New Biosecurity Law of People’s Republic of China - What you need to know

The New Biosecurity Law of People’s Republic of China was published on October 17 2020, and it will take effect on April 15 2021. The law has included a number of provisions of China’s Administrative Regulations on Human Genetic Resources (which was taken effect on July 1 2019), in many instances, particularly with respect to foreign entities and individuals. 

For major incidents and activities in the biological field that affect or might affect national security, "biosecurity review system" is applied. Biosecurity Law will prohibit foreign entities and individuals from collecting or preserving Chinese human genetic resources in China, or transferring Chinese human genetic resources abroad. International scientific research collaboration which using Chinese human genetic resources is permitted but must be approved by China’s Ministry of Science and Technology in advance on a project-by-project basis. The only exception to the approval requirement is “international collaboration in clinical trials” at clinical trial institutions that do not involve the outbound transfer of Chinese human genetic resources materials. Such clinical trial collaboration, however, must still be pre-registered with Ministry of Science and Technology, and as part of the pre-registration, the types and numbers of human genetic resources proposed to be used and the actual proposed uses must be disclosed to Ministry of Science and Technology.

Chinese Biosecurity Law demands that the permitted international collaboration must ensure that the relevant Chinese entities and their research personnel “can take part in the research substantially in the whole process of the collaboration,” and that the relevant rights and interests resulting from the collaboration be shared in accordance with relevant laws, most likely the China’s Administrative Regulations on Human Genetic Resources, which command that any patent rights based on scientific research results obtained in the collaboration must be jointly owned by the participating Foreign Person and Chinese entity, among other benefit-sharing provisions.

Penalties for violation by collecting or preserving Chinese human genetic resources or by using human genetic resources to carry out international scientific research collaboration, the department for science and technology under the State Council has the right to command the illegal conduct be stopped and confiscate illegal income and illegally collected or preserved human genetic resources, and concurrently give a fine of between 500,000 and 5,000,000 RMB, and where the value of unlawful gains is above 1,000,000RMB, give a fine of between 5 and 10 times the value; and sanction the legal representative, principle responsible person, and directly responsible managers and other directly responsible personnel in accordance with law by prohibiting their engagement in the corresponding activity for up to 5 years. 

This text is not a comprehensive review of the biosecurity law, but provides an insight of select provisions in the law that may be applicable to foreign entities or individuals. For an in-depth analysis of specific clauses or an English translation of the Biosecurity law, please contact Attorney- At-Law Patricia Leers, Managing Partner | Head of the International Department at P.leers@a-law.eu or fill in our online contact form.