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.

Public health by organizational fix?

In August 2020 the UK government announced without warning the abolition of Public Health England (PHE), the principal UK agency for the promotion and protection of public health. We undertook a research programme seeking to understand the factors surrounding this decision. While the underlying issues are complex two competing interpretations have emerged: an 'official' explanation, which highlights the failure of PHE to scale up its testing capacity in the early weeks of the COVID-19 pandemic as the fundamental reason for closing it down and a 'sceptical' interpretation, which ascribes the decision to blame-avoidance behaviour on the part of leading government figures. This paper reviews crucial claims in these two competing explanations exploring the arguments for and against each proposition. It concludes that neither is adequate and that the inability adequately to address the problem of testing (which triggered the decision to close PHE) lies deeper in the absence of the norms of responsible government in UK politics and the state. However our findings do provide some guidance to the two new organizations established to replace PHE to maximize their impact on public health. We hope that this information will contribute to the independent national COVID inquiry.

Reforming the public health system in England.

The abolition of Public Health England (PHE) during the COVID-19 pandemic has raised concerns about the future of the public health system in the UK, particularly in England. The two new bodies established in haste to replace PHE prompt reflection on the executive agency's fate and the need to identify any lessons to ensure that a public health system is put in place that is fit for purpose. The UK COVID-19 Inquiry provides an opportunity to make recommendations, but it will need to act quickly to avoid recommendations being ignored. Two areas of concern are highlighted in this Viewpoint: the respective remits of the new bodies and their governance arrangements. Both issues demand urgent attention if the new structures are to succeed and avoid a similar fate to that which befell PHE. But underlying these concerns is a much larger challenge arising from the UK's broken political system. The political system in the UK suffers from several systemic weaknesses, including departmentalism, poor implementation, an inability or unwillingness of those in power to listen to the truth, and chronic short-termism at the expense of long-term planning. Overhauling the UK's dysfunctional political system is a prerequisite for successfully improving the public health system.

Exorcising the positivist ghost in the priority-setting machine: NICE and the demise of the 'social value judgement'.

The National Institute for Health and Care Excellence (NICE), the UK's primary health care priority-setting body, has traditionally described its decisions as being informed by 'social value judgements' about how resources should be allocated across society. This paper traces the intellectual history of this term and suggests that, in NICE's adoption of the idea of the 'social value judgement', we are hearing the echoes of welfare economics at a particular stage of its development, when logical positivism provided the basis for thinking about public policy choice. As such, it is argued that the term offers an overly simplistic conceptualisation of NICE's normative approach and contributes to a situation in which NICE finds itself without the necessary language fully and accurately to articulate its basis for decision-making. It is suggested that the notion of practical public reasoning, based on reflection about coherent principles of action, might provide a better characterisation of the enterprise in which NICE is, or hopes to be, engaged.

Affordability and Non-Perfectionism in Moral Action.

One rationale policy-makers sometimes give for declining to fund a service or intervention is on the grounds that it would be 'unaffordable', which is to say, that the total cost of providing the service or intervention for all eligible recipients would exceed the budget limit. But does the mere fact that a service or intervention is unaffordable present a reason not to fund it? Thus far, the philosophical literature has remained largely silent on this issue. However, in this article, we consider this kind of thinking in depth. Albeit with certain important caveats, we argue that the use of affordability criteria in matters of public financing commits what Parfit might have called a 'mistake in moral mathematics'. First, it fails to abide by what we term a principle of 'non-perfectionism' in moral action: the mere fact that it is practically impossible for you to do all the good that you have reason to do does not present a reason not to do whatever good you can do. And second, when used as a means of arbitrating between which services to fund, affordability criteria can lead to a kind of 'numerical discrimination'. Various attendant issues around fairness and lotteries are also discussed.

Creating sustainable health care systems.

PURPOSE: In order to create sustainable health systems, many countries are introducing ways to prioritise health services underpinned by a process of health technology assessment. While this approach requires technical judgements of clinical effectiveness and cost effectiveness, these are embedded in a wider set of social (societal) value judgements, including fairness, responsiveness to need, non-discrimination and obligations of accountability and transparency. Implementing controversial decisions faces legal, political and public challenge. To help generate acceptance for the need for health prioritisation and the resulting decisions, the purpose of this paper is to develop a novel way of encouraging key stakeholders, especially patients and the public, to become involved in the prioritisation process. DESIGN/METHODOLOGY/APPROACH: Through a multidisciplinary collaboration involving a series of international workshops, ethical and political theory (including accountability for reasonableness) have been applied to develop a practical way forward through the creation of a values framework. The authors have tested this framework in England and in New Zealand using a mixed-methods approach. FINDINGS: A social values framework that consists of content and process values has been developed and converted into an online decision-making audit tool. RESEARCH LIMITATIONS/IMPLICATIONS: The authors have developed an easy to use method to help stakeholders (including the public) to understand the need for prioritisation of health services and to encourage their involvement. It provides a pragmatic way of harmonising different perspectives aimed at maximising health experience. PRACTICAL IMPLICATIONS: All health care systems are facing increasing demands within finite resources. Although many countries are introducing ways to prioritise health services, the decisions often face legal, political, commercial and ethical challenge. The research will help health systems to respond to these challenges. SOCIAL IMPLICATIONS: This study helps in increasing public involvement in complex health challenges. ORIGINALITY/VALUE: No other groups have used this combination of approaches to address this issue.

Public Reasoning and Health-Care Priority Setting: The Case of NICE.

Health systems that aim to secure universal patient access through a scheme of prepayments-whether through taxes, social insurance, or a combination of the two-need to make decisions on the scope of coverage that they guarantee: such tasks often falling to a priority-setting agency. This article analyzes the decision-making processes at one such agency in particular-the UK's National Institute for Health and Care Excellence (NICE)-and appraises their ethical justifiability. In particular, we consider the extent to which NICE's model can be justified on the basis of Rawls's conception of "reasonableness." This test shares certain features with the well-known Accountability for Reasonableness (AfR) model but also offers an alternative to it, being concerned with how far the values used by priority-setting agencies such as NICE meet substantive conditions of reasonableness irrespective of their procedural virtues. We find that while there are areas in which NICE's processes may be improved, NICE's overall approach to evaluating health technologies and setting priorities for health-care coverage is a reasonable one, making it an exemplar for other health-care systems facing similar coverage dilemmas. In so doing we offer both a framework for analysing the ethical justifiability of NICE's processes and one that might be used to evaluate others.

Associative Obligation and the Social Contract.

John Horton has argued for an associative theory of political obligation in which such obligation is seen as a concomitant of membership of a particular polity, where a polity provides the generic goods of order and security. Accompanying these substantive claims is a methodological thesis about the centrality of the phenomenology of ordinary moral consciousness to our understanding of the problem of political obligation. The phenomenological strategy seems modest but in some way it is far-reaching promising to dissolve some long-standing problems of political theory. However, it fails at just the point at which a theory of political obligation is needed, namely when individuals question the grounds of their political obligation. A principle of obligation is needed to provide individuals with a reason for compliance with authoritative social rules when the exercise of that obligation is irksome. It is at this point that we need to invoke the idea of society as an implicit social contract, in which obligations are seen as stemming from those terms that it would be in the interests of individuals to agree in a social contract. This is consistent with the method of reflective equilibrium.

Introduction: priority setting, equitable access and public involvement in health care.

Purpose - The purpose of this paper is to introduce the special issue on improving equitable access to health care through increased public and patient involvement (PPI) in prioritization decisions by discussing the conceptualization, scope and rationales of PPI in priority setting that inform the special issue. Design/methodology/approach - The paper employs a mixed-methods approach in that it provides a literature review and a conceptual discussion of the common themes emerging in the field of PPI and health priority setting. Findings - The special issue focuses on public participation that is collective in character, in the sense that the participation relates to a social, not personal, decision and is relevant to whole groups of people and not single individuals. It is aimed at influencing a decision on public policy or legal rules. The rationales for public participation can be found in democratic theory, especially as they relate to the social and political values of legitimacy and representation. Originality/value - The paper builds on previous definitions of public participation by underlining its collective character. In doing so, it develops the work by Parry, Moyser and Day by arguing that, in light of the empirical evidence presented in this issue, public participatory activities such as protests and demonstrations should no longer be labelled unconventional, but should instead be labelled as "contestatory participation". This is to better reflect a situation in which these modes of participation have become more conventional in many parts of the world.

Patterns of public participation.

Purpose - The paper summarizes data from 12 countries, chosen to exhibit wide variation, on the role and place of public participation in the setting of priorities. The purpose of this paper is to exhibit cross-national patterns in respect of public participation, linking those differences to institutional features of the countries concerned. Design/methodology/approach - The approach is an example of case-orientated qualitative assessment of participation practices. It derives its data from the presentation of country case studies by experts on each system. The country cases are located within the historical development of democracy in each country. Findings - Patterns of participation are widely variable. Participation that is effective through routinized institutional processes appears to be inversely related to contestatory participation that uses political mobilization to challenge the legitimacy of the priority setting process. No system has resolved the conceptual ambiguities that are implicit in the idea of public participation. Originality/value - The paper draws on a unique collection of country case studies in participatory practice in prioritization, supplementing existing published sources. In showing that contestatory participation plays an important role in a sub-set of these countries it makes an important contribution to the field because it broadens the debate about public participation in priority setting beyond the use of minipublics and the observation of public representatives on decision-making bodies.

Between consensus and contestation.

Purpose - Noting that discussions of public participation and priority setting typically presuppose certain political theories of democracy, the purpose of this paper is to discuss two theories: the consensual and the agonistic. The distinction is illuminating when considering the difference between institutionalized public participation and contestatory participation. Design/methodology/approach - The approach is a theoretical reconstruction of two ways of thinking about public participation in relation to priority setting in health care, drawing on the work of Habermas, a deliberative theorist, and Mouffe, a theorist of agonism. Findings - The different theoretical approaches can be associated with different ways of understanding priority setting. In particular, agonistic democratic theory would understand priority setting as system of inclusions and exclusions rather than the determination of a consensus of social values, which is the typical deliberative way of thinking about the issues. Originality/value - The paper shows the value of drawing out explicitly the tacit assumptions of practices of political participation in order to reveal their scope and limitations. It suggests that making such theoretical presuppositions explicit has value for health services management in recognizing these implicit choices.

Public involvement in health priority setting: future challenges for policy, research and society.

Purpose - The purpose of this paper is to reflect on the findings of this special issue and discusses the future challenges for policy, research and society. The findings suggest that challenges emerge as a result of legitimacy deficits of both consensus and contestatory modes of public involvement in health priority setting. Design/methodology/approach - The paper draws on the discussions and findings presented in this special issue. It seeks to bring the country experiences and case studies together to draw conclusions for policy, research and society. Findings - At least two recurring themes emerge. An underlying theme is the importance, but also the challenge, of establishing legitimacy in health priority setting. The country experiences suggest that we understand very little about the conditions under which representative, or authentic, participation generates legitimacy and under which it will be regarded as insufficient. A second observation is that public participation takes a variety of forms that depend on the opportunity structures in a given national context. Given this variety the conceptualization of public participation needs to be expanded to account for the many forms of public participation. Originality/value - The paper concludes that the challenges of public involvement are closely linked to the question of how legitimate processes and decisions can be generated in priority setting. This suggests that future research must focus more narrowly on conditions under which legitimacy are generated in order to expand the understanding of public involvement in health prioritization.