Genesis of Legal Regulation of Human Organ and Tissue Transplantation in the Russian Federation

The authors explore the genesis of human organ and tissue transplantation in our country and the legal relations arising in this connection. For a long time, this area of medical activity was not regulated at the legislative level. Prior to 1917, the issues of transplantation were predominantly theoretical. In the Soviet period of the history of the Russian state, the development of public medicine and numerous military conflicts confirmed the applied nature of experiments on human organ and tissue transplantation. During this period, rapid development of legislation also affected healthcare. The legal presumption of consent to the removal of organs and (or) tissues was formulated, which established the legal framework for donation of human organs and tissues. At the same time, until 1992, the issues of transplantation were regulated mainly by departmental acts of the USSR Ministry of Health. The Law of the Russian Federation “On Transplantation of Human Organs and (or) Tissues” adopted in 1992 determined that the legal regulation of transplantation issues, including the list of transplantation objects, is determined by the federal executive body in the field of healthcare together with the Russian Academy of Sciences. The current level of development of experimental medicine, including transplantology, makes it necessary to regularly supplement the legislation in this area. For example, only on May 1, 2022, transplantation objects were supplemented with hematopoietic stem cells, and gaps in the legal regulation of pediatric transplantation were eliminated. The authors conclude that our country has significant experience in the field of transplantation and a quite perfect legislative framework. However, work on adjusting the current legislation, adopting new laws and by-laws in this area should not stop.

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