药品说明书适老化改造行政公益诉讼探析  

Research on the Administrative Public Interest Litigation for the Elderly-Friendly Transformation of Drug Instructions

作　　者：杜敏 Du Min(People's Procuratorate of Tianjin Beichen District,Tianjin 300400,China)

机构地区：[1]天津市北辰区人民检察院,天津300400

出　　处：《卫生法学》2025年第2期103-109,126,共8页Health Law

摘　　要：药品说明书“不适老”问题存在已久,严重影响老年人群体安全用药,事关公共利益,通过行政公益诉讼手段进行药品说明书适老化改造有其必要性。办理药品说明书适老化改造行政公益诉讼案件需厘清四个重点问题,即合理认定是否损害公共利益、妥当选择检察建议制发对象、准确判断行政机关履职情况和严格规范检察建议内容。药品说明书适老化改造行政公益诉讼面临困境,可以完善药品说明书相关法律规定、拓宽案件线索来源、降低适老化改造成本、完善激励与保障机制,以推进药品说明书适老化改造工作。The issue of drug instructions being“not elderly-friendly”has existed for a long time and severely affects the safe medication use in the elderly population,which concerns public interest.It is necessary to use administrative public interest litigation to facilitate the elderly-friendly transformation of drug instructions.Handling cases of administrative public interest litigation for the elderly-friendly transformation of drug instructions requires clarifying four key issues:reasonably determining whether public interest is harmed,appropriately selecting the target of prosecutorial suggestions,accurately judging the performance of administrative agencies,and strictly regulating the content of prosecutorial suggestions.The administrative public interest litigation for the elderly-friendly transformation of drug instructions faces challenges,and improvements can be made in legal provisions related to drug instructions,expanding sources of case clues,reducing the costs of transformation,and enhancing incentive and guarantee mechanisms to advance the work on the elderly-friendly transformation of drug instructions.

关 键 词：药品说明书 适老化改造 行政公益诉讼 完善路径 

分 类 号：D922.16[政治法律—宪法学与行政法学]