The experience of Costa Rica highlights the potential for conflicts between the right to health and fair priority setting. For example, one study found that most favorable rulings by the Costa Rican constitutional court concerning claims for medications under the right to health were either for experimental treatments or for medicines that should have low priority based on health gain per unit of expenditure and severity of disease. In order to better align rulings with (...) priority setting criteria, in 2014, the court initiated a reform in its assessment of claims for medicine. This paper assesses this reform’s impact on the fairness of resource allocation. It finds three effects. First, a reduction in successful claims for experimental medication, which is beneficial. Second, an increase in the success rate of medication lawsuits, which is detrimental because most claims are for extremely cost-ineffective medications. Third, a decline in the number of claims for medicine, which is beneficial because it forestalls such low-priority spending. This paper estimates that, taking all three effects into account, the reform has had a modest net positive impact on overall resource allocation. However, it also argues that there is a need for further reforms to lower the number of claims to low-priority medicines that are granted. (shrink)

Priority setting in health care is ubiquitous and health authorities are increasingly recognising the need for priority setting guidelines to ensure efficient, fair, and equitable resource allocation. While cost-effectiveness concerns seem to dominate many policies, the tension between utilitarian and deontological concerns is salient to many, and various severity criteria appear to fill this gap. Severity, then, must be subjected to rigorous ethical and philosophical analysis. Here we first give a brief history of the (...) path to today’s severity criteria in Norway and Sweden. The Scandinavian perspective on severity might be conducive to the international discussion, given its long-standing use as a priority setting criterion, despite having reached rather different conclusions so far. We then argue that severity can be viewed as a multidimensional concept, drawing on accounts of need, urgency, fairness, duty to save lives, and human dignity. Such concerns will often be relative to local mores, and the weighting placed on the various dimensions cannot be expected to be fixed. Thirdly, we present what we think are the most pertinent questions to answer about severity in order to facilitate decision making in the coming years of increased scarcity, and to further the understanding of underlying assumptions and values that go into these decisions. We conclude that severity is poorly understood, and that the topic needs substantial further inquiry; thus we hope this article may set a challenging and important research agenda. (shrink)

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. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health (...) research resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

Rare diseases pose a particular priority setting problem. The UK gives rare diseases special priority in healthcare priority setting. Effectively, the National Health Service is willing to pay much more to gain a quality-adjusted life-year related to a very rare disease than one related to a more common condition. But should rare diseases receive priority in the allocation of scarce healthcare resources? This article develops and evaluates four arguments in favour of such a (...) priority. These pertain to public values, luck egalitarian distributive justice the epistemic difficulties of obtaining knowledge about rare diseases and the incentives created by a higher willingness to pay. The first is at odds with our knowledge regarding popular opinion. The three other arguments may provide a reason to fund rare diseases generously. However, they are either overinclusive because they would also justify funding for many non-rare diseases or underinclusive in the sense of justifying priority for only some rare diseases. The arguments thus fail to provide a justification that tracks rareness as such. There are no data in this work. (shrink)

How should governments balance saving people from very large individual disease burdens (such as an early death) against saving them from middling burdens (such as erectile dysfunction) and minor burdens (such as nail fungus)? This chapter considers this question through an analysis of a priority-setting proposal in the Netherlands, on which avoiding a multitude of middling burdens takes priority over saving one person from early death, but no number of very small burdens can take priority over (...) avoiding one death. It argues that there is some, albeit imperfect, evidence of substantial public support for such a policy. Furthermore, it provides a principled rationale for it in terms of respect for the person who faces the largest burden. (shrink)

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.

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)

Common principles for resource allocation in health care can prioritize the alleviation of small health burdens over lifesaving treatment. I argue that there is some evidence that these principles are at odds with a sizable share of public opinion, which holds that saving a life should take priority over any number of cures for minor ailments. I propose two possible explanations for this opinion, one debunking and one vindicatory. I also outline how well-designed surveys and moral inquiry (...) could help decide between them. Finally, I consider how priority-setting principles could be adjusted if the view that saving a life always trumps alleviating small burdens were vindicated. (shrink)

I outline and defend two egalitarian theories, which yield distinctive and, I argue, complementary answers to why health-related inequalities matter: a brute luck egalitarian view, according to which inequalities due to unchosen, differential luck are bad because unfair, and a social egalitarian view, according to which inequalities are bad when and because they undermine people’s status as equal citizens. These views identify different objects of egalitarian concern: the brute luck egalitarian view directs attention to health-related well-being, while social (...) egalitarianism focuses on health-related capabilities that are central to a person’s status as a citizen. I argue that both views are correct and should jointly guide priority-setting in health. (shrink)

The goal of achieving Universal Health Coverage (UHC) can generally be realized only in stages. Moreover, resource, capacity and political constraints mean governments often face difficult trade-offs on the path to UHC. In a 2014 report, Making fair choices on the path to UHC, the WHO Consultative Group on Equity and Universal Health Coverage articulated principles for making such trade-offs in an equitable manner. We present three case studies which illustrate how these principles can guide practical decision-making. These (...) case studies show how progressive realization of the right to health can be effectively guided by priority-setting principles, including generating the greatest total health gain, priority for the worse off, and financial risk protection. They also demonstrate the value of a fair and accountable process of priority setting. (shrink)

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/AIDS research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: Insofar as (...) the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting. (shrink)

-/- This chapter evaluates the ethical issues that using cost-effectiveness considerations to set animal health priorities might present, and its conclusions are cautiously optimistic. While using cost-effectiveness calculations in animal health is not without ethical pitfalls, these calculations offer a pathway toward more rigorous priority-setting efforts that allow money spent on animal well-being to do more good. Although assessing quality of life for animals may be more challenging than in humans, implementing prioritization based on cost-effectiveness is (...) less ethically fraught. (shrink)

In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in evaluating (...) the ethics of proposed research proposals when research ethics committees assess whether the social value of the research is sufficient to justify the risks and burdens to research participants and others. In assessing how far a proposed research project will advance the interests of people who are more disadvantaged, research priority setters and RECs should examine the diseases that the research targets and the type of research. Just as certain diseases impose a greater burden on people who are more disadvantaged, so certain types of intervention and forms of research are more likely to benefit people who are more disadvantaged. We outline which populations are likely to be representative of the global worst off and identify what types of health research, and which disease categories, are priorities for these populations. (shrink)

Recently theorists have demonstrated a growing interest in the ethical aspects of resource allocation in international non-governmental humanitarian, development and human rights organizations (INGOs). This article provides an analysis of Thomas Pogge's proposal for how international human rights organizations ought to choose which projects to fund. Pogge's allocation principle states that an INGO should govern its decision making about candidate projects by such rules and procedures as are expected to maximize its long-run cost-effectiveness, defined as the expected aggregate moral value (...) of the projects it undertakes divided by the expected aggregate cost of these projects? I critique Pogge's argument on two fronts: (1) I demonstrate that his view is problematic on his own terms, even if we accept the cost-effectiveness framework he employs. (2) I take issue with his overall approach because it generates results which can undermine the integrity of INGOs. Further, his approach mis-characterizes the nature of INGOs, and this mistake is at the root of his problematic view of INGO priority-setting. Ultimately, I argue for a conception of INGOs in which they are understood as ?organizations of principle?, in the sense that they are independent moral agents and so should be permitted a fairly wide sphere of autonomy within reasonable moral constraints. (shrink)

This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cases where quality of life suffers because of (...) disability-focused exclusion or injustice differently from cases where lower quality of life results from laws of nature, resource scarcity, or appropriate tradeoffs. Decisionmakers should ignore quality-of-life losses that result from injustice or exclusion when ignoring them would improve the prospects of individuals with disabilities; in contrast, they should consider quality-of-life losses that are unavoidable or stem from resource scarcity or permissible tradeoffs. On this proposal, while health systems should not amplify existing injustice against individuals with disabilities, they are not required to altogether ignore the potential effects of disability on quality of life. (shrink)

The available resources for global health assistance are far outstripped by need. In the face of such scarcity, many people endorse a principle according to which highest priority should be given to the worst off. However, in order for this prioritarian principle to be useful for allocation decisions, policy-makers need to know what it means to be badly off. In this article, we outline a conception of disadvantage suitable for identifying the worst off for the purpose of making (...) health resource allocation decisions. According to our total advantage view: the worst off are those who have the greatest total lifetime disadvantage; advantage foregone due to premature death should be treated in the same way as other ways of being disadvantaged at a time; how badly off someone is depends on the actual outcomes that will befall her without intervention, not her prospects at a time; and all significant forms of disadvantage count for determining who is worst off, not just disadvantage relating to health. We conclude by noting two important implications of the total advantage view: first, that those who die young are among the globally worst off, and second, that the epidemiological shift in the global burden of disease from communicable to non-communicable diseases should not lead to a corresponding shift in global health spending priorities. (shrink)

Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health policy choices—are only a (...) small portion of the overall impact of health policy. This chapter considers what weight health policy should give to its “spill-over effects,” namely non-health and indirect benefits. (shrink)

According to the sufficiency theory of justice in health, justice requires that people have equal access to adequate health. In this article, I lay out the structure of this view and I assess its distributive implications for setting priority (i) between health needs across persons and (ii) between health care spending and other societal goods. I argue, first, that according to the sufficiency theory, deficiency in health cannot be completely offset by providing other (...) societal goods. And, second, that it can prevent the medicalization of societies by stressing that improvements beyond the level of adequate health have relatively little weight, if any, from the standpoint of justice. (shrink)

One widely used method for allocating health care resources involves the use of cost-effectiveness analysis (CEA) to rank treatments in terms of quality-adjusted life-years (QALYs) gained. CEA has been criticized for discriminating against people with disabilities by valuing their lives less than those of non-disabled people. Avoiding discrimination seems to lead to the ’QALY trap’: we cannot value saving lives equally and still value raising quality of life. This paper reviews existing responses to the QALY trap and argues that (...) all are problematic. Instead, we argue that adopting a moderate form of prioritarianism avoids the QALY trap and disability discrimination. (shrink)

Estimates of the burden of disease assess the mortality and morbidity that affect a population by producing summary measures of health such as quality-adjusted life years and disability-adjusted life years. These measures typically do not include stillbirths among the negative health outcomes they count. Priority-setting decisions that rely on these measures are therefore likely to place little value on preventing the more than three million stillbirths that occur annually worldwide. In contrast, neonatal deaths, which occur in (...) comparable numbers, have a substantial impact on burden of disease estimates and are commonly seen as a pressing health concern. In this article we argue in favor of incorporating unintended fetal deaths that occur late in pregnancy into estimates of the burden of disease. Our argument is based on the similarity between late-term fetuses and newborn infants and the assumption that protecting newborns is important. We respond to four objections to counting stillbirths: that fetuses are not yet part of the population and so their deaths should not be included in measures of population health; that valuing the prevention of stillbirths will undermine women's reproductive rights; that including stillbirths implies that miscarriages should also be included; and that birth itself is in fact ethically significant. We conclude that our proposal is ethically preferable to current practice and, if adopted, is likely to lead to improved decisions about health spending. (shrink)

Imagine you are the CEO of a hospital [. . .]. Decisions are constantly being made in your organization about how to spend the organization's money. The amount of money available to spend is never adequate to pay for everything you wish you could spend it on, therefore you must set spending priorities. There are two questions you need to be able to answer . . . How should we set priorities in this organization? How do we know when we (...) are doing it well? When people seek to achieve good public policy, the result will tend to be good public policy. In a collective choice process, public‐spirited individual participants produce good public policy by deliberating—talking with each other, listening to each other's arguments, and being willing to learn and change their minds based on such dialogue. –Steven Kelman (1992: 181) Public policy scholars agree that those persons (or agencies) vested with the authority to establish health care priorities should elicit public input before making rationing decisions. The two most common approaches are (i) consultation and (ii) deliberation. Though deliberation has obvious advantages over consultation, it falters in the face of the objection that ordinary citizens lack the cognitive resources for the extended, rigorous inquiry required of them in undertaking the priority‐setting task. To overcome this objection, I propose that deliberative forums for health care rationing should be designed so that they imitate the natural pattern of human experience. The experience of deliberation should encompass both prolonged periods of less‐demanding cognitive activity, in which citizens passively receive information, and briefer periods of more‐demanding cognitive activity, in which they engage in active problem‐solving. In arguing for this thesis, I rely on two theoretical sources and one practical case study, in the following order: (i) John Dewey's metaphysics of experience, (ii) cognitive science research on schemas and frames, and (iii) the Health Care Council in São Paulo, Brazil. (shrink)

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. (shrink)

When allocating scarce healthcare resources, the expected benefits of alternative allocations matter. But, there are different kinds of benefits. Some are direct benefits to the recipient of the resource such as the health improvements of receiving treatment. Others are indirect benefits to third parties such as the economic gains from having a healthier workforce. This article considers whether only the direct benefits of alternative healthcare resource allocations are relevant to allocation decisions, or whether indirect benefits are relevant too. First, (...) we distinguish different conceptions of direct and indirect benefits and argue that only a recipient conception could be morally relevant. We analyze four arguments for thinking that indirect benefits should not count and argue that none is successful in showing that the indirectness of a benefit is a good reason not to count it. We conclude that direct and indirect benefits should be evaluated in the same way. (shrink)

The value of health states is often understood to depend on their impact on the goodness of people's lives. As such, prominent health states metrics are grounded in particular conceptions of wellbeing – e.g. hedonism or preference satisfaction. In this paper, I consider how liberals committed to the public justification requirement – the requirement that public officials choose laws and policies that are justifiable to their citizens – should evaluate health states. Since the public justification requirement prohibits (...) public officials from appealing to controversial conceptions of the good life, liberals committed to this principle face a significant puzzle. (shrink)

We respond to open peer commentaries on our target article, "Health Research Priority Setting: The Duties of Individual Funders".

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. (shrink)

This report from the WHO Consultative Group on Equity and Universal Health Coverage offers advice on how to make progress fairly towards universal health coverage.

This paper critically analyses the priority-setting rules used by the National Institute for Health and Clinical Excellence (NICE) in the UK and proposed by the Netherlands' Council on Public Health and Health Care (RVZ). It argues that neither gives proper weight to improving the lot of those who are worse off than others.

The assumption that procuring more organs will save more lives has inspired increasingly forceful calls to increase organ procurement. This project, in contrast, directly questions the premise that more organ transplantation means more lives saved. Its argument begins with the fact that resources are limited and medical procedures have opportunity costs. Because many other lifesaving interventions are more cost‐effective than transplantation and compete with transplantation for a limited budget, spending on organ transplantation consumes resources that could have been used to (...) save a greater number of other lives. This argument has not yet been advanced in debates over expanded procurement and could buttress existing concerns about expanded procurement. To support this argument, I review existing empirical data on the cost‐effectiveness of transplantation and compare them to data on interventions for other illnesses. These data should motivate utilitarians and others whose primary goal is maximizing population‐wide health benefits to doubt the merits of expanding organ procurement. I then consider two major objections: one makes the case that transplant candidates have a special claim to medical resources, and the other challenges the use of cost‐effectiveness to set priorities. I argue that there is no reason to conclude that transplant candidates’ medical interests should receive special priority, and that giving some consideration to cost‐effectiveness in priority setting requires neither sweeping changes to overall health priorities nor the adoption of any specific, controversial metric for assessing cost‐effectiveness. Before searching for more organs, we should first ensure the provision of cost‐effective care. (shrink)

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology’s promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate “value proposition” of their innovation and seek to respond to (...) what they consider the key expectations of their customers. Our analysis shows that the manufacturers’ framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians’ and patients’ expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others. (shrink)

Non-communicable diseases now account for the majority of the global burden of disease and an international campaign has emerged to raise their priority on the post-2015 development agenda. We argue, to the contrary, that there remain strong reasons to prioritize maternal and child health. Policy-makers ought to assign highest priority to the health conditions that afflict the worst off. In virtue of how little healthy life they have had, children who die young are among the globally (...) worst off. Moreover, many interventions to deal with the conditions that cause mortality in the young are low-cost and provide great benefits to their recipients. Consistent with the original Millennium Development Goals, the international community should continue to prioritize reductions in communicable diseases, neonatal conditions, and maternal health despite the shifts in the global burden of disease. (shrink)

What is the role of lay deliberation – if any – in health-care rationing, and administration more generally? Two potential answers are suggested by recent debates on the subject. The one, which I will call the technocratic answer, suggests that there is no distinctive role for lay participation once ordinary democratic politics have set the goals and priorities which reform should implement. Determining how best to achieve those ends, and then actually achieving them, this view suggests, is a matter (...) for experts, armed with the best evidence available to them, both of the subject area involved, and of management and administrative excellence. -/- By contrast, the second, deliberative, view holds that lay deliberation has an important role in the administration and execution of government policy, both because these latter inevitably have a political element which needs to reflect democratic norms and values, and because lay people are, themselves, a source of information, even of wisdom, that experts will want to use in fulfilling their professional responsibilities. Recent debates on the value of lay participation in healthcare provision can illuminate the strengths and weaknesses of both approaches, as can the experience of NICE. So, I will start by examining two articles by Albert Weale, which attempt to clarify the role that lay deliberation should have in healthcare, before turning to the dilemmas for both the technocratic and deliberative views which emerge from the experience of NICE. (shrink)

In carrying out cost-benefit or cost-effective analysis, a discount rate should be applied to some kinds of future benefits and costs. It is controversial, though, whether future health is in this class. I argue that one of the standard arguments for discounting (from diminishing marginal returns) is inapplicable to the case of health, while another (favouring a pure rate of time preference) is unsound in any case. However, there are two other reasons that might support a positive discount (...) rate for future health: one relating to uncertainty, and the other relating to the instrumental benefits of improved health. While the latter considerations could be modelled via a discount rate, they could alternatively be modelled more explicitly, in other ways; I briefly discuss which modelling method is preferable. Finally, I argue against the common claims that failing to discount future health would lead to paradox, and/or to inconsistency with the way future cash flows are treated. (shrink)

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. (shrink)

The article by MacKay and Saylor (2020) claims that the principle of fair subject selection yields conflicting imperatives (e.g. in the case of pregnant women) and should be understood as “a bundle of four distinct sub-principles” (i.e. fair inclusion, burden sharing, opportunity, distribution of third-party risks), each having conflicting normative recommendations (MacKay and Saylor 2020). The authors also offer guidance as to how we should navigate between subprinciples that may conflict with each other. The problem is a crucial one since (...) fair subject selection is one of the principles regulating clinical research that produces generalizable knowledge with the potential of improving people’s health. Therefore, there may be cases where the way in which participants are selected directly influences the generalizability (or its lack) of the clinically relevant knowledge and its value (if any) to different groups. In my commentary article, written from the philosophical perspective, I notice a number of interrelated problems which I believe have not been discussed thoroughly in the target article: (1) the precise way in which health care priority setting should influence the content of health research priority setting and fair inclusion principles; (2) the distinction between group and individual benefits and burdens from clinical research; (3) the reference class problem in medical research. (shrink)

The Distribution View provides a model that integrates four distributional concerns in the evaluation of risky prospects. Starting from these concerns, we can generate an ordering over a set of risky prospects, or, starting from an ordering, we can extract a characterization of the underlying distributional concerns. Separability of States and/or Persons for multiple-person risky prospects, for single-person risky prospects and for multiple-person certain prospects are discussed within the model. The Distribution View sheds light on public health policies and (...) provides a framework for the discussion of Parfit's Priority View for risky prospects. (shrink)

Like most bioethical discussion, examination of human biobanks has been largely framed in terms of research subjects’ rights, principally informed consent, with some gestures toward public benefits. However, informed consent is for the competent, rights-bearing individual: focussing on the individual, it thus neglects social, economic and even political matters; focussing on the competent rights-bearer, it does not serve situations where consent is plainly inappropriate (eg, the young child) or where coercion can obviously be justified (the criminal). Using the British experience (...) of large-scale biobanking, I argue that the focus on consenting individuals distorts our ways of thinking about biobanks and has serious practical ramifications. This becomes clear if we contrast the case of adult biobanks intended for medical research with two other forms of biobanking. Thus child cohort studies – vital for sound scientific investigation of the interplay of genetics and environment in health – have been very badly funded next to adult studies. On the other hand, forensic databases have attracted massive investment, but little debate – partly owing to a sense that here, at least, is a case where consent is not relevant. Contrasting these central types of biobanking, I will suggest that there are powerful factors at work in limiting ‘ethics’ to individual rights. Projects of this size should direct our attention to more overtly political questions concerning priority setting and organisation of medical research. (shrink)

Background: Mental health professionals working in correctional contexts engage a double role to care and control. This dual loyalty conflict has repeatedly been criticized to impede the development of a high-quality alliance. As therapeutic alliance is a robust predictor of outcome measures of psychotherapy, it is essential to investigate the effects of this ethical dilemma. Methods: This qualitative interview study investigates patients’ perceptions of their therapists’ dual role conflict in court-mandated treatment settings. We interviewed 41 older incarcerated persons using (...) a semi-structured interview guide, the interviews were subsequently analyzed following thematic analysis. Results: We first present the patients’ perceptions of their treating psychotherapist’s dual loyalty conflict, which was linked to their overall treatment experience. In a second step, we outline the study participants’ reasons for this judgment, which were most commonly linked to feelings of trust or betrayal. More specifically, they named certain therapist characteristics and activities that enabled them to develop a trustful therapeutic alliance, which we grouped into four topics: respecting the patient’s pace and perceived coercion; patient health needs to be first priority; clarity in roles and responsibilities; and the art of communication – between transparency and unchecked information sharing. Discussion: Developing a high quality alliance in mandatory offender treatment is central due to its relationship with recovery and desistance. Our findings show that some therapists’ characteristics and activities attenuate the negative impact of their double role on the development and maintenance of the alliance. To increase the effectiveness of court-mandated treatments, we need to support clinicians in dealing with their dual role to allow the formation of a high quality therapeutic alliance. Our qualitative interview study contributed to this much-needed empirical research on therapist’ characteristics promoting a trustful relationship in correctional settings. (shrink)

In many countries, the COVID‐19 pandemic varied starkly between different racial and ethnic groups. Before vaccines were approved, some considered assigning priority access to worse‐hit racial groups. That debate can inform rationing in future pandemics and in some of the many areas outside COVID‐19 that admit of racial health disparities. However, concerns were raised that “race‐responsive” prioritizations would be ruled unlawful for allegedly constituting wrongful discrimination. This legal argument relies on an understanding of discrimination law as demanding color‐blindness. (...) We argue that a, color‐blind understanding of discrimination would be hostile only to one of two rationales for prioritizing the relevant racial minorities in settings of racial health disparities. We also propose a method for incorporating appropriate race‐responsive concerns that is in many ways ethically and legally superior to ones suggested thus far. That method turns artificial intelligence, thanks precisely to its artificial and “black box” nature (features that underlie recent concerns about artificial intelligence's discriminatory potential), into an instrument of social justice. (shrink)

A comprehensive understanding of the ethics of the COVID-19 pandemic priorities must be sensitive to the influence of social inequality. We distinguish between ex-ante and ex-post relevance of social inequality for COVID-19 disadvantage. Ex-ante relevance refers to the distribution of risks of exposure. Ex-post relevance refers to the effect of inequality on how patients respond to infection. In the case of COVID-19, both ex-ante and ex-post effects suggest a distribution which is sensitive to the prevalence social inequality. On this basis, (...) we provide a generic fairness argument for the claim that welfare states ought to favour a healthcare priority scheme that gives particular weight to protecting the socially disadvantaged. (shrink)

Donors to global health programs and policymakers within national health systems have to make difficult decisions about how to allocate scarce health care resources. Principled ways to make these decisions all make some use of summary measures of health, which provide a common measure of the value (or disvalue) of morbidity and mortality. They thereby allow comparisons between health interventions with different effects on the patterns of death and ill health within a population. The (...) construction of a summary measure of health requires that a number be assigned to the harm of death. But the harm of death is currently a matter of debate: different philosophical theories assign very different values to the harm of death at different ages. This chapter considers how we should assign numbers to the harm of deaths at different ages in the face of uncertainty and disagreement. (shrink)

This mixed-method research was conducted to determine the levels of challenges, innovations and interventions in the operationalization of summative assessment in Music, Arts, Physical Education, and Health (MAPEH) of public MAPEH secondary school teachers in the Division of Iloilo for the school year 2021-2022. This study also determined whether significant relationship existed among challenges, innovations and interventions. The participants of this study were the 290 randomly selected public secondary school MAPEH teachers determined using the Slovin’s formula. The data- gathering (...) instruments were the researcher-made Challenges, Innovations and Interventions Questionnaires. Focus-Group Discussion was conducted to gather qualitative data for triangulation with the quantitative data gathered. Mean, frequency, percentage, rank and Standard Deviation were used for descriptive data analysis, while ANOVA and Pearson r were used for inferential data analysis at 0.05 level of significance. The findings of the study revealed that the level of top 10 challenges in the operationalization of summative assessment in MAPEH is “high”. Also, the level of the top 10 innovations in the operationalization of summative assessment in MAPEH is “high”. Generally, the level of top 10 interventions in the operationalization of summative assessment in MAPEH is “high” except for the top 4 interventions, “helped students with setting priorities in terms of answering summative assessment, written works and performance tasks”, “provided rubrics and performance standards to assist the learner in doing the summative assessment both written works and performance tasks”, “established clear, consistent rule which are direct and simple in the written works and performance tasks to allow learners perform the task with ease”, and “encouraged self- expression in different assessment task’s” which level is “very high”. It was also revealed that the interventions among the levels of challenges encountered by the MAPEH teachers in the operationalization of summative assessment varies significantly and there were varied interventions employed to address the challenges. Also, the interventions among the levels of innovations developed by the MAPEH teachers in the operationalization of summative assessment significantly differed. Interventions vary since there are many available innovations. It was also revealed in the study that significantly positive relationships existed among the level of challenges, innovations as independent variables and interventions as dependent variable in the operationalization of the summative assessments. (shrink)

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, (...) Health and Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

The paper presents the outlines of an ontology of plans and guidelines, which is then used as the basis for a framework for implementing guideline-based systems for the management of workflow in health care organizations. The framework has a number of special features, above all in that it enables us to represent in formal terms assignments of work-items both to individuals and to teams and to tailor guideline to specific contexts of application in health care organizations. It is (...) designed also to enable implementations to do justice to the fact that the processes carried out in health care organizations may deviate in different ways from the norms set forth in corresponding guideline definitions. This means that implementations built in conformity with the framework will be marked by a type of flexibility that might make them more likely to be accepted by healthcare professionals than are standard guideline-based management systems. (shrink)

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an effort to (...) justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)

Healthcare systems across the globe are struggling with increasing costs and worsening outcomes. This presents those responsible for overseeing healthcare with a challenge. Increasingly, policymakers, politicians, clinical entrepreneurs and computer and data scientists argue that a key part of the solution will be ‘Artificial Intelligence’ (AI) – particularly Machine Learning (ML). This argument stems not from the belief that all healthcare needs will soon be taken care of by “robot doctors.” Instead, it is an argument that rests on the classic (...) counterfactual definition of AI as an umbrella term for a range of techniques that can be used to make machines complete tasks in a way that would be considered intelligent were they to be completed by a human. Automation of this nature could offer great opportunities for the improvement of healthcare services and ultimately patients’ health by significantly improving human clinical capabilities in diagnosis, drug discovery, epidemiology, personalised medicine, and operational efficiency. However, if these AI solutions are to be embedded in clinical practice, then at least three issues need to be considered: the technical possibilities and limitations; the ethical, regulatory and legal framework; and the governance framework. In this article, we report on the results of a systematic analysis designed to provide a clear overview of the second of these elements: the ethical, regulatory and legal framework. We find that ethical issues arise at six levels of abstraction (individual, interpersonal, group, institutional, sectoral, and societal) and can be categorised as epistemic, normative, or overarching. We conclude by stressing how important it is that the ethical challenges raised by implementing AI in healthcare settings are tackled proactively rather than reactively and map the key considerations for policymakers to each of the ethical concerns highlighted. (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)

Can we identify potential long-term consequences of digitalisation on public health? Environmental studies, metabolic research, and state of the art research in neurobiology point towards the reduced amount of natural day and sunlight exposure of the developing child, as a consequence of increasingly long hours spent indoors online, as the single unifying source of a whole set of health risks identified worldwide, as is made clear in this review of currently available literature. Over exposure to digital environments, from (...) abuse to addiction, now concerns even the youngest (ages 0 to 2) and triggers, as argued on the basis of clear examples herein, a chain of interdependent negative and potentially long-term metabolic changes. This leads to a deregulation of the serotonin and dopamine neurotransmitter pathways in the developing brain, currently associated with online activity abuse and/or internet addiction, and akin to that found in severe substance abuse syndromes. A general functional working model is proposed under the light of evidence brought to the forefront in this review. (shrink)