中美罕见病药物可及性评价及其法律保障制度研究

丁锦希 孙晓东 季娜 邵雯君

中国药学杂志 ›› 2011, Vol. 46 ›› Issue (14) : 1129-1132.

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中国药学杂志 ›› 2011, Vol. 46 ›› Issue (14) : 1129-1132.
药事管理

中美罕见病药物可及性评价及其法律保障制度研究

  • 丁锦希,孙晓东,季娜,邵雯君
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摘要

目的 以白血病治疗药品为研究对象,比较分析中美罕见病药物可及性现状,分析两国罕见病用药相关法律政策差异,为完善我国罕见病法律保障体系提供建议。方法 查阅相关文献资料,通过分析、归纳进行评述。结果 与美国相比,中国罕见病药物可及性水平较低,美国从机构设置、财政支持、注册审批、知识产权保护等方面激励罕见病药物研发,保障罕用药的可及性。结论 美国已建立了完善的罕用药可及性法律保障体系,对我国政策完善具有借鉴意义。

关键词

罕见病 / 药物可及性 / 法律保障制度

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丁锦希 孙晓东 季娜 邵雯君. 中美罕见病药物可及性评价及其法律保障制度研究[J]. 中国药学杂志, 2011, 46(14): 1129-1132

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