Medicine and Public Policy, Leonard D Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles,
Health Aff (Millwood). 2011 Jan;30(1):84-90. doi: 10.1377/hlthaff.2009.1056.
Pharmaceutical companies and generic drug manufacturers have long been at odds over "data exclusivity" regulations. These rules require a waiting period of at least five years before generic drug companies can access valuable clinical trial data necessary to bring less expensive forms of innovative drugs to market. Pharmaceutical companies want the data exclusivity period lengthened to protect their investment. Generic manufacturers want the period shortened so that they can bring less expensive versions of drugs to patients sooner. We examine the long-term effect of extending the data exclusivity period for conventional "small-molecule" drugs to twelve years--the same exclusivity period already extended to large-molecule biologic drugs under the Affordable Care Act. We conclude that Americans would benefit from a longer period of data exclusivity.
制药公司和仿制药制造商长期以来一直对“数据专有权”法规存在分歧。这些规定要求在仿制药公司获得将创新药物以更便宜的形式推向市场所需的有价值的临床试验数据之前，至少等待五年。制药公司希望延长数据专有权期限，以保护其投资。仿制药制造商希望缩短这一期限，以便他们能够更早地为患者提供更便宜的药物版本。我们研究了将传统“小分子”药物的数据专有权期限延长至十二年的长期影响——这与《平价医疗法案》下已经为大型生物制药延长的专有权期限相同。我们的结论是，美国人将从更长的数据专有权期限中受益。
