Conceptual Approaches to the Legal Regulation of Genomic Researches and Their Use in the Russian Federation

This article concentrates on the problem of legislative regulation of public relations on genomic researches and the use of genomic technologies in the Russian Federation. Genomic technologies generate many ethical, social, and cultural issues for modern Russian society and bear significant risks for human rights and freedoms. Further, it presents threats to the preservation of human nature not only for existing, but also for future, generations of Russian citizens. For the protection of these values, it is necessary to create a regulatory system for genomic researches and genomic technologies in the Russian Federation.

The regulatory system in this sphere should be constructed on three levels: the international, national, and self-regulatory levels. The authors concludes that there are no fundamental contradictions between international legal acts and the Russian legislation on human rights protection in the context of genomic research. These circumstances make it possible to join the Convention for the Protection of Human Rights and Dignity of the Human Being relating to the Application of Biology and Medicine of 1997.

The article analyzes the current system of legislative regulation on of relevant issues in federal legislation and considers its further development. According to the authors, primary main models of the development of legislation in this area in Russia should be considered: the “traditional” model, developed based on a quantitative increase in norms in various branches of law; and the “complex” model, based on a single comprehensive legal act, which sets out the tasks, principles, and general approaches to the regulation of single institutions relating to genomic researches and their use. The article describes the positive and negative consequences of adopting each particular model for the development of genomics in the Russian Federation