Documents considered by the Committee on 9 February 2011 - European Scrutiny Committee Contents

13   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 Parliament20 December 2010
Basis of considerationMinister's letter of 27 January 2011
Previous Committee ReportHC 428-xii (2010-11), chapter 5 (12 January 2011)
Committee's assessmentPolitically important
Committee's decisionCleared

Background and previous scrutiny

13.1  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 certain healthcare services provided in another Member State. The Commission's proposal was cleared from scrutiny following a debate in October 2008, but our predecessors asked for regular updates on the progress of negotiations.

13.2  Last June, the Government informed us that the Council had reached a political agreement on a compromise text produced by the then Spanish Presidency. The Parliamentary Under-Secretary of State at the Department of Health (Anne Milton) wrote to tell us in December that the Council had formally adopted its common position on the draft Directive on 13 September 2010 and that negotiations were underway with the European Parliament (EP) with a view to reaching an agreement at Second Reading. She also provided an Explanatory Memorandum describing the differences between the Council's common position and the Commission's original proposal. These are set out in our Report of 12 January.[61]

13.3  We noted that the Council's common position inevitably included compromise language to help bridge differences between Member States on elements contained in the Commission's original proposal, but we questioned whether the resulting text provided sufficient clarity and legal certainty. We anticipated that the Council's common position would shortly be superseded by a revised text incorporating changes proposed by the European Parliament and therefore decided to hold it under scrutiny pending further information from the Minister on the outcome of the EP's Second Reading plenary vote.

The Minister's letter of 27 January

13.4  The Minister sends us a copy of the revised text resulting from the EP's Second Reading vote on 19 January and says that it "meets all of the negotiating aims of the UK Government." She asks us to clear the revised text of the draft Directive from scrutiny so that the Government may participate in its formal adoption at a forthcoming Council meeting.

13.5  The Minister's letter highlights the following key points:

Patients' entitlements

13.6  The draft Directive only entitles patients to be reimbursed for the costs of healthcare received abroad if they would have been entitled to receive that care within the NHS, and costs are capped at the level stipulated for equivalent treatment provided by the NHS. The Minister adds that there is some discretion to exceed this cost threshold in particular cases or to pay additional related costs, such as travel and accommodation.

Gate keeping

13.7  The draft Directive confirms that the same formalities governing access to healthcare in the UK apply, regardless of whether patients wish to receive healthcare abroad or within the NHS. So, for example, patients in the UK would still have to be assessed by a health professional, such as a GP or an NHS commissioner, to determine their entitlement to healthcare.

Prior authorisation

13.8  The draft Directive enables Member States to introduce a system of prior authorisation for certain types of cross-border healthcare, but the Minister adds that "such a system may only be used to restrict patient mobility in certain circumstances — for example, healthcare which is subject to planning requirements, or which involves at least one night in hospital or requires the use of highly specialised and cost-intensive medical equipment."

Systems of payment

13.9  The Minister says that the NHS will be free to determine its own system of payment to cover the cost of cross-border healthcare. It could reimburse patients who have paid the costs upfront or it could make direct payment to the overseas healthcare provider — in the latter case, the NHS would not be commissioning the healthcare but would be acting as a third party contributing to the costs of treatment.

Quality and safety

13.10  The draft Directive does not affect Member States' responsibility for regulating the quality and safety of healthcare provided in their territory. In the case of cross-border healthcare, the quality and safety standards applicable are those in force in the Member State where the treatment is provided. The Minister adds that, although the draft Directive makes provision for cooperation on quality and safety matters, "this is not under the auspices of any delegated powers to the Commission."

Incoming patients

13.11  The draft Directive confirms that incoming patients must be treated in a non-discriminatory manner, but access to treatment may be refused where it would undermine the treatment of home patients. The Minister says that "this is a particularly important consideration for NHS organisations providing highly specialised services, for which a possible surge of incoming patients could lead to negative implications in terms of increased waiting times for NHS patients."

Patient information

13.12  The draft Directive requires each Member State to designate national contact points to provide patients or health professionals, at their request, with information relating to cross-border healthcare.

Co-operation on rare diseases

13.13  The draft Directive provides for cooperation between Member States through the establishment of voluntary networks of healthcare providers and centres of expertise (European Reference Networks) to pool knowledge and maximise the cost-effective use of resources, particularly in the area of rare diseases.


13.14  The draft Directive also provides for the establishment of a voluntary network of national health authorities responsible for e-Health which will consider issues related to the transferability of electronic patient records to ensure continuity of care where healthcare is provided in another Member State. The Minister adds that the UK already participates in a large scale pilot (epSOS — Smart Open Services for European patients) which will test various proposed solutions for cross-border interoperability of e-Health systems.

13.15  The Minister's letter also responds to the doubts we expressed about the clarity of certain provisions in the Council's common position, notably Articles 7(5) and 8(5), which remain largely unaltered in the revised text approved by the European Parliament. She says:

"Article 7(5) does not hold great significance for the UK. It is there to ensure that patients are not treated differently with regard to the availability of cross-border healthcare, as opposed to the healthcare entitlements that exist in their home state. It was also proposed by the Spanish (during their Presidency) as a way of placating their concerns that the Directive and the underlying case law did not, in their view, apply to treatment in private facilities (which is not a general entitlement under the Spanish system). We believe that this will not stand up to challenge in the courts but were content to allow it to enable us to reach solutions on more important aspects of the Directive.

"Article 8(5) allows the home state (the Member State of Affiliation) to refuse prior authorisation for reasons relating to patient safety. The detail will need to be worked out as part of the transposition programme but in our view, this may include situations where:

  • there is reasonable evidence that the patients' safety is at risk contrary to any benefit that they might obtain from cross-border care (this could be from poor quality care or unproven procedures);
  • the public will be exposed to any substantial safety hazard (this might include where a patient who had a highly contagious disease wanted to go to another state for treatment or a patient with mental health problems and a history of violence requested authorisation);
  • there is evidence that a provider is not delivering the required standard of quality and safety under the law or systems of the Member State of Treatment (this would require evidence from the appropriate regulator or authority)."


13.16  We thank the Minister for her summary of the key points in the revised draft Directive which the European Parliament endorsed in January and note that most of the changes are not of a substantive nature. We think the revised text provides greater clarity in one respect than the Council's common position by stating expressly, in Article 8(5), that a Member State may not refuse to grant prior authorisation for treatment abroad where a patient is entitled to treatment but it cannot be provided in his or her home State within a medically justifiable time limit.

13.17  As we have noted previously, some ambiguities are inevitable in a negotiation of this nature but we think that, overall, the draft Directive will be helpful in clarifying how Treaty provisions on the freedom to provide services apply to cross-border healthcare. The revised text appears to strike a reasonable balance between the right of patients to receive healthcare in another Member State and the responsibilities of Member States to plan, organise and deliver health services and medical care. We accept the Minister's assurance that the revised draft Directive meets the Government's negotiating objectives and clear it from scrutiny.

61   See HC 428-xii (2010-11), chapter 5 (12 January 2011). Back

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