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.

Currently, the efforts of state authorities in the fields of pharmaceuticals and healthcare are also aimed at implementing the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the Period up to 2030 (hereinafter referred to as the “Pharma 2030 Strategy”). One of the goals of the Pharma 2030 Strategy is to increase the share of domestically produced medicinal products in the total consumption volume from 61.8% to 66.6% by 2030. In this regard, measures to support Russian medicinal products manufacturers continue to be implemented.

On 1 September 2025, a draft resolution of the Government of the Russian Federation “On approving the procedure and criteria for compiling a list of strategically significant medicines” (“Draft Resolution”) was submitted for public discussion.

On July 11, 2025, a joint letter from the FAS and the Ministry of Health № ТН/61566/25, № 25-7/И/2-13136 dated July 2, 2025 (hereinafter referred to as the "Joint Letter") was published, clarifying the procedure for determining the initial (maximum) contract price (IMCP) in the procurement of pharmaceuticals.

Overview of changes in the sphere of information security and personal data (hereinafter referred to as the “PD”) that will affect the activities of organizations involved in the wholesale and retail trade of medicinal products. We remind you that starting from September 1, 2025, consents for PD processing must be stand-alone documents, separate from website Privacy Policies