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)

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)

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)

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 proportion of elderly in society is growing rapidly, leading to increasing health care costs. New remote monitoring technologies are expected to lower these costs by reducing the number of close encounters with health care professionals, for example the number of visits to health care centres. In this paper, I discuss issues of priority setting raised by this expectation. As a starting-point, I analyse the recent debate on principles for priority setting in Sweden. The Swedish debate illustrates that developing an (...) approach to priority setting is an ongoing process. On the basis of this analysis, I conclude that several different ethical principles, and specifications of these principles, can be appealed to for giving priority—over close encounters—to a large-scale introduction of remote monitoring technologies in health care services to elderly people, but also that many specifications can be appealed to against giving such priority. I propose that given the different views on principles, it is necessary to develop fair procedures of deliberation on these principles and their application, in particular in order to reach agreement on exactly how much resources should be allocated to remote monitoring and how much to close encounters. I also present a few points to consider in a large-scale introduction of remote monitoring. (shrink)

In this article I analyse and discuss guidelines for priority setting in crisis management at a regional level in Sweden. The guidelines concern three types of crises: pandemics, large losses of electric power and interruptions in water supply. Pandemics are typical public health issues. Large losses of electric power and interruptions in water supply are in themselves not, but may have serious public health consequences. These guidelines are compared with guidelines for priority setting in health care. This is done because (...) of the central position of health care in the management of many different types of crises. The comparison shows clear differences. In the analysis, I use a distinction between substantive principles of priority setting and process-oriented principles. Regarding substantive principles, I have found that the guidelines point in different directions. This seems acceptable, however, since they focus on different problems. Moreover, it seems possible to integrate the various context-dependent principles by relating them to higher order principles. Regarding process-oriented principles, I have found that how and to what extent these principles are applied in the guidelines vary. If we want to apply these principles in a more satisfying way, this would require a more systematic approach. (shrink)

Currently, research ethics committees in the UK meet behind closed doors—their workings and most of the content of their decisions are unavailable to the general public. There is a significant tension between this current practice and a broader societal presumption of openness. As a form of public institution, the REC system exists to oversee research from the perspective of society generally.An important part of this tension turns on the kind of justification that might be offered for the REC system. In (...) this paper I adapt Daniels and Sabin’s accountability for reasonableness model for just resource allocation to the research ethics context to provide some structural legitimacy and to enable progress on the question of openness. After considering the consequences of adopting this model for open REC meetings, I then examine some reasons that might be offered against open meetings. These arguments do not overwhelm the core intuitions behind the presumption of openness but they do, I suggest, give us reason to retreat from fully public meetings. I conclude that there should be important adjustments to the system towards public accountability and that there are grounds for stopping short of fully public meetings. (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)

Because the demand for health services outstrips the available resources, priority setting is one of the most difficult issues faced by health policy makers, particularly those in developing countries. Priority setting in developing countries is fraught with uncertainty due to lack of credible information, weak priority setting institutions, and unclear priority setting processes. Efforts to improve priority setting in these contexts have focused on providing information and tools. In this paper we argue that priority setting is a value laden and (...) political process, and although important, the available information and tools are not sufficient to address the priority setting challenges in developing countries. Additional complementary efforts are required. Hence, a strategy to improve priority setting in developing countries should also include: (i) capturing current priority setting practices, (ii) improving the legitimacy and capacity of institutions that set priorities, and (iii) developing fair priority setting processes. (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)

Rationing in healthcare remains very much a taboo topic. Before COVID-19, it rarely received public attention, even when it occurred in everyday practices, mainly in the form of implicit rationing, as it continues to do today. There are different definitions, types and levels of healthcare rationing, according to different perspectives. With the aim of contributing to a more coherent debate on such a highly emotional healthcare issue as rationing, here are provided a number of reflections from a patient advocate perspective (...) which are specifically focused on bedside rationing, the most troublesome level, both for patients and clinicians, particularly in regard to cancer care. Oncology, with its numerous expensive therapies and increasing number of patients, is undeniably one of the main areas contributing to the increase in healthcare costs. However, the fixed budgets of today's publicly financed health systems cannot allow unlimited access to the potentially beneficial treatments to all patients. Bedside rationing constitutes the last phase of many decision-making processes occurring at different interrelated levels (macro-levels), both inside and outside healthcare systems, which implicitly and inevitably result in a bottleneck determined by the upstream decisions themselves. Shifting from implicit to explicit bedside rationing essentially means moving from a paternalistic to a citizen-before-patient approach; this implies, first of all, a cultural change. Practical bedside rationing is an ethically complex topic, but one that needs to be urgently addressed in a transparent and open debate. In this scenario, the oncological community – patients, patient advocates and clinicians – can and should play an important role. (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)

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)

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)

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)