EN Official Journal of the European Union C 120/65

Opinion of the Committee of the Regions on cross-border healthcare

2009/C 120/12

THE COMMITTEE OF THE REGIONS

— Considers that patient mobility must not threaten national healthcare systems either economically or financially

— Feels that cross-border cooperation on health should be promoted, with a special focus on border regions

— Notes that an appropriate balance needs to be struck between: (a) continuing to develop European cooperation, whose value is recognised by all interested parties, and (b) observing the subsidiarity principle

— Recommends that steps must be taken to ensure that more vulnerable patient groups are enabled to exercise their rights under Community law

— Recommends that the Member State of affiliation should have the absolute right to establish a general system of prior approval for hospital treatment in another Member State

— Believes that when the committee which is to assist the Commission in implementing the directive is being set up, account should be taken of the specialist knowledge that exists at regional and local level; the Committee of the Regions should be involved in this work.

Rapporteur : Mr Karsten Uno Petersen (DK/PES), Member of South Denmark Regional Council

Reference document

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

I. OVERALL VIEWS AND RECOMMENDATIONS

THE COMMITTEE OF THE REGIONS

General comments

1. endorses the main thrust of the draft directive which is to clarify patients' rights in line with the various ECJ rulings, and thus to guarantee more general and effective application of such rights;

2. presumes that Article 152 TEC, which states that healthcare systems providing treatment are a national responsibility, is being respected, and reiterates that responsibility for healthcare policy lies primarily with the Member States;

3. endorses and fully supports the view that health is a major concern for everybody and should be promoted both at an EU and general level through effective and transparent policies and measures in the Member States. The Commission should, by extension, make sure that regional and local authorities which are responsible for healthcare systems are consulted and involved in EU cooperation on healthcare services and medical treatment;

4. points out that free movement of services and public health are areas in which the Member States and the European Community share competences. It is therefore appropriate to assess whether the subsidiarity principle has been respected in the draft legislation put forward in this area;

5. Emphasises moreover that a distinction must be made between the free movement of persons (i.e. patients) and the free movement of services, which is subject to the laws of the internal market. Considering that healthcare is a matter of general interest, the CoR opposes the subordination of healthcare to internal market rules. The Member States and, where applicable, their local and regional authorities, must remain in a position to regulate healthcare services, to guarantee their quality and accessibility, taking the limits of financial resources into account.

6. notes that the economic balance in healthcare systems is understood to be a national responsibility which needs to be maintained as such. The potential consequences of the draft directive are quite significant, especially at local level in, for example, border regions and in smaller Member States. Patient mobility must not threaten national healthcare systems either economically or financially;

7. asks that, when comparing healthcare and service provision as set out in the draft directive, the Commission makes sure that healthcare is not driven by profit but, in contrast, is underpinned by criteria geared to an individual's health, promoting health through prevention, course of treatment and quality of life;

8. feels that cross-border cooperation on health should be promoted, with a special focus on border regions. Particular attention must be paid to developing health measures and improving public health in those Member States where the need is greatest, so as to reduce the discrepancies and imbalances that exist on the health front within the Union, in order, gradually, to come within range of the top EU benchmark;

9. believes, moreover, that the proposal must not undermine Member States' initiatives and laws that guarantee a high level of patient safety and patients' rights;

10. notes that the rights of patients which are set out in the draft directive concern primarily elective patients and patients in border regions, and that the rights of these patients must not be given preference over those of other patients, for example those needing urgent treatment, which make up by far the majority of patients;

Member States' responsibility

11. notes that an appropriate balance needs to be struck between: (a) continuing to develop European cooperation, whose value is recognised by all interested parties, and (b) observing the subsidiarity principle, with the Member States, or in some cases the regional and local authorities, guaranteeing effective healthcare systems. Greater clarity is needed regarding those sections of the directive that require Member States to adapt their national healthcare and social security systems, and with regard to the scope of these measures in relation to the subsidiarity principle;

12. draws attention, in this connection, to the CoR's subsidiarity monitoring network (1) which drew up a report on the draft directive following consultations with network members. The report underlines, amongst other things, that the proposal risks undermining the existing control mechanisms operated by local and regional authorities responsible for healthcare services;

13. also considers that it is not only a question of protecting citizens' rights under Community law and informing them about these. Greater consideration should be given to providing a responsive and accessible system that enables all patient groups to access the available rights and options. Steps must be taken to ensure that more vulnerable patient groups are enabled to exercise their rights under Community law. This includes for example older people with poor foreign language skills, or patients who cannot travel for physical or psychological reasons. It also includes a discussion on whether the competent institution of the Member State of affiliation should reimburse travel and accommodation costs during the treatment, the total cost should not exceed the cost of treatment in the member state of affiliation;

14. agrees that Member States, or in some cases the regional and local authorities, are responsible for guaranteeing a smooth-running healthcare system, and for setting clear quality and safety standards for health services, taking into account the principles of universality, access to high-quality health services, equality and solidarity. It is also important: — to find arrangements to ensure that standards are maintained and monitored, — to ensure that relevant information is provided to patients (to enable them to make informed choices) in respect of treatment and care, — to provide a complaint mechanism for patients, — to make sure that health professionals are covered by indemnity insurance, — to guarantee a high level of personal data protection, — to ensure no unequal treatment of patients, irrespective of which Member State they come from. Even though these areas of responsibility are of key importance to a smooth-running health system, they remain the responsibility of the Member State or in some cases the regional and local authorities. The draft directive should not take steps toward harmonisation; Although the responsibility for establishing quality standards in this respect lies with the Member States or, in some cases, with the appropriate territorial authorities, there is nothing to prevent EU bodies laying down recommendations with a view to standardising these criteria or to encouraging cooperation by setting up reference networks and services;

15. is pleased that health services should be provided in accordance with the rules and procedures of the Member State providing the treatment;

Admission procedures and capacity in Member States health systems

16. welcomes the fact that the Member State of affiliation's administrative procedures for admission and referrals are to be maintained, provided this does not lead to discrimination or obstruct freedom of movement;

17. welcomes the fact that the draft directive underlines that Member States may maintain the general conditions, eligibility criteria, and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs in another Member State, e.g. that referrals to specialist treatment can be made by general practitioners;

18. recommends that the Member State of affiliation should have the absolute right to establish a general system of prior approval for hospital treatment in another Member State. This will enable Member States to plan an effective health system and to deal with problems caused by patient outflow and inflow. At the same time, it would also reduce the risk of patient flows disrupting or interfering with the economic equilibrium and balance of Member States' health systems, or undermining their ability to plan — including the planning of capacity — streamline and improve access. The Commission Directive needs to set out a set of criteria for when the Member State of affiliation can deny authorisation, since without any established criteria the whole Directive risks being undermined. General prior approval arrangements would also make it easier for the Member States providing the treatment to obtain payment for the medical services they have provided. Finally, it should also help to put focus on patients' healthcare needs, for instance regarding rehabilitation and other additional care after treatment;

19. points out that the distinction between hospital treatment and out-patient treatment can create problems, since the arrangements for providing treatment vary from Member State to Member State. It should therefore be up to Member States or in some cases the regional and local authorities to determine which services they consider to be hospital treatment, based on the latest knowledge and developments, and on local and regional conditions;

20. asks that initiatives be developed to secure cross-border sharing of spare capacity and healthcare facilities, and that efforts are made to ensure that such initiatives do not adversely affect the spread of medical and health-care resources, including staff, internally as well as between the Member States, as a result of, for example, differences in remuneration systems;

21. notes that treatment of patients from other Member States should not undermine a Member State's ability and obligation to provide treatment to its own population;

22. in principle, recognises that there is a need to set up contact centres with sole responsibility for providing patients with information on their rights in connection with cross-border healthcare, provided that the necessary steps are taken to ensure that the public is given appropriate information about their rights. Contact centres should be carried out by existing bodies, if such exists. These contact centres should not have legal personality but should simply provide information to patients;

Reimbursement of treatment expenses

23. recommends that patients should only be reimbursed for cross-border healthcare expenses which are covered by the Member State of affiliation's social security system. Welcomes the Commission's proposal to prevent patients from making a profit on cross-border healthcare;

24. points to that the relevant healthcare provider in the Member States should be reimbursed for all actual cost incurred as a result of treatment. The Member State of affiliation is only obligated to reimburse costs for treatment to the level cost that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. All additional costs should be covered by the patient.

25. points out that cost reimbursement is often a problem in practice and calls therefore for Member States to be able to take measures to simplify or guarantee payment of treatment costs. This could, for example, take the form of agreements between social security and providers of medical services or agreements between Member States themselves, or even measures to ensure payment by patients;

26. calls for the rights of citizens to be clarified in the draft directive and in Regulation 1408/71 on the application of social security schemes;

Cooperation in healthcare

27. insists that only areas that are of direct relevance to patients' rights be covered by the draft directive;

28. points out that pharmaceutical products are governed by national law, and that Community law must not be detrimental to high national standards of patient safety in respect of prescriptions and pharmaceuticals. Furthermore, harmonisation efforts must not restrict Member States' ability to regulate their pharmaceuticals market with a view to achieving maximum protection for patients, guaranteeing economic balance, and regulating public spending on pharmaceuticals;

29. notes that Member States are to promote the setting up of a network within their healthcare systems to foster cooperation on highly specialist treatment and treatment requiring a particularly high level of resources. Cooperating on particular types of treatment will create added value and thus promote innovation, quality and effective use of resources. However, the centres within the network should not be concerned with harmonising or regulating highly specialist treatment;

30. points out that the Commission's initiatives on information and communication systems which are to be shared by Member States (inter-operability) must not get in the way of Member States' own initiatives in that area. Welcomes the fact that the Commission's initiative is to reflect technological developments, take account of data protection, and to identify the necessary standards and terminology for inter-operability;

31. believes therefore that structured, coordinated cooperation at European level geared to exchanges of experience, knowledge-sharing and research to promote the development of healthcare technology can create substantial added value for Member States. However, such cooperation should not involve harmonisation or regulation;

32. takes the view that access to reliable data and high-quality information is essential. However, such information should as far as possible be compiled from existing data bases in the Member States;

Involvement of regional and local authorities

33. points out that in many Member States, regional and local authorities are responsible for the planning, management, operation and development of the health sector and are close to grassroots concerns; as a result they are the key players in the health sector;

34. insists that regional and local authorities must be involved in the European community activities and initiatives on healthcare;

35. also calls on the Member States to establish procedures providing for early involvement of their regional and local authorities in the European legislative procedure on health care;

36. believes that when the committee which is to assist the Commission in implementing the directive is being set up, account should be taken of the specialist knowledge that exists at regional and local level; the Committee of the Regions should be involved in this work.

II. RECOMMENDATIONS FOR AMENDMENTS

Amendment 1

First recital — amend:

Commission proposal CoR amendment Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the Treaty establishing the European Community, and in particular Articles 152, 95 and 16, thereof,

Reason

As pointed out by the rapporteur in point 2 of the opinion, and as stated by the Commission in Recital 1 of the proposal for a directive, the reference in Article 152 of the Treaty to a high level of human health protection provides the political legitimacy for this proposal for a directive. It is also appropriate to stress the important role played by services of general economic interest, mentioned in Article 16 of the Treaty, in healthcare.

Amendment 2

Add a new recital after recital 3:

Commission proposal CoR amendment (3a) The existing disparities between health-policy objectives and objectives of the internal market in services makes it necessary, where a conflict arises, always to assign priority to health-policy objectives for compelling reasons relating to the public interest (i.e. public health, social-policy objectives, preservation of the financial balance of the social security system, etc.).

Amendment 3

Recital 10 — amend:

Commission proposal CoR amendment 10) For the purpose of this Directive, the concept of ‘cross-border healthcare’ covers the following modes of supply of healthcare: — Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as ‘patient mobility’; — Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; — Permanent presence of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and, — Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services). (10) For the purpose of this Directive, the concept of ‘cross-border healthcare’ covers the following modes of supply of healthcare: — Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as ‘patient mobility’; — Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; — Permanent presence of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and, — Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services).

Reason

The 3rd indent of the text proposed by the Commission concerns a matter which is within the remit of the Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market. To avoid any redundancies or legal uncertainties it is therefore proposed to remove this indent.

The 4th indent of the text proposed by the Commission concerns a matter which is within the remit of Directive 2005/36/EC of 7 September 2005 on the recognition of professional qualifications. To avoid any redundancies or legal uncertainties it is therefore proposed to remove this indent.

Amendment 4

Recital 31 — amend:

Commission proposal CoR amendment (31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State, where the following conditions are met: had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8. (31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State. , where the following conditions are met: had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8. A prior authorisation system is required in order to assure cross-border patients that they will be given treatment and that they will be reimbursed by the social security system of their country of residence. Such a prior authorisation system is in line with the case-law of the Court of Justice.

Reason

1) What is ‘the evidence available’ on the application of free movement principles regarding use of healthcare in another Member State? In any case, it would not be appropriate to give the impression that the objective of the proposal for a directive was to encourage the free movement of patients.

2) The second part of the amendment is self-explanatory.

Amendment 5

Article 1 — Aim — amend:

Commission proposal CoR amendment This Directive establishes a general framework for the provision of safe, high quality and efficient cross-border healthcare. This Directive establishes a general framework for the provision of safe, high quality and efficient access to safe, high quality and efficient cross-border healthcare, taking into account the fact that Member States are responsible for organising and delivering healthcare services and medical treatment.

Reason

It is important to state clearly from the outset that the draft directive must respect Member States' responsibility for healthcare systems, and that the Community's input supplements national policies on healthcare.

Amendment 6

Article 2 — Scope — amend:

Commission proposal CoR amendment Article 2 — Scope This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private. Article 2 — Scope This Directive shall apply to provision of cross-border access to healthcare for individual patients regardless of how it is organised, delivered and financed or whether it is public or private.

Reason

Self-explanatory.

Amendment 7

Article 4 — Definitions — (b) — Delete:

Commission proposal CoR amendment Article 4 — Definitions (b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established; Article 4 — Definitions (b) ‘cross-border healthcare’ means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established;

Reason

It is not the country where the healthcare provider is established that is relevant but rather the patient's country of affiliation.

Amendment 8

Article 4 — Definitions — (d) — Amend:

Commission proposal CoR amendment Article 4 — Definitions (d) ‘health professional’ means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC; Article 4 — Definitions (d) ‘health professional’ means a doctor of medicine medical practitioner or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC;

Reason

Reference should be made to ‘medical practitioners’ since in several Member States, including Spain, the specific postgraduate title of ‘doctor of medicine’ (MD) is not necessary in order to practise medicine.

Amendment 9

Article 5 — Responsibilities of authorities of the Member State of treatment — Amend the heading

Commission proposal CoR amendment Article 5 — Responsibilities of authorities of the Member State of treatment Article 5 — Responsibilities of authorities of the Member States of treatment

Reason

Article 5 also addresses the responsibilities of the Member State of affiliation.

Amendment 10

Article 5 — Responsibilities of authorities of the Member State of treatment — amend

Commission proposal CoR amendment Article 5 — Responsibilities of authorities of the Member State of treatment 1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare provided on their territory, and ensure that: (a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices; (b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology; (c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on availability, prices and outcomes of the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability; (d) patients have a means of making complaints and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive; (e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory; (f) the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC; (g) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment. 2. Any measures taken by Member States, when implementing this Article, shall respect the provisions of Directive 2005/36/EC on the recognition of professional qualifications and Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce. 3. In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperation with the Member States, shall develop guidelines to facilitate the implementation of paragraph 1. Article 5 — Responsibilities of authorities of the Member States of treatment 1. The Member States of treatment shall be responsible for the organisation and the delivery of healthcare, . In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, and ensure thatthey shall define clear quality and safety standards for healthcare provided on their territory, and ensure that: (a) mechanisms are in place for ensuring that healthcare providers are able to meet such standards, taking into account international medical science and generally recognised good medical practices; (b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technology; (c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on availability, prices and outcomes of the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability; (d) patients have a means of making complaints and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive; (e) systems of professional liability insurance or a guarantee or similar arrangement, which are equivalent or essentially comparable as regards their purpose and which are appropriate to the nature and the extent of the risk are in place for treatment provided on their territory; (a) the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC; (b) patients from other Member States shall enjoy equal treatment with the nationals of the Member State of treatment, including the protection against discrimination provided for according to Community law and national legislation in force in the Member State of treatment. 2. Any measures taken by Member States, when implementing this Article, shall respect the provisions of Directive 2005/36/EC on the recognition of professional qualifications and Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce. 3. In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperation with the Member States, shall develop guidelines to facilitate the implementation of paragraph 1.

Reason

Article 5 also addresses the responsibilities of the Member State of affiliation.

The primary motivation for this amendment is the fact that the organisation and delivery of healthcare services and medical treatment is entirely the responsibility of the Member States. See Article 152 TEC.

By demanding that national healthcare systems fulfil a range of requirements, for example the introduction of quality standards and monitoring mechanisms within national healthcare systems, the Commission is meddling in national healthcare systems and disregarding Article 152 TEC.

Amendment 11

Article 6 — paragraph 1 and 2 — amend

Commission proposal CoR amendment Article 6 — Healthcare provided in another Member State 1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. 2. The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. Article 6 — Healthcare provided in another Member State 1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State. where tThe treatment in question must be among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. Finally, treatment should be conditional on the Member State of affiliation not being able to provide it without undue delay. The competent institution of the Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security or health system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. 2. The costs of healthcare provided in another Member State shall be reimbursed by the competent institution of the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.

Reason

The proposal for directive aims at clarifying patients rights according to the European Court of Justice’s rulings.

The term ‘without undue delay’ has been used in rulings from the European Court of Justice (i.e. Watts and Inizan) and should therefore also be the term used in the proposal for directive. The Court has established, that care provided in a Member State other than that in which the insured person's social insurance institution is established shall be granted if the Member State in which the patient resides can not provide the necessary treatment without undue delay. The concept of undue delay must be interpreted on the basis of clinical considerations arising in each individual case.

The other modifications clarifies that it is not the Member State but the social insurance institution(s) concerned that should reimburse the costs and that not only the costs to be covered by the statutory social security system but also those to be covered by the State-financed health systems are to be reimbursed.

Amendment 12

Article 6 — insert paragraph 3 and 4

Commission proposal CoR amendment Article 6: Healthcare provided in another Member State 1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. 2. The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. 3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons. 4. Member States shall have a mechanism for calculation of costs that are to be reimbursed to the insured person by the statutory social security system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had the same or similar healthcare been provided in the territory of the Member State of affiliation. 5. Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. Article 6: Healthcare provided in another Member State 1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. 2. The costs of healthcare provided in another Member State shall be reimbursed by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. 3. The relevant treatment provider should be reimbursed all actual costs (full costs) incurred as a result of treatment. 4. Member States may take measures to simplify or guarantee payment of treatment costs. 3. 5. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neither discriminatory nor an obstacle to freedom of movement of persons. 4. 6. Member States shall have a mechanism for calculation of costs that are to be reimbursed to the insured person by the statutory social security system for healthcare provided in another Member State. This mechanism shall be based on objective, non-discriminatory criteria known in advance and the costs reimbursed according to this mechanism shall be not less than what would have been assumed had the same or similar healthcare been provided in the territory of the Member State of affiliation. 5. 7. Patients travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State shall be guaranteed access to their medical records, in conformity with national measures implementing Community provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.

Reason

Rules on the financial reimbursement of the Member State of treatment as well as the practical question of payment remain completely overlooked in the proposed Directive. The incorporation of a new point (point 3) into Article 6 of the Directive serves therefore to guarantee financial stability and security of provision in the system of the Member State of treatment by ensuring that the Member State of treatment is reimbursed all costs incurred as a result of treatment and implements the request made in point 24 of the opinion. The new point 4 should enable Member States to decide the way in which treatment costs are paid or guarantee the actual payment.

Amendment 13

Article 8 — Hospital and specialised care — Amend

Commission proposal CoR amendment 1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (b) healthcare, included in a specific list, that does not require overnight accommodation of the patient for at least one night. This list shall be limited to: — healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or — healthcare involving treatments presenting a particular risk for the patient or the population. 2. This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). 3. The Member State of affiliation may provide for a system of prior authorisation for reimbursement by its social security system of the cost of hospital care provided in another Member State where the following conditions are met: (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriously undermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. 4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination. 5. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3. 1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (b) healthcare, included in a specific list, that does not require overnight accommodation of the patient for at least one night. This list can include shall be limited to: — healthcare that requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; or — healthcare involving treatments presenting a particular risk for the patient or the population. c) other types of treatment that, due to the nature of the illness, are best carried out in hospitals. 2. This list shall be set up and may be regularly updated by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). by each Member State and updated regularly to ensure it is in line with the Member State's, or in some cases with region's or local authorities, healthcare system. 3. The Member State of affiliation has the possibility to may provide for a general system of prior authorisation for reimbursement by its social security system of the cost of hospital care provided in another Member State, if the healthcare is covered by the Member State's social security system where the following conditions are met: (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriously undermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member State. 4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, and shall not constitute a means of arbitrary discrimination. 4. The system of prior authorisation shall be limited to what is necessary and proportionate to protect patients rights and ensure the planning and funding of hospital care, and shall not constitute a means of arbitrary discrimination. 5. Planned care for patients from other Member States may not impinge on the Member State's ability or obligation to provide care to its own nationals. 5. 6. The Member State shall make publicly available all relevant information on the prior authorisation systems introduced pursuant to the provisions of paragraph 3.

Reason

It is not possible to draw up an exhaustive, common list, which is applicable throughout the EU, of the types of treatment that are to be considered as hospital treatment, since Member States organise their health systems in different ways.

The provision on prior authorisation (para. 3) is considered to be in breach of Article 152 TEC. At present, patient mobility across Member States accounts for only a tiny proportion of all patients in the healthcare system. Under the directive however, one would expect patient mobility to increase, especially in border regions and for certain types of treatment such as elective surgery.

We therefore recommend that a general system of prior authorisation for hospital treatment be set up giving Member States the possibility to control and plan their entire healthcare systems. Member States of treatment would thus be more likely to receive payment for the services they provided, since patients would have received prior authorisation for the treatment from the Member State of affiliation.

Prior authorisation arrangements would also help to ensure that patients benefit from relevant treatment options and that treatment is really necessary and safe for patients. It would also give patients greater peace of mind about being treated in another EU Member State, and about after-care.

Finally, it is essential for the Member State of treatment to be given the right to refuse hospital treatment for capacity reasons. This is crucial to their ability to organise and manage national healthcare systems.

Amendment 14

Article 12 — National contact points for cross-border healthcare — amend

Commission proposal CoR amendment 1. Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. 2. The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities, and with national contact points in other Member States, in particular in the Member State of treatment, and with the Commission: (a) provide and disseminate information to patients in particular on their rights related to cross-border healthcare and the guarantees of quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable; (b) help patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; the national contact point shall in particular inform patients about the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary; (c) gather detailed information on national bodies operating out-of-court settlement of disputes and facilitate co-operation with those bodies; (d) facilitate the development of international out-of-court settlement scheme for disputes arising from cross-border healthcare; 3. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt: (a) measures necessary for the management of the network of national contact points provided for in this Article; (b) the nature and type of data to be collected and exchanged within the network; (c) guidelines on information to patients provided for in paragraph 2(a) of this Article. 1. Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. 2. The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities, and with national contact points in other Member States, in particular in the Member State of treatment, and with the Commission: (a) provide and disseminate information to patients; in particular on their rights related to cross-border healthcare and the guarantees of quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable; (b) help patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; the national contact point shall in particular inform patients about the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary; (c) gather detailed information on national bodies operating out-of-court settlement of disputes and facilitate co-operation with those bodies; (d) facilitate the development of international out-of-court settlement scheme for disputes arising from cross-border healthcare; 3. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt: (a) measures necessary for the management of the network of national contact points provided for in this Article; (b) the nature and type of data to be collected and exchanged within the network; (c) guidelines on information to patients provided for in paragraph 2(a) of this Article.

Reason

It is important for patients to be able to obtain the necessary information on treatment options in other EU countries. The requirement for Member States to provide information, however, is very sweeping and would prove extremely difficult to implement in practice. Moreover, it is not clear what the Commission means with ‘legally binding as regards dispute settlement’. The role and competences of national contact points should be more clearly defined.

Amendment 15

Article 15 — European reference networks — delete text

Commission proposal CoR amendment Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria 2. The objective of European reference networks shall be: (a) to help to realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems from innovations in medical science and health technologies (b) to help to promote access to high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of resources or expertise. (c) to maximise cost-effective use of resources by concentrating them where appropriate; (d) to help to share knowledge and provide training for health professionals; (e) to provide quality and safety benchmarks and to help develop and spread best practice within and outside the network; (f) to help Member States with an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide a full range of highly specialised services of the highest quality. 3. The Commission shall adopt: (a) a list of specific criteria and conditions that the European reference networks must fulfil, including the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks: (i) have appropriate capacities to diagnose, to follow-up and manage patients with evidence of good outcomes so far as applicable; (ii) have sufficient capacity and activity to provide relevant services and maintain quality of the services provided; (iii) have capacity to provide expert advice, diagnosis or confirmation of diagnosis, to produce and adhere to good practice guidelines and to implement outcome measures and quality control; (iv) can demonstrate a multi-disciplinary approach; (v) provide high level of expertise and experience documented through publications, grants or honorific positions, teaching and training activities; (vi) provide strong contribution to research; (vii) are involved in epidemiological surveillance, such as registries; (viii) have close links and collaboration with other expert centres and networks at national and international level and capacity to network; (ix) have close links and collaboration with patients associations where such associations exist. (b) the procedure for establishing European reference networks. 4. The measures referred to in paragraph 3, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria 2. The objective of European reference networks shall be: (a) to help to realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems from innovations in medical science and health technologies (b) to help to promote access to high quality and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of resources or expertise. (c) to maximise cost-effective use of resources by concentrating them where appropriate; (d) to help to share knowledge and provide training for health professionals; (e) to provide quality and safety benchmarks and to help develop and spread best practice within and outside the network; (f) to help Member States with an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide a full range of highly specialised services of the highest quality. 3. The Commission shall adopt: (a) a list of specific criteria and conditions that the European reference networks must fulfil, including the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks: (i) have appropriate capacities to diagnose, to follow-up and manage patients with evidence of good outcomes so far as applicable; (ii) have sufficient capacity and activity to provide relevant services and maintain quality of the services provided; (iii) have capacity to provide expert advice, diagnosis or confirmation of diagnosis, to produce and adhere to good practice guidelines and to implement outcome measures and quality control; (iv) can demonstrate a multi-disciplinary approach; (v) provide high level of expertise and experience documented through publications, grants or honorific positions, teaching and training activities; (vi) provide strong contribution to research; (vii) are involved in epidemiological surveillance, such as registries; (viii) have close links and collaboration with other expert centres and networks at national and international level and capacity to network; (ix) have close links and collaboration with patients associations where such associations exist. (b) the procedure for establishing European reference networks. 4. The measures referred to in paragraph 3, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3).

Reason

We support cross-border cooperation, since this will create added value for Member States. However, it is not necessary to use a directive to regulate cooperation on highly specialised treatment and on the management of new health technology; this would create a legal obligation for Member States to cooperate. The provision is thus not considered to be amongst the objectives set out in Article 1.

Amendment 16

Article 17 — Cooperation on management of new health technologies — delete text

Commission proposal CoR amendment 1. Member States shall facilitate development and functioning of a network connecting the national authorities or bodies responsible for health technology assessment. 2. The objective of the health technology assessment network shall be: (a) to support cooperation between national authorities or bodies; (b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies. 3. Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies. 4. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged. 1. Member States shall facilitate development and functioning of a network connecting the national authorities or bodies responsible for health technology assessment. 2. The objective of the health technology assessment network shall be: (a) to support cooperation between national authorities or bodies; (b) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies. 3. Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies. 4. The Commission shall, in accordance with the procedure referred to in Article 19(2), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.

Reason

We support cross-border cooperation, since this will create added value for Member States. However, it is not necessary to use a directive to regulate cooperation on highly specialised treatment and on the management of new health technology via a directive; this would create a legal obligation for Member States to cooperate. The provision is thus not considered to be amongst the objectives set out in Article 1.

Amendment 17

Article 18(1) — Data collection for statistical and monitoring purposes — Amend

Commission proposal CoR amendment 1. Member States shall collect statistical and other additional data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes. They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data. 1. Member States shall collect statistical and other additional data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes. They shall collect such data exclusively as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data.

Reason

It is a good idea to collect and exchange data across Member States' borders, provided that only existing data is collected and forwarded. Compiling new data would severely strain resources. If new data is to be compiled, the cost:benefit ratio must be assessed.

Brussels, 12 February 2009. The President of the Committee of the Regions Luc VAN DEN BRANDE

(1) Report on the consultation of the subsidiarity monitoring network on the Proposal for a Directive on the application of a patients' rights in cross-border healthcare, http://subsidiarity.cor.europa.eu