药品上市许可持有人制度下保险赔偿范围设计研究

Scope of insurance compensation under the institutional arrangement of Marketing Authorization Holder

目的分析现有保险赔偿范围的不足与缺陷,为药品上市许可持有人制度下保险赔偿范围设计提出合理建议。方法通过文献研究法,研究国家现有试点政策对药品风险防控的覆盖范围要求,以及相关概念的界定与辨析,总结出合适的赔偿范围。结果目前保险的赔偿范围覆盖不完全且术语定义部分的界定不清晰。结论在设计保险的过程中,应该将"药品缺陷"作为MAH投保承保范围。

Objective To analyze the shortcomings and deficiencies of the existing insurance compensation scope, and propose reasonable suggestions for the design of the insurance compensation scope under the Marketing Authorization Holder (MAH) system. Methods Literature research was applied to study the existing national policies about the coverage requirements of drug risk prevention and control, as well as the definition and analysis of related concepts. And the appropriate compensation scope was summarized. Results The coverage of insurance compensation was incomplete and the definition of terms was not clear. Conclusion In the process of designing insurance,"drug defect" should be taken as the insurance coverage of MAH.