This article is about the justifiability of accepting worse cost effectiveness for orphan drugs, that is, treatments for rare diseases, in a publicly financed health care system. Recently, three arguments have been presented that may be used in favour of exceptionally advantageous economic terms for orphan drugs. These arguments share the common feature of all referring to considerations of justice or fairness: the argument of the irrelevance of group size, the argument from the principle of need, and the argument of (...) identifiability. It is argued that all of these arguments fail to support the conclusion that orphan drugs should be subsidized to a larger extent than treatments for common diseases. The argument of the irrelevance fails to distinguish between directly and indirectly relevant considerations of fairness or justice. The recent attempt to revive the moral relevance of identifiability has provided no novel reasons to think that identifiability is morally relevant in itself or due to considerations of fairness and justice. The argument from the principle of need does not fail due to any inherent flaw in the principle as such. Rather, this principle can be interpreted in different ways, and none of these interpretations support exceptionally advantageous terms economically for treating rare diseases specifically. It is concluded that we are awaiting justice based reasons for the preferential treatment of orphan drugs. (shrink)

Principles of need are constantly referred to in health care priority setting. The common denominator for any principle of need is that it will ascribe some kind of special normative weight to people being worse off. However, this common ground does not answer the question how a plausible principle of need should relate to the aggregation of benefits across individuals. Principles of need are sometimes stated as being incompatible with aggregation and sometimes characterized as accepting aggregation in much the same (...) way as utilitarians do. In this paper we argue that if one wants to take principles of need seriously both of these positions have unreasonable implications. We then characterize and defend a principle of need consisting of sufficientarian elements as well as prioritarian which avoids these unreasonable implications. (shrink)

The principle of need—the idea that resources should be allocated according to need—is often invoked in priority setting in the health care sector. In this article, I argue that a reasonable principle of need must be indeterminate, and examine three different ways that this can be dealt with: appendicizing the principle with further principles, imposing determinacy, or empowering decision makers. I argue that need must be conceptualized as a composite property composed of at least two factors: health shortfall and capacity (...) to benefit. When one examines how the different factors relate to each other, one discovers that this is sometimes indeterminate. I illustrate this indeterminacy in this article by applying the small improvement argument. If the relation between the factors are always determinate, the comparative relation changes by a small adjustment. Yet, if two needs are dissimilar but of seemingly equal magnitude, the comparative relation does not change by a small adjustment of one of the factors. I then outline arguments in favor of each of the three strategies for dealing with indeterminacy, but also point out that all strategies have significant shortcomings. More research is needed concerning how to deal with this indeterminacy, and the most promising path seems to be to scrutinize the position of the principle of need among a plurality of relevant principles for priority setting in the health care sector. (shrink)

In this paper we explore the relation between health-care needs and patients’ desires within shared decision-making in a context of priority setting in health care. We begin by outlining some general characteristics of the concept of health-care need as well as the notions of SDM and desire. Secondly we will discuss how to distinguish between needs and desires for health care. Thirdly we present three cases which all aim to bring out and discuss a number of queries which seem to (...) arise due to the double focus on a patient’s need and what that patient desires. These queries regard the following themes: the objectivity and moral force of needs, the prediction about what kind of patients which will appear on a micro level, implications for ranking in priority setting, difficulties regarding assessing and comparing benefits, and implications for evidence-based medicine. (shrink)

In health care priority setting different criteria are used to reflect the relevant values that should guide decision-making. During recent years there has been a development of value frameworks implying the use of multiple criteria, a development that has not been accompanied by a structured conceptual and normative analysis of how different criteria relate to each other and to underlying normative considerations. Examples of such criteria are unmet need and severity. In this article these crucial criteria are conceptually clarified and (...) analyzed in relation to each other. We argue that disease-severity and condition-severity should be distinguished and we find the latter concept better reflects underlying normative values. We further argue that unmet need does not fulfil an independent and relevant role in relation to condition-severity except for in some limited situations when having to distinguish between conditions of equal severity. (shrink)

ZusammenfassungAdipositas ist eine weltweite Herausforderung für die Gesundheitssysteme. In Zeiten des demografischen Wandels sind auch immer mehr ältere Menschen davon betroffen, was sowohl die Akut- als auch die Langzeitpflege vor erhebliche Herausforderungen stellt. Bislang fehlt eine detaillierte Analyse der vielfältigen Gruppe der über 65-Jährigen in diesem Bereich. Weder die Bedürfnisse der Pflegebedürftigen noch der Pflegekräfte und Einrichtungen werden beobachtet, analysiert oder systematisch bewertet. Darüber hinaus sind die ethischen Implikationen der professionellen Pflege von älteren Menschen mit Adipositas in Forschung und Politik (...) noch nicht diskutiert worden. Wir argumentieren, dass ein bedürfnisorientierter Ansatz angemessen ist, um diese ethische Komplexität anzugehen. Dafür sollte eine breite und umfassende Analyse der ethischen Aspekte aus einer interdisziplinären Perspektive erfolgen. Daher führen wir ein systematische Literaturrecherche (Scoping Review) und eine thematische Fallanalyse durch, um den aktuellen Stand der Forschung aus professionellen Pflegeeinrichtungen in europäischen und nordamerikanischen Institutionen zusammenzufassen. So gewinnen wir Einblicke in die direkten Erfahrungen von Leistungserbringern und adipösen Patient*innen im Pflegebereich. Wir kommen zu dem Schluss, dass auch in Deutschland ein erheblicher Forschungsbedarf an der Schnittstelle ethischer Herausforderungen von Langzeitpflege, Alter und Adipositas besteht. Aus der begrenzten Anzahl von (Fall‑)Studien, die sich finden lassen, geht eine Reihe von ethischen Bedenken hervor, die direkte Auswirkungen auf den Zugang, die Inanspruchnahme und die Qualität der Versorgung haben. Ein empirisch-ethischer Ansatz kann die künftige Forschung und Pflegepraxis im Bereich der Adipositas und der Altenpflege leiten. Schwerpunkte der zukünftigen Mixed-methods-Forschung sollten sein: die Bedürfnisse adipöser älterer Menschen und ihrer Pfleger*innen, Kriterien für die Abwägung von Bedürfnissen und Ressourcenallokation sowie praktische Lösungen für mehrfach stigmatisierte Menschen. (shrink)

To investigate whether Swedish physicians, contrary to Swedish health care policy, employ considerations of patient responsibility for illness when rationing expensive treatments.

Instrumentalists about need believe that all needs are instrumental, i.e., ontologically dependent upon ends, goals or purposes. Absolutists view some needs as non-instrumental. The aims of this article are: clearly to characterize the instrumentalism/absolutism debate that is of concern (mainly §1); to establish that both positions have recent and current adherents (mainly §1); to bring what is, in comparison with prior literature, a relatively high level of precision to the debate, employing some hitherto neglected, but important, insights (passim); to show, (...) on grounds not previously to the fore in the literature, that insofar as instrumentalism’s advocates have provided arguments for the position, these are unsound (§2); to argue against instrumentalism using a new dilemma concerning whether ‘end’, ‘goal’ and ‘purpose’ are interpreted in a mentalistic manner (§3); to elucidate the implications of the needs/need-satisfiers and preconditions/means distinctions for the debate (§4). (shrink)

Recent medical innovations like ‘omics’ technologies, mobile health (mHealth) applications or telemedicine are perceived as part of a shift towards a more preventive, participatory and affordable healthcare model. These innovations are often regarded as ‘disruptive technologies’. It is a topic of debate to what extent these technologies may transform the medical enterprise, and relatedly, what this means for medical ethics. The question of whether these developments disrupt established ethical principles like respect for autonomy has indeed received increasing normative attention during (...) the past years. Yet, more fundamental ethical considerations of a possible disruption of the concept of ‘medical necessity’ (and the potential ensuing clinical ramifications) have been limited if not absent. It is our modest – though morally and practically relevant – aim to address this objective in this article, by exploring how the current wave of allegedly disruptive innovation is invoking a resurgence of this concept and related debates on ‘the’ goal(s) of medicine. (shrink)

Definition of the problem Obesity is a burgeoning challenge for healthcare systems worldwide. In times of demographic change, it also affects an increasing number of older persons, presenting substantial challenges to delivering health and nursing care in both acute and long-term care (LTC) settings. So far, a detailed analysis of the diverse group of 65+ in this field is missing, particularly in the area of LTC. The needs of neither care recipients, nor those of nurses and institutions are monitored, analyzed, (...) or systematically evaluated. Moreover, ethical implications of professional care for older persons with obesity have not yet been discussed in research and policy. Arguments We argue that a needs-based approach is appropriate to address these ethical complexities. We further argue that a comprehensive mapping of the ethical terrain is best from an interdisciplinary and mixed methods perspective. For this, we conduct a scoping review to synthesize the state-of-the-art in both the healthcare and LTC settings; and we focus on challenges reported in case studies from professional care settings in European and North American institutions. Conclusion Our findings point to a lack of research on ethical issues related to the LTC needs of older persons living with obesity and the challenges faced by their professional carers. From the limited number of (case) studies that can be found, however, a series of ethical concerns emerge that have direct import for access, utilization, and quality of care. Accordingly, a new research agenda is needed to inform an ethical approach for policy and practice. It must be rooted in a concern for both care recipients and caregivers in mixed methods studies. Future research should provide criteria for balancing needs, allocating resources and developing practical solutions for people who are confronted with multiple stigma. (shrink)

In this article we argue that the principle of need, on some interpretations, could be used to justify the spending of publically funded health care resources on cognitive enhancement and that this also holds true for individuals whose cognitive capacities are considered normal.The increased, and to an extent, novel demands that the modern technology and information society places on the cognitive capacities of agents, e.g., regarding good and responsible decision-making, have blurred the line between treatment and enhancement. More specifically, it (...) has shifted upwards. As a consequence, principles of need on their most reasonable interpretations can be used to support publically funded cognitive enhancement. At least this is so, if broader aims than curing and ameliorating diseases are included in the goals of health care. We suggest that it would be plausible to see health care as accepting such broader goals already today. (shrink)

Background Healthcare systems are increasingly struggling with resource constraints, given demographic changes, technological development, and citizen expectations. The aim of this article is to normatively analyze different suggestions regarding how publicly financed plastic surgery should be delineated in order to identify a well-considered, normative rationale. The scope of the article is to discuss general principles and not define specific conditions or domains of plastic surgery that should be treated within the publicly financed system. Methods This analysis uses a reflective equilibrium (...) approach, according to which considered normative judgements in one area should be logically and argumentatively coherent with considered normative judgements and background theories at large within a system. Results and conclusions In exploring functional versus non-function conditions, we argue that it is difficult to find a principled reason for an absolute priority of functional conditions over non-functional conditions. Nevertheless, functional conditions are relatively easier to establish objectively, and surgical intervention has a clear causal effect on treating a functional condition. Considering non-functional conditions that require plastic surgery [i.e., those related to appearance or symptomatic conditions ], we argue that the patient needs to experience some degree of suffering, which must be ‘validated’ in some form by the healthcare system. This validation is required for both functional and non-functional conditions. Functional conditions are validated by distinguishing between statistically normal and abnormal functioning. Similarly, for non-functional conditions, statistical normality represents a potential method for distinguishing between what should and should not be publicly funded. However, we acknowledge that such a concept requires further development. (shrink)

Definition of the problem In Germany, there is currently a significant gap in the care of persons affected by obesity due to the absence of a standardized therapy path, regional variations in health services, and case-by-case decisions for approval. This situation prompts the discussion of integrating digital obesity applications into the existing care framework. Arguments The analysis presents an ethical reflection on the use of digital health applications for obesity treatment, examining their suitability for this complex chronic condition, which has (...) multifactorial causes and a heterogeneous patient group. We evaluate the social, advisory, and organizational aspects required to meet the diverse needs of those affected. The study highlights key ethical challenges such as avoiding stigmatization and discrimination, acknowledging the diversity of patient groups, and integrating holistic therapeutic approaches. The article also emphasizes the importance of participatory research methods to incorporate the perspectives and experiences of patients systematically. Conclusion Digital health applications hold potential to significantly improve obesity care in Germany, especially in regions with limited access to traditional therapy options. Successful implementation, however, requires careful ethical reflection and empirical research. It is crucial that these applications address the diversity and complexity of the patient population and their specific needs, which will contribute to a reduction of the care gap. (shrink)

Background: Severity plays an essential role in healthcare priority setting. Still, severity is an under-theorised concept. One controversy concerns whether severity should be risk- and/or time-sensitive. The aim of this article is to provide a normative analysis of this question. Methods: A reflective equilibrium approach is used, where judgements and arguments concerning severity in preventive situations are related to overall normative judgements and background theories in priority-setting, aiming for consistency. Analysis, discussion, and conclusions: There is an argument for taking the (...) risk of developing a condition into account, and we do this when we consider the risk of dying in the severity assessment. If severity is discounted according to risk, this will ‘dilute’ severity, depending on how well we are able to delineate the population, which is dependent on the current level of knowledge. This will potentially have a more far-reaching effect when considering primary prevention, potentially the de-prioritisation of effective preventive treatments in relation to acute, less-effective treatments. The risk arguments are dependent on which population is being assessed. If we focus on the whole population at risk, with T 0 as the relevant population, this supports the risk argument. If we instead focus on the population of as-yet (at T 0 ) unidentified individuals who will develop the condition at T 1, risk will become irrelevant, and severity will not be risk sensitive. The strongest argument for time-sensitive severity (or for discounting future severity) is the future development of technology. On a short timescale, this will differ between different diagnoses, supporting individualised discounting. On a large timescale, a more general discounting might be acceptable. However, we need to also consider the systemic effects of allowing severity to be risk- and time-sensitive. (shrink)

A pandemic may cause a sudden imbalance between available medical resources and medical needs where fundamental care to a patient cannot be delivered. Inability to fulfil a professional commitment to deliver care as needed can lead to distress among caregivers and patients. This distress is sometimes alleviated through mechanisms that hide the facts that care is rationed and not all medical needs are met. We have identified three mechanisms that jeopardise accountable and optimal allocation of resources: (1) hidden value judgements (...) that allow rationing under the disguise of triage or prioritisation, (2) disguised conflict of interest between societal and individual patient’s needs and (3) concealed biases in the application of medical tools. Under these three pitfalls decisions of resource allocation and who gets treated are handled as medical decisions: normative decisions are concealed and perceived as falling with the realm of medical judgement. Value judgements and moral agency are hidden to offer a ‘false sense of medical judgement’, while in fact there are several ethical judgements and biases at stake. The three pitfalls entail hidden normative deliberation and are inappropriate for sustainable healthcare delivery and resource allocation. We believe it is necessary to maintain transparency in decision making under conditions of insufficient resources to maintain trust in professional care givers and secure fair treatment allocation. Recognition of the pitfalls, by applying our recommendations, may help to ensure transparent and accountable distribution of care and contribute to public acceptance of the ethics behind rationing. (shrink)