Self-Regulation of Genomic Studies and Prospects of Personified Medicine

Abstract

A secular trend of the development of medicine in the 20th century was on the ways of strengthening the foundations of public health, formation of systems of affordable medical care. Human genome deciphering opens wide prospects for using the obtained data in medicine. In recent years commercial medical organizations have been developing genetic research and personal genomic testing services. The paper is devoted to the analysis of the importance of legal self-regulation in the field of genomic counseling in the Russian Federation. The authors investigate the prospects of the introduction of personalized medicine and limitations that arise today in one of the areas of the approach under consideration, namely: forecasting predisposition to diseases of mixed nature, which is related to the peculiarities of development of medical and demographic situation in the world. The question is raised about the need for broad population studies to verify the risk values for diseases with low genetic determinacy. The authors conclude that it is impossible to predict what medicine of the future will be, but the results of genome decryption and increasing availability of personal data represent a unique social phenomenon that should be developed within the legal framework. In the coming years, the debate on the role of legal mechanisms in the self-regulation of genetic research and genetic services will become increasingly important. At the international level, this discussion will be focused on the fundamental issue of respect for individual rights in the interpretation of the data received. As genetic advice evolves, the issue of responsibility for the information provided and the availability of national regulatory mechanisms within the framework of state regulation or self-regulated professional associations will become a key concern.

Self-Regulation of genetic studies in Russia: search for the optimal model

“…The accumulation and exchange of genomic data is expanding exponentially, while the genomic biomedical technologies and genomic research results are being widely applied in the socially significant spheres. At the same time this field features several legal risks of abuse and possible violations of civil, social, and public interests (Montgomery, 2018).…”