Legal regulation of the human genome editing technologies application: international standards and the national practices

The legal regulation of human genome editing for medical and scientific purposes makes possible to apply it in scientific and practical fields. Taking into account that the Russian Federation is not a participant in the formation of the most relevant international documents, there is a necessity to create a national model of the use of biomedical technologies legal regulation considering international standards and approaches. Objective. To study the specifics of the legal regulation in the field of biomedical application of human genome editing technologies at the international and national levels, to determine deficiency or redundancy of this process and to submit proposals for enhancing their effectiveness for minimizing or eliminating the risks of negative consequences. Materials and methods. A review and analysis of international and national regulatory legal acts in the field of human genome editing technologies application were carried out. Comparative legal and axiological methods were used. Results. A pressing need to establish detailed regulatory control over innovative biomedical research remains in the Russian Federation. The Chinese model of legal regulation for genome editing is characterized by a systematic approach, clear structure and is based on four key groups of regulatory acts covering biosecurity, the management of genetic resources, research ethics and related aspects. Conclusion. In the legal regulation of human genome editing technologies, it is essential to adhere to constitutional principles that reflect national interests and respect for the individual, protect the rights of citizens, and prevent any forms of discrimination based on an individual’s genetic characteristics. Key objectives include setting priorities in this field, raising public awareness about the possibilities of genetic engineering and ensuring equal access to its application in medicine.