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)

The increasing costs of healthcare delivery led to different political and administrative approaches trying to preserve the core values of the welfare state. This approach has well documented weaknesses namely with regard to healthcare rationing. The objective of this paper is to evaluate if independent healthcare regulation is an important tool with regard to the construction of fair processes for setting limits to healthcare. Methodologically the authors depart from Norman Daniels’ and James Sabin’s theory of accountability for reasonableness and try (...) to determine if new regulatory models—namely independent agencies—perform better with regard to the public disclosure of the reasons and rationales of healthcare rationing. In publicly financed healthcare systems independent regulation is an important tool to assure fair and reasonable procedures of prioritising services. In accordance with the principle of public accountability, independent regulatory agencies are particularly well suited to assure publicity of the decision-making processes, relevance of the rationale involved and particularly mechanisms for challenge and dispute resolution regarding limit setting decisions. It follows that independent healthcare regulation could be regarded not only as an instrument for performance improvement but also as a tool of social justice. The authors conclude by stating that accountability for reasonableness should be regarded as a landmark of any healthcare reform. And therefore regulators have the social task of assuring that the rationales for limit-setting decisions are clearly accessible to the public. (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)

Though the art of compromise, i.e. of settling differences by mutual concessions, is part of communal living on any level, we often think that there is something wrong in compromise, especially in cases where moral convictions are involved. A first reason for distrusting compromises on moral matters refers to the idea of integrity, understood in the basic sense of 'standing for something', especially standing for the values and causes that to some extent confer identity. The second reason points out the (...) objective nature of moral values, which seems to make them immune from negotiation and barter. If one sincerely holds some moral conviction to be true, than compromising on that belief must be a sign of serious confusion. In order to reach a better understanding of these two reasons, I analyse what is involved in personal integrity and how this relates to moral integrity. I argue that the search for moral integrity naturally brings us to the question of how one could accept moral compromises and still uphold the idea that moral values and principles have an objective authority over us. To address this question I will present a version of moral pluralism which tries to capture the enormous complexity of what should matter to us as moral persons, and which explains why value-rankings are often deeply indeterminate. The general position I defend in this paper is that compromises involving moral values and norms may be morally required and, therefore, be laudable. To sustain this position I will arrive at a view of ethical objectivity that allows the possibility to negotiate about the truth of moral beliefs. (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)

This paper addresses two questions. First, how different is the ideal underlying deliberative democracy from the ideal expressed in contemporary liberal theory, especially contractualist theory and "political liberalism"? Second, what specific institutional prescriptions, if any, follow from deliberative democracy? It is argued that the deliberative ideal has become quite abstract and, in fact, does not differ significantly from many forms of contemporary liberalism. Moreover, it is something of an open question just what institutions best realize this ideal. Specifically, the ideal (...) does not necessarily require conventional, majoritarian institutions. (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)

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.

In this paper I argue that a narrow view of justice dominates the bioethics literature. I urge a broader view. As bioethicists, we often conceive of justice using a medical model. This model focuses attention at a particular point in time, namely, when someone who is already sick seeks access to scarce or expensive services. A medical model asks how we can fairly distribute those services. The broader view I endorse requires looking upstream, and asking how disease and suffering came (...) about. In contrast to a medical model, a social model of justice considers how social determinants affect the health of a population. For example, social factors such as access to clean drinking water, education, safe workplaces, and police protection, profoundly affect risk for disease and early death. I examine one important social determinant of health, health care coverage, to show the limits of a medical model and the merits of a broader view. (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)

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)

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)

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.

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)

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)

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)

State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a risk, it (...) is not a problem unique to Medicaid, since private insurance programs have also implemented closed formularies. (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)

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)

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)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...) subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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...

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)