Resolution of the Government of Russia dated April 30, 2021, No. 687 “On state support of organizations to compensate for part of the costs associated with the certification of products, including products of the pharmaceutical and medical industry, in foreign markets” (hereinafter – “Resolution No. 687”) sets goals, conditions and procedure the provision of subsidies from the federal budget to organizations to compensate for part of the costs associated with the certification of products, including products of the pharmaceutical and medical industry, in foreign markets, within the framework of the federal project “Industrial Export” of the national project “International Cooperation and Export”.
Subsidies will be provided within the limits of budgetary commitments brought to the attention of the Ministry of Industry and Trade of Russia for the following purposes:
- when certifying products in foreign markets – to reimburse part of the costs actually incurred by the organization not earlier than 12 months preceding the date of the announcement of the competition, and within no more than 12 months from the date of the announcement of the competition;
- when certifying medicinal products in foreign markets – to reimburse part of the costs actually incurred by the organization not earlier than 12 months preceding the date of the announcement of the competition, and within no more than 36 months from the date of the announcement of the competition.
The indicators required for the provision of a subsidy for the certification of a medicinal product in foreign markets are:
- the number of documents received by the organization confirming the successful completion of the phase of clinical trials required for registration of medicines in foreign markets (at least 1 unit for each phase of clinical trials) and (or) confirming the successful completion of the WHO prequalification of the drug (at least 1 unit );
- delivery of a drug to foreign markets for which the organization has received a subsidy for certification of a drug in foreign markets in an amount exceeding the amount of the received subsidy by at least 10 times within a period not exceeding 5 calendar years from the date of completion of clinical trials and registration of the medicinal product and (or) passing the WHO prequalification of the medicinal product (in this case, the volume of supply in the year following the year of completion of clinical trials and registration of the medicinal product and (or) passing the prequalification of the medicinal product by the World Health Organization must be at least 60% of the amount received subsidy).
If the limits of the allocated funds for subsidies have not been exhausted, then their redistribution is carried out to the pharmaceutical industry in the second place (after the mechanical engineering industry). Resolution No. 687 provides formulas for calculating the subsidy.
Subsidies are provided to organizations that, as of the date no earlier than 30 calendar days before the date of application, meet the following requirements:
- the organization does not receive funds from the federal budget for similar purposes within 12 months preceding the date of the announcement of the competition;
- the organization has no overdue debts to return subsidies and budget investments to the federal budget;
- the organization has no unfulfilled obligation to pay taxes, fees, insurance premiums, penalties, fines, and interest payable;
- the organization is not in the process of reorganization (except for reorganization in the form of affiliation), liquidation, bankruptcy procedure has not been introduced in relation to it, its activities have not been suspended;
- the organization is not a foreign legal entity, as well as a Russian legal entity, in the authorized (pooled) capital of which the share of participation of foreign legal entities registered in offshores in the aggregate exceeds 50%;
- the head and founders of the organization are not in the register of disqualified persons;
- the organization must be the developer and (or) manufacturer of the medicinal product and the owner of the rights to the medicinal product, or the owner of the right to use them on the basis of a license agreement or on any other legal basis.
Subsidies are provided on the basis of a competition organized by the Russian Export Center JSC. This organization acts as an agent of the Government on the issue of granting subsidies on the basis of an agency agreement on granting subsidies concluded between the Ministry of Industry and Trade, the Ministry of Economic Development, and the Center.
May 14, 2021
