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.

Substance in bureaucratic procedures for healthcare resource allocation: a reply to Smith.

William Smith's recent article criticises the so-called orthodox approaches to the normative analysis of healthcare resource allocation, associated to the requirement that decision-makers should abide by strictly procedural principles of legitimacy defining a deliberative democratic process. Much of the appeal of Smith's argument goes down to his awareness of real-world processes and, in particular, to the large gap he identifies between well-led democratic deliberation and the messiness of the process through which the intuitively legitimate Affordable Care Act (ACA) was created. This reply aims to demonstrate that the ACA provides no counterexample to orthodox views, seizing this opportunity to explore the specific space that the procedural principles populating orthodox accounts are meant to regulate. Neither general questions of healthcare justice concerning, for example, universal access nor, relatedly, the activity of elected politicians falls within the natural scope of application of such principles, revealing a much more complex picture of the interactions between justice and legitimacy as well as substantive and procedural considerations than acknowledged by Smith. In the end, orthodox accounts of healthcare resource allocation turn out to provide a precious fund of theoretical resources for the normative study of administrators, which might be useful well beyond bioethics and health policy.

If You're a Rawlsian, How Come You're So Close to Utilitarianism and Intuitionism? A Critique of Daniels's Accountability for Reasonableness.

Norman Daniels's theory of 'accountability for reasonableness' is an influential conception of fairness in healthcare resource allocation. Although it is widely thought that this theory provides a consistent extension of John Rawls's general conception of justice, this paper shows that accountability for reasonableness has important points of contact with both utilitarianism and intuitionism, the main targets of Rawls's argument. My aim is to demonstrate that its overlap with utilitarianism and intuitionism leaves accountability for reasonableness open to damaging critiques. The important role that utilitarian-like cost-effectiveness calculations are allowed to play in resource allocation processes disregards the separateness of persons and is seriously unfair towards individuals whose interests are sacrificed for the sake of groups. Furthermore, the function played by intuitions in settling frequent value conflicts opens the door for sheer custom and vested interests to steer decision-making.

Public participation in decision-making on the coverage of new antivirals for hepatitis C.

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.