General Office of the State Council on Further Strengthening
Opinions on the management of vaccine circulation and vaccination
Guo Ban Fa [2017] No.5
People’s governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions and institutions directly under the State Council:
Vaccination is the most economical and effective measure to prevent and control infectious diseases, and it is of great significance to protect people’s life safety and health. In order to further strengthen the vaccine circulation and vaccination management, and ensure the vaccine quality and vaccination safety, with the consent of the State Council, we hereby put forward the following opinions:
First, improve the vaccine management mechanism
(a) improve the national immunization program vaccine adjustment mechanism.The National Health and Family Planning Commission should establish an expert advisory committee on national immunization programs; According to the needs of disease prevention work, organize disease prevention and control institutions to carry out vaccine monitoring for diseases, comprehensively evaluate the related disease burden, vaccine safety, effectiveness, health economics evaluation, production and supply capacity and other factors, and after being demonstrated by the expert advisory Committee, jointly with the Ministry of Finance, put forward suggestions on including or withdrawing vaccines from the national immunization program, and report them to the State Council for approval before promulgation and implementation. Gradually promote the safe, effective and financially affordable second-class vaccine into the national immunization plan, so that people can enjoy better vaccination services.
(two) improve the compensation mechanism for abnormal reaction of vaccination.All regions should strengthen the monitoring and reporting of suspected abnormal reactions to vaccination, and improve the level of investigation, diagnosis and identification of abnormal reactions to vaccination. Encourage the establishment of a mechanism to compensate the recipients of abnormal vaccination reactions through commercial insurance, and gradually establish a multi-level insurance compensation system including basic insurance and supplementary insurance to improve the compensation efficiency of abnormal vaccination reactions. Before the establishment of the compensation insurance mechanism for abnormal reaction of vaccination, compensation should be carried out according to the existing regulations. The National Health and Family Planning Commission shall, jointly with relevant departments, formulate guidance on improving the compensation mechanism for abnormal reaction of vaccination on the basis of summarizing the experience of the pilot work of compensation insurance for abnormal reaction of vaccination.
(3) Establish an inter-ministerial joint conference system for vaccine circulation and vaccination management.The National Health and Family Planning Commission and the Food and Drug Administration shall, jointly with relevant departments, establish an inter-ministerial joint conference system for vaccine circulation and vaccination management, strengthen policy coordination and convergence, timely inform the work progress and information, jointly study and solve outstanding problems, and coordinate with major emergencies to form a joint effort. All provinces (autonomous regions and municipalities) should improve the coordination mechanism of vaccine circulation and vaccination management according to local conditions.
Second, promote independent research and development and quality improvement of vaccines
Support the research and development and industrialization of new vaccines, especially multivalent vaccines, strengthen the construction of industrial technology innovation strategic alliances and other mechanisms, and support qualified vaccine research and development through scientific research projects such as national science and technology plans (special projects, funds, etc.) and major science and technology projects. Adhere to the principle that key vaccines such as national immunization program vaccines, routine vaccines and emergency vaccines are based on domestic production, encourage and support large-scale production of domestic vaccine manufacturers, and ensure that the production capacity reserves of key vaccines can meet the needs of major public health emergencies. Promote vaccine production enterprises to improve the quality management level and standardize production capacity, and continuously improve the quality of vaccine products.
Third, strengthen the management of the whole process of vaccine circulation
(1) Standardize the centralized procurement of vaccines.All regions should incorporate vaccines into the provincial public resource trading platform as soon as possible, and implement centralized online procurement in accordance with the principles of openness, transparency, competition and fair trade. Provincial disease prevention and control institutions should summarize the demand for the second kind of vaccine in the local area, and form a reasonable purchase price on the provincial public resource trading platform by directly hanging the net, bidding or negotiating, and the county-level disease prevention and control institutions will supply it to the vaccination units in the local area after purchasing from vaccine production enterprises. The General Administration of Quality Supervision, Inspection and Quarantine should strengthen the management of entry-exit vaccination and do a good job in the procurement, storage and use of vaccines required for entry-exit personnel.
(2) Strengthen the cold chain distribution management of vaccines.The National Health and Family Planning Commission and the Food and Drug Administration shall, in accordance with the relevant provisions of the Regulations on the Administration of Vaccine Circulation and Vaccination, timely revise and improve the management norms for vaccine storage and transportation, guide the establishment and improvement of the vaccine cold chain distribution management system, and strengthen the standardized management of the cold chain storage and transportation process. Provincial health and family planning, food and drug supervision departments should guide vaccine production enterprises to choose distribution enterprises with good cold chain storage and transportation conditions, and give play to the efficiency advantage of centralized distribution. Vaccine production enterprises can distribute vaccines by "trunk transportation+regional warehousing+regional distribution". Trunk transportation can entrust professional cold chain transportation enterprises, and regional warehousing and regional distribution can entrust distribution enterprises with cold chain storage and transportation conditions. The people’s governments of all provinces (autonomous regions and municipalities) should take effective measures to ensure the timely delivery of vaccines in remote areas in light of the actual research in the region.
(three) to strengthen the whole process of vaccine traceability management.The Food and Drug Administration shall, jointly with the National Health and Family Planning Commission, accelerate the construction of the vaccine traceability information system, adopt information means, and strengthen the traceability management of the whole process of vaccine production, circulation and use. The National Health and Family Planning Commission should rely on the national health insurance information project to accelerate the construction of the national vaccination information management system and gradually realize the exchange and sharing of vaccination information in different regions.
(4) Strengthening the capacity building of vaccine supervision.All regions should strengthen the inspection and inspection work of food and drug supervision departments, promote the establishment of professional and specialized drug inspectors, strengthen standardized training, and improve the professional level of inspection. Gradually improve the vaccine inspection ability of provincial drug inspection institutions.
Fourth, standardize vaccination management
(a) to strengthen the overall management of the second kind of vaccination.Provincial disease prevention and control institutions shall, according to the local disease monitoring information and the needs of disease prevention and control, organize the evaluation and selection of the second kind of vaccine, and put forward the use items of the second kind of vaccine. County-level health and family planning administrative departments shall, according to factors such as the service population and service scope, determine the inoculation units within their respective jurisdictions and make them public. In principle, rural areas implement a centralized vaccination model with townships as the unit. It is necessary to strengthen the standardization and informatization construction of vaccination clinics in communities and towns, strictly regulate the service behavior of village-level vaccination units, and may not carry out vaccination in violation of regulations. For remote and inaccessible areas, it is necessary to improve the accessibility of vaccination and ensure the quality of vaccination by strengthening the mobile service of township hospitals.
(two) to strengthen the standardization of vaccination units.All regions should, in light of local conditions, promote the standardization of vaccination units according to law, and standardize the establishment of vaccination units, personnel qualifications, vaccination facilities, cold chain management, monitoring and handling of suspected abnormal reactions to vaccination, and notification, recording, reporting and publicity of vaccination. The inoculation entity shall publicize the vaccine varieties, contraindications, inoculation methods, general reactions and abnormal reactions, as well as the price of the second kind of vaccine and the charging standards for vaccination services in a prominent position in the inoculation site.
(3) Strengthening the capacity building of vaccination.Strengthen the training of public health doctors and improve the professional and technical level. Strengthen the construction of prevention and health care departments (public health departments) in public hospitals, township hospitals and community health service centers, enrich technical strength, and implement public health duties such as vaccination. Medical personnel who undertake vaccination duties and tasks in medical and health institutions must pass the vaccination professional training organized by the county-level health and family planning administrative department and pass the examination.
(4) Strengthen technical guidance and assessment.Health and family planning administrative departments should strengthen the assessment of vaccination work, and take the assessment results as an important basis for allocating subsidies for basic public health services. Disease prevention and control institutions should strengthen technical guidance on vaccination work in primary medical and health institutions and organize training for vaccination staff in the region.
V. Implementing safeguard measures
(a) to ensure the staffing of disease prevention and control institutions.All regions and relevant departments should conscientiously implement the relevant provisions on the institutional staffing standards of the centers for disease control and prevention, and implement the staffing of disease control and prevention institutions at all levels within the scope of the total staffing. Take measures such as open recruitment and training to improve the overall quality of the disease prevention and control team.
(2) Establish a stable input mechanism for disease prevention and control institutions.Local people’s governments at all levels should implement the responsibility of expenditure, and fully arrange the development and construction expenditure of disease prevention and control institutions, such as capital construction, equipment purchase, especially cold chain system and information construction, according to the development needs and development and construction planning of disease prevention and control. Overall consideration of factors such as changes in the management mode of the second type vaccine, scientific and reasonable approval of personnel funds, public funds and operational funds of disease prevention and control institutions, full inclusion in the budget, guaranteed by the finance at the same level, and service income included in the budget management according to the two lines of revenue and expenditure.
(3) Improve the performance pay system of disease prevention and control institutions.According to the characteristics of high occupational risks in disease prevention and control institutions, the total performance salary of disease prevention and control institutions is scientifically approved. Establish a scientific and reasonable performance appraisal system, and form an assessment distribution mechanism linked with post responsibilities, work performance and actual contribution. In accordance with the relevant provisions of the state, implement the subsidy policy for disease prevention and control personnel.
(4) Improve the price policy related to vaccination.The competent price departments of all provinces (autonomous regions and municipalities) should scientifically and reasonably verify the second kind of vaccination service fee standard of vaccination units. All regions should implement the relevant provisions of this province (autonomous regions and municipalities) as soon as possible, and do a good job in the relevant work of county-level disease prevention and control institutions to collect the storage and transportation fees for the second kind of vaccines from the inoculation units.
(5) Strengthen publicity and guidance.It is necessary to give full play to the platform role of traditional media and new media, strengthen the popularization of vaccine circulation and vaccination knowledge, focus on the importance, safety and effectiveness of vaccination, guide the masses to participate in vaccination work, and improve the vaccination rate. Improve the vaccination information release mechanism, strengthen public opinion monitoring, actively respond to social and public concerns, and create a good social atmosphere.
Sixth, strengthen supervision and inspection
The people’s governments of all provinces (autonomous regions and municipalities) should formulate specific implementation measures according to the actual work, implement the responsibility of territorial management, strengthen organizational leadership, incorporate the prevention and control of diseases such as vaccination and the implementation of fiscal policies of disease prevention and control institutions into government assessment, increase supervision and inspection, and do a good job in vaccine circulation and vaccination in an orderly manner according to law. The National Health and Family Planning Commission and the Food and Drug Administration shall, jointly with relevant departments, strengthen supervision and inspection, carry out special inspections in a timely manner, and report important information to the State Council in a timely manner.
the General Office of the State Council
January 15, 2017
(This piece is publicly released)
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