Fast-Tracking Development of Medical Products and Vaccines

Concurrent Session Block 4: 1:15 – 2:15 p.m. ET Thursday, September 17

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Presentations

Expanding Access to Patents for COVID-19
Two competing sets of goals—static and dynamic— must be addressed when considering patent policy in response to a public health emergency. Static considerations relate to the allocation of existing resources among potential users, while dynamic considerations relate to the creation of new technologies over time. In the case of COVID-19 response, allocative goals, particularly satisfying demand for patented medical products in the field (e.g., ventilators, PPE and test kits), may be achieved through governmental interventions. But in cases involving the development of new technologies such as vaccines, inventive structures must be preserved to ensure that the private sector is appropriately motivated to contribute. This session will discuss why it is critical that policy makers consider both static allocative issues and dynamic innovation issues during a public health crises.

  • Jorge L. Contreras, J.D., Presidential Scholar and Professor of Law, University of Utah S.J. Quinney College of Law; Adjunct Professor, Department of Human Genetics, University of Utah School of Medicine

Drug and Vaccine Development and Access
In response to the COVID-19 pandemic, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional approval mechanisms and offer pre-approval access under the expanded access or right to try pathways. In a public health emergency, like Covid-19, an additional mechanism is also available: the Emergency Use Authorization (EUA) pathway. This session will assess how the FDA has used its EUA authorities for Covid-19 drugs to date, and will examine how the FDA has balanced the need for robust evidence of safety and effectiveness for Covid-19 pharmaceuticals against the urgent need to speed patients’ access amid the clinical and political realities of the pandemic, and will highlight considerations specific to vaccines should FDA be faced with a request to issue an EUA for a Covid-19 vaccine. The session will conclude with recommendations for policymakers and regulators at the federal and state levels.

  • Patricia J. Zettler, JD, Moritz College of Law and The James Comprehensive Cancer Center, The Ohio State University
  • Micah L. Berman, JD, College of Public Health, Moritz College of Law, and The James Comprehensive Cancer Center, The Ohio State University
  • Efthimios Parasidis, JD, MBE, The Ohio State University Moritz College of Law and College of Public Health