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Regulation of the People's Republic of China on the Administration of Human Genetic Resources [Effective]
中华人民共和国人类遗传资源管理条例 [现行有效]
【法宝引证码】

Order of the State Council of the People's Republic of China 

中华人民共和国国务院令

(No. 717) (第717号)

The Regulation of the People's Republic of China on the Administration of Human Genetic Resources, as adopted at the 41st executive meeting of the State Council on March 20, 2019, is hereby issued, and shall come into force on July 1, 2019. 《中华人民共和国人类遗传资源管理条例》已经2019年3月20日国务院第41次常务会议通过,现予公布,自2019年7月1日起施行。
Premier: Li Keqiang 总理  李克强
May 28, 2019 2019年5月28日
Regulation of the People's Republic of China on the Administration of Human Genetic Resources 中华人民共和国人类遗传资源管理条例
Chapter I General Provisions 

第一章 总  则

 
Article 1 This Regulation is developed for the purposes of effectively protecting and rationally using China's human genetic resources, and safeguarding public health, national security and public interest.   第一条 为了有效保护和合理利用我国人类遗传资源,维护公众健康、国家安全和社会公共利益,制定本条例。
Article 2 For the purposes of this Regulation, the term “human genetic resources” includes the materials of human genetic resources and information on human genetic resources.   第二条 本条例所称人类遗传资源包括人类遗传资源材料和人类遗传资源信息。
The term “materials of human genetic resources” means genetic materials such as organs, tissues and cells which contain human genomes, genes and other genetic substances. 人类遗传资源材料是指含有人体基因组、基因等遗传物质的器官、组织、细胞等遗传材料。
The term “information on human genetic resources” means information materials such as data generated from the utilization of materials of human genetic resources. 人类遗传资源信息是指利用人类遗传资源材料产生的数据等信息资料。
Article 3 The collection, preservation, utilization and external provision of China's human genetic resources shall comply with this Regulation.   第三条 采集、保藏、利用、对外提供我国人类遗传资源,应当遵守本条例。
The collection and preservation of organs, tissues, cells and other human substances and relevant activities conducted for such activities as clinical diagnosis and treatment, blood sampling and supply services, investigation and handling of violations and crimes, stimulant detection and funeral and interment shall be governed by the provisions of relevant laws and administrative regulations. 为临床诊疗、采供血服务、查处违法犯罪、兴奋剂检测和殡葬等活动需要,采集、保藏器官、组织、细胞等人体物质及开展相关活动,依照相关法律、行政法规规定执行。
Article 4 The science and technology administrative department of the State Council shall be responsible for the administration of human genetic resources throughout the country. Other relevant departments of the State Council shall be responsible for the administration of human genetic resources within the scope of their respective functions and powers.   第四条 国务院科学技术行政部门负责全国人类遗传资源管理工作;国务院其他有关部门在各自的职责范围内,负责有关人类遗传资源管理工作。
The science and technology administrative departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of human genetic resources within their respective administrative regions; other relevant departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of human genetic resources within their respective administrative regions within the scope of their respective functions and powers. 省、自治区、直辖市人民政府科学技术行政部门负责本行政区域人类遗传资源管理工作;省、自治区、直辖市人民政府其他有关部门在各自的职责范围内,负责本行政区域有关人类遗传资源管理工作。
Article 5 The state shall strengthen the protection of China's human genetic resources, conduct investigation on human genetic resources, and implement the declaration and registration system for human genetic resources of important genetic families and specific regions.   第五条 国家加强对我国人类遗传资源的保护,开展人类遗传资源调查,对重要遗传家系和特定地区人类遗传资源实行申报登记制度。
The science and technology administrative department of the State Council shall be responsible for organizing the investigation of China's human genetic resources and formulating specific measures for the declaration and registration of human genetic resources of important genetic families and specific regions. 国务院科学技术行政部门负责组织我国人类遗传资源调查,制定重要遗传家系和特定地区人类遗传资源申报登记具体办法。
Article 6 The state supports the rational use of human genetic resources to carry out scientific research, develop biomedical industry, improve diagnosis and treatment technologies, enhance China's biosafety guarantee capabilities, and raise the level of guaranteeing the people's health.   第六条 国家支持合理利用人类遗传资源开展科学研究、发展生物医药产业、提高诊疗技术,提高我国生物安全保障能力,提升人民健康保障水平。
Article 7 Foreign organizations and individuals and the institutions formed or actually controlled by them shall not collect or preserve China's human genetic resources within the territory of China, and shall not provide China's human genetic resources abroad.   第七条 外国组织、个人及其设立或者实际控制的机构不得在我国境内采集、保藏我国人类遗传资源,不得向境外提供我国人类遗传资源。
Article 8 The collection, preservation, utilization and external provision of China's human genetic resources shall not endanger China's public health, national security or public interest.   第八条 采集、保藏、利用、对外提供我国人类遗传资源,不得危害我国公众健康、国家安全和社会公共利益。
Article 9 The collection, preservation, utilization and external provision of China's human genetic resources shall conform to ethical principles and be subject to ethical review in accordance with the relevant provisions of the state.   第九条 采集、保藏、利用、对外提供我国人类遗传资源,应当符合伦理原则,并按照国家有关规定进行伦理审查。
The collection, preservation, utilization and external provision of China's human genetic resources shall respect the right of privacy of human genetic resource providers, obtain their prior consent, and protect their lawful rights and interests. 采集、保藏、利用、对外提供我国人类遗传资源,应当尊重人类遗传资源提供者的隐私权,取得其事先知情同意,并保护其合法权益。
The collection, preservation, utilization and external provision of China's human genetic resources shall comply with technical specifications of the science and technology administrative department of the State Council. 采集、保藏、利用、对外提供我国人类遗传资源,应当遵守国务院科学技术行政部门制定的技术规范。
Article 10 The trading in human genetic resources shall be prohibited.   第十条 禁止买卖人类遗传资源。
The legal provision or use of human genetic resources for scientific research and payment or collection of reasonable cost and expenses shall not be deemed as trading. 为科学研究依法提供或者使用人类遗传资源并支付或者收取合理成本费用,不视为买卖。
Chapter II Collection and Preservation 

第二章 采集和保藏

 
Article 11 The collection of China's human genetic resources of important genetic families and specific regions, or the collection of human genetic resources of the types and quantities prescribed by the science and technology administrative department of the State Council shall meet the following conditions and be subject to approval by the science and technology administrative department of the State Council:   第十一条 采集我国重要遗传家系、特定地区人类遗传资源或者采集国务院科学技术行政部门规定种类、数量的人类遗传资源的,应当符合下列条件,并经国务院科学技术行政部门批准:
(1) Having the legal person status. (一)具有法人资格;
(2) Having specific and lawful purposes of collection. (二)采集目的明确、合法;
(3) Having reasonable collection plans. (三)采集方案合理;
(4) Having passed the ethical review. (四)通过伦理审查;
(5) Having the department responsible for the management of human genetic resources and management rules. (五)具有负责人类遗传资源管理的部门和管理制度;
(6) Having places, facilities, equipment and personnel that are compatible with collection activities. (六)具有与采集活动相适应的场所、设施、设备和人员。
Article 12 In the collection of China's human genetic resources, human genetic resource providers shall be informed in advance of the collection purpose, use, possible impact on health, personal privacy protection measures and their right to voluntary participate and withdraw unconditionally at any time, and the written consent of human genetic resource providers shall be obtained.   第十二条 采集我国人类遗传资源,应当事先告知人类遗传资源提供者采集目的、采集用途、对健康可能产生的影响、个人隐私保护措施及其享有的自愿参与和随时无条件退出的权利,征得人类遗传资源提供者书面同意。
Human genetic resource providers shall be informed of the information prescribed in the preceding paragraph in a comprehensive, complete, true and accurate manner, no information shall be concealed, and providers shall not be misled or deceived. 在告知人类遗传资源提供者前款规定的信息时,必须全面、完整、真实、准确,不得隐瞒、误导、欺骗。
Article 13 The state shall strengthen the preservation of human genetic resources, and accelerate the construction of standardized and regulated basic platforms for the preservation of human genetic resources and big data on human genetic resources, to provide support for relevant research and development activities.   第十三条 国家加强人类遗传资源保藏工作,加快标准化、规范化的人类遗传资源保藏基础平台和人类遗传资源大数据建设,为开展相关研究开发活动提供支撑。
The state encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to preserve human genetic resources according to their own conditions and as required for relevant research and development activities, and to facilitate relevant research and development activities conducted by other entities. 国家鼓励科研机构、高等学校、医疗机构、企业根据自身条件和相关研究开发活动需要开展人类遗传资源保藏工作,并为其他单位开展相关研究开发活动提供便利。
Article 14 The preservation of China's human genetic resources to provide a basic platform for scientific research shall meet the following conditions and be subject to approval by the science and technology administrative department of the State Council:   第十四条 保藏我国人类遗传资源、为科学研究提供基础平台的,应当符合下列条件,并经国务院科学技术行政部门批准:
(1) Having the legal person status. (一)具有法人资格;
(2) Having specific and lawful preservation purposes. (二)保藏目的明确、合法;
(3) Having reasonable preservation plans. (三)保藏方案合理;
(4) Having lawful source of human genetic resources to be preserved. (四)拟保藏的人类遗传资源来源合法;
(5) Having passed the ethical review. (五)通过伦理审查;
(6) Having the department responsible for the management of human genetic resources and preservation management rules. (六)具有负责人类遗传资源管理的部门和保藏管理制度;
(7) Having places, facilities, equipment and personnel that comply with the national technical specifications and requirements for the preservation of human genetic resources. (七)具有符合国家人类遗传资源保藏技术规范和要求的场所、设施、设备和人员。
Article 15 The preservation entity shall strengthen the management and monitoring of the preserved human genetic resources, take security measures, and make emergency response plans to ensure preservation and use safety.   第十五条 保藏单位应当对所保藏的人类遗传资源加强管理和监测,采取安全措施,制定应急预案,确保保藏、使用安全。
The preservation entity shall fully record the preservation of human genetic resources, properly preserve the information on the source and use of human genetic resources, and ensure the legal use of human genetic resources. 保藏单位应当完整记录人类遗传资源保藏情况,妥善保存人类遗传资源的来源信息和使用信息,确保人类遗传资源的合法使用。
The preservation entity shall submit annual reports on the entity's preservation of human genetic resources to the science and technology administrative department of the State Council. 保藏单位应当就本单位保藏人类遗传资源情况向国务院科学技术行政部门提交年度报告。
Article 16 The national basic platform and database for the preservation of human genetic resources shall be open to relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with the relevant provisions of the state.   第十六条 国家人类遗传资源保藏基础平台和数据库应当依照国家有关规定向有关科研机构、高等学校、医疗机构、企业开放。
As required for public health, national security and public interest, the state may use the human genetic resources preserved by the preservation entities in accordance with the law. 为公众健康、国家安全和社会公共利益需要,国家可以依法使用保藏单位保藏的人类遗传资源。
Chapter III Utilization and External Provision 

第三章 利用和对外提供

 
Article 17 The science and technology administrative department of the State Council and science and technology administrative departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, in conjunction with relevant departments of people's governments at the same level, make overall planning and rational layout on using human genetic resources to conduct scientific research and develop the biomedical industry, strengthen the construction of innovation systems, and promote the innovated and coordinated development of biotechnology and industry.   第十七条 国务院科学技术行政部门和省、自治区、直辖市人民政府科学技术行政部门应当会同本级人民政府有关部门对利用人类遗传资源开展科学研究、发展生物医药产业统筹规划,合理布局,加强创新体系建设,促进生物科技和产业创新、协调发展。
Article 18 The research and development activities conducted by scientific research institutions, institutions of higher learning, medical institutions and enterprises by using human genetic resources and industrialization of results shall be supported in accordance with laws, administrative regulations and relevant provisions of the state.   第十八条 科研机构、高等学校、医疗机构、企业利用人类遗传资源开展研究开发活动,对其研究开发活动以及成果的产业化依照法律、行政法规和国家有关规定予以支持。
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