REPORT on the impact and consequences of the exclusion of health services from the Directive on services in the internal market
10.5.2007 - (2006/2275(INI))
Committee on the Internal Market and Consumer Protection
Rapporteur: Bernadette Vergnaud
MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION
on the impact and consequences of the exclusion of health services from the Directive on services in the internal market
The European Parliament,
– having regard to Articles 16, 49, 50, 95(1) and 152 of the EC Treaty,
– having regard to Article 35 of the Charter of Fundamental Rights of the European Union;
– having regard to the judgments of the Court of Justice of the European Communities of 28 April 1998 in Cases C-120/95, Decker/Caisse de maladie des employés privés[1] and C‑158/96, Kohll/Union des caisses de maladie[2], of 12 July 2001 in Cases C-157/99, Geraets-Smits and Peerbooms[3] and C-368/98, Vanbraekel and others[4], of 25 February 2003 in Case C-326/00, IKA[5], of 13 May 2003 in Case C-385/99, Müller-Fauré and Van Riet[6], of 23 October 2003 in Case C-56/01, Inizan[7], of 18 March 2004 in Case C-8/02, Leichtle[8], and of 16 May 2005 in Case C-372/04, Watts[9],
– having regard to Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market[10], in particular Article 2(2)(f), and recitals 22 and 23,
– having regard to the Commission communication of 26 September 2006 entitled ‘Consultation regarding Community action on health care services’ (SEC(2006)1195/4),
– having regard to its resolution of 9 June 2005 on patient mobility and healthcare developments in the European Union[11],
– having regard to the Council Conclusions on common values and principles in European Union health systems[12],
– having regard to Article 152(5) of the Treaty, enshrining the subsidiarity principle with regard to health care, and having regard to Council Regulation (EC) 1408/71 of 14 June 1971, on the application of social security schemes to employed persons and their families moving within the Community[13], European Parliament and Council Regulation (EC) 883/2004 on coordination of social security systems[14], and Article 49 of the Treaty,
– having regard to Rule 45 of its Rules of Procedure,
– having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on Employment and Social Affairs and the Committee on the Environment, Public Health and Food Safety (A6‑0173/2007),
A. whereas the Member States are responsible for organising, managing, delivering and financing health-care systems, which are different in every Member State,
B. whereas the Court of Justice of the European Communities has handed down a number of judgments, such as on the issues of access to health care, the settlement of criteria for prior authorisation procedures or for reimbursement of costs, and authorising EU citizens to move freely in order to find health care in another Member State,
C. whereas, in its conclusions of 1 to 2 June 2006, the Council adopted a statement by the 25 Health Ministers of the European Union about the common values and principles that underpin Europe’s health systems[15],
Principles
1. Considers that cross-border mobility of patients and health professionals will increase in future, thus giving patients more choice; considers that, whatever their level of income or place of residence, all European citizens should be guaranteed equal and affordable access to health care in due time, in accordance with the principles of universality, quality, safety, continuity, solidarity, thus contributing to the social and territorial cohesion of the Union while ensuring the financial sustainability of national health-care systems; considers that in accordance with those principles, the mobility of patients and professionals may contribute to improving accessibility and quality of health care;
2. Notes that the Member States do not sufficiently promote health care, as a result of which patients’ rights are restricted;
3. Recalls that the Member States that have implemented the existing case law of the European Court of Justice have not experienced any major increase of health-care budgets as a result of patients’ mobility;
4. Takes into account that the Member States may only introduce a system of prior authorisation once it has been proven that cross-border movement of patients has a negative effect on the financial balance of the national health budget; urges Member States to take note of the possibility to implement a test period during which no prior authorisation is used;
5. Stresses that access to cross-border care is required to achieve the free movement of citizens within the Community and helps raise employment and competitiveness levels in Member States;
6. Stresses the need to cut red tape connected with both the use and provision of cross-border health services;
7. Notes that, in order to cut the red tape relating to the use of cross-border health services, it is necessary to improve the electronic systems of patient identification and patient claims for reimbursement;
8. Invites the Commission to encourage the Member States to actively support the introduction of E-Health and telemedicine;
9. Points out that, in accordance with the provisions of the Treaty, the Member States retain primary responsibility for providing efficient and high quality health care to their citizens; stresses that, to this end, they should be able to use the appropriate regulatory tools, at an EU level as well as at multilateral and bilateral levels, to manage their national health-care systems and health authorities and, in exercising that power, they must always respect the provisions of the Treaties and the subsidiarity principle;
10. Points out that the situation of legal uncertainty in which health services currently find themselves is unsatisfactory, and that Court of Justice decisions with regard to individual cases cannot suffice to formulate a policy on health services;
11. Emphasises that Treaty rules, including the specific provisions on services of a general economic interest as well as the jurisprudence of the ECJ, apply to health services and stresses that health-service providers are fully entitled to establish and to provide services in any Member State, following national and EU rules; equally emphasises that patients are fully entitled to seek health care in any Member State;
12. Notes that, whilst health-care systems are not within the competence of the Community, issues relating to health-care systems, such as access to medicines and treatments, patient information, and the movement of insurance companies and health professionals, have a cross-border character; notes that those issues need to be addressed by the European Union;
13. Points out that in any case patients must be able to have equal access to appropriate treatment as close as possible to their home and in their own language; considers that Council Directive 89/105/EEC of 21 December 1988[16] on transparency should be better applied, so that medicines would be placed on the market more quickly, innovation and safety of medicines would be supported and use of the centralised procedure for marketing authorisation more strongly promoted;
14. Stresses that Member States should treat residents of another Member State on an equal basis with regard to access to health services, regardless of whether they are private or public patients;
15. Points out that patients should have access to information on which the health-care provider has obtained international accreditation and that the accredited providers of the health care should, regardless of where they are in the EU, ensure that health care is safe, based on measurable international indicators of quality;
16. Maintains that any policy initiative relating to health services should, as far as possible, be the subject of parliamentary law-making rather than being pursued on an ad hoc basis through rulings of the Court of Justice;
17. Is of the opinion that patients’ safety and rights are not ensured in the cross-border provision of health care at present and that legal uncertainty exists regarding reimbursement mechanisms, obligations on national authorities to share regulatory information, the duty of care for both the initial and follow-up treatment and the risk management provisions for private patients;
Definitions
18. Requests a clear definition of health services; and clarification of which elements of a health-care system are relevant in this context;
19. Notes that health-care services pursue objectives comparable to other social services of general interest in the sense that they are based on the principle of solidarity, are often embedded in national social protection systems, are person-centred, ensure that citizens can enjoy their fundamental rights and a high level of social protection, and strengthen social and territorial cohesion;
20. Is of the opinion that any Community action relating to health-care services should be consistent with Community action relating to social services of general interest;
21. Requests that any further clarification of concepts used in the case law of the European Court of Justice does not alter the balance struck by the European Court of Justice between Member States’ prerogatives in the field of public health and the rights of the individual patient; in this respect recalls that, as regards the concept of ‘reasonable waiting time’, the European Court of Justice has clearly indicated that it should exclusively be defined in the light of an assessment of each patient’s medical situation and that economic considerations should not play any role in that assessment;
22. Requests a clear definition of health services, so as to clarify and clearly demarcate the scope of application of future legislation in this field;
23. Points out that the case law of the Court is directly applicable and does not require implementing measures; points out, in particular, that the Commission should ensure that no authorisation is required for a reimbursement of the cost of non-hospital services provided in another Member State;
24. Points out that, as regards hospital services in another Member State, the procedure for granting authorisation must provide a guarantee for patients, protecting them from arbitrary decisions taken by their national authorities; points out that, in order to facilitate the free movement of patients without prejudicing Member States’ planning objectives, in the light of the case law of the European Court of Justice, hospital treatment should be defined narrowly, as treatment which can only be provided within hospital infrastructure and may not be provided, for example, in a practitioner’s surgery or at the patient’s home; points out, in particular, that any refusal to grant an authorisation must be open to challenge in judicial and quasi-judicial proceedings and that, for the purpose of assessing the medical situation of each patient, entirely objective and impartial advice from independent experts should be sought;
Patient mobility
25. Notes the great diversity of mobility and the different reasons for mobility among patients sent abroad by their national health system and of patients looking for medical treatment abroad of their own volition – tourists who fall ill, migrant workers, students, retired people and anyone living in an EU country other than their country of origin, or living in border regions – and stresses that those differences should be taken into account when designing policy;
26. Stresses that it is desirable to distinguish between, on the one hand, cross-border health services, meaning those which are situated on either side of a border common to two Member States in order to maintain and offer patients a high standard of access and care, and, on the other hand, international health services within the European Union, which must offer health care for the treatment of rare or orphan diseases and/or diseases which require rare and very expensive technologies (care reference centres) or provide access to care which their Member State or State of residence cannot at present offer them;
27. Calls on the Commission to provide annual statistics for each Member State on patient mobility and on the number of cases of reimbursement being refused, and the reasons for such refusal;
28. While recognising that health-care policy is primarily a Member States competence and emphasising the need for high-quality health-care provision in the country of origin of the patient, nevertheless welcomes the Commission’s initiative to launch a consultation procedure on the best form for Community action with a view to improving the access of patients, within a reasonable timeframe, to a safe, high-quality and efficient framework for cross-border aspects of health care, and calls on the Commission to come up with concrete proposals to encourage and monitor progress in this area;
29. Notes that considerable numbers of patients from several Member States are not able to receive the necessary medical treatment in their own country within a reasonable timeframe because of the waiting lists and notes that these patients are, therefore, dependent on medical treatment abroad;
Improving information for patients
30. Notes how difficult it is for patients to obtain clear and precise information on health care, especially in relation to cross-border health care, and the complexity of the procedures that have to be followed; notes that this difficulty, which is not only created by language barriers, potentially increases the risk to patient safety;
31. Considers that the EU has an important role to play when it comes to improving patients’ access to information on access to cross-border health care;
32. Notes that effective sharing and exchange of information on health, in a transparent way, is a vital requirement for ensuring consistency and maintaining a high quality of health care when using health-care services in different Member States;
33. Considers that it is important to give patients the right to choose health care in another country when this choice allows them to receive appropriate treatment, having informed them fully of both the terms and prior conditions for access and the implications of such a choice, but is of the opinion that medical tourism should not be actively encouraged; considers that, according to the case law of the European Court of Justice, as mentioned in this report, prior authorisation for hospital care should be easily obtainable, dealt with immediately and evaluated on the basis of objective and neutral criteria; refusal of authorisation should be justified on the basis of objective reasons which must be verified in a transparent way and reasoned, and that any refusal should be reasoned with reference to the opinion of independent experts;
34. Points out that Member States already have charters of patients’ rights;
Reimbursement
35. Acknowledges the existing differences between health-care systems in Member States and the complex legal frameworks which regulate reimbursements; calls for a codification of existing case law on the reimbursement of cross-border health care in order to ensure the proper application of the case law by all Member States, and to improve the information available to patients, national sickness insurance schemes and health-care providers without creating additional cumbersome bureaucratic burdens for Member States;
36. Calls on the Commission to encourage all Member States to apply the existing procedures for reimbursement of cross-border health care; considers that it should be possible for the Commission to start proceedings against Member States that fail to do so;
37. Calls for a European reference scheme to be put in place concerning reimbursement in order to allow citizens to make a comparison and to make the most suitable choice of the treatment for them;
38. Calls for examination of ways of actively supporting and promoting the work aimed at making use of the European Health Insurance Card with a standardised set of electronic patient data common practice, in order to simplify the procedures for European citizens obtaining health care in other Member States and to ensure confidentiality of sensitive medical data; considers that the holders of the card have to decide themselves the data which will appear on it; to make the most effective use of this system, calls for the adoption of European health indicators; considers that it is crucial, for patient safety reasons, to encourage national authorities to exchange information on registration and disciplinary matters relating to health-care providers operating across borders; believes that it is appropriate to expand the European health insurance card scheme to include a system of international exchange of data concerning the insurance status of the patient;
39. Calls on the Member States to ensure that health service providers post a clearly visible symbol demonstrating (in a similar way as with credit cards in hotels, restaurants, etc.) that a patient’s EHIC can be accepted in a given Member State, in line with Regulation (EC) No 883/2004; calls for a high level of data protection for patients as regards cross-border cooperation in health services in order to ensure confidentiality of sensitive medical data;
Mobility of health professionals
40. Notes that European Parliament and Council Directive 2005/36/EC of 7 September 2005 on the recognition of professional qualifications[17] does not remedy all the current regulatory shortcomings at EU level concerning the free movement of health professionals, particularly with regard to continuing training and providing assurance of the current competence of health professionals; stresses that any future legislation in this field should strongly facilitate the provision of cross-border health services and the establishment of service providers from other Member States;
41. Notes that, although mutual recognition of professional qualifications exists in Europe, there remains insufficient uniformity of quality of the content of professional training and of the ways in which professions are pursued and/or insufficient provision for such uniformity;
42. Stresses that Article 35 of the Charter of Fundamental Rights of the European Union provides that the Union shall ensure a high level of health protection and in this regard points out that the quality of health services and the ability of the sector to retain staff are conditioned by the quality of the work and the working conditions of health-service workers, including rest times and training opportunities; points out further that accompanying measures such as quality control, supervision and the use of new information technologies should ensure the best possible medical care for the patients;
43. Considers it very important for health-care providers directly in contact with patients to have a sufficient command of the language spoken in the host Member State concerned;
44. Calls on the Commission to set up a system for collecting data and exchanging information between the various national authorities on health-care providers and to set up a European card to provide access to information on the skills of health-care professionals and make that information available to patients, as well as to develop a reliable health information system for service providers with an obligation on national authorities to share such information;
45. Welcomes the work carried out by Health Professionals Crossing Borders as a good example of close multilateral cooperation between Member States’ health-care regulators;
46. Stresses the need to better inform health-care professionals of their right of mobility within the EU by using existing tools set by the Commission, such as EURES (European Employment Services);
47. Stresses the need to strengthen the protection of patients by requiring health professionals to take out professional indemnity insurance;
Legal liability
48. Insists that patient mobility cannot be allowed to grow unchecked without concurrent and clear rules governing liability for the provision of cross-border health services and the resultant need for ease of access to redress and justice mechanisms particularly if the various stages of treatment have taken place in more than one country;
49. Notes that the combination of current private international law rules on jurisdiction and applicable law, with various Community instruments, leads to a complex and difficult web of regimes on legal liability which does not promote ease of access to justice, which is a matter of particular concern in relation to health services and which are, by their nature, both personal and individual; moreover, a patient who seeks redress is likely to be both vulnerable and proceeding alone against either an institution or a professional body;
50. Therefore stresses the need to guarantee the legal security of patients and professionals, calls for clarification of liabilities in the event of injury and an obligation for all health professionals to have compulsory third-party liability insurance at reasonable cost;
51. Stresses the need to strengthen the protection of patients by requiring health professionals to take out professional indemnity insurance; notes, however, that both the means of guaranteeing that and the definition of a health professional will be determined by the relevant insurance or other financial security arrangements in each Member State;
52. Points out that health care often requires follow-up medical checks; calls for clarification of the rules on the division of responsibilities between health-care providers during the various stages of such treatment in order to ensure continuity in care; points out that telemedicine and E-health are developing on such a scale that new rules of play need to be agreed in the areas of social protection, funding and access to such care;
53. Stresses the need to strengthen patient protection by requiring health professionals to take out professional indemnity insurance;
Cooperation between the Member States
54. Considers that closer cooperation between health systems on local, regional, intergovernmental and European levels should make it possible to obtain appropriate treatment in other Member States, improve the quality of services and thus increase citizens’ confidence;
55. Points out that cross-border cooperation between those concerned can lead to finding appropriate solutions, as shown by the example of Euroregis;
56. Expects the Member States to pursue cross-border cooperation in offering health services, so as to be able to run their respective health systems more cost-effectively;
57. Calls on the Commission to draw up technical standards, and calls on the governments of the Member States to actively support the introduction of interoperable transparent information systems allowing effective exchange and sharing of information on health between health-care providers in individual Member States,
58. Encourages the development of networks of reference centres, including electronic reference centres that deal with some rare, specific and chronic diseases, and exchange of knowledge between various EU countries on best treatment practices and the organisation of health-care systems; and calls on the Commission to optimise transnational administrative cooperation;
59. Considers that the EU can play an important role in improving the availability of information for patients on cross-border mobility, including by promoting European health indicators;
60. Considers that the quality of health services will benefit more from exchanges of treatment methods than from unbridled patient mobility;
61. Recognises that there is a demand for properly regulated, quality health and pharmaceutical cross-border services and for cooperation and the exchange of scientific and technological experience between highly specialised medical centres; however, points out that surveys show that most people would prefer to receive high quality treatment near to where they live; considers that, in order to provide the most appropriate legislative response, the Commission should in advance conduct an exhaustive study firstly of real needs for patient mobility and secondly of the publics to which mobility can apply, while assessing the impact of such mobility on health systems;
62. Expects (given the existing differences) the Member States to resolve issues such as access, quality of care and the control of costs among themselves;
63. Believes that the open method of coordination is one of the appropriate instruments by which to organise closer cooperation among Member States;
64. Hopes that bilateral or multilateral agreements between Member States, regions and local authorities and between the players in the health-care sector will develop, which would stimulate sharing of material and human resources in cross-border areas, and in particular in areas with high numbers of short-term visitors, and exchanges of skills and knowledge;
65. Calls for the creation and use of a single point of contact on the basis of existing Community instruments, in accordance with the specificity of the organisation of each health-care system, to guarantee access to objective and independent information for patients, health professionals, health-care institutions and the competent authorities; considers that health professionals can assist patients in seeking this information;
66. Encourages the Commission to make use of all existing instruments, such as SOLVIT and infringement procedures, in order to assist patients who have been refused reimbursement (for non-hospital care) or authorisation (for hospital care) even though the conditions laid down in the case law have been fulfilled;
67. Encourages the Commission to continue collecting data from the Member States and to further analyse trends and challenges facing cross-border mobility of patients and health professionals;
Conclusions
68. Considers that the Treaties and the case law of the European Court of Justice are clear when it comes to the rights and obligations of patients and health professionals with regard to cross-border services;
69. Calls on the Commission to strengthen its policy of pursuing violations of EU law with a view to ensuring that all Member States comply with the case law of the European Court of Justice and that all European patients, irrespective of their country of origin, benefit from the rights conferred on them by the Treaty;
70. Invites the Commission to submit to the Parliament and to the Council a proposal for an appropriate instrument with a view, in particular, to codifying the case law of the European Court of Justice;
71. Invites the Commission to submit, to Parliament, a proposal to reintroduce health services into Directive 2006/123/EC, and a proposal to codify European Court of Justice rulings on European patients’ rights;
72. Believes that, above all, a new European regulatory framework for cross-border health care should improve access to high-quality health care in the event of illness, contribute to patient safety and increase the choices open to all patients in the European Union without contributing to inequality in health-care outcomes;
73. Instructs its President to forward this resolution to the Council and Commission.
- [1] ECR1998, p. I-1831.
- [2] ECR1998, p. I-1931.
- [3] ECR2001, p. I-5473.
- [4] ECR2001, p. I-5363.
- [5] ECR2003, p. I-1703.
- [6] ECR2003, p. I-4509.
- [7] ECR2003, p. I-12403.
- [8] ECR2004, p. I-2641.
- [9] ECR2006, p. I-4325.
- [10] OJ L 376, 27.12.2006, p. 36.
- [11] OJ C 124E, 25.5.2006, p. 543.
- [12] OJ C 146, 22.6. 2006, p. 1.
- [13] OJ L 149, 5.7.1971, p. 2.
- [14] OJ L 166, 30.4.2004, p.1.
- [15] OJ C 146, 22.6.2006, p. 1.
- [16] OJ L 40, 11.2.1989, p. 8.
- [17] OJ L 255, 30.9.2005, p.22.
EXPLANATORY STATEMENT
1. Health-care services and pharmaceuticals were excluded from the directive on services in the internal market because of their very particular characteristics which prevent them from being considered as ordinary services that can be bought and sold.
In response to the encouragement of the Council and Parliament to devote a special reflection process to the health sector, the Commission launched a consultation process on the framework for future initiatives.
2. Health services are one of the fundamental elements of the European social model; they contribute to the economic, social and territorial cohesion of the EU and can inspire citizens’ confidence, or the reverse. In such a sensitive sector which concerns people’s most precious possession and affects their daily lives with its ultimate aim of preserving life, there is a great deal at stake politically.
3. In accordance with the Treaties and the principle of subsidiarity, these services fall within Member State competence, and EU action to regulate and safeguard various forms of mobility of patients and professionals, which currently is not a large phenomenon but is continually growing, must comply with shared values and principles at European level: universality, safety, quality, solidarity and equal access for all throughout the Community’s territory.
In this way, EU added value may be essential.
4. Health services are a substantial source for creating large numbers of skilled jobs, make an active contribution to the Lisbon strategy objectives, and their economic and social role is considerable.
5. Health systems differ widely from one country to another but must adapt and evolve to maintain high levels of quality and effectiveness. Greater mobility of professionals should not lead to an imbalance in the medical demography in the Member States. Regulation at European level and improved cooperation between countries are therefore needed to preserve social and territorial cohesion and guarantee equal access to good quality health care throughout Europe through good territorial coverage, as Article 35 of the Charter of Fundamental Rights of the European Union explicitly recognises.
6. The increasing mobility of patients and health professionals should not lead to the creation of an internal market in health services competing on the basis of cost, leading to a damaging levelling down of quality of care and creating a two-speed health system where only the more well-off and better informed patients would benefit.
7. In the context of patient mobility, it is essential that they have easy access to clear and precise information without bureaucratic obstacles. Cooperation between the various institutions concerned and the various health insurance schemes is therefore needed and must preserve the confidentiality of sensitive data in medical files. Patients should have a European health microchip card that would be standard for the whole EU.
8. In view of the general ageing of the European population and pensioners’ increased transnational mobility, it seems important to anticipate the creation of sufficient structures for appropriate care, in connection with the relevant social services.
9. The mobility of health-care providers should be improved, and there should be a standard European card stating their various professional qualifications, with a view to better organised transnational systems of continuing training, which is highly recommended to keep pace with continuing developments in technologies and research.
10. It is vital to set up a legal framework that determines liabilities in the event of failure of treatment, or injury to patients, particularly in the context of medical treatment carried out in several countries.
The conditions and arrangements for monitoring should be clearly set out in the same way as those in the country where the professionals work.
Whatever the level of risk they are exposed to in their profession, health-care professionals should have access to reasonably priced insurance.
11. Certain concepts should also be defined: reasonable waiting time, which varies greatly from one country to another, and imprecise definitions of inpatient and outpatient treatment, which have been referred to in judgments by the European Court of Justice.
Better protection is urgently needed for patients, health professionals and sickness insurance schemes, and any legal uncertainty about treatments, authorisations, charges and conditions for reimbursement should be removed.
12. With a view to rationalising costs for sickness insurance schemes, it would be sensible to stress prevention policies at Member State level. In border areas, sharing human and material resources would contribute to the intelligent management of health care.
13. To optimise the conditions for research on specific and rare diseases, there should be a general rule to set up reference centres in each country as a way of improving the quality of care.
14. The Court of Justice has recognised patients’ rights in its judgments. Nevertheless, legal uncertainty remains with regard to some definitions of care, the actual rights of patients, the rights of professionals who provide their services in different countries, the conditions for checks to be carried out, the standards applicable in terms of charges and reimbursement, and liability in the event of injury to patients, particularly when medical treatment is provided in more than one country.
15.The legislator, and the legislator alone because this is its role, must therefore remove all these persistent legal uncertainties by creating a legislative instrument that anticipates the problems raised by in increase in trade in health-care services within the EU; this instrument should set out all the legal provisions applicable in the context of the diversity of cases to be treated, clarify the rules on authorisations and reimbursement and link the medical area with the social area in some cases. This necessary clarification must, however, not encourage patients to indulge in ‘medical tourism’.
16. This legislative initiative, which would provide coherent and effective responses to calls to protect the way of life of European citizens, would in fact be the only legal and ethical guarantor of a social model.
17. A directive on health services, in parallel with legislation on general interest social services, included in the objective of a framework directive on services of general economic interest therefore seems to be the only instrument that would enable the European Union to add value, which is what is needed to re-establish and increase the confidence of European citizens in an area which is absolutely central to their lives.
OPINION of the Committee on Employment and Social Affairs (26.3.2007)
for the Committee on the Internal Market and Consumer Protection
on the impact and consequences of the exclusion of health services from the Directive on services in the internal market
(2006/2275(INI))
Draftsman: Harald Ettl
SUGGESTIONS
The Committee on Employment and Social Affairs calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to incorporate the following suggestions in its motion for a resolution:
A. whereas, in its conclusions of 1 to 2 June 2006, the Council adopted a statement by the 25 Health Ministers of the European Union about the common values and principles that underpin Europe’s health systems[1],
1. Stresses that health services constitute a major component of the European social model and make an important contribution to social and territorial cohesion, and points out that the basic values of equality of access, universality, equal treatment and solidarity as well as affordability and financial sustainability must continue to be safeguarded;
2. Reiterates that access to health care is a fundamental right recognised by Article 35 of the Charter of Fundamental Rights of the European Union and that health-care systems throughout the European Union share operating principles relating to the quality and safety of care based on evidence and ethics, patient involvement, redress, privacy and confidentiality; considers, therefore, that providing equal access for all to a balanced and adequate supply of high-quality health care is a core task of public authorities;
3. Notes that whilst health-care systems are not within the competence of the Community, issues relating to health-care systems, such as access to medicines and treatments, patient information, and the movement of insurance companies and health professionals, have a cross-border character; notes that those issues need to be addressed by the European Union;
4. Expects the Member States to pursue cross-border cooperation in offering health services, so as to be able to run their respective health systems more cost-effectively;
5. Stresses that access to cross-border care is a requirement for the free movement of citizens within the Community and helps raise employment and competitiveness levels in Member States;
6. Welcomes the exclusion of health services from the scope of the Services Directive, given that cross-border health care is covered by existing legislation and given that health and social services constitute a higher good and should be recognised by further legislation at European level;
7. Takes the view that any Community framework designed to ensure the availability of safe, high-quality and efficient health services must comply with the judgments handed down by the Court of Justice of the European Communities, but must also give due consideration to the priority of maintaining and ensuring universal, unrestricted access to public health services;
8. Stresses that patient mobility contributes towards improving access to and raising the quality of health care;
9. Stresses the need to cut ‘red tape’ connected with both the use and provision of cross-border health services;
10. Notes that quick and conclusive identification of patients and their rights and claims under their respective social welfare systems is a fundamental requirement for cutting ‘red tape’ when it comes to the use of cross-border health services;
11. Calls on the Commission to speed up work on drawing up a standard, and calls on Member State governments to support actively the introduction of a European health smart card, which would be a means of identifying patients and their rights and claims under their respective social welfare systems;
12. Notes that effective sharing and exchange of health information is a vital requirement for ensuring consistency and maintaining the high quality of health care when using health-care services in different Member States;
13. Calls on the Commission to draw up technical standards, and calls on the Member State governments to support actively the introduction of mutually compatible information systems allowing the effective exchange and sharing of health information between health-care providers in individual Member States;
14. Stresses that Article 35 of the Charter of Fundamental Rights of the European Union provides that the Union shall ensure a high level of health protection and in this regard points out that the quality of health services and the ability of the sector to retain staff are conditioned by the quality of the work and the working conditions of health-service workers, including rest times and training opportunities; points out further that accompanying measures such as quality control, supervision and the use of new information technologies should ensure the best possible medical care for the patients;
15. Advocates the development of comprehensive assessment procedures for health policy at national and European level and calls for the provision of complementary, preventive and social medicine to be enhanced so as to improve the means of recording and combating the causes of illness taking into account the social environment;
16. Takes the view that the exclusion of health services from the Services Directive, which was intended to identify health services as a higher good for the European Union, calls for accompanying measures such as better networking and coordination among the centres of reference; points out that the cooperation between Member States in network centres of reference promises to provide an exchange of high-quality expertise and thus European added value, and benefits to patients with specific needs;
17. Stresses that health-care services should not be treated in the same way as other services, because it is characterised by an asymmetry of information between patients and care providers, a large degree of public financing, provider-induced demand, and the effects on the demand and supply of health care due to health-care insurance;
18. Reiterates the importance of Member States’ steering capacity and regulatory responsibilities in the field of health care and the freedom of Member States to maintain or set up instruments such as planning, tariff-setting mechanisms and authorisation schemes in order to ensure universal access to high-quality health care as well as continuity; considers that if those instruments are used by Member States to safeguard the common values and principles that underpin Member States’ health systems, to achieve general interest objectives, and to redress the existing market imperfections, they are to be regarded as justified by an overriding reason relating to the public interest;
19. Calls on the Commission to propose a sectoral directive on health services, drawing in the social partners and decision-makers, recognising national and regional authorities’ capacity to organise, finance and modernise health-care systems and furthermore clarifying the conditions under which reliance upon regulatory instruments is justified in the light of EC Treaty rules on free movement, competition and State aid;
20. Points out that the case law of the Court of Justice of the European Communities relating to health services is comprehensive, particularly with regard to the reimbursement of treatment costs, and that limited and focused EC legislation on health services and cross-border health care should clarify the circumstances under which patients are entitled to claim reimbursement for medical care in another Member State under the social security system of the Member State of affiliation in accordance with the Court’s case law and in a way that is consistent with Regulation (EC) No 883/04 on the coordination of social security systems[2];
21. Points to the current tension between health policy objectives and the aims of the internal market for services, which ensures that in the event of conflict health policy objectives always take precedence, for overriding reasons of general interest (e.g. public health and social objectives connected therewith, maintenance of the financial balance of the social security system, etc.);
22. Points out that the priority instrument for action relating to health services should be cooperation between the Member States, with the requisite degree of coordination by the Commission;
23. Calls on the Commission to take the necessary measures accompanying patient mobility in terms of patients’ rights, minimum standards on the quality of health care, liability of health-care providers and compensation issues and to initiate closer cooperation between the health-care authorities of the Member States on these matters; believes that the open method of coordination is one of the appropriate instruments by which to organise closer cooperation among Member States;
24. Notes that health-care services pursue objectives comparable to other social services of general interest in the sense that they are based on the principle of solidarity, are often embedded in national social protection systems, are person-centred, ensure that citizens can enjoy their fundamental rights and a high level of social protection, and strengthen social and territorial cohesion;
25. Notes that in reality it is hard to draw a clear distinction between the provision of health-care services and the provision of other social services of general interest since the providers of medical care are also often involved in the provision of purely social services; notes also that it would be appropriate to consider under the term health services the whole hospital and rehabilitation sector including ambulant treatment as well as all treatments in which medical practitioners and paramedical and nursing staff take part;
26. Is of the opinion that any Community action relating to health-care services should be consistent with Community action relating to social services of general interest;
27. Points out that the provisions in a future directive on health services must be compatible with Community rules on social security systems, the establishment of service providers (applying the same social standards, standards of employment law and quality standards), (patient) mobility and the mutual recognition of professional qualifications;
28. Advocates, therefore, measures to ensure the free movement of patients in health systems, since this produces shorter waiting times and improved access to specialists;
29. Expects (given the existing differences) the Member States to resolve issues such as access, quality of care and the control of costs among themselves;
30. Takes the view that, under a future directive on health services, entailing explicit recognition of the principles of subsidiarity and general interest already accepted by the Court of Justice, the law of the Member State in which a service is provided should, in principle, apply, and stresses that the full responsibility of the Member States for structuring and funding their national health systems, as well as for monitoring performance, must be safeguarded and that Community law must ensure that the financial balance of social systems is not affected by increasing patient mobility;
31. Considers that, in order to respond speedily to the needs of Europeans travelling to seek high-quality health services, the priority should be to step up the involvement of regional health systems, which are probably better suited to finding appropriate, regionally based solutions to the population’s needs, and to focus in particular on the experience and good practice which have been built up in border regions and in the Euro-regions;
32. Expects the Commission to modify the regulation on the coordination of social security systems in order to bring it into line with the principles laid down by the Court of Justice regarding patient mobility;
33. Points out that cross-border cooperation between those concerned can lead to finding appropriate solutions, as shown by the example of Euroregis shows;
34. Points out that increasing patient mobility requires the rules on liability in the case of injury arising from treatment to be aligned, and that it should be possible to enforce compensation claims in all the Member States before the relevant national courts or authorities;
35. Is of the opinion that under the relevant regulatory instruments prior authorisation should be based on easily accessible procedural rules, and should guarantee to the patient concerned that the application is processed immediately and assessed on the basis of objective and neutral medical criteria, subject to patient consent;
36. Notes that, for a foreign patient, safe, high-quality health care depends on the availability and accessibility of the patient’s medical and administrative data and that these data are often held in the patient’s country of residence, that, therefore, – in consideration of data protection – cross-border access to the relevant patient data needs to be facilitated and guaranteed adequately and safely, and that this requires not only the development of European standards but also legal provisions governing digitised medical data transmission between Member States;
37. Notes that although mutual recognition of professional qualifications exists in Europe, there remains insufficient uniformity of quality of the content of professional training and of the ways in which professions are pursued and/or insufficient provision for such uniformity;
38. Notes that the major differences in names, prescription, distribution, prices and reimbursement of the cost of medicines between Member States are a practical obstacle to patient mobility and that this is also a field where from the point of view of safe and high-quality cross-border care there will be a need for standardisation and transparency.
PROCEDURE
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Title |
Impact and consequences of the exclusion of health services from the Directive on services in the internal market |
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Procedure number |
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Committee responsible |
IMCO |
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Opinion by |
EMPL |
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Enhanced cooperation – date announced in plenary |
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Drafts(wo)man |
Harald Ettl |
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Previous drafts(wo)man |
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Discussed in committee |
24.1.2007 |
28.2.2007 |
20.3.2007 |
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Date adopted |
21.3.2007 |
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Result of final vote |
+: |
34 |
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Members present for the final vote |
Jan Andersson, Roselyne Bachelot-Narquin, Edit Bauer, Jean-Luc Bennahmias, Emine Bozkurt, Iles Braghetto, Milan Cabrnoch, Alejandro Cercas, Ole Christensen, Luigi Cocilovo, Proinsias De Rossa, Harald Ettl, Richard Falbr, Ilda Figueiredo, Joel Hasse Ferreira, Stephen Hughes, Karin Jöns, Jan Jerzy Kułakowski, Jean Lambert, Thomas Mann, Jiří Maštálka, Ana Mato Adrover, Maria Matsouka, Ria Oomen-Ruijten, Csaba Őry, Siiri Oviir, Marie Panayotopoulos-Cassiotou, Pier Antonio Panzeri, Jacek Protasiewicz, Elisabeth Schroedter, José Albino Silva Peneda, Kathy Sinnott, Jean Spautz, Gabriele Stauner, Anne Van Lancker, Gabriele Zimmer |
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Substitute(s) present for the final vote |
Dimitrios Papadimoulis, Patrizia Toia |
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Substitute(s) under Rule 178(2) present for the final vote |
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Comments (available in one language only) |
... |
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OPINION of the Committee on the Environment, Public Health and Food Safety (23.3.2007)
for the Committee on the Internal Market and Consumer Protection
on the impact and consequences of the exclusion of health services from the Directive on services in the internal market
(2006/2275(INI))
Draftsman: Jules Maaten
SUGGESTIONS
The Committee on the Environment, Public Health and Food Safety calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to incorporate the following suggestions in its motion for a resolution:
1. Emphasises that Member States’ health systems are a fundamental part of the European social infrastructure[1]; recalls that health care was excluded from the scope of the services directive because it is not like other services and requires special safeguards to ensure that everyone is able to access high-quality health care, and because it entails political choices at European, national and regional level;
2. Underlines that Europe is characterised by making high-quality health care available to all citizens regardless of personal circumstances, and therefore while access to cross-border health care and the free movement of patients and health-care professionals may contribute to the improvement of health outcomes, the point of departure should be that all patients receive proper treatment in their own country and patient mobility must not on any account impair the safety of health care;
3. Considers that the right to reimbursement of costs of treatment in another Member State of a disease which is not acute should be guaranteed if there are long waiting lists in the patient’s own Member State or the quality of treatment there is inferior to that in other Member States subject to mutual agreement between the Member States concerned; also considers that it is not permissible to bring pressure to bear on patients to undergo cheaper treatment in another country;
4. While recognising that health-care policy is primarily a Member States’ competence and emphasising the need for high-quality health-care provision in the country of origin of the patient, nevertheless welcomes the Commission’s initiative to launch a consultation procedure on the best form for Community action with a view to improving the access of patients, within a reasonable timeframe, to a safe, high-quality and efficient framework for cross-border aspects of health care, and calls on the Commission to come up with concrete proposals to encourage and monitor progress in this area;
5. Notes that the Member States do not sufficiently promote health care, as a result of which patients’ rights are restricted;
6. While fully respecting the Council conclusions on universality, solidarity and equity as fundamental values underpinning European health-care systems and the limited provisions of Article 152 of the EC Treaty, emphasises that the rulings of the European Court of Justice (ECJ) address the problems relating to patients’ rights to seek treatment abroad and subsequently get reimbursed by their national health insurance scheme in certain circumstances;
7. Recognises that health services may benefit from more open borders; stresses that treatment methods and patient survival rates vary substantially between Member States; considers that the quality of health services will benefit more from exchanges of treatment methods than from unbridled patient mobility;
8. Recognises that there is a demand for properly regulated, quality health and pharmaceutical cross-border services and for cooperation and the exchange of scientific and technological experience between highly specialised medical centres; however, points out that surveys show that most people would prefer to receive high quality treatment near to where they live; considers that, in order to provide the most appropriate legislative response, the Commission should in advance conduct an exhaustive study firstly of real needs for patient mobility and secondly of the publics to which mobility can apply, while assessing the impact of such mobility on health systems;
9. Stresses that it is desirable to distinguish between, on the one hand, cross-border health services, meaning those which are situated on either side of a border common to two Member States in order to maintain and offer patients a high standard of access and care, and, on the other hand, international health services within the European Union, which must offer health care for the treatment of rare or orphan diseases and/or diseases which require rare and very expensive technologies (care reference centres) or provide access to care which their Member State or State of residence cannot at present offer them;
10. Points out that Regulation (EC) No 1408/71 and Regulation (EC) No 883/2004 on the coordination of social security schemes and Directive 2005/36/EC on the recognition of professional qualifications do not cover all the existing regulatory gaps at EU level or assure the current competence of regulated health-care professionals; is of the opinion that patients’ safety and rights are not ensured in the cross-border provision of health care at present and that legal uncertainty exists regarding reimbursement mechanisms, obligations on national authorities to share regulatory information, the duty of care for both the initial and follow-up treatment and the risk management provisions for private patients;
11. Points out that provisions for ensuring access to information for patients and national authorities on cross-border health-care provision, accredited health-care professionals and medical treatment are lacking;
12. Considers that the EU can play an important role in improving the availability of information for patients on cross-border mobility, including by promoting European health indicators;
13. Points out that, at present, the European health card still does not make it possible to exchange patient information between health-care professionals;
14. In the context of increased professional mobility in Europe, believes it necessary to incorporate into a European legal framework a duty on national authorities to exchange registration and disciplinary information about health-care professionals where patient safety may be at risk;
15. Considers the introduction of a legislative framework at Community level as the best way to ensure legal certainty for patients, national health-care systems and for private health-care providers; such a framework should ensure compliance with the fundamental principles of universality, solidarity, equal access, quality, safety and durability; it should also guarantee the Member States’ ability to preserve their system of authorisation, in compliance with Community law on price regulation and care planning, thereby enabling them to organise and finance their health-care systems;
16. Believes that, above all, a new European regulatory framework for cross-border health care should improve access to high-quality health care in the event of illness, contribute to patient safety and increase the choices open to all patients in the European Union without contributing to inequality in health-care outcomes.
PROCEDURE
|
Title |
The impact and consequences of the exclusion of health services from the Directive on services in the internal market |
||||||
|
Procedure number |
|||||||
|
Committee responsible |
IMCO |
||||||
|
Opinion by |
ENVI |
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|
Enhanced cooperation – date announced in plenary |
|
||||||
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Draftsman |
Jules Maaten |
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|
Previous draftsman |
|
||||||
|
Discussed in committee |
22.1.2007 |
28.2.2007 |
21.3.2007 |
|
|
||
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Date adopted |
21.3.2007 |
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|
Result of final vote |
+: –: 0: |
41 0 0 |
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Members present for the final vote |
Adamos Adamou, Georgs Andrejevs, Liam Aylward, Pilar Ayuso, Johannes Blokland, John Bowis, Frieda Brepoels, Dorette Corbey, Chris Davies, Avril Doyle, Mojca Drčar Murko, Matthias Groote, Françoise Grossetête, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Eija-Riitta Korhola, Aldis Kušķis, Peter Liese, Jules Maaten, Linda McAvan, Marios Matsakis, Alexandru-Ioan Morţun, Riitta Myller, Miroslav Ouzký, Antonyia Parvanova, Frédérique Ries, Guido Sacconi, Richard Seeber, Bogusław Sonik, María Sornosa Martínez, Antonios Trakatellis, Evangelia Tzampazi, Thomas Ulmer, Glenis Willmott |
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|
Substitute(s) present for the final vote |
Alfonso Andria, Kader Arif, Giovanni Berlinguer, Alojz Peterle |
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|
Substitute(s) under Rule 178(2) present for the final vote |
Radu Podgorean |
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|
Comments (available in one language only) |
|
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- [1] EU Health Ministers statement on common values and principles – Luxembourg, 1-2 June 2006.
PROCEDURE
|
Title |
The impact and consequences of the exclusion of health services from the Directive on services in the internal market |
|||||||||||
|
Procedure number |
||||||||||||
|
Committee responsible |
IMCO |
|||||||||||
|
Committee(s) asked for opinion(s) |
EMPL |
ENVI |
|
|
|
|||||||
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Rapporteur(s) |
Bernadette Vergnaud |
|
||||||||||
|
Discussed in committee |
19.12.2006 |
24.1.2007 |
1.3.2007 |
21.3.2007 |
12.4.2007 |
|||||||
|
|
23.4.2007 |
7.5.2007 |
|
|
|
|||||||
|
Date adopted |
8.5.2007 |
|||||||||||
|
Result of final vote |
+ - 0 |
20 18 2 |
||||||||||
|
Members present for the final vote |
Adam Bielan, Daniela Buruiană-Aprodu, Charlotte Cederschiöld, Mia De Vits, Rosa Díez González, Janelly Fourtou, Evelyne Gebhardt, Malcolm Harbour, Pierre Jonckheer, Lasse Lehtinen, Toine Manders, Arlene McCarthy, Bill Newton Dunn, Béatrice Patrie, Zita Pleštinská, Guido Podestà, Zuzana Roithová, Luisa Fernanda Rudi Ubeda, Heide Rühle, Leopold Józef Rutowicz, Christel Schaldemose, Andreas Schwab, Alexander Stubb, Eva-Britt Svensson, Marianne Thyssen, Jacques Toubon, Bernadette Vergnaud, Barbara Weiler |
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Substitute(s) present for the final vote |
Šarūnas Birutis, André Brie, Wolfgang Bulfon, Ieke van den Burg, Joel Hasse Ferreira, Konstantinos Hatzidakis, Filip Kaczmarek, Othmar Karas, Manuel Medina Ortega, Pier Antonio Panzeri, Søren Bo Søndergaard, Marc Tarabella, Anja Weisgerber |
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Substitute(s) under Rule 178(2) present for the final vote |
Philip Bushill-Matthews, Marian Harkin, Mieczysław Edmund Janowski, Alexander Radwan, Herbert Reul, Horia-Victor Toma, Anne Van Lancker |
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Date tabled |
10.5.2007 |
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Comments |
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