管理评论 ›› 2021, Vol. 33 ›› Issue (5): 64-75.

• 物理-事理-人理系统方法论(WSR) • 上一篇    下一篇

基于演化博弈的药品质量安全监管“人理”分析

闫志华1, 唐锡晋1,2   

  1. 1. 中国科学院数学与系统科学研究院, 北京 100190;
    2. 中国科学院大学, 北京 100049
  • 收稿日期:2019-05-05 出版日期:2021-05-28 发布日期:2021-06-03
  • 通讯作者: 唐锡晋(通讯作者),中国科学院数学与系统科学研究院研究员,博士生导师,博士
  • 作者简介:闫志华,中国科学院数学与系统科学研究院博士后。
  • 基金资助:
    国家重点研发计划基金项目(2016YFB1000902);国家自然科学基金项目(71731002;71971190)。

Renli Analysis of Drug Safety Regulation Based on Evolutionary Game

Yan Zhihua1, Tang Xijin1,2   

  1. 1. Academy of Mathematics and Systems Science, Chinese Academy of Sciences, Beijing 100190;
    2. University of Chinese Academy of Sciences, Beijing 100049
  • Received:2019-05-05 Online:2021-05-28 Published:2021-06-03

摘要: 药品质量安全监管涉及众多利益相关者,是一个复杂的系统问题。本文应用物理-事理-人理方法论(Wuli-Shili-Renli System Approach,WSR)探讨药品质量安全监管中的物理、事理、人理,提出药品质量安全监管的WSR框架。以往WSR方法论研究中“人理”分析以描述性讨论为主,本文使用演化博弈方法对药品质量安全监管中的参与主体的行为和利益动机进行建模,探讨了参与主体的行为影响要素,为药品质量安全监管机制的设计提供依据。在此基础上,研究以长生生物疫苗造假事件为例,分析长生生物、监管机构、地方政府等的行为策略,阐明药品质量安全监管中人理对药品质量监管的重要意义。研究结果表明:基于WSR的药品质量安全监管方案需要综合考虑社会舆情、监管力度和问责力度;不断完善现有监管机构管理模式,可以规避监管机构的机会主义;社会公众通过产生社会舆情表达诉求可能会使药品质量监管陷入震荡状态。

关键词: 药品质量安全监管, WSR系统方法论, 人理, 演化博弈论

Abstract: Drug quality supervision which involves many stakeholders is a complex system problem. This paper applies WSR system approach to analyze the Wuli, Shili and Renli factors in drug safety supervision. WSR framework for drug safety supervision is proposed. Different from the traditional descriptive analysis toward Renli in the past literatures, this paper uses evolutionary game theory to model the behavior and interest motivation of participants in drug safety supervision, and provides suggestions for the design of drug quality and safety supervision mechanism. Besides, Changsheng biological vaccine incident is employed to illustrate the important significance of Renli in drug quality supervision. The results show that the drug regulatory scheme based on WSR needs to consider the public opinions, regulatory strength and accountability strength; improving the management mode of existing regulatory agencies can avoid the opportunism of regulatory agencies; the public may make the drug quality supervision fall into a state of shock by expressing their demands unreasonably.

Key words: drug safety regulation, WSR system approach, evolutionary game theory, Renli