upharmacia - march 2016

Ukrainian PharmaceUtical market monthly

UpharmaciaMacroeconomic Environment | Market & Companies News | Regulatory Updates | Healthcare News

Issue: 03 2016

UPharma Consulting is a consulting company, operating in the healthcare and pharma sectors. Our clients - pharmaceutical companies, pharmacy chains, distributors, investment funds, banks, and other stakeholders in the healthcare sector.

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Ukrainian PharmaceUtical market monthly: March 2016

2015 2016Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb

MACROECONOMIC INDICATORS Q1 Q2 Q3 Q4

GDP (US$ bn) 17.353 20.795 25.552 25.588

growth, % y-o-y -51% -35% -26% -17%

Export of Goods (US$ bn) 2.99 3.45 3.07 2.94 3.09 3.15 3.09 3.35 3.23 3.13 3.36 2.04 3.08growth, % y-o-y -37% -32% -39% -41% -30% -34% -22% -22% -23% -21% -11% -31% 3%

Import of goods (US$ bn) 2.86 3.17 2.86 2.63 2.76 2.98 3.88 3.24 3.22 3.07 3.12 2.23 2.68growth, % y-o-y -41% -35% -38% -46% -37% -34% -2% -30% - 27% -27% -32% -26% -6%

Industrial Production Sales (US$ bn) 4.56 5.51 5.91 5.65 5.79 5.71 5.42 5.72 6.29 5.92 6.37 4.93 4.93growth, % y-o-y -54% -45% -33% -38% -35% -33% -23% -20% -21% -19% -17% -18% 8%

Retail Turnover of Enterprises (US$ bn) 1.44 1.61 1.66 1.94 1.83 1.94 1.88 1.86 2.04 1.80 2.01 1.60 1.50growth, % y-o-y -61% -56% -40% -35% -38% -41% -32% -38% -31% -33% -29% -19% 4%

Unemployment Rate (%) 2.0 1.9 1.8 1.8 1.7 1.6 1.6 1.5 1.5 1.6 1.9 1.9 1.9

Average Salary (US$) 148 166 176 193 202 202 194 199 207 193 223 180 174

OFFICIAL CURRENCY EXCHANGE RATEUAH / USD 24.5 23.3 22.7 20.9 21.2 21.8 21.6 21.8 21.8 23.3 23.4 24.3 26.4

UAH / EUR 27.8 25.3 24.5 23.3 23.8 23.9 24.0 24.5 24.6 25.1 25.4 26.3 29.3

PHARMACEUTI CAL INDUSTRY INDICATORSExport of Pharma Products (mio USD) 12.05 13.37 13.46 13.00 15.36 13.85 9.01 13.79 12.2 11.7 15.77 8.31 13.33

growth, % y-o-y -42% -50% -44% -39% -39% -6% -54% -47% -37% -52% -28% -30% 11%

Import of Pharma Products (mio USD) 114.5 103.3 103.7 84.2 115.0 106.5 93.3 121.1 147.1 141.3 142.1 103.7 145.0growth, % y-o-y -47% -67% -36% -60% -44% -47% -47% -31% -28% -24% -42% 15% 27%

Pharma Retail Sales, values (mio USD) 177.0 197.6 180.0 193.0 177.7 172.6 177.1 193.2 206.3 196.6 212.3 198.9 176.0growth, % y-o-y -54% -47% -40% -28% -29% -32% -24% -28% -26% -20% -18% -17% -1%

Pharma Retail Sales, volumes (mio units) 143.9 141.5 122.6 124.5 118.4 119.5 122.5 126.7 130.2 129.0 136.4 133.6 126.8growth, % y-o-y -15% -21% -20% -11% -9% -10% -8% -11% -5% -4% -5% 1% -12%

WACP (USD) 1.81 1.24 1.41 1.47 1.52 1.48 1.45 1.52 1.58 1.52 1.56 1.49 1.39growth, % y-o-y -22% -40% -27% -23% -21% -23% -18% -19% -22% -18% -14% -23% -23%

CPI of Ukraine 134.5 145.8 160.9 158.4 157.5 155.3 152.8 151.9 146.4 138.1 134.6 131.9 126.9

Pharmaceutical Products CPI 155.5 170.3 164.7 159.5 153.5 151.8 149.4 145.8 142.1 146.6 143.3 140.3 132.7

Local Companies share, values (%) 38.5 39.6 40.7 41.5 41.7 41.8 41.4 41.4 41.4 41.7 40.9 42.3 42.9

Local Companies share, volumes (%) 75.2 77.1 77.6 77.6 77.9 78.4 78.2 76.5 75.7 75.8 76.7 75.6 76.5

MACROECONOMIC ENVIRONMENT

Description of the indicators:

MACROECONOMIC INDICATORS

GDP (Gross Domestic Product) is an aggregate measure of production equal to the sum of the gross values added of all resident, institutional units engaged in production (plus any taxes, and minus any subsidies, on products not included in the value of their outputs) calculated in current prices. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Hereinafter: excluding the temporarily occupied territory of the Autonomous Republic of Crimea and City of Sevastopol, as well as the part of zone of the antiterrorist operation. Source: State Statistics Service of Ukraine.

Export of Goods is a sale of goods by Ukrainian subjects of foreign economic activities to foreign subjects of foreign economic activities (including non-cash payment) with or without exportation of these goods through the customs border of Ukraine, including the re-export of goods. Initially calculated in USD. Source: State Statistics Service of Ukraine.

Import of Goods is a purchase (including non-cash payment) of goods by Ukrainian subjects of foreign economic activities in foreign subjects of economic activities with or without the importation of these goods into the territory of Ukraine, including the purchase of goods for domestic consumption by establishments and organizations of Ukraine located abroad. Initially calculated in USD. Source: State Statistics Service of Ukraine.

Industrial Production Sales is the value of industrial goods, which are actually shipped in the period, as indicated in documents decorated as the basis for calculating with the buyer (customer), regardless of income payments for them. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine.

Retail Turnover of Enterprises is the value of consumer goods sold via retail trade and restaurants to the population by all operating enterprises. It also includes direct retail sales by industrial, transport and other non-trade enterprises. In addition, retail turnover includes retail sales of food products to departments, organizations and enterprises to provide meals to the people they serve (at sanatoria, children’s care institutions, hospitals, etc.). Reflected in current prices. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine.

Unemployment Rate is a ratio (percent) of the unemployed registered at the State Employment Service to the average annual population of working age. Source: State Statistics Service of Ukraine.

Average Salary is an average value of remuneration in cash and in kind paid to employees for time worked or work done. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: State Statistics Service of Ukraine.

Official Currency Exchange Rate is the rate established by the National Bank of Ukraine under which Ukrainian national currency – UAH (Ukrainian hryvnia) will be exchanged for foreign currency (USD or EUR). Calculated as average value in the corresponding period. Source: National Bank of Ukraine.

PHARMACEUTICAL INDUSTRY INDICATORS

Export of Pharma Products is an export of goods related to the group “Pharmaceutical products” under the Ukrainian Classification of Goods for Foreign Economic Activities. Initially calculated in USD. Source: State Statistics Service of Ukraine.

Import of Pharma Products is an import of goods related to the group “Pharmaceutical products” under the Ukrainian Classification of Goods for Foreign Economic Activities. Initially calculated in USD. Source: State Statistics Service of Ukraine.

Pharma Retail Sales are retail sales of different product categories of “pharmacy basket” (drugs, medical devices, cosmetics and food supplements) in values and volumes. Converted from UAH to USD in accordance with an average official NBU exchange rate in the corresponding period. Source: Morion.

WACP (Weighted average cost of a pack) is a ratio of pharma retail sales in values to pharma retail sales in volumes.

CPI (Consumer price index) is an indicator of changes at the time of prices and tariffs for commodities and services being purchased by the population for unproductive consumption calculated to corresponding month of previous year. Source: State Statistics Service of Ukraine.

Pharma Products CPI is a Consumer price index of “Pharmaceutical products, medical products, appliances and equipment” group calculated to corresponding month of previous year. Source: State Statistics Service of Ukraine.

Local Companies Share is the share (percent) of sales related to Ukrainian companies in overall pharma retail sales in values and volumes. Source: Morion

Table: Key MacroeconomicIndicators in Ukraine

(Feb 2015-Feb 2016)


KEY ECONOMIC EVENTS » Ukraine’s real GDP fell 9.9% y-o-y in 2015, while nominal GDP reached UAH 1,979 bn or USD 89.2 bn by the

average exchange rate. However, the decline dynamics have been decreasing over the quarters of 2015 and in 4Q2015, real GDP decline was 1.4% y-o-y.

» Economy Ministry of Ukraine reduced its GDP growth forecast from 1.0% to 0.0% y-o-y for 1H2016 due to trade restrictions imposed by Russia and weak external demand. Later on, the Finance Minister said the government projects 1% growth in 2016, not 2%, as expected earlier.

» The National Bank of Ukraine intends to increase international reserves to USD 19.6 bn by the end of 2016, NBU Head said. The NBU expects to reach funds by restoring relations with the international community. Currently, the international reserves of Ukraine stand at USD 13.3 bn.

» Ukraine has reached credit agreement with Japan for USD 200 mio to carry out economic reforms, Finance Ministry reported.

» Ukraine and Iran are to start implementing joint projects in agricultural sector and continue cooperation in banking sector. Ukraine also proposed Iranian investors to participate in privatization of Ukrainian enterprises and investing in forestry and fishing sector.

» Fiscal revenues to the consolidated budget of Ukraine in Jan-Feb 2016 increased by 33.6% y-o-y to UAH 83.4 bn.

» European Commission will recommend abolishing visas for Ukrainians in Apr, Jean-Claude Juncker said. In Mar, the Ukrainian parliament has adopted the last law of “visa-free” package.

» In Feb, industrial output in Ukraine increased by 7.6% y-o-y. The main drivers for growth were metals, mining and machinery. Luhansk region recovered its industry by 2.5x y-o-y, while Donetsk region increased output by 26.9% y-o-y.

177.0

197.6

180.0

193.0

177.7172.6

177.1

193.2

206.3

196.6 212.3 198.9

176.0

143.9141.5

122.6124.5

118.4119.5

122.5

126.7

130.2 129.0

136.4133.6

126.8

100

110

120

130

140

150

160

100

120

140

160

180

200

220

Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb

Pharma retail sales

2015 2016

Volumes (mio units)

Values (mio USD)

12.113.4 13.5 13.0

15.413.9

9.0

13.8

12.211.7

15.8

8.3

13.3

114.5103.4 103.7

84.3

115.0106.6

93.3

122.2

147.1141.3

142.1

103.7

145.0

0

20

40

60

80

100

120

140

160

0

4

8

12

16

20

24


Ukraine's Internation trade in pharma production

2015 2016

Export

Import

4.56

5.515.91

5.65 5.80 5.715.43

5.72

6.295.92

6.37

4.93 4.93

1.44

1.61 1.66

1.941.83

1.94 1.88 1.862.04

1.802.01

1.601.50

0.0

0.5

1.0

1.5

2.0

2.5

3.0

0

1

2

3

4

5

6

7


Industrial production sales & Retail turnover of enterprises surplus

2015 2016

Retail turnover of enterprises

Industrial produc�on sales

24.5 23.3 22.720.9 21.2 21.8 21.6 21.8 21.8

23.3 23.4 24.326.4

29.0 29.526.9

25.5 24.926.1 25.9 26.1

24.6 25.1 25.4 26.329.3

134.5145.8

160.9 158.4 157.5 155.3 152.8 151.9146.4 146.6 143.3 140.3

132.7

0

20

40

60

80

100

120

140

160

0

5

10

15

20

25

30

35

40

45


2015 2016

vs. Consumer Price IndexOfficial Currency Exchange Rates

Consumer Price Index

UAH / €

UAH / $

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MARKET & COMPANIES NEWSSanofi Ukraine appointed new Director

On Mar 1, Sanofi announced the appointment of Guilhem Granier as the Director of Sanofi Ukraine and General Manager of the Rx department. Mr. Granier has replaced Jean-Paul Scheuer, who has been heading the company for seven years.

Guilhem Granier joined Sanofi in 2000. In 2007, he had been appointed as the company’s Business Unit Director in Tunisia, while in 2010 he became the General Manager in Tunisia and Libya. His last position was Business Excellence Director of Intercontinental region (Africa States, Middle East, Eurasia and South Asia).

“I have a quite diverse experience of working in crisis conditions, which I will try to use at my new position in Ukraine,” Mr. Granier said. “Certainly, my further work will be based on what Jean-Paul and Sanofi Ukraine’s team have already built.”

Jean-Paul Scheuer will continue working as County Chair of Sanofi Gulf and Yemen region.

Liktravy reported UAH 13.6 mio profit in 2015

The biggest Ukrainian producer of herbal preparations Liktravy has finished 2015 with UAH 13.6 mio net profit, the company’s officials reported. The company’s profit raised almost four times from UAH 3.5 mio in 2014.

Liktravy produces more than 70 names of brands. Hallmarks of the company are medicinal herbs and phytotea. Liktravy’s assets amounted UAH 180.2 mio, 99.35% of which are owned by German company MB

Beteiligungs Gmbh.

GSK restricts supply of Infanrix™ vaccines to Ukraine

GSK Ukraine announced the temporary restriction of supply of Infanrix™ vaccines (Infanrix™ HEXA, Infanrix™ IPV, Infanrix™) containing pertussis component to Ukraine due to increased global demand in ones and limited production capacity. The restrictions will apply to requirements of the national immunization program as well as to supply to private clinics and pharmacies. All other vaccines of the company are supplied in Ukraine as usual.

“The restrictions do not connect with the issues of quality or safety of our vaccines,” GSK’s officials said. “We expect the restrictions will apply only shortly. But the terms could change in respond to the external environment.”

Later on, the company stated it plans to register new vaccines in Ukraine to eliminate the deficit of vaccines containing pertussis component. In case if other companies are not able to carry out the supply, GSK will take steps to find an acceptable solution, the company said.

Antibiotice will open representative office in Ukraine

Romanian pharmaceutical company Antibiotice will open its representative office in Vinnytsia in 2016. The corresponding agreement was reached between the GM of the company and the Head of Vinnytsia Region State Administration.

Antibiotice was founded in

1995 and now develops and produces generic drugs for human use veterinary drugs and the active ingredient Nystatin. The company’s portfolio consists of 148 products, which are mainly intended for patients with infectious diseases, but also for cardiovascular, dermatological, oncological, digestive and central nervous system related pathologies. Antibiotice is actively expanding external markets; in 2014 the company exported production for USD 25.6 mio.

InterChem is developing three new molecules

InterChem pharmaceutical company has three molecules under development, the Director of the company Anatoliy Reder said. Lately, InterChem has finished another phase of clinical trials of a product against a sore throat. Nootropic drug for memory restore is also in the phase of clinical trials. InterChem expects to register new medicines following bioequivalence procedure.

InterChem was the 25th company on the Ukrainian pharmaceutical market by sales in 2015. The company’s primary specialization is drugs for nervous and respiratory systems. The company plans to put its new production facilities into operation in Apr 2016. Currently, InterChem considers the access to the markets of East Africa, particularly Kenya.

Indar received GMP certificate in Brazil

National Health Surveillance Agency of Brazil (ANVISA) has granted Ukrainian insulin producer Indar the International


GMP certificate. Indar has been supplying recombinant insulins in the form of ready-made medicines in Brazil, where they are prescribed to adults and children. It was reported, that the company had planned to put into operation its insulin-manufacturing site in Brazil in 2016.

Indar is the only insulin producer in Ukraine, obtaining a full cycle manufacturing of the preparation – from substances to finished dosage forms. Since 2012, 70.7% of Indar’s shares are owned by the State company “Ukrmedprom”.

Arterium Corporation launches a pregabalin drug

Ukraine’s 3rd biggest pharmaceutical company Arterium Corporation has launched Gabana™ (pregabalin) for the treatment of neuropathic pain. The drug is produced under GMP standards at the facilities of PJSC Kievmedpreparat (part of Arterium Corporation). Gabana™ is a Rx drug, which claims to be cost-effective for patients as other pregabalin analogs are quite expensive.

Arterium did not change its positions on the Ukrainian pharmaceutical market in 2015 despite the bankruptcy of the company’s owner “Finance and

Credit” Group. The company’s portfolio consists of more than 140 brands with an emphasis on cardiovascular and antiinfective groups.

Dr. Reddy’s will launch new drugs in Ukraine

Indian Dr. Reddy’s remains optimistic regarding Ukrainian pharmaceutical market and continues its business development in the country, Executive VP of the company M. V. Ramana said. The company intends to strengthen its positions in Ukraine by launching innovative products. Thus, Dr. Reddy’s plans to register molecules for the treatment of cardiovascular and neurological diseases as well as new oncology drugs.

Dr. Reddy’s was 29th company in the Ukrainian pharmaceutical market by sales in 2015.

AstraZeneca Ukraine will expand its oncological portfolio

AstraZeneca announced the launch of Lynparza™ (olaparib) for the treatment of ovarian cancer onto Ukrainian market. “Launching olaparib is a major step towards achieving leadership in the oncology field,” the Director of AstraZeneca in

Ukraine Evgeniy Gaidukov said. “The drug is at the forefront in AstraZeneca’s oncological portfolio and can significantly improve the patients’ life.’

Olaparib is a poly (ADP-ribose) polymerase inhibitor affecting DNA repair processes. The drug was endorsed for registration in Ukraine in Nov 2015.

The government endorsed Biofarma to export blood preparations

The Cabinet of Ministers of Ukraine approved the MOH’s proposition to provide PJSC Biofarma, and Biofarma Plasma LLC exclusive authority to sell donor blood components and made of blood preparations outside Ukraine.

Biofarma is one of the biggest pharmaceutical companies in Ukraine producing more than 130 brands in 11 pharmaceutical groups. The company’s key activity is the manufacturing of high-technological preparations made of donor blood as well as recombinant drugs and bacterial preparations.

REGULATORY UPDATESThe Essential Documents in the Sphere of the National Essential Medicines List Have Been Disclosed to the Public

The Order of MOH № 84 dated 11.02.2015, with which the Regulation on the National List of Essential Medicines and the Regulation on the Expert Committee on the Selection and

Use of Essential Medicines has been approved.

The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the

comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards in terms of health and level of funding for health care. The structure and contents of national lists will be based on the latest edition of the

Provided by


Basic List of Essential Medicines recommended by WHO.

The next working step is to create a competitive commission for the formation of an Expert Committee, which consists of 12-18 people, and the selection of committee members on the basis of equal access of candidates to participate in the competition.

Once an expert committee under the MOH is established, work concerning the selection of drugs to be included in the National List will be conducted by them. The drugs will be included in the National List for International Nonproprietary Names. National List updates will be carried out once a year.

Interested individuals and legal entities can apply with a package of necessary documents for inclusion of drugs in the National List of Medicines. To this end, the development and public discussion of the Regulation on the conduct of medicines selection for inclusion in the National List, which will be approved by order of the MOH, as well as the application form and its requirements is being continued.

See all news on regulatory updates on the Legal Alliance website.

Parliament will consider healthcare Draft Laws on Apr 12

Parliament will consider Draft healthcare Laws on Apr 12

Ukrainian Parliament will hold a thematic session to consider Draft Laws in the sphere of healthcare on Apr 12, the Speaker Volodymyr Groysman said on Mar 28.

“I’m asking thw Apparatus of the Parliament to process the list of laws and positions on their support for the next plenary week,” Mr. Groysman said. “I would also ask to connect associations and learn the position of regional, local councils on what should be improved in healthcare.”

Previously, Parliamentary Committee had approved the Draft Law “On autonomation of healthcare establishments”, which is expected to start the process of reformation of the National healthcare system. The Draft Laws on transplantation and increase of wages to medical workers are also to be considered by deputies.

Parliamentary Committee rejected the Draft Law to reduce drugs prices

On Mar 30, during the meeting of the Parliamentary Committee of Public Health, the PMs considered the Draft Law 1376 “On Amendments to the Tax Code of Ukraine and some other legislative acts of Ukraine (on reducing prices on drugs).” The document proposed to establish extra charges for distributors and retailers at the level of 3% and 5%, respectively, for all medicines and medical devices.

The Committee Members rejected the Draft Law, stating that it is contrary to current legislation. Moreover, it could provoke the extinction of many drugs on the pharmaceutical market of Ukraine. According to PM Irina Sysoenko, the only way to solve pricing issue is to implement reimbursement mechanism.

HEALTHCARE NEWSUkraine’s PM: Minimal guarantee level of free medical services to be introduced this year

The government plans to implement the guaranteed level of free medical services in 2016 within healthcare system reformation, the PM of Ukraine Arseniy Yatsenyuk stated. “Free health care services should be provided through the State Medical Insurance Fund, where

each Ukrainian citizen must be insured,” Mr. Yatsenyuk said.

MOH and insulin producers signed Memorandum of understanding

The MOH and the range of insulin producers have signed the Memorandum of Understanding defining the order of joint activities aimed at providing of Ukrainians with insulin drugs as

well as successful implementation of the pilot project on insulin reimbursement.

The following companies have signed the Memorandum: Farmak, Indar, Sanofi-Aventis Ukraine LLC, Bioton S.A., Eli Lilly Vostok S.A., Novo Nordisk A/T, Pharma Life LLC. The pilot project is expected to start acting since Apr 1, 2016.

http://www.legalalliance.com.ua/eng/news/

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The MOH is discussing development of new drug policy

Among the MOH’s main tasks is the provision of access to drugs, containing narcotic and psychotropic substances to patients requiring them, the Healthcare Minister Kvitashvili said during the public discussion on 03/03/2016. The issue of decriminalization of drugs consumers, which keep them in small amounts without intent to sell, is also essential, Mr. Kvatashvili said.

Excessive over-regulation of medical circulation of preparations leads to significantly limited access to pain relief for patients with severe diseases, mental illness and addiction, the acting Head of State Drug Control Service stressed.

All members of the discussion concluded the Ukraine’s need to reconsider approaches in state drug policy towards humanization and efficiency.

The Cabinet of Ministers announced tasks in HC for 2016

The Ukrainian government announced 379 tasks to be done by the Cabinet of Ministers together with the President and the Parliament in 2016. The following functions defined sphere

of healthcare:

» “Money follows the patient” – creation of a new system of medical services financing. Finance Ministry and Ministry of Social Policy will need to develop legislative acts to implement the state-guaranteed package of health services. The task also foresees the creation of National Agency on healthcare financing.

» The new system of public procurement of drugs – until Aug 31 the MoH and Economic Development Ministry must develop legislative acts regulating the centralized procurement organization in healthcare.

» The new primary medical care – developing a new model of primary healthcare provision

» Public health – protection and strengthening of national health.

» The availability of high-quality and efficient drugs – adoption of National policy on drugs following the WHO recommendations.

Antituberculosis program for 2017-2021 is under development

Ukraine is developing the program on fighting tuberculosis for

2017-2021, which considers new approaches to the disease treatment, the Director of Ukrainian Center for controlling socially dangerous diseases of the MOH Natalia Nizova said. Ukraine has 28 ths officially registered persons with tuberculosis while 50% of tuberculosis hospitals do not meet the requirements of infection control.

Israeli experts are ready to share experience on development of efficient HC system with Ukraine

Israeli experts and physicians are ready to share with Ukraine the experience on the development of efficient healthcare system, but the reforms should be carried by Ukrainian colleagues, Israel’s ambassador to Ukraine Eliav Belotserkovsky said.

Israeli partners intend to hold lectures in establishments of medical education in Ukraine and start elaborating with Parliamentary Public Health Committee. Ukrainian professionals also expect to take over the practices of family doctors and primary care.

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