The State Council this year will speed up the "gene editing" and other related legislative work

      A few days ago, Premier Li Keqiang signed a State Council decree, announced the "Regulations of the People's Republic of China on Human Genetic Resources Management" (hereinafter referred to as "Regulations"), since July 1, 2019 shall come into force.

　　According to the person in charge of the Ministry of Justice and the Ministry of Science and Technology, the Regulations focus on the protection of China's human genetic resources, promote the rational use of human genetic resources, and prevent the illegal acquisition and use of human genetic resources for biotechnology research and development activities from the source.

    It was also revealed that in order to further strengthen the "gene editing", including life sciences research, medical activities, the State Council this year will also accelerate the safety management of biotechnology research and development and the management of new biomedical technology clinical application of the legislative work, and the Regulations constitute the whole process of supervision chain.

    Human genetic resources have great potential

    "Human genetic resources are genetic materials or information that can be used individually or jointly to identify the characteristics of the human body; they are an important material and information basis for conducting life science research; they are the basic information for cognizing and mastering the laws of occurrence, development and distribution of diseases; they are an important guarantee for promoting the development of disease prevention, intervention and control strategies; and they have become a strategic, public welfare, and basic resource for public health and life safety. , basic resources." CAS academician, Fudan University Vice President Jin Li said.

　Zhao Guoping, academician of the Chinese Academy of Sciences, pointed out that China has the largest and most complete human genetic resources representing the East Asian population.

    China is a multi-ethnic populous country with unique advantages in human genetic resources, with rich genetic resources of characteristic healthy and long-lived populations, special ecological environment populations (such as plateau areas), geographically isolated populations (such as island populations) and core family lines of diseases, which provide unique conditions for the development of life sciences and related industries.

　China has always attached great importance to the protection and utilization of human genetic resources, and the Interim Measures for the Management of Human Genetic Resources, jointly formulated by the Ministry of Science and Technology and the Ministry of Health and forwarded by the General Office of the State Council in 1998, has played a positive role in the effective protection and rational utilization of human genetic resources in China.

    However, with the development of the situation, some new situations and problems have arisen in the management of human genetic resources in China: the illegal outflow of human genetic resources has continued to occur; the utilization of human genetic resources is not standardized enough and lacks coordination; the system of international cooperation in scientific research using China's human genetic resources is not perfect; the Interim Measures do not regulate the utilization of human genetic resources enough; the legal responsibility is not complete enough; and the supervisory measures need to be further improved. The interim measures also contain insufficient regulations on the utilization of human genetic resources, incomplete legal responsibilities, and regulatory measures that need to be further improved. In order to solve the outstanding problems in practice and promote the effective protection and rational utilization of human genetic resources in China, it is necessary to formulate the Regulations on the basis of the experience gained from the implementation of the Interim Measures.

　In the opinion of Jin Li, academician of the Chinese Academy of Sciences and vice president of Fudan University, the promulgation of the Regulations "will surely promote the rational development and utilization of human genetic resources in China, and contribute to the development of biomedicine in China as well as globally".

　Jin Li further pointed out that after the implementation of the "Regulations", the Ministry of Science and Technology will formulate specific measures for the declaration and registration of important genetic lineages and human genetic resources in specific areas, and organize a survey of human genetic resources in China. Relying on China's important genetic family lines and human genetic resources in specific regions, it is expected that with the help of genomics, proteomics, metabolomics, phenomics and other histological research and multidisciplinary cross-fertilization, new clues in the field of life sciences and medicine will be unearthed and new issues will be raised, and on this basis, the development of precision medicine and personalized treatment will be promoted. In the future, from the early diagnosis of diseases to providing basic information for drug development and guiding the health management of the population, human genetic resources, especially important human genetic resources, will have "great potential".

Regulating the Sharing and Utilization of Genetic Resources

　In order to effectively protect China's human genetic resources, the Regulations stipulate that: the State to increase the protection of China's human genetic resources, to carry out human genetic resources surveys, important genetic lineage and specific areas of human genetic resources to implement the declaration and registration system.

　　Where foreign organizations, individuals and the institutions they set up or actually control need to make use of China's human genetic resources to carry out scientific research activities, they shall do so by cooperating with China's scientific research institutions, institutions of higher learning, medical institutions and enterprises.

　When human genetic resources information is made available to the outside world or open for use, it shall be filed and submitted for information backup; if it may affect China's public health, national security and social public interests, it shall pass the security review organized by the science and technology administrative department of the State Council.

    In order to promote the rational use of human genetic resources in China, the Regulations stipulate that the State supports the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnostic and therapeutic technologies, enhance China's biosafety guarantee capacity, and upgrade the level of people's health protection.

　 The national basic platform and database for the conservation of human genetic resources shall be opened to relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with the relevant provisions of the State.

    The administrative departments of science and technology of the people's governments at or above the provincial level shall, in conjunction with the relevant departments of the people's governments at their respective levels, carry out integrated planning for the use of human genetic resources for scientific research and the development of the biomedical industry, rationalize the layout, strengthen the construction of the innovation system, and promote the innovative and coordinated development of biotechnology and industry.

T    he state encourages scientific research institutions, institutions of higher learning, medical institutions, enterprises to use human genetic resources to carry out research and development activities, their research and development activities and the industrialization of the results in accordance with the laws, administrative regulations and the relevant provisions of the state to be supported; to encourage the use of China's human genetic resources to carry out international cooperation in scientific research, and to enhance the relevant research and development capacity and level.

    "Competition and cooperation will always be the driving force to promote the development of scientific research, but they will also always be social problems that are not easy to deal with properly. For the utilization of genetic resources and data, how to face this challenge and transform the protection and management of resources and data into a lever to guarantee fair competition and promote high-level cooperation is a topic that needs to be properly handled." In Zhao Guoping's view, the Regulations have taken an important step forward. The above series of provisions provide clear norms from "concept" to "practice" for the sharing and utilization of human genetic resources and data in China.

    It is worth noting that the Regulations have made detailed and clear provisions for international cooperation on human genetic resources and data. "It especially emphasizes the principle of respecting the rights and interests of the Chinese side and sharing benefits fairly in the cooperation between the two sides, which is conducive to promoting the continuous development of international cooperation on the road of compliance with laws and regulations." Zhao Guoping said.

    The Regulation encourages human genetic resources of China's

Rational exploitation and utilization, in the view of Zhan Qimin, academician of the Chinese Academy of Engineering and vice president of Peking University, the Regulations provide a strong legal guarantee for China to realize the goal of a biotechnology powerhouse. "We are moving towards the era of precision medicine, and the directions of targeted drugs, biotherapy, histology technology, big data, molecular diagnosis, molecular imaging and so on are booming. The development of precision medicine requires the construction of corresponding support systems and platforms, of which human genetic resources are the cornerstone of precision medicine research."

    　Prohibition of trading human genetic resources

        In order to regulate the collection, preservation, utilization and provision of human genetic resources to the outside world, the Regulations stipulate that the collection, preservation, utilization and provision of human genetic resources to the outside world shall not jeopardize China's public health, national security and social public interests, and that they shall conform to the principle of ethics, protect the lawful rights and interests of the providers of the resources, and comply with the corresponding technical specifications. It is prohibited to buy or sell human genetic resources; the provision or use of human genetic resources for scientific research in accordance with the law and the payment or collection of reasonable costs are not regarded as buying or selling.

　    Those who carry out biotechnology research and development activities or conduct clinical trials shall comply with the relevant biotechnology research, clinical application management laws, administrative regulations and relevant state regulations.

    　The provisional measures are retained for the approval of the collection and preservation of China's human genetic resources, the use of China's human genetic resources to carry out international cooperative scientific research and the exit of human genetic resource materials, and the approval conditions are clarified and the approval procedures are improved.

　    In order to optimize the service supervision, the Regulations stipulate that the science and technology administrative department of the State Council and the science and technology administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the supervision and inspection of all aspects of the activities of collecting, preserving, utilizing and making available to the outside world the human genetic resources, and shall deal with the violations of the provisions of these Regulations in accordance with the law in a timely manner, and shall announce the results of the inspections and dealings to the society.

    The administrative department of science and technology under the State Council shall strengthen the construction of e-government affairs, and make it convenient for applicants to use the Internet to handle matters such as examination and approval and filing; formulate and timely release the examination and approval guidelines and model texts concerning the collection, preservation, utilization, and making available of China's human genetic resources to the outside world, and strengthen the guidance for applicants to handle matters related to examination and approval and filing.

　    In addition, the Regulations also improve legal responsibilities and increase penalties.

    The Regulations will also play an important role in strengthening the regulation of life science research and medical activities involving "gene editing". According to the Ministry of Justice and the Ministry of Science and Technology, the Regulations focus on protecting human genetic resources in China, promoting the rational use of human genetic resources, and preventing, at the source, illegal access to and use of human genetic resources for biotechnology research and development activities.

    In order to further strengthen the regulation and supervision of life science research and medical activities, including "gene editing", the State Council this year will also accelerate the safety management of biotechnology research and development and the management of the clinical application of new biomedical technologies in the legislative work, and the Regulations constitute the whole process of the regulatory chain.

    Among them, the legislation on safety management of biotechnology research and development focuses on regulating relevant scientific research behaviors, preventing a small number of organizations and individuals from committing serious acts against social ethics or bioterrorism in biotechnology research and development activities, and avoiding the problem of direct or indirect biosafety hazards. Legislation on the management of the clinical application of new biomedical technologies focuses on regulating related diagnosis and treatment behaviors, and through strengthening the management of the clinical application of new biomedical technologies, regulating the application of new biomedical technologies in medical institutions, ensuring the safety of the clinical application of medical technologies, and safeguarding the health rights and interests of the people.

　At present, the relevant departments are actively promoting the relevant work in accordance with the legislative procedures.