Upharmacia - January 2017 - SPECIAL EDITION

Macroeconomic Environment
Market & Companies News
Regulatory Updates
Healthcare News
UPHARMACIA
Ukrainian Pharmaceutical
Market Monthly
Issued by UPharma Consulting
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 for Pharma and
Healthcare in the CIS/CEE.
01'17issue SPECIAL EDITION:
2016 FY RESULTS

Upharmacia January 2017
2 www.upharma-c.com
CONTENTS
3 /Macroeconomic Indicators, 2016 FY
4 /Economy Development Summary In 2016
5 /Pharmaceutical Market Summary In 2016
6 /Local Pharma Companies In 2016
7 /Healthcare Sector Development in 2016
8 /Key Regulatory Changes In 2016
9 /Forecasts For 2017
11 /Economy & Pharma Dashboard, 2016 FY
page
11 /Country's Economy In Jan 2017
12 /Pharma Market & Companies News In Jan 2017
13 /Regulatory Updates In Jan 2017
15 /Healthcare News In Jan 2017
17 /CIS Pharma Markets & Events
2016FYSUMMARYJAN2017

3
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INDICATORS
2016
FY
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
MACROECONOMIC INDICATORS
Q1 Q2 Q3 Q4
GDP ($ bn) 17.655 21.053 26.185
growth, % y-o-y 0.1% -0.02% 0.87%
Export ($ bn) 2.04 3.08 2.99 3.10 2.88 2.93 2.92 3.18 3.16 3.24 3.62 3.63 36.4
growth, % y-o-y -31% 3% -13% 1% -2% -5% -7% 3% -6% 0% 16% 8% -3.9%
Import ($ bn) 2.23 2.68 3.35 3.05 2.69 2.87 3.09 3.45 3.48 3.54 3.81 4.13 38.9
growth, % y-o-y -26% -6% 5% 7% 2% 4% 4% -11% 8% 10% 24% 32% 5.8%
Industrial Prod. Sales ($ bn) 4.93 4.93 5.41 5.17 5.39 5.44 5.61 5.57 5.62 6.39 6.91 7.64 69.02
growth, % y-o-y -18% 8% -2% -12% -5% -6% -2% 3% -2% 2% 17% 20% 0.24%
Retail Turnover (US$ bn) 1.60 1.50 1.64 1.76 1.59 1.73 1.87 1.92 1.76 1.87 2.04 2.09 21.38
growth, % y-o-y -19% 4% 2% 6% -18% -6% -3% 2% -5% -8% 14% 4% -2.7
Unemployment Rate (%) 1.9 1.9 1.7 1.6 1.6 1.5 1.4 1.3 1.3 1.2 1.3 1.5 1.5
Average Salary ($) 180 174 187 191 198 214 217 208 204 208 210 247 203
CPI of Ukraine 140.3 132.7 120.9 109.8 107.5 106.9 107.9 108.4 107.6 112.4 112.1 112.4 114.9
GfK Consumer
Sentiment Index
50.2 54.1 50.6 49.1 50.3 52.7 50.1 53.7 50.1 51.6 47.4 57.1 51.4
OFFICIAL CURRENCY EXCHANGE RATE
UAH / USD 24.3 26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8 25.7 26.2 25.6
UAH / EUR 26.3 29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5 27.8 27.6 28.3
PHARMACEUTICAL INDUSTRY INDICATORS
Export of Pharma Products
($ mio)
8.31 13.33 15.54 13.90 14.17 16.15 13.36 13.58 18.81 18.40 14.75 23.95 184.2
growth, % y-o-y -30% 11% 16% 3% 9% 5% -4% 51% 37% 51% 26% 52% 18.6%
Import of Pharma Products
($ mio)
103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3 142.6 169.1 1606.5
growth, % y-o-y 15% 27% 21% 25% 31% 15% 25% 47% 15% -7% 1% 19% 17.8%
Retail Sales, values ($, mio) 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2 224.7 268.0 2344.3
growth, % y-o-y -17% -1% -5% -1% -8% -2% 2% 2% -1% 3% 14% 26% 0.9%
Retail Sales, volumes
(mio units)
133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6 139.9 164.1 1592.6
growth, % y-o-y 1% -12% -5% 2% -1% 4% 3% 3% 7% 6% 8% 20% 2.9%
Average Cost of Pack (USD) 1.49 1.39 1.40 1.42 1.44 1.43 1.43 1.43 1.41 1.53 1.61 1.63 1.47
growth, % y-o-y -23% -23% 13% 1% -2% -6% -3% -1% -8% -3% 6% 5% -4.9%
CPI, Pharma Products 131.9 126.9 113.5 108.4 107.3 108.2 107.4 107.2 107.9 107.6 107.4 106.4 111.7
Local Companies share, values
(%)
42.3 42.9 42.7 42.3 42.9 42.8 42.8 42.6 43.4 42.4 42.3 41.7 42.6
Local Companies share,
volumes (%)
75.6 76.5 76.5 76.7 77.2 77.4 77.9 77.6 76.5 75.1 74.9 73.9 76.2
MACROECONOMIC
INDICATORS / 2016 FY

4
2016 YEAR SUMMARY
ECONOMY DEVELOPMENT
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>> ECONOMY
Ukraine managed to tackle recession and demonstrate features of economic
growth in 2016. Key factors of economic recovery were the domestic demand
for investments and a household consumption.
Ukraine’s foreign trade continued a transformation in 2016: there was a shift
from the traditional Russian market (and the CIS market in general) and an
increase of EU countries in a foreign trade share.
Deteriorating Ukr-Rus relations hampered Ukraine’s trade with countries in
the South Caucasus and Central Asia.
The GDP grew by +1.8% in the 2016 FY. And the Ministry of Finance expects it
to grow further +3% in 2017.
International reserves of the NBU reached $15.5 bn at the year-end (increased
16.8% y-o-y).
Monthly CPIs decreased in Apr to 9.8 from 20.9 in Mar and was stable until
Oct when it grew to 12.4. The same amount was in Dec.
In 2016, industrial output grew 2.4% y-o-y compared to 13% y-o-y fall in 2015.
Main industries have shown slight growth: metal production – 5.9% y-o-y,
machinery production – 1.3% y-o-y, chemical – 0.4% y-o-y (pharmaceutical –
3.9%). Mining reduced by 0.3% y-o-y.
Official currency exchange rates for UAH/USD amounted 26.2 in Dec,
compared to 23.4 in Dec 2015.
CONSUMER
INFLATION12.4%
+1.8%
+5.8%
-3.9%
at the year-end, NBU
estimated by
the MoF
68.8
63.3
53.9
37.8 36.4
84.7
77.0
54.4
36.8 38.9
0
10
20
30
40
50
60
70
80
90
2012 2013 2014 2015 2016
Export & Import of Ukraine
USD bnExport Import
4.1% 5.5%
0.2% 0.0%
-6.8%
-9.9%
1.8%
2010 2011 2012 2013 2014 2015 2016
Ukraine's GDP growth
8.0 8.0
11.9
21.8
25.6
10.3 10.6
15.7
24.2
28.3
99.8 100.5
124.9
143.3
112.4
0
40
80
120
160
0
10
20
30
2012 2013 2014 2015 2016
Currency Exchange Rates vs.
Consumer Price Index
UAH/USD UAH/EUR CPI
$ 38.9 bn, NBU
GDP
IMPORT
$ 36.4 bn, NBU
EXPORT

5
Market share of foreign companies in drug segment continued decreasing in values, while in volumes, they
increased their share by 3.1%.
The share of medical devices reduced 0.5% y-o-y in values and 1.2% y-o-y in volumes. Food supplements and
cosmetics slightly increased their shares as compared to 2015.
64.5% 63.1% 59.2% 57.7%
35.5% 36.9% 40.8% 42.3%
0%
50%
100%
2013 2014 2015 2016
Market shares of Foreign&Local pharma
companies
retail segment,
in values
Foreign Domestic
32.5% 28.2% 23.2% 26.3%
67.5% 71.8% 76.8% 73.7%
0%
50%
100%
2013 2014 2015 2016
Market shares of Foreign&Local pharma
companies
retail segment,
in volumesForeign Domestic
84.5%
7.9%
3.7%
3.9%
Market structure by segments
2016, in values
Drugs
Medical devices
Cosmetics
Food
supplements 65.8%
28.4%
3.1%
2.7%
Market structure by segments
2016, in volumes
Drugs
Medical devices
Cosmetics
Food
supplements
3 979 4 485 3 534 2 323 2 344
16.6%
12.7%
-21.2% -34.3%
0.9%
0
1 000
2 000
3 000
4 000
5 000
2012 2013 2014 2015 2016
Ukrainian Retail Pharmaceutical Market
in valuesUSD mio
y-o-y growth, %
1 961 1 992 1 764 1 548 1 593
4.5%
1.6%
-11.5%
-12.3%
2.9%
0
500
1 000
1 500
2 000
2 500
2012 2013 2014 2015 2016
in volumesmio packs
y-o-y growth, %
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2016 YEAR SUMMARY
PHARMACEUTICAL MARKET
>> MARKET TRENDS
In 2016, after two years of drastic fall, Ukrainian pharmaceutical market slightly increased by 0.9% y-o-y in
values to USD 2.34 bn and by 2.9% y-o-y in volumes to 1.59 mio packs. The period of 18-month straight decrease
stopped in Jul when the market grew 2% PPG in values. In the year-end, the growth dynamics vastly accelerated
– in Nov and Dec, the market rose 14% and 26% PPG in values, respectively.

6 www.upharma-c.com
>> PHARMACEUTICAL MARKET: LOCAL PLAYERS GROWTH
Market participants are striving to further development.
—— HALYCHPHARM (a part of the Arterium Corporation) has launched an infusion solutions line.
—— On May 17, INTERCHEM has opened a new laboratory and production complex in Odessa. The company
invested EUR 42 mio in enhancing its industrial capacities, which would allow increasing its production by 4
times.
—— At the beginning of the year, DARNITSA was endorsed to acquire a little bit more than 50% shares of the Bor-
shchahivskiy Chemical Pharmaceutical Plant (BCPP). The Board of BCPP accused Darnitsa of hostile takeover
attempts. The acquisition process was halted.
—— Ukrainian company KUSUM PHARM plans to start enlargement of its plant in Sumy by the end of 2016 to
double production capacity at least 2 times by 2018.
—— In May, Ukrainian company PHARMASCO opened its own complex, which includes offices, warehouse with
appropriate temperature conditions and premises for own production.
—— In Dec, EBRD announced the provision of USD 3.8 mio loan to Ukrainian company ECOPHARM for the
construction of GMP plant. The Bank will also provide USD 3 mio loan to PHARMA-START (part of Swiss ACINO
GROUP) for equipment procurement and additional capitalization.
RETAIL DRUG SALES: +0.4% HOSPITAL DRUG SALES: -6.4%
$ 1.98 bn $ 308.9 mioSource: Morion Source: Morion
2016 YEAR SUMMARY
PHARMACEUTICAL MARKET
>> PHARMACEUTICAL MARKET: FOREIGN EXPANSION
Ukrainian pharmaceutical companies were actively exploring new markets:
—— In Jan, FARMAK acquired polish distributor KWW Kotkowski Wierzbicki Wegrzyn sp.j.
—— In Sep, ARTERIUM acquired Slovenian company Marifarm.
—— In Oct, FARMAK announced plans to enter the Malasian market in 2018.
—— In Oct, BIOFARMA signed a long-term agreement on export of its products to the Republic of Yemen.
—— ZDOROVYE GROUP plans to access the U.S. market within the cooperation with the American company
Unicity.
—— LEKHIM’S company Technolog announced the intention to triple exports of its antituberculosis drugs in next
few years.
—— In Dec, FARMAK joined Drug, Chemical & Associated Technologies Association (DCAT) in order to have the
opportunity to access the U.S. market.

7
1
2
3
4
5
Introduction of the National model of medical insurance
Introduction of a guaranteed health care package
Creation of a single national public procurments organization
Introduction of reimbursement and reference pricing systems
to increase the affordability of drugs
Autonomous status of health care institutions
Establishment of hospital districts
Shift to the principle: “Money follows a patient”
+
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>> HEALTH CARE: BUDGET
Old medical infrastructure, despite the extensive network of health care
institutions (Ukraine keeps the 4th
place in the world in the number of
hospital beds – 879 beds per 100 ths population), does not ensure provision
of quality and timely health care for the population or high wages of
health care workers, and the low level of financing leads to the need for
comprehensive health care reform aimed at reaching European level by
Ukrainian medicine.
In Nov 2016, the Ukrainian government began a health care reform by the
adoption of the Concept of health care reform financing.
Key provisions of the Healthcare reforming concept:
ARTERIAL HYPERTENSION
REFERENCE PRICING & REIMBURESEMENT LIST
TYPE II DIABETESASTHMA
3 INNs 2 INNs 16 INNs
2016 YEAR SUMMARY
HEALTH CARE SECTOR
HEALTHCARE BUDGET 2016
$ 580 mio
HEALTHCARE BUDGET 2017
$ 611 mio
EFFECTIVE DATE
Apr 1, 2017

8 www.upharma-c.com
2016 YEAR SUMMARY
KEY REGULATORY CHANGES
Changes in Procedure for Public Procurements
2016 was the year of the first experience of centralized public procurement of drugs and medical devices
through specialized international organizations, while decentralized procurements were transferred to
Prozorro system. The partners of the MOH have become UNDR, UNICEF and Crown Agents.
National Essential Medicines List
On Jan, 12 the Cabinet of Ministers Resolution #1134 came into force. The National List of Essential Medicinal
Products and Medical Devices has been renamed into the National Essential Medicines List. Therefore, the
medical devices shall not be included into this list anymore and shall not be subject to pricing regulation. The
List should be formed with due consideration of world-wide practices of rational pharmacotherapy and phar-
macotherapeutic approach to primary health care of patients with priority pathologic conditions taking into
consideration disease burden and mortality rate, and health care sector standards. The List will consist of
INNs and will updated once a year.
Simplified Registration Procedure for Medicines
On May 31, the Parliament approved the Law, which provided for the simplified registration of medicinal
products being registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada, and
the European Union in accordance with the centralized procedure.
Such products should be accepted for usage in the territories of the mentioned countries or the EU member
states. The registration procedure for such medicinal products envisages the submission of the smaller
package of documents, reduction of registration terms, and no need for the expertize of the registration
materials.
Decision on registration is issued by the MOH within 17 business days:
—— 10 business days: Review of registration materials by the State expert center.
—— 7 business days: Making the decision by the MOH on registration.
State Regulation of Prices
On Nov 9 the Government has adopted the Resolution of the Cabinet of Ministers of Ukraine #862 “On state
regulation of prices for medicines” and #863 “On the introduction of reimbursement of the cost of medicines”.
The new price regulation system will act through:
—— Maximum prices by implementation of price referencing on medicines by the MOH
—— Maximum mark-ups only for reimbursable medicines purchased through decentralized procurements:
wholesale – 5%, retail – 15%.
Provided by

9
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2017 YEAR FORECASTS
GDP
growth, %
Inflation, %
SigmaBlaizer 3.0 10.0
EBRD 2.0 -
IMF 2.5 11.0
World Bank 2.0 8.5
ECONOMY FORECASTS FOR 2017Economy
According to a majority of forecasts, it is expected that Ukraine’s
economy will recover and its GDP will continue growing. However,
such expectations are rather modest given the fact that Ukraine’s
economy has already survived deep recession at 1.5-3%.
Recovery of domestic demand is among key factors contributing to
economic growth. Private consumption will moderately recover in
the medium term as a result of pent-up demand and rising incomes.
It is also expected that business investments will rise. However, a
substantial increase in investment activity in the near future will
stimulate a respective increase in investment imports, including
machinery and equipment, which will largely increase in a negative contribution of net export to GDP.
A revival of credit activity amid expected reducing interest rates will be an additional factor contributing to
growing domestic demand.
A net export will slow down the GDP growth. Slow global economic growth, including a slowdown in China’s
growth, will curb an increase in Ukraine’s export.
Pharmaceutical Sector
Pharmaceutical market of Ukraine is expected to continue a slight
recovery in 2017. As the purchasing power of the population
continues growing with the growth of the salary levels, the retail
market will increase in both values and volumes.
The negative factor is the instability of the national currency,
devaluation of which is projected at 10% for 2017. The successful
launch of reference pricing and reimbursement for certain
categories of drugs in Apr is supposed to benefit both producers
and customers, but regulatory provisions still raise many questions
within the industry.
According to ProximaResearch projection, the market will increase
by 14-18% in hryvnias and by 2.9% in volumes.
Healthcare Sector
The plans of the Ministry of Health for 2017 are highly ambitious. The main emphasis
will be on the reformation of medical institutions through provision of wider autonomy to the management and
creation of hospital districts.
Moreover, Ukraine is starting the gradual movement towards insurance medicine. First steps are changes in
primary care funding and an introduction of family doctors.
The main factor, which could halt the reformation is the sabotage from the side of officials and lobbyists, which
use the existing system for personal gain. Moreover, the position of Ulana Suprun is unstable as she is still the
acting Minister of Healthcare, while a lot of MOH’s initiatives have been criticizing by publicity as well as senior
officials. Thereby, the success of the reforms will mostly depend on the MOH’s management credibility level and
the industry’s readiness to change.
3 534 2 323 2 344 2 539
-21.2% -34.3%
0.9% 8.3%
0
1 000
2 000
3 000
4 000
2014 2015 2016 2017
Forecast
in values
USD mio
y-o-y growth, %
1 764 1 548 1 593 1 639
-11.5%
-12.3%
2.9% 2.9%
0
500
1 000
1 500
2 000
2 500
2014 2015 2016 2017
Forecast
in volumes
mio packs
y-o-y growth, %
Source: ProximaResearch
Source: ProximaResearch

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11
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ECONOMY & PHARMA
DASHBOARD / 2016 FY
ECONOMY IN BRIEF
JANUARY 2017
—— General budget deficit amounted UAH 54.7 bn
in 2016, which is 2.4% of GDP. The projected
indication was 3.7% of GDP.
—— Average annual devaluation of the hryvnia that
was 15% in 2016 would slow to 10% in 2017, Dragon
Capital investment company projected.
—— The Ukrainian Trade Ministry expects the foreign
direct investments (FDI) in Ukraine to grow from
USD 3.8 bn in 2016 to USD 4.5 bn in 2017.
—— According to the NBU, in 2016, Ukrainians
purchased USD 747.1 mio from banks, which is
9.2% more than in 2015. Sale of foreign currency
increased 44.6% y-o-y to USD 3.22 bn.
—— In 2016, industrial prices in Ukraine, rose 35.7%
198.9
176.0
187.3
178.1 177.6 174.8 175.4
180.9
190.4
212.2
224.7
268.0
133.6
126.8
133.8
125.2 123.6 122.6 122.7
126.2
135.5
138.6 139.9
164.1
100
120
140
160
180
80
120
160
200
240
280
Pharmaceutical Market Retail Sales
mio USD
mio units
2016
8.3
13.3
15.5
13.9 14.2
16.1
13.4 13.6
18.8 18.4
14.8
23.9
103.7
145.0
125.1
130.0
110.4
132.1 133.1 137.3 140.6 137.4
142.6
169.1
0
30
60
90
120
150
180
0
5
10
15
20
25
30
Ukraine's International Trade
in Pharma Production
Export
Import
2016
mio USD
4.93 4.93
5.41
5.17
5.39 5.44 5.61 5.57 5.62
6.39
6.91
7.64
1.60
1.50
1.64
1.76
1.59
1.73
1.87 1.92
1.76
1.87
2.04 2.09
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
8
Industrial Production Sales &
Retail Turnover of Enterprises Surplus
2016
bn USD
23.4 24.3
26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8 25.7 26.2
25.4 26.3
29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5 27.8 27.6
143.3 140.3
132.7
120.9
109.8 107.5 106.9 107.9 108.4 107.9
112.4 112.1 112.4
0
20
40
60
80
100
120
140
160
0
5
10
15
20
25
30
35
40
45
50
Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
UAH/USD
UAH/EUR
CPI
2016 Official Currency Exchange Rates vs.
Consumer Price Index
y-o-y, the State Statistics Service reported.
—— Inflation in Ukraine in 2016 slowed down to
12.4% from 43.3% in 2015 and 24.9% in 2014.
According to the Statics Service, in Dec 2016,
inflation stood at 0.9% against 1.8% in Nov and
2.8% in Oct.
—— VAT refunds in Ukraine in 2016 totaled UAH
94.3 bn, which is 37.9% more than in 2015 (UAH
68.4 bn) and 87.8% more than in 2014 (UAH 50.2
bn).
—— In 2016, Ukraine reduced natural gas
consumption by 4.1% y-o-y to 32 bn cubic
meters. In 2015, the consumption of gas fall
20.9% y-o-y.

12 www.upharma-c.com
MARKET & COMPANIES
JANUARY 2017
In 2017, Biofarma to Invest
UAH 40 mio in its Production
Ukrainian
producer
of blood
preparations plans to invest
UAH 40 mio in its production
and to launch 15 new products
in 2017, the Chairman of
the Supervisory Board
Konstantin Efimenko of the
company said. The company
also expects increase of its
retail sales by 30% y-o-y and
growth of its exports by 50%
y-o-y. To expand its export
opportunities, Biofarma seeks
to finish formation of 25
pharmaceutical dossiers in the
European format. This year,
Biofarma is also to launch a
new plasma fractionation plant.
According to Mr. Efimenko,
in 2016, Biofarma increased
pharmacy sales by 36.6% y-o-y
to UAH 372.7 mio, while its
export enhanced 60% y-o-y.
Unipharm Will
Present Interests
of Bosnalijek in
Ukraine
U.S. company Unipharm,
Inc. reached the agreement
with largest pharmaceutical
company in Bosnia and
Herzegovina Bosnalijek d.d. on
presentation of the company’s
interests in Ukraine. Unipharm
will manage Bosnalijek’s
product portfolio including the
distribution, registration, re-
registration and promotion in
Ukraine. The deal is expected to
be completed by Apr 2017.
The Director of Unipharm
representative office in Ukraine
Alexander Shalunov will lead
the RO of Bosnalijek to provide
effective integration of two
businesses.
“We are sure, that the decision
made will strengthen positions
of both companies and ensure
the development within the
difficult conditions of the
Ukrainian pharmaceutical
market,” the Unipharm
press-release said.
Farmak Received GMP
Certificate for Production
of APIs in
Shostka
Production
facilities of the Ukrainian
company Farmak in Shostka
(Sumy Region) has passed
inspection on their compliance
with national and European
GMP requirements. In Dec 2015,
Farmak created a separate
manufacturing of substances
in Shostka. The manufacturing
was established as part of
expansion of production of
finished drugs and active
pharmaceutical ingredients
(API). The complex includes
manufacturing sites, quality
control laboratories and logistic
center. The staff currently
includes 86 employees.
Farmak retained a leading
position on the Ukrainian
pharmaceutical market in 2016.
Ukraine to Reach Voluntary
Settlement with Gilead on
Sofosbuvir
Ukrainian
government will
sign voluntary settlement with
Gilead Sciences Inc. regarding
patent protection of Sovaldi
(sofosbuvir). Earlier, the U.S.
company sought to cancel
state registration of sofosbuvir
generic Grateziano (Pharmco),
which had been registered
before Sovaldi. In Oct 2016, Kyiv
Administrative Court refused
to cancel state registration of
Grateziano.
“During negotiations, we have
managed to find a compromise
for Gilead to renounce it’s
claims to Ukraine,” the Justice
Minister of Ukraine said. “We
will take measures to eliminate
violations of the legitimate
patent rights, while Gilead is to
provide the Ukrainian market a
discount on the drug”.
After reaching the agreement,
Gilead would not raise any
financial claims, the company’s
officials said. Within the Global
Access Program, where Ukraine
is included, the price of Sovaldi
for public procurements should
be USD 250 per package.

13
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REGULATORY UPDATES
JANUARY 2017
Simplified Drug Registration
Came Into Force
On Jan 3, 2017, the Ministry
of Justice of Ukraine has
registered the order of
the MOH on launch of the
mechanism on simplified
registration of medicines
registered in countries with
strong regulatory authorities.
The new mechanism provides
for the simplified registration
of medicinal products being
registered by the competent
authorities of the USA,
Switzerland, Japan, Australia,
Canada, and the European
Union in accordance with the
centralized procedure.
Such products should be
accepted for usage in the
territories of the mentioned
countries or the EU
member-states.
The registration procedure
for such medicinal products
envisages the submission of the
smaller package of documents,
reduction of registration terms
(17 business days), and no
need for the expertize of the
registration materials.
New Procedure for
Calculating Maximum Gross
Wholesale Prices for
Medicinal Products on the
Basis of Reference Prices
On Dec 29, 2016, in pursuance
of Resolution of the Cabinet
of Ministers of Ukraine "On
State Regulation of Prices for
Medicinal Products" No. 862, the
Ministry of Health of Ukraine
adopted Order No. 1423, thereby
approving the Procedure for
Calculating Maximum Gross
Wholesale Prices for Medicinal
Products on the basis of
Reference Prices (hereinafter -
the Procedure).
The Procedure was officially
published and came into
force on Jan 6th, 2017. The
Procedure applies to medicinal
products used in treatment
of cardiovascular diseases,
diabetes of type II and bronchial
asthma, the cost of which is
refundable in accordance with
Resolution of the Cabinet of
Ministers of Ukraine No. 863 as
of Nov 9, 2016 (21 INNs in total).
As its name implies, the
Procedure establishes a
mechanism for calculating
maximum gross wholesale
prices for medicinal products on
the basis of reference prices.
The latter are determined in
UAH (reference prices in foreign
currencies are denominated in
UAH at the official NBU rate as
of the date of determination
of prices), taking into account
the data on registered prices
for medicinal products (of
each dosage form) obtained
from official sources of the
authorized public authorities
of the following reference
countries: the Republic of
Poland, the Slovak Republic, the
Czech Republic, the Republic of
Latvia and Hungary.
Maximum gross wholesale
price of a single dosage form
of a medicinal product from
among 21 INPN is calculated
as the smallest reference
price of a unit of each dosage
sample values of the respective
reference prices in the
countries using the following
algorithm:
MGWP = MIN (RP1 ... RPN),
Where MGWP – maximum gross
wholesale price;
RP1 RPN - reference prices in
the reference countries.
New Procedure for Pharmaco-
vigilance
A new Procedure for Phar-
macovigilance approved by
Order of the Ministry of Health
of Ukraine No. 898 as of Dec
27, 2016 (hereinafter - the
Procedure) entered into effect
on Jan 6, 2017.
In addition to significant
additions and changes to
the terminology, the new
Procedure also specifies new
requirements to the applicant's
Provided by

14
pharmacovigilance system,
without which circulation of
medicinal products, vaccines
and tuberculin is not permitted
in Ukraine.
Thus, the applicant must
establish and manage at least
one pharmacovigilance system,
which consists of elements
allowing for the monitoring of
safety of medicinal products,
vaccines and tuberculin and
determining any changes in
benefit / risk ratio, namely:
i. that the applicant
(permanently and continuously)
has at least one qualified
authorized person responsible
for pharmacovigilance.
Depending on whether the
applicant is in Ukraine or not,
the authorized person must
be either an employee of the
applicant (for applicants who
are residents), or a contact
person should be designated
on the territory of Ukraine
and be subordinated to the
applicant’s authorized person
(for non-resident applicants).
These persons must have higher
medical or pharmaceutical
education (pharmacist, clinical
pharmacist);
ii. a structured system of
organization of pharmacovigi-
lance, its update and support;
iii. documentation of all
procedure processes;
iv. creation and maintenance of
databases used by the applicant
for pharmacovigilance;
v. involvement (if needed) of
other legal and / or natural
persons and enterprises,
institutions and organizations
into pharmacovigilance by
entering into contractual
relationships;
vi. providing training of
personnel of the applicant to
carry out activities related to
pharmacovigilance;
vii. creation of pharmacovigi-
lance quality system;
viii. pharmacovigilance
documentation processing,
including its storage and
archiving;
ix. creation and support of the
risk management system.
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15
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HEALTHCARE NEWS
JANUARY 2017
The Government Postponed
Reference Pricing to Apr 1
On Feb 1, the Cabinet of
Ministers approved the decision
to postpone the introduction
of reference pricing for some
categories of drugs from Feb 1
to Apr 1.
Such decision was made after
the acting Head of the MOH
Ulana Suprun stated that
the implementation of the
mechanism would require
a longer transitional period
associated with the gradual sale
of drug residues.
“We cooperate with represen-
tatives of the pharmaceutical
market, and already have
information that some
producers reduced prices by
15-30%, others are continuing
the cooperation,” Mrs. Suprun
stated. “Therefore, we want to
give them a longer transitional
period to ensure the provision
of affordable medicines the
population”.
Earlier, the MOH has already
postponed the reference pricing
from Jan 1 to Feb 1 in order to
provide pharmacies the period
during which they could sell
the residues of drugs, which
had been supplied under the
wholesale prices that exceed the
maximum level.
Despite this, the market
operators still expressed the
concern about the possibility
of the disappearance of some
original products of foreign
manufacturers due to their
inability to decrease the prices.
Government Plans to Reduce
Duration of Hospitalization
and Increase the Number of
Primary Care Physicians
Within the government’s Plan of
priority actions for the period
up to 2020, it is planned to
decrease the average duration
of hospitalization form 11.8
days to 9.2 days. Herewith,
the number of primary care
physicians is expected to grow
from 7 ths to 20 ths.
It is noted that a lot of
healthcare funds in Ukraine are
used ineffectively. Ukraine is
the fourth country in the world
by the number of hospital beds
per capita, while the healthcare
indicators are among the worst
in Europe.
Therefore, in 2017, the
government plans to
introduce new funding model
for healthcare system with
emphasis on primary care
and to define the guaranteed
package of services.
EBA Asks for Clear
Explanations on Reference
Pricing and Reimbursement
European Business
Association (EBA) appealed
the Prime Minister of Ukraine
expressing the concerns of
the pharmaceutical industry
regarding the unclear
understanding of the norms
on reference pricing and
reimbursement of some
categories of drugs.
The EBA stated that the lack
of clear explanations could
lead to the deficit of the drugs,
which are subject to the new
mechanism.
The Association noted that
market participants need
clarification regarding the
possibility of free circulation
of medicines in the pharmacy
network, if the price of the
drugs will exceed the calculated
threshold level for Ukraine
The EBA also requested the
Government to publish a
clarification about the expected
results of the implementation of
the new regulation for the three
nosologies, the period of their
assessment and further actions
in the case of confirmation
of the lack of efficiency in
the implementation of the
mechanism.
“The patients do not know
whether they would be able to
continue individual therapy in
future. Physicians are not aware
whether they will be able to
prescribe drugs according to

their professional knowledge
and experience.
While, the pharmaceutical
producers do not have a
sufficient basis for the adoption
of a positive or negative
decision on the continuation of
business activities in Ukraine”,
the appeal of the EBA stated.
MoH Promulgated all Tenders
for 2016 Public Procurements
The MoH signed all contracts
and promulgated all tenders
on the public procurement of
medicines for the funds of 2016
State Budget, the Head of the
Ministry reported.
The funds for the procurement
of medicines under the State
Budget 2017 are expected
to come in Mar. In fact,
procurements for this year and
the previous year are to be
conducted in 2017.
The Ministry continues
cooperation with International
procurement organizations
(UNDR, Crown Agents and
UNICEF) within the delegated
public procurements.
Ukraine’s PM is asked to
appoint Head of the MoH
Parliamentary Committee
on Public Health appealed
Ukrainian Prime Minister
Volodymyr Groysman asking
to submit to the Parliament a
candidate for the post of the
Minister of Health with a view
to entrusting this person with
personal responsibility for the
formation and implementation
of state policy in the sphere of
public health or for the omission
of his department.
Mr. Groysman said the
government is to arrange the
political consultation regarding
the appointment of the Head of
the MOH.
In Jul 2016, Ulana Suprun was
appointed to the position of the
acting Minister of Health and
currently holds the position.
On Jan 1, 2017, the Director of
Heat Institute started publicly
accusing Ulana Suprun and
the MoH management in
negligence and failure of public
procurements of medicines
and medical equipment for
the treatment cardiovascular
diseases.
The acting Minister rejected the
accusations, while the Prime
Minister supported the MOH
management, calling it “an
absolutely incorruptible team
that has a chance to bring the
health care system to a new
level”.

17
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CIS REGION PHARMA
NEWS & EVENTS / 2016 FY
Azerbaijan
• The construction of Azerbaijani-Iranian pharmaceutical plant Caspian
Pharmed has been launched. USD 20 mio will be invested. The
construction is to finish in 3Q2018.
• Azerbaijan is considering the establishment of joint plants with Turkey and
Ukraine, the Economy Minister reported. European partners are also considered.
• In 2016, 80% of medicines was imported from European and other developed countries; the rest
was related to Russia, Ukraine and Belarus, the Economy Minister noted.
Belarus
• At least three new pharmaceutical plants will be opened in Belarus in
the coming years with participation of India, Chairman of the Council of
the Republic of the National Assembly said during the ground-breaking
ceremony for the new plant in Skidel. Other two plants are under the
construction and are located in Kolyadichi and Beshankovichy.
• Belarus plans to enhance export of medicines in Africa and South-East Asia, the Director of
Pharmaceutical Development Department said.
• Innovative veterinary preparations for the treatment and prevention of diseases of agricultural
and domestic animals have been developed in Belarussian State University.
Georgia
• Georgia Healthcare Group has completed the merger of JSC ABC
Pharmacia, the fourth largest pharmaceutical retailer and wholesaler in
Georgia, to form a new pharmacy network JSC Georgian Pharmacy (GEFA).
Kazakhstan
• The CEO of Kazakhstan’s Single Distributor SK-Pharmacia proposed to
work out the possibility to conduct joint public procurements of pharma-
ceuticals with member-states of the Eurasian Economic Union (EEU).
• In 2016, consumer prices of pharmaceuticals increased 17.7% y-o-y, medical
services – 12.5%. The overall CPI amounted 8.5%, the Statistics Committee
reported.
Russia
• GM of Teva Russia and Eurasia reported that Teva plans to increase the
production capacities in Russia to 2 bln tablets per year, but is not planning to

manufacture substances in the country yet.
• In 11M2016, Russian market of drugs against tobacco dependence increased 15% PPG in values to
RUB 2471.7 m. Currently, there are three OTC brands and one Rx brand presented on the market.
• Russian Prime Minister approved the new List of vital and essential drugs for 2017, which included
646 INNs. The Vice Prime Minister stated that, in 2017, the List of essential and vital drugs will be
approved not once, but as new drugs are appearing.
• Rafarma company plans to launch its production onto the market of South Korea. The first supplies
of ceftriaxone are expected to start in 2018.
Uzbekistan
• The President of Uzbekistan issue the Order on development of four
pharmaceutical industrial zones: Boysun-pharm (Surxondaryo Region), Buston-
lik-pharm (Tashkent Region), Zaamin-pharm (Jizzakh Region), Syrdarya-pharm
(Sirdaryo Region). The investors will be exempt from land tax, income tax,
property tax of legal entities, etc. for 3-10 years.

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