Civil Regulation of Genomic Data Sharing

Abstract

The legal regulation of relations concerning genomic information has undergone several transformations over recent years in the Russian Federation. Not only is a universal approach towards the regulation of such relations in civil law, including regarding the possibility of sharing such information, currently lacking, the concept of genomic information remains poorly defined as an object of civil rights. A special legal regime for big genomic data capable of processing with the help of artificial intelligence technologies is also lacking in the current legislation of the Russian Federation. Considering the great potential value of genomic data for all of humanity, and the need for the sharing of such data, a proposed balanced approach will ensure the sharing of genomic data with proper protection of personal non-propertyand other rights. Thus, the present work sets out to identify the specific features of genomic data sharing. When determining the civil legal regime for genomic information and genomic data, a balance between public and private interests can be ensured by maintaining personal non-property rights, ensuring the confidentiality of personal data, and obtaining consent for the dissemination of information in accordance with the law. However, in order to do this, it is necessary to distinguish conceptually between genomic information about a particular person and the genomic data on the basis of which such genomic information is obtained. The civil legal status of human biological material should be determined along with regulations for its processing to obtain genomic information at the same time as defining the legal regime for regulating biobanks in which such human biological material can be stored.