China Enacts Regulations on Human Genetic Resources Management, Effective July 1
China, a populous nation with multiple ethnic groups, possesses unique advantages in human genetic resources. It is endowed with abundant genetic resources, including distinctive populations characterized by health and longevity, populations living in special ecological environments (such as high-altitude regions), geographically isolated populations (such as those on islands), and core family pedigrees affected by specific diseases. These resources provide highly favorable conditions for the development of life sciences and related industries. China has always attached great importance to the protection and utilization of human genetic resources. In 1998, the General Office of the State Council forwarded the Interim Measures for the Administration of Human Genetic Resources, jointly formulated by the Ministry of Science and Technology and the Ministry of Health, which played a positive role in the effective protection and rational utilization of China’s human genetic resources. However, with evolving circumstances, new situations and issues have emerged in the administration of human genetic resources in China: illegal outflow of human genetic resources continues to occur; the utilization of such resources lacks standardization and overall coordination; the regulatory framework governing international collaborative scientific research using China’s human genetic resources remains imperfect; and the Interim Measures themselves exhibit deficiencies, including inadequate regulations on the utilization of human genetic resources, incomplete legal liabilities, and the need for further improvement of regulatory measures. To address prominent issues arising in practice and to promote the effective protection and rational utilization of human genetic resources in China, it is necessary to enact the Regulations on the basis of summarizing the experience gained from the implementation of the Interim Measures.
In January 2016, the Ministry of Science and Technology submitted the “Regulations on the Administration of Human Genetic Resources (Draft for Review)” to the State Council. Upon receipt, the former Legislative Affairs Office of the State Council solicited opinions twice from relevant departments, local governments, research institutions, enterprises, and experts, as well as from the general public; it conducted field investigations in various localities, convened expert seminars, and, in conjunction with the Ministry of Science and Technology, repeatedly studied and revised the draft for review, thereby forming the “Regulations of the People’s Republic of China on the Administration of Human Genetic Resources (Draft).” Following the “gene-edited babies” incident, the Ministry of Justice, together with the Ministry of Science and Technology, further revised and improved the Draft in light of the latest developments. On May 28, 2019, the Premier signed a State Council decree, officially promulgating the Regulations.
To regulate activities such as the collection, preservation, utilization, and external provision of human genetic resources, the Regulations stipulate:
First, the collection, preservation, utilization, and external provision of China’s human genetic resources must not endanger public health, national security, or the public interest in China; they must comply with ethical principles, safeguard the legitimate rights and interests of resource providers, and adhere to corresponding technical standards. The buying and selling of human genetic resources is prohibited. Providing or using human genetic resources for scientific research in accordance with the law, and paying or charging reasonable costs and expenses, shall not be deemed as buying and selling.
Second, entities engaged in biotechnology research and development activities or conducting clinical trials shall comply with the laws, administrative regulations, and relevant national provisions governing biotechnology research and clinical application management.
Third, the Interim Measures retain the approval requirements for the collection and preservation of China’s human genetic resources, the conduct of international collaborative scientific research using China’s human genetic resources, and the export of human genetic resource materials, while clarifying approval conditions and improving approval procedures.
The original text of the regulations is as follows:
Regulations on the Management of Human Genetic Resources of the People's Republic of China
Chapter I General Provisions
Article 1 These Regulations are formulated to effectively protect and rationally utilize China’s human genetic resources, and to safeguard public health, national security, and the public interest.
Article 2 Human genetic resources as referred to in these Regulations include human genetic resource materials and human genetic resource information.
Human genetic resource materials refer to genetic materials such as organs, tissues, and cells that contain human genetic material, including the human genome and genes.
Human genetic resource information refers to data and other informational materials generated through the use of human genetic resource materials.
Article 3 The collection, preservation, utilization, and external provision of human genetic resources of China shall comply with these Regulations.
The collection and preservation of human substances such as organs, tissues, and cells, and the conduct of related activities for purposes including clinical diagnosis and treatment, blood donation and supply services, investigation and punishment of illegal and criminal acts, doping control, and funeral services shall be carried out in accordance with relevant laws and administrative regulations.
Article 4 The science and technology administrative department of the State Council shall be responsible for the administration of human genetic resources throughout China; other relevant departments of the State Council shall, within the scope of their respective duties, be responsible for the administration of human genetic resources.
The science and technology administrative departments of the 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 areas; other relevant departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, within the scope of their respective duties, be responsible for the administration of human genetic resources within their respective administrative areas.
Article 5 The State shall strengthen the protection of human genetic resources in China, conduct surveys on human genetic resources, and implement a system of declaration and registration for important hereditary families and human genetic resources from specific regions.
The science and technology administrative department of the State Council is responsible for organizing surveys of human genetic resources in China, and for formulating specific measures for the declaration and registration of human genetic resources from important genetic pedigrees and specific regions.
Article 6 The State supports the rational utilization of human genetic resources to conduct scientific research, develop the biopharmaceutical industry, and improve diagnostic and therapeutic techniques, thereby enhancing China’s biosafety security capabilities and raising the level of health protection for the people.
Article 7 Foreign organizations, individuals, and institutions established or actually controlled by them shall not collect or preserve China’s human genetic resources within the territory of China, nor shall they provide China’s human genetic resources to overseas parties.
Article 8 The collection, preservation, utilization, and external provision of China’s human genetic resources shall not endanger public health, national security, or the public interest of society.
Article 9 The collection, preservation, utilization, and external provision of China’s human genetic resources shall comply with ethical principles and undergo ethical review in accordance with relevant national regulations.
The collection, preservation, utilization, and external provision of China’s human genetic resources shall respect the privacy rights of the providers of such resources, obtain their prior informed consent, and protect their legitimate rights and interests.
The collection, preservation, utilization, and external provision of China’s human genetic resources shall comply with the technical specifications formulated by the science and technology administrative department of the State Council.
Article 10 The buying and selling of human genetic resources is prohibited.
The provision or use of human genetic resources for scientific research in accordance with the law, along with the payment or collection of reasonable costs and expenses, shall not be deemed as buying or selling.
Chapter 2 Collection and Preservation
Article 11 The collection of important Chinese genetic pedigrees, human genetic resources from specific regions, or human genetic resources of the types and quantities specified by the science and technology administrative department of the State Council shall meet the following conditions and be approved by the science and technology administrative department of the State Council:
(i) Possessing legal person status;
(2) The purpose of collection is clear and lawful;
(3) The sampling plan is reasonable;
(4) Ethical review approval;
(5) Possess a department and management system responsible for the administration of human genetic resources;
(6) Possessing premises, facilities, equipment, and personnel commensurate with collection activities.
Article 12 Prior to the collection of human genetic resources in China, the collectors shall inform the providers of such resources of the purpose and intended use of the collection, potential impacts on health, measures for protecting personal privacy, as well as their rights to voluntary participation and unconditional withdrawal at any time, and shall obtain written consent from the providers of human genetic resources.
When informing providers of human genetic resources of the information stipulated in the preceding paragraph, such disclosure must be comprehensive, complete, truthful, and accurate; concealment, misleading statements, or deception are strictly prohibited.
Article 13 The State shall strengthen the preservation of human genetic resources, accelerate the development of standardized and regulated basic platforms for the preservation of human genetic resources and the construction of big data systems for human genetic resources, so as to provide support for relevant research and development activities.
The State encourages research institutions, higher education institutions, medical institutions, and enterprises to carry out the preservation of human genetic resources in accordance with their own conditions and the needs of related research and development activities, and to facilitate such research and development activities by other entities.
Article 14 Entities that preserve China’s human genetic resources and provide foundational platforms for scientific research shall meet the following conditions and obtain approval from the science and technology administrative department of the State Council:
(i) Possessing legal person status;
(2) The purpose of preservation is clear and lawful;
(3) The preservation plan is reasonable;
(4) The proposed human genetic resources for preservation are from legal sources;
(5) Ethical review approval;
(6) Possess a department responsible for the management of human genetic resources, as well as a preservation and management system;
(7) Possession of premises, facilities, equipment, and personnel that comply with the national technical specifications and requirements for the preservation of human genetic resources.
Article 15 Preservation entities shall strengthen the management and monitoring of preserved human genetic resources, adopt security measures, formulate emergency response plans, and ensure the safety of preservation and use.
The custodial unit shall maintain complete records of the custody of human genetic resources, properly preserve information on the source and use of such resources, and ensure their lawful utilization.
Preservation units shall submit annual reports on their preservation of human genetic resources to the State Council’s administrative department for science and technology.
Article 16 The national basic platform for the preservation of human genetic resources and its database shall be made accessible to relevant scientific research institutions, higher education institutions, medical institutions, and enterprises in accordance with applicable state regulations.
For the purposes of public health, national security, and the social public interest, the State may, in accordance with the law, utilize human genetic resources preserved by preservation institutions.
Chapter 3 Utilization and External Provision
Article 17 The science and technology administrative department of the State Council and the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in conjunction with the relevant departments of the people’s governments at the corresponding levels, formulate overall plans for scientific research involving the use of human genetic resources and for the development of the biopharmaceutical industry, ensure rational layout, strengthen the construction of innovation systems, and promote the innovative, coordinated development of biotechnology and related industries.
Article 18 Scientific research institutions, institutions of higher learning, medical institutions, and enterprises that carry out research and development activities using human genetic resources shall be supported in accordance with laws, administrative regulations, and relevant state provisions for such research and development activities and the industrialization of their outcomes.
Article 19 The State encourages scientific research institutions, institutions of higher learning, medical institutions, and enterprises to carry out international cooperative scientific research using China’s human genetic resources, in accordance with their own conditions and the needs of relevant research and development activities, so as to enhance their capabilities and levels in related research and development.
Article 20 Any entity conducting biotechnology research and development activities or clinical trials using China’s human genetic resources shall comply with the laws, administrative regulations, and relevant national provisions governing biotechnology research and clinical application management.
Article 21 Where foreign organizations and institutions established or actually controlled by foreign organizations or individuals (hereinafter referred to as “foreign parties”) need to utilize China’s human genetic resources to carry out scientific research activities, they shall comply with Chinese laws, administrative regulations, and relevant state provisions, and shall conduct such activities in cooperation with Chinese scientific research institutions, higher education institutions, medical institutions, and enterprises (hereinafter referred to as “Chinese parties”).
Article 22 Where international cooperative scientific research is conducted using China’s human genetic resources, the following conditions shall be met, and an application shall be jointly submitted by both cooperating parties for approval by the science and technology administrative department of the State Council:
(1) It poses no harm to public health, national security, or the social public interest in China;
(2) Both cooperating parties shall be Chinese and foreign entities with legal person status, possessing the foundation and capability to carry out relevant work;
(3) The objectives and content of the collaborative research are clear and lawful, and the duration is reasonable;
(4) The collaborative research plan is reasonable;
(5) The human genetic resources proposed for use are from legal sources, and their types and quantities are consistent with the research content;
(6) Obtain ethical review approval from the respective countries (regions) of both cooperating parties;
(7) Clear ownership of research outcomes, with a reasonable and explicit benefit distribution plan.
To obtain marketing authorization for relevant drugs and medical devices in China, international collaborative clinical trials conducted at clinical institutions in China using Chinese human genetic resources, which do not involve the export of human genetic resource materials, are exempt from approval. However, prior to commencing the clinical trials, the collaborating parties shall file with the science and technology administrative department under the State Council regarding the types, quantities, and intended uses of the human genetic resources to be utilized. The science and technology administrative department under the State Council, along with the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government, shall strengthen oversight of such filings.
Article 23 Where any major matters, such as the collaborating party, research purpose, research content, or duration of cooperation, are changed during the course of conducting international cooperative scientific research using China’s human genetic resources, procedures for approval of changes shall be handled.
Article 24 Where international cooperative scientific research is conducted using China’s human genetic resources, it shall be ensured that Chinese entities and their researchers participate in the entire process of the research in a substantive manner throughout the period of cooperation. All records, data, and other information generated during the research process shall be fully accessible to the Chinese entities, and copies thereof shall be provided to them.
For international collaborative scientific research conducted using China’s human genetic resources, any patent applications arising from the resulting outcomes shall be jointly filed by both collaborating parties, and the patent rights shall be jointly owned by them. For other scientific and technological achievements generated from the research, the rights to use, transfer, and distribute benefits shall be stipulated in a cooperation agreement between the collaborating parties. In the absence of such an agreement, both parties shall have the right to use these achievements; however, any transfer to a third party requires mutual consent, and the benefits obtained shall be shared according to the respective contributions of each party.
Article 25 Where international cooperative scientific research is conducted using China’s human genetic resources, the cooperating parties shall, in accordance with the principles of equality and mutual benefit, honesty and good faith, joint participation, and shared outcomes, enter into a cooperation agreement in accordance with the law, and make clear and specific provisions on relevant matters as stipulated in Article 24 of these Regulations.
Article 26 Where international cooperative scientific research is conducted using China’s human genetic resources, the cooperating parties shall jointly submit a report on the collaborative research to the science and technology administrative department of the State Council within six months after the conclusion of the international cooperation activities.
Article 27 Where international cooperative scientific research is conducted using China’s human genetic resources, or where it is truly necessary to transport, mail, or carry materials of China’s human genetic resources out of the country due to other special circumstances, the following conditions shall be met, and a certificate for exit of human genetic resource materials issued by the science and technology administrative department of the State Council shall be obtained:
(1) It poses no harm to public health, national security, or social public interests in China;
(2) Possessing legal person status;
(3) There are clear overseas partners and reasonable purposes for outbound travel;
(4) The collection of human genetic resource materials is lawful, or the materials are obtained from legally authorized preservation institutions;
(5) Ethical review approval.
For international collaborative scientific research utilizing China’s human genetic resources, if it is necessary to transport, mail, or carry human genetic resource materials out of the country, an application may be submitted separately, or the export plan may be specified within the application for international collaborative scientific research and submitted together, subject to consolidated approval by the science and technology administrative department of the State Council.
For the transport, mailing, or carrying of human genetic resource materials out of China, customs procedures shall be handled upon presentation of the Certificate for Exit of Human Genetic Resource Materials.
Article 28 The provision or open access to human genetic resource information to foreign organizations, individuals, and institutions established or actually controlled by them shall not endanger public health, national security, or the public interest of China. Where such activities may affect public health, national security, or the public interest of China, they shall undergo a security review organized by the science and technology administrative department of the State Council.
Providing or granting access to human genetic resource information to foreign organizations, individuals, or institutions established or actually controlled by them shall require filing with the science and technology administrative department of the State Council and submission of information backups.
Human genetic resource information generated through international collaborative scientific research utilizing China’s human genetic resources may be used by both collaborating parties.
Chapter 4 Services and Supervision
Article 29 The science and technology administrative department of the State Council shall strengthen the development of e-government services to facilitate applicants in handling approval, filing, and other matters via the Internet.
Article 30 The science and technology administrative department of the State Council shall formulate and promptly issue approval guidelines and model documents concerning the collection, preservation, utilization, and external provision of China’s human genetic resources, and strengthen guidance for applicants in handling matters such as approvals and filings.
Article 31 The science and technology administrative department of the State Council shall engage experts in biotechnology, medicine, public health, ethics, law, and other relevant fields to form an expert review committee. This committee shall conduct technical reviews of applications for the collection and preservation of China’s human genetic resources, the conduct of international cooperative scientific research, and the transport, mailing, or carrying of China’s human genetic resource materials out of the country, as submitted in accordance with these Regulations. The review opinions shall serve as a reference basis for making approval decisions.
Article 32 The administrative department for science and technology under the State Council shall, within 20 working days from the date of accepting an application for the collection and preservation of China’s human genetic resources, the conduct of international cooperative scientific research, or the transport, mailing, or carrying of China’s human genetic resource materials out of the country in accordance with these Regulations, make a decision to approve or disapprove the application; if the application is disapproved, reasons shall be provided. If a decision on approval cannot be made within the prescribed time limit due to special circumstances, the time limit may be extended by 10 working days upon approval by the person in charge of the administrative department for science and technology under the State Council.
Article 33 The science and technology administrative department of the State Council and the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen supervision and inspection of all links in the activities involving the collection, preservation, utilization, and external provision of human genetic resources. Upon discovering any violation of these Regulations, they shall promptly handle the matter in accordance with the law and make the results of inspections and handling public.
Article 34 The science and technology administrative department of the State Council and the science and technology administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may take the following measures when conducting supervision and inspection:
(i) Conduct on-site inspections;
(2) Interview relevant personnel;
(3) Review and copy relevant materials;
(4) Seize and detain relevant human genetic resources.
Article 35 Any entity or individual shall have the right to file complaints or reports with the science and technology administrative department of the State Council and the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government against any act in violation of the provisions of these Regulations.
The science and technology administrative department of the State Council and the science and technology administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall publish complaint and reporting telephone numbers and email addresses to accept relevant complaints and reports. Rewards shall be granted to reporters whose reports are verified as true.
Chapter V Legal Liability
Article 36 Where any of the following circumstances occurs in violation of the provisions of these Regulations, the science and technology administrative department under the State Council shall order the cessation of illegal acts, confiscate the illegally collected or preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 500,000 but not more than RMB 5 million; if the illegal gains exceed RMB 1 million, a fine of not less than five times but not more than ten times the illegal gains shall be imposed:
(1) Collecting important Chinese genetic pedigrees, human genetic resources from specific regions, or human genetic resources of types and quantities specified by the science and technology administrative department of the State Council without approval;
(2) Storing human genetic resources of China without approval;
(3) Conducting international collaborative scientific research using China’s human genetic resources without approval;
(4) Providing or granting access to human genetic resource information that has not passed security review and may affect public health, national security, and social public interests in China to foreign organizations, individuals, and institutions established or actually controlled by them;
(5) Failure to file with the State Council’s administrative department for science and technology regarding the types, quantities, and intended uses of human genetic resources to be used before conducting international cooperative clinical trials.
Article 37 Where an administrative license is obtained by submitting false materials or by other fraudulent means, the science and technology administrative department of the State Council shall revoke the administrative license already obtained, impose a fine of not less than RMB 500,000 but not more than RMB 5 million, and shall not accept any license applications submitted by the relevant responsible persons and entities within five years.
Article 38 Where human genetic resource materials of China are transported, mailed, or carried out of the country without approval in violation of the provisions of these Regulations, the Customs shall impose penalties in accordance with the provisions of laws and administrative regulations. The science and technology administration department shall cooperate with the Customs in carrying out law enforcement assistance activities such as identification. The Customs shall transfer the human genetic resource materials confiscated in accordance with the law to the science and technology administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government for disposal.
Article 39 Where any of the following circumstances occurs in violation of these Regulations, the science and technology administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order the cessation of relevant activities, confiscate the illegally collected or preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 500,000 but not more than RMB 1 million; if the illegal gains exceed RMB 1 million, a fine of not less than five times but not more than ten times the illegal gains shall be imposed:
(1) Failure to pass ethical review for the collection, preservation, utilization, and external provision of China’s human genetic resources;
(2) Collecting human genetic resources in China without obtaining prior informed consent from the providers of such resources, or obtaining consent through concealment, misleading practices, deception, or other similar means;
(3) Violating relevant technical specifications in the collection, preservation, utilization, and external provision of China’s human genetic resources;
(4) Providing or granting access to human genetic resource information to foreign organizations, individuals, and institutions established or actually controlled by them, without filing with the science and technology administrative department of the State Council or submitting an information backup.
Article 40 Where any of the following circumstances occurs in violation of these Regulations, the science and technology administrative department of the State Council shall order correction, issue a warning, and may impose a fine of not more than RMB 500,000:
(1) Failure to fully record and properly preserve information on the source and use of human genetic resources during their preservation in China;
(2) Failure to submit annual reports for the preservation of China’s human genetic resources;
(3) Failure to submit reports on collaborative research activities in a timely manner for international cooperative scientific research.
Article 41 Where foreign organizations, individuals, and institutions established or actually controlled by them violate the provisions of these Regulations by collecting or preserving human genetic resources of China within the territory of China, conducting scientific research using human genetic resources of China, or providing human genetic resources of China to overseas entities, the science and technology administrative department of the State Council shall order them to cease the illegal acts, confiscate the illegally collected or preserved human genetic resources and illegal gains, and impose a fine of not less than RMB 1 million but not more than RMB 10 million; where the illegal gains exceed RMB 1 million, a fine of not less than five times but not more than ten times the illegal gains shall be imposed.
Article 42 Where human genetic resources are bought or sold in violation of the provisions of these Regulations, the science and technology administrative department of the State Council shall order the cessation of the illegal acts, confiscate the illegally collected and preserved human genetic resources and the illegal gains, and impose a fine of not less than RMB 1 million but not more than RMB 10 million; where the illegal gains exceed RMB 1 million, a fine of not less than five times but not more than ten times the illegal gains shall be imposed.
Article 43 For entities that commit illegal acts as stipulated in Articles 36, 39, 41, and 42 of these Regulations, if the circumstances are serious, the science and technology administrative department of the State Council or the science and technology administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their respective duties, prohibit them from engaging in activities involving the collection, preservation, utilization, and external provision of China’s human genetic resources for a period of one to five years; if the circumstances are particularly serious, they shall be permanently prohibited from engaging in such activities.
For the legal representatives, principal heads, directly responsible supervisors, and other liable personnel of entities that commit illegal acts as stipulated in Articles 36 to 39, Article 41, and Article 42 of these Regulations, administrative sanctions shall be imposed in accordance with the law. The science and technology administrative department of the State Council or the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their respective duties, confiscate any illegal gains and impose a fine of not more than RMB 500,000. In serious cases, such individuals shall be prohibited from engaging in activities involving the collection, preservation, utilization, and external provision of China’s human genetic resources for a period of one to five years. In particularly serious cases, they shall be permanently prohibited from engaging in such activities.
Where entities or individuals commit illegal acts as stipulated in these Regulations, such acts shall be recorded in their credit records and disclosed to the public in accordance with relevant laws and administrative regulations.
Article 44 Any violation of the provisions of these Regulations that infringes upon the lawful rights and interests of others shall bear civil liability in accordance with the law; where a crime is constituted, criminal liability shall be investigated in accordance with the law.
Article 45 Where staff members of the science and technology administrative department of the State Council and the science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government violate the provisions of these Regulations by failing to perform their duties, abusing their powers, neglecting their duties, or engaging in malpractice for personal gain, they shall be subject to disciplinary sanctions in accordance with the law; where a crime is constituted, criminal liability shall be pursued in accordance with the law.
Chapter VI Supplementary Provisions
Article 46 Where information related to human genetic resources constitutes state secrets, confidentiality management shall be implemented in accordance with the Law of the People's Republic of China on Guarding State Secrets and other relevant national confidentiality regulations.
Article 47 These Regulations shall come into force as of July 1, 2019.