Select Committee on European Union Eighth Report


APPENDIX: CORRESPONDENCE


Letter dated 26 October 2006 from the Minister of State for Health Services to the Chairman of the European Union Select Committee

Communication from the Commission: Consultation regarding Community action on health services SEC (2006) 1195/4

I attach an Explanatory Memorandum on the European Commission's communication on health services. This communication is a consultation document on the possible EU-level action on health services. It picks up on the development of European Court of Justice case law on patient mobility over the last ten years which culminated in the Watts judgement of 16 May 2006, which confirmed that the case law patient mobility does apply to tax-funded healthcare systems like the NHS. However the case law—which currently applies to the UK and, in certain circumstances confers on NHS patients the right to be treated abroad at NHS expense—has left areas of legal uncertainty, for example on exactly how Member States can manage such cross-border health care.

Another motor behind this work is the removal of healthcare from the scope of the Services Directive. This cross-cutting Directive—which, in its original version, contained an article on the reimbursement of costs for cross-border patient mobility—was unsuitable for addressing the specificities of the healthcare sector. However, the removal of healthcare from the scope of the Directive—which we successfully argued for—has led the Commission to try to address some of these specificities through the work on health services.

The Department of Health sees potential advantages in health services legislation, not least in building a consensus between EU Member States and the EU institutions on how European Treaty articles apply to health care services. The consultation and debate that will follow offers us an opportunity to engage with other Member States and the Commission to influence the debate towards our thinking in this area.

The Health Council has already been active in this controversial area, where significant legal uncertainty remains. In June all 25 Health Ministers agreed on a statement of Values and Common Principles (a copy of which is attached) which framed the area where it thinks EU-level work should focus. The central point of this statement is that, although there are shared values across European health systems, there are very significant limits to the amount of harmonisation that could or should be attempted.

I would be delighted to come and speak to your Committee on these points, should you wish.

Letter dated 15 January 2007 from the Chairman of EU Sub-Committee G to the Minister of State for Health Services

Commission Consultation—Community Action on Health Services SEC (2006) 1195/4

Many thanks for offering to visit EU Sub-Committee G at 10am on 25 January to talk to us about the Commission's Consultation on Community Action in Health Services.

I thought it would be helpful to write to you in advance setting out how I feel the session might most profitably be structured.

We felt that your offer to visit the Sub-Committee, made in your letter to Lord Grenfell of 26 October, provided us with a valuable opportunity to add an additional informative, initial, stage to the usual scrutiny process.

We recognised the complexity and wide ranging implications of the issues relating to the Community Action on Health Services proposals, and we welcomed your suggestion that you should visit the Sub-Committee to go over the key issues with Members, in a little more depth than can be done in an Explanatory Memorandum.

It will be entirely up to you whether you would like to set out your views in an opening statement on 25 January. However, I hope that you will take advantage of the opportunity to do so. This consultation relates to an important and potentially quite contentious area of policy, and it would be most valuable for Members to hear from you the Government's view of the key issues including:

  • the problems with the current legal position that might usefully be addressed by Commission proposals;
  • the UK Government's views of how the Commission's proposals might best be framed to address these problems;
  • any concerns about possible legislative proposals that the UK Government would not find acceptable; and
  • whether a framework for non-regulatory co-operation between Member States could help to support the legal framework and, if so, the sort of issues it could most usefully cover.

Following such an opening statement, Members will probably wish to take the opportunity to ask you a number of questions, and my Committee Clerk will certainly let your departmental officials have advance warning of these.

Following your briefing, I would foresee the scrutiny moving into the more usual pattern, with a follow-up letter from Lord Grenfell raising a number of questions for the future. It is also possible that the Sub-Committee will wish to conduct an Inquiry into this topic, but no decision on this has yet been taken.

Letter dated 8 February 2007 from the Chairman of EU Sub-Committee G to the Minister of State for Health Services

SEC (2006) 1195/04: Communication from the Commission: Consultation regarding Community action on health services

Many thanks for the oral evidence which you and your officials presented to EU Sub-Committee G on Thursday 25 January. We will shortly publish a Report to the House which contains a transcript of the session.

The meeting helped to improve our understanding of the significant and sensitive issues, of both a legal and political nature, that need to be resolved in order to find an acceptable way forward in this case. In particular, we recognise the point you made that there is a need to get the framework for European Health Services right so that it can provide a fair and transparent system for people seeking health care and, at the same time, ensure that it does not undermine the UK health service.

We would be grateful if you could let us have sight of the Government's response to the Commission's consultation and, in the future, keep us informed of progress towards the formulation of firm proposals by the Commission for establishing a framework which provides greater clarity. In the meantime, we are now content to release this consultation document from scrutiny.

Attachments to letter dated 26 October from the Minister of State for Health Services

Statement on common values and principles

This is a statement by the 25 Health Ministers of the European Union, about the common values and principles that underpin Europe's health systems. We believe such a statement is important in providing clarity for our citizens, and timely, because of the recent vote of the Parliament and the revised proposal of the Commission to remove healthcare from the proposed Directive on Services in the Internal Market. We strongly believe that developments in this area should result from political consensus, and not solely from case law.

We also believe that it will be important to safeguard the common values and principles outlined below s regards the application of competition rules on the systems that implement them.

This statement builds on discussions that have taken place in the Council and with the Commission as part of the Open Method of Coordination, and the High Level Process of Reflection on Patient Mobility and healthcare development in the EU. It also takes into account the legal instruments at European or international level which have an impact in the field of health.

This statement sets out the common values and principles that are shared across the European Union about how health systems respond to the needs of the populations and patients that they serve. It also explains that the practical ways in which these values and principles become a reality in the health systems of the EU vary significantly between Member States, and will continue to do so. In particular, decisions about the basket of healthcare to which citizens are entitled and the mechanisms used to finance and deliver that healthcare, such as the extent to which it is appropriate to rely on market mechanisms and competitive pressures to manage health systems must be taken in the national context.

Common Values and Principles

The health systems of the European Union are a central part of Europe's high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development.

The overarching values of universality, access to good quality care, equity, and solidarity have been widely accepted in the work of the different EU institutions. Together they constitute a set of values that are shared across Europe. Universality means that no-one is barred access to health care; solidarity is closely linked to the financial arrangement of our national health systems and the need to ensure accessibility to all; equity relates to equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay. EU health systems also aim to reduce the gap in health inequalities, which is a concern of EU Member States; closely linked to this is the work in the Member States' systems on the prevention of illness and disease by inter alia the promotion of healthy lifestyles.

All health systems in the EU aim to make provision, which is patient-centered and responsive to individual need.

However, different Member States have different approaches to making a practical reality of these values; they have, for example, different approaches to questions such as whether individuals should pay a personal contribution towards the cost of elements of their health care, or whether there is a general contribution, and whether this is paid for from supplementary insurance. Member States have implemented different provisions to ensure equity: some have chosen to express it in terms of the rights of patients; others in terms of the obligations of healthcare providers. Enforcement is also carried out differently—in some Member States it is through the courts, in others through boards, ombudsmen etc.

It is an essential feature of all our systems that we aim to make them financially sustainable in a way which safeguards these values into the future.

To adopt an approach that shift focus towards preventative measures is an integral part of Member States strategy to reduce the economic burden on the national health care systems as prevention significantly contributes to cost reduction in healthcare and therefore to financial sustainability by avoiding disease and therefore follow up costs.

Beneath these overarching values, there is also a set of operating principles that are shared across the European Union, in the sense that all EU citizens would expect to find them, and structures to support them in a health system anywhere in the EU. These include:

  • Quality:

All EU health systems strive to provide good quality care. This is achieved in particular through the obligation to continuous training of healthcare staff based on clearly defined national standards and ensuring that staff have access to advice about best practice in quality, stimulating innovation and spreading good practice, developing systems to ensure good clinical governance, and through monitoring quality in the health system. An important part of this agenda also relates to the principle of safety.

  • Safety:

Patients can expect each EU health system to secure a systematic approach to ensuring patient safety, including the monitoring of risk factors and adequate, training for health professionals, and protection against misleading advertising of health products and treatments.

  • Care that is based on evidence and ethics:

Demographic challenges and new medical technologies can give rise to difficult questions (of ethics and affordability), which all EU Member State must answer. Ensuring that care systems are evidence-based is essential, both for providing high-quality treatment, and ensuring sustainability over the long term. All systems have to deal with the challenge of prioritising health care in a way that balances the needs of individual patients with the financial resources available to treat the whole population.

  • Patient Involvement:

All EU health systems aim to be patient-centred. This means they aim to involve patients in their treatment, to be transparent with them, and to offer them choices where this is possible, eg a choice between different health care service providers. Each system aims to offer individuals information about their health status, and the right to be fully informed about the treatment being offered to them, and to consent to such treatment. All systems should also be publicly accountable and ensure good governance and transparency.

  • Redress:

Patients should have a right to redress if things go wrong. This includes having a transparent and fair complaints procedure, and clear information about liabilities and specific forms of redress determined by the health system in question (eg. compensation).

  • Privacy and confidentiality:

The right of all EU citizens to confidentiality of personal information is recognised in EU and national legislation.

As Health Ministers, we note increasing interest in the question of the role of market mechanisms (including competitive pressure) in the management of health systems. There are many policy developments in this area under way in the health systems of the European Union which are aimed at encouraging plurality and choice and making most efficient use of resources. We can learn from each other's policy developments in this area, but it is for individual Member States to determine their own approach with specific interventions tailored to the health system concerned.

Whilst it is not appropriate to try to standardise health systems at an EU level, there is immense value in work at a European level on health care. Member States are committed to working together to share experiences and information about approaches and good practice, for example through the Commission's High Level Group on Health Services and Medical Care, or through the ongoing Open Method of Coordination on healthcare and long- term care, in order to achieve the shared goal of promoting more efficient and accessible high-quality healthcare in Europe. We believe there is particular value in any appropriate initiative on health services ensuring clarity for European citizens about their rights and entitlements when they move from one EU Member State to another and in enshrining these values and principles in a legal framework in order to ensure legal certainty.

In conclusion, our health systems are a fundamental part of Europe's social infrastructure. We do not under-estimate the challenges that lie ahead in reconciling individual needs with the available finances, as the population of Europe ages, as expectations rise, and as medicine advances. In discussing future strategies, our shared concern should be to protect the values and principles that underpin the health systems of the EU. As Health Ministers in the 25 Member States of the European Union, we invite the European Institutions to ensure that their work will protect these values as work develops to explore the implications of the European Union on health systems as well as the integration of health aspects in all policies.

EXPLANATORY MEMORANDUM ON EUROPEAN COMMUNITY DOCUMENT SEC (2006)1195/4

Commission Communication on Health Services: Consultation regarding Community Action on Health Services

Submitted by the Department of Health  27 October 2006

SUBJECT MATTER

The Commission has published a communication on health services. This document forms a consultation on health services that will run until the end of January 2007.

Two factors have prompted this Communication. Firstly, the development of European Court of Justice (ECJ) case law on patient mobility over the last ten years has left some areas of legal uncertainty (for example, on the question of who has responsibility for the safety of patients being treated in other Member States). Secondly, the removal of healthcare from the scope of the Services Directive, which has prompted the Commission to look at a sector-specific piece of work. In its 2007 Annual Policy Strategy the Commission undertook to provide certainty over the application of Community law to health services and healthcare.

The Communication emphasises that Community action does not mean harmonisation of health systems, and that the organisation of the benefits that different systems provide must remain the responsibility of the Member States, in line with the principle of subsidiarity. The Communication focuses on two pillars: legal certainty where it is needed—notably in cross-border care; and support for Member States in areas where European action can add value.

Legal certainty

On legal certainty, the Communication notes that the ECJ has ruled that healthcare services must be regarded as services within the meaning of the relevant Treaty articles on free movement of services. Thus any requirement that a patient should seek 'prior authorisation' from their home health system as a precondition on the costs of their treatment being reimbursed is a barrier to the freedom to provide services; such barriers may be justified by overriding reasons of general interest (such as maintaining the financial sustainability of health systems).

Cross-border healthcare is considered in four distinct categories:

  • Provision of services (e.g. remote diagnosis; telemedicine; laboratory services)
  • Use of services abroad by patients
  • Permanent presence of service providers from other Member States
  • Mobility of health professionals

The Communication argues that wider European cooperation has great practical utility in facing the wider challenges that healthcare systems must cope with e.g. in some areas it may be more practical for citizens of one EU Member State to visit a nearby hospital across an internal border; smaller Member States may find it more efficient to share specialized facilities where they could not afford to maintain them on their own. The 'open method of coordination' is developing mechanisms for information exchange and peer review as a means of sharing best practice in a non-regulatory framework.

It also suggests that an analysis of the impact of the economic, social, and health impacts of cross-border healthcare is required. The consultation questions on the legal certainty that is required focus on four areas:

Minimum information and clarification requirements to enable cross-border healthcare

This could include clarification of where Member States may insist on a system of 'prior authorisation' for accessing treatment abroad; and where such authorisation must be given. It also refers to the information that patients and professionals need to make choice about treatments and providers in other Member States.

Identifying the competent authorities and their responsibilities

Clarity is needed over which authority is responsible for ensuring the quality and safety of services provided to people from other Member States; also the question of whose system of redress should apply. The question of ensuring successful continuity of care for patients crossing borders for treatment is also posed.

Responsibility for harm caused by healthcare and compensation arising from cross-border healthcare

Clarity is needed over who is responsible for ensuring patient safety in cross- border healthcare, and which clinical liability mechanisms apply in case of harm.

Ensuring a balanced healthcare accessible for all

The Communication points out that, although the volume of patient mobility is relatively low, there are some circumstances where it may be much higher, such as border regions or tourist resorts. Clarity is needed on the actions that Member States may take to ensure that treating patients from other Member States does not prevent the provision of a balanced healthcare system open to all.

Support to Member States

The Communication refers to certain other actions that may add value to the actions taken at Member State level:

European networks of centres of reference

The Communication refers to the possibility of concentrating resources or expertise for treatment of rare diseases, for example.

Realising the potential of health innovation

Sharing scientific evidence to spread best practice and avoid duplication of resources.

Shared evidence base for policy-making

Strengthening mechanisms to share evidence on techniques and outcomes of treatment.

Health systems impact assessment

Implementing a mechanism to consider the impact on health systems of Community action.

Options for action

The Communication notes that there are a wide range of possible actions, but that legal certainty would be best ensured by a binding legal instrument, as an interpretative communication will probably not be sufficient.

There are also various non-legislative options, including practical cooperation through the High Level Group on health services and medical care, and the open method of coordination.

MINISTERIAL RESPONSIBILITY

The Secretary of State for Health has lead responsibility. Ministers of the Scottish Executive and the Welsh Assembly have an interest relating to their responsibilities for health care provision. Whilst the Northern Ireland Assembly and Executive are suspended the Secretary of State for Northern Ireland has these functions.

LEGAL AND PROCEDURAL ISSUES

Legal basis

As this is a Communication with no legally binding or effective provision, no legal basis is required.

Impact on UK law

As this is only a consultation document, there are no direct implications for UK law at the moment. However, it should be noted that the case law that this communication addresses currently does have an impact on UK law.

POLICY IMPLICATIONS

We intend to engage pro-actively with the Commission, Member States, and other stakeholders at an early stage of the development of this dossier, to achieve maximum influence in the process; in particular through ensuring the discussion looks at what we consider to be the key issues where clarification is needed. This engagement will be at Ministerial and official level, and will be ongoing during the coming months.

This consultation gives us the opportunity to highlight the areas of legal uncertainty that the current case law has created, and where greater legal certainty would be beneficial to health system managers.

FINANCIAL IMPLICATIONS

None

TIMETABLE

This consultation will close on 31 January 2007. The Commission's response to the consultation is expected in the first half of 2007.


 
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