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.

Bioethical and Legal Issues in 3D Bioprinting

“…Legal problems of creation and use of bioprinting human organs, discussion of a possible model of legal regulation of bioprinting technologies received special consideration in Russia[ 41 , 46 , 47 ]. The absence of norms in Russian legislation that regulates in the area of creation and implantation of bioprinted human organs is proposed to be a deterrent factor of 3D bioprinting technologies development[ 41 ].…”

“…They are formed outside of the human body and there are no significant risks to life and health of the cell donor during the biofabrication of artificial organs. Moreover, the informed consent concerns only the production of biological material, but not biofabrication of the organ itself[ 47 ]. These particular traits of 3D bioprinted organs before their transplantation to the human body might allow them to relate to objects of civil rights.…”

“…These particular traits of 3D bioprinted organs before their transplantation to the human body might allow them to relate to objects of civil rights. As a result, the assumption of limited commercialization of the creation and utilization of biofabricated organs might be permitted[ 47 ]. However, after implantation of organs and tissues, they should be recognized as an integral part of a human body.…”