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.

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.

Federal Law No. 301-FZ “On Amendments to the Federal Law “On Protection of Competition”” (the “Law”) was signed by the President of the Russian Federation on 10 July 2023 and will enter into force on 1 September 2023. As follows from the explanation note, the Law provides a set of norms aimed to improve antitrust regulation in the digital economic development. The main amendments of the fifth antitrust package you can find in this legal update.

From 1 September 2022 a new regulation in the field of advertising has been enacted. Federal Law No. 38-FZ “On Advertising” was supplemented by provisions, according to which Internet advertising should be marked and is subject to registration in the Unified Register of Internet Advertising, the operator of which is Roskomnadzor.

According to the draft Federal Law “On Amendments to the Federal Law “On the Basics of State Regulation of Trade Activities in the Russian Federation" (the “Draft”), Russian retail chains must ensure the availability of a certain number of non-food products of Russian origin.

The new General license No 6C published by OFAC on January 1, 2023, establishes exceptions from US sanctions related to the spheres of agricultural commodities, medicine, medical devices, replacement parts and components for medical devices, or software updates for medical devices.

The Government of the Russian Federation may introduce special economic measures to ensure that counter-terrorism and other operations are carried out outside the territory of the Russian Federation :

Federal Law No. 347-FZ dated July 2, 2021, has created new obligations for advertisers, advertising distributors, and operators of advertising systems.

The new version of the Draft Law “On external administration to manage a company” (Draft Law) dated 12th April 2022 was introduced to the State Duma. 

The Draft Law was significantly revised, especially in part of the scope of application and the procedure of the external administration implementation.