Kryukova E.S., Inyushkin A.N. Genetic Testing as a Comprehensive Service: The Sources and Content of the Legal Regulation
DOI: https://doi.org/10.15688/lc.jvolsu.2024.4.17
Elena S. Kryukova, Candidate of Sciences (Jurisprudence), Associate Professor, Department of Civil and Business Law, Samara National Research University named after Academician S.P. Korolev, Moskovskoe Shosse, 34, 443086 Samara, Russian Federation, This email address is being protected from spambots. You need JavaScript enabled to view it. , https://orcid.org/0000-0003-0829-9855
Alexey N. Inyushkin, Doctor of Sciences (Biology), Professor, Head of the Department of Human and Animal Physiology, Samara National Research University named after Academician S.P. Korolev, Moskovskoe Shosse, 34, 443086 Samara, Russian Federation, This email address is being protected from spambots. You need JavaScript enabled to view it. ,
Introduction: the successful conduct of genetic research has allowed moving towards the introduction of individual approaches to the prevention, diagnosis, and treatment of diseases. The widespread use of innovations, in turn, has required proper legal support for genetic testing, which is the basis of personalized medicine focused on the genetic characteristics of the patient. Despite the obvious benefits, the active dissemination of the designated medical service is associated with a number of diverse problems and risks, whose effective elimination is facilitated by a comprehensive and coordinated approach to building the legal regulation. Methods: the methodological framework for the work is made up of both the general scientific and specific scientific research methods. Results: the analysis of the concept and species diversity of genetic testing has allowed substantiating the complex nature of the service under study, identifying the interdependence of testing and medical genetic counseling (both preliminary and subsequent), and tracing a close connection with the legal regime of the genetic information obtained during its implementation. The paper determines that the specifics of this procedure require its isolation in the system of medical services in terms of the legal regulation. Expanded regulation will make it possible to clearly and in detail establish the conditions, restrictions, implementation procedure, and stages of its provision, including subsequent routing for the patient. This approach will make it possible to ensure the quality of the service, distribute the areas of responsibility of its performers, and create additional guarantees for the protection of genetic information. Conclusions: as a result of the study, it is concluded that it is necessary to build a multi-level system for regulating the “genetic testing” service, within which it is proposed to fix the fundamental provisions in the basic sectoral law, the parties, conditions, and algorithm of provision in a separate special law, and the features of some types may be reflected in the departmental acts accompanying certain areas and spheres of medical care activities. The complex nature of the service will determine the content of the legal regulation. The issue of the fate of the information additionally identified during testing that is not related to the original purpose of providing the service is subject to the regulatory resolution.
Key words: genetic testing, service, personalized medicine, legal regulation, patient.
Citation. Kryukova E.S., Inyushkin A.N. Genetic Testing as a Comprehensive Service: The Sources and Content of the Legal Regulation. Legal Concept = Pravovaya paradigma, 2024, vol. 23, no. 4, pp. 130-136. (in Russian). DOI: https://doi.org/10.15688/lc.jvolsu.2024.4.17
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