5 Cross-border healthcare
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11038/2/10 REV 2
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| Position of the Council at first reading with a view to adopting a Directive on the application of patients' rights in cross-border healthcare
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| Legal base | Articles 114 and 168 TFEU; co-decision; QMV
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| Document originated | 13 September 2010
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| Deposited in Parliament | —
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| Department | Health |
| Basis of consideration | Minister's letter of 6 December 2010 and EM of 8 December 2010
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| Previous Committee Report | None, 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).
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information requested
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Background
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.
Conclusion
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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