Conceptual principles and patterns of legal regulation of the processes of storage, access and data protection of genome sequencing in foreign countries as the basis for the modernization of Russian legislation.

Abstract

The relevance of the study of the general principles and patterns of legal regulation of access storage processes and data protection of genome sequencing in foreign countries is determined by the need to develop a general concept of legal regulation of this type of activity in Russia. The purpose of this study is to develop the system-forming principles and patterns of access storage and data protection of genome sequencing in Russia. To achieve this goal, tasks were set and solved to identify and study the general principles and patterns of legal regulation of access storage processes and data protection of genome sequencing in foreign countries. The international documents regulating the features of regulation of access storage processes and data protection of genome-wide sequencing, the doctrinal sources of Great Britain, the USA, France, Israel, and Japan are studied. Methods used: general philosophical, general scientific, private scientific, special (structural-legal, comparative-legal, formal-legal). The general principles for the formation of the concept of legal regulation of genome sequencing in Russia are proposed. It was revealed that the creation of a universal regulatory regulator aimed at protecting the subject of personal data in view of the prevalence of public interests over private ones and the constant expansion of the scope of application of genetic data obtained as a result of genome-wide sequencing is the main problem in developing a legal regulation mechanism in the studied area. For the first time, the authors determine the basic principles for developing the concept of genome-wide sequencing in Russia, including: recognition of human rights and human dignity as the highest value, the necessity of researchers' responsibility for the well-being of participants in view of the obtained research results, the mandatory informed consent of which should be voluntary, permanent, their right to get acquainted with the results obtained if it concerns their health, access to such information, ensuring the right to non-knowledge of research results and others.