Major pharmaceutical manufacturers have expressed their opposition to the creation of the List of Strategically Important Drugs, arguing that it duplicates the existing list of vital and essential drugs (VED). A number of companies have criticized the selection criteria proposed by the Ministry of Industry and Trade and the Ministry of Health for including medicines in the strategic drugs list, according to market participants cited by Kommersant. Meanwhile, the State Duma has already considered the relevant bill in its first reading.
Manufacturers assert that the new document not only replicates the VED list but will also be significantly shorter, potentially leading to a reduction in the number of entities receiving production preferences. In addition, they object to the provision that the entire cycle of drug development must take place in Russia and that the market share of the drug must not exceed 50%, warning that this could reduce interest in the development and production of modern drugs.
For example, Geropharm specifically objected to the criterion that a drug must have been supplied to public institutions for the last three years, while its market share must not exceed 50% in physical units. The Ministry of Industry and Trade hopes this criterion will prevent monopolies, but Geropharm argues it may harm, for example, the insulin market, where the company holds a 30% share. According to Geropharm’s General Director Marina Rykova, this measure could diminish manufacturers’ interest in developing modern medicines.
The requirement of a market share of less than 50% has also raised concerns within the Association of Pharmaceutical Manufacturers of the EAEU. Aleksandr Semenov, head of Aktivny Komponent, noted that this point has drawn criticism from companies that invested in establishing full-cycle production.
«It essentially negates the commitment made by the state to protect producers’ investments under the Pharma 2030 program», — Semenov explained.
The government submitted a bill to the State Duma in January 2025 aimed at officially establishing the category of strategic drugs in Russia. The document proposes adjustments to the current law on the circulation of medicines. Notably, it is suggested that drugs crucial to public health, particularly for the most common diseases in Russia, be designated in this special category.
A key condition for the drug’s inclusion will be its production within the Russian Federation. Medicines from this list are expected to gain advantages in public procurement under the «second one out» rule, as, according to the text of the new document, if drugs that are fully manufactured in Russia participate in the competitive selection procedure, the remaining applications are to be rejected.
The Ministry of Health and the Ministry of Industry and Trade maintain that the new list is essential «to ensure drug independence and national security». The amendments have already passed their first reading in the State Duma on February 25 and are set to come into effect on September 1 of this year.