I. Introduction
The COVID-19 pandemic has given rise to ambivalent feelings among European Union (EU) health lawyers. To those criticising the lack of EU response, it was necessary to point at the limited powers granted to the Union in this field. At the same time, the often-heard assertion that the “EU has no competence in health” resonated oddly,Footnote 1 for it is far from the reality of EU action. The body of EU health law and policy is vast and growing.Footnote 2 We find ourselves in a paradoxical situation: there is an apparent need and desire for a common European response to health emergencies and greater involvement of the Union in health matters, but the crisis has also highlighted the fact that EU health law and policy have mostly been developing under the radar, as a “silent revolution”.Footnote 3
The present piece argues that, prior to any new and significant development in this field, the status of health in the EU constitutional framework should be clarified and enhanced legislative powers should be granted to the EU. The Treaty framework already allows for a lot, and could arguably be further used,Footnote 4 but this approach has its limits. Indeed, to compensate for its lack of direct powers, the EU has used legal bases relating to other fields of law, in particular Article 114 TFEU. This method gives rise to three main problems: it undermines the legitimacy of EU health policy; it limits the range of actions that can be adopted; and it also prevents Member States from enacting more protective health measures. These three issues will be taken in turn, after which the paper will present a concrete proposal for a Treaty reform.
This piece takes a narrow view and focuses on legislative activity, leaving aside other crucial aspects of EU health law, important also in their relation to the internal market: negative integration and freedoms of movement, fundamental rights and executive power. The examples used here are drawn from EU anti-tobacco legislation, an area that is rich in both Union measures and case law, but the arguments developed can be applied to other fields of EU health law.
II. A limited Union competence in the field of health
The protection of human health can be considered as a fundamental objective of the EU.Footnote 5 According to Article 3(1) TEU, the “Union’s aim is to promote peace, its values and the well-being of its peoples”.Footnote 6 Health is also the object of various mainstreaming clauses present in the TFEU and the Charter of Fundamental Rights, demanding that a high level of human health protection be taken into account in the definition and implementation of all Union policies and activities.Footnote 7
The importance of health as a constitutional objective contrasts sharply with its position in the Union’s competence framework. Pursuant to Article 6 TFEU, public health is an area of complementary competence for which Union action is limited to “actions to support, coordinate or supplement the actions of the Member States”,Footnote 8 with the narrow exception of the safety concerns of Article 4(2)(k) TFEU, for which the EU is granted a shared competence.Footnote 9 The nature of complementary competences remains somewhat unclear,Footnote 10 but Article 2(5) TFEU clearly states that “legally binding acts of the Union adopted on the basis of the provisions of the Treaties relating to these areas shall not entail harmonisation of Member States’ laws or regulations”. Whichever view is taken on the precise meanings of this blanket exclusion of harmonisation, it must at least mean that approximation of existing Member States’ legislation is prohibited.Footnote 11 This prohibition is echoed in Article 168 TFEU, the health legal basis, whose fifth paragraph excludes “any harmonization of the laws and regulations of the Member States”, with the exception again of the safety concerns foreseen by Article 4(2)(k) TFEU.Footnote 12 Article 168 TFEU is therefore a rather weak legal basis, mostly enabling the Union to spend “small sums of money to promote European networks that connect people and organizations, put items on the agenda for the future, and sometimes produce research”.Footnote 13
Confronted with this severe limitation, the EU legislator has had recourse to the internal market legal basis of Article 114 TFEU to enact legislation in the field of health. This is the case for most of the flagship pieces of EU health policy, such as the Patients’ Rights Directive,Footnote 14 the General Food Law Regulation,Footnote 15 the Directive on the Community code for medicinal productsFootnote 16 or the Tobacco Products Directive.Footnote 17 Internal market measures often follow a dual objective: in the present case, the establishment and functioning of the internal market and the protection of human health. This practice has been approved by the Court of Justice, which held in the landmark Tobacco Advertising ruling that “provided that the conditions for recourse to Articles [114, 53(1) and 62 TFEU] as a legal basis are fulfilled, the Community 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”.Footnote 18 The Court considered that the exclusion of harmonisation contained in Article 168(5) TFEU did not limit the possibility for other harmonisation measures, adopted under other legal bases, to have an impact on the protection of health, to the condition that such legal bases are not used in order to circumvent the exclusion of Article 168(5) TFEU.Footnote 19
That internal market powers can be used to regulate the field of health should not in itself be controversial. Creating a single market implies lifting barriers that are very often the product of diverging health standards between Member States. Medicinal products or products having an impact on human health, such as foodstuffs or tobacco products, are also tradable products for which a market exists. Article 114 TFEU is functional in nature and, as rightly pointed out by Advocate General Fennelly, “is not limited in advance by reference to a particular subject-matter defined ratione materiae”.Footnote 20 The internal market provides the EU with a powerful and broad competence to enact measures in the field of health. Yet, this indirect competence gives rise to a series of problems.
III. Problems with the recourse to Article 114 TFEU for health purposes
The intensive use of Article 114 TFEU in the field of health creates three main problems.
1. Lack of legitimacy of EU action
The first problem – and probably the most obvious one – is one of legitimacy. “In light of the degree and extent of EU action in this field, of all the supporting policy areas public health is probably the one that is the most difficult to distinguish from a shared competence”.Footnote 21 There is a clear discrepancy between the letter of the Treaty and the reality of EU health law and policy.Footnote 22 The EU acts in the field of health without a clear mandate to do so.
Moreover, the reliance on the internal market powers of Article 114 TFEU means that health measures “are adopted but under a false label, as if they are all about promoting trade, making more of it and removing obstacles in a concrete, narrow, sense”.Footnote 23 For instance, it is clear to everyone that the EU anti-tobacco policy does not actually aim at facilitating the smooth functioning of the tobacco market, but rather at curbing the use of tobacco in the European population and, ultimately, eradicating it.Footnote 24
Union action in the field of health is a clear example of competence creep, if understood as “a process whereby the powers of the EU [are] perceived as expanding in covert or somehow unclear ways, including into areas where Member States [are] supposed to remain fully in charge”.Footnote 25 This is even more controversial if one considers that the introduction of the health legal basis in the Treaties system after the Maastricht revision, which already contained an express exclusion of harmonisation at the time, was seen by the most reluctant Member States as a way to stop the expansion of Union legislation in this area.Footnote 26 Needless to say, they have failed in this regard. One could object that Member States have agreed to these legislative developments as co-legislators of the Union. Such an approach would, however, render meaningless the limits on EU action and the very idea of having constitutional constraints on political power.
2. Limits on EU action
The second issue takes us to the heart of EU action in the field of health. Defending health with the words of the market is not only a conceptual problem – it is also a practical one. Not all necessary health measures can be said to remove obstacles to free movement or distortions to competition, the two alternative conditions needed for a measure to be lawfully adopted under Article 114 TFEU.Footnote 27 This will be illustrated with two examples taken from tobacco control – the prohibition of advertising and the protection from exposure to tobacco smoke – which are widely recognised as key components of anti-tobacco policies.Footnote 28
In the well-known Tobacco Advertising judicial saga, the Tobacco Advertising Directive was finally declared valid by the Court after it had been expunged from the aspects that did not comply with Article 114 TFEU.Footnote 29 Contrary to the prohibition of advertising in magazines or radio programmes, which could be considered as removing obstacles to trade,Footnote 30 the prohibition of more static forms of advertising, such as on billboards or in cinemas, did not make such a contribution and could hence not be lawfully adopted by the EU.Footnote 31
Regarding smoke-free environments, the only instrument currently in place at the EU level is the non-binding Council Recommendation of 2009,Footnote 32 despite the European Commission’s strong political will on the issue.Footnote 33 This can partly be explained by the lack of a legal basis to adopt binding legislation.Footnote 34 Recourse to Article 114 TFEU appears impossible, for it is hard to see how a general ban on smoking throughout the Union – say, in cafes and restaurants – could help with removing obstacles to trade between Member States.Footnote 35
These two examples show that the EU is limited in its public health action by the legal constraints of Article 114 TFEU. This is problematic. The development of EU health policy should be the outcome of a political process, where market concerns may very well be taken into account, but not be primarily decided in function of their merits for economic integration.
3. Lack of flexibility for Member States
The last problem with the use of Article 114 TFEU to pursue public health objectives resides in the limited capacity for Member States to conduct an autonomous policy adapted to local circumstances. This appears when looking at the issues of minimum harmonisation and subsidiarity.
There is an inherent tension between the protection of health and the deepening of market integration. Ideally, health would be better served if EU measures offered a common minimal level of protection from which Member States were allowed to deviate in order to adopt more stringent measures. This need appears clearly from Article 168(4) TFEU, which grants power to the EU to enact “measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives” without preventing “any Member State from maintaining or introducing more stringent protective measures”. This constitutionalisation of minimum harmonisation can also be seen in other non-market areas, such as environmental protectionFootnote 36 or social policy.Footnote 37
However, such an approach would be problematic under Article 114 TFEU. The elimination of obstacles to trade would be hypothetical if Member States were always able to derogate from an EU internal market measure. This question was already at stake in the first Tobacco Advertising judgment, where the Court partially based its decision to annul the directive at issue on its failure to ensure the free movement of the products that were in conformity with its provisions.Footnote 38 The Court seemed to consider that the possibility left to Member States to apply stricter standards would jeopardise the actual removal of obstacles to trade. This concern appears even more clearly from the recent Philip Morris judgment.Footnote 39 Called to interpret Article 24(2) of the Tobacco Products Directive, the Court considered that if this article “were interpreted as permitting Member States to maintain or introduce further requirements in relation to all aspects of the packaging of tobacco products, including those which have been harmonised by the directive, that would amount, in essence, to undermining the harmonisation effected by the directive with regard to the packaging of those products. … Such an interpretation would render Article 24(2) of Directive 2014/40 incompatible with Article 114 TFEU”.Footnote 40
This tension can be further illustrated by the current debates over nutritional labelling at the EU level. The current Regulation on food information to consumers (FIC Regulation)Footnote 41 contains important provisions for public health, but still mostly operates as an internal market instrument aimed at facilitating the free movement of foodstuffs across the EU. The nutrition declaration provided for in the Regulation is widely seen as insufficient from a public health point of view, which has prompted Member States to experiment with new, more effective front-of-pack labelling schemes.Footnote 42 However, these additional schemes can at the moment only be used on a voluntary basis. The FIC Regulation does not allow Member States to impose different labels,Footnote 43 for this would run contrary to its free movement objective.
The impossibility of pursuing public health objectives independently from internal market objectives also affects subsidiarity control. It is indeed inherent to the internal market objective that it cannot be achieved by Member States alone, since it requires harmonisation that only the EU can provide.Footnote 44 This means – as expressed by the Court in several judgments – that although Member States might be better placed to achieve the health objective underlying a measure, the EU will always be better positioned to fulfil the two objectives combined.Footnote 45 When Article 114 TFEU is used, the subsidiarity principle offers no help with challenging a measure where the EU appears to be less well suited than Member States to protect human health.
The EU prohibition of tobacco for oral use, contained in Articles 1(c) and 17 of the Tobacco Products Directive, provides a concrete example. In the second Swedish Match judgment, claims that such a prohibition breached subsidiarity were swiftly brushed off by the Court for the reason outlined above,Footnote 46 even though it seemed that a health argument could be made to let Member States decide whether or not to authorise the marketing of tobacco for oral use. Indeed, regarding the use of this form of tobacco as an aid to stop smoking, the report of the scientific committee on which the Directive is based indicated that “[the] data imply that the association between patterns of smokeless tobacco use and smoking cessation differs between populations and is likely to be affected by cultural, societal and other factors”.Footnote 47 This point was unfortunately not addressed by the Court.
These two examples – minimum harmonisation and subsidiarity – show that the internal market nature of EU public health instruments limits the capacity for Member States to reach a stronger level of protection or to enact divergent measures that are better suited to local circumstances.
IV. Health as a shared competence with direct harmonisation powers
To address these three issues and provide a solid foundation to any further expansion of EU action in the field of health, amendments must be brought to the Treaty. Public health should become an area of shared competence, with direct harmonisation powers granted to the EU and the inclusion of a constitutional minimum harmonisation clause. This would improve the clarity and legitimacy of EU action and ensure that autonomous public health policy objectives can be pursued, without the limitations inherent to the use of Article 114 TFEU. This provision would remain pertinent whenever an internal market measure has an incidental and indirect effect on health, but would cease to be used for measures having health as their primary purpose.
In more concrete terms, the “protection and improvement of human health” would be taken out from Article 6 TFEU and inserted into Article 4 TFEU, listing the areas of shared competence. This means that Article 4(2)(k) would no longer be needed and that the prohibition on harmonisation contained in Article 2(5) TFEU would cease to apply to public health. Article 168 TFEU would be amended to reflect these changes and to provide the Union with general harmonisation powers in the field, to the exclusion of healthcare.Footnote 48 Paragraphs 1, 4 and 5 would be modified and a new Paragraph 6 would be inserted. The new Article 168 TFEU could read as follows:Footnote 49
1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.
Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. …
…
4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall adopt in order to meet common safety concerns:
(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;
(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;
(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.
5. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.
6. The protective measures adopted pursuant to this Article shall not prevent any Member State from maintaining or introducing more stringent protective measures. Such measures must be compatible with the Treaties. They shall be notified to the Commission.
V. Conclusion
This short piece argues that only a Treaty change can provide the Union with the adequate competence that it needs to tackle the various health challenges that Europe does and will face. Considering the unlikelihood of any Treaty revision in the short term, this should of course not prevent the EU from continuing to use the legal tools currently available, including Article 114 TFEU, while being mindful of its limitations. Conversely, one should bear in mind that such a targeted constitutional change would not alleviate the broader shortcomings of the EU competence framework,Footnote 51 a question that goes far beyond the scope of the present piece.
