CHAPTER 9: Summary of Conclusions and
Chapter 2: Overall objective and the need for
181. Ten years of case law on cross-border healthcare
have not provided the clarity needed by both patients and healthcare
providers. We therefore agree that the main rationale for the
Directive should be to clarify the application of treaty provisions
to health services.
182. Whilst we recognise the need for action
on these grounds, the response must strike a proportionate balance
between individual choice on the one hand and effective delivery
of public health provision, within limited budgets and reflecting
different national and sub-national practices, on the other. Failure
to strike a balance between these two objectives could be detrimental
for all patients.
183. We take the view that the fundamental objective
of the proposal should be to ensure that a framework is in place
to deliver the availability of healthcare across borders but without
excessive complexity and without harming the delivery of national
health systems at a local level, and taking particular account
of patient safety and redress.
184. We recall the set of overarching values
underlying the delivery of health services throughout the EU that
were agreed by EU Health Ministers in 2006 (see Box 2). This also
finds expression in recitals 11 and 12 of the Directive. We consider
above all that Member States must ensure that the principle of
equity, within the terms of Member States' own health systems,
underpins the negotiation and implementation of the Directive.
185. We note the argument that the introduction
of patient choice may force hospitals to become much more responsive
to patient needs and acknowledge that this may provoke adjustments
to the services offered by Member States through the mechanisms
and the incentives that choice creates. Choice is welcome if it
has a positive effect on the efficient delivery of health services
locally. In particular, we recognise that the proposal could have
a positive effect where there are particular specialities with
very long waiting lists. However, we recommend that effective
delivery at the local level must remain a key objective.
186. It is clear that it will not be possible
to identify the Directive's impact until it has been transposed.
We therefore conclude that the Directive should be reviewed within
three rather than five years after it comes into effect, in order
that Member States can learn lessons from the experiences of cross-border
healthcare sooner rather than later.
187. Given the importance of patient inflows
and outflows to the stable and secure delivery of healthcare in
Member States, we believe that the report produced by the Commission
should include information on patient inflows and outflows.
Chapter 3: Legal and Regulatory considerations
188. Article 49, within which the freedom to
receive healthcare services falls, forms one of the fundamental
freedoms of the Community and is one of the key principles underpinning
the internal market. Article 95 is the legal base for measures
which have as their object the establishment and functioning of
the internal market. Article 152(5) states clearly that Member
States retain full responsibility for the organisation and delivery
of health services and medical care. We agree that Article 95
is the appropriate legal base for the Directive but emphasise
the principle embodied in Article 152(5) and urge the European
institutions to ensure that Member States' responsibility for
the organisation and delivery of health services is fully respected
in the negotiation and implementation of this Directive. Particular
attention must be paid in that regard to the requirements laid
down in Article 5 of the draft Directive.
189. The Commission relies heavily in the draft
Directive on delegation of the finer details to comitology committees.
We caution that delegated legislation runs the risk of creating
rules that go further than intended by legislators, but we recognise
that it is sometimes necessary. Recourse to the comitology procedure
should be restricted to genuine and appropriate questions of detail,
such as the provisions on the mutual recognition of prescriptions.
(See paragraph 161)
190. If Member States are to be able to organise
and deliver their own health services and medical care, it is
critical that they are able to manage the capacity of health services.
The recital in the draft Directive stating that Member States
will have the right to refuse incoming patients is therefore welcome
but would benefit from some strengthening and from clarification
of the term "detriment".
191. The freedom to receive healthcare services
is protected by virtue of Article 49, TEC, and the stated aim
of clarifying the European Court of Justice's rulings can only
be pursued by Community level action. We are therefore content
that the proposal is consistent with the principle of subsidiarity
as long as it does not go beyond the action required to clarify
and to put into effect the principles laid down the by the ECJ.
192. Regulation 1408/71 is closely linked to
the draft Directive but we were concerned to learn that there
is some confusion as to how the two pieces of legislation may
interact. We therefore urge that consideration be given to incorporating
the relevant provisions of Regulation 1408/71 into the text of
the Directive in order to clarify in which circumstances patients
may be able to rely on those provisions rather than those of the
Directive as currently drafted.
Chapter 4: Prior authorisation and payment
193. We think that a system of prior authorisation
is necessary. This will protect the financial resources of Member
States' healthcare systems. It will also allow clinicians to explain
clearly to patients the treatment options available to them, including
their respective advantages and disadvantages. This is particularly
important to enable patients to make an informed decision and
consider properly all of their treatment options and the corresponding
practical arrangements, such as translation services (see Chapter
194. A system of prior authorisation under which
a patient is reimbursed after having made a payment in the host
Member State raises issues of equity as it will exclude those
without the necessary financial resources from using cross-border
treatment. However, we recognise that issuing funds to the patient
in advance of treatment could increase the risk of fraud, a risk
that must be assessed by the Commission when reviewing the application
of the Directive.
195. These issues could be tackled by providing
that once prior authorisation has been granted, it should be possible
to transfer funds from the provider in the home Member State directly
to the provider in the host Member State. However, in line with
the principle of subsidiarity and given the different systems
in use across Member States for payment, it is important that
Member States maintain flexibility to decide whether to transfer
196. We are concerned that the definition of
hospital care does not adequately reflect clinical reality across
the EU and we query the need to distinguish between hospital and
non-hospital care for prior authorisation in the manner proposed
by the Commission. Instead, we suggest that the guidance of the
European Court of Justice should be used, whereby prior authorisation
can only be justified by overriding reasons of general interest.
In recognition of the different health systems and methods of
financing across the EU and in line with the principle of subsidiarity,
we recommend that it should be for each Member State to decide
when prior authorisation is required, subject to the principles
laid down in the ECJ's case law.
197. We agree that, where a prior authorisation
system operates, patients must have a right of appeal in case
prior authorisation is refused. This right will be distinct to
each Member State and it should be clearly communicated to the
patient, along with the procedure for exercising this right. Failure
to do so could constitute an unnecessary barrier to patients'
rights to seek cross-border healthcare.
198. We recognise the potential for Article 6
of this Directive to impact upon the equity of cross-border healthcare
and note that the prospect of additional costs may deter some
people from seeking cross-border healthcare. We consider that
it is for Member States to determine the rules for "top-up"
payments, both for medical care and for prescribed medicines.
Chapter 5: Communication, Provision of information
and language considerations
199. We believe that the provision of accessible
and comprehensive information to patients and medical practitioners
is key to the success of the Directive. Patients will only be
able to make an informed decision on whether to seek cross-border
treatment if they have access to relevant information. Similarly,
practitioners will need access to this information in order to
advise patients appropriately. We consider that the provision
and financing of information must be the responsibility of the
home Member State.
200. The Commission proposes that the information
provided should include details about receiving healthcare in
another Member State, the terms and conditions that would apply,
patients' entitlements, procedures for using those entitlements
and systems of appeal and redress if the patient is deprived of
such entitlements or harm is caused as a result of healthcare
received in another Member State. We agree with the Commission's
suggestions about what information for patients should include.
However, we recommend that a standard Community format for the
provision of this information should not be drawn up. The different
procedures and processes that would need to be taken into account
are numerous and we believe that this could result in the information
being presented in a format that is difficult for patients to
understand or use.
201. We consider that there is a lack of clarity
in the Directive as to who is responsible for providing information
on the service available in a particular Member State. We recommend
that the government of each Member State should be responsible
for describing their own health system. Furthermore, we consider
that the exact role of national contact points in the provision
and dissemination of information, and where responsibility for
them should rest, should be clarified in the Directive.
202. The current lack of clarity over who is
to provide what information, and how, creates the potential for
this burden to fall primarily on medical practitioners. While
their involvement may be beneficial for helping patients make
an informed decision about cross-border care (see paragraph 72),
we recommend that the Directive makes clear that front line health
providers giving this information to patients should be protected
against complaints made against them if a patient suffers unexpected
harm in the course of subsequent treatment abroad.
203. Furthermore, we fear that the need to provide
information and advice on cross-border treatment would interfere
with the performance of practitioners' duties and could detract
from the standard or timeliness of treatment of local patients.
We therefore recommend that the Directive should avoid the imposition
of any administrative burden on healthcare practitioners due primarily
to information provision obligations.
204. It is clear that language may prove to be
a barrier in the delivery of cross-border healthcare and that
this may impact on a patient's choice to travel. We therefore
consider that patients must be made aware of any language issues
and costs before they seek cross-border healthcare. Language barriers
could prove particularly critical in the areas of giving consent
and ensuring continuity of care and patient safety. We recommend
that the responsibility for addressing the language barrier is
decided by the home Member State.
Chapter 6: Patient safety and the pathway of care
205. We conclude that clarity is required about
the responsibilities of all those involved in the pathway of care.
This is particularly important in order to ensure patient safety
and to enable patients to make an informed decision to seek cross-border
healthcare, aware of who is responsible for every stage of their
treatment and who will be accountable should anything go wrong
along the pathway of care.
206. The secure and timely transfer of patients'
records across borders is essential for patients' continuity of
care. This may be problematic if case notes are recorded in different
languages in the host and home Member State. We recommend that
a clearer system is established for the transfer of patients'
207. We note that Directive 2005/36/EC (see paragraph
131) on the recognition of professional qualifications requires
collaboration on information exchange across the Member States.
Nevertheless, we consider that without an obligation to exchange
fitness-to-practise information this would not take place at a
satisfactory or uniform level across all Member States and could
result in problems such as medical practitioners with proceedings
against them still being able to practise in other Member States
where they were already registered. We therefore recommend that
Member States should be obliged to exchange information on medical
practitioners' fitness to practise.
208. We note that over-rigid application of data
protection rules has acted as an obstacle to such systematic sharing
of information in the past. We therefore recommend that the European
Commission examine the extent to which data protection legislation
may need to be amended in order to facilitate the exchange of
information on fitness to practise, whilst minimising the threat
of data misuse.
Chapter 7: Redress and Indemnity
209. The availability, and public awareness,
of a transparent complaints and redress mechanism for patients
is critical to the functioning of a cross-border healthcare system
in the EU's internal market. We consider that not only should
the Directive require a means of redress to be in place but that
Article 5(1)(d) should be amended so as to require that the redress
process be transparent and that patients must be aware of it.
Information on the applicable redress mechanism should be made
available to patients when investigating the possibility of securing
healthcare treatment in a different Member State and responsibility
for provision of that information should be made clear.
210. The Directive does not provide clarity on
how the home Member State might seek compensation from the host
Member State for the cost of rectifying clinical mistakes made
by the host Member State. For the purpose of delivering cross-border
healthcare, we consider it essential that the Commission examines
how a home Member State may be able to claim compensation for
the cost of tackling problems caused by clinical errors in the
host Member State.
211. The definition of "harm" in the
draft Directive does not distinguish between harm caused by poor
or negligent care and accidental harm. We recommend that the definition
be amended to ensure that it does not cover unavoidable harm.
We would also emphasise that provision should be made for compensation
in the event of accidental harm.
212. It is important, as indicated in the draft
Directive, that practitioners hold professional liability insurance
or similar and it is also crucial that the principle of subsidiarity
be respected. We consider that the precise nature of the insurance
system or similar is a matter for each individual Member State.
However, we recommend that clear information on the systems chosen
by each Member State must be made available to patients at the
national contact point in the home Member State. This information
should include the extent of insurance cover for institutions
and practitioners and the implications of insurance systems for
patients and practitioners.
Chapter 8: Co-operation between Member States
213. Cross-border recognition of prescriptions
is desirable, particularly to ensure continuity of care for those
who require follow-up treatment on returning home. While we recognise
that this is already taking place (see paragraphs 164-165), we
recommend that the Commission develops detailed rules for this
system to ensure that confusion is avoided, particularly in relation
to language, the names of medicinal products and the verification
of whether a prescription has been issued by a legitimate prescriber.
The consequence of not doing so would be to undermine the safety
and easy accessibility of cross-border healthcare. We consider
that common rules on the content and drafting of prescriptions
would assist in overcoming this confusion. This need not imply
the introduction of a common prescription template.
214. With or without the Directive, we note that
collaboration between service providers across the European Union
already takes place in order to share best practice. We nevertheless
consider that European reference networks have the potential to
assist the delivery of health services across borders and within
each Member State. We conclude that such networks may be most
effective if they are speciality-based as this would allow relevant
experience and best practice to be taken into account. We also
believe it is important that the reference networks should not
become overburdened by regulation. We recommend that European
reference networks could be a useful forum in which to develop
EU-wide benchmarking on quality standards.
215. It is clear to us that the electronic interoperability
of systems is important, particularly to ensure continuity of
care, but we note that this has proved challenging even within
Member States. We therefore urge the Commission and Member States
not to underestimate the challenge of this task and to assess
carefully the impact and modalities of introducing any system
across the EU.