我国疑似预防接种异常反应补偿制度的探讨  

Discussion on the Treatment Mechanism of Adverse Events Following Immunization in China

作　　者：仲志磊[1] 尹兴晓[1] 梁燕[1] 石昊昱 付杰 杨净思[1] ZHONG Zhilei;YIN Xingxiao;LIANG Yan;SHI Haoyu;FU Jie;YANG Jingsi(Institute of Medical Biology,Chinese Academy of Medical Sciences,Kunming Yunnan 650118,China)

机构地区：[1]中国医学科学院医学生物学研究所,云南昆明650118

出　　处：《中国药物警戒》2021年第4期328-333,共6页Chinese Journal of Pharmacovigilance

摘　　要：目的对比世界卫生组织(WHO)25个成员国家因疫苗接种造成损害建立的补偿制度,研究2019版《中华人民共和国疫苗管理法》(简称“《疫苗法》”)中的相关条款,为完善我国疑似预防接种异常反应(AEFI)补偿制度提供思路。方法综合运用情报调研、文献定性分析方法,对比美国、新西兰、日本和欧洲等疫苗损害补偿制度的特点,研究分析我国《疫苗法》相应条款。结果各国疫苗损害补偿制度各有利弊,我国《疫苗法》对AEFI补偿制度提出了指导性意见,但尚缺乏与之相应的补偿条例和细则。结论建议我国按照《疫苗法》的相关规定,尽快出台全国统一的补偿制度细则,建立多方筹措补助基金机制,保障各方利益,维护和谐的疫苗使用环境。Objective Comparing the vaccine injury relief system established by the damage caused by vaccination in 25 typical countries of the World Health Organization,Studying the relevant provisions in the"Vaccine Administration Law",provides ideas for the AEFI compensation system.Methods Using intelligence research and literature qualitative analysis methods to compare and analyze the characteristics of vaccine injury rescue mechanisms in the United States,New Zealand,Europe,and Japan.Studying and analyzing the corresponding provisions of the 2019 Vaccine Law.Results Each country’s vaccine injury treatment mechanism has its own advantages and disadvantages.China 2019 Vaccine Law provides guiding opinions on AEFI compensation,but there is still a lack of corresponding rescue regulations and rules.Conclusion In accordance with the relevant provisions of the 2019 Vaccine Law,China should introduce a unified national rescue system and detailed rules as soon as possible,consider raising subsidy funds from multiple sources,protect the interests of all parties,and maintain a harmonious vaccine use environment.

关 键 词：疫苗 疑似预防接种异常反应 疫苗法 补偿制度 

分 类 号：R994.11[医药卫生—毒理学]