Q&A with Journalists on the Regulations of the People’s Republic of China on the Administration of Human Genetic Resources
Release Date:
2021-09-15 17:17
Heads of the Ministry of Justice and the Ministry of Science and Technology Answer Questions from Journalists on the Regulations of the People’s Republic of China on the Administration of Human Genetic Resources
On May 28, 2019, Premier Li Keqiang signed State Council Order No. 717, promulgating the Regulations of the People’s Republic of China on the Administration of Human Genetic Resources (hereinafter referred to as the “Regulations”). The Regulations came into effect on July 1, 2019. Recently, officials from the Ministry of Justice and the Ministry of Science and Technology answered questions from reporters on matters related to the Regulations.
Question: Could you briefly outline the background and process leading to the formulation of the Regulations?
Answer: China is a populous country with multiple ethnic groups, endowed with unique advantages in human genetic resources. It boasts a wealth of distinctive populations characterized by exceptional health and longevity, populations adapted to special ecological environments (such as those in high-altitude regions), geographically isolated populations (such as island communities), and disease-affected core families—each representing valuable genetic resources that provide unparalleled conditions for the development of life sciences and related industries. Throughout its history, China has attached great importance to the protection and utilization of human genetic resources. In 1998, the General Office of the State Council forwarded the Interim Measures for the Administration of Human Genetic Resources, jointly formulated by the Ministry of Science and Technology and the Ministry of Health, which have played a positive role in effectively protecting and rationally utilizing China’s human genetic resources. However, with evolving circumstances, new situations and challenges have emerged in the management of these resources: illegal outflows of human genetic resources continue to occur; the use of such resources remains insufficiently standardized and lacks coordinated planning; the institutional framework governing international collaborative scientific research involving China’s human genetic resources is still incomplete; and the Interim Measures themselves suffer from inadequate regulatory provisions on the use of human genetic resources, incomplete legal liability provisions, and the need for further refinement of oversight mechanisms. To address the salient problems encountered in practice and to promote the effective protection and rational utilization of China’s human genetic resources, it is necessary to formulate a Regulation based on a comprehensive review of the experience gained in implementing the Interim Measures.
In January 2016, the Ministry of Science and Technology submitted the “Regulations on the Administration of Human Genetic Resources (Draft for Review)” to the State Council. Upon receipt of the document, the former Legislative Affairs Office of the State Council solicited opinions from relevant departments, local governments, research institutions, enterprises, and experts and scholars on two occasions, and also made the draft publicly available for public comment; it conducted field investigations in various localities, convened expert symposiums, and worked jointly with the Ministry of Science and Technology to repeatedly review and revise the draft, ultimately producing the “Draft Regulations of the People’s Republic of China on the Administration of Human Genetic Resources.” Following the “gene-edited baby” incident, the Ministry of Justice, in coordination with the Ministry of Science and Technology, further revised and refined the draft in light of the latest developments. On May 28, 2019, Premier Li Keqiang signed a State Council decree formally promulgating the Regulations.
Question: What measures does the Regulation adopt to strengthen the protection of China’s human genetic resources?
Answer: To effectively protect China’s human genetic resources, the Regulations stipulate the following: First, the State shall strengthen protection of such resources by conducting surveys on them and establishing a system of declaration and registration for important genetic pedigrees and human genetic resources in specific regions. Second, foreign organizations, individuals, or institutions established or effectively controlled by them that wish to conduct scientific research using China’s human genetic resources must do so in collaboration with Chinese research institutions, higher education institutions, medical institutions, or enterprises. Third, any provision of human genetic resource information to foreign entities or its release for public use shall be subject to filing and the submission of information backups; where such provision may affect public health, national security, or the public interest, it must undergo a security review organized by the science and technology administrative department under the State Council.
Question: What provisions does the Regulation make to promote the rational utilization of China’s human genetic resources?
Answer: To promote the rational utilization of China’s human genetic resources, the Regulations provide as follows: First, the State shall support the rational use of human genetic resources for scientific research, the development of the biopharmaceutical industry, the improvement of diagnostic and therapeutic technologies, the enhancement of China’s biosecurity capabilities, and the elevation of public health protection. Second, the national basic platform for the preservation of human genetic resources and the associated database shall, in accordance with relevant State regulations, be made accessible to relevant research institutions, higher education institutions, medical institutions, and enterprises. Third, the science and technology administrative departments of people’s governments at or above the provincial level, in coordination with the relevant departments of their respective people’s governments, shall undertake unified planning and rational spatial allocation for the use of human genetic resources in scientific research and the development of the biopharmaceutical industry, strengthen the building of an innovation system, and promote the innovative and coordinated development of biotechnology and related industries. Fourth, the State encourages research institutions, higher education institutions, medical institutions, and enterprises to utilize human genetic resources in research and development activities, and shall provide support for such activities and for the industrialization of their outcomes in accordance with laws, administrative regulations, and relevant State provisions; it also encourages international collaborative scientific research utilizing China’s human genetic resources, so as to enhance the capacity and level of related research and development.
Question: What provisions does the Regulation make to standardize activities related to the collection, preservation, utilization, and external provision of human genetic resources?
Answer: To standardize activities related to the collection, preservation, utilization, and external provision of human genetic resources, the Regulations stipulate the following: First, the collection, preservation, utilization, and external provision of China’s human genetic resources shall not jeopardize public health, national security, or the public interest; must comply with ethical principles; protect the legitimate rights and interests of resource providers; and adhere to applicable technical standards. The buying and selling of human genetic resources is prohibited; however, the lawful provision or use of such resources for scientific research, together with the payment or receipt of reasonable costs and expenses, shall not be deemed as buying or selling. Second, any entity undertaking biotechnology research and development activities or clinical trials shall comply with relevant laws, administrative regulations, and other pertinent national provisions governing biotechnology research and clinical application management. Third, the approval procedures set forth in the Provisional Measures for the collection and preservation of China’s human genetic resources, the utilization of such resources in international collaborative scientific research, and the export of human genetic resource materials are retained, with clearly defined approval criteria and refined approval procedures.
Question: What measures does the Regulation adopt to optimize service supervision?
Answer: To optimize the regulation of related services, the Regulations stipulate the following: First, the science and technology administrative departments under the State Council and those under the people’s governments of provinces, autonomous regions, and municipalities directly under the central government shall strengthen oversight and inspection over all stages of activities involving the collection, preservation, utilization, and external provision of human genetic resources; where violations of these Regulations are discovered, they shall be promptly dealt with in accordance with the law, and the results of such inspections and enforcement actions shall be made public. Second, the science and technology administrative department under the State Council shall intensify the development of e-government to facilitate applicants’ use of the internet for handling approval and filing matters; it shall also formulate and promptly publish guidelines and model texts for the approval of activities related to the collection, preservation, utilization, and external provision of China’s human genetic resources, thereby strengthening guidance to applicants in the course of completing relevant approval and filing procedures. Third, the legal liabilities have been refined and the penalties have been increased.
Question: What role will the Regulations play in strengthening the oversight of life-science research and medical activities involving “gene editing,” and are additional administrative regulations still needed?
Answer: The Regulations are primarily aimed at safeguarding China’s human genetic resources and promoting their rational utilization, thereby preventing, at the source, the illegal acquisition and use of such resources in biotechnology research and development activities. To further strengthen the standardization and oversight of life sciences research—including “gene editing”—and medical practices, the State Council will this year accelerate legislative work on the safety management of biotechnology research and development and on the clinical application management of new biomedical technologies, thus establishing, together with the Regulations, a comprehensive, end-to-end regulatory framework. Specifically, legislation on the safety management of biotechnology research and development focuses on regulating relevant research activities to prevent a small number of organizations and individuals from engaging in conduct that gravely violates social ethics or from perpetrating bioterrorism, thereby averting direct or indirect biosecurity risks. Meanwhile, legislation on the clinical application management of new biomedical technologies is designed to standardize related diagnostic and therapeutic practices; by strengthening the management of the clinical application of these technologies, it seeks to regulate the use of new biomedical technologies by medical institutions, ensure the safety of their clinical application, and protect the health rights and interests of the general public. At present, the relevant authorities are actively advancing the pertinent work in accordance with the legislative procedures.
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