论文总字数：23923字

摘 要

疫苗安全关乎人的生命健康，庞大的疫苗市场又极易使理性经济人在利润诱惑下衍生不良市场行为。因此，确保疫苗安全是重中之重，而政府监管则是实现这一目标的必要手段。本文以针对2018年长生生物狂犬疫苗案的分析为起点，着重论述了我国疫苗安全监管在生产、签发、运输以及致损补偿方面的问题，集中体现在无法防止企业造假生产记录、批签发验审方式不当、疫苗运输监管体系缺乏、环境监测技术推广不力、疫苗致损缺乏鉴定标准、疫苗致损补偿金来源单一等。并针对这些问题，结合发达国家经验和国内学界讨论提出了相应的建议，如发挥三个主体作用、变更样品递送方式、鼓励第三方物流企业发展并完善其监管机制、积极推广疫苗环境监测技术、建立疫苗致损补偿列表和疫苗致损补偿基金等，意图能够为完善我国的疫苗安全监管建言献策。

关键词：长生生物 疫苗安全 政府监管 环节

Study on the Problems and Countermeasures in the Supervision of Vaccine Safety in China : Take the Case of Changsheng Biotechnology Rabies Vaccine as an Example

Abstract

Vaccine safety concerns people's lives and health. The huge size of the vaccine market makes it more likely and easily for a rational economic man to make bad market behaviors under the temptation of profits. Thus to ensure the safety of vaccine is a top priority, and the supervision of government is indispensable. This article takes the analysis of the case of Changsheng Biotechnology rabies vaccine in 2018 as a starting point, and focuses on the problems of vaccine safety supervision in the process of production, batch release, transportation and vaccination in China. It will focus on the unlikeliness of preventing fake record, the inappropriate way of batch release, the immaturity of third-party logistics and its supervision, the lacking in the promotion of environmental monitoring technologies, the deficient compensation for vaccine damage, etc. To overcome the challenges listed above, we need to learn from those advanced countries, and extract valuable information from domestic scholars. The corresponding suggestions were put forward, such as making the three bodies play full role like replacing the Qualified Person with the listing holder, changing the way to deliver sample for inspection, developing the third-party logistics enterprise and building the supervision system, establishing a vaccine damage list and compensation fund, and so on. In all, the study is intended to provide advice and suggestions for improving China's vaccine safety supervision.

Key Words: Changsheng Biotechnology; Vaccine safety; Government supervision; Phase

目 录

中文摘要................................................................................I英文摘要...............................................................................II

引言....................................................................................1

一、疫苗安全监管的相关概念与理论基础....................................................2

（一）疫苗安全监管的相关概念.........................................................2

1.疫苗安全监管................................................................2

2.疫苗致损....................................................................2

3.生产管理负责人、质量管理负责人、质量受权人..................................2

4.药品上市许可持有人制度......................................................3

（二）疫苗安全监管的理论基础.........................................................3

1.马克思利益关系理论..........................................................3

2.新公共管理理论....... ......................................................3

1. 我国疫苗安全监管的重要性与研究现状..................................................3
2. 我国疫苗安全监管的重要性.......................................................3

1.疫苗安全关乎人的生命健康....................................................4

2.我国疫苗市场存在安全隐患....................................................4

1. 我国疫苗安全监管的研究现状.....................................................4

三、我国疫苗安全监管的成果与问题.........................................................6

（一）我国疫苗监管的成果..............................................................6

1.建立了分工合作的监管机构....................................................6

2.制定了较为完全的监管法规....................................................6

（二）我国疫苗监管的问题：以长生生物狂犬疫苗案为例.....................................7

1.长生生物狂犬疫苗案简述......................................................7

2.我国疫苗安全监管中的问题....................................................7

四、我国疫苗安全监管问题的解决对策......................................................11

（一）生产环节:间接监管与直接监管相结合..............................................11

1.充分发挥三个主体的作用......................................................12

2.加大对企业生产设备的检查力度................................................12

（二）签发环节：改良验审方式与加强公职人员管理相结合..................................13

1.变更样品递送方式............................................................13

2.成立两人以上的签字人委员会..................................................13

3.加强公职人员伦理建设........................................................14

4.增加批签发人员数量..........................................................14

（三）运输环节：完善运输监管机制与推广创新运输技术相结合..............................15

1.建立第三方物流体系及其监管机制..............................................15

2.推广创新环境监测技术........................................................15

（四）致损补偿环节：明确损害界定标准与扩大补偿金来源相结合..........................16

1.建立疫苗损害补偿列表........................................................16

2.建立疫苗致损补偿基金........................................................16

五、总结...............................................................................17

参考文献...............................................................................18

致谢...................................................................................21

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