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UPHARMACIA

Ukrainian Pharma Market Monthly

Macroeconomic Environment Market & Companies News Regulatory Updates Healthcare News

10'17 ISSUE

UPharma Consulting is a professional consulting company, operating in the Life Sciences sector. We deliver best global practices in market knowledge, people management, marketing and strategy for Pharma and Healthcare in the CIS/CEE.


Upharmacia October 2017

CONTENTS Page

3 5 5 6 7 8 9

Section

/ / / / / / /

Data period

Macroeconomic Indicators 09/2016-09/2017 Economy & Pharma Dashboard

09/2016-09/2017

Economic News 10/2017 Pharma Market News 10/2017 Regulatory Updates 10/2017 Healthcare News 10/2017 CIS Pharma News 10/2017

Disclaimer: These publications have been prepared by the research department of UPharma Consulting (“UPC”). It is provided to our clients and industry stakeholders for information purposes only, and UPC makes no express or implied warranties, and expressly disclaims all warranties of merchantability or fitness for a particular purpose or use with respect to any data included in this publication. UPC will not treat unauthorized recipients of this report as its clients. The information contained in this publication has been obtained from sources that UPC’s research group believes to be reliable, but UPC does not represent or warrant that it is accurate or complete. UPC is not responsible for, and makes no warranties whatsoever as to, the content of any thirdparty web site accessed via a hyperlink in this publication and such information is not incorporated by reference. All rights reserved. No part of this publication may be reproduced in any manner without the prior written permission of UPC. UPharma Consulting LLC is registered in Ukraine, Kyiv, 04212, 21st M. Tymoshenka str., building 7, office 5. Additional information regarding this publication will be furnished upon request.

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Upharmacia October 2017

MACROECONOMIC INDICATORS INDICATORS

2016 Sep

Oct

Nov

2017 Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

MACROECONOMIC INDICATORS GDP ($ bn) growth, y-o-y

Export ($ bn)

Q3

Q4

Q1

Q2

26.185

27.930

21.577

24.826

0.87%

9.16%

22.2%

Q3

17.9%

3.16

3.24

3.62

3.63

3.03

3.20

4.11

3.34

3.48

3.35

3.21

3.67

-6%

0%

16%

8%

48%

20%

37%

8%

21%

14%

10%

15%

19%

Import ($ bn)

3.48

3.54

3.81

4.13

3.10

3.67

4.37

3.73

3.83

3.96

4.01

4.25

4.32

Industrial Prod. Sales ($ bn)

8%

10%

24%

32%

32%

18%

35%

22%

27%

47%

30%

23%

25%

5.62

6.39

6.91

7.64

6.34

6.44

6.91

5.92

6.25

6.27

6.31

6.62

6.52

-2%

2%

17%

20%

29%

31%

28%

15%

16%

15%

13%

19%

16%

Retail Turnover ($ bn)

1.76

1.87

2.04

2.09

1.40

1.37

1.62

1.66

1.93

1.78

1.96

2.09

1.89

-5%

growth, y-o-y growth, y-o-y growth, y-o-y growth, y-o-y

3.77

Unemployment Rate (%) Average Salary ($)

-8%

14%

4%

-12%

-8%

-2%

-6%

21%

3%

4%

9%

8%

1.3

1.2

1.3

1.5

1.6

1.7

1.5

1.4

1.3

1.3

1.2

1.2

1.2

204

208

210

247

221

230

250

248

259

272

283

278

257

CPI (Consumer Prices Index)

107.6

112.4

112.1

112.4

112.6

114.2

115.1

112.2

113.5

115.6

115.9

116.2

116.4

50.1

51.6

47.4

57.1

53.7

56.2

55.5

54.9

58.0

59.4

58.5

58.2

59.0

GfK Consumer Sentiment Index

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD

26.3

25.8

25.7

26.2

27.2

27.0

27.0

26.9

26.4

26.1

26.0

25.6

26.1

UAH / EUR

29.5

28.5

27.8

27.6

28.8

28.8

28.8

28.8

29.2

29.3

29.8

30.2

31.1

PHARMACEUTICAL INDUSTRY INDICATORS Export of Pharma Products $M growth, y-o-y

Import of Pharma Products $M growth, y-o-y

Retail Sales, values $M growth, y-o-y

Retail Sales, volumes units M growth, y-o-y

18.81

18.40

14.75

23.95

8.10

13.31

22.01

12.22

14.21

19.75

14.15

13.06

16.7

37%

51%

26%

52%

-3%

0%

42%

-12%

0%

22%

6%

-4%

-11%

140.6

137.3

142.6

169.1

102.4

123.4

150.6

116.8

145.7

156.8

150.5

149.8

146.6

15%

-7%

1%

19%

-1%

-15%

20%

-10%

32%

19%

13%

9%

4%

190.4

212.2

224.7

268.0

233.2

225.4

187.0

210.5

217.5

206.5

211.4

212.7

236.5

-1%

3%

14%

26%

17%

28%

0%

18%

22%

18%

21%

18%

24%

135.5

138.6

139.9

164.1

148.8

147.6

121.9

133.9

137.3

132.0

139.5

134.3

146.7

7%

6%

8%

20%

11%

16%

-9%

7%

11%

8%

14%

6%

8%

1.41

1.53

1.61

1.63

1.57

1.53

1.53

1.57

1.58

1.56

1.52

1.58

1.61

-8%

-3%

6%

5%

5%

10%

9%

10%

10%

10%

6%

10%

15%

107.9

107.6

107.4

106.4

105.4

104.2

103.2

102.8

103.0

103.2

103.9

104.1

103.9

Local Companies Share % values

43.4

42.4

42.3

41.7

41.9

42.7

43.0

42.7

42.9

43.0

43.7

42.7

43.1

Local Companies Share % volumes

76.5

75.1

74.9

73.9

74.5

75.2

75.7

75.6

76.0

76.2

77.0

76.8

75.4

Average Cost of Pack $ growth, y-o-y

CPI, Pharma Products

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Upharmacia October 2017

ECONOMY & PHARMA DASHBOARD 280

240

212.2 200

160

233.2

224.7

225.4

148.8 138.6

210.5 217.5

164.1

206.5

211.4

146.7 133.9

137.3

139.5 132.0

Sep

Oct

Mar

Apr

May

Jun

Jul

Aug

140.6

137.4

180

150.6 123.4

23.9

156.8

150.5

149.8

146.6

116.8

14.2

13.3

10

30

14.2

12.2

13.1

90 20

2016 Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

28.5

26.3

25.8

1.66

1.78

1.96

2.0

2.09

1.89

1.37

0.5

2017 Nov

Dec

Jan

bn USD Feb

1.5

1.0

Mar

Apr

May

Jun

Jul

112.1

27.8 25.7

115.9

116.2

112.4

112.6

114.2

115.1

112.2

113.5

115.6

27.6

28.8

28.8

28.8

28.8

29.2

29.26 29.8

30.2

26.2

27.2

27.0

27.0

26.9

26.4

26.1

25.6

26.0

Official Currency Exchange Rates vs. Consumer Price Index

30

mio USD

2017

112.4

29.5

10

Im port

Ukraine's International Trade in Pharma Production

0

Oct

3.0

Aug

0.0

Sep

116.4

31.1

26.1

31.4

120 100

26.7

80 60

60

Export

8.1

5

6.52

6.62

160

40

120

16.7

14.8

6.31

2.5

1.93 1.62

6.27

140

150

19.8

18.4

6.25

50

107.9

22.0

102.4 18.8

145.7

Sep

Sep

5.92

2.09

2016

0

100

Feb

142.6

20

15

Jan

6.91

Industrial Production Sales & Retail Turnover of Enterprises Surplus

1

169.1

30

25

Dec

2.04

1.87

1.40

mio units

2017 Nov

1.76

2

mio USD

Pharmaceutical Market Retail Sales 80

134.3

6.44

6.34

3

120

121.9

120

4

140

7.64

5.62

5

187.0 147.6

139.9

2016

6

160

212.7

6.91

6.39

7

236.5

190.4

135.5

8

180

264.9

0

Sep

2016

0

Sep

Oct

UAH/USD UAH/EUR CPI

2017 Nov

Dec

Jan

Feb

40 20 0

Mar

Apr

May

Jun

Jul

Aug

Sep

ECONOMIC NEWS —— Ukraine climbed 4 positions to 76th position in the World Bank’s Doing Business 2018 report. The report admitted Ukraine’s progress in dealing with construction permits (from 140 th to 35th position), protecting minority investors (from 70 th to 81st position) and paying taxes (from 84th to 43rd position). Ukraine still has low ratings in resolving insolvency (149 th), getting electricity (128th) and trading across borders (119 th).

—— Ukrainian Parliaments approved pension reform, which was the most critical condition of the IMF. The reform is aimed to decreasing the deficit of the pension fund through increasing the work tenure and raising pension contributions for certain categories of employees.

y-o-y in Sep. Chemical sector showed 33.4% y-o-y growth.

—— Privatization of large state companies is postponed to 2018, the Head of Ukraine’s Property Fund stated. The exception may apply to Odesa Portside Plant, which will be put up for auction in Dec 2017. —— In Oct, customs revenues in Ukraine reached a record high of UAH 30 bn, which is UAH 5.3 bn higher than the target figure and 37.3% higher than in Oct 2016, the State Fiscal Service reported.

—— In Oct, Ukraine’s treasury residuals fell by 19.1% vs Sep to UAH 48.6 bn. In Sep, treasury residuals were at the highest historical level amounting UAH 63.2 bn in cash. —— Ukrainian industrial output decreased by 0.3% www.upharma-c.com

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Upharmacia October 2017

PHARMA MARKET NEWS Indar will Establish Joint Enterprise in Azerbaijan Indar, the Ukrainian producer of insulin, has signed the Memorandum with Azerbaijani Investment Company on establishing a joint pharmaceutical venture in Pirallahy Industrial Park. The company will produce infusion and injection solutions. The construction of production facilities will start in 2018 and will last for 2 years. The cost of the project is to amount USD 17 mio. The enterprise will create 350 jobs. Pirallahy Industrial Park was created in 2016 following the President’s Order to promote the development of the local pharmaceutical industry. Currently, 3 companies are constructing facilities in the Park. The residents of the Park are freed from paying different taxes for 7 years. Indar was established in 1997 by the government. 70% of the company belongs to the State company Ukrmedprom. The company is included in the list of state objects, which have a strategic importance for the economy and state security.

to cardiovascular diseases and neurology. Currently, BCPP has about 25 drugs in development. The market of cardio drugs amounted about UAH 7,1 bn in 2016. In 9M 2017, BCCP was 20 th company on Ukrainian drug market by sales. In 2016, the company doubled its net profit vs 2015 to UAH 118.7 mio.

Galychpharm Received GMP Certificate to Produce Tablets Galychpharm company received Ukrainian GMP certificate to produce drugs in form of tablets. Lately, the company reconstructed the tablet-packing shop and installed more than 14 units of new equipment. Galychpharm is a producer of about 90 herbal-based drugs and phyto-chemical substances. Some of is drugs are produced in a form of tablets, such as Mucaltine, Streptocide, Asparkam etc. Galychpharm is a Lviv-based part of Arterium Corporation, which also includes Kyivmedpreparat company. In 9M 2017, Arterium corporation held the second place on the Ukrainian drugs market by retail sales.

BCPP Plans to Launch 4-6 New Drugs by the end of 2017

Lekhim Launches Veterinary Direction

Borshchahivskiy Chemical-Pharmaceutical Plant (BCCP) plans to launch onto the market from 4 to 6 new drugs by the year-end, the company’s reconstruction and development Director sated. The preparations are related

Lekhim group of companies started producing veterinary drugs on the base of Technolog company. Thus, the company, the main focus of which are cardiology and drugs for alimentary tract, opened the

6

new direction of its development. Lekhim started developing the veterinary direction in 2016 and now has 3 veterinary drugs to produce. Lekhim group includes JSC Lekhim (Kyiv), JSC Technolog (Uman) and JSC Lekhim-Kharkiv (Kharkiv). In Oct 2017, Technolog plant received the EU GMP certificate to produce drugs.

Darnitsa Increased its Net Profits Pharmaceutical Firm Darnitsa increased its net profits by 5% in 3Q 2017 vs the same period in 2016 to UAH 252.3 mio. Gross profit for the same period grew by 19% to UAH 998.6 mio, NSSMC stated. The company was the third largest local manufacturer in 2016 following Farmak and Arterium.

More Than 70% of Medicines Bought Directly From Suppliers The UNDP has analyzed the procurement it conducted with the funds of 2016 state budget. According to the results, share of medicines bought directly from manufacturers comprised 71%, in contrast to 90% of the MoH tenders won by distributors in 2014 and earlier years - before the international procurement of medicines was introduced.

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Upharmacia October 2017

REGULATORY UPDATES The Parliament Has Adopted the Healthcare Reform On Oct 19, 2017, Ukrainian Parliament voted for 3 Draft Laws that are part of the medical reform: 1. The Draft Law "On State

Financial Guarantees for the Provision of Medical Services and Medicines" No. 6327 (adopted wholly); 2. The draft law "On Amendments to the Budget Code of Ukraine on Providing State Financial Guarantees for the Provision of Medical Services and Medicines” No. 6604 as of Jun 21, 2017 (adopted in the first reading) 3. The draft law "On Increasing Accessibility and Quality of Medical Care in Rural Areas" (adopted in the first reading) No. 7117 as of Sep 18, 2017. These draft laws concern the spheres of financing of medical care, in particular, the introduction of a state guaranteed package of medical services and medicines, the creation of the National Healthcare Service of Ukraine as the only customer for medical services, the reform of the primary healthcare system and the introduction of electronic patient records. Primary healthcare system reform provides that patients will exercise their right to choose a family doctor by submitting to the medical services provider a declaration on the choice of a doctor who provides first medical aid. The ideology of the medical reform is that the healthcare will be financed on a contractual basis. That is, healthcare institutions will receive money for specific services www.upharma-c.com

provided to specific patients. Financing the number of places in hospitals now will be substituted by the principle “money follows the patient”. The draft law introduces the concept of the program of state guarantees for medical services to the population, according to which the state pays fully from the state budget of Ukraine. Such a list includes primary, emergency and palliative care. It is worth noting that when reviewing the draft, the Parliament excluded option of copayment for medical services by patients. Special attention is paid to reforming rural medicine - this is the focus of the draft law initiated by the President of Ukraine. The document envisages the introduction of telemedicine in Ukraine, which is intended to simplify the diagnosis in those cases when not a personal examination is needed, but rather an evaluation of the examination data. In addition, the draft addresses the social issues of healthcare professionals. Thus, local authorities are recommended to develop and approve programs to provide healthcare professionals working in rural areas with official housing and office vehicles. The government is invited to take measures to ensure access of healthcare institutions in rural areas to the Internet. Commenting on this draft law, President P. Poroshenko said that the budget has at least UAH 5 bn of additional funding for medicine in rural areas for 2 years.

Provided by

Members of Parliament Proposed to Introduce a License for Manufacturing, Trade and Import of Medical Products On October 6th, 2017 the draft Law on amendments to the Law of Ukraine "On Licensing Economic Activities" was registered in the Parliament. The draft envisages the expansion of the list of types of economic activities subject to licensing. It is proposed to supplement the list with such activities as production, wholesale and retail trade, as well as import of medical products. In addition, the reference to medical products is included in the paragraph on licensing of the activities on manufacture, trade and import of medicines. The explanatory note to the draft law states that the purpose of amendments is to bring Ukrainian legislation closer to the EU law. However, the EU does not have the practice of licensing production, wholesale and retail trade, as well as import of medical products. At the same time, in order to unify the approaches to regulating the medical products market in Ukraine and the EU and in order to deregulate business, since July 1st, 2017 the requirement to register medical products has been substituted by the requirement to confirm their compliance with the technical regulations. Technical regulations provide only a register

7


Upharmacia October 2017

of subjects responsible for the introduction of medical products in circulation. This register indicates the location of the manufacturers or their authorized representatives and a list and description of the relevant medical products. However, despite the validity of technical regulations, the draft does not contain conditions for taking into account their peculiarities when issuing the corresponding licenses for medical products, but only references to the Law “On Medicines”, which, obviously, should be taken only in the context of medicinal products. We draw your attention to the fact that today medical products are sold by a wide range of subjects on the market, including selling through supermarkets, shops and refuelling stations. Accordingly, given the complexity of the licensing process and the requirement, for example, to entities to provide special conditions for the transportation or storage of

licensed products in special licensed warehouses, it is possible to predict a narrowing of the range of entities that will be engaged in the relevant economic activity.

Changes in the Procedure for Selecting Drugs to the National List Approved The MOH adopted the Order “On Amendments to Orders of the Ministry of Health of Ukraine No. 84 as of Feb 11, 2016 and No. 1050 as of Oct 7, 2016” No. 885 as of Aug 1, 2017, which amends the Regulation on the National List of Essential Medicines and the Regulation on the Expert Committee on the Selection and Use of Essential Medicines. The purpose of this regulatory act is to bring the algorithm for introducing changes into the National List in line with the needs of the healthcare system and the calendar plan, which delays the

application of the National List. Now the Expert Committee on the Selection and Use of Essential Medicines is developing a list of drugs to include in the National List by the end of 2017. In accordance with Order of the Ministry of Health of Ukraine No. 558, such selection is carried out taking into account the 20th version of the WHO Model List, the nomenclature of medicines procured for budgetary funds and industry standards. Procurements in 2018 will take place based on such supplemented National List. In the future, the National List will be supplemented regularly once a year. By Jul 1st of each year, the advisory body will form the next edition of the National List, submit it to the Ministry of Health of Ukraine, which in turn will submit the draft resolution of the Cabinet of Ministers on introducing the changes to the Government. Read more on Legal Alliance website

HEALTHCARE NEWS National Healthcare Service to be Created in early 2018 The government expects to create the National Healthcare Service of Ukraine (NHSU) – an independent customer of services responsible for financing the health system – at the beginning of 2018, the Deputy Head of the MOH Pavlo Kovtonyuk stated. According to him the Ministry has already developed a lot of legislative acts for the implementation of the Law on state financial guarantees approved by the Parliament on Oct 19. The NHSU should become the key

8

authority within the reformation of the Ukrainian healthcare system. Until it is created, the functions of funding the health care services will be carried by the MOH. Co-author of the reform MP Serhiy Berezenko stated that the functioning of the NHSU would be controlled by audit service, Chamber of Accounts, National Agency on Corruption Prevention and National Anti-Corruption Bureau of Ukraine.

Pharma Companies Considering Introduction of QR-coding Ukrainian producers of phar-

maceuticals are considering the possibilities of introduction of QR-coding of drugs packs, the Director of Professional Pharmacy Association of Ukraine Volodymyr Rudenko stated. “Such labeling of imported and local drugs in Ukraine is only at planning stage,” Mr. Rudenko stated. “Currently, the labeling with QR-codes is almost not implemented”. A number of experts thank that the implementation of QR-coding of medicinal products could take 2-3 years due to the shortage of the appropriate equipment. www.upharma-c.com


Upharmacia October 2017

Such measures are required to fight against counterfeit drugs and to be able to track their movement. Labeling of drugs with QR-codes should become mandatory in the EU since Feb 2018. In Oct, the State Service on drugs launched the pilot project on the introduction of an automated system for monitoring the movement of drugs from the producer to the end consumer, using codification and identification in a European manner.

Some Drug Prices Grew 60% in 2 months Analytical company Business Credit admitted the grows of retail prices of some categories of drugs in last months. In Sep 2017, prices of OTC otologic drugs increased 60% vs Aug 2017, OTC contraceptives – 50%. In last 2 months, 30% growth was seen in retail prices of Rx antiseptics, Rx hormonal contraceptives and sex hormones, OTC ophthalmic drugs and OTC drugs for the throat.

In 9M2017, retail sales of pharmaceuticals increased by 18.1% y-o-y in values and by 8% y-o-y in volumes vs 9M2016 to USD 1,935.9 mio for 1,242 packs. In Sep, the average of price of one unit of a drug amounted UAH 57.5. According the State Statistics Service of Ukraine, in Sep 2017, the prices of pharmaceutical products grew 3.9% PPG as compared to the overall CPI amounting 116.4.

CIS PHARMA NEWS Azerbaijan

—— Representative of the regional government of St. Petersburg stated that the city plans to produce 10% of the total Russian pharma production. This will be achieved through acceleration of industrial zone Pushkinskaya, which includes 88 producers.

—— The range of Pakistani companies are interested in entering Azerbaijan’s market through creating joint enterprises in Pirallahy Industrial Park, the ambassador of Pakistan stated.

Kazakhstan

—— The government of Azerbaijan expects that in next 5 years production of pharmaceutical production in the country will grow 58.4 times.

Georgia

—— Georgia Healthcare Group announced that its pharma business has acquired the international private label brand – “Attirance”, with specializes in natural cosmetics and personal care products.

—— The MOH proposes to postpone the launch of compulsory medical insurance in Kazakhstan from 01/01/2018 to 01/01/2020 as there is a risk that the big share of the population would not be involved. —— In 8M2017, imports of pharmaceuticals to Kazakhstan increased by 21.2% PPG in values to USD 524.2 mio. However, the amounts of 8M2015 (about USD 610 mio) were not reached.

Russia

—— Russian government endorsed the Draft Law on remote sale of OTC drugs by pharmacies. The document was later submitted to the Parliament for consideration. —— Russian company Pharmstandard will localize the production of Takeda’s innovative oncohematologic drug Adcetris® (brentuximab vedotin). —— Sanofi reached special investment contract with Russian Trade Ministry on modernization of industrial production at its plant Sanofi-Aventis Vostok (Oryol region). www.upharma-c.com

9


Upharmacia October 2017

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