The Race for a COVID-19 Vaccine: Legal Issues at Play
07/23/2020
Prof. Ana Santos Rutschman weighs in.
"The COVID-19 pandemic will almost certainly be the event 2020 will be remembered by. In my work for both the Center for Health Law Studies and the Center for International and Comparative Law, I have been monitoring the COVID-19 vaccine race since January.
I specialize in issues at the intersection of health law and intellectual property, and for years now I have been working on analysis related to vaccine development, approval and commercialization.
In this piece, I will outline some of these issues that have particular legal and policy salience for our collective approach to both short-term and long-term preparedness for future outbreaks of infectious diseases.
First, there is the sheer speed at which vaccine research and development is occurring 鈥� and for that matter, the development of drugs and treatments for COVID-19. This compression of research and development (R&D) timelines for vaccines is very unusual.
Throughout the outbreak, I have been advising producers at Netflix and Showtime on documentaries about the ongoing vaccine race. The number one question I get is how quickly can we get a vaccine to those who need it, and what is the role of the law in this process?
Questions about the timeline of a COVID-19 vaccine have been notoriously tricky to address. From a scientific perspective, vaccine development, testing and manufacturing normally occur over the arc of many years, sometimes even decades. Dr. Fauci has repeatedly pointed out that even with the unusual number of resources focused on COVID-19 research, it will take more than a few months for a vaccine to come to market. But there are already legal mechanisms at play to pave the way for that day.
Regulatory Questions
On the regulatory side of things, the Food and Drug Administration has been issuing emergency use authorizations (EUAs), which allow for unapproved medical products (or unapproved uses of approved medical products) to occur during a public health crisis. The standard for EUAs is significantly lower than the usual standards for regulatory review.
And this is where we begin treading into uncharted waters: there has been enormous pressure for regulators to streamline approval processes where COVID-19 technology is concerned, but the FDA normally does not issue EUAs for vaccines. The only exception occurred with an anthrax vaccine in the mid-2000s, but it was an authorization for expanded use of an already approved vaccine. The FDA has never granted an EUA for an unapproved vaccine because this is a particular form of technology: vaccines are administered to healthy people, so it is very hard to extract any information about efficacy of a vaccine candidate unless it is administered to high-risk populations.
While normally an EUA is a mechanism to expedite drug R&D, in the case of COVID-19 vaccines it might actually be counterproductive for one to be issued, at least during the early stages of clinical trials: scientists would be unable to pinpoint exactly how well or how poorly a given vaccine would be working. In other words, an EUA here would lead to pointless data, and if a vaccine was subsequently approved by the FDA, it might not actually protect people who need it. The solution? Consider a vaccine EUA only after vaccine candidates are tested on first-responders or other healthcare workers, while making sure that science-informed policy continues to be upheld at the FDA.
Intellectual Property Law
Bringing vaccines to market also has an intellectual property dimension to it. Vaccines consist of an amalgamation of different technologies, from viral matter to stabilizers, adjuvants, delivery devices and methods, to name a few. Many of these components are patented. The good news here is that, unlike in other areas, we do not expect a patent war surrounding COVID-19 vaccine technology: in this sense, the law is unlikely to constitute a barrier to expedited technology transfer among companies and vaccine licensure.
Nevertheless, patents do give rightsholders the ability to charge supra-competitive prices for their products. Given the United States鈥� lack of price controls for biopharmaceutical products, the affordability of drugs needed by large swaths of the population 鈥� even in the context of public health crises 鈥� has long posed problems to our healthcare system. Early on in the COVID-19 pandemic, the Secretary of Health and Human Services, Alex Azar, stated that there is no way to guarantee that COVID-19 vaccines will be priced affordably.
Yet, this is not necessarily true. First, patent law has built-in mechanisms that allow the government to intervene. In the case of federally funded inventions, the Bayh-Dole Act has given funding agencies march-in rights 鈥� the ability to grant non-exclusive licenses to non-patentees if rightsholders are not able to meet health needs. Second, the Defense Production Act allows the government to compel production of different medical technologies, including vaccines. And third, international laws the United States is subject to (the TRIPS Agreement as amended in 2017) allow for compulsory licensing of biopharmaceutical products, including patented vaccines. Early on in the pandemic, many countries 鈥� from Canada to France, Germany and Israel 鈥� changed their laws to make compulsory licensing procedurally less cumbersome (and therefore faster) than under international standards.
Next Steps
While the U.S. legal and regulatory structure poses challenges in bringing COVID-19 vaccines to market, in the coming months we have a limited window of opportunity to get the licensure of emerging vaccines right. This entails expediting FDA approval without compromising the efficacy of these vaccines, as well as pricing them affordably. Ultimately, however, we will also need to spend time considering how to improve our FDA and intellectual property laws before the next outbreak of an infectious disease occurs.
This fall, 91女神 LAW students will be spending a lot of time pondering these issues in Emerging Health Technologies: Innovation, Law and Policy, a seminar I teach that is part of the health law concentration curriculum. And it is my hope that one day they will be helping our legal system respond better to the many challenges posed by pandemics and epidemics."
About Emerging Health Technologies: Innovation, Law and Policy
This seminar explores the ways in which law and policy shape innovation in biomedical
technologies. Students first examine the role of tools including patents, market exclusivity,
grants and prizes in spurring the production, transfer and dissemination of new technologies.
Then they look at roles of institutions supporting basic scientific research, such
as the NIH, the Gates Foundation, Google and NASA. Finally, the seminar turns to discrete
topics in biomedical innovation: the landscape surrounding the development of oncology
drugs, gene therapies, precision medicine, and wearable medical devices, among others.
Students also gain in-depth knowledge of evolving controversies in emerging areas
such as drug price gouging, the development of cancer vaccines, regulation of medical
3D printing and alternative systems for fighting antibiotic resistance.
The seminar always features a guest speaker; past speakers have included the leading
U.S. scholar on gene editing (CRISPR) technology and a practitioner specializing in
artificial intelligence in health care.
Prof. Ana Santos Rutschman鈥檚 vision for this seminar is simple: 鈥渟tudying the technologies of tomorrow, today.鈥� The course enhances the health law curriculum by connecting core health law themes, such as access to medicines, to different areas in technology and policy, from intellectual property to data protection and antitrust.
The fall 2020 semester will be the third time Santos Rutschman teaches this seminar at 91女神 LAW.