Press Center: Legal updates

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.

On 27 November 2025, Decree of the Government of the Russian Federation No. 1894 “On the Approval of the Rules for Coordinating with the Federal Security Service of the Russian Federation the Participation of Foreign...” (hereinafter referred to as the “FSB Coordination Rules”) was published. It stipulates that civil-purpose scientific research, experimental design, and technological work (hereinafter referred to as “Work”) involving foreign citizens and foreign organizations, as well as Russian organizations whose participants (founders) include foreign citizens and/or foreign organizations, must be coordinated with the FSB in the fields of scientific and/or scientific-technical activities and experimental development. This coordination is carried out by submitting information to the Russian Ministry of Science and Higher Education through the Unified State Information System for Accounting of Research, Development, and Technological Work (EGISU NIOKTR).

On 24 November 2025, the Delhi High Court issued a judgment in a major patent dispute Medilabo Rfp Inc. v. The Controller of Patents C.A. (Comm.Ipd-Pat) 16/2024, concerning the patent eligibility of a drug for neurodegenerative diseases.

In June 2024, the pharmaceutical industry faced a new practice by the Federal Antimonopoly Service (FAS), which began to consistently recognize the introduction of generic drugs onto the market as unfair competition.

On 17 November 2025, the Russian Ministry of Health published the Order No. 669n (hereinafter - the "Order") approving the procedure for healthcare professionals to prescribe dietary supplements when providing medical care to citizens.