我国药品患者援助项目实施现状与监管制度分析

Analysis on the Implementation and Supervision System of Patient Assistance Programs in China

目的分析我国药品患者援助项目的发展现状、监管制度和存在的问题,为完善相关管理制度提供建议。方法通过文献研究法和对患者援助平台的梳理,归纳药品患者援助的基本实施模式和患者援助监管制度现状。结果笔者统计的81个药品患者援助项目中,均通过制药企业向社会组织捐赠药品后,由受赠组织开展患者援助,包括共助、资金援助、全额免费等援助模式。现行监管制度以《中华人民共和国公益事业捐赠法》、《中华人民共和国慈善法》与《捐赠药品进口管理规定》为法律依据,对援助项目实施主体、药品合理使用、药品质量保障及相应法律责任提出了要求,但存在援助过程中不同主体的行为定性不明确、国产药品援助行为未纳入监管体系、受赠人监管要求缺失等问题。结论应当通过完善法律法规,明确药品患者援助项目的法律定性,增加对国产药品援助行为的监管要求,并建立援助药品储存、流通、使用的全过程管理体系。

OBJECTIVE To analyze the development status, supervision system and existing problems of drug patient assistance programs in China, and to provide suggestions for improving relevant management systems. METHODS Through the literature re search and the combing of the patient assistance platform, summary the basic implementation mode of drug patient assistance and the status quo of patient assistance supervision system. RESULTS According to the 81 patient assistance programs, assistance was pro vided for patients via the charity organizations after pharmaceutical companies donate drugs to them. The assistance modes include co assistance ,financial aid, full-free drugs. Based on the Law of the People's Republic of China on Donation of Public Welfare, the Law of the People's Republic of China on Philanthropy, the Regulations about the Administration of the Importing Donated Drugs, the cur rent regulatory system put forward request towards several aspects, including the subject of assistance programs, reasonable use of drugs, drug quality insurance and related legal liability. However, there are still some problems that the behavior of different subjects during the assistance process is not clearly defined, the assistance of domestic drug is not included in the supervision system, the lack of regulation about donee. CONCLUSION It is necessary to improve the laws and regulations, clarify the legal characteristics of pa tient assistance programs, emphasize the regulatory requirements about domestic drug assistance, and establish the whole process man agement system for the storage, supply and use of patient assistance drugs.