Ukrainian Pharmaceutical Market Monthly - Upharmacia - Oct 2017
1. Macroeconomic Environment
Market & Companies News
Regulatory Updates
Healthcare News
UPHARMACIA
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.
10'17
ISSUE
Ukrainian Pharma Market Monthly
2. 2
Upharmacia October 2017
www.upharma-c.com
CONTENTS
/ Macroeconomic Indicators 09/2016-09/2017
/ Economy & Pharma Dashboard 09/2016-09/2017
Page
/ Economic News 10/2017
/ Pharma Market News 10/2017
/ Regulatory Updates 10/2017
/ Healthcare News 10/2017
/ CIS Pharma News 10/2017
3
5
5
6
7
8
9
Section Data period
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The information contained in this publication has been obtained from sources that UPC’s research group believes to be reliable, but UPC
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content of any thirdparty web site accessed via a hyperlink in this publication and such information is not incorporated by reference.
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FOR MIDDLE &
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• SALES & MARKETING • FINANCES
• REGULATORY & MEDICAL AFFAIRS
• PHARMACOECONOMICS
• MARKET ACCESS
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5. 5
Upharmacia October 2017
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18.8 18.4
14.8
23.9
8.1
13.3
22.0
12.2
14.2
19.8
14.2
13.1
16.7
140.6
137.4
142.6
169.1
102.4
123.4
150.6
116.8
145.7
156.8
150.5 149.8
146.6
0
30
60
90
120
150
180
0
5
10
15
20
25
30
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
Ukraine's International Trade in Pharma Production
Export
Import
2016 mio USD2017
190.4
212.2
224.7
264.9
233.2
225.4
187.0
210.5 217.5
206.5
211.4 212.7
236.5
135.5 138.6 139.9
164.1
148.8 147.6
121.9
133.9
137.3
132.0
139.5
134.3
146.7
100
120
140
160
180
80
120
160
200
240
280
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
Pharmaceutical Market Retail Sales
mio USD
mio units
2016 2017
5.62
6.39
6.91
7.64
6.34 6.44
6.91
5.92
6.25 6.27 6.31
6.62 6.52
1.76
1.87
2.04 2.09
1.40 1.37
1.62 1.66
1.93
1.78
1.96
2.09
1.89
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
8
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
Industrial Production Sales &
Retail Turnover of Enterprises Surplus
2016 bn USD2017
26.3 25.8 25.7 26.2 27.2 27.0 27.0 26.9 26.4 26.1 26.0 25.6
26.1 26.7
29.5 28.5 27.8 27.6 28.8 28.8 28.8 28.8 29.2 29.26 29.8 30.2 31.1
31.4
107.9
112.4 112.1 112.4 112.6 114.2 115.1 112.2 113.5 115.6 115.9 116.2 116.4
0
20
40
60
80
100
120
140
160
0
10
20
30
40
50
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep
UAH/USD
UAH/EUR
CPI
2016
Official Currency Exchange Rates
vs. Consumer Price Index
2017
ECONOMY & PHARMA
DASHBOARD
ECONOMIC NEWS
—— Ukraine climbed 4 positions to 76th
position in the
World Bank’s Doing Business 2018 report. The
report admitted Ukraine’s progress in dealing
with construction permits (from 140th
to 35th
position), protecting minority investors (from 70th
to 81st
position) and paying taxes (from 84th
to 43rd
position). Ukraine still has low ratings in resolving
insolvency (149th
), getting electricity (128th
) and
trading across borders (119th
).
—— Ukrainian Parliaments approved pension reform,
which was the most critical condition of the IMF.
The reform is aimed to decreasing the deficit of the
pension fund through increasing the work tenure
and raising pension contributions for certain
categories of employees.
—— In Oct, Ukraine’s treasury residuals fell by 19.1%
vs Sep to UAH 48.6 bn. In Sep, treasury residuals
were at the highest historical level amounting UAH
63.2 bn in cash.
—— Ukrainian industrial output decreased by 0.3%
y-o-y in Sep. Chemical sector showed 33.4%
y-o-y growth.
—— Privatization of large state companies is
postponed to 2018, the Head of Ukraine’s
Property Fund stated. The exception may apply
to Odesa Portside Plant, which will be put up for
auction in Dec 2017.
—— In Oct, customs revenues in Ukraine reached
a record high of UAH 30 bn, which is UAH 5.3
bn higher than the target figure and 37.3%
higher than in Oct 2016, the State Fiscal Service
reported.
6. 6
Upharmacia October 2017
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Indar will Establish
Joint Enterprise in
Azerbaijan
Indar, the Ukrainian producer
of insulin, has signed the
Memorandum with Azerbaijani
Investment Company on
establishing a joint pharmaceutical
venture in Pirallahy Industrial Park.
The company will produce infusion
and injection solutions. The
construction of production facilities
will start in 2018 and will last for 2
years. The cost of the project is to
amount USD 17 mio. The enterprise
will create 350 jobs.
Pirallahy Industrial Park was
created in 2016 following the
President’s Order to promote
the development of the local
pharmaceutical industry. Currently,
3 companies are constructing
facilities in the Park. The residents
of the Park are freed from paying
different taxes for 7 years.
Indar was established in 1997
by the government. 70% of the
company belongs to the State
company Ukrmedprom. The
company is included in the list
of state objects, which have a
strategic importance for the
economy and state security.
BCPP Plans to
Launch 4-6 New
Drugs by the end
of 2017
Borshchahivskiy Chemical-Phar-
maceutical Plant (BCCP) plans to
launch onto the market from 4
to 6 new drugs by the year-end,
the company’s reconstruction
and development Director sated.
The preparations are related
PHARMA MARKET NEWS
to cardiovascular diseases and
neurology. Currently, BCPP has
about 25 drugs in development.
The market of cardio drugs
amounted about UAH 7,1 bn in
2016. In 9M 2017, BCCP was 20th
company on Ukrainian drug market
by sales. In 2016, the company
doubled its net profit vs 2015 to
UAH 118.7 mio.
Galychpharm
Received GMP
Certificate to Produce Tablets
Galychpharm company received
Ukrainian GMP certificate to
produce drugs in form of tablets.
Lately, the company reconstructed
the tablet-packing shop and
installed more than 14 units of
new equipment. Galychpharm is a
producer of about 90 herbal-based
drugs and phyto-chemical
substances. Some of is drugs are
produced in a form of tablets,
such as Mucaltine, Streptocide,
Asparkam etc.
Galychpharm is a Lviv-based part
of Arterium Corporation, which
also includes Kyivmedpreparat
company. In 9M 2017, Arterium
corporation held the second place
on the Ukrainian drugs market by
retail sales.
Lekhim Launches
Veterinary Direction
Lekhim group of
companies started producing
veterinary drugs on the base
of Technolog company. Thus,
the company, the main focus of
which are cardiology and drugs
for alimentary tract, opened the
new direction of its development.
Lekhim started developing the
veterinary direction in 2016 and
now has 3 veterinary drugs to
produce.
Lekhim group includes JSC Lekhim
(Kyiv), JSC Technolog (Uman) and
JSC Lekhim-Kharkiv (Kharkiv). In
Oct 2017, Technolog plant received
the EU GMP certificate to produce
drugs.
Darnitsa
Increased its
Net Profits
Pharmaceutical Firm Darnitsa
increased its net profits by 5% in 3Q
2017 vs the same period in 2016 to
UAH 252.3 mio.
Gross profit for the same period
grew by 19% to UAH 998.6 mio,
NSSMC stated.
The company was the third
largest local manufacturer in 2016
following Farmak and Arterium.
More Than 70% of
Medicines Bought
Directly From Suppliers
The UNDP has analyzed the
procurement it conducted
with the funds of 2016 state
budget.
According to the results, share of
medicines bought directly from
manufacturers comprised 71%,
in contrast to 90% of the MoH
tenders won by distributors in
2014 and earlier years - before
the international procurement of
medicines was introduced.
7. 7
Upharmacia October 2017
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REGULATORY UPDATES
Provided by
The Parliament Has Adopted
the Healthcare Reform
On Oct 19, 2017, Ukrainian
Parliament voted for 3 Draft Laws
that are part of the medical reform:
1. The Draft Law "On State
Financial Guarantees for the
Provision of Medical Services and
Medicines" No. 6327 (adopted
wholly);
2. The draft law "On Amendments
to the Budget Code of Ukraine
on Providing State Financial
Guarantees for the Provision of
Medical Services and Medicines”
No. 6604 as of Jun 21, 2017
(adopted in the first reading)
3. The draft law "On Increasing
Accessibility and Quality of
Medical Care in Rural Areas"
(adopted in the first reading) No.
7117 as of Sep 18, 2017.
These draft laws concern the
spheres of financing of medical
care, in particular, the introduction
of a state guaranteed package of
medical services and medicines, the
creation of the National Healthcare
Service of Ukraine as the only
customer for medical services, the
reform of the primary healthcare
system and the introduction of
electronic patient records.
Primary healthcare system reform
provides that patients will exercise
their right to choose a family
doctor by submitting to the medical
services provider a declaration on
the choice of a doctor who provides
first medical aid.
The ideology of the medical reform
is that the healthcare will be
financed on a contractual basis.
That is, healthcare institutions will
receive money for specific services
provided to specific patients.
Financing the number of places in
hospitals now will be substituted
by the principle “money follows the
patient”.
The draft law introduces the
concept of the program of state
guarantees for medical services
to the population, according to
which the state pays fully from the
state budget of Ukraine. Such a list
includes primary, emergency and
palliative care. It is worth noting
that when reviewing the draft, the
Parliament excluded option of co-
payment for medical services by
patients.
Special attention is paid to
reforming rural medicine - this is
the focus of the draft law initiated
by the President of Ukraine.
The document envisages the
introduction of telemedicine in
Ukraine, which is intended to
simplify the diagnosis in those cases
when not a personal examination is
needed, but rather an evaluation of
the examination data.
In addition, the draft addresses
the social issues of healthcare
professionals. Thus, local
authorities are recommended to
develop and approve programs to
provide healthcare professionals
working in rural areas with official
housing and office vehicles. The
government is invited to take
measures to ensure access of
healthcare institutions in rural areas
to the Internet. Commenting on this
draft law, President P. Poroshenko
said that the budget has at least
UAH 5 bn of additional funding for
medicine in rural areas for 2 years.
Members of Parliament
Proposed to Introduce a
License for Manufacturing,
Trade and Import of Medical
Products
On October 6th, 2017 the draft
Law on amendments to the Law of
Ukraine "On Licensing Economic
Activities" was registered in the
Parliament.
The draft envisages the expansion
of the list of types of economic
activities subject to licensing. It is
proposed to supplement the list
with such activities as production,
wholesale and retail trade, as well
as import of medical products.
In addition, the reference to
medical products is included in
the paragraph on licensing of the
activities on manufacture, trade and
import of medicines.
The explanatory note to the draft
law states that the purpose of
amendments is to bring Ukrainian
legislation closer to the EU law.
However, the EU does not have the
practice of licensing production,
wholesale and retail trade, as well
as import of medical products.
At the same time, in order to unify
the approaches to regulating
the medical products market in
Ukraine and the EU and in order
to deregulate business, since
July 1st, 2017 the requirement to
register medical products has been
substituted by the requirement to
confirm their compliance with the
technical regulations. Technical
regulations provide only a register
8. 8
Upharmacia October 2017
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HEALTHCARE NEWS
National Healthcare Service to
be Created in early 2018
The government expects to create
the National Healthcare Service of
Ukraine (NHSU) – an independent
customer of services responsible
for financing the health system
– at the beginning of 2018, the
Deputy Head of the MOH Pavlo
Kovtonyuk stated. According to him
the Ministry has already developed
a lot of legislative acts for the
implementation of the Law on state
financial guarantees approved by
the Parliament on Oct 19.
The NHSU should become the key
authority within the reformation of
the Ukrainian healthcare system.
Until it is created, the functions of
funding the health care services will
be carried by the MOH. Co-author
of the reform MP Serhiy Berezenko
stated that the functioning of the
NHSU would be controlled by audit
service, Chamber of Accounts,
National Agency on Corruption
Prevention and National Anti-Cor-
ruption Bureau of Ukraine.
Pharma Companies Considering
Introduction of QR-coding
Ukrainian producers of phar-
maceuticals are considering the
possibilities of introduction of
QR-coding of drugs packs, the
Director of Professional Pharmacy
Association of Ukraine Volodymyr
Rudenko stated.
“Such labeling of imported and
local drugs in Ukraine is only at
planning stage,” Mr. Rudenko
stated. “Currently, the labeling
with QR-codes is almost not
implemented”.
A number of experts thank that the
implementation of QR-coding of
medicinal products could take 2-3
years due to the shortage of the
appropriate equipment.
of subjects responsible for the
introduction of medical products in
circulation. This register indicates
the location of the manufacturers
or their authorized representatives
and a list and description of the
relevant medical products.
However, despite the validity of
technical regulations, the draft does
not contain conditions for taking
into account their peculiarities
when issuing the corresponding
licenses for medical products, but
only references to the Law “On
Medicines”, which, obviously, should
be taken only in the context of
medicinal products.
We draw your attention to the fact
that today medical products are
sold by a wide range of subjects
on the market, including selling
through supermarkets, shops and
refuelling stations. Accordingly,
given the complexity of the licensing
process and the requirement,
for example, to entities to
provide special conditions for
the transportation or storage of
licensed products in special licensed
warehouses, it is possible to predict
a narrowing of the range of entities
that will be engaged in the relevant
economic activity.
Changes in the Procedure
for Selecting Drugs to the
National List Approved
The MOH adopted the Order “On
Amendments to Orders of the
Ministry of Health of Ukraine No. 84
as of Feb 11, 2016 and No. 1050 as
of Oct 7, 2016” No. 885 as of Aug 1,
2017, which amends the Regulation
on the National List of Essential
Medicines and the Regulation
on the Expert Committee on the
Selection and Use of Essential
Medicines.
The purpose of this regulatory
act is to bring the algorithm for
introducing changes into the
National List in line with the needs
of the healthcare system and the
calendar plan, which delays the
application of the National List.
Now the Expert Committee on
the Selection and Use of Essential
Medicines is developing a list of
drugs to include in the National List
by the end of 2017. In accordance
with Order of the Ministry of Health
of Ukraine No. 558, such selection
is carried out taking into account
the 20th version of the WHO Model
List, the nomenclature of medicines
procured for budgetary funds and
industry standards. Procurements
in 2018 will take place based on
such supplemented National List.
In the future, the National List will
be supplemented regularly once
a year. By Jul 1st of each year, the
advisory body will form the next
edition of the National List, submit
it to the Ministry of Health of
Ukraine, which in turn will submit
the draft resolution of the Cabinet
of Ministers on introducing the
changes to the Government.
Read more on Legal Alliance website
9. 9
Upharmacia October 2017
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Azerbaijan
—— The government of Azerbaijan
expects that in next 5 years
production of pharmaceutical
production in the country will grow 58.4 times.
—— The range of Pakistani companies are interested
in entering Azerbaijan’s market through creating
joint enterprises in Pirallahy Industrial Park, the
ambassador of Pakistan stated.
Georgia
—— Georgia Healthcare Group
announced that its pharma business
has acquired the international private label brand –
“Attirance”, with specializes in natural cosmetics and
personal care products.
Russia
—— Russian government endorsed
the Draft Law on remote sale of
OTC drugs by pharmacies. The
document was later submitted to the Parliament for
consideration.
—— Russian company Pharmstandard will localize the
production of Takeda’s innovative oncohematologic
drug Adcetris® (brentuximab vedotin).
—— Sanofi reached special investment contract with
Russian Trade Ministry on modernization of
industrial production at its plant Sanofi-Aventis
Vostok (Oryol region).
—— Representative of the regional government of St.
Petersburg stated that the city plans to produce 10%
of the total Russian pharma production. This will
be achieved through acceleration of industrial zone
Pushkinskaya, which includes 88 producers.
Kazakhstan
—— The MOH proposes to postpone
the launch of compulsory medical
insurance in Kazakhstan from 01/01/2018 to
01/01/2020 as there is a risk that the big share of the
population would not be involved.
—— In 8M2017, imports of pharmaceuticals to
Kazakhstan increased by 21.2% PPG in values to USD
524.2 mio. However, the amounts of 8M2015 (about
USD 610 mio) were not reached.
CIS PHARMA NEWS
Such measures are required to fight
against counterfeit drugs and to
be able to track their movement.
Labeling of drugs with QR-codes
should become mandatory in the
EU since Feb 2018.
In Oct, the State Service on drugs
launched the pilot project on the
introduction of an automated
system for monitoring the
movement of drugs from the
producer to the end consumer,
using codification and identification
in a European manner.
Some Drug Prices Grew 60% in
2 months
Analytical company Business Credit
admitted the grows of retail prices
of some categories of drugs in
last months. In Sep 2017, prices of
OTC otologic drugs increased 60%
vs Aug 2017, OTC contraceptives
– 50%. In last 2 months, 30%
growth was seen in retail prices
of Rx antiseptics, Rx hormonal
contraceptives and sex hormones,
OTC ophthalmic drugs and OTC
drugs for the throat.
In 9M2017, retail sales of pharma-
ceuticals increased by 18.1% y-o-y in
values and by 8% y-o-y in volumes
vs 9M2016 to USD 1,935.9 mio for
1,242 packs. In Sep, the average
of price of one unit of a drug
amounted UAH 57.5. According
the State Statistics Service of
Ukraine, in Sep 2017, the prices of
pharmaceutical products grew 3.9%
PPG as compared to the overall CPI
amounting 116.4.
10. 10
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