公共资助药物的产业价格保证:从Project NextGen学习,应对流行病及其他疾病
Holly Fernandez Lynch1, Rena M Conti2, Jorge L Contreras3
1University of Pennsylvania, Perelman School of Medicine and Carey Law School, Philadelphia, PA, United States.
Journal of law and the biosciences
|September 16, 2024
概括
政府通过最受欢迎国家 (MFN) 条款控制药品价格的努力是有希望的,但存在漏洞. 仔细的合同分析对于确保公开资助的医疗技术的真正负担能力至关重要.
科学领域:
- 卫生政策 卫生政策
- 制药经济学 制药经济学
- 生物技术监管 生物技术监管
背景情况:
- 公共资金资助的药物的负担能力是一个持续的挑战.
- 拜登政府在2023年在公共资金协议中引入了价格限制.
- 一个"最受青国家" (MFN) 条款被纳入BARDA-Regeneron协议中,用于COVID-19抗体的开发.
研究的目的:
- 批判性地分析MFN条款在控制药品价格方面的有效性.
- 在公共融资合同中使用的最优国债条款中识别潜在的漏洞和限制.
- 为未来政府努力提供见解,以确保公共资助的医疗技术的负担能力.
主要方法:
- 在BARDA-Regeneron协议中对MFN条款的分析.
- 战略准备和应对管理局 (ASPR) 对后续协议的审查.
- 批判性审查与所涵盖的买方,参考国家,价格和条件有关的特定合同条款.
主要成果:
- 在Regeneron的MFN条款中,包含了一些关于买家,国家,价格和条件的漏洞.
- 这些漏洞可能会破坏预期的价格约束,使其潜在无效.
- 纳入MFN条款被提出为政府资助协议的新标准.
结论:
- 公共资金协议中的最优惠国债条款需要仔细审查,以确保它们提供有意义的价格约束.
- 合同条款中的漏洞可以使价格控制机制变得无效,成为"窗".
- 从这次分析中吸取的教训对于未来的努力来提高公共投资开发的医疗技术的可负担性至关重要.
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