Regulations of the People’s Republic of China on the Administration of Human Genetic Resources

 

Chapter 1 General Provisions

 

Article 1 　This Regulation is hereby 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 　For the purposes of these Regulations, “human genetic resources” 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 genomic DNA, genes, and other genetic substances.

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 China’s human genetic resources shall comply with these Regulations.

The collection and preservation of human biological materials such as organs, tissues, and cells, as well as related activities, shall be conducted in accordance with the provisions of applicable laws and administrative regulations to meet the needs of clinical diagnosis and treatment, blood collection and supply services, investigation and prosecution of illegal and criminal activities, anti-doping testing, funeral services, and other such endeavors.

Article 4 　The science and technology administrative department of the State Council is responsible for the administration of human genetic resources nationwide; other relevant departments of the State Council shall, within the scope of their respective functions and responsibilities, be responsible for the administration of human genetic resources in relation to their areas of competence.

The science and technology administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the administration of human genetic resources within their respective administrative jurisdictions; 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 functions and responsibilities, be responsible for the administration of human genetic resources within their respective administrative jurisdictions.

Article 5 　The State shall strengthen the protection of China’s human genetic resources, conduct surveys of such resources, and implement a system of declaration and registration for important genetic pedigrees and human genetic resources in specific regions.

The science and technology administrative department of the State Council is responsible for organizing surveys of China’s human genetic resources and for formulating specific measures for the declaration and registration of important genetic pedigrees and human genetic resources from designated regions.

Article 6 　The State supports the rational utilization of human genetic resources for scientific research, the development of the biopharmaceutical industry, and the improvement of diagnostic and therapeutic technologies, with a view to enhancing China’s biosecurity capabilities and raising the level of health protection for the people.

Article 7 　Foreign organizations, individuals, and any institutions established or effectively controlled by them shall not collect or preserve China’s human genetic resources within the territory of the People’s Republic of China, nor shall they provide such resources to entities outside China.

Article 8 　The collection, preservation, utilization, and external provision of China’s human genetic resources shall not jeopardize public health, national security, or the public interest.

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 safeguard their legitimate rights and interests.

The collection, preservation, utilization, and external provision of China’s human genetic resources shall comply with the technical standards promulgated by the science and technology administrative department under the State Council.

Article 10 　The buying and selling of human genetic resources is prohibited.

The lawful provision or use of human genetic resources for scientific research, together with the payment or receipt of reasonable costs and expenses, shall not be deemed as trade.

 

Chapter 2: Collection and Preservation

 

Article 11 　The collection of important genetic pedigrees in China, human genetic resources from specific regions, or human genetic resources of the types and quantities prescribed by the science and technology administrative department under the State Council shall comply with the following conditions and be subject to approval by the said department:

(1) Possessing legal person status;

(2) The purposes of data collection are clear and lawful;

(3) The sampling plan is reasonable;

(4) Obtaining ethical review;

(5) Possession of a department and management system responsible for the administration of human genetic resources;

(6) Possessing premises, facilities, equipment, and personnel that are suitable for the collection activities.

Article 12 　When collecting human genetic resources in China, the purposes and uses of the collection, potential health impacts, measures for protecting personal privacy, and the right to voluntary participation and to withdraw at any time without condition must be disclosed in advance to the providers of such resources, and their written consent must be obtained.

When disclosing to providers of human genetic resources the information specified in the preceding paragraph, such disclosure must be comprehensive, complete, truthful, and accurate; concealment, misrepresentation, or deception is prohibited.

Article 13 　The State shall strengthen the preservation of human genetic resources, accelerate the development of standardized and normative infrastructure for the preservation of such resources and of big-data platforms for human genetic resources, and provide support for related 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 relevant research and development activities, and to provide facilitation for other entities in conducting such research and development activities.

Article 14 　Any entity that preserves China’s human genetic resources and provides a foundational platform for scientific research shall meet the following conditions and obtain approval from the science and technology administrative department under the State Council:

(1) Possessing legal person status;

(2) The purpose of preservation is clear and lawful;

(3) The preservation plan is reasonable;

(4) The source of the human genetic resources to be preserved is lawful;

(5) Obtaining ethical review;

(6) Possession of a department responsible for the management of human genetic resources and a system for their preservation and custody;

(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 　The biobanking institution shall strengthen the management and monitoring of the human genetic resources it houses, implement security measures, and develop emergency response plans to ensure the safe storage and use of such resources.

The biobanking institution shall maintain complete records of the preservation of human genetic resources, properly safeguard information on the origin and use of such resources, and ensure their lawful utilization.

The preservation institution shall submit an annual report to the science and technology administrative department of the State Council on the status of its preservation of human genetic resources.

Article 16 　The national basic platform and database for the preservation of human genetic resources shall, in accordance with relevant state regulations, be made accessible to relevant research institutions, higher education institutions, medical institutions, and enterprises.

For the purposes of public health, national security, and the public interest, the State may, in accordance with the law, utilize human genetic resources preserved by preservation institutions.

 

Chapter 3: Use and Disclosure to Third Parties

 

Article 17 　The science and technology administrative departments of the State Council and those of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall, in coordination with the relevant departments of their respective people’s governments, conduct overall planning and rational spatial allocation for scientific research utilizing human genetic resources and for the development of the biopharmaceutical industry; strengthen the building of an innovation system; and promote innovative and coordinated development of biotechnology and related industries.

Article 18 　Research institutions, higher education institutions, medical institutions, and enterprises that conduct research and development activities using human genetic resources shall receive support for such activities and the industrialization of their resulting outcomes in accordance with laws, administrative regulations, and relevant state provisions.

Article 19 　The State encourages research institutions, higher education institutions, medical institutions, and enterprises to conduct international collaborative scientific research using China’s human genetic resources, in accordance with their respective conditions and the needs of their relevant research and development activities, so as to enhance their capabilities and standards in such research and development.

Article 20 　Any entity that conducts biotechnology research and development activities or clinical trials using China’s human genetic resources shall comply with the relevant laws, administrative regulations, and other pertinent national provisions governing biotechnology research and clinical applications.

Article 21 　Foreign organizations and institutions established or effectively controlled by foreign organizations and individuals (hereinafter referred to as “foreign entities”) that intend to conduct scientific research activities utilizing China’s human genetic resources shall comply with Chinese laws, administrative regulations, and relevant national provisions, and shall do so in collaboration with Chinese research institutions, higher education institutions, medical institutions, and enterprises (hereinafter referred to as “Chinese entities”).

Article 22 　Any international collaborative scientific research utilizing China’s human genetic resources shall meet the following conditions and be jointly submitted by the collaborating parties for approval by the science and technology administrative department under the State Council:

(1) It poses no threat to public health, national security, or the public interest in China;

(2) Both parties to the cooperation shall be Chinese and foreign entities with legal person status and shall possess the necessary foundations and capabilities to carry out the 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 proposed sources of human genetic resources are lawful, and their types and quantities are consistent with the research objectives;

(6) Obtaining ethical review in the respective countries (or regions) of the cooperating parties;

(7) The ownership of research outcomes is clearly defined, and there is a reasonable and well-defined profit-sharing arrangement.

To obtain marketing authorization for relevant pharmaceuticals and medical devices in China, international collaborative clinical trials conducted at clinical institutions using China’s human genetic resources—provided that such trials do not involve the export of human genetic resource materials—are exempt from approval. However, prior to commencing such clinical trials, the collaborating parties shall file with the science and technology administrative department under the State Council a record of the types and quantities of human genetic resources to be used, as well as their intended purposes. The science and technology administrative departments under the State Council and those of the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall strengthen oversight over matters subject to such filing.

Article 23 　Where material changes occur in key matters such as the collaborating parties, the research objectives, the research content, or the duration of the collaboration during the conduct of international scientific research utilizing China’s human genetic resources, approval procedures for such changes shall be carried out.