我国中药注射剂不良反应救济制度的构建  

Construction of Relief System for Adverse Reactions of Traditional Chinese Medicine Injections in China

作　　者：董志洁 姚峥嵘 DONG Zhi-jie;YAO Zheng-rong(School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing,210023,China)

机构地区：[1]南京中医药大学卫生经济管理学院,江苏南京210023

出　　处：《南京中医药大学学报（社会科学版）》2022年第6期403-409,共7页Journal of Nanjing University of Traditional Chinese Medicine(Social Science Edition)

摘　　要：中药注射剂是我国自主研制的突破传统给药方式的新剂型,在现代医疗实践中发挥了至关重要的作用,然而,中药注射剂不良反应事件的频发引起了人们广泛关注。因中药注射剂不良反应事件导致患者严重损害的,相关主体应对受害人进行赔偿。但基于缺陷认定存在争议、归责原则仍未明确、救济机制尚未建立的现实困境,现行的法律救济在实践操作中尚有欠缺,无法对受害者提供有效救济。通过借鉴国外药品不良反应救济制度的成功经验,结合我国具体国情,建议完善药品缺陷解释标准,明确中药注射剂不良反应中的责任归属,设立专项补偿基金,强化对基金环节的治理与监督,建立以基金模式为主的中药注射剂不良反应的补偿制度。The traditional Chinese medicine(TCM)injection is a new dosage form independently developed in China,which breaks through the traditional way of administration and plays a vital role in modern medical practice.However,the frequent occurrences of adverse reactions of TCM injections have aroused widespread concern.If the adverse reaction events of TCM injection cause serious damage to the patient,the relevant subject shall compensate the victims.However,based on the realistic dilemma such as controversial defect identification,undefined principle of liability fixation,and unestablished relief mechanism has not yet been established,there is defectiveness of the current legal relief in practical operation and it cannot provide effective relief to victims.By drawing on the successful experience of foreign adverse reaction relief systems combined with China's specific national conditions,it is suggested to improve the interpretation standards of drug defects,clarify the responsibility attribution in the adverse reactions of TCM injections,establish a special compensation fund,strengthen the governance and supervision of the fund link,as well as establish a compensation system for the adverse reactions of TCM injections mainly based on the fund model.

关 键 词：中药注射剂 不良反应 救济制度 

分 类 号：D922.16[政治法律—宪法学与行政法学]