Abstract
To analyse these issues, Sect. 5.2 of this chapter examines the political, legal and economic context of the Commission’s proposal for a Directive on Patients’ Rights. Section 5.3 examines the content of the proposal against the background examined in Sect. 5.2. Section 5.4 traces the historical background, and Sect. 5.5 the troubled legislative history of the proposed Directive. Section 5.6 examines in greater detail three points of contention which have emerged as sticking points to achieving and an agreement in the Council: whether the EU has competence to legislate so broadly in the field of health care and what is the correct legal base to use; whether long-term health care (LTHC) should be included in the Directive, and in what circumstances can a Member State refuse to give prior authorisation for hospital medical care in another Member State and the range of institutions providing medical care which can be included in the Directive. Section 5.7 discusses the role of accountability and the role of law in the determination of rights which would flow from the adoption of the Directive. It also examines the role of accountability in the use of cooperative networks, which have been deployed for many years in this area but are now explicitly recognised in the draft proposal and will play an important role given the limited EU legislative competence in the field of health care and the need to treat certain emerging issues in a sensitive manner. Section 5.8 examines the different levels of impact the proposed Directive would have if it is ever adopted, and discusses whether the non-adoption of the Directive would be a lost opportunity.
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Notes
- 1.
COM (2008) 414 final. Available at: http://ec.europa.eu/health/ph_overview/co_operation/healthcare/docs/COM_en_OnlinePDF.pdf.
- 2.
Commission Communication of 2 July 2008 on the Renewed Social Agenda: Opportunities, Access and Solidarity in 21stEurope, COM (2008) 412 final.
- 3.
Joerges (2008), p. 291.
- 4.
The Treaty of Amsterdam 1997 raised the profile of public health issues by adding it to the list of activities of the Community in Article 3(1) (p) EC. The new Article 152 EC also mainstreamed a ‘high level of human health protection’ through Community policies.
- 5.
Words in italics denote changes made by the Treaty of Lisbon 2009.
- 6.
Seen in ECJ, Case 238/82 Duphar [1984] ECR 523 through to the most recent repetitions in ECJ, Case C-208/07 Petra von Chamier-Glisczinski [2009] ECR I-6095, para 63: ‘First of all, it follows, both from the case-law of the Court and from Article 152(5) EC, that Community law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the organisation and delivery of health services and medical care (Case C-169/07 Hartlauer [2009] ECR I-0000 (n.y.r.), para 29 and the case-law cited…)’ and ECJ, C-211/08 Commission v. Spain, judgment of 15 June 2010, paras 53 and 75.
- 7.
See the Communication from the Commission: Implementing the Community Lisbon programme: Social Services of General Interest in the European Union, COM (2006) 177, 26 April 2006, where the Commission distinguishes three broad categories of SSGI: (i) health services; (ii) statutory and complementary social security schemes; and (iii) other essential services provided directly to the person. The latter category becomes important in clarifying where health care mobility rights end where such services involve long-term care, see Mossialos and McKee (2002).
- 8.
In the academic literature, this has been called‘market citizenship’, see Everson (1995).
- 9.
See Szyszczak (2006), p. 486. On health care specifically, see the Special Edition ‘Health care and New Governance: The Quest for Effective Regulation’, 2.1. Regulation and Governance (2008).
- 10.
Statement on Common Values and Principles in EU Health Systems, Health Council 1 June 2006.
- 11.
- 12.
This is in contrast to the earlier case law where public services in education were excluded from the scope of Article 56 TFEU because the essential characteristic of payment for the service was not present: ECJ, Case 263/85 Belgian State v. Humbel [1988] ECR 5365, para 17.
- 13.
See the chapters by Pennings, Baquero Cruz and Newdick.
- 14.
Seen, for example, in ECJ, Case C-475/99 Firma Ambulanz Glöckner v. Landkreis Südwestpfalz [2001] ECR I-8089.
- 15.
See the chapters by Neergaard, de Vries, van de Gronden and Welti.
- 16.
In the original draft of the proposal Article 8(1)provided a definition of hospital care, a definition varying between the Member States and a matter neglected by the European Court of Justice. Hospital care would be defined as (a) health care which requires overnight accommodation of the patient for at least one night or (b) health care included in a specific list that does not require overnight accommodation of the patient. The list shall be limited to health care that requires use of highly specialised and cost-intensive medical infrastructure or medical treatment or health care involving treatments presenting a particular risk for the patient or the population. The concept becomes an EU law concept and the Commission would draw up the initial list of treatments covered by the concept of hospital care, updating it regularly. This seems a sensible approach given the experimentation with different kinds of health care delivery in the Member States. The draft also introduced a new concept of ‘specialised care’ which is not found in the case law. The new draft text does not contain this definition.
- 17.
- 18.
See the chapter by Pennings. Social security systems in the EU have been subject to coordination in the EU since 1971 to facilitate the free movement of workers and their families. Under Article 22 of Regulation 1408/71, workers and their families have an immediate right to emergency health care in another Member State and a right to elective health care subject to prior authorisation. See, however, ECJ, Case C-211/08 Commission v. Spain, judgment of 15 June 2010.
- 19.
The starting point is ECJ, Joined Cases 286/82 and 26/83 Graziana Luisi and Giuseppe Carbone v. Ministero de Tesoro [1984] ECR 377.
- 20.
Davies (2007), p. 158. See also Flear, who argues the free movement case law may also foster cross-border solidarity between patients fighting for certain forms of medical treatment as well as improve treatment in the home state by cutting waiting lists for treatment, allowing new forms of medical treatment to be delivered: Flear (2009).
- 21.
See Newdick (2006), p. 1645 and his chapter in this volume.
- 22.
Kostera (2007).
- 23.
Hatzopoulos (2002), p. 883.
- 24.
Newdick (2006), p. 1645.
- 25.
- 26.
The freedom to provide services and establishment under EU law allows foreign health care providers to enter and establish in a Member State but to date there is no European Court of Justice ruling on whether medical treatment provided in a private medical establishment can be reimbursed through a national health care system. At the national level see the claim in: European Surgeries Ltd v. Cambridgeshire Primary Care Trust [2007] EWHC 2758 (Admin).
- 27.
Szyszczak 2009a, b. The case law on the free movement of patients poses new challenges to legal theories of trans-national integration since the cases are concerned with ‘exit’ from the State of affiliation where the perceived barrier to free movement occurs. They require a different perspective from traditional views of ‘market access’ barriers, since in the reported cases the host State has not erected barriers to market entry. It is the State of affiliation which is compelled to open up the choice of traditional social welfare markets and take into account cross-border interests in the planning of its own social welfare provisions. Thus, it is easier for a service provider to enter the State of affiliation’s social welfare market through the agent of the patient which is easier and less costly than using the freedom of services and establishment rules of the EU to establish a presence in the State of affiliation. But cf., ECJ, Case C-211/08 Commission v. Spain, judgment of 15 June 2010.
- 28.
Seen in the different kinds of health care received abroad ranging from complex heart surgery (ECJ, Case C-444/05 Aikaterini Stamatelaki v. NPDD Organismos Asfaliseos Eleftheron Epangelmation [2007] ECR I-3185) to the less complex supply of spa services (ECJ, Case C-8/02 Ludwig Leichtle v. Bundesanstalt für Arbeit [2004] ECR I-2641).
- 29.
- 30.
On the same day as the original proposal for a Patients’ Rights Directive, the Commission also published a proposal to extend the equal treatment principle in the fields of social protection, social advantages, education and goods and services, including housing: European Commission, Proposal for a Council Directive on Implementing the Principle of Equal Treatment Between Persons Irrespective of Religion or Belief, Disability, Age, Sexual Orientation, COM (2008) 426. See also the chapter by Davies.
- 31.
See the most recent Public Consultation on Citizenship which will lead to a Commission Communication on Citizenship in October 2010. The President of the Commission, Barroso had set out political guidelines in September 2009 which included the need to give real effect to citizens’ cross-border rights by removing administrative and procedural obstacles. See: http://ec.europa.eu/citizenship/news/news1029_en.htm.
- 32.
- 33.
Proposal for a Council Directive of 2 July 2008 on implementing the principle of equal treatment between persons irrespective of religion or belief, disability, age or sexual orientation, COM (2008) 426.
- 34.
This is used here as a broad term embracing organised processes orchestrated in the EU framework as well as the coordination of various interested actors in multi-level networks, alongside communication tools used by the Commission in the publication of a range of official documents, pulling together legal and political documents and suggesting agendas for future evolution and development.
- 35.
Wincott (2001), p. 897.
- 36.
Cram describes the Commission as a ‘purposeful opportunist’ with the ability ‘to respond to opportunities for action as they present themselves and even to facilitate the emergence of these opportunities’, Cram (1994), p. 156.
- 37.
The first official documents were issued soon after The Treaty of Amsterdam was signed: Communication from the Commission on the development of public health policy in the European Community, COM (1998) final of 15 April 1998. A Community Action Programme in the field of public health was adopted in Decision No. 1786/2002/EC OJ 2002 L 271/1.
- 38.
This is an informal advisory body composed of ‘High Level’ officials from the Member States.
- 39.
ECJ, Case C-158/96 Raymond Kohll v. Union des caisses de maladie [1998] ECR I-1931.
- 40.
ECJ, Case C-120/95 Nicolas Decker v. Caisse de maladie des employés privés [1998] ECR I-1831.
- 41.
ECJ, Case C-157/99 BSM. Geraets-Smits v. Stichting Ziekenfonds VGZ and H.T.M. Peerbooms v. Stichting CZ Groep Zorgverzekeringenen [2001] ECR I-5473.
- 42.
See, for example, the linkage between health and economic growth in the Guidance Paper drawn up by DG SANCO, available at: http://ec.europa.eu/health/ph_overview/Documents/byrne_reflection_en_OnlinePDF.pdf.
Entitled ‘Enabling Good Health for all: A reflection process for a new EU health Strategy’ 15 July 2004. The then Commissioner, David Byrne states: ‘Health is closely intertwined with economic growth and sustainable development’ (p. 4) and ‘Europe needs a paradigm shift from seeing health expenditure as a cost to seeing effective health policies as an investment. Europe should look at what health puts into the economy and what illness takes out.’ (p. 6).
- 43.
High Level Reflection Group, High Level Reflection Process on Patient Mobility and Health care Developments in the European Union HLPR/2003/16, 9 December 2003. Communication from the Commission Follow-up to the high level reflection process on patient mobility and health care developments in the European Union COM (2004) 301 final.
- 44.
Available at: http://www.activecitizenship.net/content/blogcategory/32/77/.
- 45.
See the chapter by Pennings.
- 46.
Although the Court had made the point in ECJ, Case C-368/98 Vanbraekel [2001] ECR I-5363 and Kohll (supra n. 39) that in applying Article 56 TFEU there was no need to distinguish between hospital care and care outside of the hospital environment.
- 47.
An assumption settled by awkward reasoning in ECJ, Case C-372/04 The Queen ex parte Yvonne Watts v. Bedford Primary Care Trust and Secretary of State for Health [2006] ECR I-4325. See the discussion in the chapter by Baquero Cruz.
- 48.
See Press Release IP/10/505, ‘Patient Rights: Commission acts to protect patients’ rights in Spain, Slovakia and Denmark’ Brussels, 5 May 2010.
- 49.
A point developed by Robert Madelin, the then Director General of DG Sanco at a Conference on Patient Mobility Directive: Advance or Threat? organised by The Madariaga College of Europe Foundation on 29 April 2009. Conference summary available at: http://www.epha.org/a/3490.
- 50.
‘Patients Don’t Use Quality Measures When Choosing a Hospital’, The Kings Fund available at: http://www.kingsfund.org.uk/press/press_releases/patients_dont_use.html; Robertson and Dixon (2010).
- 51.
An example of this is seen in the UK where tabloid newspapers raise concerns over foreign doctors’ language ability and qualifications, see for example: Professor Sikora (2010).
- 52.
- 53.
A similar disparity is seen between aspiration and practical implementation in the UK where surveys show that respondents consider it important to have choice in hospitals where they may (potentially) be treated but in fact patients continue to use local facilities. See Choice and Competition in Public Services, Case Studies A Report Prepared for OFT by Frontier Economics, March 2010, OFT1214case.
- 54.
Communication from the Commission Follow-up to the high level reflection process on patient mobility and health care developments in the European Union, COM (2004) 301 final. See Press Release: P/04/508 21 April 2004.
- 55.
Regulation 883/2004/EC, OJ 2004 L 166/1.
- 56.
COM (2002) 119 on mutual recognition of professional qualifications.
- 57.
Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ 1995 L. 281/31.
- 58.
The EU was already supporting investments in health using the Structural Funds and the High Level Reflection Report called for EU funds to support health infrastructure and skills development, especially in the new Member States.
- 59.
Modernising 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’; Commission Communication The Future of Health care and Care for the Elderly: guaranteeing accessibility, quality, and financial viability COM (2001) 723 final. The soft law approach to coordination of social protection can be traced back to Council Recommendation 92/442/EEC, OJ 1992 L 245/49 on the convergence of social protection objectives and policies.
- 60.
- 61.
15 July 2004. Available at: http://ec.europa.eu/health/ph_overview/Documents/byrne_reflection_en_OnlinePDF.pdf.
- 62.
COM (2004) 2 final.
- 63.
See Rowland et al. (2004), p. 1200.
- 64.
Les Services Sociaux et de Santé d’Intérêt Général – Droits fondamentaux versus marché interieur?, Brussels, Editions Bruylant, 2006; Les Services Sociaux et de Santé d’Intérêt Général. Quel cadre communautaire pour les services sociaux d’intérêt général? Une contribution au debat communautaire’, Brussels Editions Bruylant 2006; Quatre notes de problematique techniques redigees a l’occasion de la conference ‘Droits fondamentaux protection social et integration europeene: Quel cadre communautaire pour les services sociaux d’intérêt general?’, Paris, 30 May 2006.
- 65.
OJ 2006 C 146/1.
- 66.
European Parliament Resolution of 23 May 2007 on the impact and consequences of the exclusion of health services from the Directive on services in the internal market (2006/2275(INI)).
- 67.
Communication from the Commission Consultation regarding Community action on health services, SEC (2006) 1195/4, 26 September 2006.
- 68.
Commission Communication of 2 July 2008, Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border health care presented by the Commission, COM (2008) 414 final.
- 69.
Ibid., at p. 22.
- 70.
Report on the Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border health care (COM (2008)0414-C6-0257/2008-2008/0142(COD) A6-0233/2009). The original Rapporteur for the proposal in the EP was John Bovis but, after the June 2009 European Parliament elections, a new Rapporteur from France, Françoise Grossetete, was appointed in September 2009 to steer the proposal through the final legislative processes in the European Parliament. The ESC delivered its Opinion on 2 December 2008 (SOC/322-CESE) and the Committee of the Regions delivered its Opinion on 12 February 2009 (CdR 348/2008 fin –DEVE-IV-032). The European Data Protection Supervisor delivered its Opinion on 2 December 2008 (16855/08).
- 71.
Public debates can be seen at: http://www.consilium.europa.eu/videostreaming.
- 72.
At the time of the original proposal the old Article 16 EC did not provide a legal base for legislation in the area of SGEIs, After the Treaty of Lisbon 2009, Article 14 TFEU allows the European Parliament and the Council to use the ordinary legislative procedure to enact ‘regulations’. See Szyszczak 2009a, b for suggestions of how health care as a SGEI could be regulated using this legal base.
- 73.
The reaction of national responses also ignores the problems faced by devolved and regional governments in the EU. For example, in Scotland, the devolved Scottish Parliament legislated (NHS (Scotland) Reform Act 2004) to abolish the English NHS market-oriented health care system and re-introduced an integrated public health care system for Scotland. This system does not use a system for determining costs of health care in advance and there is opposition to using commercial providers of health care in Scotland.
- 74.
- 75.
ECJ, Case C-377/98 Netherlands v. European Parliament and Council [2001] ECR I-7079, para 27.
- 76.
ECJ, Case C-165/87 Commission v. Council [1988] ECR 5545, para 11.
- 77.
ILO Convention C102 Concerning Minimum Standards of Social Security uses the following typology of social risks: medical care, sickness, unemployment, old age, employment injuries, maintenance of children, maternity, invalidity, loss of support as a result of the death of the breadwinner.
- 78.
European Commission, Joint Report 2008, p. 81.
- 79.
European Commission, Long-term Care in the European Union, 2008, available at: http://ec.europa.eu/employment_social/spsi/docs/social_protection/ltc_final_2504_en_OnlinePDF.pdf.
- 80.
Bulgaria, Greece, Hungary, Malta, Romania, Slovenia, United Kingdom.
- 81.
For example, in Spain LTC is defined as ‘… the situation of a person who, on account of age, disease or incapacity, and linked to lack or loss of physical, mental, intellectual or sensorial autonomy, requires assistance from (an)other person(s) or considerable help to carry out essential daily activities or, in the case of persons with a mental disability or illness, other forms of support for their personal autonomy.’ European Commission, supra n. 79.
- 82.
For example, LTC is defined in Cyprus as ‘… need of care due to mental or physical incapacity or social distress.’ European Commission, supra n. 79, p. 8.
- 83.
Mutual Information System on Social Protection in the EU Member States, the EEA and Switzerland.
- 84.
ECJ, Case C-70/95 Sodemare SA, Anni Azzurri Holding SpA and Anni Azzurri Rezzato Srl v. Regione Lombardia [1997] ECR 3395.
- 85.
Recital 9b COREPER draft of 26 November 2009. Article 2(2)(a) of the revised draft Directive.
- 86.
Cf., ECJ, Case C-208/07 Petra von Chamier-Glisczinski v. Deutsche Angestellten-Krankenkasse [2009] ECR I-0000 (n.y.r.). The dispute concerned the application of the social security Regulation 1408/71/EC but the claimant brought into play Articles 21, 45 and 56 TFEU. The Court ruled that where a person moves to a Member State on a permanent basis the claim for the provision of services does not fall within Article 56 TFEU since this Treaty measure is designed to cover situations where the provider or recipient of the services is based in another Member State on a temporary basis.
- 87.
See the chapter by Baquero Cruz.
- 88.
Recital 31d of COREPER November 2009 draft.
- 89.
Article 8(1). Cf., the ruling pending in ECJ, Case C-173/09 Elchinov v. Natsionalna zdravnoosiguritelna kasa, Opinion of Advocate General Cruz Villalón of 10 June 2010.
- 90.
- 91.
See ECJ, Case C-169/07 Hartlauer Handelsgesellschaft mbH v. Wiener Landesregierung, Oberösterreichische Landesregierung, judgment of 10 March 2009, discussed in the chapter by Baeten and Palm.
- 92.
‘Quality’ of health care is a difficult concept to quantify since a patient will be concerned with the quality of the clinical treatment provided and the quality of their experience of the medical system, especially where the treatment involves in-patient care in a hospital (for example, the cleanliness of the hospital, the food, the attitude of the medical staff). The use of performance indicators in the UK NHS has shown that the use of observable indicators may not capture unobservable factors which are important for the patient experience. If certain indicators are given preference over others, then there is an incentive for the institution to concentrate on the quality of only these indicators. By creating performance tables for public services the use of statistical analysis may be have an impact for the institution concerned, such as a hospital, but even small variations in the use of the indicators may also alter the position of an institution in league tables, bringing with it a lack of confidence in the potential consumers of its services. See Jacobs and Goddard (2007), p. 103; Propper (2008), p. 138.
- 93.
See Hervey and Vanhercke (2010).
- 94.
In Chapter IV titled ‘Cooperation in Healthcare’.
- 95.
- 96.
A good example is the EU programme to coordinate research in rare diseases: Decision No 1295/1999/EC of the European Parliament and the Council of 29 April 1999, adopting a programme of Community action on rare diseases within the framework for action in the field of public health, OJ 1999 L 155/1.
- 97.
- 98.
Thatcher and Coen (2008), p. 56.
- 99.
Piccioto (1996/1997), p. 1014.
- 100.
See for example, Fisher (2004), p. 495.
- 101.
In this sense, ‘Europeanisation’ is used to denote the movement away from national competence and processes to EU-level regulation.
- 102.
Radaelli (2009).
- 103.
European Parliament Report A6-0233/2009, p. 76.
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Acknowledgments
My thanks to comments on a draft of this chapter from the University of Leicester CELI Internal Market research cluster and participants at the conference ‘Health Care and EU Law’ at Nijmegen University in October 2009.
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Szyszczak, E. (2011). Patients’ Rights: A Lost Cause or Missed Opportunity?. In: van de Gronden, J., Szyszczak, E., Neergaard, U., Krajewski, M. (eds) Health Care and EU Law. Legal Issues of Services of General Interest. T.M.C. Asser Press, The Hague. https://doi.org/10.1007/978-90-6704-728-9_5
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