Yale Journal of Health Policy, Law, and Ethics

Transformative Models to Promote Prescription Drug Innovation and Access: A Landscape Analysis

Phebe Hong, Aaron S. Kesselheim & Ameet Sarpatwari

ABSTRACT. The patent-based pharmaceutical innovation system in the US does not incentivize the development of drugs with the greatest impact on patient or public health. It has also led to drug prices that patients and health care systems cannot afford. Three alternate approaches to promoting pharmaceutical innovation have been proposed to address these shortcomings. Delinkage models involve payments for drug innovation based on public health value rather than on a per-use basis. Public manufacturing models call upon governments and nonprofit organizations to lead drug discovery, development, and production. Public-private partnership models entail publicly-funded organizations working closely with for-profit partners on drug development and price-setting. Each model exhibits promise in promoting prescription drug innovation and access. This paper reviews these transformative models in detail, examining their key characteristics, advantages, and limitations.

AUTHOR. Phebe Hong is a member of the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School, and a student at Harvard Law School. Aaron S. Kesselheim, M.D., J.D., M.P.H., is the director of PORTAL and a professor of medicine at Harvard Medical School/Brigham and Women’s Hospital. Ameet Sarpatwari, Ph.D., J.D. is the assistant director of PORTAL and an assistant professor of medicine at Harvard Medical School/Brigham and Women’s Hospital. Correspondence to Dr. Sarpatwari (asarpatwari@bwh.harvard.edu). This project was funded by the Open Societies Foundation. Dr. Kesselheim and Dr. Sarpatwari’s work is also supported by Arnold Ventures, the Harvard-MIT Center for Regulatory Science, and the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by Novo Nordisk Foundation (grant NNF17SA0027784).

RECOMMENDED CITATION. Phebe Hong, Aaron S. Kesselheim & Ameet Sarpatwari, Transformative Models to Promote Prescription Drug Innovation and Access: A Landscape Analysis, 19 Yale J. Health Pol'y L. & Ethics (2020).