美国鼓励仿制药替代使用政策与措施研究

Analysis of policies and measures to encourage generic substitution in the United States

目的:分析美国鼓励仿制药替代使用的立法过程、政策措施以及关键要素,为我国仿制药经一致性评价后制定替代使用政策提供建议。方法:通过查阅美国联邦法律、各州法律、指南文件、国内外文献等,全面分析美国鼓励仿制药替代使用的基本原则、监管理念和实施挑战。结论:美国仿制药替代法律的制定经历探索、发展和调整三个阶段。医师、药师和患者是美国各州法律鼓励仿制药替代的关键要素,联邦政府和FDA通过橙皮书、分级医保支付和开展认知教育的途径指导和影响仿制药替代。建议我国以尊重患者为基本原则,将鼓励仿制药替代写入法律,明确界定仿制药替代使用范围;建立具有替代决策支持工具的电子处方系统;加强宣传教育提高仿制药认知度。

Objective: To analyze the policy-makingprocess, policies and key elements of generic substitution in the U.S, and after consistence assessment, provide recommendations for developinggeneric substitution policies in China.Methods: By reviewing the relevant federal laws, state laws, guidance documents and literature,this paper comprehensively analyzesthe basic principles, regulatory concepts and implementation challenges of the US s generic substitution.Conclusions: The generic substitution laws in the U.S. have undergone three stages: exploration, development, and adjustment. Physicians, pharmacists and patients played the mostsignificant rolesin encouraging generic substitution regulations. To conduct and promote the generic substitution, the U.S. government and FDA use Orange Book, tiered health insurance payments and public education.In this paper, it is suggested that China encourages generic substitution from a legal perspective,regards patient consent as a premise, clearly defines the scope of substitutable generic, establishes anelectronic prescribing system with alternative decision support tools, and strengthens publicity and public education to improve the public awareness of generic substitution.