Problems of Legal Regulation of Contractual Relations in the Process of Creating Bio-Print Human Organs

Abstract

Additive manufacturing, 3D printing and bio-printing are technologies of the Fourth Industrial Revolution. Currently, due to the possibility of hacking the human genome, it is important to define the concept of legal regulation of relations concerning bioprinting and creation of a regulatory framework for their legal regulation, which would determine who should be held responsible for the defect takes place when printing a human organ (a creator of a digital template, a manufacturer of a 3D printer or a person who operates the 3D printer), what obligations arise with regard to the template, who owns the rights to it, what contracts mediate the relationship between the template creator, the printer manufacturer, the material manufacture, the person who manages the printer and the consumer. One more question is what are the limits of the principle of freedom of contract in the field of 3D printing, in particular in the field of bioprinting. When considering the issues of 3D printing of human organs, inevitably arises the question of rights, obligations and responsibility of a medical organization within which the medical organization would carry out medical intervention in order to implant and transplant printed organs. One more issue that needs consideration is the legal framework of printed organs. It is obvious that before they are implanted in the human body, they can be subject to the regulatory framework applicable to things. After implantation, the printed organ should lose the properties of things and it should be subject to the legal regulation that is applied to intangible things. To this end, the author suggests that it is necessary to introduce certain restrictions on the principle of freedom of contract in this area and the possibility of carrying out medical intervention only by certain entities (medical organizations) authorized to perform such operations.