《生物安全法》二审草案中涉及技术及信息安全的规定简析

目录
一、出台背景
Background
二、重点概述
Summary of the Key Points
三、生物安全工作协调机制
Biosecurity Work Coordination Mechanisms
四、涉及技术开发及信息安全的相关规定
Provisions Related to Technology Development and Information Security
五、法律责任
Legal Liability
六、我们的观察
Our Observations
2020年4月26日，《生物安全法》草案二审稿（以下简称“《草案二审稿》”）已由十三届全国人大常委会第十七次会议审议，并向公众公开征求意见至2020年6月13日1。据报道，草案有望于今明两年尽快出台。
On April 26, 2020, a second draft of the Biosecurity Law (hereinafter referred to as the “Second Review Draft”) was reviewed by the 17th meeting of the 13th National People’s Congress Standing Committee and it has been published for public comment until June 13, 20201. According to various news reports, the draft is expected to come into effect soon, either this year or next year.
一、出台背景
Background
面对生物安全带来的问题和挑战，党的十八大以来，生物安全被纳入国家安全战略。全国人大常委会将《生物安全法》纳入十三届全国人大常委会立法规划和2019年度立法工作计划，并于2019年10月在十三届全国人大常委会第十四次会议对《生物安全法》草案进行了初次审议。而新冠肺炎疫情的发生进一步了推动草案的出台。2020年2月14日，中共中央总书记习近平强调要“尽快推动出台生物安全法，加快构建国家生物安全法律法规体系、制度保障体系”2。《生物安全法》的立法工作预计将加紧进行。
Since the 18th National Congress of the Communist Party of China, biosecurity law has been included in the national security strategy to confront the problems and challenges around biosecurity. The Standing Committee of the National People’s Congress incorporated “Biosecurity Law” into the legislative plan of the 13th National People’s Congress Standing Committee and the annual legislative work plan for 2019. In October 2019, the Biosecurity Law draft was reviewed by the 14th meeting of the 13th National People’s Congress Standing Committee for the first time. The outbreak of the coronavirus epidemic has pushed forward the introduction of the draft. On February 14, 2020, Xi Jinping, general secretary of the CPC Central Committee, emphasized the need to “promote the introduction of biosecurity law as soon as possible, and speed up the establishment of a national laws and regulations system and institution-guaranteed system of the biosecurity law”2. The legislative work for the introduction of biosecurity law is expected to be accelerated.
《生物安全法》出台后将成为国家安全法律体系中的重要组成部分。此前，《国家安全法》、《反恐怖主义法》、《网络安全法》、《境外非政府组织管理法》和《反间谍法》等已于2014年后相继出台。
After the release of the Biosecurity Law, it will become an important part of the national security legal system. The National Security Law, the Anti-Terrorism Law, the Cybersecurity Law, the Overseas Non-Governmental Organizations Management Law and the Anti-Espionage Law have been promulgated since 2014.
二、重点概述
Summary of the Key Points
作为生物安全基础性法律，《草案二审稿》通过十章八十五条的条款，在多个领域做出了原则性、方向性的规定，主要包括（1）防控重大新发突发传染病、动植物疫情；（2）研究、开发、应用生物技术；（3）实验室生物安全管理；（4）人类遗传资源与生物资源安全管理；（5）防范外来物种入侵与保护生物多样性；（6）应对微生物耐药；以及 （7）防范生物恐怖袭击与防御生物武器威胁。（第二条）
As the basic law for biosecurity, the Second Review Draft has provided principled and directional provisions in various fields through ten chapters and 85 articles, including: (1) the prevention and control of major new outbreaks of infectious diseases and epidemics in animals and plants; (2) research, development, and application of biotechnology; (3) biosecurity management in the laboratory; (4) human genetic resources and biological resource security management; (5) the prevention of alien species invasion and the protection of biological diversity; (6) responding to drug resistance of microbes; and (7) the prevention of bioterrorism attacks and defense against biological weapons threats. (Article 2)
《草案二审稿》将部分现有法律、行政法规中的相关规定纳入法律体系，例如，草案重申了《传染病防治法》之中单位、个人发现传染病后的报告义务；将《人类遗传资源管理条例》下有关人类遗传资源的管理规定提升到法律的高度。（第五十四、五十五条）
The Second Review Draft incorporates the relevant provisions of some existing laws and administrative regulations into the biosecurity system. For example, the draft reiterates the reporting obligations of units and individuals after discovering infectious diseases in the Infectious Disease Prevention and Control Law; it also elevates the requirements related to the management of human genetic resources under the Human Genetic Resource Management Regulation to the level of law. (Articles 54 and 55)
《草案二审稿》同时规定、创立了许多新要求、新制度，例如下文详述的生物安全信息统一发布制度、生物安全名录和清单制度等。
The Second Review Draft also stipulates and creates many new requirements and new systems, such as a unified release system for biosecurity information, a biosecurity directory and a checklist system as detailed below.
本文将重点论述与技术开发及安全机制相关的规定，《草案二审稿》之中关于防控重大新发突发传染病、动植物疫情、实验室生物安全等方面的规定未进行详述。
This article will focus on the provisions related to technology development and safety mechanisms. The provisions in the Second Review Draft regarding the prevention and control of major new infectious diseases and outbreaks, animal and plant epidemics, and laboratory biosecurity have not been elaborated upon in this article.
三、生物安全工作协调机制
Biosecurity Work Coordination Mechanisms
在管理体制上，草案明确建立国家生物安全工作协调机制，以统筹协调草案下多个方面各种不同的行为要素和行为流程，在充分发挥分部门管理的基础上，对争议问题、需要协调的问题，由协调机制统筹解决。3中央国家安全领导机构负责国家生物安全工作的决策和议事协调，研究制定、指导实施国家生物安全战略和有关重大方针政策，统筹协调国家生物安全的重大事项和重要工作，建立国家生物安全工作协调机制。（第十条）国家生物安全工作协调机制由国务院卫生健康、农业农村、科学技术、外交等主管部门和有关军事机关组成。（第十一条）
In terms of management systems, the draft clearly establishes a national biosecurity work coordination mechanism to coordinate the various behavioral elements and behavioral processes in various aspects under the draft. On the basis of giving full play to management by the different departments, any dispute and coordination issues will be solved by the coordination mechanism as a whole. 3 The central national security agency is responsible for decision-making and the discussion coordination of national biosecurity work. It will also be responsible for studying, formulating and guiding the implementation of the national biosecurity strategy and other relevant major policies, coordinating the major issues and important work of national biosecurity, and establishing a national biosecurity work coordination mechanism. (Article 10) The national biosecurity coordination mechanism is composed of State Council departments such as health, agriculture and rural areas, science and technology and diplomacy, and the relevant military agencies. (Article 11).
四、涉及技术开发及信息安全的相关规定
Provisions Related to Technology Development and Information Security
我们特别关注了《草案二审稿》之中值得医疗生物及其他行业企业关注关于技术开发及信息安全的相关规定，相关总结如下：
We have paid special attention to the relevant provisions on technology development and information security that are worthy of attention for companies involved in medical biotechnology and other industries in the Second Review Draft. The relevant summary is as follows:
（一）国家实行生物安全信息统一发布制度
The State Implements a Unified Release System for Biosecurity Information
《草案二审稿》规定，国家生物安全总体情况、重大生物安全风险警示信息、重大生物安全事件及其调查处理信息以及其他需要统一发布的信息，由国家生物安全工作协调机制组织成员单位及有关地方人民政府发布。未经授权，任何单位和个人不得发布上述信息。（第十五条）
The Second Review Draft stipulates that national biosecurity, information regarding warnings of major biosecurity risks, major biosecurity incidents and their investigation and processing, and other information that needs to be released in a unified manner should only be released by members of the national biosecurity work coordination mechanism and related local people's government. Without authorization, no unit or individual may release the above information. (Article 15).
（二）国家建立生物安全名录和清单制度
The State will Establish a Biosecurity Directory and Checklist system
国务院有关部门应当根据生物安全工作需要,对涉及生物安全的材料、设备、技术、活动、重要生物资源数据、传染病、动植物疫病、检疫物种等制定、公布名录或者清单，并动态调整。（第十六条）但草案暂未明确规定涉及技术、重要生物资源数据的安全名录和清单的具体制度要求。
The relevant departments of the State Council shall formulate and publish directories or checklists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant diseases, and quarantine species that are related to biosecurity in accordance with the needs of biosecurity work, and dynamically adjust them. (Article 16) However, the draft does not clearly specify the detailed system requirements related to the security directory and the checklist of technology and important biological resource data.
（三）国家对生物技术研究、开发活动实行分类管理
The State will Implement the Classified Management of Biotechnology Research and Development activities
“生物技术研究、开发与应用”是指通过科学和工程原理认识、利用、改造生物而从事的科学研究、技术开发与应用等活动。（第八十二条）
“Biotechnology research, development and application” refers to the scientific research, technology development and application activities conducted by the understanding, utilization and transformation of organisms through scientific and engineering principles. (Article 82).
根据对公众健康、工业农业、生态环境等造成危害的风险程度，将生物技术研究、开发活动分为高风险、中风险、低风险三类。从事高风险、中风险生物技术研究、开发活动，应当由在我国境内依法成立的法人组织进行，并依法取得批准或者进行备案。（第三十五、三十七条）
Biotechnology research and development activities are classified into high-risk, medium-risk, and low-risk categories according to the degree of the risk of harm to public health, industrial agriculture, ecological environment, etc. Engaging in high-risk and medium-risk biotechnology research and development activities shall be carried out by a legal person or organization legally established within the territory of China, and shall be approved or filed according to law. (Articles 35 and 37)
（四）重申人类遗传资源的管理制度
Reiterate the Management System of Human Genetic Resources
《草案二审稿》重申了《人类遗传资源管理条例》下有关人类遗传资源的管理规定，包括：
The Second Review Draft reiterates the management provisions governing human genetic resources under the Human Genetic Resources Management Regulations, including:
利用我国人类遗传资源开展国际科学研究合作、人类遗传资源材料出境需经科技部批准；
International scientific research cooperation utilizing human genetic resources in China and the exportation of human genetic resource materials should be approved by the Ministry of Science and Technology.
向外提供人类遗传资源信息的备案及安全审查义务（第五十一至五十五条）。
The obligation of record-filing and security reviews regarding the provision of human genetic resources information to foreign entities and individuals (Articles 51 to 55).
境外组织、个人及其设立或者实际控制的机构获取和利用我国生物资源，应当依法取得有关部门的批准。（第五十六条）
Foreign organizations, individuals and entities established or those actually controlled by them should obtain the approval of the relevant departments in accordance with the law to obtain and utilize biological resources in China. (Article 56)
利用我国生物资源开展国际科学研究合作，应当依法取得有关部门的批准。（第五十七条）
Conducting international scientific research cooperation utilizing biological resources should be approved by the relevant authorities in accordance with the law. (Article 57)
（五）生物安全能力建设之中涉及信息安全的部分
Information Security of Biosecurity Capacity Building
《草案二审稿》规定：县级以上人民政府应当支持生物安全事业发展，加强生物安全能力建设，提高应对生物安全事件的能力和水平。县级以上人民政府应当加大对生物安全事业的投入，将支持生物安全事业发展的相关支出列入政府预算，包括：
The Second Review Draft stipulates that People’s governments, at or above the county level, shall support the development of biosecurity, strengthen the building of biosecurity capabilities, and improve the ability and level of response to biosecurity incidents. People's governments, at or above the county level, should increase their investment in biosecurity, and include related expenditures to support the development of biosecurity into the government budget, including:
监测网络构建和运行；
Monitoring network construction and operation;
关键基础设施建设和运行；
Construction and operation of critical infrastructure;
关键技术和产品研究、开发；
Research and development of key technologies and products;
人类遗传资源和生物资源调查、保藏等。（第六十四条）
Investigation and preservation of human genetic resources and biological resources. (Article 64)
五、法律责任
Legal Liability
草案对从事危害国家生物安全的生物技术研究、开发与应用活动的，从事生物技术研究、开发与应用活动的单位未采取生物安全风险控制措施的，违反人类遗传资源保护的相关要求等违法行为规定了相应行政处罚，包括责令停止违法行为，没收违法所得，警告，一千万元以下的罚款，以及对法定代表人、主要负责人、直接负责的主管人员和其他直接责任人员的处罚。
The draft stipulates corresponding administrative punishments for engaging in biotechnology research, development and application activities that endangers national biosecurity, as well as on units engaging in biotechnology research, development and application activities for not undertaking biosecurity risk control measures and for violating the relevant requirements on protection of human genetic resources, etc., including orders to stop illegal activities, confiscation of illegal gains, warnings, a fine of up to 10 million RMB, as well as punishments for legal representatives, the principal persons in charge, the responsible persons directly in charge and other directly responsible persons.
六、我们的观察
Our Observations
作为生物安全领域基础性、系统性、综合性和统领性的法律，《生物安全法》出台后将填补生物安全法律体系缺乏上位法的立法空白，并发挥重要的政策导向作用，也很可能引领一系列生物安全法律体系的法规的制定与出台，对操作性、技术性问题作出更为详细的补充规定。如《生物安全法》出台，我们预计生物安全领域的企业将在产品研发，国际合作，数据等资源的收集、使用等领域面临更为严格的合规监管。
As a basic, systematic, comprehensive and dominant law in the field of biosecurity, the introduction of Biosecurity Law will fill the legislative gap in the biosecurity legal system that currently lacks higher-level laws, and it will play an important role in policy orientation. It is also likely to lead to the formulation and promulgation of a series of further laws and regulations in the biosecurity legal system and provide more detailed supplementary provisions on other operational and technical issues. Once the Biosecurity Law is released, we expect that companies in the biosecurity field will face stricter compliance supervision in areas such as product development, international cooperation, and the collection and use of data and other resources.
注：
1.http://www.npc.gov.cn/flcaw/userIndex.html?lid=ff80808171b9f1300171be85b394022a
2.http://www.gov.cn/xinwen/2020-02/14/content5478896.htm
3.http://www.npc.gov.cn/wxzl/gongbao/2015-08/27/content1945964.htm