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Upharmacia U krainian P harmaceutical M arket M onthly

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

Issue: 08 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

2015

Indicators in Ukraine

Jul

(July 2015-July 2016)

Aug

Sep

2016

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

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

Export of Goods (US$ bn)

Q3

Q4

Q1

25.552

25.588

17.655

-26%

3.15

3.35 -22%

growth, % y-o-y

-34%

-22%

Import of Goods (US$ bn)

2.98

3.88

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$)

-34%

5.71 -33%

1.94 -41%

-17%

3.09

3.24

-2%

3.23 -23%

3.22

-30%

5.42

5.72

-23%

- 27%

6.29

-20%

1.88

1.86

-21%

2.04 -31%

3.13 -21%

3.07

0.1%

2.04

3.08

2.99

-11%

-31%

3%

-13%

2.23

2.68

3.35

3.12

-27%

-32%

-26%

-6%

6.37

4.93

4.93

-19%

-17%

2.01

-18%

1.60 -19%

8%

1.50 4%

Q3

1.3%

3.36

5.92 1.80

Q2

5%

5.41 -2%

1.64 2%

3.10

2.88

2.93

1%

-2%

-5%

3.05

2.69

7%

5.17 -12%

1.76 6%

2.87

2%

4%

5.39

5.44

-5%

1.59 -18%

-6%

1.73 -6%

2.92 -7%

3.09 4%

5.61 -2%

1.87

-32%

-38%

-33%

-29%

1.6

1.6

1.5

1.5

1.6

1.9

1.9

1.9

1.7

1.6

1.6

1.5

1.4

-3%

202

194

199

207

193

223

180

174

187

191

198

214

217

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD UAH / EUR

21.8

21.6

21.8

21.8

23.3

23.4

24.3

26.4

26.4

25.6

25.2

25.0

24.8

23.9

24.0

24.5

24.6

25.1

25.4

26.3

29.3

29.2

29.1

28.5

28.1

27.5

13.79

12.2

11.7

15.77

8.31

13.36

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

13.85

growth, % y-o-y

-6%

-54%

Import of Pharma Products (mio USD)

106.5

93.3

growth, % y-o-y

-47%

Pharma Retail Sales, values (mio USD)

172.6

9.01

-47%

177.1

-47%

121.1

-37%

147.1

13.33

15.54

13.90

14.17

16.15

-52%

-28%

-30%

11%

16%

3%

9%

5%

141.3

142.1

103.7

145.0

125.1

130.0

110.4

132.1

-31%

-28%

-24%

-42%

15%

27%

21%

25%

31%

15%

193.2

206.3

196.6

212.3

198.9

176.0

187.3

178.1

177.6

174.8

growth, % y-o-y

-32%

-24%

-28%

-26%

-20%

-18%

-17%

-1%

-5%

-1%

-8%

-2%

Pharma Retail Sales, volumes (mio units)

119.5

122.5

126.7

130.2

129.0

136.4

133.6

126.8

133.8

125.2

123.6

122.6

growth, % y-o-y

WACP (USD)

-10%

1.48

-8%

1.45

-11%

1.52

-5%

1.58

-4%

1.52

-5%

1.56

1%

1.49

-12%

1.39

-5%

1.40

2%

1.42

-1%

1.44

4%

1.43

growth, % y-o-y

-23%

-18%

-19%

-22%

-18%

-14%

-23%

-23%

13%

1%

-2%

-6%

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

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

108.4 109.8 42.3 76.7

107.3 107.5 42.9 77.2

106.9 108.2 42.8 77.4

-4%

133.1 25%

175.4 2%

122.7 3%

1.43 -3%

107.9 107.4 42.8 77.9

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: August 2016


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220

180

172.6

198.9

177.1

136.4 130.2 126.7

160

150 187.3

Values (mio USD)

129.0

122.5

122.2

174.8

175.4

125.2

123.6 122.6 122.7

12

140

120

120

110

4

100

0

Pharma Retail Sales 2016

2015

100

Jul

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

8

6

5.71

5.72

5.43

5.92

6.37

4.93

4.93

5.17

5.39

5.44

5.61

2.5

2.0 1.94

1.88

2.04 1.86

2.01 1.80

Retail turnover of enterprises

3

1.87

1.76 1.60

1.64

1.59

1.50

1.73

1.5

1.0 2 1

Industrial Production Sales & Retail Turnover of Enterprises Surplus

155.3

0

2015 Jul

Aug

Sep

Oct

Nov

Dec

2016 Jan

Feb

Aug

152.8

Sep

151.9

Oct

Nov

Dec

Jan

Mar

Apr

0.0

May

Jun

Jul

80

40 20

Feb

2016 Mar

146.6

143.3

26.1

25.9

26.1

21.8

21.6

21.8

25

0

May

Jun

Jul

140.3

140

132.7 120.9

UAH / €

30

Apr

160 146.4

CPI of Ukraine

24.6 21.8

25.1

25.4

26.3

23.3

23.4

24.3

109.8

107.5

108.2

29.3

29.2

29.1

28.5

28.1

26.4

26.4

25.6

25.2

107.4 27.5

60 40

vs. Consumer Price Index 2015

0

Jul

Aug

Sep

Oct

Nov

Dec

20

2016 Jan

100

24.8

Official Currency Exchange Rates

5

120

80 25.0

UAH / $

15 10

0.5

13.4

60

2015

40

20

14.2

8.3

35

5 4

Export

45

Industrial production sales 5.41

11.7

Ukraine's International Trade in Pharma Production Jul

Jul

50

6.29

13.9

9.0

3.0

7

100 16.1

15.5

13.8 12.2

140 120

15.8

93.3

13.9

133.1

110.4

13.3

130

132.1

130.0

125.1

Import

106.6

140

145.0

142.1

103.7

16

Volumes (mio units)

119.5

177.6

133.8 126.8

141.3

20

178.1

176.0 133.6

160

147.1

24

196.6

193.2

200

160

212.3

206.3

Feb

Mar

Apr

0

May

Jun

Jul

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

In 2Q2016, GDP of Ukraine has grown 1.3% y-o-y after 0.1% y-o-y growth in 1Q2016. Ukrainian government expects the economy to grow 2% in 2016, while the IMF projects 1.5% GDP growth. In 1H2016, investment in fixed assets in Ukraine have grown 9.6% y-o-y. In July, treasury residuals of Ukraine decreased 38.9% m-o-m to UAH 11.0 bn. In August 1, 2015, the accumulations amounted UAH 33.3 bn. Ukrainian government intends to submit the draft version of stated budged to the Parliament in Sept, the Prime Minister said. The budget will be completely honest and realistic, he added. Finance Ministry expects the IMF tranche in Sep, after the fully functioning launch of electronic declaration in Ukraine since Sep 1. E-declaration is the main condition for the credit provision, the Minister said. Ukraine and Indonesia agreed to start consultations on a free trade area, Ukrainian President said. Ukraine could be a platform for Indonesian investors to reach the European market, he added. Prime Minister of Ukraine announced the intention to create full-featured trade missions of Ukraine abroad. In 1H2016, capital inflow to Ukraine amounted USD 2.9 bn, which is almost three times more than in 1H2015 (USD 1 bn), the Statistics Service Reported. The most investments came from Russia (USD 1.3 bn). 70% of investments were allocated in financial sector. In Jul, industrial output in Ukraine decreased 0.2% y-o-y, improving from 3.4% decline in Jun. The decrease was in such core industries such machinery (-11.5% y-o-y) and mining (-0.4%), while the growth was in chemicals (7.1%), utilities (6.3%) and metals (4.3%).

Ukrainian Pharmaceutical Market Monthly: August 2016


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MARKET & COMPANIES NEWS Farmak launched antiepileptic drug Ukrainian pharmaceutical company Farmak expanded its portfolio by launching Organiya (pregabalin), which affects nervous system to treat neuropathic pain, epilepsy, generalized anxiety disorder and fibromyalgia. The drug is produced in the form of capsules. The company already has two antiepileptic drugs: Meditan (gabapentin) designed for the treatment of partial epileptic seizures and Epileptal (lamotrigine) used in additional therapy against epilepsy in children. Drugs for nervous system provide about 13% of sales of Farmak in values. In 1H2016, the company retained first position on Ukrainian pharmaceutical market with USD 56.1 mio for 41.7 ths packs sales. Security Service of Ukraine inspects Indian pharma companies In late July, the Security Service of Ukraine (SSU) started the inspection of Indian pharmaceutical companies, which operate in Ukraine, the Indian Pharmaceutical Manufacturers Association (IPMA) reported. The authority requested about 10 ths pages of information regarding the activities of Indian companies in Ukraine and some products produced by them. According to the SSU, the information is requested due to the reports on side effects caused by Indian drugs being revealed by the State Expert Center of the MOH (SEC). “The SEC didn’t informed about the complete or temporary prohibition of the medical use

of the drugs, the information on which requested,” the IPMA said. “The statement of the SSU on the facts of numerous side effects provoked by the drugs is unapproved and seems to exceed its authorities. Moreover, all requested information is stored in the state bodies of Ukraine.” Notably, all Indian companies, fallen under the inspection, participated in public procurement of drugs, carried by the international organizations. In March 2016, the MOH excluded all drugs of Indian company Venus Remedies from the procurement list after the Ministry questioned the efficacy of the company’s drug proposed for the procurement by Crown Agents. Kusum Pharm plans to double production capacities by 2018 Ukrainian company Kusum Pharm plans to start enlargement of its plant in Sumy by the end of 2016 to double production capacity at least 2 times, the General Director of the company Rajeev Gupta said. The company plans to start the enlargement of storage facilities in 2016; in 2017 it will expand the administrative building and in 2018 will start expanding of production. “The crisis created unique opportunities for import substitution and expansion of Ukrainian industry,” Mr. Gupta said. “Devaluation of the National currency decreased the solvency of the population and import drugs became almost inaccessible. Consequently, the demand for local medicines increased.” Kusum Pharm’s plant started operating in 2009. The company’s portfolio includes

60 generic drugs, generally for the treatment of patients with cardio-vascular, gastrointestinal and endocrine diseases. Kusum Pharm plans to localize production of drugs, which are now imported from Indian plant Kusum Healthcare (also part of Kusum Group). In 1H2016, Kusum Pharm was 14th company on Ukrainian drug market by sales in values. In 2015, the company produced 787 ths packs of tablets, 2.4 mio packs of syrups and suspensions and 258 ths packs of sachets. The company’s revenues in 2015 amounted UAH 822.1 mio. Kreoma-Pharm demands the prohibition of production of Enterosgel in Russia Ukrainian company KreomaPharm appealed the Moscow Arbitration Court with a lawsuit against Russian company TNK Silma. The claimant demands the prohibition of manufacturing of Enterosgel by Russian company due to violation of patent law. Enterosgel is an enterosorbent, which is used for removing harmful substances from gastrointestinal tract. In 2005, Kreoma-Pharm received a Eurasian patent for an exclusive right to an invention of the preparation. TNK Silma claims it had registered the similar patent in Russia in 2004. Herewith, both companies produce the preparation under the license of Swiss company Bioline Pharmaceutical Ag. Kenya may use Ukrainian antituberculosis drugs The government of Kenya

Ukrainian Pharmaceutical Market Monthly: August 2016


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considers the possibility to use drugs produced by Ukrainian companies to fight tuberculosis, the Association of Ukrainian drug producers reported. The corresponding issues were discussed during the meeting between Ukrainian Ambassador in Kenya with the Healthcare Minister of Kenya. During the meeting, the parties discussed possible ways of boosting bilateral relations in

healthcare sphere, development of scientific and technological cooperation and conclusion of the Memorandum on intersectoral cooperation between Ukraine and Kenya. Ukrainian diplomat familiarized Kenyan Minister with abilities of Ukrainian pharmacological complex and noted the prospects of the use of Ukrainian drugs in implementation of joint projects. “Establishing cooperation with

Kenya in healthcare, including the fight against infectious diseases will promote the expansion of the Ukrainian pharmaceutical companies to local markets”, the press release of the Association of Ukrainian drug producers noted. Earlier, in Mar 2016, Ukrainian company Interchem participated in the largest pharmaceutical exhibition in the West Africa in Kenya.

REGULATORY UPDATES The Draft Law #2386a-1 “On amendments to certain Laws of Ukraine on transplantation of organs and other anatomic human materials” will be submitted for the second reading voting in Oct 2016, the Member of the Parliamentary Committee on Public Health Olexiy Kyrychenko said. The document allows organ transplantation from dead citizens of Ukraine and is based on the presumption of disagreement. The Draft Law was approved in the first reading in Apr 2016 and then was sent for revision. The document is aimed to update the existing Law “On transplantation”. It envisages the development of national register of donors and recipients and makes amendments to the State budget. The Draft Law is expected to create a brand new transplantation system in Ukraine. According to the Deputy Kyrychenko, Members of Parliament have already submitted about 100 pages of corrections to the document. -The Cabinet of Ministers of Ukraine (CMU) approved the Resolution #560 dated Aug 23, which amends the Resolution #787 dated Oct 8, 2015 and allows specialized International

organizations to procure additional amount of drugs for saved funds from the State budget 2015. Thus, International organizations will have the opportunity to make prompt decisions regarding the use of residues of saved funds. Lately, International organizations, which conduct delegated public procurement for Ukraine, said they couldn’t carry additional procurement of drugs as the contracts with the MOH do not provide the further use of saved funds. Crown Agents reported it had saved about 45% of UAH 500 mio, being allocated for drug procurement under oncology program. UNICEF also managed to save USD 3.8 mio from vaccines procurement. -In Aug, the MOH promulgated the Draft Resolution “On approval of the National strategy for blood service development”, which aims to ensure equal and timely patient access to quality and safe blood components in the required amount. The document is developed to execute the EUUkraine Association agreement in regard of cooperation development in healthcare sphere. The Draft National strategy envisages the reform of blood

service towards decentralization at regional level. The document proposes to implement multichannel system of blood service funding as well as quality control system. The main body, which is to conduct management and monitoring of blood service programs, is the National Transfusiological Center, which should be developed under the MOH. The strategy also includes development of donor recruitment program and program for donor resource management. At the same time, the National strategy does not provide the launch of the Single donor base of Ukraine. The donor registers will be kept by specialized organizations and transfusion institutions at the regional level.

Ukrainian Pharmaceutical Market Monthly: August 2016


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HEALTHCARE NEWS Ulana Suprun filed candidacies of her deputies Acting Minister of Healthcare of Ukraine Ulana Suprun submitted the candidacies for the posts of Deputy Heads of the MOH to be approved by the government. On 1 Aug 2016, during presenting Mrs. Suprun at her new position, Vice Premier Minister of Ukraine said the government gives her carte blanche on forming her own team. The candidacies Mrs. Suprun proposed are following: Oleksandr Linchevskiy, thoracic surgeon, who had worked in district hospital in the ATO zone then become tactical medicine instructor. Oksana Sivak, obstetrician gynecologist by profession, had worked as a volunteer doctor at Maidan. Used to be a coordinator of public organization Iniciativa E+. Pavlo Kovtoniuk, main editor of the magazine “PRO management in healthcare”, former project manager for the health care reform of the National Reform Council. Currently, Mr. Kovtoniuk is an expert on healthcare reform of the WHO. After her appointment, Ulana Suprun had had only one Deputy – Roman Ilyk. On Aug 23, Kyiv Court of Appeal satisfied the complaint of the former Deputy Minister of Healthcare Roman Vasilishin, who is suspected in receiving a bribe, and restored him at the position.

amounted 18,864. Herewith, none of those reports caused the termination of the registration certificates for medicinal products. In 2015, 51.8% of adverse reactions were related to Ukrainian drugs and 15.4% to Indian drugs. Ulana Suprun stopped illegal privatization of 32 health facilities Acting Minster of Healthcare of Ukraine Ulana Suprun withdrew the letter on transfer of 32 health facilities at the regional level, which had been signed by former Deputy Minister Viktor Shafranskiy in July 2016. The health facilities were supposed to be transferred to finance local budgets and subsequently privatized. “We received a lot of appeals from the public and the institutions themselves in relation to previously signed letters with the caveat about the possible nontransparent privatization and corrupt schemes,” Mrs. Suprun said. “The Ministry decided to stop the process to examine the situation and make a decision.” The main achievements in healthcare in 1H2016 determined National Reforms Council determined the main achievements in healthcare sphere in Ukraine in 1H2016, which are:

»»

In 1H2016, State Expert Center received 11 ths notification of adverse reactions to drugs In 1H2016, the State Expert Center of the MOH (SEC) received 10,943 notification of adverse reactions to drugs. In 2015, the number of such notifications

»»

approval of the Law on simplified registration of drugs, registered in countries with strict regulatory system, which is seen as an important step for pharmaceutical market deregulation; approval of the Draft Law on autonomization of healthcare

»»

»»

organizations (#2309 a-d). The document is in process of revision for the second reading voting; significant progress in the harmonization of processes in healthcare reformation and decentralization. Approval of the road map of changes in primary care and establishment of hospital districts; creation of the working group at the Cabinet of Ministers of Ukraine with participation of the MOH and other Offices for the implementation of the program of priority actions of the government in healthcare in 2016.

At the same time, the Council is concerned about the possible failure to submit the Draft Law #2309 a-d for the second reading voting. The working group made more than 40 amendments, the most of which were not supported by the Parliamentary Committee on Public Health. Another threat in healthcare is deceleration of supply of medical production procured for state budget. The Council also determined the following steps in healthcare reformation:

»»

»» »»

approval by the government of the Concept of healthcare financing reform and the Concept of public health reform; approval of the Draft Law #2309 a-d on autonomization of healthcare organizations by the Parliament; revitalization of the process of the start of procurement cycles with international organizations.

New Head of State Expert Center was appointed On Aug 16, State Enterprise State

Ukrainian Pharmaceutical Market Monthly: August 2016


Page 8

Expert Center of the MOH (SEC) was headed by Tetyana Dumenko, who replaced Tetyana Talaeva at the positon. Earlier Mrs. Dumenko was Director of the Department of rational pharmacotherapy and maintaining the state formulary system of the SEC. On Aug 12, the MOH fired Mrs. Talaeva because of “insufficient qualification”. Deputy Head of the MOH Roman Ilyk instructed the new Director of the SEC to submit proposals for the further development of the Center, in accordance with the best European practices. The SEC is a specialized expert institution in sphere of pre-clinical studies, clinical trials and state registration of drugs, which is the premier organization in the field of pharmacovigilance, standardization of medical care and health services.

Professional community expects official recognition of plastic surgery in Ukraine Professional community of plastic surgeons hopes for official recognition of plastic surgery specialty in Ukraine, the President of Ukrainian Association of Plastic, Reconstructive and Aesthetic Surgeons (UAPRAS) Vasil Pinchuk said. “Juridically there is no plastic surgery in Ukraine,” Mr. Pinchuk noted. “A lot of plastic surgeons do not advertise they do plastic surgery; they conduct them under the guise of ordinary operations. “The shadow market of plastic surgery in Ukraine is quite large, but it’s hard to precisely record the number of plastic surgeries made, Mr. Pinchuk added.” The UAPRAS is seeking the

recognition of plastic surgery specialty in Ukraine to regulate the activity of plastic surgeons, implement the licensing requirements and certification of specialists. Wheras, the Secretary of International Society of Aesthetic Plastic Surgery (ISAPS) noted the high level of Ukrainian specialists in plastic surgery as such surgeries are in big demand from foreign patients.

Ukrainian Pharmaceutical Market Monthly: August 2016


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