SECTION I. S ECTION I. Conceptual and historical background to the research
II. Evolution of EU public health: political and legal aspects
After the failure of the European Health Community project launched by the French Health Ministry, Paul RIBEYRE, in 1952, public health was not among the priorities in the Treaties establishing the European Communities.47 EU public health has developed in an evolutionary manner, public health considerations being at first an accessory effect of other policies (A).
Public health then played a critical role in the construction of the EU internal market (B), before
44 David P. FIDLER, International Law and Public Health, op. cit., p. 16.
45 World Health Organization, COVID-19 as a Public Health Emergency of International Concern (PHEIC) under the IHR, May 2020, available at https://extranet.who.int/sph/sites/default/files/document-library/document/FS15A_IHR_COVID19_EN_MAY_2020.pdf (last accessed 15 August 2020).
46 Kelley LEE, ‘Globalisation’ in Roger DETELS, Martin GULLIFORD, Quarraisha ABDOOL KARIM and Chorn Chuan TAN (eds), Oxford Textbook of Global Public Health (Oxford, Oxford University Press, 6th edition, 2015), pp. 17-20.
47 Louis DUBOUIS, ‘La politique de santé’ in Georges VANDERSANDE, Louis DUBOUIS, Patrick LATHAM et al.
(eds), Le droit de la CE: culture, santé, consommateurs, réseaux transeuropéens, recherche et développement technologique, environnement, énergie (Brussels, Éditions de l’Université de Bruxelles, Commentaire Mégret, 2nd edition, 1996), p. 17; Alban DAVESNE and Sébastien GUIGNER, ‘La Communauté européenne de la santé (1952-1954) : une redécouverte intergouvernementale du projet fonctionnaliste de « pool blanc »’ (2013) 41 Politique Européenne 40, p. 42 ; Dorte SINDBJERG MARTINSEN, ‘Governing EU Health Law and Policy – On Governance and Legislative Politics’ in Tamara K. HERVEY, Calum Alasdair YOUNG and Louise E. BISHOP (eds), Research Handbook on EU Health Law and Policy (Cheltenham/Northampton, Edward Elgar Publishing, 2017), p. 36;
Richard T. GRIFFITHS, ‘Europe’s First Constitution: The European Political Community, 1952-1954’ in Stephen MARTIN (ed), The Construction of Europe: Essays in Honour of Emile Noël (Dordrecht, Springer Netherlands, 1994), pp. 19-39.
10 becoming a major objective of EU institutions (C). While the European Union does not systematically make the distinction between health in general and public health in particular, an attempt to differentiate both of them will be undertaken in this sub-section.
A. Early concerns regarding public health
The European Union was indirectly confronted to public health issues from its origins, although in an accessory way. Public health was only used as an application of the economic principles that were at the heart of the European integration process.48 During the 1960s and 1970s, public health was taken into account to complement two crucial policies of the then European Communities: the safety of workers and the Common Agricultural Policy (CAP).
Concerning the safety of workers, public health provisions were contained in the Treaty establishing the European Coal and Steel Community49 and in the Euratom Treaty, which protected the general public and atomic industry workers from the effect of radiation.50 Additionally, the Treaty establishing the European Economic Community considered public health concerns in the framework of the four freedoms.51 Lastly, secondary legislation dealing with health matters was adopted in the area of the free movement of professionals, notably regarding social security schemes and the mobility of health professionals.52
48 Arnaud SENN, ‘La politique de santé de l’Union européenne’, Fondation Robert Schuman – Questions d’Europe n° 25, 2006, available at http://www.robert-schuman.eu/fr/questions-d-europe/0025-la-politique-de-sante-de-l-union-europeenne (last accessed 26 January 2020); Morgane DOR, ‘L’évolution historique de la santé dans les politiques européennes’ (2013) 33 Pour la Solidarité Working Paper 1, available at http://www.pourlasolidarite.eu/sites/default/files/publications/files/wp2013_21_evolutionhistoriquesante_poleur opeennes.pdf (last accessed 26 January 2020), p. 7.
49 Articles 46 (5) and 55 (1) ECSC.
50 Articles 30-39 Euratom Treaty; Judgment of the Court of 22 September 1988 in Case 187/87 Land de Sarre v Ministre d’Industrie, EU:C:1988:439, para. 11; see José Manuel SOBRINO HEREDIA, ‘La política de la salud pública en la Unión Europea’ (1998) 2 Anuario da Facultade de Dereito da Universidade da Coruña 547, p. 551.
51 Article 36 EEC Treaty, for the free movement of goods; Articles 48 (3) and 56 (1) EEC for the free movement of workers; Article 52-58 EEC for the freedom of establishment; Article 59 EEC Treaty for the freedom to provide services; Articles 117 and 118 EEC concerned health and safety in the workplace.
52 Article 7 (2) Regulation (EEC) No 1612/68 of the Council of 15 October 1968 on freedom, of movement for workers within the Community, OJ L 257 of 19 October 1968, p. 2; Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community, OJ L 149 of 5 July 1971, p. 2; Council Directive 75/362/EEC of 16 June 1975 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in medicine, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services, OJ L 167 of 30 June 1975, p. 1 and Council Directive 75/363/EEC of 16 June 1975 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of activities of doctors, OJ L 167 of 30 June 1975, p. 14 (Doctor’s Directives); then codified in Council Directive 93/16/EEC to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications, OJ L 165 of 7 July 1993, p. 1; see Miek PIETERS, Martin MCKEE and Sherry MERKUR, ‘EU Law and Health Professionals’ in Elias MOSSIALOS, Govin PERMANAND, Rita BAETEN and Tamara K. HERVEY (eds), Health Systems Governance in Europe: The Role of European Union Law and Policy (Cambridge, Cambridge University Press, 2010), p. 592.
11 The CAP was one of the major policies during the early years of the European Communities and a variety of legislative acts were adopted during the initial phase of the European project.53 These instruments highlight the relevance of public health concerns in this policy. The first EU Food Directive provided for example that ‘all rules relating to the colouring matters which may be used in foodstuffs intended for human consumption must give priority to the protection of public health’.54 However, this recital also underlined the pre-eminence of economic concerns over public health by adding that ‘the protection of the consumer against falsification and the needs of the economy must also be taken into consideration’.55 Public health concerns were taken into account, but only in a subsidiary manner.
B. Public health as a justification to barriers to the internal market
The strengthening of the internal market in the 1980s resulted in an increased examination of public health concerns, particularly with regard to the free movement of goods. However, public health as a restriction to free movement provisions is to be interpreted in a restrictive manner.56 The CJEU has been crucial in the interpretation of the public health justification, which is invoked in two scenarios: first, where Member States try to avoid implementing harmonising measures and, second, where no harmonising measures exist and Member States adopt measures having an equivalent effect to quantitative restrictions.
When a harmonising measure has been adopted under Article 114 TFEU, Member States have the obligation to implement it and they cannot rely on a public health justification to impose barriers to trade.57 Article 114 (4) TFEU provides however that a Member State can maintain its already existing national provision where a harmonising measure has been adopted if the national provision attains a higher level of public health protection. Accordingly, Member States are allowed to assess the risk of a certain substance to public health differently from the
53 Tamara K. HERVEY and Jean V. MCHALE, European Union Health Law, op. cit., p. 31.
54 Recital 1 Council Directive on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption, OJ 115 of 11 November 1962, p. 2645.
56 Catherine BARNARD, The Substantive Law of the EU: The Four Freedoms (Oxford, Oxford University Press, 6th edition, 2019), p. 146.
57 Judgment of the Court of 5 October 1977 in Case 5/77 Tedeschi v Denkavit, EU:C:1977:144, para. 35; Judgment of the Court of 5 April 1979 in Case 148/78 Ratti, EU:C:1979:110, para. 36; Judgment of the Court of 8 November 1979 in Case 251/78 Denkavit Futtermittel, EU:C:1979:252, para. 14..
12 European Union legislature.58 It is for Member States to prove that the national measure ensures a higher level of health protection and that it does not go beyond what is necessary.59
When no harmonising measures exist, Member States are allowed to legislate freely as long as national measures do not violate free movement provisions. Where a national measure constitutes a barrier to trade, such measure is prohibited under EU law but can be justified on public health grounds.60 Public health is one of the most frequently invoked reasons to justify a restriction to trade between Member States.61 However, the CJEU has adopted a strict level of scrutiny in this respect and Member States have to prove that they have real health concerns and that their health policy is coherent.62 The only cases where the Court seems to be more flexible is where Member States rely on the precautionary principle.63 Under this principle, Member States can decide what degree of health protection they want to ensure where there are uncertainties in scientific research.64 Interestingly, this principle was codified in 1992, at a time where public health started to be perceived as an autonomous field and where health concerns were given a broader interpretation.
58 Judgment of the Court of 20 March 2003 in Case C-3/00 Denmark v Commission, EU:C:2003:167, para. 63;
Order of the President of the General Court of 15 May 2013 in Case T-198/12 R Germany v Commission, EU:T:2013:245, para. 64; Judgment of the Court of 9 July 2015 in Case C-360/14 P Germany v Commission, EU:C:2015:457, para. 33.
59 C-3/00 Denmark v Commission, para. 64.
60 Judgment of the Court of 20 February 1979 in Case 120/78 Rewe v Bundesmonopolverwaltung für Branntwein (‘Cassis de Dijon’), EU:C:1979:42, para 8; see also Judgment of the Court of 26 June 1980 in Case 788/79 Gilli et Andres, EU:C:1980:171, para. 6; Judgment of the Court of 19 February 1981 in Case 130/80 Kelderman, EU:C:1981:49, para. 6; Judgment of the Court of 11 October 1990 in Case C-196/89 Nespoli and Crippa, EU:C:1990:355, para. 14; Judgment of the Court of 25 July 1991 in Case C-1/90 Aragonesa de Publicidad Exterior, EU:C:1991:327, para. 13; Eleanor Spaventa, ‘On Discrimination and the Theory of Mandatory Requirements’ (2000) 3 Cambridge Yearbook of European Legal Studies 458, p. 473; Stephen ENCHELMAIER,
‘Article 36 TFEU: General’ in Peter OLIVER (ed), Oliver on Free Movement of Goods in the European Union (Oxford/Portland, Hart Publishing, 5th edition, 2010), pp. 260-261; Vassilis HATZOPOULOS, ‘La justification des atteintes aux libertés de circulation: cadre méthodologique et spécificités matérielles’ (2013) 1 College of Europe Research Papers in Law 1, p. 5.
61 Catherine BARNARD, The Substantive Law of the EU, op. cit., p. 155.
62 Ibid., p. 155; Paul CRAIG and Gráinne DE BÚRCA, EU Law: Text, Cases and Materials (Oxford, Oxford University Press, 6th edition, 2015), p. 699; Judgment of the Court of 8 February 1983 in Case 124/81 Commission v United Kingdom, EU:C:1983:30; Judgment of the Court of 31 January 1984 in Case 40/82 Commission v United Kingdom (turkeys), EU:C:1984:33, para 38; Judgment of the Court of 22 March 1983 in Case 42/82 Commission v France, EU:C:1983:88; Judgment of the Court of 12 March 1987 in Case 178/84 Commission v Germany (Beer Purity Case), EU:C:1987:126; Judgment of the Court of 11 December 2003 in Case C-322/01 Deutscher Apothekerverband (Doc Morris), EU:C:2003:664; Judgment of the Court of 9 December 2010 in Case C-421/09 Humanplasma, EU:C:2010:760.
63 See infra, Part III, Section I, I, A.
64 Judgment of the Court of 14 July 1983 in Case 174/82 Sandoz, EU:C:1983:213; José Luis DA CRUZ VILAÇA,
‘The Precautionary Principle in EC Law’ (2004) 10(2) European Public Law 369, p. 372; Catherine BARNARD, The Substantive Law of the EU, op. cit., pp. 156-157.
13 C. Public health as an autonomous field
With the completion of the internal market, public health has developed in an autonomous manner. Public health measures have expanded and a delinkage between public health and economic concerns has taken place.
Health Ministers of the then European Community met for the first time in 1977.65 However, it is generally considered that a genuine EU public health ‘policy’66 emerged in 1985, when the former French President François MITTERRAND proposed the programme ‘L’Europe contre le cancer’ (Europe Against Cancer).67 Following this model, a second programme was launched in 1991 to fight HIV/AIDS.68 These developments were however limited by the lack of a legal basis on public health matters in the Treaties. The decisions adopting those programmes were simply based on the Treaty establishing the European Economic Community, without further specifying any provision.69 It was thus imperative to address this limit to strengthen public health.
The amendments brought by the Treaty of Maastricht in 1992 to the EC Treaty offered a specific legal basis to adopt measures in the field of public health.70 Article 129 EC (now Article 168 TFEU) contributed to the development of a proper EU public health policy. It resulted in a
65 Frédérique LAFAY, ‘Article 129’ in Vlad Constantinesco, Robert Kovar and Denys Simon (eds), Traité sur l’Union européenne (signé à Maastricht le 7 février 1992): Commentaire article par article (Paris, Economica, 1995), p. 375.
66 Note that public health is not considered a policy as such in the Treaties. However, authors tend to use this expression.
67 European Council, Conclusions, 28-29 June 1985, SN 2740/1/85; European Commission, Press Release IP/86/76, available at http://europa.eu/rapid/press-release_IP-86-76_en.htm (last accessed 29 January 2020);
European Commission, Proposal for a Council Resolution on a Programme of Action of the European Communities on Cancer Prevention, COM(85) 628 final, OJ C 336 of 28 December 1985, p. 11; Decision 88/351/EEC of the Council and of representatives of the Governments of the Member States, meeting within the Council of 21 June 1988 adopting a 1988 to 1989 plan of action for an information and public awareness campaign in the context of the ‘Europe against cancer’ programme, OJ L 160 of 28 June 1988, p. 52 (Decision 88/351/EEC).
See Sébastien GUIGNER, ‘La dynamique d’intégration par sédimentation : retour sur l’inscription de la santé dans les compétences de l’Union’ in Estelle BROSSET (ed), Droit européen et protection de la santé : bilan et perspectives (Brussels, Bruylant, 2015), p. 38; Ed RANDALL, The European Union and Health Policy (London/New York, Palgrave Macmillan, 2001), pp. 96-99; Ed RANDALL, ‘Health Policy and the European Union’
in Valerie SYMES, Carl LEVY and Jane LITTLEWOOD (eds), The Future of Europe : Problems and Issues for the Twenty-First Century (Houndmills/London, Palgrave Macmillan, 1997), pp. 285-287; Christine KADDOUS,
‘Article 152’ in Philippe LÉGER (ed), Commentaire article par article des Traités UE et CE (Bâle/Genève/Munich/Paris/Brussels, Helbing & Lichtenhahn/Dalloz/Bruylant, 2000), p. 1240.
68 Decision 91/317/EEC of the Council and the Ministers for Health of the Member States, meeting within the Council of 4 June 1991 adopting a plan of action in the framework of the 1991 to 1993 ‘Europe against AIDS’
programme, OJ L 175 of 4 July 1991, p. 26 (Decision 91/317/EEC); Ed RANDALL, ‘Health Policy and the European Union’, op. cit., pp. 288-289.
69 Decision 88/351/EEC; Decision 91/317/EEC; see Tamara K. HERVEY and Jean V. MCHALE, Health Law and the European Union, op. cit., p. 73; Nathalie FERRAUD CIANDET, Protection de la santé et sécurité alimentaire en droit international (Brussels, Éditions Larcier, 2009), p. 40.
70 Article 129 EC Treaty (Maastricht version), then Article 152 EC (Amsterdam consolidated version).
14 specific provision on public health and implied the end of systematically discussing public health matters as an accessory to other policies, notably the internal market. However, the establishment of this provision presented some limits. Article 129 EC was a way for Member States to strictly frame the areas in which the Union could adopt legislation. It restricted in a certain manner the Union’s scope of action in public health in comparison to Article 308 EC (now Article 352 TFEU).71 Additionally, Article 129 EC was not included in the citizenship part of the Treaty, it did not establish a right to health and did not define public health as a common policy.72 Article 129 EC confirmed the development of EU public health as an autonomous field but additional measures were necessary to favour the expansion of public health measures in the European Union.
The adoption of the Charter of Fundamental Rights of the European Union and, more fundamentally, its upgraded legal status with the entry into force of the Lisbon Treaty constituted the final step in the evolution of EU public health.73 Several rights in the Charter may come into consideration when discussing health issues. The right to life can be relevant for issues on abortion or end-of-life decision-making. The right to the integrity of the person could be invoked in cases involving research on humans or biomedicine. The protection of personal data has an impact on the protection of personal health records. The right to marry and found a family could be invoked in reproductive rights claims. The freedom of thought, conscience and religion might influence cases of blood transfusion. Most notably, the Charter contains a specific provision on the right to healthcare in Article 35.74
The CJEU has not frequently interpreted Article 35 of the Charter so far.75 In most cases, the right to healthcare is only invoked to emphasise the importance of public health in the EU and
71 Sébastien GUIGNER, ‘ La dynamique d’intégration par sédimentation’, op. cit., p. 59.
72 Frédérique LAFAY, ‘Article 129’, op. cit., p. 376.
73 Article 35 Charter; Article 6 (1) TEU.
74 Estelle BROSSET, ‘Article 35. Protection de la santé’ in Fabrice PICOD, Cecilia RIZCALLAH et Sébastien VAN DROOGHENBROECK (eds), Charte des droits fondamentaux de l’Union européenne - Commentaire article par article (Brussels, Bruylant, 2nd edition, 2020), pp. 759-776; Jean MCHALE, ‘Fundamental Rights and Health Care’
in Elias MOSSIALOS, Govin PARMANAND, Rita BAETEN and Tamara K. HERVEY (eds), Health Systems Governance in Europe: The Role of European Union Law and Policy (Cambridge, Cambridge University Press, 2010), pp.
298-303; Tamara K. HERVEY, ‘The “Right to Health” in European Union Law’ in Tamara K. HERVEY and Jeff KENNER (eds), Economic and Social Rights in the EU Charter of Fundamental Rights – A Legal Perspective (Oxford and Portland, Hart Publishing, 2003), pp. 202-206; Tamara K. HERVEY and Jean MCHALE, ‘Article 35 – The Right to Health Care’ in Steve PEERS, Tamara HERVEY, Jeff KENNER and Angela WARD (eds), The EU Charter of Fundamental Rights: A Commentary (Oxford/Portland, CH Beck/Hart Publishing/Nomos, 2014), pp.
952-953; Manuel LÓPEZ-ESCUDERO, ‘Artículo 35. Protección de la salud’ in Araceli MANGAS MARTÍN (ed), Carta de los Derechos Fundamentales de la Unión Europea: Comentario artículo por artículo (Bilbao, Fundación BBVA, 2008), pp. 594-605.
75 A reference to Article 35 of the Charter was contained in twenty-three cases in September 2020.
15 to confirm the validity of public health as a justification to restrictions to the internal market.76 The Court has also been required to balance the right to healthcare and the rights of expression and information and to conduct a business.77 Additionally, the CJEU has examined other fundamental rights in relation with health issues.78 In Brüstle, the Court dealt with the directive on biotechnology and, more specifically, with the concept of human embryos.79 The Court ruled that the directive does not violate the right to human dignity and integrity.80 In Kaltoft, the Court considered that there was no principle of non-discrimination on grounds of obesity in EU law.81 However, obesity could constitute a disability in accordance with the United Nations Convention on the Rights of Persons with Disabilities.82 In Léger, the CJEU considered that the prohibition to blood donation for men having had sexual relations with other men ‘contributes to the general objective of ensuring a high level of human health protection, which is an objective recognised by the EU in Article 152 EC (…) and Article 35, second sentence of the Charter’.83 This case law highlights the increasing importance of human rights and health considerations in the reasoning of the CJEU.
However, the legal value of the right to healthcare in the Charter is still a contested issue. In the above-mentioned case law, Article 35 is merely used as an interpretative tool added to other
76 On the freedom of establishment: Judgment of the Court of 1 June 2010 in Case C-570/07 Blanco Pérez, EU:C:2010:300, para. 65; Judgment of the Court of 21 June 2012 in Case C-84/11 Susisalo and Others, EU:C:2012:374, para. 37; Judgment of the Court of 5 December 2013 in Case C-159/12 Venturini, EU:C:2013:791, para. 41; on the free movement of goods: Judgment of the Court of 21 December 2011 in Case C-28/09 Commission v Austria, EU:C:2011:854, para. 121.
77 Judgment of the Court of 6 September 2012 in Case C-544/10 Deutsches Weintor, EU:C:2012:526; Judgment of the Court of 17 December 2015 in Case C-157/14 Neptune Distribution, EU:C:2015:823; Philip Morris;
Judgment of the Court of 4 May 2016 in Case C-477/14 Pillbox 38, EU:C:2016:324; Judgment of the Court of 4 May 2016 in Case C-358/14 Poland v Parliament and Council, EU:C:2016:323.
78 Judgment of the Court of 18 October 2011 in Case C-34/10 Brüstle, EU:C:2011:669; Judgment of the Court of 18 December 2014 in Case C-364/13 International Stem Cell, EU:C:2014:2451; Judgment of the Court of 18
78 Judgment of the Court of 18 October 2011 in Case C-34/10 Brüstle, EU:C:2011:669; Judgment of the Court of 18 December 2014 in Case C-364/13 International Stem Cell, EU:C:2014:2451; Judgment of the Court of 18