STRATEGY
China’s New PRC Biosecurity Law Key implications for international players
The article focuses on the key implications for international players of the PRC BioSecurity Law, especially by introducing the administration scheme emphasized by this new law on the administration of the collection, preservation, use and provision of human genetic resources. Michael Chin, Partner, Simmons & Simmon
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. Regulation of human genetic resources
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gainst the background of the COVID-19 global pandemic, China fast-tracked and passed last year its first national biosecurity law (‘Biosecurity Law’). The law, which took effect on 15 April of this year, adds another key component to China’s overall national security.
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P H A RM A F O C U S A S I A
ISSUE 43 - 2021
As a comprehensive and somewhat ambitious set of laws covering a wide range of areas under the broad definition of ‘biosecurity’, the Biosecurity Law attempts to address the absence of punishment against biotechnology related misuses in China over recent years and brings together an existing piece meal
Specifically and of importance to international players, the Biosecurity Law confirms the importance China places on the administration of Human Genetic Resources (HGR) by asserting sovereignty over China’s HGR and further strengthens current regulation over the collection, preservation, use and provision of China’s HGR under the existing Regulation on the Administration of Human Genetic Resources of 2019 (HGRAC Regulation). 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 some noteworthy changes which may have key implications for foreigners. Similar to the restrictions provided under HGRAC Regulation, the Biosecurity Law confirms that foreign persons are generally prohibited from collecting or preserving HGR in China or providing HGR abroad. Foreign persons
