On 30 April 2020, the National People’s Congress of China (the “NPC”) published the Biological Safety Law (Draft for Second Reading) (the “Draft Law”) for public consultation until 13 June 20201. Upon promulgation, this will become the first comprehensive law providing a unified legal framework to regulate biological safety in China, which constitutes a critical aspect of the conservation of biological diversity and has also been deemed by China as “part of the national security”2.
This Legal Update provides the background to and an overview of the Draft Law and discusses some specific aspects of it.
China became a party to the Convention on Biological Diversity in 1993. On 6 September 2005, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the “Cartagena Protocol”) also entered into force for China. Since then, the country has put in place disparate regulations, including 1) those implementing the Cartagena Protocol, with a focus on the regulation of transboundary movement of living modified organisms (such as the Regulations on the Safety Administration of Agricultural Genetically Modified Organisms and their implementation rules) and 2) those governing the other aspects of biological safety in a broader sense such as the control of infectious diseases, the protection of human genetic resources, the safety management of biotechnology and the laboratory biosafety management.
The enactment of the Biological Safety Law officially kicked off in 2019 one of whose purposes is to close the loopholes in the current legal framework. The COVID-19 outbreak has apparently pushed forward the legislative procedure.
What is Biological Safety, Legally Speaking?
“Biological safety” is defined as the situation where:
- “the State effectively responds to threats from biological and related factors and maintains stable and healthy development in the biological field”;
- “the interest (of the State) is relatively free of danger and threat”; and
- “the State possesses the capacity of ensuring sustainable development and continued security”.
More specifically, the Draft Law applies to:
- Prevention and control of major new outbreaks of epidemics;
- Research, development and application of biotechnology;
- Laboratory biosafety management;
- Safety management of human genetic resources and biological resources;
- Prevention of the invasion of alien species and the conservation of biodiversity;
- Activities involved in responding to drug resistance of microorganisms;
- Prevention of bioterrorism and the defence against biological weapons threats; and
- Any other activities relating to biological safety.
- The establishment of a biological safety risk control scheme
The Draft Law requires China to establish a “national biological safety coordination mechanism” consisting of representatives from various departments of the State Council and the military. Among others, the coordination mechanism will be responsible for performing biological safety risk assessments with a view to, among other things, guiding the establishment of biosafety-related lists to include materials, equipment, technologies, activities and important data on biological resources, which would be subject to prioritised control.
In particular, the Draft Law requires the relevant authorities to establish a risk-based “national entry” scheme, under which animals and plants, animal and plant products and the “high-risk biological factors” entering the country for the first time or resuming entry after suspension will be subject to specific quarantine requirements, and the relevant foreign entities which manufacture, process, store or export such products will be subject to registration or filing requirements.
- Prevention and control of major new outbreaks of epidemics
On this specific front, while the Draft Law places most of the burdens on the authorities, it also imposes a reporting obligation on companies and individuals.
More specifically, the Draft Law requires “any entity or individual” to report the discovery of an infectious disease or an animal or a plant epidemic to a medical institution, a professional institution or the relevant authority “in a timely manner”. Such an entity or individual must not conceal, misreport, delay in reporting or omit to report such a disease or epidemic, or incite others to do so.
The Draft Law places various obligations on entities which engage in the “research, development and/or application of biotechnology” (the “RDA”), including complying with the ethical rules, submitting a registration for the purchase or import of certain “important equipment and/or special biological factors involving biological safety”.
Among other things, the competent authorities will classify the R&D activities under three categories – high-risk, medium-risk or low-risk. Only legal entities established in China can conduct high-risk and medium-risk R&D activities, , subject to an approval or a filing process.
The bottom line is that the Draft Law prohibits:
- Any RDA that may endanger national biological safety; and
- Any individual from purchasing or possessing any “important equipment and/or special biological factor involving biological safety”.
The other notable, specific aspects of the Draft Law, as well as its implications for companies operating in and outside China, are further discussed in Part II of this Legal Update.
2 Indicated by President Xi Jinping at the 12th meeting of China’s Central Commission of Comprehensively Deepening Reform on 14 February 2020 http://www.gov.cn/xinwen/2020-02/14/content_5478896.htm, and also confirmed in Article 3 of the Draft Law.