Health care coverage decisions may employ many different considerations, which are brought together across two phases. The assessment phase examines the available scientific evidence, such as the cost-effectiveness, of the technology. The appraisal then contextualises this evidence to arrive at an (advised) coverage decision, but little is known about how this is done.

In the Netherlands, the appraisal is set up to achieve a societal weighing and is the primary place where need- and solidarity-related (‘necessity’) argumentations are used. To elucidate how the Dutch appraisal committee ‘constructs necessity’, we analysed observations and recordings of two appraisal committee meetings at the National Health Care Institute, the corresponding documents (five), and interviews with committee members and policy makers (13 interviewees in 12 interviews), with attention to specific necessity argumentations.

The Dutch appraisal committee constructs necessity in four phases: (1) allowing explicit criteria to steer the process; (2) allowing patient (representative) contributions to challenge the process; (3) bringing new argumentations in from outside and weaving them together; and (4) formulating recommendations to societal stakeholders. We argue that in these ways, the appraisal committee achieves societal weighing rationality, as the committee actively uses argumentations from society and embeds the decision outcome in society.

This paper brings a constitutional economics perspective to bear on the World Health Organization (WHO), the flagship United Nations intergovernmental health organisation, which is obligated by its Constitution to achieve ‘the highest possible level of health’ for the world's peoples. The WHO has in the seven decades of its existence used its formidable legislative powers only sparingly. It has been widely chided for being weak in regional coordination and unresponsive to transnational emergencies like the West African Ebola outbreak of 2014–2016. In 2020, it found itself at the centre of the COVID-19 pandemic and in the middle of the Sino-American geopolitical tug-of-war. This paper traces the discordance between the Constitution's stated purposes and the actual track record of the WHO not back to its organisational culture nor to weak leadership but to the design of the Constitution itself. It analytically distinguishes the Constitution's expressive from its instrumental halves, and shows that, whilst the former embodies a ‘constitutional moment’ of international health solidarity right after the Second World War, the latter embodies a reserved and limited delegation from member-states that are jealous of their sovereignty.

The paper addresses the issue of excessive price abuse under Article 102(a) of the Treaty on the Functioning of the European Union (TFEU), by drawing inspiration from a recent stream of cases (developed first at the national and then at the EU level) involving pharmaceutical companies marketing off-patent drugs. In particular, the two ‘most advanced’ cases are analysed: Aspen in Italy and Pfizer/Flynn in the United Kingdom. This new-found attention towards exploitative practices in the form of excessive and unfair pricing by dominant undertakings that have traditionally been subject to a cautious antitrust scrutiny seems worth exploring for a number of reasons, as illustrated in the paper. Ultimately, it is argued that this further ‘interference’ of competition law into the realms of regulation may be actually justified, albeit subject to precise conditions for enforcement, and may pursue policy objectives in the wider context of EU health law.

Public reporting of clinical performance is increasingly used in many countries to improve quality and enhance accountability of the health system. The assumption is that greater transparency will stimulate improvements by clinicians in response to peer pressure, patient choice or competition. The international diffusion of public reporting might suggest greater similarity between health systems. Alternatively, national and local contexts (including health system imperatives, professional power and organisational culture) might continue to shape its form and impact, implying continued divergence. The paper considers public reporting in the USA and England through the lens of Scott's ‘pillars’ institutional framework. The USA was arguably the first country to adopt public reporting systematically in the late 1980s. England is a more recent adopter; it is now being widely adopted through the National Health Service (NHS). Drawing on qualitative data from California and England, this paper compares the behavioural and policy responses to public reporting by health system stakeholders at micro, meso and macro levels and through the intersection of ideas, interests, institutions and individuals through. The interplay between the regulative, normative and cultural-cognitive pillars helps explain the observed patterns of on-going divergence.

Part of the controversy surrounding competition and health care stems from the complexity connected with delineating the applicability of competition law – encompassing both the provisions governing anticompetitive agreements and abuse of dominance and the state-aid rules. Cases determined at the European Union (EU) level within the past 30 years have developed a broad framework, and notable trends have emerged – for example, a distinction between health care providers and managing bodies (purchasers). The former have been subject to an ‘abstract’ test and the latter to a more sophisticated ‘concrete’ test. In this paper, we chart the development of the EU courts’ approach to developing the ‘undertaking’ concept in health care and examine the current EU competition law framework with a view to identifying future directions. van de Gronden has recently identified a ‘three-prong’ test of exemption from competition law in connection with the recent CEPPB case: firstly, where the supply of services is predominantly dependent upon public financing; secondly, the public funding aims to achieve a public interest goal and thirdly, the activities concerned are closely related to this public interest goal. We examine this test in a health care context, drawing on our findings regarding Dutch competition reforms.

This paper argues that a certain level of indeterminacy in policy design may be a factor facilitating rather than hindering system-level change in welfare governance arrangements, provided it is combined with the triggering of specific concatenations of social mechanisms shaping the dynamics of the change process. The argument is illustrated by an analysis of a case of systemic change in chronic disease management occurred in the Italian region of Lombardy over 2016–2017, when a radically novel governance of chronic disease for the 10 million population was put in place (a health care system that was later tested to its limits by the COVID-19 pandemic outburst which reached dramatic intensity in this region). This represented a major change in a key area of social and health policy. We claim that such change processes may be studied by means of the conceptual tools of social mechanisms. The analysis of social mechanisms represents a lively research agenda for explaining change in public governance and public policy.

This research longitudinally examines the association between levels of state Medicaid prescription spending and the state strategies intended to constrain cost increases: the negotiated pricing strategy, as indicated by state rebate programs, and the price transparency strategy, as indicated by state operation of All-Payer Claims Databases. The findings demonstrate evidence that state Medicaid prescription spending is influenced by the negotiated pricing strategy, especially Managed Care Organization (MCO) rebates under the Patient Protection and Affordable Care Act, but not influenced by the price transparency strategy. State decisions for MCO rebates, such as carving prescription benefits into managed care benefits, were effective in containing levels of Medicaid prescription spending over time, while other single- and multi-state rebate programs were not. Based on these findings, state policymakers may consider utilizing the MCO rebate program to address increases in Medicaid prescription spending.

Although efficiency is a core concept in health economics, its impact on health care practice still is modest. Despite an increased pressure on resource allocation, a widespread use of low-value care is identified. Nonetheless, disinvestments are rare. Why is this so? This is the key question of this paper: why are disinvestments not more prevalent and improving the efficiency of the health care system, given their sound foundation in health economics, their morally important rationale, the significant evidence for a long list of low-value care and available alternatives? Although several external barriers to disinvestments have been identified, this paper looks inside us for mental mechanisms that hamper rational assessment, implementation, use and disinvestment of health technologies. Critically identifying and assessing internal inclinations, such as cognitive biases, affective biases and imperatives, is the first step toward a more rational handling of health technologies. In order to provide accountable and efficient care we must engage in the quest against the figments of our minds; to disinvest in low-value care in order to provide high-value health care.

Bringing together the results of a large-scale review of European Union (EU) policies affecting health and a large-scale analysis of social policy and federalism, this paper uses comparative federalism to identify the scope and tensions of EU health policy at the end of the Juncker Commission. Viewing health care and public health policy through the lens of comparative federalism highlights some serious structural flaws in EU health policy. The regulatory state form in which the EU has evolved makes it difficult for the EU to formulate a health policy that actually focuses on health. Of the three faces of EU health policy, which are health policy, internal market policy and fiscal governance, health policy is legally, politically and financially the weakest. A comparison of the EU to other federations suggests that this creates basic weaknesses in the EU's design: its key powers are regulatory and its redistribution minimal. No federal welfare state so clearly pools risks at a low level while making markets so forcefully or creating rights whose costs are born by other levels of government. This structure, understandable in light of the EU's history and development, limits its health and social policy initiatives and might not be stable over the long term.

Patient safety is a complex systems issue. In this study, we used a scoping review of peer-reviewed literature and a case study of provincial and territorial legislation in Canada to explore the influence of mandatory reporting legislation on patient safety outcomes in hospital settings. We drew from a conceptual model that examines the components of mandatory reporting legislation that must be in place as a part of a systems governance approach to patient safety and used this model to frame our results. Our results suggest that mandatory reporting legislation across Canada is generally designed to gather information about – rather than respond to and prevent – patient safety incidents. Overall, we found limited evidence of impact of mandatory reporting legislation on patient safety outcomes. Although legislation is one lever among many to improve patient safety outcomes, there are nonetheless several considerations for patient safety legislation to assist in broader system improvement efforts in Canada and elsewhere. Legislative frameworks may be enhanced by strengthening learning systems, accountability mechanisms and patient safety culture.

Research and Development (R&D) in health and health care has several intriguing characteristics which, separately and in combination, have significant implications for the ways in which it is organised, funded and managed. We review the characteristics, some of which apply under most circumstances and others of which may be context-specific, explore their implications for the organisation and management of health-related R&D, and illustrate the main features from the UK experience in the 1990s.

A primary care choice reform launched in Sweden in 2010 led to a rapid growth of private providers. Critics feared that the reform would lead to an increased tendency among new, profit-driven, providers, to select patients with lower health risks. Even if open risk selection is prohibited, providers can select patients in more subtle ways, such as establishing their practices in areas with higher health status. This paper investigates to what extent strategies were employed by local governments to avoid risk selection and whether there were any differences between left- and right-wing governments in this regard. Three main strategies were used: risk adjustment of the financial reimbursements on the basis of health and/or socio-economic status of listed patients; design of patient listing systems; and regulatory requirements regarding the scope and content of the services that had to be offered by all providers. Additionally, left-wing local governments were more prone than right-wing governments to adopt risk adjustment strategies at the onset of the reform but these differences diminished over time. The findings of the paper contribute to our understanding of how social inequalities may be avoided in tax-based health care systems when market-like steering models such as patient choice are introduced.

In this comment, and drawing on the papers in the special issue, we ask: what are the core questions for the future of research into health law and policy, and European health law and policy more specifically? We first sketch the general functions and values of health law and policy. We then outline how these functions and values are affected by globalisation and Europeanisation, on the one hand, and technological change and digitalisation, on the other. In light of these developments we carve out some questions for future research and the implications of this agenda for the academic community that is working on European health law and policy.

Informal care plays a crucial role in the social care system in England and is increasingly recognised as a cornerstone of future sustainability of the long-term care (LTC) system. This paper explores the variation in informal care provision over time, and in particular, whether the considerable reduction in publicly-funded formal LTC after 2008 had an impact on the provision of informal care. We used small area data from the 2001 and 2011 English censuses to measure the prevalence and intensity (i.e. the number of hours of informal care provided) of informal care in the population. We controlled for changes in age structure, health, deprivation, income, employment and education. The effects of the change in formal social care provision on informal care were analysed through instrumental variable models to account for the well-known endogeneity. We found that informal care provision had increased over the period, particularly among high-intensity carers (20+ hours per week). We also found that the reduction in publicly-funded formal care provision was associated with significant increases in high-intensity (20+ hours per week) informal care provision, suggesting a substitutive relationship between formal and informal care of that intensity in the English system.

The coronavirus disease 2019 (COVID-19) pandemic has shifted the health policy debate in Canada. While the pre-pandemic focus of policy experts and government reports was on the question of whether to add outpatient pharmaceuticals to universal health coverage, the clustering of pandemic deaths in long-term care facilities has spurred calls for federal standards in long-term care (LTC) and its possible inclusion in universal health coverage. This has led to the probability that the federal government will attempt to expand medicare as Canadians have known it for the first time in over a half century. However, these efforts are likely to fail if the federal government relies on the shared-cost federalism that marked the earlier introduction of medicare. Two alternative pathways are suggested, one for LTC and one for pharmaceuticals, that are more likely to succeed given the state of the Canadian federation in the early 21st century.

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.