Innovation Law and COVID-19: Promoting Incentives and Access for New Healthcare Technologies

Forthcoming in I. Glenn Cohen, Abbe Gluck, Katherine Kraschel, & Carmel Shachar, COVID-19 and the Law: Disruption, Impact and Legacy. Cambridge University Press, 2022

12 Pages Posted: 7 Jun 2021

See all articles by Rachel Sachs

Rachel Sachs

Washington University in Saint Louis - School of Law

Lisa Larrimore Ouellette

Stanford Law School

W. Nicholson Price II

University of Michigan Law School

Jacob S. Sherkow

University of Illinois College of Law; University of Illinois at Urbana-Champaign - Carl R. Woese Institute for Genomic Biology; Center for Advanced Studies in Biomedical Innovation Law

Date Written: May 28, 2021

Abstract

As the devastating COVID-19 pandemic first swept the globe, it posed a crucial test of biomedical innovation institutions. Containing the virus required developing new technologies including diagnostic tests, pharmaceuticals, and vaccines; manufacturing these technologies at enormous scale; and rapidly distributing them globally. This, in turn, required mobilizing and coordinating scientists, industry, and government at levels not seen since World War II. Underlying the successes and failures of these efforts was the complex legal architecture of biomedical innovation and access.

This chapter considers how this legal architecture both encouraged and impeded the development and allocation of new technologies in the fight against COVID-19—and provides lessons about how it might be better deployed for future pandemics. The chapter focuses on three key areas of innovation law: biopharmaceutical regulation, healthcare reimbursement, and government subsidies for research and development. The first part of this chapter discusses the need to coordinate government agencies in a public health emergency, especially as such coordination pertains to developing, validating, and distributing diagnostic tests. The second part counsels agencies to ensure that early access to therapies in a public health crisis does not obviate developers’ ability (or incentive) to generate robust information about such therapies’ safety and efficacy. The third relays lessons about the successes of incentives for COVID-19 vaccine development—and their failures for vaccine distribution. Addressing the flaws in U.S. biomedical innovation institutions that have been highlighted by COVID-19 will help avoid repeating these failures in the next pandemic.

Keywords: COVID-19, innovation policy, vaccines, FDA

Suggested Citation

Sachs, Rachel and Ouellette, Lisa Larrimore and Price II, William Nicholson and Sherkow, Jacob S., Innovation Law and COVID-19: Promoting Incentives and Access for New Healthcare Technologies (May 28, 2021). Forthcoming in I. Glenn Cohen, Abbe Gluck, Katherine Kraschel, & Carmel Shachar, COVID-19 and the Law: Disruption, Impact and Legacy. Cambridge University Press, 2022, Available at SSRN: https://ssrn.com/abstract=3855608

Rachel Sachs

Washington University in Saint Louis - School of Law ( email )

Campus Box 1120
St. Louis, MO 63130
United States

Lisa Larrimore Ouellette

Stanford Law School ( email )

559 Nathan Abbott Way
Stanford, CA 94305
United States

HOME PAGE: http://law.stanford.edu/directory/lisa-larrimore-ouellette/

William Nicholson Price II (Contact Author)

University of Michigan Law School ( email )

625 South State Street
Ann Arbor, MI 48109-1215
United States

Jacob S. Sherkow

University of Illinois College of Law ( email )

504 E. Pennsylvania Avenue
Champaign, IL 61820
United States

University of Illinois at Urbana-Champaign - Carl R. Woese Institute for Genomic Biology ( email )

Urbana, IL
United States

Center for Advanced Studies in Biomedical Innovation Law ( email )

Studiestraede 6
Studiestrade 6
Copenhagen, DK-1455
Denmark

HOME PAGE: http://jura.ku.dk/cebil/staff/

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