1. Ukrainian Pharmaceutical Market Monthly
Upharmacia
Macroeconomic Environment | Market & Companies News |
Regulatory Updates | Healthcare News
Issue: 06 2016
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2. Page 2
Ukrainian Pharmaceutical Market Monthly: June 2016
2015 2016
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
MACROECONOMIC INDICATORS
Q2 Q3 Q4 Q1
GDP (US$ bn) 20.795 25.552 25.588 17.655
growth, % y-o-y -35% -26% -17% 0%
Export of Goods (US$ bn) 2.94 3.09 3.15 3.09 3.35 3.23 3.13 3.36 2.04 3.08 2.99 3.10 2.88
growth, % y-o-y -41% -30% -34% -22% -22% -23% -21% -11% -31% 3% -13% 1% -2%
Import of Goods (US$ bn) 2.63 2.76 2.98 3.88 3.24 3.22 3.07 3.12 2.23 2.68 3.35 3.05 2.69
growth, % y-o-y -46% -37% -34% -2% -30% - 27% -27% -32% -26% -6% 5% 7% 2%
Industrial Production Sales (US$ bn) 5.65 5.79 5.71 5.42 5.72 6.29 5.92 6.37 4.93 4.93 5.41 5.17 5.39
growth, % y-o-y -38% -35% -33% -23% -20% -21% -19% -17% -18% 8% -2% -12% -5%
Retail Turnover of Enterprises (US$ bn) 1.94 1.83 1.94 1.88 1.86 2.04 1.80 2.01 1.60 1.50 1.64 1.76 1.59
growth, % y-o-y -35% -38% -41% -32% -38% -31% -33% -29% -19% 4% 2% 6% -18%
Unemployment Rate (%) 1.8 1.7 1.6 1.6 1.5 1.5 1.6 1.9 1.9 1.9 1.7 1.6 1.6
Average Salary (US$) 193 202 202 194 199 207 193 223 180 174 187 191 198
OFFICIAL CURRENCY EXCHANGE RATE
UAH / USD 20.9 21.2 21.8 21.6 21.8 21.8 23.3 23.4 24.3 26.4 26.4 25.6 25.2
UAH / EUR 23.3 23.8 23.9 24.0 24.5 24.6 25.1 25.4 26.3 29.3 29.2 29.1 28.5
PHARMACEUTI CAL INDUSTRY INDICATORS
Export of Pharma Products (mio USD) 13.00 15.36 13.85 9.01 13.79 12.2 11.7 15.77 8.31 13.33 15.54 13.90 14.17
growth, % y-o-y -39% -39% -6% -54% -47% -37% -52% -28% -30% 11% 16% 3% 9%
Import of Pharma Products (mio USD) 84.2 115.0 106.5 93.3 121.1 147.1 141.3 142.1 103.7 145.0 125.1 130.0 110.4
growth, % y-o-y -60% -44% -47% -47% -31% -28% -24% -42% 15% 27% 21% 25% 31%
Pharma Retail Sales, values (mio USD) 193.0 177.7 172.6 177.1 193.2 206.3 196.6 212.3 198.9 176.0 187.3 178.1 177.6
growth, % y-o-y -28% -29% -32% -24% -28% -26% -20% -18% -17% -1% -5% -1% -8%
Pharma Retail Sales, volumes (mio units) 124.5 118.4 119.5 122.5 126.7 130.2 129.0 136.4 133.6 126.8 133.8 125.2 123.6
growth, % y-o-y -11% -9% -10% -8% -11% -5% -4% -5% 1% -12% -5% 2% -1%
WACP (USD) 1.47 1.52 1.48 1.45 1.52 1.58 1.52 1.56 1.49 1.39 1.40 1.42 1.44
growth, % y-o-y -23% -21% -23% -18% -19% -22% -18% -14% -23% -23% 13% 1% -2%
CPI of Ukraine 158.4 157.5 155.3 152.8 151.9 146.4 138.1 134.6 131.9 126.9 113.5 108.4 107.3
Pharmaceutical Products CPI 159.5 153.5 151.8 149.4 145.8 142.1 146.6 143.3 140.3 132.7 120.9 109.8 107.5
Local Companies share, values (%) 41.5 41.7 41.8 41.4 41.4 41.4 41.7 40.9 42.3 42.9 42.7 42.3 42.9
Local Companies share, volumes (%) 77.6 77.9 78.4 78.2 76.5 75.7 75.8 76.7 75.6 76.5 76.5 76.7 77.2
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
(May 2015-May 2016)
3. Page 3
Ukrainian Pharmaceutical Market Monthly: June 2016
KEY ECONOMIC EVENTS
»» Consumer inflation in Ukraine in May 2016 slowed to 0.1% from 3.5% in Apr 2016, the State Statistics Service
reported. The y-o-y inflation growth in May 2016 amounted 7.5%.
»» Cabinet of Ministers approved draft budget resolution for 2017, envisaging the deficit of up to 3% of GDP,
government debt – up to 66% of GDP and average annual exchange rate of hryvnia at 27.2/USD.
»» Brexit will not affect Ukrainian economy, while the country will not change its policy towards the integration into
the EU, Ukraine’s authorities said.
»» Ukrainian government intends by the year-end to settle legislative initiatives that would allow Ukraine to improve
its positions in the Doing Business rating and enter the TOP-50 best counties in 2017 and the TOP-20 in 2018.
In 2016 report, Ukraine was placed 83rd.
»» Ukraine’s President reported macrofinancial stabilization in the country. Foreign exchange reserves are
constantly growing without participation of foreign partners, which reflect guaranteed financial stabilization in
the Ukrainian market, he said.
»» The use of ProZorro system in public procurement, allowed saving UAH 1.5 bn for the state in 14 months, the
Minister of Economic Development noted.
»» The World Bank is ready to allocate additional USD 1 bn on programs in Ukraine, Ukrainian Prime Minister said.
Agreed that the World Bank is to assist in developing a strategy for transport corridors and roads in Ukraine,
assess what resources the strategy would require and determine where budgetary, credit or private funds
should be attracted.
»» American Congress approved the assignation of USD 663.5m to Ukraine in 2017 as financial aid.
»» Industrial growth continued to slow down and reached 0.3% y-o-y in May compared to 3.5% y-o-y in April.
Mining and machinery decreased -3.5% and 0/3% y-o-y respectively, while chemical output rose 8.4% y-o-y. In
5M2016, Ukraine’s industry increased 3.1% y-o-y.
193.0
177.7
172.6
177.1
193.2
206.3
196.6
212.3
198.9
176.0
187.3
178.1 177.6
124.5
118.4 119.5
122.5
126.7
130.2
129.0
136.4
133.6
126.8
133.8
125.2
123.6
100
110
120
130
140
150
160
100
120
140
160
180
200
220
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Pharma Retail Sales
2015 2016
Volumes (mio units)
Values (mio USD)
13.0
15.4
13.9
9.0
13.8
12.2 11.7
15.8
8.3
13.3
15.5
13.9 14.2
84.3
115.0
106.6
93.3
122.2
147.1
141.3
142.1
103.7
145.0
125.1
130.0
110.4
0
20
40
60
80
100
120
140
160
0
4
8
12
16
20
24
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Ukraine's International Trade
in Pharma Production
2015 2016
Export
Import
5.65
5.80 5.71
5.43
5.72
6.29
5.92
6.37
4.93 4.93
5.41
5.17
5.39
1.94 1.83 1.94 1.88 1.86
2.04
1.80
2.01
1.60
1.50
1.64
1.76
1.59
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
Industrial Production Sales &
Retail Turnover of Enterprises Surplus
2015 2016
Retail turnover of enterprises
Industrial production
20.9 21.2 21.8 21.6 21.8 21.8
23.3 23.4 24.3
26.4 26.4 25.6 25.2
25.5 24.9
26.1 25.9 26.1
24.6 25.1 25.4 26.3
29.3 29.2 29.1 28.5
158.4 157.5 155.3 152.8 151.9
146.4 146.6
143.3 140.3
132.7
120.9
109.8 107.5
0
20
40
60
80
100
120
140
160
0
5
10
15
20
25
30
35
40
45
50
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May
2015 2016
vs. Consumer Price Index
Official Currency Exchange Rates
CPI of Ukraine
UAH / €
UAH / $
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5. Page 5
Ukrainian Pharmaceutical Market Monthly: June 2016
MARKET & COMPANIES NEWS
Red Star PJSC Will
Conduct Private
Placement Of Bonds
Red Star pharmaceutical plant
intends to hold private placement
of bonds “A”-“J” series for UAH
30 mio. The corresponding
decision was taken by the
company’s Supervisory Body on
Jun 2.
60% of funds raised the
company plans to allocate for the
reconstruction and modernization
of tablet manufactory following
the GMP requirements; 20% for
modernization and equipment of
the new laboratory; 20% will be
invested in the development of
new drugs.
Red Star plant is one of the oldest
pharmaceutical companies in
Ukraine, which was founded in
1923 in Kharkov. The company’s
facilities can produce 188 mio
units per year. Red Star’s portfolio
includes more than 90 brand
names, 26% of them refer to
medical cosmetics.
Darnitsa
Launches The
Drug Against
Arterial Hypertension
On May 25-27 during the
National Conference on
arterial hypertension, Darnitsa
pharmaceutical company
presented its new drug Tiara
Trio® (Valsartan + Amlodipine+
Hydrochlorothiazide). It is the
first generic drug with such
combination in Ukraine.
Numerous comparative studies
have shown that efficiency
of triple therapy significantly
exceeds the double combination
therapy. It was confirmed
balanced triple combination
reduces the incidence of
metabolic and clinical side
effects that are often seen in
monotherapy.
Darnitsa continues the expansion
of its cardio portfolio, which
contributes about 28% to the
company’s overall revenues.
Darnitsa Is Ready
To Acquire 25%
Of BCPP
Pharmaceutical company
Darnitsa publicly appealed
Borshchahivskiy Chemical-
Pharmaceutical Plant (BCPP)
with the proposition to acquire
25% of the company’s shares for
UAH 80 ths per share. Darnitsa
expects the transaction to cost
UAH 207 mio. However, the
acquirer will be accepting offers
of BCPP shareholders until Aug
31 2016.
On 16/06/2016, the Supervisory
Board of BCPP unanimously
decided to recommend the
company’s shareholders not
accept the proposal, as it
significantly undervalues the fair
value of the company, the BCPP’s
Secretary of the Board said. On
23/06/2016, the Supervisory
Board of BCPP convened the
extraordinary general meeting of
shareholders on a requirement
of Darnitsa. Representatives of
Darnitsa insisted on bringing the
issue of the re-election of the
Supervisory Board and changing
the BCPP’s Statute to the agenda.
In Mar 2015, Financial Company
Kub, representing Darnitsa’s
interests, acquired 29.95% of
shares of BCPP on the auction
for UAH 171.8 mio. In Jan 2016,
the Antimonopoly Committee
of Ukraine allowed Darnitsa
to acquire 50% of BCPP’s
shares. While, in Apr 2016, the
Committee fined Darnitsa for
the acquisition of 30% package
of BCPP’s shares without
corresponding permission.
Darnitsa retained 3rd
position on
Ukrainian pharmaceutical market
in 2015, while BCPP climbed four
positions y-o-y to 16th
position.
Ukrainian Market Of Clinical Trials
Reached USD 300 mio
The value of Ukrainian market
of clinical trials in 2015 reached
USD 300 mio, while the number
of participants of drug testing
is about 50-60 ths people per
year, the estimates of Pharmaxi
company say.
According to the State Expert
Center, in 2015 the number of
positive conclusions for clinical
trials conduction in Ukraine
amounted 202, which is 25%
less than a year before (269).
This was mainly caused by the
reduction of the number of
international trials, which was
only partially offset by local
pharmaceutical manufacturers.
“In 2015, the number of II phase
trials decreased four times, while
I phase trails nearly have not
been conducted,” the director
of Pharmaxi Yuriy Lebed said.
“This drop in the number of
new projects leads to increased
competition and causes market
participants to reduce prices for
services as well as look for ways
to optimize costs.
“Ukraine uses only 10-15% of its
potential. The number of clinical
trials per capita is very low –
0.61,” Mr. Lebed concluded.
Currently, 40 CRO companies
are operating in Ukraine; 15-20%
of the market related to local
enterprises. In 2014, the biggest
CRO companies by net income
were Quintiles (UAH 217 mio),
InnoPharm/PPD (UAH 100 mio)
and PSI Ukraine (UAH 98 mio).
6. Page 6
Ukrainian Pharmaceutical Market Monthly: June 2016
REGULATORY UPDATES
Back To Reference Pricing For
Medicinal Products
Specializing ministry developed
and published for public
consideration the Draft
Resolution of CMU «On Reference
Pricing for Medicinal Products».
The document has been
developed under the instruction
of the Government. Therewith, the
CMU actions plan by 30.09.2016
envisages the new pricing
principals implementation aimed
at reducing budget expenses at
tenders up to 30%.
The CMU Draft Resolution
foresees that since 01.08.2016
the declaration shall be fulfilled
under the new procedure, and all
wholesale-retail prices declared
under currently acting procedure
should be re-declared by
01.10.2016.
It is provided, that MOH of
Ukraine should establish a
standing commission on medicinal
products prices regulation, which
shall decide on the relevance of
wholesale-retail prices’ level of
declared medicinal product and
on the possibility of its inclusion
into the register of wholesale-
retail prices. Commission shall be
composed of the representatives
of Ministry of Economic
Development, Ministry of Social
Policy and Ministry of Finance of
Ukraine.
Wholesale-retail prices for
original foreign medicinal products
are proposed to be designated
according to the minimal price
(and not according to arithmetic
average as previously) of one of
the reference countries (country
of first registration, Bulgaria,
Moldova, Poland, Slovakia, Check
Republic, Latvia, Hungary, Serbia).
In addition, there is no mechanism
for prices declaration for original
native products.
The package of documents
required for submission
should include the declaration,
statement on prices level and
power of attorney. For foreign
manufacturers the declaration
currency shall be Ukrainian
hryvnya. The term for documents
processing shall take 25 business
days.
Public Health Committee Put Off
Consideration Of Bill On Public
Health Policy
On 15/06/2016, Parliamentary
Committee on Public Heath
decided to put off consideration
of the Draft Law #2409a on the
basics of public health policy in
order to modify it. The working
group will have to offer a new
version of some articles of the
document to resolve contradiction
with the Constitution by end of
July.
The Draft Law was registered in
July 2015 as an alternative to
the one prepared by the MOH.
The initiator of the document Oleg
Musiy considered it as one of
two basic and fundamental ones
for the reformation of Ukraine’s
healthcare system. He expected
the Draft Law #2409a to be
approved in the first reading in
May-June.
Public Health Committee Put
Off Consideration Of Bill On
Autonomization Of Hospitals
Parliamentary Committee on
Public Heath postponed the
consideration in the second
reading of the Draft Law
#2309a-d aimed to improve
the healthcare legislation to
provide autonomization to medical
institutions in Ukraine. Committee
Members failed to agree on a
number of amendments, which
proposed a working group to
finalize the Draft Law. The Head
of the Committee proposed to
postpone the consideration of the
document to the next session.
The Draft Law was registered
in Dec 2015 and approve in the
first reading on 21/04/2016. In
summer 2015, the Parliamentary
Committee rejected the Draft
Law #2309 developed by the
MOH having seen the risk of
privatization of healthcare
facilities. According to ex-
Minister of Healthcare Alexander
Kvitashvili approval of the Draft
Law is fundamental to start
reformation of healthcare system
in Ukraine.
EBA Urges To Amend Tax Code
The European Business
Association (EBA) urges
Ukrainian Parliament to approve
amendments to the Tax Code
(Draft Law #3180) to regulate the
problems of drugs and medical
devices VAT taxation. First
problem is taxation of drugs with
standard 20% VAT rate instead
of preferential 7% rate when the
date of a registration certificate
expired and the next certificate is
not received yet. Second problem
is when a medical device referred
to other classification code at
customs and, therefore, the
preferential 7% VAT rate does not
apply.
The approval of the Draft Law
#3180 is expected to enhance
economic accessibility of certain
drugs and medical devices and
increase the attractiveness
of local market for foreign
manufacturers of high-tech
medical products.
Provided by
7. Page 7
Ukrainian Pharmaceutical Market Monthly: June 2016
HEALTHCARE NEWS
MOH Intends To Develop A State
Program For Import-Substituting
Industries
The MOH started the process
of development of the Concept
of State program for imports
substitution in Ukraine aimed
to increase the share of drugs
produced by local companies on
the Ukrainian pharmaceutical
market by supporting local
producers in the development
of import-substituting
manufacturing of medicines and
medical devices.
“Today the domestic
pharmaceutical industry is
quite powerful and has all
possibilities for the production
of quality drugs,” the acting
Head of the MOH said. “Thus,
development and improvement
of the competitiveness of the
local pharmaceutical market,
which would provide patients with
affordable and quality drugs, is a
strategic goal for the MOH.”
MOH Will Enhance Cooperation
With The WB In Healthcare
Reforming
The MOH of Ukraine intends to
intensify cooperation with the
World Bank (WB) within the joint
project “Improving healthcare
at the service of the people,”
which have been implementing
in nine regions of Ukraine since
2015. The parties agreed on
a tight schedule of meetings
and involvement of the WB’s
representatives in the working
groups on the principal directions
of the reformation.
In Mar 2015, the WB approved
the credit for USD 214.7 mio
for the implementation of the
project aimed to the development
of medical infrastructure and
improvement of the quality of
medical services. The project is
designed for five years and will be
implemented in Vinnytsia, Volyn,
Dnipropetrovsk, Zakarpattia,
Zaporizhia, Lviv, Poltava and Rivne
regions.
Kyiv Intends To Provide More
Authorities To Healthcare
Facilities
Kyiv government intends to
expand the authorities of medical
institutions on the part of the
administration of financial
resources and implement the
project of healthcare system
reformation, the Mayor of the
capital Vitali Klitschko said.
“Our goal is to create the efficient
system of medical care, provide
the access to medical services
and provide normal working
conditions for doctors,” the
Mayor said. “This will be achieved
through decentralization and
provision to head physicians of
opportunities to use budgetary
funds for the purchase of drugs,
equipment and paying salaries to
physicians.”
Pilot Project For Reimbursement
Of Drugs Against Hypertension To
Be Improved
The MOH created the working
group aiming to improve the pilot
project for reimbursement of
drugs against hypertension, which
was realizing in Ukraine from
2012 to 2014. The group was
headed by the Deputy Minister of
Health Roman Ilyk.
In 2014, UAH 117.8 mio were
allocated for the project; the
percentage of prescriptions for
which a partial refund of the costs
was carried out amounted 70.5%
of all prescriptions. In 2014, 61.7%
of 9 mio patients registered with
arterial hypertension in Ukraine
were involved in the project.
MOH Wants To Develop A
Concept For Import-Substituting
Industries’ Support
MOH of Ukraine announced
the intention to develop the
concept of the state program for
import-substituting industries’
development to increase the
share of local drugs and medical
devices on the pharmaceutical
market. The development of
the concept will involve the
representatives of public,
professional environment,
the pharmaceutical market.
The terms of the concept’s
development are not indicated.
“Today domestic pharmaceutical
industry is powerful enough
and has all opportunities for the
manufacturing of quality drugs,”
the press service of the Ministry
noted.
In 2015, the share of local
products on the retail
pharmaceutical market amounted
77% in volumes and 41% in
values. On hospital market, local
producers held 49% in values and
89% in volumes.
Kyiv Will Present Pilot Project On
E-Health By The Summer End
By the end of summer 2016, Kyiv
government intends to present
the first pilot project on e-health
to be realized in Podilskyi District
of the capital, the Deputy Head of
Kyiv State Administration Mykola
Povorosnik said at the conference
“Development of healthcare
system of Kyiv.” The system will
contain all information on all
appointments and diagnoses of a
patient.
Moreover, Kyiv plans the
implementation of the project
on first-aid development, Mr.
Povorosnik added.
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