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IMacroeconomic ssue: 09 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

2015

Indicators in Ukraine

Aug

(August 2015-August 2016)

Sep

Oct

2016 Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

MACROECONOMIC INDICATORS GDP (US$ bn)

Q3

Q4

Q1

Q2

25.552

25.588

17.655

21.053

growth, % y-o-y

-26%

-17%

Export of Goods (US$ bn)

3.09

3.35

growth, % y-o-y

-22%

-22%

Import of Goods (US$ bn)

3.88

growth, % y-o-y

-2%

Industrial Production Sales (US$ bn)

5.42

growth, % y-o-y

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

Unemployment Rate (%) Average Salary (US$)

-23%

1.88

3.24 -30%

5.72 -20%

1.86

3.23

3.13

-23%

3.22

-21%

3.07

- 27%

6.29

0.1%

2.04

3.08

2.99

2.88

2.93

2.92

-11%

-31%

3%

-13%

1%

-2%

-5%

-7%

2.23

2.68

3.35

3.05

2.69

3.12

-27%

-32%

-26%

-6%

6.37

4.93

4.93

-21%

-19%

1.80

-31%

-0.02%

3.36

5.92

2.04

Q3

-17%

2.01

-18%

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%

3.09 4%

5.61 -2%

1.87 -3%

3.18 3%

3.45 -11%

5.57 3%

1.92

-32%

-38%

-33%

-29%

1.6

1.5

1.5

1.6

1.9

1.9

1.9

1.7

1.6

1.6

1.5

1.4

1.3

2%

194

199

207

193

223

180

174

187

191

198

214

217

208

OFFICIAL CURRENCY EXCHANGE RATE UAH / USD UAH / EUR

21.6

21.8

21.8

23.3

23.4

24.3

26.4

26.4

25.6

25.2

25.0

24.8

25.1

24.0

24.5

24.6

25.1

25.4

26.3

29.3

29.2

29.1

28.5

28.1

27.5

28.1

12.2

11.7

15.77

8.31

13.58

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

9.01

growth, % y-o-y

-54%

Import of Pharma Products (mio USD)

93.3

growth, % y-o-y

Pharma Retail Sales, values (mio USD)

-47%

177.1

13.79 -47%

121.1

13.33

15.54

13.90

14.17

16.15

13.36

-52%

-28%

-30%

11%

16%

3%

9%

5%

-4%

141.3

142.1

103.7

145.0

125.1

130.0

110.4

132.1

133.1

-37%

147.1

-31%

-28%

-24%

-42%

15%

27%

21%

25%

31%

15%

25%

47%

193.2

206.3

196.6

212.3

198.9

176.0

187.3

178.1

177.6

174.8

175.4

180.9

growth, % y-o-y

-24%

-28%

-26%

-20%

-18%

-17%

-1%

-5%

-1%

-8%

-2%

2%

Pharma Retail Sales, volumes (mio units)

122.5

126.7

130.2

129.0

136.4

133.6

126.8

133.8

125.2

123.6

122.6

122.7

growth, % y-o-y

WACP (USD)

-8%

1.45

51%

137.3

-11%

1.52

-5%

-4%

1.58

1.52

-5%

1.56

1%

1.49

-12%

1.39

-5%

1.40

2%

1.42

-1%

1.44

4%

1.43

3%

1.43

2%

126.2 3%

1.43

growth, % y-o-y

-18%

-19%

-22%

-18%

-14%

-23%

-23%

13%

1%

-2%

-6%

-3%

-1%

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

152.8 149.4 41.4 78.2

151.9 145.8 41.4 76.5

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

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: September 2016


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220

212.3

206.3

180

6 196.6

193.2 2 193.2

200

187.3

147.1

129.0 0

177.6

174.8

175.4

150

20

140

16

126.8

125.2

122.5

123.6

126.2

130

8

110

4

100

0

120

16.1 13.9

11.7

137.3 140

15.5

15.8 8

12.2

120

130.0

13.3

13.8

12

133.1

132.1 110.4

103.7 93.3 3

122.6 122.7

mio units

140

125.1

122.2 2

160

mio USD

Import

145.0

142.1

180.9

133.8

133.6 130.2

178.1

176.0

136.4

1126.7 26.7 7

24

141.3

198.9

177.11

160

160

mio USD

Values

Export

8.3

100

14.2

13.6

13.4

60

9.0 9 .0

Volumes

40

120

2015

2016

Sep

Oct

Nov

Dec

Jan

2015

Pharmaceutical Market Retail Sales

100

Aug

Feb

Mar

Apr

May

Jun

Jul

6

5.43

Industrial production sales

5.92

5.72

5.41 4.93

5

5.39

5.44

5.61

5.57

2.5

5.17

4.93

11.88 .8 88

11.86 .86 6

1.80 1.60

3

1.64

1.76 1.59

1.50

Retail turnover of enterprises

1.73

1.87

1.92 1.5

151.9

Oct

Nov

Dec

146.4

146.6

143.3

Jan

Feb

Mar

May

Jun

Jul

Aug

160 140

132.7 120.9 109.8

107.5

29.3

29.2

29.1

28.5

28.1

26.4

26.4

25.6

25.2

25.0

UAH / EUR

30

25.9

26.1

21.6

21.8 2 1.8

25

bn USD

Apr

CPI 140.3

40

20

1.0

20

in Pharma Production

35

2.01

2.04

Sep

45

bn USD

2.0 4

1152.8 52.8 8

3.0

6.37

6.29

2016 Ukraine's International Trade

0

Aug

Aug

50

7

80

mio USD

24.6 21.8 2 1.8 8

25.1

25.4

26.3

23.3

23.4

24.3

107.9

106.9

27.5

108.4 28.1

120 100 80

24.8

25.1 60

UAH / USD

15

2

40 10

1

2015

2016 Industrial Production Sales &

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

2015 2 015

5

Retail Turnover of Enterprises Surplus

0

Aug

0.5

0.0

Aug

2016 Official Currency Exchange Rates vs. Consumer Price Index

0

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

20 0

Jul

Aug

KEY ECONOMIC EVENTS »» »» »» »»

»» »» »» »» »»

On Sept 1, Ukrainian government launched the system of an electronic declaration. The system is expected to accelerate the fight against corruption within Ukrainian officials and to push forward European integration of Ukraine. In particular, the launch of e-declaration was among the major demands from the EU to provide visafree regime to Ukraine. On 14 Sept, after completion of the second review of Ukraine’s implementation of an economic program, the IMF approved the allocation of the third tranche to Ukraine worth USD 1 bn. “Ukraine is showing welcome signs of recovery, and Ukrainian authorities make a significant contribution to the improvement,” the IMF Head Christine Lagarde stated. On Sept 27, Ukraine received USD 1 bn from placing five-year notes guaranteed by the U.S. The placement of U.S.-guaranteed bonds is a part of the IMF-sponsored program of financial assistance. Ukraine lost six positions y-o-y in the Global Competitiveness Index 2016-2017 published by the World Economic Forum and was placed 85th among 138 countries. Ukraine has the lowest ranks in Institutions (129th), Macroeconomic environment (128th) and Financial market development (130th). The highest ranks are Market size (47th), Innovation (52nd) and Health and primary education (54th). Corruption and policy instability remain the most problematic factors for doing business. On 14 Sept, Ukrainian government approved the 2017 Draft Budget. Projected revenues were increased 17% y-o-y to UAH 876.9 bn. The general budget deficit was approved at 3% of GDP of UAH 77.5 bn. The spending plan is based on a 3% y-o-y real GDP growth forecast, 8.1% y-o-y CPI increase and UAH 27.2/USD average exchange rate. Ukraine’s GDP grew 0.7% y-o-y and is expected to grow 1% y-o-y in 2016, according to the Economy Ministry’s preliminary data. In Aug, treasury residuals of Ukraine increased 16.1% m-o-m to UAH 23.8 bn. In comparison to Aug 2015, treasury accumulations decreased almost twice from UAH 45.9 bn. The EU will provide EUR 600 mio of macrofinancial aid to Ukraine by late 2016 if all modalities agreed on earlier are observed, Vice-President of the European Commission Valdis Dombrovskis said. Ukraine and Israel agreed to speed up negotiations on a free trade area agreement, the President of Ukraine reported.

Ukrainian Pharmaceutical Market Monthly: September 2016


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MARKET & COMPANIES NEWS Biofarma to set up production of tetanus immunoglobulin within 2-3 years Ukrainian Biofarma intends to start the manufacturing of tetanus immunoglobulin within the next 2-3 years. The initiative was announced after the negotiations with the MOH, which had appealed Ukrainian companies reporting the demand for tetanus vaccination medications in Ukraine. “We have technologies for such manufacturing and we know how to make it,” the Deputy Director for science and technologies of Biofarma said. “If there is a demand for tetanus immunoglobulin in Ukraine, we are ready to start production in 2-3 years.” The acting Head of the MOH also noted that in parallel the Ministry is communicating with foreign companies regarding the registration of such vaccines in Ukraine. Biofarma is a leading producer of donor blood-made preparations in Ukraine. The company produces more than 20 immunobiological preparations from donor blood as well as preparations obtained through recombinant DNA technology and probiotics. In 2015, the company increased its net profit 2.3 times y-o-y to UAH 61.6 mio and intended to invest USD 12 mio in its development. Recently, the company reported the conclusion of agreements on cooperation with Malaysian pharmaceutical companies. Antimonopoly Committee fined pharma market participants for collusion After consideration of the

case of Swiss company Alcon Pharmaceuticals regarding the violation of competition legislation, the Antimonopoly Committee of Ukraine fined the company and Ukrainian pharmaceutical distributors (BaDM, Venta, Optima-Pharm and Alba) for a total of UAH 1.56 mio. The Committee revealed that during 2011-2013 the companies had nontransparent mechanisms for providing after-sales discounts. Thus, the distributors set higher prices for Alcon’s drugs in public procurements, than in retail sales. The Committee concluded that Swiss company and Ukrainian distributors intentionally overpriced drugs in pubic procurements. Arterium acquired Slovenian Marifarm Ukrainian Arterium Corporation acquired pharmaceutical company Marifarm (Maribor, Slovenia) from Slovenian bank Nova KBM. The sum of the deal is not disclosed. According to unofficial data, Marifarm’s value estimated at EUR 6.8 mio. Arterium and Marifarm intend to establish joint opportunities for pharma markets development, exchange of experience and technologies in creation and production of pharmaceuticals. Marifarm was formed in 2008 after separation from the pharmacy chain Farmadent. The company had been unprofitable due to significant debt, and in Jun 2016 it was acquired by Nova KBM. Arterium held second place at Ukrainian market among pharma companies by sales in values in 1H2016. The Corporation includes JSC Kievmedpreparat and JSC Galychpharm.

This is the second case of acquisition of European company by Ukrainian pharma producer this year. In Jan, Farmak acquired Polish trade company KWW Kotkowski Wierzbicki Wegrzyn sp.j. The prosecutor’s office closed criminal case on Actovegin registration Takeda reported that in Jun 2016 the prosecutor’s office of Kyiv closed the criminal case on the lawfulness of registration/ re-registration of Actovegin due to the lack of the fact of a criminal offense. In Jun 2015, the Security Service of Ukraine and the prosecutor’s office of Kyiv suspected Takeda in the illegal registration of Actovegin as a drug. The authorities assumed that Actovegin is a biologically active additive, not a drug. In Sept 2015, the MOH confirmed the “drug” status of Actovegin. “Actovegin is produced in Austria and is passing secondary packaging process at the facilities of Kusum Pharm in Ukraine,” the Director of Takeda Ukraine Natalia Zago said. “Currently, the company does not have any plans for expansion of contract manufacturing in Ukraine.” Actovegin is traditionally a best-selling drug on the Ukrainian pharmaceutical market in values. It is used for the treatment of patients with vascular and metabolic brain diseases, disorders of peripheral blood circulation and its complications, as well as diabetic polyneuropathy.

Ukrainian Pharmaceutical Market Monthly: September 2016


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Key Logistics opened new logistics complex On Sept 1, the pharmaceutical logistics operator Key Logistics announced the opening of the new Class A bonded warehouse, designed for storage of imported goods, which has not yet passed the customs clearance. The new complex is located in village Khotiv (Kyiv region) near Kyiv-

Odessa highway. The warehouse is intended for more than 2,000 pallet places and is equipped with three temperature zones of storage. Additionally, the complex includes commercial and pharmacy warehouse with above 1,500 pallet places, designed for storage of pharmaceutical production after customs clearance.

Key Logistics have been operating on Ukrainian market for 2 years. It is cooperating with national distributor Pharmplanet and the International Committee of the Red Cross.

REGULATORY UPDATES On Sept 5, the MOH promulgated Draft Register for reference prices (reimbursement prices) of insulin preparations. The register contains 70 names of insulin preparations with indication of INN, trade name, producer, reference price, etc. The Draft Register is developed to implement the Resolution of the Cabinet of Ministers On implementation of Draft Project on introduction of state regulation of insulin prices dated 5 Mar 2014. The launch of Draft Project since Apr 1 2016 was failed due to the absence of the Register and the range of technical issues. -On Sept 19, the Order of the MOH #773 dated 27.07.2016 came into force. The document amended the form and description of registration certificates for drugs approved. The certificate will include the information on validity period of the drug: until the year _____/unlimited/until Dec 31, 2019. The certificate will also indicate the periodicity of submission of updated report on drug safety. The name and location of an applier is indicated in Ukrainian and optionally it could

be indicated in English. In case of simultaneous state registration of a finished medicine and an active pharmaceutical ingredient (API), which is a part of its medicine, applier submits an application for the state registration of a finished medicine and an application for the state registration of an API. An expertise of register materials for API is conducted one registration dossier for the finished medicine. -On Sept 16, the MOH promulgated the Draft Law to approve the Procedure for consideration of registration materials for drugs, applied for state registration (re-registration) and materials on amendments to registration materials for drugs, which are registered by competent authorities of the USA, Switzerland, Japan, Australia, Canada and the EU. The Procedure is developed to comply the Law of Ukraine dated 31.05.2016 on simplified registration of drugs registered in the countries indicated. The Law foresees the Procedure to take 10 days. The procedure does not foresee an expertise of registration

dossier, while the registration is conducted on the basis of application and consideration of: »» materials on the methods of quality control of a drug; »» materials of registration dossier submitted to regulatory body that registered a drug; »» samples of packages of a drug and labeling texts of primary and secondary (if available) packages as well as texts on the use of a drug; »» certified copy of the document, which confirms the compliance of conditions of manufacturing of the drug, submitted for registration, to the requirements of drug manufacturing in Ukraine, issued by the State Service of Ukraine on drugs. Or a written commitment of the manufacturer responsible for production of a series, to produce the drugs aimed for supply to Ukraine on the same production facilities used in the production of drugs for use in the USA, Switzerland, Japan, Australia, Canada and the EU.

Ukrainian Pharmaceutical Market Monthly: September 2016


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HEALTHCARE NEWS Mobile app for drug control developed in Ukraine Ukrainian developer Natalia Guran has created mobile app Liki Control Drugs control, which allows identifying the quality of a drug through indication of its series. The program will automatically check the validity of the registration certificate and the series as well as verify whether the ban on a series of a drug is temporary or permanent. It also provides all copies of the orders of the State Service for Drug Control. The app includes almost 13 ths names of drugs, while its base is updated twice a day. The developers plan to engage more public registers with the MOH’s help. Government plans to allocate UAH 5.9 bn for public procurement of drugs On Sept 15, the government presented 2017 Draft Budget, where UAH 8.2 bn (USD 301.5 mio) were intended for healthcare expenditures and UAH 5.9 bn (USD 216.9 mio) for public procurement of drugs and medical devices. For comparison, State Budget for 2016 envisaged UAH 4.15 bn for drugs procurement. In 2017, the government again plans to delegate procurements of drugs to International organizations. Ukraine will also qualify for funds of the Global Fund to achieve almost 100% provision, the Prime Minister of Ukraine said. On Sept 21, during the meeting, the Parliamentary Committee on Public Health did not approved the Draft Budget. The MPs referred to significant underfunding of healthcare expenditures.

Ukraine’s death rate is second in the world, CIA According to the World Factbook 2015 report of the Central Intelligence Agency, Ukraine is ranked 2nd among 225 countries by its death rate per 1,000 population. Ukraine has the worst indication in the world – 14.46 death/1,000 population – after Lesotho (14.89/1,000). By birth rate, Ukraine was placed at 182nd position in the world with 10.72 birth/1,000 population. According to the research associate of the Center for Health Services Study of the University of Kent Elena Nizalova, high death rate could be decreased through efficient state policy. As lung cancer and road traffic injuries are frequent causes of deaths in Ukraine, the situation could be improved through political measures in tobacco smoking and traffic control. The MOH plans to implement free choice of doctor Deputy Head of the MOH Pavlo Kovtoniuk plans implementation of free choice of doctor principle and dependence of hcp’s salaries on the number of patients by the mid-2017. “We would like to start from doctors, which patient will appeal first – family doctor, therapist and pediatrician – and implement the principle “money follows the person”,” Mr. Kovtoniuk said. “Doctor will receive money for a real person, with whom he had signed a contract.” People will have the opportunity to choose their doctor independently, while a physician’s salary depends on the number of patients served. This is expected to significantly increase the incomes of doctors.

The government resolved the issue with customs clearance of drugs for pediatric oncology On Sept 14, the Prime Minister of Ukraine reported that the government managed to resolve the issue with customs clearance of medicines for pediatric oncology procured by Crown Agents from Ukrainian distributor Ludmila-Pharm. Medicines were located in temporary storage warehouse of Kyiv customs for 92 days due to misunderstanding regarding which organization owns the medicines. After settlement of issues between Crown Agents and LudmilaPharm and involvement of the government and the Parliament, the drugs passed customs clearance and were supplied to the regions. Acting Head of the MOH Uliana Suprun said the government would continue cooperation with international organizations in public procurements, but mistakes of the first year’s cooperation should be considered. Program for CVD treatment will be presented in Oct In Oct, Expert community will introduce to the government the 5-year program for prevention and treatment of cardiovascular diseases in Ukraine, the Director of National Science Centre M.D. Strazhesko Institute of Cardiology Volodymyr Kovalenko said. The program includes wide range of activities, like prevention, medical and operative treatment as well as rehabilitation. It also envisages procurement of artificial heart valves and other consumables, which are needed to perform complex cardiac surgery in children and adults.

Ukrainian Pharmaceutical Market Monthly: September 2016


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Use of telemedicine in healthcare facilities is allowed in Ukraine On Sept 22, the Cabinet of Minister of Ukraine issued the Resolution #648, which allows health care facilities in Ukraine to provide payed medical services with the use of telemedicine. Telemedicine allows healthcare professionals to evaluate, diagnose and treat patients in remote locations using telecommunications technology. In developing countries, telemedicine offers a reduced cost solution to delivering remote care when and where it is needed without the building and staffing added facilities. The list of services was also

expanded with the conduction of microbiological, parasitological, molecular genetic, chemical, toxicological and physical researches, which do not belong to medical aid to population. Synevo to open 30 new laboratories in Ukraine European chain of medical laboratories Synevo will invest EUR 2 mio to open 30 new laboratory units in different cities of Ukraine by the end of 2017. The company also plans to introduce self-service terminals, which will reduce the time of waiting for registration of orders for a blood test. The launch of mobile application

“doctor’s private cabinet”, which is to facilitate communication between doctor and patient, is also underway. Synevo is a part of medical holding Medicover, which operates in Central and Eastern Europe. The company includes 150 laboratory hubs in Ukraine.

CIS REGION PHARMA NEWS Belarus On Aug 24, the construction of joint Indian-Belarus pharmaceutical plant JivaPharm was officially started in Kolyadichi. The company will produce medicines against HIV, hepatitis, oncology, etc. The launch of the first site of the plant is projected to 2017-2018. The full capacities of JivaPharm are expected to produce 22.5 mio tablets of antiretroviral preparations, 11 mio tables for general therapeutic and 800 ths capsules annually.

Kazakhstan SK-Pharmacy appealed to all related associations and authorities asking to inform potential investors, which intends to build and upgrade drug manufactory in Kazakhstan,

about the collections of offers on the product range to be produced. Subsequently, it is planed to conclude long-term 10-year supply contracts for the positions proposed. Pavlodar Regional Court initiated bankruptcy proceedings in regard of Pharmaceutical company Romat and Pavlodar Pharmaceutical Plant (both parts of Romat Holding). In Arp 2015, the Economic Court had assigned a rehabilitation procedure for the companies, which was failed to be implemented. In 2015, Romat Holding was among TOP10 local producers of pharmaceuticals in Kazakhstan, employing above 1,300 workers. Russian company BIOCAD will localize manufacturing of bioanalogue of rituximab for

the treatment of blood cancer at the facilities of Karaganda Pharmaceutical Complex. Kazakh company will receive needed technologies as well as data the drug’s clinical trials. The investments in the project will amount USD 3 mio. The Heads of medical organizations and representatives of the WHO and the World Bank discussed the Concept for creation of regional medical cluster in Aktobe. The cluster is aimed to provision of highquality medical service to citizens of Aktobe Region and West Kazakhstan Region. The MOH concluded contracts on transfer of advanced medical technologies with Gangnam Severance Hospital (South Korea), Hemogens Health Care (Turkey), Saint Louis University (USA).

Ukrainian Pharmaceutical Market Monthly: September 2016


The Register of Kazakh GMP and GDP-certified companies was issued. Currently, local companies obtain 15 GMP certificates and 50 GDP certificates. National Agency for Technological Development provided a grant for KZT 4 mio to Biostem company for the development of preparation on the basis of bifidoand lactobacteria. The project is expected to provide cheap analogue of essential drug and reduce Kazakhstan’s dependence on imports. The MOH approved Kazakh National Drug Formulary with free online access for patients and physicians. The Formulary provides complete and reliable information on drugs registered in Kazakhstan.

Russia Since Sept 1, customs rates for certain codes of pharmaceutical products decreased from 0.9% to 2.8%. According to RNC Pharma analytical company, for the period from Sept 2016 to Aug 2017, drug importers will subsequently be able to save RUB 450 mio. R-Pharm agreed with Korean company Il-Yang Pharmaceutical to localize the manufacturing of Noltec (ilaprazole) in Russia. R-Pharm also received the right to promote the drug in Russia, Belarus and Armenia. Nanopharma Development company launched production of generic drugs in Kazan. The capacities will be able to ensure

the needs in preparations for transplantation by 80%, HIV treatment by 20-25% and oncology by 10%.

Capacities of the new plant will allow producing 1.2 bn tablets and capsule.

Pfizer appointed Country Manager Russia Danil Blinov, at the position of the Head of Rare diseases department in 60 countries (including Russia). Mr. Blinov will continue perform the duties of Country Manager Russia until a new person is appointed.

Russian company R-Pharm resumed the construction of biopharmaceutical plant in Tekirdag (Turkey). The company froze the project in May 2016 due to unstable exchange rate of the Russian ruble and the deterioration of political relations between Russia and Turkey.

Drugs from low price segment are gradually disappearing from the market, as they were not considered in implementing the strategy for domestic pharmaceutical production development, the Head of Association of the Russian pharmaceutical manufacturers said.

Pharmaceutical cluster, which involved 10 enterprises, was created in Perm Krai. Medisorb company and Permchemical Company became anchor enterprises. The cluster is expected to launch production of over 15 medicines and substances, which are currently imported.

The MOH will launch pilot projects for the leveraging prices of drugs with same chemical formula, the Vice Prime Minister Olga Golodets said. The price dispersion for such drugs should not exceed 10-20%, she noted.

Teva reached an agreement with Russian company NANOLEK to transfer the manufacturing of the range of sterile injectable preparations in Russia.

In 1H2016, Russian pharmaceutical market decreased 3.1% PPG in values to RUB 628 bn. In volumes, the market decreased 10.5% PPG to 2.3 bn packages, DSM Group reported. On 14 Sept, Skopinpharm company (part of Pharmimex) officially opened a modernized facility of its plant. The modernization had started in 2014, the investments already amounted RUB 1 bn. Full modernization is planned to require RUB 4.5 bn by 2018.

Takeda launched full cycle manufacturing of Actovegin in a form of sterile solutions for injection at its plant in Yaroslavl. The scientists of Institute for Problems of Chemical & Energetic Technologies of the Siberian Branch of the Russian Academy of Sciences have developed an analgesic, which does not have side effects. The pre-clinical trials of the drug are at the final stage.


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Upharmacia - September 2016  

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