Zhornytskyi V. International Legal Regulation of Human Genetic Data Handling.

The dissertation is devoted to the complex analysis of the international legal regulation of treatment of human genetic data. The dissertation considers general theoretical issues of legal regulation of human genetic data management, in particular conceptual approaches, and legal content of the concept of «genetic data handling», conceptual approaches to defining the concepts of «genetic data» and «human genome» as legal categories, human rights issues. human conditions in the development of the use of genetic data; international legal standards in the field of human genetic data management by areas of their use, including the history of international legal regulation of genetic data management, international legal regulation of genetic testing and genetic therapy, international legal regulation of cloning, combating bioterrorism and trafficking genetic data. The author made a comprehensive analysis of general theoretical issues of international legal regulation of genetic data management, definition of international legal standards in the field of genetic data management in the areas of their use and clarification of prospects for further development and implementation of international legal regulation of genetic data management. data through the study of the main provisions of international treaties on the treatment of genetic data, the legislation of states in this part, the achievements of international organizations with competence in this area. The study defined the concept of «human genome» (biological subjective quality of an individual, which contains a set of hereditary material contained in a human cell and determines the somatic individuality and identity of man) and «human genetic data» (legally protected set of information about inherited sub active characteristics of a person obtained by analysis of nucleic acids or by other scientific analysis). It is proved that the first attempts to reach a general international agreement on the basic legal principles of biomedicine were made by UNESCO and the Council of Europe. Under the auspices of these international organizations, several important international documents were adopted: the Universal Declaration on the Human Genome and Human Rights, UNESCO. The analyzed international documents devote only a few general and often abstract articles to specific types of medical biotechnology. It is determined that the features of international cooperation in the field of human genetic data management are: 1) institutionalized or non-institutionalized nature; 2) carrying out within the framework of international intergovernmental and non-governmental organizations; 3) in most cases, such cooperation does not lead to the creation of any mechanisms, the solution of which would be binding on the states and which could significantly affect the domestic policy and law-making in the respective state; 4) the most detailed provisions on biomedical research, including the protection of subjects, have been developed mainly in relation to clinical trials of medicinal products; 5) one of the areas of cooperation between states is the issuance of various acts on the issues under consideration, one of the results of such cooperation is standardization.