药品盲文标签和说明书法律问题研究

Research on legal issues of braille labels and package inserts for drugs

《中华人民共和国无障碍环境建设法》的颁布并施行体现了我国注重对残障人士合法权益的保护。该法第三十七条对药品盲文的标签和说明书的提供主体以及监管主体进行了规定,为残障人士的用药安全进一步提供法律保障。但是目前仍存在制度衔接有立法空白、监管和提供主体存在模糊性、药品盲文标签和说明书书写规范不明确以及缺乏罚则的规定等问题。文章基于当前存在的问题提出相关的建议和措施,以期更好地推动无障碍格式版本的药品标签和说明书规定的落实。

The Barrier⁃free Environment Creation Law of the People’s Republic of China reflects China’s emphasis on protecting the legitimate rights and interests of person with disabilities.Article 37 of this law stipulates the providers and regulators of labels and package inserts in braille for drugs,providing further legal protection for the drug safety of persons with disabilities.However,there are concerns about the legal gap in aligning policies and systems,unclear obligations and functions of the subject of relevant liability,lack of uniform writing norms for braille labels and package insert of drugs,and lack of provisions on legal liability,and supporting systems and measures.In this regard,it is necessary to improve the convergence between regulations and solve the problem of the application of law,further clarify the respective obligations and scope of authority of the responsible parties,improve the management norms,writing norms and national standards of drug braille labels and package insert in China,supplement the provisions of legal liability,and provide certain policy and economic support from the state and society.Based on the existing problems,this essay puts forward relevant suggestions and measures to better promote the implementation of the accessibility format version of drug labels and package insert.