1  Although the founding treaties of what has now become the European Union (EU) did not envisage a distinctive body of EU health law, the seeds of that body of law lay in the objectives of ‘raising the standard of living’ (‘un relèvement accéléré du niveau de vie’) (Art. 2 Treaty of Rome). From this modest beginning, a complex and fast-developing area of EU law has now blossomed (see Hervey and McHale, 2015; de Ruijter). EU health law is critically important to individual human beings, to European populations, and to the Member States of the EU, as well as to people and countries further afield, including the EU’s near European neighbours.

2  The nature of the health challenges facing EU Member States into the twenty-first century set EU health law on a trajectory of increasing scope, significance, and ambition. These challenges include the shared experience of changing demographics and patterns of disease; threats to health security from global pandemics and other hazards like antimicrobial resistance; an increasing desire of patients to be full co-decision-makers in matters pertaining to their healthcare; a shared seeking of efficiency in healthcare systems and structures, especially in the context of Eurozone austerity; a thirst for cutting-edge biomedical, electronic, and artificial intelligence technologies and their life-changing potential; and increasing recognition that health is a critical factor in economic development and social well-being, which themselves are intertwined and mutually reinforcing.

3  Emerging from a series of health crises, dating back to the 1960s, EU health law is a distinctive body of the acquis communautaire. EU health law is expressed through a set of common values or principles [General Principles of EU Law], which embody a particularly ‘European’ approach to health and healthcare. These values or principles have been organized into four themes of EU health law, as articulated by Hervey and McHale (2015).

4  First, EU health law embodies a weak notion of [Consumer Protection] consumerism. To some extent, EU health law constructs actors within a healthcare system as ‘producers’ and ‘consumers’. Patients, for example, are seen by EU law as exercising autonomous consumer rights to access medical treatment across borders in the EU’s internal market [[Internal Market (see, for example, Luisi and Carbone; Kohll; Watts). Healthcare providers (human beings or legal persons) are seen by EU law as being established and offering services within that market (see, for example, Perez and Gomez; Pharmacists; Opticians [Freedom of Establishment of Health Institutions]). Regulation of production and sale of products which are, or may be, harmful to health, such as tobacco [Tobacco as a Health Threat], alcohol [Alcohol Production], or sugar, is framed in terms of consumer protection justifying creation of a single market, or removal of non-tariff barriers to trade (‘measures having equivalent effect to quantitative restrictions’, see, for example, Cassis de Djion; ‘rules relating to selling arrangements’, see, for example, Infant Milk), rather than as regulation focused on population health.

5  But the consumerist theme in EU health law is weak: important countervailing considerations are embodied in legislation (see, for example, ‘Patients’ Rights Directive’), rulings of the Union’s courts (see, for example, Ahokainen and Leppik; Scotch Whisky Association), and administrative acts (see, for example, Pharmaceuticals Pricing). At a broad-brush level, many of these countervailing elements of EU health law concern the way European healthcare systems are nested within welfare and social security systems. The Court of Justice of the European Union (CJEU) has continually stressed that ‘[EU] law does not detract from the powers of Member States to organise their social security systems and to adopt, in particular provisions … to promote the financial stability of their health-care insurance schemes’ (Duphar, para. 16; and repeated in numerous cases, see the discussion in Hervey and McHale, 2015, ch. 4). European healthcare systems are organized on a basis in which patients are not consumers, but people in need of care; and health professionals are not only providing medical treatment in what might look like a private transaction, but are also acting as agents of the state, taking the patient-provider relationship into the realms of public law. The place of healthcare within European welfare and social security systems is recognized by EU health law. The logics of a consumer-led market in health are far from being the only feature of EU health law. EU health law does not treat health services as essentially identical to any other consumer service. Rather, EU health law protects the distinctively solidarity-based approach to the organisation and delivery of healthcare, which is a feature of all European countries.

6  Second, EU health law is attentive to human rights: to the right to health and the right to healthcare, as expressed in Article 35 of the EU Charter of Fundamental Rights (‘CFR’); but also to associated rights including human dignity, sanctity of life, bodily autonomy, privacy, data protection, and family life. It is neither the case that the EU offers complete protection to health rights as human rights, nor that the EU is blind to or ignores health rights as human rights completely (see, for example, Grogan; contrast, for example, Biotechnology Directive; Brüstle; Deutsches Weintor). Rather, health rights constitute a justificatory and rhetorical underpinning for much EU health legislation (for example, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC), and an important touchstone for the Court of Justice as it interprets EU law (see, for example, Octapharma France; Humanplasma). For example, ‘substances of human origin’ are not ‘products’ in EU internal market law, but occupy a distinct legal category (see, for example, Regulation (EU) 2024/1938 of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application), respecting European constructions of human rights over the human body and its parts.

7  In general, however, while the CJEU’s approach is to assert that health rights as human rights are protected in the EU’s internal market, the practical effect of its jurisprudence in this regard is often to leave national and EU legislation and administrative practice unchanged. Rather than providing substantive review of decisions on the basis that they breach health rights, the most important effects of EU health law’s approach to human rights are procedural and informational (see further, Hervey and McHale, 2015, ch. 8). EU health law mandates transparency within certain aspects of healthcare systems, and in some circumstances concerning cross-border medical treatment requires individualized, timely, and reviewable decisions on a patient’s access to treatment (see, in particular, the Patients’ Rights Directive).

8  There is, nonetheless, a potential for EU health law to develop a more substantive approach to health rights, through application of health rights as human rights on the basis of the general principle of EU law of non-discrimination/equality. Here, there is scope for EU health law to be interpreted so as to require Member States to extend health protections to some of the most vulnerable people within the EU, such as asylum seekers or migrant children (see further, Hervey and McHale, 2021). These opportunities for EU health law to be used to secure equality and dignity for some of the most vulnerable people present in the EU are largely unutilized at this moment in time.

9  Third, as already alluded to above, EU health law takes a particular approach to balancing the competing precepts of promoting free and fair competition with preserving and promoting equality [Equality as an EU Value] and solidarity. EU health law does not entirely replace relationships of solidarity, trust, and a professional and state-based ethic of care and responsibility, with relationships between private entities freely interacting in a market. Instead, EU health law recognizes the need to protect the financial sustainability of national health systems (see, for example, AOK; Ambulanz Glockner; BUPA Ireland), especially in the context of fiscal austerity. In that regard, EU health law respects the systemic nature of interactions between patients on the one hand, and health professionals [Mutual Recognition of Qualifications: Automatic Recognition for Health Professionals], services [Health Services: Migrant Professionals (Mode 3)] and health institutions of various types involving light, medium or strict strutiny [Freedom of Establishment of Light Scrutiny Health Institutions; Freedom of Establishment of Medium Scrutiny Health Institutions; Freedom of Establishment of Strict Scrutiny Health Institutions] on the other, so as to ensure that the logics of market law do not undermine the logics of European solidarity-based healthcare systems (see further, Hervey and McHale, 2015, chs 9, 10).

10  The CJEU has been criticized for making decisions about healthcare systems without paying sufficient attention to their histories of promoting solidarity and securing equal access to healthcare (see, for example, Hatzopoulos; Newdick). But the strong form of this critique—liberalization breeds liberalization, with EU health law driving national health systems away from solidarity-based models (see, for example, Hancher and Sauter)—does not withstand scrutiny when details come into focus (see further, Hervey and McHale, 2015). The EU legislature has accommodated the special position of healthcare systems in its approach to migration of patients (the Patients’ Rights Directive); state aids to industry (the ‘Altmark’ and ‘Alumia’ packages; see Altmark; Commission Decision on the application of Article 106(2) of the Treaty on the Functioning of the European Union to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest); and anti-trust [Cartels of Health Institutions] and merger law [Monopolies in Health Institutions] (see further Guy; Odudu). And the CJEU’s significant jurisprudence shows that the CJEU distinguishes between health institutions which sit at the heart of a national health (insurance) system, and those more distant (see further, Hervey and McHale, 2015, ch. 10). While more peripheral institutions, such as dental clinics (see, for example, Kohll; Doulamis; Hartlauer) or opticians (see, for example, Opticians; Ker-Optika), are treated as akin to ‘ordinary’ service providers in EU internal market and competition law, institutions more central to a national health system, such as social insurance entities (see, for example, AOK; BUPA Ireland; AG2R), hospitals (see, for example, Smits/Peerbooms; Muller-Faure/Van Riet; Inizan), laboratories (see, for example, Biomedical Laboratories; Clinical Biological Laboratorie; Biomedical Laboratories), and blood centres (see, for example, CopyGene; Future Health) are not treated the same way, either in the CJEU’s interpretation of scope rules, or in its interpretation of exceptions and exemptions, such as ‘public interest justifications’.

11  Fourth, EU health law is, comparatively speaking, oriented towards a risk averse approach. It distinguishes products marketed within health systems from other products, ie:

1. 1.  medicines and vaccines (see, for example, Directive 2001/83/EC on the Community code relating to medicinal products for human use);

2. 2.  medical devices (see, for example, Schmitt v TÜV Rheinland);

3. 3.  equipment and consumables; and

4. 4.  products that are particularly hazardous to human health:

   • •  eg tobacco (see, for example, Directive 2003/33/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products; Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC, as applied in, for example, Tobacco Advertising I);

   • •  food (see, for example, Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety);

   • •  alcohol [Alcohol as a Health Threat] (see, for example, Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, as applied in Deutsches Weintor);

   • •  chemicals (see, for example, Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC).

The EU is concerned both with the technical administration of risk (for example, within the European Medicines Agency or the European Food Safety Authority), but it does not totally avoid the politics of risk management. Technocratically-determined threats of risk to consumers, and the population more generally, are balanced with risk to the internal market and the European economy more generally, should the EU fail to take action. Risk is mediated in EU health law through a notion of a ‘safe’, ‘ethical’, and ‘rights-protecting’ internal market (see, further, for example, Bache et al). This construction of the EU’s internal market is probably more rhetorical than practical: there is nothing especially ‘ethical’—or, for that matter, especially ‘unethical’—about the EU’s regulatory settlement for its internal market.

12  In terms of protecting and promoting human health against hazards, EU health law has a mixed record, and no sweeping generalisations can be supported by legal detail. Although the precautionary principle is embedded in some aspects of EU health law—such as clinical trials, xenotransplantation, or growth hormones in beef—other aspects of EU health law, such as regulation of medical devices, are less precautionary than comparator jurisdictions, although recent legal changes suggest some convergence here—the new Regulations on medical devices adopt somewhat of a more precautionary approach (see Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; and Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU). EU health law has supported changes to labelling of tobacco [Tobacco Packaging and Labelling], so that tobacco products must carry graphic health warnings. It is almost impossible to lawfully advertise tobacco in the EU [Tobacco Advertising]. Instances of food-borne disease have decreased as EU food safety law has tightened. But in many respects EU health law is insufficiently protective of health interests against the power of global capital, embodied in the international food, pharmaceuticals, tobacco, or gambling [Gambling as a Health Threat] industries. One of the few potentially effective tools of EU health law in this respect is that of transparency. Opening industry data to public scrutiny can be a force for positive change in human health. But EU health law’s record in this regard is patchy and more could be done, for instance in the regulation of medical devices or clinical trials law.

13  The four themes of EU health law (consumerism; (human) rights; competition/solidarity/equality; risk) can be considered from either or both an individual perspective or a collective/systemic perspective. The former considers the place of individual patients or healthcare providers; the latter considers healthcare systems or groups of people. The themes also apply to internal EU health law (applicable within the EU) and external EU health law, found in the EU’s external relations with ‘third countries’ and international organisations, and pursued through the EU’s trade and development law (see, for example, the reference to ‘TRIPS flexibilities’, which is pertinent to access to essential medicines, in the Economic Partnership Agreement between the CARIFORUM States, of the one part, and the European Community and its Member States, of the other part; Regulation (EU) 2016/793 to avoid trade diversion into the European Union of certain key medicines).

14  The history of EU health law (see Hervey and McHale, 2004, chs 2, 3) can be told as a tale of responding to various health crises: public events that concern human health and that set EU law on a new trajectory or new ambition. But it can equally be told as a story of quiet incrementalism, of the application of general principles of EU law, and general EU competences, to health domains, with the necessary flex to respect that health is not an ordinary consumer service, and that the EU adopts a particular approach to risk, competition, and solidarity in health contexts.

15  The early years of EU health law include the law governing the European Economic Community’s common agricultural policy [Agriculture]—essential to ensure that Europe’s populations did not starve as they had during the 1940s and into the 1950s period of economic recovery. They also include the first regulation of medicines at EU level (Directive 65/65/EEC on approximation of laws relating to proprietary medicinal products, no longer in force). This arose in response to the global Thalidomide tragedy, involving medicine sold under the brand names ‘Contergan’ and ‘Thalomid’, which was used to treat morning sickness in pregnant women, resulting in the deaths of many babies, and leaving many babies with serious limb, eye, urinary tract, and heart defects. The obligation to secure a marketing authorisation, warranting safety and efficacy of medicines, was introduced for all medicines marketed within the then European Economic Community (EEC), setting in motion the EU’s precautionary approach to risk of harm from medicines.

16  During the 1980s and 1990s, EU health law expanded with EU internal market law. Detailed measures of ‘old style’ and ‘new approach’ new approach harmonisation sought to secure protection for human health from harmful foods (see, for example, Council Directive 74/409/EEC on the harmonization of the laws of the Member States relating to honey, no longer in force; Council Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer, no longer in force), and to secure protection from the clear health harms that flow from tobacco use (see, for example, Directive 89/622/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products, no longer in force). Other potentially dangerous goods were also subject to consumer safety regulation at EU level (see, for example, Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys, no longer in force). Alongside the legislation, EU agencies were created to take administrative decisions which inter alia seek to protect human health, for example from harm arising from food as a disease vector. These gave institutional form to the weak consumerism inherent in EU products regulation, and implicitly set human health as central to the regulatory structures of internal market law.

17  At the same time, the EU’s internal market law, especially that on free movement of goods, was deployed through litigation which had the effect of scrutinizing national laws and administrative practices which purportedly protected human health. The canonical Cassis de Dijon ruling is only the best-known example of free movement of goods case law that concerns domestic policies (purportedly) seeking to protect human health. There are literally hundreds of further similar cases. To begin with, the CJEU was careful to assert that standards of human health protection were a matter of national discretion, to be articulated by each Member State by reference to its own domestic population. Over time, as EU legislation and agency decision-making elaborated health-protective standards with greater confidence, the CJEU became more and more willing to scrutinize national measures of communicable disease control, applying the proportionality principle in its strong form (see Hervey, 2012). It is now very difficult for Member States to justify non-tariff barriers to trade in goods by reference to human health protection. Only very specific evidence-based arguments, focused on particular population needs, will meet the strong version of the proportionality test by which the CJEU scrutinizes such measures (see, for an example of such an ‘outlier’ case, Scotch Whisky Association). The EU itself imposed export bans on personal protective equipment during the COVID-19 pandemic (see Commission Implementing Regulation 2020/402 of 14 March 2020), but at the same time did not pursue those Member States which unilaterally imposed such bans.

18  The EU gained an explicit health competence in 1993, with the entry into force of the Treaty of Maastricht. Initially this legal basis granted the EU power to adopt only incentive measures and not provisions of harmonisation. The latter could only be based on the Treaty’s internal market powers. Prior to 1993, general competence provisions had been relied on by the EU institutions to adopt health programmes such as Europe against Cancer (1980s) and Europe against AIDS (1990s). These programmes, which provide resources for EU collaborative efforts in health and biomedical domains, deepened and strengthened over time. Alongside this ‘soft governance’ (see Trubek, Nance, and Hervey 804–43), measures of hard law emerged at EU level, securing matters such as safety of clinical trials (Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use), protection of intellectual property in biotechnological inventions (Directive 98/44/EC on the legal protection of biotechnological inventions), and liability for harm (Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products), including from biomedical products. The EU’s harmonized medicines legislation deepened and widened in scope, covering more aspects of the ‘regulatory pipeline’ from science laboratory to patient (for discussion, see Bache et al). The EU took its first steps towards harmonisation of some national rules on substances of human origin, such as human blood and plasma (eventually resulting in Regulation (EU) 2024/1938 of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application). These provisions of EU legislation were explicitly inspired by European standards of human rights protection, recognising that the human body is a human-rights-bearing entity.

19  Early legislation on mutual recognition of qualifications of some health professionals [Mutual Recognition of Qualifications: Automatic Recognition for Health Professionals] was strengthened with the ‘new approach’ (see, for instance, Council Directive 93/16/EEC to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications; Directive 1999/42/EC establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualifications; now see Directive 2005/36/EC on the recognition of professional qualifications), and litigation based on the Treaty provisions on freedom of establishment (see, for example, Vlassopoulou; Clinical Laboratories; Haim), so all health professionals seeking to move within the internal market to establish themselves [Freedom of Establishment of Health Institutions] or provide services [Health Services: Migrant Professionals] were covered by (at least some) EU law. These developments relied on a consumerist approach to provision of health services across the internal market. Practical barriers to access remained, not least due to professional organisations seeking closure of their ‘markets’ of patients/national health (insurance) system procurers of health services. Such provisions were understood by the CJEU as inherent aspects of the solidarity-based settlement for national health systems, securing equal access to healthcare on the basis of medical need.

20  The 2000s and 2010s heralded a period of greater coherence for EU health law. The legislation and case law on goods in the internal market was recognisably cognisant of the need to protect human health. Greater mobility of people saw the need to strengthen provisions on coordination of social security [Social Security and Social Assistance], which provides a route for legally-mandated cross-border health care. The earlier Regulation (EEC) No 1408/71 on the application of social security schemes to employed persons and their families moving within the Community was substantially reformed by Regulation (EC) No 883/2004 on the coordination of social security systems, an important basis of EU law on cross-border healthcare [Cross-border Healthcare under Regulation 883/2004]. The main changes included both substantive and procedural/practical reforms. These included extending the personal and material scope of the Regulation; introducing a new principle of ‘assimilation’ of benefits, income, facts, and events; changes to provisions on posted and frontier workers; introducing the concept of a ‘contact institution’ for pensions and a ‘summary note’, which could be judicially reviewed; introduction of explicit rules on obligations to give information; and the creation of a system of electronic exchange of information between social security institutions through a database maintained by the European Commission. The controversial general 2006 Services Directive on liberalisation of services in the internal market explicitly excluded health services. But litigation based on the Treaty provisions on free movement of services continued, until the Patients’ Rights Directive consolidated entitlements of patients in a way that in effect provides strong protection for EU Member States’ national health (insurance) systems from unplanned migration of patients. This legislative settlement protects national autonomy to maintain a health system based on equality and solidarity from the impetus towards free competition and open markets that sits behind EU internal market law.

21  Responding to the Services Directive, the Council’s 2006 Conclusions on Common Values and Principles in European Union Health Systems (‘Conclusions’) strengthened the ways in which EU law reflects the ‘European’ way of organising health systems. The Conclusions refer explicitly to Europe’s human rights tradition, and to solidarity and equality. The Conclusions paved the way to the Patients’ Rights Directive. The EU’s Charter of Fundamental Rights articulated not only the ‘right to healthcare’ as a human right recognized in the EU legal order (Art. 35 CFR; see further, Hervey and McHale, 2021), but several other rights relevant to health. Biomedical ethics became more strongly articulated in both EU legislation and case law, especially concerning biotechnological inventions (see, for example, Brüstle; International Stem Cell), but also concerning human tissue, organs, and cells. The Union was formally obliged to ‘mainstream’ protection of human health in Articles 9 and 168 of the Treaty on the Functioning of European Union (TFEU), the latter of which enhanced Union competence to adopt health legislation, including legislation that harmonizes national law and policy. A flowering of health-related legislation followed, often involving a dual legal basis with internal market law. Few, if any, aspects of national health law now remain entirely untouched by EU health law, although ‘the organisation of health systems’ is still a national competence, and domestic law applies to many of the ‘standard’ elements of medical law such as consent to treatment, capacity to take decisions about treatment, medical negligence/non-contractual liability, or beginning and end of life care. Yet there is work to be done (see Bartlett and Neumann).

22  The limitations of EU health law were brought sharply into focus with the COVID-19 pandemic, seeing a retreat to uncoordinated national responses rather than the Member States using the EU institutions and EU law to structure their actions. Member States closed borders to human migration (see, for example, Goldner Lang 1–24), although measures were put in place to ensure continued free movement of products while protecting the health of those who work in the transport and logistics sector (see, for example, Communication from the Commission on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services). The EU relied on its competences in external trade to seek to secure vaccine supply, by imposing export restrictions on certain products (for example, Commission Implementing Regulation (EU) 2021/521 making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation). This variant of ‘vaccine nationalism’ represents a European version of solidarity, excluding populations outside of the EU. The COVID-19 pandemic has resulted in a greater impetus for EU competence in health to be increased, but this is unlikely to take place through Treaty reform (nor is this necessarily necessary, see, for example, Purnhagen, de Ruijter, Flear, Hervey, and Herwig 297–306). It may take place—as it has in the past—through re-interpretation of the existing competence provisions (see further Delhomme and Hervey). Several reforms are under way, notably of the EU’s medicines law, to focus upon access as well as quality and safety (COM(2023) 192 final; COM(2023) 193 final); and to create a ‘European Health Data Space’ (COM(2022) 197 final). The EU Commission is building on the ‘mainstreaming’ obligation in the TFEU to articulate the EU’s version of the contemporary (some may say vogueish) concept of ‘One Health’: the idea that the health of people, animals and planet are deeply interconnected. Hard legal instruments embodying ‘One Health’ outside the sphere of animal health are yet to be adopted, although soft law exists, for example, a Council Recommendation on EU action on antimicrobial resistance was adopted in June 2023.

23  EU health law is a ‘transversal’ topic of EU law (see Hervey, 2023). It cuts across several other areas of EU law, including EU internal market, competition, consumer protection relations, and environmental and external relations law. It is found in a substantial body of health-focused EU legislation, along with CJEU and domestic court interpretations of that legislation, and of general provisions of the EU Treaties. It is also found in the ways in which general EU law, especially internal market and competition law, is interpreted and applied with a specificity that reflects the place of health in European countries. This approach to interpretation of EU health law reflects its themes: weak consumerism; (procedural) human rights protection; attention to solidarity and equality of access rather than open market competition; and precaution in terms of risk.

24  Across the EU, health is respected as a fundamental human right. Health is also a highly significant aspect of European welfare settlements, and their associated values, even though the particularities of European healthcare systems differ significantly across the EU, and even within some Member States where health is a regionally devolved power. Respecting, protecting, and promoting health rights is implicit in securing human dignity. Where the logics of EU law pull against these state obligations, EU law must secure solutions that do not compromise these fundamental European values. So, the specificity of EU health law includes (at least) two dimensions: a recognition of the relations between health and fundamental human rights in the EU’s legal order, and a recognition of the relations between health as part of European social law, broadly conceived, not just as an ordinary service in a market in which free trade and fair competition is secured. There are also important links between EU economic governance [Fiscal Sustainability as a European Union Value] and health: the EU departed from austerity policies that damaged national healthcare systems in response to the COVID-19 pandemic, although there are worrying indications that this may be returning (see the new fiscal rules introduced in April 2024 in Regulation (EU) 2024/1263 on the effective coordination of economic policies OJ L 2024/1263).

25  As noted above, before the EU legislature was granted formal competence to adopt health measures, it relied on implied competence, based on the objectives in Article 2 of the original Treaty of Rome, particularly ‘raising of the standard of living’. Explicit competence to adopt public health measures was given to the EU legislature by the Treaty of Maastricht. Union health programmes, coordinating, incentivising, and resourcing health protection and promotion have been pursued on a small scale since the 1980s. The COVID-19 pandemic resulted in the European Commission proposing, and European Parliament and Council of the European Union adopting, a significantly more ambitious such programme: EU4Health (Regulation (EU) 2021/522 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021–2027, and repealing Regulation (EU) No 282/2014)). But much of the EU’s health law is based on other competence provisions, in particular Article 114 TFEU, on creating and sustaining the internal market. Power to use internal market law to pursue health objectives has been contested in the CJEU: a ‘high water mark’ was reached in Tobacco Advertising I, in which the CJEU held that a measure based on Article 114 TFEU was invalid, in part because it pursued health objectives (reducing smoking) without actually creating or sustaining the internal market in the relevant (advertising) services.

26  Subsequently, however, the CJEU has accepted that health objectives may be pursued in tandem with internal market objectives of EU legislation (see, for example, Imperial Tobacco; British American Tobacco and Imperial Tobacco). This is indeed anticipated in Articles 9 and 168(1) TFEU which provide that, when the EU legislature adopts measures in other fields that affect health, it is obliged to ‘take into account’ ‘requirements linked to … the protection of human health’. This ‘mainstreaming’ obligation is the basis of EU health law that flows from EU legislation.

27  The scope of EU health law is somewhat contested, but most authors agree on a common core. This common core includes individual health and healthcare, healthcare systems and the people who provide healthcare within EU countries, as well as their national healthcare institutions, and population health, also known as public health law. EU health law covers entitlements of patients [Patients in EU Health Law] and healthcare professionals to receive and provide health care services in the internal market. The source of their rights in EU law to provide or receive healthcare can be because they are migrant workers, self-employed people, long-term residents, or even just citizens, or family members of any of those groups. Some migrant third country nationals [Access to Healthcare of Migrant ‘Third Country Nationals’] also enjoy rights to access healthcare in EU law.

28  EU health law also covers a dense regulatory system for health products (medicines, including vaccines, medical devices, and equipment) as well as substances of human origin (blood, organs, human tissue, and cells) which circulate within the EU but are not legally conceptualized as products. EU health law concerns the entire regulatory ‘pipeline’ or ‘lifecycle’ of health products, from a clinical trial to patient compensation for harm caused by such products. Circulation (and regulation) of health data in the EU is also covered.

29  EU health law also seeks to protect human health and to promote good health by regulating products, and to some extent services, that are harmful to health, especially tobacco, food, alcohol, and gambling. In this regard, EU law engages with the lifestyles of EU citizens and those resident within—and, indirectly, outside—the EU.

30  When it comes to national health institutions (hospitals, clinics, pharmacies, blood establishments, and so on), the way that EU internal market and competition law interfaces with those institutions reflects their particular place within European societies. It follows that the disciplines of EU internal market are adjusted and flexed in contexts such as national rules relating to the selling arrangements for health products; freedom of establishment of health institutions; and regulation of cross-border provision of health services. EU competition law is subject to particular approaches in anti-cartel and dominant behaviour in health contexts: mergers of health institutions; state aids to health institutions; and government procurement in health contexts.

31  Much of EU public health law sits within environmental law: air and water quality, and waste law being candidate examples. Because food is a significant vector for human disease, EU food safety law is another important location of EU public health law. But EU public health law also concerns health security, through EU level laws to respond to serious health threats, such as communicable diseases (like swine flu, SARS, or COVID-19) or bioterrorism. Here there are obvious interfaces with EU security law.

32  In terms of its external health law, EU external relations law provides a means by which the EU is empowered to affect health outside of the EU. So far, its achievements in this regard have been rather minimal. EU trade law in principle contains aspects of health conditionality which protect and promote human health outside the EU, sometimes by reference to human rights. EU development law has some instruments which, for instance, seek to promote access to essential medicines in low- and middle-income countries, or to regulate the global market in substances of human origin.

33  EU health law is found in ‘hard’ and ‘soft’ law, and in the jurisprudence of the CJEU. It includes Regulations and Directives, Decisions of the EU institutions, delegated legislation, and a plethora of recommendations [Recommendations and Opinions], guidelines, and other measures of soft law. It is also found in rulings of the CJEU, both concerning the validity of acts of the EU institutions and under the preliminary reference procedure. Of course, it is also found in decisions of national courts, where they interpret and apply EU law, as they are obliged to do under the Treaties.

34  The European Commission of the 2020s is seeking a new era of EU health law, but built incrementally. Important work is ongoing in renewing medicines legislation; a ‘Beating Cancer plan’; digital health; artificial intelligence in health; developing EU-level capacity and (legal) preparedness for a future pandemic; and investment in health through the EU’s cohesion funds, and ‘Next Generation EU’, the pandemic recovery programme (see Delhomme and Hervey 2023). Others are more ambitious (see the Manifesto for a European Health Union). Given its trajectory to date, the likely future of EU health law will be based on an incremental model, but there may be surprises along the way.

35  The greatest challenge for EU health law is not its inward facing dimensions: the EU settlement concerning the place of health in the internal market is largely secure. The lost opportunity—which the EU may yet seize—lies in its external health law. The European Commission’s Global Health Strategy (November 2022) is ambitious in its scope, but modest in its practical elements, especially when it comes to health equity and global health solidarity, as opposed to health security. To what extent the EU can use its global power in trade and development relations with the rest of the world to improve human health remains in doubt.

Select Bibliography

• G Bache, M L Flear and T Hervey, ‘The Defining Features of the European Union’s Approach to Regulating New Health Technologies’ in Flear et al (eds), European Law and New Health Technologies (Oxford, OUP 2013).

• G Bartlett and A Naumann, ‘Reinterpreting the health in all policies obligation in Article 168 TFEU: the first step towards making enforcement a realistic prospect’ 16 (1) Health Economics, Policy and Law (2021) 8–22.

• V Delhomme and T Hervey, ‘The European Union’s response to the Covid-19 crisis and (the legitimacy of) the Union’s legal order’ Yearbook of European Law (2023) https://doi.org/10.1093/yel/yeac011.

• A De Ruijter, EU Health Law and Policy: The Expansion of EU Power in Public Health and Health Care (Oxford, Oxford University Press 2019).

• I Goldner Lang, ‘“Laws of Fear” in the EU: The Precautionary Principle and Public Health Restrictions to Free Movement of Persons in the Time of COVID-19’ (2021) European Journal of Risk Regulation 1–24.

• S Greer, S Rozenblum, N Fahy, E Brooks, H Jarman, A de Ruijter, W Palm, M Wismar, Everything you always wanted to know about European Union health policies but were afraid to ask (Copenhagen, World Health Organization 2022).

• M Guy, Competition Policy in Healthcare (Cambridge, Intersentia 2019).

• L Hancher and W Sauter, EU Competition and Internal Market Law in the Health Care Sector (Oxford, Oxford University Press 2012).

• V Hatzopoulos, ‘Killing National Health and Insurance Systems but Healing Patients?’ (2002) 29 Common Market Law Review 683.

• T Hervey, ‘The Role of the European Court of Justice in the Europeanization of Communicable Disease Control: Driver or Irrelevance?’ (2012) 37 Journal of Health Politics, Policy and Law 975–98.

• T Hervey, ‘The past, present and future of European Union health law’ in C Stanton, Sarah Devaney, Anne-Maree Farrell, and Alexandra Mullock (eds), Pioneering Healthcare Law: Essays in Honour of Margaret Brazier (London, Routledge 2016).

• T Hervey, ‘EU Health Law’ in C Barnard and S Peers (eds), European Union Law (4th edn Oxford, OUP 2023).

• T Hervey and J McHale, European Union Health Law: Themes and Implications (Cambridge, Cambridge University Press 2015).

• T Hervey and J McHale, ‘Article 35 EU CFR’ in S Peers, J Kenner, T Hervey, A Ward (eds), The European Union Charter of Fundamental Rights and Freedoms (London, Hart Bloomsbury 2021).

• T Hervey and J McHale, Health Law and the European Union (Cambridge, CUP 2004).

• T Hervey, C Young, and L Bishop, Research Handbook on EU Health Law and Policy (Cheltenham, Edward Elgar 2017).

• C Newdick, ‘The European Court of Justice, Transnational Health Care and Social Citizenship: Accidental Death of a Concept?’ (2009) 26 Wisconsin Law Journal 845.

• O Odudu, ‘Introduction to Anti-trust and the Provision of Healthcare in the United States and the European Union: Common Challenges’ in D Orentlicher and T Hervey (eds), The Oxford Handbook of Comparative Health Law (Oxford, OUP 2021).

• K Purnhagen, A de Ruijter, M Flear, T Hervey, A Herwig, ‘More Competences than you knew: the web of health competences for Union action in response to the COVID-19 outbreak’ (2020) 11 European Journal of Risk Regulation 297–306.

• L Trubek, M Nance, and T Hervey, ‘The Construction of a Healthier Europe: Lessons from the Fight Against Cancer’ (2008) 26 Wisconsin International Law Journal 804–43.

Select Documents

• Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, no longer in force [1965] OJ P 022/369; OJ Sp Ed 1965-6 I p 24.

• Council Directive 74/409/EEC on the harmonization of the laws of the Member States relating to honey (22 July 1974, no longer in force) [1974] OJ L 221/10.

• Council Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (18 December 1978, no longer in force) [1979] OJ L 33/1.

• Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (25 July 1985) [1985] OJ L 210/29.

• Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys (3 May 1988, no longer in force) [1988] OJ L 187/1.

• Directive 89/622/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products (13 November 1989, no longer in force) [1989] OJ L 395/13.

• Council Directive 93/16/EEC to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications (5 April 1993) [1993] OJ L 165/1.

• Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions (6 July 1998) [1998] OJ L 213/13.

• Directive 1999/42/EC of the European Parliament and of the Council establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualifications (7 June 1999) [1999] OJ L 201/77.

• Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (4 April 2001) [2001] OJ L 121/34.

• Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended (6 November 2001) [2001] OJ L 311/ 67.

• Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (28 January 2002) [2002] OJ L 31/1.

• Directive 2003/33/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (26 May 2003) [2003] OJ L 152/16.

• Directive 2005/36/EC of the European Parliament and of the Council on the recognition of professional qualifications (7 September 2005) [2005] OJ L 255/22.

• Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (12 December 2006) [2006] OJ L 376/36.

• Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods (20 December 2006) [2006] OJ L 404/9.

• Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, as amended (18 December 2006) [2007] OJ L 396/1.

• Economic Partnership Agreement between the CARIFORUM States, of the one part, and the European Community and its Member States, of the other part, as amended (30 October 2008) [2008] OJ L 289/3.

• Directive 2011/24/EU of the European Parliament and of the Council on the Application of Patients’ Rights in Cross-border Healthcare (9 March 2011) [2011] OJ L 88/45.

• Commission Decision on the application of Article 106(2) of the Treaty on the Functioning of the European Union to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest (20 December 2011) [2012] OJ L 7/3.

• Directive 2014/40/EU of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (3 April 2014) [2014] OJ L 127/1.

• Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (16 April 2014) [2014] OJ L 158/1.

• Regulation (EU) 2016/793 of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (11 May 2016) [2016] OJ L 135/39.

• Communication from the Commission on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services (24 March 2020) [2020] OJ C 96I/1.

• Manifesto for a European Health Union (2020) available at: https://europeanhealthunion.eu/ (accessed 2 August 2024).

• Commission Implementing Regulation (EU) 2021/521 making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation (24 March 2021) [2021] OJ L 104/52.

• Regulation (EU) 2021/522 of the European Parliament and of the Council establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021–2027, and repealing Regulation (EU) No 282/2014 (24 March 2021) [2021] OJ L 107/1.

• Regulation (EU) 2024/1938 of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (13 June 2024) OJ L 2024/1938

Select Cases

• Case 120/78, Cassis de Djion, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein, 20 February 1979, ECLI:EU:C:1979:42.

• Cases C-286/82 and C-26/83, Luisi and Carbone v Ministero del Tesoro, 31 January 1984, ECLI:EU:C:1984:35.

• Case C-238/82, Duphar BV and ors v The Netherlands, 7 February 1984, ECLI:EU:C:1984:45.

• Case C-221/85, Clinical Biological Laboratories, Commission of the European Communities v Belgium, 12 February 1987, ECLI:EU:C:1987:81.

• Case C-249/88, Pharmaceuticals Pricing, Commission of the European Communities v Belgium, 19 March 1991, ECLI:EU:C:1991:121.

• Case C-340/89, Vlassopoulou v Ministerium für Justiz, Bundes- und Europaangelegenheiten Baden-Württemberg, 7 May 1991, ECLI:EU:C:1991:193.

• Case C-159/90, Grogan, The Society for the Protection of Unborn Children Ireland Ltd v Stephen Grogan and ors, 4 October 1991, ECLI:EU:C:1991:378.

• Case 391/92, Infant Milk, Commission of the European Communities v Greece, 29 June 1995, ECLI:EU:C:1995:199.

• Case C-158/96, Kohll v Union des caisses de maladie, 28 April 1998, ECLI:EU:C:1998:171.

• Case C-424/97, Haim v Kassenzahnärztliche Vereinigung Nordrhein, 4 July 2000, ECLI:EU:C:2000:357.

• Case C-74/99, The Queen v Secretary of State for Health and Others, ex parte Imperial Tobacco Ltd and ors, 5 October 2000, ECLI:EU:C:2000:547.

• Case C-376/98, Tobacco Advertising I, Germany v European Parliament and Council of the European Union, 5 October 2000, ECLI:EU:C:2000:544.

• Case C-157/99, Smits/Peerbooms, B.S.M. Geraets-Smits v Stichting Ziekenfonds VGZ and H.T.M. Peerbooms v Stichting CZ Groep Zorgverzekeringen, 12 July 2001, ECLI:EU:C:2001:404.

• Case C-377/98, Biotechnology Directive, The Netherlands v European Parliament and Council of the European Union, 9 October 2001, ECLI:EU:C:2001:523.

• Case C-475/99, Firma Ambulanz Glöckner v Landkreis Südwestpfalz, 25 October 2001, ECLI:EU:C:2001:577.

• Case C-491/01, The Queen v Secretary of State for Health, ex parte British American Tobacco (Investments) Ltd and Imperial Tobacco Ltd, 10 December 2002, ECLI:EU:C:2002:741.

• Case C-385/99, V.G. Müller-Fauré v Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen UA and E.E.M. van Riet v Onderlinge Waarborgmaatschappij ZAO Zorgverzekeringen, 13 May 2003, ECLI:EU:C:2003:270.

• Case C-280/00, Altmark Trans GmbH and Regierungspräsidium Magdeburg v Nahverkehrsgesellschaft Altmark GmbH and Oberbundesanwalt beim Bundesverwaltungsgericht, 24 July 2003, ECLI:EU:C:2003:415.

• Case C-56/01, Inizan v Caisse primaire d'assurance maladie des Hauts-de-Seine, 23 October 2003, ECLI:EU:C:2003:578.

• Case C-496/01, Biomedical Laboratories, Commission of the European Communities v France, 11 March 2004, ECLI:EU:C:2004:137.

• Cases C-264/01, C-306/01, C-354/01 and C-355/01, AOK Bundesverband, Bundesverband der Betriebskrankenkassen (BKK), Bundesverband der Innungskrankenkassen, Bundesverband der landwirtschaftlichen Krankenkassen, Verband der Angestelltenkrankenkassen eV, Verband der Arbeiter-Ersatzkassen, Bundesknappschaft and See-Krankenkasse v Ichthyol-Gesellschaft Cordes, Hermani & Co. (C-264/01), Mundipharma GmbH (C-306/01), Gödecke GmbH (C-354/01) and Intersan, Institut für pharmazeutische und klinische Forschung GmbH (C-355/01), 16 March 2004, ECLI:EU:C:2004:150.

• Case C-140/03, Opticians, Commission of the European Communities v Greece, 21 April 2005, ECLI:EU:C:2005:242.

• Case C-372/04, The Queen, on the application of Yvonne Watts v Bedford Primary Care Trust and Secretary of State for Health, 16 May 2006, ECLI:EU:C: 2006:325.

• Case C-434/04, Criminal proceedings against Jan-Erik Anders Ahokainen and Mati Leppik, 28 September 2006, ECLI:EU:C:2006:609.

• Case T-289/03, British United Provident Association Ltd (BUPA) and ors v Commission of the European Communities, 12 February 2008, ECLI:EU:T:2008:29.

• Case C-446/05, Criminal proceedings against Ioannis Doulamis, 13 March 2008, ECLI:EU:C:2008:157.

• Case C-169/07, Hartlauer Handelsgesellschaft mbH v Wiener Landesregierung and Oberösterreichische Landesregierung, 10 March 2009, ECLI:EU:C:2009:141.

• Case C-531/06, Pharmacists, Commission of the European Communities v Italy, 19 May 2009, ECLI:EU:C:2009:315.

• Cases C-570/07 and C-571/07, Blanco Pérez and del Pilar Chao Gómez v Consejería de Salud y Servicios Sanitarios (C-570/07) and Principado de Asturias (C-571/07), 1 June 2010, ECLI:EU:C:2010:300.

• Case C-86/09, Future Health Technologies Ltd v The Commissioners for Her Majesty’s Revenue and Customs, 10 June 2010, ECLI:EU:C:2010:334.

• Case C-262/08, CopyGene A/S v Skatteministeriet, 10 June 2010, ECLI:EU:C:2010:328.

• Case C-108/09, Biomedical Laboratories, Ker-Optika bt v ÀNTSZ Dél-dunántúli Regionális Intézete, 2 December 2010, ECLI:EU:C:2010:725.

• Case C-421/09, Humanplasma GmbH v Republik Österreich, 9 December 2010, ECLI:EU:C:2010:760.

• Case C-89/09, European Commission v France, 16 December 2010, ECLI:EU:C:2010:772.

• Case C-437/09, AG2R Prévoyance v Beaudout Père et Fils SARL, 3 March 2011, ECLI:EU:C:2011:112.

• Case C-34/10, Brüstle v Greenpeace eV, 18 October 2011, ECLI:EU:C:2011:669.

• Case C-544/10, Deutsches Weintor eG v Land Rheinland-Pfalz, 6 September 2012, ECLI:EU:C:2012:526.

• Case C-512/12, Octapharma France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Ministère des Affaires sociales et de la Santé, 13 March 2014, ECLI:EU:C:2014:149.

• Case C-364/13, International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, 18 December 2014, ECLI:EU:C:2014:2451.

• Case C-333/14, Scotch Whisky Association and ors v The Lord Advocate and The Advocate General for Scotland, 23 December 2015, ECLI:EU:C:2015:845.

• Case C-219/15, Schmitt v TÜV Rheinland LGA Products GmbH, 16 February 2017, ECLI:EU:C:2017:128.