Documents considered by the Committee on 12 January 2011 - European Scrutiny Committee Contents

5 Cross-border healthcare


11038/2/10 REV 2

Position of the Council at first reading with a view to adopting a Directive on the application of patients' rights in cross-border healthcare

Legal baseArticles 114 and 168 TFEU; co-decision; QMV
Document originated13 September 2010
Deposited in Parliament
Basis of considerationMinister's letter of 6 December 2010 and EM of 8 December 2010
Previous Committee ReportNone, but see HC 16-xxviii (2007-08), chapter 2 (22 July 2008); HC 16-xxx (2007-08), chapter 7 (8 October 2008); HC 19-xix (2008-09), chapter 12 (10 June 2009) and HC 19-xxi (2008-09), chapter 6 (24 June 2009).
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionNot cleared; further information requested


5.1 In July 2008, the Commission proposed a Directive which was intended to clarify EU law on patient mobility in the wake of Court of Justice rulings establishing that Treaty provisions on the freedom to provide services entitled patients to be reimbursed for the cost of healthcare services provided in another Member State. The Court's rulings distinguished between hospital and non-hospital care and developed the following principles:

  • an individual entitled to non-hospital care in his or her home Member State could seek the same care in another Member State without obtaining prior authorisation and should be reimbursed to the same level as would apply for care received at home;
  • an individual entitled to hospital care in his or her home Member State could seek prior authorisation to obtain the same care in another Member State. The home State would be required to grant authorisation if its own care system could not provide the care requested within a medically accepted time limit and would have to reimburse the costs of treatment abroad at least up to the level provided for in its own healthcare system.

5.2 The Directive proposed by the Commission had three principal objectives. These were, first, to establish common principles underpinning the delivery of healthcare in all Member States — notably, universality, access to good quality care, equity and solidarity — and to make clear that the Member State of treatment is responsible for defining, monitoring and maintaining quality and safety standards for health care providers practicing within its territory. Second, the Directive should establish a clear legal framework for cross-border healthcare covering entitlement to, and reimbursement for, care obtained in another Member State. Third, the Directive proposed strengthening cooperation between Member States to include, for example, the mutual recognition of prescriptions, the development of networks of healthcare providers and of national authorities responsible for developing new health technologies, and measures to achieve the interoperability of Member States' IT systems in the healthcare field. The draft Directive was intended to supplement, not replace, long-standing arrangements for the provision of reciprocal health care services under EU legislation on the coordination of social security schemes.[31]

5.3 Our predecessors considered that EU legislation to clarify the entitlement to reimbursement for cross-border healthcare and the responsibilities of both the home Member State and the Member State of treatment would be desirable and, recognising the political importance of the Commission's draft Directive, recommended it for debate in the European Committee. The debate took place on 21 October 2008. Although the debate had the effect of clearing the proposal from scrutiny, our predecessors requested (and have received) regular updates on the progress of negotiations.

5.4 In June, the Minister of State at the Department of Health (Gillian Merron) wrote to inform us that the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) had reached a political agreement on a compromise Spanish Presidency.

The Minister's letter of 6 December 2010

5.5 The Parliamentary Under-Secretary of State at the Department of Health (Anne Milton) provides further information on the vote in EPSCO in June. She says that 23 Member States voted for the Presidency compromise text, three opposed (Poland, Portugal and Slovakia) and one abstained (Romania). The Council formally adopted its common position on the draft Directive on 13 September and negotiations are underway with the European Parliament (EP) with a view to reaching an agreement at Second Reading. She expects the EP to vote on the Council's common position between 17-20 January 2011, at which point the text may be agreed by the Council or go to conciliation.

5.6 The Minister explains how the Council's common position has sought to resolve one of the more contentious issues in the negotiation. Member States were divided on whether or not the draft Directive should apply to private healthcare providers who are not contracted to a state healthcare system. The Council text does not restrict the scope of application of the Directive but introduces new flexibility for Member States to "restrict prior authorisation for patients who wish to seek treatment with providers in the EU where there is evidence of a poor quality and safety record or where the provider does not meet the quality and safety requirements laid down in the legislation of the Member State of treatment."[32] The Minister says that the Government considers this to be "a sensible compromise."

The Council's common position text

5.7 The Minister has deposited the Council's common position of 13 September and provided an Explanatory Memorandum which describes the changes made to the Commission's original proposal. Chapter I of the Council's text contains general provisions on the subject matter and scope of the draft Directive, its relationship with other secondary EU law, and definitions. Chapter II sets out the responsibilities of Member States as regards cross-border healthcare, with separate Articles on the responsibilities of the Member State of treatment and the patient's home Member State (called the Member State of affiliation), as well as the role and responsibilities of national contact points. Chapter III covers the reimbursement of the costs of cross-border healthcare and Chapter IV identifies areas in which Member States shall strengthen cooperation in healthcare. Chapter V concerns implementation and entry into force.

5.8 The main elements of the Council's common position are as follows:

  • the legal base — this has been amended to include a reference to the Treaty Article on public health (Article 168 TFEU) as well as the internal market (Article 114 TFEU);
  • the scope — while the Directive continues to apply to "the provision of healthcare to patients, regardless of how it is organised, delivered and financed", an express reference to public and private providers is omitted in the Council's text; the text also introduces three new exclusions which concern long-term care; the allocation of, and access to, organs for organ transplantation; and public vaccination programmes against infectious diseases (Article 1);
  • assertion of Member State competence — the Council text strengthens references to Member State competence for the organisation and delivery of healthcare and says that the Directive shall not affect national rules on the organisation and financing of healthcare in situations which do not concern cross-border healthcare (Article 1);
  • responsibilities of the Member State of treatment — Article 4 clarifies that the provision of healthcare is subject to the laws and quality and safety standards applicable in the Member State of treatment which must make relevant information available to patients, if requested; there is new provision for patients to be given a written or electronic record of their treatment; while the principle of non-discrimination on grounds of nationality applies to patients from other Member States, there is new flexibility for Member States to restrict access to treatment "if justified by overriding reasons of general interest" in order to fulfil their "fundamental responsibility to ensure sufficient and permanent access to healthcare" within their territories (Article 4); and Member States must ensure that healthcare providers charge the same fees for patients from other Member States as for domestic patients;
  • responsibilities of the home Member State — Article 5 requires Member States to ensure that there are mechanisms for informing patients, at their request, of their entitlement to receive healthcare in another Member State and to have access for that purpose to their medical records;
  • national contact points — the Council text removes the general advocacy role of national contact points foreseen in the Commission's proposal and focuses, instead, on their role in supplying information about healthcare providers (including, on request, information on a specific provider's right to provide healthcare and any restrictions on its practice), as well as information on applicable healthcare standards and guidelines and on complaints procedures (Article 6);
  • reimbursement of costs — Article 7(1) sets out the general principle that the home Member State shall reimburse the costs of healthcare received in another Member State if the patient would have been entitled to the same treatment in the home Member State. However, costs are capped at the level of expenditure that would have been allowed if the treatment had been received in the patient's home State (Article 7(4)). Moreover, reimbursement of costs may be subject to satisfying the usual eligibility criteria for treatment in the home State. So, for example, a UK patient may still be required to obtain a referral from a General Practitioner (Article 7(7)). A new compromise text clarifies the responsibilities of Member States for the healthcare costs of pensioners and their families who have left their Member State of origin to live in another Member State (for example, UK pensioners living in Spain (Article 7(2));
  • new restrictions on reimbursement of costs — Article 7(9) introduces a new basis for restricting the reimbursement of costs for healthcare received in another Member State where there are "overriding reasons of general interest such as the risk of seriously undermining the financial balance of a social security system, or the objective of maintaining a balanced hospital service open to all". The home Member State may also stipulate that it will only reimburse the cost of treatment provided by healthcare providers in other Member States that have professional liability insurance;
  • prior authorisation — Article 8(2) specifies the types of treatment (mainly hospital treatment and specialised care) for which the home Member State may require prior authorisation; Article 8(5) sets out a non-exhaustive list of reasons for refusing prior authorisation for treatment in another Member State which include, for example, ineligibility for a particular treatment under the rules in force in the patient's home State or availability of the treatment in the home State within a medically justifiable time limit; prior authorisation may also be refused if the home State has "serious and specific concerns" about a particular healthcare provider's compliance with standards on quality of care and patient safety in the Member State of treatment;
  • European reference networks — the Council text emphasises the voluntary nature of these networks of healthcare providers and centres of medical expertise, with the role of the Commission limited to providing support for their development (Article 12);
  • eHealth — the ambitious goal of developing interoperable ICT healthcare systems has been replaced by a more modest commitment to voluntary cooperation to develop "European e-health systems and services and interoperable applications", with the Commission tasked to draw up guidelines on a non-exhaustive list of personal information to be included in patient summaries (Article 13); and
  • cooperation on health technology assessment — the focus here, too, is on the role of the Commission in supporting and facilitating cooperation and the exchange of information on new health technologies, including by means of EU financial support.

The Government's view

5.9 The Parliamentary Under-Secretary of State (Anne Milton) explains that the proposed Directive is intended to cover situations in which individuals seek to rely on Article 56 TFEU — on the freedom to provide (and receive) services — in order to obtain reimbursement for medical treatment received in another Member State. It will operate in parallel with Regulation 883/2004 which establishes an entitlement to emergency medical treatment in another Member State in the event of an unexpected illness while staying there and which also entitles a patient to seek authorisation (in England, from primary care trusts, in Scotland and Wales, from Local Health Boards, and in Northern Ireland, from the Health Department) for planned treatment abroad under EU arrangements for the coordination of social security schemes.

5.10 The Minister says:

"The proposed Directive acknowledges that it is for Member States to manage their own healthcare systems. It is does not create any new entitlement to obtain services in another member state that a person would not be entitled to obtain in their home state. It aims to ensure that where a patient exercises their right to obtain health care in another member state, such healthcare is of high quality and is safe and efficient. The draft Directive proposes that member states should establish national contact points to provide patients with information about cross-border care. The draft directive also proposes some areas where Member States should co-operate to facilitate the provision of cross-border care — for example, on health technology assessment."[33]

5.11 In her Explanatory Memorandum, the Minister highlights the changes made by the Council to the Commission's original proposal. She says that the introduction of Article 168 TFEU as an additional legal base (supplementing Article 114 on the internal market) is necessitated by the inclusion of provisions on European reference networks and cooperation on health technology assessment. She adds that a number of provisions have been amended because the Commission's original wording risked encroaching on Member States' competence for determining health policy and organising and delivering health services and medical care. So, for example, the Council's text makes clear that the Member State of treatment is responsible for determining standards of care, quality and safety, but without creating an obligation under EU law for it to do so.

5.12 The Minister explains in some detail the arrangements applicable to the reimbursement of costs under Article 7 of the Council's common position. She says that there was a great deal of discussion in Council about which rules should apply to pensioners and members of their families who are resident in another Member State (for example, UK pensioners in Spain) and who receive healthcare during a temporary return to their Member State of origin. Under existing arrangements on the coordination of social security systems, the UK is only responsible for the cost of emergency treatment. During negotiations on the draft Directive, some Member States had argued that the Member State of origin should meet the costs of medical treatment in all cases. The compromise agreed by the Council means that the UK will also meet the costs of planned (non-emergency) healthcare which is not subject to prior authorisation — in other words, non-specialist treatment and treatment which does not require admission to a hospital. The Minister adds:

"All of these rights of reimbursement continue to be dependent on the normal eligibility criteria, and regulatory and administrative procedures of the Member State of origin. In other words, pensioners and members of their families returning to the UK will be treated in the same way as other UK residents. The provision does not confer any entitlement to treatment that would not be made available under the NHS. It does not give any advantages over UK residents.

"The UK Government believes that this represents a reasonable compromise agreement, particularly in view of the lack of any evidence of large numbers of pensioners returning to the UK to receive healthcare that does not require prior authorisation."[34]

5.13 The Minister draws attention to Article 7(5) which enables Member States to "adopt provisions in accordance with the Treaty aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation in the Member State of affiliation." She says that this provision has been included "because some Member States believe they will be able to use it to prevent their citizens from accessing private healthcare abroad when they may not do so at home. The UK Government is of the view that this provision may be very difficult to use in this way, as it draws a distinction on the basis of the status of the provider (public or private) where the treatment in question is one which would be made available to the patient."

5.14 The Minister also highlights the inclusion of a new provision — Article 7(9)(a) — which enables the patient's home State to limit the application of the rules on reimbursement of cross-border healthcare costs where there is a risk of seriously undermining the financial balance of its social security system or of maintaining a balanced hospital service open to all. She says that "while the Government believes that the impact of patient mobility is highly unlikely to reach such levels, the existence of such a 'safety valve' clause seems a sensible precaution."[35]

5.15 According to the Minister, the Council's common position clarifies which cross-border services could be made subject to a requirement for prior authorisation as well as adding a new ground for refusing to grant prior authorisation where the home State has serious and specific concerns about a healthcare provider. She says:

"The Government believes that Article 8(5) would allow a request for treatment abroad to be refused where the patient is proposing to be treated by a provider of whom there was strong evidence of the provision of sub-standard care. However, the Government is also of the view that this may be a difficult provision to use because it will require objective evidence of the specific and serious concern."[36]

5.16 The Minister says that Article 16 on eHealth proved to be highly contentious as a result of differing views on the extent of the Commission's role in promoting interoperability of eHealth systems. She adds:

"The UK Government's view remains that legally binding measures are beyond the competence of the Commission under the Treaty and therefore any cooperation in this area should build on the voluntary cooperation already in place under arrangements such as the Epsos project.

"Following lengthy negotiations, the final text agreed by the Council does not include legally binding commitments. It sets out that the Commission will draw up guidelines in collaboration with member states on a non-exhaustive list of data to be included in patient summaries and effective methods for enabling the use of medical information for public health and research. Cooperation on broader issues such as interoperability would remain voluntary."[37]

5.17 More generally, the Minister is satisfied that the provisions subject to comitology procedures — for example, on the recognition of prescriptions and on European reference networks — are appropriate. She says that the Directive, if adopted will have financial implications for health commissioning bodies in the UK. As the reimbursement of costs of health services obtained in another Member State will be capped at the same level as equivalent treatment in the UK, the money is "in principle already in the system" but there will be additional costs in administering mechanisms for reimbursing costs. She adds that little data exist on how many patients might be expected to seek healthcare abroad, but research suggests that "the vast majority of patients prefer to be treated closer to home."

5.18 The draft Directive may require further implementing legislation in the UK to specify the services to which it applies and to make further provision for reimbursement, prior authorisation and the supply of information to patients through national contact points. Medicines legislation may also need to be amended to make provision for a possible common template for prescriptions issued within the EU.


5.19 The purpose of the draft Directive is to provide a clear EU framework for the provision of cross-border healthcare in accordance with the principles developed by the Court of Justice. The Council common position inevitably includes compromise language to help Member States overcome their differences on elements contained in the Commission's original proposal, but the Council believes that it represents a fair balance between the rights of patients to receive healthcare in another Member State and the responsibilities of Member States to organise and deliver health services and medical care.[38]

5.20 We question whether some of the provisions included in the Council common position provide sufficient clarity and legal certainty to enable patients to make informed choices about seeking cross-border healthcare. We wonder, for example, how Member States will choose to apply Article 7(5) which enables them to adopt provisions "in accordance with the Treaty aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation" in their home Member State. Similarly, it is difficult to foresee how Member States will apply Article 8(5)(e) which entitles them to refuse to grant prior authorisation for treatment in another Member State if they have "serious and specific concerns" about healthcare providers in the proposed Member State of treatment. Moreover, the grounds for refusing prior authorisation in Article 8(5) are non-exhaustive, making it difficult for patients to determine whether their request for authorisation is likely to succeed.

5.21 We understand that the Council's common position will shortly be superseded by a revised text, incorporating amendments proposed by the European Parliament following its plenary vote in January, which may form the basis for a second reading agreement with the Council. We therefore ask the Minister to provide us with further information on the outcome of the plenary vote and the Government's position on the amendments proposed by the European Parliament in sufficient time to enable us to scrutinise the amended draft Directive before a possible second reading deal is reached. Meanwhile, the Council's common position remains under scrutiny.

31   Notably, Regulation 883/04 which establishes a system of prior authorisation for medical treatment in a Member State other than the one in which the patient resides.  Back

32   See paragraph 3 of the Minister's letter. Back

33   See paragraph 9 of the Minister's Explanatory Memorandum. Back

34   See paragraphs 33 and 34 of the Minister's Explanatory Memorandum.  Back

35   Paragraph 37 of the Minister's Explanatory Memorandum. Back

36   Paragraph 39 of the Minister's Explanatory Memorandum.  Back

37   Paragraphs 42-3 of Minister's Explanatory Memorandum.  Back

38   See the statement of the Council's reasons for its common position in document 11038/10 ADD 1, 3 September 2010.  Back

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