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

更好的获取途径，更少的药物？

• 批准号: 1064122
• 负责人: Lee Branstetter
• 金额: $ 9.93万
• 依托单位: National Bureau of Economic Research Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2013-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1064122&HistoricalAwards=false
• 关键词: Better; Access; Fewer; Drugs; Examination

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.

医药创新对全球人类福祉产生了重要影响。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冲突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制药行业利润中扮演不成比例的重要角色，美国的政策取得适当的平衡尤为重要。在美国，决定这一平衡的立法是1984年的《哈奇-瓦克斯曼法案》。该法案最初被誉为两党达成的妥协方案，既提高了研发的可及性，又增加了对研发的激励。最近几年，该法案似乎为药物创新者开启了更大程度的仿制药竞争，程度之高超出了其设计者的预期。这项研究考察了仿制药进入加速对消费者福利的影响，研发投资的激励，以及对创新的影响。智力优势：该研究利用了产业组织和计量经济学的最新方法进步，评估新产品引入的福利影响。方法论工具被应用于比该领域以前的调查人员更丰富和更完整的数据集。特别是，这项研究利用了最近相当长一段时间内在美国销售的药品的产品级销售数据。这些数据与根据《哈奇-瓦克斯曼法案》授权的快速仿制药条目的综合数据相关联。研究人员还跟踪了公司层面的产品级销售数据。这与一个全面的数据库相联系，该数据库有效地涵盖了样本期内在美国进入临床试验过程的所有新化合物。更广泛的影响：这项研究为扩大准入带来的收益提供了重要的见解，以应对因放弃或延迟创新而可能积累的损失，并提供了更多关于美国市场的政策平衡是否是最佳平衡的理解。此外，本研究还为今后的研究提供了理论和实证基础。