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Visit of Dr Paula Vassallo, Hon. Treasurer, to the EU Parliament - 11/09/2008

Visit of Dr Paula Vassallo, on 11th September 2008,to the EU Parliament on ‘Cross Border Healthcare – a Debate between the EU institutions, Health Professionals and Patients on the draft directive.

European Economic and Social Committee

SOC/322
Patients' rights

Brussels, 22 September 2008

WORKING DOCUMENT
of the
Section for Employment, Social Affairs and Citizenship
on the
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 – 2008/0142 (COD)

_____________

Rapporteur: Mr Bouis

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To the members of the Study Group on the application of patients' rights in cross-border healthcare (Section for Employment, Social Affairs and Citizenship)

N.B.: This document will be examined at the meeting to be held on 1 October 2008 starting at 9.30 a.m.

Document submitted for translation: 15 September 2008

Study group:	President:	Mr Rodríguez García-Caro (ES-I)
Health – Patients' rights
	Rapporteur:	Mr Bouis (FR-III) (Rule 62 – Bloch-Lainé)

	Members:	Mr/Ms
		Adams (UK-III)
		Bontea (RO-I)
		Crook (UK-II)
		Cser (HU-II)
		Drbalová (CS-I)
		Hadjiyski (BG-I) (Rule 62 – Kendel)
		Hencks (LU-II)
		Herczog (HU-III)
		Homko (LV-II)
		Kargaard (DA-II)
		Kleemann (AT-I) (Rule 62 – Schweng)
		Komorowski (PL-I) (Rule 62 – Malosse)
		Lucan (RO-III)
		Lüneborg (DA-III)
		Reignault (FR-III)
		Szynaka (PO-II)

	Experts:
	Véronique Ghadi (for the rapporteur) 59, rue Saint Blaise BL6 F – 75020 Paris Lyn Dixon (for Group III) Director of Service Modernisation Executive Director of Nursing NHS North of Tyne 1 Esh Plaza Bevan House – Sir Bobby Robson Way – Great Park Newcastle upon Tyne NE13 9BA UNITED KINGDOM

On 23 July 2008 the Council decided to consult the European Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the

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 – 2008/0142 (COD).

The Section for Employment, Social Affairs and Citizenship, which was responsible for preparing the Committee's work on the subject, adopted its opinion on ... . The rapporteur was … .

At its … plenary session, held on … (meeting of …), the European Economic and Social Committee adopted the following opinion by … votes to …, with … abstentions.

* *

1. Summary of comments and recommendations

1.1 The EESC has addressed problems relating to health and patients' rights in a number of opinions and therefore welcomes this proposal for a Directive, especially since as well as presenting a response to the rulings of the European Court of Justice, the text is intended to consolidate the rights of patients and develop a coordinated European health policy.

1.2 However, the EESC has questions to raise about the specific methods of application. The text re-affirms that health systems fall under the remit of the Member States and seems to respect their competence for organising health systems, delivery of medical care and reimbursement of treatments provided. However, the provisions proposed will necessarily have an impact on health systems and their financing.

1.3 The efficiency and proper use of healthcare services in a cross-border context require that healthcare organisations in the different countries have equivalent capacity in terms of technical services and human resources, and determining the responsibilities of service providers. This means promoting a European policy to support healthcare facilities and the training of healthcare professionals. The ultimate goal should be to allow access to quality healthcare as close to the patient as possible.

1.4 Respecting the fundamental right of every service user to obtain the necessary guarantees of quality and safety entails obligations in relation to standardisation, certification and evaluation of material and human resources, and organisation of care.

1.5 The possibility of cross-border healthcare offered to each citizen must be an extension of direct access to the whole range of services and healthcare professionals, without discrimination on grounds of social or economic status or ethnicity, and with respect for patients' rights as set out by the EESC in its 2007 opinion on patients' rights (SOC/221), based in particular on a European medical file and health booklet that have been properly updated and to which everybody has access.

1.6 An effective information policy is even more vital in relation to cross-border healthcare because it is the only way of honouring the principle of equality of care as set out in the Directive. Only full and relevant information can enable the user to make free and enlightened choices.

1.7 Information must be provided on grievance procedures in the case of harm caused by medical accident, with or without negligence (therapeutic risk) and arrangements for dealing with legal disputes. It would thus be useful to introduce a single information point, and provision must be made for cases to be brought before the courts in the patients' place of residence.

1.8 In order to prevent unequal access to healthcare from increasing, great care must be taken to ensure in relation to systems of retrospective reimbursement that therapeutic practices and methods of delivering of medicines or appliances are determined by the country of treatment rather than country of affiliation.

1.9 In view of the considerable differences in healthcare services provided and their cost, the reimbursement system poses a risk of inequality and even legal disputes because sickness insurance systems are not homogeneous, but have particular national characteristics: direct settlement, co-payment, tiered fees, referring doctor, coding of treatments, etc.

1.10 All systems for providing information, whatever form they take, must not only ensure that messages sent meet security and quality requirements, but even more importantly must enable individuals to make a free choice and allow a democratic healthcare system to develop.

1.11 National contact points must have links with the various workers', family and healthcare user organisations as the appropriate bodies for transmitting this information. Contact points must also develop information and training activities for medical practitioners, paramedical staff and social workers so that they are aware of the options available for cross-border healthcare.

1.12 Particular attention must be paid to ensuring continuity of care, patient follow-up, adjustment of appliances and taking of medicines. In effect, healthcare professionals and systems must coordinate their activities with others outside their locality with regard to medical specialties and patients' long-term treatment protocols.

1.13 The introduction of European reference networks must go hand in hand with development of information and communication technologies that allow all patients to benefit, no matter where they live. Exchanging expertise, skills and training should help to improve quality in all the healthcare systems of the European countries to the advantage of all stakeholders - organisations, healthcare professionals and patients.

1.14 Aggregating the statistical data collected by the Member States should make it possible to evaluate the application of this Directive, but more importantly should provide indicators that can be used to understand in more detail the strengths and weakness of healthcare systems and to learn about people's needs. This evaluation should therefore also be submitted to the EESC.

1.15 Putting in place the necessary methods and means for applying real patient rights in relation to cross-border healthcare requires not just a radical change in practices but also a change in the attitudes and training of healthcare professionals, and therefore some time in which to adapt. It necessarily means incorporating into the text of a European charter reciprocal rights and duties of the various actors in the sphere of public health, regardless of their place of operation.

2. Analysis of the communication

2.1 Legal and political context

2.1.1 In the light of ECJ case law, the Commission was asked in 2003 to examine ways of improving legal certainty in relation to cross-border healthcare.

2.1.2 The 2004 Directive on services in the internal market contained relevant provisions. The European Parliament and the Council rejected these because they considered that they did not take sufficient account of the particular features of healthcare policies, which vary considerably between countries, and of their technical complexities and financing issues. Public opinion is also very sensitive on this issue.

2.1.3 The Commission therefore decided to present a communication and a recommendation in 2008 with a view to establishing a clear and transparent framework for provision of cross-border healthcare in the Union, covering the following areas:

2.1.3.1 a patient moving to a healthcare provider in another Member State for treatment ("patient mobility");

2.1.3.2 cross-border healthcare provision through delivery of a service from the territory of one Member State into the territory of another (e.g. telemedicine services, remote diagnosis and prescription, laboratory services);

2.1.3.3 as well as mobility of service providers (permanent or temporary presence in another Member State).

2.2 Proposed framework

2.2.1 The proposal presented is based on Article 95 of the Treaty, which concerns the functioning of the internal market, Article 152 on public health, and the general principles of the Charter of Fundamental Rights as set out in the reform treaty.

2.2.2 In order to achieve the objectives, the relevant legal definitions and general provisions are structured around three main areas:

2.2.2.1 the common principles in all EU health systems, as agreed in June 2006 by the Council, setting out which Member State is responsible for ensuring the common principles for healthcare and what those principles include;

2.2.2.2 a specific framework for cross-border healthcare: the Directive sets out the entitlements of patients to have healthcare in another Member State, including the limits that Member States can place on such healthcare abroad, as well as the cover provided for cross-border healthcare;

2.2.2.3 European cooperation in the sphere of healthcare: the Directive establishes the framework for European cooperation in border regions.

2.2.3 The Directive sets out the rules that apply to reimbursing the costs of healthcare in another Member State, as well as the terms under which patient rights are to be exercised in practice in line with Court of Justice case law. These rules are based on the following principles:

2.2.3.1 That any non-hospital care to which a citizen is entitled in their own Member State may also be provided without prior authorisation in any other Member State. This will be reimbursed up to the level of reimbursement provided by the citizen's own system.

2.2.3.2 Any hospital care to which a citizen is entitled in their own Member State may also be provided in any other Member State as long as there is proof that application of the Directive does not affect the planning of hospital services or financing of the healthcare system.

2.2.4 The Directive sets out important conditions, as well as criteria, in relation to procedures to be followed. It also provides for appropriate mechanisms for informing and helping patients through national contact points.

2.2.5 This proposal does not modify the existing framework for coordination of social security schemes.

2.2.6 People must have reliable information about when they will be reimbursed for healthcare provided in another Member State and the precise mechanisms they can use for decision-making and grievances. Any patient who cannot find healthcare within a reasonable time in their own country will be authorised to receive it in another Member State.

2.2.7 For any healthcare service delivered, patients must have: clear information enabling them to make choices about their health with knowledge of all the relevant facts; mechanisms for ensuring the quality and safety of the healthcare provided; continuity of care; and grievance and compensation mechanisms.

2.2.8 The Directive ensures that the quality and safety of healthcare are guaranteed throughout the Union.

2.2.9 The Directive promotes more European cooperation through the setting-up of European reference networks, evaluation of healthcare technologies, and development of online information and communication technologies.

3. General comments

3.1 The EESC has addressed problems relating to health and patients' rights in a number of opinions and therefore welcomes this proposal for a Directive.

3.2 This text reflects the values of the European Union and of the Tallinn Charter, which are intended to ensure high-quality healthcare provision throughout Europe.

3.3 However, the EESC has questions to raise about the specific methods of application.

3.3.1 The text re-affirms that health systems fall under the remit of the Member States and seems to fully respect their competence for organising health systems, delivery of medical care and reimbursement of services provided. However, the provisions proposed will necessarily have an impact on health systems and their financing.

3.3.2 In view of the considerable differences in healthcare services provided and their cost, the reimbursement system poses a risk of inequality and even legal disputes because sickness insurance schemes are not homogeneous, but have particular national characteristics.

3.3.3 The efficiency and proper use of healthcare services in a cross-border context requires that healthcare organisations in the different countries have equivalent capacity in terms of technical services and human resources, medical equipment, and determining the responsibilities of service providers.

3.3.4 In all cases, whenever cross-border healthcare is provided, patients have the right to expect guarantees of the quality and safety of such care. This fundamental right raises the question of alignment between healthcare systems in respect of certification, evaluation of professional practice, capacity of medical equipment, and compensation arrangements in the case of harm.

3.3.5 High-quality treatment in the context of cross-border healthcare requires that a number of conditions be met, in order to ensure continuity of care. These would include:

-         widespread use of a health booklet for each individual from birth;
-         existence of a properly updated European medical file to which everybody has access;
-         a common formulation for reimbursement protocols;
-         coordinated prescribing practices, including generalised use of the generic names rather than the trade names;
-         standards and certification for implants and appliances;
-         introduction of a European validation or even certification procedure for medical and paramedical hospital equipment;
-         harmonisation of marketing authorisations for medicines;
-         development of new technologies with interoperable IT systems.

3.3.6 Such conditions require not only a radical change in practice but also a change in the attitudes and training of healthcare professionals, and therefore some time in which to adapt.

3.3.7 The possibility of cross-border healthcare offered to each citizen must be an extension of direct access to the whole range of services and healthcare professionals, without discrimination on grounds of social or economic status or ethnicity. This will require an effective information policy covering two dimensions.

3.3.7.1 Firstly, information on the supply of healthcare, which every citizen must have in order to decide to use cross-border healthcare and which is published under the responsibility of healthcare authorities.

3.3.7.2 Secondly, information must be provided on the patient's medical condition, possible treatments – including benefits and risks – and the type of systems or professionals delivering the healthcare.

3.3.7.3 Since this information will be provided through an interaction with a healthcare professional, that person must themselves be up to date on what options exist in Europe and the language barrier must be overcome.

3.3.8 The information must be complete and relevant so as to enable the patient to make free and enlightened choices rather than being prey to customer poaching and commercialisation practices.

3.3.9 This obligation to provide information is the only way to realise the principle of equality of access to care as set out in the Directive.

4. Specific comments

4.1 Article 5

4.1.1 Going beyond the issue addressed in this Directive, the EESC draws particular attention to Article 5, which fixes rules that can serve as the basis for any measure relating to health policy development in each of the Member States.

4.1.2 Given the importance of healthcare systems for citizens, especially the most disadvantaged among them, as well as the impact on economic growth of better access to healthcare, the EESC stresses that any investment allowing access to healthcare services will be much more effective if it is coordinated.

4.2 Article 6

4.2.1 Great care must be taken to ensure in relation to systems of retrospective reimbursement that therapeutic practices, and methods of delivering medicines or appliances, are determined by the country of treatment rather than the country of affiliation, which is responsible for fixing the criteria for reimbursement. This means that equivalence lists must be laid down both for reimbursement rates and for obligations relating to continuity of care.

4.3 Articles 8 and 9

4.3.1 Regardless of whether criteria for prior authorisation are published, the EESC considers that any refusal should be duly justified and explained to the patient applying.

4.4 Article 10

4.4.1 It is important from the EESC's perspective that systems be introduced for informing patients so as to enable them to make a choice about cross-border healthcare. This information must include the requirements and limits of the service provided, as well reimbursement arrangements.

4.4.2 Information must be provided on grievance procedures in the case of harm caused by medical accident, with or without negligence (therapeutic risk). In this connection it would seem appropriate to apply the principle of a single point of contact for procedures and lodging complaints, and that any legal dispute should be dealt with by the courts in the patient's place of residence.

4.4.3 It would be useful to develop online information services and sites as a way of providing information to patients. However, information sources and systems cannot be limited to this medium, since a large number of people have little or no access to the internet. There would be a risk of promoting a two-speed health system in which only the more advantaged or better-informed social classes could enjoy access to cross-border healthcare.

4.5 Article 12

4.5.1 National contact points must have links with the various workers', family and healthcare user organisations as the appropriate bodies for transmitting this information. Contact points must also develop information and training activities for medical practitioners, paramedical staff and social workers so that they are aware of the options available for cross-border healthcare.

4.6 Article 14

4.6.1 The EESC endorses this article, which guarantees continuity of care in terms of patient's use of medication, but it would like to see this rigorously applied in view of the potential risks of over-consumption or even trafficking.

4.7 Article 15

4.7.1 This article partly assuages the EESC's concern about disparities in the quality of healthcare services provided in the Member States. The introduction of European reference networks must still go hand in hand with development of information and communication technologies that allow all patients to benefit, no matter where they live.

4.7.2 The following should be added to the objectives of the European networks:

- in Article 15(2)(a): "appraisal and registration of therapeutic practices";
- In Article 15(2)(d): "recognition of qualifications and monitoring of codes of ethics".

4.7.3 In addition, although a procedure is envisaged for joining these networks, the EESC highlights the importance of regular evaluation, or even introducing a regular certification procedure.

4.7.4 In the list of specific criteria and conditions that the networks must fulfil, the EESC would like the following to be added:

- in Article 15(3)(a)(ix): "Such collaboration is particularly essential in terms of involving users in defining a reasonable waiting period for treatment."
- Article 15(3)(a)(x): "promoting recognition and application of a common charter of patient rights guaranteeing the effective application of those rights both in the country of origin and in relation to cross-border healthcare".

4.8 Articles 18 and 20

4.8.1 By aggregating statistical data, the Directive should also result in indicators being produced that can be used to understand in more detail the strengths and weakness of healthcare systems and to identify the needs of patients. This evaluation should therefore also be submitted to the EESC.

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