FDA药品安全监管的PPP机制研究及启示

Research and Inspiration of Public-Private-Partnership Mechanism of FDA Drug Safety Supervision

目的:为构建和完善我国药品安全监管公共部门和私人部门的合作伙伴关系,实现资源共享、优势互补、风险共担、利益分享,为公众提供更佳的公共产品和服务的公私合作伙伴机制(public-privatepartnership,PPP)提供建议。方法:运用文献综述法,首先对PPP机制的运行原理以及在药品安全监管中的作用进行理论分析,再对FDA药品安全监管PPP机制的运行模式及实践进行深入研究并得出启示,最后提出完善和构建我国药品安全监管PPP机制的对策与建议。结果:PPP机制在FDA药品安全监管中的应用收到了良好效果,减缓了药品监管部门的资金压力、构建了多种力量参与的药品安全监管网络、推进了医药管理制度改革。结论:我国应该借鉴FDA药品安全监管PPP机制的成功经验,既需要政府部门的有力支持,还要健全法律法规制度,要保证过程的透明和结果公开。

Objective： To establish and improve the partnership relation between public sector and private sector of drug safety supervision of China to achieve resource sharing, complementary advantage, risk sharing and benefit sharing and to provide suggestions for better public products and public-private-partnership （PPP） mechanism. Methods： Literature review method was mainly used in this paper. Firstly, operation principle of PPP mechanism and its effects on drug safety supervision were theoretically analyzed. Secondly, the operation mode and practice of PPP mechanism of FDA drug safety supervision were deeply studied and inspiration was obtained. Finally, countermeasures and suggestions to improve and establish the PPP mechanism of drug safety supervision in China were put forward. Results： The application of PPP mechanism in FDA drug safety supervision got good effects, the financial pressure of drug regulatory authorities was reduced, supervision network of drug safety involving various forces was established, and reform of the medical management system was promoted. Conclusion： We should learn from the successful experiences of the PPP mechanism of FDA drug safety supervision, which needs not only the strong support from the government departments, but also the improvement of laws, regulations and systems to ensure the transparency of the process and the publicity of the results.