APPENDIX: CORRESPONDENCE
Letter dated 26 October 2006 from the Minister of
State for Health Services to the Chairman of the European Union
Select Committee
Communication from the Commission: Consultation
regarding Community action on health services SEC (2006) 1195/4
I attach an Explanatory Memorandum 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 ten years
which culminated in the Watts judgement of 16 May 2006, which
confirmed that the case law 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 (a copy of which is attached) 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.
Letter dated 15 January 2007 from the Chairman of
EU Sub-Committee G to the Minister of State for Health Services
Commission Consultation—Community Action
on Health Services SEC (2006) 1195/4
Many thanks for offering to visit EU Sub-Committee
G at 10am on 25 January to talk to us about the Commission's Consultation
on Community Action in Health Services.
I thought it would be helpful to write to you in
advance setting out how I feel the session might most profitably
be structured.
We felt that your offer to visit the Sub-Committee,
made in your letter to Lord Grenfell of 26 October, provided us
with a valuable opportunity to add an additional informative,
initial, stage to the usual scrutiny process.
We recognised the complexity and wide ranging implications
of the issues relating to the Community Action on Health Services
proposals, and we welcomed your suggestion that you should visit
the Sub-Committee to go over the key issues with Members, in a
little more depth than can be done in an Explanatory Memorandum.
It will be entirely up to you whether you would like
to set out your views in an opening statement on 25 January. However,
I hope that you will take advantage of the opportunity to do so.
This consultation relates to an important and potentially quite
contentious area of policy, and it would be most valuable for
Members to hear from you the Government's view of the key issues
including:
- the problems with the current
legal position that might usefully be addressed by Commission
proposals;
- the UK Government's views of how the Commission's
proposals might best be framed to address these problems;
- any concerns about possible legislative proposals
that the UK Government would not find acceptable; and
- whether a framework for non-regulatory co-operation
between Member States could help to support the legal framework
and, if so, the sort of issues it could most usefully cover.
Following such an opening statement, Members will
probably wish to take the opportunity to ask you a number of questions,
and my Committee Clerk will certainly let your departmental officials
have advance warning of these.
Following your briefing, I would foresee the scrutiny
moving into the more usual pattern, with a follow-up letter from
Lord Grenfell raising a number of questions for the future. It
is also possible that the Sub-Committee will wish to conduct an
Inquiry into this topic, but no decision on this has yet been
taken.
Letter dated 8 February 2007 from the Chairman of
EU Sub-Committee G to the Minister of State for Health Services
SEC (2006) 1195/04: Communication from the Commission:
Consultation regarding Community action on health services
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 session.
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.
Attachments to letter dated 26 October from the Minister
of State for Health Services
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 s 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 quality 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-centered 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 preventative
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:
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.
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 State 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.
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.
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.
EXPLANATORY MEMORANDUM ON EUROPEAN COMMUNITY DOCUMENT
SEC (2006)1195/4
Commission Communication on Health Services: Consultation
regarding Community Action on Health Services
Submitted by the Department of Health 27 October
2006
SUBJECT MATTER
The Commission has published a communication on health
services. This document forms a consultation on health services
that will run until the end of January 2007.
Two factors have prompted this Communication. Firstly,
the development of European Court of Justice (ECJ) case law on
patient mobility over the last ten years has left some areas of
legal uncertainty (for example, on the question of who has responsibility
for the safety of patients being treated in other Member States).
Secondly, the removal of healthcare from the scope of the Services
Directive, which has prompted the Commission to look at a sector-specific
piece of work. In its 2007 Annual Policy Strategy the Commission
undertook to provide certainty over the application of Community
law to health services and healthcare.
The Communication emphasises that Community action
does not mean harmonisation of health systems, and that the organisation
of the benefits that different systems provide must remain the
responsibility of the Member States, in line with the principle
of subsidiarity. The Communication focuses on two pillars: legal
certainty where it is needed—notably in cross-border care;
and support for Member States in areas where European action can
add value.
Legal certainty
On legal certainty, the Communication notes that
the ECJ has ruled that healthcare services must be regarded as
services within the meaning of the relevant Treaty articles on
free movement of services. Thus any requirement that a patient
should seek 'prior authorisation' from their home health system
as a precondition on the costs of their treatment being reimbursed
is a barrier to the freedom to provide services; such barriers
may be justified by overriding reasons of general interest (such
as maintaining the financial sustainability of health systems).
Cross-border healthcare is considered in four distinct
categories:
- Provision of services (e.g. remote
diagnosis; telemedicine; laboratory services)
- Use of services abroad by patients
- Permanent presence of service providers from
other Member States
- Mobility of health professionals
The Communication argues that wider European cooperation
has great practical utility in facing the wider challenges that
healthcare systems must cope with e.g. in some areas it may be
more practical for citizens of one EU Member State to visit a
nearby hospital across an internal border; smaller Member States
may find it more efficient to share specialized facilities where
they could not afford to maintain them on their own. The 'open
method of coordination' is developing mechanisms for information
exchange and peer review as a means of sharing best practice in
a non-regulatory framework.
It also suggests that an analysis of the impact of
the economic, social, and health impacts of cross-border healthcare
is required. The consultation questions on the legal certainty
that is required focus on four areas:
Minimum information and clarification requirements
to enable cross-border healthcare
This could include clarification of where Member
States may insist on a system of 'prior authorisation' for accessing
treatment abroad; and where such authorisation must be given.
It also refers to the information that patients and professionals
need to make choice about treatments and providers in other Member
States.
Identifying the competent authorities and their
responsibilities
Clarity is needed over which authority is responsible
for ensuring the quality and safety of services provided to people
from other Member States; also the question of whose system of
redress should apply. The question of ensuring successful continuity
of care for patients crossing borders for treatment is also posed.
Responsibility for harm caused by healthcare and
compensation arising from cross-border healthcare
Clarity is needed over who is responsible for ensuring
patient safety in cross- border healthcare, and which clinical
liability mechanisms apply in case of harm.
Ensuring a balanced healthcare accessible for
all
The Communication points out that, although the volume
of patient mobility is relatively low, there are some circumstances
where it may be much higher, such as border regions or tourist
resorts. Clarity is needed on the actions that Member States may
take to ensure that treating patients from other Member States
does not prevent the provision of a balanced healthcare system
open to all.
Support to Member States
The Communication refers to certain other actions
that may add value to the actions taken at Member State level:
European networks of centres of reference
The Communication refers to the possibility of concentrating
resources or expertise for treatment of rare diseases, for example.
Realising the potential of health innovation
Sharing scientific evidence to spread best practice
and avoid duplication of resources.
Shared evidence base for policy-making
Strengthening mechanisms to share evidence on techniques
and outcomes of treatment.
Health systems impact assessment
Implementing a mechanism to consider the impact on
health systems of Community action.
Options for action
The Communication notes that there are a wide range
of possible actions, but that legal certainty would be best ensured
by a binding legal instrument, as an interpretative communication
will probably not be sufficient.
There are also various non-legislative options, including
practical cooperation through the High Level Group on health services
and medical care, and the open method of coordination.
MINISTERIAL RESPONSIBILITY
The Secretary of State for Health has lead responsibility.
Ministers of the Scottish Executive and the Welsh Assembly have
an interest relating to their responsibilities for health care
provision. Whilst the Northern Ireland Assembly and Executive
are suspended the Secretary of State for Northern Ireland has
these functions.
LEGAL AND PROCEDURAL ISSUES
Legal basis
As this is a Communication with no legally binding
or effective provision, no legal basis is required.
Impact on UK law
As this is only a consultation document, there are
no direct implications for UK law at the moment. However, it should
be noted that the case law that this communication addresses currently
does have an impact on UK law.
POLICY IMPLICATIONS
We intend to engage pro-actively with the Commission,
Member States, and other stakeholders at an early stage of the
development of this dossier, to achieve maximum influence in the
process; in particular through ensuring the discussion looks at
what we consider to be the key issues where clarification is needed.
This engagement will be at Ministerial and official level, and
will be ongoing during the coming months.
This consultation gives us the opportunity to highlight
the areas of legal uncertainty that the current case law has created,
and where greater legal certainty would be beneficial to health
system managers.
FINANCIAL IMPLICATIONS
None
TIMETABLE
This consultation will close on 31 January 2007.
The Commission's response to the consultation is expected in the
first half of 2007.
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