法国创新药品价格谈判方法与细则

Methods and rules of innovative drug price negotiation in France

目的整理并总结法国创新药品价格谈判的流程和提交文件的主要内容,归纳其价格谈判的方法和细则,为我国创新药品价格谈判流程优化提供参考。方法通过法国官方网站公布的法律、法规、官方信息和发布的最新文件,归纳总结法国创新药品谈判流程及价格监管程序。结果法国创新药品价格谈判机制成熟,评估流程和文件提交要求及内容明确,药品价格变化和监管制度完善。法国创新药品企业完成临床效益评估和药品经济评估后,将报告提供给保健产品委员会进行价格协商和多次价格谈判,以保证评估过程公正,评估结果合理。结论我国创新药品价格谈判可参考法国建立评审专家利益审查机制,保证谈判过程公平公正;合理设置价格谈判以及价格调控机制,保证谈判结果合理且谈判成果有效落地。

Objective To study the process of French innovative drug price negotiation and the main content of the submitted documents,and to provide reference for optimizing the negotiation process of innovative drugs in China.Methods The laws,regulations,official information and the latest documents published on the French official websites were summarized to investigate the negotiation process and price supervision procedure of innovative drugs in France.Results The negotiation mechanism of French innovative drug price is mature,the evaluation process,document submission requirements and content are clear,and the drug price changes and the regulatory system are perfect.After the French innovative drug enterprises have completed the clinical benefit evaluation and drug economic evaluation,they will provide the reports to the Health Products Committee for price negotiations and to ensure that the evaluation process is fair and the evaluation results are reasonable.Conclusion China′s innovative drug price negotiation can refer to the establishment of the interest review mechanism of expert in France to ensure a fair and just negotiation process.Besides,it is necessary to set up a reasonable price negotiation and price control mechanism to ensure reasonable negotiation results that can be effectively implemented.