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CIRCULAR OF THE GENERAL OFFICE OF THE STATE COUNCIL TRANSMITTING THE INTERIM PROCEDURES FOR HUMAN GENETIC RESOURCES MANAGEMENT BY THE MINISTRY OF SCIENCE AND TECHNOLOGY AND THE MINISTRY OF PUBLIC HEALTH

    The<>
by the Ministry of Science and Technology and the Ministry of Public Health
approved by the State Council is hereby transmitted to you for earnest
implementation.

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, <> must be adhered to.
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 departnent 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 aa 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
Reources 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 intellectural 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 <System of Commodities Names and Codes>> annotated; those not in keeping with
the requirements of these Procedures shall not be approved; those whose
application documents are not complete shall be returned for completion,
and an application can be filed again upon completion.

    Article 16  In carrying, posting by mail and transporting human
genetic resources for export and exit, truthful decalaration shall
be made to the Customs, the Customs shall issue clerance 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 desisgnated regional
genetic resources and their data, materials, samples, ets, 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 eminating 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
posession 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 Reources 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.