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Survey o the
Pharmaceutical
Industry in Russia
2010
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1Survey o the Pharmaceutical Industry in Russia, 2010
Introduction
It has become traditional or Ernst & Young to prepare regular surveys o various
sectors o Russian industry. This year we have or the rst time conducted a survey
o the pharmaceutical industry in Russia.
At a business dinner held in January 2010 Ernst & Young employees discussed the
situation in the industry with 25 senior executives o major oreign pharmaceutical
companies operating in Russia. The event occurred just as industry reorms were
beginning, and market leaders expressed concerns as to what measures the
Government would take and how the market would operate under the new conditions.
This survey covers a period o active reorm o the industry by the state. Measures
taken by the Russian Government in recent times with a view to developing
pharmaceutical production within the country and strengthening the competitive
position o domestic companies have provoked much debate and dispute.
This report uses the results o the survey to show how representatives o various
companies view the current trends in the development o the industry, outlines key
legislative changes and their signicance and examines the growth potential o the
pharmaceutical market.
We would like to thank all participants in the survey who shared their opinions with us,
and look orward to uture co-operation.
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2 Survey o the Pharmaceutical Industry in Russia, 2010
Contents
Main conclusions 3
Brie economic overview 5
Reorm o the pharmaceutical industry 7
Factors aecting the development o the industry in 2010 14
Analysis o market development 16
Participants in the survey 20
Contact inormation 21
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3Survey o the Pharmaceutical Industry in Russia, 2010
Main conclusions
The comments made to us in January 2010
indicated that representatives o pharmaceu-
tical companies were in a state o conusion.
The determination on the part o the state
to change the rules o play, the rapidity with
which those changes were being implement-
ed and the scale o the changes led company
directors to express uncertainty as to the
prospects or development and as towhether the changes had been properly
thought out. Now that 2010 has passed, the
participants in our survey indicate a denite
imbalance between the prospects or the
development o the Russian pharmaceutical
market (which were rated airly high) and
the level o transparency o the existing
legislative regulatory ramework (Figure 1).
Generally speaking, Russian manuacturers
rate the clarity o current legislation higher
than oreign importers. They have a clearer
understanding o the recently proposed
changes in the regulation o the pharmaceu-tical industry.
The results o the survey indicate that
Russian manuacturers take a slightly more
optimistic view o the situation than oreign
importers. In 6% o cases Russian manuac-
turers show greater condence in the
prospects o the Russian pharmaceutical
market, which is undoubtedly a consequence
o the state’s import substitution policy.
Nevertheless, a number o analysts believe
that Russia is still attractive to investment
by oreign companies thanks to high prot
margins, the potential or market growth
and prospects or market consolidation,despite the slower pace o development
compared with other BRIC countries.
2010: the beginningo changes2010 was a momentous year in the history
o the industry, as it was the year in which
most o the reorms undertaken by the state
took eect. The reorms aected the entire
sphere o circulation o medicinal drugs,
including:
• The procedure or the registration/
re-registration o medicinal products
• The rules or the regulation o prices or
medicinal products included in the list o
vital and essential medicinal products
(ormerly the list o vital and essential
medicinal drugs), including the proce-
dure or determining and registering
maximum manuacturer supply prices
and new maximum wholesale and
maximum retail mark-ups or sales
o such products
• The importation o medicinal productsinto the territory o the Russian
Federation
• Procedures or the conduct o pre-clinical,
clinical, international multicentre clinical
and post-registration clinical research
• The manuacture and marking o
medicinal drugs
Market participants are already noting the
impact o the changes on the results o their
activities, but the eect so ar is minimal:
diculties in registering products andprices, local changes in prices and sales
volumes and the review o relationships
between participants. The current dicul-
ties are largely attributable to the rapid
pace and deciencies in the planning o the
reorms, and have not yet caused changes
in the market shares o the 15 key market
participants.
However, general orecasts made by the
respondents suggest that the geography
o the market may change as a result o the
nascent localization o the manuacturingo imported goods, the redistribution o the
market shares o key players as a result
o the reorm o the compulsory medical
insurance system and the growth in the
market shares o Russian companies
by virtue o the state support available
to them. It is quite possible that major
structural changes in the market will in act
occur in 2011. These would be the result o
substantial reorms in the state regulation
o the sector in 2010 and urther legislative
changes which may shape the uture
structure o the market.
3,7
2,2
3,3
3,6
2,1
3,1
3,8
2,3
3,5
1 2 3 4 5
Rate how far you understand the recentlyproposed changes in the regulation of the
pharmaceutical industry on a scale of 1 to 5(where 1 - do not understand them
and 5 -fully understand them)
Rate the level of clarity of legislative /regulatory acts governing the Russian market
and the transparency of regulatory bodieson a scale of 1 to 5 (where 1 - low level
and 5 - high level)
Rate your level of confidence in the prospectsfor the Russian pharmaceutical marketon a scale of 1 to 5 (where 1 - low level
and 5 - high level)
Figure 1. Rating of prospects for market development and clarity of legislation
All
Foreign manufacturers / importers
Russian manufacturers
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4 Survey o the Pharmaceutical Industry in Russia, 2010
PricingThe respondents point to a generally
unavourable legislative background as the
actor which most impacts their activities
and give a negative assessment o initia-
tives to strengthen price regulation,
believing that they are ineective and need
to be revised. Over a hal o companieshave seen prot margins all under the new
conditions (oreign companies have elt this
more acutely), but this is in keeping with
the objectives o the legislative measures
aimed at price regulation.
The survey data show that 95% o all
manuacturers managed to register
maximum supply prices or all products in
the list o vital and essential medicinal
products, excluding the 17% o Russian
manuacturers who were unable to reach
agreement with supervisory authorities on
a number o items. In this respect, 29% ooreign manuacturers / importers lowered
the prices or some items relative to the
prices stated in their applications (as
opposed to 17% o Russian manuacturers).
Despite the negative assessment o the
changes, many participants in the business
dinner organized by Ernst & Young at the
beginning o 2010 acknowledged that
pricing on the pharmaceutical market is a
prerogative o state policy. They asserted
that the time has now come to apply the
experience o European countries in the
area o price regulation.
Reaction to the changesMarket participants and experts have
expressed the view that the state has
implemented the changes too quickly and
without due regard to the opinion o the
business community, and that it ailed to
grant representatives o the business world
the opportunity to infuence the reorm
process. In this respect, Russian and
oreign companies have dierent reactions
to the changes. Russian companies arenegotiating with state bodies and consider-
ing ways o adapting marketing and
commercial strategies. Foreign enterprises,
meanwhile, are preparing or more
extensive changes in the model or doing
business in Russia, as well as carrying out
changes in their commercial, production
and distribution operations.
In our view, the diering opinions expressed
by the respondents indicate that the
companies have not yet been able to orm
clear new strategies in the context o the
adoption o the new rules governing state
regulation o the market. The eects which
the respondents expect to see include a
cardinal redistribution o market shares
among the principal players (primarily inquantitative terms), a growth in the market
share o Russian manuacturers, the ending
o supplies o certain medicinal products to
Russia and the need to change elements o
their business model.
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5Survey o the Pharmaceutical Industry in Russia, 2010
Brie economic overview
State o the pharmaceuticalmarket in 2010 and growthorecastsAccording to data compiled by industry
experts, the total volume o the medicinal
products market in 2010 was around 17.7
billion dollars (based on end consumer
prices), which is 13% higher than in 2009(8% when expressed in rouble equivalents).
The market volume in quantitative terms
increased by 9% (the highest growth gure
since 2005).
Forecasts made by CMI Pharmexpert
suggest that in 2011 the market or the
consumption o medicinal drugs in Russia
will grow by a best-case 15% and a worst-
case 8%. The rate o growth o the Russian
market, which is ahead o the global market
growth rate (5-7%), will remain steady over
the next ew years.
In 2010, like the year beore, imported
products made up a large part o the overall
volume o consumption, accounting or
around 66% in monetary terms. It is
anticipated that in the next ew years the
proportion o imports will gradually
decrease: according to a ederal special-
purpose programme it is planned that the
proportion o imported medicinal drugsshould be reduced to 50% o overall
consumption by 2020. According to data
issued by the Ministry o Economic Develop-
ment, by 2013 the quantity o medicinal
drugs manuactured in the Russian
Federation should almost double relative
to 2009.
A number o analysts believe that the
Russian pharmaceutical sector is at present
showing greater protability than develop-
ing markets, and particularly India and
China. However, Russia will lag behind other
BRIC countries in the terms o the pace o
growth in the next ew years owing to its
declining population and lower per capita
consumption o pharmaceutical products.
Brie overview o thehealth care sphereTotal state expenditure on health care
in 2010 amounted to 675.59 billion
roubles, which is 0.7% lower than the
previous year. In this respect, the share
o regional budgets in that expenditure
rose considerably in 2010.
Health care expenditure in 2010 accounts
or 3.6% o GDP. The Russian Government
has said that by 2013 health care expendi-
ture will grow by 40% and will be close
to 5% o GDP.
Figure 2. Volume of pharmaceutical market in monetary terms: optimistic forecast
310
495538
619
706
797
893
0
100
200
2008A 2009A 2010A 2011E 2012E 2013E 2014E
300
400
500
600
700
800
900
1000
b l n .
R u b .
CAGR 13%
*CAGR — Compound annual growth rate, A — Actual, F — Forecast
Source: CMI Pharmexpert, analysis by Ernst & Young.
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6 Survey o the Pharmaceutical Industry in Russia, 2010
Table 1 State health care expenditure (billion roubles), 2009-2010
Indicator Federal budget Consolidated budgets
o constituent entities
o the Russian Federation
Budgets o territorial state
unds
Total
2010 2009 2010 2009 2010 2009 2010 2009
Health care expenditure, total * 201,40 219.84 450.13 434.04 24.07 26.75 675.59 680.3
Health care expenditure
as a proportion o totalstate expenditure (%) 2.42 2.69 8.21 8.42 4.66 5.43 4.72 4.92
* Excluding expenditure on tness and sports; applied and scientic research in the eld o health care, tness and sports; other matters pertaining to health care, tness
and sports.
Source: Federal Treasury o the Russian Federation.
In 2011, 134.9 billion roubles will be
allocated to the high-priority “Zdorovye”
national project (6% more than in 2010);
49.3 billion roubles will be allocated or the
purchase o expensive medicinal products
under the “Seven High-Cost Nosologies”
programme (11% more than in 2010); 41.3
billion roubles will be allocated or the
purchase o medicinal products under the
programme or the supply o essential
medicinal drugs (ONLS).
Table 2 Volumes o fnancing under the “Zdorovye” project
2010 (Law
No. 308-FZ)
Revised budget
spending report as at
September 1, 2010
Calculated volumes o fnancing
2011 (drat) 2012 (drat) 2013 (drat)
Volume (billion roubles) 126.9 126.9 134.9 139.5 100.5
Change relative to preceding year:
billion roubles +8.0 +4.6 -39.0
% +6.3 +3.4 -28.0
Source: Ministry o Economic Development o the Russian Federation.
In 2011 it is planned to increase the per
capita level o nancial support orconcession recipients to 952 roubles per
person, which is 26% higher than in the
preceding year according to inormation
rom the Ministry o Health and Social
Development.
2011 will witness the start o the biggest
health care reorms or 20 years with
a budget o 460 billion roubles. The
reorms will include inormation systemdevelopment, renovation and re-equipping
o medical institutions, the raising o
salaries or medical workers and standard-
ization o medical services.
The state is taking a number o measures
to increase nancial support or the health
care sphere (through the programme or
the supply o essential medicinal drugs,
the hospital segment and state procure-ment). In this respect, in view o the aging
population and the consequent growing
requirement or medicines, consumer
expenditure on medicines is set to increase.
All o these actors point to the potential
growth o the pharmaceutical market as
a whole over the next ew years.
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7Survey o the Pharmaceutical Industry in Russia, 2010
Key legislative changesThe “Strategy or the Development o the
Pharmaceutical Market o the Russian
Federation in the Period up to 2020”, which
was adopted in 2009, signalled a transition
to an innovative model or the development
o the pharmaceutical industry o the
Russian Federation. At present, as part othe rst stage o the transition aimed at the
localization o the manuacturing and devel-
opment o medicinal drugs in the territory
o the Russian Federation, the Government
is implementing reorms to the regulation
o Russia’s pharmaceutical industry.
The most signicant events o 2010 in the
area o the state regulation o the Russian
pharmaceutical industry may be identied
as ollows:
• The adoption o Law No. 61-FZ “Con-
cerning the Circulation o MedicinalDrugs”
• The issuance o Decree No. 865 o the
Russian Government o October 29,
2010 “Concerning the State Regulation
o Prices or Medicinal Products Included
in the List o Vital and Essential Medici-
nal Products”
• The adoption o Federal Law No. 326-FZ
“Concerning Compulsory Medical
Insurance in the Russian Federation”
• The development o the drat law
“Concerning the Fundamental Principles
o the Protection o the Health o
Citizens in the Russian Federation”
• The approval in October 2010 o the
Conceptual Plan o the Federal Special-
Purpose Programme (FSP) “Develop-
ment o the Pharmaceutical and Medical
Industry o the Russian Federation
in the Period up to 2020 and Beyond”
(the Conceptual Plan has now been
approved by Decree No. 91 o the
Government o the Russian Federation
o February 17, 2011)
The FSP has dened the major measures othe development o the pharmaceutical
industry o the Russian Federation,
including raising the proportion o domesti-
cally manuactured drugs to 50% o total
consumption in the Russian Federation in
monetary terms and raising the proportion
o domestically manuactured drugs to 90%
o total consumption o products on the list
o vital and essential medicinal products in
monetary terms. The FSP envisages
investment o 188 billion roubles in theperiod up to 2020.
Special measures are planned to improve the
competitiveness o domestic medicines and
replace imports. Those measures include:
• Tough price restrictions on medicinal
products included in the list o vital and
essential medicinal products
• The adoption o a list o strategically
important medicinal products whose
production within Russia must be
arranged by 2015, and updating o the
list o vital and essential medicinalproducts
• Planned transition to international
standards or the manuacture o medici-
nal drugs.
Eects o regulatorymeasures in 2010Measures adopted in 2010 or the state
regulation o the sector have aected
Russian and oreign manuacturers in
dierent ways. This is particularly the case
with Law No. 61-FZ “Concerning the
Circulation o Medicinal Drugs”.
63% o respondents indicated that the
measures carried out or the regulation
o the industry aected their nancial
perormance. Legislative changes led
to a growth in sales and reduction in
protability or 33% o Russian manu-
acturers surveyed, and to a decrease
in sales and reduced protability or 38% o
oreign manuacturers-importers (Figure 3)
Reorm o the pharmaceuticalsector
Figure 3. How have the recent changes in legislation governing the circulation
of medicinal drugs affected your company’s financial results?
31,3%
50%
16,7%
33,3%
37,5%
25%
6,3%
0
10%
20%
Foreign manufacturers /importers
Russian manufacturers
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Increased sales and higher profit margins
Increased sales and lower profit margins
Decreased sales and lower profit margins
No effect
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8 Survey o the Pharmaceutical Industry in Russia, 2010
Both oreign and Russian manuacturers
encountered diculties in 2010 in connec-
tion with the new rules governing the
circulation o medicinal drugs. The problems
most requently encountered as a result
o the new law are with obtaining state
registration o medicinal products, register-
ing maximum manuacturer supply prices
or products on the list o vital and essentialmedicinal products, obtaining conrmation
o the registration o a medicinal product
and making changes to the registration le
or such a product.
In this respect, a greater proportion o
Russian manuacturers than oreign
indicated diculties with the state registra-
tion o products and the registration o
maximum prices or vital and essential
medicinal products. In particular, dicul-
ties with the registration o products were
claimed by 57% o oreign and 83% o
domestic manuacturers.
Regulation o prices or products on the list o vital andessential medicinal productsAt the business dinner organized by Ernst &
Young at the beginning o 2010, senior execu-
tives o various pharmaceutical companies dis-
cussed the prospects or changes to the rules
or price regulation in the Russian Federation.
They expressed doubts as to the ability o stateauthorities to implement changes in the
industry within a short period o time and as to
whether the new pricing conditions would be
transparent or all market participants.
Despite the rapidity with which the changes
were brought in and the strict monitoring o
compliance with the rules in 2010, 95% o all
manuacturers managed under the new
regulatory environment to register maximum
supply prices or all products on the list o
vital and essential medicinal products, and
indeed most respondents (70%) did so at the
prices stated in their applications.
In contrast to oreign manuacturers, which
registered prices or all items, 17% o Russian
manuacturers were unable to reach
agreement with the supervisory authorities
on a number o items. However, 29% o
oreign manuacturers were orced to reduce
the prices or a number o items. Among
Russian manuacturers this happened to 17%
o respondents.
40%20%0 60% 80% 100%
State registration of medicinal products
Registration of maximum supply pricesfor products from the list of vitaland essential medicinal products
Confirmation of the registration of a medicinalproduct and making amendments to the
registration file for a medicinal product
Obtaining authorizationto conduct clinical trials
Obtaining authorization to import medicinalproducts for the purpose of conductingclinical trials
Compliance with maximum regional wholesalemark-ups for products from the list of vital and
essential medicinal products
Peparation of pricing protocolsupon the sale products from the list
of vital and essential medicinal products
Other (constant update of the registerof medicinal products and inclusion
of pharmaceutical substances in the register)
Figure 4. Which changes in regulation have led to the most difficultiesfor your company?
Foreign manufacturers / importers
Russian manufacturers
57%
57%
29%
21%
21%
14%
21%
0%
83%
67%
50%
17%
17%
0%
0%
17%
% respondents
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9Survey o the Pharmaceutical Industry in Russia, 2010
A more pronounced reduction o prices or
products o oreign manuacturers (Figure
3) was also noted by market analysts.
According to CMI Pharmexpert, the
regulation o supply prices and o wholesale
and retail mark-ups caused the average
level o prices on the commercial retail
market to all in 2010. In this respect,
prices or imported products ell by anaverage o 4.5%, while those or Russian
products actually increased by 4% over
2010. The explanation given by CMI
Pharmexpert analysts or this is that
Russian manuacturers partially compen-
sated or the decrease in retail prices or
products on the list o vital and essential
medicinal products by increasing prices or
other drugs.
Figure 5. Did you succeed in registering maximum supply prices for all products
supplied by your company?
0
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Yes, all our products have been registered at the declared prices
Yes, but we had to negotiate with the relevant authorities
Yes, but we were forced to reduce the prices for a number of items
No, have been unable to reach agreement with the supervisory authorities on a number of items
40%50%
17%
30%
21%
50%
25%29%
17%
5%17%
Foreign manufacturers /importers
All Russianmanufacturers
Figure 6. Have you considered discontinuing the production of particular
pharmaceutical products in Russia owing to the fact that they
have been registered at a low price and it is therefore commercially
inefficient for the products to be distributed in Russia?
33%
67%
86%
14%
0
10%
20%
Foreign manufacturers /importers
Russian manufacturers
30%
40%
50%
60%
70%
80%
90%
100%
% r e s p o n d e n t s ( e x c l u d u i n g
t h o s e , w h o h a v e
n o v i t a l a n d e s s e n t i a l m e d i c i n
a l p r o d u c t s )
Yes No
On the other hand, Russian manuacturers
produce medicines which are in a lower
price segment, which means that there is
probably less scope or reducing prot
margins. The survey data indicate that the
reduction o supply prices was more painul
or Russian than or oreign manuacturers.
67% o Russian manuacturers (compared
with only 14% o oreign) were consideringwhether to discontinue the production o
certain drugs on the basis that price
reductions made it commercially inecient
(Figure 6).
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10 Survey o the Pharmaceutical Industry in Russia, 2010
Both Russian and oreign manuacturers
express displeasure at the current price
regulation ramework. 50% o those
surveyed are inclined to the view that the
price regulation system as it stands could
result in the discontinuation o supplies o
certain medicinal products to Russia and
the “laundering” o cheap pharmaceuticals.
This is due to the act that the pricereductions hit products in the lower price
segment which have a lower margin.
Compulsory medicalinsuranceThe law “Concerning Compulsory Medical
Insurance in the Russian Federation”
entered into orce rom January 1, 2011.
It envisages a gradual change in the system
o compulsory medical insurance and health
care in the Russian Federation, and likewise
has a signicant impact on participants in
the pharmaceutical market.
Manuacturers expect to see changes in
the structure o the market both in terms
o the transormation o product segments
and rom the point o view o the position
o major players. 83% o Russian manuac-
turers expect to see a cardinal change in
the relative market shares o the major
players as a result o the new law. In this
respect, most oreign manuacturers are
more concerned by the act that manuac-
turers o cheap non-branded productsmight assume a leading position on the
market (Figure 8).
40%20%0 60% 80% 100%
Current price regulation is ineffectiveand needs to be reviewed
Current price regulation may result in thecessation of supplies of certain medicinal
products to Russia and the “laundering”of cheap pharmaceutical products
Current price regulation favoursRussian manufacturers
Current price regulationis favourable to distributors
Current price regulation is effectiveand no changes are needed
Current regulation of supply prices causesretail prices to be reduced
Other
Figure 7. How do you assess the situation with regard to the state regulation
of prices for pharmaceutical products in Russia?
Foreign manufacturers / importers
Russian manufacturers% respondents
17%
13%
13%
27%
0%
0%
0%
0%
0%
50%
53%
67%
73%
17%
40%20%0 60% 80% 100%
There will be a cardinal change in thedistribution of shares among
the main players
Manufacturers of cheap non-brandedproducts might gain a leading position
on the market
The effect will be negligible
Other
Figure 8. How do you assess the impact of the compulsory medical insurance law
on the Russian pharmaceutical market?
Foreign manufacturers / importers
Russian manufacturers% respondents
0%
8%
17%
15%
46%
83%
31%
0%
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11Survey o the Pharmaceutical Industry in Russia, 2010
75% o Russian manuacturers believe
that they will gain rom the adoption
o the law, while more than hal o oreign
manuacturers believe that the new law
will not aect their activities (Figure 9).
Figure 9. Have you assessed the impact of the compulsory medical insurance law
on your company?
0
10%
20%
Foreign manaufacturers /importers
All Russianmanufacturers
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Yes, the new law will have a negative impact on our company’s activities
Yes, our company will gain from the adoption of the law
No, the law will not have any impact on our company’s activities
47%55%
25%
75%
18%
27%40%
13%
Figure 10. Do you conduct / organize clinical research in Russia?
0
10%
20%
Foreign manufacturers /importers
All Russuianmanufacturers
30%
40%
50%
60%
70%
80%
90%
100%
%
r e s p o n d e n t s
No, we do not conduct clinical trials in Russia
Yes, we conduct clinical trials ourselves
Yes, we conduct clinical trials with the aid of specialized companies
57% 60%50%
50%
7%
33%38%
5%
Clinical researchThe survey results indicate that Russian
manuacturers conduct 50% o clinical
research independently and 50% with the
aid o specialized companies. Foreign
manuacturers use specialized companies
or the majority o their research (60%).
According to data rom the Association o
Clinical Research Organizations (ACRO), the
Russian market or international clinicalresearch shrank by 25% in 2010. ACRO
attributes that decline to the enactment o
the Law on the Circulation o Medicinal
Drugs, administrative barriers caused by the
adoption o that Law and the need or
appropriate regulatory bylaws. ACRO
representatives ear that this could result in
signicant delays in the appearance o
innovative medicines in Russia.
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12 Survey o the Pharmaceutical Industry in Russia, 2010
However, most survey participants (47% o
oreign and 67% o Russian manuacturers)
responded negatively to the question o
whether it would be possible to restructure
clinical trials o new medicines.
On the whole, thereore, the current
situation is orcing manuacturers
to cut down on trials o innovative products.
However, only 40% o oreign manuactur-
ers have plans to review this area o
activity in Russia in the uture.
Figure 11. Have you considered the need to restructure clinical research
arrangements in connection with the enactment as from September 1,
2010 of the new law on the circulation of medicinal drugs?
0
10%
20%
Foreign manufacturers /importers
Russianmanufacturers
30%
40%
50%
60%
70%
80%
90%
100%
No
Yes
Our company does not conduct / organize clinical trials in Russia
38%
7%
67%
33%
53%
40%
5%
57%
All
% r
e s p o n d e n t s
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13Survey o the Pharmaceutical Industry in Russia, 2010
40%20%0 60% 80% 100%
Studying operating conditionsin regions of the Russian Federation
Modifying arrangementswith Russian distributors
Holding talks with State authorities
Proposed introduction of criteria for defininga domestic medicinal product
Updating the company’s marketingand commercial strategy
Updating the company’s business model
Production localization
Raising the company’s awarenessof regulatory issues
Other
Figure 12. Indicate the most serious problems faced by your company in light of the
proposed changes in the regulation of the industry.
Foreign manufacturers / importers
Russian manufacturers
17%
17%
27%
27%
67%
27%
33%
33%
40%
50%
53%
47%
33%
13%
0%
0%
0%
0%
% respondents
Manuacturers’ reactions
to regulatory measuresThe changes in the system o regulation
meet with dierent reactions rom oreign
and Russian manuacturers. Foreign
manuacturers are orced to revise their
model or doing business in Russia, while
their Russian counterparts only have to
update their commercial and marketing
strategy. Specically, 53% o oreign
manuacturers consider it necessary to
change their business model. 43% o
oreign manuacturers view the impending
introduction o criteria or dening adomestic medicinal product as a serious
problem. For Russian manuacturers,
meanwhile, the most serious problems are
updating their commercial and marketing
strategy (indicated by 50% o Russian
manuacturers) and negotiating with state
authorities (67%) (Figure 12).
Figure 13. Are you conscious of support given to domestic manufacturers?
40%
60%
54%
46%
0
10%
20%
Foreign manufacturers /importers
Russianmanufacturers
30%
40%
50%
60%
70%
80%
90%100%
% r
e s p o n d e n t s
Yes No
60% o Russian and 46% o oreign manu-
acturers are conscious o support given
to domestic manuacturers. Russianmanuacturers point in particular to the
15% preerences in the area o state
procurements which are granted on the
basis o Federal Law No. 94-FZ “Concerning
the Placing o Orders or Supplies o Goods,
Perormance o Work and Rendering o
Services or State and Municipal Needs”
and have been in eect or a number
o years.
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14 Survey o the Pharmaceutical Industry in Russia, 2010
Adverse actors aectingcompanies’ activitiesAt present the survey participants view the
overall picture as promising in the context
o the adoption o the “2020 Strategy”.
At the same time, they point to the
problems and diculties aced in the
transitional period. Paramount amongthose problems are unavourable legisla-
tion, a shortage o proessional personnel,
corruption and general economic
conditions (Figure 14).
Representatives o both Russian and
oreign companies view the impact o
legislation on their activities as the most
important actor. In this respect, they draw
attention to the adverse eects and the
need to rectiy the situation.
Since they do not yet have large-scale
localized manuacturing operations inRussia, oreign manuacturers are less
dependent on the skill level o pharmaceuti-
cal production sta, and yet they point to
the lack o qualied personnel just as local
producers do – 63% against 83% o respon-
dents respectively.
Curiously, even in the context o the
economic downturn neither local nor global
players reer to problems with nancing –
only 13% o companies indicated this as a
negative actor. Similarly, only 21% o
respondents are worried by the growth in
competition. Despite this low relative
assessment, however, in absolute terms
competition is rated as higher than average
in all segments (Figure 17).
Shortage o skilled personnelResearch results or 2010 indicate that the
shortage o skilled personnel on theRussian labour market continues to be one
o the most acute problems acing the
pharmaceutical industry – a view expressed
by 71% o all respondents.
The results o the survey indicate that or
the moment this is more o a problem or
Russian participants in the market than or
oreign importers. 83% o Russian manu-
acturers are concerned at the lack o
skilled personnel in the Russian Federation,
compared with 63% o oreign manuactur-
ers-importers (Figure 14).
The personnel shortage is expected to
become a more acute problem or oreignmanuacturers in view o the trend towards
the localization o manuacturing in the
Russian Federation in the next ew years
under the infuence o import substitution
policies. Some o them have already turned
their attention to this problem: participa-
tion in the process o the harmonization o
educational programmes and the training
o highly qualied personnel is on the list o
business development priorities noted by
oreign manuacturers in the course o the
survey.
Factors aecting the developmento the industry in 2010
40%20%0 60% 80% 100%
Unfavourable legislation
Lack of qualified personnel
Corruption
General economic conditions
Circulation of counterfeit products
Growth of competition
Lack of investment / financing
Figure 14. Which of the following factors represent the greatest threat
to the industry?
Foreign manufacturers / importers
Russian manufacturers% respondents
17%
17%
17%
6%
25%
31%
50%
25%
33%
69%
83%
63%
75%
100%
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15Survey o the Pharmaceutical Industry in Russia, 2010
With a view to addressing this problem
in the context o the implementation o the
strategy or the development o the industry
in pharmaceutical cluster regions o the
Russian Federation there are plans to invest
in the development o personnel potential,
which involves the launching o new
educational programmes and co-operation
with leading Russian medical and pharma-ceutical centres and international educa-
tional centres. According to the ederal
special-purpose programme, 5000 special-
ists are to undergo training and retraining by
2020 in order to provide sta or enterpris-
es o the pharmaceutical industry.
CorruptionThe survey results show that oreign
companies see corruption in Russia as the
second biggest problem or the industry.
Russian companies, meanwhile, placecorruption in ourth place in the list o
threats aced by the industry (Figure 14).
This dierence in assessments is easily
explained – oreign companies pay greater
attention to the problem o corruption
owing to the long-standing culture o ethical
business practices based on their own
internal policies and the requirements o
regulatory acts such as the US Foreign
Corrupt Practices Act.
That Act and similar acts adopted in other
countries have an impact on the way inwhich oreign companies do business in
Russia. For instance, under the UK Bribery
Act any companies which do business in
Great Britain may be prosecuted or the
corrupt practices o their partners. For this
reason companies class the management o
corruption risks as a priority objective.
Interaction with the stateOne o the conclusions drawn on the basis
o the year 2010 by senior executives o
oreign companies who took part in the
business dinner was a conscious need to
improve dialogue between the business
world and the state. The survey results
show that representatives o Russian andoreign companies place equal value on the
role o proessional associations in the eld
(83% and 73% respectively).
In this respect, Russian and oreign
manuacturers have dierent attitudes to
the making o private representations to
state authorities. 100% o Russian
companies surveyed use this approach,
compared to only 33% o oreign
companies.
40%20%0 60% 80% 100%
Non-commercial organizations /associations of pharmaceutical companies
Private communications from individual
companies to representativesof State authorities
Open communicationsin the independent press
Other
Figure 15. Assessment of most effective methods of communication between
pharmaceutical companies and the State
All
Foreign manufacturers / importers
Russian manufacturers
% respondents
13%
10%
13%
10%
33%
52%
83%
73%
76%
0%
0%
100%
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16 Survey o the Pharmaceutical Industry in Russia, 2010
Distribution o the marketshares o major playersAccording to data rom industry experts
consisting o sales gures or the year
2010 expressed in monetary terms, the
15 largest companies (an absolute majority
o them being oreign companies) control
around 46% o the market. The remaining54% o the market is divided up between
a large number o Russian and oreign
players. The experts consider that this
shows that the market is ragmented and
likely to undergo urther consolidation.
There were no signicant changes in the
distribution o market shares in 2010
compared with 2009. The combined market
share o the 15 largest manuacturers
remained virtually unchanged (the dier-
ence was just slightly above 1%). Virtually all
15 key manuacturers retained their places,with partial shits in position within the
group.
Despite the act that the respondents
indicated changes in sales volumes and
protability in 2010 (Figure 3), these
movements were not refected in respective
market shares.
Assessment o competition
on the marketThe survey results indicate that, as things
stand, 25% o oreign manuacturers and
only 17% o Russian manuacturers class
competition as a risk actor (Figure 14).
This is probably due to the act that only
one Russian manuacturer is on the list o
the 15 largest companies (in terms o
revenue levels) and is competing or top
places with the other 14 oreign players.
The survey participants rate the level o
competition in particular segments as
ollows:
• Competition was rated as greater than
average (i.e. not lower than 3.4 points
out o 5) in all segments
• The highest level o competition was in
the Russian distributor segment, while
the lowest was in the local manuacturer
segment.
The shits in positions among companies
on the top 15 list (during 2009-2010)
corroborate the view o the survey partici-
pants that competition or top places is
more acute among oreign players.
Market orecasts
Foreign and Russian manuacturers whotook part in the survey have divided opinions
regarding the prospects or changes in the
respective shares o market players.
To the question o how the pharmaceutical
market will develop in Russia over the next
ve years, Russian manuacturers answer
that the share o Russian companies will
naturally increase thanks to state support.
Furthermore, state support will, in their
opinion, encourage oreign manuacturers to
create production enterprises in Russia.
44% o oreign manuacturers envisagesetting up production operations in Russia,
while they regard other possible develop-
ments, such as the acquisition o Russian
companies, as less likely (only 18% o
respondents mention such possibilities).
It may be assumed that a qualitative change
in the distribution o orces will begin in
2011, aided by the ollowing actors:
Analysis o market development
Figure 16. The market shares of the 15
largest pharmaceutical companies
based on revenues for 2010
15 largest companies
Other
54%
46%
Source: CMI Pharmexpert,
analysis by Ernst & Young
1 2 3 4 5
Russian distributors
Foreign manufacturers /importers
Russian manufacturers
Pharmacy networks
Figure 17. Rate the level of competition within segments of the Russian
pharmaceutical market on a scale of 1 to 5.
All
4,0
3,8
3,4
3,5
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17Survey o the Pharmaceutical Industry in Russia, 2010
• The nascent localization o the manuac-
turing o oreign products
• The urther growth in competition and
existing deragmented state o the
market
• The eect o price regulation and
compulsory medical insurance laws
adopted in 2010
• The already ormulated strategy or the
development o the pharmaceutical
industry and the ederal special-purpose
programme.
Forms o businessdevelopment and trendstowards localizationo manuacturingThe survey results indicate that the
majority o Russian manuacturers (83%)
plan to expand their existing production
acilities, and two thirds o those surveyed
(67%) intend to begin building new
production sites.
In view o the state import substitution
strategy oreign companies are generally
considering two main business develop-
ment scenarios. Hal o oreign companies
express an interest in setting up their own
production operations in Russia. Slightly
less interest is shown by oreign companies
in establishing contract manuacturing with
Russian manuacturers – around 44% orespondents (Figure 19). Contract
manuacturing may become more attrac-
tive in the uture thanks to state support or
the process o the transition to internation-
al manuacturing standards (GMP).
The survey results show that oreign
companies have little interest in closer
co-operation with Russian manuacturers,
e.g. through the transer o patents and
technologies. There are currently only a
very ew examples o such co-operation on
the market.At present, many major oreign players on
the market are already at various stages o
production localization: they have an-
nounced their investment intentions or
have already begun construction. The
survey results show that oreign pharma-ceutical companies tend to choose Saint
Petersburg, Yaroslavl and Kaluga as the
most preerred places to set up production
(these cities were mentioned by respon-
dents three times more oten than any
others in the course o the survey).
40%20%0 60% 80% 100%
Introduction of new products to the market
Extention of existing production facilities
Building of new production sites
Entering foreign markets
Acquisition of other manufacturers
Own wholesale distribution development
No such plans
Contract manufacturing
Figure 18. Which of the forms of business development listed below is your company
considering? (Russian companies)
Russian manufacturers % respondents
0%
0%
33%
33%
50%
67%
83%
100%
100%
40%20%0 60% 80% 100%
Introduction of new products to the market
Setting up own production operations in Russia
Transfer of a patent for an end product and/orthe technology for its manufacture in the
territory of the Russian Federation to aRussian legal entity
Other
No such plans
Contract manufacturing
Figure 19. Which of the forms of business development listed below is your company
considering? (foreign companies)
Foreign manufacturers / importers % respondents
0%
44%
6%
13%
50%
100%94%
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18 Survey o the Pharmaceutical Industry in Russia, 2010
The survey results are consistent with
actually announced investment projects,
in which the Yaroslavl and Kaluga provinces
and Saint Petersburg are chosen as
locations or production operations.
In particular, according to data rom the
Committee or Economic Development,
Industrial Policy and Trade o Saint
Petersburg, nine investment projects wereinitiated during 2010 or the construction
o new actories in the city in addition to the
seven already existing medicine manuac-
turing organizations.
Wholesale distributionmarketThe wholesale distribution market may be
tentatively divided into two segments:
• The market o medium and small
distributors, characterised by a highlevel o competition as also noted by
analysts o DSM Group
• The market o large national companies,
in which the top positions are held by
ve major enterprises which are
represented in all regions o Russia and
have a ar-reaching distribution system.
There is a airly high degree o concentra-
tion in the second market segment, owing
partly to the act that top companies have
increased the proportion o indirect sales,
and particularly sales to smaller wholesal-ers.
Strict regulation and monitoring o
compliance with maximum wholesale
markets have made things even tougher or
small and medium-sized distributors.
Russian distributors have divided opinions
regarding the business prospects o
medium/small distributors: 80% o manu-
acturers believe that small and medium-
sized distributors will be taken over by large
players, while 20% take the view that small
wholesalers will simply be squeezed out o
the market (Figure 21).
Figure 20. Do you plan to set up a production enterprise in one of the pharmaceutical
centres (clusters), such as Saint Petersburg, Yaroslavl and Kaluga?
33%
50%
17%
13%
7%
27%
40%
13%
0
10%
20%
Foreign manufacturers /importers
Russianmanufacturers
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Yes, we are examining the opportunities in one of the pharmaceutical centres and (or) havealready concluded an investment agreement in one of the pharmaceutical centres
No, we have no plans to localize production activity in Russia
No, we have no expansion plans to other Russian regions
We are examining the opportunities in other regions of Russia and (or) have alreadyconcluded an investment agreement in another region of Russia
Other
Figure 21. How do you assess the business prospects of medium / small distributors?
0
10%
20%
There will be market consolidation,medium/small distributors wil be aquired
by large players
Medium/small distributors willbe squeezed out of the market
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Russian manufacturers
20%
80%
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19Survey o the Pharmaceutical Industry in Russia, 2010
The survey results show that legislative
changes have aected oreign manuactur-
ers’ relationships with distributors more
than Russian manuacturers’ relationships
with them. In this respect, 40% o oreign
manuacturers believe that relationships
within the supply chain have changed in
avour o distributors (Figure 22).
Figure 22. Have relationships within the manufacturer-distributor chain changed
as a result of changes in the legislation governing the circulation
of medicinal drugs?
0
10%
20%
Foreign manufacturers /importers
All Russianmanufacturers
30%
40%
50%
60%
70%
80%
90%
100%
% r
e s p o n d e n t s
Changed in favour of manufacturers
Changed in favour of distributors
No change
10%
53%
20%
60%
20%
40%
7%
57%
33%
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20 Survey o the Pharmaceutical Industry in Russia, 2010
The respondents most comprised oreign
manuacturer-importers (67% o those
surveyed) and Russian manuacturers o
pharmaceutical products (25%). The
remaining 8% o survey participants were
Russian distributors o pharmaceutical
products and pharmacy networks.
Participantsin the survey
Figure 23. Composition of respondents
Foreign manufacturers / importers
Russian manufacturers
Russian distributors and pharmacy networks
8%
25%
67%
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21Survey o the Pharmaceutical Industry in Russia, 2010
Dmitry Khalilov
Partner, Tax Services
Head o Pharmaceutical Group in the CIS
Tel.: +7 (495) 755 9757
Tatiana Shustova
Partner, Transaction Advisory Services,
Pharmaceutical Group
Tel.: +7 (495) 755 9867
Ivan Butyagin
Partner, Advisory Services,
Pharmaceutical Group
Tel.: +7 (495) 705 9713
Evgenia Veter
Partner, Tax Services,
Pharmaceutical Group
Tel.: +7 (495) 660 4880
Sergei Steanishin
Partner, Legal Services,
Pharmaceutical Group
Tel.: +7 (495) 755 9872
Alexander Khorovitch
Director, Audit Services,
Pharmaceutical Group
Tel.: +7 (495) 755 9844
Contact inormation
The inormation contained in this publication is presented in abridged orm and is intended only or general guidance. It must not be
regarded as a substitute or a detailed survey report or other reerenced materials or serve as the basis or a proessional judgement.Ernst & Young cannot accept any responsibility or losses incurred by any person acting or reraining rom action as a result o any material
in this publication. Advice on specic matters should be sought rom a specialist in the relevant eld.
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