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...

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

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

Kerstein and Bognar (2010) and Persad, Wertheimer, and Emanuel (2009) defend specific principles for the allocation of health care resources, but their choice of principles is influenced by the exa...

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 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)

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)

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)

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)

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)

The National Institute for Health and Clinical Excellence (hereafter NICE) was created in 1998 to give guidance on which treatments should be provided by the British National Health Service, and to whom. So it has a crucial role as an agent of distributive justice. In this paper I argue that it is failing to adequately explain and justify its decisions in the public arena, particularly in terms of distributive justice; and that this weakens its legitimacy, to the detriment of the (...) National Health Service as a whole. I argue that this failure arises from the fact that NICE works within the frameworks of positivist science and liberal ethics, largely to the exclusion of other perspectives. This narrowness of view prevents NICE from properly connecting with the range of moral concerns represented in the population. I argue for NICE’s deliberations to become more inclusive, both in terms of epistemology, and also in terms of ethical perspectives. And I suggest a range of perspectives that could usefully be included. Finally I offer a framework of structures, philosophies and discussion process that will enable competing perspectives to be debated fairly and productively in this process. (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)

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

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

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.

There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake—protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably (...) contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. (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)

It has been suggested that focusing on procedures when setting priorities for health care avoids the conflicts that arise when attempting to agree on principles. A prominent example of this approach is “accountability for reasonableness.” We will argue that the same problem arises with procedural accounts; reasonable people will disagree about central elements in the process. We consider the procedural condition of appeal process and three examples of conflicts over coverage decisions: a patients’ rights law in Norway, health technologies coverage (...) recommendations in the UK, and care withheld by HMOs in the US. In each case a process is at the center of controversy, illustrating the difficulties in establishing procedures that are widely accepted as legitimate. Further work must be done in developing procedural frameworks. (shrink)

Periodic and unexpected shortages of drugs, biologics, and even medical devices have become commonplace in the United States. When shortages occur, hospitals and clinics need to decide how to ration their available stock. When such situations arise, institutions can choose from several different allocation schemes, such as first-come, first-served, a lottery, or a more rational and calculated approach. While the first two approaches sound reasonable at first glance, there are a number of problems associated with them, including the inability to (...) make fine, individual patient-centered decisions. They also do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others. In this article I outline an ethically acceptable procedure for rationing drugs during a shortage in which demand outstrips supply. (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)

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

:This article provides a critique of the monolithic accounts that define justice in terms of a single and often inappropriate goal. By providing an array of real examples, I argue that there is no simple definition of justice, because allocations that express justice are governed by a variety of reasons that reasonable people endorse for their saliency. In making difficult choices about ranking priorities, different considerations have different importance in different kinds of situations. In this sense,justice is a conclusionabout whether (...) an allocation reflects the human interests and priorities that are at stake. The article describes how several principles of justice have a legitimate place in medical allocations. To achieve justice within medical practice, professionals should focus on the human interests and compelling reasons for prioritizing specific principles within their specific medical domain. (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)

With the human genome mapped, and with the mapping of more than one hundred animal genomes in progress, the amount of genetic data available is increasing exponentially. This exponential increase in data is having an immediate impact on the process of drug development. By using techniques of information technology to manipulate data regarding the genes, proteins, and biochemical pathways associated with various diseases, scientists are beginning to be able to design drugs in a systematic fashion. In the context of any (...) given disease, scientists look to see whether a gene, a protein for which the gene codes, or another protein in the relevant biochemical pathway could be the “target” biological molecule, the “knocking out” of which would halt or slow the disease's progression. Once a target molecule has been identified and characterized structurally, drug therapies that would be likely to knock out this target can be identified and tested systematically. The merger of information technology and genetic technology has changed the process of pharmaceutical development so much that a new term—bioinformatics—has been coined to describe this new approach to such development. (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 main aim of this paper is to investigate the views of healthcare professionals in Portugal about healthcare rationing, and compare them with the views of college students. A self-administered questionnaire was used to collect data from a sample of 60 healthcare professionals and 180 college students. Respondents faced a hypothetical rationing dilemma where they had to order four patients and justify their choices. Multinomial logistic regressions were used to test for differences in orderings, and content analysis to categorize the (...) written justifications. The findings suggest that both groups appeared to support three main rationing principles: health maximization, priority to the severely ill and priority to the young. However, professionals seemed to give less weight to the latter principle. In conclusion, professionals have similar views to students about healthcare rationing, though may be slightly less inclined to give priority to the young. (shrink)

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)

Most economists and some philosophers distinguish individual utilities from interpersonal social values. Even if challenges to that conceptual distinction can be met, further philosophically interesting questions arise. I pursue three in this paper, using, as context for the discussion, health economics and its attempt to discern empirically a social welfare function to help guide rationing decisions. (1) To discern these utilities and values in a manner that is morally appropriate if they are to influence rationing decisions, who should be queried? (...) To discern individual health state utilities, persons in precisely those states should be asked (generically, patients), but for social values, representatives of the general public should be. (2) To discern social values, what should representatives of the public be asked? They should be asked person trade-off (PTO) questions that encompass their own self-interest, not PTO questions that focus only on others. (3) What must public representatives understand before they respond to such questions? Despite the philosophically complex problem of patient adaptation, they should understand (among other things) the health state utilities elicited from actual patients with the conditions at issue. (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 lack of economic sustainability of most healthcare systems and a higher demand for quality and safety has contributed to the development of regulation as a decisive factor for modernisation, innovation and competitiveness in the health sector. The aim of this paper is to determine the importance of the principle of public accountability in healthcare regulation, stressing the fact that sunshine regulation—as a direct and transparent control over health activities—is vital for an effective regulatory activity, for an appropriate supervision of (...) the different agents, to avoid quality shading problems and for healthy competition in this sector. Methodologically, the authors depart from Kieran Walshe’s regulatory theory that foresees healthcare regulation as an instrument of performance improvement and they articulate this theory with the different regulatory strategies. The authors conclude that sunshine regulation takes on a special relevance as, by promoting publicity of the performance indicators, it contributes directly and indirectly to an overall improvement of the healthcare services, namely in countries were citizens are more critical with regard to the overall performance of the system. Indeed, sunshine regulation contributes to the achievement of high levels of transparency, which are fundamental to overcoming some of the market failures that are inevitable in the transformation of a vertical and integrated public system into a decentralised network where entrepreneurialism appears to be the predominant culture. (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)

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

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)

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)

In recent years a number of commentators have discussed the importance of measuring quality of life in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what (...) we should do from the broader universe of what we can do.The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability. (shrink)

In recent years a number of commentators have discussed the importance of measuring quality of life in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what (...) we should do from the broader universe of what we can do.The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability. (shrink)

The current U.S. health care system, with both rising costs and demands, is unsustainable. The combination of a sense of individual entitlement to health care and limited acceptance of individual responsibility with respect to personal health has contributed to a system which overspends and underperforms. This sense of entitlement has its roots in a perceived right to health care. Beginning with the so-called moral right to health care, the issue of who provides health care has evolved as individual rights have (...) trumped societal rights. The concept of government providing some level of health care ranges from limited government intervention, a ‘negative right to health care’, to various forms of a ‘positive right to health care’. The latter ranges from a decent minimum level of care to the best possible health care with access for all. We clarify the concept of legal rights as an entitlement to health care and present distributive and social justice counter arguments to present health care as a privilege that can be provided/earned/altered/revoked by governments. We propose that unlike a ‘right’, which is unconditional, a ‘privilege’ has limitations. Going forward, expectations about what will be made available should be lowered while taking personal responsibility for one’s health must for elevated. To have access to health care in the future will mean some loss of personal rights and an increase in personal responsibility for gaining or maintaining one’s health. (shrink)