我国药品患者援助项目实施现状与监管制度分析

蒋蓉, 孙圆圆, 邵蓉

中国药学杂志 ›› 2019, Vol. 54 ›› Issue (19) : 1626-1630.

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中国药学杂志 ›› 2019, Vol. 54 ›› Issue (19) : 1626-1630. DOI: 10.11669/cpj.2019.19.015
论 著

我国药品患者援助项目实施现状与监管制度分析

  • 蒋蓉, 孙圆圆, 邵蓉*
作者信息 +

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

  • JIANG Rong, SUN Yuan-yuan, SHAO Rong*
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文章历史 +

摘要

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。

Abstract

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 research 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 provided 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 current 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 patient assistance programs, emphasize the regulatory requirements about domestic drug assistance, and establish the whole process management system for the storage, supply and use of patient assistance drugs.

关键词

药品 / 患者援助项目 / 实施模式 / 监管制度

Key words

drug / patient assistance program / implementation model / regulatory system

引用本文

导出引用
蒋蓉, 孙圆圆, 邵蓉. 我国药品患者援助项目实施现状与监管制度分析[J]. 中国药学杂志, 2019, 54(19): 1626-1630 https://doi.org/10.11669/cpj.2019.19.015
JIANG Rong, SUN Yuan-yuan, SHAO Rong. Analysis on the Implementation and Supervision System of Patient Assistance Programs in China[J]. Chinese Pharmaceutical Journal, 2019, 54(19): 1626-1630 https://doi.org/10.11669/cpj.2019.19.015
中图分类号: R951   

参考文献

[1]HUANG W,CHEN Y W,SHI L W. Enlightenment to Chinese drug negotiation from pharmaceutical assistance programs in America. J China Pharm(中国药房),2013(5):388-390.
[2] China Charity Federation. Gleevec Patient Assistance Program. . http://www.chinacharityfederation.org/projectshow/0/13.html.
[3] TAO X M, DONG J P, HUANG L, et al. Relationship of ecosystems and resolution of new drug research and development. Chin Pharm J(中国药学杂志),2016,51(7):592-597.
[4] Cancer Foundation of China. Velcade Patient Assistance Program application process diagram. .(2014-09-15). http://www.cfchina.org.cn/show.php?contentid=748.
[5] LI H Y, HUANG W, GUAN X D, et al. Practice of drug negotiation modes in China. Chin Pharm Aff(中国药事), 2015, 29(11):1125-1131.
[6] NMPA. The Regulations about the Administration of the Importing Donated Drugs. (2016-06-02). http://www.gov.cn/xinwen/2016-06/02/content_5079034.htm.
[7] Interpretation of the Law of the People′s Republic of China on Donation of Public Welfare . (2001-08-01). http://www.npc.gov.cn/npc/flsyywd/jingji/2001-08/01/content_140355.htm.

基金

国家社科基金重大项目(第二批)《我国创新药物政策环境研究》基金项目资助(15ZDB167);中央高校基本科研业务费专项资金资助项目(2632019PY08)
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