The amendments to the Federal Law On State Regulation of Genetic Engineering are designed to strengthen national security and sovereignty in the collection, storage, processing, analysis and use of human genetic data. They also establish new procedures to ensure the safety and protection of such data.
Among other provisions, the amendments prohibit the transfer of human genetic data obtained during population-based genetic and/or immunological research to foreign states, foreign individuals and legal entities, as well as to representative offices and representatives of such entities.
At the same time, the law sets out the procedures and conditions under which the transfer of human genetic data outside the Russian Federation is permitted (the exceptions include the provision of medical care to a specific patient, the development and manufacture of medicines and biomedical cell products for a specific patient, and purposes related to international cooperation.)
The specific procedures for transferring human genetic data, the conditions governing such transfers, and the requirements for the organisations and individuals involved will be established by the Government of the Russian Federation.