Detailed Rules on Human Genetic Resources Released
By LI Linxu
China has released detailed rules for implementing the regulation on the management of human genetic resources, which will take effect on July 1, 2023.
In June 2019, the regulation on the management of human genetic resources was issued by the State Council.
After its release, the Ministry of Science and Technology (MOST) launched the formulation of detailed rules for implementing the regulation, so as to further improve the management efficiency of human genetic resources.
Last year, MOST released draft rules on the implementation of the regulation for public comment.
Researchers conduct biospecimen medical research in a lab, Hefei city, Anhui province. (PHOTO: VCG)
The new rules have widely solicited opinions and suggestions from various sectors of society, said an official from MOST, noting that in line with relevant laws, the rules focus on practical problems and actual demand.
The collection, preservation, utilization and external provision of the country's human genetic resources shall comply with the rules.
The information of human genetic resources includes human gene and genomics data generated from the use of human genetic resources materials, but doesn't include clinical data, image data, protein data and metabolism data, according to the rules.
Aiming at managing human genetic resources in a scientific, rigorous and efficient way, the rules clarify the responsibilities of the central and local governments to establish an integrated supervision and management mechanism, said MOST.
MOST is responsible for the administration of human genetic resources survey, administrative licensing, supervision and inspection, and administrative penalties at national level.
Local science and technology departments are responsible for the administration of human genetic resources in their respective administrative regions, including supervision and inspection, routine management, case investigation, and various tasks entrusted by MOST.
The rules also draw a clear line on management boundaries, and are expected to streamline administration, delegate power, improve regulation and upgrade services.
For emergencies such as public health events, MOST will establish a fast-track mechanism.
To enhance their enforceability, the rules stipulate procedure specifics in areas such as administrative licensing, filing and safety review, said MOST, adding that concrete measures concerning supervision and inspection, as well as administrative penalties, are also set out in the rules.