Informed consent in the economic law field of additive manufacturing

Abstract

This article is devoted to the disclosure of the meaning of informed consent in legal relations arising from the application of three-dimensional printed bioproducts, primarily through the prism of contract law. Within the framework of this article, the legal nature of 3D bioprinting and its role in the transformation and improvement of the modern health care system and the provision of medical care and medical services were investigated. The content and conditions that must be included in the informed consent are disclosed, in particular, information about information about: the device (will include information about the manufacturer and technical characteristics of the device); bioinks (in particular, the source of origin of the material, the pathological condition of the recipient, the biocompatibility of the material; further use of the material (when the identity of the patient and the donor match); the results of similar experimental studies; the implantation process; all possible conflicts of interest; as well as the condition of "minimum risks”, which will include expected results and side effects. Attention is focused on the fact that due to the benefits that additive technologies can bring to human life and health, issues of ethics and legislative regulation of this area must be resolved before the introduction of these technologies in the field of medicine. The role of contract law in the regulation of relations related to the use of three-dimensional printed bioproducts is analyzed, which will be important for determining the right of ownership and subjects of responsibility for damage that can be caused to a person. The latter can be regulated by a contract between the manufacturer and the medical institution, the software manufacturer and the owner of the 3D printer, etc., if they are performed by different entities under a separate contract. In order to achieve the goal, the work used methods characteristic of legal science. Among them are the dialectical method of learning the legal reality, the methods of analysis and synthesis, the system-structural method, the formal-logical method, which was used in the analysis of theoretical-legal developments and scientific research related to the most significant achievements in the field of three-dimensional printed bioproduction.