The Effects of the Biologics Price Competition and Innovation Act of 2009 on Biopharmaceutical Research and Development

摘要

The biopharmaceutical industry is a significant and rapidly growing sector of the U.S. economy and is critical for tackling many diseases affecting large patient populations. The Biologics Price Competition and Innovation Act (BPCIA) was enacted by Congress in 2009 with the legislative intent to increase innovation and patients' access to biopharmaceuticals by stimulating biotechnology research and development and lowering prices for patients. In this dissertation research, I analyze the impact of the BPCIA and its market exclusivity protections on biopharmaceutical innovation to influence new biological drug development. This study examines how selected indicators of research and development within the biopharmaceutical industry responded to the enactment of the BPCIA. I used published data and compiled time-series analyses to identify major shifts in selected metrics of biopharmaceutical innovation (i.e., indicators) in response to key events (i.e., milestones) associated with the emergence and enactment of the BPCIA. In my data analysis, I measure changes in indicators that mark increases or decreases in innovation activity within biopharmaceutical research and development that may have occurred in response to implementation of the BPCIA. Through this analysis of the BPCIA, I attempt to answer a broader question "Do legislative changes in market exclusivity protection affect innovation in biopharmaceuticals?" Answering this question will address the persistent public policy argument of whether stronger market exclusivity affects innovation and if so, whether the effects are positive or negative. Through interpretation of empirical evidence, my research supports the favorable linking of market exclusivity and encouraging innovation. However, the data analyses also show that biopharmaceutical industry is faced with many regulatory burdens placed by the BPCIA for the development of follow-on biosimilars, which may hinder the opportunities for future cost savings to patients.