Some understandings of European Union health law are based on a presumption of law as a static and closed system. This approach to the Union as a legal entity has important ramifications. The Union is a political system created by and subject to the rule of law. Its successes (and failures) are attributable to the legalisation of solving externalities and ensuring Member State solidarity to gain benefits from integration. Member States, which create and sustain the Union by repeated acts of sovereign choice, choose to subject themselves to the rule of (Union) law. This protects both the Member States and the Union institutions (imperfectly, but nonetheless) from charges of illegitimacy. While recognising the benefits of such an approach to European Union integration and law-making, we take the view that law also has an important dynamic potential. That dynamic potential is inherent in all law, for law is embodied in text, and always open to interpretation, as the external contexts that give legal text meaning in the real-world change through time. We trace the dynamic potential of Union health law by looking at its legal basis to its foundational Treaties, and we plot its trajectory going forward.

COVID-19 emerged as a cross-cutting problem across governance sectors and levels, urging the creation of a European Health Union. There are already a number of integrated European governance strategies – such as the European Energy Union (2015) and the European Green Deal (2019) – adopted for overcoming problems of governance fragmentation and inadequacy of fragmented policy responses to cross-cutting policy challenges. Past studies focused on the interaction between crisis and policy change and investigated the activation of different mechanisms to enhance integration. This article contributes to the debate over the creation of a European Health Union by unpacking the acknowledged dimensions of policy integration – policy frame, subsystem involvement, policy goals and policy instruments – in order to assess their manifestations in the new EU4Health policy and to establish what contextual conditions triggered the activation of the integration-enabling mechanisms that led to a more integrated European Health Union. In so doing, it offers an analytical illustration and discusses implications for decision-making.

It is a striking feature of European Union (EU) health law and policy that it has developed in a relative lack of awareness from the general public. This situation can be partly explained by the existence of only a limited competence in the field and the recourse to other legal bases to enact public health measures, particularly Article 114 TFEU. The use of internal market powers to conduct EU health policy has given rise to several problems, affecting the legitimacy of EU action and its capacity to adequately protect human health. Only a Treaty change can provide the EU with the clear competence and the solid legislative powers that it needs to tackle the various health challenges that Europe faces and will continue to face.

Calls for a European Health Union apparently challenge long-standing beliefs that national healthcare system organisation is a Member State competence. Interaction between Member State and European Union (EU) levels therefore fundamentally requires reflection in the design, overall structure and legal basis of any European Health Union. Article 168(7) Treaty on the Functioning of the European Union (TFEU) provides the current version of the seemingly limited EU competence with regards to national healthcare system organisation and has received surprisingly little attention thus far. On the one hand, within the wider EU health competence ‘web’, Article 168(7) TFEU constrains EU adoption of measures incentivising Member States to use particular treatments or to increase intensive care units in response to COVID-19. On the other hand, Article 168(7) TFEU is challenged by the perceived influence of Country-Specific Recommendations issued in the context of the European Semester on national health policies. This opinion piece provides an original assessment of Article 168(7) TFEU to argue that Treaty change to redress the balance between EU and Member State competence regarding national healthcare systems may be uncalled for given both the flexibility afforded by the provision and the complexity and diversity of Member State healthcare systems.

Health Union raises bioethical questions ranging from resource allocation and risk balancing to respect for specific bioethical prohibitions, as an analysis of the European Parliament’s proposal for such a union shows. To date, European Union (EU) health law has succeeded in avoiding or circumscribing such questions, leading to the limited and inconsistent patchwork of EU bioethical provisions we currently have. Can this continue with a Health Union? This article argues that whilst full harmonisation is neither possible nor desirable, Health Union should entail a deepening of bioethical integration. This should occur via a robust legislative process involving citizen panels and ethical advisory group input; if Treaty change occurs, this process could be included in primary law. This is so for three reasons. First, addressing Health Union’s unavoidable bioethical questions coherently and openly reduces the risk of inadequate protection and, conversely, of interest groups “smuggling in” unsupported answers. Second, this will ensure respect for primary law, including Article 2 TEU and Article 3 CFR. Third, EU biolaw offers a middle ground between limited national and weak international human rights law on bioethics, whilst also consolidating European identity.

This contribution will draw on the literature that has accumulated on how the Court of Justice of the European Union (CJEU) has responded to the European Banking Union, which was established in similar crisis circumstances that now face the European Union (EU) in the age of COVID-19, to illustrate the legal issues on which the CJEU’s input will be particularly important in the shaping of any future European Health Union. This contribution will highlight three legal issues in particular: the interpretation of EU Treaty provisions in the health field; the scope of EU competence; and the powers of EU institutions and agencies. This contribution will argue that the CJEU case law to date on health issues is encouraging with respect to competence and agencies, but more cautious with respect to the Treaty’s health provisions.

In the wake of the outbreak of the COVID-19 crisis, the Swedish and Swiss governments adopted a similar policy approach. They enacted mostly non-binding measures to contain the epidemic, relying on the high level of interpersonal trust and trust in political institutions that exist in both of these (broadly comparable) countries to ensure compliance. However, unlike Sweden’s strategy, the Swiss policy response evolved during the early weeks of the “first wave”, achieving public health and socioeconomic results that have been considered as satisfactory, notwithstanding the complex institutional setting and policy process, the central location of Switzerland in continental Europe, its openness and its closeness with deeply affected regions in Italy and France. To shed light on this policy response and to draw lessons from it, this paper firstly discusses the role played by the new Swiss Epidemics Act. This law centralises decision-making capacity at the federal level and expands the competences of the central government, while leaving leeway to subnational units for implementation and recognising the need for increased international regulatory cooperation. Secondly, it shows how such a solution – a multi-level arrangement steered from the federal level with quite strong vertical and horizontal coordination mechanisms – could work as a blueprint for a European Health Union.

The financial crisis in 2008 and the COVID-19 pandemic today have made it clear that both financial and medical crises spread pervasively across borders. The financial crisis proved that the health of the entire European banking system stands and falls with the health of a single systemically important bank. As such, in the past decade, European Union (EU)-wide cooperation and regulation have been strengthened to ensure financial health across Europe. Today, the COVID-19 crisis reveals the de facto existence of a European healthcare system, where Member States’ medical health is interlinked and challenged. It too highlights the need for a more coordinated approach. This paper will draw lessons from European financial regulation and stress testing to make recommendations for EU-wide healthcare. The paper will show the latent benefits that a stress test might have on healthcare performance through mechanisms of governmentality. Moreover, it will pinpoint shortcomings in the financial stress test that could pose looming dangers for a European Health Union, such as a lack of de facto risk sharing. The paper concludes with pragmatic suggestions for a way forward in European healthcare regulation.

What could a European Union (EU) response mechanism to health emergencies look like in the context of a more integrated Health Union? Despite an increased EU role in the preparedness, monitoring and coordination of health emergencies over the past two decades, Member States’ responses to the first wave of COVID-19 were surprisingly uncoordinated. In light of calls to improve cooperation regarding future health emergencies, this article discusses the creation of EU surveillance, preparedness and response mechanisms for health emergencies. Using insights from previous research and secondary literature, we highlight gaps in the existing serious cross-border health threats regulatory framework and discuss opportunities for further EU action. Based on a comparison with other EU crisis management mechanisms (the Banking Union, risk preparedness in the electricity sector and food safety), we discuss different crisis decision-making and coordination models and their potential applicability to the health sector. We then formulate several propositions to strengthen Decision 1082/2013/EU on serious cross-border health threats to streamline ex ante pandemic preparedness and organise emergency responses.

This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Vaccines being the universally recognised prime method of prevention, immunisation campaigns and vaccine research and development (R&D) could reasonably be expected to feature prominently in any policy and/or strategic document addressing emerging health threats. Yet, vaccination occupies a relatively subsidiary role, with a prevalent focus on risk management mechanisms. This piece outlines the main characteristics of preparedness frameworks and looks at vaccine development in the course of PED outbreaks in the recent past, concluding that the COVID-19 pandemic calls for a paradigm shift in vaccine R&D, which should become integral to public health preparedness.

In response to the SARS-CoV-2 pandemic, European Union (EU) Member States adopted technological solutions aimed at mitigating the effects of the virus, as well as enforcing newly adopted public health measures. Examples include apps for disseminating information, performing self-diagnosis, enforcing home quarantine orders and aiding contact tracing. This extensive use of technology for tracking and promoting public health raises important questions regarding EU citizens’ privacy. Thus far, the discourse in this regard has predominantly revolved around data protection, the risk of surveillance and the right to control access over one’s personal information (informational privacy). In light of the push towards a more unified approach to mitigating the current pandemic and future health crises through a European Health Union (EHU), we consider a different dimension of privacy that may be at risk when employing technology for public health, namely the right to non-interference with one’s decisions (decisional privacy). In particular, this article focuses on whether the advances in health-related persuasive technology, together with a more general movement towards “nudging” as an individual and public health tool, will require EU legislation to further protect decisional privacy by regulating “hypernudging” technologies and to guide the EHU in coordinating public health measures that utilise these technologies in a privacy-preserving way.

The marketing of tobacco, alcohol, unhealthy food and gambling services is harmful to public health, the European economy and sustainability. If the European Union (EU) has embraced the regulation of cross-border marketing for tobacco products for over two decades, it has consistently resisted evidence-driven calls to regulate the marketing of other harmful commodities, preferring instead to rely on ineffective industry pledges. This contribution reflects on why the EU has failed to use its competence to regulate cross-border marketing more systematically to protect health and highlights why the time is ripe to reconsider the issue, before concluding with a possible way forward.

In 2014, the European Joint Procurement Agreement (JPA) was introduced as an innovative instrument to organise the procurement of vaccines and medications in preparation for pandemics. An overriding purpose of the JPA is to secure equitable and cost-effective access to medical supplies for participating EU Member States during serious health crises. This article aims to understand the current use of the JPA in response to the COVID-19 pandemic. Post-analysis of the recent use of the JPA, the article will discuss how the regional procurement mechanism can be strengthened to support the development of a European Health Union. In particular, the article will firstly question whether the four recent JPA procurement actions facilitated equitable access to medical supplies and services. Secondly, it will ask whether the centralised procurement actions preserved the integrity of the Internal Market. The importance and originality of this study are that it addresses an instrument, the JPA, which has been largely overlooked by legal scholars, and it explores how the provisions for the joint procurement of medical countermeasures as included in Article 5 of Decision 1082/2013/EU on serious cross-border threats to health could be extended to support the functioning of a European Health Union.

The shortcomings in the handling of COVID-19 highlighted the salience of health and safety at work and fuelled discussions surrounding the desirability of a European Health Union. This article conceptualises occupational health and safety at the European Union (EU) level as a key driver for the creation of a European Health Union. Through recourse to the area’s roots and its relevance to the tackling of the COVID-19 pandemic, the benefits of putting occupational health and safety in the driving seat are set out. The implications of maintaining a healthy workforce are acute, from both a social and a public health perspective, especially in the time of a pandemic. Relying on a reflective approach that goes beyond the status quo, this article offers pragmatic yet imaginative proposals for strengthening the occupational health and safety acquis. The proposals act as the blueprint for health and safety in the workplace to lay the foundation for a European Health Union and advance the social dimension of the EU.

The digital health ecosystem is rife with opportunities to improve healthcare through data-driven services in the European Union (EU). The value of health data, in the multiple forms in which they come (from health records to lifestyle data collected by smartphones or wearables), can truly emerge when they are allowed to flow in the ecosystem within a governance framework supported by all relevant stakeholders, with trust as the common and clear thread underpinning it. The coronavirus pandemic has provided an additional impetus for change, showing the importance of coordination and adequate communication between Member States and quality data to inform decision-making. Significant challenges remain, however, in order to achieve a fully integrated European digital health ecosystem, including: (1) the potentially diverging rules set by Member States at the national level and the need for an EU framework for the secondary use of health data; (2) the need for transparency and accountability for sustaining a data-sharing framework involving public authorities, research organisations, industry and citizens; and (3) the need for interoperable data and processes. Taking stock of these challenges, this article puts forward policy recommendations to enable the provision of pan-European data-driven healthcare services and to build a transparent and trustworthy framework for citizens.

This contribution evaluates whether European Union State aid policy could play a role in achieving deeper and more solidary integration in the area of public health. According to Article 107 TFEU, the powers of Member States to grant aid to help their economies are seriously limited. Exceptions to the general prohibition to grant State aid are authorised by the European Commission, which enjoys wide discretion in weighing national objectives against European integration goals. The area of public health has been shielded from the application of these rules, with activities such as the provision of health insurance failing to be considered of economic nature (see most recently the Dôvera judgment). The COVID-19 experience shows that, in cases of major health crises, State aid provisions are practically suspended, with interventions allowed in the name of the fight against the pandemic. The eventual creation of a Health Union will require the re-evaluation of the application of the State aid rules to healthcare. This paper questions whether these rules should evolve as a reflective function of strengthened competences in healthcare or whether existing regulatory powers are enough to determine the interaction between national spending policies, a solidary European Health Union and fair competition.