Law and 3D Bioprinting: Problems, Risks, Prospects
Georgij Romanovskij · Journal of Russian Law · 2024
The development of additive technologies opens up new opportunities in the healthcare system, revealing its potential in three areas: biopharmaceuticals; biomodeling; 3D printing of human organs and tissues. The law does not have time to respond to the results of a technological breakthrough, while creating some artificial barriers to the implementation of the results of progress in the usual practice of public health. The presence of systemic gaps necessitates monitoring the current situation, identifying problematic aspects that require legal regulation, and identifying the risks of developing new technologies. The universality of the problematic predetermines an appeal to foreign experience (using the method of comparative law) from the point of view of the possibility of its projection in Russian lawmaking practice. The article analyzes Russian legal acts, thanks to which conclusions are presented on the possibilities of general and special regulation of bioprinting. It is proposed to expand the scope of Federal Law No. 258-FZ of July 31, 2020 “On experimental legal regimes in the field of digital innovations in the Russian Federation” to 3D bioprinting. The proposed approach of extending the regime of a medical device to the results of bioprinting — human organs and tissues — is criticized. The necessity of the appearance of special rules reflecting the peculiarities of bioprinting in pharmaceuticals and medicine is substantiated. It is proposed to introduce into the legislation of the Russian Federation the concept of hospital exclusion, which establishes a special legal regime for advanced therapy medicines, including drugs manufactured using additive technologies. The consequences of the introduction of 3D bioprinting into the practice of transplantation of human organs and tissues are shown. This will lead not only to a revision of the Law of the Russian Federation No. 4180-I of December 22, 1992 “On Transplantation of organs and (or) human tissues”, but also to a significant expansion of the regulatory powers of the Ministry of Health of the Russian Federation.