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Published online by Cambridge University Press: 17 November 2020
It is a striking feature of European Union (EU) health law and policy that it has developed in a relative lack of awareness from the general public. This situation can be partly explained by the existence of only a limited competence in the field and the recourse to other legal bases to enact public health measures, particularly Article 114 TFEU. The use of internal market powers to conduct EU health policy has given rise to several problems, affecting the legitimacy of EU action and its capacity to adequately protect human health. Only a Treaty change can provide the EU with the clear competence and the solid legislative powers that it needs to tackle the various health challenges that Europe faces and will continue to face.
The author wishes to thank Augustin Chapuis-Doppler and the anonymous reviewer for their useful comments. The usual disclaimer applies.
1 See, for instance, the following French governmental website: <https://www.europe-en-france.gouv.fr/fr/articles/la-sante-publique-nest-pas-une-competence-de-lunion-europeenne-mais> (last accessed 25 August 2020); and the following Belgian newspaper article: <https://www.lecho.be/dossiers/coronavirus/les-europeens-paient-cash-l-absence-d-europe-de-la-sante/10215297.html> (last accessed 25 August 2020).
2 For a definition of EU health law and policy and a historical perspective on its developments, see T Hervey and B Vanhercke, “Health care and the EU: the law and policy patchwork”, in E Mossialos et al (eds), Health Systems Governance in Europe: The Role of EU Law and Policy (Cambridge, Cambridge University Press 2010) pp 84–133; TK Hervey and JV McHale, “What is European Union health law?” in TK Hervey and JV McHale (eds), European Union Health Law: Themes and Implications (Cambridge, Cambridge University Press 2015) pp 30–70; M Guy and W Sauter, “The history and scope of EU health law and policy”, in T Hervey et al (eds), Research Handbook on EU Health Law and Policy (Cheltenham, Edward Elgar Publishing 2017) pp 17–35; A De Ruijter, EU Health Law & Policy: The Expansion of EU Power in Public Health and Health Care (Oxford, Oxford University Press 2019), especially pp 53–91.
3 De Ruijter, supra, note 2, p 1 and following.
4 KP Purnhagen et al, “More Competences than You Knew? The Web of Health Competence for European Union Action in Response to the COVID-19 Outbreak” (2020) 11(2) European Journal of Risk Regulation 297–306.
5 “Human health”, “public health” and “health” are used interchangeably as umbrella terms. For the absence of difference between “human health” and “public health” in the EU legal framework, see De Ruijter, supra, note 2, pp 55–57.
6 Art 3(1) TEU.
7 Arts 9 TFEU, 168(1) TFEU and Art 35 of the Charter.
8 Art 6(1) TFEU.
9 Art 4 TFEU.
10 R Schütze, “Co-operative Federalism Constitutionalized: The Emergence of Complementary Competences in the EC Legal Order” (2006) 31 European Law Review 167.
11 R Schütze, “Classifying EU Competences: German Constitutional Lessons?”, in S Garben and I Govaere (eds), The Division of Competences Between the EU and the Member States: Reflections on the Past, the Present and the Future (Oxford, Hart Publishing 2017) pp 50–51.
12 Art 168(4) TFEU. These are: measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; measures in the veterinary and phytosanitary fields that have as their direct objective the protection of public health; and measures setting high standards of quality and safety for medicinal products and devices for medical use.
13 SL Greer, “The three faces of European Union health policy: Policy, markets, and austerity” (2014) 33(1) Policy and Society 13, p 15.
14 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ L 88, 4.4.2011, pp 45–65.
15 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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, OJ L 31, 1.2.2002, pp 1–24.
16 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, pp 67–128.
17 Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 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, OJ L 127, 29.4.2014, pp 1–38.
18 Case C-376/98, Germany v European Parliament and Council, EU:C:2000:544, para 88.
19 ibid, paras 78 and 79.
20 Opinion of Advocate General Fennelly, Case C-376/98, Germany v European Parliament and Council, EU:C:2000:324, para 62.
21 S Garben, “Supporting policies”, in PJ Kuijper and F Amtenbrink (eds), The Law of the European Union (5th edn, Dordrecht, Kluwer Law International 2018) p 1208.
22 An example out of many: the statement at Art 168(7) 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” comes into contradiction with the very existence of the Patients’ Rights Directive.
23 G Davies, “The Competence to Create an Internal Market: Conceptual Poverty an Unbalanced Interests”, in S Garben and I Govaere (eds), The Division of Competences Between the EU and the Member States: Reflections on the Past, the Present and the Future (Oxford, Hart Publishing 2017) pp 74–89; see also R Schütze, From Dual to Cooperative Federalism: The Changing Structure of European Law (Oxford, Oxford University Press 2009) p 282.
24 This appears clearly from the European Commission webpage dedicated to EU anti-tobacco policy: <https://ec.europa.eu/health/tobacco/overview_en> (last accessed 25 August 2020).
25 S Garben and I Govaere, “The Division of Competences between the EU and the Member States: Reflections on the Past, the Present and the Future”, in S Garben and I Govaere (eds), The Division of Competences Between the EU and the Member States: Reflections on the Past, the Present and the Future (Oxford, Hart Publishing 2017) p 7.
26 S Guigner, “La dynamique d’intégration par sédimentation: retour sur l’inscription de la santé dans les compétences de l’Union”, in E Brosset (ed.), Droit européen et protection de la santé – Bilan et perspectives (Brussels, Bruylant 2015) pp 58–60.
27 Germany v European Parliament and Council, supra, note 18, paras 84 and 95; see, more recently, Opinion of Advocate General Sharpston, Case C-482/17, Czech Republic v Parliament and Council, EU:C:2019:321, para 44. On the non-cumulative aspect of these two conditions, see Case C-380/03, Germany v European Parliament and Council, ECLI:EU:C:2006:772, para 67.
28 See Arts 8 and 13 of the World Health Organization Framework Convention on Tobacco Control, to which the EU is a signatory.
29 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, 20.6.2003, pp 16–19; see Germany v European Parliament and Council, supra, note 18.
30 Germany v European Parliament and Council, supra, note 18, para 98.
31 ibid, paras 99, 108–14.
32 Council Recommendation of 30 November 2009 on smoke-free environments, OJ C 296, 5.12.2009, pp 4–14.
33 European Commission, “Green Paper. Towards a Europe free from tobacco smoke: policy options at EU level”, COM (2007) 27 final.
34 K Banks, “The Lisbon Treaty’s Competence Arrangement Viewed from European Commission Practice”, in S Garben and I Govaere (eds), The Division of Competences Between the EU and the Member States: Reflections on the Past, the Present and the Future (Oxford, Hart Publishing 2017) pp 196–97: “Some years ago, the competent services of the Commission were convinced that there was a need for binding EU rules on smoking in public places. However, after examination of all possibilities, it was concluded that the most they could propose was a Council Recommendation. This resulted in Council Recommendation of 30 November 2009 on smoke-free environments”.
35 V Delhomme, “Smoke-free environments: the missing link in EU anti-tobacco policy” (2018) 8(18) College of Europe Policy Brief 1–4.
36 Art 193 TFEU.
37 Arts 153(2)(b) and 153(4) TFEU.
38 Germany v European Parliament and Council, supra, note 18, para 101.
39 Case C-547/14, Philip Morris Brands SARL e.a. v Secretary of State for Health, EU:C:2016:325.
40 ibid, paras 71 and 72, emphasis added.
41 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, OJ L 304, 22.11.2011, pp 18–63.
42 V Delhomme, “Improving Food Choices through Nutrition Labelling: Towards a Common ‘Nutri-Score’ Scheme across the EU” (2020) 3(20) College of Europe Policy Brief 1–5.
43 Arts 35 and 36 of Regulation (EU) No 1169/2011.
44 See G Davies, “Subsidiarity: The wrong idea, in the wrong place, at the wrong time” (2006) 43(1) Common Market Law Review 63–84.
45 See Case C-151/17, Swedish Match AB v Secretary of State for Health, ECLI:EU:C:2018:938, paras 64–69; Case C-547/14, Philip Morris Brands SARL e.a. v Secretary of State for Health, EU:C:2016:325, paras 221–22; Case C-358/14, Poland v European Parliament and Council, EU:C:2016:323, paras 117–18.
46 Swedish Match, supra, note 45, paras 64–69.
47 Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), “Health Effects of Smokeless Tobacco Products” (2008) European Commission, p 12.
48 Healthcare touches upon fundamental components and values of national welfare states and therefore deserves to be treated separately from public health. For the difference between the public health and healthcare, see De Ruijter, supra, note 2, pp 62–63.
49 Only the parts that have been altered have been reproduced. The deleted text appears struck through and the added text appears in italics.
50 Former paras 6 and 7 would be renumbered 7 and 8.
51 In a vast literature, see, for example, T Tridimas, “Competence after Lisbon: The Elusive Search for Bright Lines”, in D Ashiagbor (ed.), The European Union after the Treaty of Lisbon (Cambridge, Cambridge University Press 2012) pp 47–76; S Garben, “Confronting the Competence Conundrum: Democratising the European Union through an Expansion of its Legislative Powers” (2015) 35(1) Oxford Journal of Legal Studies 55, pp 75–76.
