Human genetic resources have gradually become a field of global strategic competition
Protect national genetic security
Recently, the Ministry of Science and Technology has publicly solicited opinions from the public on the "Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources (Draft for Comment)" (hereinafter referred to as the "Detailed Rules (Draft for Comment)").
The "Detailed Rules (Draft for Comment)" intends to stipulate that foreign entities shall not provide my country's human genetic resources to foreign countries.
General Secretary Xi Jinping emphasized that from the perspective of protecting people's health, safeguarding national security, and maintaining the country's long-term stability, biosecurity should be incorporated into the national security system, systematically plan the construction of the national biosecurity risk prevention and control system, and comprehensively improve the country's biosecurity governance capabilities.
What are human genetic resources?
Why special legislation to strengthen the protection of my country's human genetic resources?
How to strengthen the collection, preservation and utilization of human genetic resources?
The reporter interviewed Chu Jiayou, former director and researcher of the Institute of Medical Biology, Chinese Academy of Medical Sciences.
Since the 18th National Congress of the Communist Party of China, my country's biomedical innovation and research and development have developed rapidly, and the demand for human genetic resources has become higher and higher. my country's human genetic resources management and protection system has been continuously developed and improved.
Reporter: What are human genetic resources?
Chu Jiayou: According to the "Regulations of the People's Republic of China on the Administration of Human Genetic Resources" (hereinafter referred to as the "Regulations") and the "Detailed Rules (Draft for Comment)", human genetic resources include human genetic resource materials and human genetic resource information.
Human genetic resource materials refer to the genetic materials such as organs, tissues, cells and other genetic materials that contain human genome, genes and other genetic materials.
Human genetic resources information refers to human genes, genome data and other information materials generated by using human genetic resources materials.
Reporter: At present, what is the current status of the management and protection of human genetic resources in my country, and what challenges are still facing?
Chu Jiayou: Since the 18th National Congress of the Communist Party of China, my country's human genetic resources management and protection system has been continuously developed and improved.
The legal system of human genetic resources in my country is basically formed.
The "Biosafety Law of the People's Republic of China", which will be implemented in 2021, plays a leading role in my country's biosafety laws and regulations and is the fundamental guarantee for national biosafety.
The Regulations are the specific legal basis for my country to carry out the management of human genetic resources and promote their effective protection and rational utilization.
The management mechanism is basically formed.
The human genetic resources management system and mechanism of "one vertical, one horizontal and one support" has been established. "One vertical" refers to strengthening the management responsibilities of provincial science and technology departments and strengthening territorial management; The resource management coordination group is composed of relevant departments of the State Council. Through the cooperation and cooperation of departments, it can effectively solve relevant problems involving multiple departments; "one support" refers to the construction of a management team composed of experts in medicine, pharmacy, ethics, law and other related fields. The expert group provides technical support for the scientific and standardized management of human genetic resources.
Administrative approval is more standardized and transparent.
The Ministry of Science and Technology has formulated and issued administrative licensing service guidelines, the scope and procedures of filing items, and clarified the scope of application, application process, etc.; in accordance with the requirements for standardized construction of administrative licensing, it has continuously improved the service environment of the examination and approval window, and improved the service level of the examination and approval window; continue to do a good job in government affairs Information is disclosed, frequently asked questions and answers are released in a timely manner, and the standardization and transparency of administrative examination and approval work are continuously improved.
my country's biomedical innovation capability and globalization process have improved by leaps and bounds, posing new challenges and new requirements for human genetic resources management and service capabilities.
Since the 18th National Congress of the Communist Party of China, my country's biomedical innovation and research and development have developed rapidly, and the demand for human genetic resources has become higher and higher. The collection, preservation, and international cooperative scientific research activities involving human genetic resources have exploded. The number of consultations and consultations has increased exponentially, but there are still a small number of units and individuals with weak awareness of the rule of law and illegal activities involving human genetic resources.
In the next step, the found violations will be dealt with in accordance with the law by strengthening interim and ex post supervision and daily supervision and inspection.
Promoting the effective protection and rational utilization of human genetic resources is of great significance for safeguarding individual rights and interests, safeguarding social and public interests, and building a national biosafety barrier
Reporter: In 2019, the state promulgated the "Regulations", and this time it formulated the "Detailed Rules (Draft for Comment)", why should there be special legislation on the management of human genetic resources?
Chu Jiayou: my country has a vast territory, a large population and a large number of ethnic groups, and is extremely rich in human genetic resources.
Promoting the effective protection and rational utilization of human genetic resources is of great significance for safeguarding individual rights and interests, safeguarding social and public interests, and building a national biosecurity barrier.
First, the illegal collection of human genetic resources may violate the principles of informed consent and ethics, and violate the legal rights of human genetic resources providers such as the right to know and the right to privacy.
Second, human genetic resources have become an important strategic, public welfare and basic resource for studying the laws of life, conducting medical research, and promoting new drug innovation. The loss of human genetic resources may affect the high-quality development of my country's biomedical industry and affect my country's public interests.
Third, human genetic resources are related to my country's national genetic security, and illegal outflow may affect national life and health and national biosecurity.
Therefore, it is urgent to strengthen the management and protection of human genetic resources in my country through special legislation.
Reporter: The "Detailed Rules (Draft for Comment)" has made special provisions on the subject qualifications and ethical review of the collection, preservation and utilization of my country's human genetic resources.
What are the uses and significance of the collection, preservation, utilization and research of human genetic resources?
Chu Jiayou: The collection, preservation, utilization and research of human genetic resources have important scientific and industrial value for basic life science research, clinical medical application research, and drug and medical device research and development.
In terms of basic research in life sciences, the use of human genetic resources to carry out research in cell biology, molecular biology, molecular pathology, genomics, proteomics, metabolomics, and phenomics can reveal the basic principles of life sciences and deepen Human understanding of the nature of life.
In clinical medical application research, use human genetic resources to carry out disease-related cohort studies to explore new classification, classification, diagnosis, personalized treatment and prognosis standards of diseases, which is conducive to the formulation of disease prediction and prevention, early diagnosis, molecular typing and personality New strategies and systems for diagnosis and treatment such as chemotherapy and prognosis assessment.
In the research and development of pharmaceutical and medical devices.
The large-scale verification of drug efficacy, sensitivity and drug resistance is one of the important links in the development and rapid translation research of new drugs and medical devices. The application of large-scale human genetic resources-based tissue chips, cDNA tissue chips, cell chips, PDX mice, Screening technologies such as organoids and organ chips, designing screening models, and realizing automated high-throughput drug and medical device screening will greatly reduce the manpower and financial resources expended in the development and screening of new drugs and medical devices, effectively improve screening efficiency, and greatly improve screening efficiency. Shorten the development cycle.
Human genetic resources have gradually become a field of global strategic competition, and major countries in the world have issued policies and regulations to regulate the research and utilization of human genetic resources
Reporter: From an international perspective, what are the characteristics and development trends of the research and utilization of human genetic resources?
Chu Jiayou: With the deepening of globalization, human genetic resources have gradually become a field of global strategic competition. Major countries in the world have issued policies and regulations to regulate the research and utilization of human genetic resources.
The legislation and policy practice of human genetic resources in the United States are mainly reflected in two aspects: on the one hand, the legislation on genetic patents in the field of intellectual property rights is mainly judged by the US Patent and Trademark Office.
According to the Legislation on Gene Patent, the scope of non-patentable and the patentability of biotechnological methods are clarified.
On the other hand, in practice, the transfer of human genetic resources is regulated by contracts.
There are three main contracts: the Uniform Biomaterial Transfer Agreement (UBMTA), the Model Contract for the Center for Cell Culture and Storage, and the University Model Contract.
The European Parliament and the Council have successively issued two directives to regulate the quality and safety of the collection, processing, storage and use of human blood, blood components, human tissues and cells, etc. All EU member states should abide by the relevant requirements .
Brazil has long realized the importance of protecting its own human genetic resources. The Brazilian government issued the Interim Regulations on the Protection of Biodiversity and Genetic Resources in Brazil in 2001.
Subsequently, dozens of revisions were made to the "Interim Regulations" until the Biodiversity Protection Law was passed in the form of constitutional amendments signed by the President in 2015. Benefit sharing, administrative penalties and other contents have been stipulated.
In order to better protect and manage human genetic resources, Brazil has also established a "Genetic Resources Commission" and a "National Benefit-sharing Fund".
In addition, the research and utilization of human genetic resources in various countries have gradually shifted from focusing on the management of human genetic resources materials to the management of human genetic resources information, and have established national-level databases one after another.
The U.S. Congress legislated to establish the National Center for Biotechnology Information in the United States, Europe established the European Institute of Bioinformatics, and Japan established the Japan National Institute of Genetics DNA Database. Data information in the technical and biomedical fields.
Reporter: The "Detailed Rules (Draft for Comment)" stipulates that foreign entities shall not provide my country's human genetic resources to foreign countries.
How to provide my country's human genetic resources to foreign countries?
Chu Jiayou: The state supports the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, and improve diagnosis and treatment techniques.
The "Regulations" clearly stipulate the conditions for the export of human genetic resources materials. First, there is no harm to my country's public health, national security and social public interests; second, it is a Chinese entity with legal personality; third, there is a clear overseas partner and reasonable For export purposes; fourth, the collection of human genetic resources is legal or from a legal depository; fifth, it has passed ethical review; and foreign organizations, individuals and institutions established or actually controlled by them are not allowed to provide my country’s human genetic resources to foreign countries.
The "Detailed Rules (Draft for Comment)" clarifies that as long as the conditions specified in the "Regulations" are met, the human genetic resources materials can go through customs exit matters after the Chinese unit applies and obtains an administrative license.
At the same time, the "Detailed Rules (Draft for Comment)" further clarified the scope of security review.
Specifically, it includes the following four situations: human genetic resources information of important genetic families; human genetic resources information of specific regions; exome sequencing and genome sequencing information resources of people with more than 500 people; may affect my country's public health, national security and society. Other information of public interest.
Adhere to the overall national security concept, strengthen biotechnology innovation, promote the rational use of human genetic resources, and provide strong scientific and technological guarantees for safeguarding national security
Reporter: How to implement the "Detailed Rules (Draft for Comment)" to strengthen the collection, preservation and utilization of human genetic resources?
Chu Jiayou: First, continuously improve supporting documents and carry out examination and approval work in accordance with laws and regulations.
Continue to improve the system documents such as the main points of administrative examination and approval of human genetic resources and the main points of formal examination, compile the management measures of the technical evaluation expert committee, establish the evaluation expert management platform, clarify the selection process of evaluation experts, strengthen the construction of the integrity commitment system, and standardize the management of evaluation experts; Level management authority, strengthen the internal supervision and restriction of the approval personnel, and lock the administrative approval power into the cage of the system.
The second is to strengthen active supervision of all aspects of human genetic resources activities.
Further strengthen the linkage working mechanism of human genetic resources management departments.
Combined with the human genetic resources management system and mechanism of "one vertical, one horizontal and one support", and cooperate with the establishment of a cross-departmental and cross-regional joint law enforcement working mechanism for human genetic resources management, to promote the smooth flow of information in all links, the sharing of resources among member units, and the coordination of actions of all departments; Establish a human genetic resources management collaboration mechanism and a central-local linkage mechanism to proactively discover more clues about violations of laws and regulations.
Strengthen the supervision during and after the event, formulate a supervision and inspection system for the management of human genetic resources, clarify the supervision and inspection procedures, improve the reporting mechanism, build a law enforcement team, and strengthen the guarantee of conditions.
The third is to continue to carry out policy and legal publicity.
Combined with the administrative approval application process and review points, strengthen policy interpretation and legal publicity, enhance the awareness of industry personnel to carry out the collection, preservation and utilization of human genetic resources in accordance with laws and regulations, improve the quality of administrative approval applications, and promote the effective protection and rational utilization of human genetic resources in my country .
Reporter: In the next step, what are the countermeasures and suggestions for the rational protection and utilization of my country's human genetic resources?
Chu Jiayou: First, adhere to the party's overall leadership.
General Secretary Xi Jinping emphasized that biosecurity should be incorporated into the national security system, highlighting the important role of biosecurity in protecting people's health, safeguarding national security, and maintaining the country's long-term stability.
Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we must adhere to the overall national security concept, resolutely implement the important arrangements of the Party Central Committee on scientific and technological innovation work and biosecurity work, further strengthen the management of human genetic resources, and promote the innovation and development of biomedical science and technology.
The second is to strengthen biotechnology innovation, promote the rational use of human genetic resources, realize the independent and controllable key core technologies, products and equipment of biomedicine, and provide a strong scientific and technological guarantee for safeguarding national security.
Adhere to the supremacy of the people and life, and regard the self-reliance and self-improvement of biomedical technology as an important support for protecting people's life safety and comprehensively improving public security capabilities.
Strengthen biotechnology innovation, accelerate the transformation of scientific and technological innovation achievements in infrastructure, key technologies and products that have achieved certain results, and promote the application, demonstration and promotion of results.
At the same time, it will make every effort to promote the organization and implementation of scientific and technological plans such as the "14th Five-Year Plan" national key research and development plan, strengthen the protection and utilization of my country's human genetic resources, explore the establishment of a standardized and standardized human genetic resources preservation platform, and aim at the research on cutting-edge technologies in biotechnology, biological Safety infrastructure construction and core equipment research, focus on breaking through a number of key facilities and equipment that restrict the development of my country's biomedical industry and the development of biosafety capabilities, and comprehensively enhance the country's biosafety scientific and technological support capabilities.
The third is to promote the legal construction of human genetic resources, strengthen the combination of key link control and industry self-discipline, and promote the transformation of my country's human genetic resources management from a centralized examination and approval model to strengthened supervision and deepening "decentralization, regulation and service".
On the premise of ensuring safety, in line with the principle that what should be controlled must be controlled and what should be released should be resolutely let go, strengthen the combination of management and promotion, and simultaneously improve supervision and service capabilities.
Strengthen the management and control of key links, in-depth analysis of the current domestic and foreign biotechnology development situation, study the safety risks of human genetic resources in my country, and combine the development needs and development characteristics of the industry, focus on genetic materials and information containing key genetic materials such as human genomes and genes, and further clarify human genetic materials and information. The scope and content of administrative licensing and filing of genetic resources management.
Promote industry self-discipline, and promote the standardization and standardization of the utilization of human genetic resources in my country through research and formulation of technical specifications for the collection, preservation, utilization, and external provision of human genetic resources.
Improve the human genetic resources supervision and management mechanism, formulate a human genetic resources management supervision and inspection system, and clarify the supervision and inspection procedures; give play to the roles of relevant departments and local science and technology departments, establish a joint working mechanism, and strengthen interim and ex post supervision; make full use of human genetic resources information Safety monitoring and other technical means to proactively discover clues to violations of laws and regulations.
Improve government service capabilities, strengthen the construction of the Ministry of Science and Technology's administrative examination and approval acceptance window, establish a more efficient and convenient e-government service platform, and promote the focus of service by promoting the construction of local service stations and other innovative methods, and improve the management level.
Our reporter Wu Jing