13 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 | 20 December 2010
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| Department | Health |
| Basis of consideration | Minister's letter of 27 January 2011
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| Previous Committee Report | HC 428-xii (2010-11), chapter 5 (12 January 2011)
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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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.
e-Health
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)."
Conclusion
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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