Causes of drug shortages in the legal pharmaceutical framework
Causes of drug shortages in the legal pharmaceutical framework
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DOI：
10.1016/j.yrtph.2015.01.005
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发表时间：
2015-03-01
影响因子：
3.4
通讯作者：
Huys, Isabelle
中科院分区：
文献类型：
--
作者：
De Weerdt, Elfi;Simoens, Steven;Huys, Isabelle
简介：药品短缺的不同原因可以与药品法律框架联系起来，例如：平行贸易、质量要求、暂停或停止生产的经济决策等。然而，到目前为止，还没有对影响药品短缺的不同法规进行深入研究。本文的目的是对欧洲制药框架中影响药品短缺的相关法律和监管措施进行分析。方法：分析了管理人用药品的不同欧洲和国家立法（例如指令 2001/83/EC 和指令 2011/62/EU），并辅以文献研究。结果：对于专利药品，外部价格参考可能包含对药品短缺的最大影响。对于仿制药，内部或外部参考定价、招标以及价格上限可能会影响药品短缺。制造/质量要求也会导致药品短缺，因为不合规会导致召回。平行贸易对药品短缺的影响目前仍存在较大争议。结论：价格和质量监管都是造成药品短缺或缺货的重要原因。可以得出的结论是，在欧盟为缓解药品短缺而制定的框架内，药品法律框架还有改进的空间。 (C) 2015 Elsevier Inc. 保留所有权利。
Introduction: Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages.Methods: Different European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies.Results: For patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since noncompliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable.Conclusion: Price and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages. (C) 2015 Elsevier Inc. All rights reserved.