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UpharmaciaUkrainian Pharmaceutical Market Monthly
Macroeconomic Environment |
Market & Companies News |
Regulatory Updates |
Healthcare News |
Issue: 11 2016
Page 2
Ukrainian Pharmaceutical Market Monthly: November 2016
2015 2016
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct
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) 3.23 3.13 3.36 2.04 3.08 2.99 3.10 2.88 2.93 2.92 3.18 3.16 3.24
growth, % y-o-y -23% -21% -11% -31% 3% -13% 1% -2% -5% -7% 3% -6% 0%
Import of Goods (US$ bn) 3.22 3.07 3.12 2.23 2.68 3.35 3.05 2.69 2.87 3.09 3.45 3.48 3.54
growth, % y-o-y - 27% -27% -32% -26% -6% 5% 7% 2% 4% 4% -11% 8% 10%
Industrial Production Sales (US$ bn) 6.29 5.92 6.37 4.93 4.93 5.41 5.17 5.39 5.44 5.61 5.57 5.62 6.39
growth, % y-o-y -21% -19% -17% -18% 8% -2% -12% -5% -6% -2% 3% -2% 2%
Retail Turnover of Enterprises (US$ bn) 2.04 1.80 2.01 1.60 1.50 1.64 1.76 1.59 1.73 1.87 1.92 1.76 1.87
growth, % y-o-y -31% -33% -29% -19% 4% 2% 6% -18% -6% -3% 2% -5% -8%
Unemployment Rate (%) 1.5 1.6 1.9 1.9 1.9 1.7 1.6 1.6 1.5 1.4 1.3 1.3 1.2
Average Salary (US$) 207 193 223 180 174 187 191 198 214 217 208 204 208
OFFICIAL CURRENCY EXCHANGE RATE
UAH / USD 21.8 23.3 23.4 24.3 26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8
UAH / EUR 24.6 25.1 25.4 26.3 29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5
PHARMACEUTI CAL INDUSTRY INDICATORS
Export of Pharma Products (mio USD) 12.2 11.7 15.77 8.31 13.33 15.54 13.90 14.17 16.15 13.36 13.58 18.81 18.40
growth, % y-o-y -37% -52% -28% -30% 11% 16% 3% 9% 5% -4% 51% 37% 51%
Import of Pharma Products (mio USD) 147.1 141.3 142.1 103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3
growth, % y-o-y -28% -24% -42% 15% 27% 21% 25% 31% 15% 25% 47% 15% -7%
Pharma Retail Sales, values (mio USD) 206.3 196.6 212.3 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2
growth, % y-o-y -26% -20% -18% -17% -1% -5% -1% -8% -2% 2% 2% -1% 3%
Pharma Retail Sales, volumes (mio units) 130.2 129.0 136.4 133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6
growth, % y-o-y -5% -4% -5% 1% -12% -5% 2% -1% 4% 3% 3% 7% 6%
WACP (USD) 1.58 1.52 1.56 1.49 1.39 1.40 1.42 1.44 1.43 1.43 1.43 1.41 1.53
growth, % y-o-y -22% -18% -14% -23% -23% 13% 1% -2% -6% -3% -1% -8% -3%
CPI of Ukraine 146.4 146.6 143.3 140.3 132.7 120.9 109.8 107.5 106.9 107.9 108.4 107.6 112.4
Pharmaceutical Products CPI 142.1 138.1 134.6 131.9 126.9 113.5 108.4 107.3 108.2 107.4 107.2 107.9 107.6
Local Companies share, values (%) 41.4 41.7 40.9 42.3 42.9 42.7 42.3 42.9 42.8 42.8 41.8 42.6 40.8
Local Companies share, volumes (%) 75.7 75.8 76.7 75.6 76.5 76.5 76.7 77.2 77.4 77.9 68.9 68.4 67.5
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
(October 2015-October 2016)
206.3
196.6
212.3
198.9
176.0
187.3
178.1 177.6
174.8 175.4
180.9
190.4
212.2
130.2
129.0
136.4
133.6
126.8
133.8
125.2
123.6 122.6 122.7
126.2
135.5
138.6
100
110
120
130
140
150
160
100
120
140
160
180
200
220
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Pharmaceutical Market Retail Sales2015 2016
Volumes
Values
mio USD
mio units
206.3
196.6
221122.33
130.2
129.00
113366.44
Oct Nov Dec
2015
12.2
11.7
15.8
8.3
13.3
15.5
13.9 14.2
16.1
13.4
13.6
18.8 18.4
147.1
141.3
142.1
103.7
145.0
125.1
130.0
110.4
132.1
133.1 137.3
140.6
137.3
0
20
40
60
80
100
120
140
160
0
4
8
12
16
20
24
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Ukraine's International Trade
in Pharma Production
2015 2016
Export
Import
mio USD
mio USD
12.2
11.7
15.8
147.1
141.3
142.1
Oct Nov Dec
2015
6.29
5.92
6.37
4.93 4.93
5.41 5.17
5.39 5.44
5.61 5.57 5.62
6.39
2.04
1.80
2.01
1.60
1.50
1.64
1.76
1.59
1.73
1.87 1.92
1.76
1.87
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Industrial Production Sales &
Retail Turnover of Enterprises Surplus
2015 2016
Retail turnover of enterprises
Industrial production sales
bn USD
6.29
5.92
6.37
2.04
1.80
2.01
Oct Nov Dec
2015
bn USD
21.8
23.3 23.4
24.3
26.4 26.4
25.6 25.2 25.0 24.8 25.1
26.3 25.8
24.6 25.1 25.4 26.3
29.3 29.2 29.1 28.5 28.1 27.5 28.1
29.5 28.5
146.4 146.6
143.3
140.3
132.7
120.9
109.8
107.5 106.9 107.9 108.4 107.9
112.4
0
20
40
60
80
100
120
140
160
0
5
10
15
20
25
30
35
40
45
50
Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct
2015 2016 Official Currency Exchange Rates
vs. Consumer Price Index
UAH / EUR
UAH / USD
CPI
21.8
23.3 23.4
24..66 25.1 25.4
146.4 146.6
143.3
Oct Nov Dec
22001155
Page 3
Ukrainian Pharmaceutical Market Monthly: November 2016
KEY ECONOMIC EVENTS
»» GDP of Ukraine rose 1.8% y-o-y in 3Q2016 and 1.2% y-o-y in 9M2016, State Statistics Service reported. The
IMF and the EBRD projected 1.5% y-o-y increase for 2016, while Ukrainian Trade Ministry forecasted 1.0% y-o-y
growth.
»» On Nov 24, the EU authorities once again postponed approval of visa-free regime with Ukraine due to inter-
institutional inconsistency over the issue. The next review of visa liberalization could occur on Jan 18, 2017.
»» The EBRD decreased investments in Ukraine in 2016 by 60% y-o-y to USD 400 mio. According to the Bank’s
President, the amount could be increased next year.
»» In 9M2016, Ukraine’s goods trade deficit reached USD 1.76 bn compared to a USD 0.70 bn surplus in 9M2015.
Exports of goods declined 8.7% y-o-y due to deterioration of chemicals (-32% y-o-y), minerals (-20% y-o-y) and
metals (-18% y-o-y) trade. Exports to the EU increased 4.4% y-o-y, while exports to the CIS countries fell 27.1%
y-o-y.
»» Fitch Ratings upgraded Long-Term Foreign and Local Currency Issuer Default Ratings (IDRs) of Ukraine to B-
from CCC. The agency’s outlook is stable.
»» Ukraine climbed 23 positions in Paying Taxes rating by PwC to 84th position. The improvement was mainly
caused by the introduction of the new index in the rating (obtaining of a VAT refund and dealing with a voluntary
correction of an inadvertent error in a CIT return).
»» China is interested in development of industrial parks in Ukraine and in placing its production facilities there. The
China International Chamber of Commerce has provided the corresponding plan of cooperation to the Ukrainian
side.
»» In 9M2016, FDI in Ukraine in the form of shareholder capital increased 6.2% y-o-y to USD 45.12 bn.
»» Since the introduction of free-trade zone, in 10M2016, the trade turnover between Ukraine and the EU increased
5% PPG, the President of Ukraine reported. The EU is the main trade partner for Ukraine with 41% share in total
trade.
»» According to Credit Suisse survey, the wealth of Ukrainian households decreased 18.5% from the middle of
2015 to the middle of 2016 to USD 44 bn. Ukraine, Russia and Argentina were Top-3 countries by the rates of
wealth reduction.
RECRUITING &
EXECUTIVE
SEARCH
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Partner, HR-Consulting
AMaximenko@upharma-c.com
+380 (44) 232-11-43
+380 (97) 953-68-14
Page 5
Ukrainian Pharmaceutical Market Monthly: November 2016
MARKET & COMPANIES NEWS
Vynnitsapharmacia
wants to redeem 18
mio of its own shares
PJSC Vynnitsapharmacia
intends to redeem 18 mio of
its common registered shares,
the Supervisory Board of the
company stated. The company
also plans to sign the contract
with BaDM distributor on the
supply of drugs and medical
devices for about UAH 30 mio.
PJSC Vynnitsapharmacia owns
the pharmacy chain Bazhayemo
zdorovya in Vinnitsa and also
produces and conducts sale of
pharmaceuticals. The company
is a part of Premier Finance
Corporation, which includes 30
companies in the pharmaceutical,
retail and food industries. In 2015,
the profit of Vynnitsapharmacia
amounted UAH 465 ths.
Ukraine and
Indonesia to
cooperate in
pharmaceutical sphere
On Nov 4, the State Service
on medicines and drug
control of Ukraine signed the
Memorandum of Understanding
in pharmaceutical sphere with
the National Agency on control
over medicines and food products
of the Republic of Indonesia.
The cooperation between two
agencies started after in Aug
2016, the President of Ukraine
visited Indonesia.
The Memorandum establishes
the necessary legal framework
for the expansion of bilateral
cooperation in the pharmaceutical
field between two countries and
promotes interaction to meet the
strategic needs of Ukraine and
the Republic of Indonesia in the
pharmaceutical industry.
The Head of Indonesian Agency
stated that the country is
open for cooperation and
investments, which will contribute
to the growth of the country’s
market. The most of 200
Indonesian pharmaceutical
enterprises comply with the
GMP requirements, while
the country’s pharmacopeia
generally corresponds to the US
Pharmacopeia.
PJSC Technolog
to triple exports
of antituberculosis
drugs
PJSC Technolog (part of Lekhim
group of companies) plans to
increase its export amounts of
its antituberculosis drugs 2-3
times in the next few years. To
achieve that, the company intends
to receive prequalification of
the World Health Organization
(WHO) for the corresponding
preparations by the end of 2017.
According to the company’s GM,
Technolog may also consider
the possibility of obtaining the
prequalification of drugs for the
treatment of HIV/AIDS. Currently,
the company is exporting about
15% of its products. Its main
external markets are the CIS
countries.
Production capacities of PJSC
Technolog are located in Uman
(Cherkasy region). Lekhim group
of companies includes JSC
Lekhim, PJSC Technolog and JSC
Lekhim-Kharkiv and is among
TOP-15 Ukrainian pharmaceutical
producers. It is a #1 local company
by sales of enzyme preparations,
suppositories and pelleted dosage
forms.
Head of Astellas
Pharma RO in Ukraine
leaves his post
Krzystof Siedlecki leaves Ukraine
and his post as a head of the
Astellas Pharma Representative
Office in Ukraine. He announced
this during the local pharma
conference recently.
Krzystof Siedlecki has been
leading Japanese Astellas
Pharma RO in Ukraine for 10
years. He was elected President
of EBA in Ukraine in 2015.
Page 6
Ukrainian Pharmaceutical Market Monthly: November 2016
REGULATORY UPDATES
AMCU Presented a Report
Based on the Results of Pharma
Market Survey Concerning the
Compliance with Competition Law
Requirements
On November 22, 2016, the
AMCU published the results
of pharma market survey for
2014-2016 and evaluated the
compliance with competition
law requirements by the main
players of pharma market
(manufacturers, importers/
distributors, pharmacies). The
AMCU’s report provides the
details on logistic structure of
medicinal products supply to
the territory of Ukraine and
the peculiarities of cooperation
between the players, as well as
the pricing components to include
the prices for end customers.
According to the AMCU, the
competition of pharma market
may be influenced not only by
noncompetitive behavior of
market players, but also by the
activities of public authorities
legally bound to regulate
these markets by creating
administrative barriers for
entering the market or imposing
the red tape on the players
already operating on the market
during the exercising of their
authorities. The Report mainly
focuses on the operation of
business entities at product
market and the pricing at each
stage of medicines sales.
In its analytical report the
AMCU provides the details
of the interactions between
manufacturers/importers and
distributors, and indicates the
contract provisions bearing
the risks to be qualified as
competition violations. In the
AMCU’s opinion, medicinal
products’ export ban, the liability
to prevent the third parties from
products export from Ukraine,
the obligation to provide the
reports and the implementation
of payment terms that ensure
the pharma company’s control
over the goods flow at medicines
markets of Ukraine testify
the market distribution and
competition restriction. In their
turn, the distributors agree
to these terms in exchange
for discounts provided by
manufacturers. The AMCU
believes that the discount system
raises a lot of due diligence
questions, as this system bears
the evidence of duplicate pricing,
which hampers the competition
development and does not reduce
the price for the end customer.
Moreover, the AMCU assessed
the impact of national and foreign
manufacturers/importers and
distributors on pricing. In the
course of the survey the AMCU
made a conclusion that the main
objective factors influencing the
pricing on medicines’ market
were the following: Ukrainian
currency exchange rate, inflation
rate, changes in taxation system,
introduction of additional import
fee.
It is worth to mention that during
the study on regional markets
the Committee determined
the structural features of
monopoly (dominant) position
at investigated regional markets
of 183 business entities that
conduct retail sales of medicinal
products in the form of pharmacy
chain. The tendencies for
pharmacy segment development
in Ukraine regarding the market
consolidation by the increasing
the role of medicines’ retailing
chain, in certain cases may
lead to the situation when
strong players with the signs of
monopoly position on regional
markets, shall gradually merge
the weaker competitors to
include by joining them to existing
pharmacy chains and hence
strengthening their share in the
market. The AMCU believes that
taking into consideration the
currently existing competition
situation on medicines’ retail
market, the market players should
implement the self-regulation
market mechanism together with
the establishment of general
principles of professional ethics
for all market players. This shall
let the pharmacy chain, being
a healthcare facility according
to the law, to target mainly the
patients in order to maintain their
health.
Bylaws in Effect to Ensure the
Medicines’ Selection for National
Essential Medicines List
On 04.11.2016 the following
bylaws became effective: the
Ministry of Health Order № 1049
of 07.10.2016 «On Amendment
of the Regulation on Expert
Committee on the Selection and
Use of Essential Medicines»and
the Ministry of Health Order №
1050 of 07.10.2016 «On Approval
of the Regulation on Medicines’
Selection for National Essential
Medicines List».
Upon the enforcement of the
amendments to the Regulation
on Expert Committee the list
of specialists allowed for the
participation in Expert Committee
has been extended. In particular,
the specialists with mathematical
education have been granted with
the right to become members of
this Committee. Moreover, the
provision has been cancelled
requiring from the candidates
to be obligatory employed by
Provided by
Page 7
Ukrainian Pharmaceutical Market Monthly: November 2016
HEALTHCARE NEWS
The MOH increased funding of
cancer treatment programs
The MOH denied information,
provided in some mass media,
about the shutdown of “Oncology”
program.
In 2017, the funding of
“Oncological diseases” Program
will increase 12% y-o-y to UAH
445 mio, while “Children’s
Oncology” Program will rise by
58% y-o-y to UAH 558 mio.
Herewith, in accordance with
the Resolution of the Cabinet of
Ministers of Ukraine “On efficient
use of public funds”, the form of
assistance will be changed from
“programs” to “measures”.
Government to allocate UAH 500
mio for drug reimbursement in
2017
The update Draft Budget 2017
provides the allocation of UAH
500 mio for the program for
drugs reimbursement. The
program is to be launched since
Apr 1, 2017 and envisages the
introduction of real compensation
reimbursement of drugs for the
treatment of hypertension, type
II diabetes and asthma. The
program includes INNs of drugs
without indication of dosages.
Currently, the reimbursement list
includes 16 INNs of drugs against
cardiovascular diseases, 2 INNs
of drugs against type II diabetes
and 3 INNs of drugs against
bronchial asthma.
After the meeting with
pharmaceutical producers
with the parliament members,
the Healthcare Minister Ulana
Suprun reported that the
most of companies supported
the program, but had a lot of
questions on its implementation
and operation.
The Head of the MOH noted
that the Ministry would work
to increase the funding of the
program in the Budget. According
to the Draft Budget, in 2017, the
government will also allocate UAH
5.9 bn for the public procurement
of drugs through international
organizations.
The issues with reference pricing
introduction since 2017 were
discussed
The government intends to
reduce drug prices through
implementation of reference
pricing for drugs against
hypertension, type II diabetes and
asthma since Jan 1, 2017. The
reference countries will be Czech
Republic, Hungary, Latvia, Poland
and Slovakia. The reference
pricing envisages implementation
of marginal wholesale prices. The
approach to regulation of margins
also to be changed: marginal
supply and sales margins to
be reduced to 5%, while new
regressive commercial (retail)
margins should not exceed 20%
(today marginal supply and sales
margins amount 10%, while
marginal retail margins amount
25%).
“There is a lot of data saying
that drugs in Ukraine are
overpriced, while patients pay
about 90% of drugs value,”
Ukraine’s Prime Minister said at
the meeting with pharmaceutical
healthcare or science and
research facilities. Nevertheless,
it is envisaged that preference
will be granted to candidates
working at these facilities during
the selection of Expert Committee
members by the Competition
Commission.
The abovementioned Regulation
also covers the specifics of the
application execution regarding
the National List amendment
and approves the application
template. Thus, the document in
particular provides the details on
which information should be filled
in each application clause.
It should be mentioned that
the hard copy and electronic
version (in Word format) of the
application should be submitted
in Ukrainian, and the attached
documents should be submitted
in Ukrainian or English with
Ukrainian or Russian translation
(if required) as hard or electronic
copies.
The legal framework development
for the elaboration of National
Essential Medicines List ends
with the enforcement of the
Regulation on Medicines
Selection. The National List itself
shall be harmonized with the
latest version of WHO Essential
Medicines Model List, which
includes the medicines needs
for a basic healthcare system.
Therefore, the National List
implementation shall provide
for the removal of duplicates of
different obligatory for usage
medicines lists, in favor of single
unified list to be implemented for
public regulation of medicines
prices.
Page 8
Ukrainian Pharmaceutical Market Monthly: November 2016
producers. “I urge producers to
take the government’s decisions
responsibly and to implement
them rapidly. I would like to warn
against creating an artificial
shortage of medicines. It will
not benefit the initiators of such
steps.”
Some representatives of pharma
companies see the some
issues, which may arise with
implementation of reference
pricing, in particular:
»» due to the absence of the
Procedure for calculation
of limiting drug prices,
manufacturers will not be
able to declare changes in
wholesale prices in time, while
the declaration procedure will
take at least a month;
»» in some cases reference
pricing may cause the increase
in drug prices, as some prices
in Ukraine are lower than in
reference prices;
»» decrease of sales and supply
margins to 5% may negatively
affect small distributors.
WB provided USD 40 mio to
Dnipropetrovsk region to open 39
ambulance stations
World Bank has provided USD
40 mio to Dnipropetrovsk region
for the development of 39
ambulance stations and creation
of emergency care departments
in three hospitals of the region.
The project is expected to be
implemented during 4 years.
The World Bank’s project is
intended to fight cardiovascular
diseases, and new ambulance
stations to prevent and treat
them will be opened, the Head
of Dnipropetrovsk Regional
Administration reported.
The MOH intends to cope with OTC
sale of antibiotics
On Nov 15, the MOH held press
briefing aimed to promote
responsible use of antimicrobial
drugs. According to the Member
of Parliamentary Committee on
Public Health Olexiy Kyrychenko,
excessive and uncontrolled use of
antibiotics by patients, irrational
prescription of these drugs by
doctors and their frequent use
in agriculture and veterinary
medicine are the main reasons
for the development of antibiotic
resistance in Ukraine. Lack of
public awareness and the impact
of promotional activities carried
by pharmaceutical companies
also compounding the problem.
The speakers announced the
flash mob #antibiotic_upon_
prescription, calling patients
to buy antibiotics only after
consultations with physicians.
The Deputy Head of the MOH
reported that the Ministry created
the working group to develop the
National Strategy and Action
Plan to combat antimicrobial
resistance in Ukraine. According
to the Head of Parliamentary
Committee on Public Health Olga
Bogomolets, Ukrainians spend
about UAH 15 bn on antibiotics
and about half of them are used
for self-medicating. To solve the
issue, Mrs. Bogomolets proposed
to ban advertising of antibiotics
in mass media and adapt the
European treatment standards by
the MOH.
Antimonopoly Committee
proposes to consider the
restriction of opening of new
pharmacies
Antimonopoly Committee of
Ukraine supported the idea
to restrict the opening of new
pharmacies, which had been
raised by market operators in the
Draft Codex of ethical operation
of pharmacies developed
by Professional Pharmacy
Association of Ukraine.
The Draft Codex proposes to
strive for a uniform placement of
pharmacies in localities through
prohibition of opening of new
pharmacies in the building, which
is already used as a place of
economic activity of another
pharmacy. This rule will not
apply to buildings of health care
facilities or shopping centers in
case of opening of pharmacies,
which have the license for
production (manufacturing) of
medicinal products in a pharmacy
or the license for sale of narcotic
drugs, psychotropic substances
and precursors.
Antimonopoly Committee decided
to conduct the poll of market
operators on the provisions of the
proposed Code.
MOH signed Memorandum on
creation of e-health system in
Ukraine
On Nov 25, the MOH signed the
Memorandum on cooperation
in creation of transparent and
efficient electronic health system
in Ukraine. The document was
signed by the acting Head of the
MOH, the Head of State Agency
for eGovernance as well as the
representatives of the public
initiative on healthcare sector
electronization and specialized
state-owned enterprises. At
the event there was noted that
efforts to create efficient e-health
system in Ukraine over the las
10 years had been unsuccessful
because the state tried to solve
this complex and expensive
problem on its own.
Participants of the event stressed
that the public initiative is
open to all who agree with the
declared principles and is ready to
contribute to the objectives of the
Memorandum for the sake of the
entire Ukrainian society.
The Memorandum should
lead to signing of the road
map on implementation of the
electronic system, creating
of uniform, transparent and
non-discriminatory rules of
access to the system, as well as
determination of basic software
needed to launch reforms.
Page 9
Ukrainian Pharmaceutical Market Monthly: November 2016
Belarus
Nativita company signed the
contract on cooperation with
Slovak pharmaceutical company
and distributor Unipharma, which
is to open up prospects for the
registration and distribution of
Nativita’s products in Slovakia,
the Czech Republic, Hungary,
Poland. Moreover, Nativita
signed cooperation agreement
with BioMed research center
to conduct exchange of
technology and experience and
implement joint research for the
development and creation of new
products.
Kazakhstan
Kazakh company Abdi Ibrahim
Global Pharm (part of Turkish
Abdi Ibrahim) received
international GMP certificate.
Specialized inter-district
economic court of Pavlodar
region declared bankruptcy of
one of the biggest pharmaceutical
companies in Kazakhstan
Romat and its part Pavlodar
pharmaceutical plant. The group of
companies debt to 309 creditors
about KZT 6 bn.
Kazakhstan and South Korea
signed Memorandum on
development of cluster of
pharmaceutical and medical-
biological plants Nefertem in
Kazakhstan worth USD 350 mio.
Russia
On 17/11/2016, members of the
Eurasian Intergovernmental
Council (Prime Ministers of
Russia, Armenia, Belarus,
Kazakhstan and Kyrgyzstan)
signed the unified package of
documents needed for the full
featured operation of the common
drug market within the Eurasian
Economic Union (EEU). The
documents will come into force
after ratification of protocol on
the accession of Armenia to the
EEU.
The Trade Ministry expects the
Russian pharmaceutical market
to grow at least 10% y-o-y in
values in 2016. In 2015, the
market amounted RUB 1.12 trln; in
1H2016, it has grown 4.4% PPG.
R-Pharm launched the
construction of Hayat Pharm
plant in collaboration with
Vita-A company and Azerbaijan
Investment Company. Total
investments will amount USD 70
m.
BIOCAD company intends to
launch the original drug BCD-
085 for the treatment of
ankylosing spondylitis. Currently,
the company is conducting phase
II clinical trials.
In 2017, Kraspharma company
(one of the biggest pharma
companies of the East Siberia)
plans to launch new production
lines for the production of
antibiotics and infusion solutions.
The reconstruction at the plant
started in 2014; the investments
amounted EUR 1 mio.
Biohimik company is constructing
new research-production and
engineering center for the
development of new antibiotics
in Saransk. The launch of new
medicines is expected to start in
2020.
Erkapharm group of companies
started rebranding of Doctor
Stoletov brand within the
aggressive strategy of brand
development, which is aimed to
double the company’s turnover by
the end of 2018.
Russian Trade Ministry granted
the GMP certificates to 40
foreign manufacturing facilities.
The Ministry has already received
500 applications and conducted
121 inspections. Since 2016,
foreign plants are obliged to
receive Russian GMP certificate
for companies to be able to
register new drugs in Russia.
Nanolek company launched
biotechnological department at
its plant in Kirov Region, which is
aimed to production of vaccines
and biological preparations.
The company plans to launch
production of the first Russian
polio vaccine at new facilities in
2018.
State company Rusnano
expects to put into operation
pharmaceutical plant NT-Pharma
in autumn 2017. Earlier, the
manager Board of NT-Pharma
were arrested for embezzlement.
Rusnano, which owns 49% of
the company, invested RUB 1 bn
into the project; the plant was
supposed to start operating in
2012.
Nativa company intends to
invest RUB 2.1 bln in the
production of analogues of
foreign powders for inhalation.
German company Harro Höfliger
Verpackungsmaschinen will supply
equipment for the production and
packaging of medicines.
Russian Society of Clinical
CIS REGION PHARMA NEWS
Page 10
Ukrainian Pharmaceutical Market Monthly: November 2016
Oncology (RUSSCO) signed the
Memorandum on the start of
the project for development of
immuno-oncology in Russia in
participation with AstraZeneca,
Bristol-Myers Squibb, MSD and
Roche. The project is aimed at
strengthening the competencies
in the field of Russian immune-
oncology and acceleration of
introduction of the achievements
of world science in the fight
against cancer.
Sun Pharma approved the
acquisition of 85.1% of shares of
Russian company Biosintez for
USD 60 mio. Indian company
expects to complete the
transaction by the end of the year
after obtaining the endorsement
form the Federal Antimonopoly
Service.
Russian Parliament is developing
the Draft Law aiming to regulate
the implementation of eHealth
in Russia. The consideration
of legalization of online sales of
medicines may start in spring
2017, after the approval of the
Law on telemedicine.
Business
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Analysis of Prescribers and Consumers
Business Training for Pharmaceutical Companies:
Strategy / Change Management
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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.
UPharma Consulting
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Upharmacia - November 2016

  • 1. UpharmaciaUkrainian Pharmaceutical Market Monthly Macroeconomic Environment | Market & Companies News | Regulatory Updates | Healthcare News | Issue: 11 2016
  • 2. Page 2 Ukrainian Pharmaceutical Market Monthly: November 2016 2015 2016 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct 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) 3.23 3.13 3.36 2.04 3.08 2.99 3.10 2.88 2.93 2.92 3.18 3.16 3.24 growth, % y-o-y -23% -21% -11% -31% 3% -13% 1% -2% -5% -7% 3% -6% 0% Import of Goods (US$ bn) 3.22 3.07 3.12 2.23 2.68 3.35 3.05 2.69 2.87 3.09 3.45 3.48 3.54 growth, % y-o-y - 27% -27% -32% -26% -6% 5% 7% 2% 4% 4% -11% 8% 10% Industrial Production Sales (US$ bn) 6.29 5.92 6.37 4.93 4.93 5.41 5.17 5.39 5.44 5.61 5.57 5.62 6.39 growth, % y-o-y -21% -19% -17% -18% 8% -2% -12% -5% -6% -2% 3% -2% 2% Retail Turnover of Enterprises (US$ bn) 2.04 1.80 2.01 1.60 1.50 1.64 1.76 1.59 1.73 1.87 1.92 1.76 1.87 growth, % y-o-y -31% -33% -29% -19% 4% 2% 6% -18% -6% -3% 2% -5% -8% Unemployment Rate (%) 1.5 1.6 1.9 1.9 1.9 1.7 1.6 1.6 1.5 1.4 1.3 1.3 1.2 Average Salary (US$) 207 193 223 180 174 187 191 198 214 217 208 204 208 OFFICIAL CURRENCY EXCHANGE RATE UAH / USD 21.8 23.3 23.4 24.3 26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8 UAH / EUR 24.6 25.1 25.4 26.3 29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5 PHARMACEUTI CAL INDUSTRY INDICATORS Export of Pharma Products (mio USD) 12.2 11.7 15.77 8.31 13.33 15.54 13.90 14.17 16.15 13.36 13.58 18.81 18.40 growth, % y-o-y -37% -52% -28% -30% 11% 16% 3% 9% 5% -4% 51% 37% 51% Import of Pharma Products (mio USD) 147.1 141.3 142.1 103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3 growth, % y-o-y -28% -24% -42% 15% 27% 21% 25% 31% 15% 25% 47% 15% -7% Pharma Retail Sales, values (mio USD) 206.3 196.6 212.3 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2 growth, % y-o-y -26% -20% -18% -17% -1% -5% -1% -8% -2% 2% 2% -1% 3% Pharma Retail Sales, volumes (mio units) 130.2 129.0 136.4 133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6 growth, % y-o-y -5% -4% -5% 1% -12% -5% 2% -1% 4% 3% 3% 7% 6% WACP (USD) 1.58 1.52 1.56 1.49 1.39 1.40 1.42 1.44 1.43 1.43 1.43 1.41 1.53 growth, % y-o-y -22% -18% -14% -23% -23% 13% 1% -2% -6% -3% -1% -8% -3% CPI of Ukraine 146.4 146.6 143.3 140.3 132.7 120.9 109.8 107.5 106.9 107.9 108.4 107.6 112.4 Pharmaceutical Products CPI 142.1 138.1 134.6 131.9 126.9 113.5 108.4 107.3 108.2 107.4 107.2 107.9 107.6 Local Companies share, values (%) 41.4 41.7 40.9 42.3 42.9 42.7 42.3 42.9 42.8 42.8 41.8 42.6 40.8 Local Companies share, volumes (%) 75.7 75.8 76.7 75.6 76.5 76.5 76.7 77.2 77.4 77.9 68.9 68.4 67.5 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 (October 2015-October 2016)
  • 3. 206.3 196.6 212.3 198.9 176.0 187.3 178.1 177.6 174.8 175.4 180.9 190.4 212.2 130.2 129.0 136.4 133.6 126.8 133.8 125.2 123.6 122.6 122.7 126.2 135.5 138.6 100 110 120 130 140 150 160 100 120 140 160 180 200 220 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Pharmaceutical Market Retail Sales2015 2016 Volumes Values mio USD mio units 206.3 196.6 221122.33 130.2 129.00 113366.44 Oct Nov Dec 2015 12.2 11.7 15.8 8.3 13.3 15.5 13.9 14.2 16.1 13.4 13.6 18.8 18.4 147.1 141.3 142.1 103.7 145.0 125.1 130.0 110.4 132.1 133.1 137.3 140.6 137.3 0 20 40 60 80 100 120 140 160 0 4 8 12 16 20 24 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Ukraine's International Trade in Pharma Production 2015 2016 Export Import mio USD mio USD 12.2 11.7 15.8 147.1 141.3 142.1 Oct Nov Dec 2015 6.29 5.92 6.37 4.93 4.93 5.41 5.17 5.39 5.44 5.61 5.57 5.62 6.39 2.04 1.80 2.01 1.60 1.50 1.64 1.76 1.59 1.73 1.87 1.92 1.76 1.87 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0 1 2 3 4 5 6 7 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Industrial Production Sales & Retail Turnover of Enterprises Surplus 2015 2016 Retail turnover of enterprises Industrial production sales bn USD 6.29 5.92 6.37 2.04 1.80 2.01 Oct Nov Dec 2015 bn USD 21.8 23.3 23.4 24.3 26.4 26.4 25.6 25.2 25.0 24.8 25.1 26.3 25.8 24.6 25.1 25.4 26.3 29.3 29.2 29.1 28.5 28.1 27.5 28.1 29.5 28.5 146.4 146.6 143.3 140.3 132.7 120.9 109.8 107.5 106.9 107.9 108.4 107.9 112.4 0 20 40 60 80 100 120 140 160 0 5 10 15 20 25 30 35 40 45 50 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct 2015 2016 Official Currency Exchange Rates vs. Consumer Price Index UAH / EUR UAH / USD CPI 21.8 23.3 23.4 24..66 25.1 25.4 146.4 146.6 143.3 Oct Nov Dec 22001155 Page 3 Ukrainian Pharmaceutical Market Monthly: November 2016 KEY ECONOMIC EVENTS »» GDP of Ukraine rose 1.8% y-o-y in 3Q2016 and 1.2% y-o-y in 9M2016, State Statistics Service reported. The IMF and the EBRD projected 1.5% y-o-y increase for 2016, while Ukrainian Trade Ministry forecasted 1.0% y-o-y growth. »» On Nov 24, the EU authorities once again postponed approval of visa-free regime with Ukraine due to inter- institutional inconsistency over the issue. The next review of visa liberalization could occur on Jan 18, 2017. »» The EBRD decreased investments in Ukraine in 2016 by 60% y-o-y to USD 400 mio. According to the Bank’s President, the amount could be increased next year. »» In 9M2016, Ukraine’s goods trade deficit reached USD 1.76 bn compared to a USD 0.70 bn surplus in 9M2015. Exports of goods declined 8.7% y-o-y due to deterioration of chemicals (-32% y-o-y), minerals (-20% y-o-y) and metals (-18% y-o-y) trade. Exports to the EU increased 4.4% y-o-y, while exports to the CIS countries fell 27.1% y-o-y. »» Fitch Ratings upgraded Long-Term Foreign and Local Currency Issuer Default Ratings (IDRs) of Ukraine to B- from CCC. The agency’s outlook is stable. »» Ukraine climbed 23 positions in Paying Taxes rating by PwC to 84th position. The improvement was mainly caused by the introduction of the new index in the rating (obtaining of a VAT refund and dealing with a voluntary correction of an inadvertent error in a CIT return). »» China is interested in development of industrial parks in Ukraine and in placing its production facilities there. The China International Chamber of Commerce has provided the corresponding plan of cooperation to the Ukrainian side. »» In 9M2016, FDI in Ukraine in the form of shareholder capital increased 6.2% y-o-y to USD 45.12 bn. »» Since the introduction of free-trade zone, in 10M2016, the trade turnover between Ukraine and the EU increased 5% PPG, the President of Ukraine reported. The EU is the main trade partner for Ukraine with 41% share in total trade. »» According to Credit Suisse survey, the wealth of Ukrainian households decreased 18.5% from the middle of 2015 to the middle of 2016 to USD 44 bn. Ukraine, Russia and Argentina were Top-3 countries by the rates of wealth reduction.
  • 4. RECRUITING & EXECUTIVE SEARCH We recruit pharma people in the CIS region and focus on: > Sales & Marketing > Regulatory Affairs > Quality Assurance > Finances > Operations > Administration We aim to be your trusted advisor in People Management Anastasiya MAXIMENKO Partner, HR-Consulting AMaximenko@upharma-c.com +380 (44) 232-11-43 +380 (97) 953-68-14
  • 5. Page 5 Ukrainian Pharmaceutical Market Monthly: November 2016 MARKET & COMPANIES NEWS Vynnitsapharmacia wants to redeem 18 mio of its own shares PJSC Vynnitsapharmacia intends to redeem 18 mio of its common registered shares, the Supervisory Board of the company stated. The company also plans to sign the contract with BaDM distributor on the supply of drugs and medical devices for about UAH 30 mio. PJSC Vynnitsapharmacia owns the pharmacy chain Bazhayemo zdorovya in Vinnitsa and also produces and conducts sale of pharmaceuticals. The company is a part of Premier Finance Corporation, which includes 30 companies in the pharmaceutical, retail and food industries. In 2015, the profit of Vynnitsapharmacia amounted UAH 465 ths. Ukraine and Indonesia to cooperate in pharmaceutical sphere On Nov 4, the State Service on medicines and drug control of Ukraine signed the Memorandum of Understanding in pharmaceutical sphere with the National Agency on control over medicines and food products of the Republic of Indonesia. The cooperation between two agencies started after in Aug 2016, the President of Ukraine visited Indonesia. The Memorandum establishes the necessary legal framework for the expansion of bilateral cooperation in the pharmaceutical field between two countries and promotes interaction to meet the strategic needs of Ukraine and the Republic of Indonesia in the pharmaceutical industry. The Head of Indonesian Agency stated that the country is open for cooperation and investments, which will contribute to the growth of the country’s market. The most of 200 Indonesian pharmaceutical enterprises comply with the GMP requirements, while the country’s pharmacopeia generally corresponds to the US Pharmacopeia. PJSC Technolog to triple exports of antituberculosis drugs PJSC Technolog (part of Lekhim group of companies) plans to increase its export amounts of its antituberculosis drugs 2-3 times in the next few years. To achieve that, the company intends to receive prequalification of the World Health Organization (WHO) for the corresponding preparations by the end of 2017. According to the company’s GM, Technolog may also consider the possibility of obtaining the prequalification of drugs for the treatment of HIV/AIDS. Currently, the company is exporting about 15% of its products. Its main external markets are the CIS countries. Production capacities of PJSC Technolog are located in Uman (Cherkasy region). Lekhim group of companies includes JSC Lekhim, PJSC Technolog and JSC Lekhim-Kharkiv and is among TOP-15 Ukrainian pharmaceutical producers. It is a #1 local company by sales of enzyme preparations, suppositories and pelleted dosage forms. Head of Astellas Pharma RO in Ukraine leaves his post Krzystof Siedlecki leaves Ukraine and his post as a head of the Astellas Pharma Representative Office in Ukraine. He announced this during the local pharma conference recently. Krzystof Siedlecki has been leading Japanese Astellas Pharma RO in Ukraine for 10 years. He was elected President of EBA in Ukraine in 2015.
  • 6. Page 6 Ukrainian Pharmaceutical Market Monthly: November 2016 REGULATORY UPDATES AMCU Presented a Report Based on the Results of Pharma Market Survey Concerning the Compliance with Competition Law Requirements On November 22, 2016, the AMCU published the results of pharma market survey for 2014-2016 and evaluated the compliance with competition law requirements by the main players of pharma market (manufacturers, importers/ distributors, pharmacies). The AMCU’s report provides the details on logistic structure of medicinal products supply to the territory of Ukraine and the peculiarities of cooperation between the players, as well as the pricing components to include the prices for end customers. According to the AMCU, the competition of pharma market may be influenced not only by noncompetitive behavior of market players, but also by the activities of public authorities legally bound to regulate these markets by creating administrative barriers for entering the market or imposing the red tape on the players already operating on the market during the exercising of their authorities. The Report mainly focuses on the operation of business entities at product market and the pricing at each stage of medicines sales. In its analytical report the AMCU provides the details of the interactions between manufacturers/importers and distributors, and indicates the contract provisions bearing the risks to be qualified as competition violations. In the AMCU’s opinion, medicinal products’ export ban, the liability to prevent the third parties from products export from Ukraine, the obligation to provide the reports and the implementation of payment terms that ensure the pharma company’s control over the goods flow at medicines markets of Ukraine testify the market distribution and competition restriction. In their turn, the distributors agree to these terms in exchange for discounts provided by manufacturers. The AMCU believes that the discount system raises a lot of due diligence questions, as this system bears the evidence of duplicate pricing, which hampers the competition development and does not reduce the price for the end customer. Moreover, the AMCU assessed the impact of national and foreign manufacturers/importers and distributors on pricing. In the course of the survey the AMCU made a conclusion that the main objective factors influencing the pricing on medicines’ market were the following: Ukrainian currency exchange rate, inflation rate, changes in taxation system, introduction of additional import fee. It is worth to mention that during the study on regional markets the Committee determined the structural features of monopoly (dominant) position at investigated regional markets of 183 business entities that conduct retail sales of medicinal products in the form of pharmacy chain. The tendencies for pharmacy segment development in Ukraine regarding the market consolidation by the increasing the role of medicines’ retailing chain, in certain cases may lead to the situation when strong players with the signs of monopoly position on regional markets, shall gradually merge the weaker competitors to include by joining them to existing pharmacy chains and hence strengthening their share in the market. The AMCU believes that taking into consideration the currently existing competition situation on medicines’ retail market, the market players should implement the self-regulation market mechanism together with the establishment of general principles of professional ethics for all market players. This shall let the pharmacy chain, being a healthcare facility according to the law, to target mainly the patients in order to maintain their health. Bylaws in Effect to Ensure the Medicines’ Selection for National Essential Medicines List On 04.11.2016 the following bylaws became effective: the Ministry of Health Order № 1049 of 07.10.2016 «On Amendment of the Regulation on Expert Committee on the Selection and Use of Essential Medicines»and the Ministry of Health Order № 1050 of 07.10.2016 «On Approval of the Regulation on Medicines’ Selection for National Essential Medicines List». Upon the enforcement of the amendments to the Regulation on Expert Committee the list of specialists allowed for the participation in Expert Committee has been extended. In particular, the specialists with mathematical education have been granted with the right to become members of this Committee. Moreover, the provision has been cancelled requiring from the candidates to be obligatory employed by Provided by
  • 7. Page 7 Ukrainian Pharmaceutical Market Monthly: November 2016 HEALTHCARE NEWS The MOH increased funding of cancer treatment programs The MOH denied information, provided in some mass media, about the shutdown of “Oncology” program. In 2017, the funding of “Oncological diseases” Program will increase 12% y-o-y to UAH 445 mio, while “Children’s Oncology” Program will rise by 58% y-o-y to UAH 558 mio. Herewith, in accordance with the Resolution of the Cabinet of Ministers of Ukraine “On efficient use of public funds”, the form of assistance will be changed from “programs” to “measures”. Government to allocate UAH 500 mio for drug reimbursement in 2017 The update Draft Budget 2017 provides the allocation of UAH 500 mio for the program for drugs reimbursement. The program is to be launched since Apr 1, 2017 and envisages the introduction of real compensation reimbursement of drugs for the treatment of hypertension, type II diabetes and asthma. The program includes INNs of drugs without indication of dosages. Currently, the reimbursement list includes 16 INNs of drugs against cardiovascular diseases, 2 INNs of drugs against type II diabetes and 3 INNs of drugs against bronchial asthma. After the meeting with pharmaceutical producers with the parliament members, the Healthcare Minister Ulana Suprun reported that the most of companies supported the program, but had a lot of questions on its implementation and operation. The Head of the MOH noted that the Ministry would work to increase the funding of the program in the Budget. According to the Draft Budget, in 2017, the government will also allocate UAH 5.9 bn for the public procurement of drugs through international organizations. The issues with reference pricing introduction since 2017 were discussed The government intends to reduce drug prices through implementation of reference pricing for drugs against hypertension, type II diabetes and asthma since Jan 1, 2017. The reference countries will be Czech Republic, Hungary, Latvia, Poland and Slovakia. The reference pricing envisages implementation of marginal wholesale prices. The approach to regulation of margins also to be changed: marginal supply and sales margins to be reduced to 5%, while new regressive commercial (retail) margins should not exceed 20% (today marginal supply and sales margins amount 10%, while marginal retail margins amount 25%). “There is a lot of data saying that drugs in Ukraine are overpriced, while patients pay about 90% of drugs value,” Ukraine’s Prime Minister said at the meeting with pharmaceutical healthcare or science and research facilities. Nevertheless, it is envisaged that preference will be granted to candidates working at these facilities during the selection of Expert Committee members by the Competition Commission. The abovementioned Regulation also covers the specifics of the application execution regarding the National List amendment and approves the application template. Thus, the document in particular provides the details on which information should be filled in each application clause. It should be mentioned that the hard copy and electronic version (in Word format) of the application should be submitted in Ukrainian, and the attached documents should be submitted in Ukrainian or English with Ukrainian or Russian translation (if required) as hard or electronic copies. The legal framework development for the elaboration of National Essential Medicines List ends with the enforcement of the Regulation on Medicines Selection. The National List itself shall be harmonized with the latest version of WHO Essential Medicines Model List, which includes the medicines needs for a basic healthcare system. Therefore, the National List implementation shall provide for the removal of duplicates of different obligatory for usage medicines lists, in favor of single unified list to be implemented for public regulation of medicines prices.
  • 8. Page 8 Ukrainian Pharmaceutical Market Monthly: November 2016 producers. “I urge producers to take the government’s decisions responsibly and to implement them rapidly. I would like to warn against creating an artificial shortage of medicines. It will not benefit the initiators of such steps.” Some representatives of pharma companies see the some issues, which may arise with implementation of reference pricing, in particular: »» due to the absence of the Procedure for calculation of limiting drug prices, manufacturers will not be able to declare changes in wholesale prices in time, while the declaration procedure will take at least a month; »» in some cases reference pricing may cause the increase in drug prices, as some prices in Ukraine are lower than in reference prices; »» decrease of sales and supply margins to 5% may negatively affect small distributors. WB provided USD 40 mio to Dnipropetrovsk region to open 39 ambulance stations World Bank has provided USD 40 mio to Dnipropetrovsk region for the development of 39 ambulance stations and creation of emergency care departments in three hospitals of the region. The project is expected to be implemented during 4 years. The World Bank’s project is intended to fight cardiovascular diseases, and new ambulance stations to prevent and treat them will be opened, the Head of Dnipropetrovsk Regional Administration reported. The MOH intends to cope with OTC sale of antibiotics On Nov 15, the MOH held press briefing aimed to promote responsible use of antimicrobial drugs. According to the Member of Parliamentary Committee on Public Health Olexiy Kyrychenko, excessive and uncontrolled use of antibiotics by patients, irrational prescription of these drugs by doctors and their frequent use in agriculture and veterinary medicine are the main reasons for the development of antibiotic resistance in Ukraine. Lack of public awareness and the impact of promotional activities carried by pharmaceutical companies also compounding the problem. The speakers announced the flash mob #antibiotic_upon_ prescription, calling patients to buy antibiotics only after consultations with physicians. The Deputy Head of the MOH reported that the Ministry created the working group to develop the National Strategy and Action Plan to combat antimicrobial resistance in Ukraine. According to the Head of Parliamentary Committee on Public Health Olga Bogomolets, Ukrainians spend about UAH 15 bn on antibiotics and about half of them are used for self-medicating. To solve the issue, Mrs. Bogomolets proposed to ban advertising of antibiotics in mass media and adapt the European treatment standards by the MOH. Antimonopoly Committee proposes to consider the restriction of opening of new pharmacies Antimonopoly Committee of Ukraine supported the idea to restrict the opening of new pharmacies, which had been raised by market operators in the Draft Codex of ethical operation of pharmacies developed by Professional Pharmacy Association of Ukraine. The Draft Codex proposes to strive for a uniform placement of pharmacies in localities through prohibition of opening of new pharmacies in the building, which is already used as a place of economic activity of another pharmacy. This rule will not apply to buildings of health care facilities or shopping centers in case of opening of pharmacies, which have the license for production (manufacturing) of medicinal products in a pharmacy or the license for sale of narcotic drugs, psychotropic substances and precursors. Antimonopoly Committee decided to conduct the poll of market operators on the provisions of the proposed Code. MOH signed Memorandum on creation of e-health system in Ukraine On Nov 25, the MOH signed the Memorandum on cooperation in creation of transparent and efficient electronic health system in Ukraine. The document was signed by the acting Head of the MOH, the Head of State Agency for eGovernance as well as the representatives of the public initiative on healthcare sector electronization and specialized state-owned enterprises. At the event there was noted that efforts to create efficient e-health system in Ukraine over the las 10 years had been unsuccessful because the state tried to solve this complex and expensive problem on its own. Participants of the event stressed that the public initiative is open to all who agree with the declared principles and is ready to contribute to the objectives of the Memorandum for the sake of the entire Ukrainian society. The Memorandum should lead to signing of the road map on implementation of the electronic system, creating of uniform, transparent and non-discriminatory rules of access to the system, as well as determination of basic software needed to launch reforms.
  • 9. Page 9 Ukrainian Pharmaceutical Market Monthly: November 2016 Belarus Nativita company signed the contract on cooperation with Slovak pharmaceutical company and distributor Unipharma, which is to open up prospects for the registration and distribution of Nativita’s products in Slovakia, the Czech Republic, Hungary, Poland. Moreover, Nativita signed cooperation agreement with BioMed research center to conduct exchange of technology and experience and implement joint research for the development and creation of new products. Kazakhstan Kazakh company Abdi Ibrahim Global Pharm (part of Turkish Abdi Ibrahim) received international GMP certificate. Specialized inter-district economic court of Pavlodar region declared bankruptcy of one of the biggest pharmaceutical companies in Kazakhstan Romat and its part Pavlodar pharmaceutical plant. The group of companies debt to 309 creditors about KZT 6 bn. Kazakhstan and South Korea signed Memorandum on development of cluster of pharmaceutical and medical- biological plants Nefertem in Kazakhstan worth USD 350 mio. Russia On 17/11/2016, members of the Eurasian Intergovernmental Council (Prime Ministers of Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan) signed the unified package of documents needed for the full featured operation of the common drug market within the Eurasian Economic Union (EEU). The documents will come into force after ratification of protocol on the accession of Armenia to the EEU. The Trade Ministry expects the Russian pharmaceutical market to grow at least 10% y-o-y in values in 2016. In 2015, the market amounted RUB 1.12 trln; in 1H2016, it has grown 4.4% PPG. R-Pharm launched the construction of Hayat Pharm plant in collaboration with Vita-A company and Azerbaijan Investment Company. Total investments will amount USD 70 m. BIOCAD company intends to launch the original drug BCD- 085 for the treatment of ankylosing spondylitis. Currently, the company is conducting phase II clinical trials. In 2017, Kraspharma company (one of the biggest pharma companies of the East Siberia) plans to launch new production lines for the production of antibiotics and infusion solutions. The reconstruction at the plant started in 2014; the investments amounted EUR 1 mio. Biohimik company is constructing new research-production and engineering center for the development of new antibiotics in Saransk. The launch of new medicines is expected to start in 2020. Erkapharm group of companies started rebranding of Doctor Stoletov brand within the aggressive strategy of brand development, which is aimed to double the company’s turnover by the end of 2018. Russian Trade Ministry granted the GMP certificates to 40 foreign manufacturing facilities. The Ministry has already received 500 applications and conducted 121 inspections. Since 2016, foreign plants are obliged to receive Russian GMP certificate for companies to be able to register new drugs in Russia. Nanolek company launched biotechnological department at its plant in Kirov Region, which is aimed to production of vaccines and biological preparations. The company plans to launch production of the first Russian polio vaccine at new facilities in 2018. State company Rusnano expects to put into operation pharmaceutical plant NT-Pharma in autumn 2017. Earlier, the manager Board of NT-Pharma were arrested for embezzlement. Rusnano, which owns 49% of the company, invested RUB 1 bn into the project; the plant was supposed to start operating in 2012. Nativa company intends to invest RUB 2.1 bln in the production of analogues of foreign powders for inhalation. German company Harro Höfliger Verpackungsmaschinen will supply equipment for the production and packaging of medicines. Russian Society of Clinical CIS REGION PHARMA NEWS
  • 10. Page 10 Ukrainian Pharmaceutical Market Monthly: November 2016 Oncology (RUSSCO) signed the Memorandum on the start of the project for development of immuno-oncology in Russia in participation with AstraZeneca, Bristol-Myers Squibb, MSD and Roche. The project is aimed at strengthening the competencies in the field of Russian immune- oncology and acceleration of introduction of the achievements of world science in the fight against cancer. Sun Pharma approved the acquisition of 85.1% of shares of Russian company Biosintez for USD 60 mio. Indian company expects to complete the transaction by the end of the year after obtaining the endorsement form the Federal Antimonopoly Service. Russian Parliament is developing the Draft Law aiming to regulate the implementation of eHealth in Russia. The consideration of legalization of online sales of medicines may start in spring 2017, after the approval of the Law on telemedicine.
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