Legislation of the Russian Federation in the Field of Protection of Genomic and Genetic Information in the Framework of Medical Diagnostics

Objective: to formulate recommendations and proposals for improving legislation in the field of protection of genomic and genetic information, including those obtained as a result of medical diagnostics.

Materials and methods. We analyzed 18 regulatory legal acts, including 4 international, 3 acts of foreign states, 11 domestic legislation and judicial practice in the area under study. In addition, scientific works on this topic were analyzed. In the course of the study, we used the formal-logical, dogmatic, comparative method and axiological approaches.

Results. We formulated the concepts of genomic and genetic information and demonstrated differences between these concepts. We showed topical issues of information protection, identified problems in the field of legal regulation of relevant relations, formulated recommendations and proposals for improving legal regulation.

Conclusion. Based on performed research results, we recommend: 1. To incorporate in the legislation of the Russian Federation the principle that would allow the use of genetic information for further research depending on certain cases using a criteria-based approach, when such use should meet important public interests, for example, contributes to developing methods for the treatment of serious and socially significant diseases. 2. Regulate relations in the field of obtaining consent for research of biological material for scientific purposes (for example, within the framework of the Federal Law "On Personal Data"). 3. To define in Federal Law No. 86-FZ of July 5, 1996 "On State Regulation in the Field of Genetic Engineering Activities" the cases that require ethical examination in order to comply with the principle of safety of clinical trials of gene diagnostic methods, as well as in other cases. 4. Medical organizations shall ensure compliance with the rules of professional ethics in terms of data confidentiality, carry out their depersonalization, notify patients in writing about compliance with such a regime and, as a result, provide guarantees for the protection of information about patients, as well as about their relatives.

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