| 摘要: |
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目的 通过分析欧盟及其成员国的罕用药相关政策，为我国罕用药及罕见病相关制度政策的制定提供参考。方法 采用文献研究法对欧盟及其成员国法国、意大利、荷兰、英国的罕用药相关政策进行检索，并比较分析四国相关政策与制度的异同点。结果 除欧盟统一的罕用药政策外，法国、意大利、荷兰以及英国均制定了相应的罕用药制度，设立罕见病治疗指导中心，有针对罕用药研发与价格制定的政策与措施，对于罕见病的治疗有相应的医疗保障制度，相应的政策制度较为完善。 结论 我国可借鉴其经验尽快制定罕见病的相关定义，建立罕见病中心，出台相应的研发激励与价格制定政策，并完善罕用药的报销与罕见病的医疗保障。 |
| 关键词: 罕用药 罕见病 药品政策 |
| DOI： |
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| 基金项目: |
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| Orphan Drug Policy in European Union and its Implications for China |
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| Abstract: |
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Objective
To provide references for establishing China’s orphan drug system policies by analyzing the EU and its member states orphan drug policies. Methods By literature study of the EU and its member states, France, Italy, the Netherlands and United Kingdom’s orphan drug policies were reviewed, and the four countries’ policies were analyzed comparatively. Results In addition to a unified drug policy at a European level, the four countries have developed their own orphan drug system, including the establishment of a rare disease center, policies and measures for orphan drug development and pricing, and medical insurance system. Conclusion China can learn from their experience which includes the development of the definition of rare disease, the establishment of rare disease centers, the introduction of appropriate R & D incentives and price policies, and improve the reimbursement of orphan drugs and rare disease social security system. |
| Key words: orphan drug, rare disease, drug policy |
