Supplementary memorandum by the NHS Confederation
1. Jo Webber, the NHS Confederation's Deputy
Director of Policy, gave oral evidence on 4 December as part of
the Committee's inquiry into the European Commission's proposals
on cross-border healthcare.
2. The Committee requested a supplementary
written note on the challenge of understanding the different systems
in place across the EU and obtaining practical information on
cross-border healthcare options, whilst ensuring that systems
to support cross-border healthcare remain proportionate to the
level of cross-border activity.
3. The NHS Confederation recognises that
this is a considerable challenge. The draft directive includes
proposals for a network of national contact points on cross-border
healthcare, which, it is envisaged, would be responsible for collating
and exchanging information about cross-border healthcare in each
EU member state.
4. As we said in our evidence, we think
these national contact points may be helpful in terms of providing
general information about rights to cross-border healthcare and
how other member states' systems function, but we do not think
they will be able to provide personal advice on the best care
or act as advocates for individual patients.
5. Most patients will look to their local
NHS, often their own clinician, to help them make decisions about
their healthcare. However, responses to the NHS European Office's
recent consultation on the proposals suggested that, with a few
exceptions, awareness of rights to cross-border healthcare is
very limited at local levels of the NHS. In view of this, we think
there will be a need for capacity building and support in this
area as part of implementation of any future directive.
6. We also think it is important to be realistic
about the level of information on cross-border healthcare that
health professionals and staff in local NHS organisations will
be able to give. It may be that in many cases, they would discuss
a patient's individual needs and entitlements with them, and then
signpost them to other sources for more general information, eg
on standards of quality and safety that would apply in the country
where they were interested in receiving treatment.
7. In our evidence, we explained that we
strongly support the use of prior authorisation systems as a mechanism
to provide information to patients interested in cross-border
healthcare to help them make an informed choice. It is unlikely
that the NHS would ever be able to provide the same level of information
about cross-border healthcare options as it could about options
within the NHS. However, prior authorisation systems do offer
an opportunity to make patients aware of important factors to
be considered in a decision to seek cross-border healthcare, for
example, the fact that standards of quality and safety and clinical
practices may be different in other member states.
8. There may be merit in developing materials
to support patients considering cross-border healthcare options,
such as sets of questions they could ask a prospective healthcare
provider. Involving public and patients in the development of
guidance and information on cross-border healthcare would be helpful
in trying to dispel misconceptions and misunderstandings about
what exactly patients are entitled to.
9. We also think that, in the interests
of equity, consideration will need to be given to the provision
of information in accessible formats and potential extra help
or support for vulnerable patients or those with complex needs.
This may be an area where approaches that share resources or pool
expertise could be useful.
10. We think the NHS has a responsibility
to ensure that patients can access information about their healthcare
options, including cross-border healthcare, easily and in a format
that is clear and understandable to them. Where patients are interested
in cross-border healthcare, the NHS should provide clear information
on eligibility requirements, level of reimbursements and processes
for obtaining prior authorisation, where this is required.
11. However, it would be neither proportionate
nor equitable for the NHS to devote unlimited resources trying
to provide the same level of information about cross-border healthcare
options as about options within the NHS. We do not, for example,
think it would be the role of the NHS, in the majority of cases,
to try to obtain information about whether a particular specialist
or centre in another EU country has capacity to treat an individual
patient who is interested in travelling there for treatment.
12. We consider that, where the NHS can
provide treatment in a timely manner in the UK and patients are
deciding for personal reasons to seek treatment in another EU
country, in choosing to obtain care outside the NHS, patients
take on an additional degree of personal responsibility for their
choices. We think, for example, that patients should be responsible
for finding and choosing their own healthcare provider.
13. Nevertheless, we think that a number
of actions, such as the development of materials as mentioned
above, could be taken to support patients in making informed choices
about cross-border healthcare. We think that these actions, though
requiring some additional resource, may well prove cost effective
in reducing the risk of complications arising from poor quality
or inappropriate healthcare received in another country.
NHS EUROPEAN OFFICE CONSULTATION ON THE EUROPEAN
COMMISSION'S PROPOSALS FOR A DIRECTIVE ON THE APPLICATION OF PATIENTS'
RIGHTS IN CROSS-BORDER HEALTHCARE: SUMMARY OF RESPONSES
Responses to the consultation came from a diverse
range of NHS organisations and many different opinions and points
of view were represented. However, some common themes emerged
strongly from the consultation. These can be summarised as follows:
We do not expect a large increase
in the volume of cross-border healthcare as a result of the framework
set out in the draft directive. Systems established to provide
for and facilitate cross-border healthcare should be proportionate
to the level of cross-border activity and should respect the organisation
and structure of health systems.
Where a patient makes an informed
choice that they wish to receive planned healthcare in another
EU country, they should be supported to do so. As well as looking
to remove unjustified barriers to accessing cross-border healthcare,
the legislative framework put in place should consider mechanisms
to support informed decision-making.
It is crucial to recognise that,
within many systems, decisions about what treatment an individual
can receive are made at regional and/or local levels. Such decision-making
processes must be allowed to continue.
Prior authorisation systems should
not be seen as a barrier to accessing cross-border healthcare.
They offer a valuable opportunity to ensure patients have the
information they need to make informed choices about cross-border
healthcare. They are also an important aid to help healthcare
systems plan services and manage financial resources to the benefit
of all patients.
The provision of information is absolutely
fundamental to supporting patients who are interested in accessing
cross-border healthcare. It is important to recognise that patients
will need a range of information from different sources to make
an informed choice about the best healthcare options for them.
Information on quality and safety
systems as well as differences in clinical practices and the way
healthcare is organised and delivered in other EU countries will
be a key element of patient information. However, these matters
are the responsibility of the appropriate national authorities
and the legal framework should not interfere in how they are managed
within member states.
There is significant and widespread
confusion and misconceptions throughout the NHS about the current
rules on cross-border healthcare, existing arrangements under
social security provisions and what changes EU proposals in this
area may lead to. There were strong calls for clear guidance on
the different routes to accessing healthcare abroad and their
application in the context of the NHS.
Some NHS organisations expressed
an interest in developing opportunities to offer more cross-border
healthcare. There were calls for guidance clarifying what scope
NHS organisations have to pursue such opportunities.
There were concerns that requirements
in relation to data collection on cross-border healthcare should
not be too complex or burdensome and should not result in resources
being diverted from patient care.
There was interest and support for
cooperation with healthcare systems and providers in other EU
countries, particularly from providers of highly specialised services.
It is important that current initiatives are taken into account
and that flexibility is maintained in the scope and direction
of future developments.
In the past, the NHS did not provide reimbursements
for healthcare received in other EU countries. As the vast majority
of NHS healthcare is provided free at the point of use, the NHS
had no systems for calculating levels of reimbursements due if
healthcare were paid for upfront. In addition, the NHS has no
defined list of healthcare for which all patients are eligible.
The treatment that a patient can receive is determined at a local
level, based on an assessment of their individual circumstances
balanced against the healthcare needs and priorities of the wider
local population. As a result of these and other factors, implementing
rights to cross-border healthcare raises some significant challenges
for the NHS.
In July 2008, the European Commission published
proposals for a directive on the application of patients' rights
in cross-border healthcare. The aim of the proposals is two-fold:
to clarify the rules associated with the right to access cross-border
healthcare; and to put in place measures to support the provision
of cross-border healthcare.
The right to access cross-border healthcare
in certain circumstances has been established by the European
Court of Justice, and cannot be removed. However, the detailed
framework set out in the draft directive could make a big difference
in terms of how complex and potentially burdensome implementation
is, in practice, for the NHS and how clear and easy the system
is for patients to use.
In view of this, NHS European Office undertook
a major consultation process focussing on the potential implications
for the NHS of the proposals set out in the draft directive. In
particular, the consultation aimed to explore aspects of the current
proposals which might be particularly problematic for the NHS,
or where changes to the proposals could potentially make the framework
clearer, easier to implement, or less burdensome to the NHS.
The consultation process
The NHS European Office prepared a consultation
document which was circulated to NHS organisations, and published
on the internet. A number of specific consultation meetings were
organised and the issue also raised and discussed at a range of
other meetings, conferences and events. Discussions were also
held with a range of other stakeholders from the UK healthcare
community. The consultation ran for a period of three months.
The consultation document can be viewed via the NHS European Office
Cross-border healthcare: potential impact on the
From a UK perspective, travelling to another
EU country for healthcare is likely to be associated with additional
costs and inconvenience as well as possible language barriers,
when compared to obtaining treatment at home. Bearing this in
mind, contributors did not anticipate a large expansion in the
volume of cross-border healthcare, either to or from the UK, within
the framework of the draft directive, provided that patients understood
that they did not gain any rights to receive reimbursements for
treatments that would not have been funded at home.
In view of this, contributors felt that systems
established to provide for and facilitate cross-border healthcare
should not be disproportionate in scale and cost to the level
of cross-border activity and should not have wider, unintended,
consequences for health systems as a whole. Contributors did not
believe that the promotion of cross-border healthcare should be
an objective in itself. Rather, the objective should be to provide
clarity about the rules relating to cross-border healthcare so
that interested patients are able to make informed decisions within
a framework that respects the organisation and structures of different
Some NHS organisations, for example, centres
of very highly specialised care, have long experience of providing
healthcare to patients from other countries. Other NHS organisations
have had to respond to a changing local population as a result
of recent migration patterns. Compared to these wider phenomena,
contributors did not think that incoming patient flows as a result
of cross-border healthcare provisions would, in general, have
a significant impact on NHS provider organisations.
Nevertheless, there could be an impact on a
small number of highly specialised services, where expertise and/or
capacity are limited, and some contributors felt that, in some
circumstances, there could be a need to give UK-resident patients
higher priority than incoming patients from other countries. Examples
cited included when dealing with organs for transplantation that
are in short supply and when supplying a very highly specialised
service, of which there may be no other or a very small number
of EU providers, and the number of incoming patients risked jeopardising
the NHS' ability to meet relevant standards for domestic patients,
such as the 18 week waiting standard. However, these were very
much exceptional examples, and for the vast majority of services,
contributors felt that incoming patients would be accommodated
and treated on an equal basis to local patients.
Some NHS providers said they would be interested
in exploring opportunities to provide more services to EU patients,
in particular in areas of specialist expertise. In such cases,
extra capacity would be planned so that additional patients could
be treated to the benefit of, and not the detriment of, NHS patients.
In order to facilitate this, NHS providers would welcome clarification
on the rules which apply to patients coming from other countries
and what scope NHS organisations have to pursue such opportunities.
Turning to outgoing patient flows, whilst, overall,
contributors thought that relatively few NHS patients would seek
treatment abroad, it was noted that there may be some circumstances
in which greater numbers of patients could choose to obtain cross-border
healthcare. Some examples might include:
Individuals with personal links in
other EU member states who prefer to receive healthcare in the
system they know best.
Individuals who regularly spend extended
periods of time in another EU country (eg retirees who spend three
to six months of each year in the Mediterranean region) for whom
it is convenient to receive healthcare in that other country.
If capacity limitations or the lack
of a nearby provider for a type of healthcare means that it is
easier for patients to travel abroad to access healthcare.
If a patient wished to receive treatment
from a specific specialist or facility because they perceived
they could benefit from their particular expertise.
Contributors recognised that patients in circumstances
such as those illustrated in these examples may benefit from receiving
treatment in another EU member state. There was a strong view
that where patients had made an informed choice to seek treatment
abroad they should be supported to do so. In order to facilitate
this, there was overwhelming support in favour of a system providing
for patients and their commissioner/insurer to discuss arrangements
before treatment is obtained abroad as the best way of doing this.
Patients would, in any case, need to contact
their commissioner/insurer to obtain personalised information
regarding eligibility requirements, level of reimbursements and
processes for obtaining prior authorisation, where this is required.
Therefore such an approach would not constitute an undue barrier
to cross-border healthcare and should reduce risks for both parties
at later stages, eg disputes over reimbursements or whether a
treatment was necessary.
In the UK, where most local commissioners have
relatively little experience of cross-border healthcare, capacity-building
and clear guidance on the legal framework and its application
in the NHS will be needed to support implementation.
Although not directly affected by provisions
on cross-border healthcare, discussions in this area also highlight
questions about eligibility to NHS funded healthcare. Under current
arrangements, it can be extremely difficult, in practice, to determine
whether an individual is entitled to NHS-funded treatment, for
example, in the case of individuals dividing their time between
the UK and another EU country. A number of contributors have said
that they would welcome clearer guidance on these issues.
Conditions for accessing healthcare: local eligibility
criteria and procedures
We understand the current EU framework, and
the proposals in the draft directive, to be based on the principle
that patients should be eligible for reimbursements towards the
costs of healthcare received in another EU country only to the
extent that they would have received the same healthcare at home.
So, for example, if a patient's commissioner/insurer had decided
not to fund a particular treatment for them, the patient could
access that treatment in another EU country, but would have to
pay for it themselves and would not be eligible for a reimbursement
towards the cost. Contributors were clear and unanimous in the
view that this principle is correct and it is crucial that it
In relation to this, many contributors highlighted
the fact that the NHS does not have national level eligibility
criteria for determining access to particular treatments or a
defined "basket of care" which NHS patients are automatically
entitled to receive. The treatment which an individual can receive
is determined at a local level, based on their particular health
needs balanced against the health needs and priorities of the
wider local population.
Access to specialist care in the NHS is by referral
from primary care, and decisions about an individual's care are
usually taken by their NHS clinician, where relevant taking into
account, or with reference to, local commissioners' guidance on
low priority treatments. Contributors were again unanimous in
the view that the legal framework must recognise the legitimacy
of local priority-setting and allow for the "gatekeeper function"
and local decision-making processes to continue.
Contributors noted that if NHS patients have
sought treatment abroad without a needs assessment from an NHS
clinician, it may be extremely difficult to determine retrospectively
whether treatment would have been available under the NHS, and
therefore, whether the patient is eligible for a reimbursement.
For example, the NHS will not normally fund
the removal of moles for cosmetic reasons but mole removal for
biopsy where cancer is suspected is funded. However, after the
procedure has taken place there may be no way of proving whether
the procedure was for medical or cosmetic reasons.
Supporting patients opting for cross-border healthcare:
In England, patients referred for specialist
care can choose to be seen by any provider contracted with the
NHS to provide the appropriate treatment. This is referred to
as "patient choice" and is a relatively new development
(introduced in April 2008, after a gradual phase-in). It is in
this context that many NHS organisations considered the proposals
on patients' rights in cross-border healthcare, and many felt
that cross-border healthcare could be viewed as an extension of
Contributors therefore considered that, where
it has been established that a patient is eligible to receive
a particular treatment, the fact that healthcare could be provided
locally should not, alone, be a reason to prevent the patient
from seeking treatment abroad. It was, however, felt that patients
should be advised of local options where they existed, as well
as being given information about their rights to access healthcare
in other EU countries.
One key difference between patient choice in
England and cross-border healthcare is that patient choice is
limited to providers contracted to the NHS. This includes a range
of independent and third sector providers, but crucially, all
are required to provide healthcare according to NHS standards
and conditions. By contrast, in a cross-border situation, a patient
can access treatment from any healthcare provider, private or
state/public sector, and without reference to issues such as compliance
with quality and safety standards. This difference lay at the
heart of a large proportion of contributions to the consultation.
Contributors were generally concerned about
standards of quality and safety in providers overseen by systems
they were not familiar with. Furthermore, a particular concern
was raised around the issue of different clinical practices in
other countries, which may have implications for patient outcomes
and potential complications. In England and Wales evidence-based
guidance on the appropriate treatment and care of people with
specific conditions is produced by an independent body, the National
Institute for Health and Clinical Excellence (NICE). Whilst NICE
guidance is not binding, NHS providers would be expected to take
it fully into account in deciding what treatment is appropriate
A specific example raised was In-Vitro Fertilisation
(IVF) treatment for fertility problems. NICE guidance recommends
that a maximum of two fertilised embryos are put back into the
womb in a cycle of treatment. This is because multiple pregnancies
are associated with increased risks of problems during pregnancy
and labour, including an increased risk of premature birth. Respondents
were aware of cases of UK patients travelling to other countries
where similar guidelines did not apply. The motivation was that
clinics could indicate a higher success rate in terms of clinical
pregnancy. However, this was achieved by putting more embryos
back into the womb, with a consequent increased risk of multiple
pregnancies and increased risk of complications for both mothers
and babies at a later stage.
This example illustrates why a number of contributors
were concerned about whether patients would, in reality, be able
to make informed decisions about suitable providers in other countries
if they wished to seek cross-border healthcare. From the NHS perspective,
a patient can be assured that an NHS provider will take into account
relevant clinical guidance, but this is not the case for cross-border
healthcare, and therefore additional information will be needed
to support informed choice where cross-border healthcare is considered.
In view of this, contributors very strongly
supported the use of prior authorisation systems as a mechanism
for providing patients with clarity on matters such as what specific
treatment their clinician recommends for them, what reimbursements
they will be eligible for and what costs they will have to meet
themselves, arrangements for any after-care needed and what will
happen if anything goes wrong.
Provided that prior authorisation systems met
criteria such as transparency and proportionality, were simple
and straightforward for patients to use, and gave timely responses
to requests, contributors did not feel they would constitute an
undue barrier to accessing cross-border healthcare. On the contrary,
many contributors viewed such systems as being essential to protecting
patients' interests by ensuring that they understand the conditions
that apply to cross-border healthcare, in terms of quality and
safety, potential differences between services and financial arrangements.
Contributors felt that the provisions in the
draft directive, which envisage that prior authorisation systems
could only be compulsory in exceptional circumstances, were inadequate.
In particular, the distinction between hospital and non-hospital
is a false one, as the degree of risk and resource-intensiveness
of healthcare can depend as much on the individual circumstances
of the patient as the degree of complexity of the treatment itself.
In addition, the need to plan services and manage financial resources
applies equally to healthcare provided in hospitals and in other
In view of this, it is likely that NHS commissioners
would encourage systems of prior authorisation on a voluntary
basis if the legal framework does not allow such systems to be
mandatory on a routine basis.
Alongside this, some contributors suggested
that EU healthcare providers who wished to provide services to
NHS patients could sign up to NHS terms and conditions and be
placed on the NHS "choice menu". It was suggested that
in such circumstances, as packages of treatment would be matched
to UK practice and prices, different arrangements could apply
such that prior authorisation might not be required. However,
it was recognised that different systems of regulatory oversight
might make such arrangements legally complex to realise in practice.
Guidance on the feasibility of such approaches would be welcome
as part of the implementation process.
Limiting the right to travel for treatment
In most cases, where it has been established
that a patient is eligible to receive a particular treatment,
contributors felt that if patients had made an informed choice
to seek treatment abroad that they should be free do to so. However,
contributors did suggest that in certain exceptional circumstances,
it might be appropriate to restrict a patient's right to travel
to obtain healthcare. Examples given included: patients with a
highly contagious and dangerous infectious disease, patients requiring
care in a secure psychiatric facility, and prisoners.
Some contributors also presented the view that
limiting the right to travel for treatment may be necessary in
certain low volume, highly specialised services where a small
reduction in caseload could threaten service viability. For example,
clinicians may need a minimum caseload in order to maintain their
levels of expertise in treating rare or highly complex conditions.
The strong view was that any patient refused access to treatment
abroad should be able to obtain a clear explanation of how and
why the decision had been reached.
The draft directive appears to give little scope
to providers to refuse to accept incoming patients, and contributors
felt it was important to be clear that nothing in the draft directive
interferes with the right of a provider to refuse to accept a
patient for a specific treatment if the provider deems it clinically
inappropriate to treat that patient, or the provider is unable,
eg for reasons of limited capacity or expertise, to provide adequate
or appropriate treatment to that patient.
Costs, mechanisms and levels of reimbursement
Contributors felt it was very important that
all parties were clear about costs and levels of reimbursement
in cross-border healthcare. Where it has been established that
a patient is eligible to receive a particular treatment and they
elect to receive that treatment abroad, most contributors agreed
that reimbursement should be limited to the amount that the same
treatment would have cost the home system.
Contributors noted that in practice, however,
this is likely to present particular challenges, relating to both
incoming and outgoing patients, in calculating the "NHS cost
of care". Although the NHS in England operates a system of
tariffs for healthcare, not all treatments are subject to tariff,
and for those that are, prices are factored to take account of
local costs, so there is not, in reality, a standard price for
any treatment. Furthermore, a tariff may cover a package of care,
rather than a single procedure, and therefore costs may need to
be "unbundled" if a patient receives a different package
of care in another EU country.
Whilst the majority of contributors did not
think these problems were insurmountable, several felt that national
guidance on the calculation of costs and reimbursements would
be needed to provide greater clarity to patients and local NHS
Under the provisions of the draft directive,
the patient must meet costs up front, and must cover costs that
would not be incurred if they were treated at home, such as travel
costs. If treatment is more expensive abroad, the patient must
cover the difference. If, however, treatment is cheaper abroad,
the patient cannot be reimbursed more than they have paidie
they cannot make a profit. Contributors supported this approach,
as it was felt that a patient's choice to be treated outside the
UK should not lead to higher costs for the NHS, thereby reducing
the resources available for the wider population.
Concerns were raised that patients might seek
treatment abroad without being aware that the reimbursement they
are eligible for may not cover their full costs of treatment.
Contributors considered that this was another argument to support
the use of prior authorisation systems.
Whilst some contributors suggested that treatment
costs might be paid directly from the patient's commissioner/insurer
to providers in some cases, removing the need for patients to
pay upfront, there was no support for this to be a universal requirement.
Indeed, because patients are able to "top-up" their
cross-border healthcare with additional treatments or services
that would not be funded at home, and because some systems require
patients to make a co-payment, it emerged that paying the provider
directly could, in practice, be extremely complicated and less
transparent for patients.
Furthermore contributors felt that payments
from patients to providers would avoid potential difficulties
with large scale and potentially bureaucratic systems for processing
and securing payments between healthcare systems, and reduce difficulties
associated with following up debtors from other countries where
monies are outstanding at the conclusion of treatment.
Health inequalities and cross-border healthcare
The issue of equity is challenging and there
was no clear consensus amongst contributors as to what impact
the proposals would have on inequalities. A range of issues such
as the state of an individual's health, geographical factors,
family and work commitments, how articulate and well-informed
a patient is, the ability to speak another language, as well as
their financial position, will all affect an individual's ability
to seek treatment abroad.
In general, contributors felt that rights' to
access cross-border healthcare should be well publicised, so that
patients were aware of the options. However, where treatment could
be provided in a timely manner in the UK and patients are deciding
for personal reasons to seek treatment in another EU country,
contributors felt that they should not confer a special advantage
over patients who are unable or unwilling to do so. They should,
therefore, as a general rule, be responsible for costs which would
not be incurred if they received NHS-funded treatment in the UK.
The NHS has a "Healthcare Travel Costs
Scheme" to support patients who have financial difficulties
with travel costs associated with accessing healthcare. Contributors
were not clear to what extent this scheme could apply to cross-border
healthcare, but many felt it provided a framework that could usefully
Many contributors felt that, where there was
a particular need, NHS commissioners should have flexibility to
make special arrangements on an individual basis to cover costs
of treatment abroad upfront and/or pay additional costs if care
was more expensive. However, it was not clear whether contributors
were always aware of existing options under social security arrangements
(the "E112 referral"), or whether they felt a different
mechanism was needed within the framework of the cross-border
healthcare provisions. In view of this, guidance on the various
options available to NHS commissioners would be helpful.
Requirements relating to information on cross-border
The point that emerged most consistently from
contributors was the need for patients to be able to obtain good
quality information about their options, including treatment abroad,
in a way that enables them to make informed decisions about their
healthcare. Consideration will need to be given to the provision
of information in accessible formats and potential extra help
or support for vulnerable patients or those with complex needs.
Many contributors were concerned that local
NHS organisations and clinicians lack the knowledge to advise
patients on their rights in cross-border healthcare or to direct
them to where they can find out more about these. As a result,
there were strong calls to be realistic about the level of information
that local clinicians and services will be able to provide, and
for national guidance and support in this area. Involving public
and patients in the development of guidance and information on
cross-border healthcare would be helpful in trying to dispel misconceptions
and misunderstandings about what exactly patients are entitled
A number of contributors were interested in
exploring options for shared resources or expertise. Whilst the
idea of a national contact point was thought to be potentially
useful as a source of information about other healthcare systems,
it was noted that information would also be needed at a local
level to reflect the level at which decisions are made in the
Contributors were also clear that provisions
relating to the availability of information and data collection
on cross-border healthcare should not place new costly, bureaucratic
burdens on NHS organisations. It was suggested that a useful approach
might be to collect data on a sample basis.
What happens when things go wrong: issues of liability
Based on experiences of patients seeking treatments
not available under the NHS, such as cosmetic procedures, in other
countries, many contributors raised concerns that some patients
may have unsuccessful or incompetently undertaken treatment abroad.
Whilst the number of patients affected is, overall, likely to
be small, contributors felt that this further supported the need
for a system of prior authorisation, which could help equip patients
with the information they need in order to be able to choose the
best treatment for them and a safe and high quality healthcare
In this context, contributors noted that is
important that local NHS organisations and clinicians are able
to help patients make a decision about where to receive healthcare
without liability being conferred upon them if something goes
Contributors supported the position set out
in the draft directive that it is the systems of the country where
healthcare is provided that apply in terms of liability and redress
when things go wrong. However, concerns were raised about the
draft directive's focus on compensation rather than wider redress
(which can include a range of steps such as regulatory action,
changes in practices, action to rectify a problem). Furthermore,
the definition of "harm" proposed in the draft directive
was identified as very problematic and contributors suggested
that a reference to "adverse events" or a definition
based on avoidable incidents arising from negligence which resulted
in serious harm, should replace this.
There was no support from contributors for the
development of international out-of-court settlement schemes as
proposed in the draft directive. This was because contributors
thought the situation was simply too legally complex.
Provisions relating to cooperation in the field
The Commission's proposals also include a number
of provisions designed to promote cooperation between EU member
states, in areas such as the establishment of European reference
networks (ERNs) of healthcare providers, e-health and the management
of new health technologies. Some contributors expressed an interest
in the development of ERNs particularly with regards the development
of specialist services in other EU countries, however no specific
views were expressed on whether the inclusion of this provision
in legislation would be helpful or not.
Contributors did raise concerns about proposed
provisions on mutual recognition of prescriptions, e-health and
health technology assessment. These all related to concerns that
the proposed provisions were too far-reaching and risked cutting
across existing national or local decisions or ongoing work in
In particular, contributors were concerned that
the draft provision on recognition of prescriptions was unclear
and open to misinterpretation. For example, some contributors
thought this provision could be read as conferring rights to reimbursement
for medicines not funded by a patient's health system, or placing
an obligation on clinicians to administer a drug not licensed
in the member state they work in. Contributors were strongly opposed
to either of these propositions and felt it was important to clarify
that this was not the effect of the proposed provision.
*Different arrangements apply in Scotland, Wales
and Northern Ireland.
15 The NHS European Office is part of the NHS Confederation
and is funded by the Strategic Health Authorities. It was set
up in September 2007 to inform NHS organisations of key EU developments
and to promote the priorities and interests of the NHS to the
European Institutions. Back