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Part II: Key points of the administrative measures regarding human genetic resources stipulated in the Regulations and the Interpretations
6. Regulations concerning the sampling of the human genetic resources
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Regulations |
Sampling of human genetic resources of important genetic families or in specific areas in China, or sampling of the human genetic resources of which the types and quantities are prescribed by the administrative department of science and technology under the State Council shall meet the following conditions and shall be approved by the administrative department of science and technology under the State Council. For the sampling of China's human genetic resources, human genetic resource providers shall be informed in advance of the aims of sampling, the purposes of use of the sampling, the possible impacts on health, the personal privacy protection measures and their rights of voluntary participation and unconditional withdrawal at any time, with consents from human genetic resource providers obtained in writing. When human genetic resource providers are informed of the information specified in the preceding paragraph, such information shall be informed in a comprehensive, complete, authentic and accurate manner, not containing any concealment, misleading statements or deception. |
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Draft Regulations |
The entities that are engaged in the collection and preservation of human genetic resources materials shall meet the following requirements: (Omit) The collection and preservation of human genetic resources materials should be voluntary and follow the principle of informed consent. Before collecting human genetic resources materials, the collecting entities shall give each provider a written inform consent, including the aims, the use, the possible impacts on health, benefit sharing, the personal privacy protection measures and their rights of voluntary participation and unconditional withdrawal at any time. |
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Interim Measures |
The State adopts a reporting and registration system on important pedigrees and genetic resources in specified regions. Any organization or individual that discovers or holds important pedigrees and genetic resources in specified regions shall report to the relevant authorities in a timely manner. No organization or individual may sample, collect, trade or export human genetic resources, or take them outside the territory of the People's Republic of China, or provide them to other countries in other forms without permission. |
Interpretations:
(1) During the times of the Interim Measures, and according to the Services Guidelines issued in 2015, sampling of human genetic resources that the Ministry of Science and Technology supervises includes sampling important pedigrees and genetic resources in specified regions and the sampling activities with foreign parties’ involvement. But between 1998, when the Regulations were promulgated, and 2015, when the Interim Measures were published, the supervision of the sampling of human genetic resources didn’t acquire enough enforcement, as was stated in Interpretation I.
(2) Comparing to the light regulations in the Interim Measures, the Draft Regulations is strict concerning the supervision of sampling and preservation of human genetic resources. From one hand, Draft Regulations forbids the foreign companies from participating in the activities of sampling and preservation. From the other hand, the sampling and preservation activities, without exception, were all involved in the scope of supervision.
But in the practice, the regulations will be difficult to enforce in all the sampling and preservation activities without difference. Thus, the Regulations is promulgated with supervision in three emphasized aspects: 1) narrowing down the forms that the foreign parties can adopt if they want to be involved in the abovementioned activities that was stipulated in the Draft Regulations; (I have mentioned this point of view in the Interpretation I as followed: Interpretation I of the Administration Regulations on Human Gene) 2) putting emphasis on important pedigrees and genetic resources in specified regions, the same as the Interim Measures did; 3) narrowing down the scope of supervision and adopting a more flexible criteria, i.e. empowering the Ministry of Science and Technology to issue regulations with lower level to specify the scope of supervision.
(3) There is no doubt that the Regulations gives much protection to the important pedigrees and genetic resources in specified regions. But for now, it’s unclear which types and how many samples of genetic resources should be under supervision. I suggest that the principle of national security, public safety and social interests should be considered.
(4) Since the human genetic resources, unlike animal and plant genetic resources, which can be collected in the wild, are mostly collected in hospitals and other medical institutions. the applicable national or industrial standards should be the relevant standards and applicable to the medical institutions during the clinical trials. Here list some of them: ISO15189, CNAS-CL02, WS/T 496-2017, WS/T 644-2018 etc.
(5) The requirement of Informed Consent for collecting human genetic resources has only been stipulated in the Services Guidelines, but it was not until the Regulation was officially promulgated that there was a formal legal basis. The Regulations delete the requirement of benefit sharing, which was included in the Draft Regulations. The reason, as being stated in Interpretation I, is to prevent the contribution of human genetic resources from becoming a behavior aiming at gaining benefits. The Informed Consent stipulated in the Regulations is similar with that should be signed by the participants in pre-clinical trials of drugs or medical devices. The reason is that the purposes of the two are similar. I’m glad to write an article specifically on the Informed Consent when the implementation rules of the Regulations promulgate.