Wolitz Rebecca E
J Leg Med. 2019 Apr-Jun;39(2):177-211. doi: 10.1080/01947648.2019.1648942.
The federal government subsidizes the research and development of prescription medications. Thus, a captivating critique of expensive medications is that prices are too high because of taxpayer co-financing. This critique is often framed in terms of "paying-twice"-first for the research and second through the above market pricing of resulting products. Reasonable pricing clauses-which place some kind of pricing limitation on the exercise of license or patent rights governing a federally funded medication-are one proposed policy tool for addressing the pay-twice critique. This article provides increased analytical clarity as well as historical context to present-day debates about the privatization of federally funded research and prescription drug pricing. It makes three arguments. First, despite its pervasiveness and intuitive plausibility, the pay-twice critique is subject to differing interpretations which has important implications for the appropriateness of proposed solutions. Second, despite their initial attractiveness, the costs, necessity, and effectiveness of reasonable pricing clauses render the wisdom of this policy tool uncertain. However, third, given continued interest in reasonable pricing clauses, the NIH's previous experience with such a policy offers some useful lessons.
联邦政府对处方药的研发提供补贴。因此，对昂贵药物的一种引人关注的批评是，由于纳税人共同出资，药价过高。这种批评通常以“二次付费”来表述——首先为研发付费，其次为最终产品高于市场的定价付费。合理定价条款——对管理联邦资助药物的许可或专利权行使设置某种定价限制——是为应对“二次付费”批评而提出的一项政策工具。本文为当前关于联邦资助研究的私有化和处方药定价的辩论提供了更高的分析清晰度以及历史背景。它提出了三个观点。第一，尽管“二次付费”批评普遍存在且看似合理，但它有不同的解释，这对所提议解决方案的适当性具有重要影响。第二，尽管合理定价条款起初具有吸引力，但其成本、必要性和有效性使得这一政策工具是否明智存疑。然而，第三，鉴于对合理定价条款的持续关注，美国国立卫生研究院此前在这一政策方面的经验提供了一些有益的教训。
