药品数据的公开与专有权保护被引量：16

导出

摘要屡屡发生的药害事件表明,药品的上市监管难以实现用药安全的目标,增强数据透明度是保障公共利益的重要手段。但是,药品安全性、有效性和质量可靠性等数据是品牌药商最为重要的商业利益之所在。药品数据的获取需要付出巨额的研发成本,其本质上又具有公共产品的属性,将其作为商业秘密保护是品牌药商保护自身利益的传统手段。品牌药商向药品监督管理部门递交药品数据会引发严重的利益冲突。构建以公开为基础的数据专有权,取代现行以保密为基础的药品数据保护,既保障了品牌药商的利益,又增强了药品数据的透明度,还符合TRIPS协议第39.3条下数据保护义务的要求。

作者梁志文

机构地区南京师范大学法学院

出处《法学》 CSSCI 北大核心 2013年第9期102-112,共11页 Law Science

基金中国博士后科学基金项目"药品创新知识产权保护"(2012M510678)的初期研究成果

关键词药品数据数据专有权商业秘密数据公开 TRIPS协议

分类号 D922.16 [政治法律—宪法学与行政法学] D923.4 [政治法律—民商法学]

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参考文献24

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