Legal Issues of Creation and Use of Bioprinted Human Organs

Abstract

Transplantation of human organs and (or) tissues is an effective means of saving lives and restoring health of citizens. The achievements of modern medical science contribute to a significant reduction in the potential adverse effects of such operations, which largely determines their prevalence and effectiveness. At the same time, the availability of such high-tech medical care raises certain concerns due to the insufficiency of human organs and (or) tissues suitable for transplantation. In this regard, the most promising is the introduction of modern additive technologies (3D bioprinting) into medical practice. However, the rapid development of new medical methods determines the need to address the most complex bioethical and legal problems associated with the need to ensure respect for human dignity and prevent violations of the integrity of the individual. As a result, the legal principles of creation and use of bioprinted human organs in this paper are the following: the principle of inadmissibility of obtaining donor cell material to create a bioprinted human organ in the absence of explicit and specific consent, the principle of permissible use of the resulting cell material. The principles of exclusivity and noncommercialization of the human body should retain limited effect: the first principle — in terms of allowing the production of cellular material to create a bioprinted human organ to be transplanted, only for the treatment of the recipient, and the second — in terms of determining the legal regime of cellular material and bioprinted human organs. The paper emphasizes the importance of extending the principle of priority of human interests over the interests of society and science to the analyzed sphere. In turn, models of legal regulation of social relations arising from the removal and transplantation of human organs and tissues, on the one hand, and about the creation and use of bioprinted human organs, on the other hand, should be based on the principles of unity and differentiation.