EXPORT AGENDA MAGAZINE: PHARMACEUTICAL EDITION

MADE IN KENYA FAMILY

MAUREEN MAMBO Editor-in-Chief

Dear Reader,

The pharmaceutical sector in Kenya has shown significant potential in contributing to the country’s exports, particularly within the African market. The sector has penetrated EAC and COMESA regions, with Kenya’s pharmaceutical exports primarily directed towards these markets. Currently, Kenya exports around $63 million worth of pharmaceutical products annually to these regional markets. There is a substantial opportunity for growth, with a 5% increase in Kenya’s share of the African pharmaceutical market translating to exports worth $678 million.

The government aims to increase the proportion of national pharmaceutical products demand met by locally manufactured products from the current 30% to about 65% according to the Kenya Pharmaceutical Industry Diagnostic Report 2020. This shift could remarkably boost our export capacity.

The future of Kenya’s pharmaceutical sector looks promising, driven by several strategic initiatives and market trends which include Transforming Kenya into a regional hub for pharmaceutical manufacturing and distribution, reducing the dependence on imported active pharmaceutical ingredients (APIs) and excipients by 50% and growing local production capacity, enhancing compliance with national and global good manufacturing practices (GMP) standards, adoption of advanced manufacturing technologies and innovation in drug development which is expected to drive the sector forward and Kenya is expected to grow at a compound annual growth rate (CAGR) of 3.04% from 2024 to 2029, reaching a market volume of $656.90 million by 2029 according to Statista Market Insights 2024.

Overall, the pharmaceutical sector in Kenya is poised for substantial growth, with a strong focus on increasing local production, improving quality standards, and expanding export markets. This will not only boost the economy but also enhance healthcare outcomes in the region.

In this edition we shall dive more on the country’s capabilities to enhance the sector, opportunities available to capitalise on the African market, the future of the industry and much more. Enjoy your read and as usual we value and appreciate your feedback and comments on this and other editions.

THE BOARD OF DIRECTORS

Mr. Jaswinder Bedi, EBS, MBS Chairman

Ps Alfred K’Ombudo

PS, State Department for Trade

Mr. Ambrose R.M. Ogango

Director - Alt to PS, The National Treasury

Ms. Leah Aywah Baraza

Director - Alt to the Attorney General

Mafaka Michael Ngugi Karanja Independent Director

Mulki Warsame Mohamed

Independent Director

Dr. Grace Kinya Muriithi – Kireria Independent Director

Floice Mukabana

Chief Executive Officer

THE EDITORIAL TEAM

EDITOR-IN-CHIEF:

Maureen Mambo

EDITORS:

Mariam Maina-Kamau

Molly Wambui-Editorial Assistant

DESIGN & LAYOUT:

Samuel Njaaga

CONTRIBUTORS:

Dr Robi Mbugua Njoroge

Mariam Maina

Gertrude Mirobi

Irene Van De Graaf

Charles Aminga

Mercy Kamau

James Kariuki

Carol Wanza

Whereas every editorial care has been taken, Kenya Export promotion and Branding Agency accepts no responsibility for errors or omissions in the articles. The views expressed herein are those of the contributors and do not necessarily reflect those of the Agency.

No part of this publication may be reproduced in any form or by any means without the prior permission of the publisher.

From the Editor’s desk

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Email: chiefexe@brand.ke

MARIAM MAINA Editor

Kenya’s pharmaceutical sector is a vital component of the country’s healthcare system and economic landscape. Over the years, it has grown into a dynamic industry, contributing significantly to the well-being of the population by ensuring the availability of essential medicines. As we navigate the post-pandemic era, the importance of a robust pharmaceutical industry has never been clearer.

The sector is evolving, with an increasing emphasis on local manufacturing to reduce reliance on imports and enhance self-sufficiency. Government initiatives, partnerships with international organizations, and private sector investments are driving this transformation, positioning Kenya as a potential hub for pharmaceutical production in Africa. Moreover, the sector is poised to benefit from advancements in technology, increased access to research and development, and growing demand for innovative, high-quality healthcare solutions.

As Kenya aligns with global standards and pursues regulatory reforms, the sector has a unique opportunity to strengthen its contribution to both local and regional markets. This will not only improve healthcare outcomes but also boost economic growth by creating jobs and reducing the trade deficit in pharmaceuticals.

In this issue, we explore the opportunities and challenges facing Kenya’s pharmaceutical export sector, highlighting issues on sustainability and ethics, pharmaceutical education and talent development, combating counterfeits as well as the impact of the African Continental Free Trade Area (AfCFTA) on Kenya’s pharmaceutical exports. We also present the insights from different players in the sector, sharing their views on various issues.

I invite you to delve into the key trends and insights presented in this magazine. Through the Export Agenda editions, we aim to inspire, inform and drive conversation that shape Kenya’s Export Agenda.

Enjoy!

Mariam Maina: mmaina@brand.ke

Floice Mukabana

CEO Kenya Export Promotion And Branding Agency

KEPROBA’S MANDATE

Market intelligence

International market development and promotion

Product adaptation for export markets

Export trade information services

Advocacy for policy formulation

Nation branding

The pharmaceutical industry in Kenya continues to play a vital role in improving public health, advancing local manufacturing, and fostering economic growth. As the global healthcare landscape continues to evolve, the pharmaceutical industry remains a vital component in addressing public health challenges, fostering innovation, and driving economic growth. In this context, Kenya’s pharmaceutical sector is uniquely positioned to play a pivotal role in regional and global markets, providing high-quality, cost-effective products that meet growing demand.

In 2023, Kenya’s pharmaceutical exports were primarily composed of medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, which made up 94.5% of the total exports. Other significant exports included wadding, gauze, bandages, and similar products like dressings and adhesive plasters, accounting for 1.5%.

Medicaments consisting of two or more constituents mixed together for therapeutic purposes constituted 1.4%, while pharmaceutical preparations and products falling under subheadings 3006.10.10 to 3006.93.00 represented 1.3% of the exports. Human blood and animal blood prepared for therapeutic, prophylactic, or diagnostic uses made up 1.2% of the total exports. Kenya’s pharmaceutical exports in 2023 amounted to USD 166.4 million.

Kenya’s principal markets for pharmaceuticals in 2023 included Tanzania, Uganda, Malawi, Rwanda, Somalia Ethiopia, DRC and South Sudan. Almost all destination markets were mainly from the EAC.

As we move forward, I encourage all stakeholder’s policy makers, industry leaders, researchers, and exporters to collaborate and take decisive actions that will unlock the full potential of Kenya’s pharmaceutical sector. Through joint efforts, we can solidify Kenya’s standing as a leading exporter of pharmaceutical products and ensure that we contribute to improved health outcomes both locally and globally.

Kenya’s preparedness in the war against counterfeit pharmaceutical products

By Dr Robi Mbugua Njoroge Executive Director, Anti-Counterfeit Authority

1. What role does ACA play in protecting intellectual property rights and ensuring genuine medicines for consumers?

The Anti-Counterfeit Authority (ACA) plays a critical role in safeguarding intellectual property rights in Kenya by enforcing laws that prevent the manufacture, importation, distribution, and sale of counterfeit goods, including medicines�

To fulfill its mandate, the ACA collaborates with various stakeholders such the Kenya Police Service, Kenya Revenue Authority, and Ministry of Health to ensure that counterfeit products are identified, seized, and removed from the market This not only protects the rights of intellectual property owners but also helps maintain a fair trading environment, fostering innovation and economic growth

In ensuring genuine medicines for consumers, the ACA works closely with the Pharmacy and Poisons Board (PPB) and other healthrelated authorities to monitor and control the pharmaceutical supply chain By conducting inspections, market surveillance, seizures, and public awareness campaigns, the ACA ensures that consumers have access to safe and genuine medicines This proactive approach reduces the risks associated with counterfeit medicines, such as adverse health effects or treatment failures, thereby protecting public health and reinforcing consumer trust in the healthcare system�

2. What is the biggest challenge the ACA faces in combating counterfeit pharmaceuticals in Kenya?

The biggest challenge the Anti-Counterfeit Authority

(ACA) faces in combating counterfeit pharmaceuticals in Kenya is the sophisticated and rapidly evolving nature of the counterfeit trade Counterfeiters use advanced technologies and intricate supply chain networks to produce and distribute fake medicines that closely resemble genuine products, making detection and interception difficult for regulators and law enforcement

The rise of online platforms for selling medicines has further complicated enforcement, enabling counterfeit products to be sold anonymously and across borders, bypassing traditional regulatory controls These challenges are compounded by the ACA’s limited resources and capacity constraints, as well as insufficient public awareness about the dangers of counterfeit medicines, which together hinder effective enforcement and protection of public health

3. What specific regulatory measures have been implemented to prevent the entry and distribution of counterfeit medicines?

To prevent entry and distribution of counterfeit medicines, Kenya has implemented several regulatory measures The Pharmacy and Poisons Board (PPB) requires all pharmaceutical products and distributors to be registered and licensed This ensures that only authorized entities can import, manufacture, or distribute medicines, thereby reducing the risk of counterfeit products entering the market

A recent significant step by the AntiCounterfeit Authority includes the recordation of Intellectual Property with the Authority� This process facilitates enforcement as it strengthens the ability of of customs officials to

control the borders and helps deter counterfeiters This measure together with the requirement for acquisition of IPR import license helps in tracking and verifying the legitimacy of imported medicines

Additionally, the recent signing of a Memorandum of Understanding (MOU) between the ACA and PPB has strengthened their collaborative efforts in combating counterfeit medicines Both agencies conduct regular inspections and market surveillance, including random sampling, testing of pharmaceutical products, and inspections at entry points such as ports and airports, to monitor the supply chain and identify counterfeit medicines The use of track and trace technologies, such as serialization and barcoding, have also been introduced to monitor the movement of medicines throughout the supply chain, allowing regulators to verify the authenticity of products at every stage

4. How does ACA collaborate with other agencies, such as the Pharmacy Poisons Board to counterfeit pharmaceuticals?

The Authority works in collaboration with international, regional and national private and inter-governmental bodies

At an international level, the Authority collaborates with World Health Organisation (WHO), World Intellectual Property Organisation (WIPO), International Criminal Police Organization (Interpol) and World Customs Organisation where joint operations like “Operation Pangea” are carried out in multiple countries simultaneously� In June 2024, we held an international Symposium on Intellectual Property Protection and Enforcement, bringing together

delegates from the three international bodies and 16 countries, during which presentations and insights for better global collaboration on fighting counterfeiting of pharmaceutical were shared

At the regional for instance, the Authority is a member of the PharmaCrime Working Group The group brings together law enforcement authorities from most of the 55 African countries The group shares statistics of incidents of counterfeit medicines seized and related prosecutions It also shares insights on IP protection and enforcement

At the national level, the Authority works in collaboration with other government agencies like Pharmacy and Poisons Board to tackle counterfeit pharmaceuticals The PPB collaboration is anchored on a Memorandum of Understanding between the two government agencies that entails joint inspection and enforcement, information sharing, public awareness campaigns, regulatory frameworks to develop and refine policies that address counterfeiting

5. What initiatives are in place to educate the public about the dangers of counterfeit medicines and how to identify them?

The Anti-Counterfeit Authority (ACA) has a legal mandate to educate the public about the dangers of counterfeit products including medicines and how to identify them

ACA collaborates with pharmaceutical manufacturers, like Novartis, to conduct product training sessions for its law enforcement and public awareness officials In turn, the officials develop public awareness and education

The Authority uses different platforms including digital media and legacy media like newspapers, television, and radio to inform the public about the risks associated with counterfeit trade The authority also provides educational materials to educate members of the public on the risk in supporting counterfeit trade

Additionally, ACA collaborates closely with healthcare professionals, pharmacists, and law enforcement agencies to improve the detection of counterfeit medicines and spread awareness The authority organizes workshops and seminars to train both professionals and the general public on identifying counterfeit products and understanding relevant regulations

6. Are there any new technologies being used or developed to detect and prevent counterfeit pharmaceuticals?

Yes, several new technologies are being used and developed in Kenya to detect and prevent counterfeit pharmaceuticals These technologies are designed to enhance the ability of regulators, healthcare professionals, and consumers to verify the authenticity of medicines and ensure that counterfeit products are kept out of the supply chain

ACA has rolled out the recordation of Intellectual property rights programme to aid custom officers to easily detect importation of counterfeit products This is on top of the requirement for acquisition of IPR import license for all imports entering into the country�

Other measures taken by other government agencies include the adoption of advanced technologies for traceability and authentication of drugs throughout the supply chain This ensures that medications reaching consumers are genuine Additionally, authentication devices, such as portable scanners and smartphone

Kenya's Anti-Counterfeit Authority is commi ed to protecting consumers from counterfeit pharmaceuticals through robust enforcement, international collaboration, and public education. By leveraging new technologies and partnerships with global agencies, we aim to ensure that only safe, authentic medicines reach Kenyan patients, fostering trust in our healthcare system.

apps, allow consumers and healthcare professionals to quickly verify the authenticity of medicines by scanning their packaging These technologies are enhancing the ability of Kenya’s regulatory authorities and health sector professionals to safeguard public health by effectively addressing the issue of counterfeit medicines

7. How does the ACA work with international bodies to combat the global issue of counterfeit pharmaceuticals?

The Anti-Counterfeit Authority (ACA) works closely with international bodies such as WIPO, WHO, WCO and Interpol

At continental level, ACA is part of the founder members of the Africa Pharmacrime Working Group based in Abuja, Nigeria, which uses multifaceted strategies to collaboratively tackle the global issue of counterfeit pharmaceuticals� This includes extensive intelligence and information sharing on counterfeit drugs, emerging trends, and counterfeiters’ tactics, which aids in tracking and dismantling global counterfeiting networks

The Africa PharmaCrime Working group collaboration has yielded several capacity building, training and development programmes targeting regulatory authorities to gain skills and knowledge needed to better detect and manage counterfeit pharmaceuticals ACA also participates in joint operations and task forces with East African countries and agencies, focusing on disrupting counterfeit networks through coordinated raids, seizures, and investigations

DR. ROBI MBUGUA NJOROGE, ACA Executive Director

LEARN MORE

Kenya’s pharmaceutical sector is rapidly growing, supported by government incentives and regional trade opportunities. However, high production costs, regulatory challenges, and reliance on imports pose obstacles. Addressing these issues could boost local manufacturing, exports, and healthcare access across Africa.

An overview of Kenya’s pharmaceuticals sector

By Charles Aminga: caminga@brand ke

Kenya’s pharmaceutical sector plays a pivotal role in the country’s healthcare system and economy, contributing to the availability of essential medicines and boosting local manufacturing Over the years, the sector has evolved, and today, it is regarded as one of the most dynamic in East Africa, with Kenya emerging as a pharmaceutical hub for the region� This growth is driven by a combination of government initiatives, private sector investments, and the rising demand for healthcare solutions�

Production

The pharmaceutical sector’s contribution to Kenya’s GDP is relatively modest but growing, accounting for about 0�3% of GDP (World bank)� In recent years, production quantities of pharmaceutical products declined by 0 1 per cent in 2023 compared to an increase of 1 6 per cent in 2022 (Economic Survey 2024) Between 2020/21 and 2022/23, KEMSA reported an average order fill rate of 51% for capital essential Health Pharmaceuticals and Technologies (HPTs) and 80% for program Better Medication Management System (BMMS) products, underscoring the ongoing efforts to improve access to essential medicines These fulfillment rates highlight the importance of bolstering local production to meet growing health demands across the country

To counter harmful use of non- pharmaceutical drugs in the past five years (2019-2023) there was significant fluctuation in the quantity of prohibited harmful non-pharmaceutical narcotic drugs and psychotropic substances seized in Kenya� The amount increased from 6,533 kg in 2019 to 10,909 kg in 2020 and further to 13,080 kg in 2021 However, there was a sharp decline in 2022, with seizures dropping to 5,850 kg, before rising again in 2023 to a high of 14,259

kg (National Police Service, 2023)

These variations reflect ongoing efforts by law enforcement to curb drug trafficking, though challenges in consistency remain

Export statistics

Kenya’s exports of medicinal and pharmaceutical products have shown notable changes in both quantity and value In terms of quantities, exports fluctuated from 32,377 70 tonnes in 2019 to 37,078�90 tonnes in 2023� The highest export quantity was recorded in 2020 at 39,389�10 tonnes, while the lowest was in 2021 at 30,182 20 tonnes On average, Kenya exported approximately 34,770 tonnes of medicinal and pharmaceutical products per year during this period

In terms of value, exports increased steadily from Ksh 10,326 70 million in 2019 to Ksh 17,683�50 million in 2023 The largest growth in value occurred between 2022 and 2023, with exports rising from Ksh 12,210 60 million to Ksh 17,683 50

Key challenges facing the pharmaceuticals sector

Kenya’s pharmaceutical sector, while poised for growth, faces several challenges that could hinder its development and global competitiveness Some of the challenges the sector faces include:

million, representing a 44 8% increase in export value� This sharp increase in 2023 indicates growing demand and possibly better pricing or an increase in high-value pharmaceutical exports

Market opportunities in Africa

Kenya primarily exports its pharmaceutical products to several neighboring countries within the East African Community (EAC) and beyond Key export markets include Uganda, Tanzania, Rwanda, Burundi, Ethiopia, and the Democratic Republic of Congo (DRC) The country also exports to other parts of Africa, such as the Comoros and Malawi, benefiting from trade agreements and regional market access programs Kenya is positioned as a significant player in the regional pharmaceutical market, supplying 50% of the pharmaceutical products within the Common Market for Eastern and Southern Africa (COMESA) regionGrowth Potential in AfCFTA “With the implementation of

[ Cost of Production:

Kenyan pharmaceutical manufacturers face high costs due to importing active ingredients from countries like India and China, while local production in these countries keeps their costs lower This affects Kenya’s competitiveness

AfCFTA, Kenya’s pharmaceutical industry is projected to grow exports by 20-30% annually, opening access to markets worth over USD 25 billion across Africa starting with west Africa

Support and investment

The Kenyan government does provide tax incentives on imported pharmaceutical inputs to encourage local pharmaceutical manufacturing This is part of the broader strategy to reduce dependency on imports Additionally, Kenya’s National Medicines Policy aims to strengthen the local pharmaceutical industry by encouraging domestic production, which aligns with the government’s “BottomUp Economic Transformation Agenda�” The policy focuses on reducing import dependency while ensuring affordable and accessible healthcare through enhanced local production capacity (Pharmacy Board Kenya)

[ Counterfeit Medicines:

The presence of counterfeit and substandard drugs poses health risks and damages the credibility of Kenya’s pharmaceutical industry

[ High Dependence on Imports:

Kenya’s reliance on imported pharmaceuticals makes

it vulnerable to supply chain issues, currency fluctuations, and global market changes, impacting medicine affordability

[ Intellectual Property Rights (IPR):

Balancing IPR with the need for affordable generics

is challenging, as it requires fostering innovation while ensuring access to essential medicines

[ Lack of Research and Development: Limited research and development capabilities in Kenya hinder the creation of new and innovative pharmaceutical

Constraints to the export of pharmaceuticals

Major effort is needed to translate pharmaceutical export potential to a reality The following constraints, which in the past, have acted as an impediment to export performance will need to be addressed:

o Quality and Regulatory Compliance: Meeting international quality standards and regulatory requirements for pharmaceutical products is essential for exports Some Kenyan pharmaceutical companies faced challenges in consistently adhering to these standards, which could limit their access to global markets

o Infrastructure and Technology:

Inadequate infrastructure and technological capabilities in terms of manufacturing, quality control, and research and development can hinder the production of high-quality pharmaceutical products that meet international standards

o Intellectual Property Rights (IPR) Issues:

Intellectual property rights can be complex when it comes to pharmaceutical products� Balancing the need to protect intellectual property with the goal of making medicines affordable and accessible in export markets can be challenging

o Limited Research and Innovation:

The lack of significant research and development initiatives within the Kenyan pharmaceutical sector could limit the creation of innovative and competitive products for the global market

o Supply Chain Challenges:

Reliable and efficient supply chain management is crucial for exporting pharmaceuticals� Issues such as transportation, storage, and distribution can impact the quality and availability of products in export markets

o Market Access and Trade Barriers:

Exporting pharmaceuticals often involves dealing with trade barriers, tariffs, and complex regulatory procedures in target markets These barriers can limit access to certain markets or increase the cost of doing business

o Lack of Information and Market Knowledge:

Limited awareness of international market trends, customer preferences, and regulatory requirements in target export markets can

hamper effective market entry and expansion

o Competitive Landscape: The global pharmaceutical market is highly competitive Kenyan companies need to compete with well-established multinational pharmaceutical companies that have strong brand recognition and distribution networks�

o Quality Perception: Some international buyers may have concerns about the quality and authenticity of pharmaceutical products from developing countries Establishing a reputation for consistent quality is important for building trust in export markets

o Trade Agreements and Partnerships: The absence of favourable trade agreements or partnerships between Kenya and potential export markets can impact the ease of access and competitiveness of Kenyan pharmaceutical products

o Market Entry Strategy: Developing a suitable market entry strategy, including marketing, distribution, and pricing strategies, is crucial for successful pharmaceutical exports Lack of expertise in this area can be a constraint

o Political and Economic Factors: Political instability and economic fluctuations in either Kenya or the target export markets can impact trade relations and export opportunities�

Opportunities for Kenya’s pharmaceutical sector under AfCFTA

By Mariam Maina: mmaina@brand ke

The African Continental Free Trade Area (AfCFTA) presents a significant milestone for economic integration in Africa The AfCFTA entered into force on May 30, 2019, after 24 Member States deposited their Instruments of Ratification following a series of continuous continental engagements spanning since 2012� It was launched at the 12th Extraordinary Session of the AU Assembly of Heads of State and Government in Niamey – Niger, in July 2019 The commencement of trading under the AfCFTA was on January 1, 2021

AfCFTA is the largest free trade area having united the 54 member states (to date) and creating a single 1 4 billion market comprising of 8 regional economic blocs Kenya seeks to exploit opportunities tenable in this large market owing to familiarity with the product offerings, close proximity and accessibility to some of the markets

It is estimated that the AfCFTA has the potential both to boost intraAfrica trade by 52 3 percent by eliminating import duties and to double this trade if non-tariff barriers are also reduced Kenya as a member of the AfCFTA has as well greatly benefited in trading of goods under the Guided Trade Initiative (GTI)� For the period 2019 to 2023, Kenya trade with the AfCFTA countries has recorded an average growth rate of 9 9% in exports and a direct positive change in absolute terms of USD 842 8 million same period The total volume of trade recorded in 2023 was valued at USD 4 7 billion

For Kenya’s pharmaceutical sector, the AfCFTA presents both opportunities and challenges Compared to the period 2019, Kenya’s exports in 2023 saw notable changes across various product categories including medicaments which grew to USD 157 3 million holding a 2 2% share of the total exports in 2023�

Expanded market access

The AfCFTA offers Kenyan pharmaceutical companies access to a market of over 1 3 billion people across 54 countries� This expanded market access reduces tariffs on intra-African trade, making it easier and more cost-effective for Kenyan companies to export their products to other African countries With tariffs on 90% of goods expected to be gradually eliminated, pharmaceutical companies can benefit from reduced costs and increased competitiveness in markets where high tariffs previously restricted trade

Diversification of export markets

Traditionally, Kenyan pharmaceutical exports have been concentrated in a few regional markets, such as Uganda, Tanzania, and Rwanda The AfCFTA opens opportunities for Kenyan companies to diversify their export markets beyond East Africa, tapping into West, Central, and Southern African markets

This diversification can reduce dependency on a limited number of markets and provide resilience against regional economic fluctuations or market-specific challenges�

Promotion of local manufacturing

The AfCFTA aims to boost local manufacturing across the continent by reducing barriers to intra-African trade For Kenya, this means an opportunity to enhance its local pharmaceutical manufacturing capabilities and become a key supplier of medicines and health products to other African countries

By leveraging economies of scale and improving production efficiencies, Kenyan manufacturers can lower production costs and offer competitively priced pharmaceuticals across the continent

Strengthening supply chains

Improved trade facilitation under the AfCFTA, including harmonization of regulations and standards, can help strengthen supply chains across Africa For Kenya, this means better access to raw materials and intermediates needed for pharmaceutical production Streamlined customs procedures and reduced bureaucratic hurdles can enhance the speed and efficiency of trade, reducing lead times and costs for Kenyan exporters

Potential challenges

Regulatory harmonization and standards

While the AfCFTA aims to harmonize trade regulations across member states, the pharmaceutical industry is highly regulated, with each country maintaining its own standards and requirements for drug registration, quality, and safety Kenyan pharmaceutical companies may face challenges in navigating different regulatory environments and ensuring compliance with the diverse standards of each market

Infrastructure and logistics

The success of the AfCFTA in boosting trade relies heavily on the state of infrastructure and logistics across Africa Inadequate transport networks, inefficient ports, and underdeveloped logistics can pose significant barriers to trade Kenyan exporters may encounter challenges in reaching markets efficiently, particularly in landlocked countries or regions with poor infrastructure, increasing the cost and complexity of exporting pharmaceuticals

Competition from other African manufacturers

The AfCFTA also opens the Kenyan market to pharmaceutical imports from other African countries, potentially increasing competition for local manufacturers Countries like South Africa, Egypt, and Nigeria have established pharmaceutical industries that could pose a competitive threat to Kenyan companies, particularly in the production of generic drugs and over-the-counter (OTC) medicines

Non-tariff barriers

Despite the reduction in tariffs, non-tariff barriers such as quotas, import licenses, and restrictive administrative procedures can still hinder trade� Kenyan pharmaceutical companies must navigate these barriers, which can vary significantly between countries, adding complexity and cost to the export process

Strategies for maximizing benefits

Investing in quality and compliance

To succeed in diverse African markets, Kenyan pharmaceutical companies must prioritize quality assurance and regulatory compliance� Investing in robust quality control systems and obtaining internationally recognized certifications can help build trust and ensure product acceptance across different markets� Collaborating with regulatory bodies to stay updated on changes and harmonization efforts within the AfCFTA framework can also facilitate smoother market entry

Enhancing production capabilities

To compete effectively in the expanded market, Kenyan manufacturers should focus on enhancing their production capabilities This includes investing in modern manufacturing technologies, expanding production capacity, and adopting good manufacturing practices (GMP) Public-private partnerships can play a crucial role in upgrading manufacturing facilities and increasing the output of essential medicines

Leveraging trade facilitation measures

Kenyan pharmaceutical exporters should take advantage of trade facilitation measures under the AfCFTA, such as simplified customs procedures and improved trade logistics Engaging with trade facilitation agencies and participating in capacity-building initiatives can help companies optimize their export processes Building strategic partnerships with logistics providers and utilizing digital platforms

for supply chain management can also improve efficiency and reduce costs

Market research and diversification

Conducting comprehensive market research to understand the demand dynamics, regulatory landscape, and competitive environment in different African markets is essential for developing effective export strategies Kenyan companies should focus on diversifying their product offerings and targeting underserved markets or niche segments where they can have a competitive advantage

Advocating for policy support

Engaging with the Kenyan government and regional trade bodies to advocate for policies that support pharmaceutical exports is crucial This includes pushing for further harmonization of regulations, removal of non-tariff barriers, and investments in infrastructure development Active participation in regional trade negotiations and forums can help ensure that the interests of the Kenyan pharmaceutical sector are represented and addressed

The AfCFTA presents a unique opportunity for Kenya’s pharmaceutical sector to expand its reach across the African continent By addressing the challenges and strategically positioning themselves, Kenyan pharmaceutical companies can significantly enhance their export potential and contribute to the broader goal of African economic integration and self-sufficiency in healthcare�

Shaping kenya’s pharmaceutical future: Education and innovation at the forefront

By Irene Van De Graaf: irenev@brand ke

Kenya’s pharmaceutical sector is poised to make significant strides in healthcare innovation and development. But to fully harness this potential, the country must invest in education and talent development. This article explores how Kenya is preparing its future pharmaceutical leaders through enhanced educational programs and strategic industry partnerships.

The evolving landscape of pharmaceutical education in Kenya

Kenya’s pharmaceutical education landscape is evolving rapidly, driven by a growing need to align more closely with industry demands Universities and training institutions are playing a pivotal role in shaping the future of the sector by offering specialized programs and fostering industry collaborations

Academic programs: building a strong foundation

Kenya’s educational landscape in pharmaceuticals is diverse and expanding, offering a range of programs designed to develop talent at all levels, from diploma courses to doctoral studies These programs are integral in preparing the next generation of pharmaceutical professionals who will drive innovation and growth in the sector Here’s an overview of some key programs shaping the future of pharmaceutical education in Kenya:

1. Diploma programs

· Diploma in pharmaceutical technology: This foundational program is offered by several technical institutes and colleges, including the Kenya Medical Training College (KMTC) and the Nairobi Institute of Business Studies (NIBS) Spanning three years, it focuses on preparing students to become pharmacy technicians The curriculum includes essential subjects such as pharmacology, pharmaceutical chemistry, and dispensing techniques, providing a solid base for those entering the pharmaceutical field

2. Undergraduate programs

· Bachelor of Pharmacy (BPharm): A comprehensive five-year program offered by prominent universities such as the University of Nairobi, Kenyatta University, Jomo Kenyatta University of Agriculture and Technology (JKUAT), and Mount Kenya University This degree program includes a wide range of courses, from pharmacology and pharmaceutics to medicinal chemistry, pharmacognosy, clinical pharmacy, and pharmaceutical care It also involves clinical rotations in hospitals and community pharmacies, ensuring that students gain hands-on experience in real-world settings

3. Postgraduate programs

· Master of Pharmacy (MPharm): Available at institutions like the University of Nairobi, this program offers specializations in various areas, including clinical pharmacy, pharmaceutical analysis, pharmacology, and pharmaceutics The two-year program combines coursework with a research project, allowing students to delve deeper into their chosen field and contribute to advancements in pharmaceutical sciences

· Master of Science (MSc) in Pharmaceutical Sciences: Offered by universities such as JKUAT, this program emphasizes research and development in pharmaceutical sciences Students can specialize in areas like pharmacology, pharmaceutical chemistry, drug design, and development, fostering a strong foundation in research methodologies and innovative drug discovery

· Master of Science in Clinical Pharmacy: Designed specifically for practicing pharmacists who wish to specialize further, this program is available at the University of Nairobi It integrates both coursework and clinical practice, allowing pharmacists to refine their skills in patient care and medication management

4. Doctoral Programs

· Doctor of Philosophy (PhD) in Pharmaceutical Sciences: The University of Nairobi and JKUAT offer PhD programs focusing on advanced research in pharmaceutical sciences These programs cover specialized areas such as pharmacology, drug development, pharmacogenomics, and pharmaceutical chemistry, encouraging in-depth research that contributes to the global body of pharmaceutical knowledge

5. Short Courses and Continuing Professional Development (CPD)

· Short Courses and CPD: To ensure continuous learning and adaptation to new advancements, various institutions and professional bodies like the Pharmaceutical Society of Kenya (PSK) offer short courses and CPD programs These courses are designed to enhance the skills and knowledge of practicing pharmacists and pharmaceutical technicians, covering topics such as new drug therapies, pharmaceutical care, regulatory affairs, and good manufacturing practices (GMP)

Master of Pharmacy in Industrial Pharmacy: A Specialized Focus

Among these programs, the Master of Pharmacy in Industrial Pharmacy at the University of Nairobi stands out for its focus on pharmaceutical product formulation and manufacturing processes

This two-year, full-time program is designed to address the growing demand for skilled professionals in Kenya’s expanding pharmaceutical sector It combines rigorous theoretical coursework with practical laboratory sessions and industrial attachments, ensuring graduates are equipped with both the knowledge and practical skills required for the industry

By offering a wide range of educational opportunities, from diplomas to doctoral studies, Kenya’s academic institutions are playing a vital role in nurturing the next generation of pharmaceutical leaders These programs are not only meeting current industry needs but are also anticipating future developments, positioning Kenya as a key player in the global pharmaceutical landscape�

Key Challenges and Opportunities

While Kenya’s pharmaceutical education is making progress, several challenges still need to be addressed:

Outdated curricula: Many educational programs have not kept pace with the rapid advancements in pharmaceutical science and technology This results in a disconnect between classroom teachings and the skills needed in the workforce�

Limited practical experience: Graduates often enter the job market with limited hands-on experience, which is crucial for performing effectively in professional settings� More practical training is needed to develop the competencies required in the industry

Insufficient research opportunities: There is a shortage of research initiatives and facilities to support innovative

pharmaceutical research and development Without adequate opportunities for research, the sector struggles to contribute to global advancements and address emerging health issues

These challenges create a shortage of highly skilled professionals, limiting the industry’s capacity for innovation and impacting the quality of healthcare delivery across the country

Strategies for enhancing talent development

To build a robust pharmaceutical sector, Kenya must adopt a multi-faceted approach to talent development:

Expanding training programs

Specialized training programs and workshops are critical for bridging the gap between theoretical knowledge and practical skills Collaborations with industry leaders provide students with the real-world experience needed to apply their academic learning effectively These programs also help students develop a deeper understanding of industry practices, preparing them for successful careers in pharmaceuticals

Strengthening partnerships for future success

Strong partnerships between educational institutions and pharmaceutical companies are essential for ensuring that academic programs are aligned with industry needs These collaborations facilitate internships, job placements, and joint research projects, giving students invaluable insights into the workings of the pharmaceutical sector

Innovative approaches to learning

New approaches to talent development are emerging, aimed at equipping students with the skills needed for a rapidly evolving industry:

 Mentorship programs: Connecting students with experienced professionals who can provide guidance, share industry insights, and support career development

 Continued professional

development: Offering workshops, seminars, and certification programs to help current professionals stay updated with the latest advancements and trends



Industry-Academia collaborations: Fostering joint research initiatives and development projects to encourage practical learning and drive innovation�

Learning from global successes: local and international benchmarks

Kenya can learn valuable lessons from

successful models of pharmaceutical education and talent development in other countries For example, India has fostered strong collaborations between academic institutions and pharmaceutical companies, resulting in significant advancements in research and production Similarly, Brazil has implemented robust partnerships that have enhanced the quality of pharmaceutical education and driven innovation These international benchmarks offer a roadmap for Kenya to develop effective training programs and strengthen industry-academia collaborations

Building a future of innovation and excellence

The time is now for Kenya to invest in the future of its pharmaceutical industry By focusing on education and talent development, Kenya can cultivate a new generation of skilled professionals who will drive innovation and improve healthcare outcomes Addressing existing gaps through curriculum reform, increased funding for research, and stronger industry partnerships will help build a dynamic and responsive pharmaceutical education sector

Stakeholders - educational institutions, government bodies, and industry players- should actively participate in this effort by supporting educational reforms, fostering industry partnerships, and investing in research and development

Together, we can build a brighter future for Kenya’s pharmaceutical industry and enhance its impact on global health�

Protecting local pharmaceutical companies is good business

by Mercy Kamau: mkamau@apn co ke

If implemented to the letter, the Buy Kenya, Build Kenya Policy could attract more investments in the human drugs space especially, global manufacturers eyeing a slice of the local human medicines manufacturing via signing of collaborative ventures with local manufacturers

In an interview, Cosmos Pharmaceuticals Managing Director Vimal Patel says this could see local manufacturers assigned debulking packaging roles thereby opening unrelated opportunities for different businesses in Kenya from printers, container manufacturers, certified security label printers, transporters and warehouse operators

Speaking from the company’s Industrial Area-based factory in Nairobi, MD Patel welcomed the government’s commitment to promote local manufacturing saying foreign companies keen on retaining their local market share will have no option but to build new factories thereby creating new jobs for Kenyans in skilled, semiskilled and unskilled cadres

“While this is a major plus for us pharmaceutical companies in terms of sales leading to new investments in expanding our production facilities, it creates new revenue sources hence enabling the county and national government to execute their mandates in better ways,” he said

On the government’s Universal Health

Coverage (UHC) Agenda currently in its pilot phase, Mr Patel says local manufacturers of drugs are better placed to fast-track realisation of UHC, the government should zero rate VAT on locally produced drugs/medicine (in the master roll 2 of 2022)

The Cosmos MD says the government should maintain VAT exempt status on imported pharmaceutical products not listed in the master roll 1 of 2022 and other medicines not listed on Master Roll but which are made in Kenya

To promote local manufacturing investments, Mr Patel says the government should scrap off duty and VAT on capital equipment for drugs manufacturing that is imported into Kenya such as clean room I partition panels and accessories which attract 35 percent duty and 16 percent VAT

“Laboratory equipment specifically for pharma industries should be exempted from 16 percent VAT as the cost of hitech laboratory equipment runs into millions

of shillings and is deemed obsolete every five years This means it must be replaced with more modern laboratory equipment as dictated by international standards agencies and WHO The future is solid and we hope to tap into new technologies even though they might be so expensive, hence we seek the government’s support,” he said

Such an incentive, he adds, will also eradicate instances where people import counterfeits passed on as genuine drugs thereby endangering innocent lives while boosting trust for Kenya-made drugs

Currently, Kenya has about 37 companies making human drugs for sale

locally, across Africa and to many other countries in the world�

Mr� Patel, whose company has been in existence for the past 40 years, says unpredictable fiscal and regulatory policies focused on raising revenue in the short term have continued to undermine growth prospects for local companies and hence hurting new revenue prospects for county and national governments�

For instance, he observes, India has registered phenomenal growth for years due to its commitment to support local drug manufacturing ventures Accounting for 10 percent of world’s production by volume and 1 5 percent by value The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing technologies

Some of the incentives given to drug companies in India include competitive land rates, availability of highly skilled cheap labour, low resource costs like water, electricity and lower cost of production machinery The country now ranks 3rd worldwide by volume of production and 14th by value, thereby accounting for around

Boost local pharma investments by imposing stricter human drugs import controls

James Kariuki: jkariuki@apn co ke

Kenya Medical Research Institute (KEMRI) has called for stricter drug importation controls to create a ready market for locally manufactured medical products

KEMRI’s Acting Director

General Prof Elijah Songok said this was a major lifeline for local human medicinemakers who will have to increase production to meet the local and regional demand for the said products

The reality is that eight per cent of the medical products are imported to fulfil the existing local demand. It is upon KEMRI to forge partnerships with local drug manufacturers that will drive new pharmaceutical innovations thereby making Kenya self-reliant

Acting Director General PROF. ELIJAH SONGOK

“The reality is that eight per cent of the medical products are imported to fulfil the existing local demand upon KEMRI to forge partnerships with local drug manufacturers that will drive new pharmaceutical innovations thereby making Kenya self-reliant,” he said

Prof Songok, in a statement issued at the Mombasa ASK Show, added that the ban will also enable Kenya to enhance its internal capacities in human drugs manufacturing enabling it to withstand shocks of disruptions of global supply chains and foreign exchange

“When you have the issue of supply chain breakdown, like we saw during the Covid-19 then the country will suffer but now when we go to local production, the products are cheaper and saves us from the issues of foreign exchange,” he added

To fast-track realisation of a total human drugs import ban, Prof Songok said the government must increase funding to KEMRI’s Research and Development units saying they relied on foreign donations that currently stands at about 60 per cent of all funds going towards new innovations

The KEMRI director welcomed ongoing collaborations with Kenya Medical Supplies Agency (KEMSA) saying

it will help the two parties actively participate in determining the drugs locally consumed in the country KEMSA is the sole drug procurement arm for all government hospitals located at national, county, sub-county, divisional and locational levels

“We are very happy that KEMSA is now working with KEMRI, and we want to see that the supply chain supports local products We need to be protected by the government because continued importation is going to hurt local innovations,” said Prof Songok

Among the major firsts by KEMRI was development of sanitisers that saved the country, diagnostic kits for malaria, HIV, and hepatitis

“Supporting our research and development activities at KEMRI would enable Kenya to take up more challenging tasks with a view to developing homegrown solutions� We are asking the government to help us in getting out these innovations and we need to relook at our priorities

as sometimes up to 60 percent of all funding comes from foreign funding, which is not sustainable,” he added

Prof Songok stressed that buying locally made products was the best way to promote local research saying it made it easier for local scientists to get feedback on newly made drugs thereby helping the review and improve on development of portent products adding that this will also reduce disillusionment among researchers, innovators, and the industry

He further revealed that clinical trials for sickle cell disease are ongoing in Kilifi, Busia, Siaya, and Kisumu counties KEMRI also opened its 15 research centre, Sports Science Research Center (SSRC) in Eldoret that will specialise in sports medicine and medical research components specifically targeting Nutrition Research, Social and Mental Health Research, Clinical Health aspects as well as the provision of laboratory services

Navigating the dynamic landscape of kenya’s pharmaceuticals industry

By Irene Van De Graaf: irenev@brand ke

Government Push for Local Manufacturing:

In February 2024, Kenya’s government launched an initiative to boost local pharmaceutical production, aiming to reduce drug costs and support Universal Health Coverage (UHC)

Growing International

Partnerships:

Iran expanded its pharmaceutical presence in Kenya, gaining Good Manufacturing Practices certification in January 2024, highlighting Kenya’s openness to global partnerships

GSK’s Strategic Shift:

Global pharmaceutical company GlaxoSmithKline (GSK) exited Kenya in December 2023, transitioning to a distributor-led model as part of a larger restructuring plan

WHO Recognition for Malaria Drug

Production: In November 2023, Kenya’s Universal Corporation became the first in Africa to gain WHO approval for malaria drug manufacturing, a major milestone in local pharmaceutical capabilities

Sector Poised for Growth and

Innovation: Kenya’s pharmaceutical industry stands at a transformative point, driven by local production, international collaboration, and regulatory focus to enhance healthcare access and affordability

Kenya’s pharmaceuticals industry is witnessing a transformative period marked by both opportunities and challenges Recent developments underscore the sector’s resilience and potential for growth� Against the backdrop of global shifts and local initiatives, the industry is poised to play a pivotal role in advancing healthcare accessibility and affordability across the nation

In February 2024, the Kenyan government unveiled its ambitious agenda to bolster local pharmaceutical manufacturing capacity This initiative aims to not only reduce the cost of drugs but also to fortify the implementation of Universal Health Coverage (UHC) With Kenyan manufacturers already capturing around 30% of the domestic pharmaceutical market, the push for self-sufficiency is gaining momentum�

Kenya’s pharmaceutical landscape is not confined within its borders In January 2024, Iran’s pharmaceutical industry made significant strides in strengthening its presence in Kenya Thirteen production lines across eleven pharmaceutical companies underwent inspections by Kenya’s Ministry of Health, resulting in the issuance of Good Manufacturing Practices certificates This collaboration underscores the growing global partnerships shaping the industry’s dynamics

The industry also witnessed notable shifts with the exit of GlaxoSmithKline (GSK) from Kenya in December 2023� GSK’s departure aligns with its broader global restructuring efforts, following a similar exit from Nigeria’s pharmaceutical market

The company’s pivot towards a distributor-led model in Kenya reflects evolving business strategies aimed at optimizing operations and market reach�

Amidst these developments, Kenya celebrated significant achievements within its pharmaceutical landscape In November 2023, Universal Corporation, a local pharmaceutical company, made history by becoming the first manufacturer in Africa to receive World Health Organization (WHO) approval to produce a life-saving malaria drug This milestone not only highlights Kenya’s capabilities in pharmaceutical manufacturing but also underscores its commitment to addressing critical healthcare challenges

As Kenya’s pharmaceutical industry continues to evolve, stakeholders must navigate a complex landscape characterized

Sustainability and ethics: balancing profit with social responsibility in kenya’s pharmaceutical industry

By Gertrude Mirobi: gmirobi@brand.ke

In recent years, the global focus on sustainability and ethical practices has intensified, prompting industries worldwide to reassess their operations Kenya’s pharmaceutical sector, a vital part of the country’s healthcare system and economy, is no exception As the industry grows, companies face the challenge of balancing profitability with social responsibility

So how are Kenya’s pharmaceutical companies addressing ethical concerns and environmental sustainability while pursuing economic success?

The pharmaceutical industry is unique because its products directly impact human health and well-being This creates an inherent ethical responsibility for companies to ensure that their operations prioritize societal welfare In Kenya, this responsibility extends beyond producing safe and effective medicines to include broader issues such as environmental sustainability, equitable healthcare access, and corporate social responsibility (CSR)

Kenyan pharmaceutical companies are increasingly recognizing the importance of reducing their environmental impact Pharmaceutical production involves processes that can generate waste, consume large amounts of energy, and release pollutants into the environment To address these challenges, companies are adopting more sustainable practices, such as reducing water and energy consumption, recycling waste, and using eco-friendly materials in packaging

Balancing profit with social responsibility

Balancing profit with social responsibility requires a strategic approach that integrates ethical considerations into the core business model Several Kenyan pharmaceutical companies are leading the way by incorporating sustainability into their operations and decision-making processes

For instance, some companies are investing in green technologies that reduce the environmental impact of their manufacturing processes These initiatives not only help protect the environment but also contribute to long-term cost savings, benefiting both the company and society�

Corporate social responsibility is another critical area where Kenyan pharmaceutical companies are making a difference� Many companies are actively involved in community health programs, providing free or subsidized medicines to underserved populations Others are partnering with local organizations to improve healthcare infrastructure, conduct health education campaigns, and support the research and development of medicines for neglected diseases

Leading initiatives in ethical pharmaceutical practices

Several initiatives in Kenya’s pharmaceutical industry are setting the standard for ethical practices:

 Good Manufacturing Practices (GMP)

Companies committed to GMP, as recommended by the World Health Organization (WHO), ensure that their products are consistently produced and controlled according to quality standards Adhering to GMP helps guarantee that pharmaceutical products are safe, effective, and of high quality

 Labor standards

Ensuring fair wages, safe working conditions, and adherence to human rights principles is fundamental to ethical operations Kenyan companies are making strides in upholding these standards, contributing to a fair and respectful work environment

 Transparency and reporting

There is a growing demand for transparency in supply chains Kenyan pharmaceutical firms are increasingly publishing sustainability reports and providing detailed information about their sourcing and manufacturing processes This transparency helps build trust with consumers and stakeholders

 Ethical sourcing

Responsible sourcing of ingredients and materials is another critical aspect Companies are required to source raw materials in ways that do not exploit labor or harm the environment Many Kenyan pharmaceutical manufacturers now work with suppliers who adhere to ethical and sustainable practices, ensuring that their supply chains are transparent and responsible

LEADING INITIATIVES IN ETHICAL PHARMACEUTICAL PRACTICES

 Ethical investment

Investors are placing greater emphasis on environmental, social, and governance (ESG) factors when making investment decisions Companies that demonstrate strong ESG practices are more likely to attract investment and sustain long-term growth� Kenyan firms are aligning their practices with these investor expectations to remain competitive in the global market

Challenges and opportunities

While significant progress has been made, Kenyan pharmaceutical companies still face challenges in fully integrating sustainability and ethics into their operations� These challenges include:

 Cost considerations

Implementing sustainable practices and complying with ethical standards can sometimes be costly

 Limited access to technology

Adopting new technologies and innovations can be challenging for smaller companies

 Regulatory complexity

Navigating the complex regulatory landscape can be timeconsuming and resource intensive

However, addressing these challenges also presents opportunities for innovation and growth Kenyan pharmaceutical companies can differentiate themselves in the market, attract socially conscious investors, and contribute to a healthier and more sustainable future

In conclusion, the path forward for Kenya’s pharmaceutical industry is clear: sustainability and ethics must go hand in hand with profitability Companies that embrace this approach will not only lead the way in ethical pharmaceutical practices but also set the standard for industries across the continent�

Good Manufacturing Practices (GMP)

Labor standards

Transparency and reporting

Ethical investment

Ethical sourcing

Pharmaceutical investment climate holds substantial promise for Kenya

By Carol Wanza

Kenya is poised for a robust regional pharmaceutical hub status as witnessed by increased investments from global human medicine manufacturers riding on the government’s support including donation of land as part of incentives available to investors.

Ken Gichinga, Chief Economist at Mentoria Economics spoke to Export Agenda magazine’s writer Carol Wanza.

1. Do you think Kenya has built a good investment climate for pharmaceutical sector investments?

Primarily, the pharmaceutical industry plays a crucial role in enhancing public health by contributing to advancements in the life expectancy and well-being of numerous patients

Similar to other sectors, a favourable investment environment holds significant sway over the industry’s growth The existing state of the pharmaceutical sector allows investors to engage with the domestic market

According to the 2nd EAC Regional Pharmaceutical manufacturer’s Plan of Action 2017–2027, as of 2020, Kenyan

manufacturers-controlled 30 percent of the $1 billion Kenyan pharmaceutical market, leaving an opportunity for investors to capture the remaining 70 percent Whether the investment conditions for the pharmaceutical sector are advantageous requires further examination holds greater importance is for Kenya to create a comprehensive 10year national strategy to elevate the sector into a competitive regional centre for pharmaceutical manufacturing the complex regulatory framework is also crucial, given the diverse regulatory bodies falling under different government ministries, including the Ministry of Health the operational landscape’s significance cannot be ignored, as a conducive business environment encompassing

KEN GICHINGA, Chief Economist at Mentoria Economics

reliable power and water supply, efficient waste management, and easy fund access would significantly enhance Kenya’s attractiveness for pharmaceutical sector investments, both at a regional and global level

2. Why should we encourage setting up of local drug manufacturing plants? What will it mean for access to drugs for patients?

The Kenyan pharmaceutical industry currently leans heavily on imports from countries like India, Pakistan, the US, Germany, China and the UK, outweighing its exports This dependency exposes the industry to vulnerabilities such as disruptions, geopolitical influences, and transportation delays, all of which can disrupt the supply chain By fostering local manufacturing, the industry can curtail costs by reducing the need for extensive imports, consequently lowering the end cost for consumers Moreover, local production enhances the ability to swiftly adapt to shifts in demand and emerging healthcare requirements, ensuring the consistent availability of crucial medicines This endeavour also opens up avenues for increased job opportunities, leading to

For patients, the pivotal aspect lies in accessibility Local manufacturing facilitates the creation/development of medicines tailored to the specific healthcare needs of the region, guaranteeing the constant availability of vital drugs is critical In essence, this approach results in a wider array of locally pertinent medications, effectively addressing prevalent health challenges within the community It also establishes a framework for rapid responses during health crises and pandemics, ensuring the prompt production and distribution of life-saving drugs This capability significantly contributes to elevating life expectancy within the country

3. The African Continental Free Trade Area (AfCFTA) has been positioned as a potential game changer for continental trade. What opportunities does it hold for the pharmaceutical trade?

Africa’s annual demand for packaged medicines, with an approximate value of $18 billion, witnessed 61% as imports and 36% as locally produced and retained for domestic use Surprisingly, a mere 3% of this demand is met

through intra-African trade This insight is gleaned from a report by the World Economic Forum titled ‘AfCFTA: A New Era for Global Business and Investment in Africa ’ With the implementation of the dynamic AfCFTA accord, the pharmaceutical and medicine trade in Africa is poised to undergo a significant augmentation, primarily driven by heightened intra-African trade This shift aims to reduce the reliance of African nations on external economies

Delving into the potential for the pharmaceutical trade, the intricate nature of the industry’s products presents remarkable opportunities for investing in local value chains These encompass a range of goods such as packaged and unpackaged medicines, vaccines, medical instruments, and bandages—all possessing substantial potential for local value addition AfCFTA introduces the potential to meet local demands within the continent and facilitates the rapid surmounting of production hurdles Notably, around 40% of the continent’s disease burden is attributed to conditions like HIV/ AIDS, tuberculosis, malaria, diarrhoea, and respiratory illnesses, typically treated with packaged medicines Consequently, any expansion in the packaged medicine sector on the continent stands not only as a boon for business but as a life-saving endeavour

The pharmaceutical sector has long grappled with regulatory complexities, which AfCFTA aims to alleviate through the Africa Medicine Regulatory Harmonisation (AMRH) initiative� This endeavour addresses misaligned regulatory frameworks, rectifying the issues that have hindered access to

affordable medicines The initiative has already yielded tangible results in regions like the East African Community and the Southern African Development Community, reducing marketing approval time from over a year to a more efficient 7-8 months

AfCFTA presents the opportunity to surmount the challenge of fragmented, small markets, initiating a positive cycle of enhanced regional manufacturing, research, and the cultivation of local talent While isolated markets previously obstructed African countries from competing with Asian manufacturers, a continental market enables economies of scale that lead to cost savings Regional markets foster specialisation, ultimately paving the way for beneficial regional procurement markets for investors

Beyond packaged medicines, AfCFTA unlocks an array of opportunities spanning the establishment of quality healthcare infrastructure and the expansion of vaccine manufacturing capabilities For instance, in the wake of the pandemic, the Africa Investment Forum has facilitated investments amounting to $484 million across five transactions, ranging from a multinational health fund to a mobile telemedicine product� Notably, the World Health Organisation’s mRNA technology transfer hub initiative, launched in February 2022, engaged Kenya, Senegal, Tunisia, South Africa, Egypt, and Nigeria� This initiative paved the way for the production and licensing of diverse pharmaceuticals in these six countries, particularly highlighting advancements in mRNA vaccine technology�

How can Kenya leverage AfCFTA to encourage pharmaceutical trade and investments?

To harness the potential of AfCFTA, comprehensive national awareness is paramount� This entails engaging in discussions at both national and county levels, encompassing topics such as the scope and operational status of

industry, skill enhancement, and digital technology This collaboration leverages the AfCFTA to gain access to a unified market of 1 3 billion people and an estimated GDP of US$3 4 trillion

Kenya has the potential to create collective procurement mechanisms that designate locally manufactured goods for specific purposes, incentivizing manufacturers and

for Kenya, insights from econometric modelling regarding potential outcomes, the primary arguments favouring AfCFTA, and details of the National Strategy, complete with evaluation metrics and coordination mechanisms

Armed with well-disseminated information, the government can collaborate with the private sector, employing various approaches, including public-private partnerships (PPPs) This strategic partnership enables the government to establish conducive investment frameworks within the healthcare sector, particularly targeting underdeveloped segments such as the pharmaceutical

investors to invest in and expand manufacturing capacities These pooled procurement initiatives yield the benefits of reduced prices, lowered supply chain expenses, minimised administrative complexities, and improved accessibility to safe, highquality, and cost-effective medicines for the African populace Bolstered manufacturing capacities, coupled with partnerships with key international suppliers of medical products like GAVI, UNICEF, and the Global Fund, would significantly extend the reach of local pharmaceutical products within regional and global markets�

A stable regulatory environment is essential for Kenya to capitalise on the

AfCFTA Market Size: 1.3 billion people, $3.4 trillion GDP

Kenya’s Export Potential: Increased reach via unified African market. Key Partners: GAVI, UNICEF, Global Fund boost access.

regional framework and bolster the local production and regional value chains of pharmaceutical goods

Harmonised regulations and standards address the challenges stemming from small, fragmented markets, enabling the nation’s pharmaceutical manufacturers to construct robust regional value chains and offer competitively priced medicines

Simultaneously, a stable regulatory landscape holds the key to attracting investors, fostering confidence, and sustaining growth in the sector

4. The Finance Bill, 2023 introduced the following clauses:

 To exempt charge tax on royalties paid to a nonresident person by a company undertaking the manufacture of human vaccines.

 To exempt charge tax on interest paid to a resident person or non-resident person by a company undertaking the manufacture of human vaccines.

What do these two provisions mean for drug manufacturers in the country?

The exclusion of royalties from taxation and the tax waiver on interest payments for both resident and nonresident entities hold the promise of amplifying vaccine accessibility and research Since the advent of the COVID-19 pandemic, these incentives have been strategically positioned by the government to lure investors into human vaccine manufacturing, proactively tackling potential disease outbreaks within Kenya Aligned with

the pandemic’s local and global complexities, this endeavor not only addresses pressing challenges but also empowers pharmaceutical manufacturers to bolster the supply of drugs tailored to prevalent regional illnesses

5. In your own opinion, what do you think the future of Kenya’s pharmaceutical investment climate looks like?

In my view, Kenya’s pharmaceutical investment climate holds substantial promise and displays a significant potential for expansion However, realising its full potential hinges on the intricate interplay of several key factors Foremost among these is the formulation of effective government policies that foster a conducive business environment, setting the stage for growth and innovation within the sector Equally crucial is the availability of increased financial support allocated to the pharmaceutical industry via public-private partnerships This infusion of funds would empower the industry to establish essential infrastructural elements, including specialised facilities like ‘cleanrooms’ imperative for the production of human vaccines

partnership deal with the Kenya medical Research Institute to establish a hub in the country The company is best known for making biologics, which are medical products made from living organisms or contain components of living organisms

Notably, the manufacture of vaccines necessitates the utilisation of ISO 4 (Class 10) or ISO 5 (Class 100) cleanrooms throughout the process, with an ISO 6 (Class 1,000) background

It’s worth mentioning that Kenya’s current cleanroom facilities are closer to the Class 4 level, limiting its potential for manufacturing and storing a diverse range of human vaccines

Efforts should be directed at streamlining these regulations to ensure affordability in the evaluation of biosimilars’ quality By addressing these foundational components, Kenya can effectively capitalise on the opportunities presented by AfCFTA This entails accessing a broader

"Kenya’s pharmaceutical investment climate is promising, with potential for growth through strategic policies, infrastructure advancements, and AfCFTA market access, paving the way for improved healthcare access and industry expansion."

Currently, Belgian biotech firm Univercells Group has signed a

market for its pharmaceutical products, ultimately resulting in heightened industry revenue and growth�

Kenyan company takes ‘Healing’ to the WORLD

Revital Healthcare EPZ Ltd� became the first African company to be granted Pre-Qualification (PQ) status by the World Health Organisation (WHO) for their early activation auto-disable (AD) syringe Globally, eight manufacturers have WHO PQ status for this product and Revital is now poised to produce over 300 million AD syringes annually, strengthening Africa’s healthcare infrastructure and securing the supply of essential medical equipment on the continent

Revital Healthcare (EPZ) Ltd Sales & Product Development

Director Roneek Vora spoke to Export Agenda magazine on their journey to local pharmaceutical products manufacturing�

1. In the past 15 years, your firm has been exporting 48 medical devices (including 2B syringes annually) to 29 countries in Africa, India, China, Pakistan, among other countries in the world, how has this benefited Kenya?

Over the past 15 years, our activities at Revital Healthcare (EPZ) Ltd have brought several benefits to Kenya:

† Economic Growth: By exporting medical devices, Revital Healthcare has generated revenue for the country, contributing to Kenya’s overall economic growth This has helped create employment opportunities, increase foreign exchange reserves, and stimulate local businesses in the healthcare sector

† Healthcare Access: The export of medical devices has improved access to essential healthcare products in Kenya and other African countries By providing reliable and high-quality medical devices, Revital Healthcare has contributed to better healthcare delivery and improved patient outcomes

† Technological Advancement:

Through its exports, Revital Healthcare has introduced advanced medical technologies to Kenya This has facilitated the adoption of modern healthcare practices, improved diagnostic capabilities, and enhanced treatment options, leading to better healthcare services for the population

† Knowledge Transfer:

Collaborating with various countries in Africa has allowed Revital Healthcare to share knowledge and expertise in the field of medical device manufacturing This knowledge transfer has not only benefited Kenya but also supported capacity building and skills development in the local healthcare industry

2. What does the government commitment to support human medicines and pharmaceutical products manufacturing mean to your investments and future plans?

It can have a positive impact on Revital Healthcare’s investments and future plans Here are a few potential effects:

† Increased Market Opportunities: With government support, the demand for locally manufactured medical devices is likely to increase� This can create new market opportunities for Revital Healthcare and incentivize the company to expand its operations, invest in research and development, and introduce innovative products tailored to the local market’s needs

† Policy Support: Government commitment to supporting local products can result in favourable policies, such as tax incentives, reduced regulatory barriers, and streamlined procurement processes These measures can enhance the competitiveness of Revital Healthcare and other local manufacturers, encouraging investment and growth

† Collaboration and Partnerships:

The government’s support can foster collaboration between Revital Healthcare and other stakeholders in the healthcare sector, including research institutions, hospitals, and other manufacturers This collaboration can lead to the development of a robust local ecosystem, where knowledge sharing, joint initiatives, and

resource pooling can take place for mutual benefit

† Economic Development: By supporting local products, the government contributes to overall economic development, job creation, and increased tax revenues This can have a cascading effect on the local economy, benefiting various sectors and communities

3. With your investment located away from the big cities, what does that mean to the local economy-jobs, county revenues, CSR and how does this positively affect the future of Kilifi county on matters development?

It has positively impacted the local economy of Kilifi County in several ways:

† Job Creation:

Revital Healthcare’s presence in Kilifi County likely results in direct and indirect job opportunities for the local population These jobs span across various sectors, including manufacturing, logistics, administration, and technical support The employment opportunities contribute to reducing unemployment rates, enhancing the livelihoods of individuals, and stimulating economic growth

† County Revenues:

The investment by Revital Healthcare generates tax revenues for Kilifi County These revenues can be utilised by the local government to fund infrastructure development,

social welfare programs, education, healthcare, and other essential services The increased revenues contribute to the overall development and well-being of the county and its residents

† Corporate Social Responsibility (CSR):

Revital Healthcare’s investment includes CSR initiatives focused on community development especially, supporting local healthcare facilities, education programs, environmental sustainability, and community empowerment Such efforts positively impact the local community and contribute to the overall socio-economic development of the county

† Future Development:

Revital Healthcare’s investment can act as a catalyst for further development in Kilifi County The presence of a healthcare manufacturing facility may attract other investors, suppliers, and service

4. About the snowball effect on the enhancement of the government incentives to support local manufacturing, how can we enhance government-private sector cooperation for public good? To further strengthen governmentprivate sector cooperation for the greater public good, a collaborative approach is essential

† The government can establish dedicated platforms or committees that facilitates

regular dialogue between government representatives and private sector stakeholders This open line of communication will foster a deeper understanding of the challenges faced by local manufacturers and enable the government to tailor policies and incentives accordingly�

† Furthermore, the government can encourage public-private partnerships that focus on research and development, skills training, and technology transfer By leveraging the expertise and resources of both sectors, innovative solutions can be developed, leading to sustainable growth and increased competitiveness for Kenyan manufacturers

† Additionally, the government can work closely with industry associations, such as the Kenya Association of Manufacturers, to develop collaborative initiatives that promote local manufacturing, facilitate knowledge sharing, and advocate for policies that support the sector’s growth This unified approach will strengthen the governmentprivate sector cooperation and create an environment conducive to achieving our shared goals of economic prosperity and social development

5. Lastly, I am aware you attended the health exhibitions like the Dubai World Trade Centre in 2023 that was attended by

more than 100,000 healthcare professionals and exhibitors from 70 countries. How can the government support Kenya-based medical drugs manufacturers to market their products to the world in such international fora?

The government plays a crucial role in supporting Kenya-based medical drugs manufacturers t lo effectively market their products at international fora like the Dubai World Trade Centre health exhibitions Here are some ways the government can provide support:

† Market Access Assistance:

The government can facilitate market access for Kenyan medical drugs manufacturers by actively engaging with foreign trade bodies, diplomatic channels, and international organisations This includes negotiating favourable trade agreements, reducing trade barriers, and advocating for fair market opportunities for Kenyan products in global markets

† Export Promotion:

The government can establish specialised export promotion agencies or initiatives dedicated to supporting medical drugs manufacturers

These entities can provide targeted assistance such as market research, export training programs, matchmaking services, and financial support to participate in international exhibitions and trade shows This helps Kenyan manufacturers showcase their products to a global audience and establish valuable connections with potential buyers and distributors The Agency has regularly promoted Revital Healthcare’s products in export promotion activities

† Financial Support:

The government can offer financial incentives or subsidies to Kenya-based medical drugs manufacturers participating in international fora This can include grants or low-interest loans to cover exhibition costs, product certification fees, and marketing expenses By easing the financial burden, the government enables manufacturers to present their products effectively and competitively in international markets

† Capacity Building and Training:

The government can invest in capacity building programs and training initiatives for medical drugs manufacturers This includes providing support for research and development, quality assurance, and regulatory compliance to ensure that Kenyan products meet international standards By enhancing the

knowledge and capabilities of local manufacturers, the government strengthens their competitiveness and positions them for success in global markets

† International Marketing and Branding:

The government can collaborate with medical drugs manufacturers to develop comprehensive marketing and branding strategies for international markets� This includes creating a strong national brand identity, promoting Kenya’s healthcare sector as a hub of innovation and quality, and showcasing success stories of local manufacturers Additionally, the government can organise country pavilions at international exhibitions,

highlighting the diverse range of Kenyan medical drugs and facilitating networking opportunities

† Trade Missions and Diplomatic Support:

The government can organise trade missions led by highlevel officials or ministers to promote Kenyan medical drugs manufacturers and establish strategic partnerships with key international stakeholders Moreover, the government can leverage diplomatic channels to advocate for the recognition and acceptance of Kenyan medical drugs in target markets, reinforcing their quality and efficacy

By implementing these measures, the government can effectively support Kenya-based medical drugs

manufacturers in marketing their products to the world at international fora Such support will not only boost the export potential of Kenyan manufacturers but also enhance the country’s reputation as a trusted provider of high-quality healthcare products on the global stage

In conclusion, under President Ruto’s visionary leadership, the government’s steadfast support for local manufacturers like Revital Healthcare has set Kenya on a path of unparalleled growth and prosperity� Together, we can create a future where Kenyan products are renowned globally, and our nation stands tall as a beacon of excellence and innovation GLOBAL FOOTPRINT

Countries we Trade

Unseen hand in supporting local pharma development

James Kariuki: jkariuki@apn co ke

JULIUS KIPNG’ETICH

Regional CEO,

Kenya’s human drugs manufacturing space is experiencing a major revolution as more players join the fray to reproduce generic drugs for sale locally and for the regional export markets

Jubilee Holdings Limited Regional CEO Julius Kipng’etich says this is good news as Kenyans will be able to access affordable medicine locally manufactured by Kenyan companies

“I am encouraged by increased investments in formulation and manufacture of generic drugs in the country as this could see the costs of

drugs go down by up to 10 times the current cost of branded drugs,” he said

In an interview, Dr Kipng’etich says the growth in availability of generic drugs needs to be followed by an urgent and a national campaign on change of perception by Kenyans that generics are not fake drugs but genuine drugs with the same formulations as originals

He added that generics have been found to be as good as the branded products but are cheaper since their companies are involved in making them use formulations obtained from the mother companies

“India and China have succeeded in reducing the cost of healthcare by compelling their doctors to prescribe generic drugs locally made by their respective factories Even Kenyans who go to India for specialised treatment are treated with generic drugs as hospitals, private or public are required to stock and prescribe generic drugs,” he observed

According to the regional underwriters Group Chief Executive, the cost of drugs account for upto 40 percent of health insurance claims followed by doctors’ fees that gobble up 27 per cent This he attributes to a tendency of

Kenyan doctors to prescribe branded drugs that are usually imported into the country

“We as insurance companies are ready to support a policy and a law that compels Kenyan doctors and hospitals to prescribe generic drugs It would lower the cost of healthcare and enable Kenya achieve its dream of providing free healthcare for all,” he said

Dr Kipng’etich observed that as the biggest buyer of imported drugs, the Ministry of Health must be compelled to buy locally available generic drugs first before being allowed to seek importation of branded drugs of a similar formulation from oversea manufacturers and dealers�

“A ‘Buy Kenya, Build Kenya’ policy and law must translate into holding procurement officers accountable when it is found they ignored a locally made generic human drug in favour of the costly branded drugs Such a law would be followed with a surcharge notice to the offending officer,” he said For instance, he adds, introduction of a mandatory marine law has meant increased business for local general insurance underwriters as all goods imported into Kenya are insured locally as opposed to the traditional practice

Jubilee Holdings Limited

Kenya’s pharmaceutical industry is primed for growth as local manufacturing of generic drugs gains momentum. Increased investments can reduce drug costs by up to 10 times, enhance healthcare a ordability, and create jobs. Collaboration among public and private sectors is essential to support policies promoting local drug production.

of insuring them in the country of origin�

Dr� Kipng’etich observes that increased demand for locally made generic drugs, means more investments in local human drug manufacturing units hence more jobs for Kenyans and lucrative businesses for local underwriters

“We are in the business of risk management; management of pension savings and life cover, and investments We have invested over Sh100 billion in government bonds and this contributes to infrastructure development for Kenya

“In Uganda, we have spent money on Bujagali hydropower, real estate properties across the region, flower farming and many more investments Insurance companies need to think away from real estate investments and be more creative in where they choose to invest their money for public good,” he adds

He says generic drugs are high quality drugs and must not be confused with fake drugs as these are wellformulated drugs and have been tested and approved by Pharmacy and Poisons Board

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) an international legal agreement

“Under TRIPS, local companies can produce generic drugs for treating different ailments but companies selling branded drugs are unhappy as this will block a lucrative market for their costly branded drugs,” adds Dr� Kipng’etich

Jubilee Insurance Holdings, which maintains its headquarters in Kenya with subsidiaries in Tanzania, Uganda, Mauritius, Burundi and Pakistan, has for years been advocating for enactment of laws that compel local doctors to prescribe generic drugs saying it would help Kenyans afford human drugs hence enjoying better health for longer periods

“Multinational drug companies are unhappy about Kenya having incentives that allow local human drug manufacturers to thrive� I am happy that the then Trade Cabinet Secretary Moses Kuria promised to promote local human drugs manufacturing by putting in place regulations that compel government health agencies to buy Kenya-made human medicines,” he adds

He adds that health insurance continues to be an expensive affair since most hospitals and doctors prescribe branded medicines with giving patients their honest opinions that generics are just as good as

branded drugs

Currently, he says, Kenya spends upto 73 percent on imported medicines, US spends upto 83 percent on generics while India and China markets have supported local generic drugs manufacturing�

The TRIPS agreement also allows countries to import generic drugs from other countries unlike the past when multinational companies blocked export of generic drugs from countries that have capacity to manufacture generic drugs

“For the Universal Healthcare Programme to succeed, Kenya must embrace prescription of generic drugs as a rule In India, all drugs sold have a recommended retail price that helps insurance companies to audit every claim received from the same script,” he says�

On insurance companies’ role in helping secure local drugs manufacturing, Dr Kipng’etich says they have been involved in insuring properties including machinery for various local firms He adds that with the current Marine law in force, all ingredients (raw materials) for human drug manufacturing are insured by local insurers

“More investments in local drug factories mean higher risks and that is business for us The county and national governments will get more revenues as the companies take shape with all operations generating unrelated activities that require solutions from other sectors like transport and logistics, he says

In conclusion, Dr Kipng’etich says, Kenya’s public and private sector players must come together to formulate a mechanism for closer collaboration This could see local institutional investors inject funds in human drugs manufacturing outfits while the governments put in place predictable policies that promote local drugs manufacturing while discouraging importation of the costly branded drugs

JULIUS KIPNG’ETICH

Investment opportunities abound in local pharma

James Kariuki: jkariuki@apn co ke

Pharmaceutical sector in Kenya holds significant investment potential with government backing, import restrictions, and supportive policies

Opportunities span local manufacturing expansion, import reduction, and collaborations in chronic disease treatment, with enhanced IPP support and tax incentives fostering industry growth�

With government goodwill and affirmative action, Kenya’s pharmaceutical sector can flourish, reducing import reliance, creating jobs, and expanding access to essential, affordable medicines through strategic partnerships and local manufacturing initiatives.

Kenya Biovax Institute manufacturing plant

The pharmaceutical industry stands to attract multi-billionshilling investments creating new jobs and increasing their products portfolio if government goodwill is enhanced This means affirmative action taken to bar importation of finished human medicines similar to ones made by local companies

Studies into the health of local human medicine businesses show government support should include a review of the existing global intellectual property protection (IPP) regime so as to not bar entry without compromising access to essential medicines not manufactured in Kenya that are needed to treat various ailments

According to the TradeRelated Aspects of Intellectual Property Rights (TRIPS) Agreement, Article 44, judicial authorities have the authority

to order a party to desist from an infringement, which includes prevention of entry into the channels of commerce in their jurisdiction of imported goods that involve the infringement of an intellectual property right, immediately after customs clearance of such goods�

To create ability of local human medicine makers to protect patents of medicines, the government should also increase the number of diseases declared as national disasters so as to create a leeway for local human medicine manufacturers to legally override patent protection This enables them to proceed with production of life saving generic drugs that are far cheaper than the original drugs

A good case in point is Cosmos Pharmaceuticals that applied for a licence to

manufacture generic ARV drugs, Zidovudine and Larnivudine, as well as a combination of the two, for sale in Burundi, Kenya, Rwanda, Tanzania and Uganda among other African countries� This helped increase access to the life-prolonging drugs

This gave the local company an opportunity to play a significant role in addressing the HIV/AIDS crisis in Kenya and across East Africa while enabling them to build their technical expertise This was sanctioned in 2004 by international pharmaceutical firm, GlaxoSmithKline (GSK) that allowed the Kenyan human medicines maker access to their patents to manufacture generic versions of the two anti-retroviral AIDS (ARVs) medications The two drugs became considerably cheaper, available to those infected with the HIV virus across the East African region�

A case study published by the World Trade Organisation and authored by Ben Sihanya entitled, ‘Patents, Parallel Importation and Compulsory Licensing of HIV/AIDS Drugs: The Experience of Kenya’ observed, “ AIDS drugs are expensive, partly because of royalties that must be paid to patent holders under the TRIPS Agreement and Kenya’s Industrial Property Act, 2001

An in-depth research paper for her

Master’s degree in Pharmacy entitled, ‘Assessment of the pharmaceutical manufacturing industry in Kenya to forecast local production sufficiency’, by Ms Sarah Kadesa asserts that substantial government support is required to propel the industry to improve product range, product competitiveness and production capacity utilisation This should include an increase of duty on imported drugs that are similar to those locally manufactured, make it mandatory for public health facilities to adopt the Buy Kenya, Build Kenya mantra Firstly, this gives preferential treatment to locally manufactured products That will create new demand for locally made human medicines giving impetus for the factories to invest in an expansion drive to meet the new demand

Secondly, it will help Kenya reduce the cost of importing various therapies to treat various ailments thereby enhancing availability of

the said drugs to patients that need them Thirdly, local consumption of made in Kenya human medicines boost confidence of regional countries to source for the same drugs regionally

Fourthly, this makes local human drugs makers attractive to foreign partners who will deem them as viable partners for future ventures in human medicine manufacturing

According to the International Finance Corporation study ‘Inside Africa’s Push to Make its Own Medicines’, regional pharma manufacturing hubs can expand the availability of drugs, lower costs, and strengthen local health systems Local manufacturing, it says, stands a better chance to further grow their product portfolio as many locals now enjoy access to health insurance that enables them to access long term treatment The necessity of specialised treatments for diseases that

are highly concentrated in Africa, such as waterborne diseases, malaria, tuberculosis and HIV/AIDS, “make strong arguments in favour of local pharmaceutical manufacturing ”

The IFC study observes that Kenya could attract new investments in local manufacturing if it provided investors with a predictable environment on regulation, verification, and certification Currently there are no programs to encourage investments in the development of anticancer products locally since requirements for facilities are technologically advanced and require a high level of regulatory approvals

To fast track such investments, the government ought to facilitate public private partnerships, joint ventures and collaborative technology transfers A case in point is ongoing partnerships between Kenya Medical Research Institute and foreign pharma firms�

The Kenya Pharmaceutical Industry Diagnostic Report 2020 jointly developed by the Ministry of Health and the International Finance Corporation recommends formulation of a national strategic plan is essential if Kenya’s pharmaceutical sector is to be transformed into a competitive regional hub for manufacturing pharmaceutical products including drug formulations for noncommunicable diseases, active pharmaceutical ingredients, excipients, and veterinary medicines

This is based on the work done in the EAC Regional Pharmaceutical Plan of Action 2017–2027 that recommended

that Kenya needs to develop and implement a national 10-year strategic plan to transform the pharmaceutical sector by 2030 into a competitive regional hub for manufacturing pharmaceutical products�

The studies add that local manufacturers feel enhanced protection against cheap finished product imports via imposition of higher import taxes as well as enhanced conducive business environment could attract more investments into the country Due lack of an Active Pharmaceutical Ingredients (APIs) and excipients manufacturing capacity and the high cost of electricity, Kenya imports up to 95 percent of its APIs from India

IFC’s report suggests that a multisectoral committee be created to own and facilitate the review and implementation of laws targeting Kenya’s manufacturing industry (especially for health products) with clear timelines set to review and report on the prevailing environment in Kenya (and regional markets)

The government needs to lobby and advocate for laws and policies in the East African Community (EAC) and Common Market for Eastern and Southern Africa (COMESA) trading blocs that do not restrict exports from Kenya-based factories As the African Continental Free Trade Area takes shape, Kenya needs to harmonise investment laws to position itself so as to benefit from other priority regional economic communities

The local ‘pharmas’ also support

regular academia-industry collaborations to inform development of a training curriculum that reflects market needs at university and tertiary level especially on technological advances in machinery and new research outcomes This could also elicit interest in collaboration in research and innovation leading to successful technology transfer and new products emerging from university laboratories

“The Big 4 Agenda and Kenya’s Constitution also highlight the importance of homegrown technologies in national progress, upholding IP rights in the country The Science, Technology, and Innovation Act, 2013, was enacted to provide a framework for strengthening national research and innovation,” it says

The study also urges local companies to delve into big ticket products for treatment of chronic diseases such as cancer, diabetes, and hypertension as this will improve the customer experience and clinical outcomes, and lower costs, especially for chronic disease management�

Most products manufactured across the EAC region and Ethiopia include antibiotics, gastrointestinal drugs, central nervous system drugs, cardiovascular drugs, anti-diabetic agents, antihistamines, anthelmintics, analgesics and antipyretics, antiprotozoals, respiratory drugs, dermatological preparations, minerals and vitamins

kenya paves way for global medical device maker

James Kariuki: jkariuki@apn�co�ke

Kenya has paved the way for a Sh1 4 billion investment at the light industry and urban development facility at Tatu City in Ruiru This is after medical care and protective equipment manufacturer Full Care (Kenya) Medical SEZ Limited announced plans to set up a base in Kenya to supply its products to its customers within Kenya, across Africa and other parts of the world�

In a gazette notice dated 26th May, 2023 acting Commissioner of Customs and Border Control said the decision to declare the upcoming manufacturing hub as a customs area was based on site plans deposited at the Kenya Revenue Authority offices that reveal details of the planned development�

A press statement from FullCare (Kenya) Medical SEZ Limited welcomed the development saying, “Kenya represents a great base for international investment by Asian companies, and we are pleased to

establish our first production facility on the African continent,” said Mr Wu Jianfei, Managing Director of Singapore-based FullCare

The firm has been in business for about twenty years during which they have pioneered production of medical protection materials for human healthcare management

Mr Jianfei said the first phase of FullCare’s facility will create 1,000 jobs and will produce products for export to international customers in more than 70 countries who include distributors of medical supplies The construction, currently in progress, is set for commissioning by year end

Among benefits that an investor gets when setting base in Kenya’s special economic zones include zero-rated, import and stamp duty exemptions and a 10% corporate tax holiday for the first 10 years and 15% for 10 years

thereafter

The development follows the entry of Square Pharmaceuticals, the largest pharmaceutical company in Bangladesh into the Kenyan market with a Sh740 million investment at EPZ Athi River in Machakos County

The facility, set to employ 500 employees in its initial phase, aims to produce malaria and diabetes drugs for sale in Kenya, across Africa, Asia, Europe The new investments will also enable Kenyans to access cheaper essential medicine as well as enjoy foreign exchange earnings from exports of the drugs

Establishment of new medical related facilities also opens new opportunities for skilled and semi-skilled jobs as well as opening new platforms for technology transfer for Kenyans