Legal regulation of the bioprinting process: problems and development prospects in the Russian Federation

Abstract

The relevance of this topic is due to the fact that the development of medical engineering has reached a level where it is possible to create a prototype organ using 3D bioprinting technology. The purpose of this study is to conduct a legal analysis of the implementation of this procedure in the Russian Federation and determine ways to resolve the existing contradictions. To date, we are not yet talking about the mass production of biomedical implants, however, understanding the importance of 3D bioprinting in the future of regenerative medicine, we consider it necessary to develop legislative regulation of this area of activity. The methodology consists of dialectical, structural, formal legal and comparative legal methods, analysis and synthesis. As part of the study, the legal structure of legal relations in the field of creating organs and tissues by using the functions of a 3D bioprinter was analyzed; their subsequent transplantation into the human body. It is noted that the legal issues of the implementation of transplantation of created organs and tissues using bioprinting technology remain unresolved. Their solution is seen in a comprehensive change in the current legislation governing the 3D bioprinting procedure use and the further products circulation created with its help.