On July 11, 2025, a joint letter from the FAS and the Ministry of Health № ТН/61566/25, № 25-7/И/2-13136 dated July 2, 20251 (hereinafter referred to as the "Joint Letter") was published, clarifying the procedure for determining the initial (maximum) contract price (IMCP) in the procurement of pharmaceuticals.
In the field of public procurement of pharmaceuticals, the issue of compliance by procurement participants with the exclusive rights of third parties has been increasingly raised, often leading to disputes. A notable example is a recent case reviewed by the FAS procurement control commission. The case was initiated following a complaint from a distributor of a major pharmaceutical company, which challenged a pharmaceuticals procurement, alleging infringement of third-party exclusive rights. However, the FAS dismissed the complaint as unfounded, as the complainant failed to provide sufficient evidence of such infringement. In this regard, government authorities are interested in establishing a unified approach to verifying compliance with exclusive rights in public procurement.
Thus, in the Joint Letter, the FAS and the Ministry of Health clarified the procedure for determining the IMCP in pharmaceuticals procurements and emphasized the need to verify the exclusive rights of procurement participants, as well as the methods for accounting for such rights when calculating the IMCP.
The IMCP represents the maximum price a contracting authority is willing to pay for goods, works, or services in competitive procurement. It is calculated using the comparable market prices method, which involves analyzing prices for identical goods, works, or services planned for procurement.
Previously, when calculating the IMCP, contracting authorities considered the prices of all pharmaceuticals listed in the State Register of Maximum Selling Prices, even if some could not be legally marketed due to existing patent protection for original pharmaceuticals.
Under the new clarifications, contracting authorities are advised to verify the legality of the use of exclusive rights when determining the IMCP. Such verification should be conducted by searching for legally effective rulings of arbitration courts and FAS concerning the unlawful introduction of generic pharmaceuticals into commercial circulation while the original pharmaceutical’s patent remains in force. If the search reveals that a generic pharmaceutical has been found to infringe exclusive rights, its price must not be included in the IMCP calculation.
These clarifications aim to prevent artificial understatement of the IMCP and protect the interests of original pharmaceutical rights holders, as generic pharmaceuticals are often significantly cheaper than original ones. Consequently, these clarifications may affect not only the determination of the IMCP but also the eligibility of generic pharmaceuticals that violate third-party exclusive rights to participate in public procurement. The application of the letter’s provisions will help safeguard the interests of rights holders and enhance the justification for setting the initial contract price.
1https://fas.gov.ru/documents/690025