ANNOUNCEMENT 01 Oct 2015
Decree No. 1045 of 1 October 2015 constitutes a new state act for the promotion of the local production of medicines.
2016 Update: Decree 861, 30 August 2016. http://static.government.ru/media/files/vO9D9XYEW1T2WyxmSQWl4gwHgDmby0Td.pdf
NUMBER OF INTERVENTIONS
Government of the Russian Federation
О государственной поддержке развития производства лекарственных средств и медицинских изделий
Постановление от 1 октября 2015 года №1045 в действующей редакции
Decree No. 1045 regulates the procedure for allocation of subsidies from the federal budget of the Russian Federation to Russian organisation. Their purpose is to compensate part of the expenses for clinical trials of medical products as part of the framework of the state programme for the development of the pharmaceutical and medical production in the period 2013--2020.
The state subsidies under Decree No. 1045 are provided for the development of the innovative potential of the pharmaceutical industry in accordance with the priority directions of scientific research. The priority medicines that are subsidised under Decree No. 1045 are indicated in its article 3. They are for the treatment of cancer, autoimmune and neurodegenerative diseases, endocrine diseases, diabetes, cardiovascular diseases, infectious diseases, tuberculosis, HIV-infection and viral hepatitis.
The maximum subsidy may not exceed 200 million Russian Roubles (3.04 million USD) for the whole term of validity of a contract. An eligible beneficiary may receive a subsidy not more often than twice per year. Costs incurred not earlier than 1 January 2015 in the amount of not more than 50% of the cost for acquisition of raw materials, consumables, services of external organisations for research and transportation of clinical samples, etc. are eligible.
The provided official note that accompanies Decree No. 1045 states that it (together with other indicated as related state acts by the GTA) "will contribute to import substitution in the pharmaceutical and medical industries, will enhance the investment activity of the Russian organisations with the goal to create and modernise the production, will increase the share of domestically produced medicines and medical products, will create high-performance workplaces."
On 30 August 2016, with Decree 861, the Government expanded the list of medicaments eligible for subsidisation, prolonged production and circulation deadline from 3 to 4 years and the maximum amount from RUR 200m to 400m (USD 6m). Wages of highly qualified personnel can also now be included in the subsidy request. The 2016 budget for the subsidy program is RUR 2,6B (USD 39,8M), the 2018 budget is RUR 918M (USD 16M).
The GTA includes state guarantees and other financial incentives that are likely to affect the restructuring and performance of firms facing international competition, whether from imports, in export markets and from foreign subsidiaries.