Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
- Functioning of the EAEU common market for drugs and the EAEU common market for medical devices.
- The authorization of distance selling of OTC drugs subject to the following requirements:
- The following types of drugs are excluded: prescription drugs, narcotic and psychotropic drugs, alcohol-containing drugs with a volume fraction of ethyl alcohol of more than 25%;
- Distance selling can only be performed by pharmacy organizations that have both (1) license to carry out pharmaceutical activities and (2) special distance selling permit issued by RZN;
- Distance selling of drugs is to be compliant with the applicable regulations (including the rules for distance selling of drugs approved by Resolution of the Government of the Russian Federation dd 16.05.2020 No. 697; rules for the sale of goods under a retail sale agreement approved by the Resolution of the Government of the Russian Federation dd 31.12.2020 No. 2463).
- The Pharmaceutical Register of the EAPO is available on the official website of the EAPO. The Register contains information on Eurasian patents protecting active substances of drugs. The EAPO specifically indicates that the Pharmaceutical Register shall relate to the patents protecting pharmacologically active products (chemical compounds, including those described by the same structural formula, biotechnological products, compositions, combinations), production methods, and medicinal use of the products.
- The Government of the Russian Federation granted the first compulsory license “in the interests of public security”. In accordance with the Government Decree, Pharmasintez JSC, a Russian generic company, has been granted a 1-year compulsory license to use the inventions of the US companies Gilead Sciences Inc. and Gilead Pharmasset LLC protecting Remdesivir subject to a “fair compensation”.
2. When are they likely to come into force?
- Starting from 01.01.2021 drugs are to be registered under the EAEU Rules only due to the formation of the EAEU common market for drugs. As for the medical devices, their registration under the EAEU rules and procedures becomes obligatory starting from 01.01.2022.
- The distance selling of OTC drugs is allowed starting from 03.04.2020.
- The Pharmaceutical Register of the EAPO is available on the official website of the EAPO starting from 01.03.2021.
- The Decree of the Government of the Russian Federation dd 31.12.2020 No. 3718-r was published on 01.05.2021.
3. Alterations to admission to public procurement
Alterations to admission to public procurement of vital essential and necessary drugs, set forth by Government Decree dd 30.11.2015 No. 1289, are adopted by Government Decree dd 12.05.2018 No. 572. A public customer shall decline applications to supply vital and essential drugs originated from foreign countries, which are not the EAEU members if at least one application to supply vital essential and necessary drugs originated from the EAEU member state is filed. All manufacturing stages of such drug, including molecule synthesis for API, shall be operated within the territory of EAEU member states. Such API shall be included in marketing authorization for the drug. The amendments are effective starting from 01.01.2019.