On 1 June 2023, the Ministry of Science and Technology of the People’s Republic of China (the Ministry) issued the “Detailed Rules for the Implementation of the Regulation of the People's Republic of China on the Administration of Human Genetic Resources” (the 2023 Rules). The Rules will come into effect on 1 July 2023.
China first stipulated the Interim Measures for the Administration of Human Genetic Resources (2019 Regulation) in 1998, in order to regulate the protection and use China’s human genetic resources. On 1 July 2019, the Regulation of the People's Republic of China on the Administration of Human Genetic Resources came into effect in order to deal with new issues, such as regulating the use of the human genetic resources, developing the licensing regime for the supply to foreign enterprises/individuals, and improving the system regarding the international cooperation and scientific research that use Chinese human genetic resources. The 2023 Rules are made to further implement the 2019 Regulation.
According to the policy interpretation issued by the Ministry, the 2023 Rules include the following key points:
Optimizing the scope of the administrative license and recordal
The 2023 Rules clarify that human genetic resources information includes the use of human genetic resources materials generated by human genes, genomic data and other information materials, but does not include clinical data, imaging data, protein data and metabolic data. The 2019 Regulation developed a notification requirement for the supply of genetic resources by a Chinese enterprise to a foreign one. The 2023 Rules make it clear that it is not necessary to undergo a separate notification for the disclosure or sharing of data between a Chinese enterprise and a foreign one when the following conditions are met - prior approval or a recordal filing has been obtained for a cooperative research project between the two enterprises or relevant clinical trial, and appropriate legal documentation is in place regarding joint use of the data.
Data Protection and security
The 2023 Rules make it clear that informed written consent of data subject providers is required. Further, it sets out that security reviews are required in some cases, including those where the data is to be shared with a foreign enterprise/person. Such security reviews may involve the Ministry of Science and Technology and the Cyberspace Affairs Commission in certain circumstances.
Carrying out registration and reporting systems for human genetic resources management
It specifies that a national survey of human genetic resources is to occur at least once every five years. It strengthens the system of registration and active declaration of important genetic resources, explores the establishment of a directory management of important genetic resources, and so on. It also requests that cooperating parties that obtain administrative licenses for international scientific research cooperation or the completion of international collaborative clinical trials for the record should be listed in the administrative license or record within six months after the expiration of the validity period, and jointly submit a report to the Ministry of Science and Technology on the status of collaborative research.
Defining the scope of the foreign work units
The 2023 Rules provide that with regards to activities within Mainland China, aimed at collecting, conserving human genetic resources or providing Chinese human genetic resources outside of China, such activities must be carried out by Chinese scientific research institutions, higher education institutions, medical institutions or enterprises (Chinese units). Those established in Hong Kong and Macao that are under the control of domestic Chinese institutions are deemed to be Chinese units for these purposes. Foreign organizations and institutions that are established or actually controlled by foreign organizations, individuals (hereinafter referred to as foreign units) and individuals outside of China are not permitted to collect and/or conserve human genetic resources in China, nor provide human genetic resources outside pf China.
Among them, the institutions that are established or actually controlled by foreign organizations or individuals refers to the following circumstances: (1) foreign organizations, individuals holding or indirectly holding more than fifty percent of the shares, equity, voting rights, shares of property or other similar interests in an institution(2) foreign organizations or individuals holding or indirectly holding less than fifty percent of the shares, equity, voting rights, property shares or other similar interests of the institution, but having voting rights or other interests sufficient to dominate or exert significant influence over the decision-making, management and other actions of an institution(3) foreign organizations and individuals that, through investment relationships, agreements or other arrangements, are able to dominate or exert significant influence over the decision-making, management and other acts of an institution(4) other circumstances as specified in laws, administrative regulations and rules from time to time
We expect to see additional Interpretations and Guidance Notes regarding the subject matter of the 2023 Rules and 2019 Regulations released by the Ministry of Science and Technology, and other ministries and administrations, over the next 12 months. These could well include comments on intellectual property issues, data protection and security.