Genetic passportization of the population in the context of the development of personalized medicine: legal aspect

Introduction. The desire to switch to advanced medical techniques to carry out targeted prevention, diagnosis, and treatment, improve the quality and effectiveness of medical care is largely focused on the formation of the genetic profile of the population. For the successful development of the institute of genetic certification, phased and diversified work should be carried out, including preliminary organizational and methodological measures. To date, to move in the legal field in a given direction, it is necessary to lay the foundations and structure of rationing.

The purpose of the research. To develop a principled approach to the legal regulation of the process of genetic certification in Russia in the context of the development of advanced medical technologies.

Materials and methods. The methodological basis of the research consists of both general and private scientific methods of cognition. A systematic approach ensures the formation of a holistic picture of intersectoral interaction in the context of the problems analyzed in the work.

Results. The authors outlined the prospects for the development of genetic certification in the context of modernization of the healthcare system, emphasized the role of the named institute for personalized medicine, identified and structured the main regulatory blocks that need to be developed to effectively promote a new form of accounting and registration activities.

Research limitations. The article is based on current regulations in the field of healthcare and other branches of law and twenty seven scientific sources available to the authors (Russian and foreign databases of articles, monographs, and reviews).

Conclusion. The main task of forming a genetic profile of the population is to improve the life and health of citizens, in this regard, the formation of fundamental provisions on the goals and procedure for genetic certification should be carried out within the framework of health legislation. To achieve the desired balance between the urgent need to actively promote the achievements of genetic research, on the one hand, and the need to ensure the rights and freedoms of citizens, on the other, is possible through strict goal-setting of the process of genetic certification and strict observance of the principle of voluntary conduct.

Compliance with ethical standards. The study does not require the conclusion of the biomedical ethics Committee or other documents.

Contribution of the authors:
Inyushkin A.A. — the concept of research, collection and processing of material, writing a text, editing;
Kryukova E.S. — collection and processing of material; writing a text, compiling a list of references.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Funding. The research was carried out at the expense of a grant from the Russian Science Foundation No. 23-28-00720, https://rscf.ru/project/23-28-00720/

Conflict of interest. The authors declare no conflict of interest.

Received: April 4, 2024 / Revised: May 6, 2024 / Accepted: December 11, 2024 / Published: June 30, 2025

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