Almanac of law. Issue 15 (2024), pages 660–669.

DOI: 10.33663/2524-017X-2024-15-660-669

Chornenka D. S.
Modern trends in regulatory activity in the field of bioprinting and organ donation

The article examines the problems of bioprinting and organ donation through the lens of modern trends in rulemaking. It is noted that one of the most dynamic branches of modern medicine is transplantology, which is actively developing in Ukraine, even despite Russia’s full-scale war against Ukraine and the impossibility of using medical aviation. It was emphasized that additive technologies are increasingly becoming the basis of modern progress in the field of medicine. The most common term characterizing them is three-dimensional printing, 3D printing. Yes, human organs have not yet been printed using it, but scientists are already using 3D technologies to create «organoids» that imitate organs on a reduced scale and can be used for research. Modern technologies do not stand still. Living cells are used as a material, which became the basis of bioprinting, when with the help of a 3D printer it is possible to produce tissues, human organs or special products containing living cells. In modern medicine, the use of three-dimensional technologies is developing in several directions. In particular, it is a scanning of organs using computer tomography and magnetic resonance imaging. The advantages of three-dimensional images over planar ones are obvious: during a 3D scan, a specialist can detect hidden problems and subsequently prescribe a more targeted treatment to the patient and prevent the development of serious diseases. 3D models of organs are also created, which make it possible to study the pathology and practice before the operation. In addition, implants are being actively created based on three-dimensional images using 3D printers, technologies for creating artificial bones, tissues, blood vessels and organs are being developed. It was concluded that the vast majority of developed countries adopt strategic documents aimed at introducing innovations into routine practice. At the same time, many risks arising from new discoveries in biomedicine are exacerbated by their combination with the threats posed by bioprinting. In view of this, the legislator will need to solve the basic problem: the extension of the general terminology of 3D printing to the biomedical sphere (a step towards this can be, for example, the Law «On Additive Technologies») or the use of a sui generis categorical apparatus for such created products.

Key words: law-making, health care legislation, legal regulation, human rights, bioprinting, transplantation, donation, transplantology, additive technologies, 3D printer, 3D printing.

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Danyila Stepanivna Chornenka,
Postgraduate Student at the V. M. Koretsky Institute of State and Law, NAS of Ukraine
ORCID: 0000-0002-2224-9646