Hoffman Sharona
Food Drug Law J. 2012;67(1):1-21, i.
Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon.
药品短缺正成为一个重大的公共卫生威胁。医学界和政府官员已表达了严重关切,近期媒体报道也突出了这一危机。然而,迄今为止法律文献中关于药品短缺危机的论述甚少,而这篇及时的文章开始填补了这一空白。它对药品短缺问题的根源及影响进行了全面分析,并制定了一个多层次的应对方法。文章认为,药品短缺是市场失灵和监管限制共同作用的结果。它提出了一系列立法、监管及私营部门干预措施,这些措施应能遏制制造商的不良行为,并提供适当激励以应对药品短缺现象。