Abstrakt: |
The article defines what xenoimplants are and their important place among modern methods of treatment by transplantation. It has been established that the development and functioning of the specified methodology requires the introduction of innovations and modern scientific and technical developments. In this regard, it is stated that the transplantation of xenoimplants is not regulated by legislation at the appropriate level, their legal status is not finally resolved, and what is regulated contains certain limitations. It has been proven that xenoimplants are objects of civil law and the legal regime of things can be applied to them. It was found that for the high-quality implementation of the latest technologies with the use of xenoimplants, it is necessary to attract investments. However, it has been established that the development of xenoimplants requires significant costs for research, clinical trials and production. The legal problems that an investor may face in the process of investing in such a technology as xenoimplants are analyzed. As a result of certain gaps in the legislation on transplantation, in particular, regarding the manufacture and use of xenoimplants, failure to regulate the distribution and status of animal material, failure to establish the rules for breeding animals whose materials will be used in the manufacture of xenoimplants, failure to define the medical and biological requirements that must be followed in the research activity, the lack of provisions that would regulate the conclusion of certain quality agreements that ensure compliance with standards at each stage, as well as not identifying and predicting certain risks for investors creates obstacles in the implementation of investment activities in the field of xenoimplants. It was determined that the regulation of the outlined issues by the legislation of Ukraine will solve many legal problems with attracting investments for the creation of xenoimplants and the possibility of their subsequent transplantation. [ABSTRACT FROM AUTHOR] |