Russians can get the opportunity to be vaccinated with a foreign vaccine, even if its manufacturer does not register the drug in the Russian Federation. The Ministry of Health proposes to allow the import of vaccines and medicines not registered in Russia for clinics participating in the Moscow International Medical Cluster (MMMK). MMMK has been striving for the actual granting of preferences for several years.
In the future, MMMK will be able to import medicines into the Russian Federation that are not registered in the country – and, in particular, vaccines. The Ministry of Health has developed amendments to the legislation, thanks to which Roszdravnadzor will have the powers necessary for this process, they are published on regulation.gov.ru.
As a reminder, in 2015, the Moscow government created a cluster on the territory of Skolkovo for the development of a medical business with a special legal regime. On its territory, permits for medical activities, medicines, medical devices and medical technologies issued in the OECD states, along with Russian ones, are recognized (for more details, see Kommersant dated June 2, 2017). Now on the territory of the cluster there are two buildings of the Israeli clinic “Hadassah”, in the future, patients will begin to receive a French rehabilitation center and a division of the University Hospital of Strasbourg. Despite this, some of the legal issues related to the operation of the cluster remained unresolved all these years – the most important of them is the issue of importing drugs that have not passed Russian registration into the Russian Federation. The city authorities have repeatedly tried to resolve this problem and provide the cluster members with the promised preferences – both with the help of specialized federal agencies and by addressing directly to then Prime Minister Dmitry Medvedev, back in 2019 (for more details, see Kommersant dated January 31, 2019) … The problem of importing drugs continued to be discussed in the government in 2020, and only in August 2021, Deputy Prime Minister Tatyana Golikova instructed to finalize the package of amendments proposed by the Ministry of Health.
The current version of this document assumes amending two federal laws – “On the Circulation of Medicines” and “On the International Medical Cluster and Amendments to Certain Legislative Acts of the Russian Federation.” They provide for the government to issue a separate by-law governing the procedure for issuing permits for the import of unregistered drugs by Roszdravnadzor. Such an import procedure is provided for by one of the provisions of the decision of the Board of the Eurasian Economic Commission “On measures of non-tariff regulation”, however, it could not be implemented without a national normative act of the Russian Federation in this regard.
In addition to establishing the need to issue a document, the amendment package also introduces a number of new obligations for the MMMK fund and its investors related to the circulation of unregistered drugs in the cluster. Participating clinics will have to notify the foundation of all side and undesirable effects from taking foreign drugs in patients, and the foundation, in turn, will be obliged to keep records of these data. The fund will also be able to check the quality of imported drugs in the laboratories of the Russian Federation or the OECD.
Although the ability to import unregistered drugs into the Russian Federation is important for the further development of the cluster, it is unlikely that we will talk about large quantities of drugs on a national scale. At the same time, in the future, participating clinics will be able to distribute foreign vaccines against coronavirus in the Russian Federation – and the demand for them may turn out to be significant, especially in case of further difficulties with the recognition of the Sputnik V vaccine abroad. Earlier, the management of the Hadassah Moscow clinic announced plans to agree on the supply of Pfizer / BioNTech and Moderna vaccines to the Russian Federation. However, it is unclear when foreign manufacturers of vaccines will be interested in such supplies and retail sales of their product in Russia. The Ministry of Health and Roszdravnadzor did not answer the question of Kommersant about the prospects for importing foreign vaccines into the Russian Federation. The press service of MMMK said that they would be ready to comment on the amendments proposed by the Ministry of Health only in their final version.