Health care costs have been rising steadily in most industrialized countries. These increases are driven primarily by technological advances and, to a lesser degree, by aging of the population. Many factors make it unlikely that market forces alone will limit increases in the costs of health care. These unremitting increases make health care rationing appear both necessary and inevitable.One of the least controversial mechanisms for rationing could be to allow patients to make their own choices as to which kinds of (...) care they would be willing to forgo. This is appealing because it preserves individual freedom of choice regarding health care in a way that other rationing mechanisms often do not. Rationing by patient choice, however, can only happen if patients recognize that resources are limited and need to be conserved, and are willing to forgo marginal benefits. (shrink)

This essay outlines the moral dilemma of funding orphan drug research and development. To date, ethical aspects of priority setting for research funding have not been an issue of discussion in the bioethics debate. Conflicting moral obligations of beneficence and distributive justice appear to demand very different levels of funding for orphan drug research. The two types of orphan disease, rare diseases and tropical diseases, however, present very different ethical challenges to questions about allocation of research funds. The dilemma is (...) analysed considering utilitarian and rights based theories of justice and moral obligations of non-abandonment and a professional obligation to advance medical science. The limitations of standard economic evaluation tools and other priority setting tools used to inform health policy decision makers on research funding decisions are outlined. (shrink)

“Evidence based medicine” is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, costs affect the content of EBM, (...) EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism. (shrink)

The Social Value Judgments consultation document reveals NICE’s failure to understand its role in healthcare prioritisationThe National Institute for Health and Clinical Excellence has published a draft guideline, Social Value Judgments: Guidelines for the Institute and its Advisory Bodies , which outlines the ethical framework that will guide its decision making in the future.1 NICE guidance has a profound effect upon the delivery of health care within the National Health Service so it is crucial that an overarching guideline such as (...) this is suited to the task that it needs to perform. In this paper we argue that NICE has misunderstood the way in which its advice fits into prioritisation decisions. This misunderstanding is amplified by its views about the ethical principles that should apply to prioritisation and, in particular, its failure to appreciate the role of fair processes in prioritisation.The national and international standing of NICE means that the definitive version of Social Value Judgments: Guidelines for the Institute and its Advisory Bodies is likely to have influence beyond the institute itself. There is much to welcome about the document, not least the acknowledgement that there are important ethical dimensions to NICE’s decision making. Indeed, the significance of the document lies in the fact that NICE is attempting to create an explicit ethical framework for funding decisions.There is, however, much that is of concern. Although John Harris has made some important points about the NICE position on age and sex,2 there are other important problems that need to be discussed. First, there appears to be confusion over the nature of the funding decisions taken by NICE and, as a result, the role of its guideline. It is of vital importance that professionals and public alike understand the precise nature of …. (shrink)

PhD, Institute of Public Health, Unit of Medical Philosophy and Clinical Theory, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099 1014 Copenhagen. Tel: +45 30 32 33 63; Email: s.lauridsen{at}pubhealth.ku.dk ' + u + '@ ' + d + ' '/ /- ->Citizens’ consent to political decisions is often regarded as a necessary condition of political legitimacy. Consequently, legitimate allocation of healthcare has seemed almost unattainable in contemporary pluralistic societies. The problem is that citizens do not agree on any (...) single principle governing priorities among groups of patients. The Accountability for Reasonableness framework suggests an ingenious solution to this problem of moral disagreement. Rather than advocating any substantive distributive principle, its advocates propose a feasible set of conditions, which, if met by decision makers at the institutional level, provide, so it is promised, legitimate decisions. While we agree that A4R represents an important contribution to the priority-setting debate, we challenge the framework in two respects. First, we argue that A4R, and more specifically the relevance condition of A4R, does not enable healthcare institutions to generally distinguish between relevant and irrelevant reasons for priority-setting. Second, we criticize Daniels’ and Sabin's argument that A4R and deliberative democracy constitute necessary and sufficient conditions of a feasible procedure for setting legitimate limits within healthcare. CiteULike Connotea Del.icio.us What's this? (shrink)

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems.

This paper opens a critical conversation about the ethics of international bioethics conferencing and proposes principles that commit to being anti-discriminatory, global, and inclusive. We launch this conversation in the Section, Case Study, with a case example involving the International Association of Bioethics’ (IAB’s) selection of Qatar to host the 2024 World Congress of Bioethics. IAB’s choice of Qatar sparked controversy. We believe it also may reveal deeper issues of Islamophobia in bioethics. The Section, Principles for International Bioethics Conferencing, sets (...) forth and defends proposed principles for international bioethics conferencing. The Section, Applying Principles to Site Selection applies the proposed principles to the case example. The Section, Applying Principles Beyond Site Selection addresses other applications of the proposed principles. The Section, Objections responds to objections. We close (in the Section, Conclusion) by calling for a wider discussion of our proposed principles.One-Sentence Capsule Summary: How should bioethicists navigate the ethics of global bioethics conferencing? (shrink)

This World Bank Report offers a new conception of fair decision processes in health financing. It argues that such procedural fairness can contribute to fairer outcomes, strengthen the legitimacy of decision processes, build trust in authorities, and promote the sustainability of reforms on the path to health coverage for all.

In the age of globalization, and increased interdependence in the world that we face today, there is a question we may have to raise: Do we need and could we attain a world government, capable of insuring the peace and facilitating worldwide well-being in a just and efficient manner? In the twenty chapters of this book, some of the most prominent living philosophers give their consideration to this question in a provocative and engaging way. Their essays are not only of (...) wide theoretical interest but also provide a thought-provoking approach to this most timely and urgent issue. A wide range of perspectives are represented here. -/- The authors include Richard Falk, Michael Walzer, Thomas Pogge, Larry May, Alfred Rubin, Stanley Hoffman, Jan Narveson, Virginia Held, Pauline Kleingeld and Luis Cabrera. Jovan Babic is Professor of Ethics at the University of Belgrade and Visiting Professor at Portland State University. Petar Bojanic is Senior Research Fellow at the Centre for Ethics, Law and Applied Philosophy (CELAP) as well as the Institute of Philosophy and Social Theory (Belgrade). (shrink)

The National Institute for Health and Care Excellence (NICE) is the UK’s primary healthcare priority-setting body, responsible for advising the National Health Service in England on which technologies to fund and which to reject. Until recently, the normative approach underlying this advice was described in a 2008 document entitled ‘Social value judgements: Principles for the development of NICE guidance’ (SVJ). In January 2020, however, NICE replaced SVJ with a new articulation of its guiding principles. Given the significant evolution of NICE’s (...) methods between 2008 and 2020, this study examines whether this new document (‘Principles’) offers a transparent account of NICE’s current normative approach. It finds that it does not, deriving much of its content directly from SVJ and failing to fully acknowledge or explain how and why NICE’s approach has since changed. In particular, Principles is found to offer a largely procedural account of NICE decision-making, despite evidence of the increasing reliance of NICE’s methods on substantive decision-rules and ‘modifiers’ that cannot be justified in purely procedural terms. Thus, while Principles tells NICE’s stakeholders much about how the organisation goes about the process of decision-making, it tells them little about the substantive grounds on which its decisions are now based. It is therefore argued that Principles does not offer a transparent account of NICE’s normative approach (either alone, or alongside other documents) and that, given NICE’s reliance on transparency as a requirement of procedural justice, NICE does not in this respect satisfy its own specification of a just decision-maker. (shrink)

The National Institute for Health and Care Excellence, the UK’s main healthcare priority-setting body, recently reaffirmed a longstanding claim that in recommending technologies to the National Health Service it cannot apply the ‘rule of rescue’. This paper explores this claim by identifying key characteristics of the rule and establishing to what extent these are also features of NICE’s approach to evaluating ultra-orphan drugs through its highly specialised technologies programme. It argues that although NICE in all likelihood does not act because (...) of the rule in prioritising these drugs, its actions in relation to HSTs are nevertheless in accordance with the rule and are not explained by the full articulation of any alternative set of rationales. That is, though NICE implies that its approach to HSTs is not motivated by the rule of rescue, it is not explicit about what else might justify this approach given NICE’s general concern with overall population need and value for money. As such, given NICE’s reliance on notions of procedural justice and its commitment to making the reasons for its priority-setting decisions public, the paper concludes that NICE’s claim to reject the rule is unhelpful and that NICE does not currently meet its own definition of a fair and transparent decision-maker. (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)

Algorithms can now identify patterns and correlations in the (big) datasets, and predict outcomes based on those identified patterns and correlations with the use of machine learning techniques and big data, decisions can then be made by algorithms themselves in accordance with the predicted outcomes. Yet, algorithms can inherit questionable values from the datasets and acquire biases in the course of (machine) learning, and automated algorithmic decision-making makes it more difficult for people to see algorithms as biased. While researchers have (...) taken the problem of algorithmic bias seriously, but the current discussion on algorithmic fairness tends to conceptualize ‘fairness’ in algorithmic fairness primarily as a technical issue and attempts to implement pre-existing ideas of ‘fairness’ into algorithms. In this paper, I show that such a view of algorithmic fairness as technical issue is unsatisfactory for the type of problem algorithmic fairness presents. Since decisions on fairness measure and the related techniques for algorithms essentially involve choices between competing values, ‘fairness’ in algorithmic fairness should be conceptualized first and foremost as a political issue, and it should be (re)solved by democratic communication. The aim of this paper, therefore, is to explicitly reconceptualize algorithmic fairness as a political question and suggest the current discussion of algorithmic fairness can be strengthened by adopting the accountability for reasonableness framework. (shrink)

Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we (...) convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels. This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting. (shrink)

Human civilisation faces a range of existential risks, including nuclear war, runaway climate change and superintelligent artificial intelligence run amok. As we show here with calculations for the New Zealand setting, large numbers of currently living and, especially, future people are potentially threatened by existential risks. A just process for resource allocation demands that we consider future generations but also account for solidarity with the present. Here we consider the various ethical and policy issues involved and make a case for (...) further engagement with the New Zealand public to determine societal values towards future lives and their protection. (shrink)

Recent health legislation in Norway significantly increases access to specialist care within a legally binding time frame. The paper describes the contents of the new legislation and introduces some of the challenges with proliferations of rights to health care. The paper describes some of the challenges associated with the proliferation of legal rights to health care. It explains the benefits of assessing the new law in the light of a rights framework. It then analyses the problematic aspects of establishing additional (...) priority rules as solutions to rights conflicts. It then defends adequacy criteria for acceptable priority rules when such rules are unavoidable. It finally defends our proposed method and explores concrete applications. (shrink)

Health-care goods are goods with peculiar properties, and where they are scarce, societies face potentially explosive distributional conflicts. Animated public and academic debates on the necessity and possible justice of limit-setting in health care have taken place in the last decades and have recently taken a turn toward procedural rather than substantial criteria for justice. This article argues that the most influential account of procedural justice in health-care rationing, presented by Daniels and Sabin, is indeterminate where concrete properties of rationing (...) institutions are concerned. Such properties inscribe substantial norms into institutions. These norms can derive validity only from democratic majority decisions, which must be seen as an instance of pure procedural justice. We therefore have to move the discussion to a meta-level and ask how concrete properties of institutions are being chosen. I suggest four criteria for sufficiently democratic institutional design choice and conclude that as institutional properties are likely to have effects on the resulting distribution of health care, design choices should be empirically informed and taken both democratically and deliberately. (shrink)

In modern representative democracies, much healthcare is publicly funded or provided and so the question of what healthcare systems should do is a matter of public policy. Given that public resources are inevitably limited, what should be done and who should benefit from healthcare? It is a dilemma for policymakers and a subject of debate within several disciplines, but rarely across disciplines. In this paper, I draw on thinking from several disciplines and especially philosophy, economics, and systems theory. I conclude (...) that economist and philosopher John Broome’s writing provides the framework for an answer: a healthcare system in a democracy should do as much good as possible, although sometimes we should sacrifice some overall good for the sake of fairness. This leaves open some detailed questions about what in practice we consider to be good and fair, and about when some good should be traded off in order to be fair. The answers to these questions depend on our values, or as explained by systems theory, our weltanschauung. How policy decisions should be made when citizens’ values differ is a subject of extensive academic debate. However, it is a separate question. Representative democracies have mechanisms for resolving such debates. (shrink)

This chapter concerns the normativity of the concepts of paternalism and libertarian paternalism. The first concept is central in evaluating public health policy, but its meaning is controversial. The second concept is equally controversial and has received much attention recently. It may or may not shape the future evaluation of public health policy. In order to facilitate honest and fruitful debate, I consider three approaches to these concepts, in terms of their normativity. Concepts, I claim, may be considered nonnormative, normatively (...) charged, or normative in that they involve more complex relationships between values or duties. While the last approach is often best, other approaches may be appropriate depending on the context and purpose of discussion. The chapter’s conceptual investigation is illustrated by application to two public health policies: a tax on the consumption of fat and the encouragement of health-promoting food displays in restaurants and supermarkets. (shrink)

Assessment of evidence is becoming a centralpart of health policy decisions – not least inlimit setting decisions. Limit-settingdecisions can be defined as the withholding ofpotentially beneficial health care. Thisarticle seeks to explore the value choicesrelated to the use of evidence in limit-settingdecisions at the political level. To betterspecify the important but restricted role ofevidence in such decisions, the value choicesof relevance are discussed explicitly. Fourcriteria are often considered when settinglimits:1. The severity of disease if untreated or treatedby standard care2. The (...) effectiveness of the new technology3. The cost-effectiveness of the new technology4. The quality of evidence on (1)–(3)The production and assessment of evidence isimportant for each criterion, but severalpoints are identified where the practice ofevidence-based medicine could be furtherdeveloped to capture a broader spectrum ofethical and political concerns that suchdecisions naturally evoke among citizens. (shrink)

The overall aim of this article is to discuss the organization of limit setting in healthcare in terms of legitimacy. We argue there is a strong ethical demand that such processes should be arranged to provide adversely affected people well-justified reasons to confer legitimacy to the processes despite favouring a different decision-making outcome. Two increasingly popular approaches, Accountability for Reasonableness (A4R) and Multi-Criteria Decision Analysis (MCDA), can both be applied to support legitimate decision-making processes. However, the role played by ‘fair-minded (...) people’ in the A4R framework can be shown to undermine an adequate conceptualization of legitimacy according to the ethical demand. We discuss and specify conditions enabling A4R to meet this ethical demand when being implemented in a real-world setting without having to renounce the aim of striving for ‘reasonableness’ and impartiality. The methodological approach MCDA describes how to arrange for transparent resource allocation. This approach does not encompass any normative guidance on how to shape limit settings in terms of ‘reasonableness’; it basically promotes ‘rational’ decisions. We discuss how this practical methodology can be integrated with the theoretical A4R framework to meet the ethical demand while at the same time promoting politically required impartiality of healthcare limit setting. (shrink)

Democratic societies find it difficult to reach consensus concerning principles for healthcare distribution in the face of resource constraints. At the same time the need for legitimacy of allocation decisions has been recognised. Against this background, the National Institute for Health and Clinical Excellence (NICE) aspires to meet the principles of procedural justice, specifically the conditions of accountability for reasonableness as espoused by Daniels and Sabin, that is, publicity, relevance, revisions and appeal, and enforcement. Although NICE has adopted a highly (...) standardised approach and continuously publishes key documents on its website, its technology appraisal programme does not fulfil the publicity condition of accountability for reasonableness. Economic models are not made sufficiently transparent to enable public scrutiny, and decision criteria other than cost-effectiveness remain enigmatic. NICE’s reliance on cost-utility analysis and “plausible” cost-per-quality-adjusted life year (QALY) benchmarks further raises serious issues with regard to the relevance condition of accountability for reasonableness. This is illustrated by counterintuitive cost-per-QALY rankings that are difficult to justify using reflective equilibrium methods, and by the current debate surrounding expensive therapies for rare diseases (“orphan” treatments). In addition, an excessive focus on QALYs may stand in the way of exploiting the best available effectiveness evidence. The NICE mechanism for revision and appeals is also more restrictive than provided in accountability for reasonableness. As to the enforcement condition, no effective quality assurance processes are in place for technology assessments, and implementation of guidance remains imperfect. NICE, despite impressive efforts, appears to have a long way to go before meeting the conditions of accountability for reasonableness. (shrink)

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

At the 5th International Conference on Priorities in Health Care in Wellington, New Zealand, 2004, one resonating theme was that for priority setting to be effective, it has to include clinicians in both decision making and the enforcement of those decisions. There was, however, a disturbing undertone to this theme, namely that doctors, in particular, were unjustifiably thwarting good systems of prioritising scarce healthcare resources. This undertone seems unfair precisely because doctors may, and in some cases do, feel obligated by (...) their professional ethics to remain uninvolved either in deciding priorities and in some cases in enforcing them. I will argue that the professional role of a doctor ought not be considered inconsistent with the role of a priority setter or enforcer, as long as one crucial element is in place, a rationally coherent and broadly justifiable regime for prioritising healthcare. Given this I conclude both that prioritisation and doctoring are not incompatible under certain conditions, and that the education of healthcare professionals ought to include material on distributive justice in healthcare. (shrink)

Rationing healthcare is a difficult task, which includes preventing patients from accessing potentially beneficial treatments. Proponents of implicit rationing argue that politicians cannot resist pressure from strong patient groups for treatments and conclude that physicians should ration without informing patients or the public. The authors subdivide this specific programme of implicit rationing, or “hidden rationing”, into local hidden rationing, unsophisticated global hidden rationing and sophisticated global hidden rationing. They evaluate the appropriateness of these methods of rationing from the perspectives of (...) individual and political autonomy and conclude that local hidden rationing and unsophisticated global hidden rationing clearly violate patients’ individual autonomy, that is, their right to participate in medical decision-making. While sophisticated global hidden rationing avoids this charge, the authors point out that it nonetheless violates the political autonomy of patients, that is, their right to engage in public affairs as citizens. A defence of any of the forms of hidden rationing is therefore considered to be incompatible with a defence of autonomy. (shrink)

Background: Priority setting is necessary in current healthcare services. Discussion of fair process has highlighted the value of developing reasons for allocation decisions on the basis of experience gained from real cases.Aim: To identify the reasons that those with experience of real decision-making concerning resource allocation think relevant in deciding on the priority of a new but expensive drug treatment.Methods: Semistructured interviews with members of committees with responsibility for making resource allocation decisions at a local level in the British National (...) Health Service, analysed using modified grounded theory.Results: 22 interviews were carried out. 14 reasons were identified. Four reasons were almost universally considered most important: cost effectiveness; clinical effectiveness; equality and gross cost. No one reason was considered dominant. Some considerations, such as political directives and fear of litigation, were thought by many participants to distort decision-making. There was a substantial lack of agreement over the relevance of some reasons, such as the absence of alternative treatment for the condition.Conclusions: There is a clear consensus on the importance and role of a limited number of reasons in allocation decisions among participants. A focus on the process of decision-making, however, does not obviate the need for those involved in the process to engage with problematical ethical issues, nor for the importance of further ethical analysis. (shrink)

Many societies, and nearly all wealthy, developed countries, provide universal access to a broad range of public health and personal medical services. Is such access to health care a requirement of social justice, or is it simply a matter of social policy that some countries adopt and others do not? If it is a requirement of social justice, we should be clear about what kinds of care we owe people and how we determine what care is owed if we cannot (...) possibly meet every health need, as arguably no society can. We should be clear about what constitutes appropriate access to that care, given that there are diverse barriers to access. We must also be able to say why we owe these things as a matter of justice, and, of course, different accounts of social justice will bake and serve this cake in different ways. (shrink)

abstract The argument that scarce health care resources should be distributed so that patients in ‘need’ are given priority for treatment is rarely contested. In this paper, we argue that if need is to play a significant role in distributive decisions it is crucial that what is meant by need can be precisely articulated. Following a discussion of the general features of health care need, we propose three principal interpretations of need, each of which focuses on separate intuitions. Although this (...) account may not be a completely exhaustive reflection of what people mean when they refer to need, the three interpretations provide a starting‐point for further debate of what the concept means in its specific application. We discuss combined interpretations, the meaning of grading needs, and compare needs‐based priority setting to social welfare maximisation. (shrink)

We appreciate that the theme “ethics of ethics conferences” that we introduced in 2023 (Van der Graaf et al. 2023) was echoed by the previous and current presidents of the International Association...

Background As the UK’s main healthcare priority-setter, the National Institute for Health and Care Excellence (NICE) has good reason to want to demonstrate that its decisions are morally justified. In doing so, it has tended to rely on the moral plausibility of its principle of cost-effectiveness and the assertion that it has adopted a fair procedure. But neither approach provides wholly satisfactory grounds for morally defending NICE’s decisions. In this study we adopt a complementary approach, based on the proposition that (...) a priority-setter's claim to moral justification can be assessed, in part, based on the coherence of its approach and that the reliability of any such claim is undermined by the presence of dissonance within its moral system. This study is the first to empirically assess the coherence of NICE’s formal approach and in doing so to generate evidence-based conclusions about the extent to which this approach is morally justified. Methods The study is grounded in the theory, methods and standards of empirical bioethics. Twenty NICE policy documents were coded to identify and classify the normative commitments contained within NICE technology appraisal policy as of 31 December 2021. Coherence was systematically assessed by attempting to bring these commitments into narrow reflective equilibrium (NRE) and by identifying sources of dissonance. Findings Much of NICE policy rests on coherent values that provide a strong foundation for morally justified decision-making. However, NICE’s formal approach also contains several instances of dissonance which undermine coherence and prevent NRE from being fully established. Dissonance arises primarily from four sources: i) NICE’s specification of the principle of cost-effectiveness; ii) its approach to prioritising the needs of particular groups; iii) its conception of reasonableness in the context of uncertainty, and iv) its concern for innovation as an independent value. Conclusion At the time of analysis, the level of coherence across NICE policy provides reason to question the extent to which its formal approach to technology appraisal is morally justified. Some thoughts are offered on why, given these findings, NICE has been able to maintain its legitimacy as a healthcare priority-setter and on what could be done to enhance coherence. (shrink)

Healthcare priority-setting institutions have good reason to want to demonstrate that their decisions are morally justified—and those who contribute to and use the health service have good reason to hope for the same. However, finding a moral basis on which to evaluate healthcare priority-setting is difficult. Substantive approaches are vulnerable to reasonable disagreement about the appropriate grounds for allocating resources, while procedural approaches may be indeterminate and insufficient to ensure a just distribution. In this paper, we set out a complementary, (...) coherence-based approach to the evaluation of healthcare priority-setting. Drawing on Rawls, we argue that an institutional priority-setter’s claim to moral justification can be assessed, in part, based on the extent to which its many normative commitments are mutually supportive and free from dissonance; that is, on the ability to establish narrow reflective equilibrium across the normative content of a priority-setter’s policy and practice. While we do not suggest that the establishment of such equilibrium is sufficient for moral justification, we argue that failure to do so might—like the proverbial canary in the coalmine—act as a generalised warning that something is awry. We offer a theoretical argument in support of this view and briefly outline a practical method for systematically examining coherence across priority-setting policy and practice. (shrink)

For Van Rensselaer Potter (1911–2001), Global Bio-Ethics is about building on the legacy of Aldo Leopold (1887–1948), one of the most notable forest managers of the twentieth century who brought to light the importance of pragmatism in the sciences and showed us a new way to proceed with environmental ethics. Following Richard Huxtable and Jonathan Ives's methodological 'Framework for Empirical Bioethics Research Projects' called 'Mapping, framing, shaping,' published in BMC Medicine Ethics (2019)), we propose operationalizing a framework for Global Bio-Ethics (...) by hybridizing approaches in empirical bioethics and ecosystem management. We explain this framework using the metaphor of forest management. This mixed approach is articulated through three phases: (1) mapping the “landscape” to build a working theory, (2) framing the “scene” to prepare the fieldwork, and (3) shaping bioethics “tools” to stimulate cooperation. Applying this methodology, an adaptive management cycle is outlined to help ensure that political processes are sustainable and socially acceptable, still based on strategic and ethical thinking, but also capable of reshaping failing policies. (shrink)

Fair allocation of scarce healthcare resources has been much studied within philosophy and bioethics, but analysis has focused on a narrow range of cases. The Covid-19 pandemic provided significant new challenges, making powerfully visible the extent to which health systems can be fragile, and how scarcities within crucial elements of interlinked care pathways can lead to cascading failures. Health system resilience, while previously a key topic in global health, can now be seen to be a vital concern in high-income countries (...) too. Unfortunately, mainstream philosophical approaches to the ethics of rationing and prioritisation provide little guidance for these new problems of scarcity. Indeed, the cascading failures were arguably exacerbated by earlier attempts to make health systems leaner and more efficient. This paper argues that health systems should move from simple and atomistic approaches to measuring effectiveness to approaches that are holistic both in focusing on performance at the level of the health system as a whole, and also in incorporating a wider range of ethical concerns in thinking about what makes a health system good. (shrink)

The COVID-19 pandemic has strained healthcare resources the world over, requiring healthcare providers to make resource allocation decisions under extraordinary pressures. A year later, our understanding of COVID-19 has advanced, but our process for making ethical decisions surrounding resource allocation has not. During the first wave of the pandemic, our institution uniformly ramped-down clinical activity to accommodate the anticipated demands of COVID-19, resulting in resource waste and inefficiency. In preparation for the second wave, we sought to make such ramp down (...) decisions more prudently and ethically. We report the development of a tool that can be used to make fair and ethical decisions in times of resource scarcity. We formed an interprofessional team to develop and use this tool to ensure that a diverse range of stakeholder perspectives were represented in this development process. This team, called the clinical activity recovery team, established institutional objectives that were combined with well-established procedural values, substantive ethical principles and decision-making criteria by using a variation on the well-known accountability for reasonableness ethical framework. The result of this is a stepwise, semiquantitative, ethical decision tool that can be applied to resource allocation challenges in order to reach fair and ethically defensible decisions. This ethical decision tool can be applied in various contexts and may prove useful at both the institutional and the departmental level; indeed this is how it is applied at our centre. As the second wave of COVID-19 strains healthcare resources, this tool can help clinical leaders to make fair decisions. There are no data in this work. (shrink)

Rationing is an unavoidable mechanism for reining in healthcare costs. It entails establishing cutoff points that distinguish between what is and is not offered or available to patients. When the resource to be distributed is defined by vague and indeterminate terms such as “beneficial,” “effective,” or even “futile,” the ability to draw meaningful boundary lines that are both ethically and medically sound is problematic. In this article, I draw a parallel between the challenges posed by this problem and the ancient (...) Greek philosophical conundrum known as the “sorites paradox.” I argue, like the paradox, that the dilemma is unsolvable by conventional means of logical analysis. However, I propose another approach that may offer a practical solution that could be applicable to real-life situations in which cutoffs must be decided (such as rationing). (shrink)

Novel cellular therapy techniques promise to cure many haematology patients refractory to other treatment modalities. These therapies are intensive and require referral to and care from specialised providers. In the USA, this pool of providers is not expanding at a rate necessary to meet expected demand; therefore, access scarcity appears forthcoming and is likely to be widespread. To maintain fair access to these scarce and curative therapies, we must prospectively create a just and practical system to distribute care. In this (...) article, we first review previously implemented medical product and personnel allocation systems, examining their applicability to cellular therapy provider shortages to demonstrate that this problem requires a novel approach. We then present an innovative system for allocating cellular therapy access, which accounts for the constraints of distribution during real-world oncology practice by using a combination of the following principles: maximising life-years per personnel time, youngest and robust first, sickest first, first come/first served and instrumental value. We conclude with justifications for the incorporation of these principles and the omission of others, discuss how access can be distributed using this combination, consider cost and review fundamental factors necessary for the practical implementation and maintenance of this system. (shrink)

The main aim of this paper is to investigate the views of healthcare professionals in Portugal about healthcare rationing, and compare them with the views of college students. A self-administered questionnaire was used to collect data from a sample of 60 healthcare professionals and 180 college students. Respondents faced a hypothetical rationing dilemma where they had to order four patients and justify their choices. Multinomial logistic regressions were used to test for differences in orderings, and content analysis to categorize the (...) written justifications. The findings suggest that both groups appeared to support three main rationing principles: health maximization, priority to the severely ill and priority to the young. However, professionals seemed to give less weight to the latter principle. In conclusion, professionals have similar views to students about healthcare rationing, though may be slightly less inclined to give priority to the young. (shrink)

Antimicrobial therapy is a cornerstone of therapy in critically ill patients; however, the wide use of antibiotics has resulted in increased antimicrobial resistance and outbreaks of resistant disease. To counter this, many hospitals have instituted antimicrobial stewardship programmes as a way to reduce the inappropriate use of antibiotics. However, uptake of antimicrobial stewardship programmes has been variable, as many clinicians fear that they may put individual patients at risk of treatment failure. In this paper, I argue that antimicrobial stewardship programmes (...) are indeed a form of bedside rationing, and explore the risks and benefits of such programmes for individual patients in the intensive care unit, and the critically ill population in general. Using Norman Daniels’ Accountability for Reasonableness as a framework for evaluating resource allocation policies, I conclude that antimicrobial stewardship programmes are an ethically sound form of bedside rationing. (shrink)

People tend to contribute more—and think they have stronger obligations to contribute more—to rescuing an identified victim rather than a statistical one. Indeed, they are often disposed to contribute more to rescuing a single identified victim than a greater number of statistical ones. By an “identified victim,” I mean Terry Q., lying injured in the passenger seat of the wrecked automobile on the corner of Main Street and Broadway, or Jessica McClure, the child who fell into the Texas well in (...) 1987 and whose family was sent $700,000 in donations for her. We need not know their names, however, and we can accept a very minimal form of identification. By a “statistical victim,” I mean the person who, extrapolating from traffic records, will be in a similar, serious car accident tomorrow (and may then be identified), or the children who will fall into wells next year if we do not cap them better than we did the well that trapped Jessica. Does this disposition (or perceived obligation) have any normative force? I initially thought there could be no such normative force, but consequentialist and nonconsequentialist arguments, pro and con, have convinced me that reasonable people can disagree with each other. This disagreement poses a problem for political philosophy: how should policy choices take such disagreement into account? (shrink)

Explicit forms of rationing have already been implemented in some countries, and many of these prioritization systems resort to Norman Daniels’ “accountability for reasonableness” methodology. However, a question still remains: is “accountability for reasonableness” not only legitimate but also fair? The objective of this paper is to try to adjust “accountability for reasonableness” to the World Health Organization’s holistic view of health and propose an evolutionary perspective in relation to the “normal” functioning standard proposed by Norman Daniels. To accomplish this (...) purpose the authors depart from the “normal” functioning standard to a model that promotes effective opportunity for everyone in health care access, because even within the “normal” functioning criteria some treatments and medical interventions should have priority upon others. Equal opportunity function is a mathematical function that helps to hierarchize moral relevant necessities in health care according to this point of view. It is concluded, first, that accountability for reasonableness is an extremely valuable tool to address the issue of setting limits in health care; second, that what is called in this paper “equal opportunity function” might reflect how accountability for reasonableness results in fair limit-setting decisions; and third, that this methodology must be further specified to best achieve fair limit-setting decisions. Indeed, when resources are especially scarce the methodology suggested in this paper might allow not only prioritizing in an “all or nothing” basis but can contribute to a hierarchy system of priorities in health care. (shrink)

Health care systems across the world are unable to afford the best treatment for all patients in all situations. Choices have to be made. One key ethical issue that arises for health authorities is whether the principle of the “rule of rescue” should be adopted or rejected. According to this principle more funding should be available in order to save lives of identifiable, compared with unidentifiable, individuals. Six reasons for giving such priority to identifiable individuals are considered. All are rejected. (...) It is concluded that the principle of the rule of rescue should not be used in determining the allocation of health resources. (shrink)

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the (...) latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions. (shrink)

This paper is a critique of Norman Daniels' and James Sabin's ‘Accountability for Reasonableness’ framework for making priority-setting decisions in health care in the face of widespread disagreement about values. Accountability for Reasonableness has been rapidly gaining worldwide acceptance, arguably to the point of becoming the dominant paradigm in the field of health policy. The framework attempts to set ground rules for a procedure that ensures that whatever decisions result will be fair, reasonable, and legitimate to the extent that even (...) those who would be adversely affected will have reason to abide by them. I argue that the framework's four conditions are inadequate to this task. While we certainly require a fair and legitimate procedure for making priority setting decisions in health care despite a lack of consensus on relevant ethical and political issues, we must significantly revise the four conditions, and we cannot avoid facing our substantive disagreements head on if we hope to arrive at decisions that would (and should) be acceptable to everyone. I offer two suggestions. First, there is need for greater public involvement in all stages of deliberation. Second, we should give up on the idea that we can simplify the task of democratic deliberation by disallowing particular kinds or reasons and types of reasoning. Reasons of all kinds should be on the table, but then should be judged on their merits, such as consistency, plausibility and explanatory power, without any regard for their alleged sources of authority. (shrink)

Healthcare (including public health) is special because it protects normal functioning, which in turn protects the range of opportunities open to individuals. I extend this account in two ways. First, since the distribution of goods other than healthcare affect population health and its distribution, I claim that Rawls's principles of justice describe a fair distribution of the social determinants of health, giving a partial account of when health inequalities are unjust. Second, I supplement a principled account of justice for health (...) and healthcare with an account of fair process for setting limits or rationing care. This account is provided by three conditions that comprise "accountability for reasonableness.". (shrink)

The UK’s Cancer Drugs Fund (CDF) was introduced in 2010 following the Conservative Party’s promise to address the fact that numerous efficacious cancer drugs were not available because of their cost ineffectiveness, as deduced by the National Institute of Health and Care Excellence. While, at face value, this policy appears only to promote the UK’s public welfare, a deeper analysis reveals the ethically unjustifiable inconsistencies that the CDF introduces; where is the analogous fund for other equally severe diseases? Have the (...) patients without cancer been neglected simply due to the fear-inducing advertising and particularly ferocious speech which surrounds cancer? The CDF is unjustifiable when challenged by such questions. However, it is troubling to think that the CDF might be repealed in order to abolish these ethical concerns. Intuitively, one feels uncomfortable stripping the cancer patient of their benefits just so that they might be on an equally pessimistic footing with others. In the present essay, I argue that, although there are no ethically justifiable grounds for the CDF’s introduction, its removal would be inappropriate. Following this realisation, I investigate whether the procedural steps of the CDF itself—theoretically removed from the context of resource distribution for all disease types—represent an ethically justifiable system. I believe that the answer is yes, given the CDF’s conformity to accountability for reasonableness, a robust framework of procedural justice, which continuously improves the ethical and epistemological standards of the policies to which it is applied. (shrink)

In a well-known passage from 'The Red Lily', Anatole France retorts ironically: “The law, in its majestic equality, forbids rich and poor alike to sleep under bridges, to beg in the streets, and to steal loaves of bread”. The passage highlights the different burdens experienced by different people when deciding to act or not act in certain ways. This paper critically analyzes this problem; specifically, how we ought to allocate personal responsibility for actions performed by agents who each experience different (...) social, economic, political, and internal and external influences. First, the paper outlines some prevailing conceptions of personal responsibility in the literature. Second, it offers a critique of these views, arguing that they each suffer from a variety of conceptual and practical flaws. Third, a basic framework I call the continuum- threshold account of responsibility is proposed. The account distinguishes between responsibility and blameworthiness, addresses many of our objections against other prevailing conceptions of responsibility, and takes into account background structural conditions while retaining the scope for responsibility and moral agency. (shrink)