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IMacroeconomic ssue: 11 2016 Environment | Market & Companies News | Regulatory Updates | Healthcare News |

Upharmacia U krainian P harmaceutical M arket M onthly


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MACROECONOMIC ENVIRONMENT Table: Key Macroeconomic

Indicators in Ukraine

2015 Oct

Nov

2016 Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

3.16

3.24

(October 2015-October 2016)

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

Export of Goods (US$ bn) growth, % y-o-y

Import of Goods (US$ bn) growth, % y-o-y

Industrial Production Sales (US$ bn) growth, % y-o-y

Retail Turnover of Enterprises (US$ bn) growth, % y-o-y

Unemployment Rate (%) Average Salary (US$)

Q4

Q1

Q2

25.588

17.655

21.053

-17%

3.23 -23%

3.22 - 27%

6.29 -21%

2.04 -31%

3.13

0.1%

2.04

3.08

2.99

2.88

2.93

2.92

-11%

-31%

3%

-13%

1%

-2%

-5%

-7%

3%

-6%

2.23

2.68

3.35

3.05

2.69

3.09

3.45

3.48

3.12

-27%

-32%

-26%

-6%

5.92

6.37

4.93

4.93

-19%

1.80

-0.02%

3.36

-21%

3.07

Q3

-17%

-18%

2.01

1.60 -19%

8%

1.50 4%

5%

5.41 -2%

1.64 2%

3.10

7%

5.17 -12%

1.76 6%

2.87

2%

4%

5.39

5.44

-5%

1.59 -18%

-6%

1.73 -6%

4%

5.61 -2%

1.87 -3%

3.18

-11%

5.57 3%

1.92 2%

8%

5.62 -2%

1.76 -5%

0%

3.54 10%

6.39 2%

1.87

-33%

-29%

1.5

1.6

1.9

1.9

1.9

1.7

1.6

1.6

1.5

1.4

1.3

1.3

1.2

-8%

207

193

223

180

174

187

191

198

214

217

208

204

208

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD UAH / EUR

21.8

23.3

23.4

24.3

26.4

26.4

25.6

25.2

25.0

24.8

25.1

26.3

25.8

24.6

25.1

25.4

26.3

29.3

29.2

29.1

28.5

28.1

27.5

28.1

29.5

28.5

8.31

18.40

PHARMACEUTI CAL INDUSTRY INDICATORS Export of Pharma Products (mio USD) growth, % y-o-y

Import of Pharma Products (mio USD)

12.2 -37%

147.1

11.7

13.33

15.54

13.90

14.17

16.15

13.36

13.58

18.81

-52%

15.77 -28%

-30%

11%

16%

3%

9%

5%

-4%

51%

37%

141.3

142.1

103.7

145.0

125.1

130.0

110.4

132.1

133.1

137.3

140.6

51%

137.3

growth, % y-o-y

-28%

-24%

-42%

15%

27%

21%

25%

31%

15%

25%

47%

15%

-7%

Pharma Retail Sales, values (mio USD)

206.3

196.6

212.3

198.9

176.0

187.3

178.1

177.6

174.8

175.4

180.9

190.4

212.2

growth, % y-o-y

-26%

-20%

-18%

-17%

-1%

-5%

-1%

-8%

-2%

2%

2%

-1%

3%

Pharma Retail Sales, volumes (mio units)

130.2

129.0

136.4

133.6

126.8

133.8

125.2

123.6

122.6

122.7

126.2

135.5

138.6

growth, % y-o-y

WACP (USD)

-5%

1.58

-4%

1.52

-5%

1%

1.56

1.49

-12%

1.39

-5%

1.40

2%

1.42

-1%

1.44

4%

1.43

3%

1.43

3%

1.43

7%

1.41

growth, % y-o-y

-22%

-18%

-14%

-23%

-23%

13%

1%

-2%

-6%

-3%

-1%

-8%

CPI of Ukraine Pharmaceutical Products CPI Local Companies share, values (%) Local Companies share, volumes (%)

146.4 142.1 41.4 75.7

146.6 138.1 41.7 75.8

143.3 134.6 40.9 76.7

140.3 131.9 42.3 75.6

132.7 126.9 42.9 76.5

120.9 113.5 42.7 76.5

109.8 108.4 42.3 76.7

107.5 107.3 42.9 77.2

106.9 108.2 42.8 77.4

107.9 107.4 42.8 77.9

108.4 107.2 41.8 68.9

107.6 107.9 42.6 68.4

6%

1.53 -3%

112.4 107.6 40.8 67.5

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

Ukrainian Pharmaceutical Market Monthly: November 2016


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220

212.3 2 12 .3 3

206.3 196.6

200

Values

212.2

mio USD

198.9

176.0

180

1136.4 36.4 4

178.1

177.6

174.8

175.4

126.8

135.5

138.6

125.2

126.2 123.6 122.6

Volumes

140

16

130

12

Jan

Feb

8

110

4

Mar

Apr

6.37

6.29

May

Jun

Jul

Industrial production sales

5.92 6

5.41 4.93 4.93

5

5.17

Aug

Sep

2.04

5.39

5.44

2.01 1.60

3

1.64

14.2

5.61

1.87

1.76 1.59

1.50

137.3 18.8

18.4

Export

120

100

16.1 13.6

13.4

8.3

6.39

bn USD

5.57

5.62

80

mio USD

60

1.92

3.0

146.4

Nov

Dec

146.6

45

1.76

1.73

1.87 1.5

Jan

1.0

20

Mar

25

Apr

May

Jun

Jul

Aug

Sep

140.3

160 140

132.7 120.9 109.8

UAH / EUR

24.. 6 24.6 21.8

Oct

CPI 143.3

30

20

Retail turnover of enterprises

Feb

40

bn USD

2

Ukraine's International Trade in Pharma Production

0

Oct

2.5

2016

35

1.80

133.1

137.3 140

0

Oct

2.0 4

11.7

140.6

110.4

15.5

13.3

2015

Pharmaceutical Market Retail Sales

50

7

130.0

13.9

12.2

120

100

Dec

125.1

160

mio USD

132.1

40

100

Nov

Import

145.0

mio units

120

Oct

142.1

141.3

20

122.7

140

2016

147.1

15.8

129.0 0

2015

24

103.7

180.9

133.8

133.6 130.2 160

150

190.4

187.3

160

25.1

25.4

23.3

23.4

29.3

29.2

26.4

26.4

106.9

107.9

108.4

29.1

28.5

28.1

27.5

28.1

25.6

25.2

25.0

24.8

25.1

26.3 24.3

107.5

107.9 29.5

26.3

112.4 28.5

25.8

120 100 80 60

UAH / USD

15 40 10

1

2015

2016

0

Oct

Nov

Dec

Jan

Feb

0.5

Industrial Production Sales & Retail Turnover of Enterprises Surplus Mar

Apr

May

Jun

Jul

Aug

Sep

2015 2 015

5

0.0

Oct

2016

0

Oct

Nov

Dec

Jan

Feb

Official Currency Exchange Rates vs. Consumer Price Index Mar

Apr

May

Jun

Jul

Aug

20 0

Sep

Oct

KEY ECONOMIC EVENTS »» »» »» »» »» »» »» »» »» »»

GDP of Ukraine rose 1.8% y-o-y in 3Q2016 and 1.2% y-o-y in 9M2016, State Statistics Service reported. The IMF and the EBRD projected 1.5% y-o-y increase for 2016, while Ukrainian Trade Ministry forecasted 1.0% y-o-y growth. On Nov 24, the EU authorities once again postponed approval of visa-free regime with Ukraine due to interinstitutional inconsistency over the issue. The next review of visa liberalization could occur on Jan 18, 2017. The EBRD decreased investments in Ukraine in 2016 by 60% y-o-y to USD 400 mio. According to the Bank’s President, the amount could be increased next year. In 9M2016, Ukraine’s goods trade deficit reached USD 1.76 bn compared to a USD 0.70 bn surplus in 9M2015. Exports of goods declined 8.7% y-o-y due to deterioration of chemicals (-32% y-o-y), minerals (-20% y-o-y) and metals (-18% y-o-y) trade. Exports to the EU increased 4.4% y-o-y, while exports to the CIS countries fell 27.1% y-o-y. Fitch Ratings upgraded Long-Term Foreign and Local Currency Issuer Default Ratings (IDRs) of Ukraine to Bfrom CCC. The agency’s outlook is stable. Ukraine climbed 23 positions in Paying Taxes rating by PwC to 84th position. The improvement was mainly caused by the introduction of the new index in the rating (obtaining of a VAT refund and dealing with a voluntary correction of an inadvertent error in a CIT return). China is interested in development of industrial parks in Ukraine and in placing its production facilities there. The China International Chamber of Commerce has provided the corresponding plan of cooperation to the Ukrainian side. In 9M2016, FDI in Ukraine in the form of shareholder capital increased 6.2% y-o-y to USD 45.12 bn. Since the introduction of free-trade zone, in 10M2016, the trade turnover between Ukraine and the EU increased 5% PPG, the President of Ukraine reported. The EU is the main trade partner for Ukraine with 41% share in total trade. According to Credit Suisse survey, the wealth of Ukrainian households decreased 18.5% from the middle of 2015 to the middle of 2016 to USD 44 bn. Ukraine, Russia and Argentina were Top-3 countries by the rates of wealth reduction.

Ukrainian Pharmaceutical Market Monthly: November 2016


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MARKET & COMPANIES NEWS Vynnitsapharmacia wants to redeem 18 mio of its own shares PJSC Vynnitsapharmacia intends to redeem 18 mio of its common registered shares, the Supervisory Board of the company stated. The company also plans to sign the contract with BaDM distributor on the supply of drugs and medical devices for about UAH 30 mio. PJSC Vynnitsapharmacia owns the pharmacy chain Bazhayemo zdorovya in Vinnitsa and also produces and conducts sale of pharmaceuticals. The company is a part of Premier Finance Corporation, which includes 30 companies in the pharmaceutical, retail and food industries. In 2015, the profit of Vynnitsapharmacia amounted UAH 465 ths. Ukraine and Indonesia to cooperate in pharmaceutical sphere On Nov 4, the State Service on medicines and drug control of Ukraine signed the Memorandum of Understanding in pharmaceutical sphere with the National Agency on control over medicines and food products of the Republic of Indonesia. The cooperation between two agencies started after in Aug 2016, the President of Ukraine visited Indonesia. The Memorandum establishes the necessary legal framework for the expansion of bilateral cooperation in the pharmaceutical

field between two countries and promotes interaction to meet the strategic needs of Ukraine and the Republic of Indonesia in the pharmaceutical industry. The Head of Indonesian Agency stated that the country is open for cooperation and investments, which will contribute to the growth of the country’s market. The most of 200 Indonesian pharmaceutical enterprises comply with the GMP requirements, while the country’s pharmacopeia generally corresponds to the US Pharmacopeia. PJSC Technolog to triple exports of antituberculosis drugs PJSC Technolog (part of Lekhim group of companies) plans to increase its export amounts of its antituberculosis drugs 2-3 times in the next few years. To achieve that, the company intends to receive prequalification of the World Health Organization (WHO) for the corresponding preparations by the end of 2017. According to the company’s GM, Technolog may also consider the possibility of obtaining the prequalification of drugs for the treatment of HIV/AIDS. Currently, the company is exporting about 15% of its products. Its main external markets are the CIS countries. Production capacities of PJSC Technolog are located in Uman (Cherkasy region). Lekhim group

of companies includes JSC Lekhim, PJSC Technolog and JSC Lekhim-Kharkiv and is among TOP-15 Ukrainian pharmaceutical producers. It is a #1 local company by sales of enzyme preparations, suppositories and pelleted dosage forms. Head of Astellas Pharma RO in Ukraine leaves his post Krzystof Siedlecki leaves Ukraine and his post as a head of the Astellas Pharma Representative Office in Ukraine. He announced this during the local pharma conference recently. Krzystof Siedlecki has been leading Japanese Astellas Pharma RO in Ukraine for 10 years. He was elected President of EBA in Ukraine in 2015.

Ukrainian Pharmaceutical Market Monthly: November 2016


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REGULATORY UPDATES Provided by AMCU Presented a Report Based on the Results of Pharma Market Survey Concerning the Compliance with Competition Law Requirements On November 22, 2016, the AMCU published the results of pharma market survey for 2014-2016 and evaluated the compliance with competition law requirements by the main players of pharma market (manufacturers, importers/ distributors, pharmacies). The AMCU’s report provides the details on logistic structure of medicinal products supply to the territory of Ukraine and the peculiarities of cooperation between the players, as well as the pricing components to include the prices for end customers. According to the AMCU, the competition of pharma market may be influenced not only by noncompetitive behavior of market players, but also by the activities of public authorities legally bound to regulate these markets by creating administrative barriers for entering the market or imposing the red tape on the players already operating on the market during the exercising of their authorities. The Report mainly focuses on the operation of business entities at product market and the pricing at each stage of medicines sales. In its analytical report the AMCU provides the details of the interactions between manufacturers/importers and distributors, and indicates the contract provisions bearing the risks to be qualified as competition violations. In the

AMCU’s opinion, medicinal products’ export ban, the liability to prevent the third parties from products export from Ukraine, the obligation to provide the reports and the implementation of payment terms that ensure the pharma company’s control over the goods flow at medicines markets of Ukraine testify the market distribution and competition restriction. In their turn, the distributors agree to these terms in exchange for discounts provided by manufacturers. The AMCU believes that the discount system raises a lot of due diligence questions, as this system bears the evidence of duplicate pricing, which hampers the competition development and does not reduce the price for the end customer. Moreover, the AMCU assessed the impact of national and foreign manufacturers/importers and distributors on pricing. In the course of the survey the AMCU made a conclusion that the main objective factors influencing the pricing on medicines’ market were the following: Ukrainian currency exchange rate, inflation rate, changes in taxation system, introduction of additional import fee. It is worth to mention that during the study on regional markets the Committee determined the structural features of monopoly (dominant) position at investigated regional markets of 183 business entities that conduct retail sales of medicinal products in the form of pharmacy chain. The tendencies for pharmacy segment development in Ukraine regarding the market consolidation by the increasing the role of medicines’ retailing chain, in certain cases may lead to the situation when

strong players with the signs of monopoly position on regional markets, shall gradually merge the weaker competitors to include by joining them to existing pharmacy chains and hence strengthening their share in the market. The AMCU believes that taking into consideration the currently existing competition situation on medicines’ retail market, the market players should implement the self-regulation market mechanism together with the establishment of general principles of professional ethics for all market players. This shall let the pharmacy chain, being a healthcare facility according to the law, to target mainly the patients in order to maintain their health. Bylaws in Effect to Ensure the Medicines’ Selection for National Essential Medicines List On 04.11.2016 the following bylaws became effective: the Ministry of Health Order № 1049 of 07.10.2016 «On Amendment of the Regulation on Expert Committee on the Selection and Use of Essential Medicines»and the Ministry of Health Order № 1050 of 07.10.2016 «On Approval of the Regulation on Medicines’ Selection for National Essential Medicines List». Upon the enforcement of the amendments to the Regulation on Expert Committee the list of specialists allowed for the participation in Expert Committee has been extended. In particular, the specialists with mathematical education have been granted with the right to become members of this Committee. Moreover, the provision has been cancelled requiring from the candidates to be obligatory employed by

Ukrainian Pharmaceutical Market Monthly: November 2016


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healthcare or science and research facilities. Nevertheless, it is envisaged that preference will be granted to candidates working at these facilities during the selection of Expert Committee members by the Competition Commission. The abovementioned Regulation also covers the specifics of the application execution regarding the National List amendment and approves the application template. Thus, the document in particular provides the details on which information should be filled

in each application clause. It should be mentioned that the hard copy and electronic version (in Word format) of the application should be submitted in Ukrainian, and the attached documents should be submitted in Ukrainian or English with Ukrainian or Russian translation (if required) as hard or electronic copies. The legal framework development for the elaboration of National Essential Medicines List ends with the enforcement of the Regulation on Medicines

Selection. The National List itself shall be harmonized with the latest version of WHO Essential Medicines Model List, which includes the medicines needs for a basic healthcare system. Therefore, the National List implementation shall provide for the removal of duplicates of different obligatory for usage medicines lists, in favor of single unified list to be implemented for public regulation of medicines prices.

HEALTHCARE NEWS The MOH increased funding of cancer treatment programs The MOH denied information, provided in some mass media, about the shutdown of “Oncology” program. In 2017, the funding of “Oncological diseases” Program will increase 12% y-o-y to UAH 445 mio, while “Children’s Oncology” Program will rise by 58% y-o-y to UAH 558 mio. Herewith, in accordance with the Resolution of the Cabinet of Ministers of Ukraine “On efficient use of public funds”, the form of assistance will be changed from “programs” to “measures”. Government to allocate UAH 500 mio for drug reimbursement in 2017 The update Draft Budget 2017 provides the allocation of UAH 500 mio for the program for drugs reimbursement. The program is to be launched since Apr 1, 2017 and envisages the introduction of real compensation

reimbursement of drugs for the treatment of hypertension, type II diabetes and asthma. The program includes INNs of drugs without indication of dosages. Currently, the reimbursement list includes 16 INNs of drugs against cardiovascular diseases, 2 INNs of drugs against type II diabetes and 3 INNs of drugs against bronchial asthma. After the meeting with pharmaceutical producers with the parliament members, the Healthcare Minister Ulana Suprun reported that the most of companies supported the program, but had a lot of questions on its implementation and operation. The Head of the MOH noted that the Ministry would work to increase the funding of the program in the Budget. According to the Draft Budget, in 2017, the government will also allocate UAH 5.9 bn for the public procurement of drugs through international organizations.

The issues with reference pricing introduction since 2017 were discussed The government intends to reduce drug prices through implementation of reference pricing for drugs against hypertension, type II diabetes and asthma since Jan 1, 2017. The reference countries will be Czech Republic, Hungary, Latvia, Poland and Slovakia. The reference pricing envisages implementation of marginal wholesale prices. The approach to regulation of margins also to be changed: marginal supply and sales margins to be reduced to 5%, while new regressive commercial (retail) margins should not exceed 20% (today marginal supply and sales margins amount 10%, while marginal retail margins amount 25%). “There is a lot of data saying that drugs in Ukraine are overpriced, while patients pay about 90% of drugs value,” Ukraine’s Prime Minister said at the meeting with pharmaceutical

Ukrainian Pharmaceutical Market Monthly: November 2016


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producers. “I urge producers to take the government’s decisions responsibly and to implement them rapidly. I would like to warn against creating an artificial shortage of medicines. It will not benefit the initiators of such steps.” Some representatives of pharma companies see the some issues, which may arise with implementation of reference pricing, in particular:

»»

»»

»»

due to the absence of the Procedure for calculation of limiting drug prices, manufacturers will not be able to declare changes in wholesale prices in time, while the declaration procedure will take at least a month; in some cases reference pricing may cause the increase in drug prices, as some prices in Ukraine are lower than in reference prices; decrease of sales and supply margins to 5% may negatively affect small distributors.

WB provided USD 40 mio to Dnipropetrovsk region to open 39 ambulance stations World Bank has provided USD 40 mio to Dnipropetrovsk region for the development of 39 ambulance stations and creation of emergency care departments in three hospitals of the region. The project is expected to be implemented during 4 years. The World Bank’s project is intended to fight cardiovascular diseases, and new ambulance stations to prevent and treat them will be opened, the Head of Dnipropetrovsk Regional Administration reported. The MOH intends to cope with OTC sale of antibiotics On Nov 15, the MOH held press briefing aimed to promote responsible use of antimicrobial drugs. According to the Member of Parliamentary Committee on

Public Health Olexiy Kyrychenko, excessive and uncontrolled use of antibiotics by patients, irrational prescription of these drugs by doctors and their frequent use in agriculture and veterinary medicine are the main reasons for the development of antibiotic resistance in Ukraine. Lack of public awareness and the impact of promotional activities carried by pharmaceutical companies also compounding the problem. The speakers announced the flash mob #antibiotic_upon_ prescription, calling patients to buy antibiotics only after consultations with physicians. The Deputy Head of the MOH reported that the Ministry created the working group to develop the National Strategy and Action Plan to combat antimicrobial resistance in Ukraine. According to the Head of Parliamentary Committee on Public Health Olga Bogomolets, Ukrainians spend about UAH 15 bn on antibiotics and about half of them are used for self-medicating. To solve the issue, Mrs. Bogomolets proposed to ban advertising of antibiotics in mass media and adapt the European treatment standards by the MOH. Antimonopoly Committee proposes to consider the restriction of opening of new pharmacies Antimonopoly Committee of Ukraine supported the idea to restrict the opening of new pharmacies, which had been raised by market operators in the Draft Codex of ethical operation of pharmacies developed by Professional Pharmacy Association of Ukraine. The Draft Codex proposes to strive for a uniform placement of pharmacies in localities through prohibition of opening of new pharmacies in the building, which is already used as a place of economic activity of another pharmacy. This rule will not

apply to buildings of health care facilities or shopping centers in case of opening of pharmacies, which have the license for production (manufacturing) of medicinal products in a pharmacy or the license for sale of narcotic drugs, psychotropic substances and precursors. Antimonopoly Committee decided to conduct the poll of market operators on the provisions of the proposed Code. MOH signed Memorandum on creation of e-health system in Ukraine On Nov 25, the MOH signed the Memorandum on cooperation in creation of transparent and efficient electronic health system in Ukraine. The document was signed by the acting Head of the MOH, the Head of State Agency for eGovernance as well as the representatives of the public initiative on healthcare sector electronization and specialized state-owned enterprises. At the event there was noted that efforts to create efficient e-health system in Ukraine over the las 10 years had been unsuccessful because the state tried to solve this complex and expensive problem on its own. Participants of the event stressed that the public initiative is open to all who agree with the declared principles and is ready to contribute to the objectives of the Memorandum for the sake of the entire Ukrainian society. The Memorandum should lead to signing of the road map on implementation of the electronic system, creating of uniform, transparent and non-discriminatory rules of access to the system, as well as determination of basic software needed to launch reforms.

Ukrainian Pharmaceutical Market Monthly: November 2016


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CIS REGION PHARMA NEWS Belarus Nativita company signed the contract on cooperation with Slovak pharmaceutical company and distributor Unipharma, which is to open up prospects for the registration and distribution of Nativita’s products in Slovakia, the Czech Republic, Hungary, Poland. Moreover, Nativita signed cooperation agreement with BioMed research center to conduct exchange of technology and experience and implement joint research for the development and creation of new products.

Kazakhstan Kazakh company Abdi Ibrahim Global Pharm (part of Turkish Abdi Ibrahim) received international GMP certificate. Specialized inter-district economic court of Pavlodar region declared bankruptcy of one of the biggest pharmaceutical companies in Kazakhstan Romat and its part Pavlodar pharmaceutical plant. The group of companies debt to 309 creditors about KZT 6 bn. Kazakhstan and South Korea signed Memorandum on development of cluster of pharmaceutical and medicalbiological plants Nefertem in Kazakhstan worth USD 350 mio.

Russia On 17/11/2016, members of the Eurasian Intergovernmental Council (Prime Ministers of Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan) signed the unified package of

documents needed for the full featured operation of the common drug market within the Eurasian Economic Union (EEU). The documents will come into force after ratification of protocol on the accession of Armenia to the EEU. The Trade Ministry expects the Russian pharmaceutical market to grow at least 10% y-o-y in values in 2016. In 2015, the market amounted RUB 1.12 trln; in 1H2016, it has grown 4.4% PPG. R-Pharm launched the construction of Hayat Pharm plant in collaboration with Vita-A company and Azerbaijan Investment Company. Total investments will amount USD 70 m. BIOCAD company intends to launch the original drug BCD085 for the treatment of ankylosing spondylitis. Currently, the company is conducting phase II clinical trials. In 2017, Kraspharma company (one of the biggest pharma companies of the East Siberia) plans to launch new production lines for the production of antibiotics and infusion solutions. The reconstruction at the plant started in 2014; the investments amounted EUR 1 mio. Biohimik company is constructing new research-production and engineering center for the development of new antibiotics in Saransk. The launch of new medicines is expected to start in 2020. Erkapharm group of companies

started rebranding of Doctor Stoletov brand within the aggressive strategy of brand development, which is aimed to double the company’s turnover by the end of 2018. Russian Trade Ministry granted the GMP certificates to 40 foreign manufacturing facilities. The Ministry has already received 500 applications and conducted 121 inspections. Since 2016, foreign plants are obliged to receive Russian GMP certificate for companies to be able to register new drugs in Russia. Nanolek company launched biotechnological department at its plant in Kirov Region, which is aimed to production of vaccines and biological preparations. The company plans to launch production of the first Russian polio vaccine at new facilities in 2018. State company Rusnano expects to put into operation pharmaceutical plant NT-Pharma in autumn 2017. Earlier, the manager Board of NT-Pharma were arrested for embezzlement. Rusnano, which owns 49% of the company, invested RUB 1 bn into the project; the plant was supposed to start operating in 2012. Nativa company intends to invest RUB 2.1 bln in the production of analogues of foreign powders for inhalation. German company Harro Höfliger Verpackungsmaschinen will supply equipment for the production and packaging of medicines. Russian Society of Clinical

Ukrainian Pharmaceutical Market Monthly: November 2016


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Oncology (RUSSCO) signed the Memorandum on the start of the project for development of immuno-oncology in Russia in participation with AstraZeneca, Bristol-Myers Squibb, MSD and Roche. The project is aimed at strengthening the competencies in the field of Russian immuneoncology and acceleration of introduction of the achievements of world science in the fight against cancer. Sun Pharma approved the acquisition of 85.1% of shares of Russian company Biosintez for

USD 60 mio. Indian company expects to complete the transaction by the end of the year after obtaining the endorsement form the Federal Antimonopoly Service. Russian Parliament is developing the Draft Law aiming to regulate the implementation of eHealth in Russia. The consideration of legalization of online sales of medicines may start in spring 2017, after the approval of the Law on telemedicine.

Ukrainian Pharmaceutical Market Monthly: November 2016


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Ukrainian Pharmaceutical Market Monthly. Details: www.upharma-c.com

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