新冠疫情视角下生物技术风险化解与法律规制

葛倩倩 王金金

Absract： Biotchnology risk response must be considered， before science and technology cautiously promotes the development and innovation of biotechnology for COVID-19 prevention and control， on the basis of risk prevention. The prevention and control of biosecurity threats should proceed within the law and properly handle the biotechnology risks in COVID-19 research under legal norms. The goal is to reshape the principles and attitudes for the development of biotechnology， to prevent and dissolve any ambiguity caused by the application of biotechnology， to create a suitable space for the growth of biotechnology under the rule of law， and to realize the harmonious development of biotechnology and human society under the regulation of law. The Biosecurity Law of the People's Republic of China was promulgated on October 17， 2020， improving the legal and normative system in the field of biotechnology and providing guidance for the healthy development of biotechnology. With the increasingly prominent position and the important role of biotechnology in national development systems， it is a critical legal proposition in the era of biotechnology to establish fair laws and regulations of biotechnology to achieve good governance in the field of life science， thereby establishing and protecting public welfare in the development process of biotechnology.

Key words： biotechnology risks， risk mitigation， legal regulation， COVID-19 Pandemic

CLC： D 912                     DC：A                        Article ID：2096-9783（2021）01-0140-09

1. Introduction

The biosafety risks posed by biotechnology demonstrate the power of science and technology while showing that such technology involves huge hidden risks. The new round of the biotechnological revolution has penetrated all fields of human society and aroused the close attention of the international community. At a time when the global COVID-19 crisis requires urgent responses， the vast majority of countries and regions in the world have exposed weaknesses in their biosafety systems. In 2020， Liu Chong and Deng Wenjia point out that due to the global spread of COVID-19， the complex changes and wide application of emerging biotechnology have posed severe challenges to the system of balancing interests and risks established by traditional laws[1]. In 2019， Wang Xiaoli points out that the risk of biotechnology is the risk caused by the violation of the law of technology itself and the original intention of technology development in the process of human development and the utilization of biotechnology[2]. This risk is often characterized by great difficulty in prediction， strong economic and social relevance， and major threats to overall national security.

Certain biomaterials， biotoxins in laboratories， potential pandemics， and introductions of invasive species into ecosystems have long been recognized as risk issues that affect public health and the environment. From bacteriology in the late 19th century， to aerobiology and virology in the mid-20th century， to biotechnology such as genetic engineering， gene editing and synthetic biology， hidden risks have always existed because of the "dual use" of technology. At the practical level， governments attach great importance to the risk of biotechnology. Countries such as America， Britain， and Australia have issued national strategies for biological safety to strengthen biological safety management at home and abroad. The overall goal is to build a comprehensive， international， biological defense system. The risk of biotechnology is also an important area of research for many institutions. The European Commission， the Royal Society， the German Research Foundation， and others have all carried out studies on biosafety， security risk assessment， and regulatory principles. In the academic world， Ghasemi and Karami （2019） point out that researchers have begun to pay attention to the ethical aspects of biotechnology issues， regarding morality and ethics as important factors affecting risk perception[3]. On the one hand， Van Wezel （2017） emphasizes the establishment of systematic risk prevention and control measures from the aspects of system， laws and regulations， ethics， and public opinion guidance[4]. On the other hand， in the era of globalization， Sandberg and Nelson （2020） point out that due to the differing regulatory approaches in different countries， most effectively managing the risks and benefits arising from the progress of gene technology requires a better understanding of the similarities and differences of the various national regulatory systems in[5]. There is a great need to strengthen global cooperation and establish multi-level prevention and protection actions. In general， in the process of studying the risks of biotechnology， scholars mainly focus on the frontier emerging fields of biotechnology and the forward-looking， pioneering， and exploratory major technologies in the field of biotechnology; they focus on the analysis of gene engineering and gene editing in the field of genetic engineering， as well as synthetic biology and other technical fields.

Driven by the Third Technological Revolution， human society began to become what Ulrich Beck called a "risk society" in the 20th century. Technological risks represented by biological technologies such as gene editing， synthetic biology， and stem cell manipulation are rapidly rising to become the most important risks in a modern risk society. In 2006， WHO points out that lab biosafety and the narrow sense of technical biotechnology risk are two sides of the same coin， but the latter focuses on "the protection， control， and accountability of valuable biomaterials in the laboratory with the aim of preventing unauthorized access， loss， theft， abuse， transfer or intentional release"[6]. In the age of big data， Sture and Whitby （2013） point out that not only must biomaterials be well controlled， but "equal attention must be paid to information， knowledge， processes， practices， and equipment related to potentially or actually dangerous biomaterials"[7]. The major risk of biotechnology is that it is difficult to predict; has strong economic， social， and political relevance; and can greatly threaten overall national security. Problems exist： At the operational level， how do we define risks， who decides what those risks are， and how do we address them？ Jasanoff and Sarewitz （2015） point out that the identification of technical risks is often made by the scientists themselves， rather than involving a broader group of stakeholders， which can lead to a rather narrow definition of the risks involved[8]. To this end， they suggest using a more inclusive and democratic approach to define and deal with risks.

2 Risks in the Development of Biotechnology in the Context of COVID-19

It is assumed that the COVID-19 outbreak started in Wuhan， China， in January 2020. By January 30， the number of confirmed COVID-19 cases had surpassed that of SARS in 2003. By August 27， China had reported 90，293 confirmed COVID-19 cases and 4，720 deaths. As of August 27， 2020， the disease had spread to 215 countries and regions， with more than 23 million cases and a confirmed death toll exceeding 810，000. Confirmed cases in the U.S. numbered above 5.85 million， and the U.S. cumulative death toll exceeded 1800001. Although COVID-19 is well under control in China， the force of COVID-19 is still strong in the international community. COVID-19 has brought pain to all humanity， and the epidemic is still spreading around the world， plunging the world economy into a severe recession. In the face of the COVID-19 pandemic， we need to recognize the inherent character of biotechnology， which， along with technological change and social interaction， benefits human society but also poses security threats and risks.

2.1 Consideration of Ecosystem Security Risks

Risk refers to the possibility or opportunity of suffering danger， loss， injury. From the perspective of safety science， risk is the possibility and consequence of a specific hazardous event. In this paper， risk refers to the harm that biotechnology may cause to human health or the ecological environment. Modern technologies， such as biotechnology， based on risk society theory， have brought human society into what Ulrich calls a "risk society"， in which "productivity loses its innocence， wealth gains from technological progress and becomes increasingly the dark side of risk production." In this view， technology is not only a way to solve problems; it is also a troublemaker"[9]. The prosperity and development of biotechnology have gradually become an important force to promote the progress of human society and industrial innovation.

Like other scientific and technological achievements， the development of biotechnology has a two-sided nature. On the one hand， it has solved many dilemmas such as food crises， environmental problems， human health issues， and energy problems for the development of humanity， and it has brought huge economic benefits. On the other hand， the development of biotechnology will inevitably produce internal and external negative effects. For example， this development can guarantee neither human health and safety nor ecological and environmental balance， as well as raising issues such as the right to know， privacy， and social ethics. In the face of the huge threat to human health brought by COVID-19， a series of diagnosis and treatment technologies and vaccine research and development have made outstanding contributions to the response to COVID-19 and the protection of human health. However， we cannot ignore the need to determine whether these diagnostic techniques and future vaccines will bring new unknown health risks.

The most crucial goal of COVID-19 research is to prevent more people from getting the novel coronavirus， and to achieve this goal， the new vaccine research and development of China have been at the forefront of the world. The COVID-19 vaccine developed by Academician Chen Wei's team was the first， both domestically and internationally， to enter the phase I and phase II clinical trials， demonstrating the safety and immunogenicity of the vaccine. The vaccine's stage Ⅲ international clinical trial is proceeding. The vaccine uses technical intervention to form antibodies in the body that block the development of the virus and protect the body against its invasion. This process of human intervention， however， is actually the destruction of the original ecosystem; the essence of its operation is to create a new ecosystem， which can very easy to destroy the original ecosystem. Reactions， such as allergic and immunogenic reactions， can occur. Looking back at previous epidemics caused by coronaviruses， the virus mutates rapidly， and the antibodies produced by the vaccine protect against such epidemics for only three to six months. On the one hand， there is no data to support whether vaccination will bring adverse effects. On the other hand， it is not yet known whether the antibodies produced by the vaccine can resist the mutation of the virus. These risks are currently unknown.

2.2 Consideration of Human Health Risks

The development of biotechnology can meet the growing material and cultural needs of humankind， especially in food security， human health， energy security， and other aspects of outstanding value and significance. However， biotechnology is a double-edged sword， which needs to go through a long process to mature. Especially in the early stage of technology development， there are great safety risks in the process of the research， experimentation， and release of the results， and these risks are often uncontrollable and unknown. Many treatments have been used during the pandemic of COVID-19， and so far， the results have been good， but we do not know for sure that these treatments will not harm patients. In the fight against COVID-19， the joint research team from the Department of Life Science and Medicine and the First Affiliated Hospital of the University of Science and Technology of China （USTC） attracted much attention， and the team proposed the diagnosis and treatment plan of "Tozumab + routine treatment". The team found that interleukin-6 （IL-6） is an important pathway that induces inflammatory storms in patients with COVID-19[10]. This diagnosis and treatment scheme has been popularized in more than 20 countries worldwide and widely shared in international academic circles. However， abnormal liver function， skin damage， allergic reaction， gastrointestinal damage， infection， blood system damage， and other such adverse reactions may occur during the clinical use of Tozumab. Therefore， although Tozumab has achieved good results in the treatment of COVID-19， we should not ignore the risks that this drug brings.

2.3 Consideration of Social Order and Ethical Risks

The development of biotechnology will not only bring risks to ecological security， human health， resources， but also bring many ethical risks. "In the field of science and technology， which can bring great risks and disasters to mankind， the preconditions for free research have fundamentally changed dramatically" （Ulrich， 1986）. Many biotechnologies set man against nature， and the course of life no longer follows the laws of nature but the will of man. The development of technology has changed the original ecological balance， which has led to many new problems. The origin of novel coronavirus has not yet been determined， but the over transformation of nature by humans must be responsible for it. Respect for social order and moral ethics is a necessary stipulation for the development of biotechnology. Otherwise， the balance between humanity and nature will be broken， and human beings will suffer bad consequences.

3 Legal Provision of Biotechnology Safety Risks in China

In the field of preventing the risk of infectious diseases outbreak， China's legal basis mainly includes the Emergency Response Law， the Law on the Prevention and Treatment of Infectious Diseases， the Frontier Health and Quarantine Law， and the Regulations for Emergency Response to Public Health Emergencies， which constitute the basic legal framework of China's response to public health emergencies. However， under the challenge of the epidemic， many shortcomings in the provisions of the law have been exposed. In 2020， the new Biosecurity Law included infectious diseases in the category of biosafety， which was elevated to the height of national security and provided precise legal positioning for infectious diseases. However， the authorization of local governments for emergency treatment measures still needs to be further enriched and improved. Taking the epidemic as an example， there are no clear provisions detailing the isolation of high-risk groups and whether cities can be "closed down".

In the field of preventing the misuse and abuse of biotechnology， China issued the Regulations on the Export Control of Dual-use Biological Agents and Related Equipment and Technologies in 2002， the Measures for the Ethical Review of Biomedical Research Involving Human Beings in 2016， and the Measures for the Safety Management of Biotechnology Research and Development in 2017. These specifications aim to regulate biological technology research and development， promoting and safeguarding the healthy development of biotechnology. Biosafety risks and responsibilities are stipulated in the research and development and commercial application of biotechnology. The newly promulgated Biosecurity Law has many principle provisions on the research and development and application of biotechnology， but there should still be supplementary legislation to ensure the law's implementation. Relevant legislative guidance is an important guarantee for dealing with a major epidemic. In the early stage of the COVID-19 outbreak， due to the lack of supporting legislative guidance， researchers were not qualified to provide guidance and support on the scene of such sudden outbreak of biosafety incidents， so they could only quickly set up emergency response teams. The USTC team is one of them， and it succeeded in quickly identifying the virus and putting forward a treatment plan. With appropriate legislative guidance， such teams could have stepped in with legal guidance at the beginning of an outbreak， but the current legislation in this area is lacking.

In the field of preventing biotechnological ecological security risks， China's legislation needs strengthening. Biotechnology ecological security risk prevention is a complex systematic project which needs a scientific， reasonable， coordinated， and powerful operation system to ensure the efficient and orderly development of ecological security management[11]. The Measures for The Safety Management of Genetic Engineering issued by the former State Science and Technology Commission （now the Ministry of Science and Technology） in 1993 was China's first legal norm in the field of biotechnology safety; it regulates all the behaviors related to gene research in China. In 2001， in accordance with the relevant provisions of the Cartagena Protocol on Biosafety， the Chinese State Council promulgated the Regulations on the Safety management of Agricultural GMOs， which is the first administrative regulation regulating the safety of biotechnology in China. In China， ecological security risk prevention norms of biotechnology mainly focus on the field of gene technology. In addition， no other normative documents regulate ecological security risks in China[12]. At present， China lacks a complete legislation system for the prevention of biotechnological ecological security risks， especially for such biosafety incidents as COVID-19; such legislation is urgently needed.

4 Experiences of the Major Countries in the Legal Regulation of Biotechnology Risks

With the increasing technological risks in major biosecurity fields， such as the study of epidemics， technological optimism has been questioned. Interested parties wonder whether the law should unconditionally protect the freedom of scientific research; the question of whether the country should not put any scientific issues off-limits has become a new issue that needs to be urgently addressed. The freedom of scientific research is not absolute; it should be constrained by both nature and ethics， so it is necessary to use the legal system to set restricted areas for scientific issues[13]. The typical biosafety legislation of various countries is of great significance， especially considering the experience of big countries in the legal regulation of biosafety， R&D， and application of biotechnology.

4.1 The United States： Adopting the Principle of Substantive Equivalence to Encourage the Development of Technology

In the field of biosafety management， the United States advocates the principle of substantive equivalence. This principle refers to the identification of a traditional transaction without the possibility of determining whether there is a risk for it. The United States advocates the freedom of scientific research. When the safety risks of biotechnology have not been confirmed by science， the United States government will not impose very strict management and restrictions on scientific research of biotechnology.

In the field of biotechnology safety regulation， the United States has established a series of technical evaluation standards for the safety， R&D， application， and other facets of biotechnology， mainly through relevant experience in the history of technology development. For the development of cutting-edge technologies， including biotechnology， a relatively relaxed and encouraging policy has been adopted. The green light has been given to many biotechnology projects， including synthetic biotechnology， on the premise that the source of risk can be controlled， so there is no resistance to their development.

In 1976， the National Institutes of Health （NIH） of the United States formulated the Recombinant Gene Molecular Research Guidelines， which stipulated the safety management of transgenic technology and the responsibility of the experimenter， also setting a precedent for the legal protection of biotechnology safety. In 1986， the United States government authorized the Department of Agriculture， Environmental Protection Agency， Food and Drug Administration， Occupational Safety and Health Administration， and National Institutes of Health to coordinate the management of safe progress in biotechnology. With the Recombinant Gene Molecular Research Guidelines as the main framework， the United States has successively issued the Manual for Biological Safety in Microbiology and Biomedical Laboratories; the Preservation， Use and Transfer of Selective Agents and Toxins; the Development Policy Guidelines and Suggestions on the Management and Supervision and Review Mechanism of Potential Pandemic Pathogens; the Standard Operating Procedures for Biological Safety in Laboratories of the United States， and the Training Guidelines for Standard Operating Procedures for Microbiology Laboratories Personnel; these documents all regulate biological operations. Along with the Concern on Biosafety and Biotech Dual-use Research， the US Government's Regulatory Policy on Biosafety and Biotechnology Dual-use Research， these norms constitute the legal and normative system in the field of biotechnology in the United States[14]. The National Biodefense Strategy， released in 2018 included the intentional misuse of biotechnology in the list of national biosecurity threats for the United States and tested the implementation of the national biosecurity strategy. The National Health Security Strategy Implementation Plan 2019-2022， released in the same year， emphasized the need to strengthen the management of microbiological agents and actively respond to biosecurity threats. It has to be said that the United States has made a series of explorations in biotechnology risk prevention and control.

4.2 Europe： Adopt the Precautionary Principle to Treat Technical Risks Prudently

Compared to the U.S.， which has encouraged the development of biotechnology， the Europeans are more conservative. Europe has adopted the precautionary principle in the field of biotechnology; that is， measures to prevent the occurrence of hazards are not be taken on the grounds of the uncertainty of biotechnology. According to the principle of risk prevention， biotechnology involves great uncertainty， and once the risk occurs， its damage consequences are often incalculable. Therefore， even if the current scientific evidence proves that the damage might not happen， certain preventive measures should be taken. Most European countries insist that biotechnology research that poses safety risks is monitored with caution.

The regulation of biotechnology is stricter in European countries than in the U.S.， especially for biotechnology and the products derived from it， which are often regulated by stringent legislation. The EU has formulated ten regulations， six directives， and six resolutions in the field of biotechnology， such as gene technology[15]. All the regulations have legal effect in each Member State， and each Member State needs to improve its national legislation within the specified time under the directive's requirements.

To facilitate the management of gene-editing technology， Germany has successively issued the Recombination Gene Molecular Experiment Criteria， Gene Technology Law， Gene Technology Safety Regulations， and Embryo Protection Law. Germany's Biotechnology Law came into effect formally in 1990. The law controls the development and application of biotechnology， delineates the regulatory authority for biotechnology， and stipulates the liability for compensation for damage caused by biotechnology and products. The law was designed to prevent the risks that may be brought by biotechnology and products. In the past two years， Britain issued a series of strategies related to the field of biotechnology， including the National Industrial Biotechnology Strategy 2030， 2030 National Biological Economic Strategy， and Solve the Antimicrobial Drug Resistance in 2019-2024： The British National Action Plan for 5 Years. Britain proposed to make full use of biological technology to improve the structure of its national economy but specified that attention should be paid to limiting biological technology that may bring huge risks.

4.3 China： Managing the Balance Between Risk Prevention and Prudent Development of Biotechnology

Article 2 of China's Biosecurity Law mandates adherence to the principles of people-orientation， risk prevention， classified management， and coordination. While encouraging the innovation and development of biotechnology， the paper proposes to follow the principles of risk prevention and cautious development. Biotechnology is often closely related to the development of human society. Once risks are translated into reality， the consequences are often very serious and irreversible. Therefore， it is necessary to establish the principle of risk prevention. The principle of prudent development seeks a balance between the security of biotechnology and the development of biotechnology; this principle provides theoretical guidance for the construction of a legal system to ensure the security of biotechnology， and thus lays a foundation for the realization of justice and order. Adhering to the principles of risk prevention and prudent development is a path that must be followed by the rule of law to ensure the healthy development of biotechnology in China[16].

At present， the legislation on biotechnology safety in China is composed of more than 90 laws， regulations， rules， and normative documents， dominated by the Biosecurity Law. The Biosecurity Law is a fundamental and comprehensive law in the field of biotechnology. Most of the regulations in the field of biotechnology other than biosecurity Law are administrative regulations formulated by the competent authorities of the industry. Although these other protocols provide a way to promote biotechnology safety in specific fields， some of them are old and cannot meet the needs of the current development of biotechnology. So far， China's current regulations and norms in the field of biotechnology have played a certain role in protecting the development of biotechnology[17]. However， to ensure the sustainable and healthy development of biotechnology， there is still a long way to go for the rule of law based on risk prevention and prudent development.

5 Improvement of Legal Regulations on Major Risks of Biotechnology

Apart from the Biosecurity Law， the current legislation in the field of biotechnology enforced at a low level of government and was promulgated too long ago to meet the challenges brought by the rapid development of biotechnology. After the outbreak of COVID-19， attention was once again attached to the topic of biosafety， and since biosafety is related to national security， the national Biosecurity Law came into being， which is bound to play a major guiding role in the development of biotechnology. We believe that under the legal norm system in the field of biotechnology dominated by the Biosecurity Law， the legal regulation of biotechnology can be improved in the following aspects.

5.1 Formulation of Laws Supporting the Biosecurity Law

From the perspective of legislative orientation， the Biosecurity Law is more like the basic law with broad regulatory scope and strong principles. From the perspective of content， the Biosecurity Law mainly provides the general provisions for biosafety. The promulgation of the Biosecurity Law has provided guidance for the healthy development of biotechnology， but biotechnology is complex and needs to be regulated by complete and detailed legal provisions. It is very important to formulate special laws to assist the better implementation of the Biosecurity Law. Taking the safety of human genetic resources and biological resources as an example， the Biosecurity Law stipulates that the collection， preservation， utilization， and provision of human genetic resources in China shall protect human health and safeguard national security and social and public interests[18]. The Biosecurity Law considers exact definition： the interpretation of human genetic resources is narrowed to human genetic resources with or without modification， which covers modified genetic resources such as those produced by transgenic technology， gene editing techniques， and synthetic biology technology.

5.2 Legislation on the Public Compensation Mechanism

At present， China has no relevant provisions on public compensation in any biotechnology-related legal norm， but the public compensation system is an important link in dealing with public safety accidents， so inevitably， the government must formalize and enact a comprehensive public system. Take this epidemic as an example， COVID-19 has not only harmed people's health but also caused serious economic losses and even economic stagnation. Biotechnology safety accidents typically cause economic losses within a certain range. Some of the damage is caused by the government's administrative action， and this loss cannot be compensated through the tort liability system. The biotechnology legislation on the public compensation system should be clear about dealing with such economic loss if it is caused by biotechnology safety accidents. As for public compensation funds， they may be incorporated into the government fiscal budget， or special security funds may be set up by governments at all levels as a source of compensation. As for the standard of compensation， we can refer to the local price level and the actual loss to give careful consideration. In addition， enterprises can be given preferential tax policies， and citizens can be given preferential policies.

5.3 Legislation on the Professional Ethics of Scientific Researchers

Many risks induced in the development and application of biotechnology are both ethical and legal. The inclusiveness between ethics and law provides feasibility for establishing a legal framework for the professional ethics of scientific researchers. There are few related laws at present regulating researchers in China， China lacks science and technology progress law， administrative rules， and other regulatory documents for most kinds of scientific research personnel; systematic， consistent rules for the scope of their duties are needed to coordinate such research efforts[19]. In addition， China's relevant laws and regulations on scientific researchers are dominated by the idea of encouraging the development of science and technology. Although there are provisions relating to legal responsibility， there is a lack of content specifically addressing legal responsibility， making the legal norms lack operability.

5.4 Strengthening of the Legal Principle of Extensive International Cooperation

Biotechnology risks are global in character. Guided by the vision of building an international community with a shared future for humanity， countries around the world are working to develop and improve the global rules of co-governance of biotechnology risks. China's newly promulgated Biosecurity Law incorporates into its legal principles the concept of a community with a shared future for humankind， plans extensive international cooperation on biotechnology security using this concept， and seeks to build a strategic consensus for the development of emerging biotechnology in the international community. In the global fight against the COVID-19 pandemic， China should actively advocate a global biotech safety net， form a truly feasible international agreement， and try hard to put it into practice. China should actively participate in formulating or amending international biotechnology rules and standards among the surrounding countries， regions， and regional organizations. Efforts should be made to popularize advanced ideas and to express the interests of all parties.

6 Conclusion

Both the significant innovation progress and the emerging risk threat of biotechnology will become hot spots of academic exploration and focuses of public opinion. Law is the prerequisite and the foundation to ensure that biotechnology development advances on the track of promoting scientific and technological innovation and maintaining social welfare. Chinese current legislation on biotechnology are few and dated and need to be improved. The establishment of a scientific management system adapted to the actual needs of biotechnology and the effective connection with the existing legislation will provide a more solid legal basis for strengthening the legal system construction of biotechnology safety and safeguarding national security.

It can be seen from the above discussion that attention should be paid to the risks of biotechnology in order to improve the legislation in the field of biotechnology in China and guarantee the development of technology on the basis of current laws and by referring to advanced foreign legislation.

References：

[1] Liu Chong， Deng Menja. The Impact of Emerging Biotechnology Development on Great Power Competition and Global Governance[J]. Modern International Relations， 2020（6）： 1-10.

[2] Wang Xiaoli. Biosafety Era： New Biosafety Transformation and National Security Governance[J]. International Security Studies， 2020， 38（4）： 109-135.

[3] Ghasemi， S.， Ahmadvand， M.， Karami， E. et al. Social Risk Perceptions of Genetically Modified Foods of Engineers in Training： Application of a Comprehensive Risk Model[J]. Science and Engineering Ethics， 2019： 25.

[4] Van Wezel A P， Van Lente H， Van d S J M， et al. Risk analysis and Technology Assessment in Support of Technology Development： Putting Responsible Innovation in Practice in a Case Study for Nanotechnology[J]. Integrated Environmental Assessment and Management， 2017： 9-16.

[5] Sandberg Anders，Nelson Cassidy. Who Should We Fear More： Biohackers， Disgruntled Postdocs， or Bad Governments？ A Simple Risk Chain Model of Biorisk.[J]. Health Security， 2020， 18（3）： 9.

[6] Health Organization （WHO）. （2006）. Biorisk Management： Laboratory Biosecurity Guidance. Retrieved from http：//www.who.int/ihr/publications/WHO_CDS_EPR_2006_6.

[7] Sture， J.， Whitby， S.， & Perkins， D. Biosafety， Biosecurity and Internationally Mandated Regulatory Regimes： Compliance Mechanisms for Education and Global Health Security[J]. Medicine， Conflict and Survival， 2013， 29（4）， 289-321.

[8] Jasanoff， S.， Hurlbut， J. B.， & Saha， K. CRISPR Democracy： Gene Editing and the Need for Inclusive Deliberation. Issues in Science and Technology.  2015，32.

[9] Zhang Zhiyu， Liu Xiaobing. On the Legal Prevention of Ecological Security Risks of Biotechnology[J]. China's Environmental Rule of Law， 2014（2）： 1-24.

[10] Wang Tao. Analysis of the Mechanism of Action and Safety Risk of COVID-19 Immunotherapy Drug Tozumab[J]. Pharmacovigilance in China， 2020， 17（5）： 257-260.

[11] Zhang Hui. Legislation Appeal of Biosafety[J]. Modern Law， 2008（6）： 147-156.

[12] Wang Kang. Legislation Orientation of Biosecurity Law and Risk Control of Gene Technology[J]. Journal of Beijing University of Aeronautics and Astronautics （Social Science Edition）， 2019， 32（5）： 27-29.

[13] Ding Guomin， Guo Shijie. The Value Conflict and Solution of Biosafety Legislation[J]. Journal of Shanxi University （Philosophy and Social Sciences Edition）， 2020， 43（4）： 89-95.

[14] Du Lu. Brief Discussion on Foreign Biosafety Legislation[J]. Legal System and Economy （Late Edition）， 2014（5）： 4-5.

[15] Xue Yang， Yu Hanzhi. Security Threats of the Development of Frontier Biotechnology： Countermeasures and Prospects[J]. International Security Studies，2020，38（4）： 136-156.

[16] Yu Wenxuan. Rule of Law Principle and Realization Path of Biosafety Guarantee[J]. Exploration and Controversy， 2020（4）： 160-166.

[17] Liu Xuxia. Biosafety Law Should Highlight The Safety Prevention of Biotechnology[J]. Journal of Beijing University of Aeronautics and Astronautics （Social Science Edition）， 2019， 32： 25-26.

[18] Yang J W. Construction of Collaborative Management Mode of Gene Risk under the Background of National Biosafety Risk Prevention and Control System[J]. Journal of China University of Political Science and Law， 2020（3）： 149-159.

[19] Fu Qian. Research on the Legalization of Professional Ethics of Contemporary Chinese Researchers[D]. Northeastern University， 2014： 11-13.

新冠疫情視角下生物技术风险化解与法律规制

葛倩倩，王金金*

（中国科学技术大学  公共事务学院，合肥 230026）

摘    要：生物技术风险应对必须走到科技的前面去，在风险预防的基础上审慎推动新冠疫情防治生物技术的发展创新;对生物安全威胁的防控更应走到法律的内部去，在法律规范下妥善处置新冠疫情中的生物技术风险。重塑发展生物技术的原则和态度，防范和化解生物技术应用产生的阴霾，创设适宜的生物技术生长的法治空间，实现在法律规制下的生物技术与人类社会的协调向善发展。2020年10月17日《中华人民共和国生物安全法》颁布，完善了生物技术领域法律规范体系，为生物技术健康发展提供导向。随着生物技术在国家发展体系中的地位日益突出、作用日益重要，探索规范生物技术之良法以求生命科学领域之善治，以求在生物技术发展进程中确立和保障社会公益，是生物科技时代的重大法治命题。

关键词：生物技术;风险化解;新冠疫情;法律规制