“又高又干?”《公众准备和应急准备法》和药品制造商的责任保护。

Journal of health law Pub Date : 2007-01-01
B Kurt Copper
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摘要

在一个对生物恐怖主义充满恐惧的时代,国会批准了《公共准备和应急准备法》(PREPA),以鼓励疫苗和其他对策的开发。通过向制药商提供保护,使其免于承担潜在副作用的责任,国会试图激励制药商生产全国性的应对措施。作为PREPA的一部分,政府建立了一项赔偿制度,旨在向在公共卫生紧急情况下使用的对策中受伤的人提供赔偿。虽然该法规定设立赔偿基金,但没有为该基金拨出款项。因此,在没有国会采取进一步行动的情况下,PREPA将不会向受反措施伤害的人提供赔偿。未能向美国公众保证补偿计划构成了糟糕的公共政策,并有可能激发潜在的疫苗接种者拒绝必要的药物。此外,如果国会不能为该计划提供足够的资金,就会存在关于该法案是否符合宪法的争论,这些争论的存在破坏了该法案的目的——即向制药商保证,如果他们试图帮助国家流行病保护,他们不会被起诉到遗忘。除了详细说明法案和国会试图刺激生物防御的法定先例外,本文还讨论了医疗保健、侵权行为和宪法法律等重要问题,这些问题将在这个生物恐怖主义的新时代继续表现出来。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Notes and comments "High and dry?" The Public Readiness and Emergency Preparedness Act and liability protection for pharmaceutical manufacturers.

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.

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