中国药物警戒 ›› 2019, Vol. 16 ›› Issue (7): 416-419.

• 法规与管理研究 • 上一篇    下一篇

市场份额责任规则对我国迟发性药品致害事件赔偿制度的启示

鞠梦琪1,2, 袁利佳3, 吕旭峰3, 杨丽娜1,2, 杨悦1,2,*   

  1. 1 沈阳药科大学工商管理学院,辽宁 沈阳110016;
    2 国际食品药品政策与法律研究中心,辽宁 沈阳 110016;
    3 国家药品监督管理局药品审评中心,北京 100038
  • 收稿日期:2019-08-06 修回日期:2019-08-06 出版日期:2019-07-20 发布日期:2019-08-06
  • 通讯作者: 杨悦,女,博士,教授·博导,药事法规与政策。E-mail：yyue315@vip.126.com
  • 作者简介:鞠梦琪,女,在读硕士,药事法规与政策研究。

Enlightenment of Market Share Liability on Compensation System for Delayed Drug Injury in China

JU Mengqi1,2, YUAN Lijia3, LV Xufeng3, YANG Lina1,2, YANG Yue1,2,*   

  1. 1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2 International Food and Drug Policy and Law Center, Liaoning Shenyang 110016, China;
    3 Center for Drug Evaluation, NMPA, Beijing 100038, China
  • Received:2019-08-06 Revised:2019-08-06 Online:2019-07-20 Published:2019-08-06

PDF (PC)

171

摘要： 目的 介绍欧美国家的市场份额责任规则,为我国建立迟发性药品致害事件赔偿制度提供参考。方法 通过法理学分析、案例研究等方法,分析市场份额责任规则的定义、产生背景以及在国外的应用,以期对其在我国药品侵权领域的适用提出建议。结果 市场份额责任规则是以产品具有“可替代性”且存在缺陷为前提。同时是解决由于药品致害结果迟发性,导致受害人难以确定侵权人时的特殊规则。结论 我国在借鉴欧美国家经验建立市场份额责任规则前应当明确产品“可替代性”与“缺陷”内涵、建立企业市场份额统计机制,从而为迟发性药品致害事件赔偿制度提供合理可行的参考。

关键词: 市场份额责任规则, 迟发性药品致害事件, “可替代性”产品, 缺陷药品

Abstract: Objective To introduce the Market Share Liability in Europe and America, so as to provide reference to our country. Methods By the methods of jurisprudence analysis and case study, this paper analyzed the definition, background and application of Market Share Liability, and made suggestions on its application in the field of drug infringement in China. Results The application of the Market Share Liability was based on the premise that the product was "alternative" and defective. At the same time, it was a special rule, mainly to solve the problem that the victims were unable to identify infringer due to the delayed drug injury. Conclusion Before we learnt from the European and American experiences to establish the Market Share Liability, we should clarify the definition of "alternative" and "defective", and establish a statistical mechanism for market share of enterprises, so as to provide a reasonable and feasible reference for the compensation system for delayed drug injury cases in China.

Key words: Market Share Liability, delayed drug injury case, "alternative"product, defective drug

中图分类号: