China to Strengthen Regulation of Human Genetic Resources

China to Strengthen Regulation of Human Genetic Resources

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Human genetic resources (HGR) have long been regulated in China under the Interim Measures for the Administration of HGR (人类遗传资源管理暂行办法)  (Interim Measures)1 issued by the Ministry of Science and Technology (MOST) and the former Ministry of Health (MOH; since replaced by the National Health Commission) in 1998 to govern the sampling, collection, research, development, trading, export or provision outside China of HGR.  HGR refers to such genetic materials as human organs, tissues, cells, blood specimens, preparations of any types or recombinant DNA constructs, which contain human genomes, genes or gene products as well as information or data relating to such genetic materials.  

The HGR Administration of China (中国人类遗传资源管理工作办公室) (HGRAC), jointly formed by MOST and MOH and physically housed in MOST, is responsible, inter alia, for (1) organization of the review of HGR international cooperation projects, and (2) receipt of applications for HGR export and border exit and handling of Export (Exit) Permits for HGR.  The Chinese party to an HGR international cooperation project is responsible for filing the application for approval of the project.  Documents evidencing informed consent from HGR donors and their relatives and the draft contract need to be submitted in the application.  If the plan to export or carry HGR outside China has been included in an international cooperation project, the HGRAC will issue an Export (Exit) Permit after the project is approved.  

While the ministry-level Interim Measures remain effective, the State Council in May 2019 issued the Administrative Regulations on HGR (人类遗传资源管理条例)2 (HGR Regulations) on the sampling, maintenance, utilization and overseas provision of HGR (including HGR materials and HGR data) which are more stringent than the Interim Measures with respect to ethical review, informed consent from HGR donors, express prohibition of Foreign Parties (defined as foreign organizations or individuals or institutions established or actually controlled thereby, including foreign-invested enterprises in China) from sampling and retaining such materials in China or providing Chinese HGR overseas, and express requirements for Foreign Parties to conduct scientific research on HGR in the form of cooperation with Chinese parties, as well as an express prohibition on trading (i.e., commercializing) HGR.  

Under the HGR Regulations, Foreign Parties may not sample or maintain HGR in China or provide the same overseas, and are required to conduct scientific research activities in the form of cooperation with Chinese research institutions, universities, medical institutions or enterprises for the use of Chinese HGR.  International cooperative research is subject to application to MOST by both Chinese and Foreign Parties with legal person status, after clearance of ethical review in both jurisdictions and provided that the research may not jeopardize China’s public health, national security or social and public interests.  

Applications for international cooperative clinical trials for drugs or medical devices for the purpose of applying for marketing licenses in China by utilizing Chinese HGR but without providing Chinese HGR overseas are not subject to approval but to a less demanding recordation with MOST.  Such cooperative research must ensure that the Chinese party and its researchers enjoy substantial participation throughout the entire course of cooperation, and that access to and backup for all records and data from the research are provided to the Chinese party and its researchers.  A joint report on the research must be submitted to MOST within six months after the cooperation has concluded.

Provision of Chinese HGR overseas as required for international cooperative research is also subject to MOST approval and conditional upon clearance of ethical review, designated uses for outbound transport and overseas partners, and provided that Chinese public health, national security and social and public interests are not jeopardized.  The provision of or access to HGR data to the Foreign Party is subject to security review organized by MOST if China’s public health, national security or social or public interests may be affected.  Public health comes within the scope of national security under Article 29 of China’s National Security Law (2015).

HGR donors must be informed in advance of the purpose and use of sampling, potential impact to their health, privacy protection measures, and their rights to voluntary participation and unconditional withdrawal at any time.  Written consent must be obtained from donors.

Foreign Parties which violate the HGR Regulations with respect to sampling, retaining, utilizing or providing HGR overseas may be subject to a fine of RMB 1 to 10 million; or a fine in the amount of five to ten times the amount of the illegal proceeds if the illegal proceeds equal or exceed RMB 1 million.  Entities which engage in unauthorized sampling of important genetic families and HGR from specified regions, retaining, or utilizing HGR in international cooperative research, fail to undergo a security review when such review is required, or fail to file a recordation of the type, quantity and use of HGR before conducting international cooperative clinical trials, may be barred for up to five years, or in serious cases be permanently barred, from sampling, retaining, utilizing or transferring HGR overseas.

Regulation is likely to become more stringent in the near future.  In April 2020 the Standing Committee of the National People’s Congress (NPC) reviewed the second draft of the Biosecurity Law (生物安全法(草案))3 (Draft Law), roughly seven months after the first draft was cleared.  The Draft Law would provide that biosecurity is a vital part of national security and, if enacted in its current form, will be the first omnibus legislative framework in the biosecurity sphere.  The timeline for promulgation is unclear, but given the importance of epidemic control and the rush to develop vaccine of COVID-19, the NPC will seek to complete its review of the Draft Law this year.4

The Draft Law would largely reaffirm while elevating the authority of existing requirements with regard to HGR that are already provided in the HGR Regulations as mentioned above.  In particular, the Draft Law provides (i) the collection of important genetic families, HGR in specified regions or certain specified types and quantiles of HGR; (ii) the preservation of Chinese HGR; (iii) the conduct of international cooperative research utilizing Chinese HGR; and (iv) the shipping, mailing and carrying out of China Chinese HGR are subject to approval by MOST.

As with the HGR Regulations, an exemption is available for international cooperative clinical trials for the licensing of drugs and medical devices without providing Chinese HGR overseas, but such clinical trials would remain subject to a recordation filing with MOST if Chinese HGR is to be utilized.  Foreign Parties would be barred from collecting and preserving Chinese HGR within the territory of China.  They would also be barred from providing Chinese HGR out of the country.  The provision or open access of information on HGR to Foreign Parties would be required to pass a security review by MOST if the public health, national security or public interest of China are likely to be at stake.  The Chinese party and its researchers would enjoy the right to substantively participate throughout the entire process of international cooperative research if Chinese HGR is used in the research.

Neither the HGR Regulations nor the Draft Law would restrict government authorities from collecting biometric information from citizens for security purposes.

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