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美国疫苗伤害补偿信托基金研究及对我国的启示 Δ

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王艺芳 1，2＊ ，杨丽娜 ，杨 悦 （1.沈阳药科大学工商管理学院，沈阳 110016；2.沈阳药科大学国际食品药品
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政策与法律研究中心，沈阳 110016）

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）12-1419-06
DOI 10.6039/j.issn.1001-0408.2020.12.03

摘 要 目的：为探索建立我国疫苗接种异常反应补偿基金提供可行性建议。方法：通过文献研究和法规梳理，详细介绍美国疫
苗伤害补偿信托基金的建立背景、补偿原理、管理与运作模式（包括基金的管理方式、来源、用途、风险控制措施），评价其运作效
果，并对我国预防接种异常反应补偿基金的建立提出建议。结果与结论：美国疫苗伤害补偿计划（VICP）通过向疫苗企业销售的
每剂次疫苗按一定比例征收疫苗消费税作为固定的资金来源，建立疫苗伤害补偿信托基金，用于为发生疫苗伤害的受种者提供补
偿。美国疫苗伤害补偿信托基金属于特殊需求信托，当疫苗受害者符合补偿条件时，即可将享有的补偿权转化为信托法下的受益
权。该基金由美国财政部下设的基金管理部统一管理，并采取保本型投资、代位求偿、应急准备等多种风险控制措施。截至2018
年已积累大量基金结余，足以确保VICP的偿付能力。建议我国充分借鉴美国疫苗伤害补偿信托基金的成功经验，立足国内实际，
从完善补偿基金相关立法、构建补偿管理体系、明确基金来源和用途、采取多种风险控制措施等方面入手，探索建立我国预防接种
异常反应补偿基金，以进一步拓展筹资渠道、稳定资金来源、提升补偿效果。
关键词 美国；疫苗伤害补偿信托基金；预防接种异常反应；基金补偿；管理模式；风险控制；启示

Study on Vaccine Injury Compensation Trust Fund in the United States and Its Enlightenment to China
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WANG Yifang ，YANG Lina ，YANG Yue （1. School of Business Administration，Shenyang Pharmaceutical
University，Shenyang 110016，China；2. International Food & Drug Policy and Law Research Center，Shenyang
Pharmaceutical University，Shenyang 110016，China）
ABSTRACT OBJECTIVE：To provide applicable suggestions for exploring the establishement of the vaccination rare adverse
reactions compensation fund in China. METHODS： Through literature research and regulation review， the establishment
background，compensation principle，management and operation mode（including management methods，source，uses and risk control
measures）of Vaccine Injury Compensation Trust Fund in the United States were introduced in details，while the operation effect
was evaluated，and the suggestions for the establishment of the vaccination rare adverse reactions compensation fund in China were
put forward. RESULTS & CONCLUSIONS：The U.S. National Vaccine Injury Compensation Program（VICP）imposed a certain
proportion of vaccine excise tax on each dose of vaccine sold by vaccine companies，and established the Vaccine Injury
Compensation Trust Fund as its fixed source of compensation funds to provide compensation for vaccine victims. The fund belonged
to the special needs trust. When the vaccine victims met the compensation conditions，they can convert their compensation rights
into the beneficial rights under the trust law. The fund was managed by the Fund Management Branch under U.S. Dept. of the
Treasury，and it took a variety of risk control measures such as capital guaranteed investment，subrogation，emergency preparedness.
As of 2018，a large number of fund balances had been accumulated，which was sufficient to ensure the solvency of VICP. It is
suggested that China fully learn from the successful experience of the Vaccine Injury Compensation Trust Tund of the United States，
based on the domestic reality，start from improving the relevant legislation of the compensation fund，building the compensation
management system，making clear the source and usage of the fund，taking various risk control measures，so as to explore the
establishment of China’s vaccination rare adverse reactions compensation fund，further expand the financing channels，stabilize the
source of funds，and improve the compensation effect.
KEYWORDS The United States；Vaccine Injury Compensation Trust Fund；Vaccination rare adverse reaction；Fund compen-
sation；Administration mode；Risk control；Enlightenment

预防接种的安全与风险并存，为寻求接种获益和风 险之间的平衡，对因接种疫苗产生严重不良反应损害的
受种者予以适当补偿已经成为一种国际共识，并发展出
Δ 基金项目：国家市场监督管理总局 2019 年度政策研究课
不同的补偿模式。根据补偿资金来源的不同，可将国际
题 ——“药品安全监管的国际经验借鉴”
现有补偿模式分为4种，分别为财政补偿、保险补偿、基
＊硕士研究生。研究方向：药品政策、药事法规。E-mail：yf-
[1]
金补偿及多种补偿模式的混合型补偿模式 。有研究通
wang78@163.com
# 通信作者：教授，博士生导师，博士。研究方向：药品政策、药事 过比较不同的疫苗伤害补偿模式，发现每种补偿模式各
[2]
法规。电话：024-23986372。E-mail：yyue315@vip.126.com 有利弊 。我国自2019年12月1日起正式施行的《疫苗
中国药房 2020年第31卷第12期 China Pharmacy 2020 Vol. 31 No. 12 ·1419 ·