2020.05.15 DONG, Xiao (Marissa)、GUO, Jinghe、DONG, Junjie
On April 26, 2020, a second draft of the Biosecurity Law (hereinafter referred to as the “Second Review Draft”) was reviewed by the 17th meeting of the 13th National People’s Congress Standing Committee and it has been published for public comment until June 13, 20201. According to various news reports, the draft is expected to come into effect soon, either this year or next year.
Since the 18th National Congress of the Communist Party of China, biosecurity law has been included in the national security strategy to confront the problems and challenges around biosecurity. The Standing Committee of the National People’s Congress incorporated “Biosecurity Law” into the legislative plan of the 13th National People’s Congress Standing Committee and the annual legislative work plan for 2019. In October 2019, the Biosecurity Law draft was reviewed by the 14th meeting of the 13th National People’s Congress Standing Committee for the first time. The outbreak of the coronavirus epidemic has pushed forward the introduction of the draft. On February 14, 2020, Xi Jinping, general secretary of the CPC Central Committee, emphasized the need to “promote the introduction of biosecurity law as soon as possible, and speed up the establishment of a national laws and regulations system and institution-guaranteed system of the biosecurity law”2. The legislative work for the introduction of biosecurity law is expected to be accelerated.
After the release of the Biosecurity Law, it will become an important part of the national security legal system. The National Security Law, the Anti-Terrorism Law, the Cybersecurity Law, the Overseas Non-Governmental Organizations Management Law and the Anti-Espionage Law have been promulgated since 2014.
As the basic law for biosecurity, the Second Review Draft has provided principled and directional provisions in various fields through ten chapters and 85 articles, including: (1) the prevention and control of major new outbreaks of infectious diseases and epidemics in animals and plants; (2) research, development, and application of biotechnology; (3) biosecurity management in the laboratory; (4) human genetic resources and biological resource security management; (5) the prevention of alien species invasion and the protection of biological diversity; (6) responding to drug resistance of microbes; and (7) the prevention of bioterrorism attacks and defense against biological weapons threats. (Article 2)
The Second Review Draft incorporates the relevant provisions of some existing laws and administrative regulations into the biosecurity system. For example, the draft reiterates the reporting obligations of units and individuals after discovering infectious diseases in the Infectious Disease Prevention and Control Law; it also elevates the requirements related to the management of human genetic resources under the Human Genetic Resource Management Regulation to the level of law. (Articles 54 and 55)
The Second Review Draft also stipulates and creates many new requirements and new systems, such as a unified release system for biosecurity information, a biosecurity directory and a checklist system as detailed below.
This article will focus on the provisions related to technology development and safety mechanisms. The provisions in the Second Review Draft regarding the prevention and control of major new infectious diseases and outbreaks, animal and plant epidemics, and laboratory biosecurity have not been elaborated upon in this article.
In terms of management systems, the draft clearly establishes a national biosecurity work coordination mechanism to coordinate the various behavioral elements and behavioral processes in various aspects under the draft. On the basis of giving full play to management by the different departments, any dispute and coordination issues will be solved by the coordination mechanism as a whole. 3The central national security agency is responsible for decision-making and the discussion coordination of national biosecurity work. It will also be responsible for studying, formulating and guiding the implementation of the national biosecurity strategy and other relevant major policies, coordinating the major issues and important work of national biosecurity, and establishing a national biosecurity work coordination mechanism. (Article 10) The national biosecurity coordination mechanism is composed of State Council departments such as health, agriculture and rural areas, science and technology and diplomacy, and the relevant military agencies. (Article 11).
We have paid special attention to the relevant provisions on technology development and information security that are worthy of attention for companies involved in medical biotechnology and other industries in the Second Review Draft. The relevant summary is as follows:
The Second Review Draft stipulates that national biosecurity, information regarding warnings of major biosecurity risks, major biosecurity incidents and their investigation and processing, and other information that needs to be released in a unified manner should only be released by members of the national biosecurity work coordination mechanism and related local people's government. Without authorization, no unit or individual may release the above information. (Article 15).
The relevant departments of the State Council shall formulate and publish directories or checklists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant diseases, and quarantine species that are related to biosecurity in accordance with the needs of biosecurity work, and dynamically adjust them. (Article 16) However, the draft does not clearly specify the detailed system requirements related to the security directory and the checklist of technology and important biological resource data.
“Biotechnology research, development and application” refers to the scientific research, technology development and application activities conducted by the understanding, utilization and transformation of organisms through scientific and engineering principles. (Article 82). Biotechnology research and development activities are classified into high-risk, medium-risk, and low-risk categories according to the degree of the risk of harm to public health, industrial agriculture, ecological environment, etc. Engaging in high-risk and medium-risk biotechnology research and development activities shall be carried out by a legal person or organization legally established within the territory of China, and shall be approved or filed according to law. (Articles 35 and 37)
The Second Review Draft reiterates the management provisions governing human genetic resources under the Human Genetic Resources Management Regulations, including:
International scientific research cooperation utilizing human genetic resources in China and the exportation of human genetic resource materials should be approved by the Ministry of Science and Technology.
The obligation of record-filing and security reviews regarding the provision of human genetic resources information to foreign entities and individuals (Articles 51 to 55).
Foreign organizations, individuals and entities established or those actually controlled by them should obtain the approval of the relevant departments in accordance with the law to obtain and utilize biological resources in China. (Article 56)
Conducting international scientific research cooperation utilizing biological resources should be approved by the relevant authorities in accordance with the law. (Article 57)
The Second Review Draft stipulates that People’s governments, at or above the county level, shall support the development of biosecurity, strengthen the building of biosecurity capabilities, and improve the ability and level of response to biosecurity incidents. People's governments, at or above the county level, should increase their investment in biosecurity, and include related expenditures to support the development of biosecurity into the government budget, including:
Monitoring network construction and operation;
Construction and operation of critical infrastructure;
Research and development of key technologies and products;
Investigation and preservation of human genetic resources and biological resources. (Article 64)
The draft stipulates corresponding administrative punishments for engaging in biotechnology research, development and application activities that endangers national biosecurity, as well as on units engaging in biotechnology research, development and application activities for not undertaking biosecurity risk control measures and for violating the relevant requirements on protection of human genetic resources, etc., including orders to stop illegal activities, confiscation of illegal gains, warnings, a fine of up to 10 million RMB, as well as punishments for legal representatives, the principal persons in charge, the responsible persons directly in charge and other directly responsible persons.
As a basic, systematic, comprehensive and dominant law in the field of biosecurity, the introduction of Biosecurity Law will fill the legislative gap in the biosecurity legal system that currently lacks higher-level laws, and it will play an important role in policy orientation. It is also likely to lead to the formulation and promulgation of a series of further laws and regulations in the biosecurity legal system and provide more detailed supplementary provisions on other operational and technical issues. Once the Biosecurity Law is released, we expect that companies in the biosecurity field will face stricter compliance supervision in areas such as product development, international cooperation, and the collection and use of data and other resources.