目的 梳理国内外药品个人进口计划的相关法规与案例,立足我国国情提出改进建议,为完善我国个人进口药品管理提供借鉴。方法 采用文献分析与政策分析相结合的方法对药品个人进口计划的实现形式、相关法规、作用与相关风险等进行归纳比较。结果 药品个人进口计划主要包括两种形式:个人携药入境和通过第三方购药,其适用范围在各国家有不同的规定,目前在多个国家均有实践案例。药品个人进口计划的实施具有两面性,在帮助患者更快用上境外新药和廉价药的同时,应注意药品质量和用药安全的隐患。结论 中国目前关于药品个人进口计划缺乏相关法律法规。建议针对个人进口药品建立安全监管体系;亟待完善海南进口药品先行区的相关政策,构建从进口到使用的药品保障路径;建立个人进口药品国际健康险衔接制度。
Abstract
OBJECTIVE To sort out relevant laws & regulations of domestic & foreign personal importation schemes and provide suggestions and reference for the improvement of China′s management of personal drug-importation. METHODS Literature analysis and policy analysis were used to summarize and compare the implementation forms, relevant laws & regulations, and effect and relevant risks of personal drug-importation schemes. RESULTS Personal importation schemes mainly exists in two forms: individual drugs entry and purchase through a third party. Different countries have different regulations, based on its application scope. Personal importation scheme has been successfully applied in many countries. The scheme is a double-edged sword, which can help patients to get new imported drugs and cheap drugs earlier. However, more attention should be paid to drug quality and patient safety. CONCLUSION Currently, there are no detailed regulations on personal importation scheme of drugs in China. It is suggested that relevant laws & regulations need to be improved urgently. The safety supervision system of personal importation scheme of drugs needs to be established. To construct the supportive approach from import to use based on the pilot area of import drugs in Hainan, and establish international health insurance reimbursement system of personal drug-importation schemes.
关键词
药品个人进口计划 /
药品可及性 /
安全风险 /
法律 /
法规
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Key words
drug personal importation schemes /
drug accessibility /
safety risk /
laws /
regulations
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中图分类号：
R95
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参考文献
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脚注
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基金
国家自然科学基金青年项目资助(71804032)
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