China’s new PRC Biosecurity Law

Against the background of the outbreak of COVID-19, the Standing Committee of the PRC National People's Congress fast tracked the passing of the PRC Biosecurity Law ("Biosecurity Law") on 17 October 2020 with the law to take effect on 15 April 2021. 

The Biosecurity Law seeks to cover a wide range of areas under a broad definition of "biosecurity" and in doing so brings together an existing piece meal set of regulations in the following areas:

• epidemic control of infectious diseases for humans, quarantines for animals and plants;
• research, development, and application of biology technology;
• establishment and security of pathological microorganism labs;
• administration of human genetic resources and biological resources; and
• prevention of bioterrorism and defending threats of biological weapons.

Specifically and of importance to international players, the Biosecurity Law further reinforces the importance China places on the administration of human genetic resources ("HGR") by asserting sovereignty over China's HGR and further strengthening current regulation over the collection, preservation, use and provision of China's HGR under the existing Regulation on the Administration of Human Genetic Resources ("HGRAC Regulation", issued by State Council on 10 June 2019 and which took effect on 1 July 2019).

The Biosecurity Law adopts the same legal principles as provided in the HGRAC Regulation (which remains effective unless expressly amended by the Biosecurity Law) but introduces the following noteworthy changes:

• The HGRAC Regulation stipulates that prior approval of the Ministry of Science and Technology of State Council ("MOST") is required for the collection, preservation, utilization and provision to foreign parties of China's HGR.  However the Biosecurity Law further narrows the scope of permitted exemptions from this prior approval requirement.  For example, training is no longer a permitted exemption.

• Both the Biosecurity Law and the HGRAC Regulation prohibits foreign persons from collecting or preserving HGR in China, or transferring China's HGR abroad, however foreign persons have limited rights to carry out scientific research activities in collaboration with Chinese parties using HGR as approved by MOST.  However, for permitted international scientific research collaboration activities with Chinese parties based on HGR in China, the Biosecurity Law specifies that the Chinese parties can participate in the research throughout the entire process and in an essential way.  

• Legal liabilities and penalties are drastically increased under the under the Biosecurity Law when compared with the HGRAC Regulation.  For example, where illegal income is equal to or greater than RMB 1 million violators can be subject to fines of up to 20 times the illegal income and the authorities have the power to impose suspension orders of up to 5 years as well as revoke operation permits and licenses.

Another significant development of the Biosecurity Law is the introduction of an approval and recordal system for biotechnology R&D and application. Specifically, it categorises biotechnology R&D activities into high, medium or low risk categories determined based on the risk of harm to public health, industrials, agriculture and ecology. Foreign entities are prohibited from conducting high or medium risk biotechnology R&D activities in China; in other words they will need to be conducted by a legal entity in China and obtain the necessary approval or recordal.  Further details are still to be released.

We believe the issuance and implementation of the Biosecurity Law will have significant implications for international and Chinese companies in a wide range of industries such as pharma, healthcare, biotech, cosmetics, food and agriculture, especially for global and regional R&D labs.  We are keeping a close eye on further developments, especially the implementation regulations of the Biosecurity Law.