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注释与评论:“孤立无援?”《公众应急准备与突发事件应对法案》与制药商的责任保护

Notes and comments "High and dry?" The Public Readiness and Emergency Preparedness Act and liability protection for pharmaceutical manufacturers.

作者信息

Copper B Kurt

机构信息

University of Notre Dame, USA.

出版信息

J Health Law. 2007 Winter;40(1):65-105.

Abstract

In an era filled with fears of bioterrorism, Congress approved the Public Readiness and Emergency Preparedness Act (PREPA) to encourage development of vaccines and other countermeasures. By providing pharmaceutical manufacturers with protection from liability for potential side effects, Congress has attempted to motivate manufacturers to produce a national stockpile of countermeasures. As part of PREPA, the government established a compensatory system intended to provide compensation to persons injured by countermeasures used during a public health emergency. Although the Act provides for a compensation fund, it fails to allocate monies for that fund. Thus, in the absence of further congressional action, PREPA will not provide compensation to those injured by countermeasures. Failing to assure the American public of a compensation program constitutes bad public policy and risks inspiring potential vaccinees to refuse necessary drugs. Additionally, arguments as to the constitutionality of the Act exist should Congress fail to adequately fund the program, and the existence of those arguments undermines the purpose of the Act--namely to assure pharmaceutical manufacturers that they will not be sued into oblivion should they attempt to aid national pandemic protection. In addition to detailing both the Act and the statutory precedent for congressional attempts to spur biodefense, this Article addresses important issues of healthcare, tort, and constitutional law that will continue to manifest themselves in this new era of bioterrorism.

摘要

在一个充满生物恐怖主义恐惧的时代,国会批准了《公共准备和应急准备法案》(PREPA),以鼓励疫苗及其他应对措施的研发。通过为制药商提供免受潜在副作用责任追究的保护,国会试图激励制造商生产国家应对措施储备。作为PREPA的一部分,政府设立了一个补偿系统,旨在向在公共卫生紧急事件中因使用应对措施而受伤的人提供补偿。尽管该法案设立了一个补偿基金,但却没有为该基金拨款。因此,在没有国会进一步行动的情况下,PREPA将不会向因应对措施而受伤的人提供补偿。无法向美国公众保证有一个补偿计划构成了糟糕的公共政策,并且有可能促使潜在的疫苗接种者拒绝必要的药物。此外,如果国会未能为该计划提供足够资金,关于该法案合宪性的争论就会出现,而这些争论的存在破坏了该法案的目的,即向制药商保证,如果他们试图协助国家应对大流行,不会因被起诉而陷入绝境。除了详细阐述该法案以及国会为刺激生物防御所做尝试的法定先例之外,本文还探讨了医疗保健、侵权法和宪法方面的重要问题,这些问题将在这个生物恐怖主义的新时代继续显现出来。

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