Federal Programme for Development of the Pharmaceutical and Medical Industries.

31.03.2011

Legal Update No. 228.

Goltsblat BLP advises that Resolution of the Government of the Russian Federation No. 91 “On the Federal Target Programme ‘Development of the Pharmaceutical and Medical Industries in the Russian Federation up to 2020 and Beyond’” of 17 February 2011 (the “Federal Programme”) came into effect on 29 March 2011.

The Federal Programme was adopted to guide the Russian pharmaceutical and medical industries on to an innovative development course.

Arrangements envisaged by the Federal Programme rely on public-private partnerships and co-financing of research, development and manufacture by government and business in order to deliver domestic pharmaceutical and medical products. Business is expected to fund at least 25 per cent of the research and development costs, acquisition of licences and relevant production expenditures.

Financial resources under the Federal Programme will total RUB 188 bn (subject to future price dynamics), including RUB 122.6 bn sourced from the federal budget (in particular, RUB 94.7 bn for research and development work, RUB 25.3 bn for capital expenditures, and RUB 2.6 bn for other outlays) and RUB 65.5 bn from non-government sources.

The Federal Programme action groups are as follows:

  • group 1: Developing the scientific and technical potential of the pharmaceutical industry;
  • group 2: Developing the innovation potential of the pharmaceutical industry;
  • group 3: Developing the scientific and technical potential of the medical industry;
  • group 4: Developing the innovation potential of the medical industry;
  • group 5: Developing the manpower and information infrastructure of the pharmaceutical and medical industries;
  • group 6: Investments in re-equipment, modernisation and guidance of the Russian pharmaceutical and medical industries on to an innovative development course;
  • group 7: Programme management.

Specific actions are listed for each group, specifying the number of projects to be implemented, the maximum value per project, and the government participation share in the relevant activities.

For instance, in order to tap the scientific and technical potential of the pharmaceutical industry (group 1), 155 medications have been selected for production within the Russian Federation. The Federal Programme prioritises tenders for state contracts to develop production technology for this type of medication in the country.

Four actions are to be implemented within this group:

  • Developing technology for and launching production of synthetic essential medicines not manufactured by Russian producers, both covered and uncovered by foreign patents in the Russian Federation;
  • Developing technology for and launching production of biotechnological essential drugs not manufactured by Russian producers, both covered and uncovered by foreign patents in the Russian Federation.
     

For additional information, please contact:

Nina Belozertseva,
Head of Group, Healthcare and Pharmaceuticals
Goltsblat BLP,
T: +7 (495) 287 44 44,
E: info@gblplaw.com

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