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Ukrainian Pharmaceutical Market Monthly
Upharmacia
Macroeconomic Environment | Market &
Companies News | Regulatory Updates |
Healthcare News
Issue: 11 2015
UPharma Consulting is a consulting company, operating in the healthcare and pharma sectors. Our
clients - pharmaceutical companies, pharmacy chains, distributors, investment funds, banks, and
other stakeholders in the healthcare sector.
UPharma Consulting, Kiev
www.upharma-c.com / mailbox@upharma-c.com
Page 2
Ukrainian Pharmaceutical Market Monthly: November 2015
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 (Jan-Oct 2015)
2015
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
MACROECONOMIC INDICATORS
Q1 Q2 Q3
GDP (bn USD) 17.353 20.795
GDP growth, % y-o-y -51% -35%
Export of goods (bn USD) 2.98 2.99 3.45 3.07 2.94 3.09 3.15 3.09 3.35 3.23
Export growth, % y-o-y -32% -37% -32% -39% -41% -30% -34% -22% -22% -23%
Import of goods (bn USD) 3.01 2.86 3.17 2.86 2.63 2.76 2.98 3.88 3.24 3.22
Import growth, % y-o-y -34% -41% -35% -38% -46% -37% -34% -2% -30% -27%
Industrial production sales (bn USD) 6.01 4.56 5.51 5.91 5.65 5.79 5.71 5.42 5.72 6.29
Industrial production growth, % y-o-y -41% -54% -45% -33% -38% -35% -33% -23% -20% -21%
Retail turnover of enterprises (bn USD) 1.97 2.72 4.47 6.24 8.71 10.41 12.10 14.05 15.81 17.81
Retail turnover growth, % y-o-y -50% -63% -56% -45% -39% -39% -41% -34% -35% -35%
Unemployment rate 2.0 2.0 1.9 1.8 1.8 1.7 1.6 1.6 1.5 1.5
Average salary (USD) 218 148 166 176 193 202 202 194 199 207
OFFICIAL CURRENCY EXCHANGE RATE
UAH/USD 15.8 24.5 23.3 22.7 20.9 21.2 21.8 21.6 21.8 21.8
UAH/EUR 18.5 27.8 25.3 24.5 23.3 23.8 23.9 24.0 24.5 24.6
PHARMACEUTI CAL INDUSTRY INDICATORS
Export of pharma products (mio USD) 11.79 12.05 13.37 13.46 13.00 15.36 13.85 9.01 13.79 12.2
Pharma Export growth, % y-o-y -1% -42% -50% -44% -39% -39% -6% -54% -47% -37%
Import of pharma products (mio USD) 90.2 114.5 103.3 103.7 84.2 115.0 106.5 93.3 121.1 147.14
Pharma Import growth, % y-o-y -49% -47% -67% -36% -60% -44% -47% -47% -31% -28%
Pharma retail sales, values (mio USD) 239.8 177.0 197.6 180.0 193.0 177.7 172.6 177.1 193.2 206.3
Retail sales in values growth, % y-o-y -41% -54% -47% -40% -28% -29% -32% -24% -28% -26%
Pharma retail trade, volumes (mio units) 132.4 143.9 141.5 122.6 124.5 118.4 119.5 122.5 126.7 130.2
Retail sales in volumes growth, % y-o-y -21% -15% -21% -20% -11% -9% -10% -8% -11% -5%
WACP, USD 1.95 1.81 1.24 1.41 1.47 1.52 1.48 1.45 1.52 1.58
WACP growth, % y-o-y -21% -22% -40% -27% -23% -21% -23% -18% -19% -22%
CPI of Ukraine 128.5 134.5 145.8 160.9 158.4 157.5 155.3 152.8 151.9 146.4
Pharma products CPI 149.2 155.5 170.3 164.7 159.5 153.5 151.8 149.4 145.8 142.1
Local companies share, values, % 38.7 38.5 39.6 40.7 41.5 41.7 41.8 41.4 41.4 41.4
Local companies share, volumes, % 74.9 75.2 77.1 77.6 77.6 77.9 78.4 78.2 76.5 75.7
Page 3
Ukrainian Pharmaceutical Market Monthly: November 2015
239.8
177.0
197.6
180.0
193.0
177.7
172.6
177.1
193.2
206.3
132.4
143.9
141.5
122.6
124.5
118.4 119.5
122.5
126.7
130.2
100
110
120
130
140
150
160
100
120
140
160
180
200
220
240
260
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Pharma retail sales
Values (mio USD) & Volumes (mio units)
Jan-Oct 2015
mio USD mio units
11.79 12.05
13.37 13.46 13.00
15.36
13.85
9.01
13.75
12.20
90.2
114.5
103.4 103.7
84.3
115.0
106.6
93.3
122.2
147.1
20
40
60
80
100
120
140
160
0
2
4
6
8
10
12
14
16
18
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Ukrainian Internation trade in pharma
production
Export & Import, mio USD
Jan-Oct 2015
Export Import
6.01
4.56
5.51
5.91
5.65 5.80 5.71
5.43
5.72
6.29
1.97
0.74
1.75 1.77
2.48
1.70 1.69
1.95
1.76
2.00
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0
1
2
3
4
5
6
7
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
Industrial production sales &
Retail turnover of enterprises surplus
Jan-Oct 2015, bn USD
Industrial production sales Retail turnover of enterprises
15.81
24.48
23.26 22.71
20.92 21.23 21.76 21.63 21.78 21.84
19.26
28.95 29.52
26.92
25.48 24.91
26.09 25.91 26.14
24.56128.5
134.5 145.8
160.9 158.4 157.5 155.3 152.8 151.9
146.4
0
20
40
60
80
100
120
140
160
180
0
5
10
15
20
25
30
35
Jan Feb Mar Apr May Jun Jul Aug Sep Oct
OFFICIAL CURRENCY EXCHANGE RATE
+Consumer Price Index
Jan-Oct 2015
UAH/USD UAH/EUR CPI of Ukraine
KEY ECONOMIC EVENTS
»» Moody’s Investors service upgraded long-term issuer rating of Ukraine from “Ca” to “Caa3”, with the outlook on
the rating changed from “negative” to “stable”. The decision to upgrade the rating was based on the settlement of
the restructuring of $15 billion in privately-held Eurobonds and progress in political and economic reform under
the auspices of the IMF-led programme.
»» State Fiscal Service of Ukraine is reducing the types of tax inspections from 311 to 161, the Head Roman Nasirov
announced. Moreover, since 2016, the number of employees of the Service is expected to be reduced by 30% to
41000, while the number of bodies under the fiscal service is to be cut from 370 to 25.
»» The IMF is to continue its landing program in Ukraine despite “Russian debt”, Deputy Finance Minister of Ukraine
said. Regardless Russia refused to restructure Ukrainian USD 3 bn Eurobond debt, the IMF will not halt landing-
into-areas policy in the country, which is pursuing appropriate policies and making a faith efforts to reach a
collaborative agreement.
»» Industrial production sales showed 10% PPG growth and 21% y-o-y decline in Oct.
»» The U.S. government discusses USD 1 bn loan providing to Ukraine in the coming months. To continue founding
program on encouraging reforms in Ukraine, the U.S. wants to have a clear vision of Ukraine’s fiscal policy over
the new Tax Code and the 2016 spending plan.
»» The Cabinet of Ministers of Ukraine is to submit a balanced draft of 2016 State budget jointly with the Draft
Tax Code in early December after consultations with the IMF mission, which had arrived in Ukraine on Nov 12 to
discuss economic reforms and review the third tranche if the 17.5 bn loan program.
»» In Nov, under the legislation package for visa-free regime with the EU, Ukrainian parliament has approved a
number of Laws, including creation of Anti-Corruption agency, anti-discrimination amendments to the Labor
Code, creation of State Investigations Bureau, amendments to the special confiscation procedures of the
property of corrupt officials, etc. In response, Ukraine expects the EU to endorse a visa-free regime since 2016.
»» The Cabinet of Ministers of Ukraine has approved an issue of USD 2.92 bn GDP warrants and nine series of
new Eurobonds USD 11.95 bn worth. The series of bond issue are to be conducted from Sep 1, 2019 to Sep 1,
2027 with one-year intervals.
»» On Nov 24, Russia stoped coal supply to Ukraine as a response to the sabotage of Ukraine’s electricity supply
to Crimea forced by Activists of the Citizens Blockade of Crimea in the neighboring Kherson on Nov 21. PM of
Ukraine said Ukraine does not have enough coal reserves for winter period and will need to use additional funds
provided in the budget for coal procurement.
Page 4
Ukrainian Pharmaceutical Market Monthly: November 2015
MARKET & COMPANIES NEWS
Latvian
“Silvanols”
entered into Ukrainian market
Latvian pharmaceutical company
“Silvanols” started the exportation
of its products to Ukraine. The
Company is to launch its four
original drugs: Laringospray,
Rinogel spray, Faringospray,
Fungispray, the registration of
which started a year ago.
“Despite a difficult time for
Ukrainian consumers, the results
of market study showed that
our drugs made of natural raw
materials have a bid potential,”
Silvanos’ Chairman of the Board
Artem Bortsov said. “We plan
to extend the offer with original
products for the health of nerves,
heart and food supplements
developed for children by the end
of the year.”
“Silvanos” was founded in
1994; its main owner is Latvian
company Olainfarm (96.69%).
This year, besides Ukraine, the
company started an export of its
products to Bulgaria, Grease, and
Austria and enlarged the export
in Romania, Poland, Estonia and
Georgia. In Ukraine “Silvanos”
have 16 drugs registered in total.
“Arterium”
Corp. expanded
its endocrinological portfolio with
insulin drugs
Ukrainian 3rd pharmaceutical
producer “Arterium” has launched
new genetically engineered
insulins under the tradenames
“Insular Activ” and “Insular Stabil”.
Both drugs are human insulins,
produced with use of technologies
for recombinant DNA. Insular
Activ is a shot-acting insulin, while
“Insular Stabil” has an average
duration of action.
The drugs were registered in
May by “Kyivmedpreparat”, and
have become first insulins in the
company’s portfolio.
“Arterium” Corp. includes the
national leader in manufacturing
antibiotics “Kyivmedpreparat”
JSC and “Galychpharm” JSC,
which is the largest producer of
herbal medications.
“Zdorovye
Group” has
issued bonds for UAH 400 mio
On Nov 3, it became known,
that “Zdorovye Group”, one of
the biggest Ukrainian pharma
producers, had completed an
accommodation of unsecured
interest bonds of “A” – “F” series
UAH 400 mio (USD 17.4 mio)
worth. According to the issuer, all
securities are sold at par.
Under the securities emission
prospect, 20% of funds raised
the company plans to use
for purchase of rights of use
related with organization of
drugs manufacturing, 30% – for
purchase of raw materials, 50%
– for construction financing and
equipment of a new workshop,
as well as modernization of
existing production premises and
equipment.
As of 9M2015, “Zdorovye Group”
is the fifth company on Ukrainian
pharmaceutical market, compared
to the 9th place the company held
over the same period in 2014.
“Novalik-Farm”
is launching
LIPINET
In Nov, Ukrainian pharma-
company “Novalik-Farm” has
started distribution of LIPINET,
developed by Austrian company
SANWEZZA LAB GmbH. LIPINET
is an innovative drug to maintain
normal cholesterol level and
prevent cardiovascular diseases.
“Novalic-Farm” is a modern
GMP-certified pharmaceutical
company, which produce an
innovative production: drugs,
dietary supplements, cosmetic
and hygiene products.
“Microchem’s”
Armadin shows
significant growth in sales
dynamics
As of 9M2015, “Microchem’s”
Armadin (mexidol) has entered
into TOP-30 best-selling
drugs on Ukrainian market,
being ranked 28th, improving
its position from 58th in
9M2014 and 144th in 9M2013.
Armadin is a cardiological drug,
increasing dopamine content
in the brain, it is prescribed in
acute cerebrovascular accidents,
consequences of traumatic
brain injury, discirculatory
encephalopathy, ect.
“Microchem” is the 16th biggest
Ukrainian company, with
manufacturing capacities based
in Rubizhne (Luhansk region). The
company’s portfolio, comprising
23 drugs, is mainly specialized
on cardiovascular and nervous
systems treatment.
Page 5
Ukrainian Pharmaceutical Market Monthly: November 2015
REGULATORY UPDATES
On Nov 20, the Order of the
Ministry of Healthcare of Ukraine
“On recognition of invalidation
of the Order of the Ministry of
Healthcare of Ukraine #1000
dated Dec 29, 2011” has entered
into force. The Order, developed
by the Unity of employers of
medical and microbiological
industry, is to cancel an obligatory
minimum range of drugs for
pharmacies. The main goals
of this cancellation are the
optimization of existing lists of
drugs and facilitation of the work
of pharmacy workers.
--
On Nov 19, the Draft Resolution
of the Cabinet of Minister of
Ukraine “On approval of licensing
conditions on conducting of
economic activities on drugs
manufacturing, wholesale and
retail trade of drugs, import
of drugs (except of active
pharmaceutical ingredients)”
was presented on the State
Administration of Ukraine on
medical products website. A
necessity of approval of new
licensing conditions is envisaged
by the Law of Ukraine “On
licensing of types of economic
activities” dated March 2, 2015,
under which licensing conditions
should be approved by the CMU
Resolution, not by the Order of
the profile ministry.
The new Draft Licensing
conditions establish a
comprehensive list of
requirements, necessary for
execution by a licensee and
comprehensive list of documents
attached to the application for a
license.
The new edition does not contain
regulations, regulating the issues
of succession of licenses in
case licensee ceases its activity
after the merger, division,
amalgamation or transformation.
During conduction of control
measures by a licensing body,
license applicant and licensee
have to guarantee access to the
premises of a licensee storing
drugs.
The Draft Licensing conditions
also comprise of the documents
or copies licensee has to keep
during license validity to approve
a reliability of data indicated by
a license applicant in documents
submitted to a licensing body. The
list includes:
»» documents, approving the
right of ownership or use of a
premise, occupied by entity or
its separate unit;
»» technical passport of a
premise, occupied by entity or
its separate unit;
»» technical passports of
measuring instruments and
devices which are available;
»» documents on special
education and advanced
training of a pharmacy head,
authorized person, senior
personnel of the manufacturer
and/or importer of drugs;
»» staff schedule of pharmacies
and workbooks of a pharmacy
(structural unit) head,
authorized person, senior
personnel of the manufacturer
and/or importer of drugs;
»» documents, approving legal
relations of employees with an
entity.
Current version of the Draft
Resolution is developed
considering the amendments
of the associations and public
organizations, which took part
in discussion over its previous
edition dated Jul 14, 2015.
--
On November 16, the Resolution
of the CMU #921 “On
amendments to the procedure of
accreditation of health facility”
dated Nov 11, 2015 was approved.
The Resolution establishes that
pharmacies are not subject to
mandatory accreditation under.
The legislative act is approved
according to the Law of Ukraine
#326-VIII “On amendments to
the article 16 of Fundamentals
of the legislation of Ukraine on
Healthcare” dated April 9, 2015,
providing that accreditation of
pharmacies is carried out on a
voluntary basis.
--
On Nov 20, the Draft Order
of the MOH “On approval of
the Procedure of calculation of
referent prices (reimbursement
prices) on insulin drugs” was
promulgated on the MOH web
site. According to the Procedure
of calculation of referent price:
»» of full reimbursement for
foreign insulin drugs to be
conducted on the basis of
wholesale reimbursement
price, which will be calculated
with the using a mechanism
of external referencing of
producer price, obtained
from the official sources
of information in referent
countries.
»» of full reimbursement for
domestic insulin drugs to be
conducted on the basis of
declared wholesale price of
each trading name of insulin
drug/insulin analogue, enrolled
in the registry of wholesale
prices of drugs and medical
products, considering bonuses,
taxes and fees.
The referent price of partial
reimbursement is to be calculated
for each group of insulin drugs
separately, as an arithmetic
mean price for international
unit of insulin drug with further
recalculation for secondary pack
considering bonuses, taxes and
fees.
The Draft Order specifies
Page 6
Ukrainian Pharmaceutical Market Monthly: November 2015
following referent countries:
Bulgaria, Moldova, Poland,
Slovakia, Czech Republic, Latvia,
Serbia and Hungary.
The registry is to be carried out
by the MOH and to be updated
two times a year, on February
1 and August 1 (in case if the
average month exchange rate of
the national currency does not
change by more than 5%).
--
On Nov 20, the Draft Order
of the MOH “On measures
on improvement of the state
registration system for people
with cancer” was presented on
the MOH web site.
The goal of the registry is to
increase the efficiency of medical
care for patients, ensure a proper
registration and accounting
of patients, conduction of
continuous monitoring of
population malignant tumors
destruction level, acquire relevant
information on state of cancer
care in Ukraine, conduction of
scientific researches. The Draft
Order was developed in order to
implement the measure, specified
in paragraph 6 of Tasks and
Measures on implementation of
National anti-cancer program
for the period till 2016, approved
with the Law of Ukraine dated
Dec 23, 2009 #1794-VI.
HEALTHCARE NEWS
Reformation of emergent medical
care is under discussion
The Ministry of Healthcare is to
develop proposals on reforming
of emergent medical care in the
middle November. The body says
the equipment for operational
and dispatching services in
every regional center is already
procured. Moreover, the reform
should include reorganizing of
Service for maintenance of public
order, traffic rules, technical
support, training of medical
students and civilian population
as well.
The MOH expects to create an
independent agency for drugs
procurement
The MOH proposes to create
independent agency for drugs and
medical products procurement
with a supervisory board
independent of the Ministry and
the Cabinet of Ministers. The
Supervisory Board is supposed
to ensure transparency of trades,
the Minister of Healthcare said
during the presentation of the
corresponding Draft Resolution at
the Government meeting.
Ukrainian insulins reimbursement
system is under development
The MOH started the
implementation of a registry
of insulin-dependent patients,
providing a unique electronic
code for drug’s prescription
and allowing to determine an
amount of funds regions need
for insulins reimbursement, the
Deputy Minister of Healthcare
Oleksandra Pavlenko said. The
register is a needed tool for
insulins reimbursement system
implementation.
The registry will contain
information about patient’s health
condition and insulins prescribed,
while the prescription code will
allow a patient to get the drug in
pharmacy.
The registry is already being
tested in Zhytomyr and
Dnipropetrovsk regions and by
the year end all the regions are
expected to be attached to the
system. The MOH expects to
run a pilot project for insulins
reimbursement since 2016.
Reformation of primary medical
aid is a priority for the MOH
The further development of
primary medical and sanitary
aid is a priority for the MOH
within the context of Ukrainian
healthcare reformation, the
Deputy Minister of Healthcare
Victor Shafranskiy said. The
MOH considers appropriate a
juridical and financial demarcation
of primary and secondary level
of medical aid, free choice of
family doctor, implementation
of motivational mechanisms for
effective prevention activities.
Second important direction
of healthcare reformation is a
provision of effective system
of emergency medical aid, Mr.
Shafranskiy stressed.
State expert center is to
reconsider the cost of its services
Due to appeals of applicants
Page 7
Ukrainian Pharmaceutical Market Monthly: November 2015
regarding new financial plans,
State expert center of the MOH
is to reconsider the cost of its
services at the beginning of 2016
in a planned manner. The prices
of following services are to be
reconsidered:
»» examination of materials for
drugs, submitted for state
registration (re-registration);
»» examination of materials
on amendments to registry
materials during a registration
certificate validity;
»» examination of materials on
the possibility of including
of a drug in the State Drug
Formulary.
Ukrainian producers are worried
public procurement through
international organizations could
be discriminating for them
Current tendency in Ukrainian
public drugs procurement, when
the procurement is entrusted to
International organizations, could
be discriminating for Ukrainian
pharmaceutical producers,
executive Director of the Unity
of employers of medical and
microbiological industry (UEUPP)
Svitlana Bunina said. Ukrainian
companies produce about one
third of drugs, procuring though
the MOH program, but the
procurement rules demand the
WHO pre-qualification to be
able to participate in tenders.
The UEUPP published the list of
demands for support of Ukrainian
pharmaceutical manufactures,
including the demand to provide
procurement of Ukrainian
drugs without the WHO pre-
qualification.
Representative of the WHO
in Ukraine Dorit Nizan made
clarifications on the issues,
explaining that Ukrainian
companies would need the WHO
pre-qualification only if they
are to participate in bids for
procurement of drugs against
HIV/AIDS, tuberculosis, hepatitis
B and C, medical products for
reproductive health and drugs
containing zinc. Mrs. Nizan stated
that in order to be procured by
an international organization,
the drug should be registered
in Ukraine and have a GMP
certificate in PIC/s countries.
Medical associations and societies
of Ukraine have united into the
National Medical Council
On Nov 23, Ukrainian medical
associations and societies have
signed founding documents
to unite into National Medical
Council (NMC) in order to provide
drug authority and develop
professional autonomy.
Myron Ugrin (Ukrainian Dental
Association) has become a
Chairman of the Presidium of the
NMC, Larisa Matuha (Ukrainian
Association of family doctors)
has been appointed as the
First Deputy. Under the NMC
competition there will be general
issues of medical practice, which
need to be addressed at the level
of medical authority or at the
level of legislative and executive
government bodies.
“The NMC intends to contribute
adoption of the Law on medical
autonomy and creation of the
Ukrainian medical society, as an
autonomous national organization
of physicians,” the NMC
statement says.
New Head of the State expert
center of the MOH has been
appointed
On Nov 24, Tetyana Talaeva has
been appointed as a new Head
of SE “State expert center of the
MOH”. Previously, on Oct 31, the
MOH announced the competitive
selection for the position, as its
previous Head Elena Nagornaya
had resigned in late October. Few
days after her dismissal, Security
Service of Ukraine exposed a
corruption mechanism, which
harmed the funds of the State
enterprise because of operational
expenditures being initially
overpriced.
70 companies to take part in bids
under Crown Agents procurement
programs
40 Ukrainian and 30 foreign
companies were interested
in participation of drugs
procurement by Crown Agents for
Ukrainian government. Agency’s
procedures do not demand the
WHO-prequalification from
the producers, including the
procurement of anti-cancerous
drugs, Director of procurement
department of Crown Agents Tom
Brown said.
The MOH has lately reached an
agreement with Crown Agents on
drugs procurement for UAH 750
mio (USD 33 mio).
Government want to provide
compensations to the population
due to drug VAT rate increase
The Ministry of Finance of
Ukraine is developing cost
compensation mechanism for
drugs regarding the VAT rate
rise from 7% to 20%, provided
in the Draft Tax Code. “This is a
very unpopular measure, which is
negatively perceived by pharma-
companies,” Deputy Minister of
Finance Olena Makeeva said.
“Ideally, the tax reform should
be conducted in parallel with
the Healthcare reform, but
currently we do not have a
collaboration project with the
MOH. That is why we are trying to
develop a procedure, which is to
guarantee compensations for the
population,” Mrs. Makeeva added.
The Ministry of Finance expects
the VAT rate increment allows
to collect about UAH 10 bn
in a special fund to be used
for subvention under cost
compensation mechanism.
At the same time, the Deputy
Minister of Healthcare Victor
Shafranskiy said that there are
reasons to think that current
VAT rate on drugs is to remain
unchanged in 2016.

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Upharmacia - Ukrainian Pharma Market News Digest. November 2015

  • 1. Ukrainian Pharmaceutical Market Monthly Upharmacia Macroeconomic Environment | Market & Companies News | Regulatory Updates | Healthcare News Issue: 11 2015 UPharma Consulting is a consulting company, operating in the healthcare and pharma sectors. Our clients - pharmaceutical companies, pharmacy chains, distributors, investment funds, banks, and other stakeholders in the healthcare sector. UPharma Consulting, Kiev www.upharma-c.com / mailbox@upharma-c.com
  • 2. Page 2 Ukrainian Pharmaceutical Market Monthly: November 2015 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 (Jan-Oct 2015) 2015 Jan Feb Mar Apr May Jun Jul Aug Sep Oct MACROECONOMIC INDICATORS Q1 Q2 Q3 GDP (bn USD) 17.353 20.795 GDP growth, % y-o-y -51% -35% Export of goods (bn USD) 2.98 2.99 3.45 3.07 2.94 3.09 3.15 3.09 3.35 3.23 Export growth, % y-o-y -32% -37% -32% -39% -41% -30% -34% -22% -22% -23% Import of goods (bn USD) 3.01 2.86 3.17 2.86 2.63 2.76 2.98 3.88 3.24 3.22 Import growth, % y-o-y -34% -41% -35% -38% -46% -37% -34% -2% -30% -27% Industrial production sales (bn USD) 6.01 4.56 5.51 5.91 5.65 5.79 5.71 5.42 5.72 6.29 Industrial production growth, % y-o-y -41% -54% -45% -33% -38% -35% -33% -23% -20% -21% Retail turnover of enterprises (bn USD) 1.97 2.72 4.47 6.24 8.71 10.41 12.10 14.05 15.81 17.81 Retail turnover growth, % y-o-y -50% -63% -56% -45% -39% -39% -41% -34% -35% -35% Unemployment rate 2.0 2.0 1.9 1.8 1.8 1.7 1.6 1.6 1.5 1.5 Average salary (USD) 218 148 166 176 193 202 202 194 199 207 OFFICIAL CURRENCY EXCHANGE RATE UAH/USD 15.8 24.5 23.3 22.7 20.9 21.2 21.8 21.6 21.8 21.8 UAH/EUR 18.5 27.8 25.3 24.5 23.3 23.8 23.9 24.0 24.5 24.6 PHARMACEUTI CAL INDUSTRY INDICATORS Export of pharma products (mio USD) 11.79 12.05 13.37 13.46 13.00 15.36 13.85 9.01 13.79 12.2 Pharma Export growth, % y-o-y -1% -42% -50% -44% -39% -39% -6% -54% -47% -37% Import of pharma products (mio USD) 90.2 114.5 103.3 103.7 84.2 115.0 106.5 93.3 121.1 147.14 Pharma Import growth, % y-o-y -49% -47% -67% -36% -60% -44% -47% -47% -31% -28% Pharma retail sales, values (mio USD) 239.8 177.0 197.6 180.0 193.0 177.7 172.6 177.1 193.2 206.3 Retail sales in values growth, % y-o-y -41% -54% -47% -40% -28% -29% -32% -24% -28% -26% Pharma retail trade, volumes (mio units) 132.4 143.9 141.5 122.6 124.5 118.4 119.5 122.5 126.7 130.2 Retail sales in volumes growth, % y-o-y -21% -15% -21% -20% -11% -9% -10% -8% -11% -5% WACP, USD 1.95 1.81 1.24 1.41 1.47 1.52 1.48 1.45 1.52 1.58 WACP growth, % y-o-y -21% -22% -40% -27% -23% -21% -23% -18% -19% -22% CPI of Ukraine 128.5 134.5 145.8 160.9 158.4 157.5 155.3 152.8 151.9 146.4 Pharma products CPI 149.2 155.5 170.3 164.7 159.5 153.5 151.8 149.4 145.8 142.1 Local companies share, values, % 38.7 38.5 39.6 40.7 41.5 41.7 41.8 41.4 41.4 41.4 Local companies share, volumes, % 74.9 75.2 77.1 77.6 77.6 77.9 78.4 78.2 76.5 75.7
  • 3. Page 3 Ukrainian Pharmaceutical Market Monthly: November 2015 239.8 177.0 197.6 180.0 193.0 177.7 172.6 177.1 193.2 206.3 132.4 143.9 141.5 122.6 124.5 118.4 119.5 122.5 126.7 130.2 100 110 120 130 140 150 160 100 120 140 160 180 200 220 240 260 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Pharma retail sales Values (mio USD) & Volumes (mio units) Jan-Oct 2015 mio USD mio units 11.79 12.05 13.37 13.46 13.00 15.36 13.85 9.01 13.75 12.20 90.2 114.5 103.4 103.7 84.3 115.0 106.6 93.3 122.2 147.1 20 40 60 80 100 120 140 160 0 2 4 6 8 10 12 14 16 18 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Ukrainian Internation trade in pharma production Export & Import, mio USD Jan-Oct 2015 Export Import 6.01 4.56 5.51 5.91 5.65 5.80 5.71 5.43 5.72 6.29 1.97 0.74 1.75 1.77 2.48 1.70 1.69 1.95 1.76 2.00 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0 1 2 3 4 5 6 7 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Industrial production sales & Retail turnover of enterprises surplus Jan-Oct 2015, bn USD Industrial production sales Retail turnover of enterprises 15.81 24.48 23.26 22.71 20.92 21.23 21.76 21.63 21.78 21.84 19.26 28.95 29.52 26.92 25.48 24.91 26.09 25.91 26.14 24.56128.5 134.5 145.8 160.9 158.4 157.5 155.3 152.8 151.9 146.4 0 20 40 60 80 100 120 140 160 180 0 5 10 15 20 25 30 35 Jan Feb Mar Apr May Jun Jul Aug Sep Oct OFFICIAL CURRENCY EXCHANGE RATE +Consumer Price Index Jan-Oct 2015 UAH/USD UAH/EUR CPI of Ukraine KEY ECONOMIC EVENTS »» Moody’s Investors service upgraded long-term issuer rating of Ukraine from “Ca” to “Caa3”, with the outlook on the rating changed from “negative” to “stable”. The decision to upgrade the rating was based on the settlement of the restructuring of $15 billion in privately-held Eurobonds and progress in political and economic reform under the auspices of the IMF-led programme. »» State Fiscal Service of Ukraine is reducing the types of tax inspections from 311 to 161, the Head Roman Nasirov announced. Moreover, since 2016, the number of employees of the Service is expected to be reduced by 30% to 41000, while the number of bodies under the fiscal service is to be cut from 370 to 25. »» The IMF is to continue its landing program in Ukraine despite “Russian debt”, Deputy Finance Minister of Ukraine said. Regardless Russia refused to restructure Ukrainian USD 3 bn Eurobond debt, the IMF will not halt landing- into-areas policy in the country, which is pursuing appropriate policies and making a faith efforts to reach a collaborative agreement. »» Industrial production sales showed 10% PPG growth and 21% y-o-y decline in Oct. »» The U.S. government discusses USD 1 bn loan providing to Ukraine in the coming months. To continue founding program on encouraging reforms in Ukraine, the U.S. wants to have a clear vision of Ukraine’s fiscal policy over the new Tax Code and the 2016 spending plan. »» The Cabinet of Ministers of Ukraine is to submit a balanced draft of 2016 State budget jointly with the Draft Tax Code in early December after consultations with the IMF mission, which had arrived in Ukraine on Nov 12 to discuss economic reforms and review the third tranche if the 17.5 bn loan program. »» In Nov, under the legislation package for visa-free regime with the EU, Ukrainian parliament has approved a number of Laws, including creation of Anti-Corruption agency, anti-discrimination amendments to the Labor Code, creation of State Investigations Bureau, amendments to the special confiscation procedures of the property of corrupt officials, etc. In response, Ukraine expects the EU to endorse a visa-free regime since 2016. »» The Cabinet of Ministers of Ukraine has approved an issue of USD 2.92 bn GDP warrants and nine series of new Eurobonds USD 11.95 bn worth. The series of bond issue are to be conducted from Sep 1, 2019 to Sep 1, 2027 with one-year intervals. »» On Nov 24, Russia stoped coal supply to Ukraine as a response to the sabotage of Ukraine’s electricity supply to Crimea forced by Activists of the Citizens Blockade of Crimea in the neighboring Kherson on Nov 21. PM of Ukraine said Ukraine does not have enough coal reserves for winter period and will need to use additional funds provided in the budget for coal procurement.
  • 4. Page 4 Ukrainian Pharmaceutical Market Monthly: November 2015 MARKET & COMPANIES NEWS Latvian “Silvanols” entered into Ukrainian market Latvian pharmaceutical company “Silvanols” started the exportation of its products to Ukraine. The Company is to launch its four original drugs: Laringospray, Rinogel spray, Faringospray, Fungispray, the registration of which started a year ago. “Despite a difficult time for Ukrainian consumers, the results of market study showed that our drugs made of natural raw materials have a bid potential,” Silvanos’ Chairman of the Board Artem Bortsov said. “We plan to extend the offer with original products for the health of nerves, heart and food supplements developed for children by the end of the year.” “Silvanos” was founded in 1994; its main owner is Latvian company Olainfarm (96.69%). This year, besides Ukraine, the company started an export of its products to Bulgaria, Grease, and Austria and enlarged the export in Romania, Poland, Estonia and Georgia. In Ukraine “Silvanos” have 16 drugs registered in total. “Arterium” Corp. expanded its endocrinological portfolio with insulin drugs Ukrainian 3rd pharmaceutical producer “Arterium” has launched new genetically engineered insulins under the tradenames “Insular Activ” and “Insular Stabil”. Both drugs are human insulins, produced with use of technologies for recombinant DNA. Insular Activ is a shot-acting insulin, while “Insular Stabil” has an average duration of action. The drugs were registered in May by “Kyivmedpreparat”, and have become first insulins in the company’s portfolio. “Arterium” Corp. includes the national leader in manufacturing antibiotics “Kyivmedpreparat” JSC and “Galychpharm” JSC, which is the largest producer of herbal medications. “Zdorovye Group” has issued bonds for UAH 400 mio On Nov 3, it became known, that “Zdorovye Group”, one of the biggest Ukrainian pharma producers, had completed an accommodation of unsecured interest bonds of “A” – “F” series UAH 400 mio (USD 17.4 mio) worth. According to the issuer, all securities are sold at par. Under the securities emission prospect, 20% of funds raised the company plans to use for purchase of rights of use related with organization of drugs manufacturing, 30% – for purchase of raw materials, 50% – for construction financing and equipment of a new workshop, as well as modernization of existing production premises and equipment. As of 9M2015, “Zdorovye Group” is the fifth company on Ukrainian pharmaceutical market, compared to the 9th place the company held over the same period in 2014. “Novalik-Farm” is launching LIPINET In Nov, Ukrainian pharma- company “Novalik-Farm” has started distribution of LIPINET, developed by Austrian company SANWEZZA LAB GmbH. LIPINET is an innovative drug to maintain normal cholesterol level and prevent cardiovascular diseases. “Novalic-Farm” is a modern GMP-certified pharmaceutical company, which produce an innovative production: drugs, dietary supplements, cosmetic and hygiene products. “Microchem’s” Armadin shows significant growth in sales dynamics As of 9M2015, “Microchem’s” Armadin (mexidol) has entered into TOP-30 best-selling drugs on Ukrainian market, being ranked 28th, improving its position from 58th in 9M2014 and 144th in 9M2013. Armadin is a cardiological drug, increasing dopamine content in the brain, it is prescribed in acute cerebrovascular accidents, consequences of traumatic brain injury, discirculatory encephalopathy, ect. “Microchem” is the 16th biggest Ukrainian company, with manufacturing capacities based in Rubizhne (Luhansk region). The company’s portfolio, comprising 23 drugs, is mainly specialized on cardiovascular and nervous systems treatment.
  • 5. Page 5 Ukrainian Pharmaceutical Market Monthly: November 2015 REGULATORY UPDATES On Nov 20, the Order of the Ministry of Healthcare of Ukraine “On recognition of invalidation of the Order of the Ministry of Healthcare of Ukraine #1000 dated Dec 29, 2011” has entered into force. The Order, developed by the Unity of employers of medical and microbiological industry, is to cancel an obligatory minimum range of drugs for pharmacies. The main goals of this cancellation are the optimization of existing lists of drugs and facilitation of the work of pharmacy workers. -- On Nov 19, the Draft Resolution of the Cabinet of Minister of Ukraine “On approval of licensing conditions on conducting of economic activities on drugs manufacturing, wholesale and retail trade of drugs, import of drugs (except of active pharmaceutical ingredients)” was presented on the State Administration of Ukraine on medical products website. A necessity of approval of new licensing conditions is envisaged by the Law of Ukraine “On licensing of types of economic activities” dated March 2, 2015, under which licensing conditions should be approved by the CMU Resolution, not by the Order of the profile ministry. The new Draft Licensing conditions establish a comprehensive list of requirements, necessary for execution by a licensee and comprehensive list of documents attached to the application for a license. The new edition does not contain regulations, regulating the issues of succession of licenses in case licensee ceases its activity after the merger, division, amalgamation or transformation. During conduction of control measures by a licensing body, license applicant and licensee have to guarantee access to the premises of a licensee storing drugs. The Draft Licensing conditions also comprise of the documents or copies licensee has to keep during license validity to approve a reliability of data indicated by a license applicant in documents submitted to a licensing body. The list includes: »» documents, approving the right of ownership or use of a premise, occupied by entity or its separate unit; »» technical passport of a premise, occupied by entity or its separate unit; »» technical passports of measuring instruments and devices which are available; »» documents on special education and advanced training of a pharmacy head, authorized person, senior personnel of the manufacturer and/or importer of drugs; »» staff schedule of pharmacies and workbooks of a pharmacy (structural unit) head, authorized person, senior personnel of the manufacturer and/or importer of drugs; »» documents, approving legal relations of employees with an entity. Current version of the Draft Resolution is developed considering the amendments of the associations and public organizations, which took part in discussion over its previous edition dated Jul 14, 2015. -- On November 16, the Resolution of the CMU #921 “On amendments to the procedure of accreditation of health facility” dated Nov 11, 2015 was approved. The Resolution establishes that pharmacies are not subject to mandatory accreditation under. The legislative act is approved according to the Law of Ukraine #326-VIII “On amendments to the article 16 of Fundamentals of the legislation of Ukraine on Healthcare” dated April 9, 2015, providing that accreditation of pharmacies is carried out on a voluntary basis. -- On Nov 20, the Draft Order of the MOH “On approval of the Procedure of calculation of referent prices (reimbursement prices) on insulin drugs” was promulgated on the MOH web site. According to the Procedure of calculation of referent price: »» of full reimbursement for foreign insulin drugs to be conducted on the basis of wholesale reimbursement price, which will be calculated with the using a mechanism of external referencing of producer price, obtained from the official sources of information in referent countries. »» of full reimbursement for domestic insulin drugs to be conducted on the basis of declared wholesale price of each trading name of insulin drug/insulin analogue, enrolled in the registry of wholesale prices of drugs and medical products, considering bonuses, taxes and fees. The referent price of partial reimbursement is to be calculated for each group of insulin drugs separately, as an arithmetic mean price for international unit of insulin drug with further recalculation for secondary pack considering bonuses, taxes and fees. The Draft Order specifies
  • 6. Page 6 Ukrainian Pharmaceutical Market Monthly: November 2015 following referent countries: Bulgaria, Moldova, Poland, Slovakia, Czech Republic, Latvia, Serbia and Hungary. The registry is to be carried out by the MOH and to be updated two times a year, on February 1 and August 1 (in case if the average month exchange rate of the national currency does not change by more than 5%). -- On Nov 20, the Draft Order of the MOH “On measures on improvement of the state registration system for people with cancer” was presented on the MOH web site. The goal of the registry is to increase the efficiency of medical care for patients, ensure a proper registration and accounting of patients, conduction of continuous monitoring of population malignant tumors destruction level, acquire relevant information on state of cancer care in Ukraine, conduction of scientific researches. The Draft Order was developed in order to implement the measure, specified in paragraph 6 of Tasks and Measures on implementation of National anti-cancer program for the period till 2016, approved with the Law of Ukraine dated Dec 23, 2009 #1794-VI. HEALTHCARE NEWS Reformation of emergent medical care is under discussion The Ministry of Healthcare is to develop proposals on reforming of emergent medical care in the middle November. The body says the equipment for operational and dispatching services in every regional center is already procured. Moreover, the reform should include reorganizing of Service for maintenance of public order, traffic rules, technical support, training of medical students and civilian population as well. The MOH expects to create an independent agency for drugs procurement The MOH proposes to create independent agency for drugs and medical products procurement with a supervisory board independent of the Ministry and the Cabinet of Ministers. The Supervisory Board is supposed to ensure transparency of trades, the Minister of Healthcare said during the presentation of the corresponding Draft Resolution at the Government meeting. Ukrainian insulins reimbursement system is under development The MOH started the implementation of a registry of insulin-dependent patients, providing a unique electronic code for drug’s prescription and allowing to determine an amount of funds regions need for insulins reimbursement, the Deputy Minister of Healthcare Oleksandra Pavlenko said. The register is a needed tool for insulins reimbursement system implementation. The registry will contain information about patient’s health condition and insulins prescribed, while the prescription code will allow a patient to get the drug in pharmacy. The registry is already being tested in Zhytomyr and Dnipropetrovsk regions and by the year end all the regions are expected to be attached to the system. The MOH expects to run a pilot project for insulins reimbursement since 2016. Reformation of primary medical aid is a priority for the MOH The further development of primary medical and sanitary aid is a priority for the MOH within the context of Ukrainian healthcare reformation, the Deputy Minister of Healthcare Victor Shafranskiy said. The MOH considers appropriate a juridical and financial demarcation of primary and secondary level of medical aid, free choice of family doctor, implementation of motivational mechanisms for effective prevention activities. Second important direction of healthcare reformation is a provision of effective system of emergency medical aid, Mr. Shafranskiy stressed. State expert center is to reconsider the cost of its services Due to appeals of applicants
  • 7. Page 7 Ukrainian Pharmaceutical Market Monthly: November 2015 regarding new financial plans, State expert center of the MOH is to reconsider the cost of its services at the beginning of 2016 in a planned manner. The prices of following services are to be reconsidered: »» examination of materials for drugs, submitted for state registration (re-registration); »» examination of materials on amendments to registry materials during a registration certificate validity; »» examination of materials on the possibility of including of a drug in the State Drug Formulary. Ukrainian producers are worried public procurement through international organizations could be discriminating for them Current tendency in Ukrainian public drugs procurement, when the procurement is entrusted to International organizations, could be discriminating for Ukrainian pharmaceutical producers, executive Director of the Unity of employers of medical and microbiological industry (UEUPP) Svitlana Bunina said. Ukrainian companies produce about one third of drugs, procuring though the MOH program, but the procurement rules demand the WHO pre-qualification to be able to participate in tenders. The UEUPP published the list of demands for support of Ukrainian pharmaceutical manufactures, including the demand to provide procurement of Ukrainian drugs without the WHO pre- qualification. Representative of the WHO in Ukraine Dorit Nizan made clarifications on the issues, explaining that Ukrainian companies would need the WHO pre-qualification only if they are to participate in bids for procurement of drugs against HIV/AIDS, tuberculosis, hepatitis B and C, medical products for reproductive health and drugs containing zinc. Mrs. Nizan stated that in order to be procured by an international organization, the drug should be registered in Ukraine and have a GMP certificate in PIC/s countries. Medical associations and societies of Ukraine have united into the National Medical Council On Nov 23, Ukrainian medical associations and societies have signed founding documents to unite into National Medical Council (NMC) in order to provide drug authority and develop professional autonomy. Myron Ugrin (Ukrainian Dental Association) has become a Chairman of the Presidium of the NMC, Larisa Matuha (Ukrainian Association of family doctors) has been appointed as the First Deputy. Under the NMC competition there will be general issues of medical practice, which need to be addressed at the level of medical authority or at the level of legislative and executive government bodies. “The NMC intends to contribute adoption of the Law on medical autonomy and creation of the Ukrainian medical society, as an autonomous national organization of physicians,” the NMC statement says. New Head of the State expert center of the MOH has been appointed On Nov 24, Tetyana Talaeva has been appointed as a new Head of SE “State expert center of the MOH”. Previously, on Oct 31, the MOH announced the competitive selection for the position, as its previous Head Elena Nagornaya had resigned in late October. Few days after her dismissal, Security Service of Ukraine exposed a corruption mechanism, which harmed the funds of the State enterprise because of operational expenditures being initially overpriced. 70 companies to take part in bids under Crown Agents procurement programs 40 Ukrainian and 30 foreign companies were interested in participation of drugs procurement by Crown Agents for Ukrainian government. Agency’s procedures do not demand the WHO-prequalification from the producers, including the procurement of anti-cancerous drugs, Director of procurement department of Crown Agents Tom Brown said. The MOH has lately reached an agreement with Crown Agents on drugs procurement for UAH 750 mio (USD 33 mio). Government want to provide compensations to the population due to drug VAT rate increase The Ministry of Finance of Ukraine is developing cost compensation mechanism for drugs regarding the VAT rate rise from 7% to 20%, provided in the Draft Tax Code. “This is a very unpopular measure, which is negatively perceived by pharma- companies,” Deputy Minister of Finance Olena Makeeva said. “Ideally, the tax reform should be conducted in parallel with the Healthcare reform, but currently we do not have a collaboration project with the MOH. That is why we are trying to develop a procedure, which is to guarantee compensations for the population,” Mrs. Makeeva added. The Ministry of Finance expects the VAT rate increment allows to collect about UAH 10 bn in a special fund to be used for subvention under cost compensation mechanism. At the same time, the Deputy Minister of Healthcare Victor Shafranskiy said that there are reasons to think that current VAT rate on drugs is to remain unchanged in 2016.