COMMUNITY ACTION ON HEALTH SERVICES (1195/04)
Letter from Rt Hon Rosie Winterton MP,
Minister of State for Health Services, Department of Health to
the Chairman
I attach an Explanatory Memorandum (not printed)
on the European Commission's communication on health services.
This communication is a consultation document on the-possible
EU-level action on health services. It picks up on the development
of European Court of Justice case law on patient mobility over
the last 10 years which culminated in the Watts judgment
of 16 May 2006, which confirmed that the case law on patient mobility
does apply to tax-funded healthcare systems like the NHS. However,
the case law which currently applies to the UK and, in certain
circumstances confers on NHS patients the right to be treated
abroad at NHS expense—has left areas of legal uncertainty,
for example on exactly how Member States can manage such cross-border
health care.
Another motor behind this work is the removal
of healthcare from the scope of the Services Directive. This cross-cutting
Directive—which, in its original version, contained an article
on the reimbursement of costs for cross-border patient mobility—was
unsuitable for addressing the specificities of the healthcare
sector. However, the removal of healthcare from the scope of the
Directive—which we successfully argued for—has led
the Commission to try to address some of these specificities through
the work on health services.
The Department of Health sees potential advantages
in health services legislation, not least in building a consensus
between EU Member States and the EU institutions on how European
Treaty articles apply to health care services. The consultation
and debate that will follow offers us an opportunity to engage
with other Member States and the Commission to influence the debate
towards our thinking in this area.
The Health Council has already been active in
this controversial area, where significant legal uncertainty remains.
In June all 25 Health Ministers agreed on a statement of Values
and Common Principles (Annex A) which framed the area where it
thinks EU-level work should focus. The central point of this statement
is that, although there are shared values across European health
systems, there are very significant limits to the amount of harmonisation
that could or should be attempted.
I would be delighted to come and speak to your
Committee on these points, should you wish.
26 October 2006
Annex A
STATEMENT ON
COMMON VALUES
AND PRINCIPLES
This is a statement by the 25 Health Ministers
of the European Union, about the common values and principles
that underpin Europe's health systems. We believe such a statement
is important in providing clarity for our citizens, and timely,
because of the recent vote of the Parliament and the revised proposal
of the Commission to remove healthcare from the proposed Directive
on Services in the Internal Market. We strongly believe that developments
in this area should result from political consensus, and not solely
from case law.
We also believe that it will be important to
safeguard the common values and principles outlined below as regards
the application of competition rules on the systems that implement
them.
This statement builds on discussions that have
taken place in the Council and with the Commission as part of
the Open Method of Coordination, and the High Level Process of
Reflection on Patient Mobility and healthcare development in the
EU. It also takes into account the legal instruments at European
or international level which have an impact in the field of health.
This statement sets out the common values and
principles that are shared across the European Union about how
health systems respond to the needs of the populations and patients
that they serve. It also explains that the practical ways in which
these values and principles become a reality in the health systems
of the EU vary significantly between Member States, and will continue
to do so. In particular, decisions about the basket of healthcare
to which citizens are entitled and the mechanisms used to finance
and deliver that healthcare, such as the extent to which it is
appropriate to rely on market mechanisms and competitive pressures
to manage health systems must be taken in the national context.
COMMON VALUES
AND PRINCIPLES
The health systems of the European Union are
a central part of Europe's high levels of social protection, and
contribute to social cohesion and social justice as well as to
sustainable development.
The overarching values of universality,
access to good qualify care, equity, and, solidarity have
been widely accepted in the work of the different EU institutions.
Together they constitute a set of values that are shared across
Europe. Universality means that no-one is barred access to health
care; solidarity is closely linked to the financial arrangement
of our national health systems and the need to ensure accessibility
to all; equity relates to equal access according to need, regardless
of ethnicity, gender, age, social status or ability to pay. EU
health systems also aim to reduce the gap in health inequalities,
which is a concern of EU Member States; closely linked to this
is the work in the Member States' systems on the prevention of
illness and disease by inter alia the promotion of healthy lifestyles.
All health systems in the EU aim to make provision,
which is patient-centred and responsive to individual need.
However, different Member States have different
approaches to making a practical reality of these values: they
have, for example, different approaches to questions such as whether
individuals should pay a personal contribution towards the cost
of elements of their health care, or whether there is a general
contribution, and whether this is paid for from supplementary
insurance. Member States have implemented different provisions
to ensure equity: some have chosen to express it in terms of the
rights of patients; others in terms of the obligations of healthcare
providers. Enforcement is also carried out differently—in
some Member States it is through the courts, in others through
boards, ombudsmen etc.
It is an essential feature of all our systems
that we aim to make them financially sustainable in a way which
safeguards these values into the future.
To adopt an approach that shift focus towards
preventive measures is an integral part of Member States strategy
to reduce the economic burden on the national health care systems
as prevention significantly contributes to cost reduction in healthcare
and therefore to financial sustainability by avoiding disease
and therefore follow up costs.
Beneath these overarching values, there is also
a set of operating principles that are shared across the European
Union, in the sense that all EU citizens would expect to find
them, and structures to support them in a health system anywhere
in the EU. These include:
Quality
All EU health systems strive to provide good
quality care. This is achieved in particular through the obligation
to continuous training of healthcare staff based on clearly defined
national standards and ensuring that staff have access to advice
about best practice in quality, stimulating innovation and spreading
good practice, developing systems to ensure good clinical governance,
and through monitoring quality in the health system. An important
part of this agenda also relates to the principle of safety.
Safety
Patients can expect each EU health system to
secure a systematic approach to ensuring patient safety, including
the monitoring of risk factors and adequate, training for health
professionals, and protection against misleading advertising of
health products and treatments.
Care that is based on evidence and ethics
Demographic challenges and new medical technologies
can give rise to difficult questions (of ethics and affordability),
which all EU Member States must answer. Ensuring that care systems
are evidence-based is essential, both for providing high-quality
treatment, and ensuring sustainability over the long term. All
systems have to deal with the challenge of prioritising health
care in a way that balances the needs of individual patients with
the financial resources available to treat the whole population.
Patient Involvement
All EU health systems aim to be patient-centred.
This means they aim to involve patients in their treatment, to
be transparent with them, and to offer them choices where this
is possible, eg a choice between different health care service
providers. Each system aims to offer individuals information about
their health status, and the right to be fully informed about
the treatment being offered to them, and to consent to such treatment.
All systems should also be publicly accountable and ensure good
governance and transparency.
Redress
Patients should have a right to redress if things
go wrong. This includes having a transparent and fair complaints
procedure, and clear information about liabilities and specific
forms of redress determined by the health system in question (eg
compensation).
Privacy and confidentiality
The right of all EU citizens to confidentiality
of personal information is recognised in EU and national legislation.
As Health Ministers, we note increasing interest
in the question of the role of market mechanisms (including competitive
pressure) in the management of health systems. There are many
policy developments in this area under way in the health systems
of the European Union which are aimed at encouraging plurality
and choice and making most efficient use of resources. We can
learn from each other's policy developments in this area, but
it is for individual member states to determine their own approach
with specific interventions tailored to the health system concerned.
Whilst it is not appropriate to try to standardise
health systems at an EU level, there is immense value in work
at a European level on health care. Member States are committed
to working together to share experiences and information about
approaches and good practice, for example through the Commission's
High Level Group on Health Services and Medical Care, or through
the ongoing Open Method of Coordination on healthcare and long-term
care, in order to achieve the shared goal of promoting more efficient
and accessible high-quality healthcare in Europe. We believe there
is particular value in any appropriate initiative on health services
ensuring clarity for European citizens about their rights and
entitlements when they move from one EU Member State to another
and in enshrining these values and principles in a legal framework
in order to ensure legal certainty.
In conclusion, our health systems are a fundamental
part of Europe's social infrastructure. We do not under-estimate
the challenges that lie ahead in reconciling individual needs
with the available finances, as the population of Europe ages,
as expectations rise, and as medicine advances. In discussing
future strategies, our shared concern should be to protect the
values and principles that underpin the health systems of the
EU. As Health Ministers in the 25 Member States of the European
Union, we invite the European Institutions to ensure that their
work will protect these values as work develops to explore the
implications of the European Union on health systems as well as
the integration of health aspects in all policies.
Letter from the Chairman to Rt Hon Rosie
Winterton MP
At its meeting of 30 November 2006, Sub Committee
G considered the above document, your accompanying Explanatory
Memorandum and your letter dated 26 October 2006.
We agree that this is a controversial policy
area requiring careful consideration and so we would be delighted
to accept your offer of coming to speak to the Committee on the
matter. Our staff have contacted your office to make the necessary
arrangements; a date of 10 am on Thursday 25 January has been
identified for your session.
We will retain the Communication under scrutiny,
pending our forthcoming exchange of views.
6 December 2006
Letter from the Chairman to Rt Hon Rosie
Winterton MP
Many thanks for the oral evidence which you
and your officials presented to EU Sub-Committee G on Thursday
25 January. We will shortly publish a Report to the House which
contains a transcript of the sessions.[122]
The meeting helped to improve our understanding
of the significant and sensitive issues, of both a legal and political
nature, that need to be resolved in order to find an acceptable
way forward in this case. In particular, we recognise the point
you made that there is a need to get the framework for European
Health Services right so that it can provide a fair and transparent
system for people seeking health care and, at the same time, ensure
that it does not undermine the UK health service.
We would be grateful if you could let us have
sight of the Government's response to the Commission's consultation
and, in the future, keep us informed of progress towards the formulation
of firm proposals by the Commission for establishing a framework
which provides greater clarity. In the meantime, we are now content
to release this consultation document from scrutiny.
8 February 2007
Letter from Rt Hon Rosie Winterton MP
to the Chairman
Thank you for your letter of 8 February 2007.
I was grateful for the opportunity for the appearance before your
Committee to help broaden its understanding of the issues and
way forward in this area.
I am happy to enclose a copy of our response
to the Commission's consultation and grateful to your Committee
for lifting scrutiny.
I will keep the Committee updated of further
developments.
14 March 2007
Annex A
UK CONSULTATION RESPONSE
TO COMMISSION
COMMUNICATION ON
HEALTH SERVICES
Summary
1. We welcome the opportunity to respond
to the Commission's Communication on Health Services. This response
takes account of the views of UK stakeholders that contributed
to a consultation in the UK, and views expressed in the UK Parliament,
following appearances by the Right Honourable Rosie Winterton
MP, the Minister of State for Health Services, before both a House
of Commons Standing Committee, and Sub-Committee G of the House
of Lords European Union Select Committee.
Minutes of the Commons appearance are available
at the following web link:
Minutes of the House of Lords appearance will
be published shortly at the following link:
2. This is an important piece of work. Member
States face an increasing challenge in providing sustainable health
services in the face of demographic ageing and globalisation.
Cross-border healthcare, and non-regulatory cooperation, can add
value to Member States' efforts in this field, provided that the
fundamental rights of Member States for the organisation and management
of their health care systems are respected.
3. Recent developments in the case law of
the European Court of Justice, and the ensuing debates, have raised
other, fundamental, issues:
— The first is the underlying question
of the wider impact of the Treaty on health systems. Here, we
think it is important to continue the discussion that was started
in the High Level Reflection process, and which was reflected
in the Statement on Values and Common Principles that the EU Health
Ministers agreed at the Health Council in June 2006. Further work
is needed on how the impact of the Treaty might be managed to
ensure that Member States continue to be able to discharge their
responsibilities for the management and operation of the health
systems of the European Union;
— The second is the growing need now
to address the tensions that are arising between the principles
that underpin the long-standing EU Regulations in this areas (Regulation
1408, as recently amended) and the caselaw of the European Court
of Justice. Although relatively few people are currently interested
in going abroad from the UK in order to access treatment, there
is considerable use made of other rules which allow access to
treatment while people are abroad. More work is needed, including
at the Ministerial level, to ensure that this key practical benefit
of EU membership is managed in a way that is financially sustainable
for the longer term.
4. In that context the UK welcomes the Commission's
launching of the debate on the specific issue of the terms under
which patients access health care services when they travel elsewhere
in the European Union, mostly at their own instigation, in order
to be treated. There are some important specifics to get right
in this area, and these form the main basis of our response to
this consultation.
5. The Communication also flags the importance
of non-legislative work in support of Member State action in the
health care field (for example on centres of reference and on
non-legislative guidelines for cross-border commissioning of services).
The UK agrees that there is useful work to be done in this area,
and endorses the Commission's view that this sort of non-legislative
approach is more appropriate to this sort of work.
Detail
6. The UK is pleased to have the opportunity
to respond to this Communication. The Communication essentially
asks four questions, and we will respond to these questions in
the rest of this document:
— What is the current extent of cross-border
healthcare/patient mobility?
— What legal certainty is needed in
this area?
— What work can usefully be done through
non-regulatory cooperation?
— What sort of legal instrument would
be appropriate?
What is the current extent of cross-border healthcare?
7. Whilst significant use is made in many
Member States of the provisions under R1408 that allow EU citizens
who are retired, working or travelling in other Member States
to access healthcare in other Member States, the number of patients
interested in going abroad specifically for treatment is relatively
low in many Member States: in the UK, around 280 people went abroad
for such treatment in 2005-06.
What legal certainty is needed in this area?
8. The UK thinks that there are certain
fundamental underlying principles that need to underpin, and be
reflected in, any proposals in order to ensure a system of patient
mobility that is manageable and sustainable in the long term,
and also that respects the rights and responsibilities of Member
State to organise and manage their health care systems:
— The home health system in the individual
Member State needs to be able to determine what health care services
are offered to individual patients, and to manage the clinical
decision about whether, given the individual circumstances of
the patient, "undue delay" applies. In the UK this is
done through referral processes as an integral part of the process
of determining what health services will be offered to the patient.
Such processes must be respected in any legislative proposals
(this will require a development of the case law with regard to
"hospital" and "non-hospital" services; see
below).
— Patient mobility needs to be "cost-neutral"to
the home health system: where patients choose to go abroad this
shouldn't cost their home health system more than it would have
done to treat them at home. Where the cost of treatment abroad
is lower than at home, the home health system should only be required
to pay for the actual cost of treatment.
— Clarification that, when patients
request to go abroad in order to be treated (as opposed to services
directly commissioned abroad), it is the standards of care, governance,
and redress arrangements of the MS of treatment that apply: health
systems can't take responsibility for the actions of providers
they don't regulate or assess.
— A principle of transparency could
be established making it clear what information should be made
available to patients by providers before they travel abroad for
treatment. This information should include: the nature of the
service being offered; full costs; what is covered by consent;
full details of what is included in the package; which systems
of redress, care and governance will apply. What this means in
practice may well differ substantially between Member States.
— That there is no "requirement
to treat" on MS receiving patients travelling abroad for
elective treatment (in other words, that MS can prioritise their
own residents above patients travelling to them specifically
for treatment).
— The principles of equity and solidarity
need to be respected with regard to patient mobility, thereby
avoiding the risk of creating a system whereby those EU citizens
who can afford to pay for services up front can access health
care services faster than those with greater needs.
9. In terms of any specific legal action,
it would need to be specific to three different types of patient
mobility, and their practical handling:
— Patient mobility where a patient
goes to another EU Member State (MS) for a treatment that their
insurer does not fund (eg cosmetic surgery), or their system does
not provide (and is thus not entitled to reimbursement of costs).
— Cross-border commissioning of services
in one Member State by the health system of another Member State.
— Patient mobility where a patient
goes to another EU Member State for a treatment that their insurer
will fund, or system will provide.
10. In the first case, where a patient is
essentially self-financing, legal clarity on the standards, governance,
and systems of redress that apply is needed; clearly these should
be those of the MS of treatment. Any proposals could seek to clarify
the information that providers are required to provide to patients
to enable them to make safe, informed decisions before purchasing
health services from a provider in another MS.
11. For the second type of patient mobility,
cross-border commissioning of services can be done mostly on an
intergovernmental basis, although there may be a case for some
limited European guidelines on this, eg reflecting the principle
that national standards apply, and clarifying the duty of care
that the commissioning authority has towards the patients it sends
abroad.
12. Patient mobility where patients choose
to go abroad specifically to receive treatment poses the biggest
challenge. Although the current level of this sort of patient
mobility is very low in the UK, this may not be the case in all
the EU Member States. It may also be that this kind of mobility
increases across Europe in the future. Any system that is put
in place to facilitate patient mobility therefore needs to be
both sustainable and flexible enough to take account of long-term
developments.
13. We were surprised to see in the Commission's
Communication the statement that the European Court of Justice
has ruled that people may seek any "non-hospital" care
(to which they are entitled in their own Member State) in another
Member State without prior authorisation. We do not agree with
what the Communication says on this point. In fact the Court has
said that it has yet to see a justification for a prior authorisation
system for non-hospital care.
14. The Court has stated that prior authorisation
systems were justified for "hospital" services as they
sought to ensure "sufficient and permanent accessibility
to a balanced range of high-quality treatment in the State concerned";
that they assisted in controlling costs; and that they assisted
in preventing "any wastage of financial, technical, and
human resources". We think that this justification applies
equally to some services that are delivered in a "non-hospital"
setting, as they require no less planning, funding, or careful
management than "hospital" services. Consideration should
also be given to the drive in many Member States, including the
UK, to move more services from being delivered in hospital to
being delivered in a primary care setting.
15. European Court of Justice (ECJ) case
law has stated that the decision as to whether a patient faces
"undue delay" in accessing services should be based
on "an objective medical assessment of the patient's medical
condition, the history and probable course of his illness, the
degree of pain he is in and/or the nature of his disability at
the time when the request for authorisation was made or renewed"
(Watts, para 119). The UK government is firmly of the view
that this is a sufficient definition of the factors that need
to be taken into account when assessing "undue delay".
Any attempts to define the concept of "undue delay"
further will contradict the logic of the ECJ case law, which is
that it should always be clinically assessed against the needs
and circumstances of the individual.
16. Any proposals on patient mobility should
develop the existing case law on this point. In line with the
key principles put forward in paragraph 8 of this response, the
most effective way to do this would be to state the principle
that prior authorisation systems are justified for treatments
that are accessed on referral in the home Member State.
17. The basic principles of the system by
which patients can access medical treatment in another EU Member
State by way of entitlements under Article 49 of the Treaty differ
from the basic principles of the system of referrals under Regulation
1408/71 ("E112 referrals"). This has the potential to
cause confusion, particularly to patients (eg the reimbursement
principles for the two systems are entirely different). One simple
way of addressing this confusion for the circumstances where patients
ask to go abroad would be to make the use of the E112 referral
system optional for Member States. In the long term, the principles
developed in the Court's case law (eg that reimbursable costs
for mobile patients are restricted to the level that the treatment
would have cost in the home Member State) seem a more sensible
and sustainable basis to handle requests to go abroad for treatment.
18. In areas other than cross-border healthcare
there are two issues relating to professional mobility that could
be dealt with in legislation:
— A duty on regulatory authorities
to share information about current professional status on a proactive
basis wherever possible, on health professionals moving between
countries, in line with the "Crossing Borders" Edinburgh
Agreement.
— Clarification that Member States
can require health professionals from overseas to be proficient
in the language in which they will be working.
What work can usefully be done through non-regulatory
cooperation?
19. The UK believes it would be appropriate
to consider developing further the work of groups such as the
Commission's High Level Group on Health Services and Medical Care,
so that there will be a standing mechanism of Member State experts
who can advise the EU institutions on the implications of EU activity
and proposed legislation for the health systems of the EU.
20. The UK believes that there is much benefit
to be gained from EU-level networking of clinical and health management
professionals, and from facilitating the exchange of good clinical
practice.
21. Cross-border commissioning of services,
as referred to in paragraph 11 above, may be a fruitful area for
developing information sharing systems, in order to promote intergovernmental
cooperation. This kind of information sharing will also help to
promote continuity of care in patient mobility, which is a key
concern.
22. The UK is concerned about the risks
of over-ambition in the area of the role of IT in cross-border
healthcare. IT clearly has an important role in supporting the
delivery of cross-border healthcare, and we support strategic
development of the options that will enable this in the future.
23. However, it is important to understand
that there are some very difficult problems to solve which are
not directly related to the use of IT. These are evident, particularly
in relation to ensuring confidentiality and security, and also
in adopting common standards and clinical technologies. It is
essential that we proceed cautiously and in full consultation
with the appropriate clinical professions. Where IT is used to
support cross-border care it must be effective, transport reliable
and accurate patient information, and deliver real benefits to
citizens moving between Member States. It must also take full
cognizance of the legitimate concerns of citizens about the privacy
of confidential health information. In particular, we see no case
for a central data warehouse of information about patients.
24. When discussing the development of IT,
the potential costs and benefits of any proposals must be very
carefully considered.
What sort of legal instrument would be appropriate?
25. We can see potential value in legislation
in this area provided that it helps health systems to manage requests
to go abroad effectively, and provides legal certainty to patients:
in practice, this means not just writing out the case law, but
dealing with some of its underlying ambiguities.
26. It is important that any proposed solution
is proportionate to the demand from patients. Whilst significant
use is made in many Member States of the provisions under R1408
that allow EU citizens who are retired, working or travelling
in other Member States to access healthcare in other Member States,
the number of patients interested in going abroad specifically
for treatment is relatively (very) low in many Member States:
in the UK in 2005-06 around 280 people went abroad to receive
treatment in this way. However, this may grow: any system that
is put in place to facilitate patient mobility therefore needs
to be both sustainable and flexible enough to take account of
long-term developments.
27. In the context of 27 different health
systems, and in accordance with the statement of Values and Common
Principles that EU Health Ministers endorsed in June 2006, the
detailed implementation of any systematic approach to patient
mobility will differ. The key aim for any EU-level proposal should
be to ensure that such implementation does in fact happen, in
accordance with the key principles listed in paragraph 8 above.
Any proposals should be based on these high-level principles,
and should not attempt to construct an overly-detailed system
that would prove unwieldy or unworkable.
28. There would be very limited value in
a proposal that simply transposes ECJ case law into legislation.
There are real uncertainties that arise from the existing case
law that need to be addressed, for example the question of "hospital"
and "non-hospital" care mentioned above. Clarifying
these uncertainties is in the interests of both citizens and those
planning and managing services.
122 Cross Border Health Services in the European Union,
8th Report of Session 2006-07, HL Paper 48. Back
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