Law, Ethics, and COVID-19: An interview with I. Glenn Cohen

INTERVIEW BY MARK POLK

HHPR Editor Mark Polk interviewed I. Glenn Cohen, the James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics at Harvard Law School. Professor Cohen's responses were received April 22, 2021.

MP: Can you please introduce us to the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School? What role has it played throughout the pandemic?

GC: The Petrie-Flom Center is a leading research program dedicated to the unbiased legal and ethical analysis of pressing questions facing health policymakers, medical professionals, patients, families, and others who influence and are influenced by health care and the health care system.

As such, both the Center as a whole and its individual members have been doing quite a lot during COVID-19.

For example, I have written for the New York Times and JAMA on legal issues with ventilator allocation and reallocation early in the pandemic, for JAMA on digital health passes (aka “immunity passports”), for JAMA on digital smartphone tracking for COVID-19 (aka “digital contact tracing”), for JAMA on mask mandates, for STAT news on whether universities and employers can mandate vaccination, among other topics. I have also done a lot of media/commentary on topics like vaccine tourism, sharing vaccines with non-US countries, the design and operation of vaccine trials, allocation dilemmas during COVID-19, using facial recognition and drones as part of COVID-19 infection surveillance, the sharing of data with the public on COVID-19 and the concomitant privacy issues, retaliation against health care workers who have spoken out about lack of PPE, etc.

The Center has hosted dozens of virtual events to keep the public up-to-date on some of the most pressing issues we’ve faced during the pandemic, including disparate impacts on marginalized populations, PPE shortages, and ethical resource allocation. All of our events are recorded and captioned for the public to watch at their convenience on our YouTube channel.

Our blog, Bill of Health, is another outlet through which we share timely, thought-leading scholarship in an accessible format. Our coverage of the pandemic has anticipated key issues; for example, in November 2020, we highlighted the question of whether employers can mandate a vaccine under an emergency use authorization. In addition to our daily coverage of the pandemic, we’ve hosted focused digital symposia on issues including a comparative analysis of international responses to the pandemic and a look at how COVID-19 will affect the future of the health care workforce.

We have also collaborated with our friends at the Safra Center on some of their COVID-19 Response work, contributing to the white papers Securing Justice, Health, and Democracy against the COVID-19 Threat and Federalism Is an Asset. We’ve also co-hosted events with the Safra Center on pandemic resilience, and look forward to an upcoming co-hosted discussion on vaccine passports.

MP: The response to the COVID-19 pandemic has required not only biomedical innovation but also political and economic action. Can you please talk a bit about the interdisciplinary nature of our response to the pandemic and, perhaps, any lessons we might take away from it?

GC: As I said to some friends, for many in the US this is their first time viewing scientific discovery and policy development about public health in real time. Our knowledge and understanding about COVID-19 and what policy responses worked the best (and also which faced resistance by portions of the public) evolved on a daily basis this last year. We have constantly had to make decisions under conditions of uncertainty, and there have been many meta-debates about how to do that (the most recent ACIP pause on J & J is a great example where I saw great back and forths by many people I respect on opposite sides of the issue). Civil society groups have played an extremely important role – action by disability rights groups early on prompted changes to ventilator allocation plans in some states. The U.S. Supreme Court, through its so-called “shadow docket” (orders in cases that are not up for argument, like lifting or imposing a stay, for example), has had a major impact, especially where general public health rules for COVID-19 has butted up against religious worship. And sadly many aspects of public health in the United States – from masks to vaccines – have become subject to partisan divides. While there has always been a strand of partisanship in public health law related to non-communicable diseases – smoking, seatbelt and helmet laws, etc. – that has been amplified and applied to communicable diseases in a way that saddens me.

MP: Several universities will require that students receive the COVID-19 vaccine prior to returning to in-person learning. What challenges, if any, could universities face in instituting and enforcing such policies? How might these policies be treated the same as or differently than existing vaccination requirements?

GC: While I think colleges universities may face legal challenges, as a matter of federal law I don’t think those lawsuits against them will succeed for the reasons I have written about with others here and here. That is, universities can require vaccination for students so long as they provide appropriate accommodations for individuals with disabilities, and perhaps accommodations for those with religious conflicts as well, though we may see some litigation about exactly how far they have to go in those accommodations to act lawfully. The strongest contrary argument, in my opinion, misreads the underlying statute that allowed FDA to authorize the COVID-19 vaccines as an EUA. As we put it in STAT news

“The legal argument is that the law setting out the requirements for emergency use authorization contains language requiring the Secretary of Health and Human Services to ensure that people know they can refuse or accept the vaccine. The same language requires the informational materials accompanying EUA vaccines to tell people that “It is your choice to receive” the relevant vaccine. . . . [The argument fails because] the EUA statute says nothing directed at employers or universities. Instead, it addresses the actions of federal officials, such as the HHS secretary and the president — not private actors. Private employees are generally “at will,” meaning they can be terminated for any reason that is not explicitly illegal. Those arguing that the EUA statute prohibits mandates by at-will employers are claiming that this federal law is changing existing state employment law on the topic by mere implication. They are reading in a broad prohibition covering all employers and universities in the U.S. that is not, in fact, in the statute. Such broad preemption would require, at a minimum, clearer language.”

This is the position the Federal Equal Employment Opportunity Commission has taken in its reading of the statute by announcing that employers can mandate vaccination. The contrary argument would also suggest that employers or universities who in the past year required someone to be tested for COVID-19 as a precondition to being at a job or on campus would have violated the law, since most of those tests are also authorized under an EUA, which seems implausible to me.

I said “as a matter of state law” because some states, such as Florida, have tried by action of the Governor to prohibit such mandates, at least for businesses (which may include colleges and universities). The federal government could try to preempt those state moves but the signals of the Biden administration is that they do not want to touch the issue of so-called “vaccine passports” or mandates directly, so I would not hold my breath. So, in states where the governor or legislature has not intervened, my view is that universities may lawfully require vaccination as a condition of return to campus, with an obligation to offer reasonable accommodations. How many will? It started off slowly with Rutgers going first, but it has been picking up speed with Yale, Columbia, Princeton, Brown, Cornell, NYU, Duke, Northeastern, and many more all stating they will require student vaccination. It will be interesting to see how many more follow and how faculty and staff react in universities that do not adopt these measures.

MP: With the federal government declining to develop and institute vaccine passports, it seems that state governments and the private sector will fill the void. What kind of regulation might these vaccine passports be subject to, if any, especially in terms of the data they generate on their users?

GC: The short answer is there is relatively little regulation that stands in the way. The use of a “vaccine passport” – and I much prefer the term “digital health pass” since these are not going to be limited to passports to cross borders and I think are much more akin to licensing that is calibrated to a particular activity, like an occupational or driver license – is unlikely to violate HIPAA, the law that provides most of the federal protection of health. If the information that is recorded is merely did you get a vaccine, when, and what vaccine, that’s typically not the most sensitive type of information. Indeed, one nice thing about having a single central repository for that information is it avoids individual employers making inquiries as to the status of individual employees, which might cross the line into a disability related inquiry under the ADA. So there is a way we can view this as “data minimization,” a good principle of data ethics: collect the minimum you can in terms of data about people.

What I have said above about the need for accommodations continues to apply. As I also mentioned there are some states that have essentially prohibited reliance on these digital health passes, places like Florida. In the case of unionized work forces labor law may also be implicated, though I haven’t seen much on this. So it is largely going to be a decision left to individual employers, universities, etc., though in some states like NY (which has rolled out the excelsior pass system) the state itself will facilitate the building of the passport network.

I completely understand the politics of why the Biden administration does not want to embroil itself in the vaccine passport issue, which is turning into a bit of a culture war skirmish, but it is unfortunate that as a result we are going to likely end up with a large number of separate overlapping vaccine passport systems. Ideally, it would be great to have a single, very well designed system that was usable by everyone and could be maintained at the highest level of cyber security and had the best protections against faking vaccination proof, etc. That doesn’t seem likely to happen. And that is too bad. It also means we may lose one great positive about these passports that is not their main design function – the ability to better monitor vaccine durability. We currently don’t know how long vaccinated COVID protection will last and if the answer will be different among different vaccines. A single coordinated database on the day everyone was vaccinated and with what vaccine would facilitate that kind of data gathering.

MP: Although the COVID-19 vaccine has given us a glimpse at a possible return to normalcy, much work lies ahead. Can you please talk a bit about the challenges—again, from a legal, regulatory, or ethical perspective—that we still face?

GC: I think there are a lot of challenges ahead of us in the U.S. While public health folks like to talk about the “dimmer switch” and a gradual return to normalcy that can be reset if there are outbreaks, in reality we have seen instead rapid cycles between heavy and no restrictions in many U.S. settings. That is unfortunate. If we find ourselves 6 months from now with a variant with significant vaccine breakthrough, I think it will be increasingly hard to get enacted stay at home or other restrictive orders. That is unfortunate but I think that is just the political reality. As we reopen there will also be questions about liability for infections at an employment site – will employers be found liable if they reopen without following best practices, for example? Then there are questions of what we will do if the voluntary vaccination rate in this country hits a ceiling below what is needed for herd immunity. To what extent will employers or states be willing to enact mandates that condition access to certain spaces on being vaccinated? I am not sure. Then there is the possibility of needing booster shots and how that will be financed, rolled out, etc.

As bad as these challenges are they are nothing compared to those facing LMICs. Last I checked there were about 70 countries that had undertaken zero vaccinations. In many others the pace is very slow because of undersupply. It has become clear to me that countries that have a lot of supply like the U.S. are unlikely to share much of that supply until they have reached high levels of vaccination in their own country. I understand the political impulse, but as a matter of global justice this is horrific – future generations will, I think, look at the number of preventable deaths we forewent by not facilitating more equitable sharing of vaccines between countries in the name of politics and be repulsed by us. The Biden administration, through COVAX and other measures, is doing better, but better is not enough. Even from a naked national self-interest perspective I am unsure whether in retrospect the “America first” for vaccination approach will be viewed as the right decision. We live in a deeply economically interconnected world, and when the world closes up and suffers the US does as well.

Some of the initiatives like vaccine passports may sadly exacerbate some of these inequalities. My own view is that any attempt to impose vaccine passports as a precondition to travel to the US (I think of my many students abroad) has to be combined with a measurable meaningful commitment to share vaccine doses we have produced and “grow the pie” through tech transfer and other mechanisms. But I have little faith we will get there.

MP: Is there anything else you would like to add?

GC: One last reflection is on the way in which COVID-19 has shed a light for non-experts on the way race, vulnerability, and social determinants deeply affect health. I can’t quite tell if this theme would be quite so prominent if COVID-19 had not emerged simultaneously with the call to action that was catalyzed with the killing of George Floyd – perhaps we would be as attentive to these issues within health even without that horrific episode in this nation’s history, but I see positive movement in the acknowledgement of the systematic nature of the problems in health care and I do hope this is one of COVID-19’s few positive legacies.