Asymmetry between EU public health objectives and competences

While the Union should be granted the necessary powers to pursue the objectives established in the Treaties, this balance between goals and competences is not present in EU public health.

An examination of the Treaties reveals a gradual expansion of public health objectives (A), accompanied by a much slower expansion of the Union’s competence under Article 168 TFEU

99 Laurence POTVIN-SOLIS, ‘Compétences partagées et objectifs matériels’ in Eleftheria Neframi (ed), Objectifs et compétences de l’Union européenne (Brussels, Bruylant, 2013), p. 29.

100 Eleftheria NEFRAMI, ‘Le rapport entre objectifs et compétences : de la structuration et de l’identité de l’Union européenne’ in Eleftheria NEFRAMI (ed), Objectifs et compétences dans l’Union européenne (Brussels, Bruylant, 2013), p. 5.

101 Estelle BROSSET, ‘Droit(s) européen(s) et protection de la santé: mettre en ordre?’ in Estelle Brosset (ed), Droit européen et protection de la santé : bilan et perspectives (Brussels, Bruylant, 2015), pp. 23-24; Elias MOSSIALOS, Govin PERMANAND, Rita BAETEN and Tamara Hervey, ‘Health Systems Governance in Europe: The Role of European Union Law and Policy’ in EliasMOSSIALOS, Govin PERMANAND, Rita BAETEN and Tamara HERVEY (eds), Health Systems Governance in Europe: The Role of European Union Law and Policy (Cambridge, Cambridge University Press, 2010), pp. 5-7.

28 (B). This provision is thus not suitable to pursue public health objectives and the Union has had recourse to other legal bases in order to legislate on public health.

A. EU public health objectives

The European Union’s public health objectives can at first sight seem limited. Public health is not mentioned in Article 3 TEU establishing the goals of the European Union. It is not mentioned either in Article 21 TEU, which provides the general objectives of the Union’s external action. Although both provisions are drafted in very broad terms, they do not include any reference to public health.

However, public health is essential in EU actions. It is one of the most significant non-economic interests guiding EU activities and programmes. The ‘Europe Against Cancer’

programme, adopted in 1985, was one of the first non-economic initiatives of the Union.¹⁰² Several provisions in the EU Treaties reflect public health concerns and confirm the relevance of this field.

The first indicator of the increasing relevance of public health in the European Union is found in Article 168 TFEU. Union action under this provision shall be directed towards a variety of goals: preventing physical and mental illness, fighting against the major health scourges, promoting research and monitoring cross-border health threats.¹⁰³ This provision also incorporates the objective of fighting against tobacco and the abuse of alcohol.¹⁰⁴ Article 168 TFEU thus encompasses a broad range of public health objectives. With the modifications brought by the Lisbon Treaty, these goals have considerably increased in comparison to previous versions of the Treaties. They incorporate for the first time a reference to mental health, to cross-border health threats, and to tobacco and alcohol. This provision consequently expands public health objectives in the European Union.

Public health objectives are also found in other provisions of the Treaties. One of the goals of the Union under Article 3 TEU is promoting the well-being of its people,¹⁰⁵ which seems to include a public health component.¹⁰⁶ Substantive provisions of EU law also reflect the growing relevance of public health in the Union. A high level of health protection is to be pursued when

102 See supra, Introduction, Section I, II.

103 Article 168 (1) TFEU.

104 Article 168 (5) TFEU.

105 Article 3 (1) TEU.

106 The Sustainable Development Goals, for example, consider health and well-being as a common objective; see

United Nations, SDG 3 Good Health and Well-Being, available at

https://www.un.org/sustainabledevelopment/health/ (last accessed 30 January 2020).

29 adopting harmonising measures for the establishment and functioning of the internal market,¹⁰⁷ in the field of consumer protection,¹⁰⁸ and within the Union’s environmental policy.¹⁰⁹ More indirectly, the Union social policy aims at improving the living and working conditions of EU citizens.¹¹⁰ This provision seems to include public health concerns if read in conjunction with Article 153 TFEU establishing the objectives of the EU social policy.¹¹¹ Several Treaty provisions therefore incorporate public health objectives within their specific goals, thus enlarging the scope of public health goals in the EU system.

The increased importance of public health in the European Union has been highlighted with the incorporation of Article 9 TFEU. This transversal clause provides that a high level of human health shall be taken into account ‘in defining and implementing its policies and activities’.¹¹² This statement is strengthened in Article 168 TFEU, which requires a high level of human health protection in the definition and implementation of all Union policies and activities.¹¹³ Public health protection is thus now a transversal¹¹⁴ or integration¹¹⁵ clause that needs to be taken into account in any field.

Public health objectives are therefore extremely broad in the European Union, but the question remains as to the interpretation that objectives get in the EU system. While transversal objectives are taken into account in the case law of the Court of Justice of the European Union (CJEU),¹¹⁶ their interpretation seems to be limited by the legal basis of the action under scrutiny.

The power of the European Union to act, and the extent of such action, will be determined by the competence granted through the legal basis and not by transversal objectives.¹¹⁷ It is thus essential to assess the EU public health competence to determine possible actions that the Union can undertake.

107 Article 114 (3) TFEU.

108 Article 169 (1) TFEU.

109 Article 191 (1) TFEU.

110 Article 151 TFEU.

111 Article 153 TFEU: ‘1. With a view to achieving the objectives of Article 151, the Union shall support and complement the activities of the Member States in the following fields: (a) improvement in particular of the working environment to protect workers’ health and safety’.

112 Article 9 TFEU.

113 Article 168 (1) TFEU; emphasis added by the author.

114 ValérieMICHEL, ‘Les objectifs à caractère transversal’ in Eleftheria Neframi (ed), Objectifs et compétences dans l’Union européenne (Brussels, Bruylant, 2013), p. 177.

115 Thierry RONSE, Les compétences de l’Union européenne (Brussels, Éditions de l’Université de Bruxelles, Commentaire J. Mégret, 3^ème édition entièrement refondue et mise à jour, 2017), p. 289.

116 See, for example, Judgment of the Court of 4 May 2016 in Case C-547/14 Philip Morris, EU:C:2016:325, paras. 153-157.

117 Thierry RONSE, Les compétences de l’Union européenne, op. cit., p. 291. The author makes this argument on the basis of the CJEU case law on the environmental transversal provision, which is the only clause having been interpreted by the Court so far.

30 B. EU public health competences under Article 168 TFEU

Under the principle of conferral, the Union can only act where a competence has been attributed to it in a certain field.¹¹⁸ All areas not allocated to the Union remain the competence of the Member States.¹¹⁹ The principle of conferral is the departing point when analysing the Union’s activity in any given area, both at the internal and at the external levels.¹²⁰ In order to determine whether a competence has been attributed to the Union, it is necessary to look at the provisions regulating the policy under examination. The Treaty of Lisbon has clarified the nature of EU competences. Articles 2 to 6 TFEU insert lists of the areas belonging to each category of competences: exclusive,¹²¹ shared,¹²² or complementary.¹²³

A specific public health provision was originally incorporated to the EU Treaties under the reforms brought by the Treaty of Maastricht in Article 129 EC, now Article 168 TFEU. This incorporation reveals the increased importance of public health concerns in the European Union. However, the Union holds a complementary competence in this area, both at the internal (1) and at the external levels (2). When compared to the broad objectives described in the previous paragraphs, it is concluded that a competence gap exists in this area.

1. EU internal public health competence

The European Union has been granted powers to act under Article 168 TFEU and it can thus be concluded that a competence exists in public health.¹²⁴ The Union is allowed to adopt measures in accordance with the ordinary legislative procedure in a number of areas related to public health.¹²⁵ Such areas have expanded over time and currently include common safety concerns, cross-border health threats and non-communicable diseases.

However, it is not enough to establish the existence of a competence. It is also necessary to assess the extent to which the Union is able to act. For that purpose, the nature of the competence of the Union will be analysed. With the exceptions provided for in Article 168 (4) TFEU, the Union has a complementary and coordination competence. Article 168 TFEU is explicit in this regard. The second sentence of Article 168 (1) TFEU underlines that Union action ‘shall complement national policies’, which is confirmed by Article 6 (a) TFEU. While

118 Article 5 (2) TEU.

119 Article 4 (1) TEU.

120 Opinion of the Court of 28 March 1996 in Opinion 2/94 Accession by the Community to the European Convention for the Protection of Human Rights and Fundamental Freedoms, EU:C:1996:140, paras. 23-24.

121 Article 3 TFEU.

122 Article 4 TFEU.

123 Article 6 TFEU.

124 Article 168 (4) and (5) TFEU.

125 Idem.

31 Article 168 (5) TFEU allows the Union to adopt measures to protect and improve human health, these can only take the form of ‘incentive measures’ and cannot involve any harmonisation of the laws and regulations of the Member States. This limited competence is confirmed in Article 168 (7) TFEU, where it is stated that ‘Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care’.

The implications of the complementary nature of a competence are strong. The regulatory power remains in the Member States. The Union will only complement this action. Union action and Member States action still coexist and are exercised in parallel, which means that the Union can adopt measures. Those measures can take the form of legally binding acts, as long as they do not have a harmonising effect. However, when the Union exercises a complementary competence, Member States are not blocked from regulating in the given field.¹²⁶

An exception to the coordination competence in public health is contained in Article 168 (4) TFEU. This provision grants a shared competence to the Union and the Member States in the following areas: the adoption of measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives;¹²⁷ the adoption of measures in the veterinary and phytosanitary field;¹²⁸ and the adoption of measures setting high standards of quality and safety for medicinal products and devices for medical use.¹²⁹ While Article 168 (4) TFEU is limited to three specific areas, it is a relevant provision and the Treaty of Lisbon has clarified its wording. This provision now explicitly underlines that it constitutes a

126 Theodore KONSTANTINIDES, Division of Powers in European Union Law: The Delimitation of Internal Competence between the EU and the Member States (Alphen aan den Rijn, Kluwer Law International, 2009), pp.

179-180.

127 Article 168 (4) (a) TFEU.

128 Article 168 (4) (b) TFEU. The exceptions provided in Article 168 (4) (a) and (b) were incorporated to Article 152 EC as a result of the amendments brought by the Treaty of Amsterdam. Their inclusion was the result of the BSE crisis; see Christine KADDOUS, ‘Article 152’ in Philippe LÉGER (ed), Commentaire article par article des traités UE et CE (Basel/Geneva/Munich/Paris/Brussels, Helbing&Lichtenhahn/Dalloz/Bruylant, 2000), p. 1243;

Tamara K. HERVEY and Jean V. MCHALE, Health Law and the European Union (Cambridge, Cambridge University Press, 2004), p. 79.

129 Article 168 (4) (c) TFEU. Medical devices have been regulated at EU level since 1990 based on what is now Article 114 TFEU; see Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ L 189 of 20 July 1990, p. 17. The Lisbon Treaty has crystallised this fact by including the EU harmonising power in this area under Article 168 TFEU. Two new regulations have been adopted on the basis of Article 168 (4) (c) TFEU; see Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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, OJ L 117 of 5 May 2017, p. 1; Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, OJ L 117 of 5 May 2017, p. 176.

32 derogation from Article 2 (5) and Article 6 (a) TFEU, in accordance with Article 4 (2) (k) TFEU.

2. EU external public health competence

The European Union has also been granted external public health powers. Yet, the origin of such powers is a contested issue. Article 168 (3) TFEU states that ‘the Union and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health’. This provision mentions the need to cooperate but does not expressly mention the conclusion of international agreements. It can legitimately be questioned whether an explicit external competence to conclude health-related international agreements has been granted.¹³⁰

It can, on the one hand, be argued that ‘cooperation’ in this provision refers to the conclusion of international agreements, although the prohibition of harmonisation could not be circumvented by such agreements.¹³¹ This would be consistent with the effet utile of Article 168 (3) TFEU since it seems difficult to effectively cooperate without concluding any agreement.¹³² This view is supported by the fact that health-related international agreements have in practice been concluded by the Union based on Article 168 TFEU.¹³³ However, the use of the term

‘cooperation’, the reference to the Union alongside its Member States and the nature of the internal public health competence – limited to support activities – makes it doubtful that the drafters of this provision were seeking to include the conclusion of international agreements as a form of cooperation under Article 168 (3) TFEU.¹³⁴ Actually, international agreements based on Article 168 TFEU are based either on this provision in general without further specifying the concerned paragraph,¹³⁵ or on the paragraphs granting an internal competence to act, namely

130 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne (Brussels, Éditions de l’Université de Bruxelles, Commentaire J. Mégret, 3^ème édition entièrement refondue et mise à jour, 2019), p. 64.

131 Marcus KLAMERT, The Principle of Loyalty in EU Law (Oxford, Oxford University Press, 2014), p. 168.

132 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne, op. cit., p. 66.

133 See, for example, Council Decision 2004/513/EC of 2 June 2004 concerning the conclusion of the WHO Framework Convention on Tobacco Control, OJ L 213 of 15 June 2004, p. 8 (Decision 2004/513).

134 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne, op. cit., pp. 65-66.

135 See, for example, Decision 2004/513; Council Decision 2006/914/EC of 13 November 2006 concerning the conclusion of the Agreement between the European Community and Kingdom of Norway on the revision of the amount of the financial contribution from Norway provided for in the Agreement between the European Community and the Kingdom of Norway on the participation of Norway in the work of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), OJ L 349 of 12 December 2006, p. 47.

33 paragraphs (4) or (5).¹³⁶ We could infer from that practice that the Union’s competence to conclude international agreements in public health is implied from its internal competence or from the necessity to fulfil public health objectives established in Article 168 TFEU.¹³⁷ Notwithstanding the origin of such competence, it can be assumed that the European Union has the power to conclude international agreements under Article 168 TFEU.

The nature of the EU external competence remains however limited to support activities.

The conclusion of international agreements has to be conducted under the strict application of Article 2 (5) TFEU and the subsidiarity and proportionality principles.¹³⁸ In accordance with these principles, public health agreements will generally be concluded both by the Union and its Member States in the form of mixed agreements.¹³⁹ Additionally, Member States retain the power to act even where the Union has exercised its competence, although in conformity with the principle of sincere cooperation.¹⁴⁰

Consequently, both at the internal and external levels, the Union has limited attributed powers. This competence is inconsistent with the broad public health objectives described above, leading to an asymmetry between goals and competences. The best way to deal with this situation would be granting the Union more extensive powers through a Treaty amendment.¹⁴¹ However, this solution is unlikely.¹⁴² A more pragmatic alternative has been developed by the EU, which is the use of other legal bases to legislate on public health.

II. From competence gap to competence creep? Alternative legal bases to legislate in