Press Center: Legal updates

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.

From 1 January 2027, a Patent Prosecution Highway (PPH) programme for patent applications for inventions filed with either of the two authorities will come into force in Russia and Belarus. It will apply, inter alia, to applications that have entered the national phase under the Patent Cooperation Treaty (PCT).

On September 8, 2026, the Ministry of Health and Family Welfare of India published a draft amendment to the Drugs Rules from 1945, according to which a pharmacy must dispense any prescription drugs under video surveillance that records the dispensing, and keep the recordings for at least three months. For companies operating in both markets, it is important to take into account the difference in approaches. We cover this in more detail in our legal alert.

On 1 July 2026, amendments to Resolution of the Government of the Russian Federation No. 719 of 17 July 2015 “On the Certification of the Manufacture of Russian Industrial Products” (hereinafter “Resolution No. 719”) came into force.

As part of the implementation of the Strategy for the Development of the Pharmaceutical Industry through 2030, approved by Decree of the Government of the Russian Federation No. 1495-r of 7 June 2023 (“Pharma Strategy 2030”), and discussions at the “Healthy Society” forum organized by the Roscongress Foundation with the support of the Ministry of Health (16–17 March 2026, Moscow) (“Forum”), key areas of state support for domestic drug developers and manufacturers were identified, including subsidies for clinical trials .

In addition to existing support programs, subsidies for clinical trials at all stages will help overcome the financing barrier for high-risk phases of medicines clinical trials and accelerate the market launch of medicines. The combination of current and planned measures will create the legal and economic foundation for strengthening the production and technological capacity of the domestic pharmaceutical industry and increasing its presence in international markets.

Below, we will examine planned initiatives and support measures for pharmaceutical manufacturers that have already been implemented.

The past days have been marked by landmark rulings from the Russian Supreme and Constitutional Courts, decisions that will influence future case law and the pharmaceutical market as a whole.

On 26 January 2026, a draft Resolution of the Government of the Russian Federation was published for public discussion. This resolution approves the rules for marketplace operators to verify information posted in product listings, as well as the procedure for admitting a product listing to be placed on a marketplace ("Rules").

In recent years, artificial intelligence (AI) has evolved from an experimental technology into one of the key drivers of transformation in the pharmaceutical industry and the healthcare system as a whole. Machine learning and big data analysis algorithms are used at all stages of the drug life cycle—from molecular target discovery and molecule design to clinical trials, pharmacovigilance, and personalized therapy. At the same time, AI is increasingly being used directly in medical practice: in diagnosis, disease progression prediction, clinical decision support, and robotic surgery.

Such widespread implementation of AI is accompanied by significant legal, ethical, and regulatory challenges. These include the opacity of algorithms ("black box"), the risk of systematic errors and data bias, issues of liability allocation between the physician, the medical organization, and the developer, as well as the protection of patients' personal medical data. This review combines an analysis of AI regulation in pharmaceuticals and medicine in Russia, the European Union, and the United States with practical cases of AI use and court practice, forming a comprehensive picture of the current state and trends in development.