The Russian Government Will Provide a Subsidy for Development of National Generics During the Patent Period of Original Drugs

27 April 2023
Anna Kuminova
Daniil Eremin
Legal Trainee

Decree No. 529 of the Russian Government dated April 3, 2023 entered into force on April 18, 2023. It amends the Rules for Granting Subsidies for Research and Development in the Realization of Innovative Projects, approved by Decree No. 1649 of the Russian Government dated December 12, 2019.

As one of the activities covered by the subsidy, Decree No. 529 specifies Research and Development of a Russian medical drug, conduct of clinical trials and carrying out other work and activities required for drug registration.

Subsidies of up to 100 million rubles for biologics and up to 50 million rubles for other drugs may be granted for production of drugs aimed at replacing drugs protected in Russia by patents of right holders from unfriendly states. The list of replacement drugs shall be specified by the Russian Ministry of Industry and Trade.

Moreover, in case the subsidy is received, and the developed drug is put into circulation, the recipient of the subsidy shall return 30% of the subsidy received (such an obligation is included in the agreement on receiving the subsidy).

Competition for obtaining subsidies is held by the Ministry of Industry and Trade no later than April 1st of the current financial year, within the limits of budget appropriations. An additional competition may be held within the unused funds. Russian companies complying with the established requirements may take part in the competition.

It should be noted that the information about participants of the competition, results of review of applications and results of the competition is regarded as classified information.

Decree № 529 also establishes the ultimate term of the project. The term for a project in which a biological drug is developed is 4 years, for another drug - 2 years. If the deadline is missed, the company will be fined.

In addition, kindly note that the production and put into circulation of generics developed within the project will be possible only after expiring of the patents. If patents are violated, a fine will be imposed on companies included in the registration certificate as the manufacturing site of the drug.

As the Russian Prime Minister notes, "such a decision will help rapidly set up our own production after the expiration of the foreign patent. This is crucial in conditions of external pressure that we see today".