药品标签和说明书无障碍改造法律问题研究  

Legal Issues Regarding Accessibility Improvement of Labels and Patient Information Leaflets of Medicinal Products

作　　者：刘璟锟 LIU Jingkun

机构地区：[1]华东政法大学中国法治战略研究院,上海201620

出　　处：《残疾人研究》2025年第2期57-68,共12页Disability Research

摘　　要：《中华人民共和国无障碍环境建设法》对无障碍格式版本的药品标签和说明书进行了规定,明确规定了制定相关管理规范以及负有提供义务的主体。但目前在实践中相关规定因在法律规范和技术规范的不完善而存在执行的困境。在法律规范方面,缺乏配套制度和相关规范的衔接,法定责任主体义务具体内容不明确,而且无障碍格式版本的药品标签和说明书的载体和传播方式缺乏规定;在技术规范方面,缺乏专门性和强制性的管理规范,导致对药品标签和说明书的无障碍改造缺乏明确指引。对此,在法律规范方面,应当完善执行性立法和配套法律制度,明确无障碍格式版本药品标签和说明书的法律地位和性质以及药品生产经营者提供义务的具体内容,并实现法律规范与公益诉讼制度的衔接。同时,还应当完善无障碍格式版本药品标签和说明书的相关规范,明确“应当标注”的具体内容,明确形式方面无障碍改造的责任主体以及次序,并在技术规范方面,针对药品标签和说明书的无障碍改造制定编写指南以及明确改造的具体方式。The Law of the People's Republic of China on Building Accessible Environments has stipulated the labels and instructions of medicinal products in accessible formats,clearly specifying the entities that formulate relevant management norms and those are accountable for fulfilling accessibility improvements.However,the practical implementation of relevant regulations is facing challenges due to imperfect legal and technical norms.In terms of legal norms,supporting systems have no connection with relevant norms,the specific contents of obligations fulfilled by legal entities have not been specified clearly,and there are not enough regulations on the carriers and dissemination methods of labels and instructions of medicinal products in accessible formats.In terms of technical norms,there is no clear guidance on accessibility improvement of labels and instructions of medicinal products due to lack of specialized and mandatory management norms.Accordingly,from the perspective of legal norms,it is necessary to improve the enforcement legislation and supporting legal systems,clarify the legal status and nature of labels and instructions of medicinal products in accessible formats as well as the specific content of the obligations provided by medicine manufacturers and traders,and realize the connection of legal norms with the public interest litigation system.Furthermore,it is essential to improve the norms relevant to labels and instructions of medicinal products in accessible formats,clarify the specific content that shall be labeled,clarify accountable entities and their order for accessibility improvement in terms of forms,and develop compiling and writing guidance on accessibility improvement of labels and instructions of medicinal products and clarify the specific improvement methods from the perspective of technical norms.

关 键 词：药品标签和说明书 无障碍格式版本 无障碍改造 《中华人民共和国无障碍环境建设法》 残疾人权益保护 

分 类 号：D922.297[政治法律—经济法学] D669.69[政治法律—法学]