Healthcare across EU borders: a safe framework - European Union Committee Contents

CHAPTER 9: Summary of Conclusions and Recommendations

Chapter 2: Overall objective and the need for action

181.  Ten years of case law on cross-border healthcare have not provided the clarity needed by both patients and healthcare providers. We therefore agree that the main rationale for the Directive should be to clarify the application of treaty provisions to health services.

182.  Whilst we recognise the need for action on these grounds, the response must strike a proportionate balance between individual choice on the one hand and effective delivery of public health provision, within limited budgets and reflecting different national and sub-national practices, on the other. Failure to strike a balance between these two objectives could be detrimental for all patients.

183.  We take the view that the fundamental objective of the proposal should be to ensure that a framework is in place to deliver the availability of healthcare across borders but without excessive complexity and without harming the delivery of national health systems at a local level, and taking particular account of patient safety and redress.

184.  We recall the set of overarching values underlying the delivery of health services throughout the EU that were agreed by EU Health Ministers in 2006 (see Box 2). This also finds expression in recitals 11 and 12 of the Directive. We consider above all that Member States must ensure that the principle of equity, within the terms of Member States' own health systems, underpins the negotiation and implementation of the Directive.

185.  We note the argument that the introduction of patient choice may force hospitals to become much more responsive to patient needs and acknowledge that this may provoke adjustments to the services offered by Member States through the mechanisms and the incentives that choice creates. Choice is welcome if it has a positive effect on the efficient delivery of health services locally. In particular, we recognise that the proposal could have a positive effect where there are particular specialities with very long waiting lists. However, we recommend that effective delivery at the local level must remain a key objective.

186.  It is clear that it will not be possible to identify the Directive's impact until it has been transposed. We therefore conclude that the Directive should be reviewed within three rather than five years after it comes into effect, in order that Member States can learn lessons from the experiences of cross-border healthcare sooner rather than later.

187.  Given the importance of patient inflows and outflows to the stable and secure delivery of healthcare in Member States, we believe that the report produced by the Commission should include information on patient inflows and outflows.

Chapter 3: Legal and Regulatory considerations

188.  Article 49, within which the freedom to receive healthcare services falls, forms one of the fundamental freedoms of the Community and is one of the key principles underpinning the internal market. Article 95 is the legal base for measures which have as their object the establishment and functioning of the internal market. Article 152(5) states clearly that Member States retain full responsibility for the organisation and delivery of health services and medical care. We agree that Article 95 is the appropriate legal base for the Directive but emphasise the principle embodied in Article 152(5) and urge the European institutions to ensure that Member States' responsibility for the organisation and delivery of health services is fully respected in the negotiation and implementation of this Directive. Particular attention must be paid in that regard to the requirements laid down in Article 5 of the draft Directive.

189.  The Commission relies heavily in the draft Directive on delegation of the finer details to comitology committees. We caution that delegated legislation runs the risk of creating rules that go further than intended by legislators, but we recognise that it is sometimes necessary. Recourse to the comitology procedure should be restricted to genuine and appropriate questions of detail, such as the provisions on the mutual recognition of prescriptions. (See paragraph 161)

190.  If Member States are to be able to organise and deliver their own health services and medical care, it is critical that they are able to manage the capacity of health services. The recital in the draft Directive stating that Member States will have the right to refuse incoming patients is therefore welcome but would benefit from some strengthening and from clarification of the term "detriment".

191.  The freedom to receive healthcare services is protected by virtue of Article 49, TEC, and the stated aim of clarifying the European Court of Justice's rulings can only be pursued by Community level action. We are therefore content that the proposal is consistent with the principle of subsidiarity as long as it does not go beyond the action required to clarify and to put into effect the principles laid down the by the ECJ.

192.  Regulation 1408/71 is closely linked to the draft Directive but we were concerned to learn that there is some confusion as to how the two pieces of legislation may interact. We therefore urge that consideration be given to incorporating the relevant provisions of Regulation 1408/71 into the text of the Directive in order to clarify in which circumstances patients may be able to rely on those provisions rather than those of the Directive as currently drafted.

Chapter 4: Prior authorisation and payment

193.  We think that a system of prior authorisation is necessary. This will protect the financial resources of Member States' healthcare systems. It will also allow clinicians to explain clearly to patients the treatment options available to them, including their respective advantages and disadvantages. This is particularly important to enable patients to make an informed decision and consider properly all of their treatment options and the corresponding practical arrangements, such as translation services (see Chapter 5).

194.  A system of prior authorisation under which a patient is reimbursed after having made a payment in the host Member State raises issues of equity as it will exclude those without the necessary financial resources from using cross-border treatment. However, we recognise that issuing funds to the patient in advance of treatment could increase the risk of fraud, a risk that must be assessed by the Commission when reviewing the application of the Directive.

195.  These issues could be tackled by providing that once prior authorisation has been granted, it should be possible to transfer funds from the provider in the home Member State directly to the provider in the host Member State. However, in line with the principle of subsidiarity and given the different systems in use across Member States for payment, it is important that Member States maintain flexibility to decide whether to transfer funds directly.

196.  We are concerned that the definition of hospital care does not adequately reflect clinical reality across the EU and we query the need to distinguish between hospital and non-hospital care for prior authorisation in the manner proposed by the Commission. Instead, we suggest that the guidance of the European Court of Justice should be used, whereby prior authorisation can only be justified by overriding reasons of general interest. In recognition of the different health systems and methods of financing across the EU and in line with the principle of subsidiarity, we recommend that it should be for each Member State to decide when prior authorisation is required, subject to the principles laid down in the ECJ's case law.

197.  We agree that, where a prior authorisation system operates, patients must have a right of appeal in case prior authorisation is refused. This right will be distinct to each Member State and it should be clearly communicated to the patient, along with the procedure for exercising this right. Failure to do so could constitute an unnecessary barrier to patients' rights to seek cross-border healthcare.

198.  We recognise the potential for Article 6 of this Directive to impact upon the equity of cross-border healthcare and note that the prospect of additional costs may deter some people from seeking cross-border healthcare. We consider that it is for Member States to determine the rules for "top-up" payments, both for medical care and for prescribed medicines.

Chapter 5: Communication, Provision of information and language considerations

199.  We believe that the provision of accessible and comprehensive information to patients and medical practitioners is key to the success of the Directive. Patients will only be able to make an informed decision on whether to seek cross-border treatment if they have access to relevant information. Similarly, practitioners will need access to this information in order to advise patients appropriately. We consider that the provision and financing of information must be the responsibility of the home Member State.

200.  The Commission proposes that the information provided should include details about receiving healthcare in another Member State, the terms and conditions that would apply, patients' entitlements, procedures for using those entitlements and systems of appeal and redress if the patient is deprived of such entitlements or harm is caused as a result of healthcare received in another Member State. We agree with the Commission's suggestions about what information for patients should include. However, we recommend that a standard Community format for the provision of this information should not be drawn up. The different procedures and processes that would need to be taken into account are numerous and we believe that this could result in the information being presented in a format that is difficult for patients to understand or use.

201.  We consider that there is a lack of clarity in the Directive as to who is responsible for providing information on the service available in a particular Member State. We recommend that the government of each Member State should be responsible for describing their own health system. Furthermore, we consider that the exact role of national contact points in the provision and dissemination of information, and where responsibility for them should rest, should be clarified in the Directive.

202.  The current lack of clarity over who is to provide what information, and how, creates the potential for this burden to fall primarily on medical practitioners. While their involvement may be beneficial for helping patients make an informed decision about cross-border care (see paragraph 72), we recommend that the Directive makes clear that front line health providers giving this information to patients should be protected against complaints made against them if a patient suffers unexpected harm in the course of subsequent treatment abroad.

203.   Furthermore, we fear that the need to provide information and advice on cross-border treatment would interfere with the performance of practitioners' duties and could detract from the standard or timeliness of treatment of local patients. We therefore recommend that the Directive should avoid the imposition of any administrative burden on healthcare practitioners due primarily to information provision obligations.

204.  It is clear that language may prove to be a barrier in the delivery of cross-border healthcare and that this may impact on a patient's choice to travel. We therefore consider that patients must be made aware of any language issues and costs before they seek cross-border healthcare. Language barriers could prove particularly critical in the areas of giving consent and ensuring continuity of care and patient safety. We recommend that the responsibility for addressing the language barrier is decided by the home Member State.

Chapter 6: Patient safety and the pathway of care

205.  We conclude that clarity is required about the responsibilities of all those involved in the pathway of care. This is particularly important in order to ensure patient safety and to enable patients to make an informed decision to seek cross-border healthcare, aware of who is responsible for every stage of their treatment and who will be accountable should anything go wrong along the pathway of care.

206.  The secure and timely transfer of patients' records across borders is essential for patients' continuity of care. This may be problematic if case notes are recorded in different languages in the host and home Member State. We recommend that a clearer system is established for the transfer of patients' medical records.

207.  We note that Directive 2005/36/EC (see paragraph 131) on the recognition of professional qualifications requires collaboration on information exchange across the Member States. Nevertheless, we consider that without an obligation to exchange fitness-to-practise information this would not take place at a satisfactory or uniform level across all Member States and could result in problems such as medical practitioners with proceedings against them still being able to practise in other Member States where they were already registered. We therefore recommend that Member States should be obliged to exchange information on medical practitioners' fitness to practise.

208.  We note that over-rigid application of data protection rules has acted as an obstacle to such systematic sharing of information in the past. We therefore recommend that the European Commission examine the extent to which data protection legislation may need to be amended in order to facilitate the exchange of information on fitness to practise, whilst minimising the threat of data misuse.

Chapter 7: Redress and Indemnity

209.  The availability, and public awareness, of a transparent complaints and redress mechanism for patients is critical to the functioning of a cross-border healthcare system in the EU's internal market. We consider that not only should the Directive require a means of redress to be in place but that Article 5(1)(d) should be amended so as to require that the redress process be transparent and that patients must be aware of it. Information on the applicable redress mechanism should be made available to patients when investigating the possibility of securing healthcare treatment in a different Member State and responsibility for provision of that information should be made clear.

210.  The Directive does not provide clarity on how the home Member State might seek compensation from the host Member State for the cost of rectifying clinical mistakes made by the host Member State. For the purpose of delivering cross-border healthcare, we consider it essential that the Commission examines how a home Member State may be able to claim compensation for the cost of tackling problems caused by clinical errors in the host Member State.

211.  The definition of "harm" in the draft Directive does not distinguish between harm caused by poor or negligent care and accidental harm. We recommend that the definition be amended to ensure that it does not cover unavoidable harm. We would also emphasise that provision should be made for compensation in the event of accidental harm.

212.  It is important, as indicated in the draft Directive, that practitioners hold professional liability insurance or similar and it is also crucial that the principle of subsidiarity be respected. We consider that the precise nature of the insurance system or similar is a matter for each individual Member State. However, we recommend that clear information on the systems chosen by each Member State must be made available to patients at the national contact point in the home Member State. This information should include the extent of insurance cover for institutions and practitioners and the implications of insurance systems for patients and practitioners.

Chapter 8: Co-operation between Member States

213.  Cross-border recognition of prescriptions is desirable, particularly to ensure continuity of care for those who require follow-up treatment on returning home. While we recognise that this is already taking place (see paragraphs 164-165), we recommend that the Commission develops detailed rules for this system to ensure that confusion is avoided, particularly in relation to language, the names of medicinal products and the verification of whether a prescription has been issued by a legitimate prescriber. The consequence of not doing so would be to undermine the safety and easy accessibility of cross-border healthcare. We consider that common rules on the content and drafting of prescriptions would assist in overcoming this confusion. This need not imply the introduction of a common prescription template.

214.  With or without the Directive, we note that collaboration between service providers across the European Union already takes place in order to share best practice. We nevertheless consider that European reference networks have the potential to assist the delivery of health services across borders and within each Member State. We conclude that such networks may be most effective if they are speciality-based as this would allow relevant experience and best practice to be taken into account. We also believe it is important that the reference networks should not become overburdened by regulation. We recommend that European reference networks could be a useful forum in which to develop EU-wide benchmarking on quality standards.

215.  It is clear to us that the electronic interoperability of systems is important, particularly to ensure continuity of care, but we note that this has proved challenging even within Member States. We therefore urge the Commission and Member States not to underestimate the challenge of this task and to assess carefully the impact and modalities of introducing any system across the EU.

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