中国药品安全治理的行动框架与关键问题研究

Study on the action framework and key problem of drug safety governance in China

目的为阐明中国药品安全治理的行动和发展方向提供参考。方法基于治理理论建立"动力-共享-效能与反馈"分析框架,以阐释药品安全跨部门合作治理的理论机制。通过构建"3个阶段+1个培育期"的国家药品安全治理行动框架,剖析各个阶段的内涵及可能存在的挑战,并提出改善建议。结果与结论制约我国药品安全治理效能发挥的障碍主要源于信息、资源动员和权力共享不足。因此,"基础协作阶段"应当扩大信息共享的幅度、吸纳非政府主体参与,"立法协调阶段"应注重正式的法律制度供给、使非政府力量在治理活动中发挥必要作用,"深化协同阶段"应促进社会力量正式融入治理系统、真正实现由"被动式参与"向自我管理转变。建议基于整体性视角,从治理规范、沟通机制、能力培养等方面持续完善我国药品安全治理体系建设。

OBJECTIVE To provide reference for clarifying the action and development direction of China’s drug safety governance. METHODS Based on governance theory,an analysis framework of“Motivation-Sharing-Performance and Feedback”was established to explain the mechanism of cross-sector collaboration governance of drug safety. By constructing the action framework of national drug safety governance of“3 stages + 1 incubation period”,the connotation of each stage and possible challenges were analyzed, and improvement suggestions were put forward. RESULTS & CONCUSIONS The obstacles that restricted the effectiveness of drug safety governance in China were mainly due to insufficient information,resource mobilization and power sharing. Therefore, the “basic collaboration stage” should expand the scope of information sharing and involve non-governmental entities;the“legislative coordination stage”should focuse on the provision of formal legal systems so that non-governmental forces can play a necessary role in governance activities;the“deepening of the coordination stage”should promote the formal integration of social forces into governance system,and truly realize the transition from“passive participation”to self-management. It is recommended to continuously improve the construction of drug safety governance system in China in terms of governance norms,communication mechanisms,capacity development based on a holistic perspective.