第一章 总 则
第六章 附 则
Interim Measures for the Administration of Human Genetic Resources
Promulgated by the General Office of the State Council upon the approval of the State Council on June 10, 1998
The Ministry of Science and Technology
The Ministry of Public Health
The People’s Republic of China
Chapter One: General Provisions
Article 1 The interim Measures for the Administration of Human Genetic resources (hereinafter referred to as the Measures) are enacted for the purpose of efficiently protecting and rationally utilizing human genetic resources in the People’s Republic of China, strengthening the research and development of human genes and promoting international cooperation and exchange on the basis of equality and mutual benefits.
Article 2 The term "human genetic resources" in the Measures refers to the genetic materials such as human organs, tissues, cells, blood specimens, preparations of any types or recombinant DNA constructs, which contain human genome, genes or gene products as well as to the information related to such genetic materials.
Article 3 Whoever involved in such activities in China as sampling, collecting, researching, developing, trading or exporting human genetic resources or taking such resources outside the territory of the People’s Republic of China shall abide by the Measures.
Article 4 The State adopts a reporting and registration system on important pedigrees and genetic resources in specified regions. Any institution or individual who discovers or holds important pedigrees and genetic resources in the specified regions shall immediately report to the relevant departments. No institution or individual may sample, collect, trade, export human genetic resources or take them outside the territory of the People’s Republic of China, or provide them to other countries in any form without permission.
Article 5 Where the human genetic resources and the relevant information or data are classified as State scientific or technological secrets, the Rules for the Protection of State Secrets in Science and Technology shall be observed.
Chapter Two: Administration
Article 6 The State adopts a unified review-and-approval system regulated at different levels over human genetic resources.
Article 7 The administrative department of science and technology and the administrative department of public health under the State Council shall be jointly in charge of the administration of human genetic resources of China in a national scale and shall jointly establish the Human Genetic Resources Administration of China (hereinafter referred to as the HGRAC) to carry out routine duties.
Article 8 The HGRAC in initially placed under the administrative department of science and technology under the State Council. Under the direction of the administrative department of science and technology and the administrative department of public health under the State Council, the HGRAC shall perform the following responsibilities.
1)To draft the relevant rules and implementory documents, promulgate such rules for entering into force upon approval and ensure the enforcement of the Measures through co-ordination and supervision;
2)To be in charge of the registration and administration of the important pedigrees and genetic resources in the specified regions;
3)To review and examine international collaborative projects involving human genetic resources in China;
4)To review and approve applications for exportation of human genetic resources, and thereafter to issue Export Permit for Human Genetic Materials (hereinafter referred to as the Export Permit and
5)Other duties related to the administration of human genetic resources in China.
Article 9 An expert panel shall be formed by the HGRAC to participate in formulating research plans, assist in reviewing and examining international collaborative projects, undertake relevant technical appraisal and provide professional consultation.
Article 10 The administrative department of science and technology and the administrative department of public health at the level of provinces, autonomous regions or municipalities directly under the Central Government (hereinafter referred to as the local administrative departments), shall be in charge of the administration of human genetic resources in their own respective regions.
The relevant departments under the State Council shall be in charge of the administration of human genetic resources within their own administrative domains.
Chapter Three: Application, Examination and Approval
Article 11 Where human genetic resources in China are involved in any international collaborative project, the Chinese collaborating party shall be responsible for going through the due formalities of application for approval. Institutions directly under the Central Government shall apply to the relevant administrative department under the State Council and local institutions or institutions without a specific supervisory department shall apply to the local administrative departments, and upon receiving the approval of the relevant departments, the Chinese collaborating party shall apply to the HGRAC for examination and approval prior to entering into an official contract.
Relevant departments under the State Council and local administrative departments, in reviewing any application for international collaborative projects, shall consult the relevant local administrative departments of the region where human genetic materials are to be collected.
Any international collaborative project which has been carried out but has not been completed prior to the implementation of the Measures shall follow up application for examination and approval as a makeup in accordance with the Measures.
Article 12 An application form shall be filled in and the following documents be included in going through the applying and approving formalities of an international collaborative project involving human genetic resources of China:
(1)Informed consent form of the donor of the human genetic materials and/or his (her) legal representatives:
(2) Draft contract; and
(3)Other documents required by the examining and approving departments.
Article 13 No application submitted in accordance with Article 12 of the Measures shall be approved if any of the following circumstances is involved:
(1) Where the project lacks a precise objective or purpose;
(2)Where the foreign partner fails to possess adequate research capability or advantage in the research and development;
(3) Where the Chinese partner fails to possess the required basis and conditions for the collaborative research;
(4) Where the proportioning of ownership and share of intellectual property right is unfair or unclear;
(5)Where the collaboration exceeds the proper scope or time limit;
(6)Where informed consent forms of the donor of the human genetic materials and/or his (her) legal representatives are lacking; or
(7)Where the relevant State laws or rules and regulations are violated.
Article 14 Any export of important human genetic resources outside the territory of the People’s Republic of China or provision of such human genetic resources to foreign institutions or individuals shall be under strict control.
Where, in an international collaborative project which has already been examined and approved, the plan is made for the report of human genetic materials outside the territory of the People’s Republic of China, the application form shall be filled in and the Export Permit issued by the HGRAC.
Where, under special circumstances, temporary provision of human genetic materials to other countries is needed, the application form shall be filled in and submitted to the HGRAC for approval upon the examination and approval of the local administrative departments or the relevant administrative departments under the State Council, and then the Export Permit shall be issued upon the approval of the HGRAC.
Article 15 The HGRAC shall handle the applications for international collaborative projects and export of human genetic materials outside the territory of the People’s Republic of China every quarter. Approval shall be granted if the applications meet the requirements stipulated in the Measures, Export Permit issued and the corresponding code stipulated in the Harmonized Commodity Description and Coding System noted; no approval shall be granted if the applications fail to meet the requirements stipulated in the Measures: and such applications as fail to provide adequate documents shall be returned for revision and re-applying shall be permitted upon revision.
Article 16 All human genetic materials to be exported by means of hand carrying, mailing and transporting should be truthfully declared to the Chinese Customs. The Chinese Customs will give clearance to those accompanied by the Export Permit issued by the HGRAC.
Chapter Four: Intellectual Property Right
Article 17 The Chinese research and development institution shall have the priority to access information about the human genetic resources within the territory of the People’s Republic of China, particularly the important pedigrees and genetic resources in the specified regions and the relevant data, information and specimens and any transfer of such human genetic resources to other institutions shall be prohibited without permission. No foreign collaborating institution or individual that has access to the above mentioned information may publicize, publish, apply for patent right or disclose it by any other means without permission.
Article 18 International collaborative projects involving human genetic resources shall follow the principles of mutual benefits credit and trust joint participation and share of achievements; all rights and obligations of each party should be explicated in order to fully and effectively protect their own respective intellectual property rights.
Article 19 In a collaborative research and development of human genetic resources of China between any Chinese and foreign institutions, intellectual property right therefore shall be disposed according to the following principles:
(1)Patent shall be jointly applied by both parties and the consequent patent right shall be owned by both parties if an achievement resulted from the collaboration is patentable. Either party has the right to implement such patent separately or jointly in its own country in accordance with the contract; however, the transfer of such patent to any third party or the permission of authorizing any third party to implement such patent shall be carried out upon agreement of both parties, and the benefits obtained thereof shall be shared in accordance with their respective contributions; and
(2)The right of utilizing, transferring and sharing any other scientific achievement resulted from the collaboration shall be specified in the collaborative contract or agreement signed by both parties. Both parties are equally entitled to make use of the achievement which is not specified in the contract or agreement; however, the transfer of such achievement to any third party shall be carried out upon agreement of both parties, and the benefits obtained thereof shall be shared in accordance with their respective contributions.
Chapter Five: Rewards and Penalties
Article 20 Any institution or individual that discovers and reports important human genetic resources shall be praised and rewarded: whoever exposes illegal activities shall be rewarded and protected.
Article 21 If any Chinese institution or individual, in violation of the provisions stipulated in the Measures, exports the human genetic materials without authorization by hand carrying, mailing, or transporting, the human genetic materials shall be confiscated by the Chinese Customs and the institution or individual shall be punished ranging from administrative sanctions to prosecution by the judicial department according to the seriousness of the circumstances: if anyone, in violation of the provisions stipulated in the Measures, provides human genetic materials to foreign institutions or individuals without permission, the human genetic materials shall be confiscated and the institution or individual shall be fined, if the circumstances are serious, he shall be investigated for legal responsibility according to the Chinese law. If anyone exports the human genetic resources outside China by hand carrying, mailing, or transporting without authorization, the human genetic materials shall be confiscated by the Chinese Customs and he shall be punished or put under the prosecution of the judicial department according to the seriousness of the circumstances.
Article 23 Any staff member of the administrative department or expert engaging in the examination shall have the duty to keep technological secret for the applicants. Whoever causes the exposure of technological secrets or loss of the human genetic resources of China due to negligence in his duty or malpractice for personal gains shall be imposed with a punishment ranging from administrative sanctions to being investigated for legal responsibility.
Chapter Six: Supplementary Provisions
Article 24 The military forces may formulate their own specific implementary rules in accordance with the provisions stipulated in the Measures and submit to HGRAC for record. The armed police force shall observe the Measures.
Article 25 The administrative departments of science and technology and the administrative department of public health under the State council shall be responsible for the interpretation of the Measures.
Article 26 The Measures shall enter into effect on the date of promulgation.