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.

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.

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.

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.

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.

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.

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.

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.

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.