国务院办公厅转发科学技术部卫生部《人类遗传资源管理暂行办法》

国办发199836号
(June 10, 1998)
颁布日期：19980610 　实施日期：19980610 　颁布单位：国务院办公厅转发、 科学技术部、 卫生部

The APPENDIX: INTERIM PROCEDURES FOR HUMAN GENETIC RESOURCES MANAGEMENT

(Ministry of Science and Technology and Ministry of Public Health)

Chapter I General Provisions

Article 1 These Procedures are formulated for the purposes of effective protection and rational utilization of the human genetic resources of China, stepping up the research and development of human genes and promoting international cooperation and exchange on the basis of equality and mutual benefit.

Article 2 The human genetic resources referred to in these Procedures mean such genetic materials of and relevant information on organs, tissues, cells, blood, prepared objects and the constructed body of reconstructed deoxyribonucleic acid(DNA) containing human genetic groups, genes and their products.

Article 3 These Procedures must be adhered to in engaging in activities involving the gathering, collection, research, development, buying and selling, export and exit of the country of China's human genetic resources.

Article 4 The State practises the system of declaration and registration of important genetic genealogical and designated regional genetic resources. Units or individuals that have discovered and are in possession of the important genetic genealogical and designated regional genetic resources should report to the departments concerned in time. No unit or individual shall, without permission, gather, collect, buy and sell, export, bring out of the country or provide to foreign countries in other forms on their own.

Article 5 For human genetic resources and related information and materials classified in the category of science and technology secrets of the state, <

Chapter II Management Agency

Article 6 The State practises the system of management at different levels and unified examination and approval of human genetic resources.

Article 7 The competent department of science and technology administration and the competent department of public health administration under the State Council shoulder joint responsibility of the management of human genetic resources nationwide and jointly set up the Office for Human Genetic Resources Management of China to be in charge of the routine work.

Article 8 The Office for Human Genetic Resources Management of China shall be temporarily housed in the competent department of science and technology administration under the State Council. Under the leadership of the competent departments of science and technology and public health administration under the State Council, the Office for Human Genetic Resources Management of China exercises the following duties and responsibilities:

(1)drafting of related rules for implementation and documents to be promulgated for implementation upon approval, coordination and supervision over the implementation of these Procedures;

(2)responsibility of registration and management of important genetic genealogy and designated regional genetic resources;

(3)organization in the examination and verification of international cooperative projects involving human genetic resources;

(4)acceptance and processing of export and exit application of human genetic resources, and processing of export and exit certificates; and

(5)other work related to human genetic resources management.

Article 9 The Office for Human Genetic Resources Management of China employs relevant experts to form an expert team to participate in the formulation of the research planning, render assistance in the examination and verification of international cooperative projects, and conduct related technical evaluation and provide technical consultancy.

Article 10 Competent departments of science and technology administration and competent departments of public health administration(hereinafter referred to as local competent departments) of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the work of human genetic resources of the respective areas.

Departments concerned under the State Council shall be responsible for the work of human genetic resources management of the respective departments.

Chapter III Declaration and Examination and Approval

Article 11 Units responsible for the cooperation on the Chinese side must go through the formalities of application and approval for international cooperative projects involving human genetic resources of China. Units under the central departments shall submit their reports to the departments under the State Council according to the relations of subordination, units under the localities and units with no higher competent departments or relations of subordination shall submit their reports to the local competent departments of the locality wherein the said unit is located, and upon examination and consent, file an application at the Office for Human Genetic Resources Management of China, and formally sign the contract upon examination and approval.

The departments concerned under the State Council and local competent departments should, in examining the application for an international cooperative project, seek the views of the local competent departments of the place wherefrom the human genetic resources have been gathered.

International cooperative projects in progress but not yet completed prior to the coming into force of these Procedures must, in accordance with the provisions, complete retrospectively the formalities of application and approval.

Article 12 In going through the formalities of application and approval for an international cooperative project involving human genetic resources of China, an application form must be filled in and the following materials enclosed:

(1)certification of the provider and his/her relatives' insiders' consent of the human genetic resource materials;

(2)draft of the contract; and

(3)other materials as required by the examination and approval organ.

Article 13 Applications filed in pursuance of Article 12 of these Procedures having any of the following circumstances shall not be approved:

(1)lack of clear-cut purposes and orientation in the work;

(2)the unit in charge of cooperation on the foreign side that does not have strong research and development strengths and advantages;

(3)the unit in charge of cooperation on the Chinese side that does not have foundation and conditions for cooperative research;

(4)irrationality and equivocality in the arrangement for the ownership and sharing of intellectual property rights;

(5)extended scope of work and duration of cooperation;

(6)no certification of the provider and his/her relatives' insider consent of the human genetic resource materials; and

(7)that which is in violation of the provisions of the relevant laws and regulations of China.

Article 14 Export, exit and provision to foreigners of important human genetic resources shall be put under strict control.

For those listed in the export and exit plan of human genetic resource materials in international cooperative projects already examined, verified and approved, application forms shall be filled in and export and exit certificates processed directly by the Office for Human Genetic Resources Management of China.

In the event of an actual requirement for the provision to foreigners of human genetic resource materials owing to extraordinary circumstances, an application form has to be filled in and, upon the examination and consent of local competent departments or the department concerned under the State Council, submit the same to the Office for Human Genetic Resources Management of China for the verification and issuance of export and exit certificates upon approval.

Article 15 The Office for Human Genetic Resources Management of China shall review and process applications for international cooperative projects and export and exit of human genetic resource materials once every quarter of year. For those in line with the requirements of these Procedures, approval documents shall be issued upon verification, export and exit certificates processed and corresponding codes of <

Article 16 In carrying, posting by mail and transporting human genetic resources for export and exit, truthful declaration shall be made to the Customs, the Customs shall issue clearance on the strength of the export and exit certificates issued by the Office for Human Genetic Resources Management of China upon verification.

Chapter IV Intellectual Property Rights

Article 17 Human genetic resources information within the territory of China including important genetic genealogy and designated regional genetic resources and their data, materials, samples, etc, the exclusive holding rights enjoyed by research and development agencies of China shall not be transferred to other units without permission. Units or individuals of cooperation on the foreign side that have acquired the above information shall not make public, publish, apply for patents or disclose to others in other forms without permission.

Article 18 International cooperative projects concerning human genetic resources should abide by the principle of equality and mutual benefit, honesty and trustworthiness, joint participation and sharing of achievements, explicitly define the rights enjoyed and obligations undertaken by the parties, and fully and effectively protect intellectual property rights.

Article 19 For cooperative research and development of human genetic resources of China conducted by Chinese and foreign agencies, the intellectual property rights shall be handled in accordance with the following principles:

(1)where cooperative research and development achievements are within the scope of patent protection, both parties shall jointly apply for patent, the patent right shall be owned by both parties. Both parties may, in accordance with agreement, jointly implement or separately implement the said patent within territories of their respective countries. However, transfer to a third party or permission to a third party for implementation must have the agreement of both parties, and the benefits accrued therefrom shall be shared on the basis of the extent of contribution of both parties.

(2)other achievements of science and technology emanating from/the cooperative research and development, their right to use, right to transfer and measures for benefit sharing shall be agreed upon by both parties through cooperative agreement. Where it is not agreed upon in an agreement, both parties have the right to use, however, transfer to a third party must have the agreement of both parties, the benefits accrued therefrom shall be shared on the basis of the extent of contribution of both parties.

Chapter V Rewards and Penalties

Article 20 Citation and reward shall be given to any unit or individual that has discovered and reported important genetic genealogy and resources information; reward and protection shall be given to those who expose illegal acts.

Article 21 Any unit or individual of China that, in violation of the provisions of these Procedures, secretly carry, post by mail or transport human genetic resources for export and exit without approval shall be confisticated of the human genetic resources material carried, posted by mail or transported thereby, and administrative sanctions shall be imposed or transfer to judicial organ for handling depending on the seriousness of the circumstances; whoever provides human genetic resources material to a foreign agency or individual on his/her own without approval shall be confisticated of the human genetic resources material provided and concurrently imposed a fine; where the circumstances are serious, administrative sanctions shall be imposed and legal liability investigated.

Article 22 Any foreign(overseas) unit or individual that, in violation of the provisions of these Procedures, secretly gather, collect or buy and sell human genetic resources material of China without approval shall be confisticated of the human genetic resources material in his/her possession and imposed a fine; where the circumstances are serious, legal liability shall be investigated in accordance with the relevant laws of China. Whoever secretly carries, posts by mail or transports human genetic resources material of China for export and exit shall be confisticated of the human genetic resources material carried, posted by mail or tansported by the Customs, and be imposed a penalty or transferred to the judicial organ for handling depending on the extent of seriousness of the circumstances.

Article 23 Functionaries of the departments of management and experts participating in the examination and verification bear the responsibility of keeping the technical secrets for the applicants. Whoever causes leakage of technical secrets or loss of human genetic resources material as a result of negligence of duty and malpractices for selfish gains shall be imposed administrative sanctions or investigated of legal liability depending on the circumstances.

Chapter VI Supplementary Provisions

Article 24 Departments of the armed forces may, in pursuance of the provisions of these Procedures, formulate rules for implementation for the respective departments and submit the same to the Office for Human Genetic Resources Management of China for the record. Armed police forces shall implement the provisions of these Procedures.

Article 25 The competent department of science and technology administration and the competent department of public health administration under the State Council shall be responsible for the interpretation of these Procedures.

Article 26 These Procedures shall come into force as of the date of promulgation.