The directive on cross-border healthcare or theart of codifying complex case law

Common Market Law Review

Volumn 49, Issue 1, 2012, Pages 15-46

  De La Rosa, Stephane ^a  

^a UNIVERSITÉ DE VALENCIENNES   (France)

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EID: 84859041828     PISSN: 01650750     EISSN: None     Source Type: Journal    
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References (115)

1. Translated from French. The speech, and the documents related to the European Health Community project, are available on the archive site presently transferring to .
2. Art. 36(2) TFEU (ex Art. 30 EC).
3. "le Pool blanc"was the original name.The proposals moved to the Council of Europe, but never advanced.
4. Directive 2011/24/EU of the European Parliament and of the Council of 9 Mar. 2011 on the application of patients' rights in cross-border healthcare, O.J. 2011, L 88/45. There is already a body of literature commenting on this directive.
5. See De Grove Valdeyron, "La directive sur les droits des patients en matière de soins de santé transfrontaliers. Véritable statut juridique européen du patient ou simple clarification d'un régime de mobilité?", 47 RTDE (2011), 299.
6. Under Art. 3(2) TEU, the Union "shall combat social exclusion and discrimination, and shall promote social justice and protection, equality between women and men, solidarity between generations and protection of the rights of the child".
7. Lernould, "La libre circulation du patient eu Europe", (2008) Les Petites Affiches, No. 120.
8. On the principle of territoriality, see Cornelissen, "The principle of territoriality and the Community regulations on social security", 33 CML Rev. (1996), 439-471.
9. Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, O.J. 2004, L 166/1.
10. On this regulation, see Hermesse, Lewalle and Palm, "Patient mobility within the European Union", 7 European Journal of Public Health (1997), 4-10.
11. In cases of a temporary stay in a Member State other than the Member State of affiliation, Art. 19(1) of Regulation 883/2004 guarantees support, by the latter, for in-kind sickness benefits following the scale employed in the State of stay, as soon as such benefits become necessary on medical grounds during the stay, taking into account the type of benefits and the expected length of stay. On this point, the revision of Regulation 1408/71 by Regulation 883/2004 has relaxed the conditions of support by replacing the criterion of the need for care, with the criterion of the urgency of the care. However, when an insured person visits another Member State specifically to receive in-kind sickness benefits (Art. 20(1)), the patient must seek prior approval from the competent institution. If approved, the benefits are provided, on behalf of the competent institution, by the institution of the country of stay as laid down by its law, as if the person was insured under that legislation.
12. Case C-158/96, Raymond Kohll v. Union des caisses de maladie, [1998] ECR I-1931; Case C-120/95, Nicolas Decker v. Caisse de maladie des employés privés, [1998] ECR I-1831.
13. See Hatzopoulos, "Health law and policy: The impact of the EU" in De Burca (Ed.), EU Law and the Welfare State: In search of solidarity (OUP, 2005), pp. 123-160.
14. Palm and Glinos, "Enabling patient mobility in the EU: Between free movement and coordination", in Mossialos, Permanand, Baeten and Hervey (Eds.), Health Systems Governance in Europe (Cambridge University Press, 2010), p. 509.
15. In this sense, A.G. Geelhoed stated in his Opinion in theWatts case (cited infra note 20), para 125: "The Court has thus struck a balance between, on the one hand, the freedom, in principle, of patients to receive hospital services in other Member States and, on the other hand, the budgetary concerns of the Member States resulting from persons going outside the national system of health care and health insurance".
16. There is already abundant literature on this topic, for instance Ferrera, The boundaries of welfare: European integration and the new spatial politics of social protection (OUP, 2005), p. 299.
17. For specific studies on healthcare, see Fosse, "Different welfare States: Different policies? An analysis of the substance of national health promotion policies in three European countries", 41 International journal of health services (2011), 255-272.
18. Martisen, "The Europeanization of welfare: The domestic impact of intra-European social security", 43 JCMS (2005), 1027-1054.
19. Van der Mei, "Cross-border access to medical care within the European Union: Some reflections on the judgments in Decker and Kohll", 5 MJ (1998), 277.
20. Nourissat, "Quand Panacée rejoint Europe, ou comment la Cour de justice consacre la liberté des soins dans la Communauté", (1999) La semaine juridique (ed. gén.), II 10002.
21. Lernould, "Une caisse de sécurité sociale est-elle tenue de rembourser les frais médicaux engagés par un assuré dans un autre Etat membre?", Revue de droit sanitaire et social (1998), 616
22. The Decker decision is concerned with the mobility of patients in an ancillaryway, since has to do with the applicability of the free movement of goods to the reimbursement of a pair of glasses bought in a Member State (in this case Belgium) other than the patient's Member State of affiliation (Luxembourg)
23. Joined Cases 286/82 & 26/83, Luisi et Carbone, [1994] ECR 377, para 16; Case C-238/82, Duphar, [1984] ECR 523; Case C-159/90, Society for the Protection of Unborn Children Ireland v. Grogan, [1991] ECR I-4685, para 18.
24. Such reasoning reflects the Court's broad interpretation of the concept of restriction on the freedom to provide services; this interpretation has the effect of broadening the material scope of the freedom of movement. Since the Säger case (Case C-76/90, Säger, [1991] ECR I-4221), it is settled case law that Art. 49 EC (now 56 TFEU) requires the abolition of any restriction, even if it applies without distinction to national providers of services and to those of other Member States, if it is liable to prohibit, impede or render less attractive the activities of a provider of services established in another Member State where he lawfully provides similar services.
25. For a reminder in a recent case, see Case C-173/09, Georgi Ivanov Elchinov v. Natsionalna zdravnoosiguritelna kasa, judgment of 5 Oct. 2010, nyr, para. 44.
26. Case C-157/99, Geraets-Smits v. Stichting Ziekenfonds and Peerbooms v. Stiching CZ Groep Zergverzekeringen, [2001] ECR I-5473.
27. Case C-372/04, The Queen, ex parte Yvone Watts v. Bedford Primary Care Trust and Secretay of State for Health, [2006] ECR I-4325.
28. See the comment by Azoulai, "En attendant la justice sociale, vive la justice procédurale! A propos de la libre circulation des patients dans l'Union (CJCE 16 mai 2006,Watts, aff. C-372/04)", (2006) Revue de droit sanitaire et social, 843-85.
29. Case C-444/05, Stamatelaki, [2007] ECR I-3185
30. Case-385/99, Müller-Fauré v. Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen and van Riet v. OnderlingeWaarborgmaatschappij ZAO Zorgverzekeringen, [2003] ECR I-4509; more recently Case C-255/09, Commission v. Portugal, judgment of 27 Oct. 2011, nyr, para 74.
31. See Art. 3(a) of the Directive, which defines healthcare as "services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices". However, the Directive does not apply to personal assistance services or long-term care allowing the person in need of care to live as fully and as independently as possible. This definition is consistent with the position of the Court, which believes that a spa centre cannot be considered a hospital, see Case C-8/02, Leichtle, [2004] ECR I-2641. Similarly, the Directive does not apply to care provided through public vaccination programs against infectious diseases, which are subject to specific planning measures (Art. 1(2)(c)).
32. Lewalle, Palm, "Quel est l'impact de la jurisprudence européenne sur l'accès aux soins à l'intérieur de l'Union européenne?", Rev. Belge Sécurité Sociale, (2001), 435.
33. Van der Mei, "Cross-border access to health care within the European Union: Some reflections on 'Geraets-Smits and Peerbooms' and 'Vanbraekel'", 9 MJ (2002), 189-213
34. For a comprehensive overview of all the above cases see Hatzopoulos, "Killing national health and insurance systems but healing patients? The European market for health care services after the judgments of the ECJ in Vanbraekel and Peerbooms", 39 CML Rev. (2002), 683-729.
35. Mossialos and McKee, "Health care and the European Union: Profound but uncertain consequences for national health systems", (2002) British Medical Journal, 991
36. It should be noted that there few evaluations of the cost of cross-border care. The figure of 1% was put forward by the Commission at the launch of its consultation regarding Community action on health services. See Communication from the Commission of 26 Sept. 2006, SEC(2006)1195/4, 6. The Commission itself acknowledges that this figure is very approximate.
37. Case C-202/97, Fitzwilliam Executive Search Ltd v. Bestuur van het Landelijk instituut sociale verzekeringen, [2000] ECR I-883, para 20.
38. Case C-15/81, Gaston Schul Douane Expediteur BV, [1982] ECR 1409, para 33.
39. Case C-56/01 Inizan, [2003] ECR I-12403.
40. In this case, the granting of an authorization to receive hospital treatment outside the Member State of affiliation generally allows the patient to avoid prepaying the costs. These are assumed by the institution of the State in which the healthcare is received, under the provisions of applicable legislation. The latter institution is fully reimbursed by the institution of affiliation. In this situation, the patient must pay the share of healthcare costs that the laws of the host country assigns to insured persons.
41. Newdick, "Citizenship, free movement and health care: Cementing individual rights by corroding social solidarity", 43 CML Rev. (2006), 1645-1658.
42. A bulk of studies has been carried on this discrepancy. See, among many studies, Scharpf, "The European social model: Coping with the challenges of diversity", 40 JCMS (2002), 645-670.
43. Davies, "The process and side-effects of harmonization of the European welfare state", Jean MonnetWorking Paper, No. 02/06.
44. De Burca, EU Law and theWelfare State: In search of solidarity, (OUP, 2005), p. 250.
45. This is, moreover, an extension that has been criticized on the grounds that the Court had no legitimacy to challenge the exercise by States of their competence in health and social.
46. See Fuchs, "Free movement of services and social security - Quo Vadis?", 8 ELJ, (2002), 536-555
47. In addition, this trend toward extension is all the more marked since it is concomitant with the development of case law on access to social benefits by EU citizens exercising their right to mobility on the ground of citizenship rights.
48. On this evolution, see Azoulai, "La citoyenneté européenne, un statut d'intégration sociale", in Chemins d' Europe: Mélanges en l'honneur de J-P. Jacqué (Dalloz, 2010), p. 1-28.
49. Namely, the planning requirements related to the objective of ensuring, on the territory of the State, sufficient and permanent access to a balanced range of high quality care, the will to ensure cost control and avoid waste of financial, technical and human resources, and the preservation of treatment capacity or medical competence on national territory. These reasons are noted in recital 12 of the Directive.
50. See Art. 8 of the Directive, Healthcare that may be subject to prior authorization.
51. Follow-up to the High Level Process of Reflection on patient mobility and healthcare developments in the European Union, COM(2004)301 of 30 April 2004; Consultation regarding Community action on health services, SEC(2006)1195/4, 26 Sept. 2006.
52. See Commission, Modernizing social protection for the development of high-quality, accessible and sustainable health care and long-term care: support for the national strategies using the "open method of coordination", COM(2004)304 final, 20 April 2004.
53. Hervey, "The European Union and the governance of health care" in De Burca and Scott (Eds.), Law and New Governance in the EU and the US (Hart Publishing, 2006).
54. The inclusion of healthcare regulation in a legal framework had also become necessary as few Member States had integrated in their national systems the Court's case law on patients' mobility. See the conclusions of the working document, Commission staff working paper, Report on the application of internal market rules to health services. Implementation by the Member States of the Court's jurisprudence, SEC(2003)900, 28 July 2003.
55. See Baeten, "The potential impact of the services directive on health care services", in Nihoul and Simon (Eds.), L'Europe et les soins de santé, (Larcier, 2005), pp. 239-261.
56. Van den Abeele, "Adoption of the Service Directive:A Community big bang or a velvet revolution?", in Degryse and Pochet (Eds.), Social developments in the European Union (Observatoire social européen, Brussels, 2007), pp. 127-159.
57. See the Report on patient mobility and healthcare developments in the European Union (rapporteur John Bowis), A6-0129/2005.
58. Directive 2006/123/EC of the European Parliament and of the Council of 12 Dec. 2006 on services in the internal market,O.J. 2006, L 376/36.
59. On the social dimensions of the Services Directive, see Neergaard, Nielsen and Roseberry (Eds.), The Services Directive: Consequences for theWelfare State and the European Social Model (DJØF Publishing, 2008).
60. Proposal for a Directive of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare, COM(2008)414 final.
61. A blocking minority had been formed around Spain, supported by Portugal, Poland, Romania, Lithuania, Slovakia and Greece. The reasons given were both the risk to the quality of the care and the additional cost that would be borne by the national health system if they implemented the Directive. Those countries, most of whose health systems were entirely public, feared the development of medical tourism that could hurt their economy.
62. At first reading, the European Parliament defended the principle of automaticity of prior authorization for non-hospital care and, by way of exception, the Member State could provide for a system of prior authorization for reimbursement of hospital care which can be given only within a medical infrastructure and which normally requires the accommodation of the patient. See Report on the proposal for a directive on the application of patients' rights in cross-border healthcare, 3.4.2009, A6-0233/2009.
63. According to the ECJ, the choice of legal basis is not a subjective one, but "must be based on objective factors which are amenable to judicial review" (Case 45/86, Commission v. Council, [1987] ECR 1439, para 5), such as the aim and content of the measure in question.The decisive factor should be the main object of a measure. Moreover, a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article (Case C-491/0, British American Tobacco (Investments) and Imperial Tobacco, [2002] ECR I-11453, paras. 93-94). The use of Art. 268 TFEU (ex 152 EC) as the sole legal basis would have been inappropriate as this Article excludes any harmonization of the laws and regulations of the Member States when it comes to incentive measures to protect and improve human health.
64. It also involved a recommendation for amendments formulated by the Committee of the Regions. See Committee of the Regions on "cross-border healthcare", O.J. 2009, C 120/65.
65. The text abounds in oft-repeated references to the need to preserve the competence of the States, both in the recitals (e.g. recitals 7, 10, 18, 33) and in the body of the Directive. See Art. 1(1): "This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies [sic] in organizing and delivering healthcare" and Art. 1(4): "This Directive shall not affect laws and regulations in Member States relating to the organization and financing of healthcare in situations not related to cross-border healthcare".
66. The Directive has at least 64 recitals, which is clearly an excess of justification considering the requirements set by the Court of Justice. This overabundance of justifications is probably a characteristic of directives seeking to codify developments from case law, as it is also found in Directive 2006/123/EC on services in the internal market (118 recitals). One should regard them as an expression of the compromises inherent in any attempt to codify case law principles that lawmakers seek to supplement and refine. This excess of justification does not facilitate the readability of the Directive, nor provide a clear articulation between the objectives and the provisions.
67. See Section 5.1 infra.
68. Namely, the "Member State on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established" (Art. 3(d)).
69. I.e. the Member State that is competent to grant to the insured person a prior authorization to receive appropriate treatment outside the Member State of residence according to Regulations (EC) No 883/2004 and (EC) No 987/2009 (Art. 3 (c)).
70. Art. 8(2)(b) and (c). See Section 5.1.
71. To this end, The Commission has launched a public consultation on measures for improving the recognition of prescriptions issued in another Member. The synthesis of the consultation should be presented during the spring of 2012.
72. This is the meaning of Recital 33: "this Directive does not aim to create an entitlement to reimbursement of the costs of healthcare provided in another Member State, if such healthcare is not among the benefits provided for by the legislation of the Member State of affiliation of the insured person"
73. Case C-211/08, European Commission v. Kingdom of Spain, [2010] ECR I-5267.
74. Art. 8(5). This is a legislative confirmation of Elchinov, cited supra note 18. In that decision, the Court stated that the assessment of the unavailability of treatment, which requires the institution of affiliation to issue an authorization, must be assessed on a case-by-case basis and not by general categories of care.
75. Art. 4(4), para 3: "The Member State of affiliation may decide to reimburse other related costs, such as accommodation and travel costs, or extra costs which persons with disabilities might incur due to one or more disabilities when receiving cross-border healthcare, in accordance with national legislation and on the condition that there be sufficient documentation setting out these costs".
76. Case C-466/04, Acerada Herrera v. Servicio Cántabro de Salud, [2006] ECR I-5341. The coverage is limited to the costs of medical services, in the strict sense of the term, and to the intrinsically related expenses of the stay and meals in the hospital. However, it does exclude other connected accommodation and travel expenditures.
77. Art. 8(3): "With regard to requests for prior authorization made by an insured person with a view to receiving cross-border healthcare, the Member State of affiliation shall ascertain whether the conditions laid down in Regulation (EC) No 883/2004 have been met. Where those conditions are met, the prior authorization shall be granted pursuant to that Regulation unless the patient requests otherwise". See also Recital 31: "Patients should not be deprived of the more beneficial rights guaranteed by the Union Regulations on the coordination of social security systems when the conditions are met".
78. Implementing regulation No. 987/2009 (which implements the solutions provided for in Regulation No. 883/2004) upholds the principle that the reimbursement of a patient who has sought prior authorization should be based on the rates of the State providing the care. But it also offers an alternative to insured persons by allowing them to be reimbursed according to the rates of the State of affiliation. Here, the Regulation followed in the footsteps of the Court, by allowing a refund based on methods identified in the Kohll and Smits Peerbooms cases.
79. See Lernould, "Les nouvelles règles de coordination pour les soins de santé, 'Tout va très bien, Madame la marquise' ", (2010) Revue de droit sanitaire et social, 29-45.
80. Hatzopoulos and Do, "The case law of the ECJ concerning the free provision of services: 2000-2005", 43 CML Rev. (2006), 923-991.
81. The Court regularly underlined that the prior authorization scheme, on the ground of the Regulation or on that of the free provision of services, must be based on a procedural system which is easily accessible and capable of ensuring that a request for authorization will be dealt with objectively and impartially within a reasonable time, and refusals to grant authorization must also be capable of being challenged in judicial or quasi-judicial proceedings (Smits et Peerbooms, cited supra note 19, para 90 and Inizan, cited supra note 34, para 48, for a case related to the implementation of the Regulation).
82. Thus, one can easily compareArt. 8 of the Directive on cross-border care andArts. 9 and 10 of the Services Directive. These provisions hold, in fact, that the criteria governing systems of prior authorization pertaining to the exercise, in a Member State, of a service activity should be (i) non-discriminatory, (ii) justified by overriding reasons of general interest, (iii) proportionate to that goal, (iv) clear and unambiguous, (v) objective, (vi) made public in advance, (vii) transparent and (viii) accessible.
83. See Recitals 5 and 21 in which reference is made to "a set of values and principles shared by all of the Union with regard to how the health system meets the needs of the population and patients for whom they have responsibility. The fundamental values include universality, access to good quality care, equity and solidarity". These values are identified by reference to the "Council conclusions on values and principles common to European Union health systems", O.J. 2006, C 146/1. Those conclusions, in spite of their declaratory dimension, gave an impetus to European social legislation by setting a core of common references.
84. Thus, see Art. 35 of the Charter of Fundamental Rights on the protection of health: "Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices.Ahigh level of human health protection shall be ensured in the definition and implementation of all the Union's policies and activities". It should be noted that the Charter does not recognize per se a right to health assured by EU law but, rather, a principle of access to health based on to national legislation.
85. This reflects the scope of Art. 9 TFEU: "In defining and implementing its policies and activities, the Union shall take into account requirements linked to the promotion of a high level of employment, the guarantee of adequate social protection, the fight against social exclusion, and a high level of education, training and protection of human health".
86. See Recital 43, "the refusal to grant prior authorization may not be based on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities, without carrying out an objective medical assessment". On the contrary, a medical-based waiting list can be admitted. See Art. 8(6)(d) which underlines that the Member State of affiliation may refuse to grant prior authorization when the care can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.
87. In essence, the Directive refers to the institutional autonomy of States to determine measures for their operation. The States are free to establish the scope of these centres, their possible connection to a public hospital, as well as their association with the contact points set up as part of the transposition of the Services Directive. More detailed provisions might have been viewed as an infringement of the competence of the States.
88. Part of the academic literature already stressed the importance of the information to be transmitted to the patient.
89. Davies, "The Community's international market-based competence to regulate healthcare: Scope, strategies and consequences", 14 MJ (Special issue: the impact of migration on healthcare systems in the European Union) (2007), 215-238.
90. See Opinion of the European Data Protection Supervisor on the proposal for a Directive on the application of patient's rights in cross-border healthcare, O.J. 2009, C 128/3.
91. See Art. 2 TEU: "The Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail". The inclusion of values in primary legislation reflects a desire to give ontological significance to the European Union.
92. Solidarity in health: Reducing health inequalities in the European Union, COM(2009)567 final, 20 Sept. 2009.
93. In general, the reference to solidarity in EU law has several meanings. It is, first, a justification to preserve a core of national redistribution policies by excluding the qualification of undertaking (and thus the applicability of competition rules) to organizations that operate on the basis of solidarity mechanisms. Here is the meaning of solidarity that can be deduced from cases such as Poucet and Pistre, FENIN and CISAIL. Furthermore, the solidarity dimension of certain entities may justify the application of rules on services of general interest, assuming they are to be considered as undertakings, and granting them an exemption under Art. 106(2)TFEU. But solidarity can also provide foundation support for political and social action across the Union. It conveys the sense of recognizing the role of services of general interest, particularly health and social services of general interest. For several years, the institutions have been trying to promote recognition of this category, which has no real equivalent in national laws, by adapting the application of primary or secondary law to the specificity of these services. Protocol 26 on services of general interest is a good illustration of this momentum. But it is an incomplete recognition, since the EU does not have regulatory powers to implement genuine solidarity policies.
94. On the role of solidarity in EU law, see Ross, "Promoting Solidarity: From public services to a European model of competition", 44 CML Rev. (2007), 1057-1080.
95. Boeger, "Solidarity and EC competition law" 32 EL Rev. (2007), 319-340.
96. Boutayeb (Ed.), La solidarité dans l'Union européenne (Dalloz, 2011), which looks at the concept in a cross-cutting manner.
97. Recital 5.
98. One could very well imagine language assistance to patients who, for lack access to specialized or technical care in their territory, might benefit from cross-border care.Without a targeted training of patients, one is obliged to believe that mobility will benefit those among them who are sufficiently enlightened.
99. See e.g. the Court's decisions related to the rules of establishment for pharmacists. Apothekerkammer des Saarlandes, cited supra note 39 (prohibition of foreign ownership of pharmacies) and Case C-531/06, Commission v. Italy, [2009] ECR I-4103 (national rules reserving the ownership of pharmacies for pharmacists or legal entities consisting of pharmacists); also the case law related to the requirement of an authorization to set up a private outpatient clinic for dental medicine, see Case C-169/07 Hartlauer Handelsgesellschaft GmbH v Wiener Landesregierung and Oberösterreichische Landesregierung, [2009] ECR I-1721.
100. Hancher and Sauter, "One step beyond? From Sodemare to DocMorris: The EU's freedom of establishment case law concerning healthcare", 47 CML Rev. (2010), 117-146.
101. These reasons are also listed in Art. 4(3) under Responsibilities of the Member State of Treatment.
102. As mentioned above,Art. 3 of the Directive, concerning the definitions of terms used in the Directive, does not include a definition of hospital care. Such a definition is nevertheless essential because it is what determines the possibility of a prior authorization. The latter is derived from Art. 8(2)(a)), which links hospital care to an overnight stay (at least one night) in a hospital.
103. Case C-512/08, Commission v. France, judgment of 5 Oct. 2010, nyr.
104. See Boutayeb and Raccah, "Les soins médicaux envisagés dans un cabinet de ville d'un autre Etat membre requièrent une autorisation préalable", (2011) Revue de droit sanitaire et social, 67-77.
105. Disputes are indeed to be expected in the event that prior authorization is denied for the purposes of obtaining care from a practitioner whose quality of care raises concerns, even though this care may meet the requirements of directives.
106. Namely, in cases where (1) a clinical examination reveals with sufficient certainty that the patient will be exposed to a patient-safety risk (Art. 8(6)(a)), (2) valid reasons suggest that the public will be exposed to a considerable safety risk (Art. 8(6)(b)), or (3) a health care provider raises serious concerns (Art. 8(6)(c)), health care may be provided within a medically acceptable period (Art. 8(6)(d)).
107. To be specific, "measures in the veterinary and phytosanitary fields" and "measures setting high standards of quality and safety for medicinal products and devices for medical use" (Art. 168(4) TFEU).
108. This promotion may take the form of an open method of coordination. The powers attached to this type of competence are limited: coordination instruments can, at the very most, allow no contradiction between national policies (in the absence of a real consistency) but they do not guarantee, as such, the extension of mechanisms of solidarity to citizens beyond national communities. See Art. 168(2) TFEU, 2nd para, which identifies the main characteristics of an OMCprocess: "The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organization of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation. The European Parliament shall be kept fully informed".
109. On this method for health care, see de La Rosa, La méthode ouverte de coordination dans le système juridique communautaire (Bruylant, 2007), p. 126.
110. Trubek and Hervey, "Freedom to provide health care services within the EU: An opportunity for 'hybrid Governance'", 13 CJEL (2007), 623-648.
111. For a critical appraisal of the use of governance theory, see Dawson, "Three waves of new governance in the European Union", 26 EL Rev. (2011), 208.
112. On the application of OMC to care, see also Mark, "The Open Method of Coordination on health care after the Lisbon Strategy II: Towards a neoliberal framing?" in Kröger and Sandra (Eds.), What we have learnt: Advances, pitfalls and remaining questions in OMC research, European Integration online Papers (EIoP), Special Issue 1, Vol. 13, Art. 12, .
113. Provided for by Art. 160 TFEU, The Committee on Social Protection plays a key role in the monitoring of OMC implementation. In particular, the Committee plays a central role in preparing the discussion in the Council on the annual Joint Report on Social Protection and Social Inclusion. One of its tasks is to promote exchanges of information, experience and good practice between the Member States and the Commission.
114. Moreover, the Directive does not allow the adoption of common indicators, which are essential for social inclusion OMC.
115. See Armstrong, Governing social inclusion (OUP, 2010), p. 64.