Better Access, Fewer Drugs? An Examination of the Impact of Rising Generic Entry on the Incentives to Conduct Pharmaceutical R&D

制药创新对全球人类福利产生了重要影响。重要的是，世界各地的公共政策制定者必须在药物获取和研发激励这两个相互竞争的目标之间取得政策平衡。由于美国制药市场已经并将继续在全球行业利润中发挥不成比例的重要作用，因此美国的政策取得适当的平衡尤为重要。在美国，决定这种平衡的立法是1984年的哈奇-韦克斯曼法案。它最初被誉为两党妥协，既增加了研发的机会，也增加了研发的激励。近年来，该法案似乎为药品创新者打开了更大程度的仿制药竞争的大门，这超出了其设计者的预期。本研究探讨了仿制药进入加速对消费者福利的影响、对研发投资的激励以及对创新的影响。智力价值：该研究利用了产业组织和计量经济学中最近的方法进步，评估了新产品引入对福利的影响。方法工具被应用到一个数据集是更丰富和更完整的比以前的研究者在这个领域。特别是，该研究利用了最近一段时间内在美国上市的药品的产品级销售数据。这些数据与哈奇-韦克斯曼法案授权的快速通用入境的综合数据相关联。研究人员还追踪了公司层面的产品销售数据。这与一个全面的数据库相关联，该数据库有效地涵盖了在样本期内进入美国临床试验过程的所有新化合物。更广泛的影响：该研究提供了重要的见解，以了解增加获得的收益与由于放弃或延迟创新而可能产生的损失之间的关系，并提供了对美国市场的政策平衡是否为最佳的理解。此外，本研究也为未来的研究提供了概念和实证基础。

Pharmaceutical innovation has had an important impact on human welfare across the globe. It is important that public policymakers around the world get the policy balance between the competing goals of drug access and incentives for R&D right. Since the U.S. pharmaceutical market has and will continue to play a disproportionately important role in global industry profits, it is especially important that U.S. policy strike the right balance. The legislation that determines this balance in the United States is the Hatch-Waxman Act of 1984. It was originally hailed as a bipartisan compromise that both raised access and increased incentives for R&D. In more recent years, it appears that the Act has opened the door to a greater degree of generic competition for drug innovators than its architects may have intended. This research examines the impact of the acceleration of generic entry on consumer welfare, the incentives for R&D investment, and the impact on innovation.Intellectual merit: The research takes advantage of recent methodological advances in industrial organization and econometrics that assess the welfare impact of new product introductions. The methodological tools are applied to a data set that is richer and more complete than that of prior investigators in this field. In particular, the research makes use of the universe of product level sales data for pharmaceuticals marketed in the U.S. over a substantial period of recent time. These data are linked to comprehensive data on expedited generic entry authorized under the Hatch-Waxman Act. The researchers also trace product-level sales data at the firm level. This is linked with a comprehensive data base that covers effectively all new compounds entering the clinical trials process in the United States over the sample period. Broader impacts: The research provides important insight into the gains that come with increased access against the losses that may accrue due to foregone or delayed innovation and provide increased understanding of whether the policy balance in the U.S. market is optimal one. In addition, the research provides both a conceptual and empirical foundation for future research.