On 16 October 2026, the Russian Government submitted to the State Duma bill No. 12837-9 (Bill) amending Federal Law No. 61-FZ dated 12 April 2010 "On Circulation of Medicines" (Law on Circulation of Medicines).
The Bill introduces a special circulation regime for individual gene therapy pharmaceuticals (IGTPs): a medical organisation will be able to manufacture such a pharmaceutical for a specific patient and use it on its own premises without registration, on the basis of an authorisation issued by the Russian Ministry of Health.
In international practice, this mechanism is known as the "hospital exemption". EAEU law allows it if it is provided for by national legislation (clause 5.1 of the Rules for Registration and Examination of Medicines for Human Use approved by EEC Council Decision No. 78 dated 3 November 2016 (EAEU Rules)).
In addition, the Law on Circulation of Medicines will introduce the concept of individual biotechnological pharmaceuticals (IBPs), whose circulation is currently governed by Russian Government Resolution No. 213 dated 24 February 2025 (Resolution No. 213). The Ethics Council will issue opinions on the ethical justification of their use.
Scope of the proposed changes
First of all, the Bill introduces definitions of IBPs and IGTPs (new clauses 7.3 and 7.4 of Art. 4 of the Law on Circulation of Medicines).
An IGTP is manufactured for a specific patient in the same clinic where it will be used. Somatic cell pharmaceuticals and tissue-engineered pharmaceuticals are excluded from this concept, but neither the Bill nor the current version of the Law on Circulation of Medicines defines these terms. At the same time, tissue-engineered pharmaceuticals are expressly classified as biological pharmaceuticals, alongside IBPs and IGTPs (amended clause 6.2 of Art. 4 of the Law on Circulation of Medicines).
IGTPs are exempt from registration (new clause 9 of Part 5 of Art. 13 of the Law on Circulation of Medicines). Under EAEU law, such an exemption is only possible if the pharmaceutical is prepared on a non-routine basis, i.e. not serially. The Bill does not reproduce this criterion (it is only mentioned in the explanatory note); however, the EAEU Rules are binding in Russia, so this criterion deserves particular attention. Authorisations to manufacture and use these pharmaceuticals will be issued by the Russian Ministry of Health (amended Art. 15 of the Law on Circulation of Medicines). The procedure for their circulation, the requirements for clinics, the procedure for issuing, confirming and revoking authorisations, and the procedure for maintaining the register of authorisations will be established by the Russian Government (new Art. 37.1 of the Law on Circulation of Medicines).
Finally, the Ethics Council will assess the ethical justification of manufacturing and using IGTPs, as well as of using IBPs (amended Part 1 of Art. 39.1 of the Law on Circulation of Medicines). Requirements for the Council's experts and the forms of its opinions will be established by the Russian Ministry of Health, and the forms of opinions issued in other examinations by the Russian Government. Roszdravnadzor (the Federal Service for Surveillance in Healthcare) will monitor the efficacy and safety of IGTPs.
An IBP is manufactured for a specific patient under an individual medical prescription in the same clinic where it will be used, and contains compounds synthesised based on genetic testing of material obtained from that patient (new clause 7.3 of Art. 4 of the Law on Circulation of Medicines).
In substance, this is not a new concept: the Bill moves into Art. 4 the description already contained in clause 8 of Part 5 of Art. 13 of the Law on Circulation of Medicines and replaces it there with a reference to the defined term. Unlike IGTPs, somatic cell pharmaceuticals and tissue-engineered pharmaceuticals are not excluded from the concept of IBPs.
If adopted, the Bill will enter into force on 1 March 2028. The Bill is accompanied by a list of acts that will need to be adopted or amended in connection with its adoption; drafts of these acts are to be prepared within three to six months after the Bill passes its first reading. In particular, the list of secondary legislation provides for a paid examination of IGTPs. It will be carried out by experts of a federal state budgetary institution subordinate to the Russian Ministry of Health, while the fee calculation methodology and the maximum fee will be approved by the Russian Ministry of Health (items 5 and 7 of the list).
Implications of the changes
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Medical organisations will be able to manufacture IGTPs, while pharmacies and other pharmaceutical organisations will not be granted this right (Part 3 of new Art. 37.1 of the Law on Circulation of Medicines). A pharmaceutical activity licence will probably also be required: the manufacture of such pharmaceuticals is expected to be set out as a separate type of work (service) constituting pharmaceutical activity (item 4 of the list of secondary legislation).
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Biotech companies, technology developers, consumables manufacturers and contract manufacturers will not be able to manufacture IGTPs themselves and will only be able to participate in the process as partners of clinics (for example, by supplying materials). The Bill does not regulate the forms of such cooperation.
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Serially manufactured pharmaceuticals remain subject to registration, since under EAEU law an exemption from registration is only allowed for non-routine preparation.
Conclusions
The Bill creates a legal basis for manufacturing IGTPs in clinics without registration and introduces into Art. 4 a definition of IBPs, whose circulation regime is already provided for by the Law on Circulation of Medicines, supplementing it with an ethical review. The key practical conditions (requirements for medical organisations, the procedure for examinations, and for issuing, confirming and revoking authorisations) will be determined in secondary legislation.
We recommend that market participants start monitoring the preparation of secondary legislation now, including the acts setting out the conditions for obtaining an authorisation, assess the readiness of their manufacturing capacities, prepare in advance for the ethical review, and take into account potential risks and additional costs.