Ensuring Genomic Safety: Assessment of the Peculiarities of National Regulation through the Prism of Biological Safety

The paper analyzes the basics of ensuring genomic security at the national and supranational levels. Biosafety is one of the main aspects of global security, covering such areas as health, agriculture, science and technology, education and defense. Threats to biosafety are characterized by secrecy, sudden spread, unpredictable consequences, and significant damage. Combating such threats is an integral part of national security. Today, genomic safety should be considered as part of biosafety. The paper attempts to identify the features and main directions of the development of regulation of the safety of genomic research in the national legislation of some states (including the Russian Federation) in connection with the trends of regulation of biological safety at the universal and regional levels. The authors analyze the legislation of foreign countries in the field under study, highlight the positive properties of such legislation. Various schemes for regulating the safety of genetic research are being identified. It is possible to identify some states that use «strict» regulatory schemes, which involve the legislative consolidation of prohibitions of some or significant restrictions on the implementation of other types of genetic research. In a number of states, on the contrary, self-regulation or minimal regulation by the State of ensuring the safety of genetic research is being consolidated. Special attention is given to an analytical review of international treaties affecting various aspects of biological, including genomic, safety. In conclusion, the authors’ recommendations on improving the regulatory regulation of the Russian Federation in the field of biosafety, including the framework federal legislation in this area, are presented. The paper may be of interest to various specialists whose activities are related to genomic research (biomedicine, bioinformatics, human reproduction, etc.).

1. Dongsheng Zhou, Hongbin Song, Jianwei Wang, Zhenjun Li, Shuai Xu. Biosafety and biosecurity. Journal of Biosafety and Biosecurity. 2019;1:15-18.

2. Kalinichenko PA, Nechaeva EK. Legal regulation of research and development in the field of the human genome and their practical use: Russian experience based on international standards. Mezhdunarodnyy pravovoy kurer. 2019;2(19):25-28. (In Russ.).

3. Kubyshkin AV, Kosilkin SV, Astrelina TA. International legal regulation of genetic research, biobanking, bioinformatics and human reproduction: Analysis of the main international legal acts. Mezhdunarodnyy pravovoy kurer. 2019;2(19):29-34. (In Russ.).

4. Mokhov AA, Sushkova OV (eds). Genetic technologies and law in the period of formation of bioeconomics. A monograph. Moscow: Prospekt Publ.; 2020. (In Russ.).

5. Mokhov AA. The concept of four «bio» in law and legislation. Aktual’nye problemy rossijskogo prava. 2020;8(117):146-154. (In Russ.).