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Issue: 04 2016 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 in the CIS/CEE.

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MACROECONOMIC ENVIRONMENT Table: Key Macroeconomic

(Mar 2015-Mar 2016) 2015

Indicators in Ukraine

Mar

Apr

May

Jun

Jul

2016

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

MACROECONOMIC INDICATORS GDP (US$ bn)

Q2

Q3

Q4

20.795

25.552

25.588

growth, % y-o-y

-35%

Export of Goods (US$ bn)

3.45

growth, % y-o-y

-32%

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$)

3.17 -35%

5.51 -45%

1.61

3.07

-26%

2.94

3.09

-39%

-41%

-30%

2.86

2.63

-38%

2.76

-46%

5.91

5.65

-33%

-37%

5.79

-38%

1.66

1.94

-35%

1.83

3.15

-17%

3.09

3.35

-34%

-22%

-22%

2.98

3.88

-34%

5.71 -33%

1.94 -41%

-2%

5.42 -23%

1.88

Q1

3.24 -30%

5.72 -20%

1.86

3.23 -23%

3.22 - 27%

6.29 -21%

2.04 -31%

3.13 -21%

3.07

3.36

2.04

-11%

-31%

3.12

2.23

-27%

-32%

-26%

5.92

6.37

4.93

-19%

1.80

-17%

2.01

-18%

1.60 -19%

3.08 3%

2.68

2.99 -13%

3.35

-6%

4.93 8%

1.50

5%

5.41 -2%

1.64

-56%

-40%

-35%

-38%

-32%

-38%

-33%

-29%

1.9

1.8

1.8

1.7

1.6

1.6

1.5

1.5

1.6

1.9

1.9

1.9

4%

1.7

2%

166

176

193

202

202

194

199

207

193

223

180

174

187

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD UAH / EUR

23.3

22.7

20.9

21.2

21.8

21.6

21.8

21.8

23.3

23.4

24.3

26.4

26.4

25.3

24.5

23.3

23.8

23.9

24.0

24.5

24.6

25.1

25.4

26.3

29.3

29.2

9.01

13.79

12.2

11.7

15.77

8.31

13.33

15.54

PHARMACEUTI CAL INDUSTRY INDICATORS Export of Pharma Products (mio USD)

13.37

13.46

13.00

15.36

13.85

growth, % y-o-y

-50%

-44%

-39%

-39%

-6%

-54%

Import of Pharma Products (mio USD)

103.3

103.7

84.2

115.0

106.5

93.3

growth, % y-o-y

-67%

-36%

-60%

-44%

-47%

Pharma Retail Sales, values (mio USD)

197.6

180.0

193.0

177.7

172.6

-47%

177.1

-47%

121.1

-37%

147.1

-52%

-28%

-30%

11%

141.3

142.1

103.7

145.0

-31%

-28%

-24%

-42%

15%

27%

21%

193.2

206.3

196.6

212.3

198.9

176.0

187.3

growth, % y-o-y

-47%

-40%

-28%

-29%

-32%

-24%

-28%

-26%

-20%

-18%

-17%

Pharma Retail Sales, volumes (mio units)

141.5

122.6

124.5

118.4

119.5

122.5

126.7

130.2

129.0

136.4

133.6

growth, % y-o-y

WACP (USD)

-21%

1.24

-20%

1.41

-11%

1.47

-9%

1.52

-10%

1.48

-8%

1.45

16%

125.1

-11%

1.52

-5%

1.58

-4%

1.52

-5%

1.56

1%

1.49

-1%

126.8 -12%

1.39

-5%

133.8 -5%

1.40

growth, % y-o-y

-40%

-27%

-23%

-21%

-23%

-18%

-19%

-22%

-18%

-14%

-23%

-23%

13%

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

145.8 170.3 39.6 77.1

160.9 164.7 40.7 77.6

158.4 159.5 41.5 77.6

157.5 153.5 41.7 77.9

155.3 151.8 41.8 78.4

152.8 149.4 41.4 78.2

151.9 145.8 41.4 76.5

146.4 142.1 41.4 75.7

138.1 146.6 41.7 75.8

134.6 143.3 40.9 76.7

131.9 140.3 42.3 75.6

126.9 132.7 42.9 76.5

113.5 120.9 42.7 76.5

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: April 2016


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220

160

212.3 206.3

200

197.6 141.5

180.0

177.7

180

196.6

193.2

193.0

172.6

136.4 130.2 126.7

160 122.6

124.5

122.5 118.4

140

120

187.3

198.9 176.0

16

133.6

129.0

133.8 130

126.8

Volumes (mio units)

2016

2015 Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

13.4

Jan

Feb

120

8

110

4

100

0

45

7

Industrial producon sales 5.91

6

5.51

5.65

5.80

5.71

5.43

3.0

6.37

6.29

40

5.92

5.72

5.41

5

2.5

4.93 2.0

1.94

4 1.61

1.66

1.83

1.94

2.01

2.04 1.88

1.86

1.60

1.64

1.5

1.50 1.0

2 1

Industrial Production Sales & Retail Turnover of Enterprises Surplus Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

May

Jun

Jul

160.9

158.4

157.5

155.3

145.8

Dec

30

29.5 26.9

25.5

20

23.3

0.5

2016 Jan

Feb

0.0

Mar

22.7

20.9

24.9

21.2

80

13.3

Export

11.7

Aug

152.8

Sep

151.9

Oct

146.4

26.1

UAH / € 26.1 25.9

21.8

21.6

21.8

60

8.3

40 20

2016

2015 Nov

146.6

Dec

Jan

Feb

0

Mar

160 143.3

140.3

140

132.7

35

29.3 24.6 21.8

25.1

25.4

23.3

23.4

120.9 29.2

26.3 24.3

26.4 80 60

Official Currency Exchange Rates

40

vs. Consumer Price Index

5

20

2015

0

Mar

Apr

May

Jun

Jul

Aug

Sep

120 100

26.4

UAH / $

15 10

2015

0

Apr

25

1.80

Retail turnover of enterprises

3

13.0

15.5

15.8

12.2

13.9

100

103.7

13.8

15.4

CPI of Ukraine

4.93

125.1 120

Ukraine's International Trade in Pharma Production Mar

Mar

140

141.3

93.3

9.0

Pharma Retail Sales Mar

12

84.3 13.5

147.1

106.6

103.7

103.4

145.0

142.1

122.2

115.0

20

140

119.5

100

Import

150

Values (mio USD)

177.1

160 24

Oct

Nov

Dec

2016 Jan

Feb

0

Mar

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

On Apr 15, Ukrainian Parliament formed a new coalition and approved new Cabinet of Ministers, endeavoring of resolve the political crisis in Ukraine. Arseniy Yatsenyuk was replaced by Volodymyr Groysman at the position of Ukraine’s prime minister. Mr. Groysman called corruption, ineffective state administration, and populism as the key threats for Ukraine right now to fight against. On April 6, 64% of citizens of the Netherlands voted for rejection of ratification of the Ukraine-EU Association Agreement at the national referendum. However, pro-West politicians and experts believe the poll results will not affect implementation of Ukraine-EU Association Agreement. In 1Q2016, consumer inflation in Ukraine amounted 1.6%, which was 2.4% lower than National Bank had forecasted. The Bank sees the probability that in 2016 inflation would be less than 12% estimate, however in Q1 inflation decline was mainly caused by short-term factors. Ukrainian President Petro Poroshenko and U.S. Vice President Joseph Biden agreed to sign the agreement on the third tranche of loan guarantees for USD 1 bn. The Japanese government has promised USD 1.85 bn in support for the Ukrainian government if it makes progress on reforms. To receive the next tranche from the IMF, Ukraine will need to adopt 19 Draft Laws, the Deputy Head of the Presidential Administration said. Ukrainian government expects to receive the tranche of USD 1.7 bn by the end of 2Q2016. In 2012-2015, trade between Ukraine and Russia fell by USD 98 bn due to deterioration of political relations and introduction of trade restrictions. The share of exports to Russia in overall exports decreased from 24.3% in 2012 to 12.7% in 2015. In Mar, Ukraine’s industry continued to recover. Industrial output increased by 4.8% y-o-y compared to 7.6% y-o-y in Feb. Industries of Donetsk and Lugansk regions have grown significantly – 10.1% and 174% y-o-y. In 3Q2016, industry increased by 3.7% y-o-y.

Ukrainian Pharmaceutical Market Monthly: April 2016


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MARKET & COMPANIES NEWS German company will open manufacturing of medical consumables in Ukraine German company Vogt Medical Vertrieb GmbH intends to open a plan for the manufacturing of medical consumables in Cherkasy. The plans of German investors were highly endorsed by local authorities and the MoH. “This is going to be a unique manufacturing for our country, as currently we have to import these products,” the Head of Cherkasy Region State Administration Yuri Tkachenko said. Vogt Medical have been operating on the international market of medical products and medical consumables for the last 20 years. “We have chosen Cherkasy due to convenient logistics and loyalty of the local government to investors,” the General Director of Vogt Medical Michael Fogt stated. “We plan manufacturing of consumable materials for infusion therapy, anesthesiology, gynecology, dentistry and clinical products. The project is to be implemented in a year.” Galychpharm developed new facilities to produce infusions Galychpharm company (a part of Arterium Corporation) has launched line on the manufacturing of infusion solutions. The company received the corresponding license in Dec 2015. Earlier, Arterium produced infusions on a contract basis, and now the company intends to strengthen its positions in hospital segment and take a significant share of the local

infusions market. The new production line is equipped with depyrogenation tunnel, where glass bottles are sterilized with hot air at a temperature of 250 C; this ensures a high quality of sterile intravenous preparations. GSK Ukraine reports changes in topmanagement On Apr 1, Alena Likhavets was appointed to the position of General Director of GSK Pharmaceuticals Ukraine, Belarus, Moldova. Previously, GSK Pharmaceuticals Ukraine was managed by Serkan Yagcioglu, who used to be the GM of GSK Pharmaceuticals Ukraine, Belarus, Moldova, Armenia. Currently, Mr. Yagcioglu is the Head of CIS cluster of the company. Mrs. Likhavets previously managed GSK’s representative office in Belarus. Moreover, on 01/04/2016, Rauno Pukonen was appointed as General Director of GSK Consumer Healthcare Ukraine and CIS. Previously, Mr. Pukonen was the regional manager of GSK Consumer Healthcare in the Baltic States. GSK in Ukraine is represented by two units – GSK Pharmaceuticals and GSK Consumer Healthcare. Farmak launches new drug against influenza Ukraine’s pharmaceutical market leader Farmak launched Aydrink® (paracetamol+phenylephrine) for the treatment of acute respiratory infections and influenza. The drug is produced in the form of sachets for the solution. The drug contains the

optimal dose of paracetamol, which relieves symptoms of colds, and phenylephrine, which helps eliminate nasal congestion and runny nose. The drug does not cause drowsiness. In 2015, Farmak increased its net profit to UAH 407.3 mio. Drugs for the respiratory system have the biggest share in the company’s sales. EBRD considering providing funds to 4-5 pharmaceutical companies The European Bank for Reconstruction and Development (EBRD) is working with four or five local pharmaceutical companies in Ukraine, considering the provision them with funds to implement their investment plans, the Senior Banker of the EBRD Iryna Marchenko said. “A company should have a clear investment program, and it is to suit a long-term strategy of the enterprise,” Mrs. Marchenko said. EBRD is also looking for cooperation with international companies that have bought a business in Ukraine. Moreover, EBRD is interested in supporting state enterprises, which have been privatized. EBRD has successful experience of cooperation with Farmak and Sperko companies, as well as pharmaceutical distributor Venta. Darnitsa’s Tivomaks was most selling launch in 2015 According to Proxima Research, Tivomaks (arginine hydrochloride, Darnitsa) against atherosclerosis, angiopathy, coronary heart disease, etc. was the best-selling brand among ones, which were

Ukrainian Pharmaceutical Market Monthly: April 2016


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launched onto Ukrainian market in 2015. The brand was followed by Farmak’s anti-inflammatory and analgesic injection for infusions Keyver (dexketoprofen) and Ananta Medicare’s antibacterial preparation Levacept (levofloxacin). Totally, in 2015, 83 companies have launched 175 new brands in Ukraine. Overall sales of new brand amounted UAH 211.8 mio. Drug prices in Ukraine are among lowest in Europe, CivioFoundation Researchers of Spanish nongovernmental organization CivioFoundation have presented

the results of the global study on drug accessibility. The organization compared prices on 14 key drugs in 61 countries using the database of HealthActionInternational, which contains drug prices over the period from 2001 to 2015. The research concluded Ukraine’s prices are lowest for almost all drugs among countries of the European region. However, the level of drug accessibility in Ukraine is among poorest due to an absence of reimbursement system in the country. Moreover, the low-income level of Ukrainians also makes drugs harder to access.

REGULATORY UPDATES Provided by Draft Reformation Concept for Medicinal Products and Medical Devices Procurements has been Developed Ministry of Health published on its official website the Draft CMU Resolution “On Approval of Reformation Concept for Medicinal Products and Medical Devices Procurement Mechanisms” for public consideration. The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price.

The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector. The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations in Ukraine, which requires some time and incremental actions. Reimbursement Mechanism of the Costs of Insulin Products for Pharmacies Cabinet of Ministers of Ukraine Resolution as of 23.03.2016, # 239 “Certain Issues of Insulin

Products Costs Reimbursement” designates the reimbursement mechanisms for insulin products sold by the pharmacies to diabetic patients within the framework of pilot project. The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine. These medicinal products shall be sold by prescription only. Diabetic patients were broken down into 11 categories. The patients shall receive their medication for a lowered price or for free in accordance with these categories. The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold. The report should contain each product’s international nonproprietary name and trade

Ukrainian Pharmaceutical Market Monthly: April 2016


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mark, product’s strength, pack size, quantity of insulin units per package, quantity of packages sold, reference price of full reimbursement, reference price of partial reimbursement, name of healthcare institution, amount eligible for reimbursement for the reporting period. Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month. The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt. Transition Period for Medical Devices Trade has been extended by 01.07.2017 Cabinet of Ministers Resolution as of march 23, 2016, # 240 “On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine” has been published on the official website of Ukrainian Government. The Resolution introduces changes to 3 Technical Regulations on Medical Devices. The abovementioned

governmental Resolution extends the transition period by 01.07.2017. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration. The compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date. Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market. Government Initiated the Extension of Medicinal Products List Liable for Simplified State Registration Procedures On April 20, 2016, Ukrainian Parliament registered the Draft Law of Ukraine “On Amendments to Article 9 of the Law of Ukraine “On Medicinal Products” (regarding state registration (re-registration) of medicinal products)” (# 4484). The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session. The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to

simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union. In addition, the draft proposes to shorten the term for the Ministry of Health to make its decision from one month to 10 business days. It is worth to mention that currently the simplified registration of medicinal products that are registered in the abovementioned countries is envisaged for those products that are intended for the treatment of socially dangerous diseases. The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement. Main Scientific Expert Directorate also expressed its position that the simplified registration procedure is viable to apply only to those medicinal products, which substitutes are not produced in Ukraine. See all news on regulatory updates on the Legal Alliance website.

HEALTHCARE NEWS The new government intends to launch state insurance system The new Cabinet of Minsters plans to launch the system of compulsory state medical insurance as well as voluntary insurance within healthcare

reformation in the country, the program of the Cabined states. The documents say that the government intends to provide the accessibility and quality of primary health care, through establishing an effective chain of

similar healthcare establishments, equipping them with modern diagnostic tools, ensuring the patient’s possibility of free choice of a doctor and creation of mechanisms of financial motivation for a physician.

Ukrainian Pharmaceutical Market Monthly: April 2016


Page 8

Moreover, the Cabinet plans to create a shared space of medical institutions of all forms of ownership and subordination, implement a common information space for the collection, treatment and prognosis of clinical data, create a single registry of patients, implement clinical protocols with the list of medical services to differentiate levels of medical aid. Minister of Healthcare was not appointed The new Cabinet of Minister, which had been approved on Apr 15, did not provide the candidacy of the Minister of Healthcare of Ukraine. The Prime Minister explained it with failure to find the appropriate person it time. However, the search for the new Head of the MOH is in the process, while Alexander Kvitashvili resigned. On Apr 27, the government appointed Deputy Minister Viktor Shafranskiy as acting Minister of Healthcare. Later on, the First Deputy Minister Olexandra Pavlenko was dismissed. Among the possible key candidates under consideration were the member Parliamentary Committee on Public Health Konstantyn Yarinich, the Director of Heart Institute Borys Todurov and acting Minister of Healthcare

and ex-GM of Novartis Ukraine Viktor Shafranskiy. Ukraine failed to implement insulin reimbursement system since Apr 1 On Apr 1, the launch of the pilot project on insulin reimbursement was planned to start. However, due to unsolved technical issues, the provision of insulins to patients did not start. “The range of technical and organizational issues should have been solved,” the Chief freelance endocrinologist of the MOH Boris Mankovskiy said. “For example, in any region of Ukraine the pharmacy chains, which were to provide insulin for free and then to receive compensation from the state, should have been chosen.” “To make the legislation work, few preparatory stages should be passed; this requires regular work,” Vice President of the International Diabetes Association Natalia Vlasenko said. “Some of these steps are already passed, but some issues are still to be solved.” Register of insulin-dependent patients is steadily filling. Digital prescription was also introduced. The main issue today is the selection of pharmacies, which will provide insulins to a patient on a preferential basis.

“I am not ready to say when the system will start working,” Mr. Mankovskiy noted. “But it is good that the work is not stopped.” According to the MOH, as of 01/01/2016, there were 1.22 mio diabetic patients in Ukraine, over 200 ths of them were insulindependent. Development of e-Health system in Ukraine is under discussion On Apr 27-28, the seminar on future national strategy on electronic healthcare system was held in Kyiv region with the participation of the World Bank and the WHO. e-Health system should become one of the key components of healthcare reformation in Ukraine, the World Bank’s program manager in healthcare, education and social protection Fon Zhao. Implementation of e-Heath system is a part of the major project in healthcare, which is financially supported by the World Bank. The project coordinator of the WHO Bureau Jeraldin Mcqueeney noted that cooperation with Ukraine, one of the biggest countries in Europe, is in priority and aims to support the reform process.

Ukrainian Pharmaceutical Market Monthly: April 2016


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Upharmacia - April 2016