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.

Lidings is pleased to invite you and your colleagues to a seminar on launching new drugs in the Russian market.

Regulatory incentives and objective economic realities are driving pharmaceutical companies to seek opportunities for launching new drugs. Such projects are now being conceived and implemented not only by innovative companies but also by players who have traditionally specialized in generics and biosimilars.

During our seminar, we will share our experience and propose effective, cost-efficient legal solutions to help businesses safely and promptly execute new launches at any stage.

April 10^th, 2025 annual conference Pharmaceuticals – 2025: Legal Issues will take place in Moscow organized by Pravo.ru. Lidings lawyers take an active part in the event’s program.

As a strategic partner of the conference, we aimed to make the program rich and actual. Together with pharmaceutical industry experts and lawyers, we will discuss how the market has changed in 2024 and what awaits us in 2025.

Corruption remains one of the key threats to sustainable business development. Corruption scandals demonstrate the disastrous consequences of corruption revelations for companies: multimillion dollar fines, criminal prosecutions of executives, reputational damage and loss of investor confidence.

We are pleased to announce the appointment of two new partners and counsel!

We are delighted to announce that Lidings has updated The Pharma Legal Handbook: Russia - practical directory focused on the key aspects of legislative regulation of pharmaceutical industry in Russia.

On April 11, 2024, in Moscow, the annual Pravo.ru conference "Pharmaceuticals – 2024: Legal Issues" will take place. Lidings lawyers traditionally take an active part in the event’s program.

As a strategic partner of the conference, we have endeavored to make the program as comprehensive and useful as possible. Together with experts from the pharmaceutical industry and legal experts, we will discuss current issues in industry regulation, legislative changes, market access, government procurement, and distribution. We will also touch upon marketing and promotion issues, as well as discuss strategies for protecting intellectual property.