Abstract
Objective：To understand the current situation of vaccine bidding，procurement and delivery，analyze the advantages and disadvantages of different management modes of vaccine procurement and delivery；to propose operational suggestions for improving and optimizing the management strategies of vaccine bidding，procurement and delivery in different regions and to provide references for making relevant policies and improving vaccine supplying efficiency.
Methods：The institute questionnaire was used to investigate the vaccinerelated situation of 31 provinces and Xinjiang Production and Construction Corps（hereinafter referred as“the XPCC”）in 2018.Meanwhile，a total of 70 relevant experts from vaccine management and service-related institutions，and international organizations were interviewed with the personal in-depth interview to understand the current management modes of related policies，implementation，challenges and recommendations and international experience of vaccine bidding，procurement and delivery.The literature review and typical case analysis methods were occupied to collect information on vaccine procurement，delivery and management in the domestic and overseas.After the systematic review，the major vaccine procurement，delivery and management modes in the world were sorted out，and the advantages and disadvantages of the relevant modes，the typical vaccine-related negative events and the application of new technologies were described and analyzed.In the workshops on the management modes of vaccine bidding，procurement and delivery，relevant administrators of health executive departments，relevant experts at the national level and representatives of some provinces were invited to discuss the main experiences，challenges and suggestions of vaccine procurement and delivery management system in China.
Results：
1.The vaccine bidding，procurement and delivery management policies in China
The basic framework of vaccine legal system of China was the Ordinance on the Management of Vaccine and Immunization（hereinafter referred as“the Ordinance”）.According to the Ordinance，Government Procurement Law of the People's Republic of China and Regulation on the Implementation of the Government Procurement Law of the People's Republic of China，both methods of centralized procurement and decentralized procurement were used in vaccine procurement of China.The procurement was conducted through the provincial public resource platform，usually with a minimum price evaluation method or a comprehensive scoring method.The detailed rules for the procurement were further supplemented in six documents，such as the Administrative Measures for Bidding and Tendering of Goods and Services Purchased by Government.The Ordinance stipulated that cold chain shall be maintained in the whole process of vaccine transportation，and the Management Specification for Vaccine Storage and Transportation（2017 version）further gave detailed requirements for the cold chain transportation and storage system.The detailed rules were further standardized in three documents，including the Measures for the Supervision and Administration of Drug Circulation.In addition，the local government issued 41 vaccine-related laws，regulations and policy documents.The Vaccine Management Law of the People's Republic of China （hereinafter referred to as “the Vaccine Law”）implemented on December 31，2019 put forward more stringent requirements on vaccine development and marketing license，vaccine production and batch issuance，post marketing research and management，vaccine circulation， vaccination， abnormal response monitoring and compensation，safeguard measures，supervision and management，legal liability，etc.There were no special vaccine laws or regulations in Hong Kong，Macao and Taiwan.
2.Current situation of vaccine bidding，procurement and delivery management in China
In 2018，among all the 32 provinces （including XPCC）surveyed，Guangdong Province had the largest permanent population and population inflow，and Henan Province had the largest population outflow.Two thirds of the staffs in the management of the provincial immunization program were those with senior titles in provincial Center for Disease Control and Prevention （CDC）.In China，every 100，000 6-year-old children corresponded to 0.55 provincial CDC immunization technicians，and that of the western region was higher than that of the eastern region，than the central region.
In 2018，14 provinces entrusted national centralized bidding to purchase national immunization program vaccine，and all the provinces entrusted national centralized bidding in 2019.In addition to the XPCC，31 provinces purchased non-immunization program vaccines through unified bidding by the provincial public resource platform.National immunization program vaccines were distributed from the CDC to the vaccination service sites in most provinces，but entirely by third parties in Beijing，Shanghai and Tianjin，and a small number of vaccination sites were distributed by third parties in Jilin，Heilongjiang，Guangdong and Hunan provinces.In most provinces，the distribution of non-immunization program vaccines was similar to that of national immunization program vaccines.
In the process of transportation，all institutions in each province controlled the temperature of vaccine according to the requirements，but the configuration of temperature control equipment varied greatly from region to region.There was a lack of unified temperature standard，and the configuration of cold chain cars in many provinces was still insufficient.Each province mainly focused on the internal storage of vaccines in CDC，but there were great differences in the application and configuration of new storage technologies over provinces.In addition，the basic vaccine storage equipment should be improved.A unified immunization program information system in each province had been established to achieve management functions to some degree，and most of them went well.
The vaccination rate of the national immunization program was generally high.In 2018，except Shanghai，the vaccine supply in other provinces was not sufficient or timely，and leprosy vaccine was in short supply nationwide.In addition，there was a serious shortage of DPT，Hepatitis A and BCG vaccine in western provinces，and A+C vaccine in central and eastern provinces.Ten provinces（4 provinces for immunization program and 6 provinces for non-immunization program）carried out emergency vaccine procurement，mainly in the western region.There was a long delay-time for emergency procurement of non-immunization program vaccines.
During 2014 to 2018，most of the immunization program related costs in western provinces were fully covered by the central government.In addition to the central government funding，most of the eastern provinces also had some funding at the provincial level.The per capita annual allocation was highest in the eastern provinces，then in the central and the western provinces.The sources of non-immunization vaccine financing were complex.
3.SWOT analysis of vaccine bidding，procurement and delivery management in China
1）Achievements in vaccine bidding，procurement and delivery management in China：the Vaccine Law put forward that the national immunization program vaccines should be uniformly bid and procured by the state，and the vaccine supply could be better guaranteed；non-immunization program vaccines were basically procured by the unified bidding of provincial platforms；the vaccine delivery system worked well，and the vaccine supply was basically guaranteed；a series of government policies provided institutional guarantee for the development of vaccine distribution system；China's overall investment in vaccines increased；the high-quality provincial immunization program team provided strong technical support for vaccine service management；overall，vaccine demand management was relatively accurate；the response to emergency vaccine procurement was relatively rapid.
2）Main problems in the management of vaccine bidding，procurement and delivery in China：the performance of provincial departments in the nonimmunization program vaccine bidding and procurement was lower than that expected by the governance；the insufficient supply and storage of vaccines occurred from time to time；there were differences in the allocation of human resources over the provinces，even if those in the same geographical region；there was a relative shortage of immunization program staff at all levels，with low enthusiasm and high mobility；there were significant regional differences in the equipment configuration over the internal distribution systems of CDC；there was a lack of unified acceptance standards and operational specifications for the abnormal temperature during the storage and transportation of vaccines；vaccine management information system varied over provinces，and that could not meet the requirement for tracing during the whole management process of vaccines.
3）Development opportunities of vaccine bidding，procurement and delivery management in China：with the promulgation of the Vaccine Law，there was the legal guarantee for the optimization of vaccine bidding，procurement and delivery management in China；with the development of high technology and modern management mode，there were new opportunities for the optimization of vaccine cold chain，storage，transportation and supervision；the immunization program information system in China had played an important role in the information collection but more functions called for the further top-level design and implementation of the national vaccine information management system.
4）Main challenges faced by vaccine bidding，procurement and delivery management in China：the implementation and improvement of the Vaccine Law；information barriers and security problems existing simultaneously in the information development；the gap between the staffs'enthusiasm for the immunization services and higher work requirements；the immaturity of the medical cold chain logistics and transportation industry；the objective differences among the east，central and west areas in governance，geography，socioeconomic status，human resources，etc.
4.Relevant policies and experience of international vaccine bidding，procurement and delivery management
The main bidding procurement method was centralized procurement worldwide.In the United States，the federal procurement of children's immunization program vaccines were negotiated and signed by the national CDC and vaccine manufacturers.In the United Kingdom，the vaccines included in the national immunization program were purchased by the Ministry of Health through unified public bidding.In Australia，the vaccines of national immunization program were purchased by the federal government.In the European Union，the vaccines of 25 countries were actually purchased by the Union Agency.The United Nations International Children's Emergency Fund （UNICEF）obtained lower vaccine prices through centralized procurement than through independent procurement by countries.The Vaccine Alliance（GAVI）implemented a self-procurement policy to ensure high-quality vaccines and immunization products for countries using GAVI funds to purchase vaccines.
The United States and the United Kingdom adopted the third-party delivery model，and those vaccines were directly distributed to vaccination units.Some countries integrated vaccines with other public health products to improve the existing distribution and transportation system.The World Health Organization（WHO）proposed an innovative vaccine management method— “controlled temperature chain”（CTC），which allowed vaccines to be kept at temperatures outside of the traditional cold chain of+2℃to+8℃for a limited period of time under monitored and controlled conditions.
5.Suggestions on the optimization of vaccine bidding，procurement and delivery management in China
1）To optimize the existing bidding and procurement modes：Firstly，it is necessary to improve the profit space of immunization program vaccines，and encourage the production enterprises to do more technological innovations for solving the problem of insufficient productivity.Secondly，the government should encourage the research，development and use of multi-vaccines，and explore the cooperative production among the production enterprises.Thirdly，the linkage of relevant vaccine administration departments of governments at all levels should be strengthened to promote the efficiency of bidding and procurement.Fourthly，the responsibilities of provincial agencies in the selection of vaccines for non-immunization program should be identified and evaluated to change the current situation of only listing but not selecting.Also，the more reasonable and feasible index system for the bidding and procurement effect of non-immunization program vaccines should be developed and established to avoid the lowest price selection method.For the remote or underdeveloped provinces，the combined vaccine procurement with the developed provinces should be explored.At last，increasing the initiative of provincial agencies for vaccine procurement will help to alleviate the shortage of some vaccines.
2）To develop the cold chain delivery system further：The government should increase the capital investment，and continuously improve the hardware and software construction of the cold chain system.The internal cold chain system of CDCshould be optimized，and the integrated delivery of vaccines and other temperature sensitive health products should be explored.With the relevant experience of“Shanghai mode”，the third-party cold chain logistics industry may serve as a supplement in some developed regions.In addition，the heat stability experiments for vaccines and the specific regulations of the national vaccine cold chain temperature management should be operated and introduced as soon as possible.
3）To improve the top design of the monitoring and regulatory system for vaccines：The positioning of CDC as the center， multi-department coordination，and relevant responsibilities should be defined more clearly.The accountability mechanism for disputes including vaccine negative events should be detailed.The contract management of vaccine manufacturers and related enterprises should be improved，and the effective punishment measures for the violation of vaccines contracts should be formulated according to the law and policy.
4）To increase the financial investment and support strength in vaccine procurement and delivery：In order to improve the efficiency of funds，fees for national immunization program vaccines should be paid directly by the state.Also，professional personnel should be allocated more into the vaccine management and services，and the authorized strength of staff and service fee of non-immunization program should be increased for higher enthusiasm of the related staffs.
5）To promote the development of relevant information systems：The unified national vaccination information system should be developed and established to improve the efficiency of daily vaccine management.
Keywords：vaccine；bidding；procurement；delivery；SWOT analysis；management；suggestions