On 15 April 2021, China’s sixth National Security Education Day, the Biosafety Law came into effect, providing a comprehensive, systematic and overarching law governing this key area. To highlight its growing importance, the recent 33rd Politburo collective study session of the CPC Central Committee was on the theme of strengthening China’s biosafety. President Xi Jinping delivered a speech on strengthening national biosafety risk prevention, control and governance capabilities.
Tight grip on R&D
The Biosafety Law distinguishes high, medium and low risks in biotechnology R&D. Following the introduction of the law, the specific classification criteria and lists will be formulated, revised and published by the relevant authorities.
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Previous safety regulation relating to biotechnology R&D was mainly covered by the 2017 Measures for the Administration of the Safety of Biotechnology Research and Development issued by the Ministry of Science and Technology (MoST). The annex to the measures includes a classification of biotechnology R&D activities by level of risk. However, being neither law nor administrative regulations, these measures could not serve as the basis for specific administrative permissions, i.e. approval or recordal.
In March 2019, the MoST oversaw the draft Regulations for the Administration of the Safety of Biotechnology Research and Development. Under these, biotechnology R&D activities that posed a medium to high risk would have been subject to approval or filing; those deemed of average risk would have required a risk assessment to be conducted; and for those not included on the risk list, the risk level would have had to been determined and submitted to the provincial science and technology authority. These draft regulations were not implemented.
The Biosafety Law is at the top level in the hierarchy of Chinese legislation. Following its implementation, more detailed rules for classification and regulations will be promulgated. It is not inconceivable that these may reflect criteria and approaches taken in the formulation of the previous attempts to regulate the sector.
The Biosafety Law also provides that medium to high-risk biotechnology R&D activities must be conducted by organisations legally established in China and subject to approval or filing. This should not be interpreted as a barrier for foreign investors, whose qualification will be further determined by their inclusion in the Special Administrative Measures (Negative List) for Foreign Investment Access.
Pathogenic microbe labs
In 2018, the State Council promulgated the Regulation on the Bio-safety Management of Pathogenic Microbe Labs to address the safety and experimental activities of such facilities. The Biosafety Law also contains a chapter specifically addressing this issue, further emphasising the importance of regulating these labs.
Pathogenic microbe labs are divided into four levels based on their safety protection capacity. The construction, alteration or expansion of level three and four labs are subject to review and approval by the MoST in accordance with national standards. Level one and two labs must be properly filed. Experiments involving highly pathogenic microbes are restricted to labs at level three or four, and subject to approval prior to commencing the experiments.
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Notably, less than one month into the implementation of the Biosafety Law, the government issued the Notice on Further Strengthening the Administration of the Biosafety of Animal Pathogenic Microbe Labs that pointed out a series of issues in the sector, including “failure to promptly file for newly built, altered or expanded level one and level two laboratories” and “unlawfully engaging in experimental activities involving high-pathogenicity animal pathogenic microbes”. Shanghai, Zhejiang, Beijing, Guangdong, Jilin and many other regions have also actively carried out the classification, recordal and oversight of pathogenic microbe labs, as well as biosafety training and inspection.
Heavier penalties
With respect to administrative liability for violating the regulations on the administration of human genetic resource materials, the Biosafety Law essentially retains the relevant provisions of the 2019 Regulations for the Administration of Human Genetic Resources (the Genetic Regulations).
However, the Biosafety Law imposes heavier penalties where a foreign organisation or individual, or an institution established or actually controlled by a foreign organisation or individual in China is involved in the collection, conservation or export of Chinese human genetic resources. If the illegal income derived from such activities exceeds RMB1 million (USD160,000), the fine will range from 10 to 20 times the illegal gains, up from five to 10 times in the Genetic Regulations.
Criminalisation
The Amendments to the Criminal Law (No. 11), implemented on 1 March 2021, set forth specific criminal acts relating to biosecurity, including the crime of jeopardising the safety of national human genetic resources and the crime of illegally disposing of invasive species. This achieves an “administrative and criminal convergence” between the Biosafety Law and the Genetic Regulations.
The amendments also added the crimes of illegally engaging in human gene editing and human embryo cloning to the existing list. Implanting a genetically edited or cloned human embryo in a human or animal, or implanting a genetically edited or cloned animal embryo in a human are considered criminal offences.
The ongoing and recurring outbreaks of infectious diseases that have been plaguing the world in recent memory have raised awareness of biosafety strategies in many countries, leading to an era of global governance reform. The promulgation and implementation of the Biosafety Law is a major step forward for China’s efforts to consolidate its biosafety line of defence. And in these efforts we can see the direction of China’s biosafety regulation – higher, and stricter.
Zhou Hanshuo is a partner and Wang Xiaoyun is an associate at Jingtian & Gongcheng
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