1. The dynamic structure of the EU health competence

Health has a fragmented competence structure under the TFEU, weaving together direct and indirect powers of different nature, which have evolved over time.Footnote ⁵ Under its general competence for the “protection and improvement of human health,” the EU may only carry out actions to support, coordinate or supplement that of the Member States.Footnote ⁶ This competence is further defined at Article 168 TFEU, the health specific legal basis contained in the Treaty. While the precise nature of EU supporting competence remains unclear,Footnote ⁷ a crucial aspect thereof is that no harmonisation measures may be adopted in the areas concerned.Footnote ⁸ This severely limits the ability for the EU to conduct a policy autonomous from that of the Member States. Under Article 168(5) TFEU, the EU may only adopt incentive measures, spending “small sums of money to promote European networks that connect people and organizations, put items on the agenda for the future, and […] produce research.”Footnote ⁹ This is the role of the EU health programmes, adopted every five or six years, the latest of which covers the period 2021–2027.Footnote ¹⁰ This form of intervention, while not devoid of any influence on Member State policies, is nonetheless of limited impact.

As to the content of this general health competence, according to Article 168(1):

Union action is centred on “public health” issues, understood as the management of health risks and the prevention of disease, as opposed to “healthcare,” the provision of health services and medical care,Footnote ¹² an area which remains more firmly within the ambit of Member State competence.Footnote ¹³

Along this supporting competence, the EU is granted a shared competence for a narrower set of matters, referred to as “common safety concerns in public health.”Footnote ¹⁴ These safety concerns relate to (i) organs and substances of human origin, including blood; (ii) the veterinary and phytosanitary fields, including food safety; (iii) medicinal products and medical devices.Footnote ¹⁵ Unlike for its general health competence, the EU may adopt harmonisation measures in these areas,Footnote ¹⁶ allowing it to yield considerable influence.

Finally, and crucially, EU health law and policy has indirectly developed through a number of legal bases belonging to other policy areas and categories of competence. It is the case of Article 153 TFEU on social policy, which enables the EU to adopt harmonisation measures aimed at improving “the working environment to protect workers’ health and safety,”Footnote ¹⁷ as well as Article 191 TFEU on the environment, which mentions health as a key objective.Footnote ¹⁸ One could also include Article 122 TFEU establishing a framework for EU action in situations of emergency (see Section II. below). The most important indirect health legal basis, however, is Article 114 TFEU.Footnote ¹⁹ Under this article, the EU legislature may harmonise away the differences in Member States’ legislation which give rise to obstacles to trade, hampering the proper functioning of the internal market.Footnote ²⁰ Where these obstacles arise from discrepancies in health-related national provisions, the EU is legally competent to act and to set a common health standard. This practice was approved by the Court of Justice, which held in the landmark Tobacco Advertising ruling that “provided that the conditions for recourse to [Article 114 TFEU] are fulfilled, the [EU] legislature cannot be prevented from relying on that legal basis on the ground that public health protection is a decisive factor in the choices to be made” by the legislature.Footnote ²¹

This edifice, made of interwoven fields and legal bases, is far from being an ideal structure, as will be further discussed in Section IV. This complexity is rooted in the EU competence framework, based on a catalogue of policy fields which cannot account for the plurality of social phenomena and the plurality of goals that a given legal instrument often pursues.Footnote ²² This patchwork also reflects the all-encompassing nature of health. The health of a population impacts nearly every policy – think of security, education, employment. In return it is also impacted by nearly every policy.Footnote ²³ That is why Article 9 TFEU requires the EU, ‘[i]n defining and implementing its policies and activities, [to] take into account requirements linked to the promotion of a high level of […] human health’, an obligation reiterated in Article 168(1) TFEU and Article 35 of the Charter of Fundamental Rights of the European Union. This “health in all policies” approach to policymaking recognises that factors beyond those traditionally addressed as “health” need to be addressed.Footnote ²⁴

2. A pivotal role in disease prevention and treatment, a limited role in healthcare delivery

Because of this complexity, EU health powers are generally underestimated.Footnote ²⁵ So is the extent to which the EU regulates the field. This article is not the place to provide an exhaustive account of the state of EU health law and policy, including from a historical perspective.Footnote ²⁶ Suffice it to say that EU involvement in health has dramatically increased since the 1990s, coinciding with the introduction of a devoted legal basis in the TFEU, then known as the EC Treaty, after the Maastricht revision.Footnote ²⁷ Following the public health/healthcare dichotomy introduced earlier, the EU can be described as playing today a pivotal role in public health, i.e., the prevention and treatment of both communicable and non-communicable diseases at a population level, while exercising only a modest influence on the delivery of healthcare services and the organisation of health systems.

Regarding disease prevention, the EU has acted in a wide range of public health matters. For communicable diseases, such as COVID-19, the informal group created in the 1990s to enhance common surveillance was turned into a broader framework.Footnote ²⁸ The European Centre for Disease Prevention and Control (ECDC) plays a key role. It was established in 2004, following the breakout of several health crises, including the Severe Acute Respiratory Syndrome (SARS). It is tasked to coordinate the response of Member States against infectious diseases, through monitoring, research and scientific assistance.Footnote ²⁹ Until COVID-19, the EU’s response to serious cross-border threats to health, including biological or chemical agents and environmental events, was governed by Decision 1082/2013/EU, which contained rules on surveillance, early warning and the procurement of medical countermeasures.Footnote ³⁰ The reforms brought that that legal framework are addressed in Section III.

Regarding non-communicable diseases, cancer in particular, the EU focuses on the root causes of ill-health,Footnote ³¹ targeting harmful lifestyles and the commercial determinants of health – i.e., the consumption of tobacco, alcohol and unhealthy foods.Footnote ³² Action is especially forceful for tobacco products, with measures prohibiting the advertising of tobacco in audiovisual and printed media and regulating the composition, packaging and labelling of products.Footnote ³³ On food quality, EU intervention focuses on the provision of complete and reliable nutrition and health information to consumers.Footnote ³⁴

Going beyond the communicable/non-communicable dichotomy, the EU has set up a common framework to prevent the spread of health hazards through food, in which the European Food Safety Authority (EFSA) plays a pivotal role.Footnote ³⁵ This followed the BSE or “mad cow disease” outbreak of the 1990s in the United Kingdom, a disease affecting cattle which subsequently spread to humans through meat consumption.Footnote ³⁶ One may also mention policy areas more closely related to environmental policy, where the EU has adopted measures: on chemicals,Footnote ³⁷ against water pollutionFootnote ³⁸ or for better air quality.Footnote ³⁹

Regarding treatment, the EU has adopted measures on the safety of organs and substances of human origin, including blood, tissues and cells.Footnote ⁴⁰ This is to ensure safe donations and transplantations throughout the EU. Blood transfusion raised on the top of the agenda with the HIV/AIDS outbreak of the late 1980s.Footnote ⁴¹ EU rules on medicines are similarly rooted in a crisis, the thalidomide scandal of the late 1950s, a medicine given to pregnant women to treat morning sickness which harmed the health of around 10,000 babies worldwide.Footnote ⁴² The EU has now extensive rules regulating medicines throughout their life cycle, from development, clinical trials, manufacturing, marketing, and post-marketing surveillance (“pharmacovigilance”), supported by the work of the European Medicines Agency (EMA).Footnote ⁴³ Comparable rules apply to medical devices.Footnote ⁴⁴

EU action in healthcare is more limited. The EU has very little to say on the organisation of health and social security systems. The few binding measures that exist on healthcare focus on cross-border situations, addressing the rights of patients to seek treatment abroad,Footnote ⁴⁵ the coordination of social security rights,Footnote ⁴⁶ and the recognition of medical diplomas and qualifications.Footnote ⁴⁷ This allows for the mobility of healthcare professionals and ensures that workers, students or tourists are adequately protected while being abroad. The EU nonetheless yields some influence in the area, through soft law and coordination measures aimed at promoting flexible convergence on general objectives concerning the sustainability and quality of care.Footnote ⁴⁸ This has been done through the Open Method of Coordination (OMC), a “means of spreading best practice and achieving greater convergence towards the main EU goals.”Footnote ⁴⁹ Another important process is the “European Semester,” a cycle of coordination of the Member States’s economic policies, where the Council discusses and adopts country-specific recommendations (CSRs).Footnote ⁵⁰ These CSRs address the question of the sustainability of national healthcare systems,Footnote ⁵¹ and must be put into the broader context of the (austerity) measures adopted in response to the eurozone crisis.Footnote ⁵²

This brief overview reveals three important characteristics of EU health law and policy, which will guide our discussion in the next sections. First, EU intervention in the field is closely linked to cross-border health threats. These threats expose shortcomings in the current system and create a shared desire to fight them together, resulting in strengthening the EU framework.Footnote ⁵³ Second, EU action, which extends to all fields of health, cannot reasonably be described as being only of a “supportive” nature anymore. The limits to the EU’s mandate expressed in Article 168 TFEU are easily circumvented by the use of Article 114 TFEU, the legal basis underpinning most EU health instruments – it is widely used in the fields of food, tobacco, medicines and medical devices, as well as patient and healthcare professionals mobility. That being said, this is our third point, this does not mean that EU action is wired to favour market interests. If the market may be considered the predominant face of EU health law and policy,Footnote ⁵⁴ this reflects the nature of the EU’s powers and the fact that health and economic life are closely intertwined. Regulating health means regulating products and services. Some aspects of the EU acquis and the Court of Justice’s case law may very well be criticised for their deregulatory effect, but this cannot hide the fact that the EU has largely re-regulated the field. The EU legislator is perfectly at liberty, and even required,Footnote ⁵⁵ to use its internal market competence to pursue an ambitious health agenda. Any rigorous analysis of the various instruments surveyed can establish this point.

1. The EU’s forceful response to the crisis

On 11 March 2020, the WHO classified COVID-19 as a global pandemic.Footnote ⁵⁶ By that time, the SARS-CoV-2 virus had already widely circulated in the EU. In the days that followed, most Member States adopted drastic non-pharmaceutical interventions designed to stop the spread of the virus and safeguard their healthcare systems, in the form of stay-at-home orders, curfews and other shutdown measures. The pandemic, because of its scale, was not only a health crisis, but impacted all aspects of social and economic life. Accordingly, the EU’s response to the virus was wide-ranging and multi-faceted, addressing both its health and economic consequences.

Regarding the former, the EU tried to preserve the integrity of the internal market while supporting economic recovery. In the early months of the pandemic, the Member States adopted various restrictive measures, with a total lack of coordination, severely hindering the free flow of goods, persons and services within the EU. These included border measures restricting individual mobilityFootnote ⁵⁷ and export bans or restrictions on goods like personal protection equipment or medicines.Footnote ⁵⁸ The Commission reacted promptly, aiming to convince Member States to remove restrictions progressively as the situation improved. Its action unfolded along two main lines: (i) allowing the free movement of ‘essential’ goods, workers and economically active citizens,Footnote ⁵⁹ and (ii) protecting intra-Union movement at the expense, if necessary, of extra-Union movement. As early as 16 March 2020, the Commission recommended the temporary restriction of non-essential travel from third countries into the Union for an initial period of 30 days.Footnote ⁶⁰ The main step towards a coordinated lifting of internal restrictions was made through the “EU Digital Covid Certificate,”Footnote ⁶¹ whose provisions expired on 30 June 2023.

The most dramatic developments for the EU concerned its fiscal and economic governance. After they had adopted some smaller-scale financial assistance measures, through the REACT-EU fundFootnote ⁶² or the European Solidarity Fund,Footnote ⁶³ the Commission and the Member States took the unprecedented step to issue a common debt to avert an economic meltdown and a potential new sovereign debt crisis. The NGEU recovery package is essentially a huge pot of money of 750 billion euro, made of grants and loans, distributed to the Member States to withstand the economic downturn and finance the long-term recovery and resilience of their economies.Footnote ⁶⁴ Both the scale and the nature of the borrowings made – it is the first time that borrowings were used to finance spendings rather than loans – triggered debates as to the compliance of the NGEU package with the Treaties, with the principle of conferral in particular.Footnote ⁶⁵

The EU’s health response to the crisis may be divided in three tiers: (i) the preventive aspect of limiting the spread of the virus through public health measures, such as social distancing or closure of premises; (ii) the organisation of the healthcare system, hospitals and intensive care units in particular, and the supply of necessary equipment to protect health professionals; (iii) the procurement of medical countermeasures, such as medicines or vaccines. The EU acted to different degrees in these three areas but, overall, the Member States remained mostly in charge. The EU did not order stay-at-home measures, deal with hospital planning or devise vaccine strategies, these issues touching upon the core of Member States’ responsibilities in healthcare, public security and public policy.

On the first tier, preventive measures, the EU largely followed the framework instituted by Decision 1082/2013 on serious cross-border health threats. The Decision formally establishes a Health Security Committee, composed of representatives of the health ministries of the Member States, to coordinate national responses. This committee met several times a month and played a key role driving the EU’s answer to the crisis.Footnote ⁶⁶ Regarding containment measures the Commission published a ‘Joint European Roadmap’ in April 2020, trying to persuade Member States to follow scientific evidence as closely as possible and to revise their approach as the pandemic evolved.Footnote ⁶⁷ The ECDC played a crucial role in this regard, as the body in charge of collecting, evaluating and disseminating relevant scientific data, providing scientific opinions and assistance, and exchanging information and best practices.Footnote ⁶⁸ The ECDC released many technical reports providing guidance to Member States on health countermeasures, offering advice on, for instance, the isolation of infected individuals, the use of facemasks or testing.Footnote ⁶⁹

Regarding healthcare, the second tier, EU action was limited to coordinating the collaboration and mutual support of healthcare facilities, for the transfer of patients for instance, especially in border regions.Footnote ⁷⁰ It was able to build on the long-standing “Euregios,” in which health cooperation has been a strong dimension since the 1990s, such as the Germany–Netherlands–Belgium, Denmark–Sweden or Spain–Portugal border regions.Footnote ⁷¹ No guidance was given, even in the form of soft law, regarding the organisation of healthcare systems, especially hospitals, during the crisis.

On medical countermeasures, the last tier, the EU activated its joint procurement scheme under Decision 1082/2013. It used it for various goods: personal protective equipment (‘PPE’) – i.e. gloves, coveralls, masks, etc – laboratory equipment or medicinal products.Footnote ⁷² The European Medicines Agency (EMA) piloted the roll-out of COVID-19 treatments and vaccines,Footnote ⁷³ ensuring that these were safe for human use. More controversially, Member States agreed that the Commission would centrally procure vaccines and coordinate a negotiation team that included experts from national administrations.Footnote ⁷⁴ In this context, the Commission used the Emergency Support Instrument (ESI) to conclude Advance Purchasing Agreements with vaccine producers.Footnote ⁷⁵ These agreements were entered into by the Commission on behalf of the Member States. However, the design of vaccination policies, such as the definition of priority groups, and the conduct of vaccination campaigns – who administers vaccines and where they are administered – stayed within the remit of the Member States.Footnote ⁷⁶

2. A new legal framework against cross-border health threats

Overall, the EU used its limited powers to the best it could in this crisis, even exceeding expectations. The lack of coordination at the beginning of the pandemic was not of the EU’s due alone but reflected the sudden and unexpected nature of the crisis, and the fact that the EU was not in the driver’s seat. Responsibility for a crisis response primarily lies at national or sub-national level, depending on the structures and institutions that legitimate and inspire trust in public health systems.Footnote ⁷⁷ Despite evident successes in the EU’s support to the Member States, the most spectacular one being the NGEU package, COVID-19 nonetheless exposed some weaknesses in the framework for health crisis preparedness and response. The EU faced difficulties in ensuring the availability of the medical countermeasures needed to address Covid-19, among which medicinal products and medical devices. When the Commission published a call for tender to secure masks and medical protective equipment in February 2020, not a single company replied with an offer.Footnote ⁷⁸ While a second public procurement procedure was published in March 2020 and did receive replies, the medical countermeasures could however not be delivered before mid-April, not promptly enough to fight a global pandemic of this magnitude.Footnote ⁷⁹ As a consequence, France, Germany, Italy and the Netherlands decided to procure vaccines separately from the Commission.Footnote ⁸⁰

The EU brought a series of changes to its legal apparatus, designed to address these shortcomings by strengthening the Commission’s powers and bringing more coherence to any future crisis response. The most visible of these changes was the creation in 2021 of a new Commission service, the Health Emergency Preparedness and Response Authority (HERA).Footnote ⁸¹ HERA is now primarily responsible for ensuring the availability of medical countermeasures in the event of a crisis and bears responsibility at all stages, from their development and production to their procurement and distribution.Footnote ⁸² The creation of HERA was complemented by new rules increasing the powers of the Commission to supply crisis-relevant medical countermeasures.Footnote ⁸³ In addition, a new general framework on serious cross-border threats to health was introduced, in the form of a Regulation (SCBTH Regulation), replacing previous Decision 1082/2013.Footnote ⁸⁴ The Regulation strengthens the analysis of and reporting on health systems indicators, to improve the surveillance and monitoring of health threats and to increase the cooperation between the different actors at the EU level, the Member States and the WHO.Footnote ⁸⁵ The SCBTH Regulation recognises a new power to the Commission to declare a public health emergency at EU level,Footnote ⁸⁶ in which case specific emergency measures become available, such as the possibility to activate HERA’s emergency framework.Footnote ⁸⁷ It also strengthens the rules for the joint procurement of medical countermeasures, introducing the possibility to agree upon an exclusivity clause to improve the EU’s negotiation position.Footnote ⁸⁸

The EMA was also given a greater role in the management of the necessary medicinal products and medical devices in case of crisis,Footnote ⁸⁹ with the same goal to ensure availability of supply. A number of new structures were established to improve the monitoring and mitigation of shortages of medicines and medical devices, both in preparation for or during public health emergencies.Footnote ⁹⁰ In particular, a new Emergency Task Force was created, providing scientific advice and recommendations on such products, contributing to the work of the relevant scientific committees and advising on various aspects related to clinical trials.Footnote ⁹¹ Finally, the mandate of ECDC was also reinforced. The new framework aims to improve the Centre’s role in providing robust and independent scientific expertise and its overall activities related to serious cross-border health threats.Footnote ⁹² As part of its reinforced mandate, ECDC is able to provide recommendations and support related to the prevention and control of communicable diseases and related special health issues, and relevant coordinated action.Footnote ⁹³ Other new tasks include the monitoring of national health systems capacity, the support of national monitoring of major diseases, and the identification of research priorities.Footnote ⁹⁴ In addition, an EU Health Task Force within the ECDC was introduced, to assist in the preparedness for and response to health crises.Footnote ⁹⁵

Overall, these changes strengthen the coordination at EU level, filling the gaps and/or formalising the informal actions initiated during the Covid-19 response. Nevertheless, two issues may arise as regards the Commission’s effectiveness in times of emergency. Van Kreij and De Vries identified the first, which concerns the lack of (enforcement) powers of HERA.Footnote ⁹⁶ Since medical countermeasures are often produced by private actors, their cooperation is key to HERA. This is for instance the case where HERA request an inventory to be made, according to Articles 10 and 11 of the Emergency Framework. The authority has however no means to ensure that private actors provide the necessary information.Footnote ⁹⁷ Similarly, private actors and Member States are not obliged to take measures where a risk of shortage exists, as laid down in Article 12 of the Emergency Framework. HERA’s role is limited to facilitating relevant measures. A similar problem occurs with Article 7, where HERA needs information from Member States to carry out its monitoring task.Footnote ⁹⁸ The Commission has other compliance tools at its disposal, such as the infringement procedure, but these methods may be too slow.Footnote ⁹⁹ Thus, the lack of (enforcement) powers may make it difficult for the Authority to effectively ensure the availability of medical countermeasures in times of an emergency.

A second issue concerns the new procurement regime. A joint EU procedure on an exclusive basis could strengthen the EU’s bargaining power.Footnote ¹⁰⁰ Both the SCBTH Regulation and the Emergency Framework refer to an exclusivity clause,Footnote ¹⁰¹ under which participating states cannot procure the medical countermeasure concerned via another route or run parallel procurement procedures to obtain it.Footnote ¹⁰² Such a clause is, however, optional.Footnote ¹⁰³ Thus, when an emergency occurs, the adoption of an exclusive procurement procedure would depend on the willingness of the participating states, which, as it happened in the early stages of the Covid-19 pandemic, might put their own interests first.Footnote ¹⁰⁴ This would diminish the EU’s bargaining power, which could jeopardize the (timely) availability of medical countermeasures.Footnote ¹⁰⁵

1. The European Health Union: what’s in a name?

At the highest levels of EU policy making, the first reference to a European Health Union was found in Ursula von der Leyen’s 2020 State of the Union address.Footnote ¹⁰⁷ Thus doing, she, perhaps unknowingly, walked in the footsteps of former French Minister of Public Health Paul Ribeyre, who, in 1952, proposed to establish a European Health Community alongside the one for coal and steel (ECSC).Footnote ¹⁰⁸ His proposal did not receive the necessary support, but many of his ideas, such as a coordinated approach to epidemics and the free movement of medical professionals, are now part of the EU acquis.Footnote ¹⁰⁹ Whether in the economic, monetary or energy domains, the “unionisation” of a given policy area has nowadays both a descriptive and prescriptive value. It signals that EU action has reached a certain level of maturity and coherence, as much as it sets the course for greater integration. That can be observed too with the European Health Union.

As in any other policy field, money is key. Increased funding might be the European Health Union’s most tangible contribution to health in Europe. With a 5.3 billion euros budget, the 2021–2027 “EU4Health” programme constitutes a significant financial increase, to be compared with the 450 million euros envelope earmarked for the 2014–2020 programme.Footnote ¹¹⁰ To the “EU4Health” programme should be added the 43 billion euros worth of health-related measures contained in the national recovery and resilience plans adopted in the framework of the NGEU package.Footnote ¹¹¹ While signalling greater investment in health, these sums must nonetheless be put into perspective. They are only a fraction of the total value of the EU’s financial engagements for the period – the EU’s 2021–2027 long-term budget and NGEU amount together to over 2 trillion eurosFootnote ¹¹² – and of the healthcare expenditure in the Member States – 432 billion euros for Germany alone in 2020.Footnote ¹¹³ Financially speaking, the EU remains a junior player in health matters.

While initially centred on cross-border health threats, the European Health Union came eventually to encompass the entire field of EU health law and policy.Footnote ¹¹⁴ A number of key initiatives from the Von der Leyen Commission may be singled out. On the legislative side, a key pillar of the European Health Union is the European Health Data Space (EHDS) Regulation, adopted in February 2025.Footnote ¹¹⁵ The EHDS creates a common data space in the field of health. Among other things, it will facilitate the exchange of data for the delivery of healthcare services across the EU (primary use of data), and allow for the reuse of health data for research and innovation purposes (secondary use of data). Another key pillar is the reform of the EU pharmaceutical legislation, put forward by the Commission in spring 2023.Footnote ¹¹⁶ Its overarching aim is to improve access to medicines for patients across the EU, enhance security of supply and address shortages. In conformity with the “One Health” approach,Footnote ¹¹⁷ it aims to contribute to the fight against antimicrobial resistance (AMR).Footnote ¹¹⁸

Two other important initiatives, this time in the form of Commission communications, should also be mentioned. The “Europe’s Beating Cancer Plan” is the EU’s renewed political commitment to fighting cancer,Footnote ¹¹⁹ a long-standing feature of EU health law and policy.Footnote ¹²⁰ The plan focuses on the prevention, early detection and diagnosis and treatment of cancer, and the quality of life of (recovered) cancer patients. It will receive 4 billion euros of funding, including 1.25 billion from the EU4Health programme. As part of the plan, the Commission wishes to continue promoting healthier lifestyles and achieve a tobacco-free generation – i.e. ensuring that less than 5 per cent of the population uses tobacco by 2040.

The EU Global Health Strategy is part of the EU’s external action and forms the external dimension of the European Health Union.Footnote ¹²¹ It aims to achieve three main objectives. The first two focus on improving disease prevention and treatment across people’s life course, and improving health systems and healthcare coverage, thus broadly mirroring the two pillars of EU internal health policy. The third priority concerns the fight against pandemics and other health threats, also following a One Health approach – i.e. acknowledging the relationship between human health and animal health, the environment and climate. In that regard, the EU has been instrumental in the negotiation of a global WHO “Pandemic Agreement,” a critical amendment to the 2005 International Health Regulations, aimed at improving the preparedness and response to future health threats at a global level.Footnote ¹²² The EU Global Health Strategy provides a good starting point, with a better conceptualisation of the EU’s role on the world stage. In that area, the biggest challenge remains for Member States to speak in a united voice, in a particularly difficult geopolitical climate.Footnote ¹²³

Despite early calls to discuss “the question of health competences,”Footnote ¹²⁴ there has been little appetite from Member States to open the Pandora’s box of Treaty change. This is unlikely to change in the near future. As long as this is the case, the European Health Union will remain a political slogan, a “rebranding” of largely pre-existing initiatives rather than a fundamental change to the EU’s health mandate and policy orientations.Footnote ¹²⁵ This does not mean that the concept is devoid of interest. It has undoubtedly shed some light on the EU’s doings in health, bringing together different policy fields under one umbrella. It has created a certain momentum and given rise to expectations on which one may build to reflect upon the future of EU health law and policy.

2. Better clarity, improved quality, enhanced legitimacy

The emergence of the European Health Union has left the EU’s formal position as a health actor largely unaltered. This is because, as argued throughout this paper, a form of health union has been, silently, years in the making. We believe that this form of “harmonisation by stealth,”Footnote ¹²⁶ taking place under the veil of a limited formal competence, is no longer tenable. A Treaty change, as unlikely as it may be in the short-term, is needed to clarify the EU’s responsibilities in health, improve decision- and law-making, and increase the democratic and political legitimacy of EU health law and policy.

Thinking about the European Health Union, one should first tackle the what – the need for a common European approach in health – before addressing the how – the legal/institutional changes necessary to give it shape. As should be clear to the reader by now, there is no field of health where the EU is prohibited to go. This is not only true for the negative reach of EU law, its scope of application,Footnote ¹²⁷ but also in terms of positive legislative activity. This does not mean that the EU is omnipotent. Its action is limited by legal principles – conferral, subsidiarity and proportionality,Footnote ¹²⁸ to name a few – and the political appetite of Member States for greater integration. In that regard, the current division of tasks between the EU and the national level appears broadly satisfactory, the former focusing on public health and product regulation, the latter retaining primary responsibility for the organisation and delivery of healthcare, as well as the management of health crises. Healthcare systems are at the core of modern Welfare States and express sensitive socio-fiscal choices. National or sub-national governments are better placed than the Union to respond to their population’s needs and to build a crisis response that panders to different ethos and relationships to risk.

This is not a call for the status quo. The EU Health Union, as the EU in general, suffers in particular from one major deficit, the lack of fiscal integration and financial transfers between Member States, leaving some of the national healthcare systems chronically underfunded. A comparative exercise show how little the EU does to redress the fiscal imbalances between its richest and poorest regions,Footnote ¹²⁹ if compared to other types of federal arrangements. Economic theory does recommend, however, to pool risk at the highest possible level in a federation, while leaving the concrete delivery of healthcare services to the sub-federal levels.Footnote ¹³⁰ The EU is good at the latter, but does very little for the former. Worse, since the sovereign debt crisis of 2010, its fiscal and economic governance rules have been used to entrench fiscal rigour and limit social spending.Footnote ¹³¹ A change of course is therefore needed. Greater financial solidarity would also help evening out health inequalities, which still run deep within and between Member States,Footnote ¹³² and is essential to foster a feeling of we-ness and loyalty to the EU.Footnote ¹³³ From this perspective, the NGEU recovery package constitutes a significant step forward.

Hence, from a competence point of view – i.e., the legal capacity to act – little change is needed for the EU to strengthen or improve its health policies. Fighting health inequalities, within and outside the EU, helping to strengthen national health systems, tackling major cross-border health scourges: all this can be done under the current framework, as interpreted by the EU institutions and the Court of Justice. We submit, however, that a Treaty change is needed to clarify the current division of competences in the field of health, which would in turn improve the quality and legitimacy of EU action in the field.

As is apparent from the developments in Section II, there is a clear discrepancy between the classification of health as a supporting competence and the reality of the EU’s involvement. Health is better conceptualised as a shared competence,Footnote ¹³⁴ also because a number of legal bases used to regulated health maters – Article 114 TFEU, mostly, but also Article 193 TFEU – belong to areas of shared competence. This discrepancy is problematic from the point of view of conferral, not least because Article 114 TFEU is often stretched to its limits to square health into the circle of free movement objectives.Footnote ¹³⁵ The ‘tobacco’ saga is a prime example of this.Footnote ¹³⁶ The current situation is also problematic for citizens, who do not have a clear idea of what the EU does in relation to health, if they know of its involvement at all. A clarification exercise is therefore needed, which should in turn improve the legitimacy of EU action.

The recourse to indirect legal bases to regulate the field of health also affects the quality of legislation, in the sense that it prevents health interests to be fully taken into account and reflected into the law. This is clearly visible in the field of lifestyle risks and non-communicable diseases. With regards to tobacco, the EU is for instance currently prevented from adopting laws regulating local advertisingFootnote ¹³⁷ – e.g. billboards, cinemas, as opposed to cross-border advertising.Footnote ¹³⁸ The use of Article 114 TFEU also affects the capacity for the EU to adopt measures of minimum harmonisation,Footnote ¹³⁹ or the respect for the principle of subsidiarity.Footnote ¹⁴⁰ More fundamentally, there is something disingenuous in using a market-making competence to conduct a vigorous tobacco control policy, which has very little to do with the improvement of cross-border trade flows but seeks on the opposite to eradicate an entire activity from the market.Footnote ¹⁴¹

A Treaty amendment could be designed as follows. The protection of human health would become an area of shared competence, with direct harmonisation powers granted to the EU. A Treaty minimum harmonisation clause, of the kind used in Article 193 TFEU for the environment, should be added, to ensure that Member States can always go beyond the level of protection prescribed by EU law. In concrete terms, the area of “protection and improvement of human health” would be moved from Article 6 to Article 4 TFEU. Article 4(2)(k) TFEU would hence no longer be needed and the prohibition of harmonisation contained in Article 2(5) TFEU would cease to apply to health. Article 168 TFEU would be amended to reflect these changes and to provide the Union with general harmonisation powers in the field, excluding healthcare.Footnote ¹⁴⁴ Indirect legal bases would remain relevant where the primary objective of a measure is not health. Article 114 TFEU, for instance, would be used for measures genuinely concerned with the removal of barriers to trade, with only an incidental and indirect effect on health. It would however cease being used for measures having health as their primary purpose. There are good reasons not to bring changes to Article 168(7) TFEU, which states that “Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care,” for it gives enough flexibility for the EU to have an influence on healthcare, with the field remaining primarily in the orbit of the Member States.Footnote ¹⁴⁵