Medical Resource Allocation

This article evaluates seven strategies for managing the high costs of GLP-1 receptor agonists (GLP-1RAs) like semaglutide and tirzepatide for weight management: complete exclusion of coverage, annual cost increase caps, lifetime cost caps, tiered access, formulary reevaluation, subscription payment models, and patent reform. The authors assess each strategy against three ethical objectives: benefiting people and preventing harm, showing equal moral concern, and mitigating disadvantage. Complete coverage exclusions, arbitrary reimbursement caps, and lifetime limits are deemed unethical as they fail to meet (...) these objectives. Tiering access based on relative benefit is considered justifiable, though current implementation often unfairly favors diabetes over obesity treatment. The authors recommend formulary reevaluation as the most ethical approach for smaller health plans, allowing them to prioritize more cost-effective treatments. For larger payers with market power and for governments, subscription payment models and patent reforms are potentially ethical solutions if implemented sustainably. The authors conclude that health plans should avoid ad hoc restrictions on GLP-1RAs in favor of comprehensive policy reforms that ensure sustainable access to these and future breakthrough treatments. (shrink)

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, such as tirzepatide, have been found to be effective for treating obesity and diabetes, significantly reducing weight and the risk or predicted risk of adverse cardiovascular events. There is a global shortage of these medications that could last several years and raises questions about how limited supplies should be allocated. We propose a fair-allocation framework that enables evaluation of the ethics of current (...) practices and could guide governments, professional societies, and physicians in allocation decisions. (shrink)

Healthcare systems produce significant greenhouse gas emissions, raising an important question: should healthcare be treated like any other polluter when it comes to reducing its emissions, or is healthcare special because of its essential societal role? On one hand, reducing emissions is critical to combat climate change. On the other, healthcare depends on emissions to deliver vital services. The resulting tension surrounds an idea of healthcare exceptionalism and leads to the question I consider in this paper: to what extent (if (...) any) should the valuable goals of healthcare form an exception to the burdens of reducing greenhouse gas emissions? The goals of this paper are twofold. One is to think about how to address the issue of healthcare exceptionalism. Second is to discuss the extent of healthcare’s climatic responsibilities. I examine two perspectives on healthcare exceptionalism. The first treats a responsibility to reduce emissions and the delivery of healthcare as separate issues, each governed by its own principle. I reject this view, proposing instead that we consider healthcare’s environmental responsibilities in conjunction with its essential functions. I defend an “inability to pay” principle, suggesting that while healthcare should indeed contribute to mitigating climate change, its obligations should be constrained by the necessity of maintaining its core goals like protecting health and preventing disease. Healthcare should be treated differently from other sectors, but not to the extent that it is entirely exempt from efforts to reduce emissions. (shrink)

In this paper, I am concerned with how healthcare systems ought to transition away from the greenhouse gas emissions that they have historically relied on to provide care. I address two questions in relation to this issue. The first is what emissions target should healthcare systems adopt? Second, is how should the burdens of mitigation be shared fairly in light of that target? I argue that sufficientarianism offers an attractive way to answer both of these questions because it is better (...) situated to strike the right balance between healthcare benefits and the costs of mitigation than rivals. Sufficiency describes the view that what is important from the perspective of distributive justice is that individuals have enough. I argue that this ideal can be used to set a threshold of enough health from which an emissions threshold can be set. Once an emissions threshold is in place, this can be used to demarcate permissible from impermissible emissions in healthcare. In turn, the emissions threshold provides guidance on which emissions are liable to mitigation and when it would be fair for healthcare to shoulder the associated burdens. Permissible emissions, on the other hand, are necessary to secure sufficiency and so healthcare's mitigation responsibilities should be altered in light of this. I also discuss various alternative methods of setting an emissions target like net zero, zero emissions, emissions grandfathering and emissions egalitarianism. I point to several issues with these approaches. (shrink)

In “Rationing, Responsibility, and Vaccination During COVID-19: A Conceptual Map,” coauthored with Jin Park (Park and Davies 2024), our aim was to set out a framework which would helpfully clarify...

Under which conditions may physicians who are requested to treat permanently unconscious patients refuse to do so? Wasserman et al. (2023) maintain that refusals on the basis of supposed futility are unethical as they amount to passing off personal value judgments as medical expertise. Instead, unwillingness to carry out an intervention should be framed as conscientious objection. I argue that referring to futility with regard to a patient’s presumed quality of life is appropriate if – and only if – a (...) total and irreversible loss of consciousness has been diagnosed with adequate certainty. The diagnosis turns a graded notion into a binary affair: conscious awareness is a necessary condition of any degree of quality of life to be meaningfully ascribed to an organism. Consequently, the complete absence of consciousness precludes such an ascription; further treatment is then indeed futile from a quality-of-life standpoint. (shrink)

Semaglutide, sold under the brand names of Ozempic, Rybelsus and Wegovy, is one of the most popular drugs on the market. Manufactured by Novo Nordisk, semaglutide is the newest in a family of glucagon-like peptide-1 receptor agonists used most commonly to treat type II diabetes. To date, the results of semaglutide for the treatment of type II diabetes have been overwhelmingly positive. It is for the drug’s effects on appetite suppression and weight loss, however, that have led its surge in (...) popularity, with many hailing semaglutide as the new ‘miracle drug for weight loss’. Despite its popularity, both the governmental and popular reception to the drug has largely been mixed. In this paper, we address a range of ethical concerns and argue that while many are legitimate, they do not provide conclusive reason not to prescribe semaglutide for weight loss. (shrink)

Bioethics: 50 Puzzles, Problems, and Thought Experiments collects 50 cases—both real and imaginary—that have been, or should be, of special interest and importance to philosophical bioethics. Cases are collected together under topical headings in a natural order for an introductory course in bioethics. Each case is described in a few pages, which includes bioethical context, a concise narrative of the case itself, and a discussion of its importance, both for broader philosophical issues and for practical problems in clinical ethics and (...) health policy. Each entry also contains a brief, annotated, list of suggested readings. In addition to the classic cases in bioethics, the book contains discussion of cases that involve several emerging bioethical issues: especially, issues around disability, social justice, and the practice of medicine in a diverse and globalized world. (shrink)

A volume with 14 chapters on various aspects of the relationship between responsibility and healthcare, plus a substantial introduction that offers a comprehensive overview of the relevant debates and how they relate to one another. Questions of responsibility arise at all levels of health care. Most prominent has been the issue of patient responsibility. Some health conditions that risk death or serious harm are partly the result of lifestyle behaviours such as smoking, lack of exercise, or extreme sports. Are patients (...) with such conditions responsible for them? If so, might healthcare providers, be they state-run systems or private entities, be justified in treating such patients differently? And if they are, which forms of differential treatment are justified? Responsibility isn’t just relevant for patients. Even when individuals affect their health through voluntary behaviour, other influences are also at work before, during, and after the patient’s interaction with the health care system. What are the responsibilities of individual clinicians and other medical professionals, when thinking about individual and public health? What about institutions such as governments or national health care services, or society as a whole? This collection brings together work by world-renowned experts in population ethics, distributive justice, philosophy of action, cognitive science, and medical ethics in order to push the debate forward by elucidating our understanding of these questions, their possible answers, and how they are related. (shrink)

This Viewpoint analyzes policies for covering GLP-1 receptor agonist drugs for obesity treatment across 13 high-income countries. It identifies four key lessons for developing coverage policies: 1) using up-to-date cost-effectiveness analyses that incorporate new evidence of benefits, 2) negotiating lower prices while preserving innovation incentives, 3) prioritizing coverage for specific populations rather than issuing blanket denials, and 4) treating obesity medications similarly to high-cost drugs for other conditions. It argues that blanket coverage denials are unethical and that countries should implement (...) targeted coverage policies that maximize benefits while managing costs. (shrink)

In their upcoming article, Henk Jasper van Gils-Schmidt and Sabine Salloch highlight the supposed responsibilities of healthcare professionals in addressing the global health challenges posed by climate change. They argue that healthcare professionals’ duties to future generations and their ‘climate-related obligations’ have been neglected, primarily due to potential conflicts with other responsibilities, such as providing optimal care to current patients and maintaining patient trust. The authors suggest that these competing obligations should be viewed as part of the multifaceted identities individuals (...) hold, encompassing roles as both physicians and environmentalists, each with normative and competing commitments. They propose that a transformative shift in physicians’ professional ethos, expanding from the predominant focus on individual patients to include obligations towards climate protection, could pave the way for identifying effective mechanisms to address these challenges. While acknowledging the authors’ emphasis on sustainable healthcare practices, we argue that a duty to climate protection as part of healthcare professionals’ identity lacks ethical support. We identify serious concerns that stem from the transformative shift in physicians’ professional ethos, particularly in the authors’ presentation of reasons for action. First, envisaging a stable disposition that compels healthcare professionals to ensure optimal care conditions for both immediate and potential future encounters is unrealistic. Such a scenario would necessitate a nuanced and multifaceted evaluation, weighing …. (shrink)

The aim of this article is to consider whether, when, and why it is morally right to treat members of socially disadvantaged racial or ethnic groups favorably when allocating scarce medical resources. Since the COVID 2019 pandemic has had different impacts on racial and ethnic groups, some U.S. states have given racial and ethnic minorities preferential access to COVID-19 vaccines, leading to controversy over the moral and legal permissibility of doing so. I examine three arguments for affirmative action—the compensation, equality-of-opportunity, (...) and antidiscrimination arguments—and argue that both the equality-of-opportunity and antidiscrimination arguments have the potential to provide well-founded justification for race-based affirmative action for the allocation of scarce medical resources. I also consider further moral requirements that instances of affirmative action based on both or either of the two arguments should comply with for them to be justified. (shrink)

This chapter examines the case for health care policies aimed at holding obese individuals responsible for their weight and for obesity-related health issues. In particular, it considers the merits of two arguments for policies that would seek to make obese individuals bear some of the higher health care costs associated with being that way. On the fairness argument, it is claimed that such policies would serve the interests of fairness by holding obese individuals to account for irresponsible lifestyle choices that (...) are linked to their higher weight and its associated health risks. On the public health promotion argument, it is claimed that adopting such policies could produce impressive public health benefits: encouraging people to make healthier lifestyle choices, reducing obesity rates, and reducing obesity-related health care spending. Both arguments face serious objections. Contrary to the fairness argument, policies aimed at holding obese individuals responsible for their weight or for related health problems would neither treat people as they deserve to be treated nor make the distribution of health care resources fairer. And contrary to the public health promotion argument, those policies would not produce better health outcomes for society at large. Indeed, they would tend to do just the opposite. Reflection on the shortcomings of those arguments reveals that their conclusion is false: society should not adopt policies aimed at holding obese individuals responsible for their weight or for obesity-related health problems. (shrink)

In our reply to critiques of our GLP-1 receptor agonist allocation framework, we explain that using potential years of life lost (PYLL) as a metric addresses racial health disparities without explicitly allocating resources based on race. This approach is "racism-conscious" and has legal and ethical challenges over race-based approaches. Meanwhile, though acknowledging the importance of cardiovascular risk assessment, we maintain in response to other interlocutors that focusing solely on immediate risk would ignore the broader goal of mitigating disadvantage. We emphasize (...) that our framework balances multiple ethical objectives beyond just maximizing medical benefits. (shrink)

Some philosophers and segments of the public think age is relevant to healthcare priority-setting. One argument for this is based in equity: “Old” patients have had either more of a relevant good than “young” patients or enough of that good and so have weaker claims to treatment. This article first notes that some discussions of age-based priority that focus in this way on old and young patients exhibit an ambiguity between two claims: that patients classified as old should have a (...) low priority, and that patients classified as young should have high priority. The author next argues, drawing on a problem raised by Christine Overall, that equity cannot justify giving “old” patients low priority, since there is wide variety in the total lifetime experiences of older people, partly influenced by gender, race, class, and disability injustice. Finally, the author suggests that there might be a limited role for age-based prioritization in the context of infant and childhood death, since those who die in childhood are always and uncontroversially among the worst-off. (shrink)

I introduce a distinction between health need and medical need, and raise several questions about their interaction. Health needs are needs that relate directly to our health condition. Medical needs are needs which bear some relation to medical institutions or processes. I suggest that the question of whether medical insurance or public care should cover medical needs, health needs, or only needs which fit both categories is a political question that cannot be resolved definitionally. I also argue against an overly (...) strict definition of medical need on the grounds that this presupposes, wrongly, that medical intervention should always be a last resort. (shrink)

In this paper, we address the moral justification problem concerning the use of age as a criterion for the allocation of scarce life-saving medical resources. We present and discuss four justifications that stand out in philosophical literature: efficiency, sufficiency, egalitarian, and prioritarian. We aim to demonstrate that all these justifications are unsatisfactory since they entail counterintuitive implications in cases involving fetuses and newborns. We then suggest another justification for the relevance of age based on the Time-Relative Interest Account of the (...) harm of death. Finally, we evaluate an objection that could limit the scope of the defended justification, leading us to draw a distinction between justification of harm and strict justification of harm. (shrink)

This book focuses on resource allocation in military and humanitarian medicine during times of scarcity and austerity. It is in these times that health systems bend, break, and even collapse and where resource allocation becomes a paramount concern and directly impacts clinical decision-making. Such times are challenging and this book covers this very important, yet, scarcely researched topic within the field of bioethics. This work brings together experts and practitioners in the fields of military health care, philosophy, ethics, and other (...) disciplines to provide analysis on a variety of related topics ranging from case studies and first-hand experiences to policy and philosophical analysis. It is of great interest to to academics, practitioners, policy makers and students who are looking for analyses and guidance regarding the fair provision of medical care and the use of medical rules of eligibility under adverse conditions. (shrink)

Modern medicine consumes vast amounts of resources, ranging from human to technological and financial. In a well-functioning and well-equipped health system, resource allocation considerations rarely impact clinical decision-making as all patients that need care will (eventually) receive it. In light of this, health care providers (HCPs) are often taught to focus on the patient in front of them, driven by a type of patient-centred ethics (of care) that prioritizes the individual person’s well-being above the aggregate. Informed by the principle of (...) autonomy and respect for individual self-determination, patients in well-resourced health systems often have the autonomy to make decisions that require high resource utilization with little concern directed to how these choices may impact the care provided to other patients or groups of patients. In fact, it is generally accepted that if resources are sufficient, patients and their providers should be able to make medical decisions unencumbered by considerations related to broader resource allocation (with some caveats related to personal or national health insurance schemes). This means that the average HCP in the best case and in their daily routine spends little time considering how their clinical choices might impact the care available to others—concerns related to how resources are allocated, and who receives care are far removed from clinical interaction and related medical decision-making. (shrink)

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. (shrink)

In emergency situations and while medical resources are sufficient, doctors are expected to prioritize and treat patients according to medical criteria only. In MASSCAL situations and when medical resources become insufficient, patient selection and prioritization changes. Rules of triage are applied with the aim of getting the best result possible under the circumstances, e.g., saving the largest number; collective health outweighs individual health. Still, according to the standard ethical principles, non-medical criteria should never influence the doctors’ decision of who will (...) be treated. In military contexts, so-called medical rules of eligibility (MROE) provide rules that include non-medical criteria. This chapter aims to analyze if, why, and under what circumstances it may be ethically acceptable to prioritize patients according to non-medical criteria. (shrink)

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. (shrink)

Discrimination is an important real-life issue that affects many individuals and groups. It is also a fruitful field of study that intersects several disciplines and methods. This Special Section brings together papers on discrimination and prioritization in healthcare from leading scholars in bioethics and closely related fields.

With the world grappling with continued spread of monkeypox internationally, vaccines play a crucial role in mitigating the harms from infection and preventing spread. However, countries with the greatest need - particularly historically endemic countries with the highest monkeypox case-fatality rates - are not able to acquire scarce vaccines. This is unjust, and requires rectification through equitable allocation of vaccines globally. We propose applying the Fair Priority Model for such allocation, which emphasizes three key principles: 1) preventing harm; 2) prioritizing (...) the disadvantaged; and 3) treating people with equal moral concern. Post-exposure prophylaxis (PEPV) has the most potential to mitigate harm, and so ensuring countries have sufficient supply for PEPV should be the first priority. And historically endemic countries, which face disadvantages that compound potential harms from monkeypox, should be the first recipients of such vaccines. Once sufficient supply is allocated for countries to apply PEPV, global allocation could move on to pre-exposure prophylaxis (PrEP), again prioritizing historically endemic countries first before distribution to the rest of the global community, based on projected number of cases and vulnerability to harm. (shrink)

RD, a 32-year-old male, was admitted to the hospital with hypoxic COVID pneumonia–a potentially life-threatening condition characterized by dangerously low levels of oxygen in the body- during one of the pandemic’s surges. While RD’s age gave the clinical team hope for his prognosis, his ability to recover was complicated by his being unvaccinated and having multiple comorbidities, including diabetes and obesity. His condition worsened to the point that he required extracorporeal membrane oxygenation (ECMO), a machine that maintains the functioning of (...) a person’s heart and lungs. -/- Given its scarcity–only 264 of the over 6,000 hospitals in the United States offer ECMO, according to the Extracorporeal Life Support Organization–as well as its high cost and the inadequate supply of staff required to maintain it, ECMO primarily serves as a bridge to support critically ill patients until they can receive an organ transplant or implanted medical device. For RD, ECMO was started to support him until he could be evaluated for, and possibly receive, a bilateral lung transplant. Despite its intended use as a treatment of last resort, some patients can remain on ECMO for weeks or months. And some are awake, alert, and capable of medical decision-making. -/- RD was one such patient. However, the transplant evaluation committee ruled out RD’s candidacy for bilateral lung transplantation, based on his poor potential for recovery and a lack of family and friends to provide post-transplant support. This determination raised the prospect of continued ECMO treatment being a bridge to nowhere. But RD was comfortable on ECMO and wanted to remain in the ICU. The ICU intensivist contacted the ethics consult service with questions about whether continued ECMO support was medically and ethically inappropriate. (shrink)

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. -/- Methods: The main documents discussing the two strategies are (...) examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. -/- Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. -/- Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel. (shrink)

In 2020, the world faced a new pandemic. The corona infection hit an unprepared world, and there were no medicines and no vaccines against it. Research to develop vaccines started immediately and in a remarkably short time several vaccines became available. However, despite initiatives for global equitable access to COVID-19 vaccines, vaccines have so far become accessible only to a minor part of the world population. In this article, I discuss the global distribution of COVID-19 vaccines from an ethical point (...) of view. I reflect on what ethical principles should guide the global distribution of vaccines and what global justice and international solidarity imply for vaccine distribution and I analyse the reasons for states to prioritize their own citizens. My focus is on ethical reasons for and against ‘vaccine nationalism’ and ‘vaccine cosmopolitanism.’ My point of departure is the appeal for international solidarity from several world leaders, arguing that ‘Where you live should not determine whether you live’. I discuss the COVAX initiative to enable a global vaccination and the proposal from India and South Africa to the World Trade Organization to temporarily waive patent rights for vaccines. In the final section, I argue for global vaccine sufficientarianism, which is a modified version of vaccine cosmopolitanism. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation (...) of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

In the recent literature across philosophy, medicine and public health policy, many influential arguments have been put forward to support the use of randomization procedures to allocate scarce life-saving resources. In this paper, I provide a systematic categorization and a critical evaluation of these arguments. I shall argue that those arguments justify using RAND to allocate SLSR in fewer cases than their proponents maintain and that the relevant decision-makers should typically allocate SLSR directly to the individuals with the strongest claims (...) to these resources rather than use RAND to allocate such resources. (shrink)

Although machine intelligence is increasingly employed in healthcare, the realm of decision-making in medical ethics remains largely unexplored from a technical perspective. We propose an approach based on fuzzy cognitive maps (FCMs), which builds on Beauchamp and Childress’ prima-facie principles. The FCM’s weights are optimized using a genetic algorithm to provide recommendations regarding the initiation, continuation, or withdrawal of medical treatment. The resulting model approximates the answers provided by our team of medical ethicists fairly well and offers a high degree (...) of interpretability. Possible applications of such a system include informal guidance on medical ethics dilemmas as well as educational purposes. (shrink)

The genetic modification of pigs as a source of transplantable organs is one of several possible solutions to the chronic organ shortage. This paper describes existing ethical tensions in xenotransplantation (XTx) that argue against pursuing it. Recommendations for lifelong infectious disease surveillance and notification of close contacts of recipients are in tension with the rights of human research subjects. Parental/guardian consent for pediatric xenograft recipients is in tension with a child’s right to an open future. Individual consent to transplant is (...) in tension with public health threats that include zoonotic diseases. XTx amplifies concerns about justice in organ transplantation and could exacerbate existing inequities. The prevention of infectious disease in source animals is in tension with the best practices of animal care and animal welfare, requiring isolation, ethologically inappropriate housing, and invasive reproductive procedures that would severely impact the well-being of intelligent social creatures like pigs. (shrink)

Many healthcare agencies are producing evidence-based guidance and policy that may determine the availability of particular healthcare products and procedures, effectively rationing aspects of healthcare. They claim legitimacy for their decisions through reference to evidence-based scientific method and the implementation of just decision-making procedures, often citing the criteria of ‘accountability for reasonableness’; publicity, relevance, challenge and revision, and regulation. Central to most decision methods are estimates of gains in quality-adjusted life-years, a measure that combines the length and quality of survival. (...) However, all agree that the QALY alone is not a sufficient measure of all relevant aspects of potential healthcare benefits, and a number of value assessment frameworks have been suggested. I argue that the practical implementation of these procedures has the potential to lead to a distorted assessment of value. Undue weight may be ascribed to certain attributes, particularly those that favour commercial or political interests, while other attributes that are highly valued by society, particularly those related to care processes, may be omitted or undervalued. This may be compounded by a lack of transparency to relevant stakeholders, resulting in an inability for them to participate in, or challenge, the decisions. The makes it likely that costly new technologies, for which inflated prices can be justified by the current value frameworks, are displacing aspects of healthcare that are highly valued by society. (shrink)

The allocation of scarce medical treatments, such as antivirals and antibody therapies for COVID-19 patients, has important legal dimensions. This Essay examines a currently debated issue: how will courts view the consideration of characteristics shielded by equal protection law, such as race, sex, age, health, and even vaccination status, in allocation? Part II explains the application of strict scrutiny to allocation criteria that consider individual race, which have been recently debated, and concludes that such criteria are unlikely to succeed under (...) present Supreme Court precedent. Part III analyzes the use of sex-based therapy allocation criteria, which are also in current use, and argues that they also face substantial legal obstacles, despite only being subject to intermediate scrutiny. Parts IV and V examine the use of age and health status in allocation. Part VI discusses how the nascent law on “vaccination status” discrimination might apply to therapy allocation. (shrink)

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. (shrink)

As hospitals in the US and elsewhere fill again with patients with covid-19, discussions about how to fairly allocate scarce medical resources have come to the fore once again. One frequently voiced concern is that non-covid-19 patients with urgent health needs are facing indefinitely postponed surgeries, long-distance hospital transfers, or even are unable to access medical treatment. In our view, a reserve or categorised priority system could help. It could be used to fairly distribute scarce medical capacity—such as staffing, physical (...) space, and medical treatments—between covid-19 and non-covid-19 patients, just as it has been used or proposed to allocate covid-19 therapeutics and vaccines. (shrink)

Medicines and medical devices containing animal-derived ingredients are frequently used on patients without their informed consent, despite a significant proportion of patients wanting to know if an animal-derived product is going to be used in their care. Here, I outline three arguments for why this practice is wrong. First, I argue that using animal-derived medical products on patients without their informed consent undermines respect for their autonomy. Second, it risks causing nontrivial psychological harm. Third, it is morally inconsistent to respect (...) patients’ dietary preferences and then use animal-derived medicines or medical devices on them without their informed consent. I then address several anticipated objections and conclude that the continued failure to address this issue is an ethical blind spot that warrants applying the principles of respect for autonomy and informed consent consistently. There are no data in this work. (shrink)

In the article Should rare diseases get special treatment? by Monica Q F de Magalhaes,1 it is argued that rarity is not a morally relevant feature to consider in prioritising treatment in healthcare, but severity is. A central conclusion in the article is that severity rather than prevalence should guide different cost-effectiveness thresholds. Hence, I take it, she answers no to the question in her own heading. I agree with all of this—and with most of her other arguments and conclusions (...) in the article—except for the clause ‘rather than prevalence’. For this reason, I find the article misses its’ mark. Let me explain by taking Sweden as an example. Sweden has a legally established ethics framework for priority setting in healthcare since 1997, comprising three principles: human-dignity principle, needs-solidarity principle and cost-effectiveness principle. The implication of these principles in practice is that the higher the severity—the higher the cost-effectiveness threshold acceptable.2 During the last 10 years or so, the highest accepted cost-effectiveness threshold for the most severe conditions have been in the order of €100 000/QALY. Until a few years ago rarity or prevalence was …. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

With the limited initial availability of COVID-19 vaccines in the first months of 2021, decision-makers had to determine the order in which different groups were prioritized. Our aim was to find out what normative approaches to the allocation of scarce preventive resources were embedded in the national COVID-19 vaccination schedules. We systematically reviewed and compared prioritization regulations in 27 members of the European Union, the United Kingdom, and Israel. We differentiated between two types of priority categories: groups that have increased (...) infection fatality rate (IFR) compared to the average for the general population and groups chosen because their members experience increased risk of being infected (ROI). Our findings show a clear trend: all researched schedules prioritized criteria referring to IFR (being over 65 years old and coexisting health conditions) over the ROI criteria (eg occupation and housing conditions). This is surprising since, in the context of treatment, it is common and justifiable to adopt different allocation principles (eg introducing a saving more life-year approach or prioritizing younger patients). We discuss how utilitarian, prioritarian, and egalitarian principles can be applied to interpret normative differences between the allocation of curative and preventive interventions. (shrink)

This article is about the potential justification for deploying some form of affirmative action (AA) in the context of healthcare, and in particular in relation to the pandemic. We call this Affirmative Action in healthcare Resource Allocation (AARA). Specifically, we aim to investigate whether the rationale and justifications for using prioritization policies based on race in education and employment apply in a healthcare setting, and in particular to the COVID-19 pandemic. We concentrate in this article on vaccines and ventilators because (...) these are both highly scarce resources in the pandemic, and there has been a need to develop policies for allocating them. However, as will become clear, the ethical considerations relating to them may diverge. We first set out two rationales for AAs and what they might entail in a healthcare setting. We then consider some disanalogies between AA and AARA, as well as the different implications of AARA for allocating ventilators as opposed to vaccines. Finally, we consider some of the practical ways in which AARA could be implemented, and conclude by responding to some key objections. (shrink)

Christian Munthe, David Fumagalli and Erik Malmqvist argue that well-known healthcare resource allocation principles, such as need, prognosis, equal treatment and cost-effectiveness, should be supplemented with a principle of sustainability.1 Employing such a principle would entail that the allocation of healthcare resources should take into account whether a specific allocation causes negative dynamics, which would limit the amount of resources available in the future. As examples of allocation decisions, which may have such negative dynamics, they mention those who cause a (...) lack of vaccines, anti-bioethics resistance and drug shortages. Thus, the overall thought is that we can spend and allocate healthcare resources in a certain way at t1, which means that we will have fewer resources available at a later point, t2. The authors argue that we should include a principle of sustainability to justify allocations, which avoids or diminishes the negative dynamics. The authors argue that existing principles cannot sufficiently include proper regard for how our current decisions affect future allocation decisions and, therefore, the people who need healthcare resources in the future. I am sympathetic to the developed argument and believe that the authors are correct that negative dynamics provide reasons to take our ability to meet future health needs …. (shrink)

Building on work by Peterman, Aas, and Wasserman (2021), we modify their prospective benefit analysis to include only medically-relevant information about patients as persons without reference to their broader lives. Because patients (not their lives) must be treated equally, we argue that patients are the appropriate targets of allocative justification. We go on to challenge some of our current data-collection practices on this basis.

The distribution of scarce critical care resources during public health emergencies in an ethically justified manner has been widely acknowledged as a major bioethics concern. The Center for Disease Control (CDC) recommends that critical care allocation during a pandemic emergency should uphold basic biomedical principles through maintenance of procedural justice which requires decision-making that is consistent, impartial, neutral, and nondiscriminatory. During the current COVID-19 pandemic, health systems, even in developed countries with robust existing health infrastructure, have experienced sustained demands that (...) have compelled the rationing of critical medical infrastructure, especially ventilators and intensive care beds. (shrink)

Are countries especially entitled, if not obliged, to prioritize the interests or well-being of their own citizens during a global crisis, such as a global pandemic? We call this partiality for compatriots in times of crisis “crisis nationalism”. Vaccine nationalism is one vivid example of crisis nationalism during the COVID-19 pandemic; so is the case of the US government’s purchasing a 3-month supply of the global stock of the antiviral Remdesivir for domestic use. Is crisis nationalism justifiable at all, and, (...) if it is, what are its limits? We examine some plausible arguments for national partiality, and conclude that these arguments support crisis nationalism only within strict limits. The different arguments for partiality, as we will note, arrive at these limits for different reasons. But more generally, so we argue, any defensible crisis nationalism must not entail the violation of human rights or the worsening of people’s deprivation. Moreover, we propose that good faith crisis nationalism ought to be sensitive to the potential moral costs of national partiality during a global crisis and must take extra care to control or offset these costs. Thus, crisis nationalism in the form of vaccine nationalism or the hoarding of global supplies of therapeutics during a global pandemic exceeds the bounds of acceptable partiality. (shrink)

Should we allocate costly health care to patients diagnosed with disorders of consciousness (DoC), such as patients diagnosed as being in a vegetative state or minimally conscious state? Peterson, Aas, and Wasserman (2021) argue that we should in their paper “What justifies the allocation of health care resources to patients with disorders of consciousness?” Their key insight is that the expected benefits to this patient population helps to justify such allocations. However, their insight is attached to a consequentialist framework aimed (...) at maximizing aggregate social welfare. An alleged virtue of their framework over Braddock’s (2017) approach is their agnosticism about the moral status and rights of DoC patients. In this commentary, however, we argue that their agnosticism is the biggest problem with their approach: failing to treat DoC patients as persons with rights runs the moral risk of violating their rights, which is more serious than the risk of failing to maximize social utility. A better approach that reduces moral risk would incorporate Braddock’s (2017) precautionary presumption of personhood. We should stand in solidarity with DoC patients and treat them as persons with dignity and rights. (shrink)