Cross-border healthcare in Europe: Clarifying patients' rights

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364 BMJ | 12 FEBRUARY 2011 | VOLUME 342
ANALYSIS
A proposal for a directive on patients’ rights in
cross-border healthcare—defined as healthcare
provided or prescribed in a member state other
than that of affiliation
1
—has been approved by the
European Parliament and will be formally adopted
by the Council of Health Ministers in February.
The Directive on the Application of Patients’ Rights
in Cross-Border Healthcare (http://ec.europa.eu/
health/ph_overview/co_operation/healthcare/
docs/COM_en.pdf) could provide greater clarity
on the rules governing patients travelling abroad
to receive treatment. Moreover it could affect indi-
vidual member states’ national health systems.
We should be concerned about how this issue
is addressed. First, European citizens show a
growing interest in travelling abroad to receive
treatment.2 3 A recent survey in all member states
found that 53% overall expressed a willing-
ness to seek treatment in another country of the
Eu ropean Union (EU).
2
This finding was supported
by surveys among German patients enrolled with
a nationwide health insurance fund. In 2003
only 7% had obtained non-urgent treatment in
another EU country, but by 2008 the proportion
had increased to 40%.3 Second, any solution may
have implications for how domestic health systems
are run. In this paper we describe who is affected
by the directive, review its proposals,
1
and review
the process that has given rise to the directive. We
discuss its most contentious issues and examine its
potential implications for patients, health profes-
sionals, and policy makers.
Who is aected by the directive
Mobile patients include temporary visitors abroad,
people living in border regions, people sent abroad
by their home systems, those seeking treatment
on their own initiative, and those retiring to other
countries
4
(box 1). The directive covers all patients
travelling abroad to receive treatment in another
member state, except those currently covered by
existing social security legislation (such as tour-
ists, pensioners and cross-border workers).
5
This
would include, for example, someone seeking
a specialist consultation elsewhere in the EU,
who would be re imbursed to the amount that it
would cost in their home country. Additionally,
all patients treated abroad will benefit, directly or
indirectly, from the directive’s provision of infor-
mation on treatment abroad and the establishment
of national contact points to provide it.
The content of the proposal and its
legislative process
In July 2008 the European Commission first adopted
the proposal for a directive on the application of
patients rights in cross-border healthcare.
11
It sought
to establish a clear legal framework within the Euro-
pean Union by resolving ambiguities about the
mechanisms involved in providing such care and
establishing systems in which member states can
c ooperate to resolve outstanding issues.
The right to healthcare in another EU member
state was established in 1971,12 with the regulations
updated most recently in 2004
5
and implemented in
May 2010.
13
The scope of the legislation was limited
to people in need of treatment while temporarily
abroad and those receiving advance authorisation
from their own health payer.
6
However, a series of
rulings by the European Court of Justice14-19 has
expanded these provisions, progressively escalating
the range of care that can be obtained without seek-
ing advance authorisation—but with the sp ecifics
of rulings on individual, and often quite unusual,
cases leaving several areas unclear (box 2). The
directive is intended to resolve these issues, provid-
ing clarity for patients, healthcare professionals,
and policy makers.
The directive applies to all healthcare provision
that patients are entitled to at home, regardless
of how it is organised, financed, and delivered. It
gives EU citizens the right to obtain from abroad any
care not requiring a hospital stay without advance
authorisation. However, where inpatient care or cer-
tain specialised investigations are involved, member
states may create a system of prior authorisation to
enable them to manage patient flows and avoid
threats to the financial and operational sustainabil-
ity of their health systems. In both cases, patients
will only be entitled to reimbursement under this
directive up to what would have been paid for if
the care was provided at home. National contact
points will be established to provide patients with
information on rights and procedures. The direc-
tive also makes provision for mutual recognition
of prescriptions written abroad and establishes a
system of European Reference Networks for highly
specialised care, as well as enhanced cooperation
on e-health and on health technology assessment.
11
The progress of this directive has been arduous
(see box 3 on bmj.com for timeline22-27). European
legislation is proposed by the European Commission
for agreement by the Council of Ministers (rep-
resenting national governments) and the European
Parliament. After an extensive consultation process,
the commission’s Directorate General for health and
consumers finally published its proposals on 2 July
2008. A compromise between the Parliament and the
Council was reached in December 2010.
Challenges to ensuring quality and safety,
benefits, and information needs
We focus on three issues that have proved most
challenging in creating a legal framework
for cross-border care: quality, benefits, and
information needs.
HEALTH SYSTEMS PERSPECTIVES
Cross-border healthcare in Europe:
clarifying patients’ rights
The adoption of a new directive on cross-border healthcare in the European Union could bring
clarity for patients, health professionals, and policy makers, as well as raise the awareness of how
healthcare differs between EU member states, say Helena Legido-Quigley and colleagues
This paper is part of an occasional series prepared in
conjunction with the European Observatory on Health
Systems and Policies (www.healthobservatory.eu)
bmj.com Previous articles in the Health Systems Perspectives series
ЖMaintaining the competence of Europe’s workforce (
BMJ
2010;341:c4687)
ЖCan user charges make health care more ecient? (
BMJ
2010;341:c3759)
ЖStoking the antibiotic pipeline (
BMJ
2010;340:c2115)

BMJ | 12 FEBRUARY 2011 | VOLUME 342 365
ANALYSIS
Assuring quality and safety
The directive reaffirms that member states retain
responsibility for providing safe and high quality
care on their territory and that cross border health-
care should be provided according to their own
standards of quality and safety. This requires, first,
that effective mechanisms for quality of care exist
in each country. At a system level these include
mechanisms to ensure the quality of drugs (reg-
istration and licensing), technologies including
devices and medical procedures (health technol-
ogy assessment), and the workforce (training and
continuing education of health professionals).
At a clinical level they include the creation and
implementation of practice guidelines, monitor-
ing systems, and quality assurance systems. Sec-
ond, member states will have to address issues
that are specific to cross-border care, in particular
where follow-up visits are needed.
9
28
At present,
approaches to healthcare quality and patient
safety vary widely in their nature, scope, and cov-
erage and the existing Europe-wide initiatives are
largely driven by voluntary professional groupings.
Benefits
Even though health professionals in different
countries read the same medical literature, man-
agement of similar conditions still varies consider-
ably between (and even within) countries. These
variations are apparent in the mix of staff involved
(such as whether a task is performed by a doctor or
a nurse), the extent of investigation, and the mode
and setting of treatment.29 This creates consider-
able scope for confusion when a payer is asked
to reimburse a package of care that may be quite
different from what they expected— if the greatly
varying cl assifications used even allow for such a
comparison. For example, someone with an acute
stroke may be treated much more aggressively in
one country than in another.30
Information needs
One of the most important provisions of the
di rective is the supply of good information for
cross-border patients on the care they receive—
information that will benefit not only those who
seek healthcare abroad but also those who choose
to remain in their own country. The national con-
tact points will have to provide information on
healthcare providers, including assessment,
registration status, and restrictions on practice,
patients’ rights, procedures for reimbursement,
and complaint and redress mechanisms. Each
healthcare pr ovider must supply patients with
information on availability, quality, and safety of
care, clear invoices, and information on prices.
This process will ultimately increase the transpar-
ency of healthcare systems and is likely to stimu-
late the improvement of care. However, it will
pose many challenges, especially in decentralised
health systems—including the reorganised NHS,
where it will create substantial additional respon-
sibilities for the proposed general practice commis-
sioning consortiums.21 Another important aspect
relates to communication between providers. This
is addressed through provisions on e-health and
by giving patients the right to access their medi-
cal record in both their home state and where they
receive tr eatment.
Controversial issues
The most controversial issue, ever since health-
care was first discussed at European level, has
been the principle of subsidiarity. Proposals have
been judged by politicians in terms of the extent
to which they interfered with the right of member
states to organise and deliver their own system
of healthcare, as set out in article 168 of the Lis-
bon Treaty. In part this reflects the origins of the
legislation in policies on advancing the internal
market rather than improving health. From an
internal market perspective, healthcare is a serv-
ice like any other and Europe’s citizens should be
Box 1 |
Types of patients moving within Europe4
Temporary visitors abroad
Travellers abroad who fall ill in another member state are entitled to medical treatment in the country
they are visiting on presentation of a European Health Insurance Card (which replaced the E111 form). An
example is the large seasonal influx of tourists to the Veneto region (Italy), where the local health authority
had to create special health services to cater for the tourist season.6
People retiring to other countries
Many older people from northern Europe retire to southern Europe. They include many British pensioners
retiring to Spain who register with the Spanish system and are then treated the same way as Spanish
citizens (using the E121 form).7
People in border regions
Most cross-border healthcare takes place in border regions where collaborations have served to rationalise
services, as many borders traverse sparsely populated areas, dividing communities that share common
languages and cultures. One of the oldest collaborations in Europe is that in the Euregio Meuse-Rhine region,
dating from 1976, where three countries (Holland, Germany, and Belgium), with three national legal systems
and four different cultures, collaborate in more than 15 cross-border healthcare projects.8
People sent abroad by their home systems
In some cases purchasers establish procedures to allow patients to go abroad for healthcare. This normally
happens to respond to waiting lists, overcome a shortage of domestic provision, or to obtain highly
specialised services, particularly in smaller member states where the populations are insufficient to justify
local provision. For example, a bilateral agreement between Malta and the UK allows Maltese patients to
obtain specialised hospital treatment in London.9
People going abroad on their own initiative
These people typically travel abroad to receive healthcare that is cheaper (such as spas, cosmetic surgery,
and dental treatment), faster, or considered to be of better quality than in their home country. Patients
may also seek interventions that are prohibited at home, such as abortions or fertility treatment, with the
term “fertility tourism” coined to describe travelling to countries where donor anonymity is guaranteed for
sperm and egg donations.10

366 BMJ | 12 FEBRUARY 2011 | VOLUME 342
ANALYSIS
able to obtain it freely
from anywhere within
the EU. National gov-
ernments, concerned
about costs of treat-
ment abroad and the
sustainability of their
domestic health sys-
tems, have taken a dif-
ferent view. They have
also been concerned
about exacerbating
inequalities, because
the proposal is likely
to disproportionately
benefit wealthy and
well informed patients.
The most controver-
sial issues during the
negotiations between
the council and parlia-
ment have been: prior
authorisation, prepay-
ment, treatment of
rare diseases, the defi-
nition of quality and
safety standards, and
e-health.
Governments, through the Council of Ministers,
have sought to develop criteria that increase their
scope to refuse prior authorisation. For example,
although they have tried to limit the scope of the
commission to gather information on quality of
care in other countries, they have also argued
that concerns about the quality of care elsewhere
should be grounds for refusal. The parliament and
the commission, on the other hand, have argued
that the council’s proposed criteria, which were
non-exhaustive, were so vague as to increase legal
uncertainty. Although the parliament was, in prin-
ciple, against any prior authorisation, it accepted it
as long as the criteria for refusal are objective and
limited.
The European Parliament also differed from
the council on payment, proposing that the home
country should have paid in advance rather than
citizens having to pay upfront. One potential
mechanism, rejected by the council, was the crea-
tion of a voucher system. Instead it was agreed that
member states must at least ensure that patients are
reimbursed as rapidly as possible unless they can
opt for alternative mechanisms that already exist
under social security legislation (regulation (EC) no
883/2004). Another point of disagreement related
to Europeans affected by rare diseases, which some
estimates suggest may
apply to as many as
25 million individu-
als.31 The parliament
argued that affected
patients should have
been entitled uncon-
ditionally to obtain
healthcare abroad
(including medicines)
without any form of
previous authorisation
and be reimbursed
even if the treatment
in question was not
among the benefits of
their home system—a
view contested by the
council.
The commission
and the parliament
wanted to impose on
member states the
obligation to define
cl ear quali ty an d
safety standards. The
council opposed this,
proposing as a com-
promise provisions to encourage member states
to do so, including the possibility of refusing prior
authorisation in cases of serious and concrete con-
cerns about the quality and safety of care provided
by a specific provider in another member state.
Finally, on e-health, the council has challenged
provisions that would allow the commission to pro-
mote interoperability, an action not well received by
either the commission or parliament.
Remaining controversies
Most problems have been resolved during the
negotiations, but certain areas are likely to remain
unresolved. First, some issues have been left out of
the current version of the directive1 such as e-health
services and standards of quality, which will not
be addressed at EU level. Measures on these and
issues such as rare diseases will be left to coop-
eration among member states, with the directive
simply pointing to the possibilities offered by regu-
lation (EC) no 883/2004 for referral of patients for
diagnosis and treatments which are not available
in the home member state.32
Other areas could generate confusion when
implemented—for example, the process of prior
authorisation; the mechanisms for calculating
costs of cross-border healthcare for each member
state; and what is included in the reimbursement
of a treatment. These areas could prove difficult
for member states from an administrative point
of view (particularly establishing the cost of treat-
ment). Moreover some of the concepts included in
the directive (such as what is a medically justifiable
time limit) could be difficult to define in practice
and thus give rise to different interpretations. Ulti-
mately, the directive could introduce inequalities if
there are differences in how member states decide
to reimburse the costs of cross-border healthcare,
with some only providing the minimum requested
and others deciding to reimburse related costs,
such as accommodation, travel costs, or extra costs
incurred by people with disabilities.
What does the directive mean for patients,
health professionals and policy makers?
The benefits for patients
The volume of cross-border care in Europe will
probably continue to increase, not least due to
greater awareness among patients and those advis-
ing them. The current situation is far from satisfac-
tory and a framework that brings greater clarity to
an often confusing situation is clearly welcomed.
In particular, the directive codifies and clarifies a
growing body of case law for which applicability
to a particular case is often uncertain. It will also
extend the opportunities to obtain care abroad,
although the extent to which it succeeds will only
become clear once experience has been gathered
of how the directive works in practice . European
reference networks will be of particular interest to
patients with rare diseases, offering them access
to specialised care that might not have been pos-
sible otherwise, although the ease of accessing it
remains uncertain.
Implications for policy makers
Policy makers will also benefit from the greater cer-
tainty about legal and financial aspects of cross-
border care.
33
34
The directive will offer them new
options to address common problems such as
waiting lists, underused facilities, and the ability
to manage rare diseases. It should lead to improved
mechanisms for sharing data, improving quality of
care, greater compatibility of patient records, and
the ability to prescribe across borders.21 35
Implications for healthcare providers and
professionals
Healthcare providers will need to understand
much better the diversity of treatment pathways
that exist in Europe for common conditions, as
well as becoming familiar with regulations, enti-
Box 2 |
Examples of the role of European Court
rulings
• Kohll and Decker (1998)14—Two citizens from
Luxemburg, Mr Kohll and Mr Decker, requested
reimbursement for orthodontic treatment and
the purchase of spectacles acquired in Germany
and Belgium, respectively. The European Court
considered that Luxembourg’s statutory health
insurance rules had created an impediment
to the free movement of goods and services
and established that individuals could obtain
certain goods and medical services provided
outside hospital and be reimbursed by their
health funder without prior authorisation.20
• The Watts Case (2006)18—In 2002, Yvonne
Watts, a 72 year old living in the UK, was
diagnosed with osteoarthritis. Facing a one
year wait for hip replacement at her local NHS
hospital, and being refused treatment abroad,
she decided, on her own initiative, to seek
treatment in France.10 The European Court
confirmed that patients facing “undue delay” at
home, defined by their clinical condition rather
than potentially arbitrary targets, may travel
to another member state for treatment and
expect to receive reimbursement for the cost of
treatment because of “undue delay.”18
• European Commission versus French Republic
(2010)19— French insurers required anyone
going abroad for diagnosis or treatment
that needed “major medical equipment” to
seek prior authorisation if they were to be
reimbursed. The European Court confirmed
that prior authorisation was justified given the
risk to the health system in terms of cost and
distribution of major capital investments. 21

BMJ | 12 FEBRUARY 2011 | VOLUME 342 367
ANALYSIS
tlements, and mechanisms for redress and com-
pensation.33 The directive will provide a solid
legal basis for greater co-operation across borders
(including e-health solutions), which will be of
particular value in sparsely populated areas.
Conclusion
That the organisation of cross-border care in
Europe creates many problems has long been
agreed, but achieving a solution has been diffi-
cult. Whether the directive offers such a solution
remains to be seen. A tension persists between the
Council of Ministers, which tends to see itself as a
guardian of national health systems, and the Euro-
pean Parliament, which tends to see itself as the
voice of Europe’s citizens (and potential patients),
although many different views are held within
both. The directive was approved in the European
Parliament by an overwhelming majority on 19
January. The council will adopt it formally in Feb-
ruary and the legislation will enter into force by
the spring. Member states will have 30 months to
transpose it into national law, so it should there-
fore become fully effective by 2013. This directive
will at least bring a degree of clarity to this often
confusing landscape but its success or failure will
only become apparent once it is clear how it has
been implemented.
Helena Legido-Quigley research fellow , London School of
Hygiene and Tropical Medicine, London, UK
Ilaria Passarani senior policy officerscientific researcher ,
Cecile Knai lecturer in European health policy , London School
of Hygiene and Tropical Medicine, London, UK
Reinhard Busse professor of health care management,
Technische Universität, Berlin, Germany
Willy Palm dissemination development officer, European
Observatory on Health Systems and Policies, Brussels, Belgium
Matthias Wismar senior health policy analyst, European
Observatory on Health Systems and Policies, Brussels, Belgium
Martin McKee professor of European public health, London
School of Hygiene and Tropical Medicine, London, UK
helena.legido-quigley@lshtm.ac.uk
This article was published online on 17 January 2011 and has
since been updated to reflect the approval of the directive by
the European Parliament on 19 January.
The European Observatory on Health Systems and Policies
is about to publish a new volume on Cross-border health
care in the European Union. Mapping and analyzing practices
and policies (Wismar M, Palm W, Figueras J, Ernst K, van
Ginneken E, eds).
The study will be available at www.euro.who.int/en/home/
projects/observatory/publications/studies
Contributors:
HL-Q, IP, CK, and MM drafted the article. All authors
revised subsequent drafts. MM is guarantor. All authors have
worked in EU funded projects on patient mobility and cross-
border healthcare and have published extensively on this subject.
This article arose from discussions with EU decision makers,
including participation in workshops and other meetings on this
topic. HL-Q, MM, MW, and WP contributed to the commission’s
impact assessment of an earlier draft of the directive. The
main sources of information were the official documents of the
European Institutions.
Competing interests:
All authors have completed the Unified
Competing Interest form at www.icmje.org/coi_disclosure.
pdf (available on request from the corresponding author)
and declare: HL-Q, MM, RB, MW, and WP had financial
support from the European Community (Health and
Consumer Protection Directorate General; grant agreement
2006WHO05) and through the FP7 Cooperation Work
Programme: Health (contract number 242058; contract
acronym EUCBCC) for the submitted work; no financial
relationships with any organisations that might have an
interest in the submitted work in the previous three years;
no other relationships or activities that could appear to have
influenced the submitted work.
Provenance and peer review:
Commissioned, externally peer
reviewed.
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