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 2016
Nov 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 3.62
growth, % 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 3.81
growth, % 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 6.91
growth, % 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 2.04
growth, % 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 RATE
UAH / 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 INDICATORS
Export 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) 141.3 142.1 103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3 142.6
growth, % y-o-y -24% -42% 15% 27% 21% 25% 31% 15% 25% 47% 15% -7% 1%
Pharma Retail Sales, values (mio USD) 196.6 212.3 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2 224.7
growth, % y-o-y -20% -18% -17% -1% -5% -1% -8% -2% 2% 2% -1% 3% 14%
Pharma Retail Sales, volumes (mio units) 129.0 136.4 133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6 139.9
growth, % 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 1.61
growth, % 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 Macroeconomic
Indicators in Ukraine
(November 2015-November 2016)

196.6
212.3
198.9
176.0
187.3
178.1
177.6 174.8 175.4
180.9
190.4
212.2
224.7
129.0
136.4
133.6
126.8 133.8
125.2
123.6 122.6 122.7 126.2
135.5
138.6
139.9
100
110
120
130
140
150
160
100
120
140
160
180
200
220
240
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
125.1
130.0
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
5.41
5.17
5.39 5.44 5.61 5.57 5.62
6.39
6.91
1.80
2.01
1.60
1.50
1.64
1.76
1.59
1.73
1.87
1.92
1.76
1.87
2.04
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 24.3
26.4 26.4 25.6 25.2 25.0 24.8 25.1
26.3 25.8 25.7
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
146.6
143.3 140.3
132.7
120.9
109.8 107.5 106.9 107.9 108.4 107.9
112.4 112.1
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
146.6
143.3
Nov Dec
22001155
Page 3
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.

RECRUITING &
EXECUTIVE
SEARCH
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> Quality Assurance
> Finances
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Partner, HR-Consulting
AMaximenko@upharma-c.com
+380 (44) 232-11-43
+380 (97) 953-68-14

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.

Belarus
Delegation 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.
Kazakhstan
Kazakhstan 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.
Georgia
ABC 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.
Azerbaijan
By 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.
Armenia
Prime Minister of Armenia
assigned the Minister of Health to
resolve the issue with counterfeit
pharmaceutical products on local
market.
Russia
Russia 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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Upharmacia - December 2016

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