Documents considered by the Committee on 14th October 2015 - European Scrutiny Contents


6 Cross-border healthcare

Committee's assessment Politically important
Committee's decisionNot cleared from scrutiny; further information requested; drawn to the attention of the Health Committee
Document detailsCommission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare
Legal base
DepartmentHealth
Document Numbers(37076), 11768/15, COM(15) 421

Summary and Committee's conclusions

6.1 This Commission report provides an initial assessment of how Member States have implemented a 2011 Directive on cross-border healthcare.[ 52] The Directive followed in the wake of Court of Justice rulings establishing that EU Treaty provisions on the freedom to provide services also entitled patients to seek, and be reimbursed for, medical treatment provided in another Member State. It sets out the rules and procedures which apply in such cases, including the circumstances in which a patient may be required to obtain prior authorisation for treatment in another EU country, and also seeks to strengthen cross-border cooperation between healthcare providers, for example to diagnose and treat rare diseases. Although the Directive was agreed in 2011, Member States had until October 2013 to implement its provisions.

6.2 Our predecessors considered that the Directive appeared 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. They noted the then Government's view that, despite a lack of information on the number of patients that might be expected to seek healthcare abroad, research indicated that "the vast majority of patients prefer to be treated closer to home".[ 53]

6.3 The Commission report draws a similar conclusion. The number of patients seeking planned (rather than emergency) medical treatment in another Member State remains low. The report suggests, however, that it is too soon to conclude that "use of cross-border healthcare accurately reflects potential demand", particularly as most Member States were late in giving effect to the Directive. No changes are proposed to the current legislative framework at this stage, but the Commission will publish a further report in 2018.

6.4 The Parliamentary Under-Secretary of State for Public Health (Jane Ellison) says that the Commission report "draws no conclusions" but serves as "a useful comparison tool" to assess how the Directive has been implemented across the EU. She considers that it has no new policy implications for the UK.

6.5 Contrary to the Minister's view, we consider that the Commission report draws a number of significant conclusions. It indicates that patient mobility for planned treatment in another Member State remains low and is far below the level suggested in opinion surveys exploring the potential take-up of cross-border health services. The report also indicates that the number of citizens aware of their right to seek treatment in another Member State is extremely low. Even amongst those who are aware, many are unclear how to exercise their right and may face significant obstacles. Given these findings, the Commission concludes that the potential demand for cross-border healthcare may be greater than the current figures suggest.

6.6 The Minister observes that "the UK position is favourable when compared with other Member States" but provides no information to help us understand what she means by "favourable" in this context. We would welcome further information on the flows of patients to and from the UK, based on the Directive, during 2014 (the period covered by the report) and the impact that they have had on the NHS. We also ask the Minister whether she considers that UK citizens are well-informed about the circumstances in which they may seek treatment in another Member State and to explain:

·  which treatments require prior authorisation in the UK;

·  how many requests for prior authorisation were submitted in 2014 and how many were approved;

·  how many claims for reimbursement were made in 2014 and how many were approved; and

·  how many requests for information about treatment in another Member States were received by UK contact points in 2014.

6.7 Pending the Minister's reply, the Commission report remains under scrutiny and we draw it to the attention of the Health Committee.

Full details of the document: Commission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare: (37076), 11768/15, COM(15) 421.

Background

6.8 The Directive on the application of patients' rights in cross-border healthcare ("the 2011 Directive") sets out the principles underpinning the delivery of healthcare in all Member States — notably, universality, access to good quality care, equity and solidarity — and establishes a framework for cross-border healthcare covering entitlement to, and reimbursement for, medical treatment obtained in another Member State. It identifies the areas in which the Directive does not apply — for example, long-term care, public vaccination programmes, and organ transplants — and allows Member States to limit access in other areas where justified by "overriding reasons of general interest", such as the need to ensure "sufficient and permanent access to healthcare" within their own territories.

6.9 Member States must ensure that healthcare providers charge the same fees for patients from other Member States as for domestic patients. The Directive makes clear that the patient's home Member State is only required to reimburse the costs of healthcare received in another Member State if the patient would have been entitled to the same treatment at home. Costs are capped at the level of expenditure that would have been allowed if the treatment had been received in the patient's home Member State. Reimbursement of costs may also be subject to satisfying the usual eligibility or referral criteria for treatment in the home Member State. So, for example, a patient in the UK may still be required to obtain a referral from a General Practitioner.

6.10 The Directive specifies the type of healthcare (mainly hospital or highly specialised treatment) for which the home Member State may require prior authorisation and the grounds on which authorisation may be refused. These include the availability of the treatment in the home Member State within a medically justifiable timescale. The Directive includes additional provisions on:

·  the information to be made available to patients, mainly through a system of national contact points for cross-border healthcare;

·  cross-border cooperation to facilitate the recognition of prescriptions issued in another Member State;

·  the development of European reference networks, involving healthcare providers and centres of expertise specialising in rare diseases;

·  cross-border cooperation to develop "European eHealth systems and services and interoperable applications"; and

·  enhanced cooperation in carrying out and sharing information on the assessment of health technologies.

6.11 The Reports produced by our previous Committee, listed at the end of this chapter, provide more detailed information on the content of the 2011 Directive.[ 54]

The Commission report

6.12 This is the Commission's first report on the 2011 Directive. It focuses on how Member States have implemented some of the key provisions of the Directive on patient mobility, the reimbursement of costs, prior authorisation, information to patients, and cross-border cooperation. The Commission notes that nearly all Member States experienced delays in notifying the domestic measures taken to implement the Directive and that information provided by Member States on the operation of the Directive is, in some cases, incomplete and not easily comparable. A different set of EU rules covers emergency and some other types of healthcare received in another EU country, but a number of Member States do not yet have adequate systems in place to distinguish between reimbursement claims based on those rules, and claims for planned treatment based on the Directive.

PATIENT MOBILITY

6.13 The Directive allows, but does not require, Member States to introduce a system of prior authorisation for certain types of planned treatment involving an overnight stay in hospital or the use of highly specialised and cost-intensive medical infrastructure or medical equipment. Similarly, prior authorisation may be required for treatments which present a particular risk for the patient or the population or which give rise to "serious and specific concerns" about the quality or safety of the care to be provided. The Directive requires Member States using a system of prior authorisation to publish information on the medical treatments to which it applies.

6.14 The report notes that 21 Member States (including the UK) have introduced a system of prior authorisation.[ 55] Most (14) require prior authorisation for an overnight hospital stay and highly specialised care, but have not specified the specific treatments for which prior authorisation must be obtained. The Commission suggests that this lack of clarity is confusing for patients, and that extensive systems of prior authorisation are not justified, given that "the numbers of people applying for authorisation are simply too small".[ 56] Information provided by Member States for 2014 (summarised in Annex A of the report) indicates that requests for prior authorisation are low.

6.15 The provisions of the Directive on reimbursement are intended to cap the costs for treatment received in another EU country at the level of similar treatment provided in the patient's home Member State. The Commission questions whether all Member States have correctly implemented the reimbursement provisions, citing as examples the use of an inappropriate reimbursement tariff or the imposition of additional criteria for treatment abroad which are not envisaged in the Directive. Whilst the Directive allows Member States to maintain their existing "gatekeeper" systems, so that reimbursement for specialist treatment in another EU country would depend on first obtaining a GP referral, the Commission suggests that requiring the referral to be made by a professional in the patient's home Member State is contrary to the principle of mutual recognition of professional qualifications. The Commission also highlights difficulties in applying the Directive to "telemedicine", noting that some Member States reimburse consultations with a GP conducted remotely (by phone or over the internet), whereas others do not.

6.16 The Commission concludes this section of its report by noting that patient flows for planned healthcare abroad are low. Although the information provided by Member States is incomplete, requests for authorisation for treatment in another EU country in 2014 only exceeded 100 in two Member States, and some Member States received no requests. Even in cases where prior authorisation is not required, there are relatively few claims for reimbursement and most of these (roughly 85%) are granted.

PATIENT INFORMATION

6.17 The Directive requires Member States to designate one or more national contact points to provide information on cross-border healthcare. The UK does not have a single national contact point covering all of the UK, but separate contact points for England, Scotland, Wales, Northern Ireland and Gibraltar. The Commission report highlights "significant variation in the activity" of national contact points, with most receiving relatively few requests for information.[ 57] This is consistent with the findings of a recent Eurobarometer survey indicating that fewer than two in ten EU citizens considered they were well-informed about their right to medical treatment in another EU country, and only one in ten were aware of their national contact points.[ 58] Patient organisations have expressed concern at the labyrinthine and confusing means available for obtaining information and recommended that national contact persons should provide checklists for individuals considering planned treatment in another EU country, including detailed information on procedures, costs and reimbursement rates. They have also pressed for the provision of comparable and reliable information on quality and safety. Member States have similarly voiced concern about communicating the complexities of the current legal situation on cross-border healthcare which is based on two distinct sets of EU rules.

CROSS-BORDER COOPERATION

6.18 The Commission notes that there have been delays in nearly all Member States in implementing the provisions on the mutual recognition of medical prescriptions. Progress has been made in establishing the legal framework for the creation and evaluation of European Reference Networks. The first Networks are expected to be approved in 2016. The Commission anticipates that these Networks could significantly improve access to care for rare, low-prevalence or complex diseases.

6.19 An eHealth Network has been established and has agreed guidelines on patient summary data sets and on ePrescriptions, as well as a series of position papers on electronic identification, interoperability, data protection, and investment in eHealth. Work is progressing on guidelines on methods to enable the use of medical information for public health and research. A Health Technology Assessment Network has also been set up and has agreed a strategy for cooperation in this area. The report suggests that "permanent and well-founded arrangements" are needed to facilitate joint work. The Commission has begun preliminary work on strengthening cross-border healthcare provision in border regions where closer collaboration, for example on access to critical care for heart attacks, could make a significant difference to patient outcomes.

CONCLUSIONS

6.20 The report concludes that patient mobility for planned healthcare remains low across most EU Member States (with the possible exception of France, Luxembourg, Finland and Denmark). It identifies a number of reasons:

·  late implementation of the Directive in a number of Member States;

·  low awareness amongst EU citizens of their right to be treated and reimbursed for healthcare in another EU country, coupled with difficulties in obtaining information on the practicalities involved;

·  "significant" remaining obstacles in some Member States' health systems which continue to impede access to healthcare abroad and which the Commission attributes, in some cases, to "intentional political choices" — these may include;[ 59]

o  extensive use of prior authorisation systems which are difficult to justify, given the limited demand for medical treatment in another EU country;

o  a lack of clarity as to the treatments requiring prior authorisation;

o  a reimbursement tariff for treatment abroad which is lower than the cost of similar treatment at home; and

o  burdensome administrative requirements.

6.21 The Commission also recognises that "the natural demand" for cross-border healthcare may be relatively low as a consequence of language barriers, a reluctance to travel, distance from family, price differentials between Member States, and acceptable waiting times for treatment in the patient's home country. The Commission nevertheless considers that it is too soon to conclude that the actual use of cross-border healthcare accurately reflects potential demand.[ 60]

6.22 The Commission suggests that the 2011 Directive has had a broader impact by creating a forum, through Member States' national contact points, to discuss wider healthcare reform. It notes, for example, that the provisions contained in the Directive to promote transparency for patients in exercising their right to cross-border healthcare, as well as those on the quality and safety of healthcare services, feed into a broader debate about patients' right to information. Given the differences in the way national contact points currently operate and the quality of the information they provide, the Commission considers that there may be merit in exploring common approaches or guidelines. It also suggests that the pressures faced by health services may increase interest in a more efficient use of resources through closer cross-border collaboration.

The Minister's Explanatory Memorandum of 21 September 2015

6.23 In a brief Explanatory Memorandum, the Minister notes that the Directive was given effect in the UK by the National Health Service (Cross-Border Healthcare) Regulations 2013 which came into force on 25 October 2013. She says that the UK submitted information to inform the Commission report and that "the UK position is favourable when compared with other Member States".[ 61] The Minister adds that the report contains no new proposals and indicates that it has no new policy or financial implications and no "risks, costs or benefits for the UK".

Previous Committee Reports

None, but the following Reports by our predecessors on the 2011 Directive on the application of patients' rights in cross-border healthcare are relevant: Thirteenth Report HC 428-xii (2010-11), chapter 5 (12 January 2011) and Eighteenth Report HC 428-xvi (2010-11), chapter 13 (9 February 2011).


52   Directive 2011/24/EU, OJ No L 88, 04.04.2011. Back

53   See the then Government's Explanatory Memorandum. Back

54   The NHS European Office has also published a helpful briefing note on the 2011 Directive. Back

55   The exceptions are Austria, the Czech Republic, Estonia, Finland, Lithuania, the Netherlands and Sweden. Back

56   See p.4 of the Commission report. Back

57   Three Member States - Germany, Finland and Austria - accounted for 75% of a total of 109,223 requests for information received by national contact points in 2014. The data provided by these countries include website visits as requests for information. Back

58   See p.7 of the Commission report. Back

59   See p.11 of the Commission report. Back

60   Ibid. Back

61   See para 3 of the Minister's Explanatory Memorandum. Back


 
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Prepared 14 October 2015