12 Cross-border healthcare
| (29786)
11307/08
COM(08) 414
+ ADDs 1-2
+ ADD 3
| Draft Directive on the application of patients' rights in cross-border healthcare
Commission staff working documents: impact assessment and summary of impact assessment
Commission staff working document: Towards a renewed social agenda for Europe — citizens' well-being in the Information Society
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| Legal base | Article 95 EC; QMV; co-decision
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| Department | Health |
| Basis of consideration | Minister's letters of 27 April 2009 and 3 June 2009
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| Previous Committee Report | HC 16-xxviii (2007-08), chapter 2 (22 July 2008) and HC 16-xxx (2007-08), chapter 7 (8 October 2008)
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| To be discussed in Council | 9 June 2009
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| Committee's assessment | Politically important
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| Committee's decision | Cleared (decision reported on 21 October 2008). Further information now received
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Previous scrutiny of the documents
12.1 When we considered this draft Directive (and an accompanying
Commission Communication) in July 2008,[50]
we noted that the European Court of Justice has consistently ruled
that patients who go to another Member State for healthcare are
entitled to reimbursement of the cost by their home Member State
if they would have been entitled to the treatment in the home
State. The Court's judgements have, however, left a good deal
of uncertainty. So, in 2006, the Commission initiated consultations
about what action, if any, is necessary to clarify the rights
and duties of patients, Member States and health providers.[51]
In the light of the responses, the Commission produced the draft
Directive.
12.2 It proposes, for example, that patients would
be entitled to reimbursement, without prior authorisation, for
the cost of treatment in another State which did not involve an
over-night stay in hospital so long as they would have been entitled
to the treatment in their home State. The amount reimbursed would
be limited to what the cost of the care would have been in the
home State.
12.3 The Minister of State at the Department of Health
(Dawn Primarolo) told us that the draft Directive was helpful
because it sought to clarify the case-law on cross-border healthcare.
The Government believed it to be imperative for the home Member
State to retain responsibility for deciding entitlements to healthcare
and so Member States should be able to have a system of prior
authorisation.
12.4 We agreed with the Minister and the Commission
about the desirability of EC legislation to clarify the entitlement
to reimbursement for cross-border healthcare and the responsibilities
of the home Member State and the Member State in which the treatment
is given. Because of its importance, we recommended the draft
Directive for debate in European Committee C. The debate was held
on 21 October.
12.5 In chapter 3 of our Report of 22 July, we asked
questions about the draft Directive to which we believed it would
be useful to have the Minister's answers before the debate. She
replied on 9 September and we drew her answers to the attention
of the House in our Report of 8 October.[52]
We also asked her to send us progress reports on the negotiations.
The Minister's letter of 27 April 2009
12.6 In October 2008, the Government issued a consultation
paper on the draft Directive. The Minister sent us a copy. We
asked her for a summary of the responses to it.
12.7 On 27 April 2009, the Minister sent us a copy
of her Department's published summary of the responses. It also
contains a statement of the Government's views on the responses.[53]
The European Parliament's amendments at first
reading.
12.8 On 23 April, the European Parliament gave the
draft Directive its first reading. It approved the text subject
to 115 amendments. Most of the amendments are detailed and do
not affect the substance of the draft Directive.
12.9 But the following European Parliament amendments
do affect the substance of the proposal:
- exclusion from the scope of
the Directive of residential homes, housing and assistance for
elderly people or children provided by social workers, volunteers
and professionals other than health professionals (amendment 7);
- exclusion from the scope of the Directive of
organ transplantations (amendment 8);
- recognition that Member States may organise their
healthcare and social security systems so as to provide for the
entitlement to treatment to be determined at regional or local
level (amendment 20);
- if there are several methods available for treating
an injury or disease, the patient should have the right to reimbursement
of the cost of any of the methods if sufficiently tried and tested
by international medical science even if the method is not available
in the patient's home State (amendment 21);
- deletion of Recital 45 and Article 8(2) of the
Commission's draft of the Directive which provide for the Commission,
using the comitology procedure, to draw up a list of treatments
which require prior authorisation even though the patient does
not require an over-night stay in hospital (amendments 34 and
75);
- exemption from prior authorisation for patients
with rare diseases or who have life-threatening diseases and who
are on a waiting list for treatment in their home State and who
are in urgent need of care (amendments 83 and 145); and
- within 18 months of the Directive coming into
effect, the Commission should propose legislation to set up a
European Patients' Ombudsman to consider and, if appropriate,
mediate on patients' complaints about prior authorisation, reimbursement
or harm (Amendment 92).
The Minister's letter of 3 June 2009
12.10 On 3 June, the Minister sent us the text of
the European Parliament's amendments and a transcript of the remarks
made by Commissioner Vassilliou, on behalf of the Commission,
at the end of the European Parliament's debate. The Minister's
letter summarises the amendments and comments on them.
12.11 The Minister tells us that the Government welcomed
many of the European Parliament's proposals but:
- the Government believes that
patients who decide to travel abroad for treatment should not
have an advantage over the vast majority of patients who wish
to be treated near to home and is, therefore, strongly opposed
to the Directive giving cross-border patients entitlements to
additional treatments;
- the Minister will be considering the European
Parliament's proposal that organ transplantation should be excluded
from the scope of the Directive;
- the Government supports the European Parliament's
proposals for clarification of the way that prior authorisation
will work but considers that yet further clarity is needed and,
in particular, believes that all patients should be required to
seek prior authorisation for hospital care;
- the Minister
adds that it is not yet apparent why patients with rare diseases
should be exempt from the requirement to seek prior authorisation
— their treatment may well be highly specialised, potentially
experimental and costly, which are the sorts of grounds held by
the Courts to justify the use of prior authorisation schemes;
- the Government
welcomes amendments 34 and 75 which would give Member States,
rather than the Commission, the responsibility for defining what
constitutes hospital care;
- but it notes that the European Parliament did
not propose the deletion of the other comitology requirements
in Chapter 4 of the draft Directive — in the Government's
view, any provision for comitology should be limited to actions
agreed by Member States as being necessary at an EU level in order
to codify existing case law;
- the Government welcomes the European Parliament
amendments which recognise that quality standards are the responsibility
of the Member State which provides the treatment. But, because
quality and safety standards are so closely related, the Government
considers that the draft Directive should be further amended to
provide that safety standards, too, should remain the responsibility
of the Member State of treatment; and
- the Government will carefully consider the proposal
for a European Patients' Ombudsman but, in general, takes the
view that the Directive should remain focused on clarifying and
codifying existing case law on patient mobility.
12.12 The Minister also tells us that it is too soon
to predict the Council's views on the European Parliament's amendments
and it is unclear when the Council might reach a "common
position" on the Directive.[54]
She promises to write to us again when it looks likely that a
political agreement to a text will be sought.
Conclusion
12.13 We are grateful to the Minister for providing
us with such a comprehensive commentary on the amendments proposed
by the European Parliament.
12.14 We share her view that many of the amendments
are welcome. We also share the Government's view that any provisions
for the use of comitology should be rigorously justified and strictly
limited. Moreover, we understand why, in the interests of taxpayers
and the great majority of patients who do not wish to go abroad
for treatment, the Government believes that all cross-border treatment
should be subject to prior authorisation.
12.15 We are sceptical about the European Parliament's
proposal for legislation to establish a European Patient's Ombudsman
for two reasons. First, it seems to us that, in principle, any
"European" Ombudsman should be concerned solely with
the actions of European institutions and should not have power
to investigate the actions of national or regional governments.
Second, the European Parliament proposes that complainants should
not have access to the European Patients' Ombudsman until "all
the complaint options within the relevant Member State have been
exhausted".[55]
In effect, therefore, the European Ombudsman would be a court
of appeal against the findings and conclusions of the national
ombudsmen for health services; this, too, appears to us objectionable
in principle. We should be grateful for the Minister's comments
on these points and to know if she has consulted the UK's Health
Services Ombudsmen about the proposal.
12.16 We should also be grateful if the Minister
would tell us what conclusion she reaches on the European Parliament's
proposal that organ transplantation should be excluded from the
scope of the Directive and for further progress reports on the
negotiations.
50 See headnote. Back
51
(27900) SEC(06) 1195/4: see HC 34-xlii (2005-06), chapter 3 (7
November 2006). Back
52
HC 16-xxx (2007-08), chapter 7 (8 October 2008). Back
53
The European Commission's proposals for a Directive on the application
of patients' rights in cross-border healthcare: UK Government's
response to consultation - Department of Health, April 2009. Back
54
In this context, a "common position" is an agreement
to a text which has been finalised by the jurist linguists before
the Council sends it to the European Parliament for second reading. Back
55
European Parliament amendment 92. Back
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