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COVID-19: Beyond Tomorrow
May 6, 2020

The Ethics of COVID-19 Immunity-Based Licenses (“Immunity Passports”)

Author Affiliations
  • 1Sturm College of Law, University of Denver, Denver, Colorado
  • 2Department of Medical Ethics and Health Policy, Perelman School of Medicine, Department of Healthcare Management, The Wharton School, University of Pennsylvania, Philadelphia
JAMA. 2020;323(22):2241-2242. doi:10.1001/jama.2020.8102

Chile, Germany, and the UK, among others, have indicated they will implement certifications that a person has contracted and recovered from coronavirus disease 2019 (COVID-19) or, in the future, has received a COVID-19 vaccine. Such policies have been discussed, but not implemented, in the US. However, if other countries require these certifications for entrance, the US may adopt them to enable travel, generating calls to use them more broadly.

Certifications of immunity are sometimes called “immunity passports” but are better conceptualized as immunity-based licenses. Such policies raise important questions about fairness, stigma, and counterproductive incentives but could also further individual freedom and improve public health.

Immunity licenses should not be evaluated against a baseline of normalcy, ie, uninfected free movement. Rather, they should be compared to the alternatives of enforcing strict public health restrictions for many months or permitting activities that could spread infection, both of which exacerbate inequalities and impose serious burdens. This Viewpoint presents a framework for analyzing the ethics of immunity licenses.

Liberty, Immunity-Based Licenses, and the Least Restrictive Alternative

The ethical values of liberty and autonomy support a presumption that policies should consider immunity to COVID-19 (eTable 1 in the Supplement). This may seem counterintuitive because people who are not immune may have their liberty limited if they hold certain jobs or travel to certain places that require a license. However, public health is committed to protecting liberty and autonomy through the principle of the “least restrictive alternative,”1 which proscribes measures more restrictive than necessary to achieve public health objectives. In other words, people must be allowed to pursue their life plans unless doing so is incompatible with public health.

The least restrictive alternative principle supports using COVID-19 immunity licenses if available. Current liberty-limiting restrictions on gatherings, work, and travel are justified because infected people may be harmed or die and may harm others by spreading disease or overburdening hospitals. But they are not justified when applied to people at little or no risk of infection. The principle of the least restrictive alternative supports giving people a chance to show that they are immune.

How might individuals be given the opportunity to demonstrate immunity? Driver’s and pilot’s licenses and similar policies suggest a way forward. Rather than banning risky activities, licensing permits people to participate in these activities but only after evidence of safety, such as through competency tests, has been demonstrated. The same could be true for immunity and risky activities during the COVID-19 pandemic.

The term “immunity-based licenses” is better than “immunity passports.” Passports suggest an all-or-nothing permission and endorse categorical denial of access to an entire country. In contrast, licensing requirements are more stringent for drivers of school buses or airplane pilots than for drivers of cars, and are more restrictive for younger drivers or those with conditions that may impair driving. Importantly, these restrictions are ethical and legal even when a person’s higher risk or inability to pass a test is outside their control, as with drivers who are visually impaired or have epilepsy. By analogy, in the setting of COVID-19, immunity-based licenses could apply to specific, high-risk activities, such as working in a nursing home, and could permit exceptions and gradations.

The ethical case for immunity-based licenses can be buttressed by working to ensure that licenses do not exacerbate inequality. Driver’s license fees unfairly burden lower-income individuals, and transportation for those unable to drive is often inadequate. In contrast, ethically sound immunity licensing policies would reject license fees and would ensure that unlicensed people are not subject to social or economic exclusion, “banned from entering grocery stores, using public services, or traveling,” or “confined to their homes for an indefinite period of time.”2 Activities currently permitted under public health orders, like walking outdoors, driving, interacting with household members, and shopping or working remotely or at businesses like grocery stores, should not require immunity licenses. The list of activities that require licenses should change in response to public health needs, as the least restrictive alternative principle requires.

Immunity-Based Licenses and Ethical Values

The ethics of COVID-19 immunity licenses can be assessed with respect to 3 fundamental ethical values: the maximization of benefit; priority to the least advantaged; and treating people equally (eTable 1 in the Supplement).3 These values can be consistent with a well-designed implementation of immunity licenses.

First, immunity licenses could maximize benefits by safely enabling patronage of bars and restaurants and in-person attendance of cultural, worship, and sporting events. Permitting these activities without risking infection would increase tax revenues, which could be earmarked to fund COVID-19 response, and reduce social harms caused by unemployment and isolation.

Second, immunity licenses can be consistent with priority to the least advantaged, that is, people who are medically, socially, or economically vulnerable. Under strict public health restrictions, no one would be able to perform in-person social and economic activities. Conversely, if some activities are made conditional on licensure, only people who lack immunity licenses may be disadvantaged in comparison to others. Generally, society avoids policies that “level down”: bringing every person down to the least advantaged position does not solve the problem of disadvantage.4 Meanwhile, although workers with immunity licenses might receive offers so lucrative they would be difficult to refuse, generous offers are not coercive.5 Further, all workers, including the immune, would retain legal protections against being coerced to work.

More important, just as the work of licensed truckers benefits those unable to drive, the increased safety and economic activity enabled by immunity licenses would benefit the unlicensed. For instance, preferentially hiring immune individuals in nursing homes or as home health workers could reduce the spread of the virus in those facilities and better protect the people most vulnerable to COVID-19. Friends, relatives, and clergy who are immune could visit patients in hospitals and nursing homes.

A third consideration, indeed a major concern, is that immunity licensing might seem to stigmatize people, undermining the value of equal treatment. Are immunity-based licenses like the yellow stars Nazis forced Jews to wear? Will they “split communities in two”2 and stigmatize those without immunity? The yellow star and similar forms of invidious discrimination divided people based on race, religion, or heritage: all factors that should be irrelevant to social participation. In contrast, vulnerability to COVID-19 is a factor that public health policy already legitimately considers. Any inequalities produced by immunity licenses would not be invidious and would serve the interests of public health and of the disadvantaged. Importantly, refusing to create a regulated licensing program will not avoid stigma and inequality. In the absence of licensing, businesses and individuals may instead elect to use unregulated evidence of immunity, such as test results, or to use assumptions about immunity or vulnerability that are likely to be arbitrary and biased.

Practical Challenges in Implementation

COVID-19 immunity licenses can be ethical in principle but in practice depend on 4 important questions related to both the actual evidence and effective implementation (eTable 2 in the Supplement). First, serology tests used to determine whether someone has had COVID-19 for licensing purposes must be valid and reliable, with high specificity and sensitivity. This requires a governmental body, such as the FDA, to establish and impose valid, evidence-based certification procedures. Immunity-based licenses can only be introduced if serology testing is accurate. In addition, depending on rigorous evidence regarding the duration of immunity, periodic testing and renewal of immunity licenses at designated intervals based on specific criteria may be necessary, similar to the renewal process for driver’s licenses.

Second, immunity-based licensing requires evidence that a positive serology test result indicates immunity. Otherwise, licenses could cause more harm than good by creating a false sense of immunity and facilitating spread. As research into immunity progresses, a guiding principle will be that no certification or test is perfect. Some licensed drivers drive dangerously and some unlicensed ones drive safely, but licensing improves overall safety. A similar trend would likely exist for immunity licenses.

Third, in the absence of a vaccine, the benefits of licenses might encourage uninfected people to relax protective measures or actively seek infection. This is analogous to parents organizing parties to intentionally infect their children with varicella, despite the potential for the very small risk of brain damage or death from infection. Although this incentive exists to some extent even without licensing, it is a concern that must be weighed against the benefits of licensing. It is difficult to completely prevent, particularly in a society that values individual autonomy. One strategy for mitigating this incentive could be to offer licenses first or only to people likely to encounter infection in any event, such as health care workers. Another approach could be to first license members of lower-risk groups, such as university students, who are not being asked to take as many personal protective measures. Yet another approach could be to focus licensing on high-risk groups who are less likely to voluntarily seek infection. A final option might be to have license applicants self-attest that they did not intentionally become infected. These mitigation strategies could be phased in or out depending on whether there is actual evidence that this incentive is producing undesirable outcomes.

Fourth, the benefits of immunity licenses could encourage forgery, illegal markets, or fraud by unethical physicians or testing facilities. These problems underscore the need for careful implementation through strategies like anticounterfeiting designs, cryptographic or biometric features, and reliable chains of verification for tests. But they do not vitiate the advantages of licensing. The possibility of bribed examiners or forged documents has not undermined driver’s licenses and passports.

Conclusions

Immunity-based licenses have the potential to help realize important values, including enhancing the liberty of individuals who have been infected with COVID-19 without worsening the situation of those who have not been infected, maximizing benefits to individuals and society by allowing immune people to engage in economic activity, and protecting the least advantaged by allowing safer care for vulnerable populations. Importantly, immunity-based licenses do not violate equal treatment because the factors used to grant a license are not discriminatory, like race or religion, but instead grounded in relevant evidence. While immunity-based licenses require careful implementation and scientific support to be ethical in practice, nothing makes them unethical in principle.

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Article Information

Corresponding Author: Ezekiel J. Emanuel, MD, PhD, Department Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Blockley Hall, Ste 1412, Philadelphia, PA 19104 (MEHPchair@upenn.edu).

Published Online: May 6, 2020. doi:10.1001/jama.2020.8102

Conflict of Interest Disclosures: Dr Persad reported receiving grants from The Greenwall Foundation. Dr Emanuel reported receiving speaking fees from numerous entities, stock ownership in Nuna, investment partnership in Oak HC/FT, and receipt of grants from Hawaii Medical Service Association and Oscar Health.

References
1.
Childress  JF, Faden  RR, Gaare  RD,  et al.  Public health ethics: mapping the terrain.   J Law Med Ethics. 2002;30(2):170-178.PubMedGoogle ScholarCrossref
2.
Mullin  E. “Immunity passports” could create a new category of privilege: being infected with the virus could come with more freedom. OneZero. Published April 23, 2020. Accessed April 30, 2020. https://onezero.medium.com/immunity-passports-could-create-a-new-category-of-privilege-2f70ce1b905
3.
Emanuel  EJ, Persad  G, Upshur  R,  et al.  Fair allocation of scarce medical resources in the time of Covid-19.   N Engl J Med. Published online March 23, 2020. doi:10.1056/NEJMsb2005114PubMedGoogle Scholar
4.
Parfit  D.  Equality and priority.   Ratio. 1997;10(3):202-221. doi:10.1111/1467-9329.00041Google ScholarCrossref
5.
Hawkins  JS, Emanuel  EJ.  Clarifying confusions about coercion.   Hastings Cent Rep. 2005;35(5):16-19. PubMedGoogle Scholar
6 Comments for this article
EXPAND ALL
COVID-19 Immunity Testing would be an Unmitigated Disaster
Michael Hoffer, MD | University of Miami, Miller School of Medicine
We appreciate the views of Dr. Persad and Emanuel and their thorough examination of this topic, but have grave concerns they did not reach a more firm conclusion that this licensing would be a grave mistake.

The authors acknowledge that there needs to be more science to determine if antibody testing provides immunity but don't give full weight to the volume of science that would need to be done. 1) It would have to be established what amount of antibody confers immunity, 2) the world would need to switch entirely to costly antibody titer testing rather
than simple point of care ELISAs, and 3) the permanency of immunity would need to be established, likely requiring re-issue of the license every three months.

In addition, the authors point out that restrictions based on immune protection have been used before. They do not acknowledge that such restrictions are travel-only restrictions and most often apply to immunizations that provide long-term protection (e.g. yellow fever), and that these restrictions have never been used in the U.S. or the world to restrict other activities such as employment, access to restaurants, theaters, and entertainment, or ability to socialize. The authors do not feel that people would intentionally infect themselves but do not consider the tremendous incentive that employment would present. Individuals would have to make the choice or getting infected and then being able to work or losing their job. The consequences of forcing this choice are disastrous (at best).

Finally, the authors never consider some emerging immunity algorithms which propose that other immune mechanisms as well as haplotype play a huge roll in disease susceptibility and lethality. Until these issues are fully understood it would be unwise to pursue any licensing since the most immune and least susceptible individuals may actually be those with antibodies.

In a society where leaders are often too desperate to reach for and then publicize "solutions" it is critical that science unequivocally state that this type of licensing while not unethical is potentially the most disastrous and divisive option and that implementation requires overcoming a host of very significant obstacles the list or which exceeds what this article presents.

We appreciate that the article was examining ethics but feel it is important for this journal and the AMA to state that firmly that even if ethically sound - this policy is scientifically, medically, and socially disastrously flawed.
CONFLICT OF INTEREST: None Reported
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Additional Challenges: Licensing Costs and Assumptions
Patrick Ng, MBA, MPH | The New School for Leadership in Healthcare, Koo Foundation Sun Yat-Sen Cancer Center
Drs. Persad and Emanuel offer an interesting ethical perspective on immunity-based licenses; however, there are numerous dilemmas that result from this proposed initiative:

1. Even if governments were to waive license fees, would they waive the cost of testing as well since test results are needed to determine license eligibility? If not, it would be socially and economically restrictive to disadvantaged populations.

2. Licensing requires re-certification after a predetermined length of time. Since COVID-19 is new, immunity might be found to be short-lived. Would the cost associated with issuing a license be better spent elsewhere?

3.
Determining immunity requires drawing blood and testing for antibodies. Privacy guarantees would need to limit its analysis. What are the ethical considerations if governments were the ones analyzing and storing the samples and potential privacy concerns?

4. The virus can survive on surfaces for some time as seen in recent studies. Even if workers with immunity licenses worked in high-risk environments, what are the ethical considerations for these workers becoming asymptomatic carriers or bringing fomites to friends and family who are not immune?

An immunity license assumes there will be no vaccine in the future. Governments will have to weigh the timing and possibility of these scenarios.
CONFLICT OF INTEREST: None Reported
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There's no comparison.
Rafael Oliveira, Physical Therapist | USJT
There's no way to compare Covid-19 with a driver's license. We can use public transport, walk, ride a bike, or Uber if we have not driver's license.
CONFLICT OF INTEREST: None Reported
Great Concern for Program
Drew Perkins, Bach. of Science | Concerned Citizen
You wrote that “people must be allowed to pursue their life plans unless doing so is incompatible with public health." The article you cited writes that “government has a unique role in public health because of its responsibility, grounded in its police powers, to protect the public’s health and welfare, because it alone can undertake certain interventions…that cannot be optimally provided if left to individuals or small groups.” (Public Health Ethics: Mapping the Terrain 2002). Someone might read into this that government is the only institution that knows what is best for the individual.

The security vs. freedom/liberty
debate has been ongoing. “Public health is primarily concerned with the health of the entire population, rather than the health of individuals” (Public Health Ethics: Mapping the Terrain 2002). Democracy is also a living entity, a ‘government by the people’ (Merriam-Webster). If it is not cared for, it also runs the risk of infection or death.

Throughout history, many pandemics have come and gone, raging warfare on mankind, killing millions and millions. Why this and why now?

“The least restrictive alternative principle supports using Covid-19 immunity licenses if available”. Why, because now we have the technology to track almost everyone on the planet? "Current liberty-limiting restrictions on gatherings, work, and travel are justified because infected people may be harmed or die and may harm others by spreading disease or overburdening hospitals.” Again, why now? Influenza has plagued the world for decades. We have a vaccine program for influenza and we still have people die at alarming rates. I have never seen a complete shutdown of our economy due to influenza, not since the severe pandemic of 1918. The National Strategy for Pandemic Influenza (November 2005) reports “Pandemics have occurred intermittently over centuries. The last three pandemics, in 1918, 1957 and 1968, killed approximately 40 million, 2 million and 1 million people worldwide, respectively.” This report came out in 2005, after SARS 2002-04, but before MERS 2012. Under the three pillars of the National Strategy, it lists: 1) Preparedness and Communication, 2) Surveillance and Detection, and 3) Response and Containment. Number one is addressed by the vast fear that our media has dispersed. Number two failed due to China not being more forthcoming with information about the Covid-19 virus allowing it to spread worldwide. Number three is where our current topic falls.

The idea of “immunity-based licenses” becomes a slippery slope. Once an “immunity-based license” has been developed, this opens Pandora’s box to many other illnesses and conditions that may limit a person’s civil liberties and opportunities. If a patient is required to list their infections, conditions, and underlying diseases, this may be used against them in many different situations and capacities.

As of today, the WorldOMeter has worldwide deaths of nearly 278,000 with over 4 million cases.  One can argue the accuracy of both those numbers because of many factors, but this is the data that is current. The CDC, in a December 13, 2017 press release entitled ‘Seasonal flu death estimate increases worldwide,’ states: “According to new estimates published today, between 291,000 and 646,000 people worldwide die from seasonal influenza-related respiratory illness each year, higher that a previous estimate of 250,000 to 500,000 and based on a robust, multinational survey.” Again, I pose the question, Why this and who now?

And what next time...
CONFLICT OF INTEREST: None Reported
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Immunity Ledger
Mazen Khalil, Bachelor |
Great article. We at Immunity Ledger are working on that direction. We are establishing a non-profit global network for the purpose of storing and verifying individuals' immunity in view of different regulations and security measurements.

https://www.immunityledger.org
CONFLICT OF INTEREST: None Reported
This Must be Challenged
Phillip Shaffer, MD | Riverside Methodist Hospital
The authors feel it is entirely warranted to restrict our liberties to halt the spread of disease. But they do not suggest any limits on this. At the extremes, one might agree with them. An exceedingly virulent disease as transmissible as varicella (chicken pox), combined with a fatality rate similar to rabies, nearly 100%, would call for very extreme measures. However, for a disease like influenza, our society has, by demonstrated inaction, decided no such measures are appropriate.

They advocate restricting liberties for those who have never been infected. That would be 99.6% of the US population. />
They do say that people must be allowed to pursue their life plans unless doing so is incompatible with public health. They do not define their terms. We really don’t know how far this proposal will extend. Does it mean for instance, that if one person may die next month, that 327,000,000 of us must endure virtual house arrest?They don't say that explicitly, of course, but that is where their ideas could lead.

Further: “immunity licenses could maximize benefits by safely enabling patronage of bars and restaurants and in-person attendance of cultural, worship, and sporting events.” They do not say explicitly the converse, but it is obvious – if you are not immune, they want the power to restrict you from these activities. They seem to feel they are being very generous “if some activities are made conditional on licensure, only people who lack immunity licenses may be disadvantaged in comparison to others.”

As of this date 5/10/20, 1,341,396 have been confirmed positive. Which means 326,858,604 Americans have not. This is the number that the word “only” applies to. By their proposal, 1.3 million would have their freedoms restored, and 326 million would continue to be under government lockdown. Ironically, those of us who have been careful and have not been infected will be the targets for enforcement. How fair or ethical is that?

But it is actually worse: outside of New York and New Jersey, there have been 43,962 deaths . The disease has had a death rate of 0.00015%. For this microscopic risk, they wish to dictate what freedoms 300 million people may have.

Due to my age, I have roughly a 5% chance of dying of cancer or cardiovascular disease in the next 10 year. A 0.00015% chance of dying of Covid doesn't scare me. And if it did, well, I can move to Wyoming or Alaska (total 17 deaths).

These authors want us to know they are being "ethical", thereby trying to immunize themselves from criticism. There is nothing ethical at all about restricting American freedoms for such slight risk. Any real discussion of the ethics of such a proposal must also include the potential for abuse. There is obviously unlimited potential for abuse in this proposal, but it is not mentioned at all.
CONFLICT OF INTEREST: None Reported
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