P.R.C Regulation on the Management of Human Genetic Resources

Promulgation Date: 2019-5-28
Title: P.R.C Regulation on the Management of Human Genetic Resources
Document Number:令第717号
Expiration date: 
Promulgating Entities: State Council
Source of text: http://www.gov.cn/zhengce/content/2019-06/10/content_5398829.htm

Chapter I: General Provisions

Article 1: These Regulations are drafted for the effective protection and reasonable use of human genetic resources; and for the preservation of public health, national security, and the societal public interest.

Article 2: Human genetic resources as used in these Regulations includes both human genetic resource materials and human genetic resource information.

Human genetic resource materials refers to genetic materials such as organs, tissues, and cells, that contain the human genome, genes and other genetic materials.

Human genetic resource information refers to data and other information materials produced from human genetic resource materials.

Article 3: The collection, preservation, use, and external provision of our nation's human genetic resources shall obey these Regulations.

Carrying out activities related to bodily substances, such as the collection and preservation of organs, tissues, or cells, as necessary for clinical diagnosis and treatment, blood collection and supply services, the investigation of violations and crimes, testing for stimulants, funerals or other such activities is to be carried out in accordance with relevant laws and administrative regulations.

Article 4: The State Council administrative departments for science and technology are responsible for the entire nation's efforts on the management of human genetic resources; and other relevant departments of the state council are responsible for relevant efforts on the management of human genetic resources in the scope of their own duties.

The administrative departments for science and technology of provincial, autonomous region, and directly-governed municipality's people's governments are responsible for efforts on the management of human genetic resources in that administrative region; and other departments of provincial, autonomous region, and directly-governed municipality's people's governments are responsible for efforts related to the management of human genetic resources within the scope of their duties in that administrative region.

Article 5: The state is to strengthen protections of our nation's human genetic resources, carry out surveys of human genetic resources, and implement a human genetic resources reporting and registration system for important gene families and specified regions.

The State Council's administrative departments for science and technology are responsible for organizing surveys of our nations' human genetic resources, and for formulating specific measures for implementing the human genetic resources reporting and registration system for important gene families and specified regions.

Article 6: The state supports the reasonable use of human genetic resources in carrying out scientific research, developing the bio-pharmaceutical field, improving diagnosis and treatment techniques, increasing our nation's capacity for safeguarding biological security, and raising the level of safeguards for the people's health.

Article 7: Foreign organizations and individuals, as well as institutions they establish or are the actual controllers of, must not collect or preserve human genetic resources within the territory of our nation, and must not provide out nations' human genetic resources outside the territory.

Article 8: The collection, preservation, use, or external provision of our nation's human genetic resources must not endanger our nation's public health, national security, or the public societal interest.

Article 9: The collection, preservation, use or external provision of our nation's human genetic resources shall comply with ethical principles and follow conduct ethical reviews in accordance with relevant national provisions.

The collection, preservation, use or external provision of our nation's human genetic resources shall respect the privacy rights of those providing human genetic resources, obtain their informed consent in advance, and protect their lawful rights and interest.

The collection, preservation, use or external provision of our nation's human genetic resources shall obey the technical specification formulated by the State Council administrative departments for science and technology.

Article 10: The purchase and sale of human genetic resources is prohibited.

The payment or collection of reasonable costs for the lawful provision or use of human genetic resources for scientific research is not viewed as purchase or sale.

Chapter II: Collection and Preservation

Article 11: Those collecting of our nation's important gene families ,or human genetic resources from specified regions, and collecting types and volumes of human genetic resources provided for by the State Council administrative departments for science and technology, shall meet the following requirements and be approved by the State Council administrative departments for science and technology:

(1) Have standing as a legal person;

(2) Have a clear and legal purpose for collection;

(3) Have a reasonable collection plan;

(4) Pass ethics review;

(5) Have departments responsible for the management of human genetic resources and management systems;

(6) Have venues, facilities, equipment, and personnel appropriate for the collection activities.

Article 12: In collection of our nation's human genetic resources, those providing the human genetic resources shall be informed in advance of the purposes of collection, the uses of collections, possible impacts to health, measures for protecting personal privacy, and that participation is voluntary and that they have the right to unconditionally withdraw at any time; and the written consent of the human genetic resource provider is to be obtained.

When informing the human genetic resources providers as provided in the preceding paragraph, it must be comprehensive, complete, truthful, and accurate, and must not conceal, mislead, or deceive.

Article 13: The state is to strengthen efforts on preservation of human genetic resources, accelerate the establishment of standardized and regulated foundational platforms for the preservation of human genetic resources and big data on human genetic resources, to provide support for related research activities.

The state encourages research establishments, schools of higher learning, medical establishments, and enterprises to carry out efforts to preserve human genetic resources based on their own capacity and the needs of their relevant research activities, and facilitate other units carrying out of related research activities.

Article 14: The following requirements shall be met by those providing foundation platforms scientific research in preservation of human genetic resources, and approval shall be gotten from the State Council administrative departments for science and technology:

(1) Have standing as a legal person;

(2) Have a clear and lawful purpose for preservation;

(3) Have a reasonable preservation plan;

(4) Have a lawful proposed source for the human genetic resources;

(5) Have passed ethics review;

(6) Have departments responsible for the management of human genetic resources and preservation management systems;

(7) Have venues, facilities, equipment, and personnel meeting the specifications and requirements for preservation of human genetic resource preservation.

Article 15: Preservation units shall strengthen management and monitoring of all human genetic resources they preserve, employ security measures, draft emergency response plans to ensure secure preservation and use.

Preservation units shall completely record the circumstances of preserving human genetic resources, properly keep information on the sources and uses of human genetic resources, and ensure the lawful use of human genetic resources.

Preservation units shall submit an annual report on the unit's preservation of human genetic resources to the State council administrative departments for science and technology.

Article 16: The national foundation platform and database for human genetic resources shall be open to related research bodies, schools of higher learning, medical establishments, and enterprises in accordance with relevant national provisions.

As necessary for public health, national security, and the societal public interest, the state may lawfully use the human genetic resources preserved by preservation units.

Chapter III: Usage and External Provision

Article 17: The State Council administrative departments for science and technology and the administrative departments for science and technology of provincial, autonomous regions, and directly-governed municipalities people's governments shall carry out scientific research and carry out overall planning for the development of the bio-pharmaceutical industry together with relevant departments at the corresponding level of people's government, and make rational layouts strengthening the establishment of the innovation system, promoting innovative production and coordinated development in the biological sciences.

Article 18: Research establishments, schools of higher learning, medical establishments and enterprises using human genetic resources to carry out research activities are to support marketizing of research and development activities and their outputs, in accordance with laws, administrative regulations, and relevant state provisions.

Article 19: The state encourages research establishments, schools of higher learning, medical establishments and enterprises to use our nation's human genetic resources to carry out collaborative international research based on their own capacities and the needs of their research activities, to increase the capacity and level of related research and development.

Article 20: Where our nations' human genetic resources are used to carry out biotechnology research and development activities or carry out clinical experiments, laws, administrative regulations, and relevant state provisions on the management of biotechnology research and clinical uses shall be obeyed.

Article 21: Where foreign organizations and establishments established by or actually controlled by foreign organizations or individuals (hereinafter “foreign units”) need to use our nation's human genetic resources to carry out scientific research activities, they shall obey our nation's laws, administrative regulations, and relevant national provisions, and proceed by collaborating with our nation's research establishments, schools of higher learning, medical establishments, and enterprises (hereinafter "Chinese units").

Article 22: The following requirements shall be met when using our country's human genetic resources carry out international cooperation in scientific research. and the cooperating parties are to apply jointly and obtain approval from the State Council administrative departments for science and technology

(1) not be harmful to our country's public health, national security or societal public interest.

(2) The cooperating parties are Chinese units and foreign units with standing as legal persons, and have foundation and the ability to carry out the relevant work;

(3) The goals and content of the collaborative research are clear, legal and within a reasonable period;

(4) the collaborative research plan is reasonable

(5) The source of the human genetic resources is legal, and they types and volume correspond to the content.

(6) Passage of ethics reviews in the countries (regions) of both collaborators;

(7) Clear attribution of research outputs, and clear plan for division of interests.

Approvals are not required where materials not involving human genetic resources are sent abroad in carrying out of collaborative international clinical experiments, so as to obtain approvals for obtaining permits for the sale of drugs and medical instruments in our nation. However, the collaborating parties shall file the types, volumes, and uses of human genetic resources proposed in clinical experiments, with the State Council administrative departments for science and technology. The State Council administrative departments for science and technology, and the administrative departments of science and technology of provincial, autonomous region, and directly-governed municipalities are to strengthen oversight of registration matters.

Article 23: Where, in the course of conducting collaborative international research using out nation's human genetic resources, there is a change in the collaborating parties, research goals, research content, research period, or other major matters, formalities shall be completed for the changes to be approved.

Article 24: In collaborative international scientific research using out nation's human genetic resources, the substantive participation of Chinese units and their researchers shall be guaranteed during the entire course of the collaboration period, and that all records and data, etc., from the research are open to the Chinese units and that a backup copy is provided to the Chinese units.

Where patents are applied for research outcomes produced through collaborative scientific research using out nation's human genetic resources, the application shall be submitted by both collaborating parties together, and the patent rights shall be jointly held by the collaborating parties. The usage rights, and methods for methods for transferring rights and sharing interests are to be determined by agreement of the collaborating parties; and where there is not agreement, the collaborating parties all have usage rights, but transfers to third parties must be upon consent of both parties, and benefits are to be divided in proportion to the size of the collaborating parties' contributions.

Article 25: In using our nations human genetic resources to carry out collaborative international scientific research, the collaborative parties shall follow principles of equal benefit, good faith and credit, joint participation, and sharing of outputs; and shall sign a cooperation agreement and follow the provisions of article 25 of these Regulations to make clear and specific agreements on relevant matters.

Article 26: In using our nation's human genetic resources for collaborative international scientific research, the collaborators shall provide the State Council administrative departments for science and technology with a report on the collaborative research within 6 months of the research concluding.

Article 27: Where out nation's human genetic resources are used to carry out collaborative international scientific research, or it is necessary to transport, mail, or carry our nation's human genetic resources across borders due to other special circumstances, the following requirements are to be met and an exit certificate for human genetic resources is to obtained from the State Council administrative departments for science and technology:

(1) not be harmful to our country's public health, national security or societal public interest.

(2) Have standing as a legal person;

(3) Have a clear foreign collaborator and reasonable uses outside the borders;

(4) The human genetic resource materials are lawfully collected or came from a lawful preservation unit;

(5) Pass ethics reviews.

Where collaborative international scientific research using our nation's human genetic resources requires that the human genetic resources be shipped, mailed, or carried across borders, independent applications may be submitted, or an application listing export plans may be submitted along with the application for carrying out collaborative international scientific research, and the State Council administrative departments for science and technology are to approve them together.

Where our nation's human genetic resources are transported, mailed, or carried across borders, customs formalities are to be handled based on exit certificates for human genetic resources.

Article 28: Provision, or opening for use, of human genetic resource information to foreign organizations and individuals or bodies that they have established or are the actual controllers of, it must not endanger our nation's public health, national security, and societal public interest; and where it might impact our nation's public health, national security, and societal public interest, it shall go through security review organized by the State Council Administrative Departments for Science and Technology.

Where human genetic resources are transferred to foreign organizations, individuals or bodies that they have established or are the actual controllers of, it shall be filed with the State Council administrative departments for science and technology and a backup copy of the information is to be submitted.

Both collaborating parties may use information produced through collaborative international research carried out through the use of our nation's human genetic resources.

Chapter IV: Services and Oversight

Article 29: The State Council administrative departments for science and technology shall strengthen electronic government to facilitate applicants use of the internet to handle matters such as approvals and filings.

Article 30: The State Council administrative departments for science and technology shall draft and promptly publish guides and template examples on applications to collect, preserve, use, or externally provide our nation's human genetic resources; strengthening guidance for applicants handling approval applications, filings, and other such matters.

Article 31: The State Council administrative departments for science and technology shall recruit experts in fields such as bio-pharmaceuticals, pharmaceuticals, hygiene, ethics, and law, to form an expert review committee to conduct technological review of applications for the collection and preservation of our nation's human genetic resources, the carrying out of collaborative international scientific research, or the transport, mailing, or carrying of our nation's human genetic resources abroad. Review comments are to be a referential basis in making approval decisions.

Article 32: The State Council administrative departments for science and technology shall make a decision on whether or not to grant approval within 20 working days of receiving applications for the collection or preservation of our nation's human genetic resources, carrying out collaborative international scientific research, or for transporting, mailing, or carrying our nation's human genetic resources abroad; and shall explain the reasons when not granting approval. Where for special reasons it is not possible to make a decision on approval in the legally-prescribed time period, it may be extended 10 working days upon approval of the responsible party at the State Council administrative departments for science and technology.

Article 33: The State Council administrative departments for science and technology and the administrative departments for science and technology of provincial, autonomous regions, and directly-governed municipalities' people's governments oversight and inspections of each stage in the process of activities collecting, preserving, using, or externally providing human genetic resources, and where violations of these Regulations are discovered, shall promptly handle it in accordance with law and publish the outcome of the inspections and disposition.

Article 34: The State Council administrative departments for science and technology, and the administrative departments of provinces, autonomous regions, or directly-controlled municipalities' people's governments, are to conduct oversight inspections and may employ the following measures:

(1) Enter sites for inspections;

(2) Question relevant personnel;

(3) Read or reproduce relevant materials;

(4) Seal or seize relevant human genetic resources.

Article 35: All units and individuals have the right to make a report or complaint about conduct violating the provisions of these Regulations to the State Council administrative departments for science and technology and the administrative departments for science and technology of provincial, autonomous region, or directly-governed municipality's people's governments.

The State Council administrative departments for science and technology and the administrative departments for science and technology of provincial, autonomous region, or directly-governed municipality's people's governments shall publish telephone numbers and email addresses for complaints and reports, and receive complaints and reports. Where it proves true through review, an informants' reward is to be given.

Chapter V: Legal Responsibility

Article 36: Where the provisions of these Regulations are violated by any of the following circumstances, the State Council administrative departments for science and technology are to order that the unlawful activity be stopped, confiscate unlawfully collected or preserved human genetic resources and any unlawful gains, and give a fine of between 500,000 and 5,000,000 RMB; or where the unlawful gains are 1,000,000 RMB or more, give a fine of between 5 and 10 times the amount of the unlawful gains.

(1) Failure to get approvals in collecting our nations' important gene families or the human genetic resources of specified regions, or collecting types and volumes of human genetic resources provided for by the State Council administrative departments for science and technology;

(2) Preserving our nation's human resources without approvals;

(3) Using our nation's human genetic resources to carry out collaborative international research without approvals;

(4) Without going through through security review, providing or making open for use to foreign organizations, individuals, or bodies that they have established or are the actual controller of, human genetic resources that might impact our nation's public health, national security, or the societal public interest;

(5) Carrying out collaborative international clinical experiments without first filing the types and volumes of human genetic resources proposed for use, and their uses, with the State Council administrative departments for science and technology.

Article 37: Where false materials are provided or other deceptive tactics are employed to obtain administrative permits, the State Council administrative departments for science and technology are to revoke the permits obtained, give a fine of between 500,000 and 5,000,000 RMB, and not accept applications for permit submitted by the responsible party and unit for 5 years.

Article 38: Where these Regulations are violated by transporting, mailing, or carrying our nation's human genetic resources abroad without approvals, customs is to give punishments in accordance with relevant laws and administrative regulations. Administrative departments for science and technology shall cooperate with customs in carrying out law enforcement assistance efforts such as appraisals. Customs shall transfer confiscated human genetic resource materials to be handled by the administrative departments for science and technology of provinces, autonomous regions, and directly-governed municipalities' people's governments.

Article 39:Where these Regulations are violated by any of the following circumstances, the administrative departments for science and technology of people's governments of provinces, autonomous regions, and directly-governed municipalities are to order that the relevant activities be stopped, confiscate collected or preserved human genetic resources and unlawful gains, give a fine of between 500,000 and 1,000,000 RMB, or where the unlawful gains are 1,000,000 or more, give a fine of between 5 and 10 times the value of unlawful gains:

(1) Collection, preservation, use, or external provision of our nation's human genetic resources without passing ethics reviews;

(2) Collection of our nation's human genetic resources without getting the informed consent of the human genetic resource providers; using methods such as concealment, misleading, deceit, and so forth to obtain the human genetic resource providers' consent;

(3) Collection, preservation, use, or external provision of our nation's human genetic resources against relevant technical specifications;

(4) Providing, or opening for use, human genetic resource information to foreign organizations or individuals, and bodies established by them or that they are the actual controllers of, without filing with State Council administrative departments for science and technology or submitting back up copies.

Article 40: In any of the following situations violating these provisions, the State Council administrative departments for science and technology are to order that corrections be made or give warnings, and may give a fine of up to 500,000 RMB:

(1) Not entirely recording and appropriately storing information on the sources and uses of human genetic resources in the course of preserving our nation's human genetic resources;

(2) Preservation of human genetic resources without providing annual reports;

(3) Not promptly submitting research reports in carrying out collaborative international scientific research.

Article 41: Where foreign organizations or individuals, or the bodies they have established or are the actual controllers of, violated the provisions of these Regulations by collecting or preserving our nation's human genetic resources, using out nation's human genetic resources to carry out scientific research, or providing our nation's human genetic resources abroad, the State Council administrative departments for science and technology are to order that the illegal activity be stopped, confiscate unlawfully collected or preserved human genetic resources and unlawful gains, and give a fine of between 1,000,000 and 10,000,000 RMB, or where the unlawful gains are more than 10,000,000, give a fine of between 5 and 10 times the value of unlawful gains.

Article 42: Where provisions of these Regulations are violated by the buying and selling of human genetic resources, the State Council administrative departments for science and technology are to order that the illegal activities be stopped, confiscate unlawfully collected or preserved human genetic resources and any unlawful gains, and give a fine of between 1,000,000 and 10,000,000 RMB, or where unlawful gains are 10,000,000 RMB or more, give a fine of between 5 and 10 times the amount of unlawful gains.

Article 43: Where units violate the provisions of articles 36, 39, 41, or 42 of these Regulations and the circumstances are serious, then based on their respective duties, the State Council administrative departments for science and technology and the administrative departments for science and technology of people's governments for provinces, autonomous regions, and directly-governed municipalities are to prohibit them from engaging in activities collecting, preserving, using, or externally providing human genetic resources for 1-5 years; and where the circumstances are especially serious, permanently prohibit them from engaging in activities collecting, preserving, using, or externally providing human genetic resources.

The legal representatives, principle responsible persons, directly responsible managers, as well as other responsible personnel for units with conduct violating articles 36-39, 41, or 42, of these Regulations, are to be given sanctions in accordance with law, and the State Council administrative departments for science and technology, and the administrative departments of science and technology of people's governments for provinces, autonomous regions, and directly-governed municipalities, based on their duties, are to confiscate unlawful gains and give a fine of up to 500,000 RMB; where the circumstances are serious, they are to prohibit engagement in collection, preservation, use, or external provision of our nation's human genetic resources for 1-5 years; and where circumstances are especially serious, permanently ban participation in activities collecting, preserving, using, or externally proving our nation's human genetic resources.

Where units and individuals exhibit unlawful conduct provided for in this regulation, it is to be recorded in credit records, and announced to the public in accordance with relevant laws, administrative regulations and other provisions.

Article 44: Where violations of these Provisions violate the lawful rights and interests of others, civil responsibility is to be borne in accordance with law; where a crime is constituted, criminal responsibility is to be pursued in accordance with law.

Article 45: Where the staff of the State Council administrative departments for science and technology and the administrative departments for science and technology of provincial, autonomous region, and directly-governed municipality's people's governments, violate provisions of these Regulations, do not perform their duties, or abuse their authority, derelict their duties, or or twist the law for personal gain, sanctions are to be given in accordance with law; and where a crime is constituted, criminal responsibility is to be pursued in accordance with law.

Chapter VI: Supplementary Provisions

Article 46: Where information related to human genetic resources is a state secret, the "P.R.C. Law on the Protection of State Secrets" and other national provisions on secrecy should be referenced in implementing a secrecy management.

Article 47:These Regulations are to take effect on July 1, 2019.