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Development of Legal Regulation of Synthetic Biology: Integration and Legal Aspect

https://doi.org/10.17803/1729-5920.2025.219.2.102-111

Abstract

The paper is devoted to the study of the legal regulation of public relations in the field of synthetic biology. The purpose of the paper is to identify the key features of the concept of «synthetic biology»; to conduct a study of regulatory legal acts at the global level, the level of interstate integration associations, and the Russian Federation, which are devoted to regulation in the field of synthetic biology; to identify the main aspects and directions in which the concept of «synthetic biology» is used; to formulate proposals for the legal regulation of relevant relations at the at the level of the Russian Federation. The various definitions of the concept of «synthetic biology» in Russian and foreign doctrinal sources, as well as in international legal documents and documents of international organizations are analyzed. The analysis of the statutory regulation of public relations in the field of synthetic biology is carried out. The research utilizes dogmatic and formal logical methods, an axiological approach and a method of comparison. Based on the results of the analysis, the essential features of the concept of «synthetic biology» are identified, conclusions are drawn about the main aspects and directions in which this concept is used. Proposals have been formulated for the legal regulation of relevant relations at the level of the Russian Federation, according to which it is advisable to develop regulation of the use of synthetic biology technologies for the possible creation of pathogenic organisms and other threats in the field of biosafety, while regulating the use of synthetic biology technologies in other areas is impractical, since the relevant public relations fall under existing regulation in more general areas — regulation of scientific research and regulation in the field of biotechnology, bioeconomics, and genetic technologies.

About the Authors

E. K. Nechaeva
Kutafin Moscow State Law University (MSAL)
Russian Federation

Elena K. Nechaeva, Cand. Sci. (Law), Associate Professor, Department of Integration and European Law

Moscow



M. V. Nekoteneva
Kutafin Moscow State Law University (MSAL)
Russian Federation

Maria V. Nekoteneva, Cand. Sci. (Law), Associate Professor, Department of Integration and European Law

Moscow



A. V. Kubyshkin
Kutafin Moscow State Law University (MSAL)
Russian Federation

Aleksey V. Kubyshkin, Cand. Sci. (Law), Associate Professor, Department of Medical Law, Senior Researcher, Center for Legal Support of Bioeconomics and Genetic Technologies

Moscow



References

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Review

For citations:


Nechaeva E.K., Nekoteneva M.V., Kubyshkin A.V. Development of Legal Regulation of Synthetic Biology: Integration and Legal Aspect. Lex Russica. 2025;78(2):102–111. (In Russ.) https://doi.org/10.17803/1729-5920.2025.219.2.102-111

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ISSN 1729-5920 (Print)
ISSN 2686-7869 (Online)