The article analyzes key instruments of international legal regulation of preimplantation genetic diagnostics (PGD) procedure. The authors substantiate the conclusion that the requirements and principles formulated in these instruments can be successfully used for the development and improvement of the national legal framework aimed at regulating the PGA. The main directions of such use are defined. First, it is necessary to consider the existence of genetic predisposition to a particular disease or chromosomal disorder (the medical purpose) and provide a qualified consultation of a genetic scientist concerning the mechanism and consequences of diagnostics. Secondly, the legal regulation of genetic information obtained through the PGA requires an independent normative framework: determining the framework the law-maker must be guided by the fact that any intervention in the human genome aimed at modifying it may be carried out only for preventive, diagnostic or therapeutic purposes. In this regard, it is important to prohibit the PGA for social purposes (selection of embryo according to specific characteristics, establishment of compatibility between a donor and a recipient, looking beyond the prohibition to choose the embryo gender that is currently imposed under Russian legislation). Third, a separate regulatory framework is needed to resolve the problem of informing the patient about the results of examination: in addition to the right to be informed of the results of examination, it is also necessary to recognize the individual’s «right not to know,» particularly relevant to predictive genetic research.

Modern science has achieved very significant results in different areas. For ordinary people, it is gratifying that such achievements help to treat complex diseases, and the technologies themselves now reduce the cost of treatment unlike the most other factors affecting the medicine. One of these areas of scientific knowledge is genetic engineering that can change only separate parts of the human body or influence the transformation of the human body in general. This raises ethical issues that provoke a large number of disputes in the society. To overcome them, there is a need for a clear conceptual understanding of the problems associated with the diagnosis and editing of the human genome, on the basis of which an effective normative legal framework that will satisfy the interests of all participants of these legal relations should be developed.

The article examines the legal aspects of the functioning of the mechanism of prenatal diagnosis in Canada and the genetic testing procedure, accompanied by genetic counseling, taking into account the state structure, national, ethical and other distinctive features.

The article analyzes the features of legal regulation of genetic screening for prenatal diagnosis in the people’s Republic of China. The conducted research allowed to establish the main principles and regularities of the corresponding regulation. It is summarized that the leadership of the people’s Republic of China conducts a targeted policy for improving the health of the population, where one of the priorities is not to increase the population, but to improve the” quality “ of newborns (in the context of health). Realizing, in this regard, the positive possibilities of genetic screening in HDP in terms of improving the overall level of health of the population, the state is making a lot of efforts in the financial, legal, scientific, social and other spheres for its wide implementation in everyday clinical practice. Genetic screening when PND is free and available to alsegments of the population of China, it is part of health services financed by the state. These principles, as shown by the analysis of the legal framework for genetic screening in HDP, are system-forming in the framework of its legal regulation in the PRC. Currently, the main trend in the development of Chinese legislation in the field of genetic screening for HDP is more detailed regulation of various aspects of the use of this medical technology. China’s accumulated experience in legal regulation can be taken into account by the domestic legislator

The tendency to reduce the cost of genome sequencing observed in the last decade raises the question of the feasibility of investing in the healthcare system when integrating this technology into clinical practice. In addition, it is necessary to identify factors that will contribute to lower costs and stimulate additional investment in this area. It is also necessary to evaluate the cost-effectiveness of full-genome sequencing for diagnostic and pharmacogenomic applications