First PRC Biosecurity Law Was Signed Off in Wake of COVID-19 Pandemic
ISSUING AUTHORITY:
Standing Committee of the National People’s Congress
DATE OF ISSUANCE:
October 17, 2020
EFFECTIVE DATE:
April 15, 2021
On 17 October 2020, the Standing Committee of the National People’s Congress (NPC) passed the first PRC Biosecurity Law (“Biosecurity Law”), which will become effective on April 15, 2021. There are 10 chapters and 88 articles in total, which aim to prevent and respond to the threat of dangerous biological factors and related factors, to ensure that the people’s life and the ecosystem are in a relatively safe state, as well as to promote the stable and healthy development of biotechnology. The Biosecurity Law was first deliberated by the NPC as early as October 2019. However, after the outbreak of the COVID-19, the legislature authorities may have accelerated its legislation process to prevent and manage infectious diseases.
The Biosecurity Law provides that biosecurity is a key component of Chinese national security and the government will strengthen the regulations and supervision over the handling of major pandemics, quarantines for animals and plants, R&D and application of biological technology, establishment and security of pathological microorganism labs, and collection, preservation, use and provision of human genetic resources and biological resources.
The Biosecurity Law establishes an approval and monitoring system for biotechnology research and development activities. Specifically, it classifies biotechnology research and development activities into high-risk, medium-risk and low-risk categories. The various risk categories are determined based on the risk of harm to public health, industry, agriculture and the ecosystem. Research and development of biotechnology that falls in the high-risk and medium-risk categories will need to be conducted by a legal entity in China that completes the relevant approval or recordal procedure. It also has provisions on the prevention of and response to specific biosecurity risks, including major emerging infectious diseases, epidemic and sudden outbreaks, and biotechnology research, development and application.
The release of the Biosecurity Law reflects China’s strategic positioning of biosecurity as part of its national security system. In the post-COVID-19 age, the Biosecurity Law lays a foundation for setting up a legal regime of biosecurity in China.
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