Page 30 - 《中国药房》2021年2期

ABSTRACT OBJECTIVE：To construct China’s Insurance Mode for ADR injury compensation model under marketing
authorization holder （MAH） system，and to provide reference for reducing the medical disputes caused by ADR damage and
protecting the rights and interests of patients. METHODS：Using the methods of recommendation and“snowball”，the interviewers
were invited to conduct semi-structured interviews to obtain qualitative data，and the results were analyzed by thematic analysis.
According to the results of subject analysis，the ADR injury compensation model was designed from three aspects of insurance type
setting，insurance level division and compulsory insurance protection objects，and the Fuzzy comprehensive evaluation method
based on AHP was used to evaluate the model；questionnaire and multiple factor Logistic regression analysis was adopted to
analyze the influential factors of whether drug related institutions were willing to establish ADR injury compensation system.
RESULTS：A total of 40 experts were invited and 34 of them completed the interview，with a response rate of 85.0％. At present，
the problems of ADR injury compensation in China mainly included the difficulties of third-party identification and adducing
evidence of ADR injury，the difficulty of timely and fair settlement of medical disputes caused by ADR injury，the high cost and
long time of handling ADR injury disputes，and the uncertainty of compensation mode. More than half of the experts interviewed
agreed with the compensation mode of insurance. The overall score of established model was 89.50. A total of 640 questionnaires
were distributed and 559 valid questionnaires were recovered （204 drug manufacturers，172 drug distributors and 183 medical
institutions）. The effective rate of the questionnaire was 87.3％ . Multiple Logistic regression analysis showed that the factors
positively correlated with the approval of establishing ADR injury compensation system after the implementation of MAH system in
China included the familiarity of ADR staff in drug manufacturing enterprises with ADR related policies（β＝1.697，P＜0.05），the
types of drugs operated by pharmaceutical companies（β＝2.987， P＜0.05），the cognitionlevel of medical staff on ADR（β＝
2.800，P＜0.05）. The working years of medical staff were negatively correlated with the approval of establishing ADR injury
compensation system after the implementation of MAH system （ β ＝－ 2.544， P＜0.05）. CONCLUSIONS： ADR injury
compensation model designed in this study is feasible. It has reference value for reducing the economic burden of ADR patients，
treating patients’health problems caused by ADR injury in time，and promoting the development of China’s drug insurance. Main
influential factors for the establishment of ADR injury compensation model under MAH system contain the familiarity of ADR staff
in drug manufacturing enterprises with ADR related policies，the types of drugs operated by pharmaceutical companies，the
cognitionlevel of medical staff on ADR，the types of drugs operated by pharmaceutical companies，the cognitionlevel of medical
staff on ADR.
KEYWORDS Marketing authorization holder；ADR；Injury compensation model；Influential factors

药品不良反应（ADR）是指合格药品在正常用法用 ADR后得不到及时救治及赔偿，故亟需建立符合我国国
[1]
量下出现的与用药目的无关的有害反应 。根据中国药 情的ADR损害赔偿模式。
品不良反应监测网络统计数据显示，近年来我国 ADR 药品上市许可持有人（Marketing authorization holder，

报告数量持续增加，新的和严重的 ADR 报告在总报告 MAH）是指取得药品注册证书的企业或者药品研制机
中的占比自2004年的不足5％上涨至2019年的31.5％， 构等。2019年8月26日颁布的新版《药品管理法》提出，
其中严重的ADR报告在总报告中占比也自2004年的不 国家对药品实行MAH制度，MAH应当依法对药品的非
足5％上涨至2019年的10.3％，且因严重的ADR所导致 临床研究、临床试验、生产经营、上市后研究、不良反应
[2]
的全身性损害在 ADR 所有损害中占比超过 10％ 。随 监测和处理等承担责任 。由于 MAH 是药品全生命周
[4]
着我国医药产业的发展，药品带来的风险越来越受到社 期的第一责任人，新版《药品管理法》规定，MAH在申请
会的广泛关注，一些药品潜在风险造成的损害巨大且波 药品注册时必须购买相关保险或提供担保，以保证当药
及范围广泛（例如2006年的“齐二药”事件 ），不仅使医 品发生 ADR 时，药品的质量安全信息和患者的赔偿问
[3]
药企业和医疗机构承受巨大损失，使患者身体健康受到 题有源可溯，因此MAH制度的全面实施将使我国ADR
严重损害甚至导致死亡，而且也会使政府的公信力在这 损害赔偿模式的建立成为可能。
类突发事件的应对过程中深受影响。然而，我国尚未建 2018 年 8 月开始，本课题组对我国广东、江苏、浙
立 ADR 的损害赔偿保障机制，缺乏完善的 ADR 归责和 江、北京、上海等5个省市有关MAH实施后的药品保险
受害者权益保障的法律法规，加之当前我国对 ADR 的 试点情况进行了实地考察（该5个省市于2015年率先在
行政干预仅停留在对 ADR 信息的获取和控制上，尚未 全国开展MAH试点工作），在ADR损害赔偿方面，笔者
深入到对受害者的赔偿层面，患者往往在遭受严重的 发现，当前我国关于 MAH 在申请注册时所购买的保险

·152 · China Pharmacy 2021 Vol. 32 No. 2 中国药房 2021年第32卷第2期