: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)

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

For Van Rensselaer Potter (1911–2001), Global Bio-Ethics is about building on the legacy of Aldo Leopold (1887–1948), one of the most notable forest managers of the twentieth century who brought to light the importance of pragmatism in the sciences and showed us a new way to proceed with environmental ethics. Following Richard Huxtable and Jonathan Ives's methodological 'Framework for Empirical Bioethics Research Projects' called 'Mapping, framing, shaping,' published in BMC Medicine Ethics (2019)), we propose operationalizing a framework for Global Bio-Ethics (...) by hybridizing approaches in empirical bioethics and ecosystem management. We explain this framework using the metaphor of forest management. This mixed approach is articulated through three phases: (1) mapping the “landscape” to build a working theory, (2) framing the “scene” to prepare the fieldwork, and (3) shaping bioethics “tools” to stimulate cooperation. Applying this methodology, an adaptive management cycle is outlined to help ensure that political processes are sustainable and socially acceptable, still based on strategic and ethical thinking, but also capable of reshaping failing policies. (shrink)

PhD, Institute of Public Health, Unit of Medical Philosophy and Clinical Theory, University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099 1014 Copenhagen. Tel: +45 30 32 33 63; Email: s.lauridsen{at}pubhealth.ku.dk ' + u + '@ ' + d + ' '/ /- ->Citizens’ consent to political decisions is often regarded as a necessary condition of political legitimacy. Consequently, legitimate allocation of healthcare has seemed almost unattainable in contemporary pluralistic societies. The problem is that citizens do not agree on any (...) single principle governing priorities among groups of patients. The Accountability for Reasonableness framework suggests an ingenious solution to this problem of moral disagreement. Rather than advocating any substantive distributive principle, its advocates propose a feasible set of conditions, which, if met by decision makers at the institutional level, provide, so it is promised, legitimate decisions. While we agree that A4R represents an important contribution to the priority-setting debate, we challenge the framework in two respects. First, we argue that A4R, and more specifically the relevance condition of A4R, does not enable healthcare institutions to generally distinguish between relevant and irrelevant reasons for priority-setting. Second, we criticize Daniels’ and Sabin's argument that A4R and deliberative democracy constitute necessary and sufficient conditions of a feasible procedure for setting legitimate limits within healthcare. CiteULike Connotea Del.icio.us What's this? (shrink)

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

The Social Value Judgments consultation document reveals NICE’s failure to understand its role in healthcare prioritisationThe National Institute for Health and Clinical Excellence has published a draft guideline, Social Value Judgments: Guidelines for the Institute and its Advisory Bodies , which outlines the ethical framework that will guide its decision making in the future.1 NICE guidance has a profound effect upon the delivery of health care within the National Health Service so it is crucial that an overarching guideline such as (...) this is suited to the task that it needs to perform. In this paper we argue that NICE has misunderstood the way in which its advice fits into prioritisation decisions. This misunderstanding is amplified by its views about the ethical principles that should apply to prioritisation and, in particular, its failure to appreciate the role of fair processes in prioritisation.The national and international standing of NICE means that the definitive version of Social Value Judgments: Guidelines for the Institute and its Advisory Bodies is likely to have influence beyond the institute itself. There is much to welcome about the document, not least the acknowledgement that there are important ethical dimensions to NICE’s decision making. Indeed, the significance of the document lies in the fact that NICE is attempting to create an explicit ethical framework for funding decisions.There is, however, much that is of concern. Although John Harris has made some important points about the NICE position on age and sex,2 there are other important problems that need to be discussed. First, there appears to be confusion over the nature of the funding decisions taken by NICE and, as a result, the role of its guideline. It is of vital importance that professionals and public alike understand the precise nature of …. (shrink)

Health care costs have been rising steadily in most industrialized countries. These increases are driven primarily by technological advances and, to a lesser degree, by aging of the population. Many factors make it unlikely that market forces alone will limit increases in the costs of health care. These unremitting increases make health care rationing appear both necessary and inevitable.One of the least controversial mechanisms for rationing could be to allow patients to make their own choices as to which kinds of (...) care they would be willing to forgo. This is appealing because it preserves individual freedom of choice regarding health care in a way that other rationing mechanisms often do not. Rationing by patient choice, however, can only happen if patients recognize that resources are limited and need to be conserved, and are willing to forgo marginal benefits. (shrink)

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

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

abstract The argument that scarce health care resources should be distributed so that patients in ‘need’ are given priority for treatment is rarely contested. In this paper, we argue that if need is to play a significant role in distributive decisions it is crucial that what is meant by need can be precisely articulated. Following a discussion of the general features of health care need, we propose three principal interpretations of need, each of which focuses on separate intuitions. Although this (...) account may not be a completely exhaustive reflection of what people mean when they refer to need, the three interpretations provide a starting‐point for further debate of what the concept means in its specific application. We discuss combined interpretations, the meaning of grading needs, and compare needs‐based priority setting to social welfare maximisation. (shrink)

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

Novel cellular therapy techniques promise to cure many haematology patients refractory to other treatment modalities. These therapies are intensive and require referral to and care from specialised providers. In the USA, this pool of providers is not expanding at a rate necessary to meet expected demand; therefore, access scarcity appears forthcoming and is likely to be widespread. To maintain fair access to these scarce and curative therapies, we must prospectively create a just and practical system to distribute care. In this (...) article, we first review previously implemented medical product and personnel allocation systems, examining their applicability to cellular therapy provider shortages to demonstrate that this problem requires a novel approach. We then present an innovative system for allocating cellular therapy access, which accounts for the constraints of distribution during real-world oncology practice by using a combination of the following principles: maximising life-years per personnel time, youngest and robust first, sickest first, first come/first served and instrumental value. We conclude with justifications for the incorporation of these principles and the omission of others, discuss how access can be distributed using this combination, consider cost and review fundamental factors necessary for the practical implementation and maintenance of this system. (shrink)

The COVID-19 pandemic has strained healthcare resources the world over, requiring healthcare providers to make resource allocation decisions under extraordinary pressures. A year later, our understanding of COVID-19 has advanced, but our process for making ethical decisions surrounding resource allocation has not. During the first wave of the pandemic, our institution uniformly ramped-down clinical activity to accommodate the anticipated demands of COVID-19, resulting in resource waste and inefficiency. In preparation for the second wave, we sought to make such ramp down (...) decisions more prudently and ethically. We report the development of a tool that can be used to make fair and ethical decisions in times of resource scarcity. We formed an interprofessional team to develop and use this tool to ensure that a diverse range of stakeholder perspectives were represented in this development process. This team, called the clinical activity recovery team, established institutional objectives that were combined with well-established procedural values, substantive ethical principles and decision-making criteria by using a variation on the well-known accountability for reasonableness ethical framework. The result of this is a stepwise, semiquantitative, ethical decision tool that can be applied to resource allocation challenges in order to reach fair and ethically defensible decisions. This ethical decision tool can be applied in various contexts and may prove useful at both the institutional and the departmental level; indeed this is how it is applied at our centre. As the second wave of COVID-19 strains healthcare resources, this tool can help clinical leaders to make fair decisions. There are no data in this work. (shrink)

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

In a well-known passage from 'The Red Lily', Anatole France retorts ironically: “The law, in its majestic equality, forbids rich and poor alike to sleep under bridges, to beg in the streets, and to steal loaves of bread”. The passage highlights the different burdens experienced by different people when deciding to act or not act in certain ways. This paper critically analyzes this problem; specifically, how we ought to allocate personal responsibility for actions performed by agents who each experience different (...) social, economic, political, and internal and external influences. First, the paper outlines some prevailing conceptions of personal responsibility in the literature. Second, it offers a critique of these views, arguing that they each suffer from a variety of conceptual and practical flaws. Third, a basic framework I call the continuum- threshold account of responsibility is proposed. The account distinguishes between responsibility and blameworthiness, addresses many of our objections against other prevailing conceptions of responsibility, and takes into account background structural conditions while retaining the scope for responsibility and moral agency. (shrink)

In the age of globalization, and increased interdependence in the world that we face today, there is a question we may have to raise: Do we need and could we attain a world government, capable of insuring the peace and facilitating worldwide well-being in a just and efficient manner? In the twenty chapters of this book, some of the most prominent living philosophers give their consideration to this question in a provocative and engaging way. Their essays are not only of (...) wide theoretical interest but also provide a thought-provoking approach to this most timely and urgent issue. A wide range of perspectives are represented here. -/- The authors include Richard Falk, Michael Walzer, Thomas Pogge, Larry May, Alfred Rubin, Stanley Hoffman, Jan Narveson, Virginia Held, Pauline Kleingeld and Luis Cabrera. Jovan Babic is Professor of Ethics at the University of Belgrade and Visiting Professor at Portland State University. Petar Bojanic is Senior Research Fellow at the Centre for Ethics, Law and Applied Philosophy (CELAP) as well as the Institute of Philosophy and Social Theory (Belgrade). (shrink)

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

This paper is a critique of Norman Daniels' and James Sabin's ‘Accountability for Reasonableness’ framework for making priority-setting decisions in health care in the face of widespread disagreement about values. Accountability for Reasonableness has been rapidly gaining worldwide acceptance, arguably to the point of becoming the dominant paradigm in the field of health policy. The framework attempts to set ground rules for a procedure that ensures that whatever decisions result will be fair, reasonable, and legitimate to the extent that even (...) those who would be adversely affected will have reason to abide by them. I argue that the framework's four conditions are inadequate to this task. While we certainly require a fair and legitimate procedure for making priority setting decisions in health care despite a lack of consensus on relevant ethical and political issues, we must significantly revise the four conditions, and we cannot avoid facing our substantive disagreements head on if we hope to arrive at decisions that would (and should) be acceptable to everyone. I offer two suggestions. First, there is need for greater public involvement in all stages of deliberation. Second, we should give up on the idea that we can simplify the task of democratic deliberation by disallowing particular kinds or reasons and types of reasoning. Reasons of all kinds should be on the table, but then should be judged on their merits, such as consistency, plausibility and explanatory power, without any regard for their alleged sources of authority. (shrink)

The UK’s Cancer Drugs Fund was introduced in 2010 following the Conservative Party’s promise to address the fact that numerous efficacious cancer drugs were not available because of their cost ineffectiveness, as deduced by the National Institute of Health and Care Excellence. While, at face value, this policy appears only to promote the UK’s public welfare, a deeper analysis reveals the ethically unjustifiable inconsistencies that the CDF introduces; where is the analogous fund for other equally severe diseases? Have the patients (...) without cancer been neglected simply due to the fear-inducing advertising and particularly ferocious speech which surrounds cancer? The CDF is unjustifiable when challenged by such questions. However, it is troubling to think that the CDF might be repealed in order to abolish these ethical concerns. Intuitively, one feels uncomfortable stripping the cancer patient of their benefits just so that they might be on an equally pessimistic footing with others. In the present essay, I argue that, although there are no ethically justifiable grounds for the CDF’s introduction, its removal would be inappropriate. Following this realisation, I investigate whether the procedural steps of the CDF itself—theoretically removed from the context of resource distribution for all disease types—represent an ethically justifiable system. I believe that the answer is yes, given the CDF’s conformity to accountability for reasonableness, a robust framework of procedural justice, which continuously improves the ethical and epistemological standards of the policies to which it is applied. (shrink)

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

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

At the 5th International Conference on Priorities in Health Care in Wellington, New Zealand, 2004, one resonating theme was that for priority setting to be effective, it has to include clinicians in both decision making and the enforcement of those decisions. There was, however, a disturbing undertone to this theme, namely that doctors, in particular, were unjustifiably thwarting good systems of prioritising scarce healthcare resources. This undertone seems unfair precisely because doctors may, and in some cases do, feel obligated by (...) their professional ethics to remain uninvolved either in deciding priorities and in some cases in enforcing them. I will argue that the professional role of a doctor ought not be considered inconsistent with the role of a priority setter or enforcer, as long as one crucial element is in place, a rationally coherent and broadly justifiable regime for prioritising healthcare. Given this I conclude both that prioritisation and doctoring are not incompatible under certain conditions, and that the education of healthcare professionals ought to include material on distributive justice in healthcare. (shrink)

Human civilisation faces a range of existential risks, including nuclear war, runaway climate change and superintelligent artificial intelligence run amok. As we show here with calculations for the New Zealand setting, large numbers of currently living and, especially, future people are potentially threatened by existential risks. A just process for resource allocation demands that we consider future generations but also account for solidarity with the present. Here we consider the various ethical and policy issues involved and make a case for (...) further engagement with the New Zealand public to determine societal values towards future lives and their protection. (shrink)