Biopolitics and the formation of a legal mechanism for regulating relations in the field of gene therapy and human genome editing procedures: socio-ethical and theoretical legal problems

The article examines the socio-ethical and legal vectors of the formation of legal regulation tools arising in connection with the use of gene therapy drugs and the procedure of experimental editing of the human genome. One of the most important factors in the development of  the legal mechanism of regulation in the field of genetic technologies is associated not only with  the need to protect the constitutional human rights to life, health, safety, privacy, personal and  family secrets, but also with the presence of potential threats to society as a whole. Much attention is paid in the article to the relationship between the content of socio-ethical problems and the structure of the legal paradigm in the field of biopolitics, which is gradually forming in the Russian  Federation, the USA and European countries. The explication of such a relationship, the definition of vectors for the development of this paradigm requires consideration of both the method of  genetic modification of DNA and the means of gene therapy, as well as social and ethical problems arising after the use of gene technologies. The effect of CRISPR technology is based on the use of genetic mechanisms, its application can lead to irreversible consequences, the extinction of species of flora and fauna. The peculiarities of the formation of a legal mechanism for regulating relations in the field of genetic technologies are due to the fact that these problems are not realized.  The formation of legal relations arises from already established social relations. Due to the specifics of the object of regulation of legal relations, a procedure of expert and public discussion is necessary. However, it is difficult in the context of the existing economic model, the activities of commercial organizations and lobbying for their interests. 

1. Genetic engineering. Compiled by Prof. M.R. Sharipova [Electronic resource]. Available from: https://kpfu.ru/staff_files/F_390463524/SharipovaMR_Gennaya_inzheneriya_Lekciya10.pdf (In Russ.).

2. Lemke T. From State Biology to the Government of Life: Historical Dimensions and Contemporary Perspectives of ‘Biopolitics. Journal of Classical Sociology. 2010;(10):421–438.

3. Masters R. D. The Nature of Politics. New Haven, CT: Yale University Press, 1989. 298 p.

4. Liesen L. T., Walsh M. B. The Evolution of the Meaning of “Biopolitics”. APSA 2011 Annual Meeting Paper, Aug 2011.

5. Wijesinghe P. Human Rights Violations by Multinational Corporations: Nestle as the Culprit. SSRN Electronic Journal. 2018, January. 11 p.

6. Szybalska E. H., Szybalski W. Genetics of human cess line. IV. DNA-mediated heritable transformation of a biochemical trait // Proc. Natl. Acad. Sci USA. 1962. Vol. 48: P. 2026—2034

7. Goswami R., Subramanian G., Silayeva L. et al. Gene therapy leaves a vicious cycle. Front. Oncol. 2019;(9).

8. Bezborodova O. A., Nemtsova E. R., Yakubovskaya R. I. Gene therapy – a new direction in medicine. Oncology. 2016;(2):64–72. (In Russ.).

9. Jacobsen R., Shirshova L. Genetic drive: a technology that its creator is afraid of [Electronic resource]. The KNIFE electronic magazine. Available from: https://knife.media/gene-drive/?ysclid=m2ks17qav8674865574. (In Russ.).

10. Kosilkin S.V. Principles of international legal regulation of genetic research and legislation of the Russian Federation. Lex Genetica, 2023;(2):34-52. (In Russ.).