澳大利亚药品安全治理研究及对我国的启示

Research on Drug Safety Governance in Australia and Its Enlightenment to China

目的:为改进我国药品安全治理相关支撑体系提供借鉴。方法:通过分析澳大利亚药品安全治理的主要方式、特点及成效,初步提出建设我国药品安全治理制度的建议。结果与结论:澳大利亚主要通过联邦和州/领地政府进行分工合作、与不同相关主体分别开展政策磋商、基于产业发展水平引导产业主体自律、支持行业参与药品广告监管等方式开展药品安全治理;澳大利亚药品安全治理具有搭建信息共享平台而增加政府工作透明度、开展针对性教育提高参与主体治理能力等特点;取得了药品召回事件发生状况显著改善、利益相关者对药品监管部门沟通活动的满意度大幅提升等成效。相较之下,我国相关主体参与药品安全治理的意识和能力尚不强,保障这些主体参与的制度也尚未健全。建议通过更加注重上下级政府部门之间的沟通互动、对非政府主体负责人开展针对性宣教或培训、落实非政府主体的政策磋商权利以及基于行业主体的自我管理能力引导其自律等方面,初步构建我国的药品安全治理体系,提高治理效率。

OBJECTIVE:To provide reference for improving the supporting system of drug safety governance in China.METHODS:Through analyzing the main ways,characteristics and effectiveness of drug safety governance in Australia,the suggestions for building drug safety governance system in China were put forward initially. RESULTS & CONCLUSIONS:The methods of Australia’s drug safety governance are to conduct division of labor between the federal and state/territory governments,conduct policy consultations with different related entities separately,guide industry self-discipline based on industrial development level,and support industry to participate in drug advertising supervision. Australia’s drug safety governance has the characteristics of large information sharing channels,increasing the transparency of government work,carrying out targeted education and enhancing the governance capacity of participants etc. It has achieved significant improvement in the occurrence of drug recall events,and significant increase in the satisfaction of stakeholders in the communication activities of drug regulatory authorities. In contrast,the participation consciousness and ability of relevant entities in China are still not strong,and the system to ensure the participation of these entities is not yet sound. It is recommended that China should pay more attention to the communication between the upper and lower levels of governments,conduct targeted education or training for principals of non-government entities,implement the policy consultation rights of non-government entities,as well as guide self-discipline based on selfmanagement ability of industry entities so as to initially establish drug safety governance system in China,and enhance the governance efficiency.