Biological Safety Law of the PRC

Legal Hierarchy: Constitution > national security law
> Biosafety Law
Order of application: Biosafety Act > National Security Act
> Constitution

The law was passed at the twenty-two th session of the 13th Standing Committee of the National People’s Congress on October 17,2020, and came into effect on 2021.

From a vertical perspective, the Biosafety Law is a part of the national security legal system. The National Security Act is the General Provisions and the Biosafety Act is the specific provisions. Other laws in the same field as the biosafety law include the PRC counterespionage law, the PRC counter terrorism law, the PRC cybersecurity law, the PRC Law on the administration of non-governmental organization activities outside China, and the PRC state intelligence law.

From a horizontal perspective, the biosafety Law corresponds to the international conventions to which China has acceded, such as the Convention on Biological Diversity, the Cartagena Protocol on Biosafety, the International Convention on the protection of new varieties of plants, and the International Convention on plant protection. It is an important domestic supporting law for China to fulfill its obligations under international conventions.

Catalog

Chapter I General Provisions

Chapter II Biosecurity Risk Prevention and Control System

Chapter III Prevention and Control of Major New or Sudden Outbreaks of Infectious Diseases and Epidemics in Animals and Plants

Chapter IV Security of Biotechnology Research, Development, and Application

Chapter V Biosecurity of Pathogenic Microbe Laboratories

Chapter VI Security of Human Genetic Resources and Biological Resources

Chapter VII Prevention of Bioterrorism and Biological Weapon Threats

Chapter VIII Biosecurity Capacity Building

Chapter IX Legal Liability

Chapter X Supplemental Provisions

Contents Analysis：Purpose of legislation

Article 1

This Law is enacted for the purposes of maintaining national security, preventing and responding to biosecurity risks, safeguarding the lives and health of the people, protecting biological resources and the ecology and environment, promoting the sound development of biotechnology, boosting the construction of a community with a shared future for mankind, and achieving the harmonious coexistence of man and nature.

NPC Standing Committee:

The general requirement of the Biosafety Law is to maintain national biosafety, the basic aim is to safeguard people’s life and health, and the main task is to protect biological resources, promote the healthy development of biotechnology and prevent biological threat. It is one of the concrete contents of the socialist diplomatic strategy with Chinese characteristics in the new era to realize bio-security and promote the construction of the community of human destiny. This reflects and expresses China’s good wishes and propositions for the harmonious coexistence of mankind. Legal definition

Article 2

For the purpose of this Law, "biosecurity" means that the state effectively prevents and responds to the threat of dangerous biological agents and related factors, biotechnology can develop steadily and healthily, neither the lives and health of the people nor the ecosystem is relatively in danger or under threat, and there is capability in the biological field to maintain national security and sustainable development.

This Law shall apply to the following activities:

(1) Preventing and controlling a major new or sudden outbreak of an infectious disease or an epidemic in animals or plants.
(2) Researching, developing, and applying biotechnology.
(3) Biosecurity management of pathogenic microbe laboratories.
(4) Biosecurity management of human genetic resources and biological resources.
(5) Preventing the invasion of alien species and protecting biodiversity.
(6) Responding to antimicrobial resistance.
(7) Preventing biological terrorist attacks and defending against biological weapon threats.
(8) Other biosecurity-related activities.

NPC Standing Committee:

The biosafety law, in accordance with the guidelines and policies of the central government on biosafety, defines the scope of application of the law in eight aspects:

First, to prevent and control major and new outbreaks of infectious diseases, animal and plant epidemics, reflecting the protection of people’s lives and health;
Second, research, development and application of biotechnology, with the focus on promoting the healthy development of biotechnology;
Third, safeguarding laboratory biosafety to ensure the safety of people and the environment as a platform for biotechnology research, development and application activities, to ensure the smooth development and application of biotechnology; to ensure the safety of China’s biological resources and human genetic resources, and to lay an important material foundation for national bio-security; and to prevent the invasion of alien species and protect biological diversity, to ensure the ecological security of our country; sixthly, to deal with the resistance of microorganisms so as to safeguard the life safety of human beings and animals; seventhly, to prevent the biological terrorist attacks so as to ensure social peace and people’s well-being; and eighthly, to defend against the threat of biological weapons, in the interests of national security.

These eight aspects and their related administrative acts are the scope of regulation and adjustment of this law.
Legal principle

Article 3

Biosecurity is an integral part of national security. In maintaining biosecurity, the overall national security concept shall be implemented, development and security shall be coordinated, and the principles of people orientation, risk prevention, classification management, and coordination and cooperation shall be upheld.

Precautionary Principle

The principle of risk prevention includes at least four aspects. First, the object of prevention includes both potential “Risk” and actual “Damage”. Since the transformation of risk into reality is damage, the prevention of risk is also the prevention of possible damage.

Therefore, this principle inherently contains the content of “Prevention of damage”. Second, the potential damage has reached a certain degree of seriousness. According to the existing legal threshold standards, preventive measures should be taken once it has been established that there is a risk of harm to human health. For the ecological environment, the degree of harm must reach “Serious” or “Irreversible” degree. Third, there is scientific uncertainty, that is, it may not be able to determine whether the corresponding modern biotechnology-related activities are necessarily leading to the occurrence of harm. This is consistent with the “Scientific uncertainty” of environmental law. Fourth, such scientific uncertainty does not constitute a reason to oppose or delay preventive measures against damage.

Classification Management Principle

Classified management refers to the life cycle of a biosafety risk from its origin to its final outcome, different types of biotechnology as well as different sources of biosafety risks have different degrees and ranges of risks and hazards to human health, ecological environment and homeland security. Therefore, different types of control measures need to be developed for different types of target groups such as biotechnology, root causes and risks and related activities.

Synergy Principle

Synergy is the process by which a country regulates biosafety issues, collaboration and cooperation among relevant government departments, stakeholders and the general public as well as between national and foreign governments through statutory procedures and mechanisms. It aims at protecting human health, ecological environment and homeland security, and taking into account the development of biotechnology and industry.

Stakeholders

There are multiple stakeholders in biotechnology R & D, involving at least five types of stakeholders (5p): Principal Investigator, project, premises, provider of genetic material, and purchaser. In order to achieve the goal of biosafety regulation, it is necessary to set up a mechanism of cooperation and self-regulation among these stakeholders. Mutual supervision through the whole R & D chain is needed to prevent some stakeholders from using improper means to seek illegal benefits to the detriment of the legitimate rights and interests of other stakeholders.

Between the state and the public

The highly specialized and complex nature of biosafety issues justifies top-down control by the political elite. At the same time, however, it is important to avoid creating or deepening mistrust of biotechnology achievements and products as a result of insufficient public information, which could lead to obstacles to the implementation of national policies and regulatory systems.

To this end, legislation also takes a bottom-up participatory management approach that reflects public opinion. For example, through the provision of information, public consultation, participation in decision-making and other mechanisms of public participation, to understand and incorporate public concerns and views, and on the basis of which relevant decisions are formed. This can promote the consensus of biotechnology policy, but also more conducive to the smooth implementation of biosafety regulation.
International cooperation

Due to the cross-border nature of biosafety issues, the occurrence of biosafety incidents or disasters will not only lead to the imbalance of ecosystems, but may also lead to national security risks. This is all the more urgent in preventing major outbreaks of infectious diseases, bioterrorism and the dangers of biological weapons. The spread of the COVID-19 in the world is a validation of the biosafety field “The world is a community of Destiny”.

Therefore, in the area of biosafety, there is also a need to establish and strengthen cooperation between states in the areas of entry and exit controls, exchange of information, transfer of technology and capacity-building in order to make mutually beneficial and win-win choices. Legislation on bioethics

Article 7

People's governments at all levels and their relevant departments shall strengthen the publicity on and dissemination of biosecurity laws and regulations and biosecurity knowledge and guide basic mass self-governing organizations and social organizations in publicity on biosecurity laws and regulations and biosecurity knowledge publicity, so as to promote the enhancement of whole society's awareness of biosecurity.

Relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall incorporate biosecurity laws and regulations and biosecurity knowledge into the content of education and training and strengthen the building of students and professionals' awareness of biosecurity and ethics. The news media shall give public welfare publicity to biosecurity laws and regulations and biosecurity knowledge, conduct public opinion supervision of biosecurity violations, and enhance the public awareness of social responsibility for maintaining biosecurity.

Article 34

The state shall strengthen the security management of biotechnology research, development, and application activities and prohibit biotechnology research, development, and development activities that jeopardize public health, harm biological resources, damage ecosystems and biodiversity, or otherwise endanger biosecurity.

Biotechnology research, development, and application activities shall conform to ethical principles.

Article 40

Clinical research on new biomedical technology shall pass ethical review and be conducted in a medical institution with corresponding conditions; and clinical research operations related to human subjects shall be conducted by health professional technicians who meet corresponding conditions.

Article 55

The collection, preservation, use, and outbound supply of China's human genetic resources shall conform to ethical principles and be without harm to public health, national security, or public interest.

There are three main ways to regulate bioethics in the world: The first is to make prohibitive provisions. The second is to identify specific regulatory instruments, the most typical of which is ethical review. The third is to make relevant provisions on punishment. When the Biosafety Act (Draft) was consulted, most departments and experts advised a prudent use of ethical review. To this end, the “Draft” made a clear ban on the violation of bioethics, and the actual conduct of the violation of bioethics, including penalties.

Ps: The Declaration on the concept of science adopted by the Chinese Academy of Sciences states: “In view of the positive and negative effects of modern science and technology, and its highly professional and professional characteristics, scientists are required to be more conscious of evading the negative effects of science and technology and assume the responsibility of evaluating the consequences of science and Technology. This includes examining and evaluating all possible consequences of your work. Change or even interrupt one’s own work once a defect or danger is discovered. If scientists can not make a decision on their own, they should suspend or suspend their research and Alert Society.”

Research, development and application of biotechnology

Article 35

An entity engaged in biotechnology research, development, and application activities shall be responsible for the security of its biotechnology research, development, and application, adopt biosecurity risk prevention and control measures, formulate rules of biosecurity training, tracing and inspections, regular reporting, and other work, and strengthen process management.

Article 36

The state shall exercise classification management of biotechnology research and development activities. According to the degree of risk of harm to public health, the industrial sector and agriculture, and the ecology and environment, among others, biotechnology research and development activities shall be classified into three classes: high risk, medium risk, and low risk.

The risk classification standards for and catalog of biotechnology research and development activities shall be formulated, adjusted, and released by the science and technology, health, and agriculture and rural affairs departments of the State Council in accordance with the division of responsibilities, in conjunction with the other relevant departments of the State Council.

Article 37

Biotechnology research and development activities shall be conducted in compliance with the national standards of practice for security management of biotechnology research and development.

To conduct biotechnology research and development activities, the risk class shall be judged, close attention shall be paid to changes in risks, and response measures shall be taken promptly.

Article 38

High-risk and medium-risk biotechnology research and development activities shall be conducted by an incorporated organization established within the territory of China, with approval obtained or a filing made in accordance with the law.

To conduct high-risk and medium-risk biotechnology research and development activities, a risk assessment shall be conducted, and a risk prevention and control plan and an emergency plan for biosecurity incidents shall be formulated to reduce risks in research and development activities.

Article 39

The state shall exercise traceability management of biosecurity-related important equipment and special biological agents. The purchase or introduction of important equipment and special biological agents on the control list shall be registered to ensure traceability and filed with the relevant department of the State Council. An individual shall not buy or be in possession of any important equipment or special biological agent on the control list.

Article 40

Clinical research on new biomedical technology shall pass ethical review and be conducted in a medical institution with corresponding conditions; and clinical research operations related to human subjects shall be conducted by health professional technicians who meet corresponding conditions.

Article 41

The relevant departments of the State Council shall trace and access biotechnology application activities in accordance with the law and take effective remedial and control measures in a timely manner, if a biosecurity risk is discovered.

In order to prevent and respond to biosecurity risks, the Biosafety Law has established 11 basic systems, including the Biosafety Risk Monitoring and early warning system, the risk investigation and assessment system, the information sharing system, the information release system, the Directory and list system, the standard system, the Biosafety Review System, the Emergency Response system, the investigation and tracing system, the national access system and the response system for major biosafety incidents abroad.

In addition, the law establishes a biological safety supervision and inspection system and a legal liability system, and clarifies the authority of law enforcement agencies to carry out law enforcement inspections and the duty of cooperation of the units under inspection. If any illegal act occurs, the law enforcement agencies will pursue the legal responsibility of the law-breakers.

Reference

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As early as the 1970s, the Convention on the prohibition of the development, production, stockpiling of bacteriological (biological) and toxin weapons and on their destruction entered into force. China acceded to the convention in 1984.

In the 1990s, although the development of biotechnology is still immature, its development security has attracted the attention of the international community. Therefore, as early as 1992, the international community began to develop legal documents in the field of biosafety, including the Rio Declaration and the Convention on Biological Diversity. Since then, after four years and 10 rounds of negotiations, in order to finalize the contents of the relevant legal documents, Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

On access to genetic resources and the fair and equitable sharing of benefits arising from their utilization have been published, entry into force of a land-based complementary agreement as a document of the Convention on Biological Diversity.

The main elements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity include but are not limited to: objectives and scope of application, prior informed consent procedure, risk assessment and risk management, clearing house, capacity-building, public awareness and participation, liability and redress, monitoring and reporting.

In addition, China has also acceded to the Ramsar Convention, the Convention for the protection of the world cultural and natural heritage, the International Convention for the Regulation of Whaling, the United Nations Convention to Combat Desertification, the United Nations Framework Convention on Climate Change and the Convention on the protection of new plant species. These treaties are all dedicated to the protection of biosecurity.

We’ve been keeping an eye on international developments in our experiments and the human practice. We make sure that every step is in line with international regulations. We are also thinking about the challenges synthetic biology poses to international legislation. These are areas that we will be glad to explore in the future.

Questionnaire design

In the process of questionnaire design, we have fully reviewed the content of our questionnaire.

First of all, in terms of basic information collection, we don’t make much reference to the personal information of the person who filled out the questionnaire. And we made a privacy statement beforehand. Second, when designing the questionnaire, we try to be as clear as possible so as not to produce unreliable and unverified results. In addition, in expressing the problem, we present the problem in a dispassionate manner. When it comes to technical terms within synthetic biology, we have conducted an ethical review to avoid potential adverse effects on interviewees. Thirdly, we fully respect the wishes of interviewees and have been patient in listening to and answering any questions they may have about bioethics. If they have any questions about the ethical issues involved, we will immediately stop the investigation and destroy the questionnaires they have filled out.

Interview with patients

We have conducted several simultaneous interviews with patients with diabetes mellitus type 1. This has brought helpful feedback to our entire project. First, we communicate in a gentle and appropriate manner, with full respect for the patient’s psychological condition. Second, before we started, we issued an Informed Consent Form for the interviewee. The interview begins after the patient reads and signs. Third, in the course of the interview, we conducted a self-examination of the requirements of bioethics in accordance with the law and regulations, and in no way violated them. Finally, all of our patient data is tightly controlled and protected. In addition to the necessary documents to be archived, we will complete the final data destruction after the end of the project.

Social concern

When we do experiments and various types of human practice, it inevitably draws the attention of the public. Ethical issues arising from modern biotechnology, including the conflicts between biotechnology and human beings and the natural environment, as well as the attitude of countries towards modern biotechnology. After receiving the feedback, we look forward to the development trend of synthetic biotechnology. Through the ethical construction of modern biotechnology, it can better promote the development of human society. How to promote the development of synthetic biology ethics research in the process of our iGEM project is also a question we have always been thinking about.

Our great emphasis on safety runs through the process of experimentation and human practice. When it comes to safety, we focus on three areas: Laboratory Safety, bioethics safety and intellectual property safety. In terms of laboratory safety, we followed the relevant laws and regulations of China, and the of synthetic biology industry. In addition, we have made our own laboratory rules and were strictly abide by them. In the aspect of bioethics safety, we asked the members of the team who are specialized in law as consultants to make authoritative interpretation and thereby form a manual of ethics guideline for everyone in the team. In the aspect of intellectual property safety, we carried out the self-determination of intellectual property protection of three categories respectively, according to patent, trademark and copyrights. Besides, we made a specification GUIDELINE to guide all iGEM teams to carry out intellectual property protection in the future.

In the field of safety, We are committed to complying with the relevant laws and regulations in force in the China. We have a law student as part of our team. On safety, we have more than once had a discussion and study of collective laws and regulations. We obey the law strictly and all actions are required by law. Our team has always attached great importance to laws and regulations. This is essential not only for the proper functioning of the project, but also for the development of synthetic biology as a whole.

Biological Safety Law of the People’s Republic of China


http://www.gov.cn/xinwen/2020-10/18/content_5552108.htm

Regulations for the implementation of the Drug Administration Law of the People’s Republic of China


Regulations on the biosafety management of pathogenic microorganism laboratories

In the field of laboratory safety, we have laid down strict rules and regulations and have been carrying them out. Before starting the experiment, every member read the lab’s guidelines. In particular, the experimental group leader, led the study of the relevant provisions. Even students who don’t need to do wet work in the lab are familiar with the rules.

In the field of intellectual property safety, we began to pay attention to the protection of intellectual property right from the beginning of the project design. Not only have we conducted in-depth research in the field of intellectual property, but we feel privileged to make our own unique contribution to the popularization of intellectual property in the relatively new field of synthetic biology. We hope that our IP guideline will help current and future iGEM teams better protect their IP rights.

Intellectual property, also known as “Ownership of knowledge”, refers to “The owner of intellectual labor to enjoy the fruits of property rights”, generally only a limited period of time. Intellectual creations such as inventions, designs, literary and artistic works, and logos, names, and images used in commerce can be considered intellectual property owned by a person or organization. According to Professor Mark Lemley of the Stanford Law School, the term “Intellectual property”is widely used after the establishment of the World Intellectual Property Organization in 1967.

Patents

A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.

（https://www.wipo.int/patents/en/ ）

Trademarks

A trademark is a mark used to identify and distinguish the source of a good or service. Any mark that distinguishes the goods of a natural person, legal person or other organization from those of others, including words, figures, letters, numbers, three-dimensional signs, colors, combinations and sounds, as well as a combination of the above elements, can be applied for registration as a trademark.

Copyrights

Copyright is the legal ownership of the right to reproduce computer programs, literary works, musical works, photographs, games, movies, etc. . Unless transferred to another party, the copyright is usually assumed to belong to the author. Copyright only protects the expression of ideas, not the ideas themselves. Algorithms, mathematical methods, techniques, or machine designs are not protected by copyright.

（https://searchsecurity.techtarget.com.cn/whatis/11-25126/）

Guide for IP protection

Another resource we hope will help future iGEM teams to protect IP rights or inform people interested in IP protection is the guide we have created. We created a generic guide to protect your produce based on the steps we planned out for our project. Due to the nature of our project being an Innovative and practical design, we had to specialize certain steps to ensure the IP of our project is fully protected. Examples include regulate insulin secretion with glucose concentration along with blue light and miR21 inhibit the insulin secretion in a feedback way, forming a close loop.

How to use it

This guideline takes the form of a flow chart to make it easy for the iGEM team to review their position at any time. This guideline guides the right steps at this point and provides the right guidelines for the next steps. When used, make sure that the meanings of the various specialized terms in the guideline are understood in the correct way.

Derwent Innovations Index (Web of Science)

Merges patent information from Derwent World Patents Index with the patent citation information from Derwent Patent Citation Index. Users can conduct patent and citation searches of inventions in chemical, electrical, electronic, and mechanical engineering.

United State Patent and Trademark Office (USPTO)

The United States Patent and Trademark Office (USPTO) is the federal agency for granting U.S. patents and registering trademarks.

The Lens

An open global cyber infrastructure to make the innovation system more efficient and fair, more transparent and inclusive. It serves many of the patent documents in the world as open, annotatable digital public goods that are integrated with scholarly and technical literature along with regulatory and business data.

Canadian Patents Database (CIPO)

CIPO's Canadian Patent Database allows you access 150 years of patent descriptions and images. Espacenet: European Patent Office Search Searches through patent documents filed with the European Patent Office, along with 81 other jurisdictions.

WIPo Patentscope

Searches through international patent applications along with patent documents from a large number of national patent offices.

Google Patent Search

Allows for full-text searching of patent grants and applications from the United States and several other major jurisdictions.

[1]安青虎. 品牌与商标(二)[J]. 工商行政管理, 2006(08):63-66.
[2]Patents - How to find resources by format - Research Guides at University of Minnesota Minneapolis (umn.edu)
[3]https://www.wipo.int/patents/en/
[4]https://searchsecurity.techtarget.com.cn/whatis/11-25126/