Bioprinting Technology as a Legal Challenge: Determining the Model of Legal Regulation

The technology of 3D printing creates serious challenges to the legal system that in its development is lagging behind scientific and technological progress. The development of 3D printing technology leads to the «digitalization» of objects of the material world when the boundaries between the physical world and the digital space are blurred. If 3D printing digitalizes objects of the material world, bioprinting digitalizes the human body. An individual tends to depend on the digital incarnation of his body or its individual organs in the corresponding electronic 3D models.

Bioprinting is aimed at the formation of a new medical paradigm that will result in overcoming the deficiency of human organs and tissues in the field of transplantology. The discovery of the possibility of reprogramming differentiated cells and obtaining induced pluripotent stem cells eliminates the ethical and legal problem associated with the use of stem cells of the embryo. This should be taken into account in the development of a model of legal regulation of relations connected with the creation of bio-print human organs.

Bioprint organs are synthetic organs, so the relations associated with their creation and implantation need independent legal regulation. Contemporary transplantology legislation and bans and prohibitions contained in it do not take into account the features of the creation of organs through 3D bioprinting. It is acceptable to commercialize relations in the field of bioprinting, to perform non-gratuitous transactions in this area, as well as to permit limited turnover of «bioprinting» organs subjecting them to the regulation applied to any other objects of civil law. Legislation on biomedical cellular products is also not able to regulate relations related to the creation and implantation of bio-printed human organs. Thus, the need arises to adopt a special legislative act aimed at regulating relations at all stages of the use of bioprinting technology.

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