Premier Li Keqiang
2065438+May 28, 2009
Chapter I General Principles
Article 1 These Regulations are formulated for the purpose of effectively protecting and rationally utilizing China's human genetic resources and safeguarding public health, national security and social interests.
Article 2 The term "human genetic resources" as mentioned in these Regulations includes human genetic resources materials and human genetic resources information.
Human genetic resources refer to organs, tissues, cells and other genetic materials containing human genome, genes and other genetic materials.
Human genetic resources information refers to data and other information materials produced by using human genetic resources materials.
Article 3 The collection, preservation, utilization and provision of human genetic resources within the territory of China shall abide by these Regulations.
In order to meet the needs of clinical diagnosis and treatment, blood collection and supply services, investigation and punishment of illegal crimes, doping testing and funeral activities, the collection and preservation of human organs, tissues, cells and other substances and related activities shall be carried out in accordance with relevant laws and administrative regulations.
Article 4 The administrative department of science and technology of the State Council is responsible for the management of human genetic resources throughout the country; Other relevant departments in the State Council are responsible for the management of human genetic resources within their respective responsibilities. The administrative departments of science and technology of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the management 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 be responsible for the management of human genetic resources within their respective administrative areas within their respective functions and duties.
Article 5 The State shall strengthen the protection of human genetic resources in China, carry out the investigation of human genetic resources, and implement the declaration and registration system of important genetic families and human genetic resources in specific areas.
The administrative department of science and technology of the State Council is responsible for organizing the investigation of human genetic resources in China, and formulating specific measures for the declaration and registration of important genetic families and human genetic resources in specific areas.
Article 6 The State supports the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, improve the diagnosis and treatment technology, enhance China's bio-safety guarantee capacity and improve the people's health guarantee level.
Article 7 Overseas organizations and individuals and institutions established or actually controlled by them shall not collect and preserve human genetic resources in China within the territory of China, nor shall they provide human genetic resources in China overseas.
Article 8 The collection, preservation, utilization and provision of human genetic resources in China shall not endanger the public health, national security and social interests of China.
Article 9 The collection, preservation, utilization and provision of human genetic resources in China shall conform to ethical principles and be subject to ethical review in accordance with relevant state regulations.
The collection, preservation, utilization and external provision of human genetic resources in China should respect the privacy rights of providers of human genetic resources, obtain their prior informed consent and protect their legitimate rights and interests.
The collection, preservation, utilization and provision of human genetic resources in China shall comply with the technical specifications formulated by the administrative department of science and technology of the State Council.
Article 10 It is forbidden to buy or sell human genetic resources.
Providing or using human genetic resources for scientific research according to law and paying or charging reasonable fees shall not be regarded as buying or selling.
Chapter II Collection and Preservation
Eleventh collection of important genetic families in China, human genetic resources in specific areas, or the collection of human genetic resources of the types and quantities specified by the administrative department of science and technology in the State Council shall meet the following conditions and be approved by the administrative department of science and technology in the State Council:
(1) Having the qualification of a legal person;
(2) The purpose of collection is clear and lawful;
(3) The acquisition plan is reasonable;
(4) Having passed the ethical review;
(5) Having departments and management systems responsible for the management of human genetic resources;
(six) there are places, facilities, equipment and personnel suitable for the collection activities.
Article 12 When collecting human genetic resources in China, the providers of human genetic resources shall be informed in advance of the collection purpose, the collection purpose, the possible impact on health, personal privacy protection measures and their right to voluntarily participate and unconditionally withdraw at any time, and the written consent of the providers of human genetic resources shall be obtained.
When informing the providers of human genetic resources of the information specified in the preceding paragraph, they must be comprehensive, complete, true and accurate, and shall not conceal, mislead or deceive.
Article 13 The State strengthens the preservation of human genetic resources, speeds up the standardization of human genetic resources preservation and the construction of big data of human genetic resources, and provides support for related research and development activities.
The state encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to carry out the preservation of human genetic resources according to their own conditions and the needs of related research and development activities, and provides convenience for other units to carry out related research and development activities.
Article 14 To preserve China's human genetic resources and provide a basic platform for scientific research, the following conditions shall be met and approved by the administrative department of science and technology of the State Council:
(1) Having the qualification of a legal person;
(2) The purpose of preservation is clear and legal;
(3) The preservation plan is reasonable;
(4) The sources of the preserved human genetic resources are legal;
(5) Having passed the ethical review;
(6) Having a department responsible for the management of human genetic resources and a preservation management system;
(7) Having sites, facilities, equipment and personnel that meet the national technical specifications and requirements for the preservation of human genetic resources.
Fifteenth preservation units should strengthen the management and monitoring of preserved human genetic resources, take safety measures and formulate emergency plans to ensure the safety of preservation and use.
The preservation unit shall completely record the preservation of human genetic resources, properly preserve the source information and use information of human genetic resources, and ensure the legal use of human genetic resources.
The preservation unit shall submit its annual report on the preservation of human genetic resources to the administrative department of science and technology of the State Council.
Article 16 The national basic platform and database for preserving human genetic resources shall be open to relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with relevant state regulations.
In order to meet the needs of public health, national security and social interests, the state may use human genetic resources preserved by preservation units according to law.
Chapter III Utilization and External Provision
Article 17 The administrative department of science and technology of the State Council and the administrative department of science and technology of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, jointly with the relevant departments of the people's governments at the same level, make overall plans for the utilization of human genetic resources and the development of the biomedical industry, make rational distribution, strengthen the construction of the innovation system, and promote the innovation and coordinated development of biotechnology and industry.
Article 18 Scientific research institutions, institutions of higher learning, medical institutions and enterprises use human genetic resources to carry out research and development activities, and support their research and development activities and the industrialization of their achievements in accordance with laws, administrative regulations and relevant state regulations.
Article 19 The State encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to make use of China's human genetic resources to carry out international cooperative scientific research according to their own conditions and the needs of related research and development activities, so as to improve the related research and development capabilities and levels.
Twentieth the use of human genetic resources in China to carry out biotechnology research and development activities or carry out clinical trials shall abide by relevant laws, administrative regulations and state regulations on biotechnology research and clinical application management.
Article 21 If overseas organizations and institutions (hereinafter referred to as overseas units) established or actually controlled by overseas organizations or individuals need to use China's human genetic resources to carry out scientific research activities, they shall abide by China's laws, administrative regulations and relevant state regulations and cooperate with China's scientific research institutions, universities, medical institutions and enterprises (hereinafter referred to as Chinese units).
Twenty-second the use of human genetic resources in China to carry out international cooperative scientific research shall meet the following conditions, which shall be applied by both parties and approved by the administrative department of science and technology of the State Council:
(a) does not harm the public health, national security and social interests of China;
(2) Both parties to the cooperation are Chinese units and foreign units with legal personality, and have the foundation and ability to carry out relevant work;
(3) The purpose and content of cooperative research are clear and legal, and the duration is reasonable;
(4) The cooperative research scheme is reasonable;
(5) The sources of human genetic resources to be used are legal, and the types and quantities are consistent with the research contents;
(six) through the ethical review of the countries (regions) where both parties are located;
(seven) the research results have a clear ownership relationship and a reasonable and clear benefit distribution plan.
In order to obtain the marketing license of relevant drugs and medical devices in China, international cooperative clinical trials are conducted in clinical institutions using human genetic resources in China, and materials that do not involve human genetic resources leave the country without approval. However, both parties shall, before conducting clinical trials, report the types, quantities and uses of human genetic resources to the administrative department of science and technology of the State Council for the record. The administrative department of science and technology of the State Council and the administrative departments of science and technology of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the supervision over the record-keeping matters.
Twenty-third in the process of using China's human genetic resources to carry out international cooperative scientific research, if major issues such as the object of cooperation, research purpose, research content and cooperation period change, the examination and approval procedures for the change shall be handled.
Twenty-fourth the use of human genetic resources in China to carry out international cooperative scientific research should ensure that China units and their researchers participate in the research in a full and substantial way during the cooperation period, and all records, data and information in the research process are completely open to China units and provide backup.
The application for a patent for the achievements of international cooperative scientific research by using China's human genetic resources shall be jointly put forward by both parties, and the patent right shall be owned by both parties. The right to use, transfer and benefit sharing of other scientific and technological achievements produced by research shall be agreed by both parties through cooperation agreements; If there is no agreement in the agreement, both parties have the right to use it, but the transfer to a third party must be agreed by both parties, and the benefits will be shared according to the contribution of both parties.
Article 25 When using China's human genetic resources to carry out international cooperative scientific research, both parties shall sign a cooperation agreement in accordance with the principles of equality and mutual benefit, honesty and credibility, * * participation and * * sharing of achievements, and make clear and specific agreements on relevant matters in accordance with the provisions of Article 24 of these Regulations.
Twenty-sixth the use of human genetic resources in China to carry out international cooperative scientific research, the two parties shall submit a cooperative research report to the administrative department of science and technology of the State Council within 6 months after the end of international cooperation activities.
Article 27 Whoever uses China's human genetic resources to carry out international cooperative scientific research, or needs to transport, mail or carry China's human genetic resources out of the country due to other special circumstances shall meet the following conditions and obtain the exit certificate of human genetic resources issued by the administrative department of science and technology of the State Council:
(a) does not harm the public health, national security and social interests of China;
(2) Having the qualification of a legal person;
(3) Having a clear overseas partner and a reasonable exit purpose;
(4) The materials of human genetic resources are legally collected or come from legal preservation units;
(five) through the ethical review.
If it is necessary to transport, mail or take the materials of human genetic resources out of China to carry out international cooperative scientific research, an application can be filed separately or together with the exit plan specified in the application for international cooperative scientific research, which will be examined and approved by the administrative department of science and technology of the State Council.
Those who transport, mail or carry human genetic resources out of the country shall go through customs formalities with the Exit Certificate of Human Genetic Resources.
Article 28 The provision or public use of information on human genetic resources to overseas organizations and individuals and institutions established or actually controlled by them shall not endanger China's public health, national security and social interests; May affect China's public health, national security and social interests, it shall pass the safety review organized by the administrative department of science and technology of the State Council.
Those who provide or provide information on human genetic resources to overseas organizations and individuals and institutions established or actually controlled by them shall file a record with the administrative department of science and technology of the State Council, and submit information backup.
The information of human genetic resources produced by international cooperative scientific research using China's human genetic resources can be used by both parties.
Chapter IV Service and Supervision
Twenty-ninth the State Council municipal administrative department of science and technology should strengthen the construction of e-government, so as to facilitate the applicants to use the Internet for examination and approval, filing and other matters.
Article 30 The administrative department of science and technology of the State Council shall formulate and timely release the guidelines and demonstration texts on the collection, preservation, utilization and provision of human genetic resources in China, and strengthen the guidance on the applicant's handling of examination and approval, filing and other related matters.