EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 2.7.2008 
SEC(2008) 2163 
  
COMMISSION STAFF WORKING DOCUMENT 
 
Accompanying document to the 
Proposal for a 
 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
 
on the application of patients' rights in cross-border healthcare 
 
IMPACT ASSESSMENT  
  
{COM(2008) 414 final} 
{SEC(2008) 2164}  
 
EN 2   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Organisation and timing 
In 2003 health ministers and other stakehol ders invited the Co mmission to explore 
how legal certainty in the field of cross- border care could be improved following the 
Court of Justice jurisprudence concerning the right of patients to benefit from 
medical treatment in another Member State1. The Commission’s proposal for a 
Directive on services in th e internal market at the st art of 2004 therefore included 
provisions codifying the rulings of the Cour t of Justice in applying free movement 
principles to health services. This approach, however, was not accepted by the European Parliament and Council. It was felt that specificities of health services were 
not sufficiently taken into account, in particular their tec hnical complexities, 
sensitivity for public opinion and major s upport from public funds. The Commission 
therefore developed a policy initiative specif ically targeting healthcare services as a 
separate issue.  
This report is meant to assess the impact of the different options for such an 
initiative. It only commits the Commission's services involved in its preparation. The 
text is prepared as a basis for comment a nd does not prejudge th e final form of any 
decision to be taken by the Commission. 
1.2. Consultation and expertise 
1.2.1.  Internal expertise 
An interservice group was established in  the beginning of 2007. All DGs were 
invited to participate in the group, and COMP, EMPL, ENTR, JRC, JLS, MARKT, 
RTD, SG, SJ, INFSO, REGIO, TRADE, ESTAT and BEPA have attended its 
meetings. The interservice group met for the first time in January 2007 to discuss the general concept of the initiative and to di scuss involvement of different DGs in the 
process. The second meeting took place in Ap ril. During that meeting the outcome of 
the public consultation was discussed, as well as the scope of the Commission 
proposal. During the third meeting in May, a first draft of the problem definition 
chapter of this impact assessment was disc ussed, as well as th e draft stocktaking 
exercise carried out by the European Ob servatory on Health Systems and Policies 
(see also paragraph 1.2.3.2). A fourth meeti ng was organised in the end of July, to 
discuss the Impact Assessment as a whole.  
1.2.2.  Impact assessment board 
A draft of this impact assessment report was sent to the impact assessment board on 
8 August. On 29 August DG Sanco represen tatives had a meeting with the board, 
which sent its written opinion concerni ng the draft report to DG Sanco on 6 
                                                
 
1 See the Report of the High Level Process of Reflection on patient mobility and healthcare developments 
in the European Union and the Commission Communication on the follow-up to the high level 
reflection process on patient mobility and healthcare developments in the European Union, COM 
(2004) 301 final, 20 April 2004. 
 
EN 3   EN September2. On the basis of this opinion this  report has been strengthened and 
expanded on several points. In  chapter two the consideration of subsidiarity has been 
further strengthened. In chapter four more  clarity has been created concerning the 
differences between option 3A and 3B. In ch apter five the analyses of aggregate and 
longer-term impacts have been expanded. The opinion of the board is one of the 
accompanying documents to this report. It will be made public once the proposal is adopted by the College. 
1.2.3.  Stakeholder consultation 
The Commission's minimum standards con cerning stakeholder consultation have 
been met. Stakeholders have been exte nsively involved in Commission activities 
regarding patient mobility and health care ov er many years, in particular through the 
High Level Reflection Pro cess, the Open Forum
3 and the High Level Group on 
Health Services and Medical care4.  
Consultation on the specific initiative desc ribed in this report started formally in 
September 2006 with the public ation of a Communication5, inviting all relevant 
stakeholders to contribute to a consu ltation process regarding Community action on 
health services. The objective of the consultation was to clearly identify the 
problem(s) and to get input concerni ng objectives and policy options. The 
Communication as well as the full  summary report of the responses6 is attached to 
this document as an accompanying document. 
The Commission received 280 responses to th is consultation from a wide range of 
stakeholders. From individual EU citizen s, health professi onal organisations, 
healthcare providers, national and regiona l governments, insurers, individual 
citizens, the industry etceter a. A wide range of issues  related to (cross-border) 
healthcare in Europe was raised. These ar e included where appropr iate elsewhere in 
the impact assessment. All contributions  have been published on the Commission 
website7 
                                                 
2 Impact Assessment Board Opinion, Impact Assessment on: Directive on safe, high-quality and efficient 
healthcare in the European Union, D(2007)7744, 5 September 2007. 
3 The last Open Health Forum a ttracted around 380 participants from a wide range of health 
organisations. The Forum recommended during its conference in November 2005 that the Commission 
should address the potential of targeted healthcare le gislation, because subsidiarity is not a sufficient 
guarantee of meeting the promise of universal acce ss to high quality health care. The Forum also 
confirmed the need for strong and fully implemented safeguards of patient safety at EU level whilst 
respecting for the capacity of national rules guaranteeing quality and safety. The Forum also 
recommended to establish an internet portal for th e free exchange of data, evidence and practice to 
foster continuous learning and innovation, Final Report of the Open Health Forum, Health challenges 
and future strategy, European Public Health Alliance (2005). 
4 All EU Member States are represented in the High  Level Group on Health Services and Medical Care, 
observers from the EEA/EFTA states as well as repr esentatives from civil so ciety have also been 
involved in the work of this group; Report on the wo rk of the High Level Group on Health Services and 
Medical Care in 2006, European Commission (2006). 
5 Commission Communication, Consultation regarding Community action on health services, SEC 
(2006) 1195/4, 26 September 2006. 
6 Commission document, Summary report of the responses to the consultation regarding "Community 
action on health services" (2007) 
7 http://ec.europa.eu/health/ph_overview/co_oper ation/mobility/results_open_consultation_en.htm 
 
EN 4   EN Contributors to the consultation see a need  for more and clearer information to 
patients with regard to cross-border care, and made a range of practical suggestions 
for achieving this. Greater clarity was also  sought over instrument s to control patient 
flows in cross-border care and in particular  over the conditions  under which prior 
authorisation for cross-border care is justified and can be refused. Suggestions by 
contributors for improvements include clear  information for patients; effective and 
transparent decision procedures; a pati ent-centred approach; evidence-based 
standards; the right to appeal against refu sals of authorisation;  and exceptions for 
border regions. Greater clarity was also sought over pricing for cross-border care, 
and the definition of 'health services' w ithin the scope of any Community action. 
There is broad consensus among contributors that responsibility for clinical oversight 
should be with the country of treatment. However, cooperation with the relevant 
authorities in the patient's home country  is important, and particular cases 
highlighted include managed cross-border care a nd international pa tient transport. 
There are also particular cases where any division of responsibilities leaves 
difficulties in practice, such as with control of hospital-acquired infections. Many contributors also saw value in European s upport to national author ities in ac hieving a 
high level of quality and safety in healthcare, such as through developing guidelines 
and indicators; or the introduction of a no-fault patient safety reporting system. 
Practical suggestions for ensu ring continuity of care incl uded systems for exchanging 
patient data, an EU standard discharge le tter and Europe-wide prescriptions. Many 
contributors also argued that there should be greater clarity over patients' rights. 
There is also broad consensus that the provi der of treatment shoul d be liable for harm 
and any redress arising. Contributors were  divided, though, about the need for more 
legal clarity regarding liability issues for cross-border  health care beyond that already 
provided by international private law.  However, there were many practical 
suggestions made, such as putting in place alternative dispute resolution systems for 
cross-border care (perhaps bu ilding on existing networks su ch as SOLVIT), requiring 
mandatory insurance for healthcare provide rs, or the establishment of the Europe-
wide no-fault compensation system. 
Some contributors were c oncerned about the potential  for cross-border care to 
undermine the provision of health care within their countries, in particular with regard 
to how to prioritise different patients a nd setting fair prices for cross-border care 
provided. On the other hand, some contribut ors felt that increased  cross-border care 
could have a positive effect on domestic care provision.  
Many contributors felt that there was a n eed for better monitoring of health 
professional mobility. Issues were also iden tified in relation to Community rules on 
recognition of professional qualifications , but many contributors felt that the 
implementation of Directive 2005/36/EC should be awaited before taking any new action. How to manage the impact of health professional mobility was also identified as an issue, in particular  by contributors from the newer Member States. Greater 
clarity about the rules governing the establ ishment of healthcare providers in other 
Member States was also sought by a few c ontributors, with particular regard to 
pharmacies and dentists. However, most c ontributions were more concerned about 
practical issues in cross-border pharmacy services, and made suggestions such as 
developing ePrescriptions. Information a nd communication technology solutions in 
 
EN 5   EN general were identified as a key area fo r the future by many contributors, though 
teleradiology was seen as a priority challenge where more analysis was needed. 
Some contributors identified particular issu es related to the practical operation of the 
existing regulations on coordination of soci al security systems, and made a number 
of suggestions for improvements. Also in addition to the other suggestions for practical support contributors highlighted the scope for practical support on areas 
including European reference networks; an  observatory for comparative data and 
indicators; health technology assessment; better sharing of healthcare innovations; 
and support for making effective use of poten tial investment in healthcare through 
the structural funds. However, many cont ributors argued for a rationalisation of 
activities and resources concerning healthcare at European level; others also argued 
that Community action should also involve regional authorities.  
Overall, contributors welcomed the initiative of the Commission regarding 
Community action on health services in general. The majority of national governments and many other stakeholders e xpressed the wish that any proposal of 
the Commission on health services shoul d be based on the "C ouncil Conclusions on 
Common values and principles in EU Health Systems"
8. Many contributions (in 
particular from national governments, uni ons and purchasers) emphasised that any 
Community action that affects the health systems should respect the subsidiarity 
principle, referring in part icular to Article 152 of th e Treaty establishing the 
European Community, although others argued that the principle of subsidiarity 
should not prevent the application of EU fundamental freedoms.  
On the overall approach, the majority view of  contributors was that a combination of 
both "supportive" tools (suc h as practical cooperation, or the 'open method of 
coordination') and legally binding measures would be the most efficient approach, 
although some contributors did not  see a need for a ny legal measures. In terms of the 
preferred approach for any le gal instrument there were cl early two main approaches 
preferred by different cont ributors. Some contributors  preferred to include any 
changes within the Regulations on the coordi nation of social security systems, while 
other contributors preferred a new Directive on health services. 
1.2.4.  Position of European Parliament and Council 
The inclusion of health services within the scope of the services directive was itself a 
response to the call for greater legal certainty  in the field of cross-border healthcare. 
Both the Council and Parliament felt nevert heless that th e nature of the services 
directive was inappropriate to  the health sector, hence th eir exclusion. Both Council 
and Parliament have since again called for specific proposals on health services, considering that this is the best way forwar d to provide greater legal certainty whilst 
doing so in a way specifically adapted to and respecting the specific nature of the health sector. 
The European Parliament contributed to the development of a proposal concerning 
cross-border healthcare w ith various reports. In Ap ril 2005 a report on Community 
                                                
 
8 2733rd Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 1-2 
June 2006 
 
EN 6   EN action on the provision of cross-border healthcare (the 'Bowis-report')9 was adopted 
by the Parliament. In March 2007 the Parliament adopted a resolution on Community 
action on the provision of cross-border healthcare10. The Parliament adopted in May 
2007 a report on the impact and consequences of the exclusion of health services 
from the Directive on services in the internal market (the 'Vergnaud-report)11 
The Council adopted in June 2005 conclusions  on Common values and principles in 
EU Health Systems in which it stated that it believes there is particular value in any 
appropriate initiative on hea lth services ensuring clarity for European citizens about 
their rights and entitlements when they m ove from one EU Member State to another 
and in enshrining values and principles in a legal framework in order to ensure legal 
certainty These refer to overarching values of universality, access to good quality care, equity, and solidarity, as well as ' operating principles' of quality, safety, care 
that is based on evidence and ethics, pa tient involvement, redress, privacy and 
confidentiality.
12. 
Linked to this, subsidiarity is a key concern for the European Parliament and the 
Council; the importance of the Community re specting the primary responsibility of 
the Member States for the organisation, fina ncing and delivery of health services and 
medical care. Member States and the Parlia ment have expressed concerns about what 
the margin for manoeuvre is for national and regional authorit ies responsible for 
health systems to do so and remain in compliance with Community law – what is their 'steering capacity'. This  is a concern that any propos als must take into account, 
and it is also part of the reason fo r support for proposals, both Council and 
Parliament considering that these issues shoul d be set out clearly in legislation rather 
than be left to individual rulings  by the Court on particular cases.  
1.2.5.  External expertise 
The Commission used the expertise of exte rnal experts, both when it drew up the 
problem definition and to support the assessment of the policy options. 
1.2.5.1.  EuroBarometer 
In May 2007 the Commission conducted a EuroBarometer about cross-border 
healthcare in the EU
13, in order to provide better insight into the actual scope of 
patient cross-border mobility, the willingne ss of patients to go abroad for medical 
treatment and the problems they foresee when  going abroad to receive health care. 
The EuroBarometer is a survey instrument that reveals perceptions of EU citizens. Approximately 1000 people per member ha ve been interviewed about possible 
reasons to go abroad for medical treat ment (quality, timing and financial 
implications) and reasons which might deter them from doing so (lack of information 
about availability, quality or financial implications). The report summarizing the 
                                                
 
9 A6-0129/2005 final 
10 B6-0098/2007 
11 A6-0173/2007 final 
12 10173/06 SAN 168 SOC 302 MI 132 
13 Flash Eurobarometer Series #210, Cross-border health  services in the EU, Analytical report, conducted 
by The Gallup Organization, Hungary upon the request of the European Commission, the Health and 
Consumer Protection Directorate-General (DG SANCO), 2007. 
 
EN 7   EN conclusions from the EuroBarometer is attached to this impact assessment. The 
results showed that seventy percent of the EU population believes that costs of 
healthcare treatment received elsewhere in  the EU will be reimbursed for them by 
their health authority. Overall,  four percent of Europeans, according to the results of 
the survey, received medical treatment in a nother EU Member State over the past 12 
months. However, confirming the analysis of the consultation, this figure varies 
substantially - in Luxembourg, every fifth citizen sought healthcare outside the 
country's borders.  
Slightly more than half of EU citizens ar e open to travel to another EU country to 
seek medical treatment (54%). The most  prominent reason to do so would be 
unavailability of the necessary treatment in the domestic healthcare system. Better quality and quicker access to the necessa ry treatment would also be important 
motivating factors for patients. The 42% w ho are not willing to travel abroad for 
treatment are motivated by distinctly different reasons in the old and new Member States. Generally, the survey found that citizens in the EU 15 zone would prefer to 
remain in their own country as they are satis fied with their domestic services, and the 
convenience of local treatment, while thos e in the new Member States are more 
likely to be discouraged from seeking healthcare abroad by foreseen affordability 
problems.  
1.2.5.2.  External expert support to the impact assessment 
The European Observatory on Health Syst ems and Policies provided an independent 
expert analysis in support of this impact assessment taking stock of developments on 
health care in Europe, focussing on seve n aspects of cross-border health care
14: pre-
authorization and access to healthcare; quality and safety; patient rights; cross-border collaboration; health care baskets and tariffs; past impacts of cross-border healthcare; 
and cross-border healthcare data. This exercise was based on existing research, 
examples, studies etc to provide better unde rstanding of cross-bo rder health care 
from different national health systems pe rspectives on the above mentioned aspects 
and describes how current legal and non-lega l uncertainties have had an impact on 
cross-border health care in general and the aspects mentioned above in particular 
(now and in the past), who is affecte d, in what ways, and to what extent. 
                                                
 
14 Wismar M, Palm W, Figueras J, Ernst K and Van Ginneken E, Cross-Border Healthcare: Mapping and 
Analysing Health Systems Diversity, European Observatory on Health Systems and Policies, 2007. 
 
EN 8   EN 2. PROBLEM DEFINITION  
2.1. Context 
Patients prefer healthcare to be available as close to where they live and work as 
possible. For the vast major ity of cases, the health sy stems of the European Union 
ensure that the healthcare that patients seek is provided within their own Member 
State, which meets patients' preferences. It is in general considered to be safer and 
more efficient to be treated within one  healthcare system. However, there are 
situations when cross-border healthcare  can be more appropriate, such as: 
– for highly specialised care requiring a pa rticular concentration of resources or 
expertise that is beyond the capacity of every Member St ate to provide, such as 
for rare diseases; 
– for border regions, where the nearest appr opriate healthcare provider may be 
across the border in another Member Stat e, and where efficient provision of care 
may be best achieved through providers  serving populations across borders 
throughout their local region; 
– or in cases of lack of capacity, where local services are unable to provide the 
appropriate healthcare and there is capaci ty available in another Member State. 
Cross-border healthcare may also simply be  the preferred choice for the individual. 
For example, people who have moved to anot her Member State to work or retire may 
prefer to return to their c ountry of origin for healthcare,  even if the healthcare in 
question could also be provide d in the country wh ere they now live. Or healthcare in 
question may be cheaper in another Member  State, which may represent a sufficient 
reason for a citizen to prefer to seek it abro ad where they are paying some or all of 
the costs of that healthcare themselves (for example, as is increasingly the case for 
much dental care). 
There is already Community legislation that helps to facilitate cross-border 
healthcare. The regulations on coordination of social s ecurity systems provide for 
persons for whom a medical treatment becomes necessary during a stay in the territory of another Member State to the same benefits as patients insured in the host Member State, using the European Health Insurance Card
15. The regulations also 
provide for patients to be able to seek h ealthcare in another EU country, subject to 
prior authorisation from their own system. Th at authorisation must be granted if the 
care cannot be provided within a medically ju stifiable period of time, and the patient 
will not have to pay more if the costs of  treatment in the other Member State are 
higher than in their own country. 
In addition to those regulations, the Eur opean Court of Justice has ruled in the 
specific cases brought to its attention that patients can, under certain circumstances, 
use the free movement rights provided by the Treaties directly to have access to 
                                                 
15 Council Regulation (EC) No 1408/71 of 14 June 1971 on the application of social security schemes to 
employed persons, to self-employe d persons and to members of their families moving within the 
Community. OJ L 149, 5.7.1971, p.2 
 
EN 9   EN healthcare abroad. As outlined in the Commission's communica tion consulting on 
these issues in 2006, in 1998 th e Court established new prin ciples through its rulings 
in two cases16 regarding direct applica tion of the Treaty articles on free movement 
to the reimbursement  of health services provided to  patients abroad. In its rulings, 
the Court made clear that when health se rvices are provided for remuneration, they 
must be regarded as services within the meaning of Treaty and thus relevant 
provisions on free movement of services appl y. The Court also ruled that as a result 
measures making reimbursement of costs in curred in another Member State subject 
to prior authorisation are barriers to freedom to provide services, although such 
barriers may be justified by overriding reason s of general interest. On the basis of 
these and subsequent cases17, the Court’s rulings have developed the following 
principles:  
– Any non-hospital care to which a person is  entitled in their own Member State 
they may also seek in any other Member State without prior authorisation, and be 
reimbursed up to the level of reimbur sement provided by their own system. 
– Any hospital care to which they are entitle d in their own Member State they may 
also seek in any other Member State provi ded they first have the authorisation of 
their own system. This authorisation must be given if their system cannot provide 
them care within a medically acceptable  time limit considering their condition. 
They will be reimbursed at least up to the level of reimbursement provided by their own system. 
2.2. The size of cross-border healthcare 
2.2.1.  How large is the issue? 
After repeated exercises over recent year s, it is clear that there is as yet no 
comprehensive data about cross border hea lthcare. However, there is sufficient data 
to roughly estimate its overall scale,  at least for patient mobility. 
Focusing on 'patient mobility', the Commission has estimated that cross-border 
healthcare represents around 1% of public expenditure on healthcare. This estimate 
was tested through the consultation exer cise, and was broadly confirmed by the 
responses from Member States  and other contributors, wi th similar proportions both 
of expenditure and numbers of patients moving.  
The total GDP of the Europ ean Union is € 12,149 billion
18. Of this, 7.6% (€ 967 
billion) of GDP is being spent on public healthcare19. As 1% of public healthcare 
expenditure is spent on cross-border care, this equals approximately € 9.7 billion . 
                                                 
16 Case C-158/96 Kohll [1998] ECR I-1931 and Case C-120/95 Decker [1998] ECR I-1831. 
17 For example, Case C-368/98 Vanbraekel [2001] ECR I-5363; Case C-157/99 Smits and Peerbooms 
[2001] ECR I-5473; Case C-56/01 Inizan [2003] ECR I-12403; Case C-8/02 Leichtle [2004] ECR I-2641; Case C-385/99 Müller-Fauré and Van Riet [2003] ECR I-4503. 
18 EU economic data pocketbook 1-2007, Eurostat (2007) 
19 Europe in figures – Eurostat yearbook 2006-07, Eurostat (2007) 
 
EN 10   EN However, respondents to the consultation und erlined that cross- border healthcare 
varies, and can be significantly larger in certain circumstances20. Factors influencing 
the impact of cross-borde r healthcare include: 
– Border regions : The impact of cross- border healthcare is lik ely to be greater for 
European citizens living in border regi ons, and the associated hospitals and 
providers. One contributor argued that as s oon as more than 5% of patients treated 
in a hospital are from abroad, the planni ng of capacities for different types of 
services needs to be adapted accordingly ( Euregio Maas-Rhein ). In some cross-
border areas contributors indicated that  this is addressed through EUREGIO 
projects and bilateral cro ss-border agreements on provi der, regional or national 
level, but some practical problems of organising these projects remain; 
– Smaller Member States : For smaller Member States contributors to the 
consultation indicated that th e financial impact may be much more significant. For 
example, in Luxembourg, up to 7% of th e healthcare budget has been spent on 
cross-border care in recent years. In addi tion, it was argued that it is not possible 
to provide some forms of highly speciali zed care in smaller Member States, with 
patients instead sent abroad in an organised manner to receive these treatments 
(e.g. Cyprus, Malta ); 
– Individual impact : Even though the impact may be relatively low for the systems 
in general, access to cross-border health  services may be essential for the 
individuals concerned;  
– Rare diseases : Geographical access to healthcare providers can be more difficult 
in smaller Member States (e.g. Luxembour g, Malta, Cyprus), which simply do not 
have enough patients to justify having certain institutions or technologies 
available in the country. In particular, patie nts with rare diseases may need to rely 
more on cross-border care to obtain appropr iate treatment than patients with more 
common conditions.   
– Areas attracting large amounts of tourists : Areas attracting large numbers of 
tourists, such as parts of southern Eu rope and the Mediterranean islands, face 
some specific impacts. If capacities are in tended only for the numb er of residents, 
then in the tourist season capacities may be too limited to cope  with the numbers 
of tourists, which could undermine access to emergency care for both residents 
and visitors. Tourists may also 'drain' local health systems resources, if the billing methods applied do not cover the full cost  of treatment, including the necessary 
infrastructure. However, it could also be argued that medical services that they 
offer to tourists in need of healthcare al so form part of the infrastructure which 
makes those areas an attrac tive tourist destination. 
– High co-payments increase cross-border care . In many European health 
systems, contributors said that dental treatment is paid to a large extent or even completely by the patient. This is seen by many contributors as having an impact 
on cross-border care, with increased number s of patients thus pl anning to receive 
                                                
 
20 These contributions are all published on the Commission website:  
http://ec.europa.eu/health/ph_overview/co_opera tion/mobility/results_open_consultation_en.htm 
 
EN 11   EN less costly care abroad. Some suggested that this could concern 5-10% of all 
dental care, representing 60% of all cross-border care in some countries ( Swedish 
Government ). 
2.2.2.  Future trends 
The extent of cross-border healthcare ha s grown in recent years, and is likely to 
continue to grow in the future; see data  on cross-border health care collected through 
the regulations on social secu rity annexed. Many contributor s to the consultation also 
expect a noticeable increase of cro ss-border healthca re in the future21. The 
contribution from the Portuguese Association of Private Hospitals  was typical of the 
positions of many contributions:  
"There is a clear and increasi ng tendency for people to trav el in Europe; especially 
new generations for whom the idea of a Europe without borders is starting to make sense. The "short break" tourism has been expanding dramatically in many European cities, in the past years, encouraged by the constantly emerging "low cost" airlines. Longer duration stays by citizens from other Member States have also increased. We only need to look at the success that the project ERASMUS is enjoying 
among young people. But also no ticeable are the travels of northern seniors towards 
southern Europe, for holidays,  or for seasonal stay, as a second home, or even as a 
permanent residence. In this context, the search for healthcare in a specific Member State by persons from another Member State is naturally increasing"(APHP).  
In an EU-wide survey the majority of co nsumers stated that they expect that 
travelling long distances for healthcare serv ices will be normal in 2020 (yes: 57%, it 
depends: 28%, no: 14% ; do not know: 1%) ( Health Consumer Powerhouse ). The 
Eurobarometer underlines this potential, w ith most EU citizens (53%) willing in 
principle to go abroad to receive healthcare. 
Overall, therefore, there is a rising trend for cross-border healthcare, and significant 
potential demand from citizens to explore cross-border heal thcare when it is quicker, 
better, cheaper or more convenient for th em. The actual extent  of cross-border 
healthcare is likely to depend on the extent to which care abroad is actually quicker, better, cheaper and/or more convenient. As  long as the home system meets the needs 
a patient will most likely not cons ider seeking healthcare abroad.  
The extent of unmet need for healthcare with in Member States is therefore a crucial 
factor in projecting likely future need. Th e European Statistics on Income and Living 
Conditions (EU-SILC) survey provide s cross-sectional and longitudinal 
multidimensional microdata on income, poverty, social exclusion and living conditions. This includes data on unmet hea lthcare need, which is set out in annex 1. 
As this shows, most healthcare need is met in most countries, but there are some 
significant elements of unmet need. The average percentage of people per Member State with unmet need, each Member State weighted on the basis of the amount of inhabitants, is 8.5%. However,  experience to date shows that even amongst patients 
                                                
 
21 These contributions are all published on the Commission website: 
http://ec.europa.eu/health/ph_overview/co_opera tion/mobility/results_open_consultation_en.htm 
 
EN 12   EN who have a clear unmet need, and are awar e of the possibility to go abroad for 
treatment, fewer than 10% of them actually go abroad to receive care. 
This proportion may be higher in some circ umstances, of course, as outlined above. 
For example, one particular likely reason to prompt people to consider healthcare 
abroad is where the care is cheaper, and th ey are paying some or all of its cost. One 
common example is dental treatment, as identified above. And indeed, the 
percentage of people iden tified through the EU-SILC survey as having an unmet 
need for dental examination and treatment because it was too expensive is higher than for medical treatment in general. 
2.3. The issues to address 
The first issue to address, concerns how the free movement rights recognised by the 
Court for citizens to have access to healthcar e abroad can be applied in practice. The 
second concerns how to ensu re that when cross-border healthcare is provided, it is 
safe and efficient. 
2.3.1.  Uncertainty about general application of ri ghts to reimbursement  for healthcare 
provided in other Member States 
Many contributors to the consulta tion felt that currently it is  difficult for patients to 
identify their rights with regard to cross- border healthcare. Clear information is often 
felt to be missing. It was widely argued th at in many Member States patients are not 
aware of the possibilities and their entitleme nt to receive treatment abroad and to get 
reimbursed. For example, a study conducted by the Health Consumer Powerhouse  in 
France, Poland, United Kingdom, Spain and Germany showed that 25% of citizens 
believe that they do not have the right for treatment abroad and 30% are unsure
22. 
This was confirmed by the Eurobarometer survey23 mentioned above, which showed 
that 30% of the citizens in the European Union are not aware of the possibility to 
receive healthcare outside th eir country of affiliation.  
The Court’s rulings on the individual cases outlined above are clear in themselves, 
and no pre-condition may be required for the exercise of the rights of patients 
recognised by the Court. Howeve r, it is necessary to improve clarity to ensure a more 
general and effective application of these righ ts in practice, and to ensure that they 
can be exercised in a way which is compatible with overall health system objectives of accessibility, quality and financial sustainability. 
In practical terms, this degree of un certainty and confusi on about the general 
application of rights to re imbursement for healthcare provided in other Member 
States among the authorities responsible for cross-border care and the representatives 
of providers is likely to make it more di fficult for patients to use their rights in 
practice, as those responsible will be re luctant to wholeheartedly implement rules 
and procedures when they are not clear about what they are. And if patients wish to 
contest the interpretations that are given or  the rules being applied, it is difficult for 
                                                
 
22 http://ec.europa.eu/health/ph_overview/co_oper ation/mobility/docs/health_services_co147.pdf 
23 Flash Eurobarometer Series #210, Cross-border health  services in the EU, Analytical report, conducted 
by The Gallup Organization, Hungary upon the request of the European Commission, the Health and 
Consumer Protection Directorate-General (DG SANCO), 2007. 
 
EN 13   EN them to do so in the absence of clarity about what their rights are and how they 
should exercise them. 
This analysis is corroborated by the signi ficant difference between the 1% of total 
health expenditure estimated by the Commission and confirmed through the 
consultation, and the practical experience of  patients, who report an average figure of 
4% using healthcare abroad in the previous year24. This is likely to be the case 
because  the volume of cross-border healthcare is  greater than estimated so far. And 
patients are making up the di fference through their own ex penditure or through other 
routes, such as private health or travel insurance, rather than claiming back reimbursements to which they should be entitled.  
Patient mobility is only one of the four possible types of cross-border healthcare, 
which are: 
– Cross-border provision of services (deliver y of service from the territory of one 
Member State into the territory of another) ; such as telemedicine services, remote 
diagnosis and prescripti on, laboratory services; 
– Use of services abroad (ie: a patient m oving to a healthcare provider in another 
Member State for treatment); this is what is referred to as 'patient mobility'; 
– Permanent presence of a service provide r (ie: establishment of a healthcare 
provider in another Member State), such as  local clinics of larger providers; and, 
– Temporary presence of persons (ie: mob ility of health professionals, for example 
moving temporarily to the Member State of the patient to provide services). 
In this section the lack of  clarity about the authori zation and reimbursement of 
healthcare abroad has been described. This problem is only related to the use of 
services abroad (referred to as 'patient mobility'). It has no direct links with the other three modes of cross-border healthcare. 
2.3.2.  Uncertainty over how the necessary framew orks for safe and effective healthcare 
should be ensured for cross-border healthcare 
Linked to the problem described in the prev ious section but broa der is uncertainty 
over how the necessary frameworks for safe  and effective cross-border healthcare 
work in general. Whenever healthcare is provided, it is vital for patients to ensure: 
– clear information that enables people to  make informed choices about their 
healthcare; 
– mechanisms for ensuring the quality and safe ty of the healthcare that is provided; 
– continuity of care between different tr eating professionals and organisations; 
– and mechanisms to ensure appropriate remedies and compensation for harm 
arising from healthcare. 
                                                
 
24 See the Eurobarometer results referred to above. 
 
EN 14   EN Within Member States, different structures have been put in place to ensure these 
elements at local, regional or national le vel, or through non-regulatory structures 
such as professional organisations, or through standards linked to financing 
mechanisms. However, there are no clear rules at Community level about how these requirements should be met for cross-border healthcare, or who is responsible for 
ensuring that they are. This is the case no matter how the care is paid for – whether it 
is paid for publicly or privately, whether it is undertaken thr ough the regulations on 
coordination of social security systems or  whether it is in application of the 
additional free movement ri ghts described above. 
Without such clarity, there is the risk of confusion leading to a reduction of quality 
and safety of healthcare in cross-border cases. Even in ca ses where there is long term 
experience of cooperation between  countries, it turns out to be difficult to ensure the 
quality and safety of cross- border care. An important expl anation of these difficulties 
is the different approaches in the different  Member States to ensuring quality and 
safety. For example, countries have different  treatment protocols,  different divisions 
of responsibilities and different  quality control systems. Quality and safety control is 
often integrated into financing and planni ng mechanisms. As cross-border care often 
takes place outside of those mechanisms, quali ty and safety control is at risk in the 
cross-border context.  
Several reports highlight problems with cont inuity of care in cross-border settings. 
One study analysed in detail the weaknesses in the care  chain of Dutch patients 
treated in Belgian hospitals
25. Other studies point mainly to the lack of information 
transfer from the Belgian treating doctors to the Dutch GPs and to the providers responsible for the aftercare. Several re ports also mention problems with the 
availability at home of drugs and medical  devices that were prescribed abroad
26. This 
may not just be a question of quality a nd safety structures being lacking, but 
problems with overlapping and potentially conflicting systems being applied from both the country where care is provided and th e patients’ country of  residence. This 
may be well-intentioned, but given the very different approaches to ensuring quality and safety in the different countries, attempting to have domestic standards 
accompany patients seeking healthcare in ot her countries may create additional risks 
rather than helping to ensure quality and safety.  
Ensuring quality and safety in healthcar e depends not just on the skills and 
qualifications of an individual professiona l. Rather, it depends on the functioning of 
an entire system: the indivi dual professional; the team of  professionals dealing with 
the particular patient; the overall provi ding organisation; and the applicable 
regulatory framework. It is precisely at th e borders between each of these elements 
that risks increase, and thus  cross-border healthcare (as healthcare involving borders 
between all of the systemic elements re sponsible for ensuring healthcare) raises 
greater risks than healthcare within a single Member State. 
                                                
 
25 Engels EL, Grenzeloos geketend? Explorerend onderzoek naar de transnationale zorgketen tussen 
Nederland en België, Maastricht, Universiteit M aastricht, Faculteit der Gezondheidswetenschappen 
(2003). 
26 Grunewald CA, Smit R, Grensoverschrijdende zorg – Zorg op maat in de Euregio Maas-Rijn; evaluatie 
van een experiment, Utrecht, NZI (research institute ) (1999). and Boffin N, Baeten R, Dutch patients 
evaluate contracted care in Belgian hospitals: results of a patient survey, Brusse ls, Observatoire Social 
Européen (2005) 
 
EN 15   EN There is also a lack of information to allow patients or their physicians to make 
informed choices about the possibilities  and appropriateness  of cross-border 
healthcare. There is no simple mechanism fo r seeking information in the language of 
the patient about different treatment or provi sion options, their cost and availability 
in practice, or their outcomes and succes s rates for healthcare in other Member 
States. Even when such information can be  found, the lack of comparability makes 
informed decision-making difficult at best , and thus hinders making appropriate 
choices. 
In terms of modes of supply of healthcare , the issues described in this paragraph 
mainly concerns patient mobility (ie: use of services abroad), but has some implications for the other modes of supply as well: 
– Cross-border provision of services: this  initiative does not address where the 
provider is established nor the conditions for doing so. However, it must also be 
clear for a provider providing services across borders what the applicable 
frameworks for safe and efficient health care are that apply. For example, through 
which country's error reporting systems s hould they report mistakes or issues 
arising, and in what lang uage should they do so? 
– Use of services abroad: a patient treated in another country is the main issue on 
which this section focuses, with the i ssues outlined above. For example, if a 
patient from one country is referred to another country for specialist treatment, 
should their home country check the quali ty of the treatment being provided? 
– Permanent presence of a service provider:  again, this initiative does not address 
where the provider is established nor the conditions for doing so, but simply what rules and procedures they should follow, and which authorities are responsible for 
oversight and monitoring. For example, if one country monitors standards through 
professional reporting structures but a nother country where they are present 
monitors standards through a specific in spectorate, whose reporting structures 
should monitor them? 
– Temporary presence of persons: again, th is initiative does not address where the 
professional is registered nor the conditions  for being registered (which is already 
addressed separately through the dire ctive on the mutual recognition of 
professional qualifications, 2005/36/EC), but the rules and procedures for safety 
and quality of care that they should follow in the case of providing services temporarily in another Member State. For example, if their home country uses red 
armbands to indicate patients who are alle rgic to aspirin but the country where 
they are temporarily provi ding services uses blue  armbands for the same 
indication, which colour should they use? 
The reason for focusing on 'patient mobility ' with regard to uncertainty about the 
general application of rights to reimbur sement for healthcare provided in other 
Member States is that this  is the mode of supply where the problems arise. On the 
basis of the analysis set out - there do not appear to be equivalent problems in the other modes of supply of health servi ces, and thus no need to address them. 
However, it is important to be clear that the uncertainty over the necessary 
frameworks for safe and effective healthcare is not
 limited to use of services abroad. 
 
EN 16   EN This initiative focuses on the issues which have been identified as a significant 
problem - the main concerns having been identified as being related to use of 
services abroad. For the other main mode  of cross-border healthcare provision 
(temporary presence of persons), the bulk of  issues raised are already covered by the 
directive on mutual recognition of professional qualifications. However, the initiative will have an impact for health professionals temporarily providing healthcare abroad, by clarifying the rules and procedures for sa fety and quality of care that they should 
follow while doing so, and similarly with cross-border provision of services, and 
permanent presence of a service provider. 
2.4. Subsidiarity 
As described above, there are significant pr oblems with cross-bor der healthcare, both 
in terms of uncertainty over the general a pplication of rights to reimbursement for 
healthcare provided in another Member Stat e, and over the necessary frameworks for 
safe and efficient healthcare provision. 
2.4.1.  The necessity test 
It is primarily the responsibility of the in dividual Member States  to organize their 
healthcare systems in the way that best suits their country and citizens. Nevertheless, 
sometimes the healthcare that citizens need can best be provided in another Member 
State, due to its proximity, its specialised nature, or the lack of capacity to provide 
that care in their own countr y. In accordance with the pr inciple of subsidiarity, the 
Community should only act in this area if and in so far as the objectives of the 
proposed action cannot be sufficiently ach ieved by the Member States and can 
therefore, by reason of the scale or effect s of the proposed action, be better achieved 
by the Community.  
Community law already provide s rights in principle for cross-border movement of 
goods, services and people in general and health products, services and patients in 
particular. But there are ques tions and uncertainties over what this means in practice; 
for citizens and for all other stakeholders involved. The European Court of Justice 
has interpreted Community rules in a diffe rent way compared to interpretation by 
national governments. But, as emphasise d by several Member States during the 
consultation, also after the Court came w ith its interpretation, Member States still 
lack certainty about how these individual cas es should be interpreted in general. Due 
to this uncertainty it is difficult for Member States to manage their healthcare systems properly. Cooperation on Community level, for example by the development 
of secondary legislation based on the Tr eaty, would bring the requested clarity, 
which could not be realised on national level alone.  
In the second place there are concerns about how to ensure that cross-border 
healthcare is as safe and efficient as possi ble. Cross-border hea lthcare has, as the 
name already predicts, many Community-w ide transnational aspects. For both 
patients and professionals, there is a crucial difference between having some 
confidence in the applicable  rules for cross-border ca re, and being certain. The 
potentially very serious consequences of any legal uncertainty concerning 
responsibilities in cross-borde r healthcare settings are an  important reason to act on 
this issue. When citizens cross borders to re ceive healthcare, it is important that it is 
clear which country is responsible for what. Cu rrently that clarity is  lacking. It is not 
 
EN 17   EN possible for individual Member States to define their own responsibility without 
agreeing on these responsibilities with ot her involved countries.  Therefore also to 
solve this issue, agreement concerning re sponsibilities is needed on Community 
level. 
2.4.2.  Link with the Treaties  
The European Court of Justice has confir med that even though Member States are 
primarily responsible for the organisation a nd delivery of health services and medical 
care, health systems must comply with th e provisions of Community law, including 
internal market rules. Both the European  Parliament and the Council of Health 
Ministers have asked the European Commi ssion to come up with a proposal which, 
taking account of the Court judgements, sets  a clear framework for cross-border care. 
Such a framework would provide sufficien t clarity about patient's rights to be 
reimbursed for healthcare pr ovided in other Member St ates and other aspects of 
cross-border healthcare so th at those rights could be realised in practice. On the other 
hand this framework should also support Member  States in their efforts to secure a 
healthcare system of high quality, sustainable for the future. The Treaty establishing European Communities gives the Community th e possibility to contribute to Member 
States' efforts and to support their nationa l policies to improve public health and 
consumer protection (art 152 par. 1 and art 153 par. 1). 
As confirmed by the Court of Justice on seve ral occasions, health services fall within 
the scope of the EC Treaty, and in par ticular art. 49 on the free movement of 
services, there being no need to distinguish in that regard between care provided in a 
hospital environment and care provided outsi de such an environment. Article 95 of 
the Treaty foresees adoption of measures th e object of which is the establishment and 
functioning of the internal market. This provision would therefore serve as a legal 
basis for establishing a general framewor k for provision of safe, high quality and 
efficient health services in the European  Union and to ensure free movement of 
health services and high level of protec tion of health, whilst fully respecting the 
responsibilities of the Member States for the organisation and delivery of health 
services and medical care.  
However, this does not alter the fact that health systems are primarily the 
responsibility of Member States and Comm unity action shall resp ect Member States' 
responsibilities for the organi sation and delivery of health  services and medical care 
in accordance with Article 152 TEC. Moreover, health services are indispensable part of services of general interest and as su ch, they contribute to the quality of life of 
European citizens and are one of the esse ntial pillars of the European model of 
society. Article 16 of the EC Treaty require s the Community and the Member States 
to ensure that services of general economic interest operate on the basis of principles 
and conditions which enable them to fulf il their missions. In a ddition, Article 86(2) 
of the EC Treaty allows rec onciling the rules of  Community law, including rules on 
competition and internal market, with th e fulfilment of the mission of general 
economic interest by making undertakings entr usted with the operation of services of 
general economic interest subject to the rule s contained in the EC Treaty in so far as 
the application of such rules does not obstruc t the performance, in law or in fact, of 
the particular tasks assigned to them. 
 
EN 18   EN Article 95(3) of the Treaty further stipulat es that the Commission, in its proposals for 
the establishment and functioning of the inte rnal market concerni ng health, shall take 
as a basis high level of prot ection of health, taking account  in particular of any new 
development based on scientific facts. Th e framework for cross-border healthcare in 
the EU would therefore need to ensure that the necessary requirements for high-quality, safe and efficient healthcare are also ensured for cross-border healthcare. 
Citizens would also, alternativ ely to the new framework fo r cross-border healthcare 
created under article 95 of the Treaty, cont inue to have the rights arising from rules 
based on article 42 of the Treaty and in part icular the regulation on the application of 
social security schemes to employed pers ons and their families moving within the 
Community (1408/71). In particular, wher e appropriate care for the patient's 
condition cannot be provided in their own country without undue delay, then they 
should be authorised to go abroad, with a ny additional financial costs being borne by 
their social security sche me in accordance with the provisions of that Regulation. 
 
EN 19   EN 3. OBJECTIVES  
3.1. Overall objective: A clear framework fo r cross-border healthcare within the EU 
The overall objective of this initiative is to  ensure that there is a clear framework for 
cross-border healthcare with in the EU. Addressing the issues identified above, this 
should: 
– provide sufficient clarity about  rights to be reimbursed for healthcare provided in 
other Member States for those right s to be realised in practice; 
– and ensure that the necessary requireme nts for high-quality, safe and efficient 
healthcare are also ensure d for cross-border care;  
whilst ensuring that such cross-border healthcare is compatible with the overall 
objectives of the Member States of ensuring  accessibility, quality  and safety of the 
healthcare that their health systems provide. 
3.2. Specific objectives 
3.2.1.  Ensure that rights to reimbursement for healthcare abroad can be used in practice 
This specific objective should be  therefore to ensure that there is a clear framework 
that will enable patients to exercise thei r rights to reimbursement for healthcare 
abroad in practice. This should not am end the existing regulations coordinating 
social security systems, nor the mechanisms that they provide for emergency care 
whilst abroad or prior authorisation for h ealthcare abroad. Rather, it should ensure a 
clear framework for the additional free moveme nt rights provided by the Treaties to 
have access to healthcare abroad, the princi ples of which have been established by 
the Court, in particular that the patient can  only be reimbursed for costs of healthcare 
abroad up to the amount to which they would have been entitled had they had the care in their own country.  
3.2.2.  Ensure high-quality, safe and ef ficient cross-border healthcare 
It is the objective of this initiative to ensure that th e necessary requirements for high-
quality, safe and efficient healthcare are also respected for cross-border care. This 
initiative should stipulate the general co mmon principles and obligations without 
either harmonising the organisation or the structure of healthcare provision. Member 
States will, in compliance with Article 152, paragraph 5 EC, continue to have the 
freedom to organise their health systems as they wish in order to achieve these 
common principles. The aim of this initiative  is simply to make clear which Member 
State is responsible in any given situation. This would avoid gaps or overlaps in 
responsibilities and would cl arify what those responsibil ities mean in practice.  
3.3. Operational objectives 
3.3.1.  For reimbursement for healthcare abroad: 
For the additional free movement rights pr ovided by the Treaties to have access to 
healthcare abroad, the principles of which have been established by the Court, the 
 
EN 20   EN operational objectives under this headi ng are to ensure common, clear and 
enforceable Community rules with regard to: 
– the entitlements of patients to have healthcare in another Member State, the limits 
that Member States can place on such health care abroad and the information to be 
provided to enable patients to be aware of the option of cros s-border healthcare; 
– the level of financial coverage that is  provided for cross- border healthcare; 
– the processes for decisions about such healthcare, including the criteria for 
assessment and mechanisms for appeal;  
– and what happens with regard to harm  and compensation arising from cross-
border healthcare. 
3.3.2.  For high-quality, safe and effi cient cross-border healthcare 
The operational objectives under this headin g are to ensure that the essential 
requirements for high-quality, safe and effi cient healthcare are also guaranteed for 
cross-border healthcare, in particular:  
– that people can have access to informati on that enables them to make informed 
choices about cross-border healthcare; 
– that cross-border healthcare is also covered by the mechanisms for ensuring the 
quality and safety of healthcare of th e country where trea tment is provided; 
– that the necessary transfer of information to ensure continuity of care between 
different treating professi onals and organisations is  ensured for cross-border 
healthcare; 
– and that mechanisms are in place to  ensure appropriate remedies and 
compensation for harm arising from cross-border healthcare. 
3.4. Contribution to wider objectives 
In addition to the direct obj ectives of ensuring a clear framework for cross-border 
healthcare, this initiative will also cont ribute to the overall goals of the health 
systems of the Member States, and to th e growth, competitiveness and cohesion of 
the Union as a whole.  
3.4.1.  Contribution to the overall goals of the health system s of the Member States 
In addition to the direct objectives outlined  above, putting in place a clear framework 
for cross-border healthcare will also contri bute to the overall shar ed goals of health 
systems throughout the EU of accessibility, quality and financial sustainability: 
– accessibility : although healthcare is normally best  provided within the patients' 
own Member States, sometimes the health care that patients seek can best be 
provided in another Member State. Putti ng in place a clear framework for cross-
border healthcare will therefore help to ensure accessibility also for patients for whom that is the most appropriate choice. This is particularly the case for 
 
EN 21   EN situations where the most effective form  of provision is provided in cooperation 
across more than one Member State (eg: in border regions, or for particularly rare 
conditions or specialised treatments); 
– quality : the outcomes produced by healthcare vary significantly throughout the 
Union27. This is shown for example by the vari ations in the mortality amenable to 
healthcare throughout the Union28. This is not a simple correlation with resources 
invested – rather, there are significant issu es with inappropriate use of procedures, 
under-use of generally accepted and widely known treatment standards, and medical errors, linked to overall systemic causes
29. In addition to facilitating 
access to high-quality care where this can  best be provided in another Member 
State, a framework for cross-border heal thcare will also help to facilitate 
cooperation and comparison between Memb er States, and thus can help to 
disseminate best practices and improve quality of healthcare throughout the Union 
for everyone, whether they seek healthcare abroad or not;  
– financial sustainability : as outlined above, sometimes  the most efficient and 
effective means of healthcare provisio n can be provided in cooperation across 
more than one Member State, either because of the geographical proximity, or 
because of the concentration of specialis t resources and patient volumes necessary 
cannot be provided as efficiently and sa fely within the patients' own Member 
State. The cost of healthcare systems to public funds has risen significantly faster 
than inflation in recent years, and is pr ojected to rise by one to two percent of 
GDP in most Member States between now  and 2050 as a direct  result of ageing 
populations30. However, these projections of fu ture costs are very sensitive to 
changes in costs of providing a given pack age of care. The key to sustainability 
for healthcare systems is therefore c ontrolling costs and improving efficiency, 
alongside prevention and health promotion measures to maximise the number of 
years of life spent in good health (as measured by the Healthy Life Years 
indicator). A framework for cross-borde r healthcare can therefore help to 
maximise the overall efficiency of healthca re provision and thus help to ensure the 
financial sustainability of health systems as a whole. 
                                                 
27 See http://ec.europa.eu/health/ph_information/dissemination/hsis/hsis_14_en.htm and references 
provided for additional information. 
28 Take the example of bladder cancer; although surv ival rates are improving in general, there are 
substantial differences in survival among countries in Europe, with five-year survival rates ranging 
from highs of 78% in Austria to 47% in Poland and Estonia. Another example is breast cancer, where the age standardised 5-year relativ e survival rate ranged from 60% in Slovakia to 82.6% in Sweden – 
see Coleman M.P. et al., EUROCARE-3 summary: can cer survival in Europe  at the end of the 20
th 
century in Annals of Oncology 14 (supplement5):v128-v149, 2003.  
29 For more information, see "Towards High-Performing Health Systems", the final report of the OECD 
Health Project, OECD 2004, ISBN 92-64-01555-8. 
30 The impact of ageing on public expenditure: pr ojections for the EU25 Member States on pensions, 
health care, long-term care, education and unemp loyment transfers (2004-2050), European Economy 
Special Report 1/2006, produced by DG ECFIN. 
 
EN 22   EN 3.4.2.  Contribution to general EU objectives  of economic growth and sustainable 
development 
Healthcare systems also have a specific impact on the economy, irrespective of the 
ways in which the system affects health31. As one of the larges t service industries, 
the health sector represents one of the most important economic sectors in the EU. 
Currently its output is estimat ed to account for about 7.7 % of GDP in the EU, larger 
than the roughly 5 % accounted for by the fina ncial services sector  or the retail trade 
sector. And around 9 % of all workers in th e EU-25 are employed in the health and 
social work sector. Trends in productivity  and efficiency in the health sector 
therefore have a large impact on these pe rformance measures in economies as a 
whole.  
Moreover, the performance of the health s ector will affect the competitiveness of the 
overall economy via its effect on labour co sts, labour market flexibility and the 
allocation of resources at the macroeconomic le vel. Inequalities in healthcare are also 
a key dimension of regional disparities, both in terms of the inputs provided to them 
and the outcomes they produce. Improving the efficiency and effectiveness of health 
systems is therefore a vital contribution to improving the overall economic growth, 
competitiveness and cohesion of the Union as a whole. 
                                                 
31 For more information, see "The contribution of health to the economy in the European Union", OPOCE 
2005, ISBN 92-894-9829-3. 
 
EN 23   EN 4. POLICY OPTIONS  
This section sets out four main policy opti ons, with two specific variations of option 
three (a general legal framework). These are broad groups of options – different 
elements could be combined, and in particular  'soft action' (option two) could also be 
included in support of options th ree or four, where appropriate. 
4.1. Option 1: No further acti on, the baseline scenario 
This option would mean not taking any furt her Community action on health services. 
There would be no additional legal measures  at Community level beyond the rulings 
of the European Court of Jus tice and existing rules, in particular the regulations on 
the coordination of social security system s. This could be considered to be the 
baseline-scenario. It would be for Member States to address issues of legal 
uncertainty through their own measures, and for the Europ ean Court of Justice to 
continue to develop principles at Comm unity level through ru lings at Community 
level. 
Regarding non-legal measures, there would be no additional coordination or support 
action at Community level beyond those al ready taken (including the Commission 
communication on patient mobility and healthcare developments in the European 
Union of 2004, and information provided to citizens about the existing systems32). 
Under this option, the current status quo would continue to exist, subject to 
individual initiatives by the Member Stat es on an individual or inter-governmental 
basis.  
4.2. Option 2: Soft action 
Under this scenario, the Commission woul d, in addition to existing mechanisms, 
provide guidance on cross-borde r healthcare issues, but would not propose additional 
binding legal measures. This option would envisage the following set of actions: 
– Guidance on cross-border healthcare issu es would be set out  through a more 
detailed statement of the Commission’s interpretation of the implication of the Court of Justice’s rulings for cross-borde r healthcare and application of existing 
rules on harm and liability in a Commi ssion communication. This communication 
would also include recommendations on info rmation to enable informed choices, 
plus principles or recommendations on ensu ring quality and safety of healthcare.  
– The Commission would also recommend to  the Member States to amend their 
national legislation and to incorporate the principles of the case-law of the Court 
of Justice into their national legal syst em and to make the national procedures 
related to the cross-border healthcar e more transparent and objective. The 
Commission would also provi de technical advice and assistance to the Member 
States to facilitate their efforts to implement these principles. This would be further re-enforced by initiating infri ngement proceedings against individual 
                                                
 
32 See http://ec.europa.eu/health-eu/care_ for_me/mobility_in_europe/index_en.htm. 
 
EN 24   EN Member States that do not effectively comp ly with the principles established by 
the Court of Justice. 
– Another action under this option would incl ude establishing a mechanism to bring 
Member States together to share ideas a nd best practice, building on the work of 
the High Level Group on health services and medical care, which is currently 
working on issues such as European re ference networks, pa tient safety, cross-
border healthcare purchasing and provision, health systems impact assessment or 
wider issues related to mobility of health professionals. This would not, however, include any further legal commitment from the Member States to implement the outcomes of this work in practice. 
– In parallel the European Commission w ould further strengthen the existing 
activities aiming at developing common data  and indicators as an evidence base 
for policymaking on health services. Activities in this field are currently being carried out by both SANCO and Eurostat supported by EC funded research. The 
Statistical Office of the European Communities gathers and analyses figures from the different European statistics offices in order to provide comparable and harmonised data in the field of public health and healthcare. The European 
Commission has established a Working Pa rty on Health Indicators which also 
deals with indicators and their implementation.  
– The European Commission would also conti nue its current financ ial support to the 
projects aiming at cooperation between Me mber States and networking in the area 
of healthcare systems from the current a nd future Public Health Programme and 
for research cooperation on delivery of  care and health systems under the 
current7
th Research Framework Programmes. U nder the future health programme 
2007-2013, funding is likely to be made available for € 5 million per year to support such activities.  
– The outcomes of all the previous acti on points would be widely disseminated 
through a dedicated European website. This would help to make patients aware of 
their rights and obligations, especially w ith regard to the cross-border healthcare. 
The existing EU Health Portal could be used for this purpose. 
4.3. Option 3: General legal framework on health services 
– This option would mean the establishment of a general legal framework for health 
services in the EU through a specific legi slative measure (a directive on health 
services). This option could be combined with some of the soft action described 
under option 2. Action would be taken in th e following areas: Common principles 
underpinning health systems in the EU:  The directive would establish the general 
principle that Member Stat es are responsible for ensu ring that the healthcare 
provided on their terr itory is safe and of high quali ty (i.e. provided according to 
clear standards for quality and safety, to be defined by each individual Member State); quality and safety is regularly m onitored; patient's right to complain and 
right to redress and compensation is gua ranteed; privacy and data protection are 
respected; and the requirement that thes e principles set by Member States are 
guaranteed also for patients from other Member  States, in order to ensure that safe 
and efficient healthcare is guaranteed in each member state, also for citizens 
receiving cross-border care.; This does not  mean establishing minimum European 
 
EN 25   EN standards for healthcare. It remains up to Member States to decide on the 
standards for healthcare in their country. The aim of this option would simply be 
to make clear which Member State is res ponsible in any given situation, to avoid 
gaps or overlap, and to clarify what thos e responsibilities mean in practice.  
– Providing sufficient clarity about rights to  be reimbursed for healthcare provided 
in other Member States for those rights to be realised in practice : the directive 
would establish clearly the en titlements of patients to have healthcare in another 
Member State, the limits that Member States can place on such healthcare abroad and the information to be provided to enable patients to be aware of the option of cross-border healthcare; the level of fina ncial coverage that is provided for cross-
border healthcare, based on the principl e that patients are entitled to obtain 
reimbursement up to the amount that would have been paid had they obtained that treatment at home; the pro cesses for decisions about such healthcare, including 
the criteria for assessment and mechanis ms for appeal; and what happens with 
regard to harm and compensation arising from cross-border healthcare. Specific 
issues to be addressed include the following:  
– The directive would also put in place a general requirement that Member States 
must provide information to their own citizens about their rights to healthcare  
abroad (what their entitlements are and how to access them), and that patienst should have access to relevant information from providers to allow them to make 
informed choices (e.g. on availability, prices , outcomes), where this information is 
available domestically. These general requirements would be accompanied by 
additional measures, including establishing of  national points of contact on cross-
border healthcare; comprehensive informa tion on cross-border healthcare being 
made available at the EU Health Porta l; raising awareness about the existing EU 
framework on data protection and sharing of confidential data; 
– Instruments to manage patient flows:
 the directive would provide legal clarity 
over key terms and procedures related to access to cross-border healthcare (such as prior authorisation criteria and appeals procedures), through setting out criteria 
for processes through which Member States  would make reasonable definitions at 
national level. These processes should not limit the existing rights of patients provided by the European C ourt of Justice, but still leave flexibility for the 
Member States. More details regarding th e specific issue of reimbursement for 
cross-border healthcare, including two alternative sub-options, are described 
below. This means that Member States have the freedom to define what appropriate care is and when  for example delay is undue. 
– Harm and compensation arising from cross-border healthcare:
 the provider of 
health services s hould be liable for any harm  arising through cross-border 
healthcare, including when treating patient s from other Member States. However, 
this would not prevent Member States fr om covering patients referred abroad with 
their normal domestic compensation syst em (as some already do, such as 
Sweden). 
– Practical cooperation on healthcare systems:  With the directive a framework 
would be established to support furthe r cooperation in the areas including 
European reference networks, health tec hnology assessment, data collection and 
quality and safety, in order to enable the potential contribution of such 
 
EN 26   EN cooperation to be realised effectively a nd on a sustained basis, and to agree on 
overall directions for difficult issues (ie: data standards, handling of new 
technologies or techniques) to promote e ffective long-term practical synergies. 
As indicated above, this option would have two alternative sub-options for dealing 
with the issue of legal uncertainty regarding financial entitlements and prior authorisation for cross-border healthca re. Under both options a comitology 
committee would be created which would ad opt any technical measures necessary 
for effective implementation of the general principles set out by the Directive. 
4.3.1.  Sub-Option 3A – Two parallel systems fo r financial aspects of cross-border 
healthcare (both hospital care and non-hospital care) 
As set out above, there are currently two di fferent routes for financial aspects of 
cross-border healthcare: the regulations on coordination of social security systems. 
and direct application of the free move ment rights provided by the Treaties on the 
basis of the recent jurisprudence of the C ourt. These routes are summarised in the 
following table. 
 
EN 27   EN PLANNED CARE EMERGENCY CARE  
Regulation 1408/71 (and 
later 883/04) ECJ case law applying 
Article 49 Regulation 1408/71 (and 
later 883/04) only 
Legal basis Article 42 (free 
movement of workers) Article 49 (free 
movement of services) Article 42 (free 
movement of workers) 
Prior authorisation for 
"hospital care" Obligatory May be required by the 
Member States No prior authorisation 
Prior authorisation for 
"non-hospital care" Obligatory Not needed No prior authorisation 
Means of payment Benefits in kind provided 
according to the 
legislation of the Member 
State of treatment (i.e. in 
some countries free of 
charge, in some countries 
out-of-pocket payment 
may be required). 
Settlement of costs 
between the social 
security institutions of the 
two countries concerned. Out-of-pocket payment 
with subsequent 
reimbursement from the 
social security institution 
of the patient's home 
Member State. Benefits in kind provided 
according to the 
legislation of the Member 
State of treatment. 
Settlement of costs 
between the social 
security institutions of the 
two countries concerned. 
Level of reimbursement According to the rules of 
the MS of treatment.  
If this is less than what a 
patient would receive in 
his home MS, the 
additional reimbursement 
covering that difference 
must be granted.33 According to the rules of 
the patient's home MS.  
In any event, only actual 
costs of the treatment are 
reimbursed (i.e. a patient 
cannot make profit)  According to the rules of 
the MS of treatment. 
There are two key differences about these systems from the perspective of the 
patient. The first is about the pro cess for going abroad: under the existing 
regulations, the prior authoris ation requirements are strict er, but the patient does not 
have to pay up-front. The second is about the financial outcome and specifically, 
who bears the risk that healthcare in anot her Member State will cost more than at 
home: under the Court judgements, the patie nt bears that risk – they only get 
reimbursed up to the amount that would have  been paid had they obtained that 
treatment at home. Under the social security regulations, that financial risk is borne by public funds. 
                                                
 
33 Although the current wording of 883/04 is "the insured person may ask the competent institution to pay 
the additional amount", the ECJ ruled in the Vanbraekel  case that this additional reimbursement must be 
granted where in the first place th e authorisation was refused and it wa s subsequently established that 
the refusal was unfounded(see also point 130 watts) 
 
EN 28   EN Also as set out earlier in this impact assessment, most patients want to be treated as 
near to home as possible. So  why would they wish to us e either of these routes? 
There are two main reasons why they  might prefer healthcare abroad: 
– the healthcare that they need is just not av ailable in their own system – or at least, 
not available within a reasonable time; or  because they live or work abroad, and 
rely on the system there' 
– or that healthcare is available at home, but it's more convenient for them to have it 
abroad – because it's closer , or quicker, or better.  
However, these are quite different reasons; one  is a matter of need, one is a matter of 
personal preference, and it seems reasonable they should be treate d differently. If a 
patient has to go abroad to get the healthcare th ey need because they cannot have it 
domestically, they should not lose out fina ncially by doing so. But if they could stay 
at home and they just prefer to have th e healthcare abroad, there's no reason why 
public funds should have to pay any additional costs as a result. 
So this option follows that distinction. If the care for the patients' condition cannot be 
provided in their own country without undue  delay, then they are allowed to go 
abroad, and any additional costs of treat ment will be covered by public funds; the 
mechanism for this is already in place th rough the regulations on coordination of 
social security systems. But if they could have stayed at home and the treatment in 
question is among the benefits provided in the Member State of affiliation to which 
the insured person is entitled they can go abroad if they wi sh, to receive the treatment 
– but they would have to pay for any addi tional costs above what would have been 
covered at home.  
In practical legal terms, th is means that under this sub-option, the existing framework 
for coordination of social security schemes would remain in place in its current form 
(or with the modifications proposed in th e regulation 883/04) with all the general 
principles on which the regulations on coor dination of social s ecurity schemes are 
based, including putting the patient receivi ng healthcare in another Member State on 
the equal footing with the residents of that  Member State, and with all healthcare 
abroad requiring prior authorisation, with  that prior authoris ation being granted 
where the care cannot be provided domes tically within a reasonable time.  
In parallel to this existing structure, the new directive on health services would put in 
place an alternative mechanism based on the principles of free movement and 
building on the principles underlining decisions  of the Court of Justice. This would 
allow patients to seek any healthcare abroad  that they would ha ve been provided at 
home without any prior authorisation and be reimbursed not more than the amount 
that would have been paid had they obtai ned that treatment at home. The patient 
bears the financial risk of any additional costs arising.  
Also consistent with the Court's jurispru dence, the directive would stipulate that 
Member States would still be able to impose on a patient seeking health services in another Member State the same conditions and formalities, such as the requirement 
to consult a general practitioner before cons ulting a specialist, to which receipt of the 
same health services is made subject also on their territory. So if  Member States have 
 
EN 29   EN restrictions on authorisation for hospital care within their territory, those would also 
still apply to hospital care abroad.  
This ensures that for cross-border healthcare  under the directive, Member States are 
still able to apply any conditions that they  consider necessary to plan and manage 
their health systems domestically. For ex ample, if a country requires access to 
hospital care within the Member State to have the prior agreement of a general 
practitioner, this would still be the case under the directive for hospital care abroad. 
However, where a country does not have restrictions on access to or choice of 
hospitals within that country, they would not be able to add additional conditions any such appropriate care abroad.  
By way of derogation, Member States would be  able to provide fo r a system of prior 
authorisation for assumption by their social security system of the costs of hospital 
care provided in another Member State. Th e Member State would be able to do so 
where the outflow of patients has such an  impact on the planning and rationalisation 
carried out in the hospital se ctor in order to avoid hospi tal overcapacity, imbalance in 
the supply of hospital care and logistical and financial wastage as to undermine the 
financial balance of their social security  system, the maintenance of a balanced 
medical and hospital service open to all, or  the maintenance of treatment capacity or 
medical competence on their national territo ry. Such a prior authorisation system 
should then be limited to what is necessary and proportionate in order to ensure these 
objectives and shall not c onstitute a means of ar bitrary discrimination.  
 
EN 30   EN PLANNED CARE  
Option 3A Option 3B 
Legal basis Article 95 (internal market) and ECJ 
case law Non hospital care: Article 95 (internal 
market) and ECJ case law 
Hospital care: Article 42 (free movement 
of workers), regulation 1408/71 
Prior authorisation for 
"hospital care" No prior authorisation, Member States 
may require prior authorisation by way 
of derogation.  Obligatory, in accordance with 
regulation 1408/71 
Prior authorisation for 
"non-hospital care" No prior authorisation No prior authorisation 
Means of payment Out-of pocket payment with subsequent 
reimbursement from the social security 
institution of the patient's home Member State. Non-hospital care:  Out-of pocket 
payment with subsequent reimbursement 
from the social security institution of the patient's home Member State. 
Hospital care:  Benefits in kind provided 
according to the legislation of the Member State of treatment (i.e. in some 
countries free of charge, in some 
countries out-of-pocket payment may be 
required). 
Settlement of costs between the social 
security institutions of the two countries 
concerned. 
Level of reimbursement According to the rules of the patient's 
home Member State. 
In any event, only actual costs of the 
treatment are reimbursed (i.e. the patient 
can not make a profit if treatment abroad is cheaper) Non hospital care:  According to the 
rules of the patient's home Member State. 
In any event, only actual costs of the 
treatment are reimbursed (i.e. the patient can not make a profit if treatment abroad 
is cheaper) 
 Hospital care:  According to the rules of 
the MS of treatment.  
If this is less than what a patient would receive in his home MS, the additional 
reimbursement covering that difference 
must be granted. 
 
4.3.2.  Sub-Option 3B – Two parallel systems for financial aspects of non-hospital cross-
border healthcare, hospital care thro ugh the social security regulations 
This sub-option takes the same approach as  for option 3 overall and sub-option 3A in 
all areas except for the fina ncial entitlements and prior authorisation for cross-border 
hospital care. As set out above, in its dire ct application of Article 49, the Court has 
also considered that prior authorisation requirements may be justified for hospital 
care. One way of interpreting this is to equa te the prior authorisat ion that may thus be 
 
EN 31   EN required for hospital care abroad on the basis of Article 49 with the prior 
authorisation required for any cross-border healthcare under the regulations on social 
security, and this has been the inte rpretation generally taken hitherto.  
Under this option, therefore,  the directive envisaged unde r option three would only 
deal with the direct application of Artic le 49 for financial aspects of non-hospital  
cross-border healthcare. For hospital care, patients would follow the existing mechanism for coordination of social secu rity schemes, with the conditions and 
requirements stipulated therein.  
In practical terms, this would mean th at for cross-border hospital care, prior 
authorisation would be required for only have  to be granted for hospital care abroad 
when such treatment cannot be provided with in a reasonable time within the patients' 
own country, regardless of whether or not a similar restriction is  applied in choosing 
between hospitals domestically. However, it would also mean that  all such hospital 
care would be provided on the terms of the regulations on coordination of social 
security, with care provided according to the legislation of the Member State of 
treatment, with settlement of costs between the social security institutions of the two 
countries concerned according to  the rules of the country of  treatment (and if this is 
less than what a patient would receive in their home Member St ate, an additional 
reimbursement covering that difference).  
In legal terms, as with sub-option 3A th is again would require no changes to the 
existing framework for coordination of so cial security schemes would remain in 
place in its current form (or with the modifications proposed in the regulation 883/04). As with sub-option 3A, the new dir ective on health serv ices would put in 
place an alternative mechanism based on the principles of free movement and 
building on the principles underlining decisions  of the Court of Justice, but whereas 
for sub-option 3A this directive would appl y to the financial as pects of all cross-
border healthcare, under sub-option 3B for fi nancial aspects this directive would only 
apply to non-hospital cross-border care.  
4.4. Option 4: Detailed legal rules at European level 
Under this scenario, the Commission would not propose to put in place a package of 
binding and non-binding measur es, but rather a detailed framework of harmonising 
legal measures under Community law for all cross-border healthca re issues outlined 
above – information to enable informed choices, financial issues and limits to healthcare abroad, quality and safety of healthcare, and issues concerning harm 
arising from healthcare and compensation. Su ch a detailed legal framework could be 
set out in a detailed regulation and also in clude a legally binding 'Charter of patient 
rights'.  
These binding measures would provide: 
– Detailed rules on which data about cro ss-border healthcare should be collected 
and on how and how often these data s hould be collected by each individual 
Member States;  
– detailed requirements on improved information provision to citizens with detailed 
description of the information to be given to the citizens and its format; 
 
EN 32   EN – explicit criteria for authorization and the authorization procedure, the maximum 
waiting time during the procedure etc., wit hout leaving the possibility for Member 
States to adapt it to th eir national circumstances; 
– explicit standards for quality and safety  defined at the European level, and 
detailed description of minimum requireme nts for Member States and individual 
healthcare providers concerning those standards, how compliance should be 
monitored and in which situations whic h corrective action should be taken.  
– a legally binding 'Statement on patient rights'  prescribing rights to preventive 
measures, to access care, to information, to  consent, to free c hoice of care, to 
privacy and confidentiality etcetera. Patients would have legal entitlements to compliance with those rights and all those rights would be enforceable. 
– concerning compensation for harm arising from cross-border healthcare, explicit 
measures would be adopted specifying the applicable law and jurisprudence of the 
courts for decisions on cross-border health care, adapting existi ng provisions of the 
international private law to the specifi cities of the cros s-border healthcare. 
Detailed level and requirement for compen sation for harm would be also defined. 
These detailed legislative provisions w ould provide greater certainty over the 
specific issues arising from the Court's recent jurisprudence, but also over all 
wider issues as raised in the consu ltation. This would, however, represent a 
significant degree of harmonisation of hea lthcare issues in Community law, which 
with regard to certain aspects can not be ju stified given the remits of the EC treaty 
in the field of organisation and delivery of  health services and in any case difficult 
to justify in the light of the subsidiarity principle. 
 
EN 33   EN 5. ANALYSIS OF IMPACTS  
5.1. General comments and analytical approach 
The aim of impact assessments in general is  to give insight in the economic/financial, 
social, environmental impacts of the Co mmission proposal, compared to other 
options or no further action. This assessm ent of impacts for framework directives 
will necessarily be preliminary and will not provide detailed quantitative data. As outlined in chapter four, these options represent broad approaches, of which different specific elements could be combined. The im pacts described therefore are also broad 
descriptions, but are sufficient to evaluate  the overall costs and benefits of the 
different approaches. Overall cross-borde r healthcare has significant economic and 
social impact. The impacts described in this  impact assessment will nevertheless be 
smaller, as this chapter will only focus on the impact of the in the previous chapter presented options for community action. Th is impact assessment does not describe 
the impact of cross-border care as a whole.  
This first section describes the overall analytical approach taken for the main 
economic, environmental and social impacts of the different options. 
5.1.1.  Analysis of economic impacts 
The main economic impacts of this  proposal come in the areas of: 
– additional costs of cross-border heal thcare treatment for public funds; 
– additional benefits from cross-border healthcare 
– overall cost of compliance 
– specific administrative burden 
There are also wider macro-economic imp acts to be considered. Through enabling 
cooperation and comparison, action in the fiel d of cross-border healthcare will lead 
to more efficient provision of healthcare and will improve the overall quality and resource usage of healthcare systems as whole. As the healthcare sector is in 
important provider of employment and of  innovation, its contribution to overall 
macro-economic development is substantia l, and thus these improvements can be 
expected to help contribute to the sust ainability of health systems and overall 
economic growth and development. Ho wever, these impacts have not been 
quantified for this impact assessment. 
5.1.1.1.  Additional costs from cross-border care 
The first economic impact is the additional costs to Member States of cross-border 
healthcare and in particular, the additi onal costs arising from treatment being 
provided in another Member State.  
However, in its rulings on the application of free movement rights under the Treaties 
in order to have access to h ealthcare abroad, the Court ha s made clear that that the 
patient can only be reimbursed for costs of  healthcare abroad up to the amount to 
 
EN 34   EN which they would have been entitled had they had the care in their own country. So 
in fact, the additional cost of treatment being provided in anot her Member State in 
application of these rights could be said  to be zero, as these are costs that the 
patients’ Member State would have paid in  any case. If the treatment abroad was not  
care to which the patient would have been en titled at home, then patients are still not 
entitled to have it paid for through application of internal  market freedoms if they 
have that care in another Member State, so  in principle there s hould be no additional 
costs arising for patients who ar e treated through this route.  
Nevertheless, the cost of such treatment to  public funds is still not quite zero. As set 
out in earlier chapters, the main reasons why a patient might wish to seek healthcare 
abroad are that it is quicker, or cheaper, or more convenient. Of these reasons, the 
main economic impact under this heading will  come if the patient is reimbursed for 
healthcare abroad more quickly than they would have obt ained that care 
domestically, then there is still the impact  for the Member State of having to spend 
the funds in question more quickly than would otherwise have been the case.  
In economic terms, this cost of the differe nce between spending f unds at an earlier or 
later point in time can be represented by th e interest applicable to the funds in 
question. To get a general impression of thes e costs, we therefore use a simple model 
combining:  
– the estimated number of people for whom  it is potentially quicker to seek 
treatment abroad,  
– the likely average cost if they do so,  
– an estimated average time difference in comparison to domestic treatment 
– and thus the additional cost represente d by the discount rate applied to the 
amounts and times in question.  
To estimate the number of people for whom it is potentially quicker to seek treatment 
abroad, we can use the estimates of unmet medical need due to waiting for treatment 
provided by the SILC survey data (see tables in annex). From these tables, an 
average percentage of people having unme t medical needs due to waiting lists is 
calculated, weighted for th e amount of inhabitants in  the respective countries34. On 
that basis, it can be roughly estimated that on average 1.6 percent of the European population is currently on a waiting list, wh ich is equivalent to  approximately 7.8 
million EU citizens. However, evidence a bout take-up of cross-border healthcare 
suggests that in practice, most people will st ill prefer to have healthcare at home. For 
example, when the Health Insurance Institu te of Slovenia (HIIS) offered patients on 
the national waiting list for cardiac surger y the opportunity to receive treatment 
abroad, less than 10% deci ded to take up the offer
35. We therefore assume that at 
                                                 
34 For the countries for which no reliable data exist,  we assume that on average they have the same 
percentage of citizens waiting for care as the average percentage for the other countries for which data 
are available. 
35 Cross-border care in the south: Slovenia, Austria and Italy  in Rosenmöller, M., McKee, M. Baeten, R., 
Patient Mobility in the European Union, Learning fr om experience, World Health Organisation (2006). 
This study is part of the project Europe for Patients, an EC FP6 funded research project. 
 
EN 35   EN most 10% of people waiting will seek cro ss-border care in practice on this basis. 
Although data about comparisons of costs be tween Member States and patterns of 
cross-border healthcare are largely lacking, in order to estimate average costs for 
treatment abroad, we can use recent research  comparisons of costs for different forms 
of treatment across the European Union36. For hospital care, taking as an example 
treatment a hip operation, as a common electiv e procedure, we take an estimate of 
average cost of treatment abroad of €7000. For non-hospital care, we take as an 
example eye surgery (cataracts), with thus an estimate of average cost of treatment 
abroad of €80037. 
Regarding estimated time differences in treatment, we can assume that maximum 
waiting times will be no longer than a fe w months, as otherwise the delay in 
treatment will be sufficient to justify acce ss to cross-border healthcare not under the 
direct application of free movement right s being assessed in th is proposal, but under 
the existing regulations on the coordination of social securi ty, the costs of which fall 
outside the scope of this impact assessmen t. Estimates within the framework of the 
OECD Health Project38 are that on average, a waiting time of more than six months 
worsens outcomes of elective surgery. Taking this as an outer limit of waiting times, 
we therefore assume an average waiting time of three months for domestic treatment, 
and take that as the average time difference between domestic treatment and treatment in another Member State.  
To calculate the opportunity costs of earlier treatment, we use a discount rate of 
4%
39. If a patient receives treatment abroad  immediately instead of receiving it in 
three months time in their own country, the additional costs will therefore be 
approximately 1% of the total cost of the tr eatment. Thus for hosp ital care, taking our 
estimated average treatment cost of €7000, th e additional cost to the patient's home 
system would be €70. For non- hospital care, taking our es timated average treatment 
cost of €800, the additional cost to th e patient’s home system would be €8. 
Of course, this assumes that the treatment abroad is at least as expensive as the 
treatment would have been at home – if it is cheaper, the net cost to the patient's 
home system is also reduced correspondingly. If it is more expensive, then there is 
no additional cost to public funds, as Member States are only required under the 
Court’s jurisprudence to reimburse the amount that they would have  paid in any case, 
but the patient would have to  bear the additional costs. 
The different options invol ve different assumptions about how many people are 
likely to seek such cross-border healthcare in practice, and the consequent estimated 
costs under the model are given under the analysis of impacts for each option.  
                                                 
36 Based on research on health baskets and tariff s in different member states, Observatory mapping 
exercise and Health BASKET( www.ehma.org/projects/healthbasket.asp ). Health BASKET – Health 
Benefits and Service Costs in Europe – is a project funded by the European Commission within the 
Sixth Framework Research Programme. 
37 Based on data provided through Health BASKET, where this can be broken down to give an 
approximation of hospital and non-hospital care; these examples are likely to be a slight over-estimate. 
38 The OECD Health Project, Towards High-P erforming Health Syst ems, OECD (2004) 
39 In the Annexes to Impact Assessment Guidelines, European Commission (2005) a discount rate of 4% 
is required.. This rate broadly corresponds to the average real yield on longer-term government debt in 
the EU over a period since the early 1980s. 
 
EN 36   EN 5.1.1.2.  Additional benefits fr om cross-border care 
Of course, being treated more  quickly abroad does not si mply bring costs, but also 
benefits through treatment being provided more quickly.  
In order to put a quantified value on such benefits for cost–utility analysis, health 
improvements are typically measured in quality-adjusted life-years (QALYs). The 
quality adjustment is based on a set of refe rences or weights called utilities, one for 
each possible health state. These utilities refl ect the relative desirability of the health 
state and are measured on an interval scale,  where 1 refers to full health (otherwise 
described as perfect or excellent health) and 0 refers to death. An example of an 
instrument that has produced a series  of health utilities is the EQ-5D40.  
Research shows that in case a patient has problems with walking, utility of life is 
reduced by at least 10 percentage points. Taking our example intervention of a hip 
replacement, we therefore assume that the consequent benef it to them can be 
represented by a 0.1 increase in quality-adjus ted life years (for example from 0.9 to 
1.0 QALYs)41 For eye surgery to treat cataract, we  use a QALY increase of 5 percent 
points42. 
The amount of time spent in a health state is weighted by the utility score given to 
that health state. If a patient is treated quicker abroad, he/she will be able to get to a 
healthier status more quickly. In our model we assume that a cross-border patient is 
treated three months ear lier than at home. 
The remaining element is how much a QAL Y is worth. Estimates vary widely, and 
of course any such average figure cannot fu lly reflect the variations in development 
and cost of living throughout the European Union. We have therefore opted to take a 
relatively conservative estimate of €40,00043, but this is only an  indicative figure to 
enable some rough modelling of the potential  benefits of cross-border healthcare.  
Extending the model set out in the previous  section, we can therefore represent the 
benefits for hospital ca re of quicker treatment as being that the average patient is 0.1 
QALYs healthier for a period of three mont hs (0.25 years), leading in total to 0.025 
extra QALYs. Assuming that a QALY is  worth €40,000, this increase in quality-
adjusted life years can thus be said  to be worth € 1000 (0.025* €40,000). For non-
hospital care, the treatment adds 0.05 QALYs for a same period of time, worth € 500 
(0.0125* €40.000). 
                                                 
40 What is a QALY?, Hayward Medical Communications, Hayward Group plc. (2003) 
41 L. M. Lamers, J. McDonnell, P. F. M. Stalmeier, P. F. M. Krabbe and J. J. V. Busschbach; The Dutch 
tariff: results and arguments for an effective design for national EQ-5D valuation studies, in Health 
Econ (2006) and A. O’Hagan, J.E. Brazier, S.A. Kharroubi; A comparison of United States and United 
Kingdom EQ-5D health states valuations using a nonparametric Bayesian method; Health Economics and Decision Science Discussion Paper Se ries, University of Sheffield (2007)) 
42 For the specific example of eye su rgery the QALY increase might be slig htly higher. However, as this 
is an example case intended to represent the ge neral case of non-hospital care for which the QALY 
impact will generally be lower, we have used a more representative figure for this general case. 
43 In comparison, for example in 2006 the Dutch Council for Public Health and Health Care (an 
independent body which advises the Dutch government on public health and care) published a report to 
support debate about costs of hea lthcare and stated that not more than € 80.000 should be spent on 
healthcare to save one QALY. 
 
EN 37   EN Again, the different options  involve different assump tions about how many people 
are likely to seek such cross-border hea lthcare in practice, and the consequent 
estimated benefits under this model are give n under the analysis of impacts for each 
option. 
5.1.1.3.  Cost of compliance 
Apart from the direct costs and benefits of treatment provided in another Member 
State, there are also the associated costs for administrations in implementing the necessary systems to administer such cros s-border care, such as  additional systems 
for paying for such care, estimating how mu ch the care in question would have cost 
had it been provided domestically, and ensu ring appropriate monitoring of care and 
continuity between domestic providers a nd providers in other Member States. 
Regardless of whether there is any new legislative proposal by the Commission or 
other action, Member States are still required to take such steps, in order to comply 
with the existing jurisprudence of the Europ ean Court of Justice on  the application of 
free movement rights in order to have acce ss to healthcare abroa d. All of the policy 
options therefore involve some such costs for Member States, including the option of 
no further action.  
As in other areas, data about the size and nature of such compliance costs for health 
systems is largely lacking. Moreover, the si ze and nature of costs will vary according 
to the different organisations of health system used within the different Member 
States. Any estimation of such compliance costs is thus necessarily approximate. 
Subject to these qualificatio ns, however, and based on th e experience of existing 
cross-border cooperation projects, we es timate that the total additional compliance 
cost due to health care being obtained in a different EU country is 5% of the total 
cost of the care involved
44. 
From this, we can make a baseline estimate for compliance costs related to cross-
border care as it stands now. As stated earlier in this re port, total public expenditure 
on healthcare in the European Union is approximately € 1000 billion. Taking the 
estimate set out in chapter two that cross- border care currently accounts for about 1% 
of that total amount, the total amount of  money spend on cross-border care is 
therefore roughly € 10 billion per year. On the basis of the estimate that compliance 
costs equate to 5% of the total cost of cross-border healthcare, the total current 
compliance burden is therefore approximately  5% of €10 billion, or € 500 million per 
year. 
In the assessment of the different options , we therefore take this amount as a 
baseline. For the different options for action we estimate in what direction this compliance cost might alter, and assume example percentages to thus give an 
impression of how much the consequent  compliance cost would also change.  
                                                
 
44 Grunwald CA, Smit R. Grensoverschrijdende zorg – Zorg op Maat in de Euregio Maas-Rijn; evaluatie 
van een experiment. Utrecht, NZ I (research institute), 1999. 
 
EN 38   EN 5.1.1.4.  Administrative burden 
In the context of impact assessment, admini strative burden has a specific definition, 
being the costs incurred  in meeting legal obligations to  provide information. As with 
overall compliance costs, data about the size  and nature of this administrative burden 
for health systems is largely lacking; and ag ain, the size and nature of these costs will 
vary according to the different organisati ons of health system used within the 
different Member States. The standard cost  model has been used  to calculate the 
administrative burden although, due to lack of robust data, in a simplified manner. 
In order to provide some approximation of these costs, we have taken a model of 
how Member States could develop information mechanisms such as websites, brochures and information centres to in form citizens about cross-border care, 
drawing on comparisons with existing ini tiatives and projects providing information 
to citizens under the public health programme. We also need some estimate of the 
likely scale of enquiry from citizens for inform ation; for this, we take the results of 
the Eurobarometer in terms of the numbe r of citizens receiving cross-border 
healthcare, and assume that at least tw ice as many people will make information 
enquiries as actually go abroad, giving a to tal of 8% of the population as the likely 
scale of people seeking information. If for example we assume that these 8% of the 
population (40 million citizens) seek further information, requiring a transaction time 
of approximately 8 minutes of staff time to answer, costing approximately € 20 per hour, the total costs for the Union as a whole will be around € 100 million per year.  
This is of course a highly theoretical and simplified model, simply intended to give 
some kind of impression of the overall scale of the admini strative burden of 
Community action in this area, and the dire ctions of change under each option. It is 
not intended to imply that any given health system would use the specific mechanisms outlined in the model; each system would of course use different 
mechanisms as appropriate to its circumstances. 
As with compliance costs overall, for each opt ion we then estimate in what direction 
such information provision activities woul d change, and assume example figures in 
order to give an impression of how much  the consequent administrative burden 
would also change. 
5.1.1.5.  Wider economic impacts 
As set out in chapter 3, in addition to th ese direct impacts re lated to the direct 
objectives of the initiative, Community acti on on cross-border healthcare would also 
have a wider impact on the overall goals of the health systems of the Member States, 
and to the growth, competitiveness and cohe sion of the Union as a whole. Although 
it is not possible to quantify this contribu tion, the types of impacts and the likely 
relative magnitude of impact  between the different opti ons is briefly indicated.  
5.1.2.  Analysis of environmental impacts 
The analysis of the environmental impacts of  the different options is brief, as we do 
not expect the changes brought about by th e different options to have any major 
environmental impacts. We briefly indicate however the likely di rection of change 
for two groups of environmental impacts: effi cient use of natural resources (as part of 
 
EN 39   EN efficient use of resources in general), and use of transport linked to travelling across 
borders for care. 
5.1.3.  Analysis of social impacts 
The main social impacts to be asse ssed for the different options are: 
– different impacts for different social groups; 
– longer-term consequences for health sy stems as a whole, both for sending and 
receiving countries; 
– and the impact on existing inequalities within and between Member States. 
5.1.3.1.  Analysis by socio-economic groups 
Direct application of free movement rights in the Treaty to obtain reimbursement for 
cross-border healthcare provides additi onal choices to patients in particular. 
However, this choice is clearly not withou t its problems, as set out in chapter 2 
above. Moreover, even when this route for cross-border healthcare works well, 
concerns have still been expressed by seve ral stakeholders about the potential impact 
of this additional choice on equity within  health systems as a whole, and how the 
impact of the different options might affect different socio-economic groups. 
Inequality in healthcare can co me from a variety of sources45, including in particular: 
– lower expectations of good health or th e potential benefit of treatment by people 
in lower socio-economic groups, leading to lower healthcare usage; 
– unequal skills in understanding and navigating often complex healthcare 
pathways; 
– unequal levels of knowledge about a patien t’s own health needs and the options 
available to address them; and, 
– unequal resources to meet direct  and indirect costs of care. 
Socio-economic inequalities in health care use have been identified in practice. A 
2004 OECD study looking at “Income-related ine quality in the use of medical care in 
21 OECD countries”, conducted by van D oorslaer, Masseria and the OECD Health 
Equity Research Group Members46 finds significant income-biased inequality in 
doctor use: the rich or more educated are significantly more likely to see a specialist and a dentist than the poor or  less educated are, and also  more frequently. However, 
this is not necessarily the case for the sp ecific issue of patie nts exercising choice 
between providers. An evaluation of a pa tient choice scheme in London showed no 
significant difference in the numbers of pa tients exercising choice by socioeconomic 
                                                
 
45 See in particular “Is greater patient choice consiste nt with equity? The case of the English NHS”, Anna 
Dixon and Julian Le Grand, Journal of Health Services Research & Policy Vol 11 No 3, 2006: 162–166. 
46 For more information see http://www.oecd.org/dataoecd/14/0/31743034.pdf 
 
EN 40   EN status.47 In fact, by providing a mechanism th at can be used by all socio-economic 
groups, increasing the choice to go elsewhere may help to compensate for the greater 
‘health literacy’ of people in higher socio- economic groups, and thus help to improve 
equity overall. However, this clearly depends on how easily such a choice mechanism can be exercised, and the issues of uncertainty set out in chapter 2. The 
current framework for cross-border healthcar e is sufficiently complex and unclear for 
many patients that they decide to cove r the costs related to the cross-border 
healthcare from their own funds instead
48. However, unequal levels of knowledge 
about the options available cr oss-border care has been cl early identified as key issue 
by stakeholders, and is likely to be a ma jor factor in determining the impact on 
equity of different options. By increasi ng the legal clarity and availability of 
information concerning the possibilities of  cross-border healthcare to a wider public, 
these inequalities would be reduced. 
Likewise, the resources necessary to obtai n cross-border care will clearly have an 
impact on equal access, in particular as the direct applicati on of free movement 
principles will normally involve the pati ent paying for care in itially and being 
reimbursed. The extent to which people will be able to do so will depend on the 
resources they have available. Also the de gree of certainty they have about whether 
they will get their money reimbursed afterwards will influence their possibilities to obtain healthcare abroad.  
These two elements will therefore be the fo cus of analysis of the impact of the 
different options by socio-economic group. Ho wever, as has been described above 
with regard to economic im pacts, citizens will be able  to use the free movement 
rights to have access to healthcare abroad  that have been established through the 
existing jurisprudence of the European Cour t of Justice in any event, regardless of 
whether there is any new legislative propos al by the Commission or other action, All 
of the policy options theref ore involve some such impacts on equity for different 
socio-economic groups, including th e option of no further action. 
It is also important to bear in mind that  in any case, the regulations on coordination 
of social security systems still exist for cases where care to which such citizens are 
entitled cannot be provided within a medically acceptable delay. The impact on different socio-economic groups is thus not  a question of patients not having access 
to cross-border healthcare that cannot be provided  domestically (or at least not within 
a reasonable time), but rather an issue of differential impacts of the additional option 
of direct application of  free movement rights.  
5.1.3.2.  Analysis by long-term impact of cross-borde r healthcare on health system as a whole 
Some contributors to the public consulta tion were concerned about the potential 
longer-term impact of cross- border healthcare on health systems as a whole, raising 
four types of concern in particular: 
                                                
 
47 See Dawson D, Jacobs R, Martin S, Smith P. Is patient choice an effective mechanism to reduce waiting 
times? Appl Health Econ Health Policy, 2004;3: 195–203; cited by Dixon and Le Grand, ibid.  
48 Techniker Krankenkasse (TK), Medizin in Europa: Ergebnisse der TK-Mitglieder-Befragung 2003 
(2003) 
 
EN 41   EN – would pressures from cross-border health care force restructuring of the health 
system more generally, to change demand- control measures? No; the quantitative 
analysis of cross-border healthcare in this impact assessment (in particular in 
paragraph 5.5.1.3) shows that the costs of a ny such restructuring would be vastly 
higher than any likely additional costs from cross-border healthcare, even in the long term, and thus the pressures of cro ss-border care would not justify any such 
wider restructuring; 
– would cross-border healthcare create ineffi ciencies in healthcare provision which 
would undermine overall planning and provisi on? On the contrary, the evidence 
available, described in th is section, suggest s that a clear fra mework for cross-
border care will improve
 efficiency in healthcare, bot h for the healthcare provided 
abroad and through transferring best  practice into domestic care; 
– would there be unsustainable additional cost s for the health system of the 'sending' 
Member State? No; this impact assessment sets out clearly (in particular in paragraph 5.4.1.2) that the a dditional costs from cross-bor der healthcare will be 
marginal and are projected to remain at  low levels, given that Member States 
retain control of the unit cost of such treatment, and the vast majority of patients 
will continue to prefer to have domestic care in any case; 
– would there be additional pressures for 'receiving' Member State? No. The small 
overall volumes of patients have not crea ted unsustainable pressures from existing 
cross-border care and will not be enough to create them in the future; and in any 
case, Member States can address this issue by taking steps to ensure that patients from other countries are inte grated into domestic provisi on on an equitable basis. 
The broadly positive long-term impact of cross-border healthcare is confirmed by 
experience to date, as shown by case studies of countries for which cross-border healthcare systems with many of the features  of the preferred option have been in 
place for some time. These examples show  that the experience of cross-border 
healthcare can complement domestic provision and may help to spread best practice, 
but has not had an overall impact that w ould undermine the planning or organisation 
of health systems in the longer term for the reasons set out above, nor  is it considered 
to restrain Member States to develop or ma intain health care services in less densely 
populated areas. Also without using the possi bilities that cross-border care could 
give, Member States are now already able  to withhold regions from healthcare 
facilities by only allocating healthcare facilitie s to the more densely populated areas. 
There is no indication that an increase of possibilities co ncerning cross-border 
healthcare would lead to a growth of inequality between regions.  
• Denmark  has had a system of 'extended fr ee choice' for hospital care since 2002. 
This allows patients free choice of hospitals  if they cannot be treated within eight 
weeks, and puts hospitals and clinics out side Denmark on an equal footing with 
those inside Denmark in providing such trea tment. On the basis of the use made of 
this system up to 2006, however, the im pact for the system as a whole has 
remained low; only 1.5% of patients have made use of their extended free choice, 
 
EN 42   EN and only 0.02% received that treatment abroad49. However, even with this low 
take-up of 'extended free choice', the SI LC data on unmet medical need in table 
8.1 show that over 98% of the Danish popula tion considers that their health needs 
are met, and thus there is no reason to thi nk that this pattern is  not sustainable for 
the future; 
• Malta : the smallest Member State faces some  of the greatest ch allenges in terms 
of providing specialised care in partic ular, and has had an arrangement for 
referring some patients for specialist treatment to the United Kingdom for 30 
years50. This is used for specialised treatme nts such as bone marrow transplants, 
complex major spinal surgery, and specia list paediatric cases, for which it is 
neither clinically nor economi cally appropriate to develop services in Malta, with 
the investment cost being too high, th ere being too few pa tients and full-time 
professional staff providing such services would quickly become deskilled. The number of patients referred through the sy stem is stable at around 300 a year (or 
around 0.06% of the Maltese population). Agai n, the combination of this referral 
system and domestic provision appears to meet the health needs of Malta, as 
shown by the SILC data on unmet medi cal need - over 96% of the Maltese 
population considers that their health n eeds are met, and estimates of people 
seeking treatment abroad outside the form al referral system are low. There is 
again therefore no reason to think that this  pattern is not sustainable for the future; 
• Belgium  has had larger patient flows for pl anned care than most other Member 
States, in particular with Dutch patie nts being treated in Flanders through 
contracts between Dutch health insurers and Belgian providers
51. In this case 
study, the researcher s consider that as well as bei ng convenient for patients, this is 
more efficient for both the Dutch insurers  (providing care th at is faster and 
cheaper, as well as being perceived as be ing technologically a dvanced and of high 
quality) and the Belgian providers (helping to overcome overcapacity in the acute 
hospital sector by treating pa tients from abroad), and there was no indication of 
increased waiting times for Belgian patients as a result of Dutch patients also being treated in Belgian hospitals. 
Regarding efficiency, it is clear that there ar e very large variations in efficiency of 
supply within
 Member States. The HealthBasket project52 compared costs for some 
typical treatments between nine different sy stems, and the overall cost and variations 
for the specific case of hip replacement are shown below53 
                                                 
49 See consultation response R-039 from the Danish Regions; additional data on overall hospital usage 
from Eurostat (comparison year 2 003, as the most recent available). 
50 This example draws in particular on the case study presented in Chapter 8 of the "Patient Mobility in 
the European Union – Learning from experience" of the Europe 4 Patients research project, published 2006, ISBN 92 890 2287 6. 
51 Ibid, Chapter 7. 
52 For more information and the full reports of the project, see 
http://www.ehma.org/projects/de fault.asp?NCID=112&NID=91 . 
53 The small dots show the unexpl ained difference in cost of each  hospital from the overall mean 
(hospital-level residuals). The coloured circles show  different calculations of the overall mean and the 
country mean. The bars show 95% c onfidence limits (+/- 2 x standard errors) for the different models. 
Costs in a country are said to differ from the overall mean at the 5% significance level if the confidence 
 
EN 43   EN 
 
Without going into the detail of the analysis , this illustrates the overall finding of the 
project, that while differen ces in average costs were significant between countries, 
within-country variation was also unexpected ly large – in some cases, larger than 
between-country varia tion. These differences are partly due to different accountancy 
standards, but also due to prices per i nput unit and, most importantly, due to large 
and apparently real differences in prac tice (and therefore differences in actual 
coverage of services). 
This is confirmed by data on variations in  outcomes which can be at least largely 
attributed to the performance of health systems, as shown by the chart below for 
prostate cancer. As this clearly shows, the variations in mortality within  countries are 
often as large as the variations between  countries, as can be seen by the differences 
between minimum and maximum levels of mo rtality within countries being as large 
as the differences between countries. 
                                                                                                                                                         
bar does not cross the horizontal axis. For more explanations, see 
http://www.ehma.org/_fileupload/File/Proje cts/WP10%20REPORT_31_Jan-07_revised.pdf  
 
EN 44   EN  
This suggests two conclusions: 
– first, that the variations in efficiency and management that already exist within 
health systems are much more significant for overall planning and efficiency than the impact of cross-border healthcare, and thus there is no basis to consider that 
the additional element of cross-border healthcare will have a major additional effect on those systems; 
– second, that given the variations within Member States (where resources levels 
are approximately equal), variations ca nnot only be explained by resources but 
also substantially by the efficiency in the use made of resources. The potential for cross-border healthcare to help impr ove efficiency including by comparisons 
between providers will provide significant added-value to health systems overall, 
including for domestic provision. 
Far from undermining national provision, in  the long term cross-border healthcare 
can therefore provide concrete comparisons  and demonstration of better practices 
that help to improve domestic care, not reduce it. Having the alternative of 
contracting abroad not only means that dema nd for health care is better satisfied as 
supply is increased, it also se rves as a strategy to warn national providers that they 
could lose patients and contracts as purchaser s turn to providers in other countries. 
The very possibility of going cross-border puts pressure on national providers to 
improve their performance and/or lower their prices. In th e English NHS, cross-
border contracting aimed, for instance, at putting pressure on the domestic private 
sector to lower their prices for contract s with the NHS; cross- border care reduced 

 
EN 45   EN sharply once appropriate domestic capacity was restored. In the Belgian case study 
referred to above, the researchers report that  one Dutch insurer gave the example of a 
Dutch hospital, situated very close to several major Belgian hospitals where the waiting times for heart surgery had decr eased significantly (to a few weeks) 
compared to another hospital located in the middle of the Netherlands where people were waiting six months. Another Dutch si ckness fund had clear i ndications that the 
local hospital was performing much better in terms of waiting lists, while also striving to become more patie nt-oriented, and was attributing this to the risk of 
significant outflow of patients to Belgium if  the local hospital did not offer improved 
services to the local population. 
Turning to the potentially different so cial impacts for countries ‘sending’ and 
‘receiving’ patients through cross-border ca re, for sending count ries, there is a 
potential social impact through differential ta ke-up of this possibil ity for cross-border 
care, as outlined in the prev ious section. But as also ou tlined above, cross-border 
care can provide an additional choice that allows all citizens to ‘exit’, which for 
cross-border care will be particularly releva nt for specialised services that otherwise 
have low domestic contestability. By doing so, this can provide an additional signal 
of patient dissatisfaction, which may bring about improvements in quality of the care 
concerned that would also benefit patients w ho do not move. There is also potentially 
the issue of 'supplier-induced' demand, wher e the possibility of  additional supply 
from outside the country could bring a bout additional demand beyond that already 
identified within the country itself. However,  this is unlikely to have a large impact 
on the health system as a whole, given th e relatively low elasticity of demand for 
healthcare, and the already-identified preference of patients to be treated domestically in any case.  
For receiving countries, there are potentia lly both advantages and disadvantages. If 
providing cross-border care undermined dom estic planning and prioritisation, this 
could have a negative effect on the equity and accessibility of health services overall. 
For example, patients from other countries seeking cheaper care could create an additional demand that would result in an increase in prices or waiting times for those services overall, including for domestic  patients. However, as described in the 
examples above, there is no evidence of su ch effects in practice, even for systems 
which have had significant volumes of cross-border he althcare for many years. 
There are also potential advantages: healthcar e provision requires a critical mass of 
patients to enable high-quality services a nd to justify investments, and if providing 
cross-border care can help to generate such  a critical mass, it can also help to support 
more developed services which will also benefit domestic patients. The balance of these impacts for receiving countries will therefore depend on how well cross-border 
care is integrated into overall health se rvice planning and provi sion on an equitable 
basis. And in any event, as outlined above , the extent of cross-border healthcare is 
always likely to remain limited, as the vast majority of patients are satisfied by their 
domestic provision and ther efore are unlikely to seek healthcare abroad. 
The impact of cross-border healthcare is ther efore not likely to bring about major 
changes to health systems ove rall, given that the size of  cross-border healthcare will 
remain marginal, despite its importance to the individuals concerned. 
 
EN 46   EN 5.1.3.3.  Analysis by inequalities between Member States 
As set out above, additional choice through cr oss-border care can act as a signal to 
focus attention on improving quality, safety and efficiency of services, in particular 
for specialised services with little domes tic contestability. Increased clarity about 
possibilities to receive healthcare abroad, but also more insight in differences in quality of care between healthcare providers , will make citizens better able to make 
informed choices about their healthcare. It is clear that there are significant 
inequalities within and between countries in  outcomes amenable to healthcare. This 
combined with greater awareness of sta ndards elsewhere may help to improve the 
quality of health services overall, both fo r patients who cross borders and those who 
do not.  
The impact of free movement rights to obtain reimbursement for cross-border 
healthcare will not be equally spread thr oughout the Union. As set out above, this 
route involves greater financ ial risk for patients than  cross-border care through the 
mechanisms provided through the regulations  on coordination of social security 
systems. Quite apart from questions of risk and certainty outlined above, it is therefore also likely that this route will be less used by patients from poorer Member 
States, for whom care in better-off Memb er States will i nvolve a significant 
additional financial cost.  
This represents more fundamental regiona l disparities in hea lthcare overall. The 
Community is acting to address these, in  particular through investment through 
structural funds, including specifically for h ealth infrastructure, though this is outside 
the scope of this initiative and this impact assessment. However, as has been described above, citizens will be able to use the free movement rights to have access to healthcare abroad in a ny event. All of the policy op tions therefore involve some 
degree of inequality in their impact between Member States, including the option of no further action. 
5.2. Option 1: No further acti on, the baseline scenario 
The key issue with this option is that it w ould leave the problems set out in chapter 2, 
and would not provide a Comm ission response to the clea r requests for action from 
the Parliament, the Council and other stakeh olders. It would provide flexibility to 
Member States to address cross-border heal thcare issues accordi ng to their healthcare 
systems and national circumstances. However, this is unlikely to effectively resolve the outstanding issues and problems outlined in the previous chapters.  
With regard to uncertainty over general application of rights to reimbursement, the 
responses to the consultation regarding Co mmunity action on health services show a 
variety of interpretations and understandi ngs of the current position, which are 
therefore likely to persist under this opti on. It is clearly diffi cult for individual 
Member States to address uncertainty over interpretation of Community law on their own, with the consequence of the con tinued problems identified in chapter 2. 
Moreover, continued uncertainty over who is responsible for ensuring the necessary 
requirements for safe and efficient healthcar e in the case of cross-border care will 
compound reluctance to implement rights to reimbursement in practice.  
 
EN 47   EN The European Commission develops and backs many initiatives to improve cross-
border care and to strengthen European c ooperation. Important examples are the 
further improvement of the legislation on the coordination of so cial security in 
Europe and the legislation on the recogniti on of professional qualifications, as well 
as many projects to improve the use of  eHealth. However, although all these 
initiatives facilitate cross-border healthcare in  general, they are not sufficient to solve 
the challenges identif ied in chapter two. In  particular, the upda ting of the social 
security coordination regulations covers  only publicly-funded h ealthcare through 
statutory social security schemes, not othe r types of healthcare; it does not cover the 
direct application of free movement right s under the Treaty as clarified by the 
Court54; and it does not address issues of quality and safety, continuity of care or 
redress and compensation. And although the directives on mutual recognition of 
professional qualifications ensu re a common standard of initi al professional training 
for health professionals, they do not a ddress subsequent continued professional 
development; and do not ensure quality and safety for the wider issues of the teams of professionals dealing with a particular  patient, the providing organisation overall, 
and the applicable regulatory framewor k, nor do they ensure clarity over which 
authority is responsible for ensuring monitoring and oversig ht of the overall system 
for different cases of cross-border care.  
5.2.1.  Economic impact 
Overall, no further action does not mean  no cross-border care. Rather, it means 
continuation of current trends, but accompanied by costs of managing the 
uncertainties identified in chapter 2 in practice.  
5.2.1.1.  Additional treatment costs due to cross-border care 
To assess the additional treatment costs due to cross-border care under this option, 
we apply the model set out in section 0 above . For this particular option, we therefore 
only need to assess the a dditional treatment costs due  to non-hospital care, as 
(assuming that Member States apply the Commission’s current in terpretation of the 
Court’s rulings) hospital care will be dealt with through the regulations on 
coordination of social security. We therefor e assume that of those people waiting for 
care overall, only half will be waiting for non-hospital care; 5% of the total population waiting for non-hospi tal care equates to roughly 195,000 patients having 
cross-border care. Taking our example of  eye surgery, our model suggests that the 
total costs under this option would be  approximately € 1.6 million (195,000 people 
multiplied by an additional cost of € 8 per person).  
5.2.1.2.  Breaking this down by country according to the estimated numbers of people waiting 
suggested by the SILC data, this would mean for example for Germany that total 
additional costs of increasing cross-borde r hospital care would be roughly € 290,000; 
for Poland € 175,000; for Hungary € 15,000;  and for Ireland roughly € 5,000. In 
these examples differences between Member St ates in terms of costs of an individual 
treatment and possibility for citizens to a fford treatment abroad is not taken into 
account. When patients use the possibilities of cr oss-border care created on the basis 
                                                
 
54 Although the regulations could be considered to a ddress this issue for hospital care, depending on the 
interpretation taken of the Court's jurisprudence, as set out for option 3 in chapter 4 above. 
 
EN 48   EN of the free movement principle, they w ill only have the costs reimbursed up to the 
level of the costs of the tr eatment in their country of affiliation. Additional treatment 
benefits due to cross-border care 
On the basis of the same assumptions, we also apply our model estimating the 
additional benefits from being treated more quickly abroad. 
On the basis of our assumptions that  under this option 195,000 extra patients are 
treated through cross-border care, the total benefit estimated through the corresponding increase in qual ity-adjusted life years can be  equated to a monetary 
value of approximately € 98 million. 
5.2.1.3.  Cost of compliance 
As stated earlier, the total compliance burde n of no further action is estimated to be 
approximately € 500 million per year.  
Without any action to make the authoriza tion procedure easier, and without bringing 
any additional clarity concerning quality control mechanisms for cross-border care and costs related to clinical  oversight, responsibility for harm and redress, the total 
cost of compliance of current cross-border ca re is likely to remain at this level. 
5.2.1.4.  Administrative burden 
Under this option, Member States will sti ll need to provide information about the 
principles set out by the Court, and how th ey can be exercised in practice, although 
without additional Community guidance about  how to do so. Uncertainty over cross-
border healthcare combined with the high le vels of potential interest from citizens 
shown above will result both in a high de mand for information and difficulty in 
supplying it.  
Using the model described in section 5.1.1.4 above, this option would involve our 
baseline estimate of the tota l administrative burden fo r the Union as a whole of 
around € 100 million per year. However, as emphasised above, this is of course a 
highly theoretical and simplified model, simply intended to give some kind of 
impression of the overall scal e of the administrative burden of Community action in 
this area, and the directions of change unde r each option. It is not intended to imply 
that any given health system would use the specific mechanisms outlined in the 
model; each system would of course use diffe rent mechanisms as appropriate to its 
circumstances. 
5.2.1.5.  Wider economic impacts 
With no further action at Community level, the potential contribut ion of cross-border 
healthcare to national and Eur opean objectives is unlikely to be realised in practice. 
This means that for example the potential economies of scale of European cooperation on areas such as European refe rence networks will lack a consistent 
framework of minimum requirements for safe  and efficient healthcare, and are thus 
unlikely to realise their potential in practice.  
 
EN 49   EN 5.2.2.  Environmental impact 
This option does not entail any significant e nvironmental impacts, as it would mean 
only continuation of the existing system. Th ere would be some additional transport 
use for cross-border healthca re (although this might in so me cases represent less 
distance travelled, where the ne arest provider is in anothe r Member State). However, 
as outlined above, this option is unlikely to  realise the potentia l for economies of 
scale through European cooperation due to lack of a clear framework for safe and 
efficient cross-border care, and thus will not enable the most efficient use of natural 
resources. 
5.2.3.  Social impact 
As already underlined for economic impacts,  the option of no further action does not 
mean no cross-border care. Rather, it mean s continuation of current trends, but 
accompanied by the social consequences of  cross-border care without a clear 
framework at Community level.  
5.2.3.1.  Impact on socio-economic groups 
Under this option, there woul d be no additional clarity or inform ation about cross-
border care provided at  Community level. The lack of  such information has been 
clearly identified as a majo r concern through the consultation. If this lack of 
information persists, this is likely to have a negative impact on equity. Likewise, lack 
of certainty about how proce dures work in practice and whether money advanced for 
treatment for reimbursed is likely to have  a regressive impact on use of this 
mechanism by different socio-economic groups , as less well-off patients will be less 
willing to take the financial risk involve d. As outlined above, the current framework 
for cross-border healthcare is sufficiently  complex and unclear for many patients that 
they decide to cover the costs related to the cross-border healthcare from their own funds instead, and this is pa rticularly the case for patients from lower socio-economic 
groups
55. 
5.2.3.2.  Impact on health system as a whole 
As outlined above, cross-border care can pr ovide an additional choice for patients 
that can provide an additional signal to he lp bring about improvement of services. 
Given the likely inequalities in use of  cross-border healthcare described above, 
however, this option is corre spondingly less likel y to bring about such changes in 
practice for ‘sendi ng’ countries.  
For receiving countries, the lack of any additional clarity about the tools that 
Member States can use to manage their ow n systems and integrate cross-border care 
risks undermining domestic planning and prioritisation, with a corresponding 
negative effect on the equity and accessi bility of health services overall.  
                                                 
55 Techniker Krankenkasse (TK), Medizin in Europa: Ergebnisse der TK-Mitglieder-Befragung 2003 
(2003); and Eurobarometer; and Eurobarometer 
 
EN 50   EN 5.2.3.3.  Impact on inequalities between Member States 
As set out above, additional choice through cr oss-border care can act as a signal to 
focus attention on improving services, in partic ular for specialised services with little 
domestic contestability. The lack of a dditional Community action to enable the 
potential of this approach to be realised in practice will also mean that its potential 
contribution to improving the quality of health services overall through greater 
comparison and collaboration will also not be realised 
5.3. Option 2: Soft action 
Under this option each challenge could be  tackled by further Commission guidance 
and support, providing a further interpreta tion from the Commission about how these 
issues should be addressed in practice.  
However, by its nature, such guidance can provide therefore only limited additional 
certainty for national authorities, patients,  providers and other stakeholders, and is 
thus unlikely to be sufficient to achiev e the objectives set out above. This is 
underlined by continued uncertainty on the sp ecific issue of rights to reimbursement 
for cross-border care, despite these principles already being set out by the Commission in COM(2004)301 on the follow-up  to the patient mobility reflection 
process. Although not formally titled as an  'interpretative' communication, that 
communication specifically included as part of its aims to provide citizens with a 
clear statement of their ri ghts to healthcare under Co mmunity law, and stated 
following general principles for patients in particular: 
– Any non-hospital care to which you are entitled in your own Member State you 
may also seek in any other Member St ate without prior au thorisation, and be 
reimbursed up to the level of reimbur sement provided by your own system. 
– Any hospital care to which you are entitled in your own Member State you may 
also seek in any other Memb er State provided you first have the authorisation of 
your own system. This authorisation must be given if your system cannot provide 
your care within a medically acceptable time limit, considering your condition. 
Again, you will be reimbursed up to at le ast the level of reimbursement provided 
by your own system. 
– If you wish to seek treatment abroad, your  health authorities can provide you with 
information on how you can seek authorisa tion for care in another Member State, 
the reimbursement levels that will appl y and how you can appeal against decisions 
if you wish to. 
Yet despite this clear statement from  the Commission in 2004, there is a clear 
consensus from Council, Parliament and stakeh olders that these issues are not clear 
in practice, and thus this rights provided in  principle are not able to be realised in 
reality. The limited data available also suggest s that this is the case, indicating that 
far fewer citizens having cross-border healthcare are not exercising the rights to reimbursement which Community law should provide them.  
This reluctance to rely on guidance alone is logical, and unlikely to change. For both 
patients and professionals, it is not enough to  be only reasonably sure about who will 
 
EN 51   EN ensure minimum standards for safe and efficient cross-border care. Given the 
potentially very serious consequences if there are problems, the additional risk represented by any degree of uncertainty ove r who is responsible and for what will 
act as a serious obstacle to cross-border care. Likewise, for the specific issue of 
reimbursement for cross-border healthcare, many patients will only be willing to advance funds for treatment if they can be  certain of being reimbursed, on what basis 
and within what timetable. Simply providi ng guidance at Community is unlikely to 
provide sufficient this certainty in practice. 
Feedback from all relevant stake holders, including Council and European 
Parliament, suggests that after years of this  'bottom up' approach a critical mass has 
developed which recognises the potential of cross-border healthcare, but which 
requires a clear framework on which all st akeholders can rely, which soft action 
alone is insufficient to provide. 
5.3.1.  Economic impact 
5.3.1.1.  Additional treatment costs due to cross-border care 
To assess the additional treatment costs due to cross-border care under this option, 
we apply the model set out in section 5.1.1.1. For this particular option, we only need 
to assess the additional treatment costs due to non-hospital care, as (assuming that 
Member States apply the Commission’s curre nt interpretation of the Court’s rulings) 
hospital care will be dealt with through th e regulations on coordination of social 
security. Nevertheless, we assume that providing guida nce at Community level will 
somewhat increase the take-up of cross-bor der care in comparison to option one, and 
we equate this to a 7% take-up. 
We therefore assume that of those people waiting for care overall, only half will be 
waiting for non-hospital care; 7% of the population on the waiting list equates to 
roughly 270,000 patients having  cross-border care. Ta king the example of eye 
surgery, our model suggests that the to tal costs under this option would be 
approximately € 2.2 million (270,000 people multiplied by an additional cost of € 8 per person).  
Breaking this down by country according to the estimated numbers of people waiting 
suggested by the SILC data, this would mean for example for Germany that total 
additional costs of increasing cross-borde r hospital care would be roughly € 402,000; 
for Poland € 245,000; for Hungary € 20,000; and for Ireland roughly € 7,100. 
5.3.1.2.  Additional treatment benefits  due to cross-border care 
As stated in paragraph 5.1.1.2, an important  advantage of cross- border care over care 
within the country of insurance is that it can at some occasions be used as a way to 
avoid waiting lists. Higher qual ity of life is then (re-)gai ned at an earlier stage. 
Analogous to the model presented in paragraph 5.1.1.2, a rough estimation can be made of the additional treatment benefits which would occur when this option would 
be implemented. 
 
EN 52   EN If we continue to assume that this opti on will lead to 270,000 ex tra patients to be 
treated outside their country of affiliation, to tal benefit due to earlier treatment would 
according to this model be approximately € 135 million. 
5.3.1.3.  Cost of compliance 
Cooperation between Member States woul d be a way to slightly reduce the 
compliance costs related to the author isation procedure and quality control 
mechanisms for cross-border care. Member States would be able to exchange good 
practices and learn from each other to redu ce the compliance costs. We assume that 
the total administrative burden of the actua l cross-border mobility will be reduced 
slightly from 5% of the total budget spent on cross-border care (see also paragraph 
5.1.1.3) to 4%. In financial terms this could be equated to a reduction of 
approximately € 100 million.  
5.3.1.4.  Administrative burden 
Some coordination and coope ration on Community level concerning information 
provision might be a slightly more efficient a nd lead to more appropriate results, it is 
assumed that this option would therefor e lead to a minor decrease of the 
administrative burden due to the legal obligation to provide information. It is 
assumed that the administrative burden will decrease, similar as the decrease in 
compliance cost.  
Using the theoretical model described in  section 5.1.1.4, this option would therefore 
also involve our baseline estimate of the to tal administrative burden for the Union as 
a whole of around € 100 million per year, re duced by 20% to € 80 million per year.  
5.3.1.5.  Wider economic impacts 
With only soft action at Community level, the potential contribut ion of cross-border 
healthcare to national and European objectives is unlikely to be fully realised in practice. Even though some potential econom ies of scale of European cooperation 
can be reached by soft action only, they will lack a consistent framework of minimum requirements for safe and efficient healthcare, and are thus unlikely to realise their potential in practice. In part icular for planning purposes, when looking 
years ahead to plan necessary facilities, h ealth authorities are unlikely to be willing 
to rely on cross-border care even where it could be the best solution to meet their 
health system objectives overall, without the certainty of a clear legal framework 
within which they can cooperate and plan. 
5.3.2.  Environmental impact 
This option is likely to entail marginal additional transport us e for cross-border 
healthcare (although this might in some cases  represent less dist ance travelled, where 
the nearest provider is in another Member State). However, as outlined above, this 
option is also unlikely to realise the potential for economies  of scale through 
European cooperation due to lack of a clea r framework for safe and efficient cross-
border care, and thus will not  enable the most efficient use of natural resources. 
 
EN 53   EN 5.3.3.  Social impact 
5.3.3.1.  Impact on socio-economic groups 
This option would provide some additiona l information to patients about cross-
border care, and would thus a ddress one of the key factors likely to hinder equitable 
impact of cross-border care in practice.  
However, the lack of legal certainty about  reimbursement is likely to have a major 
negative effect on ensuring an equitable impact of this option across socio-economic groups. As outlined above, the direct applic ation of free movement principles will 
normally involve the patient paying for care initially and being reimbursed. The extent to which people will be willing to do so will depend on the resources that they 
have to do so, and the degree of certainty that they have about whether they will get their money back. Simply providing guidanc e at Community level is unlikely to 
represent a sufficient degree of certain ty for many people to risk advancing 
significant amounts of money. This option is therefore likely to continue the likely 
negative impact on socio-economic equity of the direct application of free movement 
principles for cross-border care.  
5.3.3.2.  Impact on health systems as a whole 
As mentioned in paragraph 5.3.1.2, under this option only a limited extra amount of 
citizens will be able to find their way to  healthcare abroad. The impact on health 
systems, in both social and financial te rms, and both for countries receiving and 
sending patients, of additional patient mobility will therefore be limited in comparison with the current position. 
Nevertheless, the existing difficulties Me mber States encounter concerning cross-
border care will continue to exist. For recei ving countries, the lack of any additional 
clarity about the tools that Member States  can use to manage their own systems will 
not be addressed with the introduction of this option. 
5.3.3.3.  Impact on inequalities between Member States 
Exchange of best practices enables Memb er States to improve their healthcare 
systems and to reduce differences in quality between Member States. The 
introduction of more soft action would fu rther facilitate such processes and thus 
contribute to a reducti on of inequalities. 
As in the current situation, choice through cross-border care can act as a signal to 
focus attention on improving the quality and efficiency of servic es. Possibilities to 
find healthcare abroad will remain even though unchanged. However, given the low 
overall impact of this option, the impact  on inequalities will also remain low. 
5.4. Option 3: General legal framework on health services 
This option is likely to have a significant im pact in addressing the issues outlined in 
chapters two and three, by providing a clear and binding framework on which both 
patients and professionals can rely in pract ice. As outlined above, for both patients 
and professionals, there is a crucial diffe rence between having some confidence in 
the applicable rules for cross-border car e, and being certain. The potentially very 
 
EN 54   EN serious consequences of any problems for cross-border care means that certainty 
about the applicable ru les is likely to make them mu ch more effective than guidance 
or soft action alone. However, it should not  represent a substantial additional burden 
for health systems, as it reflects principles to which health systems already subscribe. Moreover, such a general legal framework wo uld leave flexibility to Member States 
to implement these principles in practi ce according to local circumstances. For 
reimbursement issues, this option would ensu re a clear binding set of rules to help 
ensure that free movement rights provided in principle by the C ourt can be realised 
in practice. These rules complement th e existing regulations on coordination of 
social security schemes by ensuring clarity for care provided through the alternative 
route established by the Court, which is not covered by those regulations (though see 
the specific issue of hospital care desc ribed in sub-options 3a and 3b below). 
This option would also create clear bind ing rules over who is responsible for 
ensuring the necessary requirements for high- quality, safe and efficient healthcare 
and thus ensure that these are also in place for cross-border care. This should not 
mean creating separate quality and safety  systems for cross-border healthcare. 
Rather, ensuring high-quality, safe and e fficient cross-border healthcare can be 
achieved by having that health care properly integrated in to existing systems of the 
Member States, based on the principle of the country responsible being the country 
where the treatment is provided, with any sp ecific issues related only to cross-border 
healthcare addressed in a proportionate way to the relatively small size of the issue. 
This would again complement existing Commu nity provisions, as  there is no such 
framework at Community le vel, and would thus avoid duplication or gaps in 
ensuring these standards. In particular, these provisions would add value to thee 
existing regulations on coordination of soci al security schemes, which do not cover 
these issues; and would cover all health services irrespective of how they are 
financed. 
In this impact assessment only direct additio nal costs and benefits of increased cross-
border healthcare are taken into considera tion. More additional costs and benefits 
could arise, in the short and in the long run. Costs could for instance arise due to 
supply induced demand and demand induced supply. In the past higher costs have been reported due to duplication of examin ations. Increasing cooperation in cross-
border care could result in a fu rther decrease in costs due to  an increase in efficiency 
and the quicker availability of appropriate care. 
5.4.1.1.  Economic impact 
As outlined in chapter 4, within this ove rall option there are two sub-options which 
have different costs and be nefits arising from cross- border healthcare. The key 
differences between sub-options 3A and 3B  concern access to cross-border hospital 
care. There is no difference between these sub-options if the appropriate care for the patients' condition cannot be provided in their own country without undue delay; 
under both sub-options they are then allowe d to go abroad, and any additional costs 
of treatment will be covered by public funds through the exis ting regulations on 
coordination of social security systems. However, sub-option 3A would also allow 
patients to use cross-border care for hos pital care which their system could have 
provided in a reasonable time but which they just prefer to have  abroad – but with 
the patient paying any additional costs a bove what would have been covered at 
 
EN 55   EN home. Sub-option 3A therefore has both hi gher costs arising from cross-border 
treatment than sub-option 3B, and hi gher benefits through greater take-up. 
5.4.1.2.  Additional costs of cross-border heal thcare treatment for public funds 
To evaluate the additional costs of cr oss-border healthcare treatment for public 
funds, we apply the model set out in s ection 5.1.1.1. For sub-option 3A, this means 
modelling take-up of both non-hospital (using the example of cataract treatment) and 
hospital care (using the example of hip repl acement). We assume that take-up will 
again increase in comparison to options 1 & 2, rising to the maximum likely level on 
the basis of current evidence of 10%. 
Assuming that take-up is divided equally between hospital and non-hospital care, the 
additional costs of cross-border treatmen t of sub-option 3A for non-hospital care 
would therefore be € 3.1 million (390,000 patie nts multiplied by an additional cost of 
€8 per operation through earlier reimburseme nt). For hospital care, the additional 
costs would be € 27.3 million (390,000 patients multiplied by an additional of €70 per operation through earlier reimbursement) . That would mean in total for sub-
option 3A (both hospital and non -hospital care) an increase  in treatment costs of € 
30.4 million. This would mean for example that for Germany the total additional 
costs of increasing cross-border hospita l care would be roughly € 5.6 million, for 
Poland € 2,7 million; for Hungary € 285,000; and for Ireland approximately €100,000
56 
As sub-option 3B would mean providing an additional mechanism for only cross-
border non-hospital care, we apply the same model as above but only for non-
hospital care, taking the example of cataract treatment, the additional costs of which 
would be €3.1 million, as set out above. That  would mean, keeping the examples of 
Germany, Poland, Hungary and Ireland that to tal additional costs of increasing cross-
border non-hospital care would be roughly € 575,000; €349,000; €29,000 and € 10,000 respectively.
57 
5.4.1.3.  Additional benefits fr om cross-border care 
On the basis of the same assumptions, we also apply the model estimating the 
additional benefits from being treated more  quickly abroad, as set out in section 
5.1.1.2 above. For sub-option 3A, if we assume that, as stated above, this option will 
lead to 780,000 extra patients to be treated more quickly  through cross-border care, 
the total benefit due to earlier treatment can be equated to € 585 million (390*€500 + 390*€1000, reflecting the likely difference in QALY benefit from hospital and non-
hospital care). For sub-option 3B, as th is would be limited to non-hospital cross-
border care, the benefits would also be correspondingly lower at approximately €195 
million (390*€500). 
5.4.1.4.  Cost of compliance 
Providing a definite le gal framework at Community level is likely to reduce the 
overall compliance cost in comparison with the current situation. By providing legal 
                                                
 
56 For a more detailed calculation see paragraph 5.2.1 of this report. 
57 Again, for a more detailed calculation see paragraph 5.2.1 of this report. 
 
EN 56   EN certainty about however reimbursement for cross-border healthcare should work, and 
avoiding duplication, gaps and uncertainties over who is responsible for oversight of 
the quality and safety of cross-border care,  this option will pr ovide a clearer and 
easier working environment for implementing free movement rights with regard to 
cross-border care. In comparison with our  baseline estimate set out in section 5.1.1.3 
above, we represent this as implying a reduction in compliance costs to 
approximately 3% of total cross-border ca re. In a formula this calculation would 
have the following shape (where T1 = comp liance costs as percentage of total costs 
under the baseline scenario, T2 = compliance costs as percentage of total costs under 
option 3, P = percentage of treatments conc erned and TC = tota l healthcare costs.  
∑ (T2– T1)/T1 * P * TC 
∑ (0,03 – 0,05)/0,05 * 0,01 * € 1000 billion 
Most of the cost of compliance arises from  the general management of cross-border 
care, having processes for reimbursing cross- border care and conti nuity of care, and 
is not linked to the different options for handling hospital care and non-hospital care. 
We therefore assume that the difference in  compliance cost between sub-options 3A 
and 3B will be relatively small; we assume  that for the extra money spend on cross-
border hospital care, the compliance cost will be 0.5%-point higher. With 390,000 
treatments of on average € 7000, these cost s would approximately be € 15 million. 
Administrative burden 
As with the overall cost of compliance,  providing a clear legal framework at 
Community level should provide an easier environment for Member States with 
regard to providing information than the cu rrent situation. We th erefore assume that 
these costs reduce by a similar proportion as w ith the overall costs of compliance, to 
a total of around € 60 million per year. 
5.4.1.5.  Contribution to wider objectives 
By providing a solid basis for cross-border care, a clear legal framework will also 
contribute to the overall shared goals of  health systems throughout the EU of 
accessibility, quality and financial sustainability. Quality requirements as described in the legal framework are aiming at incr easing the trust and confidence in cross-
border healthcare and healthcare in general.  The additional burden on health systems 
of these requirements will nevertheless be limited, simply because Member States have committed themselves already to fu lfil these requirements by agreeing on the 
Council Conclusions on Common values and principles in European Union Health 
Systems. The same would count for the requirement for mandatory professional insurance for healthcare providers. These s hould not result in significant additional 
costs as such requirements already exist in many Member States. But, even where 
insurance is not mandatory at the moment, it is generally normal business practice to 
take out professional indemnity insurance or to provide some kind of equivalent 
guarantee.  
Clear legal certainty over reimbursement conditions as well as responsibility for 
minimum requirements for safe and high qual ity care will provide sufficient basis for 
patients and providers to take full advantag e of the potential of cross-border care 
where this is appropriate, with cons equent contribution to cooperation and 
 
EN 57   EN comparison between Member States that will  contribute to impr oving access, quality 
and financial sustainability.  
5.4.2.  Environmental impact 
With this option, one has to also look mo re closely at the potential environmental 
impacts, in particular related to the increas ed demand for transport. Establishing clear 
framework for cross-border healthcare is likely to increase cross-border mobility to a 
certain extent, which is likely to also mean  increased demand for transport. However, 
given the fact that a large proportion of cr oss-border healthcare would take place in 
the border regions (i.e. patient s travelling a shorter distan ce across the border rather 
than travelling to a major city in thei r Member State) woul d reduce the potential 
impact on the environment. 
Regarding overall efficient use of natural resources, by providing a clear legal 
framework that will help to take full a dvantage of economies of scale from cross-
border care, this option would also contri bute to making more efficient use of 
resources overall, including natural resources. 
5.4.3.  Social impact 
5.4.3.1.  Impacts on different socio-economic groups 
As set out in section 5.1.3.1 above, the di fferent resources of different socio-
economic groups will clearly be a factor in affecti ng their ability to take advantage of 
using free movement principles to have cross-border care and be subsequently 
reimbursed, given the initial financial outlay at stake (and this i ssue will be more 
important for more expensive care, clearly ). However, the ce rtainty of a legal 
framework provided under this option will go some way to compensating for this 
problem. Patients will be more willing to advance the necessary costs depending on 
how certain they can be of their rights to  be reimbursed and how quickly that will 
happen, and that if they need to contes t these formally through legal proceedings, 
that their legal rights are clear. By provi ding this legal certainty, this option will 
therefore help to improve the equity of  cross-border care thr ough this route in 
comparison with options 1 or 2. 
In terms of the two sub-options 3A and 3B, given that hospital care will generally be 
more expensive than non-hospital care, this issue of inequality will be particularly important for sub-option 3A. However, sub-option 3A also provides a greater 
possibility for using cross-border care to increase contestability for specialised 
services for which there are few domestic a lternatives, which is also likely to be 
particularly important for hospital care. By  providing such a mechanism for all socio-
economic groups, increasing choice for hospita l care as well may help to compensate 
for the greater ‘health literacy’ of people in higher socio-economic groups, as also set 
out in section 5.1.3.1 above, and thus he lp to improve equity overall.  
The impact of a legal framework in re quiring information provision and itself 
helping to raise awareness of the option of  cross-border care wi ll help to address 
unequal levels of knowledge betw een different social groups. 
 
EN 58   EN 5.4.3.2.  Impact for health systems as a whole 
Although this option would establish a le gal framework of responsibilities for 
ensuring safe and efficient healthcare at European level for the first time, the impact of this on health systems as a whole would not be substantial, as these should not represent new or different obligations. By taking as a basis the ‘common values and 
principles in EU health systems’ endor sed by the Council, this legal framework 
should not add additional ob ligations, but rather simply provide clarity over which 
authority is responsible for ensuring what in the different possible cases of cross-
border care. Rather than creating a separa te specific set of obligations for cross-
border care, this approach therefore ensu res the minimum impact compatible with 
legal certainty of cross-border healthcare on health systems as a whole by ensuring 
that its management and oversight is integrated into existing systems within Member States. 
In terms of the longer-term impacts of this option, as se t out in section 5.1.3.2 above, 
the long-term impact will also be broadly positive. 
For sub-option 3A, even if we assume  that double our estimated proportion of 
patients use cross-border hospital care, the overall financial impact remains marginal, 
and certainly not enough to  justify any wider restru cturing of demand control 
mechanisms. Also as set out above, the e xperience of countries who already have 
provision for cross-border care does not suggest that it will undermine overall 
planning or create unsustainable pressures for 'receiving' countries; on the contrary, 
in the long term, it is likely to help improve efficiency both for cross-border 
healthcare and for domestic care as well. 
In terms of planning and cont rol of costs, there is a di fference between sub-options 
3A and 3B. Under option 3A, the public authorities control costs of both hospital and 
non-hospital care by limiting the unit costs re imbursed (the costs are reimbursed up 
to the level of the cost of the same tr eatment at home). Without an authorisation 
procedure, the costs are not limited by restri cting patients to go abroad. Nevertheless, 
as explained above, total financial impact of this option will be limited. Under option 
3B, the public authorities pa rtly control the cost of hospital care by limiting the 
number of patients treated abroad, though not  the unit cost of such treatment. The 
criteria for authorization procedure make it more difficult to have healthcare abroad 
reimbursed. On the other hand, the paying Memb er State does not have control of the 
unit cost (as the patient is treated according to the tariffs  of the Member State of 
treatment).  
Neither option provides complete contro l for Member States for cross-border 
hospital care, but as already set out above, evidence to da te suggests th at the total 
impact of cross-border hosp ital care will remain low in  the long term. Ultimately, 
patients prefer to have healthcare (espec ially hospital care) as close to home as 
possible. Provided that all Member States  continue meet the needs of the vast 
majority of their population w ithin their own systems, the overall impact of cross-
border hospital care will conti nue to be low, even if th e absolute numbers concerned 
are likely to rise somewhat and despite its  importance for the individuals concerned.  
 
EN 59   EN 5.4.3.3.  Impact on inequalities within and between Member States 
By helping to realise the full potential of  cross-border care a nd thus maximising 
access for patients for whom cross-border care  is more geographically appropriate, or 
patients requiring particularly specialise d care, this option would have a greater 
effect on reducing inequalities than options 1 or 2.  
5.5. Option 4: Detailed legal rules at European level 
This option would provide a detailed fr amework of harmonising legal measures 
under Community law for all cross-border healthcare issues.  
The advantage of detailed rules, established on Community level, is  that it leads to a 
maximum amount of clarity and uniformity. This is especially an advantage for citizens crossing borders. They know exactly what they can expect in the country 
where they receive medical treatment. Howe ver, this would represent a significant 
degree of harmonisation of healthcare i ssues in Community law, which would 
include a significant additional administrativ e burden and would be more difficult to 
justify in the light of the subsidiarity principle. It is not the role of the European Union to harmonize healthcare policy and he alth care systems, given the limits 
provided by the Treaty (art.152.5 EC). Memb er States have different backgrounds 
and different healthcare systems. This diversity makes a 'top down' approach to 
Community action as the case for this optio n potentially unfeasible and ineffective in 
several instances. This is especially true  for harmonising healthcare systems, because 
of the difficulty of achieving consensu s about what direc tion the harmonisation 
should take. Harmonisation would, due to  current differences between Member 
States, mean a need for considerable change  of health systems of several countries. 
This would require considerable financial costs and organisational change for those 
Member States. There is a sense that ma ny stakeholders and national governments 
would simply refuse to implement European  legislation. For the European Union as a 
whole a detailed regulation may be a good co mpromise, but that would not be the 
best remedy for the individual Member States . Especially when such reforms have to 
be accompanied by substantial changes in the administrative organisation and an 
increase in costs, necessary support from stak eholders will be difficult to obtain. It is 
therefore unlikely to be appropriate or desi rable to oblige Member States to follow a 
uniform organisation of health systems, wh ich may not be the most appropriate for 
that specific country. 
5.5.1.  Economic impacts 
As regards economic impacts, this opti on would provide a detailed framework 
applicable throughout the Union, which w ould increase confidence of the patients 
also in healthcare provided in  other Member States. This, together with appropriate 
information, would enable them to ma ke informed choices and increase the 
opportunities to benefit from the cross-bord er healthcare. Howe ver, it would be 
extremely difficult to implement this detaile d binding system in a short term, due to 
the existing great va riety of organisation, financi ng and delivery of healthcare 
services among (and also w ithin) the Member States. Th is option would also not 
allow flexibility to take into account particular regional or local needs and 
circumstances. 
 
EN 60   EN 5.5.1.1.  Additional treatment costs due to cross-border care 
The financial impact of this option w ould be comparable with option 3A. By 
increasing clarity and certainty through the introduction of a new detailed regulation 
and by improving information about advantag es and disadvantages of cross-border 
healthcare, about 10% of the people on the waiting list would possibly travel abroad 
to receive their care. This conservative estimate would mean that 780,000 additional 
people would be treated abroad. The total costs of this initiative would be € 30.4 
million. That would mean, for example, that for Germany the total additional costs of 
increasing cross-border hospital care w ould be roughly € 5.6 million, whereas for 
Poland they would amount to roughly € 3.4 million, for Hungary € 285,000 and for 
Ireland to roughly € 100.00058 
5.5.1.2.  Additional treatment benefits  due to cross-border care 
For the additional benefits counts the same as  for the additional costs; the impact of 
this option would be comparab le with option 3A. Higher qual ity of life is then (re-) 
gained at an earlier  stage for 780,000 people. 
Total benefit due to earlier treatment  would according to this model be 
approximately € 585 million (see also 5.1.1.2). 
5.5.1.3.  Cost of compliance 
Using the model which was introduced in  paragraph 5.1.1.3, we assume that these 
costs will be reduced from 5% in the case of no further action to approximately 1% 
of the amount of the cross-border transaction when detailed legal rules are implemented at European level. In financia l terms this means, compared to no action, 
a reduction of costs of € 400 m illion from € 500 to € 100 million.  
However, such a detailed pan-European system would undoubtedly also significantly 
raise the compliance costs for the Member St ates, due to the need for transformation 
of the existing healthcare systems and its compliance with detailed European rules. 
This would have particularly  heavy effect on the poorer Member States. Given their 
existing limited healthcare budgets and administrative capacity, also because they need to put already much effo rt in bringing their healthcare systems up to date, this 
option would therefore have adverse effects on regional inequalities. The 
implementation of detailed legal rules will have to lead to changes of the total healthcare systems of each Member State. It will therefore lead  to a significant 
increase of the compliance and implementation costs. If we assume that these costs will be approximately 2% of the total health care expenditure, this would mean a cost 
of approximately € 20 billion yearly for the Union as a whole, during a transition 
period of approximately 3 years.  
5.5.1.4.  Administrative burden 
The specific administrative burden of such  a harmonised system would in principle 
be similar to option 3, as providing a clear legal framework at Community level 
should provide an easier envi ronment for Member States with regard to providing 
                                                
 
58 For a more detailed calculation see paragraph 5.4.4 of this report. 
 
EN 61   EN information than the current situation. We therefore assume that these costs reduce 
by a similar proportion as with the overall co sts of compliance, to  a total of around € 
60 million per year. However, this would of course be a small fraction of the total costs to Member States of implemen ting such a system, as outlined above. 
5.5.1.5.  Wider economic impacts 
This option would have a positive contri bution to wider objectives by enabling the 
full potential of cross-border care to be r ealised, and thus to maximise the potential 
contribution from economies of scale and sharing best practi ce through comparison 
and cooperation. However, it would come at  a high cost, with major expenditure and 
systemic change required to implemen t detailed harmonising requirements at 
European level. Given those high costs, it s eems unlikely that this option would be of 
overall benefit to health systems as a w hole or to the overall economy, the potential 
benefits of cross-border car e being outweighed by the cost s of substantial regulatory 
harmonisation of health systems across Europe. 
5.5.2.  Environmental impact 
As this option would enable patients to ma ke informed choices involving also cross-
border healthcare, one may expect increased mobility of patients and health services 
providers and thus the increased demand fo r transport, as with the previous two 
options. However, volume of patient mobility would always be limited due to factors such as inconvenience for si ck people to travel, distan ce from the relatives or 
language barrier. Moreover, a large proportion of cross-bord er healthcare would take 
place in the border regions, so patients do no t travel long distances. These factors 
would therefore reduce the potential impact on the environment. 
5.5.3.  Social impacts 
5.5.3.1.  Impact on socio-economic groups 
As regards social impacts, this option w ould provide guarantees to the patients about 
quality and safety of health services a nd confidence about their rights throughout the 
European Union. This would therefore have  a positive effect on social inclusion, 
quality of life and improved access to high quali ty care to all social groups, including 
patients with rare diseases, chronically ill,  low-income patients or patients from 
remote areas.  
5.5.3.2.  Impact on health systems as a whole 
As outlined above, the impact on health systems overall would be very substantial, 
marking a clear shift from national and local organisation to wards significant 
European harmonisation. 
If there were a clear 'correct' model of h ealth system organisatio n and there could be 
reasonable grounds for assuming that European harmonisation would help to make progress towards such a model, then it mi ght be possible to envisage long-term 
benefits in achieving overall health syst em objectives of accessibility, quality and 
financial sustainability. However, there is no evidence to date to suggest that there is 
such a single 'correct' model. Many different  approaches are used successfully, and 
some similar approaches are used successfully  in one context but are less effective in 
 
EN 62   EN others. Moreover, as all EU health syst ems seek to constantly improve their 
efficiency and effectiveness, the variety of  approaches taken within the EU provide a 
unique resource of comparison and mutu al learning of the advantages and 
disadvantages of the various appro aches taken toward shared goals.  
Substantive regulatory harmonisation at Eu ropean level would therefore lose the 
benefits of current comparison and mutual  learning, without any guarantee of putting 
in place a 'better' system, but with certa in undermining of the local solidarity on 
which all European health systems depend. This option is therefore unlikely to have a positive overall impact on health systems. 
5.5.3.3.  Impact on inequalities between Member States 
Of all presented options, this option will cont ribute most to a decrease of inequalities 
between Member States in the long term . However, this option would require 
fundamental changes in the national healthcar e and social security systems. Although 
the healthcare systems across the European  Union share certain common values and 
principles, the practical ways in which th ese values and principles are implemented 
in the national health systems vary significantly
59 These diverse systems are based on 
different national traditions, geographic orga nisation of each Member State, different 
distribution of competences between centr al, regional and lo cal authorities and 
different modes of healthcare funding. The a ttempt to achieve uniform application of 
detailed European rules among those nationa l systems would entail enormous costs 
for the national social security systems (leaving aside the issue of subsidiarity 
mentioned in chapter 2). 
Moreover, as outlined above, such regulator y harmonisation of health systems would 
place a particularly heavy burden on the poor er Member States. Given their existing 
limited healthcare budgets and administrative ca pacity, also because they need to put 
already much effort in bringing their health care systems up to date, this option would 
therefore have adverse effect s on regional inequalities in the short term, at least. 
                                                 
59 See the Council statement on common values and principles. 
 
EN 63   EN 6. COMPARING THE OPTIONS  
Table 6.1  Impact of each option pres ented in financial terms60 
 
On the basis of table 6.1 it is possible to compare the different options in financial 
terms. The calculations and modelling on whic h this table is based are presented in 
chapter five of this report. From table 6.1 it becomes clear that an increase of 
possibilities to receive healthcare abroad w ill create an increase in treatment costs. 
The more patients receiving healthcare abroa d, the larger the increase of treatment 
costs will be. Where under option 1, the ba seline scenario with only a very limited 
increase in cross-border care, additional tr eatment costs due to cross-border care will 
increase by € 1.6 million per year, in option 3A and 4 these costs have increased by 
more than €30 million. These extra costs rema in nevertheless marginal compared to 
the increased treatment benefits, which also  increase with the in crease of possibilities 
to receive healthcare abroad (from € 98 million in option 1 to €585 million per year 
under option 3A and 4). The compliance costs,  associated costs to  administer cross-
border care, were also analysed. The imp act assessment makes clear that with the 
creation of more legal certainty and cl arity these compliance costs decrease. 
Nevertheless, the creation of a detailed lega l framework (option 4) creates initially a 
significant increase in costs, due to the fact  that each healthcare system needs to be 
significantly adapted to the new detailed rules. In chapter five of this report changes of administrative costs in each of the options have been analyzed. The legal 
obligation to provide information creates co sts. By creating more clarity and legal 
certainty, information provision becomes cheaper and easier. By creating more 
clarity about possibilities for cross-border ca re, more people will be able to receive 
the treatment they need at an  earlier stage. Therefore the social benefits increase with 
more patients being involved. 
                                                
 
60 All data in this table are presented in more detail chapter five of this report. These data are based on 
modelling and are therefore only rough estimations.  Option 1 Option 2 Option 3A Option 3B Option 4 
Treatment costs € 1.6 million € 2.2 million € 30.4 million € 3.1 million € 30.4 million 
Treatment benefits € 98 million € 135 million € 585 million € 195 million € 585 million 
Compliance costs € 500 million € 400 million € 315 million € 300 million € 20 billion 
Administrative costs € 100 million € 80 million € 60 million € 60 million € 60 million 
Social benefit 195,000 extra 
patients receive 
treatment  270,000 extra 
patients receive 
treatment 780,000 extra 
patients receive 
treatment 390,000 extra 
patients receive 
treatment 780,000 extra 
patients receive 
treatment 
 
EN 64   EN Table 6.2  Comparison of the impacts of each of  the options in qualitative terms 
 Advantages Disadvantages 
1. No further action, the baseline scenario Flexibility for Member States to tackle identified 
objectives themselves.  
Likely costs of treatments low, and outweighed by 
benefits; though overall costs of administering the 
system outweigh the likely benefits to patients. Difficulty for Member States to develop action on 
their own, because of the scope and nature of the 
problem.  
Continuation of current cost trends, accompanied 
by high costs of managing uncertainty. 
Social inequality in utilisation of this mechanism 
for cross-border care, with the less well-off 
unwilling to advance the cost of healthcare without 
solid legal guarantees that they will be reimbursed. 
Potential contribution of cross-border care to wider 
health system and economic goals not fully 
realised. 
 2. Soft action Flexibility for Member States to increase legal 
clarity and certainty concerning cross-border 
healthcare, combined with some additional guidance at European level.  
Some improved realisation of the potential of 
cross-border care; likely costs of treatment remain 
low.  
 Guidance unlikely to provi de sufficient certainty 
for either patients or professionals, given the 
importance of the issues at stake. 
Social inequality in utilisation of this mechanism 
for cross-border care not likely to be significantly 
improved. 
Some reduction in overall costs of administering 
cross-border care, but still higher than the estimated benefits to patients.  
 
EN 65   EN 3. General legal framework Ensures sufficient bindin g clarity to enable 
patients and professionals to take full advantage of 
cross-border care, whilst avoiding a significant additional burden for Member States.  
Does most to overcome social inequality in 
utilisation of cross-border care by minimising financial risk through guaranteeing 
reimbursement.  
Enables full potential of cross-border healthcare to 
support wider health system objectives through 
comparisons and coopera tion to be realised.  
Sub-option 3A : only option where the additional 
costs of treatment and the costs of administering 
the system are outweighed by the benefit to 
patients. 
Sub-option 3B : lower additional costs of 
treatment than sub-option 3A.  Will set binding obligations on health services 
overall at European level, though these reflect 
already-agreed political principles.  
Sub-option 3B : lower benefits to patients, with no 
clear net benefit comparable to the overall costs of 
the system. 4. Detailed rules Highest possible legal clarity and uniformity for 
all stakeholders concerning cross-border 
healthcare.  
Guarantees for patients about quality and safety of 
health services. 
Maximum reduction of disparities between 
Member States. 
 
 No flexibility for Member States to adopt 
community rules to differences in national 
circumstances and makes it therefore difficult for them to implement. 
There will be little support from stakeholders for a 
top-down approach. 
High extra initial administrative burden due to 
strict, and therefore not always most efficient rules 
concerning reimbursement rules, information provision for patients and collection of data on 
cross-border healthcare.  
Preferred Option 
Under option one the current problems identifie d in chapter two continue, with rights 
to reimbursement for cross-border health care through direct application of free 
movement principles established in theory  but difficult to us e in practice, and no 
clear framework for ensuring minimum re quirements for safe and efficient cross-
border healthcare. Moreover, no further action does not mean avoiding costs of 
cross-border healthcare. Rather, it m eans continuation of current trends, but 
accompanied by costs of managing the uncer tainties identified in chapter two in 
practice, compounded by social in equity in how the limited be nefits are likely to be 
distributed with the less well-off unwilling to  advance the cost of healthcare without 
solid legal guarantees that they will be reimbursed.  
With option two, there is some improvement . But the key issue here is certainty; 
given the potentially catastr ophic consequences of probl ems with cross-border care, 
merely having guidance about cross-border ca re is not enough, either for patients or 
professionals. So the costs of cross-borde r care continue but without its potential 
benefits being fully realised. 
 
EN 66   EN Option three provides the best balance. It  achieves the core aim of providing 
sufficient certainty about the key issues in cross-border to enable its potential to be 
fully realised in practice. By doing so it maximises the benefit of cross-border care 
overall, and does most to ensure social equi ty in its usage by providing certainty of 
reimbursement to compensate for differen ces in initial resources, whilst also 
allowing citizens to exercise as much choi ce as is compatible with overall health 
system accessibility, quality and financial sustainability. In contrast, although option 
four provides a still greater degree of certainty, it involv es wholly disproportionate 
costs and implies a degree of change and harmonisation which is not appropriate and 
not consistent with the pr inciple of subsidiarity. 
Within option three, the key choice is a bout the handling of cr oss-border hospital 
care. As set out in chapter f our, under either sub-option if the appropriate care for the 
patients' condition cannot be provided in th eir own country without undue delay, then 
they are allowed to go abroad, and any additional costs of treatment will be covered by public funds; the mechanism for this is already in place through the regulations on 
coordination of social security systems. Sub-option 3A provides an additional opportunity for patients to go abroad for hosp ital care if it suits th em better, provided 
that they are willing to cover any additi onal costs above what would have been 
covered at home. By maximi sing the potential access to cross-border care, this sub-
option is the only one where the likely valu e of the benefits of  care to patients 
outweighs the overall costs of the system itself. Sub-option 3B has lower costs of treatment, but also provides lower benef its, and thus does not provide a clear net 
benefit over the cost of the system itself. The preferred option is therefore option 3, 
sub-option 3A. 
7. M
ONITORING AND EVALUATION  
7.1. Data collection 
All stakeholders confirm that in the field of cross-border care many challenges exist 
which have to be tackled. Th ere is a general consensus th at there is a problem, and 
data confirm that. We lack at the moment nevertheless structured and comparable 
data which can exactly quantify the scope of  the challenges and which would be able 
to give insight in the development of the pr oblem. It is therefore important that this 
initiative contains a proposal to strengthe n the data availability. Only with more 
structural data available, it will be possi ble to see whether the solutions implemented 
have the effect hoped for. Data are not onl y needed to quantify the development of 
the challenges and to monitor the impact  of the policy options , but coherent and 
comparable data are also a tool to tackle the problem itself. Member States will have a tool to better manage their healthcare  system when they know how many citizens 
receive healthcare abroad and for which reas on. On that basis they can plan their 
healthcare service better and adjust the availa bility of healthcare services within the 
border of the country. 
7.2. Monitoring mechanism 
Parallel to that, the Commission will deve lop a monitoring mechanism to monitor 
whether this initiative is appropriately implemented in each of the Member States. Within 3 years after the date the initiativ e enters into force, the Commission will 
 
EN 67   EN carry out an assessment of the actual implementation of this initiative and the impact 
the initiative had on legal clarity concerning cross-border care, impact on information provision to patients and impact on cross-border patient mobility itself. 
The Commission will therefore,  in cooperation with all Me mber States, collect data 
on the actual amount of citizens receiving hea lthcare abroad. It will  also periodically 
measure the awareness of EU-citizens con cerning their rights and the possibilities 
concerning cross-border care. The Commissi on will, in cooperation with the Member 
States, investigate how in each country ci tizens are informed a bout the possibilities 
concerning cross-border care, and about its limitations and risk. In cooperation will 
all Member States the commission will take stock of possible authorization procedure for reimbursement of healthcare received abroad and possible procedures to challenge the decision of the national authority responsible for the authorization 
procedure. 
7.3. Comitology 
The new directive will provide for a co mitology committee. This committee will 
adopt measures necessary for the implem entation of the dire ctive. For example 
mechanisms will have to be developed for the collection of appropriate information 
and data on cross-border health care, as mentioned in the directive. Detailed rules will 
have to be agreed upon concerning requireme nts for Member States to send regularly 
appropriate data on cross-bor der health services  to the Commission. The statistical 
element of this data collection system will be developed in the context of the 
Community Statistical Programme in genera l and in the context of the forthcoming 
EP-Council Regulation
61 on Community statistics on publ ic health and health and 
safety at work in particular.   
8. ANNEXES  
8.1. Data about cross-border healthcare 
The recently available EU-SILC62 data for 2005 (see Table 8.1 below) provide an 
overview of the main reasons for unmet need for medical examination and treatment.  
                                                 
61 COM(2007)46 final 
62 The European Statistics on Income and Living Conditions (EU-SILC) provide cross-sectional and 
longitudinal multidimensional microdata on income, poverty, social exclusion and living conditions. 
 
EN 68   EN Table 8.1  Main reasons for unmet need for medical examination and treatment 
(2005)
 
 
Country 
  
Could not afford (too e xpe ns ive) 
  
Too far too travel / no transportation   
Waiting list  
Other*  
No unmet need 
Austria 0.23% ** # # 1.57% 98.04% 
Belgium 0.68% # # 0.24% ** 99.04% 
Cyprus 2.95% # # 2.76% 94.13% 
Czech Rep 0.32% ** 0.47% ** 0.40% ** 5.95% 92.86% 
Ge rmany 6.69% 0.14% ** 1.74% 7.93% 83.49% 
Denm ark  # # # 0.81% ** 98.94% 
Es t onia  2.74% 0.81% 2.15% 2.55% 91.75% 
Sp a in 0.41% 0.19% 0.70% 4.87% 93.84% 
Finland 1.41% # 0.98% 0.93% 96.62% 
France  1.24% # 0.21% ** 2.10% 96.42% 
Greece 3.44% 0.45% 0.62% 1.66% 93.83% 
Hun gary 2.44% 0.37% 0.73% 12.56% 83.90% 
Ireland 1.06% # 0.65% 0.51% 97.67% 
Italy 3.14% 0.09% ** 1.36% 2.11% 93.30% 
Lithuania 3.65% 0.39% ** 2.32% 2.89% 90.75% 
Luxembourg 0.35% ** # # 4.30% 95.23% 
Latvia 17.01% 0.62% ** 1.72% 10.27% 70.38% 
Malta 1.01% # 0.50% ** 2.12% 96.35% 
Ne therl an ds  # # 0.28% ** 0.97% 98.57% 
Poland 7.13% 0.44% 2.26% 6.32% 83.85% 
Portugal 3.77% # 0.77% 0.77% 94.56% 
Sweden 0.50% ** # 2.02% 12.38% 85.00% 
Slov enia # # # 0.19% ** 99.48% 
Slovakia 2.52% 0.19% ** 0.34% ** 4.80% 92.15% 
United K ingdom # # 2.14% 2.96% 94.77% 
  
Source : EU-SILC (2007); *“Other” includes: (1) Coul d not make time because of work, care for 
children or for others; (2) Fear of doctor/hospitals/examination/ treatment; (3) Wanted to wait and see 
if problem got better on its own; (4) Did not know any good doctor or specialist; and (5) Other 
reasons. **unreliable due to small N (20<n<50); # omitted due to very small N. 
Table 8.1 shows that although most need is met in most countries, there are some 
significant elements of unmet need. For exam ple, 17% of Latvians state that they 
could not afford at least one medical exam ination or treatment they needed (in 2005). 
Other figures that stand out in this resp ect are in Poland (7.13%) and, remarkably, 
Germany (6.69%). The high figure for Germany may be related to the negative publicity and public opinion surrounding th e introduction of €10 co-payments for 
every first visit to a physician in 2004. Polis h data do not correlate with the official 
co-payment requirements (officially none fo r dental care) but may be related to 
expected “gratitude payments”.  
The table shows as well that waiting lists are still an important reason for unmet 
medical needs. In some cases cross-border ca re could be a way to meet those needs. 
To calculate the average percentage of people having unmet medical needs due to 
waiting lists, an average is calculated on th e basis of reliable figures in table 8.1, 
adjusted for the amount of inhabitants in the respective countries. The countries for 
which no reliable data exist, it is assumed that on average they have the same percentage of citizens waiting for care as  the average percentage for the other 
countries for which data do exist. On that  basis, it can be roughly estimated that on 
average 1.6 percent of the European populat ion is currently on a waiting list, which 
is equivalent to approximat ely 7,8 million EU citizens. 
 
EN 69   EN It is stated that some Member States use waiting lists as an instrument to contain 
costs. When legal clarity concerning cr oss-border care is increased and more 
information is provided about possibilities concerning cross- border care, citizens will 
more and more use cross-border care to avoi d waiting lists. Some argue that Member 
States will in that case use other instrument s to contain healthcare costs. One of such 
examples is co-payment. In table 8.2 the main reasons for unmet need for dental examination and treatment are shown. Dent al treatment is a healthcare field 
subjected to many cost sharing policies alr eady. The percentage of Europeans that 
had an unmet need for dental examination and treatment because it was too expensive is therefore higher than for medical  treatment in general (see table 8.2). It 
is an important incentive for patients to look for cheaper dental care abroad. Therefore both the existen ce of waiting lists and introduction of co-payment are 
reasons for increased cross-border mobility of  patients. This increase of cross-border 
healthcare, a spec ific from of health tourism, is not linked to the discussion about 
clarity and legal certainty as pects of authorization and re imbursement of cross-border 
care, nevertheless the quality and safety aspect s of this type of cr oss-border care need 
to be stressed. 
Table 8.2  Main reasons for unmet need for dental examination and treatment in 2005 
 
Country  
Hu rdle 3: Coul d n ot 
afford (too 
expensiv e)  
Hurdle 4: T oo far 
too trav el / no 
means of 
transp ortation 
  
Hurdle 6: Waiting 
list  
Other *  
No unmet need 
Austria 0.85% # 0.23% ** 1.38% 97.48% 
Belgium 1.56% # # 1.14% 97.20% 
Cyprus 5.92% # # 6.99% 86.84% 
Czech Rep 0.51% ** # # 4.34% 94.84% 
Ge rmany 6.13% 0.12% ** 0.54% 5.47% 87.75% 
Denm ark  1.76% # # 2.54% 95.48% 
Es t onia  11.63% 0.32% ** 0.29% ** 1.28% 86.48% 
Sp a in 4.07% 0.11% ** # 4.59% 91.20% 
Finland 2.82% # 1.39% 2.30% 93.42% 
France  3.24% # 0.14% ** 2.76% 93.77% 
Greece 5.00% # 0.17% ** 1.83% 92.84% 
Hun gary 6.51% # 0.38% 7.83% 85.18% 
Ireland 1.64% # 0.25% ** 1.48% 96.58% 
Italy 6.03% # 0.75% 3.43% 89.71% 
Lithuania 8.85% # 1.00% 1.49% 88.53% 
Luxembourg 0.69% # # 3.55% 95.71% 
Latvia 22.60% # 0.57% ** 5.78% 70.85% 
Malta 1.19% # # 2.73% 95.93% 
Ne therl an ds  1.25% # # 5.24% 93.28% 
Poland 9.77% 0.15% 1.52% 5.05% 83.51% 
Portugal 7.85% # 0.27% ** 2.21% 89.58% 
Sweden 6.16% # 0.39% ** 5.95% 87.44% 
Slov enia # # # # 99.37% 
Slovakia 4.03% # 0.26% ** 3.23% 92.43% 
United K ingdom 0.73% # 4.09% 1.35% 93.75% 
  
 
EN 70   EN Source : EU-SILC (2007); *“Other” includes: (1) Coul d not make time because of work, care for 
children or for others; (2) Fear of doctor/hospitals/examination/ treatment; (3) Wanted to wait and see 
if problem got better on its own; (4) Did not know any good doctor or specialist; and (5) Other reasons. **unreliable due to small N (20<n<50); # omitted due to very small N. 
There is some data available about cros s-border healthcare undertaken through the 
regulations on coordination of social securi ty. These data are presented in table 8.3. 
Table 8.3  Claims for/on countries under Counc il Regulation (EEC) No.1408/71 in €,  
% of total and € per capita for 2004 
Claims from other countries (debt) Claims on other countries (credit) Country € (1000) %  € / cap ita € (1000) %  €/ cap ita 
Austria 24.321 1.99 2.96 72.255 5.92 8.80 
Belgium 112.084 9.19 10.73 66.564 5.46 6.37 
Sw it zer la nd 12.321 1.01 1.66 73.514 6.02 9.91 
Cyprus 0 0 0 0 0 0 
Czech  Re pu blic 174 0.01 0.02 0 0 0 
Denm ark  6.440 0.53 1.19 1.634 0.13 0.30 
Es t onia  1 0 0 0 0 0 
Finland 9.802 0.80 1.87 3.173 0.26 0.61 
France  103.927 8.52 1.72 346.235 28.38 5.72 
Ge rmany 295.232 24.20 3.58 154.068 12.63 1.87 
Greece 63.067 5.17 5.69 8.693 0.71 0.78 
Hungar y 14 0 0 0 0 0 
Iceland 569 0.05 1.94 750 0.06 2.55 
Ireland 6.303 0.52 1.53 0 0 0 
Italy 157.961 12.95 2.70 130.452 10.69 2.23 
Lithuania 5 0 0 0 0 0 
Luxembourg 73.537 6.03 161.62 58.48 4.81 128.90 
Latvia 2 0 0 0 0 0 
Malta 0 0 0 15 0 0 
Ne therl an ds  74.006 6.07 4.54 42.651 3.50 2.62 
Norway 11.161 0.91 2.42 1.191 0.10 0.26 
Poland 131 0.01 0 218 0.02 0.01 
Portugal 58.552 4.80 5.56 40.182 3.29 3.82 
Sw ed en 9.483 0.78 1.05 17.179 1.41 1.91 
Sp ain 37.349 3.06 0.87 155.772 12.77 3.62 
Slov enia 281 0.02 0.14 1.989 0.16 1.00 
Slovakia 52 0 0.01 0 0 0 
United K ingdom 163.001 13.36 2.72 45.011 3.69 0.75 
To t al  1.220.194 100 2.59 1.220.194 100 2.59 
 
Source: Administrative Commission 200563 
The data in this table give only a very limited picture of the use of cross-border 
healthcare. The table shows the outst anding claims under the regulation on 
coordination of social security at the end of 2004. These figures represent only a part 
of total cross-border health care. There are several reas ons why the figures in the 
above mentioned table are an underestima tion of the actual dimensions of cross-
border healthcare: 
                                                 
63 In: Commission consultation contribution Mutualités Belges, see 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co83.pdf 
 
EN 71   EN – The data may (often) exclude those pati ents for which healthcare abroad is 
financed through monetary transfers on a lump-sum basis (especially pensioners 
living abroad who get an E121); 
– Waiver agreements between many countries lead to a situation that the countries 
do not calculate and therefore re port utilisation and cost data; 
– Several public payers, maintain cross-bor der collaborations out side the scope of 
Council Regulation No1408/71; 
– Providers may accept the EHIC but – due to  not receiving any extra payments for 
such treatment – do not bother to report utilisation; 
– Patients may purchase care in another Member State completely privately, and 
can easily do so if they have bought 't ravel insurance' for their holiday; or 
– Patients may deliberately choose (under th e "Kohll/Decker procedure") or are – 
due to forgetting the EHIC or through non-acceptance of it by providers – forced 
to initially pay out-of pocket for cross-bo rder services/goods and then ask for 
(partial) reimbursement. 
A survey among insured members of the Ge rman TK sickness fund showed that a 
relatively low percentage of patients has been able to use th eir E111-form (now 
E H I C ) ,  w h e n  t h e y  w e r e  i n  need of medical care abroad64. In for example the 
Netherlands 52%, Austria 66% and in Spain 84% of the insured Germans had to pay 
the treatment upfront, instead of having the bill settled between the healthcare provider and their sickness fund. So for 2003, this would mean that rather than 
Austrian having treated the 85,535 cases they provided bills for to Germany, the likely figure for patients treated is three times that.  
8.2. Accompanying documents 
– Commission Communication, Consultati on regarding Community action on 
health services, SEC (2006) 1195/4, 26 September 2006. 
– Commission document, Summ ary report of the respons es to the consultation 
regarding "Community action on health services" (2007) 
– Flash Eurobarometer, Cross-border health services in the EU, Analytical report 
results  
– Cross-Border Healthcare: Mapping and Analysing Health Systems Diversity, 
European Observatory on Health Systems and Policies (2007) 
– Relevant articles of Regulation (EEC ) No 1408/71 of the Council of 14 June 1971 
on the application of soci al security schemes to employed persons and their 
families moving within the Community 
                                                
 
64 Techniker Krankenkasse (TK), Medizin in Europa: Ergebnisse der TK-Mtiglieder-Befragung 2003 
(2003) 
 
EN 72   EN – Impact Assessment Board Opinion, Impact Assessment on: Directive on safe, 
high-quality and efficient healthcare in the European Union, D(2007)7744, 5 September 2007.