2020.10.26 DONG, Xiao (Marissa)、GUO, Jinghe、DONG, Junjie
On October 17, 2020, the Standing Committee of the 13th National People’s Congress voted at its 22nd session1 to adopt the Biosecurity Law (“BSL”). The Biosecurity Law has ten chapters and 88 articles, which fill the gaps in the basic law on biosecurity in China and also provides a foundation for the evolution of the biosecurity legislative framework of China.
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 draft BSL was reviewed by the 17th meeting of the 14th National People’s Congress Standing Committee for the first time. 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 the biosecurity law was expected to be accelerated. Spurred on by the COVID-19 pandemic, the introduction of the BSL was fast tracked. On April 26, 2020, a second draft of the Biosecurity Law (the “Second Review Draft”) was reviewed by the Standing Committee of the 13th National People’s Congress at its 17th session and was published for public comment.3 Within six months, on October 17, 2020, the BSL was enacted after the third round of the review. After the release of the BSL, the law will become an important part of the national security legal system, which evolves incrementally with the recent enactments of the National Security Law, the Cybersecurity Law and other legislation.
As the basic law for biosecurity, the BSL provides principled and directional provisions in various fields, 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 pathogenic microbiology laboratories; (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), covering substantially the same provisions contained in the Second Review Draft.
Compared with the Second Review Draft, there are no significant changes in the general subject matter and basic framework of the BSL. The relevant provisions of certain existing laws and administrative regulations, for example, the Infectious Disease Prevention and Control Law and the Human Genetic Resource Management Regulation are incorporated into the biosecurity legislative system, and once the BSL comes into force, many new requirements and new systems will also be established, such as a release system for biosecurity information and a biosecurity review system as detailed below.
This article will focus on the provisions of the BSL related to technology development and safety mechanisms as well as the alternations from the Second Review Draft. The BSL regarding the prevention and control of major new infectious diseases and outbreaks, animal and plant epidemics and biosecurity management in pathogenic microbiology laboratories have not been elaborated upon in this article.
On the basis of the management system set out under the Second Review Draft, the BSL clearly establishes a national biosecurity work coordination mechanism. Under such a mechanism, the central national security agency is responsible for decision-making and the discussion coordination of national biosecurity work, studying, formulating and guiding the implementation of the national biosecurity strategy and other relevant major policies, coordinating the major issues and the important work of national biosecurity, and establishing a national biosecurity work coordination mechanism; the corresponding biosecurity work coordination mechanism shall also be established at the level of provinces, autonomous regions and municipalities directly under the central government to direct the coordination of and supervise and promote the activities and programs related to biosecurity within the local jurisdiction. (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. A general office is set up under the national biosecurity coordination mechanism to take responsibility for the day-to-day operation of the coordination mechanism. (Article 11).
Compared with the Second Review Draft, the BSL specifically establishes the local biosecurity work coordination mechanism, and briefly lays out the main functions and duties of the office of the national biosecurity work coordination mechanism.
The provisions of the BSL relating to technology development and information security that are worthy of attention for companies involved in medical biotechnology and other industries in the Second Review Draft are summarized as follows:
(1) The State will Establish the Systems for Biosecurity Risk Investigation and Assessment and Biosecurity Information Sharing
The BSL stipulates that a national system for biosecurity risk investigation and assessment shall be established. The national biosecurity work coordination mechanism shall conduct biosecurity risk investigations and assessment both periodically and promptly after becoming aware of the events or circumstances giving rise to a biosecurity risk. (Article 15)
The State will establish a biosecurity information sharing system. In order to accomplish information sharing, the national biosecurity work coordination mechanism will establish a unified national biosecurity information platform, and the relevant agencies shall submit data and information relating to biosecurity to such a platform. (Article 16)
The above is substantially consistent with the provisions of the Second Review Draft.
(2) The State will Establish a Biosecurity Information Release System
The BSL stipulates that a national system for biosecurity information release shall be established. The general information about national biosecurity, information regarding warnings of major biosecurity risks, major biosecurity incidents and their investigations and resolutions, and other significant biosecurity information should be released by the applicable members of the national biosecurity work coordination mechanism within their respective functions and duties; and other biosecurity information should be released by the competent departments of the State Council and the local people's governments at or above the level of counties and the competent departments thereof. Entities and individuals are forbidden from fabricating or conveying false biosecurity information. (Article 17).
Compared with the Second Review Draft, under the BSL, the “unified national system for biosecurity information release” has been changed to the “national system for biosecurity information release”, the functions for releasing biosecurity information other than significant biosecurity information are conferred upon the competent departments of the State Council and local governments, and the provision that “without authorization, no entity or individual may release the above information” has been deleted. As so modified, the requirements for the unified release of biosecurity information are diluted, subject to details to be set out by way of supporting regulations promulgated under the BSL.
(3) The State will Establish a Biosecurity Directory and Checklist system
In accordance with the BSL, the State Council and its relevant departments shall formulate and publish directories and/or checklists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant diseases and invasive species that are related to biosecurity in accordance with the needs of biosecurity work, and adjust them accordingly. (Article 18)
Similarly to the Second Review Draft, the BSL does not clearly specify the detailed system requirements related to the security directory and the checklist of technology and important biological resource data.
(4) The State will Establish a Biosecurity Review System
The BSL stipulates that a national biosecurity review system shall be established. In order to effectively prevent and mitigate biosecurity risks, any material matter or event in the field of biosecurity which affects or could affect national security shall be notified to the competent department of the State Council for biosecurity review. (Article 20)
In accordance with Article 28 of the Human Genetic Resource Management Regulation, any supply or availability of information regarding the human genetic resources of China to foreign organizations or individuals or any entities established or actually controlled thereby, which could affect the public health, national security or public interest in China, shall be subject to a security review by the science and technology administrative department of the State Council. The security review is extended to cover the entire field of biosecurity for the first time by the BSL; nevertheless, the definition of “material matter or event” and the detailed requirements for biosecurity review are not explicitly set out in the BSL.
(5) The State will Implement the Classified Management of Biotechnology Research and Development activities
“Biotechnology research, development and application” refers to the scientific research, technology development and application activities conducted by the understanding, transformation, synthesis and utilization of organisms through scientific and engineering principles. (Article 85). The State will implement the classified management of biotechnology research and development. 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 36 and 38)
(6) Reiterate the Management System of Human Genetic Resources
The BSL reiterates the management provisions governing human genetic resources under the Human Genetic Resources Management Regulations, including:
The collection of certain human genetic resources, the preservation of human genetic resources in China, the utilization of human genetic resources in China to conduct international scientific research cooperation and the exportation of human genetic resource materials should be subject to approval; (Articles 56 and 59)
The supply or availability of information on human genetic resources to foreign organizations or individuals or any entities established or actually controlled thereby shall comply with the pre-filing or pre-notification requirements; (Article 57).
Foreign organizations, individuals and entities established or those actually controlled by them should obtain approval in accordance with the law to obtain and utilize biological resources in China; (Article 58)
Compared with the Second Review Draft, there are no significant changes in the BSL in respect of the management of human genetic resources, except for the following adjustments:
Firstly, in accordance with Article 53 of the BSL, it is the first time to explicitly emphasize the sovereignty of the State over human genetic resources and biological resources in China; and
Secondly, as to the exemptions from administrative permit requirements for human genetic resources, the purpose for “teaching and education” set forth under the Second Review Draft has been deleted from Article 56, which is consistent with the Human Genetic Resource Management Regulation.
(7) Information Security of Biosecurity Capacity Building
The BSL stipulates that the State shall formulate the plan for 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 support the development of biosecurity, and include related expenditures to support the development of biosecurity into the government budget according to the division of powers and responsibilities, 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 66)
The above provisions of the BSL are substantially consistent with the Second Review Draft and give more emphasis on the overall planning at the national level for biosecurity capacity building and add the provisions as Article 68 for strengthening the construction of the national biosecurity infrastructure.
The BSL stipulates the corresponding administrative punishments for engaging in biotechnology research, development and application activities that are prohibited in China, for engaging in biotechnology research and development activities in violation of the national best security practice for biotechnology development and research and for violating the relevant requirements on protection of human genetic resources, etc., including orders to stop illegal activities, the confiscation of illegal gains, warnings, a fine of up to 10 million RMB, legal prohibition from conducting biotechnology research, development and application for a prescribed period of time, the revocation of permits and licenses, as well as punishments for legal representatives, the principal persons in charge, the responsible persons directly in charge and other directly responsible persons.
Compared with the Second Review Draft, the conducting of biotechnology research, development or application in violation of the law will result in more severe legal liability, including the imposition of fines with a cap increased from RMB 500,000 to RMB 2 million. In addition, a new provision is added under Article 84 that any foreign organizations or individuals that transport, mail or carry hazardous biological agents into China or otherwise post a threat to China’s biosecurity shall be prosecuted for legal liability in accordance with law and be subject to other actions where necessary.
In a nutshell, there are no significant changes in the BSL in comparison with the Second Review Draft. Under the current circumstances, biosecurity has become an important factor of national security. The introduction of the BSL, as a basic law in the field of biosecurity, represents a landmark in the development of the biosecurity legal system of China. It will also lead to the formulation and promulgation of a series of further laws and regulations in the biosecurity legal system and provide more comprehensive provisions and guidance for various sectors across the biosecurity field.
It is suggested that concerned companies develop a full understanding of the requirements of the BSL and pay close attention to the evolution of the legislative and enforcement practices in the biosecurity field, particularly regarding product development, international cooperation, and the collection and use of data and other resources. It is suggested that concerned companies implement compliance measures that comply with the new rules in a timely manner.