upharmacia - december 2016

UpharmaciaUkrainian PharmaceUtical market monthly

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

issUe: 12 2016

Ukrainian PharmaceUtical market monthly: December 2016

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

MACROECONOMIC INDICATORS Q4 Q1 Q2 Q3

GDP (US$ bn) 25.588 17.655 21.053

growth, % y-o-y -17% 0.1% -0.02%

Export of Goods (US$ bn) 3.13 3.36 2.04 3.08 2.99 3.10 2.88 2.93 2.92 3.18 3.16 3.24 3.62growth, % y-o-y -21% -11% -31% 3% -13% 1% -2% -5% -7% 3% -6% 0% 16%

Import of Goods (US$ bn) 3.07 3.12 2.23 2.68 3.35 3.05 2.69 2.87 3.09 3.45 3.48 3.54 3.81growth, % y-o-y -27% -32% -26% -6% 5% 7% 2% 4% 4% -11% 8% 10% 24%

Industrial Production Sales (US$ bn) 5.92 6.37 4.93 4.93 5.41 5.17 5.39 5.44 5.61 5.57 5.62 6.39 6.91growth, % y-o-y -19% -17% -18% 8% -2% -12% -5% -6% -2% 3% -2% 2% 17%

Retail Turnover of Enterprises (US$ bn) 1.80 2.01 1.60 1.50 1.64 1.76 1.59 1.73 1.87 1.92 1.76 1.87 2.04growth, % y-o-y -33% -29% -19% 4% 2% 6% -18% -6% -3% 2% -5% -8% 14%

Unemployment Rate (%) 1.6 1.9 1.9 1.9 1.7 1.6 1.6 1.5 1.4 1.3 1.3 1.2 1.3

Average Salary (US$) 193 223 180 174 187 191 198 214 217 208 204 208 210

OFFICIAL CURRENCY EXCHANGE RATEUAH / USD 23.3 23.4 24.3 26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8 25.7

UAH / EUR 25.1 25.4 26.3 29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5 27.8

PHARMACEUTI CAL INDUSTRY INDICATORSExport of Pharma Products (mio USD) 11.7 15.77 8.31 13.33 15.54 13.90 14.17 16.15 13.36 13.58 18.81 18.40 14.75

growth, % y-o-y -52% -28% -30% 11% 16% 3% 9% 5% -4% 51% 37% 51% 26%

Import of Pharma Products (mio USD) 141.3 142.1 103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3 142.6growth, % y-o-y -24% -42% 15% 27% 21% 25% 31% 15% 25% 47% 15% -7% 1%

Pharma Retail Sales, values (mio USD) 196.6 212.3 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2 224.7growth, % y-o-y -20% -18% -17% -1% -5% -1% -8% -2% 2% 2% -1% 3% 14%

Pharma Retail Sales, volumes (mio units) 129.0 136.4 133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6 139.9growth, % y-o-y -4% -5% 1% -12% -5% 2% -1% 4% 3% 3% 7% 6% 8%

WACP (USD) 1.52 1.56 1.49 1.39 1.40 1.42 1.44 1.43 1.43 1.43 1.41 1.53 1.61growth, % y-o-y -18% -14% -23% -23% 13% 1% -2% -6% -3% -1% -8% -3% 6%

CPI of Ukraine 146.6 143.3 140.3 132.7 120.9 109.8 107.5 106.9 107.9 108.4 107.6 112.4 112.1

Pharmaceutical Products CPI 138.1 134.6 131.9 126.9 113.5 108.4 107.3 108.2 107.4 107.2 107.9 107.6 107.4

Local Companies share, values (%) 41.7 40.9 42.3 42.9 42.7 42.3 42.9 42.8 42.8 41.8 42.6 40.8 41.8

Local Companies share, volumes (%) 75.8 76.7 75.6 76.5 76.5 76.7 77.2 77.4 77.9 68.9 68.4 67.5 68.2

MACROECONOMIC ENVIRONMENT

Description of the indicators:

MACROECONOMIC INDICATORS

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

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

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

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

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

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

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

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

PHARMACEUTICAL INDUSTRY INDICATORS

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

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

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

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

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

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

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

Table: Key MacroeconomicIndicators in Ukraine

(November 2015-November 2016)

196.6

212.3

198.9

176.0

187.3

178.1177.6 174.8 175.4

180.9

190.4

212.2

224.7

129.0

136.4133.6

126.8 133.8125.2

123.6 122.6 122.7 126.2

135.5

138.6 139.9

100

110

120

130

140

150

160

100

120

140

160

180

200

220

240

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

Pharmaceutical Market Retail Sales2015 2016

Volumes

Values mio USD

mio units

196.66

221122.33

129.00

136.4

Nov Dec

2015

11.7

15.8

8.3

13.3

15.5

13.9 14.2

16.1

13.4 13.6

18.8 18.4

14.8

141.3 142.1

103.7

145.0

125.1130.0

110.4

132.1 133.1

137.3 140.6

137.3 142.6

0

20

40

60

80

100

120

140

160

0

4

8

12

16

20

24


Ukraine's International Trade in Pharma Production

2015 2016

Export

Import

mio USD

mio USD

11.7

15.8

141.3 142.1

Nov Dec

2015

5.92

6.37

4.93 4.93

5.415.17

5.39 5.44 5.61 5.57 5.62

6.39

6.91

1.80

2.01

1.601.50

1.641.76

1.591.73

1.871.92

1.761.87

2.04

0.0

0.5

1.0

1.5

2.0

2.5

3.0

0

1

2

3

4

5

6

7


Industrial Production Sales & Retail Turnover of Enterprises Surplus

2015 2016

Retail turnover of enterprises

Industrial production sales

bn USD

5.92

6.37

1.80

2.011

Nov Dec

2015

bn USD

23.3 23.4 24.326.4 26.4 25.6 25.2 25.0 24.8 25.1

26.3 25.8 25.7

25.1 25.426.3

29.3 29.2 29.1 28.5 28.1 27.5 28.129.5 28.5 27.8

146.6143.3 140.3

132.7

120.9

109.8 107.5 106.9 107.9 108.4 107.9112.4 112.1

0

20

40

60

80

100

120

140

160

0

5

10

15

20

25

30

35

40

45

50


2015 2016 Official Currency Exchange Rates vs. Consumer Price Index

UAH / EUR

UAH / USD

CPI

2233.33 23.4

25..11 25.4

146.6143.3

Nov Dec

22001155


KEY ECONOMIC EVENTS

» Ukrainian government made the decision to fully nationalize the biggest Ukrainian bank Privatbank to avoid its insolvency. The National Bank of Ukraine estimated the capital cap of the bank at UAH 148 bn. It plans to contribute UAH 116 bln in state bonds to the bank’s equity.

» The IMF endorsed the nationalization of Privatbank and noted that negotiations on provision of the next tranche to Ukraine resume in Jan 2017.

» Ukrainian Parliament approved the 2017 State Budget, which based on 3% GDP deficit, 3% y-o-y GDP growth forecast, 8.1% y-o-y inflation and average exchange rate at 27.2/USD.

» Economic experts see the war conflict in the east of Ukraine as the #1 restraining factor for the economic development. The complete cease of the war will lead to returning of international investors to Ukraine, while the creditors will provide declared tranches, experts say. However, if the baseline scenario for 2017 will be realized (GDP growth 2.5-3%, inflation 8-10%), experts envisage the national currency rate at UAH 29-30/USD 1 by the year-end.

» EU Council committee achieved compromise with the European Parliament on the mechanism of halting a visa-free regime for Ukraine and Georgia. The approval of the document should occur in mid-Jan 2017.

» The EBRD opened its second regional office in Ukraine in Kharkiv. The Bank plans to accelerate its activity in Eastern Ukraine. The third regional office is to open in Odesa in Feb 2017. “The EBRD is sending a strong signal that we see the prospects and a great potential of the country,” the Managing Director for Eastern Europe and the Caucasus Francis Malige said.

» “Ukraine has lately carried out intense and unprecedented reforms across its economy and political system, while its democratic institutions have been further revitalized,” the joint report of the European Commission and the European External Action Service stated.

http://www.liga.net/projects/prognozi2017/

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MARKET & COMPANIES NEWS

Gilead defends exclusivity of sofosbuvir in Ukraine

American company Gilead intends to continue defending the exclusivity of its sofosbuvir drug (Sovaldi) in Ukraine by appealing to the Court of Appeal. On Oct 24, 2016, Kyiv District Administrative Court refused to cancel the state registration of sofosbuvir generic drug Grateciano, which had been registered in Nov 2015 after Sovaldi in Oct 2015. Gilead appealed for 5-year exclusivity for Sovaldi, while the Court stated that the company had not received the “blocking patent”, prohibiting the sale of other drugs with the same active ingredient on the territory of Ukraine.

Grateciano is produced by European Egyptian Pharmaceutical Industries (part of Pharco). It was registered in Ukraine by Euro Pharma International, LLC; it’s marketing is carried by Ayapharma, LLC. In Jul 2016, Gilead included Ukraine in Global Access Program, which allowed to supply Sovaldi in Ukraine for $250. Retail prices of Grateciano vary from $500 to $1,000.

EBRD will credit two Ukrainian companies

EBRD will provide USD 3.8 mio loan to Ukrainian Scientific and Production Company Ecofarm for the completion of construction of GMP plant in Slavuta (Khmelnytskyi region). The 7-year loan is provided within the program for financial support of SMEs and EU4Business initiative. Ecofarm produces herbal antiviral drugs. Currently, the company’s portfolio includes

4 original preparations, which are contractually produced at the facilities of several Ukrainian companies.

The Bank will also provide a EUR 3 mio loan to Pharma-Start (part of Acino). The funds will be used for the procurement of equipment and the implementation of energy efficiency measures, as well as to satisfy company’s working capital needs. The company is also to receive the grant for EUR 110 ths for energy efficiency measures. Swiss pharmaceutical group Acino acquired Ukrainian company Pharma-Start in 2015. The integration of Pharma-Start to Acino will take two years, while the company’s portfolio is to expand to include 50-90 generic products.

Teva admitted to paying bribes to Ukrainian officials

Israel pharmaceutical company Teva agreed to pay about USD 283 mio to resolve charges for corrupt activity in Ukraine, Russia and Mexico. The company admitted that between 2011 and 2011, it engaged the official within the Ukrainian MOH to influence registration of Teva’s medicines, including Copaxone and insulin. In exchange, the company payed him a monthly fee and covered some expenses.

Teva was the 10th company on Ukrainian retail drug market in 2015. It also actively participates in public procurements.

Ukraine to access new markets in Africa

On Dec 8, the Trade Mission to Africa, headed by the Deputy Head of

the Trade Ministry of Ukraine, held the meetings with the representatives of the Bureau of standards of the United Republic of Tanzania, the State Service for drug and food safety and the Head of the Department of medical shops of Tanzania. At the meetings, Ukrainian side received the detailed information on the demands to import the medical production in the country and the features of participation in public tenders. After the meetings, it was agreed, that Ukrainian companies concerned will send requests to the authorities for quick registration to participate in the nearest tenders for the supply of medicines to Tanzania.

Moreover, the Head of the MOH of Kenya reported the intention to accelerate the access of Ukrainian medicines to the local market. Earlier this year, Kenyan authorities stated about the possibility to use Ukrainian drugs to fight tuberculosis in the country.

Farmak intends to access the US market

Leading Ukrainian pharmaceutical company Farmak joined Drug, Chemical & Associated Technologies Association (DCAT). DCAT is a non-profit organization, that powers relationships and industry knowledge for companies engaged in the business of pharmaceutical development and manufacturing. DCAT membership allows its participants to receive support to pass regulatory requirements of the FDA.

The receiving of the membership is aimed to contribute to Farmak’s plans to jointly launch its strategical drugs onto the


REGULATORY UPDATES

New license terms for the production of medicinal products, wholesale and retail trade in medicinal products and import of medicinal products (except for active pharmaceutical ingredients)

On Nov 30th, 2016, the Cabinet of Ministers of Ukraine by its Resolution No. 929 approved the License Terms for the Production of Medicinal Products, Wholesale and Retail Trade in Medicinal Products and Import of Medicinal Products (Except for Active Pharmaceutical Ingredients) (hereinafter – the “License Terms”).

The License Terms have combined license terms for four types of economic activities regarding medicinal products that were previously approved by two separate regulatory acts. It will make it somehow difficult for the licensees engaged not in all, but only in a single type of economic activities, such as import of medicinal products, to “navigate” in them, however, it complies with the requirements of the current licensing legislation.

Although the list of documents to be attached to the application for a license for the relevant types

of activities has not changed significantly, rather than making a blanket reference to the article of the ineffective law, the entire exhaustive list of such documents in accordance with the Law “On Licensing of Economic Activities” is provided in the License Terms. The only essential change for the licensees was the requirement to provide plain-text information that the activities of the applicant for a license are not controlled by persons - residents of other states engaged in armed aggression against Ukraine and/or whose actions create conditions for the emergence of armed conflict and the use of military force against Ukraine. As the licensees already known provisions of the Law of Ukraine “On Licensing of Economic Activities”, establishment of such a decisive influence on economic activities of the licensee is one of the reasons for cancellation of the license.

Another change, which is bringing the License Terms in line with the Law “On Licensing of Economic Activities”, is to secure the place of activities for each type requiring licensing. Information about such places of activities (their change, termination of activities and establishment of new places) is entered to the

Unified State Register. Each of such premises must be specified in the application for a license, since as opposed to the currently effective license terms, it is prohibited to carry out activities outside such places.

As for import, as mentioned earlier, most of the changes take effect in 2018. Other changes are rather specific, however still require individual amendments, for example, to medicinal products supply agreements.

Thus, the License Terms introduced a number of general organizational requirements under the Law “On Licensing of Economic Activities”, and set some rules for each type of economic activities in the area of medicinal products circulation.

Draft amendments to the mechanism of state regulation of prices for medicines published

On Dec 23, 2016 Draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine No. 862 as of Nov 9, 2016” was published on the of the Ministry of Health of Ukraine website.

One aim of this draft is to return the supply and sale, and retail

Provided by

US market. Thereby, Farmak continues to expand its external markets striving to enhance its sales. Within the strategy, in Jan 2016, the company acquired Polish distributor KWW Kotkowski Wierzbicki Wegrzyn sp.j.


markups on medicinal products and medical supplies that were stipulated in para 1 of Resolution of the Cabinet of Ministers No. 955.

You will recall that para 1 of Resolution of the Cabinet of Ministers No. 955 provided for maximum supply and sale, and retail markups not exceeding 10 percent on gross wholesale prices including taxes and duties, and maximum trade (retail) markups not exceeding 25 percent on the purchase price including taxes, for all medicines included in the National List of Essential Medicines. Moreover, the paragraph stated that the maximum supply and sale markups and maximum trade (retail) markups for medicines procured in whole or in part at the expense of the state and local budgets should be 10 percent.

However, Resolution of the Cabinet of Ministers of Ukraine No. 862 will cancel the above markups from Jan 1, 2017. Instead it states that markups will remain only for 21 International Non-Proprietary Names (INPN) of the list validated by the recently adopted Resolution of the Cabinet of Ministers of Ukraine No. 863 as of Nov 9, 2016 in the amount of 5 percent of supply and sale markup and 15 percent of retail markup including taxes and duties.

The MOH has promulgated the procedure for reimbursing cost of medicines

On Dec 23, 2016 draft Order of the Ministry of Health “On Approval of the Procedure for Determining the Cost of Medicines Reimbursement Amount” was published on the website of the Ministry of Health of Ukraine for public comment.

Cost of medicines included in the list of 21 International Non-Proprietary Names (INN) for hypertensive diseases, bronchial asthma and diabetes of the

second type treatment approved by Resolution of the Cabinet of Ministers of Ukraine No. 863 as of Nov 9, 2016 is subject to reimbursement.

The key aspect is the division of all medicinal products that are subject to reimbursement into 2 groups as follows: the cost of which is reimbursed in full and the cost of which is not subject to reimbursement. The draft stipulates that the price of the medicines, gross wholesale price of which per unit of a form of a prescribed dosage is in the range between the maximum gross wholesale price and the minimum gross wholesale price, will be reimbursed, which is price for the medicines of 1 group.

The minimum gross wholesale price is the cost of one unit of a form of prescribed dosage of a medicinal product included in the INPN List, which is determined in accordance with this procedure based on internal reference pricing excluding supply and sale, and trade (retail) markups. This maximum gross wholesale price is determined through external referencing.

Thus, if the price of a medicine is between the minimum and maximum gross wholesale price, it will be 100% reimbursed. The rest of the medicines included in the List of 21 INPN, the price of which is beyond these limits, are not subject to reimbursement.

It should be noted that the price subject to reimbursement will be determined per unit of a medicinal product. Full cost of the package subject to reimbursement will be calculated by multiplying the cost of such one unit by the number of units in the package.

In order to include a medicinal product trade name in the Register of Reimbursement, an owner or authorized representative of the owner of the registration certificate for the medicinal product will have to file with the Ministry of Health the

documents, the list of which is stipulated in the Procedure and is exhaustive.

The MOH has developed drafts to be guided by when calculating maximum grow wholesale prices

On Dec 23, 2016 two regulatory drafts adopted pursuant to Resolutions of the Cabinet of Ministers of Ukraine No. 862 and 863 were published on the website of the MOH of Ukraine for public comment.

The draft order of MOH of Ukraine “On Approval of the Procedure for Calculating the Maximum Gross Wholesale Prices for Medicinal Products” establishes a mechanism for setting maximum gross wholesale prices for 21 International Non-Proprietary Names (INN) of medicines for hypertensive diseases, bronchial asthma and diabetes of the second type treatment approved by Resolution of the Cabinet of Ministers of Ukraine No. 863 as of Nov 9, 2016.

Maximum gross wholesale price will be calculated for each form of effect of each medicine from the list of 21 INN. These maximum indicators will be calculated based on the least unit of a form of effect of each medicinal products from the list of 21 INN in reference countries. In other words, gross wholesale price in Ukraine cannot exceed a minimum price per unit of a form of effect established in the reference countries.

The reference countries for the purposes of external price referencing are the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia and Hungary. At the same time, the sources from which the MOH will receive the value of gross wholesale prices in these countries are listed in the annex to the draft Order.

Please note that business entities


HEALTHCARE NEWS

Hospital districts to be developed is Ukraine

On Nov 30, the MOH approved the Procedure for the creation of hospital districts and obliged the local authorities to develop them in accordance with the standards provided by the Ministry.

Hospital district is a functional association of health care institutions located in the respective territories, ensuring the provision of secondary (specialized) medical care to the population of these territories. Each district will contain one intensive care hospital, which should be the most powerful in the district, while the other ones are reoriented to provide services that do not require high-tech equipment. The administrative center for the district should be the city with a population of over 40 ths., where the head intensive care hospital is located.

Hospital districts should be created and function on the basis of criteria developed and approved by the MOH. According to the plan, the Ministry is obliged to approve the Provision on the hospital district by the end on

Dec 2016 and submit to the government the Draft regulatory act on approval of the list and the composition of hospital districts by Feb 1, 2017.

MOH wants to adapt ProZorro to medical procurements

The Head of the MOH noted that the Ministry intends to adapt ProZorro system to procurement of drugs for the state funds. “Medical procurements have its features,” Mrs. Ulana Suprun said. “For example, drugs have a dosage form, while ProZorro currently does not provide such features. That is why, the specialists are developing the possibility to procure drugs through the system.”

ProZorro is an electronic system of public procurements, which allowed to save about UAH 8 bn funds in 2016. The government plans to start carrying public procurement of medicines through the special national procurement organization since 2019. The organization is currently under development by the MOH together with international procurement

organizations.

MVP of eHealth to be developed by Feb 2017

The MOH and participants of eHealth initiative plans to develop the draft version of the Minimum viable product (MVP) of eHealth by the end of Feb 2017. MVP is aimed to provide management and administration of processes of primary health care reform. It is to become the first stage within the creation of eHealth system in Ukraine, which planned for 2017-2018.

Stage 1 – development of MVP to reform the funding of primary health care.

Stage 2 – introduction of additional electronic tools to ensure the process of drug reimbursement and provision of diagnosis to the patient.

Stage 3 – creation of the new tools to support other directions of healthcare reformation.

Stage 4 – functional expansion, introduction of additional services that contain medical information about the patient.

The Head of the MOH called

are not involved to calculate the maximum gross wholesale prices. All maximum wholesale prices for medicines are contained in a single register maintained by the Ministry of Health and published on its website.

Monitoring of changes in wholesale prices, as well as updating of the register of maximum gross wholesale prices of medicinal products will be

carried out on a quarterly basis by the fifth day of the first month of the next quarter (Jan 5th, Apr 5th, Jul 5th and Oct 5th) and will be made public on the official website of the MOH. Carrying out such monitoring and updating the Register is assigned to a state-owned enterprise belonging to the sphere of the MOH management.

On Dec 28, 2016, the government amended the Resolution No.

862 to allow the sale of residues of drugs included in reference pricing list, which have been supplied in the pharmacy network under the wholesale sell prices, which were higher than the maximum level, until Feb 1, 2017.


BelarusDelegation of Pakistan pharmaceutical producers will visit Belarus in 2017 to discuss the possible ways of cooperation. Some companies are interested in creation of joint enterprises with Belarus partners.

KazakhstanKazakhstan authorities registered Sofgen (sofosbuvir, Hetero Labs Ltd), the first generic of sofosbuvir in the country. Original drug Sovaldi is not registered in Kazakhstan yet.

According to Business Monitor International forecast, in 2016, the pharmaceutical market of Kazakhstan to decrease 28.5% y-o-y in values to USD 1.120 bln. In 2017, the 12.5% y-o-y growth is projected.

GeorgiaABC Pharmacy that holds a dominant position (second place

after PSP) since 2015, plans to merge with GPC and establish a new corporation – Georgian Pharmacy (GEPHA), which will combine Pharmadepot and GPC management.

AzerbaijanBy 2018, Azerbaijan will have four operating pharmaceutical plants, the Prime Minister said. To decrease the country’s dependence on imports of pharmaceuticals, in Sep 2016, the government created the Pirallahi Industrial Park. In 2016, the construction of two pharmaceutical plants with participation of foreign investors from Iran and Russia has started.

ArmeniaPrime Minister of Armenia assigned the Minister of Health to resolve the issue with counterfeit pharmaceutical products on local market.

RussiaRussia plans to start registration of medical devices within the Eurasian Economic Union (EEU) since Jan 1, 2017. The Parliament will need to amend the Tax Code.

Binnopharm company (part of Sistema Corporation) acquired 100% share in Alpharm, LLC, and announced the entrance to the OTC market. Alpharm was producing two OTC drugs in form of suppositories. In Dec, Binnopharm also signed the license agreement with MEDICE Arzneimittel Pütter GmbH & Co. KG (TOP-15 OTC producer in Germany) to become its exclusive representative in Russia.

The government added 62 positions in the list of foreign medical devises, the sales of which is limited within public procurements.

The government postponed the pilot project on drugs labeling

CIS REGION PHARMA NEWS

the reform the most important one in the last 25 years, which changes the entire logic of the relationships between the state, doctors and patients.

The MOH wants pharmaceutical producers and public organizations to amend the National list of medicines

The MOH proposes pharmaceutical companies and public organizations to develop additions and amendments to

the National list of essential medicines.

“We expect form you the ideas regarding inclusion and exclusion of medicines from the List,” the Head of the MOH said. “In two years, we aim to develop the common National list of high quality and economically feasible drugs to provide them to the maximum number of patients.”

The Minister noted that since 2019, the government will procure only drugs included in the National list. Some of

them will be also included in the reimbursement program. The Draft National list of essential medicines was promulgated for public discussion in Dec. It included 345 INNs (265 INNs – essential, 100 INNs additional). The List is expected to be approved in Jan 2017.


from Jan 1, 2017 to Mar 1, 2017.

Russian company Novamedica signed contract with Pfizer, within which Pfizer will invest in the construction of Novamedica’s plant and will give it the licenses for manufacturing of more than 30 drugs to be produced under Novamedica’s brand

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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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+380 (44) 232 1142+380 (44) 232 [email protected]

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