Priority setting (also known as resource allocation or rationing) occurs at every level of every health system and is one of the most significant health care policy questions of the 21st century. Because it is so prevalent and context specific, improving priority setting in a health system entails improving it in the institutions that constitute the system. But, how should this be done? Normative approaches are necessary because they help identify key values that clarify policy choices, but insufficient because different (...) approaches lead to different conclusions and there is no consensus about which ones are correct, and they are too abstract to be directly used in actual decision making. Empirical approaches are necessary because they help to identify what is being done and what can be done, but are insufficient because they cannot identify what should be done. Moreover, to be really helpful, an improvement strategy must utilize rigorous research methods that are able to analyze and capture experience so that past problems are corrected and lessons can be shared with others. Therefore, a constructive, practical and accessible improvement strategy must be research-based and combine both normative and empirical methods. In this paper we propose a research-based improvement strategy that involves combining three linked methods: case study research to describe priority setting; interdisciplinary research to evaluate the description using an ethical framework; and action research to improve priority setting. This describe-evaluate-improve strategy is a generalizable method that can be used in different health care institutions to improve priority setting in that context. (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)

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)

The inevitable need for rationing of healthcare has apparently presented the medical profession with the dilemma of choosing the lesser of two evils. Physicians appear to be obliged to adopt either an implausible version of traditional professional ethics or an equally problematic ethics of bedside rationing. The former requires unrestricted advocacy of patients but prompts distrust, moral hazard and unfairness. The latter commits physicians to rationing at the bedside; but it is bound to introduce unfair inequalities among patients and lack (...) of political accountability towards citizens. In this paper I shall argue that this dilemma is false, since a third intermediate alternative exists. This alternative, which I term 'administrative gatekeeping', makes it possible for physicians to be involved in rationing while at the same time being genuine advocates of their patients. According to this ideal, physicians are required to follow fair rules of rationing adopted at higher organizational levels within healthcare systems. At the same time, however, they are prohibited from including considerations of cost in their clinical decisions. (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)

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)

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)

Fair resource allocation in humanitarian medicine is gaining in importance and complexity, but remains insufficiently explored. It raises specific issues regarding non-ideal fairness, global solidarity, legitimacy in non-governmental institutions and conflicts of interest. All would benefit from further exploration. We propose that some headway could be made by adapting existing frameworks of procedural fairness for use in humanitarian organizations. Despite the difficulties in applying it to humanitarian medicine, it is possible to partly adapt Daniels and Sabin's ‘Accountability for reasonableness’ to (...) this context. This would require: (1) inclusion of internally explicit decisions and rationales; (2) publicity to donors, local staff, community leaders and governments, as well as frank answers to any beneficiary—or potential beneficiary—who asked for clarification of decisions and their rationale; (3) a consistent reasoning strategy to weigh conflicting views of equity in specific situations; (4) advocacy within the organization as a mechanism for revision and appeals; and (5) internal regulation according to publicly accessible mechanisms. Organizations could generate a common corpus of allocation decisions from which to draw in future similar cases. Importantly, the complexity of these challenges should encourage, rather than hinder, broader discussion on ethical aspects of resource allocation in humanitarian medicine. CiteULike Connotea Del.icio.us What's this? (shrink)

The COVID-19 pandemic is affecting countries across the globe. Only a globally coordinated response, however, will enable the containment of the virus. Responding to a request from policy makers for ethics input for a global resource pledging event as a starting point, this paper outlines normative and procedural principles to inform a coordinated global coronavirus response. Highlighting global connections and specific vulnerabilities from the pandemic, and proposing standards for reasonable and accountable decision-making, the ambition of the paper is two-fold: to (...) raise awareness for the justice dimensions in the global response, and to argue for moving health from the periphery to the centre of philosophical debates about social and global justice. (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)

Norman Daniels' and James Sabin's theory of “accountability for reasonableness” (A4R) is a much discussed account of due process for decision-making on health care priority setting. Central to the theory is the acceptance that people may justifiably disagree on what reasons it is relevant to consider when priorities are made, but that there is a core set of reasons, that all centre on fairness, on which there will be no disagreement. A4R is designed as an institutional decision process which will (...) ensure that only those reasons which everybody will agree are relevant and appropriate form part of decision-making. The argument which we will put forward in this paper questions whether it is a simple matter to delineate the core set of reasons and claims that it is a potential problem in A4R that it does not provide an indication of the exact content of this process. The paper first briefly outlines the content of A4R. It is argued that disagreement on what services should be high priorities cannot be resolved solely with a reference to “due process.” In order to retain consistency over time, decision-makers are required to agree and articulate what reasons qualify as relevant and how conflicting reasons are to be balanced in the course of the process. The second and main part of the paper then considers how the reason of “solidarity” can be handled within the A4R framework, and it is shown that deciding whether solidarity should be admitted to the core set of allowable reasons is not a simple matter. (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 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)

Gaucher disease is a rare, chronic,ethnic-specific genetic disorder affecting Jewsof Eastern European descent. It is extremelyexpensive to treat and presents difficultdilemmas for officials and patients in Israelwhere many patients live. First, high-cost,high-benefit, but low volume treatment forGaucher creates severe allocation dilemmas forpolicy makers. Allocation policies driven bycost effectiveness, age, opportunity or needmake it difficult to justify funding. Processoriented decision making based on terms of faircooperation or decisions invoking the ``rule ofrescue'''' risk discriminating against minoritieswho may already suffer from inequitabledistribution of (...) heath care resources. Apartfrom cost, Gaucher disease prompts questionsabout abortion. Unlike severe geneticdisorders, Gaucher offers no grounds forabortion and, in many ways, is analogous togender based abortions that are prohibitedregardless of fetal age. Finally, Gaucherraises concerns about the disclosure of geneticinformation. These affect potential carriersasked to participate in population studies andcarriers and patients who must considerdisclosure to others. These concerns weigh theright to privacy against communal interests andbilateral commitments. (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)

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)

Social workers must often decide about priority at a case level, in a context of scarce resources. These decisions are disputable and controversial, which raises the question on what grounds are they made in practice. This article addresses that question through an empirical study of real-life case discussions in youth care in Flanders, the Dutch-speaking part of Belgium. Toulmin’s argumentation model is used to analyse the data. The study finds that most case discussions are processed in a rather technical manner. (...) But where there is active deliberation, key incidents show that the decision-makers undertake active and personal interpretation of the situation at hand, and that they also take a personal stance on the criteria for assigning priority. In other words, their practice can be understood as a hermeneutical activity. The article’s main conclusion is that the prioritisation process illustrates the moral-political core that is present in any social work decision-making practice. As this moral-political core seems to be hidden most of the time behind a technical-rational approach, questions remain whether the professionals involved are aware that it characterises their own judgements and whether insights into its nature are stimulated. (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)

The UK’s Cancer Drugs Fund 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)

The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...) the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes. (shrink)

Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and (...) Allen make in the paper lack force, and why the ‘governance problem’ in research ethics that they allude to ought to be explained differently. (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)

Within contemporary health care, many of the decisions affecting the health and well-being of patients are not being made by the clinicians or health professionals, but by those involved in health care management. Existing literature on organizational ethics provides insight into the various structures, processes and strategies - such as mission statement, ethics committees, ethical rounds … - that exist to create an organizational climate, which fosters ethical practices and decision-making It does not, however, show how health care managers experience (...) their job as being intrinsically ethical in itself. In the present article, we investigate the way in which ethical values are present in the lived experiences and daily practice of health care management. What does it imply to take up a managing position within a health care institution and to try to do this in an ethically inspired way? We carried out a qualitative study (Grounded Theory Approach) to explore the essence of values-based leadership in health care. We interviewed 15 people with extensive experience in health care management in the fields of elderly care, hospital care and mental health care in the various regions of Flanders, Belgium. Six predominant themes, presented as metaphors, illustrate the essence of values-based leadership in health care management. These are: (1) values-based health care management as managing a large garden, (2) as learning and using a foreign language, (3) going on a trekking with an ethical compass, (4) embodying integrity and authenticity in a credible encounter with everyone, (5) being a present and trustworthy leader during sun and storm, and (6) contributing to human flourishing by giving people wings to fly. Notwithstanding the importance of organizing a good ethics infrastructure, values-based leadership in health care entails much more than that. It is about the co-creation of an integrated and comprehensive ethical climate of which community-model thinking and authentic leadership are essential components. As a never-ending process, the six metaphors can help leaders to take substantive proactive steps to shape a fruitful ethical climate within their organization. (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)

The ArgumentSome have claimed that negative genetic interventions are morally permissible while positive ones are not, but the distinction cannot be used to draw this moral boundary. Underlying the negative/positive distinction is a distinction between treatment and enhancement. The treatment/enhancement distinction at best provides an imperfect guide to which health care services we are obliged to provide and which we are not. It offers only some “warning flags” to help us think about what is permissible or not.

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)

A moral right to health or health care is a special instance of a right to fair equality of opportunity. Nation-states generally have the capabilities to specify the entitlements of such a right and to raise the resources needed to satisfy those entitlements. Can these functions be replicated globally, as a global right to health or health care requires? The suggestion that “better global governance” is needed if such a global right is to be claimed requires that these two central (...) capabilities be present. It is unlikely that nation-states would concede these two functions to a form of global governance, for doing so would seriously compromise the authority that is generally included in sovereignty. This claim is a specification of what is often recognized as the “sovereignty problem.” The argument of this paper is not an “impossibility” claim, but a best guess about whether the necessary conditions for better global governance that supports a global right to health or health care can be achieved. (shrink)

In recent years there has been growing scholarly interest in the relationship between bioethics and human rights. The majority of this work has proposed that the normative and institutional frameworks of human rights can usefully be employed to address those bioethical controversies that have a global reach: in particular, to the genetic modification of human beings, and to the issue of access to healthcare. In response, a number of critics have urged for a degree of caution about applying human rights (...) to such controversies. In particular, they have claimed that human rights have unresolved distributive and foundational problems. Interestingly, however, some of these critics have gone on to suggest that it might be possible to draw on certain bioethical insights to remedy these problems with human rights. This paper evaluates these recent attempts to apply insights from bioethics to the theory and practice of human rights. It argues that while these insights do not constitute an entirely new and original contribution to human rights thinking, they do force human rights scholars and campaigners to reflect on some key issues. First of all, they force us to question the prevalent idea that human rights are always 'inviolable trumps'. Secondly, they demand that we pay close attention to the 'fairness' of the institutions we charge with determining our concrete rights. And finally, and perhaps most radically, these insights challenge the notion that human rights are held exclusively by members of the human species. (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)

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)

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)

Genome Canada has funded a research project to evaluate the usefulness of different forms of ethical analysis for assessing the moral weight of public opinion in the governance of genomics. This paper will describe a role of public consultation for ethical analysis and a contribution of ethical analysis to public consultation and the governance of genomics/biotechnology. Public consultation increases the robustness of ethical analysis with a more diverse and rich accounts experiences. Consultation must be carefully and respectfully designed to generate (...) sufficiently diverse and rich accounts of moral experiences. Since dominant groupstend to define ethical or policy issues in a manner that excludes some interests or perspectives, it is important to identify the range of interests that diverse publics hold before defining the issue and scope of a consultation. Similarly, a heavy policy focus and pressures to commercialize products risk oversimplification of the discussion and the premature foreclosure of ethical dialogue. Consequently, a significant contribution of ethical dialogue strengthened by social analysis is to consider the context and non-policy use of power to govern genomics and to sustain social debate on enduring ethical issues. (shrink)

The manner in which limited vaccines are distributed during a pandemic is an ethical issue. The utility principle has been used to argue priority be given to certain individuals based on factors such as the epidemiology of the spread of disease and maintaining the functioning of society. The equity principle has been used to encourage fair practices that account for the economic and social costs of all decisions made. We argue that both principles are met through priority vaccination of homeless (...) individuals, as this strategy protects a medically vulnerable population while reducing the chances of transmission to others as they move through populated urban spaces. We begin by reviewing debates around ethical vaccine distribution. We then argue the homeless are a medically high-risk population who may contribute to the spread of disease through their mobility. As immunization rates are generally lower among the homeless and many do not access mainstream health care, we argue that community vaccine clinics must be used to reach these individuals. We provide support by analyzing Toronto Public Health’s operation of vaccine clinics in shelters and drop-in centres during pH1N1 and conclude that this strategy is effective for immunizing homeless individuals, bringing together the equity and utility principles. (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)

The focus of this essay is on conflicts of values and rival options in public decision-making, ethics and justice that seem to require us to balance the values or options against each other. The aim is to investigate implications of the so-called fourth value relation between competing valuable options for the possibility to weigh and balance them. The fourth value relation applies to many alternatives that represent important but conflicting or incompletely compatible human values. In this essay I will try (...) to show that in those cases it is implausible that relative weights and right balances can be determined or that they exist at all. The fourth value relation has significant implications for the resolution of the relevant value conflicts because it renders the answer to the question ‘what’s the right thing to do?’ indeterminate as far as this answer depends on comparative weights of the alternatives. (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)

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)

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)

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)