Chinese state council releases regulation on the handling of human genetic resources

The State Council of the People's Republic of China (PRC) released the Administrative Regulation on Human Genetic Resources, which details the handing of human genetic resources (i.e. genetic materials such as organs, tissues, cells, genomes and genes) and human genetic information (i.e. any data generated from human genetic materials). Passed on 10 June 2019, the regulation (to read the full text, click here) takes effect on 1 July 2019.

According to the regulation, it is now prohibited to trade in human genetic resources with the exception of the reasonable cost and expense of providing or utilising human genetic resources for scientific research. It is also prohibited for foreign organisations and individuals, including any institutions established or controlled by any foreign organisations, to collect or preserve Chinese human genetic resources within China or to transfer Chinese human genetic resources abroad.

If a foreign organisation intends to utilise Chinese human genetic resources for scientific research, it can only conduct these activities with the cooperation of Chinese scientific institutions, universities, medical institutions or enterprises. In this case, the foreign entity, together with the supporting Chinese entity, should file an application with China's Ministry of Science and Technology (MoST), which is the main authority regulating human genetic resources.

The only case in which approval from the MoST is not necessary is if a clinical institution uses the human genetic resources for multinational clinical trials to get marketing approval for relevant drugs or medical devices in China, and if no human genetic resources will be transferred abroad. Before such a clinical trial, the foreign and Chinese entities should file a report with the MoST specifying the types, quantity and usage of the proposed human genetic resources.

To legally transfer Chinese human genetic resources abroad, the parties must obtain an export permit from the MoST and satisfy the following conditions:

• The transfer cannot damage the public health, national security or public security of the PRC, and if MoST determines there is a potential for risk, it will conduct a national security review;
• Both the foreign entity and the Chinese entity must attain the status of a legal person;
• There is a specific partner in the foreign country and the usage of the exported resources is deemed reasonable;
• In collecting the human genetic resources, the parties have complied with all legal requirements or obtained the material from a recognised storage entity; and
• The project has passed the relevant ethical review.

The application for transferring Chinese human genetic resources can be filed independently or together with the application for scientific research.

During any cooperative scientific research, should there be alterations in the cooperating parties, purpose, contents or terms of a project, the parties must obtain approval for these changes.

During the research process, the foreign entity should fully engage the Chinese entity and its researchers, making all records and data fully open and available to the Chinese entity. A copy of all records and data should be provided to the Chinese Entity.

If the research results are to be patented, the foreign entity and the Chinese entity should jointly file the patent application and afterwards share ownership of the patent. For all other unpatented results of scientific research, the parties can sign a cooperation agreement to establish the rights of use, assignment and distribution of benefits. If the parties fail to reach such an agreement, each party will have the right to use the results, but cannot transfer the results to a third party without mutual agreement. Unless otherwise specified, the benefits gained from transferring research results should be distributed between the parties according to their contribution to the project. At the termination of the project, the parties should submit a research report to the MoST within six months.

In the event of violations of this regulation, the MoST can order the responsible parties to stop their activities, confiscate any illegally collected human genetic resources and any illegal gains, and impose a penalty of between CNY 1 million to 10 million. If the gain from illegal acts is over CNY 1 million, the penalty can be up to ten times the illegal gain. If the MoST considers the illegal act serious, the relevant entity or individual may be banned from collecting, preserving, utilising or exporting human genetic resources for one to five years, or even permanently.

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