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

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