Effectively protect and rationally utilize China's human genetic resources
——Relevant responsible persons of the Ministry of Science and Technology interpret the "Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources"
On June 6, the Ministry of Science and Technology promulgated the Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources (hereinafter referred to as the "Implementation Rules"), aiming to deeply implement the Regulations of the People's Republic of China on the Management of Human Genetic Resources (hereinafter referred to as the "Regulations"), further improve the level of standardization of the management of human genetic resources in China, and effectively protect and rationally use human genetic resources in China.
The Detailed Rules, which will come into force on July 7, clarify that human genetic resources information includes human genes, genome data and other information materials generated by using human genetic resource materials, but does not include clinical data, imaging data, protein data and metabolic data.
How can the use of human genetic resources be promoted while ensuring security? What optimization measures have been introduced to deepen the reform of "decentralization, management and service"? What are the specific provisions on the definition scope of foreign parties of external concern?
In response to the hot topics of public concern, the relevant responsible persons of the Ministry of Science and Technology were interviewed by the reporter of Science and Technology Daily to solve doubts and confusion one by one.
Reporter: What is the background of the "Implementation Rules"?
Relevant responsible person: In order to strengthen the management of human genetic resources and promote the effective protection and rational use of human genetic resources, the Ministry of Science and Technology initiated the formulation of the "Implementation Rules" after the promulgation of the "Regulations", and after extensively soliciting the opinions of relevant departments of the State Council, provincial-level administrative departments of science and technology, relevant scientific research institutions, enterprises, experts and scholars and the public, and fully studying and absorbing them, the "Implementation Rules" were formed.
Reporter: What is the general idea of the "Implementation Rules"?
Relevant person in charge: The Implementation Rules are based on relevant laws such as the Biosecurity Law of the People's Republic of China, the Administrative Licensing Law of the People's Republic of China, the Administrative Punishment Law of the People's Republic of China, and the Science and Technology Progress Law of the People's Republic of China.
The first is to implement laws and regulations such as the "Biosecurity Law of the People's Republic of China" and "Regulations", administer in accordance with law, perform duties and responsibilities, and carry out the management of human genetic resources in a scientific, rigorous and efficient manner. The second is to clarify the responsibilities of the central and local governments in the management of human genetic resources, and promote the establishment of an integrated supervision and management mechanism. The third is to clarify the boundaries of management, deepen the reform of "decentralization, management and service", strengthen the control of key links, and resolutely control and effectively release the management and release under the premise of resolutely safeguarding national biological security. Fourth, realize the accessibility of system implementation, improve procedural provisions in all links of administrative licensing, filing, and security review, strengthen specific measures for supervision and inspection and administrative punishment, and ensure the efficient operation of human genetic resources management in accordance with laws and regulations.
Reporter: What are the optimization measures in the "Implementation Rules"?
Relevant responsible person: Deepen the reform of "decentralization, management and service", and optimize the administrative licensing and filing requirements and procedures for human genetic resources activities.
The first is to optimize the scope of administrative licensing and filing. The scope of prior reporting on the collection, preservation, and international scientific research cooperation of human genetic resources, as well as the filing of international clinical trials, the provision of information to the outside world, or the open use of international cooperation has been optimized. For example, it is clarified that the scope of information management of human genetic resources is human genes, genomic data and other information materials, excluding clinical data, imaging data, protein data and metabolic data; Refine the specific definition of foreign organizations, individuals, and foreign entities such as their establishment or actual control institutions; Add "The collection of human genetic resources for common diseases such as hypertension, diabetes, red-green color blindness, and hemophilia is not included in the management of important genetic families"; Clinical trials involving collection activities that obtain marketing authorization for relevant drugs and medical devices in China do not need to declare collection approval;
For matters that meet the requirements of the preservation permit declaration, there is no need to apply for a separate collection permit; For the filing of international cooperation clinical trials that have obtained marketing authorization for relevant drugs and medical devices in China, the restrictions will be expanded from clinical institutions to clinical medical and health institutions, or human genetic resources collected in clinical medical and health institutions and tested, analyzed and processed by domestic units designated by the relevant clinical trial protocol for the marketing authorization of drugs and medical devices, and the international cooperation approval and approval meeting the above two circumstances will be converted to international cooperation filing; Where data and information generated by international scientific research cooperation that have obtained administrative licenses or have been filed are stipulated in the international cooperation agreement to be used by both parties, there is no need to separately make separate provisions such as prior reporting of information and submitting information backups. Through this series of combined regulations, we will earnestly fulfill the requirements of "decentralization, management and service" and promote self-discipline in the industry.
The second is to strengthen the operability of the system. Standardize the procedures for application, modification, continuation, and revocation of administrative approval and filing, refine the circumstances of major changes and non-major changes in international cooperation approval, and simplify the procedures for changes in international multi-center clinical research.
The third is to implement the management registration and reporting system for human genetic resources. It is clarified that the national survey of human genetic resources is to be carried out once every 5 years, and when necessary, it may be carried out according to actual needs. Strengthen systems for the registration and active declaration of important genetic resources, explore the establishment of inventory management of important genetic resources, and discover important genetic lineages and human genetic resources in specific regions, and shall promptly make active declarations through the declaration and registration management information service platform. Establish an annual preservation report and inspection system, clarifying that the previous year's preservation situation is submitted to the Ministry of Science and Technology before January 1 of each year, and the Ministry of Science and Technology organizes all provincial-level administrative departments for science and technology to conduct random inspections of the preservation activities of the region's human genetic resources preservation units every year. Both parties that have obtained an administrative license for international scientific research cooperation or completed the filing of international cooperative clinical trials shall jointly submit a report on the cooperative research to the Ministry of Science and Technology within 31 months after the expiration of the effective period of the administrative license or filing.
Reporter: What are the specific provisions on the definition scope of foreign parties of external concern?
Relevant responsible person: Institutions established or actually controlled by overseas organizations or individuals as referred to in the Detailed Implementing Rules, including the following circumstances:
(1) Foreign organizations or individuals hold or indirectly hold more than 50 percent of the shares, equity, voting rights, property shares, or other similar rights and interests of the institution;
(2) Where foreign organizations or individuals hold or indirectly hold less than 50 percent of the shares, equity, voting rights, property shares, or other similar rights and interests of the institution, but the voting rights or other rights and interests they enjoy are sufficient to dominate or exert a major influence on the institution's decision-making, management, or other conduct;
(3) Overseas organizations or individuals who, through investment relationships, agreements, or other arrangements, are sufficient to dominate or exert significant influence on the institution's decision-making, management, or other conduct;
(4) Other circumstances provided for by laws, administrative regulations, and rules.
Reporter: Please introduce the situation of the rapid approval mechanism?
Relevant responsible persons: For major public health incidents and other emergencies, the Ministry of Science and Technology is to establish a rapid approval mechanism, and shall expedite the handling of applications for administrative licenses for human genetic resources involved in the emergency handling of emergencies. The Ministry of Science and Technology is to accelerate the organization and carrying out of efforts such as acceptance, review, and review of administrative licensing applications for human genetic resources in accordance with the principles of unified command, efficient and rapid, and scientific approval. The circumstances, procedures, time limits, requirements and other matters for expedited examination and approval shall be separately stipulated by the Ministry of Science and Technology.
Reporter: Regarding supervision and inspection and administrative punishment, what are the provisions of the Detailed Rules for Implementation?
Relevant responsible person: On the basis of deepening the reform of "decentralization, reform and service", strengthening the supervision of human genetic resources activities, and realizing the combination of strict supervision and promoting innovation, the "Detailed Rules for Implementation" provides more detailed provisions on the entities and procedures for the management, supervision, inspection and administrative punishment of human genetic resources.
First, in terms of supervision and inspection, differentiated and categorical supervision mechanisms such as daily supervision and inspection, key supervision and inspection, and special supervision and inspection have been designed, and specific and clear provisions have been made for the implementation of the requirements of "double randomness and one disclosure"; Measures such as administrative compulsion and evidence preservation that may be involved in the process of supervision and inspection are refined. Second, in terms of administrative punishments, establish and complete administrative law enforcement mechanisms, specifically providing for the hearing system, review, decision, and enforcement of administrative punishments, which not only meets the new requirements of the revision of the Administrative Punishment Law, but also strengthens the legal responsibility for the supervision of human genetic resources. (Science and Technology Daily reporter Liu Yin)