In order to harmonize the rules for the import of drugs for medical use with the legislation of EAEU, the Government of the Russian Federation adopted Resolution No. 853 dated 1 June 2021, which established new rules for the import of drugs for medical use into the Russian Federation ("Resolution No. 853"). The Resolution No. 853 will enter into force on 1 September 2021, in connection with which the Resolution of the Government of the Russian Federation of 29 September 2010 No. 771 ("Resolution No. 771") will expire. Below is an overview of important changes introduced by Resolution No. 853.
1. A key change, in our opinion, is the introduction of the possibility of importing drugs for the provision of medical care to a limited contingent of patients with rare and/or especially severe pathologies in the presence of an import permit of the Ministry of Health of the Russian Federation, issued under a single form of import permit for the import of certain goods (provided for by the Decision of the EEC Board dated 16 May 2012 No. 45) (the "Import Permit"). Previously, Resolution No. 771 provided for the possibility of importing drugs only for the provision of medical care to a specific patient. Taking into account the deadlines provided for by Russian procurement legislation, as well as the possibility of unfair delaying of these deadlines (for example, by filing a complaint against a customer with the Federal Antimonopoly Service of Russia), deliveries for the provision of medical care to a specific patient, carried out under government contracts, could be delayed. At the same time, the life and health of the patient often depends on the speed of delivery of an unregistered drug. From 1 September 2021, medical organizations will have the opportunity to purchase the necessary drugs for a group of patients at once, which should significantly facilitate drug provision with rare drugs in case of urgent need for them
2. The second most important change, we consider the expansion of the grounds for the import of unregistered drugs – if earlier the only reason was the conclusion of the council of doctors, then from 1 September 2021, a copy of the protocol of the conclusion of the medical commission can be provided to the Ministry of Health of the Russian Federation for issuing the Import Permit.
3. The following is closely related to the second change, from 1 September 2021, the impossibility of obtaining several Import Permits will be legally fixed due to the prohibition of re-submission of the protocol of the medical commission or council of doctors to the Ministry of Health of the Russian Federation. This change will not affect drugs prescribed for life or for long-term therapy of the disease.
4. Also, the Government of the Russian Federation added the obligation to provide the Ministry of Health of the Russian Federation with a copy of the agreement (contract), as well as annexes and/or additions to such an agreement (contract) or a copy of another document confirming the intentions of the parties in order to obtain the Import Permit. On the one hand, such an amendment is aimed at solving an important problem that often arose in practice during the validity of Resolution No. 771, when it was possible to obtain Import Permits from the Ministry of Health of the Russian Federation to import an unregistered drug before determining the supplier through a competitive procurement procedure and, accordingly, before the conclusion of the state contract. So, earlier, the supplier that won the competitive procurement procedure and the legal entity – the holder of the Import Permits of the Ministry of Health of the Russian Federation – could not coincide, which, coupled with the lack of legal confirmation of the possibility of obtaining a "second" Import Permit, gave rise to a lot of practical difficulties.
5. Finally, the obligation of the Ministry of Health of the Russian Federation to keep a register of issued Import Permits in electronic form was introduced, as well as the obligation to send the issued Import Permits to the customs authorities on a weekly basis. In our opinion, these changes are aimed at conducting an effective fight against the supply of counterfeit drugs, and also once again emphasize the impossibility of supplying unregistered medicines to the territory of the Russian Federation by two or more suppliers on the basis of several Import Permits.
