, although it is still an

Pfizer is a US-based global pharmaceutical company present

incipient process. According to AMIIF, Mexico could be

in over 180 countries with a strong research focus. It works in a

looking at a US$500 million investment in clinical research

variety of therapeutic areas including oncology, cardiovascular

in the near future. Pfizer will invest US$16 million in Mexico

health, vaccines, ophthalmology and infectious diseases

in research in 2017.


INSIGHT

GAME CHANGER: STOP DISEASE IN ITS TRACKS MARIO STURION Director General of Janssen Mexico

71

Mexico has a clear and impactful chronic disease problem

drugs will play a role in this, leading cancer to become

caused, among other reasons, by the lack of prevention at

more of a chronic disease.”

primary-level care. Many are afraid to go for check-ups in case a problem is discovered, thus worsening conditions.

To work on prevention, Janssen collects statistics

There are also those that refuse to believe they are ill, shown

through its website from volunteer patients. “For Mexican

clearly in the results of the 2016 ENSANUT survey. Better

healthcare, prevention is still a hope but it is a challenging

prevention and early detection is key to changing this

area to move in. The actions, resources, programs and

panorama, something Janssen, the pharmaceutical division

initiatives are still limited across the country,” he says. In

of US behemoth Johnson & Johnson, is working on.

this sense, the company is also working on a solution for treatment-resistant depression, the stage of the disease

The company is also focusing on innovation to stop

when people begin to have suicidal thoughts.

diseases in their tracks and prevent patients from reaching critical stages. “Our vision is to have a world without disease, including cancer. With that mindset, we created an area for disease interception. This looks at how we can intervene in the pathway of the disease before it even becomes a disease,” says Mario Sturion, Director General of Janssen. “There are many studies that show that the best investment is in prevention. However, preventive solutions are still in phases that include nutrition, sports and moving around but there are no solutions developed to test populations at risk

Prostate cancer killed 6,152 men in 2014 in Mexico, 13.8 percent of all male cancer deaths

of developing diabetes during pregnancy. If detected and treated in a timely manner, this problem will never

In Mexico alone, there are more than 6,400 suicides

develop. It is too early to estimate the full impact, but it

each year, according to INEGI 2015 figures, many of

will be huge. It will be a game changer.”

which result from untreated or poorly treated major depression. “There is a critical need for drugs that can

Prostate cancer, one of the areas Janssen is working on,

interrupt the thought processes that can lead to suicide

is the most common cancer diagnosed in men in Mexico,

in patients with severe depression, particularly as most

accounting for 6,152 deaths in 2014, 13.8 percent of all

current antidepressants can take weeks to have an effect.

male cancer deaths in Mexico, according to the WHO.

This drug blocks the neuro-transmissions and the effects

That supports the importance of early diagnosis for this

are unbelievable,” says Sturion. The WHO estimates that

disease: when diagnosed in local and regional stages, the

depression affects 322 million people globally as of 2017.

survival rate is almost 100 percent, which plummets to 28

It is the first cause of disability and is a factor in suicide.

percent when detected in distant stages, according to data from the American Cancer Association.

In addition, Janssen is making strides in HIV treatment. “We produce an inhibitor called EVIPLERA for HIV patients and we

“In prostate cancer, there is also a new treatment that will

have developed a booster, PREZCOBIX, to optimize results in

be launched in one to two years. We believe it should be

patients. It will be launched in 2017,” says Sturion, adding that

prioritized at the same level as breast cancer, because

“the company is also working on the development of an HIV

prostate is the second cause of death among adult

vaccine that has shown promising results in primates in phase

males,” says Sturion. “Genomics and immuno-oncology

I trials, potentially ready in a six to seven-year time frame.”


VIEW FROM THE TOP

CHALLENGES IN THE FACE OF A CHANGING MARKET KAREL FUCIKOVSKY Director General of Pierre Fabre Médicament LATAM

72

Q: What challenges do transnational companies face in the

A: The pharmaceutical industry in Mexico has been impacted

Mexican market?

in different ways from the budget cuts and constraints in

A: Overall, market access poses challenges and question

the public health sector. In our case, the impact has lacked

marks for all players. We are a heavily regulated industry

strength because our marketed products, such as Navelbine

and even more so due to our internal compliance with

Oral, are targeted at patients with lung cancer and breast

government policies. In Mexico and Latin America, our time

cancer, both considered top national health concerns

to market for drugs is getting slower and our capability as a

regarding treatment priorities in Mexico.

transnational company versus local players at times cannot be compared.

We are fully aware that the operational and financial strategy of the authorities should be to lower the fixed

Registration for market authorization for new products is one

costs of institutions, which is the reason there is a strong

of the hardest hurdles to comply with for many companies,

movement in Mexico to substitute innovative drugs with

especially for innovative drugs and therapies, even considering

generic forms.

that the authorities have simplified processes and timeframes. Fortunately, our generic exposure is still limited in our Unfortunately, we have examples of novel drugs that have

various therapeutic segments. We agree absolutely on

been in the registration process for almost six years and

the need of generics in the market to make medicine

there is still no answer as to when market authorization will

more accessible to the whole population because we

be granted. This obviously generates financial and business

fully understand that a healthy population creates a more

forecasting issues for us, plus big questions from our partners

productive country. But there should be an examination

in Europe trying to understand the situation.

of whether transnational and national companies are competing on a level playing field, because that is not

Q: How are your sales divided between the government and

the case in some locations.

private sector? A: Of our overall business, 45 percent relies on government

Q: What new products has Pierre Fabre launched in the

sales, consolidated purchases from the main health

past year?

institutions and some decentralized organizations that are

A: Through a joint venture effort with Ferring

also within our business scope. This 45 percent is divided

Pharmaceuticals, we obtained a license agreement and

between two branches: oncological drugs for lung and

distribution rights for Lysteda, a prescription product

breast cancer and Fabroven®, indicated for patients with

indicated for patients with excessive menstrual bleeding

venous insufficiency.

conditions. Lysteda is a key product that strongly contributes to enhancing our women’s health portfolio.

The retail market drives 55 percent of our business, with our franchise products in women’s health. Navelbine Oral and

Lysteda has been on the market for over a year and a

Fabroven® are our top-selling and most prescribed products

half and has seen great acceptance among our medical

in the Mexican market. They will continue to grow in the

community and patients. This development represents

institutional segments as well as in the retail market because

an interesting approach for us because we are marketing

they have strong active promotion, investment and medical

it as a training product for physicians and use the same

and scientific fundamentals.

traditional sales channels as wholesalers do.

Q: How have public sector budget cuts affected your business

We also produce an orphan drug called Busilvex, used to

over the past year?

support bone marrow transplants. This is a one-of-a-kind


product in Mexico, as it is the only drug available in IV form.

A: Worldwide, mature products are our bread and butter.

Busilvex has been on the market for five and a half years

They allow us to continue investing in R&D globally and

and even though it does not represent large volumes for

to power ourselves in joint ventures locally.

our business it does makes a big difference in the way procedures are managed by professionals, especially when

As an example of this, Pierre Fabre has signed a worldwide

considering that patients need an exact quantity of product

agreement with Array Pharma, a big pharmaceutical

present in their bodies to be prepared for a procedure.

company, for the co-investment and development of two molecules for melanoma and colon cancer.

Busilvex is not at the core of our business strategy, but surely represents an opportunity to support our oncology

Q: What are your expectations for the next five years?

franchise development. I do not think the company will

A: We will continue to focus on our portfolio management

migrate to an orphan drugs business model. It will be

strategy, based on specific therapeutic areas: stay strong

much more oriented toward oncology, women’s health

in oncology, be a fundamental player in the women's

and dermatology.

health market and grow in dermatology and oral care.

Q: What difficulties have you faced getting an orphan drug registered in Mexico? A: Orphan drugs have different registration processes and “go to market” possibilities than conventional medicines. Perhaps the registration pathway for orphan drugs could provide faster market entry but the medication must still meet all regulatory requirements. Q: What challenges do transnational companies face in the Mexican market? A: Overall, market access poses challenges and question

Mature products allow us to continue investing in R&D globally and to power ourselves in joint ventures locally

marks for all players, be they national or transnational companies, public or private. The pharmaceutical sector

We will continue to enhance partnerships worldwide

is a heavily regulated industry, and even more so due to

and as an example of this, five months ago, we signed a

internal compliance policies, which differ on a company

licensing and distribution deal with Grupo Biotoscana, a

to company basis. In Mexico and Latin America, our time

strong and respected pharmaceutical company in Latin

to market for drugs is slowing and our ability to compete

America, for Navelbine Oral and our full oncology portfolio.

as a transnational company versus local players at times cannot be compared.

In our five-year strategic plan, we will focus on portfolio management and a solid arm of our development will

Registration for market authorization for new products

be looking for strategic alliances. We have seen in

is one of the hardest regulatory hurdles to comply with

Mexico, Argentina and Brazil that many transnational

for many companies, especially in regards to innovative

companies are suffering due to divestment strategies

drugs and therapies, even considering that there have

on their mature portfolios. They have focused on high-

been huge improvements from our authorities and that

end technology and biotechnology products without

we are on the right path to simplifying proccesses and

considering access barriers and the low rates of payers.

time frames.

Now, some of these big companies are realizing they are losing out but lack the resources to revive their mature

Unfortunately, we have novel drugs that have been in the

products that still have strong brand equity. We have

registration process for almost six years and still have no

grasped these opportunities and started partnering with

definite answer as to when the marketing authorization

some companies. We have been working with Janssen for

will be granted. This obviously generates financial and

the past three years on part of its gynecology line, with

business forecasting issues for us, plus big questions

positive results for both companies.

from our partners in Europe trying to understand our authorities’ processes and timeframes as we have invested a lot of money in those products.

Pierre Fabre is the third largest French pharmaceutical laboratory. It has two main lines of business: Pierre Fabre Médicament, which

Q: How can your company sustain growth while relying

focuses on the pharmaceutical sector, and Pierre Fabre Dermo-

only on mature products?

Cosmetics, related to dermatology and cosmetology

73


74


ROUNDTABLE In addition to the general challenges companies have faced last year, such as fluctuating exchange rates and insecurity, Big Pharma has seen revenues dip as both consumers and top national and international politicians assail the industry’s pricing methods and as patented products come under attack from a growing generics market. Mexico Health Review asked several relevant players what, in their opinion, have been the greatest challenges for the pharmaceutical industry between 2016 and 2017.

WHAT ARE THE GREATEST CHALLENGES PHARMACEUTICAL COMPANIES FACE? 75

Overall, market access poses challenges and question marks for all players. We are a heavily regulated industry and even more so due to our internal compliance with government policies. In Mexico and Latin America, our time to market for drugs is getting slower and our capability as a transnational company versus local players at times cannot be compared. Registration for market authorization for new products is one of the hardest hurdles to comply with for many companies, especially for innovative drugs and therapies, even considering that the authorities have simplified processes and time frames. Unfortunately, we have examples of novel drugs that have been in the registration process for almost six years and there is still no answer as to when market authorization

KAREL FUCIKOVSKY Director General of Pierre Fabre Médicament LATAM

will be granted. This obviously generates financial and business forecasting issues for us, plus big questions from our partners in Europe trying to understand the situation.

We have seen significant currency devaluation, so the cost to import products and our operational costs have increased. There are many services we have to cover in foreign currencies. In some cases, we have to take the loss, but we must also reduce and relocate resources. For example, if for next year we had three projects planned, we should only go ahead with two. I remember reading a report from a financial expert saying the value of the dollar would reach 30 pesos per dollar. The international environment is not friendly right now and it presents many challenges. Companies like ours have to be selective when investing and focus on finding returns. There is a tremendous opportunity for local companies

VINCENZO D’ELIA Director General of Alfa Wassermann

that can be more aggressive and gain market share.

The biggest challenge we face as an industry is market access, as our innovative products must be available to the patients who need them. Unfortunately, this situation is not good enough at the moment and is below international standards set for a country with the size and population of Mexico. When compared to other OECD countries and those in the region, Mexico has one of the lowest access indexes, so we are working on this through AMIIF. There have also been several budget cuts, the institutions were not financially viable and they were really struggling, but this is improving. While we understand the issues, the country needs to push for health to improve productivity. Mexico’s economic situation is not that different to that of other countries, as budget constraints are an issue all over the world. We have been looking at alternative contracting models and risk-sharing options among others ideas to increase access to innovation.

PEDRO GALVIS General Manager of Merck Mexico


VIEW FROM THE TOP

WORKING TOGETHER TO IMPROVE PATIENT HEALTH ALEXIS SERLIN Director General of Novartis

76

Q: Novartis has implemented a patient-centric focus. What

arthritis and ankylosing spondylitis. We also have an area

impact has this had on access to healthcare?

for respiratory conditions focused on chronic obstructive

A: This strategy has had a great impact. We are focusing

pulmonary disease, for which we have developed a

more on improving our patients’ outcomes by helping

product with a new action mechanism that has been

institutions measure results and apply effective solutions,

recognized as new paradigm in the treatment of this

which gives us a competitive advantage. AMIIF and IMSS

disease. Our fifth priority area is neuroscience. We are

are also launching a project to prioritize a group of critical

focused on multiple sclerosis but we also have treatments

diseases in which they create rules so that the different

for Alzheimer’s, epilepsy and Parkinson’s. Finally, we have

companies offer shared-risk models that can provide access

a portfolio for problems related to both the back and

to innovations.

front of the eye.

Q: Novartis has a 2015-2020 investment plan for Mexico.

We always aim to match our portfolio to the main Mexican

So far, how has it been allocated?

health concerns. Diabetes is among the diseases that

A: This plan was established in agreement with the

IMSS is currently prioritizing and we have a product to

Ministry of Health and the Ministry of Economy and it has

manage diabetes that is supported by the largest study

five pillars to accomplish over five years. One is a US$50

done among Mexican patients. We also develop solutions

million investment in clinical research in five years. Another

for diabetic macular edema and diabetic retinopathies

pillar is the creation of a Novartis Center of Operations for

and we have the market’s most integral portfolio for

Latin America here in Mexico to support all the companies

transplants.

from the group and their divisions. This project is a great opportunity for Mexico. Once completed, the team will grow

Q: What is the strategic balance between providing the

by 1,000 associates.

government with access to innovative medicine and developing generics?

Q: What are Novartis Pharma’s main therapeutic areas and

A: Novartis is one of the top three global companies for

how is the company targeting them?

innovative and generic medicine. In terms of generics,

A: We have six priority areas. The first is oncology, for

we believe we must respect patents, but once a

which we recently submitted to COFEPRIS a product

patent expires we have quality generics that open new

for monastic breast cancer that will produce disruptive

possibilities and reduce expenditure and that could be

results for the management of this disease. Second, is

used by the system to create new innovations. It is very

the cardiovascular and metabolic health segment. In

important that the population has access to all new

2016, we launched a product for cardiac failure that

products. However, the challenge in Mexico is that the

has shown a significant reduction in mortality and

investment in health is low: it is 6 percent, while the

hospitalization due to this condition, which is the main

average government investment in health among OECD

cause for hospitalization in IMSS for adults over the age

countries is 9 percent. Poor investment limits the capacity

of 65. Next is immune dermatology and also in 2016 we

to acquire new technology but we recognize that we are

launched products for psoriasis rheumatology, psoriatic

at a moment in history where the development of drugs has advanced. Therefore, in an environment of budget constraints, we have a responsibility to help institutions

Novartis is a global pharmaceutical and biotechnological

gain access to these products. We do this by introducing

company with a history that spans over 200 years. The

pharma economic models. The role of the pharmaceutical

company’s three main divisions are Novartis Pharma, for

industry should transform from being just a seller to

innovative medicine, Novartis Oncology and Novartis Eye Care

becoming a partner of the health system.


ANALYSIS

PHARMACEUTICAL DEALS COMPLETED IN 3Q16 THROUGH 2Q17 OVER US$1 BILLION M&A activity in the pharmaceutical sector has continued over

In addition to the big names and deals,

the past year, despite global fears of a slowdown due to US

investment in younger companies in life sciences

elections. The combined value of deals over US$1 billion in

continued, with the top 10 venture capital rounds

3Q16-2Q17 topped that of the previous year

in 2016 reaching a combined value of US$1.9 billion. One of the most notable is BlueRock

Global M&A activity in the pharmaceuticals sector has been

Therapeutics’ Series A Round, which raised US$225 million

slow in the first months of 2017 and the second half of

in December 2016 from investors Bayer and Versant Ventures,

2016, according to FiercePharma. Although many experts

a biotechnology investment firm. BlueRock Therapeutics will

predicted a pick-up in M&A activity in 2017, FiercePharma

initially focus on pluripotent stem-cell treatments.

reports that this is yet to materialize. Only 12 deals surpassed the US$1 billion mark in the year from 3Q16 through 2Q17, compared with 16 in the same period a year

PHARMACEUTICAL DEALS COMPLETED OVER US$1 BILLION (US$ billions) in 3Q16 through 2Q17

earlier. But the combined value totaled US$138.7 billion,

Fresenius Helios/Quironsalud

surpassing the US$120.3 value of the deals negotiated in

Takeda/ARRIAD Pharmaceuticals

3Q15 through 2Q16.

Sanofi/Boehringer Ingelheim There were two large deals completed that together account

Johnson & Johnson/Actelion

for just over 50 percent of the value of all deals over US$1

Pfizer/Medivation

billion, the largest of which went through in August 2016

Allergan/LifeCell Corporatain

when Teva Pharmaceuticals acquired Actavis. “Through our

Teva/Actavis Generics

acquisition of Actavis Generics, we are creating a new Teva

Mylan/Meda

with a strong foundation, significantly enhanced financial

Quintiles/IMS Health

profile and more diversified revenue sources and profit

New Huadu Industrial Group/Yunnan Baiyao Holding

streams backed by strong product development engines.

Allergan/Tobira Therapuetics

This is a platform that is expected to generate multi-year

Galenica/Relypsa

top-line and bottom-line growth as well as significant cash flow,” said Erez Vigodman, President and CEO of Teva in

in 3Q15 through 2Q16 Pfizer/Hospira

a press release.

Endo International/Par Pharmaceutical A second deal also hit the US$30 billion mark when

Celgene/Receptos

Johnson & Johnson completed the acquisition of

Shire/Baxalta

Actelion in June 2017. In a company press release, J&J

Shire/Dyax

announced that it expected the deal to provide value

AstraZeneca/Acerta Pharma

to Actelion shareholders, extend the geographical and

Merck/Sigma-Aldrich

commercial reach of its products while also enhancing

AstraZeneca/ZS Pharma

value for Johnson & Johnson shareholders. It will be

Abbvie/Stemcentrx

spun off into an R&D unit based in Switzerland that “will

Pfizer/Anacor

have a broad portfolio of drug candidates in clinical

Teva/Rimsa

development across four focused therapeutic franchises:

Concordia Healthcare/Amdipharm Mercury

specialty cardiovascular disorders, central nervous system disorders, immunological disorders and orphan diseases,”

Lannett/Kremers Urban Pharmaceuticals

the company said in its release.

Valeant/Sprout Pharmaceuticals Mallinckrodt /Therakos

KPMG reports that oncology is a particular area of interest

Allergan/Kythera

for companies within the biotech sector and it expects three of the top five selling drugs in 2017 to belong to the

0

sector. EvaluatePharma reports that oncology was the top-grossing therapeutic area in 2016 with global sales

„„Acquisition „„Asset Swap

of US$93.7 billion.

Sources: PwC, FiercePharma, KPMG

10

20

30

40

„„Merger „„Mixed Ownership

50

60

„„ Bought

70

55% Share

77


VIEW FROM THE TOP

MENTAL DISEASES: UNDERSTANDING AND PREVENTION OSCAR PARRA Managing Director of Mexico, Central America and Andes of Lundbeck

78

Q: How prevalent is depression in Mexico and to what

regarding patients with depression. The results showed that

extent is it on the rise?

patients were first treated for depression 10 years after they

A: The prevalence of depression and other mental diseases

first showed symptoms. Those treated earlier were able to

should be very similar in Mexico as in the rest of the

recover more easily while for others the disease became

world. I do not think the number of cases has increased.

more complex. The Danish and Mexican authorities have

The question is whether more cases have been detected.

agreed to work together and exchange perspectives on

There is a large number of people who will get some sort of

mental health issues. The Danish government is promoting

mental disorder at some point in their life and the concern

grants for Danish researchers to conduct research in Mexico,

is whether or not doctors are diagnosing them.

generally in collaboration with Mexican researchers.

The world is becoming more aware of mental health and

There are more people that at some point in their life

within 10 years depression will be the most debilitating

suffer an episode of depression than any other mental

disease, more than diabetes or heart conditions. One

disease. However, in Mexico there are many patients with

reason is that depression strongly impacts productivity,

Alzheimerâ&#x20AC;&#x2122;s, Parkinsonâ&#x20AC;&#x2122;s and schizophrenia, which is a very

firstly due to absenteeism from work but also because of a

difficult disease and patients are rarely understood.

new concept called presentism whereby people go to work but do not perform. They sit at their desk, unable to make

Q: How does the demography of these diseases in Mexico

decisions or perform their work effectively.

compare to that of other Latin American countries? A: Latin America is moving in the same direction. We

Additionally, in the case of mental diseases, the economy

are shifting from infectious disease to chronic diseases.

not only loses the person who is mentally impaired but

Before, bacteria caused illnesses but now diabetes, cancer,

also the family member who leaves their job to take

depression and coronary diseases are more prevalent.

care of this person. The annual cost of mental illness in

Mexico is a young country and the main driver for growth

Europe is pegged at â&#x201A;Ź798 billion. In Mexico awareness is

is its large population. Therefore, it is important that all

improving and for the first time there is a working group in

decision-makers in this country realize that the young

the legislative body looking at mental diseases.

population needs to be healthy to be productive.

Q: In 2016, the Table of Work-Related Diseases was

Q: How can companies work with the public sector to

updated to include stress and other mental afflictions.

prevent the young population becoming unhealthy?

How does this impact awareness?

A: First, we need to understand the issue before we fix it. For

A: There is more and more information available on

example, diabetes has been quite well researched and now

mental diseases and the government, health authorities

the authorities are doing something about it. We have fallen

and companies are realizing this is a big issue. We are

behind in other areas and we need to calculate the impact

hearing about it more now than a few years ago because

of mental disease. I think getting data on how many people

it is something we cannot hide. Recently during a visit to

are absent from work due to depression would be quite

Mexico by the Danish Minister of Health, data was presented

interesting and would help to understand the magnitude of the impact these diseases have on the economy.

Lundbeck is a Denmark-based Big Pharma focused on

Q: What are the main risk factors for mental disease? How

researching and developing solutions for neurological and

much do environmental factors influence this?

psychiatric conditions that affect people of all ages, such as

A: Urbanization and depression go hand in hand. As an

depression, schizophrenia and dementia

economy develops, the population is weighed down


with heavier workloads, we spend more time in traffic

Q: What programs are in place in Mexico to help with this?

and we produce more pollution, all of which are stress

A: There are some support programs for specific population

factors that can lead to depression. There is a correlation

segments with high suicide rates such as HIV patients,

between economic development and the development

alcoholics and drug addicts. One of the main issues with

of depression. There are other risk factors for specific

depression is that a large number of the people who suffer

diseases.

from it commit suicide. If you think mental illness does not kill, it does.

Q: What percentage of sufferers are diagnosed and what percentage of those receive treatment?

Q: Which state of the art products has Lundbeck recently

A: In general, you see more diagnoses in places like Europe,

launched?

the US and Canada, and less in Asia, Latin America and

A: We launched an anti-depressant last year that is creating

Africa. In Mexico, the likelihood of being diagnosed when

a completely new way to treat the disease. It is called

going to a psychiatrist is extremely high and almost 100

Brintellix and it not only targets the feeling of depression but

percent of the patients that are diagnosed by a psychiatrist

also the way we think when we are depressed. Depression

are treated, but few people go to a psychiatrist. The

not only affects a patientâ&#x20AC;&#x2122;s mood but also their cognitive

majority go to a general physician (GP) and so the process

abilities, which prevents them from being as productive as

for diagnosis and treatment could be lengthier.

they could be.

Visiting a psychiatrist is a big step for many people

Also, next year we will launch a product called Nuvigil for

because mental disease sufferers are more prone to

excessive sleepiness. It helps patients stay awake during the

stigmatization. For example, schizophrenia is a difficult

day and when it wears off they can go to sleep. It also works

condition to talk about because it falls out of the common

for people who want to regulate sleep patterns, such as

and many people think of depression as a weakness. Many

shift workers. This new product will have a broader range of

do not recognize depression and tell sufferers to stay

efficiency so patients will not only be awake but more alert. In

calm and go to work, but this is not the right way to deal

2018, we will market a product for schizophrenia. These will be

with it. In the first two weeks, depression is just a feeling

our new products for the next three years. Lundbeck Mexico

but after two or three weeks it becomes a biological

will be the central hub for Central America and the Andes so

problem. The neurotransmitters in the brain start working

we are excited about the opportunities our industry has here.

differently because the body is adapting to a condition. Q: How do COFEPRISâ&#x20AC;&#x2122; regulations differ to those of the Q: Which demographic suffers the most from depression?

FDA or EMA?

A: There is a high prevalence of depression in older people

A: COFEPRIS has done a fantastic job accelerating the

but it is also common in the younger population aged late 20s

processes and reducing bureaucracy. There are many

to 50s. It is becoming more frequent in teenagers and this is

differences from the other organizations. For instance in

troubling because young people should not be depressed yet

Europe you do not need to do local releases by repeating

suicide in the younger population is on the rise.

clinical testing.

79


VIEW FROM THE TOP

WAITING FOR NEW OPPORTUNITIES VINCENZO Dâ&#x20AC;&#x2122;ELIA Director General of Alfa Wassermann

80

Q: Alfa Wassermann had plans to expand its gastroenterology

presents many challenges. Companies like ours have to be

portfolio. How far along are you?

selective when investing and focus on finding returns. There

A: We have invested in product registration in this field but

is a tremendous opportunity for local companies that can

we are a little behind schedule. COFEPRIS processes are

be more aggressive and gain market share.

taking longer than we expected. In our opinion, in some cases it is requesting more information than described in

Q: How do government tender processes affect an

norms. Perhaps it is trying to show a stricter profile than

international company?

the FDA. Nonetheless, we are continuing with our plan

A: We do not sell to the government. It has been a

to launch three products for gastroenterology in 2017.

challenge for international companies to enter the National Formulary and being accepted by IMSS and ISSSTE is a

Q: In the wake of the Teva-Rimsa deal, what is the appetite

long process. People that come to Mexico have to plan

for M&A in Mexico?

for the long haul if they want to be in that business. It

A: It has become a little more difficult to find M&A

is difficult to have access and frankly for the next two

opportunities due to prices. After the price Teva paid to

years we do not foresee a positive environment because of

acquire RIMSA, many now have lofty price aspirations. But

the budget cuts in healthcare. Evidently, the government

we will keep looking for other business opportunities.

has no funds to get new technology. It is going to be a challenge to get access to the government without a

Worldwide, Alfa Wassermann is expected to expand

generics division.

its presence through smart and focused geographic investments. There is no question the pharmaceutical

Q: How does the Mexican market differ from other Latin

sector continues to face multiple challenges on many fronts.

American markets?

Despite this short-term uncertainty, I believe Mexicoâ&#x20AC;&#x2122;s

A: One of the main differences is getting products into

economy in the medium and long term will do fine.

the government healthcare system. New technology is more easily accepted into the National Formulary in

Q: Has peso depreciation affected your operations?

others countries than in Mexico. Also, the generics market

A: We have seen significant currency devaluation so the

in other countries is more stable. Here it is too young and

cost to import products and our operational costs have

is still growing. However, Mexico enjoys price freedom.

increased. There are many services we have to cover in

This is a positive benefit for us because price controls and

foreign currencies. In some cases we have to take the

caps in other countries have been a challenge. Here, we

loss, but we must also reduce and relocate resources. For

are also experiencing new models like those of Farmacias

example, if for next year we had three projects planned, we

Similares and Genoma Lab, which I have not seen in other

should only go ahead with two.

countries.

I remember reading a report from a financial expert saying

Q: What are your short-term ambitions for Mexico?

the value of the dollar would reach MX$30 per dollar. The

A: Our goal is to consolidate our presence here and ensure

international environment is not friendly right now and it

we become a well-positionned company. We will continue in gastroenterology, in deep venous diseases and in new therapeutic areas. We bought a company in Italy that has a

Alfa Wassermann is an Italian Big Pharma company focused

large cardio metabolic portfolio, which we will assess after

on R&D for a population that is living longer thanks to medical

the merger is completed. I continue to see Mexico as a long-

advances. The companyâ&#x20AC;&#x2122;s strategy is based on three guidelines:

term opportunity. We must stay open-minded and keep an

research, technology and internationalization

eye open for new chances.


INSIGHT

ORPHAN DRUGS FACE TOUGH ENVIRONMENT DAVID LÓPEZ Country Manager of BioMarin Mexico

81

Rare diseases are often difficult to treat because developing

disease treatments, while another 40 percent rely on the

medications for them is costly for manufacturers, which

Seguro Popular. However, public institutions are sometimes

can make them prohibitively expensive for patients and

reluctant to spend a large portion of their ever-shrinking

insurers. To address this problem, COFEPRIS is supporting

budgets on drugs that will treat very few patients. “In the

drug manufacturers, such as BioMarin, with simpler

last 18 months, Seguro Popular cut around MX$10 billion

administrative processes.

(US$555 million) from its catastrophic fund, which is the budget for rare diseases and other expensive afflictions

Rare diseases affect less than five in 10,000 individuals,

such as cancer. At the same time, IMSS has not accepted

but with thousands of rare diseases, millions are affected.

any new molecule for rare diseases in the last five years,”

In Mexico, 8 million individuals are estimated to have one,

says López. Patients at private institutions may not have an

according to the Mexican Federation for Rare Diseases

easier time finding relief. Most private insurers do not cover

(FEMEXER). Medications used to treat rare diseases are

rare diseases, which are considered pre-existing conditions.

called orphan drugs and their development can be costly due to the nature of the diseases themselves. BioMarin, a

There are three steps for a drug to become available in

California-based pharmaceutical company specializing in

Mexico. The first is registration, which usually takes four

orphan drugs for achondroplasia, hemophilia and several

to six months, but the second and third steps are more

types of Mucopolysacharidosis (MPS), says there are several

complicated. The second is to register the drug with the

factors that complicate their production and distribution.

National Health Council (CSG), which then adds it to the National Formulary. Finally, a purchaser, such as IMSS,

“Gaining access to treatment is becoming more and more

ISSSTE, Seguro Popular or PEMEX, must accept the product.

complex, mainly due to three reasons: cost, availability of government resources allocated to rare disease care and

Considering all the challenges to introduce orphan drugs

lack of knowledge of the authorities and doctors,” says

into the Mexican healthcare sector, regulators are trying to

David López, Country Manager of BioMarin in Mexico.

simplify the process. “COFEPRIS understands very well how

The correct diagnosis of a rare disease can be hindered

orphan drugs are developed. It never asks for a long and

by a physicians’ unfamiliarity with it, complicating the

complex clinical trial because it knows a 50-100 patient trial

generation of a patient population for clinical trials. López

requires the same, or frequently more effort and investment

says that frequently it is only after a successful treatment

to develop and it is really open to approving these drugs,”

is developed that doctors increase their awareness and

López says. Due to those small numbers, orphan drugs do

know what to look for in patients. All medications must be

not need to be retested in Mexico because the country

tested on sufferers of the condition they treat, yet for rare

accepts FDA or EMA certification.

diseases these patients can be scattered over countries and continents. For this reason, clinical trials are multinational

The result is a faster introduction of orphan drugs into

with a handful of patients in each country, complicating

the country, benefitting many patients. “There are about

logistics and raising costs.

500 patients receiving lysosomal treatment for six different diseases and the compliance rate or adherence

Providing treatment for these diseases in Mexico runs into

to treatment is just under 80-90 percent. This is very good

additional difficulties since the drugs, produced at high

when compared with that of chronic diseases,” López says.

cost and in fewer quantities, tend to be more expensive,

This will also benefit orphan drug manufacturers, which are

leaving a large percentage of sufferers depending on the

studiously working on the development of more medicines

social security system for their treatment. López estimates

to treat those patients. According to López, the future of

that 40 percent of sufferers depend on IMSS for their rare-

the market depends on continued innovation.


Production line at the Jadcherla facility


GENERICS & BIOSIMILARS

4

After overcoming initial mistrust from the public, generics are making inroads in the Mexican drug market, including private institutions, as a cost-effective alternative. A change in law requiring doctors to write the generic name of a medicine on a prescription has greatly boosted consumer awareness of prices and the efficacy of generics. Many companies focus on sales to the government, which needs to stretch budgets to cover an increasing number of patients, thus choosing generic medicines over brands where possible. In recent years however, public sector institutions have begun a consolidated purchasing process to increase efficiency and savings, which has driven prices so low companies are beginning to turn away from the single largest purchaser of generics looking for alternative business opportunities.

This chapter will present an overview of the companies that produce nonpatented medicine in Mexico, be it chemical or biotech, branded or non-branded generics and OTCs. It will explore the challenges generics have yet to overcome and the future that the men and women at the helm of the companies have in mind for these medicines, especially in light of the wave of patent expirations during 2015-2020.

83


CHAPTER 4: GENERICS & BIOSIMILARS 86

ANALYSIS: Price Pressures Pushing Generics to Private Sector

88

VIEW FROM THE TOP: Efrén Ocampo, Grupo Neolpharma

90

VIEW FROM THE TOP: Alfredo Rimoch, Liomont Laboratories

91

VIEW FROM THE TOP: Juan Aguirre, Grupo Bruluart

92

INSIGHT: Aristides Torres, Vanquish

93

VIEW FROM THE TOP: Felipe Espinosa, Laboratorios Collins 

94

VIEW FROM THE TOP: Américo García, Apotex

96

VIEW FROM THE TOP: Guillermo Ibarra, Teva

97

INSIGHT: Alexis Espinoza, AMSA

98

INSIGHT: Gurulinga Konanur, Hetero

99

VIEW FROM THE TOP: MS Nagendra, Zydus Pharmaceuticals

100

VIEW FROM THE TOP: Francisco Hernández, Wockhardt

102

VIEW FROM THE TOP: Sandeep Bane, Accord Farma

103

INSIGHT: Arístides Salazar, Emcure Pharmaceuticals

105

VIEW FROM THE TOP: Ricardo Ganem, Perrigo

106

INSIGHT: José Díaz, Micro Pharmaceuticals

107

INSIGHT: William Escobar, Grupo Unipharm

85


ANALYSIS

PRICE PRESSURES PUSHING GENERICS TO PRIVATE SECTOR Generics, a cheaper alternative to patented medications,

generic company wants to increase in size

are a key government strategy to provide healthcare for an

and importance, it must have a presence

increasingly sick population. However, pushing down prices is

in the larger markets and Mexico is the 11 th

pushing some companies to seek business elsewhere

largest pharmaceutical market in the world,” says MS Nagendra, Director General of Indian

The government’s decision to initiate consolidated

pharmaceutical company Zydus Pharmaceuticals.

purchasing schemes to buy generics as an access

86

strategy has made it one of the largest single generics

According to Seale & Associates, the Mexican generics

customers in the world. That purchasing power has been

market as a whole was worth US$3.3 billion in 2015 and

a double-edged sword, however, with prices dropping to

according to the latest available data from statistica.com,

such a point that many generics companies have stopped

generics sold to the public sector represented 59 percent

seeing sales to the government as a priority.

of units in 2014 but only 15.2 percent of value. Retail brands or private labels represent 8 percent of units and

“We hardly sell to the government because it has adopted

20.2 percent of value.

an aggressive price-reduction policy. This policy erodes income at companies like pharmaceuticals, which need

In the past, generics were seen as unreliable alternatives

to earn money to continue reinvesting in research. For

due to cultural stigma but this has changed over the

companies like us, selling to the government is not

last decade, mostly due to government purchasing

viable. We have decided to only sell particular products

preferences and increasingly strict regulation. NOM-

to state hospitals, so 95 percent of our sales are to the

220 – SSA1 – 2015 is the updated law that regulates

private market,” says Felipe Espinosa, CEO of Mexican

pharmacovigilance, a final version of which was published

pharmaceutical company Laboratorios Collins.

in the Federal Official Journal in July 2017. Such regulation helps guarantee the validity of medicines and stops unreliable drugs from tarnishing the sector's reputation. Additionally, to improve access to treatment, COFEPRIS has begun liberating the patents of groups or packets of drugs so that more affordable, generic versions can be produced and commercialized. These actions from the

Out-of-pocket expenditure dropped from 41.8% to 40.8% between 2012 and 2014

regulatory body have resulted in 491 new medicines that cover 71 percent of causes of death in Mexico. “In total, 37 active substances have been liberated through our generics strategy, producing 491 generics, which represent MX$25 billion (US$1.4 billion) in savings while an extra 2 million people can be treated thanks to these savings. In

In the 2016-2017 consolidated purchases, MX$41.9 billion

2017, we will continue with this strategy and more than 40

(US$2.3 billion) was spent and MX$3.4 billion (US$188

new molecule authorizations will be announced,” says Julio

million) was saved. Sixty-three percent of the total amount

Sánchez y Tépoz, Commissioner of COFEPRIS.

spent, or MX$23.4 billion (US$1.3 billion), was spent on generics, according to IMSS. Generics companies, those

One alternative for those that already have manufacturing

either intent on entering the Mexican market or already

plants in Mexico is to focus on private sector sales, as

established here, are adopting alternative strategies to

the margins are typically higher. “At Wockhardt we are

boost sales and to detect new opportunities for growth.

focused on the private and semi-private sectors. Tenders

The market, many say, is just too big to ignore. “Zydus

might give the perception that the government is the

is a new operator in Mexico and we are interested in

biggest market but we need to realize that most of the

expanding our operations. There are various options to

money is in the private sector. Most of us will never go to

do so and to become relevant to the market. We entered

an IMSS hospital. We prefer to go to a private hospital,

Mexico in 2013 and we want to grow both organically and

which means that private insurance policies are increasing

inorganically. There are few trillion-dollar economies in

and are becoming a benefit that some companies offer

the world, so Mexico is a huge opportunity. If any global

their employees in Mexico,” says Francisco Hernández,


Vice President Latin America of Wockhardt, a generics

GENERICS IN MEXICO

company. “We want to reach the private market because there we can promote the new model of doctor’s offices in pharmacies that many prefer because it is cheap, fast and closer to the point of sales,” he says. “In 2013, when I started operations in Mexico, the government market was 70 percent of our sales and private market sales were 30 percent. This number has changed over the years and in

Between 20122016 the price of generics in Mexico dropped 61%

37 active substances have been liberated in 14 packets Resulting in 491 new medicines That address 71% of total disease-related deaths

2016, 60 percent was private and 40 percent government.”

Lower prices have enabled the treatment of an additional 1,998,202 patients

Another option generics companies are exploring is to manufacture private labels for others, such as pharmaceutical chains or retailers that market their

And represent savings of MX$24.6 billion (US$1.4 billion)

own-brand. “The fastest-growing sector in Mexico is the private-label business, of which the largest manufacturer worldwide is Perrigo. That, combined with the trend of having doctors’ consultancies in pharmacies, socalled “doc-in-a-box” programs, is the factor boosting the private-label sector,” says Paul Doulton, Founder & Managing Partner of Oriundo, a consultancy composed of former CEOs that helps new entrants to Latin American pharmaceutical markets. Those without a production plant can do the exact opposite: to look for a company to manufacture for

THOSE RESPONSIBLE FOR PHARMACOVIGILENCE UNDER NOM-220-SSA1-2015

US$3.3 billion

value of the Mexican generics market

Registration holder

them. “One of the alternatives we are looking at while waiting to gain critical mass is to associate with national laboratories that can manufacture for us here in Mexico,”

Sanitary authorities

says José Díaz, Executive Director of Indian generics company Micro Pharmaceuticals Mexico. Health professionals

Patients

Pharmacies

Distributors

Other strategies being looked at by companies include making the most of COFEPRIS’ agreements and Mexico’s central position in the Americas to export to Central and South America and licensing products to well-established companies in the Mexican market. “Mexican requirements cover many of the demands other countries make, so if we

Clinical research centers

Warehouses

Doctors

comply with COFEPRIS we are covering other countries’ rules too. There is also fast-track with other authorities like INVIMA in Colombia, which makes it easier for us to export to other countries,” says William Escobar, Director General of Swiss-Guatemalan generics company Grupo Unipharm.

KEY DIFFERENCES BETWEEN BIOSIMILARS AND GENERICS Biosimilars Similar but not identical to

Generics Bioequivalent and identical to

reference product

reference product

Those that are committed to selling to the public sector plan to win on volume instead of on price by building or buying a manufacturing plant in Mexico, thus gaining access to an increased number of tenders. “Mexican law states that only Mexico-produced products can

20-30% discount over reference product

US$100M – US$200M in development costs

80 – 90% discount over reference product

US$1M – US$5M in development costs

participate in the largest tenders. This is why we want to construct a manufacturing plant,” Díaz says. “This is

8 – 10 year development timeline

3 – 5 year development timeline

stock elsewhere. At the moment, we can only aim for

No interchangeability or

Interchangeable with reference

the crumbs of the cake, while companies that produce

automatic substitution

what we are doing: supplying products that are out of

in Mexico take large slices.”

Sources: COFEPRIS, Deloitte, Seale & Associates

product

87


VIEW FROM THE TOP

PRIZE STIMULATES R&D INNOVATION IN BIOTECH, NANOTECH EFRÉN OCAMPO President and Executive Director of Grupo Neolpharma

88

Q: What areas has Grupo Neolpharma targeted in the last

provide us with a smaller mechanism that would let us break

12 months?

through this barrier. By allying with CONACYT and using

A: We have just completed construction of the plant

its methods of diffusion, if something could be useful for

area in which we will be producing nanotechnology. We

other laboratories they can come to an agreement with the

are moving our production capacity for pilot batches of

council. This also enables us to approach others directly.

biotechnology products there and we are also increasing

It is much more concrete and there are fewer risks when

investment so that all pilot production is carried out under

approaching someone.

GMP conditions. Q: What new heights would nanotechnology enable the Q: What is Grupo Neolpharma and CINVESTAV’s prize for

pharmaceutical industry to reach?

innovation in bio-nanotechnology?

A: Nanotechnology is a technique that can be used to

A: Biotechnology and nanotechnology are two lines in

produce medicine. If a medicine that causes unwanted

which we are interested in stimulating research. The prize

side-effects is made using nanotechnology, those effects

was linked to pharmacology but it is now more open as it

can be reduced instead of damaging the stomach or liver.

has enabled the creation of new materials. The invitation to

Therefore, it is most useful for eliminating the side-effects of

participate is open to all the institutions and professionals

already approved medicines, such as in oncology. Basically,

working in those disciplines and the prize is MX$300,000

nano-capsules can reach cells and they enable the use of

(US$16,666). Half of the award is to reward the researcher

smaller doses. Our innovation in this area is focused on

and the other half is to fund the continuity of the winning

oncology and diabetes.

project. The purpose of the prize is to create new talent, provide exposure and increase the diffusion of these kinds

Q: What solutions is the group providing to the Mexican

of scientific proposals. We are approaching 2016’s winning

health industry?

researcher to ask for his help capsulating some drugs we

A: We must first develop medicines and provide it to the

want to deliver to the limbic part of the brain. He could

greatest number of patients possible. In our case, this


implies a national cost, which determines the price. We have

Q: Where do you rank Mexican talent globally? Is it

done this with our product Transkrip, the patented version

prepared for the rapid changes occurring in companies?

of which costs six times more. Our body is constantly

A: There are no problems with talent for making

defending itself against attacks and when certain cells get

biotechnological medicine in Mexico. We should look

infected, they no longer work as well. Transkrip activates

at Denmark and Sweden, where they have recognized

our cells to better absorb the medicine and in some cases

through studies that biosimilars do not have more adverse

it also reactivates the immune system. TransKrip is a drug

effects than innovative products and that they have the

based in epigenetic therapy that increases the progress-

same therapeutic benefits. We must focus on the resulting

free period of patients with advanced cervical cancer.

benefits in terms of cost once the patents expire.

Currently it is used for cutaneous lymphoma of T-cells and myelodysplastic syndromes. We are completing a project

Q: How is the groupâ&#x20AC;&#x2122;s growth oriented?

on the application of this technology for lymphoma in D

A: By 2020 we want to reach 100 percent growth in

cells. In some cases it has 100 percent efficacy and there is

comparison to where we are now. We have already achieved

a fast therapeutic benefit.

a respectable size in Mexico and other strategic foreign markets so we are confident we will be able to meet this

Q: Where is most of your R&D being carried out?

new expectation. Toward the achievement of this goal we

A: I am looking to mix research by stages, to do some in

have increased our presence in the oncology and metabolic

Mexico and some in the US. There is an innovation and

areas with our biosimilar offer. In the future we want to grow

development research center called Cediprof in Puerto Rico,

in therapeutic areas and begin producing patented and

a site that allows some of our research to be conducted in

high-efficiency treatments, while increasing our sales force.

an FDA environment. This is a strategy we want to extend to other Mexican companies that are working on innovative

Q: What is Grupo Neolpharmaâ&#x20AC;&#x2122;s message to the industry?

projects, so they can develop the early research phases in

A: Grupo Neolpharma wants to coordinate the efforts of the

Mexico and then conclude their research in Puerto Rico

research institutions, the laboratories and the government

without a major investment. This will create fiscal benefits

to lead the Mexican pharmaceutical industry to an

and empower research.

international level. The industry has to keep in mind Mexican epidemiology and which technologies could lead us to the

Q: What opportunities will IMSS opening to clinical

best medicines for the Mexican population. However, this will

research bring for Grupo Neolpharma?

only be possible with a confident attitude that overcomes

A: That is extraordinary because it is where the most patients

the financial challenges we might encounter in the process.

are. For example, the application of the D-cells treatment is valid only for a small number of sick patients with those characteristics. IMSS is where most of them are. In the INCan,

Grupo Neolpharma is a Mexican group that comprises

the process of incorporating the number of required patients

several pharmaceutical companies: Alpharma, Neolpharma

was long. However, with IMSS we can more quickly identify

and

people with a certain condition and deliver the product.

commercialization and distribution

Psicofarma.

It

specializes

in

R&D,

manufacturing,

89


VIEW FROM THE TOP

BIOTECHNOLOGY, THE SCIENCE OF THE PRESENT ALFREDO RIMOCH Director General of Liomont Laboratories

90

Q: What are Liomont’s most important contributions to the

amount to 6 percent of the company’s income. In terms of

Mexican pharmaceutical industry?

regulations, clinical trials have become more complex and

A: Liomont has about 2.7 percent market share and has

expensive. We need transparency and support in terms of

brought products to a broader range of the population.

intellectual property and regulations.

We have created a number of alliances with academic institutions such as the Institute of Biotechnology of UNAM

Q: What are the challenges associated with introducing

and the National Genomics Laboratory for Biodiversity

biotech medicines to Mexico?

(LANGEBIO) of CINVESTAV. Liomont is an active

A: It is an expensive process that we have approached

participant in associations such as ANAFAM, CANIFARMA

through two different routes. The first is by allying with

and the Mexican Pharmaceutical Council (CFM). We

foreign companies such as Oncobiologics and another one

have entered the field of biotechnology with the first

in Spain. We are also preparing some of the test designs,

recombinant influenza vaccine and we are working on the

while some of the protocols are being approved by

development of an anti-zika vaccine in collaboration within

COFEPRIS. The second approach is through alliances with

an international consortium that includes companies from

local universities. Liomont creates projects with scientists

Argentina, Brazil, Japan, the US and Mexico.

from academic institutions. The government has limited funds but it is the main buyer of biotech and high-specialty

Q: At what stage of development is the zika vaccine and what

drugs in Mexico. Liomont must achieve accessible prices to

testing does Liomont do in Mexico?

supply the demand for these products in the public sector.

A: Clinical trials for the zika vaccine will start soon through a program with a partner company called Protein

Q: How does Liomont compete in the generic business with

Sciences. Liomont has started an important clinical trial

pharmacy chains that develop their own brands?

of its influenza vaccine in Mexico with children between

A: Physicians know Liomont’s products, they trust our

six months and 18 years. We are developing two biosimilar

brands and prescribe them. However, pharmacists often

products together with the company Oncobiologics.

substitute the prescribed product for a generic house brand.

The phase I clinical trials for those products have

A change in the Regulation of Health Inputs requires doctors

already concluded. We have also developed another

to prescribe an active ingredient, as well as a brand, which

monoclonal antibody in collaboration with the Institute

has boosted consumer awareness of prices. Nevertheless,

of Biotechnology of UNAM.

Article 79 of the same regulation states that if there is a substitution, this must be authorized by the physician who

Q: What sector presents the greatest opportunity for

wrote the prescription. If not, the product supplied must

Liomont?

be the brand as prescribed. Our main strategy to prevent

A: Liomont is mainly present in pain, respiratory,

generic substitution is based on the doctors associating our

gastrointestinal, antivirals and antibiotics. In terms of

products with quality and trust, so that their prescriptions

economic sectors, Liomont is mainly focused on the private

are supplied as they are issued, and not substituted.

market. Even though 40 percent of Liomont’s products are destined for the public sector, sales in this sector only

Q: What are your development plans in the short term? A: Liomont will continue marketing the trivalent version of its biotech influenza vaccine while filing with COFEPRIS for

Liomont is a Mexican pharmaceutical company with high quality

the tetravalent version that will be sold in 2018. Liomont is

products in the prescription and OTC segments, currently

building a manufacturing and distribution site in the State

occupying the 8th position in the national pharmaceutical

of Mexico. In the area of generics, Liomont will be launching

market in units

around six new brands in Mexico each year.


VIEW FROM THE TOP

PUSHING PATENTED MEDICINES INTO THE IMPULSE CHAIN JUAN AGUIRRE Commercial Director of Grupo Bruluart

Q: How is Grupo Bruluart working to make patented

A: We are working on these liberated molecules. COFEPRIS

medicines more widely available?

has developed a useful strategy based on risk assessment

A: One of our biggest projects has been pushing lines of

and this patent liberation makes the register of new and

patented medicines into the impulse chain. Besides the

generic products more efficient. We can now get generic

old big distributors, there are several pharmacies, clinics

drugs to market much faster and even expect to release

and other retailers where patented drugs are sold. It was

between six and eight products this year from the packages

thought the most economically challenged social group

of 2016 and 2017 in hormonal treatments, some in painkillers

would not buy patented medicines because of the high

and anti-inflammatories.

price but some prefer to acquire medicines at their local pharmacy.

These areas were chosen because we have noticed that painkillers and anti-inflammatories have undergone a

Q: What were the advantages of being ready six months in

similar process to that of antibiotics in the past. People

advance before the change in NOM â&#x20AC;&#x201C; 059 in 2016?

have become accustomed to consuming them without a

A: It helped us get ahead and minimize the effort needed to

prescription, developing a higher tolerance to painkillers, so

comply with the standards. Since we were ready, the number

we expect the new molecules to have a more efficient effect.

of topics we had to cover once the norm was approved was small so we did not have to dedicate many resources to it

Q: What are your ambitions and plans for 2017?

to comply. We also founded the Instituto de Farmanegocio,

A: We have already expanded production at our plant, partly

through which we provide an integral advisory service,

due to COFEPRISâ&#x20AC;&#x2122; regulations. We are complying with all

guiding our clients step-by-step to meet COFEPRIS, SAT and

these regulations and are ready to continue our growth in

other regulatory requirements. Some of our customers are

the manufacturing business through development of more

taxed according to the small contributor regime. As a result,

products. We are looking for new international ventures for

the taxes of those companies are sometimes in disarray

products we sell in large volumes, such as paracetamol or

and they fail to meet regulations. We have convinced and

diclofenac, which in Mexico are largely sold as commodities

advised several customers to fix their fiscal situation so they

and have a better margin elsewhere.

can access various benefits and minimize the risk of not meeting fiscal and health regulations.

On the commercial side, Farmacias GI has a new image and an aggressive expansion plan that includes the launching

Q: To what extent do your products target specific niches?

of a new media campaign. In the distribution business, our

A: We started selling generic drugs that target the general

goal is to train independent pharmacies. Many of these are

population, such as painkillers, multivitamins and antibiotics.

important to rural communities and underdeveloped parts of

Now we are specializing in the hormone niche, especially

the country. We are also expanding our business by visiting

in contraception and hormonal care, because there is

convenience stores and large national chain pharmacies to

less competition and only a few can develop injectable

address a renewed interest in our products in sectors that

contraceptives and hormone drugs. There is a learning curve

traditionally were not attracted to generics but now cannot

with hormonal medicine so we have been focusing on these

get enough of them.

areas for around two years. It is difficult to come up with a market percentage but we manage three of the top 10 products in the public sector.

Grupo Bruluart includes the importer and manufacturer IM Bruluart, Laboratory Bruluagasa, generics company Brudifarma

Q: COFEPRIS is liberating several packages of innovative

and pharmacy chain Farmacias GI. Its goal is to make high-

medicines. How is that affecting Grupo Bruluart?

quality medicine accessible to all

91


INSIGHT

SPECIALIZED APPROACH TO ACCESS THE PRIVATE SECTOR ARISTIDES TORRES Director General of Vanquish

92

In Mexico, the main health concerns are a national public issue

National Institute of Geriatrics, around 800,000 people in

demanding attention from all players in the industry. As a

Mexico are suffering from Alzheimer’s. The company is also

result, national pharmaceutical companies such as Vanquish

commercializing a drug for Huntington disease, a progressive

are shaping their business units to assist the Mexican needs.

brain disorder. “We have the only orphan drug in the country: a product approved by the FDA to treat Huntington and

“Our institutional portfolio deals with cardiovascular diseases,

similar diseases that guarantees 85 percent efficacy,” Torres

CNS, some endocrine issues and antiretroviral drugs for HIV.

says. According to the National Institute of Neurology and

Our private line is specialized in women’s health and abnormal

Neuroscience, in Mexico there are around 8,000 people

conditions like Huntington's, Parkinson’s, and Alzheimer’s,”

suffering from Huntington's and other similar diseases.

says Aristides Torres, Director General of Vanquish. Expiring patents offer the manufacturer another avenue to The company’s current product distribution is 90 percent

expand its base of therapeutic alternatives. “We have recently

generics and 10 percent innovative. However, it expects to

started a portfolio of all generics whose patents are about to

grow its patented medicine area. “Our initial intention was

expire and we are working with a combination of products

to have a 50/50 split between the public and private market.

that today are generics and could have therapeutic benefits

Probably the private is harder to reach but we expect at

for the diseases we are focused on,” says Torres. Vanquish is

least a proportion of 60-65 percent against the rest of the

pursuing the patent for Tenofovir, which is a component of

market,” says Torres. Its strategies for private-sector players

Atripla, the most important product in treating HIV. “It is the

include boosting its portfolio options, targeting neurology and

main therapy used by CENSIDA. It has the biggest demand in

women’s health. Vanquish’s business objective is to achieve

the country.” According to Torres, no company in Mexico has

growth between MX$1.5 billion (US$83 million) and MX$2

a complete antiretroviral portfolio. “We want to manufacture

billion (US$111 million) in revenues by 2019.

and commercialize it, so we can offer a complete service to institutions and create greater access at reduced prices.” The

Vanquish is the first pharmaceutical company to bring a patch

goal is to provide a generic line that could work well with the

therapy system for Alzheimer’s to Mexico. According to the

government’s tighter budget.


VIEW FROM THE TOP

CAUGHT BETWEEN DEVELOPMENT AND REGULATION FELIPE ESPINOSA CEO of Laboratorios Collins

Q: What hurdles do Mexican generics companies face when

expertise can refine their offering and make their businesses

trying to supply the government?

more profitable. We want to make health products more

A: We hardly sell to the government because it has adopted

affordable for the general population so people have

an aggressive price-reduction policy. This policy erodes

options. We also expect this to help us reach the objective

companies like pharmaceuticals, which need to earn money

of 1 percent market share.

to continue reinvesting in research. For companies like us, selling to the government is not viable. We have decided to

Q: To which Central American countries are you planning

only sell particular products to state hospitals, so 95 percent

to export to and what criteria do you use?

of our sales are to the private market. Any business on which

A: COFEPRIS has done a great job becoming an international

we do not make a 20 percent margin is not viable for us.

regulatory agency, which has allowed us to open borders. The first criterion is to select those countries that recognize

Q: Collins has said it is targeting 1 percent market share of

our sanitary regulations with no extra paperwork needed.

generics in Mexico in five years. What are your next steps?

Many of our products are already available in Chile, for

A: In this changing market, five years is a long time. Beyond

example. The second criterion is the size of the market,

that time frame is unpredictable but we plan to penetrate the

leading us to be interested in Colombia and Costa Rica.

market to 1 percent and then change the type of business we manage. We work in pharmachemical generics but in five

Argentina and Brazil are not priorities as the latter is

years we would like to enter the biosimilars market. We also

protectionist and the former has economic issues. Colombia

would like to enter the oncological sector because it is more

is the second most important market after Brazil to which

profitable and sells in greater volume. Biosimilars already

we already export a little but we paused this because the

exist in Europe but many problems with sanitary regulations

Mexican market demands our entire production; it has

remain, which has impeded biosimilars from developing

grown significantly so we are 100 percent concentrated

worldwide. These problems appear close to being resolved

on it. Once we have expanded industrially, we will continue

and once they are, biosimilars will develop quickly because

to export, which may merit us building an annex to our plant

many companies in Europe and the US are moving rapidly.

in Guadalajara. Next to the plant there is a land plot that

Here in Mexico, some companies like ProBioMed, Cryopharma

we are clearing and preparing for expansion. We hope to

and Silanes have undertaken extensive research but have

begin building in the first quarter of 2017.

not advanced further due to uncertainty with regulations. There is still no fixed date for this to conclude because so far

Q: What other short-term plans do you have for

COFEPRIS has mainly focused on revising technical aspects.

Laboratorios Collins? A: Within the group there is another subsidiary called

Q: What results are you expecting from your joint venture

Salud Natural that has a naturist focus and markets herbal

with FEMSA?

products. We hope to obtain the GMP for Salud Naturalâ&#x20AC;&#x2122;s

A: FEMSA wants to enter the Mexican market with 1,000

plant. It would be the first natural product plant in Mexico

pharmacies and began acquiring units three years ago. It

to obtain a GMP and would allow us to export products to

established strong relationships with commercial partners

the US, which is another objective for 2017.

and we were lucky enough to be selected. The relationship is just beginning but is going well and we are working on becoming one of their main laboratories. Our goal with all

Laboratorios Collins is a Mexican pharmaceutical group

our partners is to bring our experience and knowledge to

with 47 years in the market focused on the manufacturing of

the table. Sometimes we can suggest a product they do not

high quality medicine at affordable prices. Its main areas of

have in their portfolio and generally our laboratories and

operation are generics and veterinary care

93


VIEW FROM THE TOP

GENERICS FIGHT BRAND BIAS AMĂ&#x2030;RICO GARCĂ?A Director General Latin America of Apotex

94

Q: What is Apotexâ&#x20AC;&#x2122;s strategy for launching its products

bidding process will make some distributors stronger than

in Mexico?

they already are and that concerns me. For example, a hospital

A: Over the past 12 months we have been first to market

far away in Hermosillo may request a product within 24 hours.

for mometasone, a nasal spray for rhinitis and allergies;

For this, we need to work with a distribution company that

diosmin-hesperidin, for chronic venous insufficiency;

has its own center because Mexico is five times the size of

leflunomide, on the side of rheumatoid arthritis and we

France and we cannot deliver any given product anywhere

are now launching tramadol-paracetamol, a painkiller for

in the country within 24 hours. To become more efficient,

moderate to severe pain. We are reshaping our strategy

healthcare providers are ditching their warehouses and we

to be more active and efficient in product launches. The

are becoming their warehouse. We also must have different

company is targeting different opportunities in the generics

logistics partners because some prefer to work in certain

segment and launching a broad portfolio in CNS products,

therapeutic areas or in specific regions. Ahead of a tender,

which comprises antipsychotics and antidepressants, among

they want a letter of endorsement that says we will supply

others. We will launch over 25 products in three years through

them with a certain product if they win. We sign with the

a full portfolio with a different strategy targeting physicians,

minimum volume and price and if they win the tender, we sell

which is unusual for Apotex. The company will also introduce

the product to them. Some tenders are national, international

some branded products rather than simply generics to

or mixed. It is not that they actually want to bring in someone

complement our product lines. The use of generics in Latin

from the outside but it happens that no local company can

America is different to North America and Europe. It is still

meet the requirements. We participate as a national company

generally a branded market. Bioequivalent products are

if the product is manufactured in Mexico and international if

not available in every Latin American country for example.

it is manufactured in Canada or India. Products made in India

Patients associate brands with quality so, despite the quality

are more problematic because the tender process generally

of bioequivalents, there is still a preference for brands. We

does not accept these, perhaps because the government is

are catering to the demands of the market.

not confident about the quality.

Q: Why do generics generate this level of resistance?

Q: How is the authorized third-party system working?

A: Generics have come a long way. Initially regulation was

A: It works well. It costs money because we have to pay for the

not so strict, so in those days there were products that

service but we get faster approvals. It is beneficial to us and to

did not comply with international quality standards. This

patients, who get new products sooner, and puts lower-cost

bias still exists but regulation is now stricter. COFEPRIS is

generics on the market faster. Some Big Pharma companies

overwhelmed with the work of auditing all manufacturers

are trying to extend IP protection, looking for opportunities

and ensuring the stricter requirements are properly covered.

in the legal framework. As patients and consumers, we

This is an issue and some will be left behind because they

should not allow this. At Apotex Mexico we respect patents,

cannot keep up with rising standards. They would have to

of course, but they should not be extended for reasons that

invest a lot of money to catch up.

do not represent real invention.

Q: What problems do you see with the bidding process

Q: How much R&D is done in Mexico and how important is

established by the government?

that to the development of your business?

A: It changes constantly. At the moment it is talking about

A: Most of the R&D is performed in Canada but our Mexican

packages, which we are still trying to understand. Packaging

research complements our efforts in R&D and is more focused

is more complex because it is not possible to have every

on local needs. Canada focuses on the big markets like itself

product. There are some requirements that are impossible

and the US, while in Mexico we look at Latin American

for us to meet so we need to use distributors. I think the

opportunities to complement them. We have developed 55


95

View of a blister packing and conditioning assembly line

products in our local facilities and many more in Canada.

Republic, Chile, Argentina and we are about to close a deal

In Mexico, we invest 6 percent of sales revenue in R&D and

for Colombia. The generics segment will remain one of the

4-6 percent more in renewing equipment to improve our

main sources of growth for Mexico. We will continue to expand

technology. Canada invests a much higher percentage.

to new therapeutic areas, such as prescription. We will start with CNS over the next three years. It will take us that time to

Q: What types of drugs are researched in your Mexican

gain the relevance we want to have in that area and then I will

facility?

jump to another therapeutic area. Apotex has been a leader

A: I have been working on getting back to basics, reshaping

in Mexico since it entered the country. We are celebrating

the organizationâ&#x20AC;&#x2122;s main activities, and then working a

20 years here and 41 years in Canada. We are one of the few

little on the strategic view of where we are going. Over

vertically integrated companies, with two API manufacturing

the past few years we have been focusing on doing things

sites in Mexico. For 60 percent of our products manufactured

better rather than on specific therapeutic areas, except for

in Canada, the APIs come from our Mexican sites. We are

the CNS line. What we are doing now is aligned with the

committed to this country like no other company.

opportunities we see to penetrate segments in which we do not yet have a presence.

Q: How does the legal environment protect generics companies from litigation in Mexico?

Q: Has the peso depreciation affected your operations? How

A: We still have to work on this. We need to get together and

do you mitigate currency risk?

be more visible to the authorities to make sure we are being

A: It has affected us, of course. We try to not transfer the full

treated fairly. Being close to the US in general helps because

impact to our customers. The company is absorbing some

we want to be recognized as a highly regulated country that

of it by developing efficiencies. Some we are tackling now,

can manufacture products that can be sold everywhere. As

improving efficiencies and productivity. We are also trying

we deliver on that, it becomes easier to build trust.

to develop the export segment because we export in a hard currency. When reviewing market figures, it is possible to see

Q: How has the wave of patent expirations benefited Apotex?

that Apotex is not raising prices as quickly as inflation or in

A: The products I mentioned for which we will be first to

line with the currencyâ&#x20AC;&#x2122;s depreciation. My view is that we will be

market have expiring patents and we are using the opportunity

depreciated, but with the fundamentals under control it will be

as soon as we can. This is happening across therapeutic areas.

strategy more than a consequence. We export a good number

For the CNS line, it will be branded so we do not need to

of our Mexican manufactured products to South America. We

launch the product as soon as the patent expires. For generics

negotiate most of those sales in dollars, which mitigates the

however, it is vital to be first.

effect to a certain extent. Q: What expansion plans do you have for the coming years?

Apotex is the largest Canadian-owned pharmaceutical company,

A: We manage the LATAM region from Mexico. Now we

with over 10,000 people employed worldwide in its research,

have three affiliates in Panama, Nicaragua and Costa Rica

development, manufacturing and distribution facilities. The

and we already have partners in Guatemala, Dominican

company produces around 300 generic pharmaceuticals


VIEW FROM THE TOP

BRINGING INNOVATION TO THE ENTIRE POPULATION GUILLERMO IBARRA Director General of Teva Mexico

96

Q: What are the challenges associated with operating in

to balance the products we bring from Teva Global with

so many different therapeutic areas?

the needs we see in the country.

A: The biggest challenge Teva faces is to follow people through all the stages of their life. We are present in several

Q: Quite a bit of your pipeline is in pain and respiratory.

areas, including CNS, women’s health, pain, multiple-

What market need does this respond to?

sclerosis and oncology; our goal is to give patients access to

A: Pain is the number one cause of medical consultations in

innovative pharmaceutical solutions at an accessible price

the world, including Mexico. Patients go to doctors because

across the countries we work in. We want to contribute to

of symptoms and one of the primary symptoms is pain.

generating greater access to healthcare worldwide.

Because of this, pain is something that we at Teva take very seriously. We want to offer patients choices that include

Q: How does Teva operate in both the public and private

innovative combinations to make them feel better.

sectors and how does it choose which areas to focus on? A: In Mexico, we take part in the public sector by selling

Q: Eritropoyetina theta was recently brought to Mexico.

products to the government and health institutions by

What are Teva’s expectations for this product?

participating in government tenders. In the private sector

A: An area in which Teva is innovating is in its oncology

we participate through chain pharmacies, self-service

supportive care portfolio. So far, we have brought

retailers, distributors and local and regional wholesalers.

two innovative molecules to Mexico. Eritropoyetina

Finally, a company must choose its therapeutic areas based

theta, which helps patients undergoing chemotherapy

on its R&D capabilities. Companies must deliver products

treatments improve their levels of red cells by treating

that provide value for the payer, the institution, the patient

secondary anemia that results from chemotherapy. The

and the doctor.

second molecule is Lipegfilgrastim, which treats febrile neutropenia (fever and low white blood cells). Both

Q: How much R&D does Teva do in Mexico?

products are extremely important for patients undergoing

A: Globally, we have 26 R&D centers. In Mexico, our products

chemotherapy because they allow them to continue with

undergo bioequivalence testing with patients through

their treatment without having to suspend due to negative

authorized third parties. In addition, we have participated

effects. Some state institutions have already begun using

in phase III and phase IV studies here in Mexico.

these products, which suggests that we are on the right track. We want to have these products included in the

Q: How do you choose which products to bring to Mexico?

National Formulary in the future.

A: There is a selection committee in which medical, commercial and business development perspectives

Q: How many of Teva’s products are included in the

are taken into account. The country faces chronic-

National Formulary?

degenerative challenges and there is a change underway

A: We participate every year in the public tenders held

in the population pyramid. Twenty years ago, the common

by the government through IMSS, ISSSTE and other

problems patients faced were mainly infections; today, we

institutions. Regulation has resulted in many benefits

face chronic and chronic-degenerative diseases. We try

for both patients and the government. We can compete because we have the necessary scale to offer competitive prices, a network of pharmaceutical plants throughout

Teva is the world’s largest generics company, producing 120

the world and we are also one of the world’s main API

billion tablets and capsules per year. The Israeli pharmaceutical

manufacturers. This gives us significant power to offer

offers specialty medicines, generics, OTCs and APIs in CNS,

quality products at reasonable prices in government

respiratory, oncology and women’s health

tender processes.


Q: What are the advantages of manufacturing APIs instead

improving, updating and raising the bar for our plants. An

of buying them?

economist said that even if we do not want it to happen,

A: We do buy APIs from others but we manufacture a

Mexico will be the seventh-biggest economy in the world

large percentage of our consumption. We have three

by 2027. There is an opportunity for us to partner with the

pharmaceutical plants in Mexico: one in the State of Mexico,

government, institutions, payers and doctors to provide

another in Mexico City and the largest in Jalisco, in addition

accessible and innovative medicinal solutions that benefit

to an API plant, also in the State of Mexico. Most of what

patients and their families.

we produce is for Mexican consumption but we also export to South America.

Q: What benefits have resulted from the company’s acquisition of RIMSA?

Q: How beneficial is having a Mexican office and having

A: It brought us a portfolio of products in the primary care

COFEPRIS approval for operations in other LATAM countries?

segment in which Teva did not previously have a significant

A: Exporting is not easy. We export to Brazil, for example,

presence. These products will be relaunched after being

a country with strict regulations. We are glad to see that

reformulated. They are products that have a strong reputation

COFEPRIS is taking the necessary steps to become an

and differentiation in areas such as pain.

internationally recognized agency.and has made the decision to become a recognized and renowned agency.

Q: What are your ambitions in Mexico over the next five years?

Q: What is Mexico’s role in Teva’s global operations?

A: We have a defined 10-year plan. We want to continue

A: Teva has drawn up a list of countries with growth

beefing up our portfolio from our pipeline and to continue

markets and Mexico is among them. One of my jobs has

our organic growth, introducing the best talent we can to

been to internally sell Mexico to our global headquarters.

the company while being socially responsible. We have a

It is a country that has industrialized greatly and is not

portfolio of innovative products that touch lives, which is a

reliant on commodities; it has steady economic growth

privilege for us because our activities transcend commercial

of around 2-2.5 percent per year, which in the long term

objectives. Our growth will be organic moving forward. We

makes Teva Global want to continue investing in the

have a generous pipeline of new products that are being

country. We have invested many millions of dollars in

evaluated, reformulated or undergoing COFEPRIS submission.

INSIGHT

GENERICS STILL FACE RESISTANCE FROM DOCTORS ALEXIS ESPINOZA Managing Director of AMSA

Laboratorios AMSA is the generics arm of Laboratorios

The company aims to provide affordable medicines to

PiSA, one of the largest Mexican pharmaceutical

Mexican patients through retailers, distributors and a

companies. Its main therapeutic areas are hydration,

range of pharmacies.

dermatology, diabetes, cardiovascular, obesity and weight control, pain, fever and inflammation. A particular area of

Espinoza says that although patients have begun to

success the company has found is in its antibiotics line.

recognize the quality of generic medicines, challenges remain. “One challenge is the resistance to change by

“AMSA probably has the third-largest sales volume of

prescribing doctors. They cling to patented medicines

antibiotics in the country. However, today we have many

as a means of identification and forget the patient’s

products for cardiology. These two types of products

budget, which is what determines their decision to find

have something in common: they are generics. This is

more affordable medicines,” he says. Present nationwide,

AMSA’s most important business,” says Alexis Espinoza,

the company’s goal is to increase its sales volume and to

Managing Director of AMSA Laboratories.

continue a steady pace of organic growth.

97


INSIGHT

MANUFACTURE LOCALLY TO CREATE AFFORDABLE PRICES GURULINGA KONANUR Director General of Hetero Mexico

98

Generics provide a cost-effective alternative to branded

National Center for the Prevention and Control of HIV/

products, allowing for more accessible healthcare. This is

AIDS (CENSIDA) reported around 200,000 people

important as the general population is more financially able

living with HIV in Mexico and an estimated 100,000 new

to purchase the treatment it needs and the public sector

infections. UNAIDS estimates there were 4,000 AIDS-

health institutions are able to purchase a larger quantity of

linked deaths in Mexico that year.

drugs. Despite initial reservations, the generics market in Mexico is growing, mostly due to government consolidated

Although generics are growing at a faster rate and allow

purchasing preferences for generics as it allows the

for better access, the population continues to demonstrate

treatment of more patients on a shrinking budget.

a brand bias, showing a preference for branded generics. “I think over 70 percent of the Mexican population would

Hetero Group, an Indian generics company, is one of the

look for a good branded generic,” says Konanur. He adds

main manufacturers of antiretroviral therapy drugs (ARVs)

that although it took some time for branded generics to

worldwide with a third of the world’s market share. “For

be accepted, doctors are now comfortable prescribing

every three patients, one is taking a Hetero product either

them. “Pharmacists also encourage generics. They receive

directly or indirectly as we supply APIs to other suppliers,”

many kinds of incentives to promote the generics of the

says Gurulinga Konanur, Director General of Hetero Mexico.

pharmacies they belong to,” Konanur says. This is most

“We want to bring all these high-tech, high-specialty

likely aided by the fact that many pharmacies stock their

products to Mexico, manufactured locally at an affordable

own-brand generics and are looking to boost sales, he says.

price,” he says, adding that the company expects Mexico to be among its best growth performers in Latin America.

Another main issue with access to medicine is the

“The generics market in Mexico is growing over 20 percent

growing counterfeit or black market. Many companies are

per year and even branded generics are growing when

taking precautions to ensure they are not inadvertently

compared to innovative products.”

participating in this by ensuring both their medicine and packaging does not fall into the wrong hands, says

The general population is also increasing its generic

Konanur. He explains that the generics sector is seemingly

purchases as many must pay out of pocket in one of the

less affected because the products are cheaper and more

most privatized healthcare systems in the world. The OECD

widely available, adding that it is often the larger names

reports that only 5.8 percent of GDP in 2015 in Mexico

that are subject to counterfeit, just as in other sectors. “I

was spent on healthcare, almost half of which was out of

have not seen as many issues with counterfeits in generics

pocket. Indeed, access to healthcare is one of the greatest

as in innovative products. The sales margins are smaller in

challenges facing the Mexican healthcare system. INEGI

generics so they are not affected so much,” says Konanur,

figures show that only 62.2 million people had access to

adding that his company employs many innovative

IMSS services as of July 2016 and despite government

packaging techniques that make the boxes difficult to

efforts, this figure represents only a 33.3 percent increase

imitate. “We have one of the most innovative packaging

in the 10 years since 2006.

departments in the world.”

The prevalence and availability of generics is important

To further expand its Mexican presence, the company has

for pandemics such as HIV/AIDS because drugs for these

acquired land near Toluca and expects to be manufacturing

diseases can be expensive and are needed by many.

products from a custom-built factory there by the second

HIV/AIDS treatment in Mexico is free for all, whether

quarter of 2018. “We are in the planning stages and by

registered with a health institution or not. It is therefore

January 2017 we will be kick-starting construction,” Konanur

important for drugs to be cost-effective. In 2015, the

says, adding that foreign investment has aided the process.


VIEW FROM THE TOP

MEXICO PROVIDES ROOM TO GROW MS NAGENDRA Director General of Zydus Pharmaceuticals

Q: Zydus works in generics but is looking at biosimilars

A: The vision established by our chairman is to make Zydus

and vaccines. Which strategic therapeutic areas interest

a quality, global research-based company. Regulation

you most?

surrounding biotechnology and biosimilars is not yet

A: Zydus started as a generics company but its unique

extensive. We took some time to fully understand this and

distinction from other Indian pharmaceuticals is that it is

we are now efficient at handling small molecules. Officials

the first company to register a new chemical entity (NCE).

worldwide face big challenges in laying down the pathways

Saroglitazar, used to treat diabetic hyperlipidemia, was

and putting systems in place for biotech. COFEPRIS is

launched in 2013 and we are looking to commercialize it

dynamic and understands the importance of biosimilars due

globally under the name Lipaglyn, starting with a handful

to the exorbitant cost of innovators. Over the past 10 years,

of countries including Mexico. The second area we are

the importance of biological products in terms of usage and

considering entering is biosimilars and vaccines. We started

market share has increased, which is a clear indicator of

working on this as few companies will provide a portfolio to

the future of the pharmaceutical industry. Few are capable

the extent of over 20 biosimilars and around 20 vaccines.

of producing them, which gives Zydus an advantage in

Some of these products have already been launched in India

tending to this need.

and they will be taken to other emerging markets. Q: What will be Zydus’ priorities for next five years in Q: What is the company’s strategy to carve out a bigger

Mexico?

slice of the Mexican market?

A: We want to consolidate our CNS business in the next five

A: Zydus is a new entrant in Mexico and we are keen to scale

years. We will look at how to leverage our strengths for R&D

up our operations. There are various options to do so and to

capabilities, to look for opportunities for inorganic growth

become relevant to the market. We entered Mexico in 2013

and to fulfill our aspiration to access the tender market. We

and we want to grow both organically and inorganically.

will try to carry out some global clinical trials here to make it

There are few trillion-dollar economies in the world and so

easier and faster to get COFEPRIS approval. The regulatory

Mexico is a huge opportunity. If any global generic company

environment is extremely dynamic and COFEPRIS does not

wants to increase in size and importance, it must have a

depend on others to approve its decisions. It is self-sufficient

presence in the larger markets and Mexico is the 11 largest

and it knows the countries’ needs.

th

pharmaceutical market in the world. Q: Do you have plans to build a plant in Mexico to bolster Q: What strategy did introducing the CNS portfolio to

your chances of selling generics to the government?

Mexico correspond to?

A: To be successful in Mexico there is no one particular

A: We initially explored various areas as CNS is not one

segment or style of operation. The government tender

of our major business lines. Overall, we have strong lines

market is worth around US$2-2.5 billion. We have the

in gynecology, respiratory, cardiology and diabology, but

capability to supply to it but we do not have local facilities.

not CNS. However, CNS is in the top five chronic diseases

However, there are ways to circumvent this: one is to

and the area is growing. Looking at health indicators,

manufacture indirectly. It would be a key move from an

depression is classed among the top five, which is rare for

investor point of view.

an emerging market such as Mexico. We found that CNS could be important for us and our decision was the right one, so we are confident we will continue to see growth.

Zydus Pharmaceuticals is an Indian generics laboratory, part of Cadila Group. In Mexico, it offers solutions mostly in the

Q: Zydus aims to be a research-based company by 2020.

CNS area and hopes to soon commercialize biosimilars and

What roles will CNS and Mexico play in this?

vaccines, becoming a research-based company by 2020

99


VIEW FROM THE TOP

BUILD GENERICALLY FIRST THEN ESTABLISH BRANDS FRANCISCO HERNÁNDEZ Vice President Latin America of Wockhardt

100

Q: What is Wockhardt’s main area of focus for new products?

which means that private insurance policies are increasing

A: Wockhardt Latin America and especially our branch in

and are becoming a benefit some companies provide to

Mexico is focused on three big areas: diabetes, CNS and

their employees in Mexico. In fact, IMSS is looking to apply

antibiotics. Last year we launched two drugs for diabetes:

an integral model wherein private clinics participate because

human recombinant insulin and oral anti-diabetics. For CNS,

it is spending too much on diabetes, cancer, CNS and other

we developed a product for epilepsy, which in Mexico is

chronic diseases.

increasing by 12-14 percent each year, and released a product for depression. The third area is antibiotics. Wockhardt

This is the next step for the healthcare system, to look at

performs clinical R&D of new chemical entities and we have

privatization or semi-privatization for the most concerning

at least nine of these developed at our sites in India, Europe

diseases. Patients who need dialysis and hemodialysis

and the US, where we have at least two products in phase

consume 45 percent of IMSS resources and they are a very

III. The others are in phase I and II but with a really good

small population. Two million to three million require dialysis,

performance, so they will probably be released in 2020 or

whereas the remaining 45 million IMSS beneficiaries require

2022. We are now launching three generic antibiotics. We

other services. We want to reach the private market because

want to first build our base with generics and then establish

there we can promote the new model of doctor’s offices in

our own products in the market.

pharmacies that many prefer because it is cheap, fast and closer to the pharmacy.

Q: Is there still resistance to generics in Mexico or are they now accepted by consumers?

Q: In 2015 the private market accounted for 40 percent of

A: The market penetration for generics is increasing as more

Wockhardt’s business. How did this evolve during 2016?

people make their own purchasing decisions. Pharmacists

A: Now it is more. In 2013, when I started operations in

can let customers choose between a brand and a generic.

Mexico, the government market was 70 percent of our sales

People are selecting the generic because of the price but in

and private market sales were 30 percent. This number has

the generic market there are three differentiation points: price,

changed over the years and in 2016, 60 percent was private

quality and efficacy. These are fulfilled in the Mexican market,

and 40 percent government. We made this change because

which gives people the perception generics are as good as

the government has an issue with payments, so for us it was

branded medicine.

better to secure our income through these sales.

Q: To what extent do you participate in government tenders?

Q: What security measures do you use to protect the chain

A: For many national companies, especially those focused on

of custody?

generics, the tender market is where most of the opportunities

A: In the pharmaceutical industry, we must be as vigilant as

are but at Wockhardt we are focused on the private and semi-

banks. It is important to assure that those who buy products

private sectors. Tenders might give the perception that the

get originals, so we take protective measures with tablet

government is the biggest market but we need to realize that

packaging. We put the batch number and expiration date on

most of the money is in the private sector. Most of us will never

a special foil. Also, we apply a hologram in the middle and we

go to an IMSS hospital. We prefer to go to a private hospital,

want to put a QR code on the boxes so when the patients scan it with their phone, the doctor’s name and dose should appear. These tools are important because without them there is a risk

Wockhardt is a pharmaceutical and biotechnology company

of medicine ending up on the black market. The authorities do

headquarted in Mumbai, India, providing high quality

nothing about it. This personal approach is important in areas

medicines. It has relevance in the fields of pharmaceuticals

like diabetes because you need to handle insulin carefully.

and biotechnology

A bigger dose can put the patient in a coma and a smaller


dose can cause a diabetic shock. We are trying to move to

the Andes region, Ecuador, Peru and Venezuela; from Brazil

personalized service and sell to patients directly.

we reach Uruguay, Argentina, Paraguay and Chile and from here we control Mexico and Central America. We have many

Q: How can you sell directly to the customer?

customers and partnerships in these countries, all focused on

A: To do that, it is necessary to create a relationship

diabetes, CNS and antibiotics.

between specialized centers and the patient, and to use an app that can provide client information. If government

Q: How does having a COFEPRIS authorization for your plant

tenders become a system where patients are referred

help you expand?

to associations or clinics, it is possible to provide a

A: Definitely. Having authorizations in big countries like Brazil,

personalized service through a database.

Mexico and Colombia helps because COFEPRIS, the National Agency of Sanitary Vigilance (ANVISA) and the National

Q: What time frame are you considering for this innovation?

Institute of Medicine and Food Vigilance (INVIMA) are

A: This is going to take three or four years to develop.

ministerial authorities, which the rest of the region is looking

An example of this is the Mexican antidiabetic center

for best practices.

in Guadalajara, which is the governmentâ&#x20AC;&#x2122;s first attempt at a semi-private service. The government referred at

Q: What new products do you have in the pipeline?

least 30,000 patients to the center for integral diabetes

A: This year we are launching a generic insulin drug, glargine,

treatment. Patients consult with a physician, nutritionist

to treat diabetes. It is long-acting and gives the patient better

and physiologist and the medicines are paid for by Seguro

control of the treatment because it provides them a 24-hour

Popular. This is a model the government wants to scale up

insulin dose in one shot, eliminating the need for two or three

across other states early next year.

shots per day. We are trying to improve the performance of the drugs and control of the disease.

Q: What expansion plans are in Wockhardtâ&#x20AC;&#x2122;s future? A: Wockhardtâ&#x20AC;&#x2122;s expansion in Latin America started in 2014.

The company will introduce another four generic antibiotics

Today, besides Mexico, we have an office in Brazil and are

and is looking forward to developing a clinical trial for two

looking to open one in 2017 in Colombia. These will be our

new chemical entities at a nutrition institution and an IMSS

three LATAM offices, because those are three big countries in

hospital. As for CNS, we will try to register more drugs in the

the pharmaceutical industry. From Colombia we can handle

epilepsy and depression segments.

Wockhardt is a Mumbai-based global research-oriented pharmaceutical

and

biotechnology

organization

that

manufactures vaccines, APIs and generics. It has a marketing presence on all five continents and has plants in the US, Europe

101


VIEW FROM THE TOP

AGGRESSIVE GROWTH FOR INDIAN PHARMA SANDEEP BANE Director General of Accord Farma

102

Q: Accord Farma promotes itself as a fast-growing

will launch four patented products next year that we will

generics company. What is your growth rate and how will

manufacture in Toluca.

you sustain it? A: We work in specialty medicines, oncology mostly.

Q: Accord Farma is present in over 70 countries. How

We grew by 40 percent in 2016 in Mexico and we intend

important is Mexico for its global sales?

to grow by a similar margin next year through our

A: Mexico contributes around 1-1.5 percent to Accord’s US$2

biotechnology facility in Toluca, which will begin operating

billion global sales. There are plans to increase this, which

in July-August 2017. We are adding new molecules,

is why we have invested in the biotechnology plant here. In

which will ensure our continued growth and we expect

the next three years, we will add around 80 products to our

biotechnological products to boost this further, with a

portfolio, from 62 now, and we expect the Mexican branch to

30-40 percent year-on-year increase expected in that

be a MX$1 billion (US$55 million) company by 2021. These

segment. The biotechnological facility will produce mostly

new products will be across generics, oncology and our

oncological products. Around 15 percent of our revenue

hospital line. The latter already includes 10 products and we

comes from biotechnological products.

will be adding 20-30 products. The hospital products include our anesthesia line and we have just launched two new

We are among the top three companies for oncological

anesthetics, with three more coming by June 2017. Although

products in Mexico in the private generics segment. We sell

our hospital line does include some niche products, we will

seven or eight molecules to the government and oncology

be focusing on high-volume products because they will

is our core business here. We are not actively seeking to

boost our presence and help us grow rapidly. In oncology,

increase government sales — we want 33 percent of our

we focus on oral therapy and hematological injectable

business to go to the government and we are maintaining

products because there is less competition in this market.

this percentage. The advantage of this strategy is that as government business is acquired year by year, even if we

Q: What are the company’s plans to enter other Latin

lose a tender we will not suffer that much.

American markets? A: We have already selected a portfolio of around 15 products

Q: What is the strategy behind manufacturing solely your

to be sold in Latin America. In the near future, Accord Farma

oncological line in Mexico?

will be exporting to most Latin American countries. We will

A: We import around 80 percent of our products but we

increase our plant’s capacity in the first half of 2017 by 30-40

know that the future also lies in manufacturing locally. We

percent and by 2018 at least 10 molecules will be exported to

chose to produce oncological products because those

at least two to three countries. By the time this is completed,

require a smaller manufacturing facility with high potency,

stability studies will have been carried out and we will be fully

while other products are sold in high volumes, requiring a

ready to export. We will rely more on CM but if after 2018

large plant, which involves high costs. Therefore, we are

we require more plants then we will build them. A plant can

choosing niche products to manufacture locally and we can

be built in a year.

go down the contract-manufacturing (CM) route for others. We already manufacture four oral generics this way and we

Q: What have you learned from other generics markets and how is that applied to Mexico? A: Actually, many of the strategies we implemented in Mexico

Accord Farma is an Indian-based generics company that

were copied elsewhere. Globally, the company is known for

entered Mexico in 2006. It has three lines: Onco Care, Farma

CNS drugs, which we did not implement here. We chose

Care and Cliniq Care. Oncological treatments are its primary

oncology, which other countries are now copying and

focus in Mexico

globally there is now a large pipeline of oncological products.


INSIGHT

ALLIANCES CREATE A PATH TO GROWTH ARÍSTIDES SALAZAR General Manager of Mexico, Central America & the Caribbean Region for Emcure Pharmaceuticals

Generic medicines are on the way up in Mexico, forcing

to sell its products locally under its own brand name. “If

changes on Big Pharma that are reshaping the market,

we can support Mexican health with accessible and high-

says Arístides Salazar, General Manager of Mexico,

quality products, we must do it,” says Salazar.

Central America & the Caribbean Region for Emcure Pharmaceuticals, a company that works in R&D and

Alliances are key to the company’s market penetration

manufactures for leading companies such as Roche.

in Mexico because they allow the company to insert its products into the portfolios of its partners. For example,

“The golden years of Big Pharma are over and the entrance

Emcure has licensed out its gastrointestinal product

of generics has changed the game,” Salazar says, adding

Gamo (Levopantoprazol) to Sanfer, one of the largest

that “the future of the industry besides genomic medicine

Mexican generics players. “Our company has at least four

is in biosimilar drugs and generics.” According to Deloitte’s 2016 Global Life Sciences Outlook, generics were expected to reach 36 percent of health spending by 2017. “In Mexico, around 80 percent of medicines in terms of units are generics,” says Salazar, which he attributes to the high volume purchased by the public sector in tenders and due to their low-price points. “The problem with Big Pharma companies is that the process of decision-making does not take place locally, which means decisions must be taken at higher levels of the corporate

other partnerships under development,” said Salazar.

In Mexico, around 80 percent of medicine units are generics” In Mexico, the most important segments for Emcure are gastrointestinal and cardiovascular. However, it works a series of therapeutic sectors at the global level

ladder, thus delaying negotiations. Emcure’s ideal is to have

with distinct production lines focused on each target

a flexible business without ruling big companies out.” Its

country’s needs. Emcure’s global portfolio includes HIV,

flexible approach allows the company, which manufactures

oncology, biosimilar drugs, diabetes, gastrointestinal,

chiral molecules, generics, biosimilars and novel drug-

cardiovascular and painkillers, among other areas.

delivery systems, to adapt to the markets it enters. “The top

“Diversification enables Emcure to adapt to the needs

priority is to consolidate the Mexican subsidiary by taking

of the market and customers and to the portfolios of our

advantage of the opportunities we have here,” he says.

partners,” Salazar says.

The company has no manufacturing plant in Mexico. With

The company looks forward to eventually participating in

no FTA between Mexico and India, it is licensing out the

the diabetes segment with an integral portfolio of related

production of its medicines to other companies. “There are

products, as therapeutics for diabetics mkae up one of

several companies with unused capacity that are looking

the biggest sectors in the global pharmaceutical market,

to manufacture for other companies,” Salazar says. Emcure

especially in Mexico. Its portfolio includes modified

considers entering alliances with those companies, although

molecules and innovative combinations that reduce

it may invest in building or acquiring a manufacturing plant

cholesterol levels and thus the chance of cardiovascular

once it has reached sufficient critical mass in sales. “Then,

arrest in diabetic patients. Emcure expects to start selling

we could harness distribution to the US and the rest of Latin

its products under the Emcure brand in three to four

America and the Caribbean,” he adds.

years. Building a manufacturing plant is a possibility in five to 10 years but its short-term priority is to consolidate

Emcure aims to introduce revolutionary products to the

partnerships and to start the registration process for its

Mexican market, to start taking part in public tenders and

products.

103


104

Production line at Aspen Labs' Vallejo plant


VIEW FROM THE TOP

INNOVATING WITH HIGH-QUALITY GENERICS RICARDO GANEM Vice President and General Manager of Perrigo

Q: What does innovation entail for a company focused

developing products and brands that best fit each of their

on generics?

strategies. Even smaller pharmacies have varying strategies.

A: For us, innovation has to do with effectively developing

Some sell from behind a counter like traditional pharmacies,

high-quality and affordable generic versions of drugs

whereas others are more like mini-supermarkets where you

whose patent has or will expire. To achieve this, we

could even buy groceries and other convenience items. This

must develop the products our customers require, file

is a model more often seen in the US but it is a growing

for approval from local health authorities and do our

trend in Mexico.

best to be first to market. Another source of innovation comes from our business model, as we develop strategic

Q: How much more receptive are Mexican consumers and

partnerships with our customers to launch their private

authorities to products from a US-based company than

labels. Retailers do not have manufacturing and we are

from other countries?

manufacturers without stores.

A: Perrigo has a significant footprint in Mexico with four state-of-the-art manufacturing sites. The vast majority

Q: Perrigo now owns NiQuitin. How popular are these

of our products are manufactured locally and all have

tobacco-replacement products in Mexico?

marketing authorizations from COFEPRIS. I am not sure

A: NiQuitin is a great brand and a very effective treatment.

that consumers make any distinction between local and

Unfortunately, we found that NiQuitin had been somewhat

imported products but both retailers and consumers have

neglected in the Mexican market and there were many

confidence in our quality and service. The big change in

out-of-stocks resulting in many consumers not being able

recent years has come from the growing confidence in

to continue their treatment. However, we are correcting

generics by Mexican consumers. Every day, more and

those supply issues and customers are now able to stock

more people prefer to buy generics vs brands, with full

the products. There is a global trend to stop smoking

confidence that the quality and therapeutic effect will be

and Mexico is not the exception. Recent legislation is

the same but at a much more affordable price.

making it harder to be a smoker and there is a growing trend toward wellness that has made people more likely

Q: How important is Mexico for Perrigo globally?

to drop the habit.

A: Our business in Mexico is extremely important to Perrigo's global operations. Not only do we share a very

Q: How are your products distributed between the public

similar business model with the US branch of Perrigo, but

and the private sectors?

we service many of the same strategic customers that have

A: The public sector represents around 15 percent of

presence on both sides of the border. We have identified

our sales and we sell only through distributors and only

Mexico as the country in Latin America with the greatest

specific products. In the private sector, we are partners

potential for growth as the economic and demographic

with large and small retailers in Mexico in the development

conditions are very promising for our industry. We believe

of their store brands. Some laboratories focus more on

that each day there will be more opportunities to develop

their own brands and others sell almost exclusively to

significant supply chain partnerships between our countries

the government. We operate opposite to that because

due to NAFTA.

most of our business, capacity and efforts are focused on manufacturing for our retail customers. Perrigo is one of the worldâ&#x20AC;&#x2122;s largest manufacturers of private

Q: How does Perrigo develop its strategy for each retailer?

label goods for retailers, leading the OTC sector. Founded in

A: Each retailer is different, with distinct formats and

1887 in the US, it has been present in the Mexican market

specific strategies. Our job is to work with them in

since 1954

105


INSIGHT

STRICT RULES FAVOR LOCAL PRODUCTION In Mexico, the largest single purchaser of generic medicine is the public sector. It is no wonder then that increasing sales to this sector is widely seen as a solid growth strategy. In 2017, IMSS alone spent MX$41.9 billion (US$2.3 billion) on the consolidated purchases, acquiring 1,371 types of products, 63 percent of which were generics. However, the tender system favors companies 106

that have manufacturing plants in Mexico, seemingly leaving those that do not out in the cold. That is enough incentive to build and produce locally, says José Díaz, Executive Director of Indian pharma company Micro Pharmaceuticals.

One of the alternatives we are looking at while waiting to gain critical mass is to associate with national laboratories that can manufacture for us here in Mexico” José Díaz, Executive Director of Micro Pharmaceuticals Mexico

“Mexican law states that only Mexico-produced products can participate in the largest tenders. This is why we want to construct a manufacturing plant.” There is a profitable

alliances with pharmacies and national pharmaceutical

loophole, however: companies that do not produce in

laboratories. “One of the alternatives we are looking at

Mexico can sell to the government when larger companies

while waiting to gain critical mass is to associate with

cannot meet the tenders. “This is what we are doing:

national laboratories that can manufacture for us here in

supplying products that are out of stock elsewhere. At

Mexico,” says Díaz.

the moment, we can only aim for the crumbs of the cake, while companies that produce in Mexico take large slices,”

Micro Pharmaceuticals Mexico is also looking at

Díaz says.

pharmacies for allies because they have a great volume of own-branded products. The company is keen to enter

The consolidated purchasing system often means

this segments with the large pharmacy chains, including

enormous savings for the public institutions that

those in supermarkets.

participate, representing MX$3.4 billion (US$188 million) in 2017. However, Díaz points out that this often obliges

An expansion from Mexico to Central America is also in

companies to operate at a loss and is not necessarily

the works. “We are on the verge of closing a deal with

better for everyone. “Sometimes the health sector sets

a Guatemalan distributor and we are participating in a

costs extremely low and it seems impossible that the

US$12.5 million tender in Guatemala. We will continue to

product could be sold at a price so low it is below the

look for similar opportunities across Central America,”

production cost,” Díaz says.

says Díaz. The products it takes to Central America will not be those available in Mexico, as the company adapts

Micro Pharmaceuticals Mexico is not closed to working

each portfolio to the country’s needs. “What sells in India

with the public sector and once its manufacturing

will not necessarily sell in Mexico,” he explains.

plant is up and running, it looks forward to finding new opportunities, Díaz says.

These countries are easier to enter for foreign companies because regulation is not as strict as in Mexico. “Whereas

The Mexican generics market as a whole was worth

in Mexico we cannot sell a product that does not have

US$3.33 billion in 2015, according to Seale & Associates.

Mexican registration, in Central America a product need

Although Micro Pharmaceuticals has almost 500 products

only be registered once, anywhere, to be available for

available to purchase in India, only 12 are on Mexican

sale,” Díaz says. In addition, COFEPRIS is becoming

shelves due to slow regulatory approval.

increasingly recognized globally as a regulatory agency that demands high standards. Díaz believes the company

“We do not know how long it will take to get approval

can compete against the multitude of products available

for the other products,” says Díaz. This means that

in less-strictly regulated countries with its high-quality

Micro Pharmaceuticals Mexico cannot rely on its large

products produced in FDA-certified manufacturing

portfolio for sales and growth. Instead, it has created

plants.


INSIGHT

RENEWING COMMERCIAL VISION IN A COMPETITIVE MARKET WILLIAM ESCOBAR Director General of Grupo Unipharm

For generic companies, the rules of the public purchasing

planning a new aperture to the market with a line of branded

system have become clearer since the establishment of the

generics to expand private purchases and thus balance its

consolidated purchase. However, the low prices paid by

sales in the public and private sectors, which now represent

the government in the process have led them to seek more

76 and 24 percent, respectively. “The essence of Grupo

opportunities in the private sector, says William Escobar,

Unipharm is to be a branded generic laboratory. Now we have

General Director of Grupo Unipharm, an international generics

both lines, pure generics for the government and branded

company that is expanding to the commercialization of

for private companies,” says Escobar. Given the race to the

branded generics in its Mexican division.

bottom in terms of prices in the generics industry, Unipharm’s new line is aimed at chronic diseases, providing solutions for

“We want to go out with a new sales projection in the

patients with recurrent cardiometabolic conditions such as

Mexican market. Our corporate structure here is still at a

hypertension, diabetes and obesity. There are also products

low level compared to our businesses in the Andes and

for CNS, depression and for neuropathic pain. According to

Central America. Our vision is for Mexico to represent 75

Escobar, this line will help the company migrate to a position

percent of our operations and make the country our largest

halfway between the generic and the innovative brand. “With

market,” Escobar says.

the quality and prices we will bring to the market we want to create more loyalty with patients and show the medical

The company’s main objective with this commercial change

community that we are cost-effective.”

is to go from “quality product at a very low price, to highquality product at a fair price,” Escobar says. To achieve this

Besides increasing its portfolio from 36 to 54 products by

goal, the pharmaceutical company, founded in Switzerland

2018, Grupo Unipharm’s strategy also focuses on getting

and based in Guatemala, is working to restructure its brand

closer to health professionals by sending sales representatives

in the Mexican market, where the company’s operations

to visit them face to face. Just like other medium-sized

grew 186 percent over the past year and with growth

companies, Grupo Unipharm is pressured by market demand

expected to reach 300 percent in 2017-2018.

to be more efficient, faster and better. To meet this demand, the company is developing plans for the construction of a

Grupo Unipharm has been in the Mexican market for 20

new plant in the State of Mexico that will manufacture solid,

years and its portfolio is composed of a primary care line,

liquid, semi-solids and sterilized drugs. The plant will pursue

antitussives, antibiotics, products for women’s health,

international certifications to be more functional and dynamic

minerals and vitamins. In this context, the company is

for the grup's operations in the region.

DISTRIBUTION OF MEXICAN BRAND VS GENERIC DISTRIBUTION OF MEXICAN BRAND VS GENERIC DRUG MARKET AS OF 2014 BY VALUE DRUG MARKET AS OF 2014 BY UNIT 2014 MEXICAN DRUG MARKET SHARE

„„Patented brand retail sales

By value

By unit

„„45.2% „„10.2% „„20.2% „„9.2% „„15.2%

„„59% „„17% „„14%

„„8% „„2%

„„Branded generic retail sales „„Non-branded generic retail sales „„Generic institutional sales „„Patented brand institutional sales

Source: statistica.com with the latest information available

Original retail brand

Retail generic Original retail brand

Retail brand generic

Institutional

Retail generic

107


Babyleo equipment for neonatal care


MEDICAL DEVICES

5

Mexico has great potential for medical device manufacturing. Baja California has become a cluster for many international brands attracted to the quality human capital and low operating costs in a strategic location. According to Global Health Intelligence, more than 4,000 people are employed in this manufacturing hub. Technological development is driven by the aging population and the widespread prevalence of age-related conditions such as hearing problems, mobility issues, cardiovascular and CNS conditions. Another driver is the burden of chronic diseases that suggest the development of devices that aid people with cancer, diabetes and lung diseases. Innovation has mostly focused on facilitating treatment and early diagnosis, which is key to improving quality of life and the rate of successful outcomes.

Medical devices come in all shapes and sizes and this chapter will provide an overview of devices big and small. From the production of MRI machines to surgical equipment, from wound care to pregnancy tests and heart valves to knee replacements, all will be discussed in this section. It will showcase interviews from the companies that make these devices and will focus on their role in the Mexican healthcare system and the regulatory challenges they face.

109


CHAPTER 5: MEDICAL DEVICES 112

ANALYSIS: Good Manufacturing Picture Helps Overcome Economic Challenges

114

VIEW FROM THE TOP: Mauricio Valero, Linet Group SE

116

VIEW FROM THE TOP: Javier Giraud, Fujifilm

117

VIEW FROM THE TOP: Juan Pablo Solís, Becton Dickinson

119

VIEW FROM THE TOP: Francisco Morales, 3M

120

VIEW FROM THE TOP: Martín Ferrari, Dräger

121

VIEW FROM THE TOP: Alejandro Paolini, Siemens Healthineers

122

VIEW FROM THE TOP: Nelson Valenzuela, Arthrex

123

SPOTLIGHT: SynergyRF

124

INSIGHT: Germán García, Smith & Nephew

125

VIEW FROM THE TOP: Fernando Oliveros, Medtronic

126

INFOGRAPHIC: The Medical Devices Segment in Mexico

128

VIEW FROM THE TOP: Carlos Jiménez, B. Braun Aesculap

130

INSIGHT: Ulises Bacilio, Grupo PTM

131

VIEW FROM THE TOP: Zaid Badwan, MediPrint

TM

System with ApolloRF

TM

Probes and SynergyUHD4

TM

System

111


ANALYSIS

GOOD MANUFACTURING PICTURE HELPS OVERCOME ECONOMIC CHALLENGES Over the last year, the medical devices industry has

“The prices are also low so they are not

faced challenges from currency depreciation to budget

sustainable in the long term. We can offer

cuts that have forced it to make the most of the Mexican

those prices for one year but not several years

manufacturing industry’s capabilities

running, especially with the depreciation of the Mexican peso against other currencies.

112

In November 2016, the Mexican peso became a victim

This is not sustainable and endangers quality,” said Martín

of the US elections. Before voters went to the polls, the

Ferrari, Director General of Dräger Mexico. Ferrari says

already-weakened currency was at MX$18.5 per dollar.

the first step should be for the government to understand

By the time the votes were counted, the peso had sunk

the value of complete solutions and then change the

to MX$20.74, a historic low against the US currency that

model to purchasing based on specific therapeutic needs.

pushed up prices of imported goods. Coupled with lower

He believes that government purchases of equipment

oil prices that forced government budget cuts, medical

from different brands for a surgical room will then require

devices companies have increasingly turned to the

different maintenance teams, different guarantees and

private sphere to support their bottom lines.

different providers. If it buys integral solutions, there will be more guarantees, he believes.

“We gained market share and we grew above the market but it was difficult because of the peso’s devaluation

OUTSOURCED MANUFACTURING

against the US dollar and cuts to public budgets due to

Despite the economic difficulties, foreign companies

the drop in oil prices. However, our growth was stable

are tapping into Mexico’s strong potential as a base

thanks to the private market, which continued to invest

for outsourced manufacturing of both medical devices

despite the fact that the public market contracted,”

types classified by CANIFARMA: Supportive Products

says Alejandro Paolini, General Manager of Siemens

for Health (PAPs) and Reactive and Diagnosis systems

Healthineers Mesoamerica.

(RSD). According to CANIFARMA, PAPs are widely produced in Baja California and, based on ProMéxico

Mexico generates US$8 billion in medical device exports and 92 percent of those go to the US

data, the northern state has become a cluster for many international brands, mostly from the US and Europe, attracted by low operating costs in a strategic location and quality human capital for manufacturing. In fact, the US provides 70 percent of the firms based in Tijuana and Tecate and 86 percent of the top investors, according to ProMéxico.

As the government trimmed its budget, it also offered lower

Mexico generates US$8 billion in medical devices exports

prices for products. In 2016, the Ministry of Finances and

and 92 percent of those exports go to the US, says Edgar

Public Credit rolled out a series of cuts, slashing its budget

Romero, President of AMID. Broken down by product,

in February by MX$132 billion (US$7.3 billion), in April by

Mexico is the third global exporter of tubular suture

MS$175 billion (US$9,7 billion) and in September by another

needles and the fourth for instruments and devices for

MX$239 billion (US$13.2 billion). Among the top targets were

medicine, surgery, dental and veterinary health, based

health and education, which had a direct impact on the

on ProMéxico data.

purchasing capacities of health institutions. The consolidated purchase system has helped the government to continue

According to INEGI Mexico is home to approximately

purchasing supplies and drugs while saving money. Since

400 exporting companies, most of them focused in the

2013, IMSS has saved MX$14 billion (US$777 million) through

manufacturing industry. INEGI data also shows there

the scheme, said IMSS Director General Mikel Arriola in 2016.

are more than 2,500 economic units specialized in

Companies have few qualms about the system, believing

medical devices in Baja California, Tamaulipas, Sonora,

it a good government initiative; however, they say the

Nuevo Leon, Mexico City, Jalisco, State of Mexico and

purchases should be oriented toward integral acquisitions

Coahuila. In addition, ProMéxico predicts that by 2020

by therapeutic areas instead of individual products that, sold

the production of medical devices in Mexico will reach

at low prices, are not profitable.

US$25 billion.


Classification of medical devices

Categories of medical devices

according to the risk implied by their use

Medical equipment: apparatus, accessories and instruments that have a specific use and are intended for surgical or exploratory procedures, diagnosis,

Class I

treatments, rehabilitation or for biomedical research activities.

supplies for which security and

Prosthetic, orthosis and functional aids: devices intended to replace or

not introduced inside the body.

efficacy is approved and that are

complement a function, an organ or tissue.

Class II

Diagnosis agents: all supplies, including antigens, calibrating antibodies,

might have variations in

controls, reactive, reactive equipment, crop and contrast tools and any others

concentration of the material they

used as aids for other clinical or preclinical procedures.

are made from, usually they are introduced inside the body for less

Supplies for dental health: all tools and substances used for dental health. Surgical and healing materials: devices and materials that with or without

than 30 days. •

Class III

antiseptics and germicides that are used in surgical practice or in treatments of

supplies recently approved for

continued use.

medical practice that are introduced

Hygienic products: materials and substances that are applied to the skin or cavities that have pharmacological or preventive purposes.

inside the body and stay in for more than 30 days.

Source: COFEPRIS

Adding to Mexico’s attractiveness is the pool of human

will increase investment in innovation because less time needs

resources available to companies looking to establish

to be spent on other things,” says Romero.

manufacturing sites in Mexico. According to Global Health Intelligence, more than 4,000 people are employed in

In addition to local incentives for the medical devices industry,

the Baja California manufacturing hub. US-based health

Mexico still has room to boost its position in the outsourced

technology company Becton Dickinson, which focused on

manufacturing sector. ProMéxico's Sector Diagnosis study for

IV devices for drug administration, is among those taking

the medical devices industry suggests the main obstacles to

advantage of the country’s talent. “Of BD’s 45,000 global

development are a fragmented and bureaucratic healthcare

associates, 9,500 are Mexican, or nearly 20 percent. They

system, a low expenditure in health per capita and a lack of

are distributed throughout our operations in Mexico City, San

trained staff in health institutions to use the technology. “The

Luis Potosi, Sonora and Baja California. We export products

medical devices market in Mexico is underdeveloped, which

made in Mexico to the US, Asia, Europe and the rest of Latin

means there are many opportunities to grow,” says Germán

America,” says Juan Pablo Solís, Vice President and General

García, Director General of Smith & Nephew, a UK company

Manager of Becton Dickinson Mexico, Central America and

specialized in wound management and orthopedics.

the Caribbean. According to the study Medical Devices Outsourcing Mexico’s strategic location, with access to the Latin American

Market 2016-2020, the global outsourced manufacturing

markets as well as the US and Canada, is attractive for

industry is growing at a compound annual rate of 11 percent.

European companies, such as global supplier of hospital beds

A study developed by Technavio showed that the major

Linet Group SE. “To ship beds from the Czech Republic to

reasons for outsourcing are “gaining specialized expertise,

Chile takes two and a half months. The entire Pacific coast

harnessing a high supply chain, avoiding issues such as high

is far from Europe, so a Tijuana plant (which Linet plans to

manufacturing costs and overcoming capacity constraints.”

build) would benefit these countries, especially Peru and to some extent Ecuador,” says Mauricio Valero, the company’s

AMID’s Romero says the government faces the challenge

Managing Director in Mexico.

of how to evaluate the new devices and ensure that the most innovative medical devices reach patients. “Now,

The process for approval of medical devices has also improved

from releasing a product to releasing its next generation,

after COFEPRIS decided to deregulate certain accessories.

there are only two or three years and the evaluation system

AMID is responsible for 80 percent of COFEPRIS’ sanitary

for new products is not used to working with such short

registers and the association’s President believes the

time frames. Medical devices account for 70-80 percent

decision to deregulate some items ultimately will lead to

of sanitary registrations in Mexico. How to evaluate them

more investment. “Deregulating these items is good because

and the cost/benefit over time is a new challenge for any

COFEPRIS can use its time to check true technological

government, including Germany and the US. The main

innovations instead of regulating these other products. This

challenge is bringing these devices to the country.”

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VIEW FROM THE TOP

HIGH-TECH BEDS SECRET TO GOOD HOSPITALS MAURICIO VALERO Managing Director of Linet Group SE in Mexico

114

Q: How is your business divided between the public and

Czech Republic has been recognized for many years for its

private sector?

excellence in cars, trucks and heavy equipment. Beds are

A: The public sector’s contribution in terms of medical

no exception. There are two manufacturing centers, one

devices is much more important. As of 2016, the public

in Germany and one in the Czech Republic. The quality

sector accounted for around 60-65 percent. Our business

control we gain by manufacturing the product under one

model does not include direct sales; we work only with

roof and our competitive pricing also contribute to the

distributors and we reach most of the public sector. This

product’s success. In addition, we sell in Mexican pesos,

is part of our strategy to serve the market in the best

not in a hard currency. This is an important part of our

way possible. Distributors are much better at navigating

financial work here, which improves our profitability. There

the public market. Hospital chains, the main contributors

are two major global companies selling these products,

to the private market, know that they would not receive

both from the US, and they are comfortable in their

a high degree of added value from local distributors so

positioning. Linet Group SE is surely the third biggest

they prefer to do business directly with a company if it is

producer globally. Our solid marketing, our strategy and

located within the country. Private sales do happen and it

the experience of our employees helped us make the right

is an area of business we are looking to further develop

decisions when establishing our model. Picking the “low-

in the future. Our range of products is the same for both

hanging fruit,” as the Americans say, has helped us grow

sectors and globally. There is no difference between

quickly. We do not have national coverage and we do not

developing countries or mature markets. If people need

have a presence in the most remote areas. There are many

a solution then it must be offered to them, even if it costs

areas yet to be explored, such as our German beds for

a little more.

geriatric or chronic care. This is a market that is opening as there are many retirement homes opening, especially

Q: What is the company’s strategy in the face of public

for those with greater economic resources.

sector budget cuts? A: Fortunately, our products suffer less from budget cuts.

Q: What is the potential in Mexico to explore this new

Cuts tend to affect the entire construction of a hospital

market opportunity?

rather than our business, which comes mostly from new

A: The retirement-home market will grow greatly, amid

hospitals. Because information pertaining to new hospitals

an increase in the elderly population and in chronic-care

is widely available, we can begin working in advance to

patients and as the number of children to look after their

position our products. The past two years have not been

parents decreases. We need general guidelines for this

easy for the medical devices industry in general but they

area and companies like ours must create the appropriate

have been fantastic for us. This is our third year of operations

models. The National Institute of Geriatrics (ING) is starting

here as a subsidiary and Mexico is our most important

to operate public centers for this type of care, but the states

market in north Latin America. In our first year, we sold a

are not sure what infrastructure they should offer. The private

little under €2 million B2B, €4 million the following year and

side is developing again, although it is a little disorganized.

an estited €8 million in 2016. This is exponential growth and

Some homes have high standards and are very expensive

we hope it continues.

while others only offer shared rooms with no professional care, furniture or fittings. A multidisciplinary team with

Q: What is behind the company’s strong growth?

nutritionists, a geriatrician, nurses and the adequate

A: One factor is the product itself. It is of high quality

equipment are required. We are focusing on geographical

and produced in the Czech Republic, which in terms of

areas that are agreeable to retirees, especially areas that

manufacturing costs has many similarities with Mexico and

have a large economic capacity such as popular tourists

both have a high-quality labor force. Manufacturing in the

spots like San Miguel de Allende or Baja California.


Q: How is innovation shaping Linet’s offering?

clients a larger range of products. Borcard specializes in

A: Our intensive therapy beds are extremely important

birthing beds, which is in line with our vision to provide

medical devices for a patient’s hospital stay. The first

quality care for women in labor. I believe this is an intelligent

challenge is making people understand that this is not

and logical acquisition.

a piece of furniture. It is a medical device that can cost up to MX$1 million (US$55,000). That is a lot of money

Q: What are the company’s plans going forward?

and technology but the goal is for a patient to have the

A: Our growth in Mexico, Latin America in general and in

best quality of life possible. One of our most important

the US is good. Linet Americas sold almost US$50 million

innovations with this bed is the possibility to offer

of beds. This is the market where the world number one and

automatic lateralization therapy because its construction

two of the sector are from so it shows promise. The beds are

allows it to move laterally and to incline. In this way, a

shipped from the Czech Republic so we have a disadvantage

serious disease called ventilator-associated pneumonia

on delivery times compared to the competition. It was

can be avoided. This disease occurs in intensive-care

decided that we will need to find somewhere to put another

patients who are immobile. It is much simpler to avoid

factory when the time and the sales volumes are right. At

this disease, which is costly and prolongs the patient’s

the end of 2015 we went on a commercial and diplomatic

care, increasing the burden on the public sector.

mission to Tijuana where there is an important cluster and a number of companies producing medical devices. There is

We also have a line of active mattresses built around

a well-developed logistics chain there and the possibility to

plastic cells filled with air. The part in contact with the

have three ports for exportation: two to Mexico and one to

patient’s body inflates and deflates, preventing the

the US. There are advantages that are not found elsewhere

patient from developing pressure ulcers. These are

in the Americas and so it is practically decided that Linet

serious wounds that are caused by immobility and are

Group SE will build a factory in Tijuana. Global political

expensive to treat. There are protocols in place to avoid

uncertainties combined with the Mexican election campaign

these pressure ulcers but there may be cases in which

can delay projects. We will most probably see a few years

the nurses cannot move the patient because they are too

that are not so dynamic. Although this sector is a little

heavy, for example.

more immune to these factors, it will surely be affected to some extent.

Q: How can this technology help address the scarcity of beds in Mexico?

Q: What other countries in Latin America does Linet want

A: The idea is to reduce as much as possible the length of

to expand to?

a patient’s stay in more complex and expensive areas such

A: To ship beds from the Czech Republic to Chile takes

as intensive care. There are not enough beds in Mexico,

two and a half months. The entire Pacific coast is far from

which has a deficit of at least 20,000-30,000 beds. If we

Europe, so a Tijuana plant would benefit these countries,

can free up beds in complex areas through technology,

especially Peru and to some extent Ecuador.

more patients can be treated and moved to less complex areas of hospitalization. Another trend that could arise is

We also hope to increase our number of technicians and

an increase in home care.

clinical specialists. Because our beds are made in the Czech Republic, they are designed with the strictest security

Although there is much to be done, the situation is

standards in the world. In 2012, the previous security

improving. We differentiate ourselves through aftersales

standard of 1998 was updated and our competitors in the

services. Beds are medical devices, not furniture, and they

US have not yet adopted this stricter standard. It means

require maintenance. As far as I know, we are the only

the beds support a little more weight, are a little taller and

company with a clear aftersales service strategy. We also

are less likely to collapse. Measures have been put in place

have personnel specialized in clinical applications. We

to ensure that a patient’s extremities cannot be trapped

provide thorough training to all that will be in contact with

by the bed. The number of accidents that occurred in beds

the beds. Services such as how to clean and dry the beds

was high, which is why this standard was adopted. Our

seem simple, but the useful life of a bed can shrink due to

competitors have bought factories in Europe to sell to that

something simple being ignored.

market, instead of updating their own factories.

Q: How will the acquisition of Borcard impact Linet’s Mexican operations?

Linet Group, based in the Netherlands, is a supplier of high-tech

A: We were previously collaborating with the company

hospital and nursing beds for over 100 countries worldwide.

because it complemented our product line and now we

The Linet range also includes accessories such as anti-pressure

have decided to acquire it. It is much simpler for us to offer

ulcer mattresses, mobile equipment and healthcare furniture

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VIEW FROM THE TOP

INNOVATING IN PREVENTIVE MEDICINE: IMAGENOLOGY, SOFTWARE JAVIER GIRAUD Medical Systems Manager at Fujifilm Mexico

116

Q: What solutions do you offer in Mexico? Who are your

A: In medicine, there is a smaller amount of Big Data than in

key customers?

other industries, so we manage it differently. While there is a

A: There are five great subdivisions in which we are

high quantity of small data in other sectors useful for creating

working but imagenology is the most important for us. In

statistics, in medical IT we have fewer files, but they occupy

this division, we sell the only 50-micron mammography

much more digital memory. For example, a mammography

machine on the market able to perform tomosynthesis and

machine is used to produce a final image of around 40MB,

enhanced-contrast mammographies. Over 400 hospitals

although our latest mammography machine can produce a

and clinics are fully integrated through our medical IT

final image of over 200MB. If this mammography includes

division, either through the cloud or individual clouds.

tomosynthesis, the file is 10 times larger. Finally, the resulting

To this end, Fujifilm just released its newest product

mammography will be a single file of one gigabyte. Thus, Big

globally: Vendor Neutral Archive (VNA) software, which

Data must be managed differently.

fully interconnects hospitals and their departments. Our endoscopy division participates in tenders for both IMSS

Digital technology enables the making of thousands of

and ISSSTE, because these institutions perform many more

photographs to produce more precise diagnoses and our

endoscopies than the private sector. The fifth division is

imagenology system can produce four or five thousand images

ultrasound, an area in which we are highly specialized and

per test. New technology is needed to process and manage

which produces Sonosite, our key product.

these images at the rate the physician needs to visualize them. To meet this need, Fujifilm developed a visualizing platform

Q: What value does VNA software offer the health industry?

called Picture Archiving and Communications Systems

A: VNA interconnects hospitals within a system to produce

(PACS). This software administers the images and uses a

the complete medical profile of a patient, including the

new platform called DICOMweb. This technology interprets

results of medical tests, and provides it to the physician.

all the archives it receives and provides better test results in

It would be complicated for a single software supplier to

less time. Mexico invests the least in health in the OECD, with

provide all required solutions in this category to IMSS,

public spending at US$541 per capita yearly and US$1,052

the second-biggest health institution worldwide. I think

including both private and public spending per capita per year

the best choice is not a single unified system for every

as of 2015. About 30 percent of this money will be used for

physician but rather there should be an appropriate system

medicine and the portion left for medical equipment is low.

for each physician and the chance for that system to be

I think this has been changing lately and we are becoming

interconnected with the rest. Telecommunication companies

less corrective and more preventive. To prevent breast cancer,

will be Fujifilmâ&#x20AC;&#x2122;s allies during the entrance process of VNA

Mexico needs to invest in early detection equipment, which in

and therefore we work hand-in-hand with them. We have

the long-term will save more money.

signed a commercial alliance with Telmex. We have the know-how, but they are aware of the market.

Q: Fujifilm invested in cellular regeneration company Regcell. What are the advantages of such investments?

Q: How will Fujifilm manage the Big Data obtained

A: Fujifilmâ&#x20AC;&#x2122;s value is its innovation and the company does

through VNA?

not want to fall behind. As part of that the company has been investing in cellular regeneration through companies such as Regcell. Today, it is possible to send a DNA sample

Fujifilm Mexico is the local subsidiary of Japanese giant

and receive a piece of skin for healing burns. The goal of

Fujifilm Holdings Corporation. Its medical systems division

the technology is to develop a cellular 3D printer capable

comprises the areas of imagenology, endoscopy, ultrasounds,

of printing different kinds of tissue. Tissue and organ

dry chemistry and related support services

regeneration is where the industry is heading.


VIEW FROM THE TOP

THE ANSWER TO TOP HEALTH CONCERNS: TECHNOLOGY JUAN PABLO SOLÍS Vice President and General Manager of Becton Dickinson Mexico, Central America and the Caribbean

Q: How important is Mexico to Becton Dickinson’s global

of-the-art medical devices, it is more likely he or she leaves

position?

the hospital sooner.

117

A: Mexico has long been a successful market for the company. The country is the second-largest market in Latin

Q: What business models help keep high technology

America after Brazil. Over the years we have gone from

affordable for the public and private sectors?

being a syringe company to taking up a leading position in

A: We work on different axes, first generating local clinical

clinical diagnosis, molecular chemistry and flow cytometry

evidence about the benefits of our innovative products to

markets. Of Becton Dickinson's (BD) 45,000 global

the healthcare system, then early adopters among public

associates, 9,500 are Mexican, nearly 20 percent. They are

and private institutions embed the new technologies. Once

distributed throughout our operations in Mexico City, San

a product is proven to work, the system tends to adopt it

Luis Potosi, Sonora and Baja California. We export products

en masse. At Becton Dickinson, we have a wide range of

made in Mexico to the US, Asia, Europe and the rest of Latin

products that are affordable depending on the need, which

America. Our success in Mexico can be explained through

is why we play at different levels of the healthcare system,

our commercial and manufacturing history of over 60 years.

following our purpose to advance the world of health.

Q: How has Becton Dickinson permeated the Mexican

Q: What is Becton Dickinson doing to support the

market to ensure continued growth?

digitalization of the Mexican healthcare system?

A: 2016 was an important year for BD. Globally, it was the

A: We have several technologies that support healthcare-

first year we operated with the integration of Carefusion,

system digitalization. Through our solutions for lab

acquired in 2015. Carefusion has a strong portfolio of

automation, for example, we can connect different

innovative products and with this alliance, the company

instruments to link clinical results to a lab and a hospital

widened its footprint around the world. In Mexico, BD

database. Our value proposition in medication-management

consolidated its market leadership, focusing on providing

systems can help with drug/patient traceability that is so

solutions for the country’s main health issues. We are

badly needed in our country to avoid medication errors.

relevant in key fields such as women’s health and cancer — we produce the best technology for the early and accurate

Q: What type of technology have you developed for the

integrated diagnosis of cervical cancer. We continue to be

protection of healthcare professionals?

an important player in healthcare worker safety, providing

A: We have developments designed to prevent accidental

a wide range of products that make clinical and medical

punctures. A traditional syringe has a barrel and a needle,

practices safer for Mexican professionals, and we are

so when nurses give an injection, they are vulnerable to

becoming more relevant in diabetes management, with a

punctures. With our system, once the injection is made, there

large percentage of patients using our specialized syringes

is a mechanism activated by a spring that covers the needle.

and pen needles for their daily care.

These security products have seen great acceptance in the private sector and we want to show the benefits of this line

Q: How can BD technology help to improve the effectiveness

to public institutions. Our clinical evidence shows that using

and productivity of the Mexican public healthcare system?

these products greatly benefits the entire healthcare system.

A: Many innovative medical device companies, including BD, offer a set of products that in the short-term may appear to be more expensive than traditional devices. However,

Becton

the new features, such as safety for healthcare workers

technology company focused on IV devices for drug

and for patients, bring benefits in the long-run for the

administration, cancer diagnosis, diabetes treatment and

healthcare system. If a patient can be treated with state-

cellular research

Dickinson

is

a

US-based

international

health


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VIEW FROM THE TOP

INNOVATION SAVES LIVES, LONG-TERM COSTS FRANCISCO MORALES Director of the Healthcare Divison of 3M

Q: 3M manages a large variety of brands. Which are the

Q: What system is in place to track the user’s experience

most important in Mexico and what is your added value?

of 3M products?

A: We divide our business into five groups, each of which

A: We have well-established metrics. In hospitals, for

is responsible for driving brand awareness locally. We want

example, we can measure infection rates and their

the same image to be projected in Mexico, China and the

reduction. This is hard data that can corroborate our

US. I am in charge of healthcare. In this sector, Littmann

progress. The same goes for hand hygiene. If people

is one of our most recognized brands and is synonymous

comply, infections are reduced. The same applies to food

with quality. Another strategic brand is Tegaderm, which has

safety because we can prove there are no pathogens or

been growing globally and is the most important brand in

food viruses on instruments.

Mexico in terms of sales. Both Tegaderm and Littmann will receive strategic investments in 2017. 3M provides added-

Q: What are the results of 3M’s work with the Fundación

value because although a product may be more expensive,

Carlos Slim?

its positive outcome will reduce total healthcare expenditure.

A: We signed an agreement with the foundation to participate and collaborate in education through the

Q: What are the greatest challenges 3M faces in Mexico?

healthcare academy, which is an umbrella for any kind

A: The country’s improving life expectancy and increase in

of educational activity. We worked on this with the

chronic diseases present an opportunity. The more cost-

foundation and with IBM. Students are eager to learn

efficient solutions we can offer, the better the system

about new practices and new technologies and we struck

will work. One 3M solution helps to prevent infections in

an alliance with Del Valle University to provide these.

operating rooms, creating savings for patients and hospitals.

Part of the university’s responsibility is to show students

An example is a patient’s temperature. The longer patients

not only the history of their field but also what they will

are in surgery, the lower their temperature drops, which

encounter on a daily basis in their practice. If students

puts them at a higher risk of infection and cardiac arrest. A

graduate knowing the latest technology, they can jump

blood transfusion also increases risk and thus the cost. By

into the workforce right away with the necessary skills.

maintaining a patient’s temperature throughout the surgery, risk and costs are lowered. We estimate that less than 5

Q: Which are your main objectives for 2017?

percent of surgeries in Mexico happen with a temperature-

A: In healthcare, we are investing heavily in coverage,

management system. This is an opportunity for us.

adding more resources to broaden our reach, covering more hospitals, dentists and areas in food safety. We look forward

Q: What strategy do you employ to enter your products

to greater growth, considering that the market is expanding

onto the National Formulary?

due to chronic diseases. We are focusing on adding more

A: We need to show a positive clinical outcome, the expected

technicians, providing more education to the market and

cost and the potential savings. If we add innovation just

more sales reps to reach more people. We look forward to

for the sake of it, the authorities will not be interested

identifying key opportunities to offer solutions that improve

because it will increase cost without improving clinical

lives every day through science and innovation. This is our

outcomes. If the clinical outcome is positive but does not

ultimate and main goal as a company.

generate savings, it will not be accepted. We offer all these requirements through health-related economic and data analysis tools that allow us to show an infected patient’s

3M is one of the world’s largest manufacturers of science

hospital stay would be longer, increasing overall costs. In

and innovation products. An American company, it is focused

addition, this person is not going to work, impacting family

on health, automobile, energy, communications, security,

life. These are direct savings.

manufacturing and transportation

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VIEW FROM THE TOP

BENEFITS OF DIGITAL ERA ALREADY ON DISPLAY MARTÍN FERRARI Director General of Dräger Mexico

120

Q: What have Dräger’s main achievements been in

monitoring equipment. This is a good initiative from the

digitalization since last year? What are you pursuing

government, but it should focus on purchasing solutions

through digitalization in healthcare?

that could be integrated and become part of a system in

A: We had a lot of success with the INCan and we have

the future to provide a better service instead of purchasing

integrated five data digitalization systems with electronic

individual pieces of equipment. The prices are also low so

records for critical care areas and the surgical rooms that

they are not sustainable in the long term. We can offer those

use our equipment. At a government level, we still have

prices for one year but not several years running, especially

the same flows and issues in the compliance process.

with the depreciation of the Mexican peso against other

However, we have seen the benefits in the institutions we

currencies. This is not sustainable and endangers quality.

are already working with. Now, nurses have more time to

The first step should be to understand the value of complete

focus on patients instead of collecting data on paper. The

solutions and then change the model to purchasing based

doctors can make better and more precise decisions with

on specific therapeutic needs. If the government purchases

the new tools.

equipment from different brands for a surgical room, they will have different maintenance teams, different guarantees

Q: What are the obstacles to integrating these solutions

and different providers.

in more hospitals? A: There is a budget for equipment purchases but the

Q: How are Dräger’s commercial interests split?

problem is the way the government buys and plans

A: Our business operations are split 50/50 between

investment in the mid to long term. The purchase is focused

government and the private sector. We want to increase

on solving immediate problems, so we are missing better

our business with the private sector and achieve a

evaluations and long-term planning to invest in solutions

split more like 40 percent government and 60 percent

that impact problems and processes. IMSS has changed its

private. Due to its business model, the private sector is

purchasing process greatly and we hope this filters through

more dynamic in its purchasing and we can process our

to other federal institutions.

sales directly with clinics. The sector is on its way to establishing integrated solutions that we can support

Q: What other priorities does Dräger have within Mexican

with our portfolio. We are seeing some success with

healthcare?

Dalinde and Hospitales Star Médica. We created an

A: We want to change our business model and go directly

alliance with Christus Muguerza for building surgical

to market, without intermediaries. We have been working

rooms with B.Braun and Diphsa that could bring many

on this for a long time and many doors have opened as a

benefits for private institutions.

result of the government’s new purchasing systems. Q: In what areas does Dräger focus its innovation activity Q: What benefits have you had from the new purchasing

and what new products are in the pipeline?

schemes?

A: We are focused on intensive care, ventilation, anesthesia

A: We saw a great result with the IMSS’ scheme and we were

and neonatal care. In the specific case of neonatal care,

successful in the consolidated purchasing of ventilators and

this year we are launching a new incubator called BabyLeo, a crib with thermoregulation. It provides many benefits when working with newborns, such as efficiency, a quiet

Dräger is a German company established in 1889 that operates

environment for the baby at 40 dB(A) and ease of care-

across sectors including mining, oil and gas and health, where

giving for clinicians and parents. It is also possible to

it specializes in medical devices for hospitals in the surgical,

perform surgical procedures inside the incubator while

intensive and neonatal care and monitoring sectors

maintaining humidity, temperature and oxygen control.


VIEW FROM THE TOP

CHANGE IN FOCUS FOR MEDICAL DEVICES GIANT ALEJANDRO PAOLINI General Manager of Siemens Healthineers Mesoamerica

Q: There is a trend toward deregulation of medical devices

Siemens as a whole. In addition, there are many synergies

in Mexico. How does this impact your operations?

and similarities between the other parts of the business,

A: This trend is good for us as long as it is done intelligently

although not for healthcare. We can now take strategic

and efficiently. Regulation is a difficult topic because our

decisions faster. If we want to make an M&A decision, take

industry is highly regulated in all parts of the world and

a new strategy or create new products we no longer need

it has to be protecting the population. However, it must

to refer back to Siemens. The brand name is to give us a

also be efficient and not be an obstacle for the population

specific identity. Not everyone understands the meaning

to have access to the latest technology. A balance must

at first but Healthineers expresses our engineering and

be struck between protection and access and I believe

pioneering background applied to the healthcare industry.

COFEPRIS is working on this in an intelligent way. What is important is that COFEPRIS has maintained an open

Q: In 2016 you reached agreements with hospitals in

dialogue with the industry and we need to talk with them

Turkey. To what extent is Siemens interested in agreements

through our associations such as AMID and CANIFARMA.

with hospitals in Mexico?

Serious companies want a regulated industry but regulation

A: We absolutely are. At the same time as continuing

that is efficient enough to avoid being an obstacle.

investment in new products and R&D, we want to expand our business into new services related to our products.

Q: What growth has Siemens Healthineers seen in 2016?

That is the final goal: to be the enabler or facilitator of

What were the main drivers of this?

healthcare providers, enabling them to perform better with

A: In 2016, Siemens Healthineers Mexico had a good year

higher output and lower costs. We are not looking for any

considering the context. We had double-digit growth, so we

specific types of hospitals but it would have to be at least

can say that it was a good period in terms of revenue, as we

a midsized hospital as this is not the type of project that

had many orders pending from 2014/2015. In terms of new

could be implemented with a small hospital.

orders, we continued to grow but this slowed down and we ended 2016 with high-single digit growth. We gained market

Q: In February 2017 Siemens announced a US$200 million

share and we grew above the market, but it was difficult

investment for the next 10 years in Mexico. How much of

because of the peso devaluation against the US dollar and

this is going to healthcare?

public budgets being cut due to a drop in oil prices. However,

A: A small part of it will go to health. There are factories

it was stable thanks to the private market as it continued to

and development centers related to the other businesses

invest despite the fact that the public market contracted.

but it would be difficult to have local production for health. The typical example is magnetic resonance, as the annual

Q: How has rebranding as Siemens Healthineers boosted

Mexican market is probably for around 20-25 systems. This

Siemens’ image and operations? What benefits is it

is not mass production, these are high technology products

bringing to your operations and clients?

and manufacturing is concentrated in one or two places

A: The new brand is just the final stage of a bigger process

across the world. This is why healthcare will only receive

that began with the separation of the healthcare business

a small part of the US$200 million because most of it will

into an independently managed business. The second step

go to plants.

was the implementation of the new strategy. Then, a new structure, new business principles and corporate values and the introduction of the new brand came. The main benefit

Siemens Healthineers is the healthcare branch of the German

is that we have gained speed to react to client and market

electronics giant. It is mostly known for its medical devices,

needs. Siemens is huge and diversified. Total revenue

which cover a wide range of therapeutic areas, with a focus

for health is €15 billion compared to over €80 billion for

on diagnostics, imaging and IT

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VIEW FROM THE TOP

ARTICULATE GROWTH FOR MEXICO NELSON VALENZUELA LATAM and Caribbean Director of Arthrex

122

Q: What is your view on selling through public tenders

Q: Which products are you bringing to Mexico?

in Mexico?

A: We do not want to deprive Mexico of innovation, so

A: Due to the market niche we work in, we are obligated

we work on a diversified portfolio for A and B markets as

to deal with huge distributors that offer integral services,

physicians move between distinct hospitals and different

which is complicated. They consolidate several brands and

reimbursement scenarios. In Mexico, the most common

sell a complete service to the hospitals of IMSS and ISSSTE,

surgeries would be shoulder instability, rotator cuff tears,

although PEMEX, SEDENA and SEMAR have remained

anterior cruciate ligaments rupture, meniscus reparation,

outside this model. Both IMSS and ISSSTE classify Arthrex’s

syndesmosis, Achilles tendon repair and internal braces for

technology as minimally invasive (MI) and 90 percent of these

ankle stability. These seven surgeries all have an A and B

MI procedures are abdominal, while 10 percent is for joints.

portfolio available in Mexico.

This turns into a fight every year as the volume reduces. Being only 10 percent of the contract, distributors do not place the

Q: Arthrex has an educational center in Florida. To what

same emphasis on arthroscopy. The ideal scenario for us

extent does the education you offer in Mexico help

would be for integral services to end or include arthroscopy in

doctors improve their skills?

orthopedic tenders. Ideally, we would provide services directly

A: In addition to the Florida Center we have one in Mexico

to government institutions but they never have the budget

and one in Brazil because we have the obligation to correctly

to buy everything.

train doctors to use our products. The courses are open to everyone, even those who do not use our products. Some

Q: What is Arthrex’s strategy to expand its reach in the

courses are available online through Arthrex’s webpage,

private market and to stand out against its competitors?

which puts over 4,000 videos online, and through our

A: We have learned we need to analyze more factors before

Surgeon’s Virtual App, which enables doctors to first

making the decision to launch a new product, to focus on

practice digitally before moving onto dry labs. In our labs we

more profound marketing studies using a sniper technique.

use imported cadaveric pieces from the US. Unfortunately, in

Globally, Arthrex has 12,000 products, of which 2,600 are

Mexico the culture of organ donation is poor and if we have

available in Mexico, which is the right number of SKUs

chance to use a Mexican cadaver, the law is clear, demanding

based on the Mexican market’s need. This has enabled us

use of the full body. Can you imagine putting a full body on

to see growth rates of 17-18 percent in the country. Another

a table just to practice on the knee?

key point is service: when we sell an anchor, we are also selling the accompanying equipment and a technician to

Q: What is the most important product you will be

help. For MX$25,000 (US$1,389) worth of sales, we have to

launching in Mexico in 2017?

move MX$600,000 (US$33,000) of equipment, products

A: Apollo, a bipolar radiofrequency for arthroscopy. It will

and personnel. We have to define our service standards

be brought to Mexico in July 2017. Arthrex has the fastest

and stick to them. We go with a full set of equipment, the

processing times of all medical device companies in Mexico

instruments are in perfect condition, the technician will be

and our products are approved within an average of 60

well-trained and we will be there for anything needed. This

days. In our 2015-2016 financial year, we registered 102

reinforces our credibility with doctors.

products. The priorities for this year will be to maintain operational excellence and for our sales team to begin identifying new opportunities and to relaunch technologies

Arthrex is a medical devices company and a leader in new

that did not have the initial impact we had hoped for. The

product development and medical education in orthopedics.

second priority will be human capital management. The

The US-based company is a pioneer in orthobiologics,

third point will be to continue our great work in compliance,

arthroplasty and in the surgical treatment of arthritis

not as an obligation but as a way of business.


SPOTLIGHT

SYNERGYRF SYSTEM WITH APOLLORF_ PROBES AND SYNERGYUHD4 SYSTEM TM

TM

TM

The First Biopolar RF System to integrate with an Arthroscopic Imaging System. The SynergyRF System with ApolloRF Probes completes the Arthrex® Synergy arthroscopy platform with an easy-to-read “heads-up display” of operational settings on the Synergy 4K monitor. The Apollo MP90 Probe with multiple suction ports is designed

123

for efficient ablation and coagulation, and has an ideal working length for shoulder, knee and hip arthroscopy.

MP90 Probe

XL90 Probe

Hook Probe

Aviso de publicidad No.17330020202C3318


INSIGHT

FLEXING MUSCLE IN MIDTIER KNEE REPLACEMENT GERMÁN GARCÍA Director General of Smith & Nephew

124

Midtier knee replacements designed with affordability and

to reduce the price,” García says. The company, which

quality in mind offer a solution for shrinking health budgets

specializes in advanced wound management, sports

in emerging countries like Mexico. Prosthesis and medical

medicine, orthopedic reconstruction and trauma, works

devices manufacturer Smith & Nephew believes the key

with both the public and private sector. In Mexico, around

clues to reducing costs can be found in the specifics of

90 percent of its medical devices go to the public sector,

the population.

its largest single purchaser in the country.

Knee replacement, a form of arthroscopy, is a common

“Innovation can drive costs down for the system. Sometimes

procedure performed daily worldwide. It is most often

an innovative product is less expensive, more efficient and

done on patients over 50 years-old, with over 90 percent

carries many benefits for patients,” García adds.

experiencing dramatic pain relief after the surgery, according to the American Academy of Orthopaedic Surgeons.

Speaking to general market trends in medical devices, García says that “the trend is to make smaller products

ANTHEM, Smith & Nephew’s artificial knee, was developed

and less invasive procedures for the faster recovery of

in emerging countries worldwide, where the population

the patient.” The materials used are also relevant. Smith

is typically shorter than Americans and Europeans. The

& Nephew has developed highly resistant plastics that are

company has also simplified the replacement process, as

lighter and less expensive than metal and can be used safely

it requires only three trays of surgical tools rather than the

for instruments and specific parts of prosthetics. A knee

seven previously required, which also reduces the overall cost.

prosthetic with these plastics can last for over 20 years. The company also develops tools to perform arthroscopy,

“This product is the combination of two innovations: it is

such as TWINFIX, used for repairing joints. “This device is

specifically designed for Latin American and Asian markets

friendly for physicians and the fixation products we use are

due to the size of the population and we have simplified

high quality,” says García.

the number of pieces required for the procedures,” says Germán García, Smith & Nephew’s Director General

Despite the government being a large client, doing business

for Mexico. “During the research phase, we began by

with it is not so easy. “We have to develop a tender for our

identifying bone characteristics of patients and then we

new products, it does not come automatically,” García says.

identified the best fit for those bones, combining the skills

“We must first present the product then talk to doctors

of researchers, physicians and marketing personnel to also

and institutions so they can develop the tender and then

reduce the number of pieces.”

we can participate.”

Smith & Nephew works in both medical devices and

Registering a new device can also be time-consuming,

arthroscopy, the latter of which represents around a third

taking as much as two years. García calls for simplification

of its yearly sales and between 30 to 45 percent of the

of the registration process because the medical devices

Mexican market, thanks to a focus on cost efficiency and

industry evolves rapidly. He also hopes for improved

innovation. The global arthroscopy market was valued at

access to medical devices in Mexico. “Half the population

US$4.0 billion in 2015, according to Grand View Research.

has Seguro Popular, which is limited because it covers only catastrophic diseases. They do not have access to

“We know that in developing countries in Latin America,

advanced medical products,” he says. But he is optimistic

Africa and Asia the public sector budget is constrained,

about growth in the country. “The medical devices market

so we try to develop products that are affordable for that

in Mexico is underdeveloped, which means there are many

sector while maintaining quality. We implement innovation

opportunities to grow.”


VIEW FROM THE TOP

OPENING THE ROAD TO A NEW HEALTHCARE SYSTEM FERNANDO OLIVEROS Vice President of Medtronic

Q: Medtronic has said the government needs to place more

patients. There are approximately 200,000 people with this

importance on the healthcare sector. What progress has

condition and only 1,300 insulin pumps users. Medtronic

been made?

is also open to sharing its global experience to quantify

A: Over the last two years, we have reached out to the

and identify uncover needs inside the institutions. We are

authorities, private companies, regulators, patients and

working to develop information that will provide real data

insurance companies to create an alliance to communicate

on the costs of diseases because providers cannot offer

a common message: there is a need for a health reform

solutions without having total knowledge about the cost

in Mexico that should focus on two areas. The first is to

of a problem. Finally, we can offer expertise in production

separate financing from service provisioning and establish

and manufacturing processes to institutions like IMSS or

a payment system that provides finance for any medical

ISSSTE thanks to our five manufacturing plants and the

service. The second change should be to open access to

13,000 employees we have in Mexico.

the healthcare system, meaning that they should be able to choose where to be treated.

Q: Does the system have access to the technology it needs to improve?

Q: What strategy could lead the system to a better use of

A: Patients in Mexico do have access to great technology.

healthcare resources?

There are patients who can get an artificial pancreas

A: We are one of the leading companies open to the creation

at a clinic with integral services, but the majority of

of a new health financing system in which the risks are

the population has no access or very limited access to

shared between providers and clients. As providers, we are

basic health services. The responsibility for companies

looking to work with the client to share risk by establishing

like Medtronic is also to make technology available for

strategies such as performance-based payments. Under

everyone. Lagging behind on technology implies a higher

such schemes, the customer will only pay if the product

cost for the system and for patients. As an example, we

achieves the desired performance or results.

have remote monitoring of heart rates that could allow 80 percent of patients to stay at home instead of going to a

Q: What has been the governmentâ&#x20AC;&#x2122;s response to these

hospital. However, the level of knowledge of doctors and

alternative strategies?

patients to use the equipment and the service model are

A: It has been very good, but it is a challenge to make

not connected.

it a reality because private companies are changing from being providers to becoming partners. We are finding

Q: What actions is Medtronic taking to open access to

many barriers. The regulatory bodies are very price-based

healthcare?

and they are close-minded to ideas like payment for

A: For us, access has four definitions: education and

performance. Inertia has ruled the system for a long time

training of human resources, doctors and nurses; available

and it is very hard to change that. Lack of transparency is

and useful infrastructure; promote financing and establish

also a major problem that prevents us from moving forward.

efficient service models. In education, we are working on projects to better introduce technology to doctors,

Q: What is Medtronicâ&#x20AC;&#x2122;s value proposition to ensure the

especially in cardiovascular health, diabetes and obesity.

productivity and effectiveness that health institutions require? A: In terms of portfolio, Medtronic is the largest medical

Medtronic is a global technology company. It is a leader in

devices company in the world. We provide integral

the development of medical devices focused on solutions for

solutions for Mexicoâ&#x20AC;&#x2122;s main health concerns. We are

diabetes, cardiovascular health and obesity. It has been in Mexico

the unique provider in Mexico of insulin bombs for T1D

for more than 40 years and it is present in more than 140 countries

125


INFOGRAPHIC

THE MEDICAL DEVICES SEGMENT IN MEXICO A growing list of international companies have

higher life expectancy, patients with critical illness, an aging

invested US$1.94 billion (from 2005 to 2015) to

population and increasing home-based assistance will boost

take advantage of the country’s human capital,

new products and services

low operating costs and strategic location.

It took only 12 years for Mexico to become a major cluster in

Medical devices come in all shapes, sizes and levels of

medical devices manufacturering, achieving solid participation

sophistication. The growth of the sector shows no sign of

in the global industry and a solid growth perspective.

slowing down.

AT A GLANCE (US$ billions)

TOP INVESTORS

$8.41 $3.96 156,831 $1.94 Exports

Imports

FDI (2005-2015)

Jobs

US Italy

TOP INVESTORS

Over 30

Over 75

Over 7,100

Over 1,400

Production

Medical

Sanitary

Products released

plants

specialties

registrations

(2013-2018)

„„86% US „„6% Italy „„5% Germany

DRIVEN BY TIJUANA

COMPETITIVE ADVANTAGES • Top exporter in LATAM • Eighth exporter worldwide • Low production costs • Qualified talent • Export platform • Special federal programs • Next to the world’s top producer

70%

Only 30km away from San Diego,

of firms based in Tijuana/ Tecate are from the US

Tijuana’s medical devices hub impacts both Baja California's GDP and the US market (the biggest with a global 38% market share).

EXPORTATION OF MEDICAL DEVICES BY STATE (US$ billions) 2.5

79

36

2 39

1.5

„„Number of companies 44

41

5

8 Queretaro

195

Yucatan

35

State of Mexico

18

0.5

Jalisco

1

Sources: ProMéxico, El Economista

Mexico City

Nuevo Leon

Sonora

Tamaulipas

Chihuahua

0 Baja California

126

Medical-device manufacturers have reason to be positive. A

Mexico’s relevance for the US industry: Over

$US7.7 billion per year in sales from Mexico

Germany


MEXICAN MARKETDEVICES (US$ billions) MEXICANMEDICAL MARKETDEVICE OF MEDICAL

„„Exports Export

„„Imports

2011

2012

2013

3.96

6.34

6.07

2010

4.44

3.95 3.74

2009

3.47

2.48

2008

3.41

3.15

3.04

3.18

2.44

2007

1

3.01

3.03

2.18

2.37

2

0

2.64

2.61

2.78

3

5.13

4.56

4

5.06

5

5.79

6

6.88

7

7.69

8

8.40

9

2014

2015

——Trade balance 127

Import TOP 20 COUNTRIES FOR MEDICAL DEVICE IMPORTS AND EXPORTS (US$ billions) 0

10

US Germany Netherlands China Belgium Ireland Switzerland Mexico France Japan UK Singapore Italy South Korea Denmark Costa Rica Austria Australia Hong Kong Malaysia

20

„„Export

30

40

50 US Germany Netherlands China Belgium Japan France UK Italy Canada Australia Switzerland Spain Mexico Singapore South Korea Russia Brazil India Austria

„„Import

EXPORTS: MEXICO'S GLOBAL RANKING

3rd 4th

Tubular suture needles

Instruments and devices for medicine, surgery, dental and veterinary / furniture for medicine, surgery, dental and veterinary / syringes, catheters, cannula and similar products

50

40

MAIN COMPANIES WORLDWIDE*

30

20

10

AMID’S AGENDA

PROJECTED GLOBAL GROWTH

Johnson & Johnson

27.50

AMID is the sector’s top association of

GE Healthcare

18.29

companies; it has 30 Mexican and global firms

Medtronic

17.00

as members.

Baxter International

16.67

• For the health sector: simplify access to

Siemens Healthcare

15.77

Philips Healthcare

11.17

innovative technologies. and improve transparency in acquisitions.

11.00

• For economic promotion: build public

Covidien

10.66

policies to boost competitiveness and

Abbott Labs

10.11

Stryker

9.66

US$663 billion in 2015

• For tax authorities: encourage investment

Cardinal Health

0

US$894 billion expected for 2020

exports.

*Sales FY2014. Figures in US$ billions

MEDICAL DEVICE PRODUCTION BY COUNTRY

US

Swiss

China

Japan

„„38.2% US „„22.1% China „„6.5% Germany „„4.2% Switzerland „„4% Japan „„25% Other

MEDICAL DEVICE PRODUCTION BY REGION

„„41.0% North America „„30.9% Asia Pacific „„19.2% Europe „„1% South/Central America

„„7.9% Other

North America

other

Asia Pacific

South/Central America


VIEW FROM THE TOP

COMMITTED TO THE FUTURE OF HEALTH CARLOS JIMÉNEZ Director General of B. Braun Aesculap

128

Q: What were B. Braun’s growth numbers in 2016 and what

smaller particles. The speed of flow can be modified to

challenges did it overcome?

better respond to patient needs. This is an easier therapy

A: We grew 25 percent in 2016 between the two divisions,

for patients than hemodialysis and the results are better.

while Aesculap alone grew by over 30 percent. This

This technique could help around 65,000 people in Mexico

growth was achieved despite the government’s budget

that are being treated with hemodialysis. However, there

cuts and new purchasing habits. We participate in few

are between 80,000 and 100,000 more people that are

categories in the public tenders as the National Formulary

undergoing peritoneal dialysis.

is increasingly targeting generalized products, which hurts us. Sometimes, products with current technology and

Although the associated costs are higher because more

quality compete against products with old technology

advanced equipment is required, at the moment neither

that are cheaper to produce, which limits our chance of

insurers nor the public sector recognize a distinction

successful participation in certain areas. Of the 600 or so

between hemodialysis and hemodiafiltration, so hospitals

categories in medical devices, we participate in only seven.

are bearing the extra costs themselves and to provide

It is not that all our products are state-of-the-art, but a

better care to patients. It is covered separately for patients

10-15 year-old product is also at a disadvantage because

in private care because the supplies are billed separately.

the required specifications for the product may be 30-40

Six clinics are now using hemodiafiltration equipment. We

years old. I do not believe this will change anytime soon

do not sell the equipment but loan it as the machine is

because the public sector is working on a reduced budget.

much more expensive than hemodialysis technology.

There are between 80,000 and 100,000 people in Mexico that are undergoing peritoneal dialysis

Q: What are the main surgical trends permeating Mexico’s operating rooms? A: There is a strong focus on integral services and on costreduction in public centers. Previously, criteria stated that to offer integral services, one had to provide equipment of a certain technological level and age but these specifications have been removed to reduce costs. Now, devices can be reused but the regulation does not specify how to reprocess certain pieces, such as disposable devices. We are still waiting on standards: how to wash them, for how long, with

Q: What impact do you expect hemodiafiltration will

which substance and which chemicals and how to perform

have in Mexico? How does it differ in performance from

functionality controls. This has led to uncertainty regarding

hemodialysis?

cost. For example, if a service costs MX$100 million (US$5.5

A: Hemodiafiltration – a technology that combines

million) one year and MX$80 million (US$4.4 million) the

hemodialysis and hemofiltration – was launched here at

next, ostensibly that means MX$20 million (US$1.1 million) in

the end of 2016. Compared with hemodialysis, the machine

savings. But if products are reprocessed, the internal costs

purifies the blood of urinary toxins and also filters out

generated to do so should be taken into account. We do not know what the true savings are.

B. Braun is 178-year-old German medical devices giant. It

As for the private sector, insurers are putting pressure

operates in four main areas: hospital care, out-patient, aesculap

on hospitals to not pay high increases in the cost of

and atvium, which are concentrated in two divisions in Mexico.

medical care. Hospitals are allowing for increases of 3-4

Medical encompasses the first two, Aesculap the latter two

percent due to inflation but most products are imported


in US dollars or in euros. The increase in prices hospitals negotiated with insurers was a maximum 8 percent, so we are reaching a point where they cannot absorb these costs. Possible solutions might be found by having more efficient processes and through innovations, products and patient treatments. Q: Innovation has always been at the forefront of B. Braunâ&#x20AC;&#x2122;s operations. What is next for the company? A: We have many product lines to launch, including a prosthetic that helps maintain bone structure. It will be available in 2017 and will enter the National Formulary so that public patients can have access. We will also launch products intended for intensive care. Our technology of continual therapy is connected to a patient for a few days to slowly clean the blood and requires little effort from the patient. This was a key theme in the World Nephrology Conference, held in Mexico City in April 2017. We are also building an auditorium for the Aesculp Academy and B. Braun will participate in over 40 congresses in 2017, demonstrating our commitment to the industry. Q: How do solutions such as B. Braun Knowledge Center and the Academy help you manage a more successful business? A: The Aesculap Academy is a foundation that was created 20 years ago and is independent of B. Braun. The concept is to bring health professionals, specialized education and knowledge to execute patient treatment in a safer manner and to achieve better patient outcomes. B. Braun supports the Academy through donations. The Academy has a grant system and offers paying courses, which helps it maintain its autonomy. B. Braun started the Academy but now it has other partners such as the Mexican Academy of Surgery, which has developed programs with the Aesculap Academy. The Knowledge Center responds to a need to better train our staff members in understanding processes, knowing products and learning about authorization processes. This is the basic platform for teaching B. Braun employees how to work well in the company. Q: To what extent are you impacted by COFEPRIS deregulation of medical devices? A: It is vital that deregulation happens, because it makes no sense that a medical spatula used to hold down a tongue has such high registration requisites. Technically, it is not dangerous in use nor complicated to manufacture. Deregulation is needed for these types of products. However, B. Braun would see no benefit from such deregulation because our product portfolio is much more precise and more impactful on patients. We do not manufacture a single product on COFEPRISâ&#x20AC;&#x2122; huge list of deregulated products.

129


INSIGHT

MEXICAN HEALTHCARE INCHES INTO THE DIGITAL FUTURE ULISES BACILIO CEO of Grupo PTM

130

Digitalization is making its way across every sector of

are afraid they will not be able to see the image in as much

the health industry. In addition to being environmentally

detail. “They are a dogmatic profession; they are not used

friendly, these solutions save costs and are practical, says

to changing their ways. This is true worldwide, not only in

Ulises Bacilio, CEO of Grupo PTM adding the biggest

Mexico.” The X-card is in use in four hospitals in Mexico:

obstacle is not patients. “Doctors are the greatest resistance

two in Toluca, one in Puebla and one in Cuautla. “Millions

we face,” he says.

of radiographic sheets are still used every year in Mexico. ISSSTE alone spends MX$30 million (US$1.7 million) per

Working in conjunction with global medical imaging giant

year on these sheets,” Bacilio says, adding that eliminating

Phillips, Grupo PTM, a leader in technology solutions for

the radiographic sheet has been the company’s motto and

hospitals, provides interpretations of radiographs that are

mission from the beginning.

delivered digitally in a matter of days. That compares with the months it previously took to get an interpretation to

The company has also digitalized its internal processes,

a patient, especially those in remote areas. The company

shortening its operating cycle by asking for immediate

also provides cloud storage for the interpreted radiographs.

payment and resolving cash flow issues. This has allowed

The X-card, its key product, allows patients to have their

PTM to further invest in its technology and to provide

medical history and images on hand at any point in time,

its customers and ultimately patients with newer, better

no matter where they are in the world.

products and services. PwC predicts the global value of connected health to reach US$61 billion by 2020.

PTM technology has diagnosed over 100,000 mammograms and 7,000 cancers

Another product on offer is the Invox, a voice recorder designed especially for medical professionals that speak Mexican Spanish. It uses linguistic analysis to automatically register keywords and categorize the recording, allowing users to easily search through voice albums at a later date and retrieve data. “We provide updates to the software almost every month, constantly improving the product,” says Bacilio, who believes that digitalization will also allow companies and public-sector institutions to begin

The patented invention consists of a credit card-sized

collecting data on the services they offer and that they

plastic card that bears a unique code. The patient can scan

will be able to analyze it and put it to good use, to better

this code or enter it into the Grupo PTM website to instantly

serve patient needs.

access their medical images and share them with their specialist of choice. In addition to being environmentally

Grupo PTM works with over 400 clients in every Mexican

friendly, these solutions save costs and are practical. “A

state, ranging from small clinics to large hospitals. As of

patient can load all his studies onto the card and it can

December 2016, over 100,000 mammograms and 7,000

be read with a simple QR scanner on a cellphone,” says

cancers had been diagnosed through PTM’s technology. The

Ulises Bacilio, CEO of Grupo PTM. If a patient loses the card,

volume of clients it works with has allowed the company to

he only needs to inform the company, which cancels the

begin compiling statistics. “The data we collect could be

code and reissues a new card and code. Despite the many

useful for clinical research. For example, there are many

benefits, implementing digital solutions is not always easy.

gastrointestinal cancers, in particular in Hidalgo,” says

“Patients rapidly accept innovations such as the X-card.

Bacilio. “We also realized that Tuesday is the busiest day

They find it amazing,” says Bacilio, explaining that doctors

of the week for medical appointments in Mexico.”


VIEW FROM THE TOP

CASTING A 3-D APPROACH ZAID BADWAN Director General of MediPrint

Q: What are the benefits of creating new products in

that market will be in healthcare. This makes sense to me

Mexico and how open is the country to innovation?

because although there are applications for the automotive

A: Mexico is an interesting market. It is a country with a

and aerospace sectors, they usually work B2B. None of

large population with different problems, so there are

them are B2C. Health is probably the only market that

plenty of fields in which we can innovate. The creation of

requires printing to be B2C, which is why it will grow a

innovative products should be aligned with national needs.

lot. Also, we have made many improvements. We can print

But it is important to understand that the distribution chain

hydroxyapatite, the material that makes up between 50

for the healthcare sector is different in Mexico than in other

and 60 percent of human bones. If we print this material

countries. The government, the private sector, integrators

and implant it into a person using stem cells, the body will

and distributors interact based on different interests. Also,

react to its foreign shape as if it were made of bone cells

there is a strong regulatory environment here and if you are

and real bone will form around it. This is something that

a startup, raising resources for a product you are not yet

could be possible in the next few years. The problem is

selling can be complicated because it needs to be certified.

that certification for something of this kind is extremely

One of the advantages in starting with innovative products

complicated. It requires a cleanroom that costs millions

is the possibility of being recognized in other ways, such

of pesos. It is complicated for startups to fund elements

as through published papers or giving keynote speeches

such as cleanrooms and big companies do not do it yet

in hospitals and medical congresses. Entrepreneurs can be

because they are not sure about entering this B2C 3D

recognized through competitions. We have won some in

printing market. It is complicated but I think it will happen.

Mexico and Europe and that was our main source of funding in the beginning. We also received some government aid

Q: How is the 3D printing industry regulated in Mexico?

and now we are closing our first round of investment. Most

A: There is no effective regulation for 3D printing around

of our money goes to R&D and the government helped

the world. The FDA has just started thinking about

us through programs offered by the National Institute of

regulating it differently from other devices but technology

Entrepreneurship (INADEM).

will always advance faster than regulation. 3D printing can make almost anything but you need to regulate every

Q: How much is 3D printing used in healthcare and what

product that comes out of the printer. If the product is

are the technologyâ&#x20AC;&#x2122;s main advantages?

sufficiently different from another, there must be another

A: In Mexico not very much. Aside from MediPrint, I have

piece of regulation. That is why people are only producing

only seen some instances in which disabled people are

one product and why regulating institutions such as the

given or sold prosthetics that have no regulatory approval.

FDA are thinking of implementing a special scheme. It is

That is illegal but there is a need that has to be satisfied,

complicated though. How will you know that someone

which wasnâ&#x20AC;&#x2122;t happening at an adequate market price point.

printing casts but who also wants to do brackets will do

Besides that, 3D printing is not something broadly used yet.

them correctly? That is why I think regulation is there for a

This technology is available and used around the world but

reason, to protect people. So far in Mexico we do not have

not as much as it should be. 3D printing has been around for

a specific regulation or norm for 3D printing and we have

30 years but many patents held by big companies expired

to comply with the general norms regulating casts.

just a few years ago. Q: What are the potential healthcare uses of this

Mediprint is a Mexican start-up dedicated to the research,

technology?

development and creation of personalized medical solutions

A: McKinsey says the 3D printing market will reach around

using 3-D scanning, modelling and printing technology. Their

â&#x201A;Ź500 billion by 2020. Deloitte has said that 60 percent of

product ambitiously aims to replace the traditional plaster cast

131


Magnetic resonance


BIG DATA & HEALTH APPS

6

Technology is developed with the objective of making lives easier and better lived. This has specific potential in healthcare, in which technology has become an opportunity to save lives and optimize patient comfort. The need to become more efficient in patient care and to manage the large amount of data generated has made the adoption of technology necessary to automate processes and highly standardized and repetitive tasks. Recording patient data has become a priority in itself to guarantee the existence of a broad database to offer the best treatment and follow-up for patients, but this also represents a security challenge. The digital world has been rocked by several high-profile international breaches and healthcare institutions and companies must ensure the confidentiality and protection of the data they collect to earn patient trust. The effectiveness of Big Data is a result of its veracity, velocity, variety and volume. This information will help guide doctors and policymakers on the efficiency of medicine and research, among other trends.

This chapter will give an overview of the companies that deal in Big Data and digital applications for smartphones that have a health focus. In addition, those designing wearable health technology will shed light on the impact they have had on the Mexican market and mindset.

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CHAPTER 6: BIG DATA & HEALTH APPS 136

ANALYSIS: Digitalization Advances But Pace Remains Uneven

138

VIEW FROM THE TOP: Xavier Valdez, QuintilesIMS

139

INSIGHT: Antonio Carrasco, Grupo PLM

140

VIEW FROM THE TOP: Guillermo Ferrari, Eseotres

142

VIEW FROM THE TOP: Guillaume Corpart, GHI

143

VIEW FROM THE TOP: Enrique Martínez, IIIFAC

 José Ferreyra, IIIFAC

144

VIEW FROM THE TOP: Alejandro de la Parra, Astrum Salud

146

VIEW FROM THE TOP: Santiago Ocejo, Salud Cercana

148

VIEW FROM THE TOP: Mario Amadio, GE Healthcare

149

INSIGHT: Maciek Drejak, Northcube

150

VIEW FROM THE TOP: Benjamín Villaseñor, Uhma Salud

Roberto González, Uhma Salud

151

VIEW FROM THE TOP: Melanie Chase, Fitbit

152

INSIGHT: Javier Cardona, 1DOC3

153

VIEW FROM THE TOP: Federico Casas-Alatriste, T-Systems

154

INSIGHT: Julián Ríos, Higia Technologies

155

VIEW FROM THE TOP: Xavier Ordoñez , Deloitte

Horacio Peña, Deloitte

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ANALYSIS

DIGITALIZATION ADVANCES BUT PACE REMAINS UNEVEN Digitalization is key to ensuring access to healthcare. Industry

approach. According to Guillermo Ferrari,

players and public organisms must overcome technological

General Manager of Eseotres, which provides

barriers to make the most of the possibilities offered by Big

digital-imaging solutions, IMSS carries out

Data for better management of institutions and patient health

between 19 and 20 million image studies every year, using 1.5 million square meters of

136

Well-designed and effectively used information

Eseotres’ analog film. “The vast majority of imaging studies

infrastructure has the potential to become the lynchpin

done by public health institutions is archived in boxes.

of quality for successful healthcare systems globally,

Through digitalization, the studies’ archives can be easily

according to the OECD. However, the industry lags

retrieved and shared and become a source of Big Data

other sectors in adopting the tools that could elevate its

to develop useful information for the creation of health

management and delivery of care. In Mexico, where budget

policies, efficient resource allocation and productivity

cuts to the public health system have hampered spending,

measurement,” says Ferrari.

it is critical that Big Data and high-tech solutions begin playing a greater role in the sector.

EMPOWER PEOPLE Gathering the data is only the first step and making it

The OECD report, Mexico’s Health System Review 2016,

available and shared is among the top challenges Mexico’s

highlights some of the core uses of well-managed health

public healthcare institutions have faced. Technology

data: evaluation, monitoring, personalization of care,

companies recognize this and are creating solutions.

ensuring of continuity, support provision, purchase and

Five years ago, IMSS would have more than two medical

prediction of care needs. Consulting firm Deloitte says

records for patients who had visited different institutions.

connected health or technology-enabled care (TEC),

This increased the out-of-pocket expenditure whenever a

which refers to the merging of health technology, digital

patient had to re-take a test or analysis. Businesses like

media and mobile devices, is capable of providing cost-

GE Healthcare have worked to develop common systems

effective alternatives at a time of increasing demand in

of shared information. For example, GE Health Cloud is a

health and social care.

product designed by GE Healthcare to integrate clinical workflows while managing the volume, velocity and variety

Unfortunately, the health industry is behind other

of healthcare data. According to Mario Amadio, President

sectors in terms of digitalization, not just in Mexico but

and CEO of GE Healthcare Mexico, “the cloud will be

internationally. Research from the McKinsey Global Institute

capable of connecting to more than 500,000 GE medical

(MGI) looked at digitalization in different economic sectors

imaging machines and more than 1.5 million imaging

in the US. The results showed the workforce of companies

machines worldwide, linking to millions of other healthcare

in leading sectors are 13 times more digital than the rest

devices, including patient monitoring, diagnostics,

of the economy. An article written by McKinsey partners

anesthesia delivery, ultrasound, mammography and various

and published in the Harvard Business Review in 2016

data sources. The future is not about having an application

pointed to the disparity between the sophisticated use

in a machine, it is about getting the information produced

of high-tech in specialized health areas and the lack of

by the machine in a cloud and working with it.”

digital fluency in others: “Many healthcare organizations use incredibly sophisticated technology in diagnostics and

The public sector is also making progress. In October 2016,

treatment but substantial parts of their workforce use only

Mikel Arriola, Director General of IMSS, and Ángel Gurria,

rudimentary or no technology. Fewer than 20 percent of

the Secretary General of the OECD, signed a cooperation

payments to healthcare providers and their suppliers are

agreement to apply a digitalization and simplification

done digitally, for example.”

program for the institution´s procedures. Early in 2017, Mikel Arriola announced during a press conference that

In the case of Mexico, it has been almost 15 years since

IMSS has saved MX$5.5 billion (US$305 million) through

the implementation of NOM - 024, which requested the

the digitalization of 78 percent of its procedures. Processes

application of electronic medical record systems in health

that before took 40 days, now take three.

services providers. A decade and a half later, the pace of digitalization at healthcare institutions remains uneven. The

Patients themselves have a role to play by adopting the

OECD discovered that data is generated only at various

solutions digitalization offers, such as apps, to take control

points in the Mexican system, creating a fragmented

of their health. IMSS’ success is in part thanks to the design


of a mobile and web application available to patients,

Given these trends, many entrepreneurs have focused on

but awareness and knowledge are essential – and

the development of apps that promote preventive care

unfortunately, lacking. The Health Future Index developed

and empower healthy lifestyles through fitness control,

by the global technology company Philips evaluates

fertility follow-up and sleep tracking. That is the case

how well companies and governments are overcoming

of Salud Cercana, a Mexican digital service providing a

health challenges through connective technologies.

platform focused on the management of patients with

The study discovered there is a clear need to empower

chronic diseases to reduce costs. “Ninety percent of the

the population so they can play an active role in the

population has access to public health but 50 percent of

management of their health. It was conducted through

expenditure in Mexico is out-of-pocket. […] Our long-term

interviews and surveys with healthcare professionals,

goal is to achieve an integrated healthcare sector and

insurers and members of the public to evaluate how

we want to be the platform from which we can manage

connectivity is oriented toward access to healthcare,

patient health and integrate services around them,” says

integration of health systems and adoption of oriented-

Santiago Ocejo, Director General of Salud Cercana.

care technology. The data collected by Philips shows that 24 percent of the population feels no ownership at all

SUPPORT FROM AI

over their medical records and 23 percent of the users

Many entrepreneurs and medical devices companies

of connected health technology do not know how to

also have jumped on the artificial intelligence (AI)

interpret the results delivered by the technology.

bandwagon, which through the gathering of Big Data can assist professionals and patients with decision-making.

STARTUP OPPORTUNITIES

One example is 1DOC3, an online platform that provides

According to Deloitte, mobile technology can empower

answers to health-related inquiries for users. According

patients by giving them more control over their health

to Javier Cardona, Co-Founder and Director General

and making them less dependent on HCPs for health

of 1DOC3, through a series of algorithms, inquiries are

information. Deloitte’s data show that the number of health

processed in fractions of seconds. Typed questions are

apps for iOS and Android in the world has doubled in the

compared by the AI with previous inquiries. If a match is

last two years to almost 100,000. The opportunities in the

found, the user is directed toward that answer. “Ninety-

sector have empowered startup companies attracted by the

nine percent of inquiries match previous answers,” says

possibilities of technology in changing health management

Cardona. Another is Higia Technologies, an AI startup,

for a population of 121 million. “The startup healthcare sector

created a high-tech bra that helps detect cancer through

is very active for innovation in biotechnology, strategies

bio-patches that capture temperature data that is sent

for healthcare access and home monitoring,” says Vincent

to a mobile app, which keeps a record of the information

Speranza, Managing Director of Endeavor Mexico.

received.

DIGITAL INNOVATIONS TO ACHIEVE MORE FOR LESS IN HEALTHCARE 3D-printed devices

To create highly customized, low-cost medical technology products that can be tailored to suit the physiological needs of individual patients.

Artificial intelligence (AI)

AI, the ability of computers to think like humans, is anticipated to transform health care by completing tasks currently performed by humans with greater speed and accuracy, and using fewer resources.

Virtual reality (VR)

Virtual reality can engage patients in low-risk, artificially generated sensory experiences that could accelerate behavior change in a way that is safer, more convenient, and more accessible to the consumer.

Leveraging social media to improve patient experience

Social media offers health care organizations a potentially rich source of data to efficiently track consumer experiences and population health trends in real time, much more efficiently than current approaches. Organizations have the ability to track consumer experience and population health trends in real time.

Biosensors and trackers

Biosensors included in rapidly shrinking wearables and medical devices allow consumers and clinicians to monitor and track more aspects of patients’ health, enabling earlier intervention— and even prevention—in a way that is much less intrusive to patients’ lives.

Telehealth

Telehealth offers a more convenient way for consumers to access care while potentially reducing office visits and travel time. This convenient care model has the potential to increase self-care and prevent complications and ER visits.

Source: Top 10 Healthcare Innovations: Achieving More For Less, Deloitte Center for Health Solutions, 2016

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VIEW FROM THE TOP

EASING ACCESS TO INFORMATION XAVIER VALDEZ Director General of QuintilesIMS

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Q: Last year, IMS Health merged with Quintiles to become

manufactures and the benefit and cost to the customer. We

QuintilesIMS. What are the resulting benefits and what new

also analyze the product portfolio strategy to understand

services have been integrated into your portfolio?

where the laboratory should filter its resources to achieve

A: We inherited clinical research services from Quintiles and

a better market result. In addition, we customize research

today we can offer its clinical studies portfolio for phases II

to understand why doctors prescribe a specific drug.

and III and our own for phase IV on observational studies. Thanks to the merger, we have a stronger capacity to offer

Q: What new product launches is the company planning

follow-up services when launching a product. Of course, we

for 2017?

are still in the process of completing the merger.

A: We are launching the Prescription Based Service (PBS), a database of over 45 million prescriptions built by pharmacy

Q: What role does Mexico play in QuintilesIMSâ&#x20AC;&#x2122; global

chains, our commercial partners. With this system, our

strategy?

laboratory clients can see how they are positioned with

A: The country has the potential to become a pioneer for

doctors, based on the prescriptions those doctors write.

clinical research and for launching new products. The world

They can also see what a doctor prescribes and what each

invests around US$162 billion, Latin America captures

doctor uses for certain diseases. We are also interested in

US$6-8 billion in clinical research and Mexico could attract

developing a platform to provide doctors with information

a bigger slice of that pie. The goal is to make this innovation

and we want to do observational studies to see what

available to the medical community by integrating it into

happens with patients after drugs go to market.

institutional purchasing. IMS Health also bought a company that provides certifications Q: Which of your areas of operation attract the most focus:

for clinical and patient services in hospitals. The company

information, technology or consulting?

uses a series of indicators to evaluate the different services

A: Before QuintilesIMS, IMS Health participated in the

a hospital offers and the institution receives feedback

information segment and later it developed additional

showing where it must improve. We are planning to extend

businesses, with a consultancy department, technology

the operations of this new company to Mexico and offer the

and design. With all the recent possibilities in information

certification. It will help patients rate hospitals, allow insurance

management, the next step is to take advantage of the

companies to be aware of who they are working with and give

technology tools that allow us to do analysis and answer

hospitals information on areas for improvement. We are also

more questions about the effectiveness of treatments,

working with COFEPRIS to develop a platform where doctors

disease management and the efficiency of sales force

can receive embargoed news releases.

resources. Q: Digital health trends include digital interventions, data Q: How does QuintilesIMS approach its solutions to offer

integration and analytics and behavioral health. What are

added value for its clients?

the key innovations in Mexico?

A: Almost all our projects are tailor-made. We analyze the

A: In Mexico, we are talking a lot about Big Data. However, we

efficacy and efficiency of the products each laboratory

are still in the early stages because to make Big Data work we need solid information, visualization and capture systems. In Mexico, some hospitals should have a system to manage

company

information on chronic diseases that can feed indicators that

offering intelligence solutions for clinical research and

track the evolution of these conditions. It is important to

commercialization services to help companies reach the

establish the foundation that will keep the system fed. If we

market in a faster and more cost-effective way

do not have that ready, we could fall behind other countries.

QuintilesIMS

is

an

American

multinational


INSIGHT

SPECIFIC INFORMATION UNVEILS GENERAL TRENDS ANTONIO CARRASCO CEO of Grupo PLM

No one can predict the future but Big Data provides

hike of 1,113 percent in searches for Tamiflu in February 2016 in

professionals with the kind of specific information needed

comparison with the previous month. “We knew there was an

to make fairly accurate projections. In the healthcare sector,

epidemic because general doctors were desperately looking

Big Data can help detect dangerous trends and provide the

for Tamiflu. Normally, this trend should be relatively steady but

necessary knowledge to allow for decisive action that could

the spike in searches was due to thousands and thousands

save lives. How effective it is relies on the velocity, volume,

of patients coming down with the flu,” says Carrasco, adding

variety and veracity of the information collected.

that in 2016, there was a scarcity of Tamiflu. “It was sold out in all drug stores in Mexico because they were not expecting

“Big Data is mobile, analytics, cloud computing and social

an epidemic. The increase in searches for the drug was

networks,” says Antonio Carrasco, CEO of Grupo PLM,

atypical.” Carrasco adds that H1N1 was responsible for over

which specializes in Big Data for the healthcare sector

6,000 deaths in Mexico in early 2016. Sharing such data

in 13 Latin American countries.

could improve the detection of trends and ultimately improve healthcare for patients. It would also enable companies to

The company, which started 75 years ago as an editorial

improve treatment and their cost-efficiency.

house for the medical segment, collects medicinal information from manufacturers and publishes the data on its website, which visitors can search. In 2016, over 100 million health professionals clicked on Grupo PLM’s Mexico website, Carrasco says. The site can handle over 2,500 searches per second and receives a variety of information over its 35 digital channels. “When talking about Big Data, it is necessary to include most users in the sector, which is what PLM does. We have over

Grupo PLM noticed a hike of 1,113 percent in searches for Tamiflu in February 2016 compared to January

200,000 physicians working with our information on a daily basis,” says Carrasco. The sheer number of doctors searching

Big Data helped identify the epidemic and action was

the site’s resources gives the company ample data to analyze

taken, Carrasco says. The patent for Tamiflu was expired

and detect trends. “We are like a small Google because people

by COFEPRIS in March 2016, leaving the way open for

search for very specific medical information through us.”

other companies to use the medicine’s active substance, oseltamivir phosphate, to create generic versions of

PLM is also working with artificial intelligence or semantic

the drug. In addition, the Mexican Ministry of Health ran

analytics. “We teach IBM’s Watson to understand what

preventive campaigns throughout the country in winter

is written on paper. This is semantic analytics. Artificial

2016 to remind people to get their flu shot.

Intelligence (AI) can begin reading a page and give you the remaining information,” says Carrasco. Among its applications,

The flu is not the only trend Big Data can reveal. Carrasco

AI can recommend a dosage, inform a doctor if the prescribed

says PLM’s data has uncovered a number of surprising

drugs will interact with each other or if there is a certain type

results. One example illustrates his point: the majority

of food or environmental element the medicines will react to.

of specialists searching for erectile dysfunction drugs are gynecologists. “Erectile dysfunction is a couple

By detecting trends, Big Data can be used to improve

problem, not a man problem,” Carrasco says. “That is

healthcare. Carrasco points to the 2017 flu H1N1 season as an

the advantage of Big Data: discovering something you

example. During the 2016 flu season, Grupo PLM noticed a

never would have thought of.”

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VIEW FROM THE TOP

DIGITALIZING THE FUTURE GUILLERMO FERRARI General Manager of Eseotres

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Q: What process does a clinic undergo once it hires your

can be of two months or more; digitalization can reduce

digitalization services?

that. This allows other savings, such as with fees related to

A: The success of these kinds of solutions relies on how

incapacitations, which can be lowered as a result of having a

well they are designed according to each customer’s

patient diagnosed more quickly. A timely diagnosis can save

specifications. There are many variables to take into account

lives. Doctors can see more details on digital images, zoom

that will define the optimum design: the existing medical-

in, analoguely track changes, change contrast, brightness

imaging equipment, its operating status, a hospital’s

and carry out a faster and more precise diagnosis. If needed,

infrastructure, human resources, current volume of studies

a doctor can ask for a second opinion from a colleague

per type and its growth projection. We begin by sending

who can access the image remotely, avoiding the need to

an engineer to do a survey of the situation and assess what

transfer patients between hospitals.

growth may look like for the following one to two years in terms of demand, new equipment, specialties and new

Q: What is the next step to expand healthcare digitalization

health units. This will determine the type of hardware, its

in Mexico and what role does Eseotres want to play in this

capacity, infrastructure adjustments, software and tools that

process?

will better suit today’s needs and those in the medium term.

A: Image digitalization opportunities are infinite and

Part of our added-value is the ability of our engineers to

we have seen this on our mobile devices. Soon, our

design a custom-made solution ready to scale up to the

medical history will be on the cloud. What will change is

client’s future plans. Another differentiation factor we offer

the selection criteria of patients because we will prefer

is service. We train all a customer’s staff that will operate

institutions that can upload our clinical information to a

or interact with the solution. We continue to provide

shared platform. For these solutions to be as effective

training over the term of the contract to compensate for

as possible, these platforms should be cross-institutional,

employee rotation and natural knowledge loss and we focus

private or public, and cross-manufacturers. Eseotres

on preventive maintenance to anticipate system failures,

wants to be the platform where these changes happen.

new needs and to avoid operating downtimes. This is also

We want to develop a cloud without institutional, brand or

empowered by our expertise, which is our biggest strength.

manufacturer barriers. The vast majority of imaging studies done by public health institutions is archived in boxes.

Q: What can digitalization mean for a company in terms

Through digitalization, the studies’ archives can be easily

of savings?

retrieved and shared and become a source of Big Data

A: When technicians take an image with analog film, they

to develop useful information for the creation of health

check the image’s clarity with a radiologist and decide if

policies, efficient resource allocation and productivity

the image should be retaken. Twenty-five percent of analog

measurement. Public health institutions are doing what

studies have to be repeated, which means that patients

they can but it is important that we as business do our

have to be irradiated twice, 25 percent of films are wasted

part to facilitate the adoption of these solutions. It is unreal

and the x-ray tube is used 25 percent more. Appointment

to think that one company can satisfy the entire public

deferrals for image studies are another big problem of

demand alone and the same goes for other public health

analog technology because in some cases these deferrals

institutions; this is why the technical standardization of these solutions is a priority. We need to make sure that any solution that we install anywhere in Mexico can connect

Eseotres

is

an

engineering

company

that

provides

to any other solution in the market.

diagnostics solutions. It is a former x-ray film provider now focused on providing services for the digitalization of x-rays

Q: You are a former Walt Disney Home Entertainment

in medical institutions

executive. How do you apply that expertise to healthcare?


A: The shift from home entertainment media to medical

their own budget and government. We have applied our

imaging was drastic. However, sometimes there are

solutions in 19 hospitals in San Luis Potosi and 29 in State

similarities within seemingly very different industries.

of Mexico, where we want to finish the digitalization of the

When I started working at Disney, movies were sold in VHS

units that still use analog film processing. The results in

and DVD before digital arrived. Video on demand, digital

these clinics have been great, they have radically increased

download, streaming and other forms of digital distribution

their productivity as a consequence of the technology itself

generated changes within the company and at an industry

and the reduction of service downtimes, and there is an

level; new and different partners, business models, different

impact on the diagnosis quality as well.

pricing, marketing, operations as well as a different meaning of product ownership to the retail and to the end customer.

Q: What are the challenges of digitalization in Mexico?

Something similar happens in the medical imaging industry.

A: The first challenge is to achieve a cultural acceptance of

We went from selling X-ray films to offering digital-

change, to break the barrier of resistance to install solutions

imaging services, from selling a consumable to selling an

whose end product is digital and not tangible. Our clients

intangible digital image. Therefore, this similarity with the

have been working 15 to 20 years in the same way so it

industry I come from helps me understand how important

is not easy to make them embrace change. Working with

this change is for the industry, how deeply it affects the

public institutions presents other challenges. Budgets

different stakeholders and what can we do to be prepared

need to be reassigned, to adjust to service contracts.

to embrace and take advantage of that change.

Tenders often do not have a proper budget to contract the needed digitalization services. Some budget items,

Q: How has the adoption of digitalization in the health

such as those assigned to the maintenance of old film-

sector evolved in Mexico?

developing processors, should be assigned to the digital

A: IMSS carries out between 19 and 20 million image studies

imaging services. In addition, the process of tenders

every year. We are still its providers of analog films and

is complicated as there is a lack of standardization and

they still buy around 1.5 million square meters. We believe

technical specifications often do not match the real

that only between 25-30 percent of its imaging studies

customerâ&#x20AC;&#x2122;s needs, they also require the presentation of

are digitalized, so there still is an important opportunity to

past contracts with public institutions to demonstrate the

broach. However, it has to standardize their process. There

companyâ&#x20AC;&#x2122;s expertise; this is a bit contradictory when we

are around four or five companies offering solutions similar

consider the few contracts for this kind of service that the

to ours. The most digitalized countries are looking for, or

public institutions have signed.

have already adopted, a digitalization solution where the images can be shared among different institutions. IMSS is

This is why we received with great anticipation the IMSS

the biggest health institution in Latin America and it will

Innovation Olympics, an event that IMSS launched in

be a great advantage if at some point it could have the

March 2017 for the first time. We see this competition as

information of all its patients in the same platform available

a key aspect that was missing for IMSS to properly adopt

for all its clinics, and moreover, such a platform should also

innovation; a space where the public and private sectors can

be shared across health institutions. The High Specialty

transparently team up to develop innovative solutions that

Medical Units (UMAES) are already digitalized; they have

are tailor-made to fit the reality and needs of the institution.

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VIEW FROM THE TOP

PROPRIETARY IT SHINES LIGHT ON HOSPITAL DEMOGRAPHICS GUILLAUME CORPART Founder and Managing Director of GHI

142

Q: How are GHI’s sales divided between intelligence and

institutions. Laboratories and diagnostic centers are also

consulting services? Which services are most in demand?

evolving. INEGI indicates there are over 13,000 laboratories

A: GHI has three business lines: its hospital demographics

and diagnostic centers, with Chopo and Laboratorio Médico

database, which is the world’s largest hospital database

Polanco being the largest.

focused on Latin America and covers 14 countries and over 15,000 hospitals regionwide; assessing market size

Q: How can various levels of the healthcare sector help

and share for medical devices and equipment in Mexico,

combat chronic disease in Mexico and Latin America?

Colombia, Brazil, Argentina, Chile and Peru, among others;

A: We are no longer in the era of large infrastructure

and customized consulting assignments, the design and

ownership. Contemporary economic models such as

execution of consulting research specific to the needs of any

Uber, Airbnb, Instacart and Rappi demonstrate that

client, including strategy definition, competitive intelligence,

specialization, sharing and collaboration are valued

customer profiling and interviews with key opinion leaders.

and sought by customers. The first step in generating

In 2017, the business was well-balanced between these three

efficiencies lies in the ability to measure actions in a

service lines and we expect this to continue in years to come.

standardized manner across systems. This means, for example, measuring the number of procedures conducted

Q: How does GHI handle the big data it gathers to develop

by hospitals with the same codes, preferably ICD-9 or -10.

market analyses and databases? How does it ensure data

Only once this is accomplished will the various healthcare

protection?

systems be able to communicate effectively and efficiently

A: We have invested in creating proprietary IT systems and

among themselves.

platforms to meet our unique data-gathering needs, which enables us to validate previously collected information as

Q: What steps have been taken to prepare for the future

well as collecting new data points. Our systems also enable

burden of senior citizens in Mexico and Latin America?

us to scale horizontally to other countries and regions, as well

A: Private institutions are the most active and dynamic in

as expand vertically into other fields of application, such as

seizing such opportunities. Furthermore, medical device

laboratories and diagnostic centers. So far, we have not heard

and equipment manufacturers continue to develop

of any other company in Latin America with such robust,

homecare solutions, giving the elderly the opportunity

time-tested tools.

to receive care in their home and from their loved ones. Payers should soon recognize that such solutions help

Q: How are hospitals adopting information technology

reduce the financial burden of care and present viable

infrastructure and what specifically is of interest?

alternatives to improving their margins.

A: Generally, hospital IT is a hot topic. Hospitals are increasingly interested in electronic medical records, system

Q: Last year you said that investing in hospitals is not a

integration and the move toward digital equipment. Hospital

solution to the burden of an aging population. What are

adoption of such technology is growing from a small base,

the alternatives?

starting in the private sector. In the public sector, efforts

A: As it pertains to the aging population, we will see two

are being made to standardize systems across the multiple

major trends play out: expansion of private care facilities that focuses on enabling an aging population to maintain an active lifestyle and live with dignity. There is a growing interest

Global Health Intelligence (GHI) is a US-based business

in homecare solutions that enable the aging population to

intelligence firm focused on healthcare analysis in Latin

receive care within the comfort of their home surroundings. A

America and Asia. GHI developed the world’s largest hospital

third and underlying element will be the organic growth and

demographics database focused on Latin America

expansion of laboratories and diagnostic centers.


VIEW FROM THE TOP

NEW TOOLS TO ACCESS THE PUBLIC MARKET

Enrique Martínez Director General of IIIFAC

José Ferreyra President of the Pharmaceutical Research of IIIFAC

Q: What have been IIIFAC’s biggest challenges and

Q: IIIFAC offers a certification in access to public health

opportunities over the last year?

institutions. What training needs have you recognized?

JF: We worked to create a database of Big Data on

JF: There is a dramatic need for specialization. Pharmaceutical

purchasing behaviors in the public pharmaceutical market

companies have recognized that there is not much growth

and we developed a multiplatform business-intelligence

with private clients and one representative in the government

system covering over 70 million unitary registries. The

can be as rentable as 17 in the private sector. Therefore, most

database contains information about each drug available

of our students are representatives of the pharmaceutical

in the market, such as the contract value, the consumption

companies who we are helping shift from the concept of

and inventories, as well as the number of prescriptions, in

medicine based on experience to medicine based on existence.

more than 100 public-sector institutions. Today, more than

Government physicians do not have freedom of prescription

45 pharmaceutical companies in the country are using it.

but they are subject to the authorized basic chart of what is available at the time of prescription. Therefore, executives

Q: In what areas is innovation more prevalent in the

should be able to sit down with the directors of the public

Mexican pharmaceutical industry?

institutions and talk about costs and benefits.

JF: We believe that our business intelligence system enables our clients to predict market movements.

Q: What are the main objectives for your institution in 2017?

For example, we saw last year that ISSSTE requested

EM: Increase our client base and continue our certification

approximately 237,000 units of duloxetine but we saw in

program to strengthen our presence as a research institution

our business intelligence that months before, ISSSTE had

in the healthcare sector. We expect that in five years the

decreased the authorized consumption of duloxetine to

public sector will represent 60 or 70 percent of the units in

practically zero. We are committed to working with our

the market in Mexico and that, at that point, there will be a

clients to resolve these inquiries. We also launched market

health reform that insists on the regulation of data, which is

research on the consolidated tender results published

very important to health economics models.

in June 2017 in which we were able to recognize which product categories IMSS is over-purchasing and predict

Q: What are the industry’s expectations for current

which of these categories will not reach 100 percent

pharmacoeconomic strategies?

consumption over the year.

EM: The industry is focused on the consolidated purchase. This is an interesting initiative because it allows better prices

Q: What advantages can this system provide regarding

and fewer processes to acquire medicines. However, there

the provision of healthcare in Mexico?

are some issues. Consolidated purchasing does not mean

JF: The access to this information will raise awareness

access to drugs for the population. The purchases only

about the current model of health administration. For

represent between 50 and 60 percent of the market and the

example, we all know the advantages of early insulinization;

main institutions, such as IMSS and ISSSTE, do not reach 70

however, IMSS continues to treat patients with Metformin

percent. In the end, the consolidated purchase is focused only

because it is cheaper and reaches a wider range of the

on saving money and not better service because the prices

population, although its continued use causes pancreatic

demanded of the laboratories are not sustainable for them.

insufficiency. The institutions have to choose between purchasing expensive drugs that delay the progression of a disease or cheap medicine that can only help send

The Institution for Pharmaceutical Research and Innovation

patients home. Article Four of the Mexican Constitution

(IIIFAC) offers information and educational services for the

says that citizens have the right to medical care but does

pharmaceutical industry in the public Mexican healthcare

not state that their life is above an assigned budget.

system through in-person courses and digital applications

143


VIEW FROM THE TOP

MODERNIZING HEALTH TECHNOLOGY ALEJANDRO DE LA PARRA Director General of Astrum Salud

144

Q: How is Astrum Salud positioned to take advantage of

medicinal treatments in Mexico through the use of our

advancements in global connectivity?

telemedicine solutions.

A: We have formed solid commercial and academic alliances with various organizations across the globe to

Q: To what extent will the courses be adapted to other

offer better solutions to our users in health, education

Latin American countries?

and communication services. This has further improved

A: The courses themselves are to be presented in Spanish

our overall service quality by giving it a globally

and include localized mentions of technologies used in

competitive edge. We have recently allied with CloudVisit,

the region for professional opportunities. As we connect

a prominent New York-based IT development company

education and labor, we trigger the pragmatic learning

with vast telemedicine experience, to create a reliable

path and refocus on action. We combine our efforts with

and integrated videoconferencing CMS implementation,

other institutional organizations and take several factors

exponentially empowering our secure IT development with

into consideration, including connectivity, local access to

pristine tropicalized services at competitive prices.

the technologies mentioned in each course and the rate at which these technologies are prospering locally to create

Our alliance with the New York-based organization Life

an effective impact on local communities.

Extension Advocacy Foundation has developed new and better ways of providing educational and informative

We firmly believe that to incite foreign investment in

content in Spanish, closing the gap for Spanish-speaking

Latin America it is our responsibility to fully engage in

communities and enabling them to learn, engage and

the development and expansion of our own infrastructure,

support other prominent organizations in the life sciences

culture and society. We face a challenge to mitigate the

industry. We emphasize that education is a prime concern

current brain drain situation as well as the flight of capital

in improving healthcare in the modern world and it must be

and it is entirely in our hands to assemble a proper Latin

addressed correspondingly to be offered in an accessible

American industry to advance. We are able to accomplish

and effective manner. This is the reason we have focused on

this as the local education level rises with a globalized

malleable digital implementations for education, allowing

vision in various industries with the use of technology but

us to adjust accordingly to technological advances.

we need to pay attention to the rate at which these and other efforts echo across communities and see to their

Q: What are the goals of your latest project Astrum

implementation.

EducaciĂłn? A: We have established a coalition with the World

Q: What methods are you implementing to maintain

Academy of Medical Sciences, an inspiring institution

high follow-through rates and what tools will you use to

based in the Netherlands, that allows us to provide online

encourage people not to give up?

services in Spanish for continued medical education and to

A: As we learn from our development, we come to

cooperate on congresses and seminars. We can also offer

understand that e-learning deals not only with the quality

our videoconferencing platform to the academyâ&#x20AC;&#x2122;s medical

and variety of the educational content provided but also

members. This will extend access to novel treatments to

with how education itself is made available to the users.

Latin America, allowing the region to move forward in

Having access to on-demand online education is not a

clinical science as e-learning consolidates and knowledge

choice but a necessity in our current lifestyle because it

spreads. Astrum Salud has also formed relationships with

allows students to have a malleable management of time

cutting-edge biotechnology entities such as RegenerAge

while being able to move forward with their academic

Clinic in Mexico City and Bioquar in Philadelphia. The

enrichment. As education shifts to a more personalized

goal is to expand the reach of revolutionary regenerative

experience, we are inclined toward versatility for


knowledge acquisition which, in turn, means we enjoy

the future. Our dedication and focus will teach us the

better follow-through and retention rates as students

best way to coincide with the government for the sake

have a chance to complete studies at their own pace. This

of our communities.

approach involves simplifying how each student is able to enroll in a course, interact, acquire knowledge and how the

Q: Astrum Social has been live since June 2016. What

student gets certified. The process is being structured to

results have you seen so far?

allow automated operations for a fluid and convenient way

A: Astrum Social is a social network platform that involves

to benefit from online education. As we also focus on basic

the sharing of knowledge, emotions and experiences that

education, our content is provided with a gamified spirit,

reflect the current Latin American view of health and

allowing younger audiences to be introduced to medical

wellness around the world while also directing the vision

science in a fun and energetic manner.

of where it is going in the future. The platform allows users to interact with content provided by other users and to

Q: How are people receiving new online-education

communicate with each other with the ability to create

platforms and how are they adapting to e-learning?

personal profiles, groups, dedicated pages, and also be

A: The efficacy of online education is a proven fact as it

able to play games, listen to music and watch videos,

encompasses a more immersive and interactive experience.

all focusing on promoting a healthy lifestyle between

It has been restructuring society for over a decade now.

its users. All users see the Astrum feed on their home

Online education has been disruptive and repercussions

page, which offers diverse, educational and informative

are seen worldwide in formal e-learning and also with

content related to health and medicine to stay updated

non-formal, concomitant knowledge acquired from mixing

while interacting with other users. Users can create bonds

modern entertainment content with access to global

and meet in person while being collaboratively proactive

information. As larger segments of society organically

about their health.

adopt these new information channels, we believe that this is the perfect time for LATAM to invest and harness the

After we launched phase one of the platform, we received

power of a broadened and more pragmatic approach to

productive feedback from our limited user database and

resolving our needs with the use of both formal and non-

have redesigned certain features, fixed minor bugs and

formal online education. The technologies we use have

reconditioned our news feed according to comments.

been in use in the e-learning community for decades, but

Additionally, we have implemented an enhanced music

we are always looking to combine new and more effective

store that allows users to purchase content from different

alternatives with our current development.

artists and therapists focused on mindfulness, music therapy and meditation. As we expand these features and include

Not only does the student need to adapt to e-learning

products and services from our other branches, such as

but so does the instructor. In our experience, instructors

Astrum Educaciรณn and Astrum Mรณvil, we aim to deliver an

have had a harder time embracing these new ways of

integrated social ecosystem that encompasses both the

providing access to knowledge; they are increasing

social and commercial value that digital infrastructures often

their own adeptness at the same time as the student.

provide. We are in production release, as we say in the IT

This is the reason we invite LATAM academics to dive

development sector, but we are always fine-tuning to focus

deeper into globally available online education. As the

our global vision on how to provide access to better health,

intercontinental mission to better educate society is

better education and to push social development forward.

rapidly being redefined, providing the lens through which each community interprets information requires even

Q: What are the main projects you will be focusing on

more direction and objectivity. We are always excited

this year?

to strategically address these issues in conjunction with

A: In healthtech, we will be acclimatizing our telemedicine

other entities and open our doors to innovative education

services for particular conditions and diseases to be able

initiatives around the world.

to extend the benefits of our platform. We are proud to serve an all-encompassing digital solution for diabetes

Q: The largest education and healthcare provider is the

patients as well as a program for obesity, both of which

government. Do you have plans to work with it?

we will be launching during 2017.

A: Indeed, the government sector has a categorical role in both education and healthcare. Combined efforts with the private industry have helped to build the foundation

Astrum Salud is a Mexico-based company specialized in digital

of our government infrastructure. On that account, we are

solutions for the Latin American community in communication,

and will continue to be active in undertaking collaborative

measurement and health. It has designed and runs dozens of

initiatives with governmental bodies to plan and act for

health-related apps, bringing services to the wider community

145


VIEW FROM THE TOP

MANAGING HEALTH THROUGH DIGITAL AIDS SANTIAGO OCEJO Director General of Salud Cercana

146

Q: What is Salud Cercanaâ&#x20AC;&#x2122;s role in the Mexican healthcare

of service. In addition, we give them a lower cost so that

system?

they can access the same platform. We have attended over

A: Salud Cercana is a digital platform that integrates health

3,000 walk-in patients in our physical office and around

services. We are a patient-management system especially

200 have acquired the program for the management of a

focused on patients with chronic diseases that enables middle

chronic disease. We are also working with two companies

and low-income patients to find doctors who are certified by

through our B2B model, one with 6,000 clients.

Salud Cercana and who belong to our network. In addition, our patients can interact with nutritionists, psychologists and

Q: What is the added value Salud Cercana brings to the

a special figure we call a care coordinator, a wellness authority

Mexican healthcare system?

and supportive mentor who motivates individuals to cultivate

A: In dealing with chronic diseases, patients need

positive health choices. The lack of care coordination is one of

behavioral changes, so we help those patients find

the biggest issues in the Mexican healthcare system and there

the right professional to treat their condition. We are

is a large amount of money wasted on the public system and

managers of chronic diseases. This is our priority and we

out-of-pocket expenditure due to bad coordination.

would like to work with the public sector on managing its population with chronic diseases. We also want to reduce

Q: Salud Cercana is the first prepaid healthcare system

out-of-pocket expenditure on medication and coverage

in Mexico. What is the protocol when a client acquires

of chronic disease complications. Ninety percent of the

the service? A: Once patients download the app and accept our terms SALUD CERCANA'S COORDINATED HEALTH PROGRAMS (PCS)

and conditions, they can go to any convenience store in our network or any payment center and prepay the service. After verifying the payment, the care coordinator connects with the patient and explains how the platform works and the benefits of the acquired service. The coordinator also schedules the first interview with a doctor in our

The purpose of the PCS offered in the application is to help patients adopt healthy habits. Through these programs, users have access to a community of hospitals and pharmacies that help them save money and to certified specialists, providing all the tools to optimize health and save on expenditures. The platform offers five PCS:

network to create a clinical record. The first appointment is covered by the initial payment and after that the care

Basic

for people with specific health goals who wish to improve their success with the support of a coordinator.

Nutrition

for people who wish to change their eating habits to reach their ideal weight, maintain it, increase their satisfaction and welfare and reduce the chances of developing a chronic disease.

Mind

for those who seek better emotional health and need support to control stress, effectively overcome grief, reduce anxiety, overcome a chronic disease or episodes of depression.

Equilibrium

for those who want to change their lifestyle with the help of a nutrition expert, a psychologist and a physician.

Medichat

for people who do not require an urgent diagnosis or treatment but who wish to receive advice from certified professionals.

coordinator will schedule a phonecall with a nutritionist and a psychologist to design a personalized plan that will then be monitored by the coordination team. Additionally, the care coordinator will be in charge of tracking all customer contacts, clinical records, doctor appointments and prescriptions, as well as laboratories and required prescriptions. Our platform has an embedded chat that patients use to ask questions, participate in forums, read relevant content and follow up on notifications with their nutritionist, psychologist and care coordinator. Q: Who are the specific beneficiaries of Salud Cercana? How many people are already using it? A: Right now, most of our users belong to C and D socioeconomic strata because they cannot afford this type

Source: Salud Cercana


MEXICO - FREIGHT MODE BREAKDOWN (%) DISTRIBUTION OF PATIENTS WITH A2017 PREVIOUS DIAGNOSIS OF DIABETES, HYPERTENSION, AND DYSLIPIDEMIA IN MEXICO’S HEALTH SERVICES

AVERAGE WAITING TIME PER MEDICAL VISIT (minutes) 100 80

91 70

64

60

2,529

PATIENTS SURVEYED BY ENSANUT 2016

42

40

32

Other public services

(PEMEX, SEDENA, SEMAR, etc.)

Private

„„5.6% ISSSTE „„2.7% Other public services

Federal health services

„„33% IMSS air „„32.7% State health services Rail „„26% Private

ISSSTE

0

IMSS

20

Source: ENSANUT 2016 Road

Source: ENSANUT 2016

population has access to public health, but 50 percent of

Q: How is Salud Cercana’s initiative contributing to the shift

expenditure in Mexico is out-of-pocket. Lastly, our main

to preventive medicine?

long-term goal is to achieve an integrated healthcare

A: We are focused on secondary prevention, which

sector and we want to be the platform from which we

means we help patients who are already diagnosed

can manage all patients health and integrate services

with a chronic disease to access care more quickly and

around them.

avoid complications. However, our platform is focused on preventive care. We also know that companies suffer when

Q: What business models are you using for your operations?

their employees get ill so we are developing preventive

A: Salud Cercana has a B2C and a B2B channel in which it

strategies with our B2B clients.

works directly with companies. Both have the same goal: to manage patient health. In the B2C model, single users pay

Q: What regulations do you follow?

for coordination, nutritional and psychological support and

A: Dealing with health data requires following regulations

patients can have access to doctors at discounted prices. They

closely. We are careful with our terms and conditions and we

pay MX$900 (US$50) for our basic plan for a three-month

have invested heavily in protecting information. COFEPRIS

process, MX$1,700 (US$94) for psychology and nutritional

has also set specific guidelines for primary doctors to

support and MX$2,300 (US$128) for the complete service.

provide consults, so we help our doctors comply with the

The price is around MX$150 (US$8) and MX$250 (US$14)

requirements of having a physical office, an exploratory area

a month for receiving all these services. In the B2B channel,

and gathering patient information. As a healthcare company,

the price varies depending on what type of coverage the

we are aware of legal requirements and we know how to

company wants to offer to its workers; it might vary from

monitor them.

MX$75 (US$4) to MX$150 (US$8) a month. Q: What are your growth expectations for 2017? Our business models adapt to every type of company, but

A: First, our target is to expand our network of doctors and

our main source of revenue is the care coordination program

our geographical coverage. Secondly, we want to reach

(PCS), which is the added-value we bring to the market. In

10,000 app users with PCS. Third, we will grow our network

the future, we want to work with insurance companies and

of other providers such as laboratories and pharmacies,

government institutions through this service.

integrating our services with theirs. We are working on agreements with labs so when our patients go to them, the

Q: How do you recruit talent to Salud Cercana and how

labs send us the results. In the end, that follow-up is the value

do you establish the relationship with doctors?

we provide. Our goal is to work with at least 10 companies by

A: We have used traditional recruiting platforms and located

the end of 2017, managing both clients and patients.

doctors through word-of-mouth. We have also attracted talent by networking with doctors in the private and public sector and with nutritionists and physiologists. We have to

Salud Cercana is a Mexican company founded in 2015 that

be careful in this selection process because we need to train

provides a healthcare app for people with chronic diseases.

the talent we attract on how to use our platform and how

It is focused on simplifying access to health services from

to deliver quality through the service we offer.

the cell phone

147


VIEW FROM THE TOP

MEXICO READY TO SHIFT TO DIGITAL MARIO AMADIO President and CEO of GE Healthcare Mexico

148

Q: Mexico must shift to preventive medicine, which is GE’s

performance. We are in an era of change and GE is planning

main focus. What are you doing to guarantee patients

on leading that change. We used to talk about IT, now we talk

access to it?

about operation technology, a step further than IT because

A: Prevention is fundamental to us and the public sector

it is the way to understand how to manage information for a

should be spending on this. Expenditure will never be

determined operation.

enough but this only requires us to be more effective and find a way to optimize the value of our offer. Our portfolio

Q: What benefits could GE digitalization bring to the

is focused on diagnosis and includes different modalities:

healthcare system?

magnetic resonance, computed tomography, ultrasound,

A: We try to bring more efficiency and productivity to our

mammography, x-ray, life-care solutions, life sciences and the

portfolio through our new platform. The value of our digital

information systems that support this. Our strategy is focused

proposition is focused on service provision and control and

on diagnosis and there are three pillars for us: first, we aim

maintenance of our clients’ assets. For example, GE Health

to provide accessible costs and quality by creating products

Cloud is a product designed to integrate clinical workflows

affordable for each country to reach coverage; second, we

while managing the volume, velocity and variety of healthcare

work on the client-provider relationship, we never work

data. It will be capable of connecting to more than 500,000

alone and we always need the support and confidence of

GE medical imaging machines and more than 1.5 million

our partners and third, we support PPPs, which will help us

imaging machines worldwide, linking to millions of other

reach more patients.

healthcare devices including patient monitoring, diagnostics, anesthesia delivery, ultrasound, mammography and various

Q: Last year you mentioned that projects for GE will be

data sources. The future is not about having an application

focused on the digital realm. What advances have been made

in a machine, it is about getting the information produced by

in the shift to digital?

the machine in a cloud and working with it. We have launched

A: The main leaders of the company and business areas

the application of Predix internationally, while in Mexico and

are committed to transforming GE into a digital industrial

Latin America we are taking the first steps in healthcare. GE’s

company. GE Store is our name for the company’s competitive

main engineering IQ research center is in Queretaro with a

advantage. There is no other company that has the ability to

multidisciplinary team for healthcare development. The

transfer intellect and technology across industries and around

platform has been developed under standards that address

the world as GE can; from advanced technology, materials,

GE policies and each country’s regulations.

software and analytics, to commercialization, process, and business model best practices. We also have our own

Q: What are your main objectives in Mexico for the

operative system for the industrial internet, Predix, that is

coming years?

transversal for all GE businesses, including healthcare. The

A: There are three main targets for the next three years. First,

platform enables us to manage the information we gather over

we want to be acting and delivering as a digital healthcare

the years and make it available to our clients. By connecting

company. Then, we want to ensure profitability for our

industrial equipment, analyzing data and delivering real-time

shareholders through healthy growth. Next, we want to make

insights, Predix-based apps are unleashing new levels of

GE Healthcare Mexico an opportunity for talent. We want the best people for a better understanding and performance. These three objectives meet because if we are profitable,

GE Healthcare is the pharmaceutical and medical devices

we can focus on innovation and think about developing

division of the US-based company General Electric. It is a

talent. Talent leads to a better development, which leads to

world-leader in services in medical imaging and information

possibility for innovation. There is a lot of talent in Mexico and

technology for diagnostics

we need to attract it to our company.


INSIGHT

SLEEP RIGHT: IMPROVING HEALTH WITH APPS MACIEK DREJAK CEO of Northcube and Founder of Sleep Cycle

A decade ago, the arrival of smartphones also introduced

microphone to identify sleep phases by tracking movements

the world to the app. Today, millions of apps permeate

in bed,” Drejak says. The app then analyzes sleep, records

mobile platforms and among the most popular are those

its findings and wakes up users during their lightest sleep

related to health. Maciek Drejak, CEO of Northcube and

phase, using a predefined 30-minute alarm window.

Founder of Sleep Cycle, an app that wakes users during their lightest phases of sleep, says the increased use of

In the modern on-the-go world, getting the right amount

technology and the advances of Big Data can help improve

of adequate sleep can be difficult. A study carried out by

a variety of conditions, including those related to sleep.

UNAM shows that 35 to 40 percent of Mexicans have sleep problems that have been linked to further health problems

“[Health apps] help users quantify their sleep data. They

such as overweight and obesity.

give users all the information they need to find ways to improve their sleep and follow up on progress,” says Drejak.

In addition to looking for the specific sound-fingerprint of bed sheets moving, several other filters are deployed in

Sleep tracking has become a world trend and with millions

the app. It detects and filters rhythmic, reoccurring sounds

of users worldwide, Sleep Cycle, developed by Swedish

such as breathing and snoring, in addition to certain specific

company Northcube, is among the most popular. Sleep

sounds that are problematic for the fingerprinting system

Cycle alarm clock has been available for download since

like those of Continuous Positive Airway Pressure (CPAP)

2009 and is used to track sleep patterns. Users can add

machines, a breathing apparatus used by those who suffer

sleep notes such as “drank coffee” or “worked out,” to figure

from sleep apnea.

out what habits improve their sleep quality and which ones are detrimental.

Sleep Cycle can help detect differences in the population’s sleeping habits due to its bank of sleep notes and due to

“Sleep Cycle alarm clock iOS features a patented state-

the feeling of happiness users input upon waking. “Men

of-the-art sound analysis technology that records sleep

sleep less but wake up happier and have higher sleep

patterns. During sleep, our movements vary with each

quality. Women sleep more but wake up in a worse mood,”

sleep phase. Sleep Cycle alarm clock uses the phone’s

says Drejak.

EXAMPLESOF OFSLEEP SLEEPGRAPHS GRAPHSGENERATED GENERATEDBY SLEEPCYCLE ALARM CLOCK (time of day) EXAMPLES BY SLEEP CYCLE ALARM CLOCK: REGULAR DISTURBED SLEEP SLEEP

Regular Sleep

Disturbed sleep

Awake

Awake

Sleep

Sleep

Deep Sleep

Deep Sleep

00:00 01:00 02:00 03:00 04:00 05:00 06:00

01:00 02:00 03:00 04:00 05:00 06:00 07:00

Source: Sleepcycle

Source: https://www.sleepcycle.com/how-it-works/

Source: https://www.sleepcycle.com/how-it-works/

149


VIEW FROM THE TOP

CREATING INCENTIVES TO IMPROVE WELLBEING Benjamín Villaseñor CEO of Uhma Salud

150

Roberto González CFO of Uhma Salud

Q: Uhma Salud’s goal is to change life habits, a major

employees is a better place to work and will attract the very

challenge. How do you achieve this target?

best talent, which will directly impact its results. We have seen

BV: We look to hack habits, for which there are three steps.

people’s perspective changing greatly. Previously, certain

The first is imitation. We think that every decision we make

directors saw our services as a cost. Not anymore. They see

is based on an analysis of all the data we have available, but

them as an investment because they can check certain metrics

many decisions are imitations of what is happening around

that generate a return. Once this is measured, they notice

us. What we do at Uhma is institute policies such as not

the savings, including in recruitment costs. Retaining talent

allowing sugary drinks. We also promote the use of stairs

will become a key and these programs will be a must-have

instead of elevators and we replace biscuits in meeting

for companies.

rooms with vegetable snacks. Although Mexicans drink many sugary drinks, by putting water coolers in the office

Q: There are several startups that offer a similar service to

and handing out bottles of water we generate behaviors

Uhma. What puts Uhma above the rest?

that workers start imitating. Second is the theme of co-

BV: We have invested greatly in technological development.

responsibility. We build dynamics in which we ask people

Our online platform, which enables us to perform a thorough

to generate changes with the help of their co-workers.

biometric assessment in five to 10 minutes, is the result of

When planning to run a marathon, the first step is not to

eight years of work. There are other companies that offer

buy running shoes but to sign up and tell all your friends

similar services but having invested in technology allows us

so that you cannot back out. This engagement is known

to operate more inexpensively and swiftly. Our competitors

to be effective in acquiring healthy habits. The third part is

operate manually, rather than having an automated process

gamification. During the first biometric assessment, we give

like ours and their nurses take blood pressure, for example and

individuals an objective. People who achieve these goals

hand out the results written on a paper, which participants

receive a prize, such as an extra paid day off work or they

then enter into a health-risk assessment manually. Their

get to leave work early or arrive later. Of all the methods, that

participation rates are lower and the costs are higher.

linked to punishment saw the greatest results and, although

Fortunately, our market is growing greatly. There are lists

at first participants were the least happy, after three months

showing that all the Fortune 500 companies have a wellness

they were the most satisfied with their wellbeing program.

program. Especially those in the top 10 or 20 take great care of employee wellness and they attribute the success they see

RG: On average, they lost 1.5kgs per person in three months,

to these types of programs.

which multiplied by the number of participants is a huge amount of burned fat. The theme of work culture is clear and

Q: Of your three solutions, which has witnessed the most

this will generate much value in the future. The demographic

effective results in improving employee healthcare?

bonus in Mexico is about to explode. This will impact

BV: The portal enables us to follow an employee’s progress

companies as talent will become scarce and more expensive.

remotely. It enables us to reach a large, geographically

Not everyone will choose jobs based solely on salary. These

dispersed population. Each person that enters the portal

intangible benefits will attract talent to companies and will

has access to two telephone sessions per month with the

help with retention rates. A company with happy, healthy

professional of their choice. Annual access to this service costs MX$95 (US$5.20) per employee. The biometric evaluations are what reveal the most information about the individual. In

Uhma Salud develops wellbeing programs for the individual

2016, we performed 30,000 evaluations, all standardized. By

employees of a client company. It measures their current

automating the process, we eliminate the risk of human error.

health status and potential risks to offer personalized

As a company we have performed more evaluations than even

wellbeing plans

the government through its ENSANUT survey.


VIEW FROM THE TOP

CONNECTIVITY INSPIRES FITNESS MELANIE CHASE Director of International Product Marketing at Fitbit

Q: How does Fitbit create user engagement? What makes

up, our devices are designed for all-day wear to show how

the company a fitness social network?

the small steps users take each day can have a big impact on

A: Fitbit has one of the largest online communities in the

their health. We also know social connections help provide

world and the Fitbit app helps users find and engage with

the motivation and support that is fundamental to a user’s

family, friends and coworkers, creating positive network

health and fitness journey. For example, we have found that

effects that reinforce user engagement and increase

Fitbit users with one or more friend connections move more,

retention. As of the end of 2015, we had 16.9 million active

taking on average 700 more steps than users without friends.

users worldwide, up 152 percent year on year. Our growing user base has increased activity, taking 50 percent more

Based on aggregated and anonymous data from over 1 million

steps YoY in 3Q16. Over the past year, there has been a 98

Fitbit users, we found that, on average, some users can be

percent increase in the number of users who have at least

sedentary for up to 90 minutes at a time throughout the day,

one friend on the Fitbit platform and, on average, Fitbit users

which is a significant amount of time for the typical 9-to-5

have more than six friends, a 23 percent increase from 2015.

office worker. Getting up to move for even just two minutes every hour can help chip away at those sedentary periods and

We are continually looking for new ways to encourage our

we have made it a point to encourage that with our Reminders

community to engage with Fitbit and each other. At CES

to Move feature. We know that every user has a unique set of

Las Vegas we introduced Community, a new section in

needs that requires different forms of guidance. With Fitstar

the Fitbit app that offers more ways for users to connect

by Fitbit and Personal Goal Setting we are delivering a more

with others to build on and inspire them on their path to

personalized experience with unique insights and guidance

better health. Within Community, users will have access to

to empower users to achieve their goals.

Feed, Friends and Groups, all with the goal of providing a more appealing social experience. Feed is a new feature

Q: Fitbit has partnered with Qualcomm and UnitedHealthcare

that provides an engaging way to connect with friends,

(UHC). What projects will these alliances develop?

family and groups of like-minded individuals so users can

A: We are thrilled with these new partnerships. In the US we

find added support and inspiration to reach their health

partnered with UHC to offer the top-selling Fitbit Charge

and fitness goals. Friends easily connects users to others

2 to members of UHC’s Motion program, an employer-

across the globe where they can stay encouraged to climb

sponsored wearable device wellness program that rewards

the leaderboard, as well as cheer, taunt and direct message

participants with up to US$1,500 in reimbursements for

friends and family as they compete to get the most steps.

achieving specific health goals. This is the first time Fitbit

Groups lets users discover and join communities of like-

has designed a custom feature on a device and Qualcomm

minded people to help support and inspire them on their

played a role in providing technological capabilities and

journey. They can choose from over 20 groups related to

horsepower. In the future, our two companies will focus on

fitness, nutrition, wellness and weight loss. Community will

new UHC health programs and services that incorporate

be available later this year to all Fitbit users.

the latest generation of wearables, medical devices and home diagnostic tests that utilize Qualcomm Life’s 2net™

Q: How important is technology in creating a state of

Platform for medical-grade connectivity.

health consciousness? A: It is undeniable that technology helps us to be connected, which is why Fitbit is introducing new tools that deliver

Fitbit is a US-based company that has been a pioneer and

inspiration, personalization and smarter guidance to help drive

leader in the connected health and fitness category for nearly

behavior change and maximize positive health outcomes. To

10 years, helping millions of people across the globe reach

provide a complete picture of how a user’s daily activity adds

their health and fitness goals

151


INSIGHT

AI PROVIDES DIGITAL ANSWERS TO TECH-SAVVY GENERATION JAVIER CARDONA Co-Founder and Director General of 1DOC3

152

Despite the efforts of the main health institutions, some

fit the Mexican demographic and epidemiological profile. The

Mexicans are still falling through the cracks of the universal

app allows low-income people aged between 17 and 27, the

healthcare system. E-health services, such as 1DOC3, are

main users of this service, to solve some health inquiries.

helping to fill the gap as an easy alternative to face-to-face doctors’ appointments, fueled in part by improved artificial

The success of 1DOC3 is a consequence of a solid investment

Intelligence (AI) and the rise of a tech-savvy generation.

in developing AI, which has helped the app’s user platform triple between 2016 and 2017, up to a million users a month.

Services such as Colombian start-up 1DOC3 deliver answers to

Through a series of algorithms, inquiries are processed in

simple medical inquiries for free, providing basic, specialized,

fractions of seconds. Typed questions are compared by the

medical information. “We have become a family doctor to

AI with previous inquiries. If a match is found, the user is

whom young people ask questions from their phones,” says

directed toward that answer. “Ninety-nine percent of inquiries

Javier Cardona, Co-Founder and CEO of 1DOC3. The e-health

match previous answers,” says Cardona. If no matches are

company entered Mexico about three years ago and provides

found in the database of solved inquiries, the user sends

tens of thousands of users with free medical information daily.

the question and waits between 40 and 90 minutes for the answer from a professional physician.

Mexico comprises 1.5 percent of the global e-health revenue and 4.4 percent of the regional

Questions presented by Mexican users are answered directly by one of the 10 Mexican physicians employed by the company, a strategy that aims to provide the best possible answers to users of each nationality and to provide a better user experience. Answers follow what Cardona calls the

“1DOC3 has grown incredibly. The potential of the health

ABC Protocol: confirming and clarifying the user’s problem,

industry is large in terms of efficiency and savings and

providing medical grounds for the answer physicians provide

increasing people’s access to services over the internet,” says

and concluding what recommendation is most suitable for

Cardona. According to Statista, revenue in the e-health market

the user. 1DOC3 does not provide diagnoses but rather, gives

worldwide amounts to US$9.8 billion in 2017, of which only

basic recommendations and insights on common diseases.

North America accounts for US$3.3 billion and Mexico US$147 million. Thus, Mexico comprises 1.5 percent of the global

The company also offers a series of services that include

e-health revenue and 4.4 percent of the regional. Statista

publishing articles related to the most consulted topics

forecasts that by 2020 the Mexican e-health market volume

in each country, providing insurance companies with

will increase to US$265 million.

statistics on different diseases and developing ondemand awareness campaigns for UN agencies, public

Mexico has the highest rate of adolescent mothers in the

health institutions, laboratories and NGOs. 1DOC3’s main

OECD, with a teenage fertility rate of 65.7 births per 1,000

strategy is to strengthen its technological development as

women in 2014, according to the National Population

AI enables the most efficient allocation of resources. The

Commission (CONAPO), while the National Center for

company expects to strengthen relations with all clients,

Prevention and Control of HIV & AIDS (CENSIDA) reported

continue growing its user platform and make new alliances

706 new registered cases of AIDS in 2016, so it is not surprising

with insurance companies and public health institutions.

that sexual and reproductive health are the most requested

It is also working on providing users with quicker answers

topics. Diabetes, the second-most common cause of death

in case of an emergency. “The opportunity to impact the

in Mexico, at 98,521 in 2016, according to INEGI, is the second

health industry through new technologies and digital

topic on which Mexicans inquire. The inquiries made on 1DOC3

channels is increasingly greater,” says Cardona.


VIEW FROM THE TOP

DIGITALIZATION UNDERWAY BUT ACCELERATION NEEDED FEDERICO CASAS-ALATRISTE Managing Director of T-Systems Mexico

Q: What role does Mexico play in your global strategy?

Healthcare is a strategic industry for T-Systems, with a

A: We have been in the Mexican market for over 20 years.

very important market penetration in Europe but with

When we first started in the country, we operated under the

a low participation in the Mexican market because the

name Gedas, providing services to the automotive industry.

digitalization of the Mexican health sector is slow. However,

Our focus is now on providing services to the premium

we have high growth expectations for it. We are investing

segment of companies and public-sector entities.

heavily in the sector.

Mexico has contributed heavily to our global growth. In

To push and accelerate a change in the digitalization of

2015 and 2016, we grew in revenue on average 30 percent

the Mexican healthcare system there are two verticals:

annually in the country. Repeating this growth in coming

one comes from the government through the National

years will be complicated but we expect to continue growing

Digital Strategy and the other from the industry itself.

at an accelerated rate. We have a strong presence in the

The digitalization of health services is a race against time.

industrial sector and we have an important but selective

Digitalization is something that is not being questioned,

presence in the public sector. In the health and financial

it either happens or companies will not have a chance of

sectors we have a very small presence. However, we expect

survival. Regardless of what politicians may say, the world is

to increase this in both and thus continue growing.

already digitally connected. It is imminent and it needs to be done now, we cannot think of doing it in the coming years.

Q: How has digitalization been received in Mexico? A: Companies are already undergoing the transformation

Q: In terms of human capital, is the countryâ&#x20AC;&#x2122;s workforce

of the digital revolution but it is a change that needs to

prepared to face the challenges the digital era will bring?

be accelerated in the country. At first, it was hard for

A: Human capital is a critical issue that deserves to be a

the Mexican business community to understand certain

top priority. Mexican technicians are extraordinarily good

concepts such as the cloud. However, the cloud is like

and competitive worldwide. The fact that we provide

the entry ticket to digital transformation. It is impossible

services from Mexico to more than 30 countries means

to conceive this transformation without a model such

that our human capital can perform world-class services.

as the cloud.

Universities are producing professionals and technicians with competitive levels. While the technical skills of

Up until a few years ago, companies in Mexico thought that

graduates are at a good level, an element to improve is the

having control or exclusivity of their technological resources

studentsâ&#x20AC;&#x2122; English level. Especially in the telecoms industry,

was of extreme importance since it belonged to their core

people must be able to at least read in English and interact

business. Today, few companies have their own data center,

with clients in English. However, besides this and given the

since it makes no sense for them to have one. From a cost

transformation dynamic of the industry, companies must

perspective for IT, instead of being a fixed-cost model as it

invest a lot of money in training, which is understandable

used to be, it has now become a variable cost, which has

given the characteristics of our business. We invest heavily

viability repercussions, particularly for investment projects.

in training and certifications. It is a matter of creating a processes culture, which requires time and effort.

One of the most common concerns for the business community regarding the use of the cloud was security. The truth is that the level of information security

T-Systems is a global IT Services and Consulting company.

companies can have when using our services versus the

It specializes in providing cloud services, M2M solutions and

security level they can have in an in-house data center with

communication services, among others, helping companies

limited conditions cannot be compared.

construct a digital platform

153


INSIGHT

APPROACHING EARLY CANCER DIAGNOSIS WITH AI JULIÁN RÍOS Director General of Higia Technologies

154

Breast cancer mortality is on the rise in Mexico and early

high expenditure for the government and a main concern

detection can be a strong tool to combat the disease. Self-

given the lack of an effective early diagnosis test. “The

examination has traditionally been the first line of defense

government will be one of our main buyers because this

but it is far from ideal. After watching his mother survive

product will help rural clinics, associations, universities,

two battles with the cancer, 17-year old entrepreneur Julián

insurance companies and hospitals reduce costs.” Eva will

Ríos thought artificial intelligence could provide a better

initially sell for MX$2,000 (US$111) without government

approach and the result of his work is attracting serious

support, but Ríos says its business model will enable the

attention both in the public and private spheres.

company to reduce the price.

Ríos’ company, Higia Technologies, produces Eva, a bra

Higia Technologies works with a team of 10 people made up

Ríos says can detect breast cancer through the use of

of engineers and oncologists and the company has received

bio-sensory patches. He believes the detection methods

an invitation to work at investor Y Combinator in Silicon

currently available are more for diagnosis, mammography

Valley. “It will help us formalize the business part. It receives

and biopsy, while there are few effective early detection

7 percent of the company for a very small investment.

processes. Ríos hopes to meet this need with Eva.

However, the real value of this opportunity is to be part of an ecosystem in which we can gather important contacts

The high-tech bra’s bio-patches capture temperature data

that could lead us to higher investment,” says Ríos.

that is sent to a mobile app, which keeps a record of the information received. “Cancer increases blood flow due

Ríos began researching breast cancer when he was 13

to the abnormal production of cells that could produce

and locked onto the idea that changes in temperature

a tumor. This leads to an uncommon temperature in the

could lead to a correct diagnosis. He then gathered his

affected area.” The app’s algorithms analyze the collected

high-school friends to create Higia Technologies with an

temperature data to produce a thermal conductivity curve

investment of less than US$250. By 2017, the company

that is compared with a database of 2,000-3,000 curves

had raised US$75,000 from awards and donations,

of data from women from different parts of the world who

US$33,000 from investors and it is about to close a round

have been diagnosed with cancer. “Different tumors have

for US$300,000 from an investment fund. Ríos believes

different thermic fluids. If there is a curve similar to a case

the Mexican entrepreneurial ecosystem is talented but

from the file, the probabilities of having breast cancer are

lacks support. “Many projects are changing the world

between 93 and 94 percent,” says Ríos.

but not in Mexico. The industry of risk analysis is very small, which restricts investment.” He also thinks many

Eva will be available early in 2018 in Mexico and Latin

entrepreneurs in the country have good ideas but poor

America through online platforms and convenience

execution. “We have often seen how in Mexico ideas are

stores. The project is awaiting approval from COFEPRIS

adjudicated without evaluating whether they can be

and the team recently signed an agreement with IMSS

executed,” he says.

to carry out trials. Higia Technologies is in the process of developing new According to the Ministry of Health, in 2015, 6,252 women

products, including a device to detect testicular cancer

died in Mexico due to breast cancer, almost 5 percent

through men’s underwear. Ríos says information is the

more than the previous year, figures that Ríos wants to

key component of his company. “Higia Techonologies is

reduce. According to Ríos, a women with cancer in phase

moving from a company that develops medical devices

III costs IMSS MX$5 million (US$277,000) every year and

to an information company. Our value is in the amount of

MX$250,000 (US$13,888) if she is in phase I. That is a

information we have.”


VIEW FROM THE TOP

THE CASE FOR STRONGER DIGITAL SUPPORT

Xavier Ordoñez Partner in Strategy and Operations Consulting at Deloitte

Horacio Peña Senior Manager in Strategy and Operations Consulting at Deloitte

Q: What challenges in digitalization is the healthcare

are now web events that become physical when the expert

system faced with?

reaches the participant’s city.

A: By pushing digitalization you often lose a physical

155

interaction, which in Mexico and other Latin American

Technology has developed greatly and has decreased direct

countries makes a huge difference. The visual contact and

sales to producers but they have strengthened innovative

dialogue with a physician makes the commercial process

tools that allow for better follow-up with an increased

more effective. There was a moment when companies

chance of achieving a drug’s purpose.

tried to become more digital, using tools such as iPads as a mechanism for communicating with the physician, but in

Q: What are the main challenges regarding cybersecurity

many cases the physician refused to see them. Mexico is a

in healthcare?

country where interaction is still important and that presents

A: Deloitte has a department specialized in cybersecurity

a challenge to companies that want to be more innovative.

although this branch has not yet developed much at

Many laboratories have reduced the number and size of their

an industrial level in Mexico. Cybersecurity allows the

sales teams, which is a trend seen in Big Pharma over the

verification of information veracity and a better follow-up

past 10 years. National laboratories still have larger sales

on patient health and on a drug’s effectiveness. Companies

teams but there are fewer companies with these numbers.

have not yet reached the point where they feel they need cybersecurity for health-related issues. They focus more

Perhaps, the most important challenge we have in Latin

on financial issues and economic risks, where there is

cultures is making the digital become more human.

tangible and confidential information management. Health

Making use of it with the purpose of increasing the quality

companies in Mexico have not placed as much importance

and content of our interactions instead of reducing or

on cybersecurity concerning drugs or services as they have

eliminating them.

on information management and patient communication.

Ten years ago, laboratories enjoyed double-digit growth

Q: How can you use data analytics to track and eliminate

rates. Many top labs had a large portfolio for general

epidemic viruses in Mexico?

practitioners and general medicine and a smaller portfolio

A: There are technological support tools available during

for highly specialized drugs. Over time it has become

epidemic periods but they are uncommon because the

impossible to maintain the same growth rates in the primary

difficult epidemics are usually centered in low-income

care sector, where many national companies are competing

communities, which have less access to technology.

and where generic products are gaining important market share. Many Big Pharma laboratories are not willing to go

For segments of our population with access to electronic

into generics with the same resources. Instead, they venture

media, advanced analytics that are available today would

into highly specialized areas, where you need to educate

allow a web search and would become a predictor of possible

physicians and provide consulting and advice. Training is

diseases depending on the nature of the questions and

now undertaken in many ways not possible before. There

information searched. This constitutes a great opportunity

are webcasts and online events in which people interact

in prevention, an area in which we have a long way to go.

across the world, physicians want to have access to more digital information rather than mountains of paperwork and commercial representatives are also asking for this.

Deloitte is one of the world’s leading audit, consulting,

Laboratories are implementing digital ways of reaching

tax, financial advisory and risk advisory brands, with about

them while keeping human interaction alive. For example,

245,000 people at member firms in 150 countries and

speaking tours that used to be only in-person experiences

territories


Research on growth disorders


CLINICAL RESEARCH & TESTING

7

For years, many have spoken of Mexicoâ&#x20AC;&#x2122;s clinical research industry as a boom waiting to happen. The country has an ideal geography, ethnical diversity and the sanitary installations, but it still only accounts for an insignificant proportion of the number of clinical trials carried out worldwide, at just over 1 percent, according to clinicaltrials.gov. Its northern neighbor has a hefty 42 percent of global trials, despite the US being more costly. According to ProMĂŠxico, conducting clinical trials in Mexico is 46.2 percent cheaper than in the US. Most of the testing performed here is retesting, as required by local sanitary regulations. Authorized third parties have helped enormously in this area, speeding up processes and efficiency. According to a COFEPRIS 2014 press release, authorized third parties had reduced authorization wait times from an average of two years to 20 business days.

Clinical research is vital worldwide for drug companies, regulatory bodies and consumers alike. Mexico has all the attributes to become a hub for research in the Americas. This chapter will present interviews with the labs and contract research organizations that undertake the research and will examine the obstacles and opportunities for Mexico to attract more investment in this area.

157


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CHAPTER 7: CLINICAL RESEARCH & TESTING 160

ANALYSIS: Demographics Among Keys to Clinical Research Success

162

VIEW FROM THE TOP: Arturo Rodríguez, Infinite Clinical Research and ACROM

164

INSIGHT: Israel Vega, PRA Health Sciences

165

VIEW FROM THE TOP: Ciro García, Accelerium Clinical Research

166

VIEW FROM THE TOP: Cecilia Moreno, PPD

José Viramontes, PPD

167

INSIGHT: Annette Ortiz, Epic CRO

168

VIEW FROM THE TOP: Melissa Rosales, RM Pharma

169

VIEW FROM THE TOP: Karen Hahn, ICON

170

VIEW FROM THE TOP: Héctor Ávila, Cecyc Pharma

Mezly Rodríguez, Cecyc Pharma

Diego Ávila, Cecyc Pharma

172

VIEW FROM THE TOP: Abel Hernández, ANCE

Yoloxóchitl Macías, ANCE

173

VIEW FROM THE TOP: Carlos Pérez, NYCE

174

VIEW FROM THE TOP: Sonia Pérez, UDIBI

175

VIEW FROM THE TOP: Andrés Ferrara, Analitek

176

ANALYSIS: Authorized Third Parties Ease Registration Backlog

177

ROUNDTABLE: What Must Mexico do to Become a Clinical Research Hub?

159


ANALYSIS

DEMOGRAPHICS AMONG KEYS TO CLINICAL RESEARCH SUCCESS Mexico is trying to scale up its clinical research by taking

Mexico already has a foothold, standing

advantage of its natural traits: a large and diverse population,

with the leaders in health sector R&D

supportive regulatory authorities and competitive

among the countries participating in KPMG’s

operational costs

Competitiveness Alternative 2016 Study. In clinical research, it is strongest on T2D,

With its diverse demographic profile, a vast pool of

landing the top spot on the KMR Group Index and among

potential volunteers and widely recognized regulatory

the top three for arthritis.

arm that is bent on speeding up processes, Mexico According to a report by Zion Market Research, the CRO

clinical research and drug testing. Despite its numerous

market was worth US$34 billion in 2014 and is expected

advantages, the country remains on the outside looking

to be valued at US$59 billion in 2020. Pharmaceutical

in. It carries out just 1 percent of global clinical trials,

manufacturing companies in emerging countries in Asia-

about 2,850, according to clinicaltrials.gov.

Pacific, Latin America and Eastern Europe are responsible for most of the outsourcing activities due to the large

To move Mexico up the ladder, the government is working

population of treatment-naive patients, low labor and

with regulators and industry associations to promote

manufacturing costs and a skilled medical workforce, the

improved protocols, speed up processes and boost

report states.

recognition of the country’s strong attributes, including a skilled but economical labor pool, to attract investment

PATIENT RECRUITMENT OPPORTUNITIES

and help establish itself among the sector’s elite hubs.

Mexico has a diverse population of 121 million inhabitants

While there remains a long way to go, the establishment

and has more than 10 cities with over 10 million

of a framework agreement in 2017 to promote clinical

inhabitants, providing a large pool for recruitment. “The

research and the clear emergence of authorized third

big international pharma companies have demonstrated

parties, established in 2014 and now coming into their

their interest in the available patient pool, which offers a

own, has created an air of optimism.

substantial opportunity to accelerate their research,” says Francisco Corpi, Latin North Regional Director of Elsevier.

“The creation of the authorized third-party system was a great decision. The fact that the government accepted that its

To take advantage of this favorable demographic, President

internal structure could not deal with the volume of demand

Peña Nieto signed a collaboration agreement in January

was a good move,” says Carlos Pérez, Director General of

2017 with COFEPRIS, SAT, CANIFARMA, IMSS, ANAFAM

NYCE, an authorized third party that works across sectors.

and AMIIF to promote the development of protocols for health research, opening the door to new opportunities

THE COST OF R&D SERVICES COMPARED TO THE US R&D servicesInternational results (US=100.0) (US=100.0)

for the industry. According to the Ministry of Health, this agreement will make the most of the potential available of more than 83,000 doctors, 459 researches, 155 nurses,

100 88.1 87.2

84

80

1,786 medical units and about 62 million IMSS members 79 77.9 77.6

and 487,000 registered with ISSSTE.

74 72.3

60

55.3

According to Corpi, the possibility of finding volunteers in Mexico has been considered a key factor for bringing clinical research to the country, although, he believes there

40

is a concern from regulatory agencies and policymakers regarding the safety of patients. “While both Big Pharma

20

corporations and policymakers here in Mexico are still Mexico

Canada

France

Australia

Italy

Germany

Netherlands

Source: KPMG

Japan

figuring out the most adequate formula for success, we UK

0

US

160

has all the ingredients to become a hub for global

see many clinical trial opportunities lost to other countries in the region. The challenge is not just the bureaucracy of policy but it is even at the infrastructure, personnel and information level,” Corpi adds.


EASING APPROVAL TIMES

studies. “There are not many international phase I studies

In May 2017, Julio Sanchez y Tépoz said during a forum

brought to Mexico, in part because the research process

with AMIIF that COFEPRIS is working very closely with the

requires higher quality standards and a higher degree of

industry to create incentives for investment. New research

sophistication and organization,” García says.

protocols allow product approvals within 45 days, making the sector more competitive. José Viramontes, Director

INDUSTRY TRENDS

of Remote Site Management and Monitoring of PPD,

While overcoming obstacles, the country must also keep

said 2016 was an excellent year for Mexico in terms of

up with prevailing trends such as biotechnology, an area

clinical research since regulation became more consistent

that has captured the attention of many industry players.

with the company’s internal processes. “The year closed

According to ProMéxico, there are 406 companies in

with a meeting between the authorities and associations

Mexico that develop or use modern biotechnology

during which a few changes to the law were proposed.

and 33 percent of those operate in the health industry.

For example, Mexican law requires the involvement of

“It used to be that only 20 percent of diseases were

three committees: ethics, research and biosafety. One

healed with biotechnology, but now pharmaceutical

proposal seeks to include only one committee, which is

companies want to treat other diseases like diabetes and

an approach comparable to the rest of the world. Another

cardiovascular with these types of drugs,” says Annette

consideration is to run processes in parallel rather than

Ortíz, Director General of Epic CRO. The main benefits of

sequentially, which can help shorten approval times.” He

this technology are personalized treatments, reduction

added that the purpose of these changes was to support

of adverse effects and higher control of the disease

industry efforts to bend both costs and the time required

for both patient and physician, she adds. Nevertheless,

for drug development.

companies are concerned that although the new pharmacovigilance standard developed by COFEPRIS

Authorized third parties, companies certified by

controls the chemical medicine, it does not respond to

COFEPRIS to support authorities with sanitary control

the need for biotechnology.

and vigilance, have also played a significant role in speeding up approval times. There are 122 authorized testing laboratories, 62 units of interchangeability and bio-comparability and 26 verification units. “We have authorized a series of third parties to be much faster in clinical authorizations, which will allow Mexico to become a center of clinical research,” said Rafael Gual, Director General of CANIFARMA.

STRATEGIC LOCATION It helps to have the world leader in clinical research as

The global contract research organization market is expected to reach a value of US$59 billion by 2020

a next-door neighbor. The US conducts about 103,000 studies, says data from clinicaltrials.gov. According

Another industry trend is the need for e-services to

to ProMéxico, the Mexican population suffers chronic

manage information that can be used for preventive

conditions similar to those of Americans, which helps

medicine or the development of biotechnological drugs.

conduct studies.

As mentioned by Carlos Oviedo, Director General of Grupo Diagnóstico Aries (GDA), Big Data applications

For these reasons, among others, Mexico could become

should translate into timely disease prevention. “In this

a reference for the evaluation of biosimilars worldwide

area, we would like to cooperate with local governments

due to its geographical location and the fact that many

and companies by sharing all the information we gather

countries are seeking to access other markets, says Sonia

to increase prevention. The Ministry of Health is the

Pérez, Executive Director of UDIBI. “The knowledge we

appropriate entity to use this information for the benefit

gather when we perform a detailed evaluation might

of Mexican citizens,” he says.

be useful in developing innovative molecules. Mexico has great potential but our innovation system is not

Mexico’s attributes demonstrate it has great potential to

articulated,” says Pérez. Similarly, Ciro García, Director

develop research. Some companies, such as Sanofi have

General of Accelerium Clinical Research, believes

already taken advantage of the local opportunities. The

conducting early phase clinical research could result in

leading pharmaceutical company has 35 active studies in

significant opportunities for Mexico, although there are

Mexico, making it the second-most important clinical research

constrains that are impeding the arrival of these types of

unit after India for Sanofi’s emerging economies markets.

161


VIEW FROM THE TOP

LEADING THE CLINICAL RESEARCH CHARGE ARTURO RODRĂ?GUEZ Director General of ICR and President of ACROM

162

Q: How is Infinite Clinical Research (ICR) fulfilling its mission

back into the country because that amounts to importing

to be an outsourcing leader in the pharmaceutical industry?

tissue. Covering all these elements under one umbrella would

A: To meet an objective it is necessary to understand the main

increase security, productivity and reduce response times.

requirements of the industry, including regulation. We are continually attentive to possible changes or lines that could

Q: Regarding pediatric care, in which main therapeutic areas

be worked on to achieve these updates and improvements.

are you concentrating research?

We do this by participating in all the regulatory events held

A: In pediatrics, our studies are mostly in vaccines and

by COFEPRIS and the National Commission of Bioethics

developmental or growth conditions that require growth

and International Commerce in combination with our day-

hormones. The challenges we face are that the researcherâ&#x20AC;&#x2122;s

to-day experience in working with the authorities. Any alert is

profile must be much more focused on the therapeutic

immediately communicated to our clients and we implement

area involved, while patients are seen in more specialized

it in our processes. Through a corrective and preventive

institutions and finally there is not much availability of these

action plan we remodel our activities and strive to always

medicines. Also, children are under the protection of their

be at the vanguard of what is happening. With the advantage

parents and, because babies and children are fragile, parents

of working hand in hand with ACROM, which participates

do not allow them to participate in research protocols. Our

directly in the revision and elaboration of process guides,

main strategy to convince parents is to explain the benefits

we are ready when new laws come into force.

of the medicine for the patient. The most important point is to be clear and open, explain that trials are not black and

Q: What particular regulation is ICR lobbying to establish

white and highlight the possible downsides in addition to

or change?

the opportunities. This can make a difference in a patient

A: It is not that we want to change a point but we want

participating or not.

to homogenize regulation and see what processes can be carried out simultaneously. When a research center

Q: What are the advantages of performing clinical research

or country is chosen, companies look at the time elapsed

in Mexico over other Latin American countries?

between sending in the first documents and recruiting the

A: Mexico has long wait times but not as long as other Latin

first patient. This is what has left Mexico out of the market

American countries. In Mexico, in line with FDA rules, if an

because we have time frames of over 300 days. Sometimes

efficient rescue medicine is available, trials can be held with

this is due to the authorities, sometimes ethics committees

groups taking placebos. This is not the case in some Latin

while other times it could be due to internal processes. The

American countries. The Helsinki Declaration states that a

internal processes element is what we need to optimize

placebo should not be given to patients but that a drug

because we realized that many days are added to processing

should always be compared to what is available on the

times due to internal delays. Running things simultaneously

market. The downside of this is that researchers will not know

will allow us to reduce this.

the base state of the patient or the efficacy of the product. Researchers will know the percentage of how efficient it is

We are also working with the Ministry of Foreign Affairs to

compared to the available treatment but that treatment itself

achieve greater flexibility for products brought in and out

is not 100 percent effective, therefore you may be getting a

of the country. At the moment, medicine is brought in on

false positive: believing the product works well but in reality,

exceptions but it then becomes a struggle to import any

providing a lesser level of efficacy than that needed by the

supplementary products. We are asking to be able to bring

population. There are cases such as CNS, cancer or high-risk

everything in together through the approval service rather

diseases in which it is not possible to give placebos because

than taking out licenses for each one. Samples taken for

the patientâ&#x20AC;&#x2122;s treatment would be unbalanced and their lives

analysis are another issue because they cannot be brought

would be put in danger.


CLINICAL TRIALS CARRIED OUT IN JUNE 2017 (percentage of global trials) 45 40

41.4%

35 30 23.5%

25 20 15 10

7.1%

6.9%

5

6.4%

5.5%

4.0%

2.3%

0 US

France

Canada Germany

UK

China

Brazil

1.1%

0.9%

Mexico Argentina

0.5% Chile

0.4% Colombia Other

Source: www.clinicaltrials.gov

Another advantage is that doctors here are closer to the

around 60 percent of research takes place in the capital.

information available in the US and are more up to date

The following two states are Nuevo Leon and Jalisco and

on what is needed. They are also better informed about

others such as Durango and Chihuahua are beginning to

new medicines and can thus achieve better results. Central

develop their centers and facilities. Mexico has several types

and South America often receive more medicine from

of climate: forest, dessert and tropical, which enables the

Europe, which is closer in terms of flying hours. The work

research of tropical and rare diseases, further boosted by

methodology in Europe is different. They work with less time

our large population and our urban/rural split.

pressure than in the US, which gives them the ability to work with Central and South America’s processing times.

Q: ACROM is still a young association. What have been its greatest challenges and how has it approached its

Mexico’s main obstacle was that it did not have access to

relationship with the authorities?

public hospitals, whereas in 2016 and 2017 an agreement

A: The first challenge was to create ACROM as it involved

was reached with IMSS and COFEPRIS to open the doors

bringing together companies that were competitors.

to clinical research. The same will happen with ISSSTE and

Finally, the alliance was created and we worked on

other public institutions. This dramatically increases our

creating respect between the partners as what benefits

chances of recruiting patients. In 2016, 80 percent of trials

one will benefit the other. The hardest challenge has been

were carried out in private institutions. We hope to attract

credibility, having both the industry and the authorities

more trials to Mexico, maintaining the amount carried out

believe in us. We are trying to work with CETIFARMA

in the private sector but increasing the amount in the public

to certify companies as ethically responsible, which

sector to achieve a 50/50 balance.

complements the credibility of the association in front of the authorities and the industry. We are interested in

Q: COFEPRIS Comissioner Julio Sánchez y Tépoz told MHR

them seeing we have no issues in covering ethical issues.

he hopes to triple investment in clinical research in Mexico in two years. Is that possible?

Q: What will your priorities for 2017 be in ICR and in

A: I agree with his actions. We are working hand in hand with

ACROM?

COFEPRIS. One of the problems seen in Mexico was the lack

A: ICR has been working hard on developing

of certitude. For example, when Mexico first implemented

pharmacovigilance and risk management. One of the points

certifications, operations and processing times were

of new norms, a global movement, is the need to create

forgotten and they multiplied, which caused clinical research

risk management plans. We require much more specialized

to move away from Mexico. Before this, the number of trials

people than other CROs, this is an opportunity to develop.

entering Mexico was extremely high. The commissioner’s vision is progressive because he is looking at facilitating the

The vision of ACROM is to promote that Mexico has

arrival of trials and not at implementing obstacles, which

credibility, opportunity and could move from being an

gives us a great opportunity to support him.

emerging zone to a country of primary decisions.

In addition, the links between Mexico City and the other states allow fluid communication. To get to Monterrey takes

Infinite Clinical Research (ICR) is a Mexican CRO that has

the same amount of time as getting to the south of Mexico

15 years of experience in clinical trials in Mexico and in Latin

City. By going to other states, clinical research is spread

America. ACROM is the Mexican association of CROs, which

throughout Mexico and capacity is increased although

promotes quality in clinical R&D in Mexico

163


INSIGHT

PROCESSING TIMES SLOWING MEXICO DOWN ISRAEL VEGA Clinical Operational Manager of PRA Health Sciences

164

The paradigm is set: Mexico has the correct infrastructure

trial, due to the health system working differently it is

in place, an ideal mix of ethnicities and research talent

possible to enroll 100 subjects in just one day. “That’s

and a privileged location close to the US and relatively

something we cannot compete against.”

easy to reach from Europe, but despite the hopes expressed by industry insiders in previous Mexico Health

The Mexican government is stepping up its efforts to attract

Review editions, the percentage of global clinical trials

further clinical trials. In addition to speeding up processing

carried out in Mexico is decreasing rather than increasing,

times to become more attractive against other countries.

according to clinicaltrials.gov.

In December 2016 the IMSS modified its terms and conditions for conducting clinical trials, which has sparked

However, the sentiment in the industry remains optimistic

widespread interest among the private sector as the IMSS’

and Israel Vega, Clinical Operational Manager of PRA Health

large population of beneficiaries is an ideal patient base for

Sciences, believes that the trend will pick up. “We should

carrying out sponsored clinical trials. IMSS, the country’s

have more than 1 percent of trials. We are close to the US,

largest health institute, reports that as of May 31, 2017, it

so we could act as a hub for processes that

had 19.04 million affiliated workers. “Over

are currently being done in Panama,” he says.

the past year the agreements we have with

PRA Health Sciences is a US-based CRO with 41 years of expertise in clinical research, phase I-IIa, phase II-III, post-approval, safety and risk management, biosimilars, rare diseases and oncology. It operates in over 80 countries and

1.1%

the proportion of global clinical trials Mexico performs

is one of the largest CROs in the world.

public institutions have changed: we are now able to work with IMSS,” Vega says. He explains that the CRO will work through the department of research at IMSS, contacting researchers centrally. Researchers will not be able to carry out more than two active studies at a time.

According to clinicaltrials.gov, Mexico performs only 1 percent of global clinical trials, whereas the US carries out 42 percent

IMSS clinical trials will mostly focus on treating the

and Brazil 2 percent. Asia performs 15.4 percent compared to

conditions that weigh down a large proportion of the

5.5 percent in Central and South America and the Caribbean.

population and thus the institute, such as diabetes, cardiovascular diseases and cancer. “They also have the

“Mexico usually does very little phase I testing, that is done

potential to conduct rare disease trials,” Vega adds. “I

elsewhere. We concentrate on phase II and phase III,” says

think that starting to work with IMSS in 2017 will be a

Vega. He explains that despite faster timelines in Mexico

big boost to the sector. We will get a lot of patients and

over the past few years, there is yet work to be done.

quick results. If we focus on not losing quality, then it could be the first step toward opening up the market.”

“Although timelines have been improved, it still takes us

He adds that the industry has seen increased interest

six to seven months from receiving the protocol to begin

in Mexico from Big Pharma and that negotiations have

enrolling subjects in the first site. In the US, this can be done

already begun to conduct clinical trials with ISSSTE.

in two to three weeks. In Guatemala or Panama, it can be started in three to four months,” Vega says.

Vega also does not believe that the general economic fluctuations of 2016/2017 will keep the industry down. “Peso

It is not just the timelines, Vega adds, it is the system.

depreciation will probably not impact the attractiveness

Brazil, for example, remains an attractive destination

of Mexico as a destination for clinical trials because most

because although it takes 11 to 13 months to set up a

budgets are still negotiated in US dollars,” says Vega.


VIEW FROM THE TOP

MOVING BEYOND THE BASICS OF CLINICAL RESEARCH CIRO GARCÍA Director General of Accelerium Clinical Research

Q: Given the speed of innovation across sectors, what is

jettisoned even faster. Any failure of this process may

the state of clinical research today?

represent potential losses for pharmaceutical sponsors.

A: There is a new trend in biotech drugs and personalized

We are trying to attract early phase studies to our state-of-

medicine. Biotechnology has made it possible to create

the-art phase I unit and show that Mexico is now capable of

therapies focused on specific mutations or biomarkers. In

delivering results comparable in quality with the other phase

addition, it is also now common to evaluate participant

I units in the world. In fact, we are pioneers in conducting

genotypes in clinical trials because drugs have different

international phase I trials in complex therapeutic areas

interactions depending on genetics. A drug dosage that

such as oncology. We are one of the few centers in Mexico

works well for the Asian population might have different

that has the infrastructure and organization to hold phase

results for Latin Americans. The trend is to understand the

I or first-in-human studies sponsored by the international

effect of a drug among different groups.

industry. One of our strategies is to bring more phase I trials to Mexico. We have been moving forward and we are

Q: What is Accelerium Clinical Research doing in line

now working with multinational CROs to create enough

with this trend?

confidence to bring this process to the country.

A: As we increase our work in more complex clinical trials, we are able to assume the level of sophistication

Q: What system do you use to protect patient information?

demanded by the industry. The international requirements

A: We have designated restricted areas with high-security

for conducting clinical trials are becoming increasingly

digital access controls to protect physical records and

stringent. Consequently, we have had to enhance our

any patient-related information. Each system requires

own infrastructure and organization to stay in line with

a validation to store the patient data. We comply with

these trends. Previously, clinical research could have

the Code of Federal Regulations Title 21 for electronic

been easily performed in a small doctor’s office with

information, which requires us to use a validated system

basic equipment. To keep up with quality and safety,

that meets those regulations. We must understand that

regulators now require more complex infrastructure

research is not something random. It requires attention

and controls. The new generation of drugs is inherently

and consideration of local and international regulations.

more complex, warranting more thorough studies and increasingly stringent procedures.

Q: What results did you see in 2016 and what are your plans for 2017?

Q: To what extent is it possible to start developing phase

A: 2016 was an important year for Accelerium. We saw

I research in Mexico instead of focusing on solely phases

significant growth in the number of projects we worked on

II and IV?

across therapeutic areas. We recently started operating

A: Early phase clinical research is another important area

our second phase II – IV research center south of the

of opportunity in Mexico. There are not many international

state of Nuevo Leon. We plan to focus on leveraging

phase I studies brought to Mexico, in part because the

technology to enhance the productivity and efficiency of

research process requires higher quality standards and

our operations, while overall helping the industry increase

a higher degree of sophistication and organization. The

access to larger patient populations.

strategic and tactical work done in phase I has a greater impact on downstream phase II and phase III costs than any other factor, and has the greatest impact on drug

Accelerium is a Monterrey-based research center dedicated

development success. This is a critical point in the research

to the pharmaceutical and biotechnological industries. It

process. Drugs that should go forward need to move ahead

operates trials from phase II to phase IV and aims to contribute

quickly and drugs that should be abandoned should be

to scientific research and development in Mexico

165


VIEW FROM THE TOP

EXPANDING TO REACH PUBLIC AND PRIVATE ENTITIES

Cecilia Moreno Associate Director of Clinical Management of PPD

166

JosĂŠ Viramontes Director of Remote Site Management & Monitoring of PPD

Q: In 2016, you told MHR you had plans to open more centers

is still very similar to what it was before. Also, we will

in Mexico. To what extent have you fulfilled these plans?

probably participate in more risk-management studies

CM: We are opening an increasing number of centers in

or observational studies going forward.

Mexico to work with the private and public sectors and in new therapeutic areas, such as vaccines. Additionally, IMSS

JV: Although the section of the NOM that deals with

is modifying its internal processes to allow more interaction

the reporting of adverse events in clinical trials has seen

with pharmaceutical companies and has changed its

a few slight modifications, it has not had a substantial

contract template to better support the industry. We

impact. It has more of an impact on the spontaneous

already have started working with the agency in oncology,

adverse events for medicine already commercially

allowing patients with less prevalent diseases to be enrolled

available. Most of the industry is working on how to

in clinical trials. We are also working with IMSS on vaccines

implement these changes in their internal processes.

for infectious diseases.

There is a Mexican association of pharmacovigilance that holds regular meetings in which the details of the new NOM

Q: What are the specific challenges in working with

are discussed. They are in contact with the authorities.

vaccines? CM: One of the main challenges of working with vaccines is

Q: Looking to the future, what are PPDâ&#x20AC;&#x2122;s goals for

the number of patients who have to be recruited. Studies can

Mexico?

include hundreds or thousands of patients, so centers have to

CM: Our goal is to continue growing. National regulation

have the necessary infrastructure and personnel to support

has been beneficial to our industry and over the past few

those needs. Also, vaccines are often for endemic diseases,

years we have seen an improvement in approval times and

many of which are tropical like zika and dengue and occur in

greater willingness to strengthen and improve regulatory

Mexico, so there is an area of opportunity for these studies.

processes, which has made Mexico more competitive when compared to the rest of the world. COFEPRIS

JV: Another challenge is finding healthy volunteers and

continues to improve its processing time frames and

conducting the follow-up to ensure the vaccine is effective.

research sites continue to operate at increasingly higher

The informed consent applied to healthy volunteers is

standards, which improves overall recruitment times.

different than that used to invite patients who are conscious of their disease. An additional factor to be considered is that

JV: 2016 was an excellent year for Mexico in many ways.

in many cases vaccine clinical trials include children.

The regulatory authorities have brought much greater consistency to their internal processes and they have

Q: What impact has NOM-220 had on your Mexican

greatly expanded their interactions with companies.

operations and what changes do you expect from future

The year closed with a meeting between the authorities

modifications?

and associations, during which a few changes to the

CM: We have not seen much impact but we are waiting to

law were proposed. For example, Mexican law requires

see what new follow-up activities result from the vigilance

the involvement of three committees: ethics, research

plans. The reporting of adverse events in clinical trials

and biosafety. One proposal seeks to include only one committee, which is an approach comparable to the rest of the world. Another consideration is to run processes in

PPD is a US-based contract research organization present

parallel rather than sequentially, which can help shorten

in 47 countries and working in early development, clinical

approval times. The purpose of these changes is to

development, post-approval studies and consulting, among

support the industryâ&#x20AC;&#x2122;s ongoing efforts to curb the cost

other areas. It has been present in Mexico since 1998

and time curve of drug development.


INSIGHT

INNOVATION BLAZES TRAIL TOWARD PERSONALIZED TREATMENTS ANNETTE ORTIZ Director General of Epic CRO

The development of a biotechnology drug industry is

concern for clients. As a solution, Epic CRO has a two-

setting up a panorama of innovation in the country that

server protection system.

could provide personalized treatments and better disease management. However, without strict data collection and

A large obstacle for this industry is the lack of regulation.

regulation, patient health could be endangered.

Ortiz says that COFEPRIS was expected to prepare regulation on this subject for 2016. However, “companies

“It is not easy,” says Annette Ortiz, Director General of Epic

that were supposed to start clinical research realized

CRO. Companies like Epic CRO are offering clinical research

COFEPRIS was not yet ready to answer many of the

solutions to anticipate the changing terrain. The company,

questions they had.” She says that there is a big difference

which works in pharmaceuticals, nutrition and medical

between traditional pharmacy and biotechnology, which

devices is also highly interested in the biotech industry and

requires an understanding and new technology that is not

in acquiring clients that want to start clinical trials for drugs

common in the Mexican pharmaceutical context.

with a biological basis. Ortiz believes it will take at least one more year to complete Epic CRO has 10 years of experience conducting clinical

the regulation. Meanwhile, the company’s plan is to

trials in Latin America, providing integral and tailored

gain as much knowledge as they can from each of their

services to local and foreign clients looking for clinical

biotechnology trials and get a full understanding of how

development to take their products to market.

each molecule works to sharpen each protocol, so when the time comes they will be prepared to explain to patients the

“It used to be that 20 percent of diseases were healed

benefits of this new technology.

with special chemistry, known as biotechnology, but now pharmaceutical companies want to treat other diseases like

Epic CRO's priority is to push the industry to do clinical

diabetes and cardiovascular with these types of drugs,”

research. “The challenge I find is that Mexican companies

Ortiz says. The main benefits of this technology are

want to bring products onto the market as fast as they

personalized treatments, reduction of adverse effects and

can so they try to take shortcuts to get approvals,” she

higher control of the disease for both patient and physician.

says. CROs could help prevent this issue by analyzing the studies before they are performed and suggest potential

Epic CRO clinical research focuses on vaccines, diabetes,

modifications in case a more complete trial is required.

respiratory and gastric disease medication. The company has developed trials for influenza and hepatitis C vaccines,

This could be an issue for local companies. Epic CRO has

in addition to a formula for chromate testing to detect

done clinical development for companies from Spain and

lymphatic cancer. However, Ortiz recognizes this traditional

the US that want to enter Mexico and are taking the right

clinical research process completely changes when dealing

steps to perform trials for their products here. “Mexico

with biotechnological drugs. “Data collection becomes a

is one of the countries in Latin America that is trying to

new challenge when we need to consider more factors

speed the authorization process without cutting steps and

because any patient behavior can vary the molecule’s

reviews” although international companies are more open

effects. During regular clinical trials we have two patient

to these requirements.

groups to observe, now we have to control every patient separately,” she says.

“Biotechnology represents a strong commitment for us. What we are doing in research right now will show results in

Given the complexity of the trials and their cost,

10 years and all the data you are accumulating will probably

pharmacovigilance and techno-vigilance become a main

save lives,” Ortiz concludes.

167


VIEW FROM THE TOP

SUCCESSFUL RECRUITMENT FOR MORE SPECIALIZED STUDIES MELISSA ROSALES Director General of RM Pharma

168

Q: What advances has RM Pharma made in its operations

the profiles to see who has the best potential for the study

over the past year?

and we call them. We also advertise in newspapers and

A: Our main achievement over the last year was the

we hold talks with first-contact doctors to provide them

establishment of an alliance with Bio Clinica, an American

with information on new molecules and to see if they are

company, which enabled us to be part of a global network

interested in participating or in referring patients. For

of research sites focused on making clinical trials a success

pediatric studies, most of the recruitment is achieved by

and to diversify our activities in different therapeutic areas.

referral from specialists so we distribute brochures among pediatric associations, explaining the type of conditions

This year, we will launch a protocol for dyslipidemia that

we are looking for. It is hard to find the ideal patient for

could help prevent heart attacks, based on a new model

every study, which is why we have to work every day to

to reach a large number of participating patients. We are

expand our database.

also starting to work with children for a local allergic rhinitis study and with an international study on pediatric psoriasis.

Today, inclusion criteria is increasingly complicated, so when we need samples of 10 patients with certain

Q: How has the new pharmacovigilance NOM impacted

characteristics, we need to contact at least 300 patients

RM Pharma?

from our database because there will be criteria most

A: We are focused on pharmacovigilance follow-ups and we

of them do not meet. However, we always keep those

report side-effects and serious adverse events and submit

patients in the database and continue to perform follow-

real-time reports. We provide training to our doctoral staff

ups because we know that at some point they may be

on the normâ&#x20AC;&#x2122;s updates so they can be aware of patient

the patients we need for a study.

progress and report any changes to COFEPRIS. Q: What added value does RM Pharma bring to the health However, we will need at least another year to completely

industry over other companies?

integrate the norm, because we have to invest more in

A: Based on our client feedback, one of our values is the high

educating patients so they know there is a line they can

quality of data we provide to the industry, rapid recruitment

call if they have an unusual reaction and we need to train

and our high rates of patient retention in studies, which is

first-contact doctors and laboratory staff to register all the

around 93 percent. Some of our studies have lasted four

important data when patients call.

years and the patients are still participating. This is achieved through the quality of the medical service we provide and

Q: What strategy does RM Pharma employ to recruit

the experience of our doctors.

volunteers and how difficult is it to find the ideal patient for studies?

Q: What are your goals for 2017 and how will you reach them?

A: Our database grows mainly through references from

A: Our goal is to start providing more CRO services, such

existing patients. To keep them engaged we provide free

as monitoring of clinical studies, capturing electronic

check-ups. A specialist evaluates them and creates a

databases and protocol reporting. We will start reaching

patient profile, so when we start a new protocol we check

out to national labs that require more local studies, especially with the new pharmacovigilance norm. We have plans to open operations in Queretaro next year, a

RM Pharma is a Mexico City based CRO that performs

region that is growing rapidly due to the automotive and

clinical research in the fields of rheumatology, cardiology,

aerospace industries and we know there will be a need for

nutrition, pediatrics, endocrinology, otorhinolaryngology

more studies because national and international hospitals

and ophthalmology

are settling there.


VIEW FROM THE TOP

EXPOSURE NEEDED TO MAKE MEXICO A RESEARCH HUB KAREN HAHN Director of Clinical Trial Management for ICON

Q: What has shaped ICON’s evolution over the past year?

Q: What techniques can be applied to increase patient

A: It has been a successful year for the company. We

recruitment and take advantage of the possibilities offered

received recognition for the second time as the Best CRO

by the Mexican population?

at the Vaccine Industry Excellence Awards. Last year, we

A: We have a close relationship with patient-recruitment

invested a lot in recruiting the best professionals and

sites and provide quality training to professionals so they can

in having a bigger footprint for our private and public

understand their target population. We perform a close follow-

customers through our Vaccine Center of Excellence.

up and we ensure we choose the right sites through a site

Through this center, we lead research on vaccines for

selection system. There are many recruitment opportunities

infectious diseases and global pandemics. We also

across the country, so we are expanding to reach a population

received the Outstanding Partner Award from Amgen for

we could work with and which is not receiving treatment.

a Functional Service Provider partnership we established a year ago for global project management.

Q: Many people do not know the benefits of receiving treatment through a clinical study. How are you taking this

Q: What is Mexico’s role in ICON’s global operations?

message to more patients?

A: In Mexico, which is ICON’s biggest office in Latin

A: We are designing a campaign with ACROM to explain the

America, followed by Brazil and Argentina, we employ

benefits of clinical research to patients. A few years ago, we

211 people and have high growth expectations. However,

did this for doctors who were not aware of the benefits of

while Mexico and Latin America have a lot to offer, they

working in clinical research. ACROM also approaches many

lack exposure. The region represents just 6 percent of

patient associations to inform them about the research we

the global clinical research market, as attention is usually

want to conduct. The effort to recruit patients is shared

given to the US, Europe and Asia, but we are investing

among all players in the sector.

in strategies and working with associations such as ACROM, AMIIF and the Association of Clinical Research

Q: Where is technology development oriented at ICON?

Professionals (APEIC) to make us more visible to the

A: ICON is committed to developing technology for monitoring

rest of the world. Fortunately, the new administration

based on risk. Our goal is to reach real-time analysis of what is

in COFEPRIS is maintaining continuity, bringing in new

going on in each site, so we do not have to wait till the end of

and good ideas and they are studying models from other

the study to discover there were problems in measurements.

countries’ regulatory organisms to see what could be

Thanks to real-time analysis, we can assess trends and

useful for Mexico.

determine which resources each site needs.

Q: What is Mexico’s value proposition as a potential

Q: Which are the main therapeutic areas in Mexico that are

clinical research hub for international companies?

driving the efforts of CROs?

A: The IMSS now allows clinical studies, which will provide

A: There is a global focus on research in oncology and cardio-

great opportunities for the sector. The institution has a

metabolic areas. However, we are investing to gain terrain in

huge patient population and is also a good source of

late-phase studies through ICON’s new Commercialization

patients with rare diseases that are hard to find in other

and Outcome hub in Mexico.

institutions. In addition, Mexico has a lot of potential in pediatric clinical studies due to the large population of children and the good relationship between doctors

ICON is an international clinical research company founded in

and parents we have identified in previous recruitments.

Ireland in 1990 and present in 37 countries. It operates as an

Therefore, ICON has already developed expertise in

outsourced developer for the pharmaceutical, medical devices

pediatric studies.

and biotechnological industries

169


VIEW FROM THE TOP

AUTHORIZED THIRD PARTIES PROMOTING MEXICO’S RESEARCH POTENTIAL

Héctor Ávila Director General of Cecyc Pharma

170

Mezly Rodríguez Operations and Strategy Director of Cecyc Pharma

Diego Ávila Commercial Director of Cecyc Pharma

Q: What mix of drugs does Cecyc Pharma test?

NOM - 220 demanded pharmacovigilance and NOM - 177

DA: As an authorized third party for COFEPRIS we are

regulated bioequivalence. All three had a regulatory impact

focused on generics but we also test new combinations of

on manufacturing and commercializing drugs in Mexico.

drugs, which is becoming more common in the industry.

Cecyc Pharma is in the medical research area, in which we

We offer the pharmaceutical industry registry renewal

evaluate the efficiency of drugs. Laboratories may not have

and elaborate new registers with the development of

much clarity on the steps they have to follow or the type

bioavailability studies.

of studies they must undertake, especially now when there is a larger variety of studies available, so our mission is to

Q: What are the main regulatory issues companies

help them run the right study.

registering generics face and how are those overcome? MR: COFEPRIS has fixed the processes for each type of

Q: Do laboratories need more regulation or more clarity?

drug. We are a third party authorized by COFEPRIS and we

HA: The regulatory aspect is more than covered. When

are its experts on clinical research. The biggest challenge is

COFEPRIS was born, regulation became a headache for

when COFEPRIS regulation does not specify which study

many companies in the industry. However, because of

should be undertaken for a certain drug. That is where we

it, companies became better and Mexican laboratories

intervene and propose which study should be undertaken

gained the option to export because they complied with

to obtain registration. We mostly deal with generics but as

international regulations. Laboratories should make a

a research center we offer advice on other types of drugs

greater effort to adapt to the rules. Sometimes, it can be

like new registrations or combinations, anything that goes

complicated, but at Cecyc Pharma we keep in close contact

in a category that COFEPRIS has not yet determined.

with COFEPRIS to always propose the right study for each case. As an authorized third party, we help companies

HA: In 1998, the Mexican government launched a program

when they need regulatory advice, we become their

to create interchangeable generics. There was a great need

channel to register new drugs. We do the clinical research

in the healthcare sector for affordable and high-quality

that companies need to show COFEPRIS their products

drugs so the federal government started a drug evaluation

are safe and efficient. We are also in charge of dissolution

program and created NOM - 177 for bioequivalence tests.

profiles, clinical phases, protocol creation and analytical

In 2005, an agreement was reached to re-register all drugs

methodology. We specialized in this to offer our clients an

in Mexico. This forced laboratories to guarantee good

efficient solution.

practices and quality providers. Also, registered drugs that were not a reference product or an innovative drug

Q: Previously, a generic could rely on the safety and

had to comply with a bioequivalence test. From 2005

efficiency results of the innovative drug. Is this still the case?

there were also changes in the manufacturing practices:

MR: When a company develops an innovative drug, the

NOM - 059 made producers comply with new regulations,

drug must pass through the phases of medical research to prove safety and efficiency. What the Mexican authority asks of generics is that they prove their bioequivalence

Cecyc Pharma is an authorized third party located in Mexico

with the innovative drug. COFEPRIS asks the manufacturer

City. Its goal is to provide integral outsourcing solutions

for studies done on humans to see if the medicine is

and services to the pharmaceutical industry in the clinical,

absorbed and eliminated by the body in the same manner

analytical and regulatory areas

as the innovative drug. There is no need to do all the


phase studies. What has changed is that there are new

a clinical history and perform a checkup. If they have a

combinations between drugs that are not innovative and

condition like high cholesterol, we offer them treatment

drugs that already exist. We prove safety and efficiency

and a follow-up. By testing our volunteers we can also take

for drugs that already exist or we prove they do not

a look at the population in general.

interact between them. Q: Is it difficult to find healthy volunteers given the Q: How do you determine that two drugs are

burden of chronic diseases in Mexico?

bioequivalent?

HA: Yes, regularly many people come without antecedents

HA: It would be absurd for a national or international

but when tested we discover they sometimes have high

laboratory to repeat the preclinical test that the laboratory

cholesterol or conditions of this type. In those cases,

that approved the molecule already did. There is an efficient

we recommend a diet and ask them to come back at a

international scale to prove that a drug is as efficient as the

future date. For our studies, we interview around 2,500-

original. If I get the same profiles from a manufacturer, I

3,000 people and every year we can see by their studies

assume it will have the same effect. Bioequivalence proof

how the populationâ&#x20AC;&#x2122;s health has changed. The products

takes between five and eight months. All we do is reduce

we tested 10 years ago, now have a different impact on

it to a graphic. The graphic shows the relationship between

the population because people have also changed. It is

the time and quantity of absorption of the drug. With all

important to consider that the Mexican population has

those who participate we show a drug was absorbed in a

particular characteristics given the local diet. That is why

certain quantity in a certain amount of time. The product

COFEPRIS asks for tests for imported products to be

we are evaluating should behave similarly and within

performed on the Mexican population.

the parameters of 125-80. This is an internationally used number that determines if drugs work equally or not.

Q: What are your objectives for the next five years? DA: It is important to keep expanding our services. We are

Q: How do you recruit volunteers for testing, especially

always looking to give more to the industry and become

given advertising restrictions?

a unique company in the sector. We have authorizations

MR: We have a recruitment department in charge of

from COFEPRIS and the Institute of Public Health in

attracting people to participate in our studies and once they

Chile. They are for dissolution profiles, clinical units and

get involved, we follow their progress. All our trials must

clinical analysis. We also provide APIs for the industry,

be done on healthy volunteers because we need to start

pharmaceutical development and advisory, and we are

with a group of people who present similar characteristics

working with biotechnological companies. We have

but who have no illnesses that would influence the result.

clients in Chile, Colombia, Puerto Rico and the Dominican

Internally we have many filters to ensure they are healthy.

Republic. However, we want to work with more foreign

When testing physiotoxic drugs, those that are dangerous

companies that will soon arrive in Mexico because this

or affect health, volunteers should be patients suffering

is an interesting market for them. Also, we want to gain

from the illness the drug is designed to treat. We have

more certifications because it would allow us to reach

developed a database of volunteers who are constantly

more countries so our clients would be able to sell to more

participating. We perform lab tests on them, compile

countries with a single study.

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VIEW FROM THE TOP

TECH ADVANCES MAKE HEALTH INDUSTRY HIGHLY ATTRACTIVE Abel Hernández Director General of ANCE

172

Yoloxóchitl Macías Chief of Health Area of ANCE

Q: What percentage of ANCE’s activities is in the health

Q: How much does ANCE’s technology innovation

sector? Which segment offers the greatest potential?

center in Nuevo Leon contributes to the health sector?

AH: We are mainly focused on security and risk management

YM: We have experience in test laboratories and look

but our key operations are in electro-technology, which

forward to applying this experience to the health sector.

accounts for about 60 percent of our activities, while a

ANCE is defining which products will be the first to be

bit over 35 percent is in rational use of environmental

tested in our labs, because we expect significant growth

resources and 2.73 percent is in the food and the health

in validations, inspections and tests in Mexico and globally.

sectors. We entered the health industry with expertise on

By the end of 2017 ANCE will be performing lab tests for

intelligent regulation. The state must regulate the liberties

the food and health sectors.

of economic players – the possibilities for producers and the needs of consumers – in order to improve the

Q: What will be the focus for health innovations in the

quality of life of its citizens. Mexico is a big consumer of

coming years?

health products like medical devices and drugs. ANCE is

AH: Innovation for hospitals is directed toward intelligent,

betting on medicines because the growth of the health

interconnected medical devices that monitor vital signs,

industry is highly attractive in terms of technological

administer medicine or perform medical interventions. This

development. Moreover, Mexico’s quality of life is improving

is in line with a global trend called assisted life environment.

and the country is among the most attractive regarding its economic and social growth potential.

YM: Biotechnological products are going to be the medicine of the future. Pharmacogenetics will prevent diseases by

Q: Of the services ANCE offers, which attract the most

addressing genetic deficiencies that predispose people

demand?

to certain diseases. Nanotechnologies will also be an

YM: ANCE is an authorized third-party. Medical devices

important area. Small robots will target tumorous cells

represent the largest segment of our health market, about

and administer antitumor medicine directly instead of

80 percent of applications we receive. The most in-demand

administering it in general and damaging both the tumor

service is sanitary registration of innovative technologies.

and healthy cells as some oncologic medicines do.

Q: What benefits can ANCE offer its clients that other

Q: What is ANCE’s contribution to Mexico’s health industry?

authorized third-parties cannot?

AH: We attract attention to the required regulations.

AH: We focus on differentiating ourselves from our

Health is a dynamic sector with expected growth of

competitors through high-multidisciplinary expertise, as

50 percent between 2015 and 2020 in the pharma

multidisciplinary analyses can reduce response times while

segment. If COFEPRIS is saturated with requests for

increasing service effectiveness. Our value proposition

sanitary registrations as of 2017, it will be overwhelmed

is reliability, IT and institutional strength. ANCE also

by 2020. We are in an era of disruptive innovation

implements best practices regarding testing, inspection

and new technologies and developments will require

and certification from its experience with international

a flexible legal framework. ANCE is part of several

compliance-evaluation systems.

regulation and standardization associations such as the National Commission on Normalization (CNN) and the Normalization Commission of the Industry Chambers

ANCE is an association founded in 1992 that provides

Confederation (CONCAMIN). We try to make private

support by certifying industry standards and compliance with

initiatives more pro-active regarding the development of

regulations in industries such as automobile, energy, health

regulations. The private sector will be required to propose

and construction

solutions and options as COFEPRIS becomes inundated.


VIEW FROM THE TOP

DIVERSIFICATION KEY TO GROWTH CARLOS PÉREZ Director General of NYCE

Q: What aggregated value does NYCE offer that gives it a

while medicines were ignored. In 2015, we did not reach our

competitive advantage?

pharma goals. Therefore, in 2016 we changed our strategy

A: Third party organizations create standards for the

and focused on medicine rather than medical devices. It

industry. NYCE has an 18-year-old quality system that

was a challenging decision because drugs require much

relies on the constant improvement of our activities. In

more responsibility and capacity than the other business

our healthcare division, we have three elements to achieve

line. We are working with Pfizer and more organizations

this. First, our management system must control and define

are considering our services, mainly because we provide

metrics to improve our efficiency. Second, we have an

additional benefits. This has given us the opportunity to

internal program called Unifying Hands and Efforts through

register several specialized operating cells during 2016.

which collaborators suggest initiatives. Our third element is the satisfaction surveys we send to our clients, where we

Q: What does NYCE need from COFEPRIS to improve

measure market perception and receive feedback. These

its operations?

three improvement tools have helped us achieve an average

A: The creation of the authorized third party system was

of 97 percent customer satisfaction.

a great decision. The government’s acceptance that its internal structure could not deal with the volume of demand

All 330 of our staff members have been trained in client

was a good move. We have 22 years of experience as a

service. In fact, we trained COFEPRIS staff on the same

standardization organism, 21 as certification institution and

subject because it is one of our strengths. Our last COFEPRIS

20 as a verification unit. However, we recognize some third

audit was excellent, which motivated us to participate in the

parties are facing operational constraints. The new NOM-

National Quality Price. Those are elements that give us a

057 regulates the pharmaceutical industry but authorized

competitive advantage against other companies.

third parties are not allowed to provide certificates under this standard. NYCE is allowed to verify food content labels

Q: How can you improve processing efficiency for your

for the alimentary industry but is not authorized to verify

clients?

nutritional information, despite the fact that we operate

A: In January, we launched an online system to assist clients.

in the health industry. If we want integral solutions for the

We have already implemented electronic tools for many of the

market, we should be able to offer both services.

other industries we work with. In oil and gas, electronics and communications we have a secure online depository to protect

Q: What are NYCE’s plans for the near future?

information. If an industry accepts our security measures, a

A: We want to grow our market access by regionalizing our

confidentiality agreement and responsibility for information

services. We can help organizations export their products

management, companies will not have to be present physically

to other countries of the Pacific Alliance. Hypothetically

for every procedure they need. They will save time and money

speaking, if COFEPRIS closes an agreement with the

with us. We are an organism that certifies information security

regulatory authorities of the Pacific Alliance countries,

through ISO 2700. We are certifiers of personal data security,

authorized third parties would be able to provide services

giving us another competitive advantage.

to the whole region. It is an idea that may help many players in the system.

Q: What type of healthcare companies are you focused on certifying? A: When we first started our activities in healthcare, we

Normalización y Certificación Electrónica (NYCE) is an

noticed a large need for medical devices. We focused

authorized third party that certifies electronics, medical

on that but then we realized that the existing number of

devices, medicines, information security and food labels. It is

authorized third parties fully covered the devices sector,

looking to further expand its operations

173


VIEW FROM THE TOP

CHALLENGES, OPPORTUNITIES EMERGING IN BIOTECH SONIA PĂ&#x2030;REZ Executive Director of UDIBI

174

Q: What challenges in implementing the pharmacovigilance

NOMs and pharma regulation. To modify something, we have

NOM in biotech is UDIBI helping overcome?

to work from basic issues. Unfortunately, in Mexico science

A: The law in Mexico is not designed to provide security for

moves faster than law. Everything has to go through a legal

biotechnological drugs because it does not consider relevant

process in which the different chambers have to approve it

aspects related to their nature. The regulations demand

and by the time this happens, science has already moved on.

reports of adverse events but they do not control the post-

A few years ago, the concept of biotechnology did not even

marketing phase to prevent them from occurring. In biotech, it

exist in the law. It took us two years to establish NOM-177,

is necessary to know what happens when the drug reaches the

which is already obsolete. Trying to change it will take us two

open population because patients might present therapeutic

more years and by then it will be outdated. We have a real

failure or develop antibodies against the drug, which is

issue with this regulatory path because we cannot produce

not reversible. Once the organism has produced antidrug

guidelines easily. There is a group of researchers like me who

antibodies, the patient cannot take the drug or another related

are trying to speed up the process for updating guidelines.

drug because the antibodies would neutralize its effect. There

Usually, we follow what is already published by international

should be active vigilance in testing patients taking biotech

agencies such as the FDA and EMA, but sooner or later our

drugs, which would help pharmaceutical companies gauge

normativity must change because we operate differently

when to intervene or when to stop administrating the drug.

from other countries. The WHO is also asking for it and

This is a totally different concept to pharmacovigilance.

COFEPRIS is becoming a more concrete regulatory agency

Therefore, we must make recommendations to COFEPRIS

with a strong group of experts but we lack the dynamism

and other health institutions about the pharmacovigilance of

to improve it. Without clear guidance, we will have to check

proteins because it is conceptually different.

every case individually. If we do not have an established metric for evaluation, the process becomes complex.

Q: What more can regulators and companies do? A: Regulatory institutions and manufacturing companies

Q: What are your expectations for the future of biotech

should take greater responsibility. In other countries, regulatory

in Mexico?

agencies also monitor the market. They do not solely rely on

A: If we become more competitive, Mexico could be a

the information provided by manufacturers. They have fixed

reference for evaluation of biosimilars worldwide due to

verification measures, which is lacking in Mexico because

its geographic location and because many countries are

there is not enough infrastructure to handle the demand.

looking to access other markets. Furthermore, laboratories

Mexico also needs a more consolidated pharmacovigilance

like UDIBI could continue supporting the authorities since

culture. From the beginning of a drugâ&#x20AC;&#x2122;s life onward we should

they do not have the infrastructure required to evaluate new

be checking the patientâ&#x20AC;&#x2122;s reaction to the drug.

molecules. The knowledge we gather when we perform a detailed evaluation might be useful in developing innovative

Q: How can Mexico overcome its biotech development

molecules. Mexico has great potential, but our innovation

limitations?

system is not articulated. In other countries, the academy and

A: Our regulatory system is rigid, pyramidal and based on

the industry have been working hand in hand for years, while

the political constitution, the general health law, the ISOs,

in Mexico the science and technology law was implemented just last year. This will advance technology but laboratories like ours that already know the path of elemental testing must

The Unit for the Research and Development of Bioprocesses

provide an opening to innovative Mexican drugs. We will also

(UDIBI) is a part of the National School of Biological Sciences

start attending technology summits in the US because we are

of the National Polytechnial Institute (IPN) and is an authorized

now working with US companies that have reached out to us

third party

due to our high-quality service at lower costs.


VIEW FROM THE TOP

FINE-TUNING HEALTHCARE ANDRĂ&#x2030;S FERRARA Director General of Analitek

Q: Analitek has a national presence. What is the companyâ&#x20AC;&#x2122;s

create awareness about the creation of new calibration and

strategy to maintain, or even accelerate growth?

accreditation laboratories.

A: Internal growth occurred because our markets and territory were becoming saturated. We looked for new areas

Q: What ratio of sales in your biomedical business is destined

to work in such as life sciences, which is a much larger

for the public sector?

market. In the biomedical field, we want to be a company

A: We have only recently entered the biomedical business

that medical service providers can rely on, knowing that

in Mexico and we mostly cater to the private market. In the

their equipment functions properly and precisely. We

future, we will venture into the public sector to ensure growth

connect international manufacturers to national customers

because the public sector is the main client for these products.

and we offer services to ensure the products, equipment

In our analytical business, our sales are split 50/50, which

and instruments always provide the correct results. In this

is where we will probably end up in the biomedical market.

way, our clients can ensure their patients they are receiving medical services that will improve their health.

Q: What new areas will you look to expand to and what will be your focus in 2017?

All equipment requires a continuous maintenance program.

A: There is still a long way to go in Mexico in health and

This should happen several times per year, depending on

in the medical segment, so focusing new investment in

the piece of equipment. Through use and time, all analytical,

health and life sciences research makes good sense. It

electronic, mechanical and medical equipment may lose

fits with our mission to change and improve the world

their accuracy and calibration, which makes well-designed

through the work of our clients. When they reach their

maintenance programs a must.

goals, we have contributed to future generations having better care and quality of life. Perhaps we will expand

Q: To what extent do you have to convince clients that

our horizons to the north and to the south of Mexico, as

your products represent an investment rather than a cost?

we have done for analytics. In the medical area, I think

A: That is the challenge we face. I believe the authorities

we will first expand to the north of Mexico and then go

ensure that all clinics and hospitals are providing

nationwide. We are also opening an office in Texas for

services correctly. Our challenge is to help our clients

analytics and offer services in Central America.

appreciate that calibration and correct functioning is elemental in healthcare. In many cases, this makes the

Q: What is the impact of the security environment on your

difference between a patient being cured or not. Foreign

logistics operations?

companies develop the technology and the innovations,

A: Our logistics are specific, not massive, so we are little

new products, devices and treatments, but we ensure that

affected by insecurity. What may impact us is the coverage

in Mexico all these devices work at peak performance 100

of our clients in certain territories where we need to be more

percent of the time.

careful. What we need to look after most is not the products that we move, because those are unlikely to be impacted by

Q: Which norms regulate the calibration and maintenance

insecurity, but ensuring that our people can come and go

of devices in Mexico?

in safety. This impacts us a little, but it is not a major issue.

A: We are working with the authorities to elaborate such norms. Stricter regulations and control in this field would ensure better treatment for patients. We are participating

Analitek, founded in 1994 in Monterrey, supplies analytics

in forums and working with EMA and COFEPRIS regarding

solutions for a variety of industries including academia, life

the shaping of these norms. We are also working with the

sciences, pharmaceuticals, research and development and

Mexican Society for Biomedical Engineering (SOMIB) to

chemistry. It is further expanding into biomedics

175


ANALYSIS

AUTHORIZED THIRD PARTIES EASE REGISTRATION BACKLOG All drugs sold in Mexico must be tested by COFEPRIS, which

Tijuana, Nuevo Laredo and Matamoros,

led to a backlog that has since been solved by the creation of

according to ProMéxico. Investment in the

authorized third parties. This has helped the regulatory authority

pharmaceutical sector in the same period

speed up processes and clear the bottleneck for new products

almost doubled that at US$3.2 billion, according to government figures, and in

Only a few years ago, it could take up to two years for a

January 2017, COFEPRIS signed an agreement with industry

company to register a new drug product in Mexico. Today,

players hoping to boost investment in clinical research from

that wait time has been reduced to 20 business days.

under US$200 million to US$600 million per year in the

Behind this turnaround is a decision by COFEPRIS to allow

next two years.

private parties to do the leg work and put products on 176

a fast track to approval. These private parties, known as

According to a COFEPRIS 2014 press release, ATPs had

authorized third parties (ATPs), perform testing and grant

reduced authorization wait times from an average of two

acceptance of a certain category of product, although the

years to 20 business days. “The creation of the authorized

regulatory agency does reserve the right to reverse any

third-party system was a great decision. The fact that the

decision an ATP makes.

government accepted that its internal structure could not deal with the volume of demand was a good move,” says

“As an authorized third party, we help companies when

Carlos Pérez, Director General of NYCE, an authorized third

they need regulatory advice; we become their channel

party that works across sectors.

to register new drugs. We do the clinical research that companies need to show COFEPRIS their products are

To become an ATP, there must be no conflict of interest,

safe and efficient and we are also in charge of dissolution

the lab must have the technical, human, financial and

profiles, clinical phases, protocol creation and analytical

infrastructure capacity to carry out its function and comply

methodology,” says Héctor Ávila, Director General of

with the respective norms of the three classifications of

Cecyc Pharma, an authorized third-party in Mexico City

ATPs: testing laboratories (NMX-EC-17025-IMNC-2006),

that specializes in bioequivalence testing.

units of interchangeability and bio-comparability (NOM177-SSA1-1998), and verification units (NMX-EC-17020-

There are 122 authorized testing laboratories, 62 units of interchangeability and biocomparability and 26 verification units

IMNC-2000). As of May 2017, there are 122 authorized testing laboratories, 62 units of interchangeability and biocomparability and 26 verification units. Each authorization is valid for a period of two years and must then be renewed, ensuring standards are kept. In the first five months of 2017, four ATPs lost their status, which can be regained once conditions are met again. But challenges remain. As science and medicine advance,

The appearance of ATPs has helped to clear the backlog of

regulation sometimes struggles to keep up. “The biggest

pending authorizations. Products are now registered much

challenge is when COFEPRIS regulation does not specify

faster, albeit with the same level of security and testing

which study should be undertaken for a certain drug. That

before being allowed onto the market. The system has

is where we intervene and propose which study should be

been widely praised by industry insiders. “Speeding up

undertaken to obtain registration,” says Mezly Rodríguez,

processes through authorized third parties helped make

Operations and Strategy Director at Cecyc Pharma.

the regulatory procedures more efficient and thus increased the attractiveness of Mexico as an investment destination

The next step, many hope, is for other countries to recognize

for health,” says Geraldine Rangel, Director General of

Mexico’s authorized third parties to improve exporting

Healthlinks, a Mexican firm that provides market analysis

conditions to Central and South America. “Hypothetically

to companies wishing to enter Mexico.

speaking, if COFEPRIS closes an agreement with the regulatory authorities of the Pacific Alliance countries,

Between 2005 and 2014, US$1.7 billion was invested in

authorized third parties would be able to provide services

Mexico in the medical devices sector, mostly in Guadalajara,

to the whole region,” says NYCE’s Pérez.


ROUNDTABLE Mexico has a strategic geographical location, a large and diverse population and competitive operational costs — all the essential elements to become a global hub for clinical research. In addition, in early 2017, President Peña Nieto signed a collaboration agreement with IMSS, COFEPRIS, CANIFARMA, SAT, ANAFAM and AMIIF to promote the development of health research protocols. A greater appreciation of these tools could increase

WHAT MUST MEXICO DO TO BECOME A CLINICAL RESEARCH HUB?

national investment in research and attract international companies. Mexico Health Review spoke with three CROs about the best strategies that can help Mexico become an international hub for clinical research.

Mexico has strong potential to become a clinical research leader worldwide. We

177

have all the elements, such as population, disease profile, ensemble of trained investigators and the local representation of the international bio-pharmaceutical and CRO industries, as well as the support of COFEPRIS and the most recognized agencies worldwide. However, we need to assimilate all the elements together in the most synergistic manner to significantly elevate the total number of the active trials in the coming years. Research sites should orient their activities to quality and performance to attract more research projects. Mexico accounts for less than 1 percent of all clinical research worldwide, a very low rate compared

CIRO GARCÍA Director General of Accelerium Clinical Research

to other countries.

IMSS now allows clinical studies, which will provide great opportunities for the sector. The institution has a huge population of patients and is also a good source of patients with rare diseases that are hard to find in other institutions. In addition, Mexico has a lot of potential in pediatric clinical studies due to the large population of children and the good relationship between doctors and parents we have identified in previous recruitments. Therefore, ICON has already developed expertise in pediatric studies.We have a close relationship with patientrecruitment sites and provide quality training to professionals at each institution so they can understand their target population. We perform a close follow-up and

KAREN HAHN Director of Clinical Trial Management of ICON

we ensure we choose the right sites through a site selection system.

Mexico has long wait times, but not as long as other Latin American countries. In Mexico, in line with FDA rules, if an efficient rescue medicine is available, trials can be held with groups taking placebos. Mexico’s main obstacle was that it did not have access to public hospitals, whereas in 2016 and 2017 an agreement was reached with IMSS and COFEPRIS to open the doors to clinical research. The same will happen with ISSSTE and other public institutions. This dramatically increases our chances of recruiting patients. In 2016, 80 percent of trials were carried out in private institutions. We hope to attract more trials to Mexico, maintaining the amount carried out in the private sector but increasing the amount in the public sector to achieve a 50/50 balance.

ARTURO RODRÍGUEZ Director General of Infinite Clinical Research and President of ACROM


The Genium X3, developed for sporting activities


BIOELECTRONICS & BIOTECH

8

Imagine that after losing a limb, a patient is fitted with a prosthetic that can be moved at will. This is the magic that bioelectronics are bringing to the world. The future of health is now and the main challenge these companies will face is making their advanced technology available to the wider public. These advanced prosthetics will perform wonders but will be proportionally expensive and it is unlikely that public institutions will provide them to patients, especially in light of budget cuts. As new disease trends emerge, new vaccines also are needed. A dengue fever vaccine was released in Mexico in September 2016 and many companies are working on zika vaccines.

Another area explored in this chapter is stem cell procedures. Although they are still subject to case-by-case approval in Mexico, research is ongoing and is led by private companies who extract and store the cells for patients as a way of funding their R&D. Mexico is considered a regional hub for stem cell research as it is subject to less stricter regulations than its northern neighbor.

This chapter will feature interviews from these cutting-edge companies and will feature technology spotlights that highlight their state-of-the-art innovations.

179


CHAPTER 8: BIOELECTRONICS & BIOTECH 182

ANALYSIS: Medicine, Devices of the Future

184

VIEW FROM THE TOP: José Benziger, Ottobock Group

186

VIEW FROM THE TOP: Luis Bravo, Probionics

188

VIEW FROM THE TOP: Francisco Soberón, INMEGEN

189

ROUNDTABLE: What are the Most Relevant Applications for Stem Cells in Mexico?

190

VIEW FROM THE TOP: Jeimy Pedraza, Instituto Ingenes

191

VIEW FROM THE TOP: Martha Luna, RMA Mexico

192

EXPERT OPINION: Rosa María Del Ángel, CINVESTAV

Enrique Villegas, ABC Medical Center

194

VIEW FROM THE TOP: Francisco Kuri, Landsteiner Scientific

195

VIEW FROM THE TOP: Félix Scott, Sanofi

196

ANALYSIS: The Black Hole of Black Market Medicine

197

VIEW FROM THE TOP: Maarten Pouw, DSM Sinochem Pharmaceuticals

198

VIEW FROM THE TOP: Abraham Franklin, Grupo Franklin

199

VIEW FROM THE TOP: Jesús Esparragoza, Biostem Technologies

200

VIEW FROM THE TOP: Victor Saadia, Bioeden

201

ANALYSIS: The Rise of the Superbug

181


ANALYSIS

MEDICINE, DEVICES OF THE FUTURE Biotech and bioelectronics are at the forefront of medical

three diseases from the WHO 2017 priority list

innovation. Ranging from vaccines and stem cell research,

it considers could be the next epidemics: Lassa

to robotic limbs connected to the central nervous system,

fever, Middle East respiratory syndrome (MERS)

this is the medicine of the future

and the Nipah virus. According to clinicaltrials. gov, as of July 2017 there were two ongoing

Biotechnology, from the development of vaccines to the use

Lassa fever trials, 10 for MERS and one for the Nipah virus.

of stem cells, has opened a range of possibilities for medicine and health, including the use of genomics to pinpoint the

Stem cells are another promising area but here too, the

appropriate medicine for a particular disease and improving

segment is embroiled in controversy. Private companies

fertility or ensuring a baby does not suffer from a genetic

that extract and store stem cells for patients as a way of

condition. But strict regulations, high costs and even personal

funding their R&D are leading the way in research; however,

viewpoints stand in the way.

procedures are still subject to case-by-case approval in Mexico. Easier regulations than in the US have made the

182

Despite recent debate over the use of vaccinations, they

country a regional hub for this research for applications

remain among the most significant advances in preventive

as varied as preventing wrinkles and curing cancer. But

medicine of the past century and a half. As new disease trends

here too, outdated laws and lack of awareness despite

emerge, new vaccines are required. Inovio began trials for its

an abundance of information are keeping the sector from

second zika vaccine in June 2017, while Sanofi Pasteur with the

reaching 100 percent potential. “Processes are limited by

US Army; Fiocruz, Takeda and Moderna with Barda; and GSK

laws that are 10-15 years old and policymakers are slow to

with the NIH are working on their own vaccines for the virus.

react to innovation. Mexico is a pioneer in this area so there

A dengue fever vaccine was released in Mexico in September

are fewer countries to copy from and thus more fear, which is

2016, although it is only available privately in Mexico.

normal. This can be solved by reading scientific information, which is available for all, and there are many aspects that

"Mexico was the first country to register the dengue vaccine.

have already been tried and tested. It is a waste of time

We are leaders in emerging economies because we work to

and money to repeat those tests here, since that money

meet the specific needs of patients in those countries. Mexico

could be used for further research. Regulation of dental

played a key role in the investigation of the dengue vaccine

stem cells in particular is scarce and mesenchymal cell

because, among the 15 countries included in the research

regulation is tied to that of hematopoietic cells. COFEPRIS

program, it was one of only two countries, along with the

is conscious of these things and is moving forward. We are

Philippines, that participated in the phase I clinical studies.

not completely blocked by legislation,” says Victor Saadia,

That is why Mexico became the first country to obtain the

CEO and Founder of Bioeden Mexico and LATAM and CCO

sanitary registry: it was a collaborative approach with the

Bioeden USA, a company dedicated to stem cell research.

country’s health institutions that allowed us to establish the necessary processes to comply with the many strict

Like stem cells, fertility procedures are the subject of debate:

requirements of the authorities and to provide them with

for some, these procedures go against God’s will or interfere

solid local data. It was not an easy process but it was also

with nature, while for others they represent hope, either to

the first time that COFEPRIS had certified a new vaccine

conceive or to do so without passing on a genetic condition.

before agencies such as the FDA and the EMA," says Félix

Mexico offers state-of-the-art technology in this field, with

Scott, Director General and Country Chair of Sanofi. "We are

some clinics such as RMA Mexico working closely with the

developing research within our global operations for other

US. Research and Markets puts infertility and obesity as the

vaccines, including one for zika. We have a collaboration

main factors driving demand globally.

agreement with the US Army to conduct research into this type of infection and we believe we are in the best position

In addition, genomic or precision medicine was pegged as

to achieve a fast and efficient solution for zika after our

a global medical technology trend for 2017 by the World

experience with the dengue vaccine. We must apply this

Economic Forum. Markets and Markets estimated the value

know-how to achieve answers as soon as possible."

of the global genomics market at US$12.5 billion in 2015 and expects it to hit US$20 billion by 2020. Mexico’s public

Unfortunately, these medicines take years to develop. In an

institute dedicated to genomics, INMEGEN, is collaborating

attempt to pre-empt the lag between the emergence of an

with international institutions to advance science and with

epidemic and the development of a vaccine, the Coalition

government-owned oil giant PEMEX, that provides health

for Epidemic Preparedness Innovations (CEPI) has selected

services to its workers, to begin implementing precision


such as Mexican company Landsteiner Scientific. “We have

WHO 2017 PRIORITY PATHOGENS LIST FOR R&D OF NEW ANTIBIOTICS

recently opened a new platform in genomic medicine focused

PRIORITY 1: CRITICAL

medicine. Private companies are also working in this area

on oncology. Landsteiner is starting with colon cancer, a

1. Acinetobacter baumannii, carbapenem-resistant

common disease among men in Mexico and the US,” says its

2. Pseudomonas aeruginosa, carbapenem-resistant

Vice President, Francisco Kuri. “The genetic information of

3. Enterobacteriaceae, carbapenem-resistant, ESBL-producing

a population is used to identify genetic traits that can help either control or cure the prevalent diseases. Our industry evolved into personalized medicine but now the discourse has evolved into precision medicine. We know that some drugs do not work equally well in different populations. Genomic

PRIORITY 2: HIGH 4. Enterococcus faecium, vancomycin-resistant

medicine could show what medicines work best according

5. Staphylococcus aureus, methicillin-resistant, vancomycin-intermediate and resistant

to common Mexican genetic traits.”

6. Helicobacter pylori, clarithromycin-resistant 7. C ampylobacter spp., fluoroquinolone-resistant

Imagine that after losing a limb, a patient is fitted with a prosthetic that can be moved at will. This is the technology

8. Salmonellae, fluoroquinolone-resistant 9. Neisseria gonorrhoeae, cephalosporin-resistant, fluoroquinolone-resistant 183

that bioelectronics wants bring to the world. Probionics, the first Mexican company to build prosthetics, is seeking

PRIORITY 3: MEDIUM

approval for its upper artificial limbs that use myoelectric

1.

Streptococcus pneumoniae, penicillin-nonsusceptible

control movement. Össur, an Icelandic company, is working

2.

Haemophilus influenzae, ampicillin-resistant

on developing upper and lower limb prosthetics that connect

3.

Shigella spp., fluoroquinolone-resistant

technology to detect a pulse through the chest muscles to

to nerve endings and thus the brain. “Bionic products are intelligent pieces with microprocessors. In the case of knees, the microprocessors communicate with ankles and feet, so if the patient trips, the knee locks, preventing the patient from falling. This is automatic once a sudden movement is detected. Our most advanced hands are the Michelangelo hands. They have sensors so that when grabbing a cup, the hand grasps with the correct amount of strength not to break it and not spill the contents. If the cup is made of glass, the hand will not shatter it, if the cup is made of plastic, the hand will not squeeze it so hard that it distorts and the contents spill down the sides. It also has a rotating wrist like a real hand,” says José Benzinger, Director General of German market-leader Ottobock. Analysts at Future Market Insights

REVISED LIST OF PRIORITY DISEASES, JANUARY 2017 • Arenaviral hemorrhagic fevers (including Lassa fever) • Crimean Congo haemorrhagic fever (CCHF) • Filoviral diseases (including Ebola and Marburg) • Middle East respiratory syndrome coronavirus (MERS-CoV)

• Other highly pathogenic coronaviral diseases (such as severe acute respiratory syndrome (SARS) • Nipah and related henipaviral diseases • Rift Valley fever (RVF) • Severe fever with thrombocytopenia syndrome (SFTS) • Zika

Source: WHO

Intro Chapeter 8

THE GLOBAL BIOPHARMACEUTICAL MARKET (percent)

pegged the value of the global orthopedic prosthetics market at US$1.6 billion in 2015, 56 percent of which is lowerextremity prosthetics. Amputations caused by diabetes in Mexico are also increasing the need for prosthetics. “In 2017, emphasis should be placed on the prevention of diabetes and its complications. Data from [ENSANUT 2016] show there has been a 175 percent increase in diabetic foot amputations,” says José Campillo, Executive President of FUNSALUD, a private foundation dedicated to improving community health. The future of health is now and the main challenge these companies will face is making their advanced technology available to the wider public, as Benzinger notes. “As we are a cost-sensitive market, price is an issue for bionics in Mexico. Most private insurance companies may cover these types of products if specified but the majority of patients pay outof-pocket. Their cost means they are only available to some segments of the population.”

„„37.32 Monoclonal

„„2.39 Recombinant

„„21.37 Synthetic

„„2.32 Purified proteins „„0.48 Recombinant

antibodies

immunomodulators

„„20.06 Vaccines „„0.59 Recombinant growth factors

Source: Mordor Intelligence 2015

enzymes

proteins

„„0.12 Others


VIEW FROM THE TOP

PROCEDURE, NOT BRAND, THE ISSUE FOR PROSTHETICS JOSÉ BENZIGER Commercial Director for Mexico and the Caribbean of Ottobock Group

184

Q: What is the current size of the Mexican prosthetics

our main concern because there is no established regulation

market and what is Ottobock’s share?

for importing and selling. COFEPRIS regulations for our

A: Our prosthetics division is our core business worldwide

medical devices are not excessively complex; we need only

and also has the most sales in Mexico. Eighty percent

give notice of import and commercialization. We do not

of our sales are basic products. Diabetes is prominent

need to do any further studies or background checks and

in Mexico and as a result, lower limbs are the most

it is relatively easy to import both high-quality and low-

common amputations. According to the Mexican Diabetes

quality products.

Association, about 75,000 amputations are performed each year because of this condition. Of those, 90 percent are

Our customers have established statu quo operations, but

lower limbs, so foot, below the knee and above the knee

they are also facing other competitors arriving from China

prosthetics are the most commonly required.

that say they can implant at a lower cost. This threatens the credibility of the procedure, not the brand. Many patients

It is difficult to approximate our market share but based

say they do not want a prosthetic because they think it

on the number of tenders we have won and our B2B, we

hurts, or because they think they will not be able to use

estimate it to be 45-50 percent. Of the total number of

them or walk. This reputation emerged due to the bad

amputees in Mexico, we estimate that 7-10 percent receive

experiences some have had with low-quality products.

a prosthetic. Of those, only three quarters will continue to use the prosthetic. The other quarter stops because the

Q: What are Ottobock group’s protocols for rehabiliation?

prosthetic is badly made and causes the patient pain.

A: The protocol we are trying to build handles three rehabilitation schemes: preprosthetic, postprosthetic and

Q: What is Ottobock Group’s relationship with the public

using the limb with the prosthetic. None of these happen in

and private sectors?

reality. When a patient requires an amputation, the patient

A: We participate in both tenders and direct purchases with

is taught to bandage the remains and it is important for

the government. In addition, we support our customers that

the limb to gain form and then start the prosthetic process.

participate in tenders. We do not sell directly to patients

After amputation, the greatest challenge a patient will

in the private sector. The company has a B2B segment

face is the size of the remaining limb as it swells and then

through which we sell to orthotic and prosthetic stores that

reduces but once the rehabilitation process begins it will

in turn sell to patients. We also sell to private insurance

swell again and then reduce to its final size.

companies and thus patients. Generally, 90 percent of our business is B2B. When we win a tender, we provide

We first work on the socket. We create a test socket,

education to the institutions and ensure continuous visits

which is what the patient will use while they get their limb.

to revise the process. Twice a year, and we hold an event

After 30 to 60 days the socket is resized because the limb

with staff and experts from Germany, the US and Brazil to

changes and an oversized socket will cause injury. The

teach new techniques and revise current techniques. We

socket needs to be checked every year. The patient should

visit most of our customers at least twice a year.

go to rehabilitation but usually they do five to 10 sessions and then are left to their own devices.

Q: What hurdles do your products face in the Mexican market and how can that be overcome?

High-tech bionic prosthetics need yearly maintenance and

A: The public market is price sensitive and our competitors

checkups because they have microprocessors and software

from South Korea and China have lower manufacturing

that need upgrading to function fully. Depending on the

costs and quality. Although some purchasers from public

type of prosthetic, necessary maintenance can vary. The

tenders can relate to quality, most relate to price. This is

basic mechanical leg is the most common in Mexico. These


The Genium X3 being used in water

185

are low maintenance, with a lifespan of five to 10 years.

by an orthopedist, an endocrinologist, a vascular surgeon

Maintenance is required only every two to three years

and a psychologist, which is what usually happens in other

because they are sturdy.

parts of the world. In Mexico, the approach is separate. A knowledgeable patient may go to the orthopedist or the

Q: What advantages do bionics have and what are your

vascular surgeon by themselves but they are not sent there.

top products in this area?

Our growth would be based on getting these physicians to

A: Bionic products are intelligent pieces with microprocessors.

agree on a protocol for patients facing amputation.

In the case of knees, the microprocessors communicate with ankles and feet, so if the patient trips, the knee locks,

The actual amputation is usually performed by a surgeon

preventing the patient from falling. This is automatic once a

or an orthopedist. Afterward, nothing happens. In the US,

sudden movement is detected. Our most advanced hands

the following day a prosthetics team is sent to evaluate

are the Michelangelo hands. They have sensors so that when

the patient. It may not result in an immediate prosthetic

grabbing a cup, the hand grasps with the correct amount

but psychologically the patient experiences a 180-degree

of strength not to break it and not spill the contents. If the

turnaround in mindset, instead of having them wake up

cup is made of glass, the hand will not shatter it, if the cup

every morning with only half a limb.

is made of plastic, the hand will not squeeze it so hard that it distorts and the contents spill down the sides. It also has

Q: What other challenges does Ottobock face here?

a rotating wrist like a real hand. The Michelangelo hand and

A: Budget is the greatest challenge because institutions have

the X3 knee are the most technologically advanced pieces.

limited funds for prosthetics. Those that offer them are social

The X3 knee was developed alongside US Navy Seals and

security, Integral Family Development (DIF), the military

it is the knee they use to return to active duty after injury.

hospital and PEMEX in some cases. Many people go to the National Institute of Rehabilitation (INR), which also operates

As we are a cost-sensitive market, price is an issue for

on a limited budget. The foremost solution is for the public

bionics in Mexico. Most private insurance companies may

health system to realize that diabetes is a public health issue

cover these types of products if specified but the majority

in Mexico, so complications of that issue are going to arise in

of patients pay out of pocket. Their cost means they are

the near and not-so-distant future. If they ignore this, it will

only available to some segments of the population.

bite back later. If those 75,000 yearly diabetes amputees are to have a productive return to working life, the system will

Q: What is your growth strategy for Mexico?

have to invest in their treatments.

A: We decided on a basic approach. We need to create protocols that get patients to institutions and help them receive a prosthetic limb. There is a lack of awareness

The Ottobock group consists of four units, including Otto Bock

on the part of patients about how to get a prosthetic. A

HealthCare (medical technology). The prosthetics division is the

diabetic patient, for example, is handled by a doctor or an

largest business unit of Otto Bock HealthCare GmbH, which has

endocrinologist. A lower limb complication should be treated

distribution and service companies in 50 countries


VIEW FROM THE TOP

MYOELECTRIC TECHNOLOGY: THE NEXT STEP FOR PROSTHETICS LUIS BRAVO Director General of Probionics

Q: Which of your products represent the biggest

information to COFEPRIS and now it has to work on it and

opportunity for Probionics?

request more information from us if needed.

A: We founded the company in 2006 with a core R&D 186

business in prosthetics for amputees. We began by developing

Q: When do you think you will have this certification?

technology for a prosthetic hand, then a wrist, a forearm and

A: We need to have a facility with certain characteristics.

then an elbow and a shoulder. We have modified the electronic

The entire production line must be certified by a NOM or an

base of the device and we work with myoelectric technology,

ISO and we need an operations manual. Therefore, once the

an electronic principle that registers the electric flow of the

plant is ready, the auditors will evaluate it and then it takes

skin when the patient contracts a muscle. This electric signal

from eight to 12 months to get the certification. During

goes into an electronic chip, on which we perform a procedure

this time, we need to prove to them that we can produce

to digitalize it, making the muscle the control tool for the

without selling, so it is our responsibility to assume the

patient. We also make rechargeable batteries with a biological

cost of salaries, services and manufacturing for a year with

shape that powers the whole system. We now have a mature

no income. It is incomprehensible that COFEPRIS would

technology that we are working to commercialize. However,

evaluate our production without allowing us to sell.

our products are medical devices that require COFEPRIS certification, which is proving to be complicated because

Q: What are you doing to raise money?

there is no Mexican law regulating this type of device. We

A: We have been to different forums and our project has

are the first Mexican company doing it and are seeking

garnered acclaim for its technological and social impact.

classification for these products.

However, investors do not know the market and they would rather invest in cheap, crude products. Our investors will not

Q: What are you doing to help COFEPRIS establish a

help us until we are certified by COFEPRIS because they are

regulation and reach the next step?

afraid of the risks this business might imply. We appeared

A: We submitted a petition for classification, requesting that

on Shark Tank Mexico in March 2016 and our project raised

COFEPRIS inform us which classification for medical devices is

US$1 million, the most money of the season. Nonetheless,

right for our products because medical devices worldwide are

the money will be handed over upon meeting the conditions

usually classified into three categories based on the risk they

for COFEPRIS certification.

represent for health. Class 1 is a device that is worn outside the body; class 2 is for mechanisms that penetrate the body

Q: What are the biggest technological challenges you face

for a short period, like a catheter, and class 3 are devices

when designing and manufacturing prosthetics?

that penetrate the body long term, like a hip prosthetic. Our

A: Patients have different degrees of injury. There are patients

devices are class 1 because the prosthetics are external and

who have had a wrist amputation while others are at the

the patient can remove them at will.

middle of the forearm or at the shoulder. Therefore, the key was designing flexible technology that could adapt by

We are cooperating with COFEPRIS by providing a detailed

units like Lego pieces to give each patient the module he

description of the materials that make up the product, the

or she requires. It took us four to five years to understand

way the materials are handled when transformed from

this because we started working on a fixed model and had

raw material to prosthetic and on how the prosthetic is

to adapt to each patient. We had to do a complete redesign

activated. One of our main obstacles is that our prosthetics

and we came up with a modular prosthetic model. Thanks

work with a battery and an electron that registers the

to this technology, we will go to market with 34 products, 17

bodyâ&#x20AC;&#x2122;s pulse and COFEPRIS does not regulate this

modules for the right arm and 17 for the left. Additionally, we

directly. The electric and electronic part of the prosthetic

are working on developing prosthetics for children using the

arm is already certified by NYCE. We have presented the

same technology and modules on a smaller scale.


In 2015 we began developing fingers. We believe it will be

they do not have the money to pay for European prosthetics.

easier getting this product to market because globally, fingers

Besides innovating in technology, we will innovate in a

are the most frequently amputated limbs. At Probionics, the

business model that will allow us to sell prosthetics with

amputations we more frequently see are the arms or hands

deferred payments. The prosthesis will be programmed to

of employees who have suffered work-related accidents

power down if the monthly payment is not received. This

or people who were in car accidents. However, finger

will help us give clients easier access to prosthetics.

amputations are the most common because they do not only happen to workers but are also caused by domestic accidents. Q: How and who do you plan to sell and distribute your products to? A: Patients come to us and we manufacture the prosthetic. We work with an orthopedist who creates the mold from the patient so we can provide personalized prosthetics. We

NUMBER OF ORTHOPEDIC TECHNOLOGY CLINICS AND NUMBER OF ORTHOPEDIC TECHNOLOGY WORKSHOPS PER STATE CLINICS/WORKSHOPS Aguascalientes Baja California Baja California South Campeche Coahuila

manufacture the device and train the patient on how to use

Colima

it but when we get into the market we will focus on R&D

Chiapas

and will have a division that manufactures the products and delivers them to our clients. We will reach the public sector by competing in government tenders and the private

Chihuahua

187

Durango Guanajuato Guerrero

through partnerships with select orthopedic houses.

Hidalgo Jalisco

We have six patents: two in Europe, two in the US, one in Mexico and one in South America. This is very important

Mexico City Michoacan Morelos

because it is a negotiation tool we have with the investors.

Nayarit

We have 20 years of exclusivity and commercial exploitation.

Nuevo Leon

We obtained our first patent in 2011 so we still have time.

Oaxaca

However, there are countries that take longer than others. The US issued a patent within four years and, although we

Puebla Queretaro Quintana Roo

simultaneously asked for the same patent in Brazil, we are

San Luis Potosi

still waiting. However, it is important for us to enter the

Sinaloa Sonora

Brazilian market because it has one of the highest industry indexes among South American countries. There is a direct correlation between industry and working accidents. Producing prosthetics is not just about being a design

State of Mexico Tabasco Tamaulipas Tlaxcala

engineer, we have to look at patents, read about state-of-

Veracruz Yucatan

the-art technology, raise capital and comply with regulations.

Zacatecas 0

Q: What are your expansion plans?

2

4

6

8

10

A: We have offers from orthopedic houses in South America, the US and Germany. I think we will start with South America because COFEPRIS approval is valid in those markets. However, to enter the US we need an equivalency with the FDA and for European markets we need one with the European Commission. Q: What will your strategy be to compete with international companies? A: We are going to compete with a good product that

3.5

million people in Mexico have mobility issues

2,000

the approximate number of prosthetics/orthotic clinicians in Mexico

Source: US Aid 2015

meets the quality expectations of an amputee. Also, we will compete on price. American and European prosthetics are very expensive. An upper-elbow prosthetic in the US

Probionics is a Mexican startup founded in 2006 that designs,

costs US$150,000 and very few people have that amount

produces and commercializes prosthetics. Originally starting

of money. There are Syrian refugees entering Europe with

with hands, it has moved up the upper limb to the shoulder and

missing arms and legs. They represent a large market but

uses myoelectric technology


VIEW FROM THE TOP

MEXICO, WORLD LEADER IN GENOMICS FRANCISCO SOBERÓN Director General of INMEGEN

188

Q: How effective would a 4P (prevention, prediction,

medicine will increase drug effectiveness and reduce adverse

personalization and participation) approach be in Mexico,

effects. Soon, when a novel or unusual drug is prescribed or

where prevention is so low?

a person is born, a pharmacogenetics test will be performed

A: Prevention should be analyzed not only through old

and a patient’s genetic profile will last forever.

paradigms but by thinking through new ones. Prediction, the second of the 4Ps, is weaker when based on general

Q: Can INMEGEN train medical professionals in genomic

recommendations rather than personalized predictions

medicine?

generated from genetic traits, the third P. The fourth of

A: The researchers of INMEGEN are both generating

the 4Ps is participation. It is also necessary to consider

knowledge and involved in educational programs. We

the role of insurance companies. Imagine them inserting

offer between four and five courses each semester for both

themselves into personalized medicine and prevention,

graduate studies and as continuous education. INMEGEN is

managing differentiated premium costs and even complete

also putting the final touches on plans for an integral course

health-service provision systems not based on the scheme

in genomic medicine and a series of specialized modules

of a hospital for sick people but based on health-promotion

on the applications of genomic medicine and is involved in

systems entailing some elements of precision medicine.

some undergraduate courses with the School of Medicine

Detection and analysis methods of personalized medicine

at UNAM, but they are insufficient. An obstacle we face is

will be decreasingly invasive and increasingly automatic. This

that specialists cannot do their main residence in genomic

transition will be a matter of lustrums, not even decades.

medicine. Physicians must conclude their main residence before moving on to study an advanced course in genomic

Q: What obstacles stand in front of this transformation?

medicine at INMEGEN. Since INMEGEN cannot offer

A: There is a technological barrier. Technologies and

scholarships at that level, students who take that course

knowledge must mature and be applied. The lag is not often

are usually specialized physicians with a solid income.

in technological advancement, but in the application of molecular diagnoses. There is a regulatory barrier too. The

Q: What are INMEGEN’s priorities for the next two years?

FDA now will no longer approve the use of drugs for cancer

A: Continuing and finishing the characterization of Mexican

exclusively in the original organ but in any cancerous organ

genetic diversity, applying this knowledge to the most

with the same gene as an impeller, which is a complete change

advanced areas of genomic medicine and finding more

because now the basis for cancer treatment is not the organ

correlations between genes and diseases, especially

but a biomarker indicative of several cancers. In Mexico, where

chronic diseases. INMEGEN has a joint project with PEMEX’s

physicians prescribe more freely, physicians use molecular

health services to develop a series of precision-medicine

diagnosis to prescribe for a cancer in another organ. There

services and to study rare, psychiatric and metabolic

is also a cultural barrier because health professionals have

diseases. INMEGEN will correlate genetic parameters with

not yet assimilated genomic medicine and medical faculties

these diseases in the areas of pharmacogenomics and

still follow study programs that lack a genomic medicine

predisposition diagnoses to create prevention programs.

component. With cancer, it is impossible for an oncologist

INMEGEN’s Genomic Diagnosis Laboratory will continue

to ignore genomic issues. In pharmacogenomics, precision

offering a series of genetic tests, including an advanced version of genomic molecular cancer tests. There will be an incursion in the area of infectious disease through research

The National Institute of Genomic Medicine (INMEGEN) is

and data collection of common diseases constituting public

a institute belonging to the Ministry of Health. It is in charge

health issues. INMEGEN expects to provide specific services

of developing projects of genomic medicine for the Mexican

in the most mature areas of genomic medicine: cancer,

population based on its genome

pharmacogenomics and infectious disease.


ROUNDTABLE Hailed by some as a wonder-cure, shunned by others due to ethical concerns, stem cells and their research applications are subject to great debate across the globe. In Mexico, practical applications for stem cells are still granted on a case-by-case basis by the authorities. During the wait for regulation to change, companies are researching potential applications that could be commercialized at a later date. Mexico Health Review asked industry players to explain which potential applications they are researching and foresee for the Mexican market.

WHAT ARE THE MOST RELEVANT APPLICATIONS FOR STEM CELLS IN MEXICO?

The potential applications are still being researched, but in Mexico they have mostly been 189

used for orthopedics, lesions in articulations such as the knee, hip and shoulder or for diabetes. We are running an interesting protocol on autism and stem cells also can be used for neuro-degenerative diseases such as Parkinson’s. There are also intravenous applications to help regenerate tissues and cells, as stem cells have anti-aging properties that are popular with athletes. Stem cells help our cells regenerate. The next five years will be very interesting. Legislation has to change and if the authorities understand that Mexico could become one of the most innovative and leading countries in the area we could make rapid advances. Regulation would need to be more flexible to allow R&D, because in other countries much of the R&D is financed through bursaries and the

VICTOR SAADIA CEO and Founder of Bioeden Mexico and LATAM and CCO of Bioeden USA

academic world. We are limited in this regard in Mexico.

Some studies on spine lesions have provided positive results on the implantation of stem cells in comparison to cases where none were applied. Thus, patients prefer to use these products with the expectation that they may work. This treatment can also be used to treat T1D, which involves an inflammatory process that damages the pancreas. The application of stem cells in this situation can help partially revert the damage to the pancreas and reduce the amount of insulin that a patient will require. These cells are injected in the pancreatic artery to slow down the inflammatory processes. It is theorized that applying them even earlier would even have a better result. However, there are no indications that this treatment is useful for T2D as this is not an inflammatory process

JESÚS ESPARRAGOZA Director of Biostem Technologies Mexico

but a degenerative one. T2D must be handled through a multidisciplinary approach that involves the government, health systems, schools and families.

We are developing cardiac cells for regenerative medicine and working with 3-D printing to replace foot bones. We can print skin for burns and produce cells for laboratory tests, thus avoiding animal testing. Additionally, our experts are developing beta pancreatic cells that produce insulin, taking steps toward treating T1D. Also, we are trying to help people who suffer from macular edema and retinitis pigmentosa by producing cells found in the eye’s rods and cones. From MSC, we can fabricate fibroblast to produce a serum that helps reduce wrinkles and our partners in Spain have already treated 20 patients, 18 of which saw positive results. MSC also have immunomodulating properties, meaning the cells can reduce inflammation and rejection rates. We injected MSC into eight paralyzed rats and after six weeks four started walking again. Parkinson’s and Alzheimer’s are other diseases we want to treat.

ABRAHAM FRANKLIN Director General of Grupo Franklin


VIEW FROM THE TOP

ACCESS TO FERTILITY SOLUTIONS JEIMY PEDRAZA Laboratory Director of Instituto Ingenes

190

Q: What are the main fertility issues in Mexico?

Q: What is your client profile and which services do they

A: Approximately, 15 percent of the Mexican population has

require the most?

fertility issues. Among the infertile population, we include

A: Most of our patients are infertile women with a history

couples who have tried for one year to conceive a baby

of failed treatments in other centers and older patients

through sexual relations without success. Fifty percent

that seek for our services not only due to their difficulty

of the causes of infertility among couples are due to the

to conceive, but because they want to avoid the risk of

woman, 30 percent are related to the man and 20 percent

having a baby with a genetic disease. We also help couples

are a result of combined factors between the two. Among

who are not sterile but who want their baby to be of a

women, polycistic ovary syndrome (PCOS) is the leading

certain gender to create a gender balance in their family.

cause, which is common in Mexican women due to genetic

Instituto Ingenes also provides solutions for people who

or environmental factors. It expressed with irregular cycles,

want to preserve their fertility and choose to store their

propensity to overweight and obesity and it is associated

eggs or sperm. Currently, Ingenes develops around 4,000

to diabetes and cardiovascular diseases. The second most

treatments in its plant of Santa Fe, in Mexico City; however,

common cause is endometriosis and the third is infertility

we also offer integral solutions in our sites of Guadalajara,

caused by age. Other women look for our solutions because

Monterrey and Merida. Our goal is to establish more offices,

they have previously undergone a tube ligation surgery

so we can reach the entire the Mexican population.

and wish to have children afterwards. As for men, the main causes of infertility are genetic conditions such as

Q: Fertility solutions are luxury procedures. What can be

Klinefelter syndrome, testicular cancer and environmental

done to make them available for more people?

factors such as tobacco, drug and alcohol use or high

A: There is not much public health investment in fertility

exposure to radiation or chemicals.

and what is available is not very complex. The technology in the public sector does not compare to that offered by a

Q: What is Ingenesâ&#x20AC;&#x2122; added value compared to other clinics?

private institution. Fertility treatments might seem expensive

A: Any laboratory can buy technology, but without

but you have to put in perspective all the investment in

adequate experience investment means nothing. Through

infrastructure, technology and human capital behind these

the correct education of our staff, we will be able to acquire

types of services. At Ingenes, we offer a variety of financial

the technology and provide professional expertise. We

options to patients. One is BEC Facil, in which the patient

are always looking to participate in international-learning

first pay only part of the program, while we prepare the

opportunities and every year we are seek to be audit by

embryos to avoid any further problems associated to the

international entities, one of the experts that audit us is Dr.

maternal age during that time. When the patient has the

Juergen Liberman, director of the Fertility Center of Illinois.

economic resources to pay for the rest of the program we

We invest a lot in infrastructure, technology and training

proceed to transfer the embryos that were previously saved.

to prepare the best specialists in assisted reproduction, to

We also have a category of product called BEC Plus, insured

provide the best services in all of our branches and we

programs that were to guarantee that if the couple or patient

follow strict security measures regarding the protection of

is not able to get pregnant, we return the investment.

the identity of the gametes and embryos for our patients. Q: What would be the right preventive approach? A: Delayed maternity is among the most important factors Instituto Ingenes is a fertility center providing services in assisted

affecting the fertility of women due to the deterioration of

reproduction in Mexico through in vitro fertilization, gametes

eggs caused by age. Therefore, we must raise awareness

preservation and egg and sperm donation bank. It has clinics in

and inform women about the existence of technologies that

Mexico City, Guadalajara, MĂŠrida and Monterrey

help them prevent the aging of their gametes.


VIEW FROM THE TOP

BRINGING HOPE TO THE FIGHT AGAINST GENETIC DISEASES MARTHA LUNA Co-Director of RMA Mexico

Q: What are the main trends you see in Mexico in infertility?

a mutation onto their offspring. Being a silent carrier for

A: During the past couple of decades, there has been a clear

these mutations means that the given disease will never

increase in the mean age of patients who undergo fertility

develop; however, this person can pass on the mutation

treatments worldwide and Mexico is no exception. Age is one

to the next generation. If it turns out that the partner is

of the most important variables associated with prognosis and

also a carrier for the same mutation, then the couple will

outcome. As women age, there is a significant decline in the

have a 25 percent chance of having an affected child if

number and in the quality of the oocytes or eggs found within

the offspring inherits both mutations. This same couple

the ovary. We need to keep in mind that women are born with

will have a 50 percent chance of having carrier offspring

an established number of oocytes and that there is a constant

and a 25 percent chance having a mutation-free child.

loss and programmed cell death of these eggs that begins before birth and continues until the end of the reproductive

We use a genetics laboratory in Mount Sinai Medical Center

lifespan. Around 40 percent of the patients we treat have a

in New York, capable of detecting 281 autosomal recessive

significant diminution of their ovarian reserve. However, other

mutations. We do not obligate our patients to undergo this

factors such as endometriosis, multiple ovarian surgeries,

testing, although we recommend it, especially if they are

autoimmune disorders, chemotherapy and genetic mutations

planning to undergo In Vitro Fertilization (IVF) because

have been associated with premature ovarian insufficiency.

through pre-implementation genetic diagnosis (PGD) we can analyze the embryos and identify those that are not affected

Q: To what extent do environmental factors impact fertility?

by the analyzed disease.

A: Environmental factors are often accounted for as contributing causes of unexplained infertility. However,

Around 70 percent of our patients decide to get tested;

there has been no clear data regarding environmental

around 50-60 percent of patients are carriers of at least

factors affecting fertility backed up by medical evidence.

one mutation and approximately 1 percent of couples tested

This causal relationship between such factors and the

find out they are carriers of the same mutation. We have

infertility of a couple are seldom well-established. We

had many patients who seek our services to request PGD

are told someone with a healthy lifestyle will most likely

because their naturally conceived child was born with an

have less difficulty getting pregnant but no scientific data

autosomal recessive disease. One current patient, whose

proves that. In that respect, it is important to point out

baby was born with spinal muscular atrophy, found out they

that nutrition can definitely impact fertility prognosis as

were both carriers and now are undergoing an IVF cycle

clear evidence demonstrates that being overweight and

with PGD, precisely to ensure the embryos we transfer are

having metabolic disorders can affect fertility potential

either noncarriers or only carriers but crucially not affected

and obstetrical outcome.

by the same mutation. Some of the most common in the Mexican population are cystic fibrosis, thalassemia, spinal

Q: What percentage of your clients has a genetic disease

muscular atrophy and among the Jewish population we

they hope to avoid passing on to a child? How can RMA

see familial mediterranean fever. However, there is no over-

Mexico help them?

riding trend as we often see patients test positive for a

A: When we talk about genetics, we have to categorize.

variety of extremely rare mutations.

There are chromosomal abnormalities that are associated with oocyte age. Nature is wise so abnormal embryos will not usually implant in the womb, a common phenomenon

Reproductive Medicine Associates Mexico (RMA Mexico)

seen as all women age. There is a second part to genetics,

is widely recognized as a national and international leader in

which are genetic diseases. These are not associated with

state-of-the-art reproductive medicine, led by an integrated

age and represent a possibility of carrying and passing

team of doctors and scientists

191


EXPERT OPINION

VACCINES AGAINST VIRAL DISEASES: MYTHS AND REALITIES Rosa María Del Ángel Chief at the Department of Infectology and Molecular Pathogenesis of CINVESTAV

192

Enrique Villegas Resident in Traumatology and Orthopedics at ABC Medical Center

Viruses are responsible for a number of diseases that

countries to guarantee public health through prevention

constitute significant public health problems in Mexico

measures, as well as the proper and timely diagnosis and

and in the world. It is easy to pinpoint these infections

treatment of patients, epidemiological monitoring for

as responsible for creating the most harm to humankind

detection and control of epidemics caused by viruses.

throughout history. Such is the case of smallpox, which until 1980, the year in which it was eradicated, was one of

The strategies for the control of viral infections are initiated

the deadliest and most feared viral diseases, according to

with the development of diagnosis methods, design and

the article The Rediscovery of Smallpox. However, there

preparation of vaccines. Should the virus have an animal

are a number of other viral diseases, such as poliomyelitis,

reservoir or be transmitted by vectors, a strategy designed

that generated thousands of deaths and led to paralysis in

for vector control is required. All control strategies should

children, or influenza, a viral disease responsible for the 1918

be based on the knowledge of the virus’ structure, the

European pandemic that caused a significant decrease in the

nature of its genetic material, mechanisms to enter the

continent’s population. More recently, AIDS, which prior to

organism and replicate within the target cells and the

its identification caused the deaths of thousands of young

pathogenesis mechanisms.

people in several parts of the world. For those viral infections that have been present among In the past couple of years, new viral infections have captured

the human population for a longer time, such as rubella,

the attention of different national and international health

mumps, measles and chickenpox, health systems have

organizations. Such is the case of the ebola outbreak in three

developed not only efficient monitoring systems but also

different countries in Africa, the Middle East respiratory

vaccines to prevent the disease. Vaccination against some

syndrome coronavirus (MERS) and the chikungunya and

viruses such as polio have been so efficient that the last

zika viruses in the Americas. Without going too far, the zika

poliomyelitis case in the Americas was recorded in 1991.

virus generated a global health alert, according to the WHO, due to its association with microcephaly in newborns and

Vaccines are no more than a biological mix containing

with Guillan-Barré syndrome in adults.

virus' proteins or a virus’ genetic material that allows the generation of acquired immunity (protection) against a

It is important to note that the wide geographic spread of

disease. The first vaccine generated was against smallpox

high pathogenic types of viruses that infect birds, such as

and used the cowpox virus, a smallpox variant that

the H5N1 and H7N9 influenza viruses, represent a constant

generated a slight infection in humans but that could

threat to global public health. In addition, the possibility of

induce protection against the lethal human smallpox.

facing new zoonotic events increases due to the accelerated

The experience of the vaccine against smallpox led to

growth of the world’s population and its expansion. Climate

the generation of other vaccines against diseases such

change, environmental changes and the destruction of the

as rabies, yellow fever, polio, measles, mumps, rubella,

habitat of several species generate new opportunities for

chickenpox, papilloma, hepatitis A, hepatitis B and

disease transmission. The prior has led to the creation of

influenza. Countries like Mexico entered the 21st century

the One Health Concept, in which direct connections are

with a national vaccination scheme of wide coverage that

made between people’s health and the wellbeing of animals

includes hepatitis A, hepatitis B, poliomyelitis, rotavirus,

and the environment.

measles, rubella, mumps, papilloma and influenza viruses. Unfortunately, not every country guarantees vaccination

There are a number of viral infections that usually present

compulsion nor offers them free of charge. This has led

themselves in human beings, such as measles, chickenpox,

to the continued appearance of a number of preventable

rubella and papilloma, among others. It is the duty of all

diseases in the population.


Quality analysis of ovules obtained by ovarian puncture to determine which will be implanted via IVF

193

Another aspect that has contributed heavily in the

of recombinant proteins, which only use certain proteins

last years to the appearance of vaccine-preventable

from a virus to generate immunity. The organism generates

infections has been the misinformation surrounding

antibodies against the virusâ&#x20AC;&#x2122; proteins and is thus protected

vaccines as a leading cause of autism. Even though the

against them. These vaccinations are fairly safe because

report that once related vaccination with autism has

they do not generate the disease in order to protect the

been totally refuted, as mentioned in the article Safety of

body from it. An example of this sort of vaccination is that

Vaccines used for Routine Immunization of US Children,

used against human papillomavirus. DNA vaccines are the

a significant number of parents have decided that it is

fourth type, in which organisms are immunized through a

more natural to permit their children to immunize through

DNA sequence that can replicate the virusâ&#x20AC;&#x2122; proteins. When

the infection. These decisions have resulted in significant

the DNA sequence enters the body, it introduces itself within

consequences, such as the presence of measles and

certain cells that will generate the viral proteins against which

mumps among college students in the US or in children

antibodies will be created. Though this type of vaccinations

visiting Disney parks.

is still in an experimental phase, results have been promising.

Misinformation regarding vaccination can have important

Unfortunately, there are a number of viral diseases for which

global consequences. If a population is protected with a

there are no vaccines. This is due to the fact that viruses

vaccine, the virus will not multiply in that specific population

have a high mutation rate, which means that whenever a

and vaccinated individuals can travel to any part of the

vaccine is ready for a certain virus, a new variant of the virus

world without the risk of getting sick. Nevertheless, if some

appears and the antibodies created are unable to avoid

members of the population choose to not vaccinate, there

the infection of the mutant virus. This has been, among

will be individuals susceptible to the disease, which will

others, one of the reasons why we still do not have a vaccine

allow the virus to incubate in certain locations. Hence the

against the AIDS virus, though it has been in the works for

importance of not straying from the efforts that have been

the last three decades.

made to overcome these diseases. Although Mexico has done a good job in terms of public health Vaccines can be of several types. Attenuated vaccines

to battle virus-generated infections, the country still faces

are made up of live viruses that will not generate serious

millions of annual cases of respiratory infections different from

infections in human beings but which can help the body

influenza, calicivirus gastroenteritis or dengue epidemics. Even

to produce antibodies that will prevent the infection from

now, the country faces viral infections such as chikungunya

occurring. For instance, an attenuated vaccine is the oral

and zika for which no vaccine has been developed. That is the

vaccine against polio or yellow fever. A second type of

reason why, within public health budgets, the mortality and

vaccines is made of deactivated viruses, in which viruses

morbidity rates associated with viral infections, continue to be

are treated with chemical compounds that destroy the virus

considerable. We should not let our guard down regarding the

but not its proteins, allowing for the creation of antibodies

prevention of those diseases that have an available vaccine.

that protect against the virus but that do not cause the

Misinformation can contribute to misguided decisions and

disease. These vaccines are very safe, such as the Salk

hurt the population most susceptible to being affected by a

vaccine against polio. A third vaccination type is made

serious disease, such as children.


VIEW FROM THE TOP

INTRODUCING NEW OPPORTUNITIES THROUGH GENOMIC MEDICINE FRANCISCO KURI Vice President of Landsteiner Scientific

194

Q: What are Landsteiner Scientific’s key product lines?

Q: What support does Landsteiner Scientific receive from

A: Our pipeline includes biotechnological drugs, genomic

academic institutions?

medicine, injectables and oral solids. We have several

A: We have received support from the Metropolitan

research lines but the most advanced is related to obesity.

Autonomous University (UAM), the National Institute

We started phase I clinical trials for this line in Spain,

of Genomic Medicine (INMEGEN) and UNAM through

although phase III will eventually take place in Mexico. We

the Institute of Biomedical Research. There are only a

have recently opened a new platform in genomic medicine

few countries where this kind of research is being done,

focused on oncology. Landsteiner is starting with colon

including Mexico, Spain and the US. Landsteiner’s Spanish

cancer, a common disease among men in Mexico and the

subsidiary GENMED is focused on projects in genomic

US. The company currently has a line of semi-solids such

medicine in several therapeutic lines.

as creams, a line of injectables and a line of immunosuppressants, high-specialty drugs whose production

Q: What kind of medicines are you developing against

must be separated from others.

colon cancer? A: When colon cancer develops, there is a metabolic

Q: What opportunities does Landsteiner Scientific see in

component that makes colon cells go rogue. Landsteiner

genomic medicine?

aims to interrupt the signal that orders cells to continue

A: Besides Landsteiner, there is no research being done by

reproducing, which is possible through genomic medicine.

Mexican companies in genomic medicine. If we continue

Once the factors that enable cancer to appear are discovered,

on this path, we could be one of the first to launch a

our researchers look for the best place and moment to stop

drug obtained from genomic medicine. There are many

the cancer from growing. There are two alternatives: one is a

diagnoses and studies in genomic medicine but no

medicine that interrupts the uncontrolled cell-reproduction;

medicines yet. As an example, 23andMe, a genetics lab,

the other creates memory in the human body so that

genotypes its clients’ DNA samples and informs them of any

cancerous cells can be recognized and eliminated regardless

genetic predispositions. For a while, the FDA had banned

of where they are or whether there is metastasis.

the company from doing that because people did not know Q: How are your sales distributed among the public and

what to do with this information.

private sectors? Q: How can genomic medicine help improve the health

A: 90 percent of Landsteiner’s sales used to go to the

of Mexicans?

government, but we started changing that in 2016 by

A: The genetic information of a population is used to identify

strengthening our private sales division. Our target is a

genetic traits that can help either control or cure the prevalent

70-30 sales ratio.

diseases. Our industry evolved into personalized medicine but now the discourse has evolved into precision medicine. We

Q: What is Landsteiner doing to reduce the cost of

know that some drugs do not work equally well in different

medicine and improve access?

populations. Genomic medicine could show what medicines

A: To achieve this, the company works with generic and

work best according to common Mexican genetic traits.

biosimilar medicines. However, to reduce prices and make access to drugs easier it is necessary to make drug registration simpler. COFEPRIS has done a great job, yet these normative

Landsteiner Scientific is a Mexican pharmaceutical company.

changes are difficult to apply and the industry is struggling.

It

and

We restructured our medical division because we set the goal

commercialization of biotechnological, genomic medicine,

of submitting 15 new medicines for registration per year to

injectables and oral solids. It recently open a plant in Toluca

keep our pipeline from becoming obsolete and unprofitable.

is

focused

on

the

manufacturing,

distribution


VIEW FROM THE TOP

BIOTECHNOLOGY DESIGNED TO MEET LOCAL NEEDS FÉLIX SCOTT Director General and Country Chair of Sanofi

Q: How is Sanofi and its biotechnology addressing Mexico’s

Q: As a leader in insulin supply, what innovative solutions

main health concerns?

are you developing for diabetes?

A: We are redefining treatment for cardiovascular

A: Sanofi was the first pharmaceutical company to create

diseases. Sanofi was the first company in Mexico to

glargine insulin, the first analogue insulin that improved

launch a monoclonal antibody for controlling LDLC, a

a patient’s quality of life. Recently we launched a new

solution that revolutionized the industry. The monoclonal

generation of insulin to redefine control of the disease. It is

antibody inhibits a protein called PCSK9, which hinders

a safer insulin because the patient now has a range of up to

the receptor that clears cholesterol from blood. In Mexico,

36 hours between doses, instead of 24 hours. The solution

cholesterol is a critical topic. The burden of cholesterol

is complemented with a platform that provides support

as a cardiovascular risk is due to ethnic features and

to patients in terms of nutrition, exercise and everything

unhealthy lifestyles. Usually, diabetic patients have

related to changing habits.

problems with their lipid levels. Previously, patients were treated with statins, but eventually they reach a point

In a wider context, diabetes and obesity might also lead to

where the statin becomes ineffective. This new therapy

other complications that can result in the need for further

provides patients with an alternative.

treatment, such as knee replacements. For these cases, we developed an injection that helps delay the need for

Q: What role did Mexico play in the development of the

a knee replacement. The treatment restores the cartilage,

dengue vaccine?

providing pain relief in the knee and allowing the patient

A: Mexico was the first country to register the dengue

to continue walking. The cost of knee replacement surgery

vaccine. We are leaders in emerging economies because

is very high and this product, which is already available

we work to meet the specific needs of patients in those

through public institutions, helps reduce costs.

countries. Mexico played a key role in the investigation of the dengue vaccine because, among the 15 countries

Q: What makes Sanofi unique in Mexico?

included in the research program, it was one of only two

A: We are a company focused on people, the development

countries, along with the Philippines, that participated in

of talent, inclusion, diversity and gender equality. What

the phase I clinical studies. That is why Mexico became

makes us different is the human dimension in everything we

the first country to obtain the sanitary registration: it

do, whether working with patient associations, authorities,

was a collaborative approach with the country’s health

doctors or our own employees. This includes, for example,

institutions that enabled us to establish the necessary

helping our employees and their families. Children in Mexico

processes to comply with the many strict requirements of

do not have school on the last Friday of every month, which

the authorities and to provide them with solid local data. It

can be an issue for parents. We established Kids Office Day,

was not an easy process but it was also the first time that

an initiative in which all our employees can bring their children

COFEPRIS had certified a new vaccine before agencies

to work on that Friday. We organize activities for the children

such as the FDA and the EMA.

and in so doing, we help our employees comply with their parenting responsibilities. So far, we have received a great

Q: What other vaccines is Sanofi developing?

response from our employees and their children.

A: Our global operations are developing research for a zika vaccine, among others. We have a collaboration agreement with the US Army to conduct research into this

Sanofi is a pharmaceutical group founded in 2004 after the

type of infection and we believe we are in the best position

merger of Sanofi-Sythelabó and Aventis. It is the world’s

to achieve a fast and efficient solution for zika after our

third-largest pharmaceutical group and a leader in research in

experience with the dengue vaccine.

Mexico with over 35 active studies

195


ANALYSIS

THE BLACK HOLE OF BLACK MARKET MEDICINE Selling fake medicine is an opportunity for counterfeiters to

In Mexico, El Universal reports that between

make money, but the results for patients can be damaging or

Jan. 1, 2007 and Dec. 31, 2015, the Attorney

fatal. Mexico has cracked down on this problem in recent years

General’s Office seized 945,152 fake medicines,

but issues remain

just under 942,000 of which were seized in Mexico City. Industry reports on how much

In some industries, counterfeit products can lead to

medicine in Mexico is false varies wildly from as little as

financial losses. In the medical sector, it can lead to death.

4.5 percent of the total to 60 percent. Reasons for the

Fake medicines can be destructive and even devastating

discrepancy include insufficient controls and the expanse

but the lack of global coordination is impeding the fight

of the supply chain across borders, where one country’s

against these illicit drugs despite local efforts to curb their

health authorities cannot survey operations in the other.

use. In Mexico, trade on the black market is on the rise. 196

Although some countries have anti-counterfeit measures in “Counterfeit, altered or contaminated drugs are an

place and are actively seeking and destroying fakes, one of

issue several clients of ours have faced recently and the

the main issues in the fight is the lack of global coordination

prevalence of this occurrence is growing in Mexico. There

against this international plague. Countries have yet to

are several reasons for this, including organized crime,”

agree on a standardized term to be used and even Big

says Ernesto Algaba, Partner of the Life Sciences Practice

Pharma companies have an opinion on what should be

at Hogan Lovells BSTL.

included within the definition of illegal medicine. They insist that counterfeits, which are defined as functioning

The issue is neither new, nor particular to Mexico. China’s

copies of a patented drug, be included while NGOs protest

state-controlled Shenzhen Evening News newspaper has

that although violating intellectual property, they pose little

reported that in 2001, 192,000 Chinese patients had died

or no health risk. Interpol has several ongoing operations

due to the use of fake drugs.

in the pharmaceutical field, including Operation Pangea, which targets the online sale of illegal medicines. The

Globally in 2015, there were 3,002 incidences of counterfeit

European Council has drafted the MEDICRIME convention,

medicine involving 1,095 pharmaceutical products,

“a binding international instrument in the criminal law field

according to the US-based Pharmaceutical Security

on counterfeiting of medical products and similar crimes

Institute. The three categories of drugs most targeted by

involving threats to public health,” according to its website.

counterfeiters are genito-urinary, anti-infectives and CNS. Cardio-vascular medicines, an important category for

As for Mexico, Algaba says that “COFEPRIS is working on

the Mexican population, saw a 29 percent increase in the

eliminating these health risks by increasing inspections and

number of fakes from 2014 to 2015 and dermatologicals, a

visits. It also has an open dialogue with companies to agree

category few think to question, experienced a 57 percent

on proper measures for suspending and recalling a product

rise in the same period.

and also in finding those responsible.”

HIDDEN POISONS IN COUNTERFEIT MEDICATIONS Heavy metals

Hidden Ingredients

Impact

Mercury, aluminium, lead, cadmium, arsenic, chrome, uranium, strontium, selenium

Poisons PCBs, benzopyrenes, rat poison, boric acid, antifreeze

Kidney damage, Carcinageric or toxic kidney failure, to CNS kidney, liver, cancer and skin, bones or teeth developmental defects

Source: safemedicines.org

Common household items Road paint, wall paint, brick dust, floor wax, sheet rock, paint thinner Vomiting, abdominal pain, dizziness, blurred vision, respiratory difficulty, nervous system disruption, coma, death

Drugs you did not ask for Aminotadafil, homosildenafil, xanthoanthrafil, pseudovardenafil, hongdenafil, sibutramine, haloperidol Difficulty breathing, muscle spams, muscle stiffness, high blood pressure, stroke

No drugs at all Dextrose, dextrin, lactose, starch, saline, salt

Harm or death


VIEW FROM THE TOP

GLOBAL LEADER IN ANTIBIOTICS PRIORITIZES RESPONSIBILITY MAARTEN POUW CEO of DSM Sinochem Pharmaceuticals

Q: What solutions does DSM Sinochem Pharmaceuticals

Q: What does Mexico represent for DSM Sinochem

propose to the growing anti-microbial resistance (AMR)

Pharmaceuticals within LATAM and globally?

problem?

A: In terms of size, Mexico is our second-largest market in Latin

A: There is increasing evidence that API manufacturers that

America after Brazil, followed by Colombia and Argentina.

do not adequately treat waste products contribute to the

We truly believe in the strong potential of the Mexican

problem. Releasing high concentrations of antibiotic active

pharmaceutical industry, as the country is the 11th market for

ingredients into the environment creates “reservoirs” of

pharmaceuticals in the world. In addition, it is important to

antibiotic resistant bacteria that can be easily propagated

mention that Mexico is considered a gateway to the rest of

due to increased global travel. At DSM Sinochem

the countries in Latin America and the US due to its location.

Pharmaceuticals we strongly believe in producing APIs in the most responsible and sustainable way. Regulation

Q: What are the main challenges DSM Sinochem

concerning wastewater disposal is definitely needed but

Pharmaceuticals face in the Mexican health sector? How

its implementation can take several years. In October 2014,

does it overcome them?

we launched our sustainable antibiotics program, which

A: DSM Sinochem Pharmaceuticals is the only producer of

initially targeted our in-house wastewater treatment. We

antibiotics in Mexico so we are in the spotlight of Mexican

have already implemented basic requirements for clean

regulators. The sense of urgency in Mexico is entirely

and sustainable antibiotics production at all our sites.

different from that of countries with a larger antibiotics

These include the use of technology with the lowest

industry, such as India or China, but the commitment exists

environmental impact throughout our supply chain,

and there is significant debate nationally and regionally

dedicated wastewater treatment plants at every antibiotic

on the regulation of antibiotics. We actively communicate

manufacturing site and antimicrobial activity testing.

all information related to AMR to our public and private stakeholders in Latin America. We know it will be difficult

Q: How are private companies pushing forward on this

to solve such a large challenge by ourselves so we are

issue? What dangers does AMR pose to global health?

constantly communicating with the sector. I am proud to

A: DSM participated alongside 12 leading biopharma

say that the response has been positive so far and we are

companies in the generation of the UN General Assembly’s

glad to be leading such a process in the region because it

Roadmap to Combat AMR. The AMR Industry Alliance

ensures that DSM Sinochem Pharmaceuticals will be able

was established in May 2017 to review progress on the

to anticipate any regulatory change in this area.

commitments made by the Roadmap. This alliance is chaired by the International Federation of Pharmaceutical

Q: What products will be game-changers in the next year?

Manufacturers & Associations (IFPMA) and warns that

A: We have well-established products in our portfolio

700,000 people worldwide die from resistant bacteria

that have been commercialized for a long time. These

annually. Of those, 50,000 die in the US and Europe

products enjoy a stable and steady sales performance.

alone. Furthermore, 58,000 newborn babies die each year

As part of our corporate business development strategy,

in India as a result of drug-resistant infections and almost

we also expect strong growth in cardiovascular and anti-

every minute a child under five dies from pneumonia,

fungal product sales.

for a total of 410,000, according to the NCDC India. In the US, two million people contract a serious antibioticresistant infection every year, of which 23,000 will die.

DSM Sinochem Pharmaceuticals, founded in 1869, is one of

By 2050, over 10 million people will die from resistant

the oldest fermentation companies in the world. It develops,

bacteria every year, costing the global economy US$100

produces and sells intermediates, active pharmaceutical

trillion per year.

ingredients and drug products

197


VIEW FROM THE TOP

PROMISE OF MSC LIES IN FLEXIBILITY ABRAHAM FRANKLIN Director General of Grupo Franklin

198

Q: What advantages do dental mesenchymal stem cells

Q: What process is used to extract the cells?

(MSC) have over those extracted from bone marrow or

A: The ideal process is for children to go to the dentist

the umbilical cord?

when a tooth is loose but not out. If the child waits until

A: Bone marrow contains a small portion of mesenchymal

the tooth falls naturally, the mature tooth behind the milk

stem cells and extracting the cells is invasive. They also cannot

tooth may have eaten the entire root, from which the

be taken from cancer patients because they are already sick,

stem cells are extracted. The dentist will put the tooth

although milk teeth have cells that can be used to treat direct

in a fluid we provide that will preserve the tooth exactly

family members. The umbilical cord contains hematopoietic

as it is. We work with a network of dentists who have

cells, which can only produce blood and not tissue. Those are

the necessary boxes to preserve the teeth, which can be

useful for certain blood diseases but they cannot be multiplied.

preserved for up to four days, although we should receive

Additionally, hematopoietic cells can only be used in children

it within 24 to 48 hours. We then freeze and expand the

under 16 pounds because the procedure requires a certain

stem cells.

number of cells per pound and more cannot be produced. Q: How does current regulation govern the use of stem MSC can convert rapidly into any tissue. We are developing

cells in Mexico?

cardiac cells for regenerative medicine and working with

A: We cannot use them openly right now because they

3-D printing to replace foot bones. In the US, scientists are

are still in trials. We need to apply to COFEPRIS on a

3-D printing human hearts and putting them in pigs. We can

case by case basis, with a specific patient and a specific

make and print skin for burns and we can produce cells for

treatment in mind. The ethics committee assigned by

laboratory tests, thus avoiding animal testing. Additionally,

the government will then decide if what we are doing is

our experts are developing beta pancreatic cells that

proper and whether there will be any harmful effects for

produce insulin, taking steps toward treating T1D.

the patient. Also, patients can only use their own stored cells for the treatment. If they want to do something else

At the same time, we are trying to help people who suffer

we need to repeat the process.

from macular edema and retinitis pigmentosa by producing cells found in the eyeâ&#x20AC;&#x2122;s rods and cones. From MSC, we can

Q: How can regulations be improved to take advantage

fabricate fibroblast to produce a serum that helps reduce

of this technology?

wrinkles and our partners in Spain have already treated 20

A: We know these cells can do a lot of good and regulatory

patients with this product, 18 of which saw positive results.

bodies are trying to move faster regarding regulations. But this technology develops more quickly than the law,

MSC also have immunomodulating properties, meaning

as evidenced by the fact the FDA is granting permission

the cells can reduce inflammation and rejection rates.

today for procedures invented in 1985. Everything in this

We injected MSC into eight paralyzed rats and after six

field is new and people can be afraid, so we need the

weeks, four started walking again, which means the neuro-

scientific basis to justify new techniques.

transmission is perfect. Parkinsonâ&#x20AC;&#x2122;s and Alzheimerâ&#x20AC;&#x2122;s are other diseases we want to treat.

The government asks us for advice on how to handle new cases. It is remarkable that COFEPRIS is recognizing the need for support in areas it is unfamiliar with and that

Grupo Franklin operates in diverse sectors, including health. It

they are willing to integrate this support. Social security

owns a chain of dental clinics, a stem cell bank and a research

is also burdened because of the money required for long-

center, distributes medical equipment and runs a biohazard

term treatments. We want patients to have access to

waste disposal company

these opportunities as soon as possible.


VIEW FROM THE TOP

EXPENSIVE PROCEDURES SPUR STEM CELL INNOVATION JESÚS ESPARRAGOZA Director of Biostem Technologies Mexico

Q: What led you to use stem cells to treat injuries?

due on the efficacy and applications of these therapies

A: We decided to research and develop stem cell treatments

that could define which cases can use such applications.

after performing a heart transplant 16 years ago in San Javier Hospital, Guadalajara. The process was extremely

Q: What are the short and long-term goals for Biostem

complex and expensive both for the doctor and for the

Technologies?

patient, who ran out of money after a month in recovery.

A: We have a team comprised of certified researchers from

This motivated us to look for an alternative solution that

Guadalajara studying how many changes can be performed

could help patients with a certain level of heart failure avoid

before a cell is damaged and monitoring existing cultures

the need for a transplant. We researched the role of stem

for signs of damage. Our goal is to generate a cell bank,

cells in cardiac failure and we allied ourselves with groups

which will include adult autologous and mesenchyme cells

that were already investigating it. This research led us to

for anyone who may need them. This bank is already in

develop a comprehensive approach to treating heart failure

progress and now we are fulfilling the requirements for

that involved the injection of stem cells and significant

regulatory data so the bank can be approved by COFEPRIS.

changes in the patient’s habits and diet. Afterward, we

To get the approval, all hospital and laboratory infrastructure

started researching the impact of stem cells in spinal, joint

has to be certified by the council. We have been developing

and muscular injuries.

these projects for over eight years because generating research protocols is a long process.

Q: How do you extract the cells? A: We extract the stem cells from the patient’s iliac crest

Our goal is not just to store the cells but to study their

bone marrow. These cells are purified and cultivated. They

applications and potential to cure diseases. There are many

are then implanted in the damaged tissue or wherever there

studies to be made on the efficiency and applications of

is a mobility problem. While umbilical cord cells can also be

these treatments and that could indicate which specific

used for these purposes, COFEPRIS only authorizes us to

patients could benefit. We have a research laboratory in

use stem cells from a patient’s bone marrow. These are also

Miami but our ultimate goal is to create one in Mexico.

much easier to obtain and equally good for our purposes as cells from the umbilical cord. Cells from teeth can also

Q: Which new products are you developing?

be used but they require more purification and cultivation

A: In 2017, we will branch into different areas. Our goal

because they are in shorter supply than bone marrow cells.

will be to generate wellness products including food supplements, which contain omega-3 and other nutrients

After cultivation, we isolate mononuclear stem cells, which

and pure water. We are also developing nutraceuticals

are implanted in tissues including the heart, lungs and

targeting patients who suffer from obesity and diabetes. We

other damaged areas autologously. We are planning to

are looking at developing products that can neutralize the

store these cells to create a bank. We will also isolate

negative effects of inflammation, which could help patients

mesenchyme cells, which can be implanted in any

with autoimmune diseases such as lupus and scleroderma.

individual because they have no antigenic receptors.

Mononuclear stem cells and mesenchyme cells can also be

During the replication processes, it is necessary to

used as anti-inflammatory agents.

closely monitor samples to ensure cells do not deteriorate or mutate, which could lead to tumors. We have been developing these projects for over eight years as the

Biostem Technologies focuses on research and development

generation of research protocols entails a long process.

of stem cell therapies for Mexico, a pharmaceutical line that

Our goal is not just to store the cells but to study their

provides high-quality products and a wellness line focused on

applications and curative potential. There are many studies

anti-aging and rejuvenation products and services

199


VIEW FROM THE TOP

STEM CELLS DO WHAT YOU NEED THEM TO DO VICTOR SAADIA CEO and Founder of Bioeden Mexico and LATAM and CCO of Bioeden USA

200

Q: What are the advantages of using dental stem cells over

helps with the inflamed pancreas and the regenerative

those of the umbilical cord or bone marrow?

element helps to regenerate pancreatic function. For the

A: The cells from the umbilical are hematopoietic and they

best outcome when treating chronic diabetes, several

are mainly used to treat blood conditions such as lymphoma,

sessions are advisable for the cells to work. In addition to

leukemia and anemia. Dental stem cells are mesenchymal;

pancreatic malfunctioning, T2D causes a great number of

they form tissue and can differentiate into bone, cartilage,

problems such as blurred vision, glaucoma, poor circulation

heart, liver, etc. The other fundamental difference is that

in the extremities and liver, kidney and heart issues. There

umbilical cord cells cannot be multiplied and often there are

is a protocol in Monterrey under research that is aggressive

not enough cells for treatment. Mesenchymal cells can be

but efficient, which involves submitting the patient to

used several times for different applications. Finally, there

chemotherapy to destroy their immune system because it

is only one opportunity to collect umbilical cord stem cells

has been attacking itself. After it is killed off the patient is

but there are many opportunities to obtain cells from teeth.

given a new immune system with stem cells. This is done with hematopoietic cells collected from bone marrow. This is also

Bone marrow is a rich source of both mesenchymal and

helping allogenic transplants achieve lower rejection rates.

hematopoietic cells. Their collection is much more painful as a thick needle is inserted into the bone several times.

Q: Although authorization is granted on a case by case

It is invasive and hospitalization is required. In addition,

basis, what are the main uses of stem cells in Mexico?

the cell quality is not as good because they are prone to

A: The potential applications are still being researched. In

environmental damage. This is a good option for those who

Mexico, they have mostly been used for orthopedics, lesions in

have not persevered cells in another form.

articulations such as the knee, hip and shoulder or for diabetes. We are running an interesting protocol on autism and stem

Q: T2D is affecting Mexico and consuming the public health

cells also can be used for neuro-degenerative diseases such

budget. How can stem cell research help?

as Parkinsonâ&#x20AC;&#x2122;s disease. There are also intravenous applications

A: Many auto-immune diseases are inflammatory, so stem

to help regenerate tissues and cells. Stem cells have anti-aging

cells can help with their anti-inflammatory properties. In

properties that are popular with athletes.

addition to becoming tissue, over the past five years it has been discovered that stem cells have additional properties:

Q: What regulations are stem cell clinics like Bioeden

anti-bacterial, anti-inflammatory and regenerative. They

lobbying for in Mexico?

also recruit other cells to help with repair and protect cells

A: Processes are limited by the laws that are 10-15 years

by stopping apoptotic processes, which is programmed

old and policymakers are slow to react to innovation.

cell death. Stem cells are also immune-regulating. These

Mexico is a pioneer in this area so there are fewer countries

are environmentally responsive therapeutics. Applied

to copy from and thus more fear, which is normal. This

intravenously, these cells will do what you need them to.

can be solved by reading scientific information which is available for all, and there are many aspects that have

As for T2D, the immune regulating aspect helps because it

already been tried and tested. It is a waste of time and

is an auto-immune disease; the anti-inflammatory function

money to repeat those tests here, since that money could be used for further research. Regulation of dental stem cells in particular is scarce and mesenchymal cell

Bioeden, a US-based tooth stem cell bank, collects and stores

regulation is tied to that of hematopoietic cells. COFEPRIS

dental stem cells using cryopreservation. It is present in 30

is conscious of these things and is moving forward. We

countries and has three laboratories: one in the US, one in the

are not completely blocked by legislation. I hope there

UK and another in Thailand

will be greater openness in the next two years.


ANALYSIS

THE RISE OF THE SUPERBUG Antibiotics have saved many lives over the past 70 years

Practice at Hogan Lovells BSTL. “[…]Key

but the rise of the “superbug” threatens this. Bacteria

provisions will need to be amended to provide

is developing resistance to antibiotics, leaving experts

guarantees products are safe for human

scrambling for a new solution

consumption. I do not think we have the detailed provisions that may exist in other jurisdictions,”

Before antibiotics were accidentally discovered by Sir

he says, adding that “the regulatory framework needs to

Alexander Flemming in 1945, an infection of a small cut

take best practices from other jurisdictions into account. We

could kill. For the past 70 years, the discovery of an

know that in Europe and in the US there are more specific

increasing number of antibiotics has prevented millions of

provisions and limitations. Fortunately, products are mainly

deaths but this is under threat. Resistance or immunity to

coming from these jurisdictions into Mexico. Even though

antibiotics, known as antimicrobial resistance, is emerging

we have complex labeling requirements, this is an area that

and such resistant bacteria are known as “superbugs.”

could potentially be improved.”

How superbugs developed is simple to understand. In

ANTIBIOTIC RESISTANCE TIMELINE

the words of CDC researcher and superbug expert Maryn McKenna: “Bacteria compete against each other for resources, for food, by manufacturing lethal compounds that they direct against each other. Other bacteria evolve

DISCOVERY

201 RESISTANCE IDENTIFIED

Penicillin 1943 1945 (2 years)

defenses against that chemical attack. When we first made antibiotics, we took those compounds into the lab and

Vancomycin 1972

made our own versions of them and bacteria responded

Imipenem 1985

1988 (16 years)

to our attack the way they always had.” 1998 (13 years)

The Review on Antimicrobial Resistance, funded by the British

Daptomycin 2003

2004 (1 year)

government, pegs the annual death toll caused by infections no drug can help at 700,000. It estimates that this number

Source: Maryn McKenna TED 2015

will rise to 10 million by 2050 if no action is taken. The WHO estimates that every year 480,000 people are infected with

By 2015, over half of the world’s countries did not have

multi-drug resistant tuberculosis. Extensively drug-resistant

relevant antibiotic legislation. Ensuring food chain security is

tuberculosis had been detected in 117 countries by the end

vital for human health. Over 60 percent of human pathogens

of 2015, including Mexico, and it kills 50-70 percent of those

are of animal origin and over 20 percent of animal losses

infected. The global health body also says that between 2000

are caused by disease. In addition, the OIE reports that five

and 2015, 49 million lives were saved due to diagnosis and

new human diseases are reported every year. For this reason,

treatment of tuberculosis, which consists of four antibiotics.

maintaining animal health is a vital public health issue.

The use and prescription of antibiotics for humans is

“We also need a more developed legal framework regarding

heavily regulated. In Mexico consumers cannot purchase

organic products or those free of antibiotics. We need to

antibiotics without a prescription, which is kept by the

know if the animal consumed the legal amount of antibiotics

issuer. However, the CDC estimates that upto 50 percent

or if it is completely drug-free. General regulations in food

of antibiotics prescribed for people and most of those

products need to be connected with organic food and animal

used in animals are unnecessary or not as optimally

antibiotic consumption requirements. Ensuring the quality

effective as prescribed. Unfortunately, the CDC also

of meat containing antibiotics and the effects of that meat

estimates that “1 in 5 resistant infections are caused by

on humans is vital,” says Cecilia Stahlhut, Senior Associate of

germs in food or animals”. “COFEPRIS tightly controls

the Life Sciences Practice at Hogan Lovells BSTL.

the human consumption of antibiotics but animal meat is the greatest source of antibiotics for humans,” says Felipe

Because bacteria develop resistance so quickly, there

Espinosa, CEO of Laboratorios Collins.

is little incentive for pharmaceuticals to search for new antibiotics. McKenna says that a new generation

In Mexico, tighter regulations that take their cue from other

of bacteria develops every 20 minutes, whereas drugs

countries could help limit the impact from a contaminated

take years to develop. She calls for more incentives for

food chain, says Ernesto Algaba, Partner of the Life Sciences

pharmaceuticals to continue the fight.


Functional training classes


NUTRITION & WELLNESS

9

Wellness is the key to prevention, which is vital for lowering the chronic disease burden in Mexico and improving the general health of the population. Improving healthy eating habits can make an enormous difference to health and to the amount spent on health matters. This is nowhere more relevant than Mexico, which holds one of the top spots worldwide for both adult and child overweight and obesity. With Mexican nutrition being largely insufficient, companies are capitalizing on this opportunity to provide vitamin supplements or complements to the market. With the trend of eating healthy comes the trend of avoiding chemical medicine, leading to a resurgence in natural remedies or herbal medicine. Although COFEPRIS has cracked down on these sectors in recent years to guarantee the safety of patients, it is now emerging as a viable alternative for public institutions with budgets bursting at the seams. People are also increasingly turning to dermatological and surgical solutions to meet their aesthetic needs.

This chapter will provide insight into the national wellness market and how it is looking to develop.

It will feature companies devoted to improving nutrition,

innovative skin care products and fitness alternatives that best meet Mexican needs.

203


204


CHAPTER 9: NUTRITION & WELLNESS 206

ANALYSIS: Change of Habit Required for Wellness

209

VIEW FROM THE TOP: Javier Luna, Nestlé

210

VIEW FROM THE TOP: Raúl Camarena, Aspen Labs

211

VIEW FROM THE TOP: Víctor Anaya, Merz Pharma

212

INSIGHT: Geraldine Waked, Sesderma

213

VIEW FROM THE TOP: Alejandro López, IM Natural

214

VIEW FROM THE TOP: Adriana Azuara, Agave Spa

215

VIEW FROM THE TOP: Ricardo Spínola, Farmapiel

216

VIEW FROM THE TOP: Cédric Ertlé, Expanscience

217

VIEW FROM THE TOP: Fabián Bifaretti, Sports World

218

VIEW FROM THE TOP: Miguel Marín, Industrias Sintoquim

220

INSIGHT: Ignacio Luna, Biofarma

221

ROUNDTABLE: What Factors Impede Skin Care and What are Some Protective Measures?

205


ANALYSIS

CHANGE OF HABIT REQUIRED FOR WELLNESS Nutrition and exercise are key to fighting overweight and

trend toward healthy eating also often avoid

obesity, conditions prevalent in Mexico. However, most

chemical medicines, leading to a resurgence

patients see this as an aesthetic issue, not a health problem,

of natural remedies and herbal products.

in the same way as they view skincare

Although COFEPRIS has cracked down on these sectors in recent years to guarantee

Maintaining general wellness is the key to prevention,

the safety of patients, it is now emerging as a viable

a vital issue for lowering the chronic disease burden

alternative for public institutions with budgets bursting

in Mexico and improving the general health of the

at the seams.

population. Accordingly, improving eating habits can The OECD reports that in 2012 over 71 percent of the

expenditures. This is increasingly relevant than Mexico,

Mexican population was either overweight or obese.

which holds one of the top spots worldwide for both

It also reports that in 2013 Mexicans were consuming

adult and child overweight and obesity.

3,072 kilocalories per capita per day. “Behavioral change is the key to reducing the disease burden of obesity and

“Overweight and obesity in children is more serious

diabetes, the leading cause of disease and healthcare

than these issues in the general population. However,

spending,” says Paul Doulton, Founder and Managing

children suffering from these problems almost certainly

Partner of Oriundo, a consultancy composed of former

will continue to do so in adulthood. Childhood overweight

CEOs that helps new entrants to Latin American

and obesity are also more difficult to solve. They are still

pharmaceutical markets.

growing, so restricting nutrition is not as simple as in adults,” says Carlos López, Director General of Medix, a

Obesity is a risk factor for T2D, which in turn is caused

company dedicated to fighting overweight and obesity

partly by poor nutrition. Maintaining healthy eating habits

since 1940.

can make an enormous difference to health and to the amount of money spent on health matters.

The 2016 ENSANUT report shows that Mexicans are not only overweight, they are unaware of it and do not know

“ENSAUT 2016 was representative of how people see

correct alimentation or exercise requirements. With

themselves versus how they are. The health side is more

Mexican nutrition being largely insufficient, companies

complicated, as often people do not feel ill. By posing

are capitalizing on this opportunity to provide the market

overweight and obesity solely as a health problem,

with vitamin supplements or complements. Those who

people do not identify with this. We have therefore

PERCENTAGE OF ADULTS OVER 20 THAT CONSUME GROUP ADULTS OVER 20 THAT CONSUME EACH FOOD GROUPEACH DAILYFOOD IN MEXICO (percent) 100 80 60 40

„„Urban

Sweetened dairy drinks

Sweetened non-dairy drinks

Sweet cereals

Snacks, sweets and deserts

Fast-food and mexican snacks

Dairy

Eggs

Water

Non-processed meat

Processed meats

„„Rural

Source: ENSANUT 2016

Pulses

0

Vegetables

20

Fruit

206

make an enormous difference to health and to public


wellbeing. We ask patients if they would like to change Level

their image,” says López. Another area of health often associated with aesthetics

Low

is dermatology. A person’s skin condition is also greatly

Ultra-violet index

taken a different approach, focusing on aesthetics and

impacted by the food consumed and is an external show

Moderate

of wellbeing. With many Mexican cities plagued with high levels of pollution, protection from such external damage is vital. A 2015 MicroMarketMonitor report pegs Mexico as the fastest growing country in the North American

High

dermatology devices market with a compound annual growth rate of 9.8 percent from 2014 to 2019.

Very high

“People need to protect their skin against pollution, even indoors where it can sometimes be more polluted because people are crowded into a room or working long hours under artificial lighting, among other factors. It is necessary

Extremely high

to use anti-oxidants to protect the skin against this,” says Adriana Azuara, CEO of All4Spas and Agave Spa. Another major wellness factor is physical fitness, vital for keeping obesity in check. “Gyms are able to link sedentary people with a more active life, not only through strength and cardio equipment but with a robust wellness

According to skin type, the maximum time of exposure, without protection, should be (in minutes) Very pale

Pale

Light Dark brown brown

Dark

Very dark

1

112

140

175

219

274

342

2

56

70

88

109

137

171

3

37

47

58

73

92

144

4

28

35

44

55

68

86

5

22

28

35

44

55

68

6

19

23

29

37

47

57

7

16

20

25

31

39

49

8

14

18

22

27

34

42

9

12

16

19

24

30

38

10

11

14

18

22

27

34

11

10

13

16

20

25

31

12

9

12

15

18

23

29

13

9

11

14

17

21

26

14

8

10

13

16

20

24

15

8

9

12

15

18

23

Source: aire.cdmx.gob.mx

orientation that includes group classes, meditation, yoga, Pilates, steam rooms, saunas, massage services, nutrition

price range, walking and running in the street is free.

experts, facilities for kids (and) swimming pools,” says

In addition, many state ministries of health have been

Fabián Bifaretti, CEO of Sports World.

implementing free outdoor gyms in cities, although their use is not recommended when pollution levels reach

El Financiero reports that there are 1.9 sports clubs in

excessive heights.

Mexico per 100,000 inhabitants, compared to 8.8 in Brazil and 12.4 in Argentina. However, experts argue that there

Despite these issues, life expectancy in Mexico has increased

is no access issue to physical fitness because, although

steadily in recent years, reaching an average of 75 years in

top-end gyms are few and out of the average Mexican’s

2016, 72.3 years for men or 77.7 years for women.

LIFE EXPECTANCY AT BIRTH (years) 85

80

75

70

——US

2006

2007

——Mexico

Source: OECD

2008

——Japan

2009

——Colombia

2010

——China

2011

——Chile

2012

——Brazil

2013

2014

2015

207


VIEW FROM THE TOP

DIFFERENT ISSUES REQUIRE DIFFERENT APPROACHES JAVIER LUNA Senior Manager in Health Nutrition and Wellness at Nestlé Mexico

Q: What are the main nutritional issues in Mexico and how

world, which is known to cause illness, especially in infants.

is Nestlé approaching these?

Through our process called OPTIPRO, we are trying to

A: Our research has highlighted several issues in Mexico.

make the milk we use for our infant formula as close as

We have conducted a series of studies we developed

possible to breast milk, which will make it easier to digest.

(Kids Nutrition and Health Study and Feeding Infants and Toddlers Study) and we have performed R&D with our

Q: How are Nestlé’s programs encouraging healthy eating

partners at Nestlé Research Center in North Carolina,

habits in Mexico?

and Nestlé Mexico has worked with different national

A: Nestlé has reorganized its business vision to focus on

research institutes, such as the Public Health Institute

three areas: the person and the family, the community

(INSP). The first study relates to hydration among

and the planet. In the first category, the goal of our full

children. They consume a large quantity of sugary drinks

portfolio is to provide better nutrition and nutritional

but lack regular water intake. Second, in Mexico around

options for consumers. Toward that goal, we also have

17 percent of children and teenagers skip breakfast every

three philanthropic programs: United for Healthier Kids,

day, which is very serious in nutritional terms. Many of

Healthy Kids and Start Healthy, Stay Healthy. These three

those who do have this meal eat sugary bread in addition

programs promote nutritional orientation, the prevention

to sweetened beverages, while the intake of grains is

of child obesity and healthy pregnancy and baby health.

very low. Finally, a third trend is a shortage of fruit and

The second category includes: Cocoa Plan, Nescafé Plan

vegetables in infant diets.

and Dairy Commitment to ensure a stronger value chain and to help local agricultural entities become certified

To battle these issues, we have established different

providers for Nestlé. Finally, for the planet, Nestlé has

approaches. Nestlé has pledged to reduce ingredients

made a water-usage pledge and implemented a waste-

such as sugar and salt in all its products globally.

reduction initiative. In Mexico we even have one factory

Locally, we have different action plans. Among these

that operates with zero water.

there is a program called Portion Guidance, which includes suggested portions in a product’s label.

Q: How important is Mexico to Nestlé’s global operations?

Another campaign related to our water lines promotes

How much of your manufacturing is done here?

water consumption and we have also been improving

A: Mexico is an important location. Within Nestlé’s global

our cereal brands (no artificial flavors, whole grains as

operations, in terms of sales, it is ranked seventh generally

a first ingredient and reduced sugar). Mexico Gerber

and number three worldwide for infant nutrition. Nestlé

has reformulated its infant cereals to eliminate added

also has 17 factories in the country. In 2016, we opened our

sugar. Gerber has also launched a new organic product of

infant nutrition factory called Nantli with an investment of

fruits and vegetables for babies and preschoolers that is

more than US$245 million. This factory will supply markets

presented in pouches. Regarding all the diabetes issues in

in Mexico, Latin America and Asia. In 2013, Nestlé Mexico

the country, in 2017 we will launch a new line of products

exported more than 86 tons of locally manufactured

under the Boost brand called Boost Glucose Control. This

products to 29 countries and imported more than 29 tons

product specializes in nutrition for diabetics.

from 14 countries.

Q: What new technology are you pursuing in children’s nutrition?

Nestlé is a leading nutrition, health and wellness company present

A: Infant nutrition is a constant topic for our research

in more than 197 markets with around 2,000 brands. Nestlé also

budget and we are now focused on low-protein infant

executes local philanthropic and awareness campaigns in Mexico

formulas in response to excess protein intake around the

to battle the main nutrition problems in the country

209


VIEW FROM THE TOP

BABY FORMULA: THE CASH COW OF NUTRITION RAĂ&#x161;L CAMARENA General Manager of Aspen Labs Mexico

210

Q: What products did Aspen Labs launch in 2016 to

Mexico has made great advances in promoting maternal

address the needs of the Mexican population?

milk, which we support. A few years ago, for example,

A: In the nutrition segment, we launched our Infacare formula,

mothers had to take their maternity leave 45 days before

which complies with all requirements established by the

the birth of the baby and return to work 45 days after. In

WHO. Our installed capacity at Aspen Labsâ&#x20AC;&#x2122; Vallejo plant

2016, the labor law was changed and now a mother can

in Mexico City gives us the ability to offer this product at a

take her leave from the day before giving birth and up to

competitive price compared to what is traditionally available

90 days after. This encourages mothers to breastfeed, to

in the Mexican market. Our product is superior in quality to

be closer to and spend more time with the baby. To give

the dominant market equivalent and costs 10 percent less

mothers even more time with their babies and to deal

than that of our competitors. For those that require an infant

with any situation that might arise, Aspen Labs provides

formula, it is a great advantage to have a product that is not

its employees an extra 30 days maternity leave.

only accessible but of the best quality and efficacy. Q: What are the main issues in infant nutrition in Mexico?

Labor law changes in 2016 allow mothers to take maternity leave from the day before giving birth and up to 90 days after

A: The main issue with babies is undernutrition or malnutrition, which becomes obesity later in childhood and which is a major problem. There are also allergy issues that present during the lactation period and as babies begin to consume solid food such as mash or juices. Mexican families quickly acclimatize babies to the family diet, which causes serious obesity problems. The health system ends up dealing with the fallout from that. Q: To what extent do you carry out R&D in Mexico for specific formulas and conditions? A: We launched a significant project in the second half

Q: Is this formula designed for both healthy babies and

of 2017 to develop a new formula that addresses the

those with complications?

needs of Mexican babies and toddlers. The project is

A: This product would be suitable for healthy babies

being developed with renowned players in the public and

who require formula because their mothers cannot

private sectors that are dedicated to this matter.

breastfeed, for example. Infacare is part of a portfolio that we acquired in 2013. Infacare 1 is for babies aged

Q: What factors are driving growth in your infant nutrition

0-6 months, Infacare 2 for those aged 6-12 months and

sector and what are your expectations for 2017?

Infacare 3 for those over 12 months. We have another line

A: We saw significant growth in our nutritional segment

for children who have a medical complication. However,

due to the fact that, for the first time in many years, we won

we always emphasize the importance of breastfeeding

a public tender to provide nutrition for babies aged 0-6

as part of our core values and principles.

months and 6-12 months. This broke paradigms because for 20 years the tender had been won exclusively by one firm.

Aspen Labs is a South African pharmaceutical company, the

Our milk sales are not growing in the private sector due

largest listed on the Johannesburg Stock Exchange. Present in

to complicated market conditions, although we hope that

over 150 countries, it specializes in OTCs, infant nutrition, male

the launch of the new versions of Infacare will help us

and female health and cardiology

resume growth in this sphere in 2017.


VIEW FROM THE TOP

AESTHETICS TO OVERCOME ECONOMIC DOWNTURN VÍCTOR ANAYA CEO of Merz Pharma

Q: Merz Pharma enjoyed 13.2 percent revenue growth in

Mexican market. We acquired a patch in 2016 that helps

Latin America in 2015-2016. How important is Mexico to

remove tattoos quickly and with fewer inconveniences for

Merz’s regional strategy?

patients and doctors. The process for removing a tattoo

A: Mexico is Merz’s most important market in Latin

is long, painful and requires many sessions but this patch

America and the fourth most important worldwide.

reduces the time, pain and number of sessions. This is one

Latin America is a young region for us: our Argentinian

of the areas we are entering.

subsidiary was opened in 2016 and our Colombian and Brazilian units just before that. Merz’s financial year

Q: What possibilities are there for Mexican and Latin

runs from July to June, so the 13.2 percent growth is for

American companies to benefit from the Merz Corporate

the second half of 2015 and the first half of 2016. Our

Venture Capital Initiative?

aesthetics division saw the most growth in this period.

A: We are incentivized to look for new opportunities

Globally, the company is focusing on the aesthetics and

for development, not only globally but also locally. We

neurotoxins markets. The rest of our portfolio consists of

are working with a local company that may become an

what we call regional products.

opportunity for Mexico and, if it works, we will later make it a global opportunity. Our company invests through the

Q: What is Merz Pharma’s strategy to expand its portfolio?

venture capital fund and through other channels as the

A: Merz Pharma invests part of its profit annually in R&D,

Merz family has different businesses.

mostly in aesthetic medicine but also in research on neurotoxins, an important element in the study of the

Q: What is Merz’s strategy for growth in Mexico?

nervous system. Merz is working to find new applications

A: We believe we still have great organic growth potential.

for this compound. The company is also expanding its

The aesthetics market in Mexico is just starting to develop.

portfolio through strategic acquisitions such as Ulthera, a

The country’s economic situation has slowed the aesthetic

medical devices company that develops applications for a

market down a little, but we believe that growth will resume.

therapeutic ultrasound platform technology, and Anteis, a manufacturer of biomedical products. In 2016, we closed

We are interested in growing through new products and

the purchase of ON Light Sciences, a US company.

offering new options to patients. This represents a great opportunity as we have several product lines in aesthetics

Q: What solutions does Merz Pharma offer in the area of

in the US and in Europe that are not yet available in Mexico

personalized medicine?

and that would be attractive to the Mexican consumer.

A: Our personalized solutions involve neurotoxins and have specific medical uses, with applications in spasticity,

Q: What are Merz Mexico’s plans for 2017?

dystonia and blepharospasm. We have also published

A: The deceleration of the Mexican economy has created

the results of an important clinical study called Tower.

a greater challenge to continue growing at the same rate.

These results show that Xeomeen, our toxin, can provide

During 2017 we want to continue bringing new options to

personalized options for patients, allowing doctors to adapt

doctors and patients and to see growth in the markets in

treatments to each specific patient, including higher doses

which we already participate.

and different intervals. The toxin is available on the National Formulary and through the private market. Merz Pharma is an international pharmaceutical company

Q: Which aesthetics products will be introduced to Mexico?

focused on aesthetic medicine and neurotoxin solutions. Its

A: We have an extensive global line and we are analyzing

main therapeutic areas are medical dermatology, liver diseases,

options to see which can be adapted to the needs of the

Parkinson’s and Alzheimer’s

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INSIGHT

BE AWARE: SKIN CARE NOT JUST FOR WOMEN GERALDINE WAKED Director General of Sesderma

Skin diseases are varied and although skin-care advertising

September 2016 shows the extent of air pollution globally: 92

often targets women, men and particularly children are

percent of the world’s cities breathe polluted air, and so does

vulnerable groups that are often overlooked. “We need to

much of Mexico with the worst rates seen in Monterrey, Toluca

learn to have healthy eating habits but also to keep our

and Salamanca, according to a WHO 2016 report.

skin healthy. Skin cancer is not an adult disease,” says 212

Geraldine Waked, Director General of Sesderma, a Spanish

The male population is another segment that is often

dermatology laboratory founded in 1989.

overlooked, Waked says. “Men are beginning to use solar protection more and more,” says Waked, explaining that

“We have to raise awareness among the population and

men suffer from the same skin diseases and conditions as

among mothers that they should not send children to school

women, although skincare is mostly perceived as a female

without sun protection,” Waked says. She points out that 100

market. “Publicity is always focused on women, but really, the

percent cloud coverage only blocks 20 percent of UV rays.

purchasing level is similar between men and women,” she says.

Also, SPF only blocks UVB rays, responsible for sunburn, but not UVA rays, responsible for premature aging and cancer. In

The Mexican Society of Oncology (SMeO) reports that

addition, these rays are stronger at higher elevations, a factor

the number of malignant melanomas doubles every

to be considered in mountainous Mexico that sits at a mean

decade and that 5-10 percent of skin-cancer patients

elevation of 1,111m. Add in pollution that is prevalent in cities like

have a family history of the disease. “Skin cancer is the

the country’s capital and there is a double threat to children’s

worst skin affliction. It is becoming increasingly common,

health. “Children in cities like Mexico City often are not taught

especially in Mexico,” says Waked. One of the main issues

about pollution and even when an emergency contingency is

faced in Mexico is the lack of awareness around skin

in place, there is never talk of protection,” Waked adds. The

protection. Many people do not wear sun screen, even

WHO notes that children are more at risk of suffering from

though Mexico City sees an average of 200-270 hours

side-effects of air pollution due to the immaturity of their

of sun per month. “The dermatology industry’s eyes are

respiratory organs, and that those in middle-income countries

set on Mexico as the country with the most potential in

are among those most impacted. A map the WHO released in

Latin America,” says Waked.


VIEW FROM THE TOP

SHIFTING MARKET DEMANDS ADAPTABILITY ALEJANDRO LÓPEZ Founder and CEO of IM Natural

Q: What is IM Natural doing to accomplish its expectations

Q: What are your distribution channels?

for 11 percent growth in the cosmetics industry by 2019?

A: We have two levels of self-service partners in Mexico:

A: The company is changing its internal structures so it

regional, such as Casa Ley in Sinaloa and Operadora

can procure the necessary merchandise to supply national

Futurama in Chihuahua, and national, such as Walmart,

demand. Competition is also growing daily, so we update

Chedraui, Soriana, H-E-B, Farmacias Guadalajara and

all our resources constantly because the Mexican cosmetics

Farmacias Benavides. We started in naturist retailers and the

market can be unpredictable. Although trends may vary on a

market pulled us toward new distribution channels. IM Natural

daily, weekly and monthly basis, in general when the economy

then started exporting, assembling for foreign companies,

contracts it is reflected in lower demand but sometimes the

licensing its products and finally developing private labels

market does the contrary and our main customers place

for national companies such as ISSSTE-marts, Farmacias

bigger purchasing orders than usual. We must be wary of

Benavides and Almacenes García.

transnational companies noticing this bipolarity. L’Oréal, for example, whose products are meant for a wealthy, high-

Q: How would you describe IM Natural’s success in entering

income market, may notice that our products, destined for

foreign markets?

the middle and lower-income segments, have higher demand

A: We have had mixed results. IM Natural exports its

strength in terms of volume and bulk, so it turns its focus

products and also negotiates licensing representations and

to our market. Those companies retain their prestigious and

manufactures for foreign companies. The company has

high-end market while also producing products to compete

entered new foreign markets thanks to our distributors and

with midlevel companies.

the support of ProMéxico. We have exported our products to Europe and South America and recently we started selling our

Q: What is your focus in terms of internal corporate changes?

products in the US, performing especially well in states with

A: The goal of these corporate changes is to enhance

a high concentration of Latinos, such as California, Texas and

efficiencies in product delivery, quality, replenishing delivery

Illinois. IM Natural is negotiating with new distributors such

reach and general operational effectiveness. This internal re-

as Walmart, CVS and Walgreen’s to enter other markets but

engineering entails a commercial re-engineering.

these processes are lengthy.

IM Natural is a traditional company known for its mamey seed

The company has faced various levels of market openness in

oil mascara. However, we sell a great variety of eye mascaras

countries that recognize COFEPRIS. For example, we have

made of different ingredients, which provide different

already entered Colombia. Argentina is more difficult but

benefits and different presentations. We also have a wide

easier than Chile, while Brazil is virtually impossible. In other

range of face creams and lotions that will be affected by the

markets such as Peru and Ecuador, IM Natural is deciding

re-engineering of our operations. We are changing the image

whether to export or produce for local companies. The

of our face creams, creating new creams and formulating

company has received sanitary registrations in Bolivia to

new lotions. IM Natural is known for using a variety of natural

produce mascara. IM Natural produces for a Mexican-owned

ingredients like chamomile, snail slime, argan and marrow

company in Australia and we are about to grow its cosmetics

in its cosmetics. This company was the first to use mamey

line with new creams and facial products.

seed oil, which enhances eyelash growth, and traditionally employs national ingredients. It is important for some of our customers that animal ingredients are not used in our

IM Natural has been focused on the naturist segment and

products while other countries require that our mascaras

cosmetics industry since its foundation in 1989. This company

contain no parabens. One of our policies is not to test any of

uses natural colors and pigments and has never tested on

our products on animals.

animals. It promotes environmental protection

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VIEW FROM THE TOP

ANCESTRAL REMEDIES, EUROPEAN TECH, MEXICAN-MADE ADRIANA AZUARA CEO of All4Spas and Agave Spa

214

Q: To what extent is the demand growing for the natural

to pollution, the skin gets thinner due to pollution and

products Agave Spa produces?

people want face-lifts to appear younger. Our after-sun

A: Everyone wants natural and organic products but the

treatments are also popular because the sun can be

consumer needs to be aware because nothing is completely

extremely damaging and we need to not only protect

organic or natural. Talking about natural ingredients means

ourselves at the beach but afterward as well.

that we do not use chemicals that damage the skin or lifestyles. Many people now want natural products that

Q: How aware is the population of the need to protect

produce tangible results, which is why we combine the

skin against pollution?

ancient with the modern. We use ancestral remedies and

A: People need to protect their skin against pollution,

the knowledge of the Mayans combined with European

even indoors where it can sometimes be more polluted

technology, dermatological tests and exact combinations

because people are crowded into a room or working long

to ensure it provides accurate results for the body and

hours under artificial lighting, among other factors that

skin. We want to create rituals that are suited to a personâ&#x20AC;&#x2122;s

produce free-radicals that damage and destroy skin. It is

lifestyle so that the effect of the treatment not only lasts for

necessary to use anti-oxidants to protect the skin against

a moment but actually changes energy points. We choose

this, and also wrinkles and acne.

23 points on the body that energy flows through and these can be opened and closed. If those points hurt when

We have discovered that the blue agave plant is full of

pushed, they are blocked. We unblock these energy points

active ingredients that are good for the skin and hair.

and with obsidian stones we loosen the energy left in the

It contains a powerful antioxidant, a moisturizer and

body and then use massage oils containing tepezcohuite, a

stimulates the collagen in skin. The latest research shows

Native American plant, and other ancestral herbs.

that there is a fungus on blue agave leaves that has the same properties as hyaluronic acid. It is a powerful plant.

Q: What factors are driving your growth? A: When people come to Mexico, they want to try Mexican

Q: What alliances allow you to source your ingredients?

products and this company meets that need. In March 2017

A: I work directly with agave farmers. We choose our agaves

we launched an unscented line that can be mixed with

and then create our phyto-complex and other products

natural herbs and fruits, allowing spas to create their own

from the agave leaves, plant, cooked plant, fermented plant

scents like alchemists. There is also a new tepezcohuite

and other parts. This is because each part of the blue agave

line combined with blue agave for the face. This is what

has different properties for different things. We source

will make it a success: everyone wants to mix and play and

coconut oil from Guerrero and we have recently launched

create their own unique products.

a massage candle without paraffin. The clay bases were created by Mexican artisans, each handmade and dried

Q: What are the main skin care needs you have detected

in the sun. We work directly with Mexican farms for all

in Mexico?

ingredients, such as those that make up our four blends of

A: Dryness and the resulting wrinkles are a common

essential oils. They contain San Juan herbs, passion-flower

concern, as are hyper pigmentation and lifting. Due

and hibiscus. These ingredients are unique and require cooperation with Mexican farmers.

Agave Spa is a luxury Mexican cosmetics range created with

We will soon launch videos on how we work with

natural and traditional Mexican ingredients, the main one

communities that have four generations of experience in

being agave. All4Spas is a retailer of every piece of equipment

what they do. Instead of growing our lines uncontrollably,

needed for spas

we prefer our products to be exclusive and luxurious.


VIEW FROM THE TOP

SUCCESS BREEDS NEED FOR CASH, TALENT RICARDO SPÍNOLA Director General of Farmapiel

Q: How has Farmapiel’s expansion plan impacted its business

anti-aging products contain topical vitamins for the skin.

operations and what is the end goal?

These products are used at night after washing the face and

A: Since changing stockholders around three years ago,

neck and hydrate and replenish the skin with vitamins.

we have been expanding quickly and are engaging in an aggressive growth strategy to become a big dermatology

Q: To what extent is the Mexican population focusing on its

player in Mexico. We have enjoyed triple digit annual growth

dermatological needs?

over the past year. This is a good result but it also increases

A: The market has grown significantly and, as the economy

the need for cash, changes in business processes and new

grows, people take more care of themselves. For example,

people. We are now building the organization for the future.

more people go to gyms and because they are exercising more, people are more aware of their image. Twenty years

We launched 12 products in 2016, split between the Rx

ago, teenagers with acne treated it by using soap. Now,

segment, dermo cosmetics and a new line of aesthetics and

they go to a physician and then a dermatologist, who also

we have made advances on our manufacturing plant in San

looks at the accompanying parent and might point out un-

Juan del Rio, Queretaro, which we acquired from GSK two

diagnosed diseases such as rosacea, dark spots or adult

years ago. It has been remodeled and has received approvals

acne. Innovations in dermatology mean treatments no longer

from COFEPRIS. At that plant, we manufacture for local and

irritate so much while the combination of ingredients provides

international companies, which is the reason we undergo

better treatment. We have an acne product, for example, that

many audits. We are also working on getting FDA approval

combines an antibiotic and a retinoid. The latter helps the

for next year. We have been reorganizing the company and

skin regenerate while the antibiotic fights the infection. The

we are close to seeing positive financial results. Measuring

general derma market grows on average 5-7 percent per year.

market share can be complicated so we use QuintilesIMS and

This covers OTCs, Rxs and cosmetic products.

ATV as yardsticks. Three years ago, we were ranked 84th for dermatology in Mexico. We are now 15th.

Q: What is Farmapiel’s strategy for expansion? A: We want to consolidate the company, export products

Q: How will the company use the extra income generated?

and establish subsidiaries outside Mexico, in the Latin

A: We will be paying off our debts first, since the

American region. Ideally, we will start with Central

management of the company and the complexity of rapid

America and the Caribbean, due to proximity. We will

growth can be difficult. The demand for working capital is

then move to selected countries in South America. If

high with triple-digit growth, so we need to manage the

we have confidence in Mexico, good things can happen.

cash cycle closely. A steep sales curve is nice to see but is

Our factory is generating employment opportunities, the

costly. Products need to keep moving but distributors will

economic benefits of our production chain trickle down

not risk buying something that will not sell.

and the company can grow with the right people, products and confidence. With backup and investment from the

Q: What is the company’s best-selling product?

international private equity fund we work with, we have

A: We have many best-selling products such as our

managed to grow exponentially. Hopefully many other

prescription products for acne and whitening products for

Mexican companies will follow this rapid growth route.

fighting dark spots on the skin, which can be caused by sun exposure. We also have products from Europe that treat hair loss, such as Bioscalin, a top-selling product in Italy

Farmapiel is a Mexican pharma laboratory with 24 years of

and France, high-tech-enhanced shampoos and lotions and

experience that is focused on dermatology. It has innovative

psoriasis products. All our solar protection products are

and quality solutions in therapeutic derma areas such as acne,

hypoallergenic and contain no perfume or color while our

dermatitis, depigmentation and hair loss

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VIEW FROM THE TOP

R&D GOALS FOCUS ON HEALTHIER SKIN, ALLERGIES CÉDRIC ERTLÉ CEO of Expanscience

Q: What are Expanscience’s main business lines in

are doing anything about their skin during pregnancy in

Mexico?

Mexico, so we want to create this new market.

A: Our Mexican business leans on two pillars. First is

216

the Mustela brand, which includes products for babies,

Q: How is Expanscience’s osteoarthritis portfolio

children and new and expecting mothers. The second pillar

addressing the new challenges brought about by Mexico’s

is our osteoarthritis solutions portfolio, with medicines

aging population?

and medical devices for the elderly. We put the same

A: We have a drug called Piascledine 300, a solution

effort and a similar investment into both business lines.

designed to reduce pain and the progression of osteoarthritis. It is a leading treatment in the rheumatology

Q: What is the company’s R&D focus in Mexico?

pharmaceutical market and it was also developed to lower

A: Expanscience has three R&D goals for Mexico. First, we

the use of nonsteroidal anti-inflammatory drugs, which

want to launch our Mustela products designed for specific

usually have secondary effects. Our Euflexxa TA treatment

skin types. It was previously believed that environment

can help prevent surgery in advanced cases. It consists

caused skin to become dry or atopic but we recently

of injecting hyaluronic acid into the damaged articulation

discovered that all babies are born with a certain skin

for six months. This will create a buffer solution that

type. We are in the process of bringing to the market

replaces cartilage lost due to osteoarthritis. We expect

specialized products for babies who have either dry or

to become leaders with this drug – so far it became the

normal skin types, in addition to a product for babies who

second best-selling product in Mexico. We are seeing

have a higher probability of developing allergies.

significant growth from prescription drugs, representing 35 percent of our sales. We have included a collagen

The second priority is to become stronger in the diaper-

supplement called Orangel in our osteoarthritis portfolio,

cream market and to introduce Mexican parents to

a product that produces a great effect with just 40mg of

this product, as many still use powder. The volume of

active ingredient. Although our competitors have similar

this market is 9 million units per year, led by Bayer’s

products, those need 10g or 20g to produce the same

Bepanthen, which sells 3 million units per year. However,

effect. Also, we can offer capsules of this supplement

the market could be even bigger as 2.3 million babies are

while others offer dissolvable medicine, so we expect

born annually in Mexico. Our diaper cream is designed

great success with this product.

to prevent, calm and repair rashes and it is registered as a medical device by COFEPRIS and recommended by

Q : H ow i m p o r t a n t i s t h e M ex i c a n m a r ke t fo r

the Mexican Organization of Dermo-Pediatrics. When we

Expanscience’s global business?

first entered Mexico in 2002, we sold around 250,000

A: Mexico is important for Expanscience because it is

units annually. Now we are focused on reaching 1 million

one of the company’s four strategic subsidiaries, along

units. Our third development area is skin care for mothers.

with Brazil, Russia and the US. In 2016, Expanscience saw

Most pregnant women fear stretch marks, so we have

30 percent growth in Mexico, 56 percent of which was

developed a daily cream and oil that guarantee the

provided by the osteoarthritis business and 26 percent

reduction of stretch marks by 96 percent. Few women

by the Mustela line. Mexico is also the manufacturing base for the Orangel OTC brand. The raw material comes from the US and the product is manufactured in Mexico with

Expanscience is a French pharmaceutical and dermo cosmetic

a partner company, Salutary. Euflexxa in Mexico is also a

laboratory focused on wellness solutions for newborns,

result of a partnership with Ferring, the pharmaceutical

teenagers and the elderly. Its main lines, Mustela and

company in the US that holds the license for Euflexxa in

Piascledine 300, are present in almost 100 countries

every country except Mexico, where we have exclusivity.


VIEW FROM THE TOP

ACTIVE AND EXPANDING FABIÁN BIFARETTI CEO of Sports World

Q: How important is it for Mexican companies to work

A: New gyms and studios are constantly appearing and

together, such as Sports World does with Grisi?

innovating with new forms of exercising. The competitive

A: One of the major advantages is the direct contribution

advantage we have is that we can easily adapt to new

to the national economy via the increasing quality of goods

trends and offer those new activities within our facilities

and services that can be attained through joint efforts.

at a very low or zero cost. We have a comprehensive offer

These alliances also foster competition and consumers

that we are constantly innovating and adapting to new

reap the benefits of a bigger and more balanced market.

trends in the market.

Q: Membership also comes with access to Dentalia. What

Q: How many new clubs do you expect to open in 2017 and

is the strategy behind this?

how will you finance that expansion?

A: In line with our wellness strategy, we keep adding

A: During 2017, we have opened four clubs and four more

different services and products related to enhancing

are under construction with the pre-sale of memberships

our customers’ health and wellbeing. Dentalia offers

ongoing, so we are in line with our expansion plans for

our customers two free-of-charge dental cleanings per

the year. Most of these openings have been and will be

year as well as significant discounts on all their services.

financed with debt.

Some of our additional health benefits are yearly blood tests, nutritional and 24-hour medical phone assistance,

Q: Last year, Sports World mentioned wanting to expand

two ambulance services per year and special medical

outside of the capital. What growth and results has it

insurance discounts.

seen from this? A: We have 15 clubs outside of Mexico City and its

Q: To what extent has Sports World incorporated activities

metropolitan area. We have had a very good acceptance

for children?

and positive results in the states we are present in and we

A: At Sports World we have an area of approximately

plan to expand to other states. In 2017, three of our eight

400m named FitKidz that is designed exclusively for

new clubs will be outside of Mexico City. In the coming

children. They can join more than 30 different activities

years, most clubs will be opened outside of Mexico City

such as SafeSplash, aerial dance, indoor climbing, tae-kwon-

but we will continue to look for opportunities in the

do and baby gym, among others. The goal is to start the

capital.

2

habit of exercising from a very early age and introduce children to a wellness lifestyle.

Q: What are your overall revenue expectations for 2017 and

Q: How can gyms inspire more people to be active and help

A: Our objective is to open eight clubs during 2017,

lower the chronic disease burden in Mexico?

achieving 19-21 percent growth in revenues and an

A: Gyms are able to link sedentary people with a more active

EBITDA margin over revenues of more than 17 percent. In

life, not only through strength and cardio equipment but with

terms of international expansion, we do not have specific

a robust wellness orientation that includes group classes,

plans yet but we are open to opportunities that might

meditation, yoga, Pilates, steam rooms, saunas, massage

come either through organic expansion or acquisitions.

are there any plans to expand internationally?

services, nutrition experts, facilities for kids, swimming pools and a Feel Healthy Program (for people with T2D and hypertension), as well as many other special activities.

Sports World is a chain of high-end gyms in Mexico that aims to promote a well-rounded healthy life, going beyond

Q: As new gyms appear, how is Sports World prepared to

providing a space to exercise with classes, nutritional advice

rise above the competition?

and other health services

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VIEW FROM THE TOP

VIRGIN MARKET A POTENTIALLY GREAT NICHE MIGUEL MARÍN CEO of Industrias Sintoquim

Q: Sintoquim turns 40 this year. What are the company’s

begun wearing make-up from a younger age and adding

most important achievements in these four decades?

sun protection.

A: One of the biggest achievements has been consolidation

218

and remaining a 100 percent Mexican company. We began

Q: How aware is the Mexican population that it must care

with focused distribution for food, pharmaceuticals and

for its skin against the sun?

cosmetics and afterward we entered manufacturing. We

A: I think skincare is more a theme of vanity than health.

produced aluminum clorohydrate for over 20 years and

As a result, skincare is much more about avoiding

during this period we started with the distribution of other

wrinkles, blemishes, pigmentation, cellulitis and stretch

raw materials. That is our current business model. We are

marks because these are the issues that people worry

venturing into nutritional supplements, particularly those

about. Sun care is not growing at the pace it should but

that benefit skin, hair and nails.

it is improving. We need to get into the habit of doing this every day.

Q: How will you ensure your supplements stand out from those already in the market?

Q: What are the greatest challenges and opportunities

A: Mexico is a virgin market for supplements and there

you have seen in skincare and cosmetics?

is a lower culture of prevention here. We believe there

A: There are two macro trends in the cosmetics industry.

is a great market niche and we are bringing specific

The first is multifunctionality. People prefer one product

ingredients that will add value. One of the most important

that does many things, which is where the success

elements of these supplements is organic and bioavailable

of BB creams stems from. The second main trend is

silicon. Part of Sintoquim’s contribution is ensuring the

personalization. Products are increasingly specialized and

product will be absorbed upon digestion. “In and out” is

consumers want a cream adapted to their skin type. There

a trend we have seen in other countries and that we want

are now devices that measure skin type, evaluating which

to bring to Mexico: products taken orally and applied

type of make-up is best for that person. This technology

topically that will act in synergy to achieve more visible

enables such personalization. If companies can find a

results in less time.

way to make these two trends complementary, they will achieve great success.

Q: In Mexico there is little culture of prevention. What is your strategy to achieve your sales goals in supplements?

Q: What type of technology are you implementing in

A: Data show it is more expensive to treat an illness

your products?

than to pay for prevention. It is better to convince

A: The cosmetics industry is one of the most dynamic because

people who may become diabetic to change their diet

it follows fashions and the color of the year, the ingredient of

and to exercise. The government has realized this and

the year, or the new claims that arise. Some concepts that

is promoting prevention. Mexico tends to copy more

were previously unheard of are now fundamental. Consumers

advanced countries and what was launched around five

are increasingly informed and aware of the ingredients in

years ago in Japan or the US is now trending in Mexico.

their products and the benefits. We are bringing new

There are many people that go to gyms, consumers have

technology propositions to the Mexican market. We work with ingredients houses that are researching today what will be launched in five to 10 years. There are now many products

Industrias Sintoquim is a Mexican family-owned company

that aim to energize mitochondria in cells, or prevent the

focused on the commercialization of prime materials and other

accumulation of proteins, or promote collagen and elastin,

specialties for the cosmetics industry. It operates in sun care,

for example. These products promote certain functions

skincare, make-up, hair and color

directly in skin cells.


219

An athlete from the swimming academy SAFESPLASH

Q: Where do you source your ingredients?

clients to use as a base. For larger companies, we can offer

A: We use ingredients from different parts of the world,

the product within the timeframe and in the quantity that

such as the US, Monaco, Germany, Brazil and Japan. We

they require. We are also able to offer a safety stock to

have just signed an agreement with an Indian company

cover any eventuality. The other two fundamental drivers

and we also work with Chinese sources. Our goal is to

are the quality of products and price. These elements make

have a broad portfolio to offer complete solutions to the

Sintoquim a market-leader and persuade clients to work

market so a client can buy everything they require from

with us instead of the competition. Should a client wish to

us without needing to look elsewhere. Much of our added

develop any type of cosmetic, they can find almost every

value lies here.

ingredient with us, except for the very simple ones, such as mineral oil, ethylic alcohol, etc. Clients do not have to

Q: How have you achieved your current market presence?

waste time looking for 10-15 suppliers.

What strategy will you employ to boost it? A: We are the strongest player in hair color and make-up

Q: What strategy will you implement to continue

color and we are also strong in skincare. Our main virtue

growing?

is that we have suppliers and commercial partners that

A: The main challenge is adapting to change. Companies

are classed among the top three players of their specialty.

that subsist and are successful are those that identify new

We have a good mix between global and local companies.

niches and trends, advancing and changing faster than

We sell to Lâ&#x20AC;&#x2122;OrĂŠal, Avon, Unilever, Jafra, IM Natural, Grisi

others. We are in the midst of many changes: replacing

and Genomma Lab, in addition to catalogue sellers such

our operating system, obtaining ISO certification and

as House of Fuller, Zermat and Arabela.

redesigning our commercial model to be more efficient and more agile. The market is also demanding lower prices

Q: What is the added value Sintoquim offers that retains

as big companies in particular are looking to improve

customers?

cost-efficiencies. A final challenge will be to generate

A: We have a marketing division that researches trends

alternative markets. I am confident that supplements

from around the world. In addition, our applications

combined with topical products will be among the most

laboratory generates complete proposals or formulas for

important market niches in coming years.


INSIGHT

REGULATORY CRACKDOWN CREATES HERBAL OPENING IGNACIO LUNA CEO of Biofarma

220

The authorities charged with regulating health matters

He explains that the herbal medicine industry is

have launched a war on so-called “miracle” products. In

experiencing a boom that would not have been

2015, COFEPRIS removed 5 million products from sale and

thought possible 25 years ago, when the company was

a further 1.4 million in 2016. This extra vigor in regulating

established. “It has grown significantly in monetary terms

Mexico’s herbal medicine market has left few competitors

and in numbers,” he says. This does, however, bring its

standing — and created an opening for companies like

own set of problems because herbal medicine is copied

Guadalajara-based Biofarma.

and sold on the black market as much as pharmachemical medicine. “NOM-059 dictates that companies have to

“In terms of herbal supplements, Mexico is much more

ensure packaging does not fall into the wrong hands,”

advanced in regulation than the US,” says Ignacio Luna,

says Luna, explaining how Biofarma helps reduce the

the company’s CEO. He explains that in the US, companies

opportunities for counterfeit medicine by ensuring its

are free to manufacture their products but need to self-

packaging remains safe and its products cannot be

regulate because a bad product will quickly be the subject

tampered with.

of litigation. “Mexico has done an incredible job. It has very strong regulations,” he adds.

In addition to adherence to strict regulatory standards, certification from the FDA, the National Safety in Food

Due its strong regulations, COFEPRIS is recognized as a

(NSF), strict quality control and GMPs reinforce Biofarma’s

reliable sanitary authority in many Central and South American

strong position in the market. The company will continue

countries. The same agreements that enable pharmachemical

to release new products including a herbal remedy for

medicine to be exported to those countries also apply to

menopause, vitamin gummy bears and an anti-obesity

herbal products. “I believe Mexico’s regulation is increasing.

product. “We have noted the same opportunity in the

The treaties we have with different countries include herbal

obesity market as the joint product market,” says Luna.

medicines with GMPs and NOM-059-SSA1-2015. We receive the same treatment as a generic or any other kind of

Biofarma operates four lines of business, namely OTCs,

medication,” Luna says.

herbal medicine, remedies and supplements. Its bestselling product is glucosamine, which provides pain

NOM-059-SSA1-2015 regulates the manufacturing and distribution of medication

relief for joints with osteoarthritis, where it claims over 40 percent market share. While figures for that particular segment are hard to come by, Euromonitor estimated in September 2016 that the herbal and traditional products market in Mexico would be worth MX$9.5 billion (US$527 million) by 2021, not including vitamins and supplements which it pegs at a potential MX$23.2 billion (US$1.3 billion) for the same year.

The National Association of the Nutritional Supplements Industry (ANAISA) is working to further improve regulation

With a presence in Mexico, the US, Peru, Guatemala,

surrounding nutritional supplements. The appellative for

Colombia and Costa Rica, Biofarma has plans to expand

the products is one of the first objectives. “In Mexico our

to Panama, Brazil and Chile in 2017 — large markets that

products are known as nutritional supplements but they do

offer opportunities and consumer behavior similar to

not supplement. They are more complements, as our diet is

that of Mexico. “These consumers appreciate Mexican

rich in vitamins and minerals. Our products fill the gaps in our

products and view us with respect, which is good for

diet,” Luna says.

us,” says Luna.


ROUNDTABLE Prevention is the key to good health but action usually derives from awareness. Today, a greater percentage of the population is cognizant of the dangers posed by headline-grabbing conditions such as cardiovascular, diabetes and obesity. There is much less mindfulness regarding the impact and subsequent consequences of environment on the skin from a daily onslaught of pollution, sun and dirt from the outside and poor nutritional habits from the inside. Mexico Health Review asked relevant players in the dermatology industry about

WHAT FACTORS IMPEDE SKIN CARE AND WHAT ARE SOME PROTECTIVE MEASURES?

the level of awareness of the general population of their dermatological care needs.

People need to protect their skin against pollution, even indoors, where it can sometimes be more polluted because people are crowded into a room or work 221

long hours under artificial lighting. These are factors that produce free-radicals that damage and destroy the skin. It is necessary to use anti-oxidants to protect the skin against this, and also to protect against wrinkles and acne. We have discovered that the blue agave plant is replete with active ingredients that are good for the skin and hair. It contains a powerful antioxidant and a moisturizer and stimulates the collagen in skin. The latest research shows that there is a

ADRIANA AZUARA CEO of All4Spas and Agave Spa

fungus on blue agave leaves that has the same properties as hyaluronic acid. It is a powerful plant.

The market has grown significantly and people are taking more care of themselves as the economy grows. Twenty years ago, teenagers with acne dealt with it by using soap. Now, they go to a physician and then a dermatologist, who also looks at the accompanying parent and might point out un-diagnosed diseases such as rosacea, dark spots or adult acne. Innovations in dermatology mean treatments no longer irritate so much while the combination of ingredients provides better treatment. We have an acne product, for example, that combines an antibiotic and a retinoid. The latter helps the skin regenerate while the antibiotic fights

RICARDO SPĂ?NOLA Director General of Farmapiel

the infection. The general derma market grows on average 5-7 percent per year.

I think skincare is more a theme of vanity than health. People want to stay young. As a result, skincare is much more about avoiding wrinkles, blemishes, pigmentation, cellulitis and stretch marks because these are the issues that people worry about. Sun care is not growing at the pace it should but it is improving. People now use sun block but they still have the idea that this should be done only at the beach; we need to get into the habit of doing this every day. The cosmetics industry is one of the most dynamic because it follows fashions and the color of the year, the ingredient of the year, or the new claims that arise. Some concepts that were previously unheard of are now fundamental. Consumers are increasingly informed and aware of the ingredients in their products and the benefits.

MIGUEL MARĂ?N CEO of Industrias Sintoquim


A robotic arm sorts blister packages according to the number of blisters it contains


LOGISTICS & SUPPLY CHAIN

10

In a growing pharma and medical market such as Mexico, efficient logistics are vital for healthcare businesses. Companies are moving products and devices nationally and internationally while looking for the fastest and safest way to do it. In Mexico, the challenge of access to medicine is not only economical, it is also geographical. Some states are difficult to access due to rough terrain, long distances or security concerns. Many companies have also commented on the rise of the black market in Mexico, which makes guaranteeing the authenticity and chain of custody of a product all the more vital. The greatest challenge for Mexican logistics and components providers is thus ensuring the supply chain in this expansive and sometimes dangerous environment.

This chapter explores the strategies of logistics companies for dealing with and preventing these security problems, in addition to the high-tech innovations they have implemented in their fleets. While some are implementing apps and designing temperature controlled trucks, others are working on electromagnetic locks to prevent merchandise theft and putting systems in place to chase down thieves.

223


CHAPTER 10: LOGISTICS & SUPPLY CHAIN 226

ANALYSIS: Rough Terrain: Navigating Mexico’s Logistics Segment

228

VIEW FROM THE TOP: Víctor Soto, Levic

229

VIEW FROM THE TOP: Rafael Figueroa, Aeroméxico Cargo

230

VIEW FROM THE TOP: José Alberto Peña, Grupo Marzam

232

INSIGHT: Daniel Pardo, Medistik

233

INSIGHT. José Aedo, SINGREM

234

VIEW FROM THE TOP: Mario García, GNK Logística

236

VIEW FROM THE TOP: José Eric Delgado, Sicamsa

237

VIEW FROM THE TOP: Ingrid Ritter, UPS

238

VIEW FROM THE TOP: Erick Jiménez, Majicarga

239

VIEW FROM THE TOP: Sergio Chabolla, ANADIM

240

VIEW FROM THE TOP: Alberto Wicker, Signufarma

241

VIEW FROM THE TOP: Alonzo Autrey, DVA Mexicana

242

VIEW FROM THE TOP: Manuel Sánchez, Diphsa

243

VIEW FROM THE TOP: Abraham Franklin, Grupo Franklin

244

VIEW FROM THE TOP: Ángel De Vecchi, VECO

245

VIEW FROM THE TOP: Edgar Arteaga, Inframedica

246

VIEW FROM THE TOP: Guillermo Martorell, Grupo RFP

247

VIEW FROM THE TOP: Antonio Pascual, ANAFARMEX

248

ROUNDTABLE: How are You Overcoming the Logistics Hurdles in Mexico?

225


ANALYSIS

ROUGH TERRAIN: NAVIGATING MEXICO’S LOGISTICS SEGMENT Mexico presents a great number of logistics challenges but just

To combat this, trucks are fitted with GPS,

as many opportunities. Geography, gas prices and insecurity

cameras, electromagnetic locks and many

fall on the minus side of the ledger while increased demand

have an alarm system to quickly alert local

for transportation and storage are on the plus side

authorities who can then track down the

Mexico can be a tough place to navigate. The country

with private security at the request of the client, often

is the 14th territorially most expansive in the world,

for high-value cargo.

thieves. In certain cases, transports are sent

according to the CIA Factbook, with a mean elevation

226

of 1,111m above sea level. It is no surprise then that

In addition, in January 2017, the Mexican government

transporting goods through rugged mountains, low

eliminated gas subsidies from most Mexican states,

coastal plains, high plateaus and deserts is no easy feat,

which meant an increase in the costs of logistics

especially when the goods are as sensitive to temperature

providers and provoked protests throughout the country.

as in the healthcare industry. The distances also represent

However, companies are already working on strategies

a challenge: Mexico’s 1,943,945km2 of land extend from

to counteract this. “2017 will be a challenge from an

the US in the north, to Guatemala and Belize in the south.

exchange-rate perspective,” says José Alberto Peña, Director General of Grupo Marzam. “For us, another key

KEEP COOL

component is gasoline, which has a direct impact on

To overcome such logistical hurdles, distributors travel

our expenses. The exchange rate will have an impact on

by land, sea and air employing the latest technological

the industry as a whole because 90 percent of material

advances. Temperature control has become a basic-must

used to produce medicines is imported. Before, perhaps

among Mexico’s varied climates, ranging from tropical

businesses did not focus as much on driving efficiency

to desert, so companies are innovating to provide the

in all areas but it is about the details now. For example,

smallest thermal variation possible during transportation.

we have almost 500 vehicles and we have decided that

In addition to maintaining huge cold chain infrastructure,

whenever we change a vehicle, it should be at least diesel.

creating strategic alliances is a key strategy.

We want to move to hybrid or electric in the future.”

"We own thousands of square meters of refrigerated

HIT THE ROAD

space throughout the world and we have agreements

Despite its challenges, Mexico still presents many

with suppliers such as vaQtec and Envirotainer, which

opportunities for logistics and companies expect growth

enable us to maintain the cold chain throughout the entire

in the country. In June 2017, PwC forecast road freight to

process. The most difficult products to transport are those

grow by 3.2 percent in Mexico in 2017, rail by 4.9 percent

that require a controlled temperature because they are

and air by 1.2 percent. Overall, the report states that road

shipped from the factory to conservation warehouses and

remains the most used mode of transport in Mexico,

then to our customers or final consumers," says Rafael

accounting for 80.8 percent of transportation.

Figueroa, Director General of air freight market-leader, Aeroméxico Cargo.

“Five or six years ago, two-thirds of the global healthcare market was in the US and Europe. Now, those are mature

HIGHWAY ROBBERY

markets and, although they are significant in size,

Other challenges include navigating the security

emerging markets are growing at faster rates. The number

environment, as the vast and sometimes remote expanses

one region for growth in healthcare is the Asia-Pacific

traversed by fleets increase risk. There were around 1,000

Economic Cooperation (APEC) region, mostly driven by

assaults on cargo vehicles on highways from January to

China and India and followed by Latin America,” says

November 2016, according to the National Public Security

Ingrid Ritter, Healthcare Strategist Latin America of UPS.

System (SNSP). “[Insecurity] has impacted us significantly, especially during times of strikes and demonstrations. During

Factors pushing growth in the logistics area are many,

a period of countrywide protests in January 2017 (following

including the expansion the generics market has

a hike in gas prices), our deliveries were delayed, sometimes

seen in recent years, mostly due to the government’s

up to a week, because there was no way to get through,”

consolidated-purchasing schemes. “Information has also

says Mireya García, Director General of Distribuidora Alpilo.

pushed growth because people are increasingly aware


that patented and generic medicines are the same. The

SCORE OF CATEGORIES THAT CONTRIBUTED FOR MEXICOTHAT COMPETITIVENESS SECTORS CONTRIBUTED2016-2017 TO MEXICO'S COMPETITIVENESS 2016-2017

difference is only in the cost to patients. As Mexico is

Institutions

and have access to more information. People now know

an emerging economy, people need medicines and need to be able to obtain it. This theme of accessibility has boosted growth for us,” says Víctor Soto, Director General

Innovation Business sophistication

of Levic, a Mexican logistics provider.

7 6 5 4 3 2 1

Infrastructure Macroeconomic environment

Health and primary education

Market size

Additionally, NOM-059-SSA1-2015, which regulates good practices for medicine manufacturing, came into effect in February 2016, impacting national and international logistics companies. “It stipulates that to transport pharma goods within Mexico, a company

Technological readiness Financial market development

must use vehicles specifically for this purpose and cannot transport anything but pharma goods. As we

Higher education and training

Labor market efficiency

Goods market efficiency

——Score based on key indicators

are already dedicated to this and have a cold chain in place, this norm has benefited us,” says Mario García, Vice President of Operations at GNK Logística. “It is excellent because it eliminates foreign companies from

36,139km of urban roads

227

providing transportation between states and also benefits the security and safety of goods because they could be contaminated by other goods and supplies in the cargo. I am sure that within two years, labs will be working only with logistics operators dedicated 100 percent to

158,180km

of paved highways (federal, state and toll highways)

pharma.”

E-COMMERCE Pharmacies are working to improve their position in the market, grouping together in associations such

118,812km

847

39

3,476

178

of rural (unpaved) roads

toll stations

ferry routes

as ANAFARMEX or Grupo RFP. They share a desire to modernize their operations and venture into e-commerce with logistics companies. “We are hoping for aggressive growth, because we are still small. We need to more than double our revenue from home deliveries in 2018, reaching around 150 percent growth as we are starting

bridges

from a small base. We expect to see growth of around

tunnels

300-400 percent in our online services,” says Guillermo Martorell, Director General of Grupo RFP, which brings together small and medium pharmacies. In 2016, Milenio reported that although independent pharmacies were the greatest in number at 22,000 across Mexico, the 7,500 branches of pharmacy chains dominate the market with 65 percent of sales. In addition to implementing e-commerce, several logistics

25,844 MEXICO - FREIGHT MODE BREAKDOWN 2017 (%) places linked

MEXICO - FREIGHT MODE BREAKDOWN 2017 (percent)

„„80.86% Road „„19.12% Rail „„0.02% Air

companies have also highlighted the trend of increasing demand for storage and just-in-time services from

1,943,945km2

hospitals and pharmacies. “I see this every day. Those

Size of Mexico

wanting to work in this sector understand their main markets will be Brazil and Mexico and that they will need to establish a presence in these high-consumption areas. Mexico itself is a significant consumer market so there is significant need for our customers to find the right logistics provider,” says Ritter.

Source: PwC

air Rail


VIEW FROM THE TOP

MARKET FACTORS DRIVING GROWTH, WEB SALES IN FOCUS VĂ?CTOR SOTO Director General of Levic

228

Q: What main changes did Levicâ&#x20AC;&#x2122;s operations undergo

Q: How is technology impacting the logistics business

in 2016?

and your operations?

A: We amplified our portfolio, opened a new distribution

A: We are investing in R&D to allow our customers to buy

center in Vallejo and worked to improve our service.

from us online. We have a web portal that clients can log

We are a distributor of mostly generic medicines and

into and browse our catalogue of products and costs,

we have greatly improved our just-in-time model. The

and any order placed will arrive within seven days. We

company already has a strong portfolio in generics, herbal

have been working on this since the summer of 2016 and

medicine and wound care, so we have mostly expanded

it is continually growing. In the first month, sales were

in prescription drugs from transnational companies, which

laughable, but by March 2017 online sales represented

have a slightly higher cost. Our work with transnational labs

9 percent of our total. We are promoting this directly

has grown by 60 percent but in general Levic saw growth

through our sales force and through our logistics. We

of 14.5 percent in 2016.

have no fixed target for where we want to be by the end of the year. It depends on what the market demands

Q: What have been Levicâ&#x20AC;&#x2122;s main drivers of growth?

because our objective is to cater to market needs.

A: Market factors have driven our growth, while prices and accessibility have been fundamental over the past 10 years.

Q: How will you achieve your 2017 goals?

Information has also pushed growth because people are

A: In 2017, we will begin operations in Monterrey. We are

increasingly aware and have access to more information.

also working with restocking technology, that is to say

People now know that patented and generic medicines are

robots that stock quicker than humans and with 99.9

the same. The difference is only in the cost to patients. As

percent exactitude. We are only missing a pincer in our

Mexico is an emerging economy, people need medicines

stocking technology. Our goal is to implement this in

and need to be able to obtain it. This theme of accessibility

four of our eight centers, three in Mexico City and one

has boosted growth for us.

in Michoacan. Levic is working on a project in Central America and in 2017 we will enter the Belizean market,

Q: To what extent does Levic work with the public sector?

where we have a project with the government to send

A: Only around 2 percent of our sales go to the government,

Mexican medicines there.

while the other 98 percent goes to the private sector. Previously, a cure for a general illness cost MX$500-1,000

Q: How do you prepare for uncertainties such as strikes

(US$28 -56) out of pocket to pay for a doctor and medicine.

and protests?

Today, patients can receive medical care and medicine at

A: Protests do not affect us much. What does impact

many pharmacies for MX$150-250 (US$8-14). Because of

us greatly is the Hoy No Circula (No Drive Day). In 2016,

this not everyone needs to use government services.

40 percent of our vehicles could not circulate on any given day. With one No Drive Day per week, 20 percent

Although we have no plans to change our sales ratio,

of our vehicles are idle but with the double measure,

we will need to work more in other areas, including the

two of every five are out of action. Distributing medicine

government, to maintain growth rates.

becomes much more difficult. There are also security issues and areas we cannot enter because drivers are asked to pay bribes. We do not enter areas where the

Levic is a Mexican distributor based in the State of Mexico

driver will be at risk, or when the risk is larger than the

that is specialized in the pharmaceutical sector. It began

reward. If we were to push this, then we would be putting

operations in 2000 as a generics distributor and has expanded

the health of the driver and the good condition of the

operations throughout Mexico

medicine at risk.


VIEW FROM THE TOP

PHARMA TAKES TO THE SKIES FOR DELIVERIES RAFAEL FIGUEROA Director General of Aeroméxico Cargo

Q: What are the greatest challenges in health for

Q: As you already manage so much domestic cargo, what

Aeroméxico Cargo? How do you overcome them?

is your objective for the rest of 2017?

A: Pharma is one of the top five products we transport. Due

A: The pharmaceutical market is much bigger than what is

to quality and security concerns with land transportation

being moved via air freight today. We are a reliable option

services, the industry has increased the volume of pharma

and we have a commercial strategy for the pharmaceutical

products transported by air. We have been offering

market that is very aggressive. Our goal is to move more

specialized services for the domestic market for the last

pharma and to continue as a leader in air freight. As

three years and our market penetration has grown over

an airline, we prefer to work with high-yield products.

100 percent each year. Today, we transport around 12,000

However, Aeroméxico’s network is so large that it operates

tons of pharma products every year, which represents 90

many flights on which we can accommodate many types

percent of the domestic air pharma market. Our biggest

of medicine and cargo; for example, if something very

strength is Aeroméxico’s security processes, which make

urgent needs to go to Monterrey in the next two hours,

us the most secure airline to fly with. We have invested

we can do it. Aeroméxico moves one of every five kilos

a lot of resources over the past three years to make sure

of the Mexican air cargo market and we want to keep

that 100 percent of our cargo is screened and sterile,

growing at the same pace.

which makes us the preferred carrier for most agencies. Q: What are your plans for pharma and health in Mexico? Q: What health products does Aeroméxico Cargo

A: Aeroméxico Cargo has an investment plan of several

manage?

million pesos that will help further strengthen our position

A: In addition to pharma, we also move biomedical

in the national pharmaceutical market. In addition, with the

products and vaccines. We own thousands of square

objective of increasing participation in the international

meters of refrigerated space throughout the world and

market, in December 2016, we formally finished remodeling

we have agreements with suppliers such as vaQtec

our facilities in the New Mexico City International Airport

and Envirotainer, which enable us to maintain the cold

(NACIM), an investment of several million dollars that

chain throughout the entire process. The most difficult

positions us as the company with the most modern facilities

products to transport are those that require a controlled

and with the highest standards of safety and quality.

temperature because they are shipped from the factory to conservation warehouses and then to our customers

Finally, in February 2017 we launched the Health Chain

or final consumers.

Service, which will first target the European, US and South American markets. It will have the capacity to offer our

Q: How does working in pharma impact your business

clients specialized active and passive solutions to achieve

strategy?

a cold chain that includes freezing, refrigeration and

A: The challenge for us is to keep pace; entering the

temperature maintenance during our cross-border flights

pharmaceutical sector has been our most important

thanks to strategic alliances with the most recognized and

achievement so far. Four years ago, we had almost no

certified companies in the market such as Envirotainer,

business in this area and now we manage a large majority

vaQtec and Cold Chain Technologies.

of the domestic pharma market. We have become an airline that is flexible, that cares for its clients’ products, employing the correct conditions and delivering the

Aeroméxico Cargo is a leading air cargo carrier and part of

products undamaged. Previously, we moved 20-30 tons

the airline Grupo Aeroméxico. The company strives to meet

per month in pharma, whereas now we move over 600

the needs of the supply chain, including pharma, delivering to

tons per month.

Mexico and the world

229


VIEW FROM THE TOP

PUSHING EFFICIENCIES FOR 360° LOGISTICS JOSÉ ALBERTO PEÑA Director General of Grupo Marzam

Q: Grupo Marzam deals with high volumes of medicines.

people for the position. This is setting us apart, thinking of

What management systems are in place for this?

where we are now and where we anticipate going in the

A: That is one of our key strengths as an organization. There

future. We will be bringing new technology to an area of

is continuous opportunity to improve but we are a company

the industry I believe has been static for decades.

that has been in the market for 83 years so experience has 230

gradually made us increasingly effective and efficient. We

Q: From where are you recruiting your talent? To what extent

have 10 distribution sectors in the country, nearly 3,000

do you have to go to other sectors or abroad?

employees and 500 vehicles. That allows us to cover almost

A: We have not gone abroad. Our HR director comes

95 percent of the country. We also have a strong focus

from outside the distribution and logistics market but

on technology because that is how we can drive more

has experience in many industries. Wherever possible, we

efficiencies. We are a large-volume company in a low-margin

would like to provide opportunities internally. I want to

industry, so we need to be as efficient as possible.

be in a situation where all future opportunities are filled through promotions. We are looking for the right people,

Q: What state-of-the-art technology is implemented

not necessarily thinking about the right person for the

throughout the company’s operations?

position today but looking at this with a three to five-

A: Four of our distribution centers are automated, which

year perspective, bringing in those that will be able to

drives efficiency throughout the organization. Grupo

complement our strategy going forward.

Marzam differentiates itself from its competitors in that all our salespeople work off apps on smartphones. All our

Q: To what extent do you have relationships with Mexican

technology is developed internally. While pharmaceutical

universities?

companies usually have limited numbers of people in the

A: We do not have any at this moment but that is an area we

IT department, Grupo Marzam’s is over 100 strong. This

are looking to develop. I want to bring in high-potential talent

demonstrates how important technology is to us and that

who could be our future leaders, bring them into our growth

we keep it top of mind in everything that we do. We also

strategy areas to drive new models and then take them from

have a strong focus on e-commerce. We are trying to see

the conceptual phase to implementation. We have planned

how we can interact continuously with our customers

for 2017 to bring in three high-potential MBA graduates who

from a 360° perspective.

are ready to land in a position knowing they may not be quite ready but that we want to develop them. We are beginning

Q: How has Grupo Marzam’s adapted its operations to

to reach out to universities so we can develop this program.

e-commerce over the past year? A: Our app was not fully in use 12 months ago, but today

Q: What are the most important skills that you will be

100 percent of our sales reps use it. It is also being used

looking for?

by about 500 reps in the pharmaceutical industry, who

A: We will certainly be more focused on the commercial side.

use it to collect orders that come directly to us. We have

We will be looking for people with learning agility, flexibility

undergone a massive reorganization, changing 95 percent

and able to coordinate groups. I want this company to be

of our executives and ensuring that we bring in the right

different to others and I see it evolving into different areas, such as specialized segments, focusing more on customized models. This does not mean we are walking away from what

Grupo Marzam is a Mexican company that started its

we do today, it will be complementary. I am looking at many

operations 83 years ago distributing medicines to pharmacies

sectors, such as private hospitals and insurance. At the

in Mexico City. Now it distributes healthcare products across

moment only 4 percent of Mexico’s population has private

the country

medical insurance. This is an opportunity.


Warehouse tunnel

Q: What drove the 2 percent growth Grupo Marzam

Q: How has the global economic environment impacted you?

enjoyed over the past year?

How do you foresee its future impact?

A: There are many factors involved. When Marzam was

A: 2017 will be a challenge from an exchange-rate perspective.

purchased 12 months ago, there were financial difficulties.

For us, another key component is gasoline, which has a

We have been ensuring that, from a business perspective,

direct impact on our expenses. The exchange rate will have

we are driving as much efficiency and profit as possible to

an impact on the industry as a whole because 90 percent

ensure we are paying our customers. We have gone from

of material used to produce medicines is imported. Before,

having a 65 percent fill rate 12 months ago, to a 97 percent fill

perhaps businesses did not focus as much on driving

rate at the end of 2016. That was driven mainly through pure

efficiency in all areas but it is about the details now. For

product availability. We are probably unique in the interaction

example, we have almost 500 vehicles and we have decided

we have with the healthcare sector in general. There is much

that whenever we change a vehicle, it should be diesel at the

more confidence in what Marzam is today than there was one

very minimum. We want to move to hybrid or electric in the

year ago. A massive change in the way we operate puts us in

future. We are already evaluating if this is economically viable

a much stronger position.

on a four-year horizon, which is the life a vehicle for us. This drives us to think differently now. It is not necessarily bad but

Q: How do you ensure that your trucks can reach their

we were not ready for a 20 percent increase in gas prices.

destination through times of unrest? A: We have implemented more technology in that area.

Q: What are you short-term plans for Mexico?

Our distribution network has GPS, trucks are tracked

A: For us, short term means three to five years. We want

and they have other security aspects. Our vehicles are

to become a holistic, logistics provider in the healthcare

monitored centrally by a control center and we coordinate

segment and we will not be moving away from that.

them with the corresponding authorities to ensure there

Marzam was very much a pharmaceutical distributor

is a rapid response from the police.

but today we are in branded, patented and generic pharmaceuticals and we have moved into wound care,

Q: What are the greatest challenges Grupo Marzam faces

medical devices, medical equipment and specialized

as a distributor?

medicine. All these segments are growing.

A: One of the greatest challenges we face is Mexicoâ&#x20AC;&#x2122;s size because it is an expansive country. We must ensure we

From a customer perspective, we were focused on

provide an effective, efficient and continuous service. Security

pharmacies. However, our focus expands now to private

is a hot topic that requires care. We are a low-margin industry,

hospitals and clinics, healthcare insurance and the

so all additional costs immediately impact our profitability.

government sector, which is much more holistic. Our most

We need to be prudent about how we manage additional

important strength is the infrastructure we have. Why

expenses, which, ideally, we should not have. The health

not get involved with a broader range of products and

industry in Mexico is also a complex and fragmented industry

segments if we are already going past these places and our

that requires different skillsets. Having had experience with

infrastructure can cope with it? We are also open to creating

many markets around the world, I truly believe that Mexico is

partnerships and alliances. I am a strong believer in alliances

one of, if not, the most complex healthcare market.

and complementing our infrastructure and expertise.

231


INSIGHT

EVOLVING TO TAKE ON NEW SUPPLY-CHAIN CHALLENGES DANIEL PARDO CEO of Medistik

232

Logistics services can be a challenge for the Mexican

trucks to have redundancy control. Now, they use a dual

health industry’s supply chain. Companies have to maintain

GPS system that can detect jammers and can send an

safety, ensure the chain of custody and comply with their

alert to the monitoring center that works with authorities

customers’ requirements in times of high delinquency

to recover stolen vehicles. Trucks have electromagnetic

and peso depreciation. To mitigate these challenges,

closures, so they can only be opened at the delivery point.

health companies like Medistik have developed strategic

When transporting certain products, Medistik also works

solutions, latching onto new opportunities in the process,

with private-security agencies that offer escort services.

says Daniel Pardo, the company's CEO. Besides insecurity, another challenge the logistics sector The company, formerly Bomi Mexico, a business with 20

is trying to mitigate is the peso’s depreciation. The cost

years of experience in the healthcare logistics sector in

of equipment, rent and other elements are usually in

Mexico, is looking to reinvent itself and expand in the

dollars, which affects companies and customers. As

local market, which has limited integral logistics solutions.

Pardo explains, Medistik is working to become more

It wants to triple in size in the next five years through

efficient by proactively improving transportation and

organic growth that includes improving its services and

warehouse management. Part of its responsibility is

offering solutions to new health segments. To further

ensuring companies gain control of their products

underpin its evolution, Medistik has developed and

through better inventory management. Pardo highlights

implemented a training and repair center to which clients

that the main issue in this area is that large healthcare

can bring their equipment and personnel, who receive full

institutions like hospitals do not have total product

training on how to use it.

visibility. The company looks to implement technological tools that will provide clarity on the location and quantity

Insecurity in the country has also created the need for

of every product, reducing inventory-related costs. “We

stringent security measures, especially in high-risk areas

are adapting, anticipating and inviting our clients to join

such as Mexico City or the State of Mexico, says Pardo.

us in this process,” says Pardo.

There were around 1,000 assaults on cargo vehicles on highways from January to November 2016, according to

Ensuring full compliance with the supply chain and

the National Public Security System (SNSP), although

product requirements is among the most difficult tasks,

that number might be higher because many companies

specifically in Mexico, where the challenge in such an

do not report the crimes, according to Mario Espinosa,

extensive territory is being able to get everywhere. “Any

President of the Mexican Association of Vehicle Tracking

given company cannot cover the whole country. The

and Protection (ANERPV).

service we provide should help our clients deliver further and reach the point of sale faster.”

The company has taken several steps to maintain safety and ensure the chain of custody. “We started

Medistik hopes to offer the public sector some of the

by establishing a security manager position. We

solutions already in place for the private sphere, which

then enhanced our recruitment process to ensure the

accounts for 100 percent of the company’s customers.

trustworthiness of all our drivers,” Pardo says. A report

“We do keep in mind that the government is the

from FreightWatch International, a security logistics

largest user. There are big opportunities to help it to

agency, says that assailants usually operate in groups

be more actively efficient and to drive down the cost

of six to eight people in three cars and use systems that

of healthcare,” says Pardo. He believes that Medistik’s

block their target’s communications network. Pardo says

evolution is not limited to updating its image but in also

this is why Medistik changed the GPS system on all its

giving the broad vision of its service a makeover.


INSIGHT

AFTER MEDICINE IS THROWN AWAY JOSÉ AEDO Director General of SINGREM

While all households purchase medicine, few dispose of

counterfeit medicine, Aedo says that in the three years he has

it properly. This leads to a variety of problems including

headed SINGREM only two containers have ever been stolen.

counterfeit medicine and environmental pollution. According to the General Law for the Prevention and

Some states dispose of less medicine than others. Aedo says

the Integral Management of Residues, “large generators,

that the longer they have been present in a state, the more

producers, importers, exporters and distributors” of

the program collects. “In the center of the country, Mexico

special handling products are responsible for “formulation

City, Puebla, Jalisco and Veracruz, our program works well,

and execution of management plans.” Yet, not all take

but there are still many states that are lagging behind,”

responsibility for their generated residues.

Aedo says. “The North only represents 6 percent of our collection and it is an area reasonably well covered.” He puts

SINGREM, a civil association, was created to tackle the

this down to the fact they only entered these states a year

problem, collecting unneeded and expired medicine from

and a half ago and expects results to improve with time. “In

around the country to prevent it from being tossed into

Mexico City, we collected over 12 tons in September 2016. In

landfills. Over the past year, the association has expanded its

the entire state of Nuevo Leon, we collected 0.2 tons,” Aedo

reach, moving into Chiapas. “We entered Chiapas through

says. To make greater advances, more government support

an agreement with the state government. We delivered 40

is needed for companies to allocate funds to the collection

containers, half of which were placed in government clinics

of expired medicine. “Each state supports us differently.

and the other half in Farmacias del Ahorro,” says José Aedo,

Hidalgo, for example, has its own collection projects and

Director General of SINGREM.

invited us to partake. Others are practically not interested in expired medicine. The support we receive in Guanajuato

One hurdle the association faces is the challenging security

is incredible, as is that of Mexico City,” he says.

environment in some areas of Mexico. This is the case of Tamaulipas, in the northeast of the country, where according

While it is obligatory for companies to participate in the

to Aedo it is not present because the risks are too great.

disposal of the medicine they produce, many neglect their

Another example is Michoacan, a state it abandoned when

responsibilities, leaving SINGREM to clean up after them.

the situation became unstable, although the association

From January to July 2016, only 57 percent of the medicine

returned once it was safe to do so.

collected by SINGREM came from affiliated companies, while it received no contribution from the companies the

Today, SINGREM has almost extended its coverage across the

produced the other 43 percent. In addition, many generics

country and is now only missing from Tabasco, Baja California

laboratories refuse to participate outright because of a lack

Sur, Chihuahua, Sonora and Tamaulipas. It hopes to have

of law enforcement. This is an issue for SINGREM because

collected around 520 tons of medicine or 15 million units by

52 percent of the medicine it collects is generic. Because

the end of 2016, which it estimates to represent around 15-

these are expired meds sold two to three years previously,

20 percent of medicine discarded. It has agreements with

Aedo expects this rate to rise in line with the proportion

103 laboratories to perform collections and the association

of generics sold.

managed 4,750 containers as of September 2016. “Most of these are in national pharmacy chains, 2,470 of them, such as

Despite the setbacks, SINGREM will continue its effort to

Farmacias Guadalajara, Farmacias Benavides and Farmacias

cover all 32 states as soon as possible. Once this is achieved,

San Pablo,” Aedo says. To minimize security risks, the trucks

it hopes to increase publicity nationwide and push people

that collect the meds from SINGREM containers bear no logo

to dispose of their medicine adequately. By implementing

so as to avoid unwanted attention. While it may seem like a

6,000 containers nationwide, it hopes to collect 1,000 tons

container full of expired medicine is the perfect source for

of medicine per year.

233


VIEW FROM THE TOP

INFORMATION IS POWER MARIO GARCÍA Vice President of Operations at GNK Logística

234

Q: Why should companies contract GNK Logística for their

because we have encountered situations in which it does

logistics operations?

not, or is not where thought. Once corroborated, we analyze

A: As a Mexican third-party logistics company (3PL),

all the data from the census and other variables to establish

our core business is the design, development and

delivery frequencies. There have been times when we have

implementation of integrated logistics solutions built to

had to hire small planes or boats to get to the correct place

suit each client’s specific requirements for warehousing,

at the correct time because there was no road.

control, distribution of goods and database management for the health and pharma industry. We are not dedicated

Q: What steps do you take to maintain security in the chain

to buying and selling goods, we leave that to our clients.

of custody?

We are dedicated to generating valuable information, to

A: We have security protocols and procedures as

the traceability of goods and nationwide consolidated

determined by our quality management system. Since

transportation.

we began working with the government, the goods we distribute are low cost or have no price value because 3

We have more than 1,000m of cold rooms, all of which

they are free and destined to meet the population’s

have temperature ranges of 2-80°C as recommended by

needs. We also are well known in the communities to

COFEPRIS. Our parameters are from 4-70°C, meaning that

which we deliver. At the beginning, we did face a certain

when the temperature reaches those limits, automatically

amount of risk in some areas like Durango, where we

a visual and audio alarm activates to ensure the cold chain

had to establish certain routes and schedules that were

is not broken. We also have units with thermostats for

secure. Our vehicles bear our logo, which is recognized,

transporting cold products.

and they are all tracked via GPS, have interior cabin cameras and are constantly monitored. Our warehouse, fleet of trucks and the goods of our clients are all insured. We have also used and hired custodians in the past as requested by our client protocols. Q: What are the biggest challenges and risks a logistics company faces?

NOM-059 stipulates that to transport pharma goods within Mexico, vehicles must be specifically for this purpose

A: The greatest risk is the loss or damage of the client’s assets. NOM-059, ratified in August 2016, is also important for us. It stipulates that to transport pharma goods within Mexico, a company must use vehicles specifically for this purpose and cannot transport anything but pharma goods. As we are already dedicated to this and have a cold chain in place, this norm has benefited us. Beginning a project is

Q: What logistical strategies are used to service locations

often the most difficult phase because companies do not

that are difficult to access?

have the full scope of the project.

A: Before we start any operation or project, we always perform an initial census for which we focus on distant, rural

Q: How does NOM–059 compare to international standards?

or difficult to access communities, so we can make a note

A: It is excellent because it eliminates foreign companies

of its address, GPS localization, type of road encountered

from providing transportation between states and also

and all the information we need to design and establish the

benefits the security and safety of goods because they

best cost-benefit route. We check that the address exists

could be contaminated by other goods and supplies


in the cargo. I am sure that within two years, labs will

A: We differ greatly from our competitors, mainly because

be working only with logistics operators dedicated 100

we treat our clients as business partners or allies. When

percent to pharma. Because we are solely dedicated to

we notice they are doing something wrong, we tell

pharma, we are not looking to expand to other sectors

them about it. We also give them reliable, punctual and

or industries. We are totally convinced that we can be of

auditable information. We are flexible in our operations

great value to our clients because of all the specialization

and we do not have hidden costs. Our solutions are

and investments we have made in this area.

tailor-made and we strive to offer the best cost-benefit solutions. Finally, our personnel is highly qualified and

Q: How important is tracking and how does it improve GNK

field-trained to offer outstanding customer service and

Logística’s services?

a quality response.

A: Whoever has information has power and tracking has become an important tool for us and the service we

Q: What are the main differences when working with the

provide. As an example of how tracking benefits us, we

public and private sectors?

also offer reverse logistics to our clients, who often use

A: The private sector is more demanding due to their

it for returns, rejections or short expiry dates of goods.

corporate governance and compliance structures and

We once collected a lot that was subject to inspection by

procedures. The tolerable margin of error is extremely

COFEPRIS and had to trace it to its final user. It helped that

narrow. Governments often do not have standardized

our tracking system gave us that information, otherwise we

procedures or high standards when dealing with pharma

would have been in trouble.

goods and their warehouses in most cases do not comply with any NOM rules or regulations, nor do their vehicles.

Q: To what extent do you have a database of consumed

We are the ones to suggest they improve to the standards

goods?

required by private industry. If companies do not have

A: We have developed in-house systems and also registered

reliable information, they do not have sales or consumption

them at the National Institute of Author Rights (INDAUTOR),

projections. Health services were created to preserve

which can give us full traceability of each lot number and

health, not to worry about logistics. This is the area that is

the expiry date of every good we have distributed. We

usually contracted out but there are still states and private

collect inventory information at the place of delivery or

labs that do not contract their logistics operations.

through our systems and we generate the data to know what and when is consumed. We give this information and

Q: What is GNK Logística’s strategy to remain competitive

other reports about inventory levels and displacement of

over the next five years?

goods to our clients and they decide when to buy, at what

A: We look to strengthen the systems we have in a

price, from whom and in what quantities. All the information

well-structured enterprise resource planning. We think

and reports needed by our clients are available 24/7 to help

any other Mexican or foreign company with plenty of

them improve and speed up decision-making.

economic resources can store and distribute pharma goods correctly and in accordance with legislation

Q: How are health practitioners embracing technology

but we doubt they can better our learning curve and

such as iPads and what are the challenges to adoption?

experience of almost 11 years. We are always researching

A: In rural communities, digital advances take longer to

new technology and systems that can help us be a

permeate. For example, it takes around 40 minutes for

cutting-edge company. Generally, we would like to have

doctors to deal with the paperwork from a five-minute

our systems working across the supply chain, from

medical consultation. Implementing a system that relies

doctors that generate the demand of goods by typing

on a certain device is not ideal because these quickly

the prescription into our system to the supply planning,

become obsolete. We have developed our systems to be

control, warehousing and distribution of those goods.

compatible with tablets and while they can be used, it

Prescriptions and requirement orders are still written

is necessary for hospitals and rural communities to have

by hand, so we are looking forward to digitalizing that

the right hardware and network in place, which is the

information to shorten times. That will help our clients

main challenge we have encountered. Another challenge

and us to have better control and timings throughout

is to change the mindset of doctors from doing things

the supply chain.

manually to electronically. Tablets are extremely useful because they put the complete supply chain information in one’s hand.

GNK Logística is a Mexican logistics company with a division fully dedicated to the health industry. It focuses on the design

Q: What does GNK do differently from other pharma

and development of logistics systems that incorporate the

logistics companies?

latest technological advances

235


VIEW FROM THE TOP

CUSTOMIZED SOLUTIONS FOR MEXICO’S LOGISTICS CHALLENGES JOSÉ ERIC DELGADO Director General of Sicamsa

236

Q: How is Sicamsa dealing with the challenges of logistics

Q: How do Sicamsa’s solutions make its clients’ operations

in the pharma and health industries in Mexico?

more cost-effective?

A: The main problem is the lack of logistics regulations for

A: Our main line of business is the transport of laboratory

the transportation of laboratory samples and other types

samples in Mexico. We offer personalized solutions for 24-

of materials. Shippers are often unaware of the logistical

hour delivery to IMSS and private companies and we also

complexities involved and delivery companies can be blamed

transport vaccines, corneal layers and tissue for transplant.

for any problems. We are facing these problems through

Our main differentiators are our fast delivery times and the

internal rules and by training our staff. The samples we

level of security we can offer. Sicamsa offers transportation

transport can be essential to a patient’s health so our mission

of unlabeled drugs and hazardous material, which requires

is to deliver it in the right way and as quickly as possible.

special documentation. We also transport veterinary material for small towns and municipalities.

Q: How do you cover the whole country and reach your clients in 24 hours with so many logistical obstacles?

Q: Given the range of services, to what extent do you

A: We have contingency plans prepared for every

incorporate client requests into your offering?

situation. In many cases, we incur expenses that are

A: Due to our dedication to providing 24-hour delivery

not accounted for in the client’s budget and we bear

schedules, we must provide a custom-made operation for

the cost ourselves. This kind of service, along with our

each client. This also means that if one of our clients cancels

rapid response to unexpected issues, has generated a

the order, we cannot charge the other more or decide not

significant client loyalty. We also have a hangar in Nuevo

to go to this location at this time, as many other logistics

Laredo with four jets and two pistol-engine planes, one of

companies that operate with consolidated purchases must

which is a cargo plane, and we are introducing a seven-

do. We adapt our infrastructure to client needs but we need

ton aircraft for a new project in which we guarantee our

a commitment in return because a fleet of reserve vehicles

clients zero loss of products.

can become expensive.

THE WILD, WILD NORTH

Mexico is an expansive country and distributing outside the capital city presents a unique set of challenges. In the face of insecurity and civil demonstrations, among other disruptive factors, companies have had to adapt strategies to keep products moving, says Mireya García, Director General of Distribuidora Alpilo, a Monterrey-based logistics company. “[Insecurity] has impacted us significantly, especially during times of strikes and demonstrations. During a period of countrywide protests in January 2017 (following a hike in gas prices), our deliveries were delayed, sometimes up to a week, because there was no way to get through,” says García. In response, the company began forging alliances with other distributors to lend products to each other. “We now manage a larger stock and take larger orders so that our clients are better prepared for unforeseen circumstances,” García adds. The National Survey of Public Urban Security (ENSU), carried out in December 2016, found that 67.8 percent of the population aged over 18 considered that living in Nuevo Leon state was unsafe, up from 62.8 in September of the same year. Being a small company, exchange-rate fluctuations also had an impact. “The appreciation of the dollar does impact us as our costs are sometimes in dollars and the products we distribute come from the US. We have to continually be checking costs and margins while also paying attention to the client because we cannot be increasing prices every three months,” García says.


VIEW FROM THE TOP

SPECIALIZED SERVICES FOR SPECIALIZED PRODUCTS INGRID RITTER Healthcare Strategist Latin America of UPS

Q: UPS Temperature True options enable the transport

Q: What makes Latin America attractive as a region?

of sensitive products. What products are you most often

A: Five or six years ago, two-thirds of the global

asked to handle?

healthcare market was in the US and Europe. Now, those

A: UPS Temperature True is one of our most specialized

are mature markets and, although they are significant in

solutions when it comes to the transportation

size, emerging markets are growing at faster rates. The

o f te m p e ra t u re - s e n s i t i ve h e a l t h c a re p ro d u c t s .

number one region for growth in healthcare is the Asia-

Pharmaceuticals, biologics, vaccines, blood products and

Pacific Economic Cooperation (APEC) region, mostly

medical devices are the types of products we are most

driven by China and India and followed by Latin America.

asked to ship with UPS Temperature True. UPS has control

UPS has four strategic priority segments: healthcare,

towers that monitor all shipments, help protect against

e-commerce, emerging markets and technology. In Latin

temperature excursions and can also activate contingency

America, we will continue to increase our footprint in

plans in the event there are unexpected shipment delays.

emerging markets with continued investments, especially in the healthcare segment.

Q: What are the most common challenges faced when transporting health products across borders? How do

Q: What are your priorities for 2017?

you overcome them?

A: Our latest investment in Latin America is a new

A: In Mexico, many products are transported over land

healthcare storage and distribution facility in Bogota,

and a challenge that is not often considered is the

Colombia. In addition, we also just added cold-chain

number of times a package can be exposed throughout

capabilities to our distribution centers in Mexico and Brazil.

the transportation cycle. Before picking up a UPS Temperature True shipment, UPS works with its customers

Companies that want to conduct business in the Latin

to provide a comprehensive analysis of shipping options

American healthcare market need to understand the

and procedures such as routing, type of transportation

current and upcoming changes in regulations, as well

required, who will come into contact with the shipment,

as how channel strategies are evolving for customers. In

what types of carriers are acceptable for that type of

2017, for both Mexico and the region, we will focus on

shipment and set up of contingency shipment plans.

our ongoing commitment to continue investing in the

Everything is defined beforehand, so when we do pick

sector. We have strong partnerships with our customers

up a shipment we know exactly how it is going to move,

and, more than being a logistics provider, we want to be

from where to where and who needs to be notified.

their strategic partner and ally that works hand-in-hand to understand their supply chain needs and ensure the

Q: To what extent is the demand for storage services

success of their business. For example, our procurement

increasing in Mexico?

of Marken, a specialty courier service, is a clear example

A: As Healthcare Strategist for UPS Latin America, I

of a new acquisition that is going to impact our ability to

see this every day. Those wanting to work in this sector

service the clinical trials logistics market in Mexico and

understand their main markets will be Brazil and Mexico

in Latin America, allowing us to partner with companies

and that they will need to establish a presence in these

much earlier in the supply chain.

high-consumption areas. Mexico itself is a significant consumer market so there is significant need for our customers to find the right logistics provider. In 2014,

United Parcel Service (UPS) is an American company and

we opened our newest healthcare distribution center in

one of the worldâ&#x20AC;&#x2122;s largest distributors. Working across over

Mexico City. It measures over 7,000m , is GMP compliant

220 countries and territories, it handles 101.5 million tracking

and has temperature-controlled storage capabilities.

requests per business day

2

237


VIEW FROM THE TOP

NEW MARKET ENTRANTS COMPETE WITH GIANTS ERICK JIMÉNEZ Director General of Majicarga

238

Q: How do changes in regulations in the health industry

Insecurity is another significant challenge. Although we have

affect Majicarga?

a sophisticated monitoring system, the existent technology

A: COFEPRIS is one of the world’s strictest regulatory

is limited. No distributor or technology company in the

agencies. Majicarga transports pharmaceutical products,

security market can fully guarantee that a unit carrying

medical devices and even clinical tests but also groceries,

a client’s product will not get lost or robbed. The most

equipment and other products that require sophisticated

stolen products are drugs like anti-flu medicine, aspirin and

handling. COFEPRIS’ regulations, the policies of

cosmetics because OTCs are the easiest to sell on the black

governmental agencies like the Ministry of Health and the

market. To combat this, all of our employees must have a

ability of the health industry to respond to these changes

reliable-worker accreditation. The company that provides

affect us. NOM-059 regulates good practices regarding the

this service visits with our staff and performs an obligatory

manufacturing and distribution of drugs. We are in line with

socio-economic study, checks local and federal criminal

this regulation, but we have been informed there will be

records and performs psychological tests.

some updates so we are preparing for those. We are also preparing for ISO-9001-2015 certification, which deals with

Q: What are the emerging trends in storage?

quality-management systems.

A: Pharmaceutical companies are closing their storehouses and centralizing storage and distribution within the

Q: What are the main challenges for Majicarga?

metropolitan area, specifically in Cuautitlan Izcalli,

A: Cost-efficiency is the most pressing issue. We must

Tlalnepantla and Naucalpan, in the State of Mexico. These

make our routes more profitable because many new, bigger

storehouses are both storage and distribution centers and

competitors are entering the business, including giant

help reduce costs.

companies like UPS, FedEx and FEMSA Logistics. These new competitors are attracted to the segment because

Q: What is your relationship with the public sector?

distribution in the pharmaceutical sector is one of the best

A: We have little direct contact with the government, but

remunerated. However, for a company like Majicarga it is

we would like to increase our business with the public

difficult to compete against fleets of thousands of units

sector because it is a good, well-remunerated market with

and the entrance of these new competitors. The prices we

attractive contracts. We have focused on marketing reliable

must offer are much lower than three years ago. Mexico

solutions that provide security in the transportation of

used to be a paradise for transportation companies, but

medicines for the private sector.

regulations have increased in number and strengthened and have become more complex.

Q: What are your priorities for the next five years? A: The most important priority is to find new customers,

The main challenge for businesses is to find sustainable

because sometimes companies become too confident with

strategies that help growing companies maintain or even

the clients they have. We want to implement new means for

further develop so as not to be bought out or absorbed by

advertising through innovative channels and participation in

larger ones. Additionally, there needs to be regulation to

expos, conferences and other industry gatherings. Investing

incentivize and boost Mexican companies.

in better security controls is preponderant: the number of robberies increased 60 percent between 2016 and June 2017. We also need to renew our fleet. In the midterm,

Majicarga is a Mexican logistics and transportation company

e-commerce may impact us, but there are new ways of

based in Mexico City and specialized in delicate cargo, with

doing business in transportation, where people upload

over 25 years of experience. In health, it deals with drugs,

information about specific cargos and transportation

medical devices and clinical tests

players choose what they want to transport.


VIEW FROM THE TOP

SUPPORT FOR PHARMACY CHAINS SERGIO CHABOLLA Executive Director of ANADIM

Q: What strategies should pharmacies put in place to

Q: What must be done to ensure the Mexican

guarantee access to health?

pharmaceutical industry grows to its potential?

A: There are many strategies. Farmacias del Ahorro, for

A: The innovation industry has grown greatly because

example, provides loyalty cards, giving clients discounts

there is a lot of competition between generics,

or the opportunity to receive a free service. For our part,

interchangeable medicines and biosimilars. I think the

the number of generics purchases has increased greatly

industry of innovation should be better organized and

and we stock our own brands, which gives us the margin

implement prices wisely to be more competitive. This

and opportunity to keep growing. The Ministry of Health

would improve access for everyone.

and COFEPRIS want lower prices to help those with few economic resources buy medicine. By stocking generics we

Q: What added value do companies receive as members?

are responding to that need. Laboratories ask us to respect

A: There are several benefits. Firstly, as most of our

their prescriptions and not make any changes, which we try

members work in Mexico, they can use our facilities in

to do. Despite having our own brands, we also continue to

Mexico City to conduct meetings whenever they like and we

buy the same number of generics from other laboratories.

can help arrange any meeting with industry contacts they

What clients want from us are good-quality products.

would like to see. We also offer support to help solve any regulatory issues they may face. This instills our members

Q: To what extent does ANADIM enable members to

with confidence, knowing there is always a team that will

participate in consolidated purchases?

support them with anything they need.

A: We do not need consolidated purchasing because our members have enough purchasing power on their own.

Q: What changes have you seen over your time with

Independent entities have to do this because they do

ANADIM? What are your expectations for the coming

not have our levels of organization. Our members work

years?

together to make decisions and to support each other, so

A: There have been many ups and downs, moments in

that everyone operates under the same conditions and

which we thought the association would not survive due

with the same discounts. Otherwise, we would not work

to many issues, such as disloyal competition, price-fixing

as an association.

and leonine conditions. However, the environment has greatly improved in the past eight to nine years and we

Q: How does ANADIM function and what characteristics

have grown significantly. We are on the right path and

does it look for in member companies?

in five years I hope our members account for 80 percent

A: When there is a governmental issue that impacts all of

of total distribution. Over the next three to five years,

us, we can help each other and this has strengthened us

ANADIM will continue to play an important role in the

over our 73 years of existence. Companies that join the

distribution sector as some of our members, such as

association must carry out distribution or run a strong

Tallis, are enjoying exceptional growth. We account for

chain of pharmacies. Our group includes the largest

65 percent of the distribution of medicine in the country.

chains in Mexico, such as Grupo Benavides, Farmacias del

A few years ago, that figure sat at 35 percent. This growth

Ahorro, Farmacias Guadalajara, Walmart and FEMSA. We

is due to the expansion of pharmacy chains.

meet every two months across the country, sometimes at the facilities of a member company. The association just inaugurated Analpharmaâ&#x20AC;&#x2122;s facilities, which are incredible.

The National Association of Distributors of Medicines

We could invite companies from across the world and

(ANADIM) comprises 18 Mexican companies that are engaged

present the achievements of this 100 percent Mexican

in the distribution and dispensation of pharmaceutical products

laboratory with pride.

for consumption in Mexico

239


VIEW FROM THE TOP

DIGITAL COMPLIANCE TO IMPROVE HEALTH ALBERTO WICKER CEO of Signufarma

Q: What significant trends are emerging in Mexico’s

them when physicians orient, monitor and help address

health industry and what role is technology playing?

their problems. Creating value in this model is possible

A: There has been significant change related to patient

through information technologies by, for example, using

centricity. Organizations in this sector need to look

virtual reality to teach the patient the mechanics of both

inward and develop a patient-oriented culture because

pathology and therapy.

patients look at the pharma industry as they would the 240

tobacco industry: as if we were taking advantage of them.

Q: What benefits has Signufarma observed through the

This is due to ethical issues related to clinical trials, the

use of patient-oriented IT?

perception of abusive practices regarding medicinal costs

A: Signufarma’s hepatitis-C platform has been a positive

and a general lack of services related to the provision

achievement in terms of the information collected and

of pills. However, there are opportunities beyond

patient monitoring. This protocol creates a treatment

merely providing medical treatment. The development

card that includes the complete treatment history:

of collaborative models is a key step toward achieving

when it started, whether the patient followed a therapy

patient centricity. Such models would help companies

beforehand and how the patient has evolved, all while

to improve their image and the level of health of the

maintaining the privacy of the patient’s personal

population while also achieving a reduction in costs.

information. The objective of these cards is to show how many patients have become permanently free of

To improve the industry’s image, several steps must be

the hepatitis C viral load. In Mexico hepatitis C is not a

taken. First, we must ensure that patients know what is

well-identified health problem, so the program enables

being done for them. They see a pill but not the effort in

Signufarma and the National Institute of Medical Science

R&D and manufacturing behind it. Actively listening to

and Nutrition Salvador Zubirán to measure the number of

them is another key step. That is something the industry

patients that start treatment and its success rate through

is not used to doing, although it is aware of the necessity.

monitoring and clinical tests. We expect to help more people by integrating more health-sector institutions into

Involving the patient’s voice in the equation, going “beyond

the program.

the pill” and making a holistic effort to offer integral solutions requires making changes within organizations. We

Q: What is your strategy for sales and what results have

should train our sales forces to move beyond the “science

you seen?

behind the drug” approach and educate physicians on the

A: Signufarma’s direct sales model enables us to do

relationships they need to have with patients and how to

several things. First, deliver medicine of a guaranteed

offer more integral solutions. It is necessary to generate

standard to the homes of chronic patients or to their

real-life and real-time information through technological

doctor’s office, which enables us to keep a record of

platforms and to have this data corroborated by the patient.

a patient’s intake. We deliver the exact prescribed product in the correct dosage, preventing the problem

IT enables patients to inform themselves about the

of prescription substitution. Second, monitoring the

pathologies they suffer and possible therapies, empowering

patient has increased our sales in certain chronicdegenerative areas between 20 and 25 percent. Patients provide feedback about their specific needs, particularly

Signufarma is a Mexican company that provides compliance

in oncologic and chronic-degenerative therapies. Third,

programs for chronic diseases to pharmaceutical customers

Signufarma provides patients with commercial options

through information technology and CRM programs, providing

such as deferred payments and discounts. We increased

solutions to low patient adherence

our sales because we take better care of patients.


VIEW FROM THE TOP

SOLUTIONS IN A THIRD OF THE STANDARD TIME ALONZO AUTREY Managing Director of DVA Mexicana

Q: What value is DVA Mexicana bringing to the healthcare

production cost and performance. For example, we

sector?

reformulate products to prevent syneresis, which occurs

A: EasyCoat, our own brand, includes the manufacturing

when packaged products like beverages, ham and cheese

of pharmaceutical film coatings for medicines. We are

start losing water and consumers find water accumulated

focused on understanding trends and the direction of

when they open the package. We also provide the

the market so we can build strong relationships with

vegetable proteins raw burgers need to stay consistent

our clients, offer an integral solution and launch it to

when the consumer cooks them. For those clients that

market as quickly as possible. If a client wants to launch

manufacture nutritional beverages and supplements, we

a medicine that has a soon-to-be expired patent, we look

create a functional mix that aims to make the product

at how to get supply sources that could be validated by

better. With this mix, the client can obtain the right

COFEPRIS to launch it in the shortest time possible. The

amount of proteins, vitamins and flavor.

diversity of our excipients and our film coating EasyCoat are key strengths for our pharma division. These allow

Q: What is your main focus: increasing the volume of

us to develop solutions in short periods of time, about a

production or entering new areas?

third of the market standard.

A: We are focusing on higher added-value activities for our customers. We do expect COFEPRIS to fully regulate

Q: What is the profile of DVA Mexicanaâ&#x20AC;&#x2122;s ideal client?

the excipient business in the same way as others, which

A: As most development does not occur in Mexico but

means having a plant with a GMP is an advantage and

in the US, some ingredients cannot be changed, so the

provides us with opportunities to export in the near future.

majority of our clients are those companies that do carry

Having a plant that is up to international standards is

out local development, often generics companies. Some are

opening the door for us. Thankfully, all the transnationals

from the US but also from India and Israel, among others.

that are in Mexico buy high-quality products from the US

For these types of companies, 50 percent of their sales go

and so we can compete. We must also comply with the

to the government through the public tenders. Generics

requirements of our foreign clients because many export

have much future potential in Mexico. The generics market

to the US and so must follow FDA regulations. Today, the

continues to grow expansively, at double digits.

Mexican industry is facing a challenge: how to become more efficient in logistics and productivity when buying

Q: What benefits is DVA and its clients deriving from the

ingredients.

changes in COFEPRIS regulations? A: COFEPRIS decided that all manufacturers must have a

When we began to see the dollar appreciating against the

GMP from an authorized source, such as the US, Brazil or

peso, the pressure on clients of pharmaceutical products

Mexico. It also mandated the separation of high-risk and

and food increased because everything is sold in pesos. The

low-risk products, which means that low-risk products

food sector has been challenging, but we have seen many

require a local GMP, whereas high-risk products have to be

opportunities. We have decided to invest in a functional

certified by another source. This makes the process more

blends manufacturing plant to continue to expand in the

agile and opens more opportunities for manufacturers.

higher added-value solutions.

Q: What nutritional products does DVA Mexicana offer? A: We are focused on dairy products, bakery, meat and

DVA is a pharmaceutical company focused on the elaboration

beverages. We have a plant in Atitalaquia, Hidalgo, and a

of active ingredients and pill coatings such as Easycoat,

laboratory where we elaborate functional solutions such

which has been in the market for more than 10 years. It also

as Appenmix to optimize our clientsâ&#x20AC;&#x2122; product quality,

manufactures industrial chemicals and nutritional products

241


VIEW FROM THE TOP

HYGIENE ENGINEERING: INTEGRATING SOLUTIONS FOR INFECTION CONTOL MANUEL SÁNCHEZ Director General of Diphsa

242

Q: What was behind Diphsa’s decision to offer hygiene

Q: What process is the company following to provide these

engineering solutions?

solutions?

A: Diphsa was founded 27 years ago as a local supplier

A: We begin with a diagnosis in which we apply a method

of medical devices. Around 2000, public institutions

we developed for hospitals. We sit down and listen to our

centralized most of their purchases and the added value

customers to understand their processes, their workflows

that local suppliers like Diphsa offered to the market began

and the problems they face in daily operations. After the

to disappear. We had to identify new opportunities in the

diagnosis, we develop a proposal and establish a roadmap

health market and reformulate our business model.

that can take from one to five years.

Because we were working in infection control, we realized

Q: What added value does Diphsa offer to the health

that in Mexico there was a lack of solutions for hospitals.

sector’s supply chain?

The approach to the problem was the same as that which

A: We continuously work on state-of-the-art analyses

many vendors use in other hospital areas: machine, sell and

regarding medical technology to stay up-to-date with

service. But this was insufficient for solving the challenges

the latest innovations in the health sector. We are not

associated with infection control.

manufacturers, so we have the flexibility to identify and choose the best technology available regardless of brand.

Among healthcare stakeholders there also was, and still is,

This has been key in identifying technological trends and

a misconception that technology can solve operational and

innovations for all the different devices and technologies

procedural problems. To ensure safe processes we needed

required for a complete CSSD proposal. Our supply chain

to focus on having the right human resources within the

is global, with a very strong orientation toward Europe and

company, as well as training and infrastructure. With this in

Asia and we are constantly adding new products to our

mind, we began to develop the concept of turnkey solutions

portfolio. Our value is that we articulate a process rather

for the Central Sterilization Service Department (CSSD),

than a product approach.

examining each step of the process: architectural and operational diagnosis, workflow analysis, conceptual and

We have partnered with and made strategic alliances with

engineering re-design, construction, equipment, software,

global companies established in Mexico and specialized

training and process implementation. This approach has

in surgical instruments and operating rooms. The goal is

been effective in more than 80 hospitals and we have

to provide a complete solution that guarantees patient

expanded the model to other areas of infection control,

safety throughout the entire surgical cycle, from instrument

such as hydrogen peroxide room-disinfection systems, by

sterilization, to recovery after surgery.

developing our own brand and manufacturing in France. Starting this year, we are implementing the model for the

Q: What is Diphsa’s relationship with the public sector?

generation of medical oxygen in hospitals, for which we

A: We do not work with public institutions due to different

currently have a research and development project with

factors. First, standard procurement for medical devices

CONACYT. We are about to start exporting this approach

does not consider quality as a core value and most of the

through two joint ventures, in China and Uruguay.

time price is the main factor in purchases. We would like to work with public institutions to include the best and most cost-efficient devices in the National Formulary.

Diphsa is a Mexican hygiene engineering company with 25 years in the market supplying solutions for infection prevention.

The second reason we try to avoid public tenders is bribery

It elaborates integral solutions for sterilization, hygiene and

and corruption. We do not believe in this practice as a

medical oxygen solutions for private hospitals

business model and believe that value must be created in


terms of technology and knowledge. Most international

by Germany or France. Considering the conditions of Mexican

health companies are public or based in countries that

hospital infrastructure, this does not make sense. There should

have very strong sanctions for corruption, so they have

be a team in each hospital dedicated to epidemiological

strict compliance standards that would not allow them to

surveillance and the continuous systematic collection, analysis

overestimate their sales to bribe bureaucrats, which is the

and interpretation of all the information related to health

rule in most of the public tenders. International companies

matters. This analysis helps identify the risks and the source

that sell directly and have local offices represent a very small

of infections. In Mexico, we do not have the incentives to

number of the tender winners, which means higher prices,

gather and analyze this information because public hospitals

less access to technology and a scattered responsibility of

are very regulation-oriented and since the regulation is weak

technovigilance. The public institutions are not open to the

they actually can claim that they comply with the local norms.

new arrangements for CSSD projects, such as public-private

There is no reliable and public information that could help

partnerships with long-term contracts, while many private

patients demand higher infection-control standards. In the US

hospitals have understood this can benefit the population

and Europe the insurance organizations took action against

because of the accessibility of state-of-the-art technology

this so if a patient gets infected it is the hospitalâ&#x20AC;&#x2122;s responsibility.

for patient care. This is the reason we have been working

Therefore, hospitals started implementing measures to ensure

mainly with them. Although there are many economic

proper hygiene. However, this has not happened in Mexico yet.

incentives to invest our time in the public sector, it does

Training for nurses and doctors regarding infection control is

not match our corporate values to improve our offer and

also outdated. It is quite difficult for them to acknowledge this

guarantee the best for patients.

and to ask for internal training. We offer continuous education and training for everyone involved with the CSSD: training in

Q: What is the current situation of hospital-acquired

the use of medical equipment, the best practices for washing

infections in Mexico?

surgical instruments, technical support for engineering

A: According to the Ministry of Health, in Mexico the number

departments, safety in the handling of sterile material and

of hospital-acquired infections is only a third of those reported

other important topics.

VIEW FROM THE TOP

REGULATIONS HAMPERING WASTE-DISPOSAL OPPORTUNITIES ABRAHAM FRANKLIN Director General of Grupo Franklin

Q: What are the challenges of biowaste disposal and how

containers. The waste must be refrigerated at all times

do you overcome them?

because if gas escapes from one of the bags and is from

A: Challenges in our line of business begin with regulations.

contaminated blood, the effects could be disastrous. We

Getting the permits for the waste-collection trucks can take

need to transport our cargo at low temperatures to avoid

seven to eight months, so if we want to serve a hospital or

evaporation and to ensure no syringes or needles break.

to participate in a tender, we have to register trucks we

At the plant, workers dressed in biohazard suits put the

are not yet using. Also, we can only collect waste within a

waste into a large container, which has an enormous tube

catchment area and we are limited to working in the center

that rotates every hour to change the wasteâ&#x20AC;&#x2122;s position so

of the country. Opening a new plant to obtain clients further

that everything is burned evenly in our three chambers. The

away would require a US$20 million investment, which is

ashes obtained from that process are filtered through a fine

extremely risky without a signed contract in place.

fabric and taken to dumps. By the end of the process, all we emit is water. We also burn expired pharmaceuticals for

Q: What process do you use to safely dispose of

hospitals, for which they receive a tax reduction. If they did

biohazard waste?

not burn them, someone could take them from the trash.

A: Refrigerated trucks pick up garbage from public

Our trucks also have to be zero-emission vehicles, because

and private hospitals and take it to our plant in special

this is our companyâ&#x20AC;&#x2122;s distinguishing characteristic.

243


VIEW FROM THE TOP

SECURITY IS IN THE AIR ÁNGEL DE VECCHI Director General of VECO

Q: How important is the health sector to VECO’s operations?

problems in Mexico, especially in cities such as Monterrey,

A: Traditionally, VECO has been more focused on pharma since

Toluca, Leon, Silao, Mexico City and Guadalajara, are

we invest heavily in pollution control. Now, we are starting

respiratory infections resulting from the terrible air quality.

to focus on hospitals, because they should invest more in

244

controlling the environment in both critical and noncritical

Q: What benefits do hospitals receive from VECO systems?

areas. We have just installed eight QUIROVECO air-filtering

A: An air-quality control system enables the reduction

units in Mexico City’s Hospital General. With this equipment,

of nosocomial infections caused by air contamination,

the operating room lamp is in the center and has a High

resulting in cost savings due the reduction of

Efficiency Particulate Air (HEPA) filter around it, ensuring the

hospitalization time and the use of antibiotics. Our air-

air is sterilized above and around the operating table. When it

filtering technology, coupled with a highly trained staff,

comes to innovation related to air purification, it is necessary

can reduce or eliminate the need for antibiotics.

to improve the validation processes and standardized operating procedures because air-filter technology has not

Q: Previously, 60 percent of your business went to the public

changed much in the airborne particle-efficiency filtered. The

sector. In which areas is VECO working specifically?

application design, however, evolves along with our clients’

A: The public sector is an important part of our business,

needs, which modify over time. There may be cases in which

especially in research and energy generation. Those working

clients require us to design an entire air-filtration system for

with hazardous substances understand the importance of

a special application and we validate the equipment’s quality.

ensuring they do not breath the virus. The same goes for the construction of laboratories. We also offer services to nuclear

Q: What steps are followed when a client requests a system?

laboratories that work in cancer treatment. We manage the

A: It is a long process. First, the customer sets out the

air-quality control of these centers, ensuring that radiation

required system and the air efficiency to be achieved

does not leak. Finally, VECO works with public-sector

according to ISO standards. Then, each component of

institutes that mix medicines.

the system is designed in accordance with the process requested. One of the greatest issues for hospitals is

Q: VECO sells its products worldwide. What is the added

nosocomial infections because hospitals are badly designed

value it offers as a Mexican company?

and the investment to correct this would be large. A

A: Our price/quality ratio is very good and some of our

hospital should be designed so that each consulting room

products from 1970 are still in use today. In 2016, we

has a system that brings in clean air from the corridor

began a process to redesign our equipment to prepare

and safely removes contaminated air from the consulting

ourselves to go out and look for stronger distributors in

room. However, to implement this change in the air system

the US, Canada and Europe, where investments of this

in existing large hospitals would require demolishing the

type are most common.

building and starting over. Q: What role do you see VECO playing in health in Mexico? We are developing systems that mitigate this not only for

What solutions can improve access to health?

hospitals but also for home applications. One of the main

A: We should get more involved in regulatory affairs, bringing the knowledge we have acquired nationally and internationally to generate regulations that force institutions to use adequate

the

air-pollution control systems. The CSG has begun certifying

purification of air and gases. It provides services to industries

hospitals and has increasingly raised standards, which has

including electronics, energy, nuclear engineering, aerospace,

enabled some to improve at a manageable pace. The main

pharmaceuticals, biochemistry and oil chemistry

objective should be standardization at a high-level.

VECO

manufactures

systems

and

equipment

for


VIEW FROM THE TOP

BETTER GAS MANAGEMENT, BETTER HEALTH SERVICES EDGAR ARTEAGA Director of the Medical Division for Inframedica

Q: What are the main solutions Inframedica offers the

Q: How are you addressing sleep issues?

healthcare sector?

A: We have a high-tech sleep clinic for the diagnosis and

A: Inframedica offers design, engineering and installation

treatment of obstructive sleep apnea. We treat more than

of supply networks for oxygen and medical gas through

1,000 patients and we have more than 80 mobile clinics

our wholesale and retail sales to hospitals and small

across the country offering this service.

clinics. We have good relationships with many medical groups, such as Ángeles, StarMédica, Hospital San José,

Q: What innovation is possible in the gas distribution market?

Hospital ABC and Beneficiencia Española.

A: The cooperation with our main partners, Air Products and Chemicals, allows us to modernize and use vanguard

Q: What strategy do you implement to ensure these clients

equipment for the supply of medicinal gases that contribute

stay with you from the start to the end of a project?

to long-term competitiveness.

A: Our solid infrastructure allows us to guarantee the maximum strength, efficacy, professionalism and responsibility that

Q: As a market leader, what is the added value Inframedica

our customers deserve. With hospital projects, we have a

brings to the healthcare industry?

complete team of specialists who are ready to collaborate

A: We are investing in large infrastructure to provide

on each part of the project. We collaborate with the main

services to treat diseases with high mortality in Mexico,

health institutions and physicians in respiratory care in Mexico.

like Chronic Obstructive Pulmonary Disease, which in 2016

Such is the case of Seguro Popular, which uses our solutions to

became the third cause of death in Mexico. We also develop

provide services in respiratory care to low-income populations.

alliances with the main health organizations and institutions that have allowed us to create solutions for the diagnosis,

Q: How do you manage your distribution?

treatment and follow-up of patients.

A: We have the largest distribution network in the country, which guarantees the delivery of medicinal oxygen to hospitals, clinics, homes of patients and those patients with

Inframedica is part of Mexican company Grupo Infra and has

affiliated insurance companies or government institutions.

almost 100 years of experience. It focuses on the development

This network is supported by 30 production plants and 200

of devices and infrastructural products for gas management,

sales points across the country.

health and work safety

Analyzing human gametes

245


VIEW FROM THE TOP

SMALLER PHARMACIES FIGHTING BACK AGAINST BIG CHAINS GUILLERMO MARTORELL Director General of Grupo RFP

246

Q: What are the greatest challenges that pharmacies are

Q: To what extent will specialists in pharmacies be linked

facing in the current market?

to the specialized areas within stores?

A: We face aggressive competition from national chains that

A: They will be in two senses. First, salespeople will be

are entering areas where regional chains had maintained

specialized in what they are selling, usually linked to the

an unchallenged presence for many years. Everyone can

provider, which trains those people to use the products.

compete on price, but the main issue is service and a big

Secondly, we want to add specialized doctors such as

pharmacy can offer all the medicines listed on a prescription.

dermatologists. We will first see how this progresses and

The national chains often have large inventories and if a

then bring other areas online. We are even considering

regional pharmacy does not, it becomes less competitive.

offering basic dental services. The company we are

Medicines for chronic diseases are now in high demand

working with to provide doctors also collaborates with

and although people are cost-conscious, they also prefer to

us to set up clinics in those small towns that suffer from

obtain all the items they need at one store. Service, stock,

access issues.

location and price are the top four challenges. Q: What growth do you expect for home deliveries and Q: To what extent would you consider creating your own

online sales?

brand?

A: We are hoping for aggressive growth because we are

A: More than an own-brand, we would be creating an

still small. We need to more than double our revenue from

exclusive brand because it would be sold through our

home deliveries in 2018, reaching around 150 percent

pharmacies and would not bear the logo and branding of

growth as we are starting from a small base. We expect

each individual pharmacy. We are in the process of creating

to see growth of around 300-400 percent in our online

such a brand that would be available throughout the group.

services. The platform is already running in two chains. The

Generics are enjoying the most growth, so combining

back end of the platform will be the same for each chain,

generics with a private label should produce good results.

although the front end will reflect the individual chain.

To date the brand is designed and developed, we are simply awaiting regulatory approval. We hope to launch it in 4Q17.

Q: How is the platform organized and what impact is e-commerce having on pharmacies?

Q: What plans do you have to put doctors in these

A: We sell through various channels, one of which is online,

pharmacies?

which is an emerging and growing area. By technological

A: We have set up 100 consultancies so far from a base of

platform, we mean mostly two things. The first is information

zero and we continue to grow. Of those, 62 pharmacies

management at the point of sale. The second enables

are in operation and the others are still a work in progress.

operations related to inventory control, to sales statistics, costs

The doctors are not our employees and they have full

and putting costs online to allow customers to make quick

liberty to decide which treatment to prescribe. We use

decisions, promotions and discounts. In addition, we want to

a third party that is specialized in this area to find those

implement specialized software for personnel management,

doctors. In addition to general doctors, we hope to add

because there is a high level of rotation in the pharma-retail

specialized consultancies.

sector and constantly training people is expensive. Q: Will independent pharmacies have a role with the group?

Grupo Regional de Farmacias Productivas (Grupo RFP) was

A: We are working on a program to invite independent

founded in 2016, uniting pharmacies such as Farmacias San

pharmacies that we hope will be ready by the end of 2017.

Francisco de AsĂ­s, Farmatodo, Farmacia Noscaro, Farmacias

We hope to close 2017 operating around 600 pharmacies,

de Dios, SFG and SĂşper Farmacia Gems

not counting those that are independent.


VIEW FROM THE TOP

PHARMACIES: SAFE ACCESS TO HEALTH ANTONIO PASCUAL President of ANAFARMEX

Q: What main challenges in terms of administration are

important that the doctors in these offices are trained. With

pharmacies facing right now?

generics, pharmacies need to be clear about what is said

A: There are 45,000 outlets, including pharmacies and

regarding these products. We must avoid the conflicts of

convenience stores, that sell over-the-counter drugs and

interest that arise through prescription substitution.

30,000 pharmacies, including chains, self-service and SMEs. ANAFARMEX is pushing for a new model that strengthens

Q: What can be done to promote local businesses over

SME pharmacies or community pharmacies so that the

their larger counterparts?

network is composed mainly of this type of business, as

A: The quality of service is fundamental. If there is no quality

it is in Europe. In Mexico, we follow the American model,

service or certified staff related to those investments, the

which is vertical and employs a large inventory but with little

projects will be small. A prescription must be treated as

rationality at the sales point. The pharmacy is a service that

an official document and free access to drugs must be

provides drugs to the population and the European model

supported with advice from the operator. The price factor is

accomplishes this because in SME pharmacies, 80 percent

also affecting SME pharmacies, so the challenge is to reduce

of the inventory is pharmaceutical while the remaining 20

that gap between supermarkets and chain pharmacies.

percent is of another variety. In the American model, 30

COFECE has been researching noncompetitive business

percent of the products at supermarket pharmacies are

practices and hopefully in the future these will decrease.

pharmaceutical, while the remaining 70 percent are not. Q: There are products that have been withdrawn from the Q: What is ANAFARMEX’s main priority?

foreign market but are still sold in Mexico. What can be done?

A: We want to claim the role of pharmacies in dispensation.

A: Mexican pharmacies were not submitting pharmacovigilance

The WHO has proposed that all countries achieve better

reports but after the WHO started demanding these reports,

product management. To that end, Mexican authorities

certified pharmacy operators became obligated to do them.

are working to certify pharmacy operators. We provide

We also need to reinforce the importance of the patient report.

performance ratings based on CONOCER’s Competency

These new responsibilities brought by the new regulations will

Standard 468, which addresses the dispensation of drugs

help authorities decide when to remove a drug.

and health-related products at pharmacies. Through an agreement with the Ministry of Public Education and the

Q: How does ANAFARMEX contribute to the eradication of

Ministry of Health, we provide pharmacy employees with

illegal products in the pharmaceutical market?

training from the Integral System for Training on Dispensing

A: The WHO says that 10 percent of everything commercialized

(SICAD), COFEPRIS and CONOCER. In the future, we hope

in the market comes from illegal sources. Fortunately, in

that when customers enter a pharmacy of any type, they

Mexico the figure is 1.5 percent. We recommend that when

will see a sanitary or operating license, which lets them

consumers purchase products, they verify that the provider

know there is a certified operator on site. Right now, only

is a reliable company that has the official document of

30 percent of operators are certified.

recognition as a distributor issued by the Ministry of Public Education (SEP). ANAFARMEX has a permanent committee

Q: Medical consultations and branded generics are now

focused on the illicit market.

available at pharmacies. What challenges and opportunities does this represent? A: Fifty percent of the country’s 30,000 pharmacy outlets

ANAFARMEX is an association that represents mainly small

now have Pharmacy Anexed Consultories (CAF), where

and medium pharmacies but also some pharmaceutical chains,

there are around 10 million consultations per month, more

making up a network of 30,000 sales points. The association

than ISSSTE provides in the same period. However, it is

has been providing members with services for over 31 years

247


ROUNDTABLE

HOW ARE YOU OVERCOMING THE LOGISTICS HURDLES IN MEXICO?

Mexico is the 14 th largest country in the world, making distribution and transportation a logistical challenge. Added to its vastness is its reputation for insecurity, an issue companies must overcome to successfully transport goods. These issues not only pose logistical hurdles but can also contribute to higher expenses. Mexico Health Review asked relevant players from the logistics industry how they are tackling these and other challenges while delivering services and products in health and pharma in Mexico.

One of the greatest challenges we face is Mexico’s size, so we must ensure we provide an effective, efficient and continuous service. Security is a hot topic that requires care. We are a low-margin industry, so all additional costs immediately impact our 248

profitability. We need to be prudent about how we manage additional expenses, which, ideally, we should not have. The health industry in Mexico is also a complex and fragmented one that requires different skillsets. I truly believe that Mexico is one of

JOSÉ ALBERTO PEÑA Director General of Grupo Marzam

the most complex healthcare markets. 2017 will be a challenge from an exchange-rate perspective. For us, another key component is gasoline, which has a direct impact on our expenses. The exchange rate will have an impact on the industry as a whole because 90 percent of material used to produce medicines is imported.

In Mexico, many products are transported over land but a challenge that is not usually considered is the number of times a package can be exposed along the transport cycle. Before picking up a UPS Temperature True shipment, UPS works with its customers to provide a comprehensive analysis of shipping options and procedures, such as routing, type of transportation required, who will come into contact with the shipment, what type of carriers are acceptable for that type

INGRID RITTER Healthcare Strategist Latin America of UPS

of shipment and set up of contingency shipment plans. Everything is defined beforehand, so when we do pick up a shipment, we know exactly how it is going to move, from where to where and who needs to be notified.

The greatest risk is the loss or damage of the client’s assets. NOM-059, ratified in August 2016, is also important for us. It stipulates that to transport pharma goods within Mexico, a company must use vehicles specifically for this purpose and cannot transport anything but pharma goods. As we are already dedicated to this and have a cold chain in place, this norm has benefited us. Beginning a project is often the most difficult phase because companies do not have the full

MARIO GARCÍA Vice President of Operations at GNK Logística

scope of the project. The private sector is more demanding due to their corporate governance and compliance structures and procedures. The tolerable margin of error is extremely narrow. Governments often do not have standardized procedures or high standards when dealing with pharma goods and their warehouses in most cases do not comply with any NOM rules or regulations, nor do their vehicles.


Protests do not affect us much. What does impact us greatly is the Hoy No Circula (No Drive Day). In 2016, 40 percent of our vehicles could not circulate on any given day. With one No Drive Day per week, 20 percent of our vehicles are idle but with the double measure, two of every five are out of action. Distributing medicine becomes much more difficult. There are also security issues and areas we cannot enter because drivers are asked to pay bribes. We do not enter areas where the driver will be at risk, or when the risk is larger than the reward. If we were to push this, then we would be putting the health of the driver and the good

VÍCTOR SOTO Director General of Levic

condition of the medicine at risk. We are investing in R&D to allow our customers to buy from us online. In the first month, sales were laughable, but by March 2017 online sales represented 9 percent of our total.

Cost-efficiency is the most pressing issue. We must make our routes more profitable because many new, bigger competitors are entering the business attracted to the segment because distribution in the pharmaceutical sector is one of the best 249

remunerated. However, for a company like Majicarga it is difficult to compete against fleets of thousands of units and the entrance of these new competitors. The prices we must offer are much lower than three years ago. Businesses must find sustainable strategies that help growing companies maintain or even further develop so as not to be bought out or absorbed by larger ones. Insecurity is another significant challenge.

ERICK JIMÉNEZ Director General of Majicarga

Although we have a sophisticated monitoring system, the existent technology is limited. No distributor or technology company in the security market can fully guarantee that a unit carrying a client’s product will not get lost or robbed.

The main problem is the lack of logistics regulation for the transportation of laboratory samples and other types of materials. Those in charge of shipments are often unaware of the logistical intricacies involved and delivery companies can be blamed for any problems. We are addressing this by providing more training for our staff and we have established certain internal rules. For example, if the container provided by our client to transport a sample is inappropriate, we would reject the order or use one of our available containers. Even though a value cannot be placed on samples, an inappropriate protocol can translate to a loss of millions of dollars for

JOSÉ ERIC DELGADO Director General of Sicamsa

clinical laboratories. The samples we transport can be essential to a patient’s health so our mission is to deliver it in the right way and as quickly as possible.

Due to quality and security concerns with land transportation services, the industry has increased the volume of pharma products transported by air. We have been offering specialized services for the domestic market for the last three years and our market penetration has grown over 100 percent each year. Today, we transport around 12,000 tons of pharma products every year, which represents 90 percent of the domestic air pharma market. Our biggest strength is Aeroméxico’s security processes, which make us the most secure airline to fly with. We have invested a lot of resources over the past three years to make sure that 100 percent of our cargo is screened and sterile, which makes us the preferred carrier for most agencies.

RAFAEL FIGUEROA Director General of Aeroméxico Cargo


Novo Nordisk cycling team


HEALTH CONCERNS

11

The increase of life expectancy due to the control of infectious diseases has given foot for new concerns such as chronic diseases, common in the elderly population and a group of young people prone to these conditions due to unhealthy lifestyles. Chronic diseases such as diabetes, obesity, cardiovascular conditions, cancer and renal deficiency are a priority for citizens and healthcare institutions. Also, issues such as teenage pregnancy, breast feeding, maternal mortality and geriatrics are demanding more attention and more resources. Efforts from the public healthcare system are focused on providing care for these patients once they are diagnosed, which is sucking up most of the shrinking public budget without producing effective results. The new action plan is focused on prevention strategies that could help reduce the rising number of cases, together with the creation of awareness campaigns on the main health issues. The Mexican population lacks discipline in medical checkups, only visiting a doctor when feeling discomfort or pain, which leads to conditions being diagnosed in late stages when very little or nothing can be done to alleviate the condition. This also results in higher costs for health institutions. This chapter will cover the main health concerns in Mexico explaining what healthcare players in the sector are doing to solve them.

251


CHAPTER 11: HEALTH CONCERNS 254

ANALYSIS: Serious Diagnosis for the Mexican Population

256

VIEW FROM THE TOP: Yiannis Mallis, Novo Nordisk

258

VIEW FROM THE TOP: Irma Egoavil, Ferring Pharmaceuticals

260

VIEW FROM THE TOP: Erick Alexanderson, SMC

261

VIEW FROM THE TOP: Claudio Castro, Synthon

262

ANALYSIS: The Three Types of Diabetes

263

VIEW FROM THE TOP: Carlos Oviedo, GDA

264

VIEW FROM THE TOP: Julián González, Check-Up Center

265

VIEW FROM THE TOP: Sergio Brown, Beckman Coulter and Danaher

266

INFOGRAPHIC: Obesity: A Growing Problem

267

VIEW FROM THE TOP: Carlos López, Medix

268

VIEW FROM THE TOP: Juan Carlos Borgatta, Borgatta

269

VIEW FROM THE TOP: Rogelio Villarreal, Centro de Oftalmología Monterrey

and Ojos Para México Foundation

270

ANALYSIS: Cancer a Top Killer Among Men and Women

272

EXPERT OPINION: Myriam Lingg, Swiss Tropical and Public Health Institute

and the University of Basel

274

ANALYSIS: Success Of 90-90-90 Aids Program Requires 20/20 Vision

275

INSIGHT: Juan Tamayo, COMOP

276

EXPERT OPINION: Carlos Ortiz, ABC Medical Center

Janet Pineda, ABC Medical Center

277

ANALYSIS: Maternal and Infant Health

278

VIEW FROM THE TOP: Felipe Espinosa, Laboratorios Collins

279

VIEW FROM THE TOP: Ignacio Castañón, Alcon Labs

280

ANALYSIS: Beware of Mosquitoes

253


ANALYSIS

SERIOUS DIAGNOSIS FOR THE MEXICAN POPULATION Public health policies in Mexico have evolved to tackle the

but now diabetes, cancer, depression and

challenges of a population that is living longer. The emergence

coronary diseases are more frequent. Mexico

of chronic disease control as a priority is putting a strain on

is a young country and the main driver for

public finances and highlighting the need for preventive care

growth is its large population. Therefore, it is important that all decision-makers in this

According to the Deloitte 2017 Global Healthcare Outlook,

country realize that the young population needs to be

by 2020, 50 percent of global healthcare expenditure

healthy to be productive.”

(around US$4 trillion) will be spent on three causes of

254

death: cardiovascular diseases, cancer and respiratory

In 2016, diabetes was the second-leading cause of death in

diseases. Today, Mexico’s main health concerns pivot

Mexico, accounting for 14 percent of all deaths nationwide,

around endocrine disorders, cardiometabolic diseases

according to the WHO report for that year. According to

and CNS conditions and finding cost-effective strategies

ENSANUT, the incidence of obesity among the Mexican

to prevent, diagnose and treat these conditions. The main

adult population is 71 percent although that varies across

cause of death among the Mexican population in 2015,

the country depending on a number of factors, a situation

according to INEGI, were heart conditions, followed by

that subsequently demands different tactics, making

diabetes mellitus and cancer.

a concerted policy approach difficult. “There are very clear regional differences based on the cultural traits and

Mexico’s top priorities can be categorized by age group.

customs of the population. For example, the folklore of

First, fight child obesity and teenage pregnancy to

each state has an impact on eating habits and this can vary

ensure the wellbeing of future generations. According

widely across the country, requiring a different approach

to ENSANUT, the combined prevalence of obesity and

in each location,” says Erik Alexánderson, President of the

overweight in children between the age of 5 and 11 is

Mexican Society of Cardiology (SMC).

33.2 percent. Second, address the increasing prevalence among an aging population of CNS diseases such as

The Mexican government is addressing the problem by

Alzheimer’s, diabetes and cardiovascular diseases. Third,

implementing a special tax on production and services

educate the generation of young adults who are prone to

(IEPS) related to sugary drinks. In addition, the country is

diseases caused by unhealthy lifestyles. “We are shifting

considering the possible application of a tax on products

from infectious disease to chronic diseases,” says Oscar

with a high sugar or fat content. But taxation alone will

Parra, Managing Director of Mexico, Central America and

not solve a problem that begins with the population’s lack

Andes of Lundbeck. “Before, bacteria caused illnesses

of knowledge about the disease and its causal factors.

PERCENTAGE OF THE POPULATION PER AREA WEIGHT IN MEXICO PER REGION (percent)

PERCENTAGE OF THE POPULATION PER REGION WEIGHT IN MEXICO PER AREA (percent)

50

50

40

40

30

30

20

20

10

10

0

0 Rural

Urban

OBESE (EQUAL OR THAN 30) „„Obese „MORE „Normal OVERWEIGHT (25-29.9) „„Overweight „„Underweight NORMAL (18.5-24.9) Source: ENSANUT 2016 UNDERWEIGHT (LESS THAN O EQUAL TO 18.5)

North

Center

Mexico City

OBESE (EQUAL OR THAN 30) „„Obese „MORE „Normal OVERWEIGHT (25-29.9) „„Overweight „„Underweight NORMAL (18.5-24.9) UNDERWEIGHT (LESS THAN O EQUAL TO 18.5)

South


ENSANUT’s results showed that 76.3 percent of Mexicans

the costs of treatment, especially amid a rise in life

do not know how many calories they should consume each

expectancy. According to INEGI, life expectancy for

day and only 14 percent of adults comply with the WHO’s

Mexican men increased from 71 years in 2010 to 73 in 2016

suggestion of 150 minutes of exercise per week. Yet. the

and for Mexican women from 77 in 2010 to almost 78 in

survey also revealed that 62.3 percent of the population

2016. According to Deloitte’s Global Health Care Outlook

considers they have healthy nutrition and 67.3 percent

2017, life expectancy in Mexico is projected to increase

consider themselves physically active.

by one year by 2020. The report estimates that by 2020, global health expenditure will climb to US$8.7 trillion, from

TEEN PREGNANCY

US$7 trillion in 2015. Prevention and early diagnosis could

Another major concern, both at the health and social levels,

help reduce this burden. “Mexico has done a great job in

is the high rate of adolescent pregnancies. According to

generating consciousness, due in part to the government’s

the OECD report Society Glance 2016, Mexico ranks first

sponsorship of a large number of campaigns, although

among OECD countries in teenage pregnancy. Of every

there is still a great deal of work to do. Habits need to

1,000 babies born, 73.6 babies belong to teenage mothers

change, which is difficult,” says Carlos López, Director

between the age of 15 and 19, while the average for all

General of Mexican company Productos Medix, which is

OECD countries is 14 babies per 1,000.

dedicated to fighting overweight and obesity.

BABIES FROM WITH TEENAGE MOTHERS IN OECD OECDBORN COUNTRIES HIGHEST TEENAGE COUNTRIES FERTILITY(per 1,000 births)

ESTIMATED NUMBER OF PEOPLE WITH DEMENTIA ESTIMATED NUMBERS OF PEOPLE WITH DEMEN-IN TIA, MEXICO MEXICO (millions)

80

18

70

16

60

14

50

12 10

40

8

30

6 20

4

10

2 Hungary

Slovakia

US

Turkey

Chile

Mexico

0

Source: OECD data

0

„„Men

2015

2020

2025

2030

„„Women

Source: World Alzheimer's Report 2015

In response, the government has adopted a national

The private sector also has a significant role to play in

strategy MOTHERS for prevention of teenage pregnancy: ENAPEA, a FOR EVERY 1000 BIRTHS

the landscape of prevention and care and partnerships

program that was established to address this issue, targets

between private and public companies have become

zero pregnancies for ages 10 to 14 and a reduction by half

strategic. “We are focusing more on improving our

for ages 15 to 19 by 2030.

patients’ outcomes by helping institutions measure results

BABIES BRON FROM TEENAGE

and apply effective solutions, which gives us a competitive

FIGHTING CNS CONDITIONS

advantage. AMIIF and IMSS are also launching a project

Regarding CNS conditions, the most recent National Survey

to prioritize a group of critical diseases in which they

of Psychiatric Epidemiology shows that 23 percent of the

create rules so that the different companies offer shared-

population suffers from a mental condition. According

risk models that can provide access to innovations,” says

to the Mexican Health and Aging Study (ENASEM),

Alexis Serlin, Director General of global pharmaceutical

which appeared in the World Alzheimer Report 2016, the

and biotechnological company Novartis.

prevalence of dementia was 6.1 percent in the population aged 60 and above. The study also found that diabetes and

These initiatives and joint efforts between the private

depression were a risk factor for this condition.

and public sector will be key to addressing Mexico’s main health concerns. “Private companies are changing from

To face these health issues, the public healthcare systems

being providers to becoming partners,” says Fernando

are investing in prevention and early diagnoses to lower

Oliveros, Vice President of Medtronic.

255


VIEW FROM THE TOP

TREAT NOW TO AVOID COMPLICATIONS LATER YIANNIS MALLIS Vice President and General Manager of Novo Nordisk Mexico

Q: COFEPRIS is known for its strict regulatory approach.

256

Q: Novo Nordisk is working on oral insulin. What would

How did this impact Novo Nordiskâ&#x20AC;&#x2122;s operations?

the impact be in Mexico, where diabetes rates are so high?

A: Mexico has implemented strict regulations that have

A: Oral insulin has been the Holy Grail of diabetes for

impacted the entire value chain. These restrictions are

many years, other than finding an outright cure. It would

well-founded and are a natural evolution of the Mexican

be significant in a market like Mexico, but it is not a silver

industry. This is a positive tendency. There are some

bullet. In the midterm, it is more likely that oral glucagon-like

restrictions placed on operations, but overall the standard

peptide 1s (GLP1s) reach the market, which could offer an

of production in the country is positive.

excellent level of glycemic control for patients, with minimal risk of lowering glucose below optimal or safe levels. The

Q: With the increasing number of generics companies

arrival of oral GLP1s will transform treatment across the

entering Mexico, what strategy are you employing to

globe. As a company, we are investing in both technologies,

ensure Novo Nordisk products retain market share?

but we see oral GLP1s as a faster and better route into the

A: Mexico is a market in which generics are now dominant,

oral market, which should occur in the next five to 10 years.

mostly in oral treatments, but less so for insulin and injectables. Protein products cannot be copied exactly

Q: What advantages does Novo Nordiskâ&#x20AC;&#x2122;s new drug

due to the many intricacies and stages of the production

semaglutide for obesity offer and why move into this

process and their impact on the resulting molecule. Novo

segment?

Nordisk has a broad range of innovative insulin products

A: We have been working in diabetes for more than 90

and injectables, so the biosimilar/generics trend has not

years. For us, obesity is an adjunct area that has always been

had a dramatic effect on our business.

very exciting, but has never been considered a disease by the community of physicians. We have developed two GLP1

In addition to the top products, we offer high quality

molecules that work on both diabetes and obesity. One is

previous generation products at even more affordable

commercially available in Mexico, called liraglutide, which is

prices. We compete directly with biosimilars in the high

available in two formats: one to treat diabetes and a second for

volume/very low price segment, while our previous-

treating obesity. The other is semaglutide, the next generation

generation products compete in the medium price-range

of GLP1, which will also hopefully be used for diabetes and

and our latest and most innovative products compete in

obesity. The current GLP1 has excellent data in terms of

the best-in-class tier.

efficacy, safety and weight lowering effect and clinical trials with semaglutide have shown even greater promise. The good

Q: Last year, Novo Nordisk was the governmentâ&#x20AC;&#x2122;s top

news for us is that we have made an entry into this market and

provider of human insulin and had the third-largest share

we have other products in the pipeline for the next five to 10

of the overall diabetes segment. Can the company keep

years. We carry out many clinical trials in Mexico and the sites

pace going forward?

here are among the most efficient in the world.

A: Novo Nordisk is the largest insulin provider in the world, with over 50 percent of the global insulin market and

Q: Just over 6,000 people suffer coagulation issues in

25-30 percent of the overall diabetes market. In Mexico,

Mexico. What is the advantage for Novo Nordisk to cater

we are not the market leader yet and last year we had

to such a small number of patients?

8-10 percent of the market, depending on the segment,

A: There is an unmet medical need for patients, so our

which is three times less than our global average. As the

products make a very real and significant difference. As

demand for better diabetes care and products in Mexico

a company, we only enter a therapeutic area if we can

is growing, we are sure we will continue to grow strongly

make a difference. With our strong history in molecular

in coming years.

engineering, hemophilia is an attractive space in which


257 Technological innovation at MĂŠdica Sur

we can apply this principle of synthesizing, developing,

the industry and patients must all contribute in tandem. We

creating and producing proteins. Apart from the

will continue to offer attractive price points for our products

gratification of improving the everyday lives of people with

to make sure that an increasing number of patients can

hemophilia, it is also an attractive commercial opportunity.

receive better treatment. If they are using human insulin now, perhaps they could move onto modern insulin and

Q: What is the companyâ&#x20AC;&#x2122;s market position in the

then potentially to our best-in-class and most innovative

hemophilia segment?

insulin: insulin degludec.

A: For patients with hemophilia who have developed inhibitors, we are leaders with recombinant factor VIIa

We need to help and empower people with diabetes to

(rFVIIa) in Mexico, offering treatment to almost three-

take ownership of their disease, follow the regimen, do not

quarters of them. From the smaller inhibitors segment,

cut corners and become really interested in achieving the

we are now entering the broader hemophilia population.

best outcome, to see real progress in bending the diabetes

Turoctocog, our new recombinant factor VIII product,

complications curve. If patients follow this path, they may

entered the market in 2017 and it has been successful so far.

be able to avoid retinopathy, blindness or kidney disease and live a healthy life.

Q: What is the added-value Novo Nordisk provides in the growth hormone segment over its competitors?

In most countries, pharmaceuticals represent only 10

A: We offer a constant presence and dedication to the

percent of the total cost of diabetes. If people can invest

patient. When we enter a segment or a medical need, we

that first 10 percent or even a little more to get access

are there to stay. People know they can depend on us, that

to better products, a big part of the other 90 percent of

we will continue focusing on that area and supporting the

costs can hopefully be avoided. In Mexico, this is critical,

patients for as long as there is demand for our products. We

because the system is now treating the complications of

have attractive devices for patients, such as a pen instead

people that began suffering from diabetes 15 years ago.

of a needle and syringe. In addition, we support patients

Since then, the diabetic population has more than doubled.

and doctors with education and other services. Q: As head of Novo Nordisk Mexico, how will you

Novo Nordisk is a Danish pharmaceutical company that is a

contribute to Mexican healthcare over the next two years?

world-leader in diabetes, growth hormones, and hemophilia.

A: Diabetes is a problem that is too big for one company or

With a global presence in over 180 countries, it has been

party to solve. The public sector, the medical community,

operating in Mexico since 2004


VIEW FROM THE TOP

DIVERSE NICHES PROVIDING GROWTH IRMA EGOAVIL Director General of Ferring Pharmaceuticals Mexico

258

Q: Ferring operates in many areas, some quite specialized.

casa (Baby at home) that helps patients with a fertility

Which are the most relevant for the Mexican market?

need who do not have the purchasing power to access

A: Our urology portfolio contains a product aimed at

treatment. The major problem in reproductive health is

hormonal dependent prostatic cancer, an antagonist that

that all costs are paid for fully out-of-pocket, so not all

enables fast and safe disease control without increasing

patients are able to undergo treatment. As world leaders in

cardiovascular risk, a relevant factor for the Mexican

reproductive care, through our Proteger (Protect) program

population. In addition, in August 2017 we will be launching

we work with INCan and other associations to identify

a product for the treatment of patients with erectile

and support female patients who have cancer and could

dysfunction. Although it would be a first-line treatment,

potentially have a future reproductive need. Our program

it will be particularly useful for patients with metabolic

enables them to protect their ovules and thus ensure

syndrome, obesity or cardiovascular disease because this

future possibilities of getting pregnant. We work mostly

segment is at risk if systemic treatment options are used.

with breast cancer patients because it is a disease that can be cured if detected early enough.

Q: What is Ferring’s most interesting project at this time? A: Ferring is not a Big Pharma nor an orphan drugs

Q: What internal and external factors have contributed to

manufacturer but a specialized company attending niche

the company’s growth?

pathologies. We are becoming a more technology-oriented

A: Ferring has enjoyed success in the private and the public

company, which is due to the areas in which we work. For

sectors due to our portfolio and because we are committed

example, we manage a portfolio for patients with chronic

to helping people become parents and to keeping mothers

intestinal disease, which is not so frequent, is difficult to

and babies healthy, from conception to birth. Over one-third

diagnose and patients need a lot of follow-up during the

of our investment in R&D targets innovative treatments in

treatment. We have been providing digital tools to provide

reproductive and maternal health but we are also passionate

such follow-ups for the past three years.

about making a difference to people’s health and quality of life through our work. Something we are working on

Q: How can technological innovations help patients?

is diversification. We supply to 18 countries in the region,

A: The way they work varies according to therapeutic

which has also helped us to grow and we have striven to

areas. For example, we have an app for patients with

differentiate ourselves and bring products here that could

inflammatory bowel disease that provides information on

have an impact on the population.

the different stages of the disease and the reasons behind its progression. The main issue for these patients is that

Q: Which products will you bring to Mexico?

even though the disease may be controlled, there could be

A: We will be launching three new products in the short

a specific event that pushes it to another stage. We provide

to medium term. The first is the treatment for erectile

support and teach them to identify symptoms. Another

dysfunction. The others are focused on fertility. One is a

program helps patients with prostatic cancer track the

biotech product that is a recombinant treatment, different

disease properly, providing them with access to prostatic

from what is on the market because it enables doctors to

antigen testing. Ferring also runs a program called BB en

tailor doses to a patient’s specific needs. The other is a treatment that makes it easier for a fertilized egg to attach to the uterus at the beginning of pregnancy. This treatment

Ferring Pharmaceuticals is a Swiss company that has a wide

has an innovative application and dissolution method

portfolio of products spanning prostate cancer, birth, intestinal

that supports the proper absorption of the drug, which

inflammation, assisted reproduction, bed wetting, cirrhosis

differentiates it from other intravaginal alternatives. This

bleeding and coagulation issues

will be on the market in September 2017.


Q: What challenges do you face when bringing innovation to Mexico and how do you overcome those? A: Sometimes, access to innovation in Mexico is not easy and can take a long time. Even if innovation can deliver added-value, it must be proven. Adoption of innovation can also be challenging as it sometimes means that the therapeutic conduct has to be changed. For example, our new erectile dysfunction product will meet an unmet need and for it to be effective we have to work with physicians and medical associations to ensure it is used in the right way and prescribed for the right patients. The testing and dosage adjustment for the recombinant personalized fertility treatment that we will be launching will be different from current alternatives in the market and will require us to support physicians as they adopt the product. Q: Ferring entered a partnership with Metabogen to produce probiotics for pregnant women. What role do alliances play for the company? A: Alliances are important. However, Ferring is a private company focused on innovation and clinical research and just like all companies we need to be selective in this area, allying with those that could help maximize our business. The investment required to put a product on the market is huge, sometimes over US$1 billion, and the likelihood of success is limited. Companies that are good at R&D in a specific area can benefit from these alliances. Q: There is a lack of reliable, updated information on health in Mexico. Is there an opportunity to use your apps to provide a database? A: That is not so easy. We can extract some epidemiological data but the aim of our digital tools is to support doctors with patient management and to understand diseases. Institutions are becoming more open to collaboration so perhaps there may be an opportunity to explore an alternative like this in the future. If we want to be successful as a country and society in changing Mexicoâ&#x20AC;&#x2122;s healthcare indicators we have to find ways to make alliances with public and private players. Q: What will your priorities be for 2017 other than launching those three new products? A: We will have to maintain our leadership in the area of fertility. We closed 2016 with over 60 percent market share in Mexicoâ&#x20AC;&#x2122;s fertility segment. We have to keep doing what has worked and also find new ways to support our business over the long term. There is an opportunity with our product for prostatic cancer to help more patients at an institutional level, so we need to work with public institutions to show the benefits this hormonal treatment could provide without increasing cardiovascular risk and to ensure it is fully reimbursed. We will also work to maximize our digital platforms to ensure that everyone who can benefit from them has access.


VIEW FROM THE TOP

NATIONAL-LOCAL EFFORT NEEDED TO COMBAT HEART DISEASE ERICK ALEXANDERSON President of the SMC

Q: What are the main problems the society faces in the

an absolute truth 20 years ago is no longer useful. In half a

different regions of the country?

century, cardiology has changed immensely and I cannot

A: There are very clear regional differences based on the

imagine what it will be like in 50 years.

cultural traits and customs of the population. For example,

260

the folklore of each state has an impact on eating habits

Q: What cardiac problems most plague Mexicans?

and this can vary widely across the country, requiring a

A: Cardiac diseases are the main cause of death in the

different approach in each location. Some eating habits make

Mexican population, accounting for about 127,000 deaths

people more prone to atherosclerosis, the accumulation of

every year. This mortality rate is higher than that of cancer,

cholesterol in the arteries, because they eat too much fat

pulmonary diseases and even diabetes. In fact, most diabetic

and red meat. Also, working habits and stress levels to which

patients die due to heart failure. Ischemic heart disease and

each population is exposed have an impact. The northern

heart attack are the main cardiac problems causing these

states have a strong custom of achieving targets rapidly, so

deaths. There are many risk factors for these conditions

they work under a lot of stress. In higher income locations,

and our population has most of them. The major ones are

work hours are longer, so people usually eat out and lack

tobacco use, hypertension, atherosclerosis, dyslipidemia

time to exercise, which puts people under more stress. With a

and diabetes mellitus. Then there are secondary factors like

lower income demographic, people have more time to move

overweight, obesity, sedentarism, stress and tension. What

and walk. The weather and pollution also play an important

triggers the burden of cardiovascular problems is that 20

role. Considering these factors, we cannot pretend that what

million Mexicans are hypertensive, only a third of them

we do in one place is applicable to others. We cannot look

know it and just a portion of those are well-treated. Plus,

at Mexico as a unique concept because it is the result of

about 60 to 70 percent of our population has altered lipids.

a group of situations and environments. We cannot make

But since these are problems that do not generate major

public health solutions based on a standard citizen because

discomfort for a long time, people only seek care when they

there is no standard citizen.

are experiencing grave symptoms.

Q: What is the associationâ&#x20AC;&#x2122;s relationship with regional

Q: What are the main challenges in addressing these issues?

cardiology societies?

A: The number of patients with cardiovascular disease is

A: For the Mexican Society of Cardiology it is important to

rising every day. We see young people dying of a sudden

approach the organizationâ&#x20AC;&#x2122;s regional branches. We believe

heart attack. There are patients 30 or 40 years of age with

there should be more cooperation between associations,

heart problems due to diabetes, hypertension or obesity at

so their projects can have a national health and educational

a young age, and many of them never did anything about

impact and have access to the improvements developed in

it. This is due to the Latin culture of not going to the doctor

our central offices. That also creates a stronger sense of

until presenting pain. In Mexico, there is no preventive culture

belonging. We have signed agreements with seven regional

like in Europe, the US or Canada. Besides these young people

societies and we are working on more. These agreements will

dying of heart disease, we have a population niche that did

give them access to our expertise, databases and academic

not exist before: the elderly. With the control of infectious

sessions. Cardiology is evolving at a high speed; what was

diseases, we have increased life expectancy and people now live to 76 on average, much more than 20 years ago. Today, we have many 80-year-old patients and their probability of

The Mexican Society of Cardiology (SMC) focuses on the

suffering from cardiac disease is high as these are chronic

study, research and execution of new knowledge in the field of

diseases caused by age. Our challenge is to take care of

cardiology for scientific and academic applications in Mexico.

these two population groups and achieve the WHO objective

Based in Mexico City, it has branches throughout the country

of reducing cardiac death by 25 percent by 2025.


VIEW FROM THE TOP

RECONSIDERED MISSION BROADENS FOCUS FROM GENERICS CLAUDIO CASTRO General Manager of Synthon

Q: What is the strategy behind Synthon’s shift from

and in certain circumstances almost 50 percent. Our

generics to CNS, oncology and MS?

company is always betting on the future.

A: We still produce generics in these therapeutic areas but the dream of Synthon’s founder was to develop

Q: What are your plans for the plant in Jalisco, soon to

high-quality molecules at affordable prices to reach

open and how will it impact your position here?

unattended populations.

A: The plant required an investment of around US$20 million and will measure 8,000m2 with a capacity of 200

During its early stages, the company developed molecules

million tablets, 200 million capsules, 15 million blister

for large consumer volumes. International market trends

packs and 1 million bottles. The plant is mainly focused on

eroded the price of these molecules and in 2007 the

high-containment products such as oncological products,

company reconsidered its mission. Generics were growing

for which volumes are small. It will be certified by the

because countries were seeking quality drugs at good

EMA, as are all our sites, because we have plans to export

prices and biotechnology provided the biological medicines

in the future.

to replace small molecule medicines. We wanted to reach patients in both areas so we created a division called Synthon Generics and another called Synthon Biopharmaceuticals. The latter develops new molecules such as antibody drug conjugates to fight cancer, especially breast

The main focus right now is to produce for

35%

of total sales revenue is invested in R&D globally

and prostate cancer.

Mexico but since COFEPRIS is recognized in certain Central American countries, some products manufactured in this plant will be sent to Central America. Given Mexico’s proximity to the US, in the future it could be an option to gain FDA approval to send our products north as well. There is no doubt

Synthon focuses on CNS because the

the plant will make our company stronger.

population is aging. If we had evaluated the market 50 years

We did not build it to increase our production capacity

ago, we would have chosen to tackle tuberculosis or typhus

because we have enough capacity globally to supply

because people died of these illnesses at a young age. A

Mexico without a problem.

change in hygiene habits controlled those diseases but new ones developed as people grew old, such as Alzheimer’s,

Q: What are Synthon’s plans and expectations in the

Parkinson’s and cancer. Now CNS is a big market because

coming years?

there is a large population that needs care.

We want to become a quality reference in oncology and to be ranked within the top 15 laboratories worldwide treating

Q: What areas of research do you manage in Mexico?

CNS and MS. We have two chemotherapy products in the

A: In Mexico we carry out the clinical studies that the

market and are launching products for multiple myeloma

authorities require of us and participate in the company’s

and lung cancer, and we are working on Imatinib, our first

global research projects. We are planning to start phase

product for leukemia. We are the only lab in Mexico that

three of our SYD 985 project involving breast cancer

has three aromatase inhibitors for breast cancer.

monoclonal antibodies and Mexico is one of the study’s sites. We will look for patients needing treatment and register the protocol with CROs. We need patients with

Synthon, founded in 1991, looks to become a recognized

terminal breast cancer that bear specific technical traits,

leader in specialty pharmaceuticals, focusing on autoimmune/

such as HER 2 positive tumors. Globally we invest around

neurodegenerative diseases, particularly multiple sclerosis

35 percent of our total sales in research in a regular year

(MS) and oncology

261


ANALYSIS

THE THREE TYPES OF DIABETES In recent decades, diabetes has crept into people’s lives

TYPE 1 DIABETES (T1D)

to become a main cause of mortality in Mexico. A chronic

T1D, previously known as insulin-dependent,

disease, diabetes impacts the sufferer for life and has a

juvenile or childhood-onset diabetes, is usually

variety of devastating side effects

present from birth, childhood or adolescence and is characterized by a lack of insulin.

It is no secret that diabetes is rampant in Mexico, linked

Causes and risk factors remain unknown and prevention

to the poor lifestyle choices of its citizens and increase

techniques are yet to be discovered, though it is thought

rates of obesity. Despite the efforts of health organizations

to be the result of genes and environmental factors yet to

and private companies around the country to prevent

be determined. A daily dose of insulin, the hormone that

development and promote early diagnosis of the condition,

controls blood sugar levels, is needed to prevent death.

prevalence rates are still high. By 2014, around 422 million

Symptoms of T1D include frequent urination, thirst, constant

people worldwide suffered from diabetes, which is one in

hunger, weight loss, vision changes and fatigue.

every 11 people, a figure that has quadrupled since 1980. The

262

latest WHO figures attribute 1.5 million deaths per year to

TYPE 2 DIABETES (T2D)

diabetes, most of which occur in low and middle-income

T2D is known as acquired diabetes, as it is usually caused by

countries as the population lacks access to the medicine

risk factors such as obesity and by the body’s ineffective use

and technology needed.

of insulin. It is much more common than T1D and accounts for most diabetes-related deaths. T2D is preventable and

“The number of deaths due to diabetes multiplied by

global health organizations and governments recommend

about seven times between 1980 and 2015, from around

maintaining healthy eating habits, avoiding tobacco use

14,600 in 1980 to 98,500 in 2015. In the 21st century so

and exercising adequately. Most recently, a high intake of

far, there have been 1.1 million Mexican deaths directly due

sugary beverages has been linked to diabetes. This is an

to diabetes. This is a grave problem,” says José Narro,

issue in Mexico, a country consistently ranked among the

Minister of Health of Mexico. According to a WHO report,

top five worldwide for consumption of sugary beverages.

in 2016 diabetes was responsible for 14 percent of deaths

Poor disease management can trigger seizures, loss of

in Mexico, more than all cancers, which killed 12 percent

consciousness and diabetic ketoacidosis (KDA), which leads

of the population. In 1980, diabetes was responsible

to a diabetic coma in T1D and T2D. A hyperosmolar coma is

for only around 7 percent of deaths in Mexico and has

a possible complication of T2D and it carries a mortality rate

consistently risen year on year. Being overweight, obese

of 10-20 percent. Other major complications are blindness,

or physically inactive increases the risk of contracting

heart attacks, stroke and lower limb amputation due to poor

diabetes. Mexico has an operational strategy for fighting

blood flow causing nerve damage and the development of

diabetes, overweight and obesity and physical inactivity.

foot ulcers, worsening to the point of amputation. Diabetes

It has implemented evidence-based national diabetes

is also one of the main causes of kidney failure.

guidelines and standardized criteria for referral of patients from primary care to higher levels of care. It also maintains

GESTATIONAL DIABETES (GD)

a diabetes registry. Furthermore, primary care facilities

Gestational diabetes is the least well-known of the three

generally carry insulin, metformin, sulphonyl urea, blood

types of diabetes, occurring during pregnancy. It is a form

glucose measurements, HbA1c tests and urine strips for

of hyperglycemia with blood sugar levels above normal

glucose and ketone measurement.

but below those of T1D or T2D. This leaves women at an increased risk of pregnancy and delivery complications and

Private companies are also capitalizing on this opportunity

also increases their risk and child’s risk of developing T2D

to provide services for the millions of Mexicans that suffer

in the future. It occurs as the body struggles to produce

from the condition and need follow-up services. Some such

enough insulin to control the increased blood sugar levels

as Uhma Salud, are providing diagnostics and online portals

during pregnancy and usually disappears after giving birth.

to change habits and prevent the conditions from developing in the first place. Others such as Salud Cercana are providing

Although any woman can develop GD, certain factors

follow-up services for those already diagnosed with chronic

place women more at risk including obesity, previously

conditions. However, despite the opportunities, investment

having given birth to a baby weighing over 4.5kg, previous

fund Dalus Capital remarks that many young companies lack

experience of GD, having a parent or sibling with diabetes

the knowledge, network and understanding of the ecosystem

and being of South Asian, Chinese, African-Caribbean or

to create impactful companies.

Middle Eastern origin.


VIEW FROM THE TOP

LAB ACQUISITIONS BOLSTER BRAND VALUE CARLOS OVIEDO Director General of GDA

Q: Lab acquisitions have helped spur GDA’s growth. What is

and symposiums to spread knowledge and best practices

the strategy to integrate these labs?

in the industry. These efforts will translate into better

A: Over the past two years GDA has acquired Olab

diagnostic services in the country.

Diagnósticos Médicos, Laboratorios Azteca and Laboratorio Clínico Jenner, which were the third, fourth

Q: How is GDA responding to Mexico’s need for quick and

and fifth most important players in Mexico City and its

precise diagnostics?

surrounding urban area and have made GDA the second-

A: The group is joining forces with international suppliers to

largest player in the industry. GDA is now integrating the

implement the highest available technology that will improve

operations of these companies, retaining the best qualities

diagnoses. Our blue room has the technology to conduct live

and practices of each.

sessions between the treating doctor and our radiologists. The platform also allows us to share images with experts

We are a multibrand group that will leverage operational

around the globe to improve the diagnosis in difficult cases.

and administrative synergies to enhance the value of each of our brands. Olab is recognized by many doctors and public

Q: What is your strategy to put Big Data to use?

and private-sector institutions for its expertise in imaging

A: In this industry, Big Data applications should translate

tests such as MRIs, tomographies, mammographies, x-rays

into timely disease prevention. In this area, we would like

and ultrasounds. Azteca is well-known for its leadership in

to cooperate with local governments and companies by

clinical analysis, especially in forensic science and toxicology

sharing all the information we gather to increase prevention.

analysis, while Jenner and Swisslab are focused on disease

The Ministry of Health is the appropriate entity to use this

prevention through clinical analysis. Although our brands have

information for the benefit of Mexican citizens. We believe

specializations, each has medical-imaging equipment.

COMED will accelerate the creation of such synergies and regulations to help the Mexican population without

We will concentrate our laboratory tests and analysis in a

threatening the privacy of our clients.

central location and our imaging diagnosis in a blue room, a model that will improve the quality and reduce time during

Q: What are your growth expectations for the following

the diagnosis process. The new 5,000m2 central laboratory

five years?

will be robotized and will provide service to our brands, clients

A: The president of Empresas Aries drafted an aggressive

and other potential clients, both nationally and internationally.

growth plan comprising organic and inorganic growth. This is why we are building strong foundations such as our new

We will continue to look for small to medium-size companies

central lab, which will be 10 times larger than the current lab

that complement the group’s portfolio and we will also resume

and capable of meeting our growth needs. Our goal is to

inorganic growth during the second half of 2017 through the

increase our market penetration in Mexico and expand our

expansion of our brands in Mexico City.

coverage in Latin America. To achieve this, we will open several branches across our brands, mostly in the same markets in

Q: How are these alliances impacting your operations?

which we are already present. We also have a few companies

A: In 2017, GDA collaborated with Grupo Diagnóstico

in sight that will increase our national and regional coverage.

PROA and Laboratorio Médico Polanco to establish the Mexican Council of Medical Diagnosis Companies (COMED), which aims to unite all the diagnostic labs in

GDA was founded in 2007 in Mexico as a private equity fund

Mexico to help lawmakers improve current regulations.

focused on real estate and later expanded to other sectors. The

We also want to put regulation in place to ensure

clinical diagnostics unit GDA has become a leading industry

healthy competition while also organizing congresses

player through various acquisitions

263


VIEW FROM THE TOP

REGULAR DIAGNOSTICS KEY TO GOOD HEALTH JULIÁN GONZÁLEZ Director General of Check-Up Center

Q: Check-Up Center’s target clients are high-level

forbidden for us to write prescriptions or change

executives. What is your strategy to reach this target?

prescriptions. Many doctors recommend us, but it is

A: In 2017, we will be opening a new center in the upscale

based on personal experience and merit.

Polanco neighborhood of Mexico City, although it has

264

been delayed by the remodeling of our center in the Santa

Q: Mexicans are well-known for avoiding check-ups. How

Fe business district. Check-Up Center has been in the

does this vary with high-level executives?

market for 15 years and was the first in Mexico to merge

A: They are more conscious of the need for check-

a full-body scan through computerized tomography with

ups and prevention. Around two-thirds of our clients

a traditional check-up.

are companies that send their top-level executives. Many of these are only meeting a requirement of

We renew most equipment every two to three years and

their company and around 10-15 percent do not come

tomography machines every five years. We renew with

back for their results, although digital results are kept

such frequency to also be at the height of innovation.

permanently. Some companies are active in making sure

In addition, all our studies are non-invasive. Take the

their employees do get the result and ask for statistics.

example of rectal sigmoidoscopy, part of a colonoscopy.

Cardiovascular diseases are the main trends. Some are

Only 5 percent of the population really needs this. We use

already conscious that they have an issue, others not.

our studies to determine whether a patient is a potential candidate for a full colonoscopy or not, limiting the

Q: What strategy is behind your remodeling the Santa

invasiveness of the procedure.

Fe clinic? A: We will be completely renewing the clinic, from the

Q: To what extent do you consider other clinics as your

reception to the distribution of space, and we are introducing

competitors?

more tests, such as for high-performance athletes. The sports

A: We only consider the two largest hospital chains as

check-up will be 100 percent focused on cardiovascular

our competitors due to target clients and the quality of

issues and causes of sudden-death and we will bring in the

their studies. Our doctors are experts in imagology and

new clients through marketing. Athletes are more aware of

our labs are managed by Quest Diagnostics, the largest

the importance of prevention and are concerned with their

diagnostics lab company in the world. It has the highest

health. This will be introduced by July 2017.

quality in Mexico and no one else reaches its standards. The tests are carried out in only two hours and the results

Q: How do you ensure that your doctors have the latest

are returned within a week. We obtain much more medical

knowledge?

information than standard check-ups.

A: Our medical director is active in making sure our doctors stay up-to-date and take courses. We also incentivize this;

Q: To what extent do you have partnerships with clinics

for example, our doctors have just taken a course on echo

to refer patients if they have an issue?

and heart ultrasounds. Although this is usually reserved for

A: We only produce diagnostics, we do not recommend

echo cardiographists, it is important for us because we will

anyone and we do not perform any treatment. It is

be including it in our check-ups for athletes. Q: Why is now the ideal moment for your expansion?

Check-Up Center has been providing preventive diagnostics

A: The perspective of Mexicans has changed. It is true

for 15 years in exclusive locations in Mexico City. It aims to

that Mexicans, especially the elderly, do not worry about

provide a full check-up in two hours, using the most up-to-

prevention, but young people are increasingly looking after

date technology on the market

themselves. We expect to fill the new clinic within six months.


VIEW FROM THE TOP

DIAGNOSING GROWTH OPPORTUNITIES SERGIO BROWN Vice President LATAM of Beckman Coulter and Director of Danaher LATAM

Q: How has Beckman Coulter adapted its solutions

volumes to achieve more efficient clinical diagnosis. We

portfolio to Mexico?

lead the automation market for Mexican public and

A: In Mexico, our solutions help health professionals to

private laboratories. In fact, we are the medical devices

deliver earlier diagnosis and more precise treatments.

manufacturer with the most automatized laboratory

We have solutions for immunology, clinical chemistry,

installations in the market. When a sample tube arrives

hematology, microbiology and urinalysis. Our products

to the lab, the process is automated from the beginning

simplify, automate and innovate complex biomedical

to when the final result is obtained. All this is possible

testing. In the microbiology field we developed cultures

through our working methodology, the Danaher Business

to identify what type of microorganisms are affecting

System, which applies the Kaizen methodology or the

the patient and which is the best treatment to eliminate

continuous improvement ideal to make processes more

the infection. Overall, we have a complete portfolio for

efficient. Besides our quality products and solutions, we

diagnosis and technology for medium-sized laboratories

transfer this methodology to our clients to help them

and we offer automatization for central laboratories that

achieve their objectives.

deal with high volume. Q: You recently bought the clinical microbiology business Mexico belongs to what we call high-growth markets

from Siemens Healthineers. How has this shaped your

and it is our main office in Latin America. We have been

plans?

here for a long time so we adapted our proposal to the

A: It has been an interesting opportunity that has enabled

marketâ&#x20AC;&#x2122;s needs. We have created a value proposition

us to expand into an area in which we had minimal

for both the public and the private sector and we have

activity. Microbiology has become very important for

established strategic relations with other companies to

us. In five years we have gone from having a strong

reach our final clients. Our equipment and instruments

business in hematology, immunoassays and clinical

have provided our clients with efficient results so they feel

chemistry, to expanding to microbiology and urinalysis.

safe working with us. Also, this success was led by our

All the acquisitions we have made are investments with

highly qualified team in the commercial and engineering

the purpose of creating a bigger value proposition for

sectors, which is our main differentiator.

our laboratory partners and our commercial partners.

Q: What type of customers are driving Beckman Coulterâ&#x20AC;&#x2122;s

Q: What new technologies and tests have you integrated?

growth in Mexico?

A: We have two new tests: P2PSA for men and

A: In Mexico, the market is segmented into the private and

antimullerian hormone for women. The latter helps women

the public sector. A larger volume is sold to the public sector

identify where they are in their reproductive age. The

through IMSS, Seguro Popular, ISSSTE and the Ministry of

time frames of human reproduction have changed greatly

Health. Our sales to the private sector are also growing

and this solution is helpful for women who postpone their

through the establishment of reference laboratories. We

maternal stage due to their professional life. The P2PSA

are offering the private sector solutions that allow them to

evaluates prostate health according to the prostate health

handle more test volume.

index, improving prostate cancer diagnosis.

In the public sector, we work with our network of authorized distributors, with whom we decide which

Beckman Coulter is an American manufacturer of analytical and

government tenders to participate in. We cannot

diagnostic solutions. It merged with US-based Danaher, which

always participate in all those we would like to, but the

owns innovation companies focused on testing and measurement

government is starting to consolidate and purchase larger

in several sectors, including life sciences and dental

265


INFOGRAPHIC

OBESITY: A GROWING PROBLEM There is no escaping the health problems being overweight or

dietary requirements. These statistics show

obese cause, especially as almost three of every four Mexicans

that Mexicans do not know what their ideal

fall into one of these two categories. Yet these conditions cannot

weight range is, nor when they step over it,

be solved with a pill and require profound behavioral change

and demonstrates the state of confusion in which the Mexican population resides and

The statistics tell a convincing tale, even if the people

the need for better diffusion of clearer information from

disagree: despite high overweight and obesity rates

the health authorities. In addition to unhealthy eating,

and low rates of fruit and vegetable consumption, in

the population suffers from a range of other influential

a self-evaluation the Mexican population reports lower

factors such as lack of sleep or insomnia and long work

rates of excess bodyweight and higher rates of healthy

hours which contribute to sedentarism and leave little

eating, in addition to not understanding food labeling and

time for exercise and healthy living.

OF MEXICAN ADULTS

61.3%

28.4 percent

considers they have a healthy diet

266

67.3%

considers themselves to be physically active

42.3%

regularly consumes vegetables

51.4%

reported sleeping less than seven hours. Insomnia (classed as difficulty in sleeping at least three days per week) affects almost a fifth of the population, mostly women.

2/3

of Mexicans report watching TV in the hour before going to sleep.

regularly consumes fruit OVERWEIGHT OR OBESE PER AGE RANGE IN MEXICO (percent) 100

80%

considers themselves capable of eating five or more portions of fruit or vegetables per day

76.6%

of the population suffers from abdominal obesity

48.4%

considers themselves overweight

6.7% 76.3%

44.6%

Source: ENSANUT 2016

considers themselves obese does not know how many calories one should consume in a day

reports that nutritional labelling on food is little comprehensible or incomprehensible

80 60 40 20 0

children 5 to 11

teenagers 12 to 19

GENDER COMPARISON OF OVERWEIGHT AND OBESITY IN MEXICAN CHILDREN (percent)

adults over 20 OF MEXICAN ADULTS AGED OVER 20

40

72.5%

30

Overweight or obese

20

10

0

Five to 11 years old

12 to 19 years old

Girls

Boys

„„Obesity „„Overweight

„„Obesity „„Overweight

76.6%

Abdominally obese


VIEW FROM THE TOP

MEXICO'S ONGOING ISSUE CARLOS LÓPEZ Director General of Medix

Q: Overweight and obesity was declared an epidemic in

Q: What are your priorities for 2017?

Mexico in late 2016. How has this impacted your operations?

A: For both 2017 and 2018, we will be focusing on

A: We have been focused on this problem for many years,

increasing sales. We grew by 7 percent in 2016 despite

but having overweight and obesity declared an epidemic

uncertain global conditions. Our target is 20 percent

helps us with the diffusion of knowledge because it

growth in sales in 2017 and we also want to maintain a

generates a higher consciousness that it is a problem, a

profitable model that satisfies shareholders as well as

chronic disease. When the company was first founded,

employees. In addition, Medix will be working on the

obesity was not seen as an epidemic but as an aesthetic

consolidation of its model and expanding sales channels.

problem. We must still figure out how to face this and

Database and knowledge integration will be improved to

how to reduce prevalence rates. Mexico has done a

offer more options in the future, factoring in Big Data.

great job in generating consciousness, due in part to the

Medix is working on a geographical expansion to have

government’s sponsorship of a large number of campaigns,

an important impact on the health of other countries. We

although there is still a great deal of work to do. Habits

are the biggest company offering obesity solutions in

need to change, which is difficult. Education also plays an important role. Overweight and obesity in children is more serious than these issues in the general population, yet, children suffering from these problems almost certainly will continue to do so in adulthood. Childhood overweight and obesity is also more difficult to solve because they are still growing, so restricting nutrition is not as simple as in adults. Despite the declaration having awoken consciousness, the solution remains a puzzle. Q: The ENSANUT 2016 results show overweight and obesity is considered a problem for other people. How is

Mexico and we want to achieve this in Latin America too.

Among people who are trying to lose weight, 70 percent are doing it for image and 30 percent for health”

Q: Does that expansion plan also include acquisitions?

Medix addressing this?

A: We are pursuing businesses in Chile, Bolivia, Uruguay,

A: ENSANUT 2016 was representative of how people

Peru, Colombia and Europe. Our strategy is to build

see themselves versus how they are. There are two ways

partnerships with major market players in each country,

of convincing people they have a problem. The health

not only in the pharmaceutical sector but in logistics and

side is more complicated, as often people do not feel ill.

distribution as well. We are always looking for opportunities

By posing overweight and obesity as a health problem,

to expand our product portfolios in the markets in which

people do not identify with this. We have taken a different

we are already present. In addition, Medix is working

approach, focusing on aesthetics and wellbeing. We ask

on an e-learning project with the objective of creating

patients if they would like to change their image. If we

an overweight and obesity community across different

ask what a person’s goal is, perhaps to play football with

countries, with specialists who can share experiences and

their children or go camping, but they are generally too

knowledge in this field.

tired to do so, this could be a target. Among people who are trying to lose weight, 70 percent are doing it for image and 30 percent for health. We help people reach

Medix has been dedicated to the fight against overweight and

their goals safely, which is vital. To drop a large amount

obesity since its inception in 1940, providing integral solutions

of weight quickly is bad for one’s health and in the long-

in 11 countries with the goal of diminishing the impact of these

term, the body responds negatively to this.

conditions

267


VIEW FROM THE TOP

INNOVATION, DIGITAL PUSHING DENTAL HEALTH JUAN CARLOS BORGATTA Director General of Borgatta

Q: How does Borgatta’s app contribute to improving

Nemocast 3D is only one of several software applications

healthcare?

developed by our partner NemoTec that we use, all

A: As with any medical specialization, orthodontics

deal with diagnoses and treatment planning. Nemotec

is influenced by technology and today diagnoses are

software has helped develop this new business model and

largely supported by technological tools such as 3D

35 percent of our platform is based on their technology.

images. Once the diagnoses are done, a treatment plan is 268

developed and executed based on images and software.

Q: How important is innovation to the success of

This eases the work of the physician and clearly shows

Borgatta’s business?

the patient what the treatment will be and the results.

A: Companies that want to be profitable must stay up-

The information can be illustrated with an interactive

to-date or they will not remain in the market. Innovation

app. This is the future of orthodontics and 90 percent

must be in your DNA and focused on the customer’s

of what we do.

needs. At Borgatta, we understand this and seek to develop simple and useful solutions for our clients.

Q: What is Borgatta doing to raise awareness of the importance of dental health among patients?

Q: In the past you have stated that customers today have

A: As a company, we are not only a supplier of materials

more information. How does this impact the industry?

but we also focus on continuous education through

A: It has both a good and an adverse impact. Good

courses, bringing scholars from different parts of Latin

because they look for information and adverse because the

America, supporting local researchers and wo