Estimating the Impact of Accelerated Generic Entry on Consumer Welfare and Innovation in the Pharmaceutical Industry

战后时代的制药创新为人类福祉带来了巨大收益。为了继续取得这些进展，世界各地的公共政策制定者必须在药物获取的竞争目标与通过新药知识产权保护创造的足够的激励措施进行研究和开发（R&D）之间取得正确的政策平衡。在美国，这种平衡主要由《哈奇-韦克斯曼法案》（1984 年）确定。然而，近年来，法院裁决、随后的立法和监管变化导致仿制药进入急剧加速，减少了原研药发明者赚取的利润。由于缺乏涵盖大量药品市场的高质量数据以及可以估计现代离散选择需求模型的合理时间间隔，过去量化仿制药爆炸式增长所产生的消费者利益的努力受到了阻碍。通过获取从 1990 年代末到 2000 年代末的美国药品销售数据，该项目能够量化专利保护药品仿制药挑战激增对特定药品市场药品购买者（短期）消费者福利的影响。初步结果表明，收益相当大，消费者福利收益很容易超过生产者损失。进一步的研究将为这些收益提供更精确的估计。虽然经济学家、政策制定者和公众都清楚降低药品价格的潜在好处，但同样清楚的是，从理论上讲，仿制药进入的加速可能会对进行某些药品研发的积极性产生抑制作用。该项目调动的数据资源可以确认药物市场和时间之间这种关系的存在和量化。初步结果表明，总体药物开发并未下降，但药物创新的性质和方向已因仿制药竞争的加剧而发生了显着变化，这可能对未来药物消费者的福祉产生重大影响。该项目将提供对这些影响的更精确的测量，可能会显示出在产品领域，随着特定药物类别内仿制药竞争的加剧，研究工作会转移到哪里。 更广泛的影响：美国最近的政策变化加速了仿制药的进入，更激烈的仿制药竞争有助于降低美国的药品价格。该研究项目将量化仿制药竞争加剧所带来的消费者收益，同时也衡量仿制药竞争的加剧对药品开发的规模、方向和性质的影响程度。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，因此美国政策在一方面获得药品和另一方面充分激励药品创新之间取得适当的平衡尤为重要。该项目的结果将为政策制定者寻求最佳平衡提供重要指导。

Pharmaceutical innovation in the postwar era has produced enormous gains in human welfare. To continue these advances it is essential that public policymakers around the world strike the right policy balance between the competing goals of drug access and sufficient incentives to conduct research and development (R&D) created by intellectual property protection for new drugs. In the U.S., this balance is set primarily by the Hatch-Waxman Act (1984). In recent years, however, court rulings, subsequent legislation, and regulatory changes have led to a sharp acceleration in the entry of generic drugs, reducing the profits earned by the inventors of the original branded drugs. Past efforts to quantify the consumer benefits generated by this generics explosion have been hampered by the lack of high-quality data spanning a large number of pharmaceutical product markets and a reasonable interval of time over which modern discrete choice models of demand could be estimated. Access to the universe of U.S. drug sales data at the product level from the late 1990s through the late 2000s allows this project to quantify the impact of a surge in generic challenges to patent-protected pharmaceutical products on the (short-run) consumer welfare of drug purchasers in select pharmaceutical markets. Preliminary results suggest the gains are quite large with consumer welfare gains easily outweighing producer losses. Further research will provide more precise estimates of these gains.While the potential benefits of lower drug prices are clear to economists, policymakers, and the public, it is equally clear that the acceleration of generic entry could, in theory, have a depressing effect on the incentives to conduct some kinds of pharmaceutical R&D. The data resources mobilized by this project allow for the confirmation of the existence and quantification of the strength of this relationship across drug markets and time. Preliminary results suggest that overall drug development has not declined, but that the nature and direction of pharmaceutical innovation has shifted significantly in response to rising generic competition, with potentially significant consequences for the well-being of future drug consumers. This project will provide more precise measures of these effects, potentially showing where, in the product space, research effort gets diverted as generic competition within a particular drug category rises. Broader Impacts: Recent policy changes in the U.S. have accelerated generic entry, and greater generic competition has helped lower drug prices in the U.S. This research project will quantity the consumer gains generated by rising generic competition, but also measure the extent to which the rise in generic competition has influenced the scale, direction, and nature of pharmaceutical drug development. Because 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 between access to drugs on the one hand and sufficient incentives for drug innovation on the other. The results of this project will be an important guide to policymakers seeking the optimal balance.