Every Minute Matters: Improving the Regulatory Response to Vaccine Development During a Public Health Emergency
In recent months, our lives have been turned upside down by the novel coronavirus (COVID-19) emergency. With no cure or vaccine in sight, millions of people have contracted the virus, and the death toll has surpassed that of World War I in a fraction of the time. In fact, the past decade has been marked by a series of highly publicized public health emergencies, including the devastating Ebola and Zika virus global outbreaks. Some of this panic arose from a failure to manufacture and distribute vaccines in a timely fashion. This failure occurred despite having several viable vaccine candidates, adequate funding, and strong public support for the vaccines. This Article explains how these failures are the consequence of a complex network of existing regulatory pathways and insufficient incentives to produce affordable vaccinations during a public health emergency. Fortunately, there are several ways that both the U.S. Patent and Trademark Office and the U.S. Food and Drug Administration can improve and streamline the process of patenting, approving, manufacturing, and distributing a vaccination. The last decade has demonstrated that public health emergencies occur quickly, and affected communities cannot afford the delays and mishaps that characterized the vaccine response to COVID-19, Ebola, and Zika.
This Article explores three ways to facilitate the development and distribution of vaccinations during a public health emergency. First, the U.S. Patent and Trademark Office can establish a dedicated public health emergency patent pathway for vaccine technology developed specifically in response to a public health emergency. Second, the U.S. Food and Drug Administration can better process investigational new drug applications filed for qualifying vaccines by revising its Qualified Infectious Disease Product pathway to include biologics and by providing targeted incentives for qualifying applications that reduce some of the financial burdens of providing vaccinations at low cost. Finally, Congress can pass legislation allowing for the issuance of a compulsory license to manufacture and distribute the vaccination, if vaccine developers and manufacturers are unable to independently agree on a licensing transaction that will be financially feasible for the targeted population and for all parties involved. With improved regulatory pathways developed in advance of the next public health emergency, researchers and manufacturers will be better positioned to develop and distribute vaccines to affected communities in time for them to be effective.
Food and Drug Law Journal
Volume 75, Number 2