[Abstract]China’s Vaccine Management Law is the first comprehensive vaccine law in the world to make comprehensive and systematic provisions on vaccine management. Its promulgation and implementation provide a strong legal guarantee for responding to public health emergencies, preventing and controlling emerging major infectious diseases and safeguarding people’s health. This law stipulates the whole process and chain of vaccine development, production, circulation, inoculation and supervision, which is groundbreaking and pioneering and has a leading role in the world vaccine management system. It is necessary to persevere in the complete, accurate, comprehensive and effective implementation of the vaccine management law, and further strengthen the legal protection of public health.
[Keywords:]Vaccine management; Rule of law; Healthy China; Epidemic situation; Law enforcement
[Chinese library classification number]D63 [Document Identification Code]A
On June 29th, 2019, the 11th meeting of the 13th the National People’s Congress Standing Committee (NPCSC) passed the People’s Republic of China (PRC) Vaccine Management Law. On the same day, the Supreme Leader of president signed the 30th Presidential Decree and promulgated it, which will take effect on December 1st, 2019. The Vaccine Management Law stipulates the whole process and chain of vaccine development, production, circulation, inoculation and supervision, and brings vaccine-related activities into the track of rule of law. Shortly after the promulgation and implementation of the Vaccine Management Law, the epidemic broke out in COVID-19, and the global public health was in crisis. In response to the epidemic and crisis, people further deepened their understanding of the functions and functions of vaccines, and placed high hopes on using vaccines to overcome the epidemic. The value and significance of the legislation of the Vaccine Management Law were further highlighted, and relevant system norms were further tested and played an important role in the anti-epidemic practice. The CPC Central Committee with the Supreme Leader as the core attaches great importance to the important role of vaccines in preventing and controlling the epidemic situation in COVID-19, safeguarding people’s health and public health safety, and promotes the research, production, supply and inoculation of vaccines in COVID-19 according to law, making significant progress, and a number of COVID-19 vaccines have been listed on the market with conditions. At present, China is promoting vaccination in COVID-19 in an all-round and orderly way. At this moment, it is necessary to further understand the significance, main contents and spirit of the vaccine management law, further promote its implementation, and add the rule of law to the fight against the epidemic.
First, the significance of the promulgation and implementation of the vaccine management law
Vaccine is a preventive biological product used for human immunization to prevent and control the occurrence and prevalence of diseases, and it is a great invention produced in the process of human struggle against diseases. As the first comprehensive vaccine law in the world, China’s vaccine management law has made comprehensive and systematic provisions on vaccine management, and its promulgation and implementation is of great significance.
First, implement the major measures taken by the CPC Central Committee with the Supreme Leader as the core to strengthen vaccine management and safeguard people’s health. General Secretary of the Supreme Leader attaches great importance to vaccine management, and demands that a scientific and perfect food and drug safety governance system be established with the strictest standards, the strictest supervision, the severest punishment and the most serious accountability. After the problem vaccine case of Jilin Changchun Changsheng Company occurred in 2018, the General Secretary of the Supreme Leader made important instructions on many occasions, demanding a thorough investigation, serious accountability, strict handling according to law, speeding up the improvement of the long-term mechanism for vaccine drug supervision, and improving laws, regulations and institutional rules; It is emphasized that we should always put the health of the people in the first place, improve China’s vaccine management system with the determination of using strong drugs to treat boils and curettage, resolutely hold the bottom line of safety, and fully protect the vital interests of the people and the overall situation of social security and stability. In September 2018, the General Secretary of the Supreme Leader presided over the fourth meeting of the Central Committee for Comprehensively Deepening the Reform, deliberated and adopted the Opinions on Reforming and Improving the Vaccine Management System, and demanded that relevant laws and regulations be improved. In order to implement the spirit of the important instructions of the Supreme Leader General Secretary and the decision-making arrangements of the CPC Central Committee, the National People’s Congress Standing Committee (NPCSC) gave full play to the leading role of legislation, strengthened communication and coordination with relevant departments, promoted the establishment of a working group for drafting the vaccine management law, and promoted the legislation of the vaccine management law with high quality and high efficiency. This major legislative task was successfully completed in more than half a year, creating an "express" speed of legislation.The Vaccine Management Law implements the spirit of the important instructions of the Supreme Leader General Secretary on vaccine management and the major decision-making arrangements of the CPC Central Committee on reforming and improving the vaccine management system, and establishes and improves a scientific and standardized vaccine management system. There are many innovations and developments, which are conducive to long-term adherence and universal compliance.
The second is to provide a strong guarantee for implementing the strategy of healthy China and improving people’s health level. General Secretary of the Supreme Leader emphasized that people’s health is the foundation of social civilization and progress, an important symbol of national prosperity and national prosperity, and also the common pursuit of the broad masses of the people. [1] Vaccine is an important guarantee to safeguard people’s health, and it is the most concerned, direct and realistic interest of the people. Infectious diseases are a major threat to human health. Throughout the history of human development, vaccines have played an important role in preventing and controlling infectious diseases and maintaining people’s health. For example, human beings’ overcoming and eventually eliminating the ancient smallpox disease is inseparable from the innovation and development of vaccines. In the mid-Ming Dynasty, "human pox" vaccination was introduced to prevent smallpox in China. At the end of 18th century, British scientist edward Cenna invented the method of vaccination against smallpox. After several generations of scientists’ unremitting efforts, a vaccine for inactivating smallpox virus was finally developed. Smallpox was finally eliminated by vaccination. China is committed to maintaining people’s health, giving priority to people’s health in a strategic position, and promoting the construction of a healthy China. The state establishes a system for the prevention and control of infectious diseases, adheres to prevention first, implements a vaccination system, strengthens immunization planning, and provides residents with immunization vaccines free of charge.
China is one of the few countries in the world that can provide all EPI vaccines by its own ability. According to the characteristics and outstanding problems of vaccine management, the Vaccine Management Law integrates the relevant provisions of existing laws and administrative regulations, and makes targeted, systematic, forward-looking and operational provisions on vaccine management according to the development needs and practical situation of the situation. The whole process and chain ensure vaccine safety and ensure vaccine research and development, production, supply and inoculation, which will surely promote the construction of healthy China.
Third, it provides a strong legal guarantee for responding to public health emergencies and preventing and controlling new major infectious diseases. Preventing and resolving major risks such as major epidemics and sudden public health risks is related to national security and development, and to the overall social and political stability. In January 2018, the General Secretary of the Supreme Leader listed 16 risks in 8 aspects at the opening ceremony of the seminar on studying and implementing the spirit of the 19th National Congress of the Communist Party of China, in which he specifically mentioned that "major infectious diseases like SARS should always be vigilant and strictly guarded". [2] The vaccine management law adheres to the bottom line thinking, and has made forward-looking institutional arrangements for vaccine development and management that are urgently needed for public health emergencies and prevention and control of emerging major infectious diseases.
Under the strong leadership of the CPC Central Committee with the Supreme Leader as the core, the research and development of COVID-19 vaccine in China is progressing smoothly, and it has always been in the first phalanx in the world. Many technical routes, such as inactivated vaccine, adenovirus vector vaccine and recombinant protein vaccine, have been promoted at the same time. Many candidate vaccines have entered clinical trials, and many vaccines have been conditionally approved. The World Health Organization has approved two China vaccines to be included in the emergency use list, actively and steadily promoting universal vaccination of COVID-19 vaccines. The vaccine management law provides direct and specific legal support and guarantee.
The fourth is to provide systematic institutional guarantee for strict vaccine management, improving vaccine quality and giving full play to the important role of vaccines in disease prevention and control. Since the founding of New China, especially since the reform and opening up, China’s immunization program has achieved remarkable results and made great contributions to disease prevention and control. At the same time, we should also be soberly aware that for a period of time, problem vaccine incidents occurred from time to time, exposing outstanding problems such as non-implementation of the main responsibility, irregular vaccination, insufficient innovation motivation, insufficient protection, inadequate supervision, weak supervision ability and low illegal cost. Especially after the problem vaccine case of Changchun Changsheng Company, it caused public doubts and worries about the vaccine. The vaccine management law adheres to the systematic concept, coordinates the development of vaccine industry and the bottom line of vaccine safety. It not only solves the deep-seated problems faced by vaccine management based on the thinking and methods of the rule of law at that time, but also focuses on the long-term, builds the foundation of the rule of law, implements the power of the rule of law, accumulates the trend of the rule of law, promotes the vaccine management system to be more mature and stereotyped, and provides long-term institutional guarantee for the healthy development of vaccine industry and adherence to the bottom line of vaccine safety. The vaccine management law takes "strengthening vaccine management, ensuring vaccine quality and supply, standardizing vaccination, promoting vaccine industry development, safeguarding public health and safeguarding public health safety" as its legislative purpose, emphasizing that the state implements the strictest management system for vaccines, adheres to safety first, risk management, whole-process control, scientific supervision and social co-governance, clarifies the positioning of vaccine products as strategic and public welfare products, and creates a good institutional environment for vaccine development.Vaccine management legislation reflects the great importance attached by the party and the state to vaccine safety and people’s life and health, the strong determination to build a defense line for vaccine safety by means of the rule of law, the response to people’s expectations for vaccine safety, and the reshaping of the confidence of the whole society in vaccine safety, which will surely promote the development of vaccine industry.
At present, vaccines, especially COVID-19 vaccines, have become an important tool in the competition and game among big countries and a powerful weapon to overcome the COVID-19 epidemic. China has declared Xinguan pneumonia vaccine as an important international public product, and China’s vaccine management law, as the world’s first comprehensive law on vaccine management, is groundbreaking and pioneering, which has a leading role in the world vaccine management system and contributed to China’s wisdom.
Second, encourage innovation and strengthen research and development
Since the founding of New China, especially since the reform and opening up, China’s vaccine industry has developed rapidly. There are more than 40 vaccine production enterprises, which can produce more than 60 kinds of vaccines and prevent more than 30 kinds of diseases, and have become a major vaccine production country; However, China’s vaccine as a whole is large but not strong, and the innovation power is insufficient, and there is still a distance from the "vaccine power". Strengthening the innovation of vaccine research and development is a major decision made by the CPC Central Committee. The General Secretary of the Supreme Leader stressed that it is necessary to concentrate on tackling key core technologies and solve a number of "stuck neck" problems in the fields of medicines, medical devices and vaccines. [3] The vaccine management law has made a series of institutional arrangements around encouraging innovation and strengthening research and development.
First, improve policy planning and establish a clear orientation. In the general provisions, it is clearly stipulated that the state supports basic and applied vaccine research, promotes vaccine research and innovation, and incorporates vaccine research, production and storage for preventing and controlling major diseases into the national strategy. The state formulates development plans and industrial policies for the vaccine industry, supports industrial development and structural optimization, encourages large-scale and intensive production, and constantly improves the vaccine production technology and quality level.
Second, demand guidance and active support. It is clear that according to the epidemic situation of diseases, the immune status of the population and other factors, the state formulates relevant research and development plans, arranges necessary funds, and supports the research and development of new vaccines such as multiple vaccines and multiple vaccines. Multi-vaccine is a vaccine which is composed of antigens of two or more different pathogens to prevent and control many diseases. A multivalent vaccine is a vaccine that consists of two or more antigens of the same pathogen, which can prevent and control diseases caused by different groups or types of infections of the same pathogen. Multi-valent vaccine is helpful to reduce vaccination times, expand immune protection effect, reduce vaccination cost and risk of abnormal reaction, and is the focus of national encouragement and support. In addition to multi-linked multivalent vaccines, new vaccines also include innovative vaccines for diseases that have no effective means of prevention and control, and vaccines produced by new strains of bacteria. The formulation of vaccine-related development planning by the state is conducive to clarifying the direction and focus of vaccine development and innovation, and improving the accuracy of vaccine development and innovation.
The third is to promote vaccine marketing license holders to strengthen innovation and research. The state encourages vaccine marketing license holders to increase investment in research and innovation, optimize production technology, improve quality control level and promote vaccine technology progress. Vaccine marketing license holders should establish and improve the whole life-cycle quality management system of vaccines, carry out post-marketing evaluation, post-marketing research and post-marketing management of vaccines according to regulations, further confirm the safety, effectiveness and quality controllability of vaccines, establish a retrospective analysis and risk reporting system of vaccine quality, conduct quality tracking analysis of vaccines, continuously improve quality control standards, improve production technology and improve the stability of production technology.
The holder of the vaccine marketing license is an enterprise that has obtained the vaccine drug registration certificate and drug production license according to law. It should strengthen the quality management of the vaccine throughout its life cycle and be responsible for the safety, effectiveness and quality controllability of the vaccine. In the process of legislation, there is an in-depth discussion on whether to implement the marketing license holder system in the field of vaccines. Some suggest that the vaccine marketing license holder is different from the general drug marketing license holder, and the requirement must have production capacity. In fact, it means that the vaccine production enterprise is required, and under normal circumstances, it is not allowed to entrust production. The pilot scope of the drug marketing license holder does not include vaccines, so it is recommended not to implement the vaccine marketing license holder system; Some suggest that it is necessary to implement the vaccine marketing license holder system, but it is necessary to make it clear that the vaccine marketing license holder is an enterprise that has obtained the drug production license to distinguish it from the general drug marketing license holder. After in-depth study, the holder of vaccine marketing license stipulated by law is different from the holder of drug marketing license, and must be an enterprise that has obtained both vaccine drug registration certificate and drug production license. Establishing the vaccine marketing license holder system in law is conducive to ensuring the sustainable and benign development of vaccine research, production and supply; It is conducive to clarifying and implementing the legal responsibilities of all participants in the whole life cycle of vaccines and strengthening the main responsibility of vaccine marketing license holders for vaccine quality; It is conducive to the formation of a full-process and full-chain supervision model with vaccine marketing license holders as the core, and improves the efficiency of vaccine supervision; Ensure that vaccine developers enjoy the fruits of innovation to the maximum,It is conducive to stimulating the innovation enthusiasm of vaccine developers and promoting vaccine research and innovation.
Fourth, encourage clinical trials to provide favorable conditions for innovative research and development. Clinical trial is a systematic trial aimed at human body (patients or healthy subjects), aiming at discovering or verifying the clinical medicine, pharmacology and other pharmacodynamic effects and adverse reactions of an experimental drug, or the absorption, distribution, metabolism and excretion of the experimental drug, so as to determine the efficacy and safety of the drug. Clinical trials are an important link in the process of vaccine development. Vaccine management law regulates clinical trials from the aspects of clinical trial approval, experimental institutions, experimental schemes, safety monitoring and evaluation of trials, informed consent, and protection of subjects’ legitimate rights and interests. In practice, the number of qualified vaccine clinical trial institutions is small, and their own business is generally heavy, so there is a problem of low enthusiasm for carrying out vaccine clinical trials. Therefore, the law stipulates that the state encourages qualified medical institutions and disease control institutions to carry out vaccine clinical trials according to law.
In addition, the vaccine management law also forces vaccine research and innovation through post-marketing management and selective elimination. For example, it is clear that National Medical Products Administration should cancel the drug registration certificate of a vaccine that has a serious abnormal reaction to vaccination or is harmful to human health for other reasons. If it is found that the product design, production technology, safety, effectiveness or quality controllability of vaccine varieties are obviously inferior to other vaccine varieties for preventing and controlling the same disease after marketing evaluation, the drug registration certificates of all vaccines of this variety should be cancelled and the corresponding national drug standards should be abolished.
Third, the combination of peace and urgency to meet urgent needs
Vaccine is a strategic product to prevent and control diseases. Vaccination is not only the basic work of disease prevention and control at ordinary times, but also a powerful weapon to deal with the epidemic situation of major sudden infectious diseases. It is necessary to adhere to the combination of emergency and emergency to meet urgent needs and ensure that it is used at critical moments. The vaccine management law has made overall plans to meet urgent needs and made relevant institutional arrangements.
First, strengthen organization and jointly tackle key problems. The vaccine development cycle is long and the investment is large, which requires strong support from the state. The Vaccine Management Law stipulates that the state shall organize vaccine marketing license holders, scientific research institutions and medical and health institutions to jointly tackle key problems and develop vaccines urgently needed for disease prevention and control. After the outbreak of COVID-19, 12 departments, including the Ministry of Science and Technology, National Health Commission and National Medical Products Administration, formed the scientific research team of the joint prevention and control mechanism in the State Council according to law. [4] COVID-19 vaccine research and development was regarded as one of the five main directions of scientific research, and it was placed in the most important position, and related vaccine research and development enterprises, scientific research units, medical institutions, disease control institutions and research institutions of experimental animals were organized to jointly tackle key problems, and inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines and so on were promoted simultaneously. [5]
Second, give priority to the review and approval system, and make it clear that National Medical Products Administration should give priority to the review and approval of urgently needed vaccines and innovative vaccines for disease prevention and control. In the research and development and marketing of COVID-19 vaccines, such as the conditional listing of Covid-19 inactivated vaccine of Sinopharm Zhongsheng Beijing Company, National Medical Products Administration Drug Testing Center issued five guiding principles, such as "Guiding Principles for Clinical Evaluation of Preventive Vaccines in novel coronavirus (Trial)", which National Medical Products Administration gave priority to the review and approval according to law, speeding up the research and development and marketing process of COVID-19 vaccines.
The third is the conditional approval system, which clearly defines the vaccine urgently needed to deal with major public health emergencies or other vaccines urgently needed by National Health Commission. If the benefits outweigh the risks after assessment, National Medical Products Administration can conditionally approve the application for vaccine registration. For the vaccine that requires further research when approving the application for vaccine registration, the vaccine marketing license holder shall complete the research within the prescribed time limit; If the research is not completed within the time limit or it cannot be proved that the benefits outweigh the risks, National Medical Products Administration should deal with it according to law until the drug registration certificate of the vaccine is cancelled. On December 23rd, 2020, Sinopharm Zhongsheng Beijing Company formally applied for the registration of Covid-19 inactivated vaccine with conditional listing on the basis of the previous rolling submission of research materials. After a series of legal procedures such as strict examination, review, verification, inspection and data analysis, it was assessed that the known and potential benefits of Sinopharm Zhongsheng Beijing Company’s Covid-19 inactivated vaccine were greater than the known and potential risks, which fully met the preset requirements of conditional listing standards. Considering that the COVID-19 epidemic is prevalent all over the world, and there is no specific medicine to treat COVID-19 in the world, on December 30th, 2020, National Medical Products Administration approved the registration application for conditional listing of Covid-19 inactivated vaccine of Sinopharm Zhongsheng Beijing Company, and put forward specific requirements for conditional post-marketing research.
The fourth is the emergency use system, which clearly indicates that there are particularly serious public health emergencies or other emergencies that seriously threaten public health. National Health Commission puts forward suggestions for emergency use of vaccines according to the needs of prevention and control of infectious diseases, and it can be used urgently within a certain scope and time limit after being approved by the National Medical Products Administration organization. After a series of legal procedures, such as strict argumentation and review, in June 2020, the Covid-19 Vaccine Emergency Use Plan was approved according to law, and then started on a small scale, steadily and prudently. On the basis of informed consent and voluntariness, on the premise of adequate adverse reaction monitoring and emergency treatment preparation, emergency vaccination of COVID-19 vaccine was carried out for high-risk groups. [6] The vaccine for emergency use is a vaccine that has completed all animal tests, phase I clinical trials and phase II clinical trials in strict accordance with relevant regulations, and has achieved very good safety indicators and immunogenicity indicators in phase I and II clinical trials.
Fifth, ensure the production and supply system, and make it clear that the Ministry of Industry and Information Technology and the Ministry of Finance, together with National Health Commission, the Ministry of Public Security, the State Administration of Market Supervision and National Medical Products Administration, will strengthen the production capacity and product management of vaccine reserves and establish a dynamic adjustment mechanism according to the needs of disease prevention, control and public health emergency preparedness. When an infectious disease breaks out and is prevalent, the holder of the relevant vaccine marketing license shall timely produce and supply vaccines for the prevention and control of infectious diseases; Transportation units should give priority to the transportation of vaccines for the prevention and control of infectious diseases; Governments at or above the county level and their relevant departments should do a good job in organization, coordination and guarantee. Since the outbreak of COVID-19, the Ministry of Industry and Information Technology and other relevant parties have strengthened production scheduling, accelerated capacity building, ensured the smooth supply chain of vaccine production, and done a good job in organizing and ensuring the production of vaccines in COVID-19. By the end of 2020, 18 enterprises have successively carried out capacity building according to their respective vaccine research and development progress in COVID-19. Three enterprises, Sinopharm Zhongsheng Beijing Company, Sinopharm Zhongsheng Wuhan Company and Beijing Kexing Zhongwei Company, have expanded their production capacity on the basis of completing the task of capacity building in 2020. Sinopharm Zhongsheng Beijing Company and other enterprises have started large-scale vaccine production in COVID-19, laying a foundation for meeting the large-scale vaccination demand of vaccines in COVID-19 in China. At the same time, Chinese enterprises have given full consideration to meeting overseas demand. [7]
The sixth is to establish a system of exemption from batch issuance under special circumstances. Vaccines that are urgently needed to prevent and control the epidemic situation of infectious diseases or respond to emergencies are exempted from batch issuance with the approval of National Medical Products Administration to ensure emergency needs; Arrangements have also been made for mass vaccination and emergency vaccination in a certain area during the outbreak and epidemic of infectious diseases, so as to effectively cope with and control the epidemic situation of major sudden infectious diseases.
In addition, the usual management systems such as vaccine circulation and vaccination will be used in emergencies with stricter requirements. Many systems in the vaccine management law are applicable to both peacetime and emergency situations. For example, the vaccination system such as vaccination taboo check, the Notice on Further Doing a Good Job in the Prevention and Control of Epidemic Situation in COVID-19 in Winter and Spring requires that vaccination work be standardized in strict accordance with the provisions of the Vaccine Management Law, vaccination work norms and so on, and procedures such as health inquiry, vaccination taboo check, informed notification, information registration, "three checks and seven to one verification" and observation after vaccination should be strictly implemented, and preparations should be made for monitoring and handling suspected abnormal reactions as required.
COVID-19 epidemic is the most serious epidemic of infectious diseases in the world in the past century. It is a major public health emergency with the fastest spread, the widest infection range and the most difficult prevention and control in China since the founding of New China. Vaccines are urgently needed to provide strong support for the prevention and control of COVID-19 epidemic. China adheres to the principle of people first, life first, gives full play to the advantages of the new national system, and successfully develops COVID-19 vaccine, which provides a powerful weapon for epidemic prevention and control. The Vaccine Management Law insists on meeting urgent needs, which provides a strong guarantee for the overall promotion of vaccine research, production, supply and vaccination in COVID-19, and has made positive contributions to the overall promotion of epidemic prevention and control and economic and social development.
Fourth, strict production and quality assurance
Vaccines are produced, and strict production is an important guarantee for vaccine quality. Changchun Changsheng Company’s problem vaccine case is a major case in which vaccine producers bent the law for profit, violated the national drug standards and good manufacturing practice, and fabricated false production inspection records, reflecting the institutional defects in vaccine production. In view of the outstanding problems in vaccine production in the past and summing up practical experience, the vaccine management law further tightened the production management system.
First, strict production access. It is clear that the state implements a strict access system for vaccine production, and the activities of vaccine production must meet the corresponding conditions and be approved by the drug supervision department at or above the provincial level to obtain a drug production license. Vaccines belong to drugs, and engaging in vaccine production activities should first meet the conditions stipulated in the Drug Administration Law for engaging in drug production activities. For example, there are pharmaceutical technicians who have been qualified according to law and factories that are suitable for drug production. At the same time, vaccines, as special drugs, must meet the following conditions in vaccine production activities:
It has a moderate scale and sufficient production capacity reserve. Under normal circumstances and emergencies such as public health emergencies, vaccine demand changes greatly. To ensure vaccine supply in emergencies, enterprises must be able to expand production urgently and have sufficient production capacity reserves.
It has systems, facilities and equipment to ensure biological safety. Vaccine is a active immunity preparation for preventing and controlling diseases, which is made of pathogenic microorganisms and their metabolites through artificial attenuation, inactivation or genetic engineering. Viruses and bacteria are the main starting materials of vaccines, and there are biological safety risks in the process of vaccine development, production and inspection. The Vaccine Management Law specifically stipulates that the biosafety management system should be established and improved in the process of vaccine development, production and inspection, so as to strictly control biosafety risks, strengthen biosafety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure that pathogenic microorganisms such as bacterial strains are used legally and justly. The bacterial strains and cell strains used in vaccine development, production and inspection should be clear about their history, biological characteristics and generations, and detailed files should be established to ensure that their sources are legal, clear and traceable. Those with unknown sources should not be used. In October, 2020, China enacted the Biosafety Law to strengthen the biosafety system, which clearly stipulated that the biosafety management of production workshops involving the operation of pathogenic microorganisms should be carried out in accordance with the regulations on pathogenic microorganism laboratories and other biosafety management norms.
Meet the needs of disease prevention and control. There are some problems in China’s vaccine industry, such as low concentration and serious homogenization competition. Some vaccines are produced by many companies, and many companies only produce one vaccine. The benign industry ecology has not been fully established. According to the needs of disease prevention and control at home and abroad, China’s vaccine industry should be enlarged and strengthened.
Whether the vaccine can be commissioned is an important issue in the legislative process. The draft Law on Vaccine Management stipulates that vaccines shall not be commissioned for production, unless otherwise stipulated by National Medical Products Administration. During the process of deliberation and revision, some people suggested that the entrusted production of vaccines is a common practice in the world. From the perspective of the development of vaccine industry, in order to improve the quality and efficiency of vaccine production, entrusted production should be allowed, and the conditions and approval of entrusted production of vaccines should be stipulated, and the supervision of entrusted production enterprises should be strengthened. It has also been suggested that the "Regulations on the Implementation of the Drug Administration Law" (which is currently being studied and revised) clearly stipulates that vaccines may not be commissioned for production. The vaccine incidents that occurred in the past are also related to commissioned production, and vaccine production should be further strictly managed to clarify that vaccines may not be commissioned for production. Through research, it is indeed necessary to entrust production in some cases in practice. For example, the R&D and production capacity of combined vaccine in China is still relatively weak. When producing combined vaccine, entrusting other enterprises to produce some antigens can improve the quality and efficiency of combined vaccine production. Therefore, the law stipulates that if it is really necessary to entrust production beyond the vaccine production capacity, it should be approved by National Medical Products Administration; Those who accept commissioned production shall abide by the provisions of this law and the relevant provisions of the state to ensure the quality of vaccines. Vaccine management law provides a basis and standard for vaccine commissioned production.
The second is to strictly control the whole production process. Vaccine, as a biological product, has complex composition and properties. Compared with general drugs, the whole process of vaccine production requires higher and stricter control.
First of all, the vaccine should be produced and tested according to the approved production technology and quality control standards. The holder of the vaccine marketing license shall review and inspect the whole process of vaccine production and vaccine quality according to the regulations. Vaccine production technology and quality control standards are important documents to ensure vaccine quality and important basis for vaccine production and inspection. When National Medical Products Administration approves the application for vaccine registration, it shall approve the production technology and quality control standards of the vaccine. If the production process is changed, it shall be evaluated and verified, and shall be filed or reported according to National Medical Products Administration’s regulations on change management, such as the Measures for the Administration of Post-marketing Changes of Drugs (Trial); Changes that may affect the safety, effectiveness and quality controllability of vaccines shall be approved by National Medical Products Administration. Change management is the focus of all aspects in the legislative process. Before the revision in 2019, the Drug Administration Law stipulated that pharmaceutical production enterprises must report to the original approval department for examination and approval if they change the production process that affects the quality of drugs. In practice, it is strongly reflected that it is difficult for production enterprises to accurately grasp which changes affect quality, which leads to the implementation of this regulation is not in place. The vaccine management law clearly implements classified management of changes and makes specific provisions.
Secondly, the whole process of vaccine production should meet the requirements of good manufacturing practice (GMP). Good manufacturing practice, as a part of quality management system, is the basic requirement of drug production management and quality control, aiming at minimizing the risks of pollution, cross-contamination, confusion and errors in drug production, and ensuring the sustained and stable production of drugs that meet the intended use and registration requirements. As a special drug with biological activity, the whole production process of vaccine should meet the requirements of GMP; In the appendix of GMP "Biological Products", there are also some special requirements for vaccine production, and the whole process of vaccine production should also meet these requirements.
Thirdly, vaccine marketing license holders should establish a complete production quality management system, continuously strengthen deviation management, and use information technology to truthfully record all the data formed during production and inspection. Any deviation from the production process, material balance limit, quality control standards, inspection methods and operating procedures during vaccine production may affect the quality of vaccines, and management should be strengthened.
In addition, units and individuals engaged in vaccine development, production, circulation and vaccination activities should ensure that the information in the whole process is true, accurate, complete and traceable. The country implements the whole-process electronic traceability system for vaccines, establishes a national electronic traceability collaborative platform for vaccines, integrates the traceability information of the whole process of vaccine production, circulation and vaccination, and realizes the traceability of vaccines. The holder of the vaccine marketing license shall establish an electronic vaccine traceability system, which is connected with the national electronic vaccine traceability collaborative platform to realize traceability and verification of the minimum package unit vaccine in the whole process of production, circulation and vaccination. Disease control institutions and vaccination units shall truthfully record the vaccine circulation and vaccination according to law, and provide traceability information to the national vaccine electronic traceability collaborative platform according to regulations. In accordance with the provisions of the Vaccine Management Law, the supply and inoculation of vaccines in COVID-19 have been traced back to the whole process.
The third is strict management of vaccine batch issuance. Batch issuance of vaccines is an activity in National Medical Products Administration, in which each batch of vaccines that have obtained marketing permission is audited and tested by a designated batch issuing agency before being marketed or imported, and a batch issuance certificate is issued to those that meet the requirements. National Medical Products Administration designated the Central Inspection Institute and some provincial drug inspection institutions to be jointly responsible for the issuance of vaccine batches. Batch issuance of vaccines is the last inspection pass before vaccine sales and the last line of defense to prevent vaccines with quality problems from entering the circulation. The vaccine management law clarifies that the state implements the vaccine batch issuance system; Except in very special circumstances, each batch of vaccines should obtain a batch issuance certificate before sale or import; Vaccines that are not issued in batches shall not be sold and shall be handled according to regulations.
The fourth is to optimize the procurement and supply of vaccines. Vaccines include immunization programs and non-immunization programs. Immunization planning vaccine is the vaccine that residents should be vaccinated according to the regulations of the government, including the vaccine determined by the national immunization planning and other immunization planning vaccines other than the national immunization planning vaccine (including vaccines added by the provincial government when implementing the national immunization planning, and vaccines used for emergency vaccination or mass vaccination organized by the government at or above the county level or its health department); Non-immunization program vaccines are other vaccines voluntarily vaccinated by residents. According to the Vaccine Management Law, the National Immunization Program vaccines are subject to centralized bidding or unified negotiation by the National Health and Health Commission and the Ministry of Finance, and the winning bid price or transaction price is formed and announced, and all provinces (autonomous regions and municipalities) implement unified procurement. Other EPI vaccines and non-EPI vaccines other than the national EPI vaccine are purchased by the provinces (autonomous regions and municipalities) through the provincial public resource trading platform.
Vaccines are subject to market-adjusted prices, that is, they are independently set by operators and form prices through market competition. The price of vaccine shall be set by the holder of vaccine marketing license independently and reasonably according to law, and the price level, price difference rate and profit rate of vaccine shall be kept within a reasonable range. Vaccine procurement involves buyers and sellers, and the price independently and reasonably set by the vaccine marketing license holder is only the seller’s quotation. The final sales price of vaccines (bid winning price, transaction price, etc.) needs to be determined by both buyers and sellers, and high quality and good price are the most basic requirements.
The production cycle of vaccines is generally long, and some vaccines have a relatively short validity period, so the risk of vaccine shortage is high. In the process of legislation, ensuring the supply of vaccines is also one of the key issues concerned by all parties. In order to strengthen vaccine reserves and effectively ensure the safety of vaccine supply, the Vaccine Management Law has improved the relevant systems, including vaccines in strategic material reserves and implementing central and provincial reserves. Provincial disease control institutions should formulate immunization planning vaccine use plans including vaccine varieties, quantity, supply channels and supply methods, and report and put on record according to regulations. National Health Commission provides vaccine demand information according to the national immunization program vaccine use plan, and vaccine marketing license holders arrange production reasonably according to the vaccine demand information; When there is a risk of vaccine supply shortage, National Health Commission and National Medical Products Administration put forward suggestions, and the Ministry of Industry and Information Technology and the Ministry of Finance should take effective measures to ensure vaccine production and supply; The holder of the vaccine marketing license shall organize the production according to law, ensure the vaccine supply, and stop the vaccine production, and shall promptly report to the drug supervision department.
V. Safe circulation and standardized inoculation
(A) interlocking, closed-loop operation
As a special medicine, one of the important manifestations of its particularity is that the circulation of vaccine is different from that of general medicine, even different from that of general biological products (for example, the storage and transportation of vaccine require a high cold chain). In 2016, the State Council focused on revising and perfecting the Regulations on the Administration of Vaccine Circulation and Vaccination formulated in 2005 (abolished on March 27, 2020 after the implementation of the Vaccine Administration Law), in view of the outstanding problems exposed by a series of cases of illegal operation of vaccines in Jinan, Shandong Province, such as the long circulation chain of Class II vaccines, the large profit-making space, the poor effectiveness of vaccines during storage and transportation, and the imperfect traceability system of vaccines. The vaccine management law adheres to the spirit of optimizing circulation and distribution, such as the Opinions on Reforming and Perfecting the Vaccine Management System, and insists on ensuring circulation safety and strict distribution system.
The first is a tight closed-loop supply chain. Vaccines are supplied by vaccine marketing license holders to disease control institutions, and then by disease control institutions to vaccination units. This supply chain is one-way irreversible, which is conducive to reducing vaccine quality risks. Only disease control institutions can supply vaccines to vaccination units, and units and individuals other than disease control institutions may not supply vaccines to vaccination units; Inoculation units can only receive vaccines supplied by disease control institutions, and may not receive vaccines supplied by units or individuals other than disease control institutions.
The second is strict vaccine distribution. How to distribute vaccines safely is a concern in the process of legislation. The draft vaccine management law stipulates that vaccine marketing license holders distribute to disease control institutions, and then the disease control institutions organize distribution to vaccination units; You can distribute it yourself, or you can entrust a vaccine distribution unit to distribute it. At that time, there were many distribution methods in practice, some were production enterprises-CDC-inoculation units, some were production enterprises-distribution enterprises-inoculation units, and some were arranged by CDC to directly distribute vaccines to inoculation units by production enterprises. Some suggest that since the CDC can entrust the distribution enterprise to deliver the vaccine to the inoculation unit, and the production enterprise has the cold chain transportation capacity of the vaccine, it should also be able to directly deliver the vaccine to the designated inoculation unit under the organization of the CDC. After in-depth study, the law stipulates that vaccine marketing license holders can also distribute vaccines to inoculation units designated by disease control institutions. Disease control institutions, vaccination units, vaccine marketing license holders, vaccine distribution units engaged in vaccine distribution and other activities must abide by the management norms of vaccine storage and transportation to ensure the quality of vaccines. The core requirement of the management standard of vaccine storage and transportation is that the vaccine should be in the specified temperature environment during the whole process of storage and transportation, and the cold chain storage and transportation must meet the requirements, and the temperature should be monitored and recorded regularly. Disease control institutions, vaccination units, etc. should establish and maintain relevant records such as distribution, obtain record certificates according to law, and establish a regular inspection system.
(two) standard vaccination, should be done.
Vaccination is the implementation link of vaccine serving public health. Great achievements have been made in vaccination in China, and the vaccination rate of immunization program is high, which has played an important role in establishing immune barrier and protecting public health. At the same time, there have been some problems in vaccination in the past, which have been concentrated for some time. Many vaccinations are aimed at minors, and the public is generally concerned. In order to do a good job in vaccination, the vaccine management law regulates the relevant systems.
The first is to strengthen the immunization planning system. Immunization planning is "planned immunization". The vaccine management law has made specific provisions on the immunization planning system. For example, it is clear that the national immunization program is formulated by National Health Commission, the National Health and Health Commission and the Ministry of Finance draw up the vaccine types of the national immunization program and establish a dynamic adjustment mechanism. The vaccine types of the national immunization program are announced after being approved by the State Council, and provincial governments can increase the vaccine types of the immunization program; National Health Commission established the National Advisory Committee of Immunization Program Experts; In order to ensure the vaccination rate of children’s immunization program and strengthen the responsibility of guardians, it is stipulated that guardians who fail to ensure timely vaccination of school-age children according to law shall be criticized and educated by health and health departments.
The second is to clarify the conditions of vaccination units. Inoculation unit refers to the institutions that undertake the task of vaccination (including urban medical institutions, township hospitals, community health service centers, etc.), and must have the conditions of obtaining the practice license of medical institutions and qualified medical and health personnel. The vaccination units engaged in immunization planning vaccination work need to be designated by the local health department at or above the county level and define the responsible area; Eligible medical institutions engaged in non-immunization vaccination should be reported to the relevant health departments for the record.
The third is to standardize vaccination behavior. Clear vaccination units to carry out vaccination work should comply with the vaccination work norms, immunization procedures, vaccine use guidelines formulated by National Health Commission and vaccination programs formulated by provincial health departments. Disease control institutions at all levels should strengthen the technical guidance of vaccination units and the management of vaccine use. At the same time, in order to further standardize vaccination behavior, the vaccine management law has made specific provisions on some important contents in vaccination work. For example, before vaccination, we should inform and ask about the situation and give medical advice when necessary; Before vaccination, we should check the health status of the recipient, check the vaccination contraindications, check the vaccination certificate, check the appearance, batch number and expiration date of the vaccine and syringe, and check the name and age of the recipient and the name, specification, dosage, vaccination site and vaccination route of the vaccine; If the seed recipients have adverse reactions during on-site observation, measures such as treatment should be taken in time; Medical and health personnel should establish and keep vaccination records according to regulations to ensure that vaccination information can be traced and inquired.
The state implements a vaccination certificate system for children, and the vaccination certificate is handled by the guardian at the vaccination unit or the birth hospital and properly kept. When children enter kindergartens and schools, nursery institutions and schools should check the vaccination certificates. If it is found that they are not vaccinated according to the regulations, they should report and deal with them according to the regulations. A small vaccination certificate affects the hearts of thousands of parents. In the process of legislation, the most prominent thing is that the format is not uniform, which is not conducive to vaccination in different places. It is not convenient to apply for a certificate, and even in some cases it is impossible to apply for a certificate. In view of these problems, the Vaccine Management Law stipulates that birth hospitals can apply for vaccination certificates, and individuals of the masses can apply for vaccination certificates, and vaccination units and birth hospitals may not refuse to apply for them, and the format of vaccination certificates will be adjusted from the provisions of provinces (autonomous regions and municipalities) to the unified provisions of National Health Commission.
(C) improve the compensation system, lifting vaccination concerns
Abnormal reaction of vaccination refers to the adverse drug reaction caused by qualified vaccine during or after the implementation of standardized vaccination, which causes damage to the tissues, organs and functions of the recipient, and all parties concerned are not at fault. General reaction, coupled disease, psychogenic reaction and the damage caused by vaccine quality problems to the recipients are not abnormal reactions to vaccination.
Because of the characteristics of the vaccine itself and the individual differences of the recipients, any vaccine will inevitably produce abnormal reactions to vaccination, which is called "devil’s lottery". Although the probability of abnormal vaccination reaction is extremely low, and the probability of death and serious disability is even lower, once an individual has an abnormal vaccination reaction, he is the bearer of the abnormal reaction and must face it. Properly handling the abnormal reaction of vaccination is related to the vital interests of the recipients and the smooth development of vaccination work, which is the focus of attention in the legislative process. Its core is the scope, standard and guarantee of compensation. According to various opinions, the vaccine management law mainly makes the following provisions in improving the system of compensation for abnormal reaction of vaccination:
First, strengthen the monitoring and reporting of abnormal reactions to vaccination. Disease control institutions, vaccination units, medical institutions, vaccine marketing license holders, etc., should report according to the vaccination work norms and the national suspected vaccination abnormal reaction monitoring plan.
The second is to standardize the investigation, diagnosis and identification of abnormal reactions to vaccination. For the suspected abnormal reaction to vaccination, the disease control institution shall organize investigation and diagnosis according to the regulations, and inform the recipient or his guardian of the conclusion; If there is any dispute over the conclusion of investigation and diagnosis, you may apply for appraisal; Due to vaccination, the recipient dies, is severely disabled, or is suspected to have an abnormal reaction to vaccination in groups. The health department and the drug supervision department shall organize investigation and handling according to their respective responsibilities and authorities.
The third is to improve the compensation for abnormal reaction of vaccination. The Vaccine Management Law stipulates that the state shall implement a compensation system for abnormal reactions of vaccination, and clearly stipulates the compensation scope, compensation funds, compensation principles and supporting regulations.
1. About the scope of compensation. Compensation shall be given for the "death, serious disability, organ and tissue damage and other damages" caused by the abnormal reaction of vaccination; The above damage can not be ruled out because of the abnormal reaction of vaccination, and compensation will also be given. This is an important development of the compensation system for abnormal reactions in the vaccine management law. In practice, after investigation, diagnosis and identification, some suspected abnormal reactions to vaccination can be clearly identified, some can be ruled out as abnormal reactions to vaccination, and some can neither be clearly identified nor ruled out. Some countries and regions also give compensation to those that can neither be clearly defined nor excluded. During the legislative process, it was learned that some provinces and cities in China also included those that cannot be excluded into the scope of compensation, which was affirmed by the Vaccine Management Law. At the same time, define the scope of compensation, implement directory management, and make dynamic adjustments according to the actual situation. Catalogue management of compensation scope is to make the compensation scope clearer, easier to operate and reduce unnecessary disputes. After the scope of compensation is managed by catalogue, if the damage is not in the catalogue, but it can be proved that there is a causal relationship between the damage and vaccination, compensation should also be given. "Reference Catalogue and Description of Compensation Scope for Abnormal Vaccination Reaction (2020 Edition)" stipulates that in the process of investigation, diagnosis or identification of abnormal vaccination reaction, in addition to referring to this catalogue, it is necessary to combine clinical and laboratory information to determine whether it belongs to or cannot rule out abnormal vaccination reaction.Whether it is within the scope of this catalogue should not be used as a direct basis for judging whether it belongs to or cannot rule out the abnormal reaction of vaccination.
2. About compensation funds. The compensation expenses required for immunization planning vaccine shall be arranged by the provincial financial department in the vaccination funds. The compensation expenses required for vaccination of non-immunization program vaccines shall be borne by the holders of relevant vaccine marketing licenses. The state encourages people who have received abnormal vaccination to be compensated through commercial insurance and other forms.
3. On the principle of compensation. In view of the problems existing in practice, such as the lack of timely compensation, simple procedures and unreasonable standards, it is clear that the compensation for abnormal reaction of vaccination should be timely, convenient and reasonable.
4. About supporting regulations. The compensation for abnormal reaction of vaccination is a very complicated problem, and the law can only stipulate in principle. The scope, standards and procedures of compensation are stipulated by the State Council, and the provinces (autonomous regions and municipalities) formulate specific implementation measures.
Six, clear responsibility, increase punishment
(A) clear responsibilities, plug loopholes
In order to ensure that units engaged in vaccine production, circulation, vaccination and other activities strictly perform their main responsibilities, the government and its relevant departments should strictly supervise. The problem vaccine case of Changchun Changsheng Company exposed many loopholes such as inadequate vaccine supervision. In order to resolutely plug the regulatory loopholes, in accordance with the decision-making arrangements of the CPC Central Committee, strengthen supervision, and improve and innovate the supervision system in view of the outstanding problems in vaccine supervision.
The first is to strengthen the organization and coordination at the government level. Governments at or above the county level should strengthen the capacity building of vaccine supervision and establish and improve the working mechanism of vaccine supervision; Formulate an emergency plan for vaccine safety incidents, and clarify the classification of vaccine safety incidents, disposal command system and responsibilities, prevention and early warning mechanism, disposal procedures, emergency safeguard measures, etc. Local governments at or above the county level shall be responsible for the vaccine supervision in their respective administrative areas, and uniformly lead, organize and coordinate the vaccine supervision in their respective administrative areas, including emergency response. The State Council and provincial governments have established departmental coordination mechanisms to co-ordinate the work related to vaccine supervision, regularly analyze the vaccine safety situation, strengthen vaccine supervision and ensure vaccine supply.
The second is to strengthen the supervision responsibility of the competent authorities. Drug supervision departments are responsible for vaccine supervision, health and health departments are responsible for vaccination supervision, and other relevant departments are responsible for vaccine-related supervision within their respective responsibilities.
The drug supervision department and the health department shall supervise the whole process of vaccine development, production, circulation and vaccination according to their respective responsibilities. Drug supervision departments shall supervise and inspect the vaccine quality in vaccine development, production, storage, transportation and vaccination according to law; Health departments shall supervise and inspect the implementation of immunization planning system and vaccination activities according to law. The drug supervision department focuses on on-site inspection of vaccine marketing license holders; If necessary, an extended inspection can be carried out. Drug supervision departments, health and health departments, vaccine marketing license holders, disease control institutions, vaccination units, medical institutions and other aspects should jointly do a good job in vaccine safety incident reporting, medical treatment, risk control, investigation and handling, information release, explanation, after-treatment and other work.
The state builds a team of drug inspectors at the central and provincial levels and strengthens the supervision and inspection of vaccines. Provincial drug supervision departments send inspectors to settle in vaccine marketing license holders. Inspectors are responsible for supervising and inspecting the implementation of GMP, collecting vaccine quality risks and illegal clues, reporting the situation to the dispatched department and making suggestions, and being responsible for the behavior during the stationing period. The Opinions on Establishing a Professional and Specialized Team of Drug Inspectors has made specific provisions on improving the system and mechanism of drug inspection, implementing the allocation of inspectors and strengthening the management of the team of inspectors.
The third is to strengthen supervision means. The administrative punishment law, the administrative enforcement law and the administrative licensing law have clear provisions on the setting authority of punishment, coercion and license. If some regulatory measures are not set by law, laws and regulations have no right to set them, which is also an important consideration in the special legislation on vaccine management. The Vaccine Management Law enriches and improves the regulatory measures that can be taken by drug supervision departments, health and health departments and other departments, including interviews, ordering suspension of vaccine production, sales, distribution and use, establishing credit records, publicizing information of serious dishonesty and implementing joint punishment according to regulations, taking measures such as sealing up and detaining according to law, ordering recall, supervision and inspection, licensing and punishment.
The vaccine management law requires the government and its relevant departments to strengthen supervision and protection at the same time. For example, the government should incorporate vaccine safety and vaccination into the national economic and social development plan at the corresponding level, include the funds needed for vaccine safety, purchasing immunization vaccines and vaccination, and information construction into the government budget at the corresponding level, provide subsidies to rural doctors and other grassroots medical and health personnel engaged in vaccination according to regulations, provide support and financial subsidies for vaccination in economically underdeveloped areas, and determine and ensure the implementation of vaccination-related projects in this administrative region.
(B) severe punishment, form a deterrent.
The problem vaccine case of Changchun Changsheng Company exposed the outstanding problems such as low illegal cost and weak punishment of vaccine drugs. The vaccine management law further embodies the "four strictest" requirements, improves the legal responsibility, increases the punishment for vaccine violations, increases the amount of fines, increases the types of penalties, strengthens the punishment to people, and supplements and improves the legal responsibility for illegal acts. The legal liability part of the Vaccine Management Law includes criminal liability, administrative liability and civil liability, with a total of 18 articles, accounting for nearly one-fifth of all articles. Insist on severe punishment and strict legal responsibility. Severely crack down on those unscrupulous enterprises that are greedy for profits and ignore the rules, and those who dare to challenge the bottom line of morality and conscience, and will be severely sentenced and will never be tolerated; The illegal and criminal personnel who endanger public safety, such as vaccines and drugs, will be severely punished according to law, and a huge penalty will be imposed and the business will be banned for life; Serious accountability for dereliction of duty.
First, those who explicitly violate the provisions of this law and constitute a crime shall be severely investigated for criminal responsibility according to law. According to the principle of legally prescribed punishment for a specified crime, criminal responsibility is usually uniformly stipulated by criminal law. The provisions of administrative law on criminal responsibility are usually connected, which is expressed as "those who violate the provisions of this law and constitute a crime shall be investigated for criminal responsibility according to law". In the process of legislation, some people suggested that illegal activities such as the production of fake and inferior vaccines, in addition to providing more severe administrative penalties than general drug violations, should also be severely investigated for criminal responsibility according to law, reflecting the spirit of "four strictest". In fact, there is a basis for criminal judicial practice to severely investigate criminal responsibility for some vaccine crimes. Articles 141 and 142 of the Criminal Law stipulate the crime of producing and selling fake and inferior drugs. The Interpretation on Several Issues Concerning the Application of Laws in Handling Criminal Cases Endangering Drug Safety stipulates that counterfeit and inferior drugs produced and sold are vaccines and should be given heavier punishment as appropriate. On the basis of judicial interpretation, the Vaccine Management Law makes it a legal requirement to severely investigate the criminal responsibility of vaccine-related crimes.
The second is to impose the most severe punishment. For illegal acts such as producing and selling fake and inferior vaccines and falsifying data, warnings and huge fines are stipulated (for example, if a fake vaccine is produced or sold, a fine of more than 15 times and less than 50 times the value of the illegal production and sale of vaccines is imposed; If the value of the goods is less than 500,000 yuan, it will be calculated as 500,000 yuan, that is, a minimum fine of 7.5 million yuan), confiscation of illegal income, confiscation of illegal property, order to suspend production and business for rectification, and revocation of batch issuance certificates, drug registration certificates and drug production licenses. In order to meet the requirements of punishment, the legal representative, principal responsible person, directly responsible person in charge, key position personnel and other responsible personnel of the illegal unit are provided with penalties such as confiscation of income, fine, prohibition of employment until life, suspension of practice, revocation of practice certificate and administrative detention. The types of administrative punishment include reputation punishment, property punishment, qualification punishment, behavior punishment, personal punishment and so on. In January 2020, the Administrative Punishment Law was revised and passed, and relevant parties should implement administrative punishment according to the spirit and requirements of the revised Administrative Punishment Law.
The third is to adhere to the most serious accountability. Local governments at or above the county level, their drug supervision departments, health and health departments and other departments, batch issuing institutions, disease control institutions and other illegal acts, such as failing to perform their duties of supervision and inspection according to law, illegally issuing batches, and failing to purchase vaccines according to regulations, have stipulated that the principal responsible person, the directly responsible person in charge and other directly responsible personnel of the illegal units shall be given a warning according to law until they are expelled.
In addition, the Vaccine Management Law also stipulates the civil liability of vaccine marketing license holders, disease control institutions and vaccination units, and clarifies that the state implements a compulsory vaccine liability insurance system. If the vaccine quality problems cause damage to the recipients, the insurance company will pay compensation within the underwriting liability limit.
VII. Perseverance and thorough implementation
The vitality of law lies in implementation, and the authority of law also lies in implementation. Since the implementation of the Vaccine Management Law, especially since the outbreak of the COVID-19 epidemic, all parties have actively and thoroughly implemented the provisions of the law, effectively guaranteed vaccine safety, and achieved remarkable results in the healthy development of the vaccine industry. At present, COVID-19 has made great strategic achievements in epidemic prevention and control, but it is still necessary to do a good job of "external defense input and internal defense rebound"; The task of prevention and control of infectious diseases in China is still very arduous. According to the official website of National Health Commission, in December 2020, 542,172 cases of legal infectious diseases were reported nationwide, with 2,379 deaths, including 264,109 cases of Class B infectious diseases and 2,377 deaths. The top five reported diseases were viral hepatitis, tuberculosis, syphilis, gonorrhea and AIDS. We should always adhere to the people first and life first, continue to thoroughly implement the vaccine management law, strengthen and improve vaccine management, promote the prevention and control of COVID-19 epidemic and other infectious diseases on the track of the rule of law, and earnestly safeguard people’s health and public health safety.
First, the research, production, supply and inoculation of vaccines should be promoted in accordance with the law, so as to provide a powerful weapon for finally defeating the COVID-19 epidemic and other infectious diseases. At present, the COVID-19 vaccine that has been conditionally approved for marketing still needs post-marketing research according to law, and COVID-19 virus is still mutating, so it needs targeted research and development. There is still an arduous task to meet the domestic and international demand for vaccine production in COVID-19, and there are still some bottlenecks in the production and supply of other vaccines. It is a long way to go to promote vaccine development, production, supply and vaccination according to law.
The vaccine management law clarifies the responsibilities and obligations of the government, its relevant departments and relevant parties. The government and its relevant departments should adhere to the principle that the law is without authorization, and their statutory duties must be to fully perform their statutory duties, to give full play to the role of the inter-ministerial joint conference system for vaccine management, to strengthen the linkage between departments and between higher and lower levels, and to form a scientific, efficient and authoritative vaccine supervision and guarantee system. Vaccine marketing license holders, disease control institutions, vaccination units and other relevant subjects should fully fulfill their legal obligations and do a good job in vaccine development, production, supply and vaccination with high quality and efficiency according to law.
At present, the COVID-19 epidemic is still raging around the world. The vaccine management law stipulates that the state encourages vaccine production enterprises to produce and export vaccines in accordance with international procurement requirements; The exported vaccines shall meet the standards or contract requirements of the importing country (region), and arrangements have also been made for entry-exit vaccination and procurement of needed vaccines. Viruses have no national boundaries, epidemics are not racial, and human destiny is a community. Unity and cooperation are the most powerful weapons to deal with global public health emergencies. We should uphold the concept of human health community and strengthen international cooperation in vaccines in accordance with the provisions of the Vaccine Management Law to protect the health of all mankind.
Vaccine industry is an important part of health care, especially public health. It is necessary to thoroughly implement the decision-making arrangements of the CPC Central Committee, improve the disease prevention and control system, strengthen and improve the propaganda, training, technical guidance, monitoring, evaluation, epidemiological investigation and emergency response of disease control institutions related to vaccination, strengthen the construction of vaccine supervision capacity and other aspects, prevent vaccine safety incidents, and vigorously develop the vaccine industry.
The second is to adhere to social co-governance, benign interaction and cohesion. Social co-governance is a new measure to innovate social management, and strengthening vaccine management is a systematic project. It is necessary to fully mobilize the participation of all social forces and give full play to the positive role of social co-governance. The Vaccine Management Law clearly stipulates the systems of information disclosure, information sharing, information exchange and communication, and unified announcement of information, so as to facilitate the public to obtain information and deeply participate in vaccine management activities; The reward for reporting, media supervision, social supervision, etc. are stipulated to strengthen public participation; China Vaccine Industry Association is required to strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry credit system, and guide and urge members to carry out production and operation activities according to law. The government and its relevant departments, disease control institutions, vaccination units, vaccine marketing license holders and vaccine industry associations should carry out publicity, education and popularization of the vaccine legal system according to law.
In the early days of COVID-19’s vaccine market, some lawless elements took advantage of the temporary scarcity of supply, and made huge profits by making and selling fakes, reselling at high prices, illegally operating in violation of state regulations, and carrying out mass vaccination without authorization. Some even smuggled fake vaccines abroad, seriously disrupting the epidemic prevention order, endangering people’s health and public health safety, and tarnishing the national image. This kind of criminal behavior is bad in nature and has serious consequences. By February 10, 2021, the national procuratorial organs had approved the arrest of 70 suspects in 21 cases according to law. [8] Relevant parties should strictly implement the provisions of the Vaccine Management Law, strengthen law enforcement and severely punish vaccine violations.
The third is to carefully evaluate the implementation of the vaccine management law and strengthen the legal protection of public health. Since the outbreak of COVID-19, the vaccine management law has been tested in practice, which proves that the system stipulated in the vaccine management law is scientific, effective and forward-looking. The General Secretary of the Supreme Leader stressed that it is necessary to conscientiously sum up the experience and models that have been tested in practice in epidemic prevention and control and solidify them in the form of systems. [9] The 13th the National People’s Congress Standing Committee (NPCSC) Work Plan for Strengthening the Legislative Revision of Public Health Legal Protection proposed that the vaccine management law and other legislative projects related to public health should be combined with the prevention and control of epidemic situation and the improvement of public health emergency management system to carry out in-depth evaluation. After research and demonstration, it is necessary and feasible to take various forms, make targeted amendments and arrange deliberation in due course. In accordance with the spirit of the important instructions of the Supreme Leader General Secretary and the requirements of the 13th the National People’s Congress Standing Committee (NPCSC) Work Plan for Strengthening the Legal Protection of Public Health, we should conscientiously sum up the experience of epidemic prevention and control, thoroughly evaluate the implementation of the vaccine management law, and put forward evaluation opinions in a timely manner. It is necessary to form a systematic, scientific, standardized and effective legal system for vaccine management. If supporting systems are needed to fill in the details, we will continue to promote the formulation and improvement of supporting laws, regulations, standards and norms, and concretize the principled and general provisions in the vaccine management law to ensure that all systems stipulated in the vaccine management law take root and are effectively implemented. In the prevention and control of epidemic situation in COVID-19, the practice of vaccine research, production, supply and inoculation, especially in COVID-19, has enriched and developed the vaccine management system.If the experience and model of vaccine management that has been tested in practice need to be solidified in the form of legal system, suggestions for amending the vaccine management law should be put forward in time.
The promulgation and implementation of the vaccine management law has promoted the new major achievements in China’s vaccine industry and even health care. We should persevere in the complete, accurate, comprehensive and effective implementation of the vaccine management law, promote vaccine development with the vaccine management law, deal with and solve the problems in vaccine production, circulation and inoculation, consolidate and expand the achievements of epidemic prevention and control and economic and social development according to law, safeguard people’s health and public health safety, and comprehensively promote the construction of a healthy China.
(The author is the deputy director of the Legal Affairs Committee of the National People’s Congress Standing Committee (NPCSC).)
[References]
[1][3][9] Speech by the Supreme Leader at the Symposium of Experts in the Field of Education, Culture, Health and Sports [N]. People’s Daily, 2020-09-23.
[2] Supreme Leader. Build a strong public health system to provide a strong guarantee for safeguarding people’s health [J]. Qiushi, 2020(18).
[4] the State Council Information Office’s press conference introduced the situation of "accelerating the construction of an innovative country to support and lead high-quality development" [EB/OL]. China Government Network, http://www.gov.cn/xinwen/2020-05/19/content_5512981.htm, 2020-05-10.
[5][6][7] the State Council Joint Prevention and Control Mechanism held a press conference on the conditional listing of Covid-19 vaccine and related work [EB/OL]. the State Council Press Office official website, http://www.scio.gov.cn/xwfbh/xwbfbbh/wqfbh/42311/44679/index.htm # 1.
[8] the Supreme People’s Procuratorate severely punishes typical cases of vaccine crimes involving COVID-19 [EB/OL]. official website, the Supreme People’s Procuratorate, https://www.spp.gov.cn/spp/xwfbh/wsfbt/202102/t20210210 _ 509077.shtml, 2021-02-10.
