II. History of Union competences in health

From the inception of the Union in the Coal and Steel Community and then the European Economic Community, there was no formal legislative basis for health law and policy.Footnote ⁵ And yet, there was European health law and policy. In the context of the common agricultural policy – which was fundamentally concerned with ensuring that (Western) Europe did not starve again, as it had in the 1940s – communicable disease control was implemented to ensure that milk that was traded across borders was free of bovine tuberculosis. Furthermore, there was access to cross-border health benefits for steel workers, and the European-level rules on pharmaceuticals marketing were adopted to avoid a repeat of the thalidomide tragedy. But there were also “Europe against Cancer” and then “Europe against AIDS” programmes initiated to tackle the some of the most serious non-communicable and communicable diseases facing its populations at the time. Legally dubious,Footnote ⁶ as the Union then lacked formal power to establish such programmes of training, information exchange and research, these programmes could be understood as based on Article 2 EEC, establishing “the raising of the standard of living” as a Union objective, and Article 235 EEC, giving competence to meet objectives where no more specific power was given in the Treaties. However, rather than law-makers per se, it was also the health elites that would find linkage on health-related issues where cross-border exchange of expertise was seen as an advantage for health-related objectives. Union law and institutions, whether there was a legislative basis or not, provided a framework that was flexible enough to give some formality to these interactions without making them more binding than any law-maker at the time would have felt comfortable with vis-à-vis its own electorate. This is an example of one feature of the dynamic potential of Union law: if there is no political opposition mobilised, then Union action can be based on very loose and surprising interpretations of the relevant legal texts, with scant judicial oversight of those interpretations.

The year 1993 saw the entry into force of the first formal Union health competence under the Treaty of Maastricht. Then Article 129 EC provided power for the Union to “contribute towards a high level of human health protection by encouraging cooperation between Member States, and, if necessary, lending support to their action”. Health here is a prime example of the paradox that epitomises EU integration when it comes to legislative competence. Some Member States felt that a specific legal basis for Union health law would be good in order to limit the increasing activity and interest by Union (supranational) law-makers in the topic, while other Member States felt that a formal legal basis would create a good platform for intensifying some of the activity that was already taking place in the field.Footnote ⁷ Action of the Union institutions was to be focused on specific areas, particularly major health scourges, research into those diseases and health education and information.

Substantively, the focus here was collectively determined health (public health) rather than individual protection of health (healthcare) or governance of healthcare systems. Most importantly, Union action was to be limited to the coordination and incentivisation of national action, and the harmonisation of national laws with respect to public health was explicitly excluded in the legal text. The specific prohibition on the harmonisation of national laws in the legal text that attributes legislative powers to the Union underlines the paradox that was part of the health competence from its inception. In addition, at the time, the attribution and subsidiarity principles were well enshrined within Union law. Hence, a health-specific recitation of a prohibition on harmonising national laws would seem excessive. However, it is exactly that push and pull that forms the basis for the further dynamics that became the breeding ground for the development of Union health law and policy.

Article 129 EC and its successors gave the basis for further action programmes, which eventually became the Union’s various public health programmes,Footnote ⁸ and, most recently the proposed EU4Health programme.Footnote ⁹ The provision in Article 129 EC was amended, and renumbered at Article 152 EC, by the Treaty of Amsterdam, which entered into force in 1999; and again renumbered at Article 168 TFEU, by the Treaty of Lisbon, which entered into force in 2009. Several textual changes strengthened the Union’s powers in the field of health. Union activities were no longer limited to the prevention of disease, but expanded to include promotion of good health. Arguably, all Treaty changes in the field of health are related to constitutional moments and public health crises. In 1992, the tobacco advertising litigation saga and the HIV/AIDS pandemic formed important backdrops of the discussion during the Maastricht Treaty amendments. At the time of the Amsterdam amendments, the bovine spongiform encephalopathy (BSE) crisis had just put enormous political pressure on Member States to come up with a “Union” answer. By 2008, there had been the anthrax scare in 2001, followed by the bird flu, severe acute respiratory syndrome (SARS) and a number of other public health scares.

Hence, in the Lisbon Treaty amendments in 2008, the obligation on the Union institutions was strengthened from merely “contributing” to a high level of human health protection to an obligation to “ensuring” a high level of human health protection in all Union activities. This “mainstreaming” obligation, now reflected in Articles 9 and 168 TFEU, is a key aspect of the dynamic potential of the competence provisions of Union health law and policy. It has been understood as a response to the argumentation of the UK government in Case C-180/96/R UK v Commission concerning the emergency measures taken by the Union against the UK to stop the spread of BSE.Footnote ¹⁰ The UK argued that the measures, which restricted export of British meat, were adopted on the basis of protecting the beef market and did not take account of actions taken by the UK to eliminate risk, or of products for which the risk of BSE was not at the time established, and hence were unlawful. The essence of the Court’s reasoning was that the protection of public health is a duty of all Union institutions, which cannot be disregarded in the pursuit of other Union policies such as free movement of goods or the common agricultural policy. The Court in this case implicitly recognised the centrality of human health to all Union activity on the basis of its reading of the Treaty texts as a whole. The revised Treaty included this provision in its account of Union competence. This is an example of a second feature of the dynamic potential of law: in this case, the tensions implicit in legal texts meant that the law got “ahead” of the politics. Consequently, this paves the way for Member States to embody a “catch-up” in a Treaty revision.

The BSE case also serves as an example of the dynamic potential of Union law in its amenability to use by litigants seeking to secure market access in another or even their home Member State, or otherwise to challenge domestic law or policy. The direct effect and supremacy of the provisions securing free movement of the factors of production in the internal market has led to de facto Union health law-making in a wide range of aspects of national health systems. These include cross-border access of patients to medical treatments, sometimes because of waiting times or costs in the home Member State, or occasionally because of ethical or other differences in the “basket of care” available at home, resulting in changes to domestic practices or provision.Footnote ¹¹ Union law has also been used to challenge restrictions on pharmaceutical sales conditions that inter alia have an effect on pharmaceutical pricing or on ready access to pharmaceuticals for patients. And Union law has been used by health professionals such as dentists, ophthalmologists or pharmacists seeking access to markets in other Member States (or even in their home Member State), opening up cartels based on professional exclusion, as well as by aspiring medical professionals to secure access to training opportunities. Union law on equality or non-discrimination has been relied upon to challenge national rules about blood donation, Union competition law has been relied upon to challenge hospital mergers, and so on. The logics of Union law reach deep into the logics of national health systems, disrupting their territorial bases and creating new efficiencies and opportunities.

The standard response in Union law to the deregulation inherent in such internal market or other litigation is to re-regulate at the Union level by adopting harmonised law. Here, in Union health law, we run against a classical constitutional tension that is amplified in health as a result of the legal text in Articles 168(5) and (7) TFEU. The key constraints to the Union’s competence provisions in health reiterate that there is no Union power to harmonise national law or policy in order to protect or improve human health or directly to protect public health.Footnote ¹² But this apparent “no harmonisation in health policy” rule does not mean what it seems to mean. In fact, this apparent constraint upon Union action is not reflected in Union health law and policy as it developed through the 1990s, 2000s and 2010s. The Union has adopted many harmonising measures in health law and policy, deploying other legal bases within the Treaties, principally the power to create and sustain the Union’s internal market.Footnote ¹³ Safety of medicines, medical devices and equipment, blood and human organs and other substances of human origin;Footnote ¹⁴ clinical trials regulation; protection of privacy of medical data; liability for harm from novel health technologies; recognition of medical qualifications; intellectual property in biotechnological inventions; food safety, labelling and traceability; and, infamously, tobacco regulation and advertising are all subject to harmonised Union law.Footnote ¹⁵ Such law-making based on creative interpretations of the Union competences does not take place without at least the possibility of judicial oversight, either because parties are dissatisfied with process (eg as in the case with the Directive on the Legal Protection of Biotechnological Inventions, which was adopted only with parliamentary consultation) or outcome (eg as in the case with the Tobacco Advertising Directive, which prohibited advertising services where there was no link to creating or sustaining the internal market). But judicial review does not necessarily mean asserting narrow or literalistic readings of legal texts – another feature of law’s dynamic potential.

III. The dynamic potential of the current law

Those features of law’s dynamic potential (its contextualised, constructed, interpreted nature; the phenomenon of politics “getting ahead” of the law; its amenability to strategic litigation; an open approach to judicial review) pertain today. The legal texts in the Treaty for health law and policy look restrictive in terms of the Union’s competence to create a European health Union, but actually they are amenable, if the political will is present. The Union powers to incentivise, encourage, support, coordinate and resource activities in the health field are significant in this regard. Most laws are intended to incentivise particular behaviour. Although in most understandings the power to create “incentivising” legislation in Article 168 TFEU might have been seen as relatively non-binding and inconsequential, who is to say that “incentivising” cannot entail carrot-and-stick-type laws. In the context of COVID-19, for example, the Union may lawfully support work towards collaborative research into vaccines, treatments and new medical equipment; epidemiological research into the spread of the disease; and social sciences research into its economic, political, social, cultural and other consequences. The Union has the power to pool medical professional capacities, to develop capacities in regions or specialisms that are lagging, to secure the benefits of digital technologies in health fields or to bargain with the pharmaceutical industry in procuring vaccines or medicines. Many of these ideas are part of the European Commission’s proposal on an EU4Health Programme 2021–2027.

Despite the apparent restriction on harmonisation, the Union has the power to adopt binding laws that have the effect of improving health, so long as those measures remove obstacles to trade or prevent appreciable distortions of competition. Union laws in many policy areas, including trade, consumer protection, agriculture and security, must protect and promote health. And as outlined, the Union’s powers to incentivise Member State action “to protect and improve human health and in particular to combat the major health scourges” is untested. The Union has a range of incentives under its control and can offer access to resources, collectively held equipment, human resources, pooled expertise or knowledge, administrative capacity or information or the Union’s geopolitical capital. Taken together, as a “web of competence”,Footnote ¹⁶ these powers will go a long way to creating a European health Union.

IV. The “dark side” of Union health law’s dynamic potential

So far, we have considered the dynamic potential of Union health law as a benefit – a positive and a force for improving human health in the Union, and potentially beyond. Deployed creatively, the Union’s legal powers in health domains have been, and can be, used in this way. The Union has developed its health laws and policies in ways that include all stakeholders, including patients, health professionals, the biomedical research community, public health specialists, health system institutions and governmental bodies. Where “many eyes” are on legal or policy proposals, particularly where that scrutiny represents expert knowledge from the logics of human health, rather than the logics of trade relations, we increase the chances of beneficial policy outcomes.

Two constitutional problems arise from using the opportunities that are offered by the primary legal text in the Treaty for the creation of health law and policy. The first is procedural and the second is substantive. Procedurally, as a result of health being a side issue to other policies, competence creep can create a democratic problem, which has been well described in Union (legal) studies.Footnote ¹⁷ But substantively, for health specifically there is a constitutional problem, where a competence to act in other policy areas (indirect legislation), such as the internal market or agriculture, is used to create public health protections of healthcare entitlements. The tobacco advertising saga and the Cross-Border Health Care Directive are prime examples of this phenomenon.Footnote ¹⁸ In health, then, the problem for legitimacy is not so much the democratic safeguards, but rather that there are no limits to Union competence, as these are formulated in Article 168(5)(7), when legislation is based on wider, more undetermined areas of legal competence such as Article 114 TFEU (internal market).Footnote ¹⁹

For the content of Union health law and policy, this presents a “dark side” when the dynamic potential for health law and policymaking is fully exploited without a sense for the constitutional stakes at play: using indirect legislation constrains the consideration of the full spectrum of rights and values that are involved in health law and policy generally at the Member State level.Footnote ²⁰ Furthermore, it changes the institutional actors around the table, who might not have a full grasp of the substantive issues and health-related fundamental rights at stake. Health law and policy represent highly complex systems of regulated markets, self-organisation and expert policy at the Member State level. Furthermore, this is a politically sensitive policy area, so putting another policy expert on the table can have the effect of the proverbial “bull in a china shop”, as the negotiations around the Patient’s Rights Directive exemplified.Footnote ²¹

Furthermore, its legally loose base may turn Union law and policy into a tool for political capture. The tobacco industry, for example, has used (Union) law to seek to secure access to new markets, particularly of young people, and particularly for novel products. The pharmaceutical industry has sought to undermine European pharmaceutical pricing approaches deployed by Member States to keep negotiated prices relatively low for their national health systems. For sure, it remains important to pay attention to who might deploy law to challenge Union competence to act in the creation of a European health Union, as well as to how they might do so. The locus for bringing judicial review claims before the Court of Justice of the EU (CJEU) is quite restrictive (although privileged applicants such as the European Parliament or Member States enjoy such a locus); but judicial review may also be brought by private actors before national courts, and from there a preliminary reference to the CJEU is possible. And the direct effect of Union law means that it can be relied upon in litigation by private actors.

At the same time, much of the detail of Union health law and policy lies in technocratic decision-making at the agency level through committee processes or through private standards bodies. Here is where decisions about the safety of medicines, devices and equipment, chemicals and other components, about the permissibility of clinical trials, about food safety, contents and labelling, about environmental effects on health and a host more are made. Much more than the high-profile, broad-brush legislation, these areas are where the specifics about the European ways of thinking about health – especially public health – are embedded into dense regulatory structures. These areas are where, for example, the Union’s precautionary principle is instrumentalised in practice.

Union law and policymaking have not always been successful in protecting and promoting human health through such processes and mechanisms, partially given that its hands were tied legally, but also due to a lack of political will, capacity and knowledge.Footnote ²² The decision-making under the Common Agricultural Policy did not prevent the BSE scandal. Oversight by standards bodies did not prevent the Poly Implant Prothèse (PIP) breast implants scandal. The European Centre for Disease Prevention and Control (ECDC) failed to protect Italy and other Union countries from the ravages of COVID-19. One of the key roles of law in the Union’s constitutionalised structures is to secure the accountability and legitimacy of decision-making. This can be through compensation for harm, mandating transparency and accounting for decisions made, perhaps with political consequences including being relieved of public office. This is the case as much for technocratic decision-making as it is for high-level legislative decision-making.

To be sure, matters related to human health are rarely only technocratic matters. Technocratic decision-making may be appropriate where a matter is truly only technical, but not so much for matters where there are ethical or other similar dimensions. In such matters, constitutional legitimacy requires parliamentary or other representative and/or stakeholder oversight, as well as consistency with fundamental human rights. The dynamic potential of the Union’s constitutional and institutional legal frameworks hides a “dark side”: the possibilities for political and/or technocratic decision-making without any real reference to legal oversight.