Issues of legislative regulation in the field of human genetic data

Introduction. Genetic data, which are subject to legal protection, require the creation of specialized legislative acts regulating the collection, processing, and storage of such information. The development of a conceptual framework that could take into account the diversity of genetic data types and their application purposes represents a relevant task.

Objective. Determining directions for the development of a regulatory framework governing the circulation of human genetic data in the Russian Federation based on an assessment of the current state of legal regulation in this field.

Discussion. All types of genetic information are subject to legal protection according to their significance. In terms of current terminology, such concepts as “genetic information” and “genetic data,” require clarification. The Russian legislation is currently lacking a regulatory document governing the circulation of genetic data and genetic information obtained from humans. Foreign experience demonstrates active adoption of specialized legal acts protecting genetic information. Active development of biobanks and databases of genetic information requires clear legislative algorithms for data protection. In cases of anonymized data stored in databases, personal or medical data protection regimes become impractical. Thus, databases should occupy a separate position in the legal landscape. Issues regarding the regulation of creation, storage, and dissemination of genetic data repositories remain unresolved. Approaches to protecting and securing individual-level genetic information (in the context of medical care or private use) and safeguarding anonymous genetic data banks (for research purposes) should be delimited.

Conclusions. The existing disparity between the current advances in genetic technologies and legislation governing the generated data can be resolved by introducing new legislative initiatives and enacting laws that take into account the knowledge of modern biomedical science.

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