From competence gap to competence creep? Alternative legal bases to legislate in EU public health EU public health

The European Union’s public health competence is limited to support actions. However, public health objectives are broad and, more importantly, they are incorporated to several

136 See, for example, Council Decision 2003/822/EC of 17 November 2003 on the accession of the European Community to the Codex Alimentarius Commission, OJ L 309 of 26 November 2003, p. 14 (Decision 2003/822/EC); Council Decision 2011/56/EU of 26 July 2010 on the signing, on behalf of the Union, of the Agreement between the European Union and the Republic of Croatia on the participation of the Republic of Croatia in the work of the European Monitoring Centre for Drugs and Drug Addiction, OJ L 26 of 29 January 2011, p. 1;

Council Decision 2011/841/EU of 5 December 2011 on the conclusion of the Agreement between the European Union and the Republic of Croatia on the participation of the Republic of Croatia in the work of the European Monitoring Centre for Drugs and Drug Addiction, OJ L 334 of 16 December 2011, p. 6.

137 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne, op. cit., pp. 66-67.

138 Article 5 (3) and (4) TEU; Protocol No 2 on the Application of the Principles of Subsidiarity and Proportionality, OJ C 202 of 7 June 2016, p. 206.

139 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne, op. cit., p. 172.

140 Article 4 (3) TEU.

141 See infra, Part IV, Section III, I.

142 Oliver BARTLETT, ‘The EU’s Competence Gap in Public Health and Non-Communicable Disease Policy’

(2016) 5(1) Cambridge Journal of International and Comparative Law 50, p. 76.

34 Treaty provisions. The European Union has used such objectives to circumvent the prohibition of harmonisation. Harmonising measures can be adopted on the basis of Article 352 TFEU.

With the modifications brought by the Lisbon Treaty, the flexibility clause is however unlikely to succeed in EU public health (A). The European Union has rather used policy-specific provisions that require a high level of human health protection. Article 114 TFEU allowing the adoption of harmonising measures for the proper functioning of the internal market has been the favoured provision (B). Other legal bases can also be useful. Article 38 TFEU on the Common Agricultural Policy (CAP) or Article 191 TFEU on the environmental policy are interesting tools to pursue public health objectives (C). The use of alternative legal bases has been extremely relevant. Numerous public health measures have been lawfully adopted and, while it has facilitated the attainment of public health goals, it has also resulted in an institutional fragmentation that will be explored in the following section.

A. The unsuitability of the flexibility clause as a legal basis

The flexibility clause is a general legal basis that allows the adoption of legislation under several conditions (1). These conditions are drafted in broad terms in Article 352 TFEU. This provision could accordingly be considered an appropriate legal basis for the adoption of public health legislation. However, the CJEU has ruled out the possibility of circumventing the delimitation of powers through Article 352 TFEU. In accordance with this case law, the flexibility clause is considered an unsuitable legal basis for public health purposes (2).

1. Evolution of the conditions in the flexibility clause

The flexibility clause is provided for in Article 352 TFEU modifying Article 308 EC.¹⁴³ The former provision enabled the Community to adopt legislation if it was necessary to attain, in the course of the operation of the common market, one of the objectives of the Community and the Treaty had not provided the necessary powers. This provision was interpreted in broad terms. The only limit was the necessary connection between the measure pursued and the common market, but this condition was easily fulfilled.¹⁴⁴ For instance, Article 308 EC was used to adopt measures related with the environmental policy,¹⁴⁵ legislation on the protection

143 And, previously, Article 235 EEC.

144 Joseph WEILER, ‘The Transformation of Europe’ (1991) 100 Yale Law Journal 2403, pp. 2445-246 cited in Paul CRAIG and Gráinne DE BÚRCA, EU Law: Text, Cases and Materials (Oxford, Oxford University Press, 6^th edition, 2015), p. 91; Thierry RONSE, Les compétences de l’Union européenne, op. cit., pp. 161-162.

145 Council Decision 81/462/EEC of 11 June 1981 on the conclusion of the Convention on long-range transboundary air pollution, OJ L 171 of 27 June 1981, p. 11; Council Decision 77/585/EEC of 25 July 1977 concluding the Convention for the protection of the Mediterranean Sea against pollution and the Protocol for the prevention of the pollution of the Mediterranean Sea by dumping from ships and aircraft, OJ L 240 of 19 September 1977, p. 1; Council Decision 77/586/EEC of 25 July 1977 concluding the Convention for the protection of the

35 of wild birds or the protection of swimming areas,¹⁴⁶ or legislation in development aid, humanitarian and emergency aid and economic cooperation with countries other than developing countries.¹⁴⁷ All these areas were unrelated to the common market, thus highlighting a broad interpretation of Article 308 EC.¹⁴⁸

Article 352 TFEU as amended by the Treaty of Lisbon provides the possibility for the Union to adopt measures in areas where the Treaties have not provided the necessary powers when it is necessary to attain one of the objectives of the Treaties. Article 352 TFEU is also drafted in broad terms and can potentially be used in all areas of EU law. New elements are apparent in this provision.¹⁴⁹ The main difference is the removal of the reference to the common market.¹⁵⁰ The new provision seems to broaden its scope of application, thus enhancing the competence of the European Union.¹⁵¹ In accordance with this view, public health objectives could potentially be pursued through Article 352 TFEU. However, the flexibility clause has to be interpreted in light of the CJEU case law, which has adopted a strict view on the application of this provision. Consequently, while Article 308 EC was frequently relied upon during the 1970s and 1980s, Article 352 TFEU can currently be considered relatively weak.¹⁵²

2. Interpretation of the flexibility clause by the CJEU

The Court established in Opinion 2/94 that Article 308 EC had to be interpreted consistently with the principle of conferral. This provision is ‘an integral part of an institutional system based on the principle of conferred powers’ and ‘cannot serve as a basis for widening the scope of Community powers beyond the general framework created by the provisions of the Treaty as a whole and, in particular, by those that define the tasks and the activities of the

Rhine against chemical pollution and an Additional Agreement to the Agreement, signed in Berne on 29 April 1963, concerning the International Commission for the Protection of the Rhine against Pollution, OJ L 240 of 19 September 1977, p. 35; Council Decision 75/438/EEC of 3 March 1975 concerning Community participation in the Interim Commission established on the basis of Resolution No III of the Convention for the prevention of marine pollution from land-based sources, OJ L 194 of 25 July 1975, p. 22; see Theodore KONSTANTINIDES,

‘Drawing the Line between Circumvention and Gap-Filling: An Exploration of the Conceptual Limits of the Treaty’s Flexibility Clause’ (2012) 31(1) Yearbook of European Law 227, p. 228.

146 Thierry RONSE, Les compétences de l’Union européenne, op. cit., p. 162.

147 Alan DASHWOOD, ‘Article 308 EC as the Outer Limit of Expressly Conferred Community Competence’ in Catherine BARNARD and Okeoghene ODUDU (eds), The Outer Limits of European Union Law (Oxford/Portland, Hart Publishing, 2009), p. 40.

148 Idem.

149 Niki ALOUPI, Catherine FLAESCH-MOUGIN, Christine KADDOUS and Cécile RAPOPORT, Les accords internationaux de l’Union européenne, op. cit., pp. 95-99.

150 Article 352 (1) TFEU.

151 German Federal Constitutional Court (Bundesverfassungsgericht), Judgment of the Second Senate of 30 June 2009, 2 BvE 2/08, DE:BVerfG:2009:es20090630.2bve000208, paras. 327-328.

152 Theodore KONSTANTINIDES, ‘Drawing the Line between Circumvention and Gap-Filling’, op. cit., p. 228.

36 Community’.¹⁵³ Article 308 EC could therefore not be used to amend the Treaty without following the appropriate procedure to do so.¹⁵⁴ Although a consistent reading of Articles 5 TEU and 308 EC could be expected, it had been argued in the past that Article 308 EC risked being used to make minor Treaty amendments. This possibility was referred to as la petite révision.¹⁵⁵ Opinion 2/94 put an end to that discussion. The reading of the Court was consistent with the European Council Conclusions of 1992 of the Edinburgh European Summit. Member States ruled out the use of the flexibility clause for harmonising measures in pursuit of the objectives in the areas of education, vocational training and youth, culture, and public health.¹⁵⁶ Such conclusion resulted from provisions on those areas, which explicitly excluded harmonisation.¹⁵⁷

This interpretation has been codified in the post-Lisbon era. Under Article 352 (3) TFEU,

‘measures based on this Article shall not entail harmonisation of Member States’ laws or regulations in cases where the Treaties exclude such harmonisation’. This paragraph forbids the use of the flexibility clause in areas of complementary competence, where harmonisation measures are prohibited.¹⁵⁸ Article 168 (5) TFEU states that the Parliament and the Council may adopt incentive measures to protect and improve human health ‘excluding any harmonisation of the laws and regulations of the Member States’. This interpretation is confirmed by Declaration 42 on Article 352 TFEU, which states that this provision ‘cannot serve as a basis for widening the scope of Union powers beyond the general framework established by Treaty provisions’ and ‘cannot be used as a basis for the adoption of provisions whose effect would, in substance, be to amend the Treaties without following the procedure which they provide for that purpose’.¹⁵⁹ The reading of both provisions excludes any possibility to use Article 352 TFEU in public health.

153 Opinion 2/94, paras. 30-31.

154 Idem.

155 Alan DASHWOOD, ‘Article 308 EC as the Outer Limit of Expressly Conferred Community Competence’, op.

cit., p. 38; Robert SCHÜTZE, ‘Organised Change towards an “Ever Closer Union”: Article 308 EC and the Limits to the Community’s Legislative Competence’ (2003) 22 Yearbook of European Law 79, p. 81; Theodore KONSTANTINIDES, ‘Drawing the Line between Circumvention and Gap-Filling’, op. cit., p. 234.

156 European Council, Conclusions of the Presidency, 11-12 December 1992, SN 456/92, available at http://www.europarl.europa.eu/summits/edinburgh/default_en.htm (last accessed 29 January 2020).

157 Ibid., Annex 1 to Part A ‘Overall approach to the application by the Council of the subsidiarity principle and article 3b of the Treaty on European Union’, p. 5.

158 Thierry RONSE, Les compétences de l’Union européenne, op. cit., p. 166.

159 Declaration 42 on Article 352 of the Treaty on the Functioning of the European Union, OJ C 202 of 7 June 2016, p. 351; Theodore KONSTANTINIDES, ‘EU Foreign Policy under the Doctrine of Implied Powers: Codification Drawbacks and Constitutional Limitations’ (2014) 39(4) European Law Review 511, p. 521.

37 With the entry into force of the Lisbon Treaty, new elements have further restricted the possibility to use the flexibility clause in general and in public health in particular. Several specific legal bases have been incorporated to the Treaties, leading to new leges speciales that make recourse to Article 352 TFEU unnecessary.¹⁶⁰ The CJEU has precluded having recourse to Article 352 TFEU when a more specific legal basis exists, the Council even qualifying this provision as a ‘default legal basis’.¹⁶¹ Procedural constraints regarding the involvement of the European Parliament and national parliaments make the use of Article 352 TFEU more difficult.¹⁶² Since the entry into force of the Lisbon Treaty, this provision has been used for the adoption of about twenty legislative acts.¹⁶³

The flexibility clause is not an appropriate tool to adopt public health measures. With the impossibility of having recourse to Article 352 TFEU, the most appropriate legal basis for the adoption of health-related measures is Article 114 TFEU. The CJEU has adopted an expansive approach in this regard and EU institutions can easily adopt public health measures based on this provision.

B. The appropriateness of Article 114 TFEU as a legal basis

Article 114 TFEU on the adoption of measures to ensure the proper functioning of the internal market is strongly linked to public health (1). It has thus been frequently used to adopt measures with an impact on public health. The most striking example is undoubtedly the adoption of tobacco-control legislation. The case law of the CJEU is helpful to understand the complementarity between the internal market provision and Article 168 TFEU. The Court first defined the limits to the use of Article 114 TFEU in the Tobacco Advertising I judgment (2).¹⁶⁴ However, subsequent case law enhanced the possibility to use the internal market for public health protection in the European Union (3). Article 114 TFEU can therefore be currently seen as a useful and hardly limited tool to adopt health-related legislation.

1. Article 114 TFEU and public health protection

The links between Article 114 TFEU and public health are two-fold. On the one hand, when adopting a harmonising measure under Article 114 TFEU, a high level of public health

160 Theodore KONSTANTINIDES, ‘Drawing the Line between Circumvention and Gap-Filling’, op. cit., p. 258.

161 Judgment of the Court of 2 May 2006 in Case C-217/04 United Kingdom v Parliament and Council, EU:C:2006:279, para. 33; Judgment of the Court of 13 July 1995 in Case C-350/92 Spain v Council, EU:C:1995:237, para. 26.

162 Art. 352 (1) and (2) TFEU; Theodore KONSTANTINIDES, ‘Drawing the Line between Circumvention and Gap-Filling’, op. cit., pp. 228-229 and 257.

163 Twenty-two legal instruments had been adopted on the basis of Article 352 TFEU by September 2020.

164 Judgment of the Court of 5 October 2000 in Case C-376/98 Germany v Council (Tobacco Advertising I), EU:C:2000:544.

38 protection needs to be taken as a base.¹⁶⁵ On the other hand, once a harmonising measure has been adopted under Article 114 TFEU, Member States can derogate to such measure for public health reasons.¹⁶⁶ However, the fact that public health is an important element in Article 114 TFEU does not mean that this provision can be used to adopt measures essentially aimed at public health protection.¹⁶⁷ One must keep the principle of conferral in mind and the CJEU has established the basic principles on the interaction between harmonising measures and public health protection.

2. Limits to the use of Article 114 TFEU for public health reasons

In the Tobacco Advertising I judgment, the CJEU dealt for the first time with the interaction between Article 114 TFEU and public health protection. The case concerned Directive 98/43 on Tobacco Advertising,¹⁶⁸ which banned all forms of advertising and sponsorship of tobacco products. This directive was adopted under Article 100a EC (now Article 114 TFEU). To justify this legal basis, the preamble of the directive provided that there were differences between the tobacco-control laws of Member States, which were likely to rise barriers to the movement of tobacco products between Member States, thereby impeding the functioning of the internal market.¹⁶⁹ Germany considered that ‘the legislative history of the directive and its content and purpose show[ed] that the centre of gravity of the measure [was] public health protection’.¹⁷⁰ This argument would invalidate the directive, as Article 129 EC (now Article 168 TFEU) excluded any harmonising measure in the field.

The directive was successfully challenged by Germany.¹⁷¹ While the Court noted that harmonising measures adopted on the basis of Article 100a EC could have an impact on human health,¹⁷² it was not possible to use the internal market provision to circumvent the express exclusion of harmonisation laid down in Article 129 (4) EC.¹⁷³

165 Article 114 (3) TFEU.

166 Article 114 (4) and (5) TFEU and Article 36 TFEU.

167 Tamara K. HERVEY, ‘Community and National Competence in Health after Tobacco Advertising’ (2001) 38 Common Market Law Review 1421, p. 1437.

168 Directive 98/43/EC of the European Parliament and of the Council of 6 July 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products, OJ L 214 of 30 July 1998, p. 9 (Tobacco Advertising Directive I).

169 Preamble, para. 1, Tobacco Advertising Directive I.

170 Tobacco Advertising I, para. 34.

171 See Ricardo GOSALBO BONO, ‘Arrêt du 5 octobre 2000 (aff. C-376/98), République fédérale d’Allemagne c/

Parlement européen et Conseil de l’Union européenne – « L’arrêt ″Tabac″ ou l’apport de la Cour de justice au débat sur la délimitation des compétences »’ (2001) 4 Revue trimestrielle de droit européen 785, p. 790, and doctrine cited therein.

172 Tobacco Advertising I, para. 78.

173 Ibid., para. 79.

39 The Court explained the conditions under which Article 100a EC could be applied. In a concise formula, it stated that ‘a measure adopted on the basis of Article 100a of the Treaty must genuinely have as its object the improvement of the conditions for the establishment and functioning of the internal market’.¹⁷⁴ Recourse to what is now Article 114 TFEU is possible when obstacles are merely potential, but their emergence must be likely and genuine. An abstract risk of obstacles to the free movement of goods is not sufficient, as it would empty the judicial review carried out by the CJEU of its proper function.

In the circumstances of the case, the Court made a distinction between ‘static advertising media’ (posters, parasols, ashtrays)¹⁷⁵ and ‘non-static advertising media’ (periodicals, magazines, and newspapers).¹⁷⁶ A prohibition on the latter kind of marketing could be adopted on the basis of Article 100a EC because it did ensure the free movement of press products.

However, the prohibition of advertising on posters, parasols, ashtrays and other articles used in hotels, restaurants and cafés, and the prohibition of advertising spots in the cinema ‘in no way helps to facilitate trade in the products concerned’, namely, advertising products.¹⁷⁷ The Court concluded that Article 100a EC did not constitute an appropriate legal basis for the adoption of the Tobacco Advertising Directive I, which was annulled accordingly.

Following the annulment of Directive 98/43, EU institutions adopted Directive 2003/33 on advertising and sponsorship of tobacco products.¹⁷⁸ This tailor-made measure only covered the areas the Court had considered to be compatible with Article 114 TFEU. The directive prohibited advertising in the press and in the radio, banned the sponsorship of events taking place in more than one Member State, and contained a free movement clause. Although Germany also challenged this directive, the Court upheld its validity in the Tobacco Advertising II judgment.¹⁷⁹

The Tobacco Advertising I judgment consequently limited the use of Article 114 TFEU as a legal basis. However, subsequent case law seems to contradict this thesis and advocates for a broad interpretation of this provision.

174 Ibid., para. 84.

175 Ibid., para. 99.

176 Ibid., paras. 97-98.

177 Ibid., para. 99.

178 Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products, OJ L 152 of 20 June 2003, p. 16 (Tobacco Advertising Directive II).

179 Judgment of the Court of 12 December 2006 in case C-380/03 Germany v European Parliament and Council (Tobacco Advertising II), EU:C:2006:772.

40 3. The mainstreaming of Article 114 TFEU as an alternative legal basis for public health

measures

The limits imposed by the CJEU in the Tobacco Advertising I case did not last long. Article 114 TFEU was admitted as a legal basis in the case law immediately following this landmark judgment (a), and this line of reasoning has been confirmed in recent case law (b). Article 114 TFEU has also been used in the EU external action. Implied external powers can consequently result from this provision (c).

a. Article 114 TFEU in the early case law on tobacco control

In the above-mentioned Tobacco Advertising II judgment, the Court upheld the validity of Article 114 TFEU for the adoption of the second directive regulating tobacco advertising. A similar outcome was reached in Swedish Match¹⁸⁰ and Arnold André,¹⁸¹ both of which concerned the Tobacco Products Directive I.¹⁸² In those judgments, the Court admitted the validity of a total ban on the marketing of oral tobacco products under Article 114 TFEU even though ‘a ban might appear to fly in the face of a single market in goods’.¹⁸³

In a different context, it is also interesting to mention the Alliance for Natural Health judgment.¹⁸⁴ It concerned the Food Supplements Directive,¹⁸⁵ which prohibited the manufacturing and marketing of food supplements containing certain vitamins and minerals.

The Court stated that the Treaty provision on public health ‘provides that a high level of human

The Court stated that the Treaty provision on public health ‘provides that a high level of human