On 26 May 2023, China’s Ministry of Science and Technology (MOST) issued the “Detailed Rules for Implementing the Regulation on the Management of Human Genetic Resources” (hereinafter the “Rules”, 人類遺傳資源管理?xiàng)l例實(shí)施細(xì)則).
Previously, the Chinese legislature had enacted the Biosecurity Law. On that basis, China’s State Council, as the central government, issued administrative regulations entitled “Regulations on the Management of Human Genetic Resources”. Subsequently, the MOST, as a ministerial department of the State Council, further issued the Rules.
The highlights of the Rules are as follows:
- Information on human genetic resources includes human genes, genomic data, and other information and materials generated from the utilization of human genetic resource materials. It excludes clinical data, image data, protein data, and metabolic data.
- The collection and preservation of China’s human genetic resources within China as well as providing China’s human genetic resources to overseas entities, must be conducted by Chinese scientific research institutions, institutions of higher education, medical institutions or enterprises.
- Overseas organizations, overseas institutions established or actually controlled by overseas entities, or overseas individuals shall not collect or preserve Chinese human genetic resources within China or provide Chinese human genetic resources to overseas entities.
- Where the information on human genetic resources is to be provided or made available to overseas organizations, individuals or institutions established or actually controlled thereby, the Chinese information owner shall report to the MOST in advance and submit the information backup.
- Where Chinese human genetic resources are used for international cooperation in scientific research, Chinese entities and researchers must be fully involved in research in the entire process and substance of the research. All records, data, and information generated should be completely open to Chinese entities, and relevant rights and interests should be shared with them.
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Contributors: CJO Staff Contributors Team
