Govind Persad

In this commentary, I suggest expanding the deliberative aspects of critical care policy development in two ways. First, critical-care policy development should expand the scope of deliberation by leaving fewer issues up to expertise or private choice. For instance. it should allow deliberation about the relevance of age, disability, social position, and psychological well-being to allocation decisions. Second, it should broaden both the set of costs considered and the set of stakeholders represented in the deliberative process. In particular, it should consider efforts to reduce the cost of end-of-life care and to redirect resources away from the provision of costly interventions, and should expand the set of individuals included in deliberation to include stakeholders outside the health-care system.

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA’s provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions. First, I argue that the ACA is neither uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality. Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the health care system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy). Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry.

Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, and health policy discuss if age should guide rationing decisions.

By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the single-dose Johnson & Johnson vaccine, the FDA permitted a single booster dose for all adults aged 18 or older. These eligibility schemes were endorsed by the Centers for Disease Control and Prevention shortly after FDA approval.

Our Viewpoint argues that expanding access to less effective or more toxic treatments is supported not only by utilitarian ethical reasoning but also by two other ethical frameworks: those that emphasise equality and those that emphasise giving priority to the patients who are worst off. The inadequate resources available for global health reflect not only natural constraints but also unwise social and political choices. However, pitting efforts to reduce inequality and better fund global health against efforts to put available resources to their best use mistakes complementary objectives for conflicting ones.

When life-saving medical resources are scarce and not everyone can be saved, is the only relevant goal saving the most lives? Or can other factors be considered, at least as tiebreakers, such as how early in life the people we don't save will die or how much future life they are likely to lose? This commentary defends a multiprinciple allocation approach that considers objectives in addition to saving more lives, including preventing early death and preventing harm in the form of lost future life. Particularly compared to an arbitrary, coin-flip tiebreaker, this multiprinciple approach more effectively prevents harm, prioritizes the worst-off, mitigates socioeconomic and racial health disparities, and tracks public values regarding allocation under scarcity—and is legally sound.

Through engagement with key informants and review of ethical theories applicable to refugee policy, this paper examines the ethical and policy considerations that policy-level stakeholders believe should factor into setting the refugee resettlement ceiling. We find that the ceiling traditionally has been influenced by policy goals, underlying values, and practical considerations. These factors map onto several ethical approaches to resettlement. There is significant alignment between U.S. policy interests and ethical obligations toward refugees. We argue that the refugee ceiling should be restored to historical norms, and that there exists a corresponding obligation to counter negative public perceptions about refugees and the costs of resettlement.

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution.

This chapter explores two questions in detail: How should we determine the threshold for costs that individuals are asked to bear through insurance premiums or care-related out-of-pocket costs, including user fees and copayments? and What is an adequate relationship between costs and benefits? This chapter argues that preventing impoverishment is a morally more urgent priority than protecting households against income fluctuations, and that many health insurance plans may not adequately protect individuals from health care costs that threaten to drop their financial status below a decent minimum. A design that places greater emphasis on preventing impoverishment and finances the achievement of that goal by reducing unnecessary subsidies to better-off households would better accord with a sufficientarian approach to health care.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

The U.S. FDA has issued emergency use authorizations for monoclonal antibodies for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA’s Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants with increased infectivity and/or severity emerge, further rationing may be required. We identify relevant ethical principles and priority groups for access to therapies based on an integrated approach to population health and medical factors. Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors.

When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should, while others disagree. We offer a framework for evaluating when it is ethical and briefly discuss its legality in American law.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), and equal access may compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods.

Reserve systems are a tool to allocate scarce resources when stakeholders do not have a single objective. This paper introduces some basic concepts about reserve systems for pandemic medical resource allocation. At the onset of the Covid-19 pandemic, we proposed that reserve systems can help practitioners arrive at compromises between competing stakeholders. More than a dozen states and local jurisdictions adopted reserve systems in initial phases of vaccine distribution. We highlight several design issues arising in some of these implementations. We also offer suggestions about ways practitioners can take advantage of the flexibility offered by reserve systems.

Objective: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. Summary of key data: The vast majority of drug development and repurposing during the COVID-19 pandemic – an event that has made clear the ever-present scarcity in healthcare systems –has been ignorant of scarcity and dose optimisation's ability to help address it. Conclusions: Future pandemic clinical trials systems should obtain dose optimisation data, as these appear necessary to enable appropriate scarce resource allocation according to societal values.

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need (1). Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oral antiviral Paxlovid (2) Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend to disadvantage individuals with barriers in access to care (3). There is mounting evidence of racial, ethnic, and socioeconomic disparities in access to medications for COVID-19 (4, 5). One potential method to promote equitable allocation is to use a weighted lottery, which is an allocation strategy that gives all eligible patients a chance to receive the scarce treatment while also allowing the assignment of higher or lower chances according to other ethical considerations (6). We sought to assess the feasibility of implementing a weighted lottery to allocate scarce COVID-19 medications in a large U.S. health system and to determine whether the weighted lottery promotes equitable allocation

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; and treating similar individuals similarly. Ethically and equitably marshalling available countermeasures requires articulating these fundamental objectives, identifying priority tiers, and recognising trade-offs between prioritising the people at the highest risk of infection and the people at the highest risk of harm if infected. These five values can provide guidance on preferable priority categories for a more ethically sound response and suggest methods for optimising allocation of countermeasures for mpox and other diseases for which countermeasures are in short supply. Properly marshalling available countermeasures will be crucial for future effective and equitable national responses to outbreaks.

In this Commentary, I propose an ethical framework for ethical discussions around the allocation of scarce resources in COVID-19 response. The framework incorporates four principles: beneficence (benefiting people by saving lives or years of life), equality, remedying disadvantage, and recognizing past conduct. I then discuss how the framework interacts with ethical constraints against using people as a mere means and against causing death. The commentary closes by criticizing the equation of deontological ethics with random or first-come, first-served allocation and of allocation that aims to save more lives or years of life with utilitarianism..

Initial vaccine allocations for the coronavirus disease 2019 (COVID-19) will be limited. It is crucial to assess the ethical values associated with different methods of allocation, as well as important scientific and practical questions. This Viewpoint identifies three ethical values, benefiting people and limiting harm; prioritizing disadvantaged populations; and equal concern for all. It then explains why these values support prioritizing three groups: health care workers; other essential workers and people in high-transmission settings; and people with medical vulnerabilities associated with poorer COVID-19 outcomes. In contrast, two other groups, people over 65 without medical vulnerabilities and participants in clinical research, present more complex ethical questions. This prioritization also encompasses valuing direct benefits to vaccinated individuals, indirect benefits to individuals protected from spread of infection, and indirect health and socioeconomic benefits to those protected from harm as health system and societal functioning improve. Vaccine allocation that recognizes important ethical values and avoids arbitrariness, waste, and corruption can ensure that the distribution of a COVID-19 vaccine is both fair and perceived as fair.

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.

Recent disputes over whether older people should pay more for health insurance, or receive lower priority for transplantable organs, highlight broader disagreements regarding the legality of using age-based criteria in health care. These debates will likely intensify given the changing age structure of the American population and the turmoil surrounding the financing of American health care. This Article provides a comprehensive examination of the legality and normative desirability of age-based criteria. I defend a distributive justice approach to age-based criteria and contrast it with two prevailing theoretical approaches to age-based criteria, nondiscrimination and discretion. I propose a detailed normative framework for the use of age-based criteria in health care, the lifetime justice approach, that considers the future life patients can gain from treatment and the past years of life they already have experienced. This paper is available by open access from the Boston College Law School Digital Commons.

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination.