How will the issue of subsidies to state institutions for the development of medical devices affect vendors

The Ministry of industry and trade of the Russian Federation has developed changes to the program “Pharma-2020”, allowing to provide “grants in the form of subsidies” for the development of medicines and medical devices to budget scientific institutions.

Currently, pharmaceutical companies and medical device vendors can apply for subsidies. The purpose of these amendments is to support the development of medical institutions that are in the first and second phase of clinical research. It is assumed that scientific centers will be able to be involved “regardless of their departmental subordination”.

Since January 1, 2020, the rules for granting subsidies to producers under the “Pharma-2020” program have changed. Now they are issued for projects to develop modern technologies, organize their production and launch medicines and medical products on the market.

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Pharmaceutical companies and manufacturers of medical devices will be able to compensate for no more than 70% of the costs of labor, material expenses, overhead (up to 60%), and services of Russian and foreign partners for conducting clinical trials (up to 80%). Subsidies will be provided on a competitive basis.

The current state program allocates 11 billion rubles for implementation in 2020. In addition, the Agency together with market participants identified a list of substances that are not currently produced in the Russian Federation, but are needed for the production of vital drugs. They should be import-substituted, taking into account the capabilities of Russian companies.