Biosecurity is a new area of the national security system, and the basic law, Biosecurity Law (“the law” hereinafter), is expected to be officially implemented in October after several rounds of deliberations. Biosecurity Law is a regulation occupies a vital position in the legislation filed, covers a wide range of fields and highly technical. The party who breaks the law may face a huge penalty of up to 10 million yuan or ten times the illegal income and serious criminal liability. As the first article, we will start with the basic legal concepts of biosecurity, and explain the legislative background and important content of the draft. We will also continue to follow up and provide our further interpretation and explanation after the formal approval of the law.
1. What is “Biosecurity”?
According to the second draft of the Biosecurity Law (“Second Review Draft”), Biosecurity refers to the capacity that the state can effectively response to the biological factor and other related factors threats, maintain stable and healthy development in the biological field, keep the interest in a relatively safe and threat-free status, and ensure sustainable development and continued safety. In terms of application scope, the “Biosecurity Law” governs all activities related to biosecurity.
Specifically, the following activities are applicable to the Biosecurity Law:
- The prevention and control of major new outbreaks of infectious and animals and plants epidemics;
- Research, development, and application of biotechnology;
- Biosecurity management in the laboratory;
- Human genetic resources and biological resource security management;
- The prevention of alien species invasion and the protection of biological diversity;
- Microorganisms resistance management;
- The prevention of bioterrorism attacks and biological weapons threats defense;
- Other activities related to biosecurity.
The above activities subject to scientific activities, and are neutral and constantly developing. However, the actual risks of using scientific activities and technology to endanger national security and biosecurity objectively exist. Therefore, it is necessary to issue the “Biosecurity Law” to delimit the development of bio-related activities at the legal level.
2. The Covid-19 Pandemic Accelerates the Legislation Work
Before the outbreak of the Covid-19, the concept of “biosecurity” may be relatively unfamiliar. Biosecurity is actually an important part of national security, as early as April 15, 2014, General Secretary Xi Jinping clearly put forward the concept of “Holistic National Security Concept” for the first time, which includes ecological security. On February 14, 2020, after the outbreak of Covid-19, General Secretary Xi Jinping pointed out over the 12th meeting of the Central Committee for Comprehensively Deepening Reforms, that “biosecurity shall be included into the national security system” and “speed up the establishment of a national biosecurity laws and regulations system and institutional frameworks”.
On the one hand, with the rapid development of international and domestic biotechnology, cutting-edge issues are emerging one after another. The development of the technology needs to be regulated urgently. On the other hand, with the outbreak of Covid-19, the importance of biosecurity on national security has become particularly prominent. However, under our current national security legislation, biosecurity legislation is relatively backward. Consequently, under certain circumstances, we could not found a clear and systematic legal basis for our prevention and control towards the Covid-19. Therefore, the enactment of the Biosecurity Law is urgently required.
In fact, the “Biosecurity Law” has long been incorporated into the legislation plan of the Standing Committee of the Thirteenth National People’s Congress and the legislative work plan for 2019 and 2020. On October 21, 2019, the “Biosecurity Law (Draft)” was first submitted to the Standing Committee of the 13th National People’s Congress for deliberation. After that, the second review draft was reviewed on April 26, 2020, and the opinions were solicited from all sectors of society on the China National People’s Congress website from May 3 to June 13, 2020. It is understood that the “Biosecurity Law” is likely to be officially issued after the third review by the Standing Committee of the National People’s Congress in October this year.
3. International and domestic biosecurity legislation practice
Biosecurity is an international issue. As early as 1972, the United Nations adopted the “Biological Weapons Convention”, and subsequently adopted a series of biosecurity related international conventions such as the “Biodiversity Convention” and the “International Convention for the Protection of New Varieties of Plants”. As a country with rich biological resources, China has already joined above said conventions and made commitments to fulfill the related treaties.
In China, although there is no basic law in the field of biosecurity before, in fact, relevant legislation has been implemented since the 1980s. The main features are as follows:
3.1 Main 12 fields:
3.2 Multiple in-charge government authorities
Biosecurity involves and covers a wide range of fields, and belonged to different authorities according to different fields, mainly including the National Health Commission, the Ministry of Ecology and Environment, the Ministry of Agriculture and Rural Affairs, the Ministry of Science and Technology, the Ministry of Commerce, the General Administration of Customs, the State Administration for Market Regulation (including the National Medical Products Administration, etc.), the State Forestry and Grassland Administration, etc.
3.3 Nearly a hundred laws, regulations and rules are involved
From the legal level, there are “Law on Prevention and Treatment of Infectious Diseases” and the “Frontier Health and Quarantine Law”. At the level of administrative regulations, there are the “Regulation on Responses to Public Health Emergencies”, “Regulation on the Administration of Human Genetic Resources”, and “Regulation on the Bio-safety Management of Pathogenic Microbe Labs”, etc. In addition, many departmental rules or regulatory documents also play a special role in certain biosecurity-related fields. Based on our research, currently there are nearly a hundred laws and regulations in the biosecurity field in China.
The existing legislation can protect biosecurity interests from different perspectives. However, as different departments issue the regulations, and some of them were issued comparatively early and have outdated legislative concepts with low level of validity, thus these regulations also have limitations in binding force, enforceability, coordination and comprehensiveness. Therefore, it is urgent to formulate and develop a governing biosecurity act from the law level.
4. Interpretation of the Second Review Draft
4.1 High-risk industries and fields
According to the “Second Review Draft”, China will establish a “National Coordination Mechanism for Biosecurity Work”, which is composed of the health, agriculture and rural, science and technology, diplomatic and other competent departments of the State Council and relevant military agencies. In addition to these departments, the “Second Review Draft” also stipulates that the in-charge departments such as Customs, ecological environment department, medical products supervision department, forestry and grassland department shall supervise and manage specific biosecurity activities.
According to the applicable scope and above-mentioned authorities, we could foresee that the following activities and areas related to biosecurity may become the focus of supervision in the future. Companies engaged in biotechnology, medicine, agriculture, livestock, food, cosmetics and other industries need special attention regarding below issues.
- Animals and plants importation/exportation
- Research, development and application of biotechnology
- Establishment and experiment of pathogenic microbe labs
- Collection, preservation, utilization and external provision of human genetic resources
- Introduction of alien species
4.2 Important mechanism innovation
First, with regard to the specific biosecurity related risk prevention and control system, China has established a biosecurity risk monitoring and early warning system, a biosecurity information sharing system, a biosecurity directory and checklist system, a biosecurity emergency system, a biosecurity incident investigation and traceability system, and a national access system for entry animals and plants based on risk analysis.
Second, with regard to the security of biotechnology research, development, and application, it is stipulated that the purchase or introduction of related equipment and biological factors should be registered in accordance with the control list of important equipment and special biological factors. Biotechnology research and development activities are subject to categorized management. A domestic legal person that is approved or filed according to law can only carry out high-risk and medium-risk activities.
Third, with regard to laboratory biosafety, there are strict principles for management of pathogenic microbe labs. Not only does the establishment of pathogenic microbe labs require approval or filing, the activities of laboratories at all levels are also restricted accordingly under the categorized management. In addition, China also applies security review on pathogenic microbe labs set up by foreign investors.
Fourth, with regard to the safety of human genetic resources and biological resources, agencies established or actually controlled by foreign organizations, individuals and institutions shall not collect and preserve Chinese human genetic resources in China. Their obtaining and utilization of biological resources in China also need approval.
4.3 A penalty up to ten million yuan coexist with criminal risks.
Chapter 9 of the “Second Review Draft” stipulates the administrative responsibilities for violating the “Biosecurity Law”. It is worth noting that in the following two situations, a maximum penalty of ten million yuan or ten times of the illegal income can be imposed.
One is, in violation of the law, to engage in biotechnology research, development and application activities that endanger national biosecurity.
The other is, in violation of the law, agencies established or actually controlled by foreign organizations, individuals and institutions collect and preserve Chinese human genetic resources in China, or provide Chinese human genetic resources to overseas entities.
In addition, for some illegal activities, the legal representative, the main person-in-charge, the direct responsible person-in-charge and others relevant direct responsible person will be punished according to law and be prohibited to engage in relevant activities during a certain period.
More significantly, the article 70 of the “Second Review Draft” stipulates that if the violation of the Biosecurity Law constitutes a crime, the relevant person or entity will be prosecuted for criminal responsibility in accordance with the law. According to the relevant provisions of the Criminal Law, the possible crimes are as follows:
|The Articles of the Criminal Law||Crimes||The maximum statutory penalty||Entity crime or not|
|Article 151||Crime of Smuggling Goods or Articles Prohibited from Import and Export||No less than five years of fixed-term imprisonment with certain amount of penalty||YES|
|Article 330||Crime of impairing the Prevention and Treatment of Infectious Diseases||No more than seven years fixed-term imprisonment||YES|
|Article 331||Crime of Spreading Bacterial or Viral Strains of Infectious Diseases||No more than seven years fixed-term imprisonment||NO|
|Article 332||Crime of Impairing Frontier Health and Quarantine||No more than three years of fixed-term imprisonment with certain amount of penalty or penalty only||YES|
|Article 337||Crime of Impairing Animal and Plant Epidemic Prevention and Quarantine||No more than three years of fixed-term imprisonment with certain amount of penalty or penalty only||YES|
|Article 338||Crime of Environmental Pollution||Three to seven years of fixed-term imprisonment with certain amount of penalty||YES|
|Article 398||Crime of Intentionally Divulging State secrets, Crime of Negligently Divulging State secrets||Three to seven years of fixed-term imprisonment||NO|
|Article 409||Crime of Negligence in the Prevention and Treatment of Infectious Diseases||No more than three years of fixed-term imprisonment||NO|
In addition, in order to connect with the “Biosecurity Law”, the “11th Amendment to the Criminal Law (Draft)” also provides for new clause on biosecurity crimes, including crimes of seriously endangering the security of national human genetic resources, crimes of illegal human gene editing and embryo cloning, and crimes of illegally disposing of invasive alien species
Currently, the Covid-19 is still raging around the world. For China, the prevention and control of the Covid-19 may become the “New Normal Condition” for a period of time. Attaching great importance to biosecurity and issuing an official “Biosecurity Law” is one of the best responses to Covid-19. On the other hand, for domestic and foreign enterprises engaged in biotechnology research, development, and application activities, the compliance challenge in biosecurity is also unprecedented. It is recommended that relevant enterprises pay close attention to the legislative developments of the Biosecurity Law and related regulations, take precautions, and make biosecurity compliance a top priority for their own interests and also from national security perspective, and escort the biotechnology research, development, and application activities.
 The “Codification of PRC Biosecurity related Laws, Regulations and Rules” (compiled by the China National Center of Biotechnology Development and published by the Scientific and Technical Documents Press in 2019) classifies the current laws, regulations and rules related to biosecurity in accordance with the twelve fields.