We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment.

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper - developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting - seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.

Health, Health Care, and Equality of Opportunity: The Rationale for Universal Health Care.

This article discusses what arguments best support universal health care (UHC), with a focus on Norman Daniels' equality of opportunity account. This justification for UHC hinges on the assumption of a close relationship between health care and health. But in light of empirical research that suggests that health outcomes are shaped to a large extent by factors other than health care, such as income, education, housing, and working conditions, the question arises to what extent health care is really necessary to protect and promote health, and thereby opportunity. The author argues that, although this challenge to the equality of opportunity rationale is legitimate, it is not sufficiently specified to allow us to adequately assess the extent to which universal health succeeds in protecting equality of opportunity. The article concludes by outlining a more promising strategy for developing a viable rationale for UHC.

The ethics of grandfather clauses in healthcare resource allocation.

A grandfather clause is a provision whereby an old rule continues to apply to some existing situation while a new rule applies to all future cases. This paper focuses on the use of grandfather clauses in health technology appraisals (HTAs) issued by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. NICE provides evidence-based guidance on healthcare technologies and public health interventions that influence resource allocation decisions in the National Health Service (NHS) and the broader public sector in England and Wales. In this context, a grandfather clause is included when NICE does not recommend treatment with a given technology. The grandfather clause provides an exemption from the general recommendation for patients who have already started treatment with the technology in question, before the publication of the NICE guidance. In this paper we first lay out the contexts in which grandfather clauses occur in NICE guidance, and then consider ethical arguments against and in support of grandfather clauses and the continuation of treatment. We argue that NICE's current practice of automatic inclusion of a grandfather clause is ethically problematic and unfair. While the inclusion of a grandfather clause may be appropriate and justified in specific cases, we argue that inclusion of such a clause should be considered as part and parcel of the decision making process on a case by case basis, rather than adopted as the default.

Towards theoretically robust evidence on health equity: a systematic approach to contextualising equity-relevant randomised controlled trials.

Reducing inequalities in health and the determinants of health is a widely acknowledged health policy goal, and methods for measuring inequalities and inequities in health are well developed. Yet, the evidence base is weak for how to achieve these goals. There is a lack of high-quality randomised controlled trials (RCTs) reporting impact on the distribution of health and non-health benefits and lack of methodological rigour in how to design, power, measure, analyse and interpret distributional impact in RCTs. Our overarching aim in this paper is to contribute to the emerging effort to improve transparency and coherence in the theoretical and conceptual basis for RCTs on effective interventions to reduce health inequity. We endeavour to achieve this aim by pursuing two more specific objectives. First, we propose an overview of three broader health equity frameworks and clarify their implications for the measurement of health inequality in RCTs. Second, we seek to clarify the relationship between theory and translational challenges that researchers would need to attend to, in order to ensure that equity-relevant RCTs are coherently grounded in theory.

The Norwegian National Council for Priority Setting in Health Care: decisions and justifications.

Different countries have adopted different strategies for tackling the challenge of allocating scarce health care resources fairly. Norway is one of the countries that has pioneered the effort to resolve priority setting by using a core set of priority-setting criteria. While the criteria themselves have been subject to extensive debate and numerous revisions, the question of how the criteria have been applied in practice has received less attention. In this paper, we examine how the criteria feature in the decisions and justifications of the Norwegian National Council for Priority Setting in Health Care, which has played an active role in deliberating about health care provision and coverage in Norway. We conducted a comprehensive document analysis, looking at the Council's decisions about health care allocation as well as the reasons they had provided to justify their decisions. We found that although the Council often made use of the official priority-setting criteria, they did so in an unsystematic and inconsistent manner.