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)

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

In the book Valuing Health, Daniel Hausman sets out a normative framework for assessing social policy, which he calls restricted consequentialism. For the restricted consequentialist, government policy-making not only is, but ought to be, largely siloed in individual government departments. Each department has its own goal linked to a fundamental public value, which it should pursue in a maximizing way. I argue that, first, Hausman’s argument appears to be internally inconsistent: his case for thinking that health policy should default to (...) a form of maximization is plausible only if a much narrower vision of the goals of policy is adopted than Hausman thinks appropriate in the case of education. Secondly, it turns out that none of Hausman’s analysis helps us with the crucial question of how maximization should be constrained by other values—a question that even on Hausman’s account looks to be crucial, and that will be even more important if adopt a broader perspective on the purposes of health policy than Hausman allows. (shrink)

Priority setting in healthcare is a highly contentious area of public decision making, in which different values often support incompatible policy options and compromise can be elusive. One promising approach to resolving priority-setting conflicts divides the decision-making process into two steps. In the first, a set of eligible options is identified; in the second, one of those options is chosen by a deliberative process. This paper considers the first step, examining proposals for identifying a set of options eligible for deliberation. (...) It focuses on the approach proposed by Anders Herlitz, which limits deliberation to options that are on a par; neither better or worse than, nor strictly equal to the alternatives. Once these “maximal” options are identified, the choice among them is made though a deliberative process that acknowledges the difficult tradeoffs which must be made. While parity and kindred notions are clearly useful in resolving some priority-setting conflicts, this paper argues that the conflicts that arise in setting priorities make it as difficult to decide which options are on a par as it is to decide among those options. The paper draws on priority-setting debates that occurred during the recent pandemic to illustrate the challenges in identifying eligible options: There may be sharp disagreement about how to understand and individuate relevant values; about whether certain values are relevant in a priority-setting context; about how to establish parity between “consequential” and “deontic” options, and about whether one option remains on a par with others after it is modified in various ways. (shrink)

One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, risk thresholds serve to demarcate risk (...) categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk. (shrink)

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)

This article investigates whether or not theories of justice from political philosophy, first, support the position that health research should contribute to justice in global health, and second, provide guidance about what is owed by international clinical research (ICR) actors to parties in low- and middle-income countries. Four theories—John Rawls's theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Ruger's health capability paradigm—are evaluated. The article shows that three of the four theories require the (...) conduct of health research for justice in global health. The theories help identify the ends of justice to which ICR is to contribute, but they cannot tell us how to organize ICR to promote these ends. Aside from Ruger's health capability paradigm, the theories also lack an allocative principle for assigning specific duties to specific actors. This creates difficulties for establishing obligations for certain types of ICR actors. (shrink)

When writing about policy, do you think in green or white? If not, I recommend that you do. I suggest that writers and journal editors should explicitly label every policy ethics paper either ‘green’ or ‘white’. A green paper is an unconstrained exploration of a policy question. The controversial ‘After-birth abortion’ paper is an example. Had it been labelled as ‘green’, readers could have understood what Giubilini and Minerva explained later: that it was a discussion of philosophical ideas, and not (...) a policy proposal advocating infanticide. A serious policy proposal should be labelled by writer(s) and editor(s) as ‘white’. Its purpose should be to influence policy. In order to influence policy, I suggest three essential, and two desirable, characteristics of any white paper. Most importantly, a white paper should be set in the context in which the policy is to be made and applied. (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 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)

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

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)

The rapid development in healthcare technologies in recent years has resulted in the need for health services, whether publicly funded or insurance based, to identify means to maximise the benefits and provide equitable distribution of limited resources. This has resulted in the need for rationing decisions, and there has been considerable debate regarding the substantive and procedural ethical principles that promote distributive justice when making such decisions. In this paper, I argue that while the scientifically rigorous approaches of evidence-based healthcare (...) are claimed as aspects of procedural justice that legitimise such guidance, there are biases and distortions in all aspects of the process that may lead to epistemic injustices. Regardless of adherence to principles of distributive justice in the decision-making process, evidential failings may undermine the fairness and legitimacy of such decisions. In particular, I identify epistemic exclusion that denies certain patient and professional groups the opportunity to contribute to the epistemic endeavour. This occurs at all stages of the process, from the generation, analysis and reporting of the underlying evidence, through the interpretation of such evidence, to the decision-making that determines access to healthcare resources. I further argue that this is compounded by processes which confer unwarranted epistemic privilege on experts in relation to explicit or implicit value judgements, which are not within their remit. I suggest a number of areas in which changes to the processes for developing, regulating, reporting and evaluating evidence may improve the legitimacy of such processes. (shrink)

Triage is a widespread principle for prioritizing patients in emergency departments. The purpose of triage is to ensure that in emergency situations, whenever medical demand exceeds medical supply, limited resources should be directed to the case with the greatest clinical need. Triage fulfills this purpose by ranking patients according to how acute their condition is and then giving priority to the most acute ones. In this paper, I argue that this current practice of triage needs to be supplemented. Contemporary triage (...) is based on a principle of preserving patients’ core capabilities, which is relevant when it comes to prioritizing acute patients above sub‐acute ones, but not for prioritizing among sub‐acute patients, which is the largest group of emergency patients. Henceforth, I propose to supplement triage with what I term the real dialogue model, a framework that, when combined with enhanced professional autonomy for clinical decision‐makers, enables fair prioritizing among sub‐acute patients. (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 allocation of vaccines and therapeutics for Covid‐19 obviously raises ethical questions, and physicians and ethicists have begun to address them. Writers have identified various criteria that should guide allocation decisions, but the criteria often conflict and need to be balanced against one another. This article proposes a model for thinking about how different considerations that are relevant to the distribution of vaccines and scarce treatments for Covid‐19 could be integrated into an allocation procedure. The model employs the construct of (...) a weighted lottery, which is a construct that has been employed in other contexts that involve the distribution of scarce resources. The article highlights the advantages of applying a weighted lottery to the Covid‐19 context and offers an illustration for how it might work in practice. The primary aim of the article is to articulate the structural features of a weighted lottery for this context and to bring out its advantages over other methods for allocating Covid‐19 medications. (shrink)

Background: Existing ethical guidelines recommend that, all else equal, past receipt of a medical resource (e.g. a scarce organ) should not be considered in current allocation decisions (e.g. a repeat transplantation).DiscussionOne stated reason for this ethical consensus is that formal theories of ethics and justice do not persuasively accept or reject repeated access to the same medical resources. Another is that restricting attention to past receipt of a particular medical resource seems arbitrary: why couldn't one just as well, it is (...) argued, consider receipt of other goods such as income or education? In consequence, simple allocation by lottery or first-come-first-served without consideration of any past receipt is thought to best afford equal opportunity, conditional on equal medical need. There are three issues with this view that need to be addressed. First, public views and patient preferences are less ambiguous than formal theories of ethics. Empirical work shows strong preferences for fairness in health care that have not been taken into account: repeated accessto resources has been perceived as unfair. Second, while difficult to consider receipt of many other prior resources including non-medical resources, this should not be used a motive for ignoring the receipt of any and all goods including the focal resource in question. Third, when all claimants to a scarce resource are equally deserving, then use of random allocation seems warranted. However, the converse is not true: mere use of a randomizer does not by itself make the merits of all claimants equal.SummaryMy conclusion is that not ignoring prior receipt of the same medical resource, and prioritizing those who have not previously had access to the medical resource in question, may be perceived as fairer and more equitable by society. (shrink)

A notorious debate in the ethics of healthcare rationing concerns whether to address rationing decisions with substantial principles or with a procedural approach. One major argument in favour of procedural approaches is that substantial principles are indeterminate so that we can reasonably disagree about how to apply them. To deal with indeterminacy, we need a just decision process. In this paper I argue that it is a mistake to abandon substantial principles just because they are indeterminate. It is true that (...) reasonable substantial principles designed to deal with healthcare rationing can be expected to be indeterminate. Yet, the indeterminacy is only partial. In some situations we can fully determine what to do in light of the principles, in some situations we cannot. The conclusion to draw from this fact is not that we need to develop procedural approaches to healthcare rationing, but rather that we need a more complex theory in which both substantial principles and procedural approaches are needed. (shrink)

Artificial intelligence (AI) is a powerful tool for several healthcare tasks. AI tools are suited to optimize predictive models in medicine. Ethical debates about AI’s extension of the predictive power of medical models suggest a need to adapt core principles of medical ethics. This article demonstrates that a popular interpretation of the principle of justice in healthcare needs amendment given the effect of AI on decision-making. The procedural approach to justice, exemplified with Norman Daniels and James Sabin’saccountability for reasonablenessconception, needs (...) amendment because, as research into algorithmic fairness shows, it is insufficiently sensitive to differential effects of seemingly just principles on different groups of people. The same line of research generates methods to quantify differential effects and make them amenable for correction. Thus, what is needed to improve the principle of justice is a combination of procedures for selecting just criteria and principles and the use of algorithmic tools to measure the real impact these criteria and principles have. In this article, the author shows that algorithmic tools do not merely raise issues of justice but can also be used in their mitigation by informing us about the real effects certain distributional principles and criteria would create. (shrink)

Accountability for Reasonableness has gained international acceptance as a framework to assist with resource allocation within healthcare. Despite this, one of the four conditions, the relevance condition, has not been widely adopted. In this paper I will start by examining the relevance condition, and the constraints placed on it by Daniels and Sabin. Following this, I review the theoretical limitations of the condition identified to date, by prominent critics such as Rid, Friedman, Lauridsen and Lippert—Rasmussen. Finally, I respond to Daniels (...) and Sabin’s enthusiasm for testing the accountability for reasonableness framework in different contexts, by evaluating the challenges of implementing the relevance condition within the NHS. I use the funding of treatments for patients on the basis of their exceptional circumstances as a case study to examine whether the relevance condition could be applied in practice. (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)

This paper responds to discussion and criticism contained in a mini-symposium on Just health: meeting health needs fairly. The replies clarify existing positions and modify or develop others, specifically in response to the following: Thomas Schramme criticises the claim that health is of special importance because of its impact on opportunity, and James Wilson argues that healthcare is not of special importance if social determinants of health have a major causal impact on population health. Annette Rid is concerned that the (...) relevance condition in accountability for reasonableness is unclear and does little work. Harald Schmidt aims to flesh out where an account of responsibility for health should go since one is under-developed in Just health. Michael Schefczyk and Susanne Brauer challenge aspects of the prudential lifespan account. Samia Hurst asks what impact a population view should have on clinician obligations. (shrink)

The UK’s National Institute for Health and Care Excellence is responsible for conducting health technology assessment on behalf of the National Health Service. In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness —and one substantive—an ‘ethics of opportunity costs’ that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to NICE’s approach and to analyse (...) whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. (shrink)

Norman Daniels’s theory of ‘accountability for reasonableness’ is an influential conception of fairness in healthcare resource allocation. Although it is widely thought that this theory provides a consistent extension of John Rawls’s general conception of justice, this paper shows that accountability for reasonableness has important points of contact with both utilitarianism and intuitionism, the main targets of Rawls’s argument. My aim is to demonstrate that its overlap with utilitarianism and intuitionism leaves accountability for reasonableness open to damaging critiques. The important (...) role that utilitarian-like cost-effectiveness calculations are allowed to play in resource allocation processes disregards the separateness of persons and is seriously unfair towards individuals whose interests are sacrificed for the sake of groups. Furthermore, the function played by intuitions in settling frequent value conflicts opens the door for sheer custom and vested interests to steer decision-making. (shrink)

Approaches relying on fair procedures rather than substantive principles have been proposed for answering dilemmas in medical ethics and health policy. These dilemmas generally involve two questions: the epistemological (factual) question of which benefits an intervention will have, and the ethical (value) question of how to distribute those benefits. This article focuses on the potential of fair procedures to help address epistemological and factual questions in medicine, using the debate over antidepressant efficacy as a test case. In doing so, it (...) employs concepts from social epistemology such as testimonial injustice (bias resulting from the exclusion of evidence) and hermeneutical injustice (bias resulting from a prevailing discussion framework’s conceptual limitations). This article also explores the relevance of scientific consensus to determinations regarding medical evidence. (shrink)

PURPOSE: The purpose of this paper is to consider some of the philosophical and bioethical issues raised by the creation of the draft social values framework developed to facilitate data collection and country-specific presentations at the inaugural workshop on "Social values and health priority setting" held in February 2011. -/- DESIGN/METHODOLOGY/APPROACH: Conceptual analysis is used to analyse the term "social values", as employed in the framework, and its relationship to related ideas such as moral values. The structure of the framework (...) (process and content values) is considered in light of current debate in philosophy and bioethics about the political and moral aims served by these kinds of values, and the extent to which they are either suited to, or sufficient for, the policy context. -/- FINDINGS: There is much to be gained by engaging with the arguments presented in the philosophical literature in order to further refine the framework. The framework should remain neutral in respect of the importance of procedural values in different contexts and should be as inclusive as possible in respect of the principles it includes. Further development would be best served by taking a multidisciplinary approach. The framework could provide a valuable space in which future debates about procedural/substantive values can be considered. -/- ORIGINALITY/VALUE: The paper brings philosophical and bioethics perspectives to bear on a new framework proposed for the analysis of social values in health priority setting. It identifies how such a practical, policy-focused framework might be informed by engagement with deeper, and often unresolved, questions or principle around resource allocation in health. (shrink)