Foreign Experience in the Legal Regulation of Direct Consumer Genetic Testing

Genomics methods and the results of genomic research are widely used in many areas of human activity. However, the rapid development of technologies leads to the fact that legal regulation does not take into account all their opportunities and risks. Thus, in recent years, the so-called direct-to-consumer genetic testing (DCGT), a type of genetic testing performed at the initiative of the consumer and for his personal purposes, has become widespread. The range of issues that the tests touch on is very wide: from the origin and family ties determination to recommendations for choosing an occupation and hobbies. In Russia, this industry is currently rapidly developing. At the same time, there is no legal regulation of the industry. The paper examines the foreign experience of DCGT services regulation. The authors show significant influence of the concept of "genetic exclusivity" on the legislation regulating this industry. However, the integrity of approaches to the regulation and the depth of consideration of controversial issues vary greatly. For the United States—the leader in both the number of companies providing DCGT services and the number of their clients—a self-regulation strategy remains the most characteristic one (at least until recently). Countries such as France, Germany, and Israel have adopted the tough stance against DCGTs, effectively prohibiting genetic testing without prescription. This is preconditioned by both the objective shortcomings of genetic tests and the originality of the historical past and social structure of these countries. We believe that the optimal way for Russia is self-regulation with the provision of the broadest and most objective information about the possibilities and limitations of DCGT on the part of professional communities (geneticists, bioethics specialists).