A list of requirements has been developed for the sole suppliers of medicines for the purpose of their procurement within the framework of Federal Law No. 44
The draft of the relevant decree of the Government of the Russian Federation in order to fulfill the requirement provided for in subparagraph "l" of paragraph 4 of the Procedure for preparing draft legal acts and instructions of the President of the Russian Federation, draft legal acts of the Government of the Russian Federation approved by Decree of the President of the Russian Federation dated 14.09.2020 N 558, was prepared by specialists of the Ministry of Health of the Russian Federation. According to the document, it is planned to approve:
- a list of criteria applied to sole suppliers when purchasing medicines for medical use;
- a list of criteria for the selection of medicines for medical use.
The criteria imposed on the sole suppliers included requirements for the organizational and legal form of the counterparty (the supplier must be a legal entity - the manufacturer of the medicinal product), localization of production of the medicinal product (on the territory of a member state of the Eurasian Economic Union), the origin of the supplier's capital (must not be under the control of a foreign investor). The sole supplier must also have experience in executing a contract or an agreement concluded in accordance with Federal Law No. 223. The specified contract must be executed within 3 years preceding the date of sending an application to the Government of the Russian Federation to determine the sole supplier. In addition, the supplier must have the exclusive right to an invention related to the corresponding chemical compound, with a validity period of at least the period for which the sole supplier is determined.
The list of criteria for the selection of medicines includes the following requirements:
- all stages of drug production are carried out on the territory of the member states of the Eurasian Economic Union.
- the active substance of the drug is protected by a patent on the territory of the Russian Federation, available from a supplier with a validity period of at least the period for which the sole supplier is determined.
It is assumed that the relevant decree of the Government of the Russian Federation will come into force seven days after the date of its official publication and will be valid for two years.
Document: Draft Resolution of the Government of the Russian Federation "On approval of the list of criteria for sole suppliers in the Procurement of medicines for medical use and the list of criteria for the selection of medicines for medical use" (prepared by the Ministry of Health of the Russian Federation on 03/29/2023)