Pharma-2020 Strategy
Description
The Ministry of Industry and Trade of the Russian Federation Decree from 23 October 2009 №
965 the strategy of pharmaceutical industry development up to 2020 was proved. It is aimed at
increasing the competitiveness of the domestic pharma industry.
The strategy has the following benchmarks:
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Increase of domestic products share in the internal market consumption up to 50 % (in value
terms) by 2020.
Change of assortment of medications sold in Russia, including increase of innovative products
number up to 60 % in value terms.
Increase of pharmaceutical products export by 8 times compared to 2008.
Provision of medicinal safety of Russia in compliance with the list of strategic medications and
vaccines.
Stimulation of establishing pharmaceutical substances productions on the Russian territory in the
volumes necessary for output of 50 % of finished substances (in money terms), including no less
85% by assortment of the list of strategic medications.
The benchmarks are to be achieved through:
1. Stimulation of localization on the Russian territory of high technology production of
medicines.
2.Stimulation of establishing production of high technology chemical and biochemical
substances in Russia.
3. Stimulation of obligatory transition of the domestic pharmaceutical manufacturers to Good
Manufacturing Practice (GMP) standards.
4. Stimulation of development and production of generic and innovative medicines.
5. Elaboration of new educational programmes and modification of existing ones in order to
enhance staff qualification and provide the pharmaceutical industry with new specialists.
6.
Provision
of
medicinal
safety
of
the
Russian
Federation.
The total finance of the programme for 2009-2020 makes 177 620 mln. roubles (6 billion US
dollars).
The Government is expected to keep the Russian pharma market attractive for the international
manufactures in order for them to fulfil their localisation plans.
The approved version of the Strategy of pharmaceutical industry development up to 2020 takes
into account the amendments requested by all government agencies involved (such as Ministry
of Defense, Ministry of Economic Development and Federal Antimonopoly Department of the
Russian Federation). The approved Strategy also incorporates proposals from the regional
governments for the development of local pharmaceutical clusters. According to the Government
of the Russian Federation request the Strategy includes now the list of INN (International
Nonproprietary Names), which are not produced in the country but production of which should
be established on the territory of the Russian Federation.
Description
Strategy of pharmaceutical industry development in the Russian
Federation up to 2020
Government
customer
Russian Federation Government
Principal developer
Ministry of Industry and Trade of the Russian Federation
Goal
Transition to innovation development model of the RF pharmaceutical
industry.
Tasks
Terms and stages of
implementation
1. Enhancement of provision of the population, health care establishments
and RF Armed Forces with domestically produced medicines.
2. Improvement of the domestic pharmaceutical industry competitiveness
through harmonization of Russian standards of medication
development and production with international requirements.
3. Stimulation of innovative medications development and production,
support of Russian medications export, also through elaborating
additional mechanisms of original products financing.
4. Protection of the internal market from unfair competition, and
equalization of access conditions for domestic and foreign producers.
5. Technical re-equipment of the Russian pharmaceutical industry.
6. Enhancement of the system of quality conformity confirmation of
medications, including measures to eliminate excessive administrative
barriers during registration of domestic medicines, and provide due
control of their quality.
7. Enhancement of the educational system for preparation of specialists
for the pharmaceutical industry, also including creation of new
educational programmes that comply with international standards.
2009—2020, including:
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List of main measures
I stage: 2009—2012
II stage: 2013—2017
III stage: 2018—2020
Stimulation of localization on the RF territory of high technology production
of medicines.
Stimulation of establishing productions of high technology chemical and
biochemical substances on the RF territory.
Stimulation of obligatory transition of the domestic pharmaceutical
manufacturers to GMP standards the latest in 2011.
Stimulation of development and production of analogues of foreign import
generic and innovative medicines.
Elaboration of new educational programmes and modification of existing
ones in order to enhance staff qualification and provide the pharmaceutical
Description
Strategy of pharmaceutical industry development in the Russian
Federation up to 2020
industry with new type specialists.
Provision of medicinal safety of the Russian Federation.
Responsible for
implementation
The Ministry of Industry and Trade of the Russian Federation; Ministry of
Health of the Russian Federation; Ministry for Economic Development of the
Russian Federation; Ministry of Education and Science of the Russian
Federation; Federal Antimonopoly Service of the Russian Federation;
Federal Customs Service of Russia; Federal Tariff Service of Russia;
Ministry of Internal Affairs of the Russian Federation; Federal Security
Service of the Russian Federation; The Russian Federation Ministry of
Defence; The RF Ministry of Civil Defense, Emergency Situations and the
Elimination of the Consequences of Natural Disasters; Ministry of Foreign
Affairs of Russia; The Federal Drug Control Service of the Russian
Federation; other interested agencies and territorial subjects of the Russian
Federation.
Scope and sources of
finance
The total finance destined for 2009-2020 makes 177 620 mln. Roubles (in
prices of February, 2009), including:


36 000 mln. roubles for transition to GMP standards
35 220 mln. roubles for preparation of specialists for the
pharmaceutical industry
 196 400 mln. roubles for development of medications
Expected final results
of the Strategy
implementation
System of
performance control
1. Increase of domestic products share in the internal market consumption
up to 50 % (in value terms) by 2020.
2. Change of assortment of medications selled in the RF, including
increase of innovative products number up to 60 % in value terms.
3. Increase of pharmaceutical products export by 8 times compared to
2008.
4. Provision of medicinal safety of the RF in compliance with the
essential drug list.
5. Stimulation of establishing pharmaceutical substances productions on
the RF territory in the volumes necessary for output of 50 % of finished
substances (in money terms), including no less 85% by assortment of
the list of strategic medications.
The Strategy implementation is controlled by the Ministry of Industry and
Trade of the Russian Federation