The relevance of the European Union (EU) for health has been widely recognised within the health community for some time, and is increasingly apparent to European policy-makers and publics. Despite being an area of policy that national governments would prefer to keep exclusive control of, and though in the past it has rarely been at the top of the agenda, many elements of health have been gradually ‘Europeanised’. This special issue marks the culmination of a British Academy-funded project – EU Health Law and Policy: Shaping a Future Research Agenda – which sought to build on the growing web of expertise in this field and reflect upon the future of health as an EU competence, at a time when it appeared to be under threat.

At present, pay for prescription models are insufficient at containing costs and improving access to medicines. Subscription financing through tenders, licensing fees and unrestricted or fixed volumes can benefit stakeholders across the supply chain. Pharmaceutical manufacturers can reduce the need for marketing expenses and gain certainty in revenue. This will decrease costs, improve predictability in budget expenditure for payers and remove price as a barrier of access from patients. Inherently, low- and middle-income countries lack the purchasing power to leverage price discounts through typical price arrangements. These markets can realise substantial savings for branded and generic medicines through subscription financing. Procuring of on-patent and off-patent drugs requires separate analysis for competition effects, the length of contract and encouraging innovation in the medicine pipeline. Prices of competitive on-patent medicines and orphan drugs can be reduced through increased competition and volume. Furthermore, pooling expertise and resources through joint procurement has the potential for greater savings. Incentivising research and development within the pharmaceutical industry is essential for sustaining a competitive market, preventing monopolies and improving access to expensive treatments. However, technical capacity, forecasting demand and the quality of generic medicines present limitations which necessitate government support and international partnerships. Ultimately, improving access requires progressive financing mechanisms with patients and cost containment in mind.

Before his incoherent response to the COVID-19 pandemic, the focus of President Trump's health policy agenda was the elimination of the Patient Protection and Affordable Care Act (ACA), which he has called a ‘disaster’. The attacks on the ACA included proposals to repeal the law through the legislative process, to erode it through a series of executive actions, and to ask the courts to declare it unconstitutional. Despite these ongoing challenges, the ACA remains largely intact as the U.S. heads into the 2020 election. The longer term fate of the law, however, is uncertain and the outcome of the 2020 election is likely to have a dramatic effect on the direction of health policy in the U.S.

Dr Anna Dixon, Chief Executive at the Centre for Ageing Better, examines the issues around an ageing population, how we have reached this stage and offers potential solutions to the problems it presents. Her book, The Age of Ageing Better? turns the misleading and depressing narrative of burden and massive extra cost of people living longer on its head and shows how our society could thrive if we started thinking differently. She presents a refreshingly optimistic vision for the future that could change the way we value later life in every sense.

In publicly funded health systems, reform efforts have proliferated to adapt to increasingly complex demands. In Canada, prior research (Lazar et al., 2013, Paradigm Freeze: Why is it so Hard to Reform Health Care in Canada?, McGill-Queen's Press) found that reforms at the end of the 20th century failed to change the fundamentals of the Canadian system based on physician independence and assured universal coverage only for medical and hospital services. This paper focuses on reforms since the turn of the millennium to explore the transformative capacities developed in seven provinces within this system architecture. Longitudinal case studies, based on scientific and grey literature, and interviews with key informants, trace the patterns of reform in each province and reveal five objectives that, to varying degrees, preoccupied reformers: (1) address chronic disease, (2) align health system actors with provincial objectives, (3) shift from hospital to community-based care, (4) integrate physicians, and (5) develop improvement capacities. The range of strategies adopted to achieve these objectives in different provinces is compared to identify emerging pathways of reform and extract lessons for future reformers. We find significant cross-learning between provinces, but also note an emergent dimension to reforms, where multiple strategies aggregate through time to create unique patterns, presenting their own set of possibilities and limitations for the future.

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

The expansion of privatisation in health care has been discussed extensively in most European countries and remains a hot topic nowadays. In China, privatisation results in considerable changes in its health care system, especially accelerating the ever-growing private medical institutions (PMIs). The rapid growth of PMIs raises the question of regulation for the Chinese government. Given the fact that few studies are available on the regulation of PMIs in China, I attempted to fill that gap by discussing the development of PMIs with a special focus on legal–regulatory strategies. After assessing current legal–regulatory strategies concerning PMIs, the paper identifies three major concerns regarding effective legal rules (i.e. weak coherence, inconsistency and legislative vacancy) and three difficult issues regarding government capacity (i.e. the negative effects of decentralised political structure, the low professionalism of bureaucrats and lack of reliability) that impede the well-functioning of regulatory agencies in China. As a plausible response, the paper recommends that the newly drafted basic health law should assign a separate chapter to regulate PMIs and also an independent regulatory body should be established to manage the issues of PMIs in China. Detailed recommendations are the practical implications of ICESCR General Comment No. 14.

The EU Treaties oblige the EU institutions to take health objectives and concerns into account in all policy fields. Nevertheless, this obligation is only marginally honoured in many EU policy areas at best. One problem is the lack of enforcement options to pursue further implementation. This paper examines the obligation to ‘mainstream’ health in Article 168 TFEU and demonstrates the difficulties in enforcing the obligation in more detail. It then offers a new, deeper interpretation of the contents of the mainstreaming obligation and discusses how this definition may be used to facilitate better enforcement in the future.

In health care systems based upon managed competition, insurers are expected to negotiate with providers about price and quality of care. The Dutch experience, however, shows that quality plays a limited role in insurer–provider negotiations. It has been suggested that this is partly due to a lack of cooperation among insurers. This raises the question whether cooperation amongst insurers is a precondition or a substitute for quality-based competition. To answer this question, we mapped insurers' cooperating activities to enhance quality of care using a six-stage continuum. The first three stages (defining, designing and measuring quality indicators) may enhance competition, whereas the next three stages (setting benchmarks, steering patients and selective contracting) may reduce it. We investigated which types of insurer cooperation currently take place in the Netherlands. Additionally, we organized focus groups among insurers, providers and other stakeholders to examine their perceptions on insurer cooperation. We find that all stakeholders see advantages of cooperation amongst insurers in the first stages of the continuum and sometimes cooperate in this domain. Cooperation in the next stages is almost absent and more controversial because without adequate quality information, it is difficult to assess whether the benefits outweigh the cost associated with reduced competition.

This work quantitatively assesses the potential reasons behind the difference in prices paid by care home residents in England. Evidence suggests that the price paid by private payers is higher than that paid for publicly supported residents, and this is often attributed to the market power wielded by local authorities as the dominant purchaser in local markets. Estimations of private prices at the local authority level are used to assess the difference in price paid between private and public prices, the fees gap, using data from 2008 to 2010. Controlling for local area and average care home characteristics, the results indicate that both care home and local authority market power play a role in the price determination of the market.

The prevention of antimicrobial resistance (AMR) has been a flagship of the EU's health policy since the early 2000s, leading the European Commission to mandate three European agencies to cooperate in the fight against AMR: EMA (the European Medicines Agency), ECDC (European Centre for Disease Prevention and Control) and EFSA (the European Food Safety Agency). This article is at the intersection of EU health policy and the burgeoning scholarship on bureaucratic reputation. Little is known on the role played by reputational incentives on inter-agency cooperation. This empirical work supports the claim that cooperation creates incentives for agencies to protect their reputational uniqueness vis-à-vis each other. However, rather than threatening their cooperation, it amounts to a process of sense-making of their respective roles in the integrated fight against AMR. Evidence is generated through the agencies' textual sources, as well as in-depth interviews and analysed through a narrative analysis. From the early days of inter-agency cooperation, to recent legislative work, this paper offers in-depth insights on the EU's governance against AMR.

While ensuring adequate access to care is a central concern in countries with universal health care coverage, unmet health care needs remain prevalent. However, subjective unmet health care needs (SUN) can arise from features of a health care system (system reasons) or from health care users' choices or constraints (personal reasons). Furthermore, investigating the evolution of SUN within a health care system has rarely been carried out. We investigate whether health needs, predisposing factors and enabling factors differentially affect SUN for system reasons and SUN for personal reasons, and whether these influences are stable over time, using representative data from the Canadian Community Health Surveys from 2001 to 2014. While SUN slightly decreased overall during our period of observation, the share of SUN for system reasons increased. Some key determinants appear to consistently increase SUN reporting over all our observation periods, in particular being a woman, younger, in poorer health or not having a regular doctor. The distinction between personal and system reasons is important to better understand individual experiences. Notably, women report more SUN for system reasons and less for personal reasons, and reporting system reasons increases with age. Given this stability over time, our results may inform health policymakers on which subpopulations to target to ensure access to health care is universal.

While policy attention is understandably diverted to COVID-19, the end of the UK's post-Brexit ‘transition period’ remains 31 December 2020. All forms of future EU−UK relationship are worse for health than EU membership, but analysis of the negotiating texts shows some forms are better than others. The likely outcomes involve major negative effects for NHS staffing, funding for health and social care, and capital financing for the NHS; and for UK global leadership and influence. We expect minor negative effects for cross border healthcare (except in Northern Ireland); research collaboration; and data sharing, such as the Early Warning and Response System for health threats. Despite political narratives, the legal texts show that the UK seeks de facto continuity in selected key areas for pharmaceuticals, medical devices, and equipment [including personal protective equipment (PPE)], especially clinical trials, pharmacovigilance, and batch-testing. The UK will be excluded from economies of scale of EU membership, e.g. joint procurement programmes as used recently for PPE. Above all, there is a major risk of reaching an agreement with significant adverse effects for health, without meaningful oversight by or input from the UK Parliament, or other health policy stakeholders.

Over the last three decades, a system of European Union mental health governance (EUMHG) emerged, via instruments including strategies for action, joint actions, pacts and high-level expert groups. It sponsored multiple projects, initiatives and research, and involved state, non-state and European institutional actors. This paper attempts to understand how EUMHG operated and the structure of political relations within it, attending especially to opportunities for citizen participation. It adopts a global governmentality approach that focuses on practices and discourses. It finds that EUMHG practices including benchmarks, best practices and risk-thinking reinforced larger EU policy goals of market-optimisation, and that the central discourses of de-institutionalisation (DI) and community mental health (CMH) shifted meaning over time, first apprehending mental health as a public-health goal, then targeting mental ill-health as a burden to states. Finally, it finds that non-governmental organisations' (NGOs) work within EUMHG rendered them both objects and subjects of government. Through these dynamics, citizens usually were positioned outside governance, and NGO identities were altered, though CMH's transformative potential remained. Citizen participation in EUMHG was heavily conditioned. NGO and citizen power will need vigilant protection in any future EUMHG.

How do experts judge the legitimacy of technical policy processes, and do their ideas change as these processes are opened to other stakeholders and the public? This research examines the adoption of public and patient involvement in pharmaceutical assessment in Canada. It finds tensions between scientific legitimacy that prioritizes rigor and objectivity, and democratic legitimacy that values inclusion and a broader range of evidence. In response to policy change, experts incorporate new ideas about democratic inputs and processes, while maintaining scientific policy goals. The research responds to calls for more precise measurement of ideas and ideational change and more evaluation of public and patient involvement in health policy. It helps us understand the significance of, and limits to, ideational change among experts in health policy domains that are highly technical and publicly salient. Understanding the way democratic and scientific legitimacy are negotiated in policy decisions has a wide applicability in health, but is particularly relevant during a global pandemic when evidence is being generated rapidly, decisions must be made quickly, and these decisions have a significant, immediate effect on the lives of all citizens.

In recent years, a variety of ‘accelerated access’ schemes have been introduced by pharmaceutical regulators and funders globally. These schemes aim to overcome perceived regulatory and reimbursement barriers to accessing medicines – particularly for patients with limited time or therapeutic options. However, patient access to approved medicines is mediated by a number of third parties including regulators and payers, and physicians who act both as gatekeepers and guides to prescribed medications. It is therefore essential to know how physicians think about accelerated access as they are responsible for advising patients on and prescribing medicines made available via these pathways. We conducted semi-structured interviews with 18 Australian physicians focusing on their attitudes towards accelerated access. We identified three ‘archetypes’ of physicians: ‘confident accelerators’, ‘cautious accelerators’, and ‘decelerators’. Although all acknowledged the potential risks and benefits of accelerated access, they disagreed on their magnitude and extent and how they should be balanced in both policy formation and clinical practice. Overall, our results illustrate the diversity of clinical opinions in this area and the importance of monitoring both the prescribing and clinical outcomes that result from accelerated access programmes to ensure that these are both clinically and morally acceptable.

Currently, reimbursement decisions based on health technology assessments (HTA) in the Netherlands mostly concern outpatient pharmaceuticals. The Dutch government aspires to broaden the systematic application of full HTA towards other types of health care in order to optimise the content of the basic benefit package. This paper identifies important challenges for broadening the scope of full HTA to other types of health care. Based on a description of the Dutch reimbursement decision-making process, five important characteristics of outpatient pharmaceuticals were identified, which are all relevant to the successful application of HTA: (i) closed reimbursement system, (ii) absence of alternative policy measures, (iii) existence of marketing authorisation, (iv) identifiable and accountable counterparty, and (v) product characteristics. For a selection of other types of health care, which may be subject to HTA more frequently in the future, deviations from these characteristics of outpatient pharmaceuticals are discussed. The implications of such deviations for performing HTA and the decision-making process are highlighted. It is concluded that broadening the application of HTA will require policy makers to meet both important policy-related and methodological challenges. These challenges differ per health care domain, which may inform policy makers which expansions of the current use of HTA are most feasible.

One explanation for increases in health care costs has been malpractice lawsuits. States have introduced several types of tort reforms to control increases in health care costs. This paper adds to the literature by examining how the differences in joint and several liability (JSL) reforms affect the state-specific growth rate in health care expenditures. Additionally, the paper addresses the potential for a fundamental difference between states that pass different types of liability reforms. The results show that JSL reforms that limit joint liability based on percentage of blame have statistically and economically significant impacts on health care expenditure growth rates.

The Affordable Care Act requires all insurance plans sold on health insurance marketplaces and individual and small-group plans to cover 10 Essential Health Benefits (EHB), including behavioral health services. Instead of applying a uniform EHB plan design, the Department of Health and Human Services let states define their own EHB plan. This approach was seen as the best balance between flexibility and comprehensiveness, and assumed there would be little state-to-state variation. Limited federal oversight runs the risk of variation in EHB coverage definitions and requirements, as well as potential divergence from standardized medical guidelines. We analyzed 112 EHB documents from all states for behavioral health coverage in effect from 2012 to 2017. We find wide variation among states in their EHB plan required-coverage, and divergence between medical-practice guidelines and EHB plans. These results emphasize consideration of federated regulation over health insurance coverage standards. Federal flexibility in states benefit design nods to state-specific policymaking-processes and population needs. However, flexibility becomes problematic if it leads to inadequate coverage that reduces access to critical health care services. The EHBs demonstrate an incomplete effort to establish appropriate minimum standards of coverage for behavioral health services.

To what extent does inadequate market regulation contribute to poor health outcomes? A series of prominent scandals involving harmful medical devices has made improving the regulation of these devices an urgent problem for the European Union (EU). This is, however, a specific example of a general phenomenon. The EU remains first and foremost a large and integrated market within which the EU institutions have considerable regulatory authority. Even if there is little EU commitment to a health or social policy agenda, its use of that regulatory authority shapes health care cost and quality and should be understood as health policy. We use data from EU-level and national policy documents to analyse the EU's current regulatory framework for medical devices and assess its likely future efficacy. Despite revising the medical devices directive to require more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance, the key underlying problems of market fragmentation and patient safety persist. Without strong and consistent support for the implementation of the new directive, the likely result is the status quo, with significant consequences for health in Europe.