Strategically important medicines in the Russian Federation

The Ministry of Health of the Russian Federation plans to amend Federal Law No. 61 to consolidate the concept of "list of strategically important medicines – LSIM" in the regulatory framework. The draft federal law also states that the government will approve the list of LSIM, as well as the procedure and criteria for its formation.

According to the text of the draft law: "the list of strategically important medicines is a list of medicines for medical use that meet the priority needs of healthcare for the prevention and treatment of diseases, formed from among the medicines included in the list of vital and essential medicines, the production of which must be ensured in the Russian Federation at all stages of the technological process"

The purposes of forming such a list according to the text of the explanatory note are: 

1. ensuring the production of high-quality, effective and safe medicines for medical use in the Russian Federation, which are competitive in the domestic and foreign markets. 

2. meeting the needs of the Russian healthcare system and realizing the export potential of the pharmaceutical industry.

3. prevention of drug defects or the risk of its occurrence due to the introduction of restrictive measures against Russia.

It is planned that manufacturers of medicinal products included in the list of LSIM will be provided with support measures, the forms and list of which will be determined by the Ministry of Industry and Trade.

These amendments to Federal Law No. 61 have been prepared as part of the implementation of the Pharmaceutical Industry's Development Strategy for the period up to 2030, as well as the first item of the action plan for the implementation of the strategy.

Currently, the list of LSIM has been approved by Government Decree No. 1141-r and includes 215 INN.