Ukraine Pharmaceutical Market Monthly - Upharmacia - Aug 2017
1. Macroeconomic Environment
Market & Companies News
Regulatory Updates
Healthcare News
UPHARMACIA
Ukrainian Pharmaceutical
Market Monthly
Issued by UPharma Consulting
UPharma Consulting is a professional
consulting company, operating in the Life
Sciences sector. We deliver best global
practices in market knowledge, people
management, marketing and strategy for
Pharma and Healthcare in the CIS/CEE.
08'17
issue
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Upharmacia August 2017
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CONTENTS
/ Macroeconomic Indicators 07/2016-07/2017
/ Economy & Pharma Dashboard 07/2016-07/2017
Page
/ Economic News 08/2017
/ Pharma Market News 08/2017
/ Regulatory Updates 08/2017
/ Healthcare News 08/2017
/ CIS Pharma News 08/2017
3
5
5
6
7
8
9
Section Data period
Disclaimer:
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does not represent or warrant that it is accurate or complete. UPC is not responsible for, and makes no warranties whatsoever as to, the
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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5.61 5.57 5.62
6.39
6.91
7.64
6.34 6.44
6.91
5.92 6.25 6.27
6.31
1.87 1.92
1.76
1.87
2.04 2.09
1.40 1.37
1.62
1.66
1.93
1.78
1.96
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
8
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Industrial Production Sales &
Retail Turnover of Enterprises Surplus
2016 bn USD2017
175.4
180.9
190.4
212.2
224.7
264.9
233.2 225.4
187.0
210.5
217.5
206.5
211.4
122.7
126.2
135.5
138.6 139.9
164.1
148.8 147.6
121.9
133.9
137.3
132.0
139.5
100
120
140
160
180
80
120
160
200
240
280
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Pharmaceutical Market Retail Sales
mio USD
mio units
2016 2017
13.4 13.6
18.8 18.4
14.8
23.9
8.1
13.3
22.0
12.2
14.2
19.8
14.2
133.1 137.3
140.6 137.4
142.6
169.1
102.4
123.4
150.6
116.8
145.7
156.8
150.5
0
30
60
90
120
150
180
0
5
10
15
20
25
30
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Ukraine's International Trade
in Pharma Production
Export
Import
2016 mio USD2017
24.8 25.1
26.3 25.8 25.7 26.2 27.2 27.0 27.0 26.9 26.4 26.1 26.0
27.5 28.1
29.5
28.5 27.8 27.6 28.8 28.8 28.8 28.8 29.2 29.26 29.8
107.9 108.4 107.9
112.4 112.1 112.4 112.6 114.2 115.1 112.2 113.5 115.6 115.9
0
20
40
60
80
100
120
140
160
0
10
20
30
40
50
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
UAH/USD
UAH/EUR
CPI
2016
Official Currency Exchange Rates
vs. Consumer Price Index
2017
ECONOMY & PHARMA
DASHBOARD
ECONOMIC NEWS
ââ In 2Q2017, Ukraineâs GDP grew 2.4% y-o-y vs
2.5% y-o-y in 1Q2017, Statistics Service of Ukraine
reported. In Jun, National Bank of Ukraine lowered
2017 GDP growth forecast to 1.6% y-o-y.
ââ On Aug 1, FTA zone between Ukraine and Canada
was launched. Canada opened its market to 98%
of Ukrainian goods. Ukraine removed custom
duties for 72% of Canadian products.
ââ Moody's Investors Service upgraded Ukraineâs
ratings in Ukrainian and foreign currency from
Caa3 to Caa2 with a âpositiveâ outlook.
ââ Goldman Sachs investment bank projects
Ukrainian hryvnia to continue strengthening
until the end of 2018 to UAH 24.8/USD 1. Since
the beginning of 2017, hryvnia has strengthened
against the US dollar by UAH 1.555.
ââ In 7M2017, budget revenues from taxes and duties
increased 27.7% y-o-y to UAH 412 bn, State Fiscal
Service reported. Total budget revenues in 7M2017
exceeded the target for the period by 10.3%
(UAH 41.8 bn).
ââ In 1H2017, deficit of foreign trade in goods
increased 2.6 times vs 1H2016 to USD 1.88
bn. In 1H2017, exports of goods from Ukraine
increased 24.2% y-o-y, imports of goods â
29.9%.
ââ In 1H2017, Ukrainian airlines saw a 40% rise in
passenger transportation to 4.565 mio people.
Cargo and mail transportation deceased by 9%,
to 35,500 tonnes.
ââ In Jul, industrial output in Ukraine decreased
by 2.6% y-o-y. Chemical sector showed 26.7%
y-o-y growth, while other main sectors have
worthened. Output in Luhansk and Donetsk
regions declined by about 20%.
ââ In 1H2017, FDI to Ukraine downed by 75% y-o-y
to USD 711 mio. At the same time investment in
Ukraineâs fixed assets increased 22.5% y-o-y vs
1H2016.
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Upharmacia August 2017
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PHARMA MARKET NEWS
Interchem
Localized
Manufacturing
in Kazakhstan
Ukrainian company Interchem
reached agreement on localization
of manufacturing of its three drugs
at the facilities of Kazakh company
Viva Pharm in Almaty. The plant
will produce antiviral drug Tilaxin
(tilorone), anxiolytic Gidazepam VIC
(hydazepam) and opioid analgesic
Morphine sulfate VIC (morphine).
Medical director of Viva Pharm
stated that the companies striving
to localize another range of drugs.
The cooperation was stimulated
through government policy to
support local manufacturing
providing that the transfer of
production technologies in
Kazakhstan is more profitable than
the import of finished medicines.
âKazakhstanâs pharmaceutical
market is developing dynamically,â
Deputy GM of Interchem said.
âConsidering state policy of
Kazakhstan on stimulation of
local pharmaceutical production,
we decided to arrange the
manufacturing of demanded
drugs there. We have found the
partner, which we sure would
ensure a consistently high quality
of products.â
Moreover, in Aug, Interchem
entered the sports nutrition
market with three products: BCAA,
creatine, L-carnitine. All products
are presented under the name
SMARTPITÂŽ.
In 2016, Interchem was 25th
company on Ukrainian retail drug
market by sales.
Acino Will
Represent 9
Medicines of Merck
in CIS and Moldova
Swizz company Acino reached
distribution agreement with Merck
to represent 9 medicines against
cardiovascular and endocrine
diseases. Since Jan 1, 2018, these
drugs will be available in Ukraine,
Armenia, Azerbaijan, Kazakhstan,
Kyrgyzstan, Moldova, Turkmenistan,
Tajikistan, Uzbekistan, Georgia,
Belarus and Mongolia.
âPartnership is an integral part of
our strategy,â GM of Acino said. âThe
high demand for Merck products
will quickly strengthen Acino's
position in the CIS and Mongolia
and will accelerate the growth of
our business.â
In Ukraine, distribution of the drugs
will be carried by Pharma-Start
company (part of Acino Group).
Acino acquired Pharma-Start
in 2015. The joined portfolio
of Acino-Pharma Start incudes
45 generic drugs. In 1H2017,
Acino-Pharma Start held 18th
position on Ukrainian retail drug
market by sales, improving its
position by 4 places vs 1H2018.
BCPP to
Increase
Production of
Reimbursable Medicines
Borshchahivskiy Chemical-Phar-
maceutical Plant has reoriented
its manufacturing to increase
production medicines included
in the reimbursement list. The
company produces 7 drugs, which
are reimburced by the state
within the âAffordable medicinesâ
program.
âIn May we saw considerable
increase in demand for
reimbursable medicines,â
commercial director of BCPP
Eugene Sova said. âWe reoriented
our production to increase its
volumes: we added another
working shift and significantly
increased reserves of raw
materials.â
Mr. Sova also noted about the need
to create the patients register so the
companies could plan their work in
advance.
âAffordable medicinesâ program
was launched in May 2017. Prime
Minister of Ukraine stated that since
then 1.5 mio of Ukrainians took the
opportunity to get medicines for
free or with a small copayment.
In 2016, BCPP doubled its net
income vs 2015 to UAH 118.7 mio.
At the end of the year, the company
retained 15th position on retail drug
market by sales.
Farmak
Considering
Contract
Manufacturing of API at its
Facilities
New CEO of Ukrainian
pharmaceutical company Farmak
Augustin Dubnicka stated that the
company is considering possibilities
of placing contract manufacturing
of active pharmaceutical ingredients
(API) at its facilities in Shostka (Sumy
region).
âWe are negotiating with some
producers on contract production
of APIs,â Mr. Dubnicka said. âWhen
our company is ready to sell
APIs produced in Shostka for the
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Upharmacia August 2017
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REGULATORY UPDATES
Provided by
markets of Europe and the US,
we will organize inspection of the
FDA and the European Directorate
for the Quality of Medicines &
HealthCare (EDQM)â.
At the same time Farmak is testing
the possibility of producing own
products at pharmaceutical plants
in Ukraine and Europe. This may
apply to solid forms of drugs
(granules and tablets).
According to Mr. Dubnicka, in 2017
Farmak plans to invest UAH 230 mio
in development of its projects.
Augustin Dubnicka replaced Filia
Zhebrivska at the position of
Farmakâs CEO in Jul. The company
plans to increase its presence on
European market to reach USD 1
bln sales in 2020. In 2016, Farmak
increased its income by 67% y-o-y to
UAH 677 mio.
A Change in the Procurement
of Medicines Has Been
Approved
The Cabinet of Ministers of Ukraine
has again reinstated the deadlines
for mandatory observance by
healthcare institutions and facilities,
fully or partially financed from
the state and local budgets, of the
requirements of Resolution âSome
Issues of State Regulation of Prices
for Medicinal Products and Medical
Devicesâ No. 333 as of March 25th
,
2009.
Thus, on August 23rd
, 2017, the
Cabinet of Ministers adopted
a decision according to which
institutions and health care
institutions, fully or partially
financed from state and local
budgets, may procure medicinal
products legitimately registered in
Ukraine and included in the State
Register of Medicinal Products
of Ukraine. Therefore, these
healthcare institutions and facilities
are not required to follow the
National List of Essential Medicines
while procuring medicines in 2017.
The List of Rare Diseases Has
Been Supplemented
The Ministry of Health has approved
changes to the List of Rare (Orphan)
Diseases which Shorten Life of
Patients or Lead to Disability and
for Which There Are Recognized
Methods of Treatment (hereinafter
- the List). The corresponding Order
of the Ministry of Health of Ukraine
No. 731 as of June 29, 2017 has
been registered with the Ministry of
Justice.
Rare endocrine diseases, digestive
disorders and metabolic disorders,
as defined in Section I, have been
supplemented with following 7
new positions: impaired ornithine
metabolism, argininemia, ornithine
carbamoyltransferase deficiency;
impaired glycine metabolism; other
disorders of lipid accumulation,
Wolman's disease; hereditary
erythropoietic porphyria; late
cutaneous horphyria; other
porphyrias; lipomatosis which was
not classified elsewhere.
Section IV list âRare Diseases of
the Nervous Systemâ has been
supplemented with 10 positions,
which include the following:
ââ encephalitis, myelitis and en-
cephalomyelitis; encephalitis,
myelitis and encephalomyelitis
together with diseases classified
in other sections; progressive en-
cephalomyelitis with rigidity and
myoclonus;
ââ secondary parkinsonism caused
by other external factors;
ââ other forms of secondary
parkinsonism;
ââ dystonia;
ââ craniocervical dystonia spreading
to the larynx and upper limbs;
ââ blepharospasm;
ââ other dystonia;
ââ unspecified dystonia;
ââ specific epileptic syndromes;
ââ hereditary motor and sensory
neuropathy.
Also, the List has been amended
with Section XI âRare Diseases
of Sclera, Cornea, Iris and Ciliary
Bodyâ, containing 2 points:
interstitial (stromal) and deep
keratitis (Kogan syndrome), and
iridocyclitis.
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The MOH to Include Five New
Directorates
Within administrative reform, five
new directorates will be allocated
within the MOH. The structure of
the Ministry will be expanded by the
Directorate for Strategic Planning
and Eurointegration, Directorate
on Public Health, Directorate on
Medical Services, Pharmaceutical
Directorate, Directorate on Medical
Education, Human Resources and
Science.
âOur team is very interested in
strengthening the Ministry and
will make any effort for operative
and detailed communication of all
parties of this process,â acting Head
of the MOH Ulana Suprun stated.
In Aug, Cabinet of Ministers of
Ukraine approved the range of
legislative acts aimed to launch the
next stage of reformation of the
state governance.
Deputy Health Minister Sivak
Resigned from the Office
Deputy Minister of Healthcare
Oksana Sivak reported she
would leave her position due to
âdisagreements in the approaches
to teamwork and the loss of mutual
trustâ. On 9/08/2017, the Cabinet of
Minister upheld the resignation of
Ms. Sivak.
âHealthcare system of Ukraine still
needs real changes,â Ms. Sivak
stated. âA lot of reformation phases
has already been implemented, part
of them is in process, some of them
were failed. I wish that all plans
were implementedâ.
Oksana Sivak was appointed at
the position of Deputy Minister in
Aug 2016 by acting Minister Ulana
Suprun. In the MOH Ms. Sivak
was responsible for the issues of
European integration. She aslo
oversaw the development of the
Public Health Center, as well as the
Ukraine Launches Procurement
of Medicines/Medical Devices
Reform
The Cabinet of Ministers approved
the reformâs Concept on August
23, 2017. The reform shall be
implemented by 2019 to bring
transparency, efficiency, best
international practices and fair
competition into the procurements
system.
The Concept introduces a new
approach to public procurement
of medicines and medical
devices through the independent
centralized procurement
organization, coordinated through
MoH. The organization shall take
over the public procurement
functions from MoH, regional
governments and public healthcare
institutions.
The Concept defines two
main stages of the reform
implementation:
1. Setting up of the organization,
creating regulatory framework
and internal policies/
procedures, selection and
training of the core team;
conducting pilot procurement
projects (2nd half of 2017);
2. Further development and
capacity building of the
organization in the areas
of e-infrastructure (using
a specialized electronic
procurement platform),
analytics, international
cooperation; conducting
selected regional procurement
projects (2018).
When fully implemented,
the centralized procurement
organization will procure medicines
and medical devices at the national
(replacing the current temporary
system of procurement through
international organizations), as well
as local level.
MoH is now developing a detailed
implementation step plan, to be
approved further by the Cabinet.
The need for the reform is caused
by ineffective and non-transparent
centralized procurement system
of MoH, as well as decentralized
system on the regional level, used in
the recent decades.
Source: Marchenko Danevych legal
alert
HEALTHCARE NEWS
Provided by
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Upharmacia August 2017
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reformation of the blood service in
Ukraine.
Dobrobut Medical Chain to
Open a Cardio Center by the
End of 2019
Ukrainian medical chain Dobrobut
plans to open new cardiology center
by the end of 2019 to conduct
stenting and coronary angiography
as well as open heart surgeries. The
amount of USD 100 mio is planned
to be invested. Dobrobut launched
its first cardio clinic in 2016. It plans
to conduct 200-250 heart surgeries
in 2017; in 2018, they should
increase to 400.
Moreover, the chain plans to
develop oncology and pediatric
directions. The company is building
its second childrenâs hospital. In
Oct 2017, Dobrobut will launch
diagnostic oncology center in
Cancer Institute.
Dobrobut medical chain was
established in 2001. It currently
includes three children clinics, two
polyclinics and one hospital for
adult patients, as well as a first
aid station. The companyâs stuff
amounts 10 ths employees, which
provide services to 1.5 mio patients
per year.
Voting for the Medical
Reform Undermined
On Jul 8, Ukrainian Parliament
preliminarily approved the Draft
Law #6327 on state financial
guaranties in provision of medical
services and drugs. Afterwards, the
document was proceeded by the
Parliamentary Committee on Public
Health.The MPs proposed 886 edits
to the Draft Law; 396 of them were
approved in the end. However,
according to the acting Head of the
MOH Ulana Suprun, the Head of
the Parliamentary Committee Olga
Bogomolets refused to sign the
document for voting. Consequently,
the document was signed by the
Deputy Head of the Committee, but
the Parliament didnât have time to
vote the Draft Law.
Therefore, the approval of the
medical reform actively pushed
by the MOH, was sabotaged in
the Parliament. According to
the board member of the Anti
Corruption Action Centre, the
blocking of the medical reform is
in the interests of the medical elite,
which uncontrolledly manages the
budgets of medical institutions.
The voting for the reform was
postponed till Sep, when the
Parliament resumes its work. Ms.
Suprun stated that the MOH would
continue working on the reform
implementation.
The New Reimbursement List
Approved
The MOH approved the new
register of drugs, which are subject
to reimbursement. The list was
expanded by 33 new position to 199
names. The value of 30 drugs will
be reimbursed 100% by state, the
other positions assume co-payment.
Among 199 drugs, 21 are produced
in the EU, 17 â in Ukraine, 4 â in
India, 1 â Israel.
The reimbursement program
âAffordable drugsâ was launched in
April 2017. Since then, the 3.6 mio
prescriptions were issued and fully
or partially payed by the state. As on
middle Jul, about 6.2k pharmacies in
Ukraine participate in the program.
The MOH Initiated a Creation
of the Procurement Agency
The MOH submitted to the
government the Draft Resolution
on creation of the National
Procurement agency, which is to
carry out procurement of drugs
and medical devices. Accordion to
the acting Minister, the agency is
supposed to be launched in 2019.
At the same time, the MOH signed
agreements with international
organizations (UNDR, Crown
Agents and UNICEF) on delegated
procurement of drugs and medical
devices for the state budget funds
of 2017. The organizations have
already supplied 98% of medical
products procured for the funds of
2016.
10. 10
Upharmacia August 2017
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Azerbaijan
ââ Bulgarian pharmaceutical companies
take an interest in Pirallahi industrial
park and consider possibilities of
cooperation in pharmaceutical sphere.
Belarus
ââ Indian company Chokhani Pharma
proposed Belarus to establish joint
manufacturing of drugs against
hepatitis, including sofosbuvir.
ââ In 1H2017, the share of Belarussian drugs on the
internal market increased to 57.2% in values, the
MOHâs official reported.
ââ The government closed out Pharmaceutical
Industry Department and subordinated four
state companies (JSC Borimed, JSC Nesvizh
Plant of Medical Preparations, JSC Ekzon and JSC
Ferane) to Management company of the holding
Belpharmprom.
Russia
ââ Janssen intends to localize in Russia
the production of the range of
innovative drugs for the treatment
of malignant blood diseases including Imbruvica
(ibrutinib).
ââ Roche signed agreement on localization of
obinutuzumab at the facilities of Pharmstandard
company in Ufa. First series of the drug are
expected to be produced in the end of 2018.
ââ Venture Biotech Fund Primer Capital invested in the
development of the drug by Gemopharm company
for the treatment of multiple myeloma. The drug
has already shown high efficacy in vivo. It is being
prepared to pre-clinical trials.
ââ BIOCAD company will build a production complex in
Pushkin district in St. Petersburg. It will include the
center for pre-clinical trials, as well as production of
substances and finished drugs. The investments to
amount RUB 3bn.
ââ BIOCAD company plans to open representative
office in Egypt by the end of 2017 with intention to
enter the whole market of Near East. The company
may localize manufacturing in Russian Industrial
Zone in Port Said.
ââ In 4Q2017, Pharmsyntez intends to launch onto the
market the new portfolio of hypoglycemic drugs,
which will include gliclazide, repaglinide, metformin,
glibenclamide, glimepiride, glycidone, glibenclamide
+ metformin.
Kazakhstan
ââ LLC R-Pharm Kazakhstan, LLC
ULNANOTECH and LLC TestGen
signed cooperation agreement to
implement innovative developments in non-invasive
prenatal diagnosis and diagnosis of cancer in the
Republic of Kazakhstan.
ââ Within the state program for industrial
development, three new pharmaceutical
plants will be opened in Kazakhstan by the end
of 2019. Hikma CIS will invest KZT 6.5 bn to
construct plant in Almaty. JuldyzKenan Co., LTD
is to launch manufacturing of disposable medical
products made of polymers worth KZT 1.7 bn.
ASTANA PHARMBIOSYNTESIS will produce vital
pharmaceutical preparations at the facilities worth
KZT 32.9 bn.
ââ Teva does not plan to close its representative office
in Kazakhstan, as it has long-term plans for presence
on the market, the companyâs officials reported.
Teva was 7th company on Kazakh market in 2016
with 278 products represented.
ââ Single distributor SK-Parmacia reached agreement
with 23 local companies on the procurement of
523 positions of drugs and 389 positions of medical
devices. These products will be procured for state
needs during next 10 years. The agreement is aimed
to guarantee the sales of manufactured products
and thereby to support local manufacturers.
CIS PHARMA NEWS
11. 11
Upharmacia August 2017
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