Approaches to Legal Regulation of the Circulation of Human Genetic Information and Genetic Data: The Case of the People’s Republic of China

Objective. This article analyzes the approaches to the legal regulation of genetic information and human genetic data in the People’s Republic of China. The study is motivated by the forthcoming entry into force, on September 1, 2026, of amendments to Federal Law No. 86-FZ “On State Regulation in the Field of Genetic Engineering Activities”, which introduce the concept of human genetic data and establish restrictions on their cross-border transfer. This makes it necessary to examine foreign experience, particularly that of China, which has established a system of legal regulation in this area, in order to assess the applicability of its positive practices in the Russian Federation.

Methods. The research employed both general research (analysis, synthesis, generalization) and special legal methods, such as comparative legal, formal legal, and dogmatic analysis. A review of doctrinal sources by Russian and Chinese authors, as well as regulatory legal acts of the PRC, including the Biosafety Law, the Personal Information Protection Law, the Regulations on the Management of Human Genetic Resources, and other subordinate legislation was conducted. Additionally, empirical data on the dynamics of administrative licensing in 2021–2024 were examined.

Results. The Chinese model of genetic data regulation is based on the principle of state sovereignty, which permeates all levels of normative regulation. The legislation employs a dual structure of “human genetic resource materials” and “human genetic resource information,” each of which has its own legal regime. Genetic data simultaneously fall under the scope of biosafety legislation, personal data protection legislation, and medical big data legislation, thus creating a multi-layered system of requirements. The circulation of resources is carried out predominantly under a permissive (authorization) procedure, while cross-border transfer and access by foreign entities are subject to the strictest control. The liability system includes administrative fines, criminal prosecution, and disqualification. At the same time, the subordinate regulations adopted in 2023–2025 reflect a trend towards rationalization of regulation (narrowing the scope of licensing, simplifying procedures for clinical trials).

Conclusion. China’s experience may be useful for the Russian Federation in developing a comprehensive legislation framework on genetic technologies. The need to adopt a basic federal law that would combine norms on the protection of indi-
vidual rights and ensuring national security, establish clear criteria for the cross-border transfer of genetic data, and provide effective mechanisms for control and liability is argued.

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