EN    EN EN 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 2.7.2008 
SEC(2008) 2164 
  
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 
 
SUMMARY OF THE IMPACT ASSESSMENT  
{COM(2008) 414 final} 
{SEC(2008) 2163} 
EN 2   EN 1. INTRODUCTION  
The aim of the impact assessment is to consider the need for and the potential impact 
of different options for Community action in  the field of cross-border healthcare. 
After exclusion of healthcare services from  the services directive, the Commission 
accommodates with this initiative the wish  of both the European Parliament and 
Council to investigate the need to come up with a specific proposal in the field of cross-border healthcare.  
Cross-border care can take different forms. This report will mainly focus on 
initiatives related to cross-border mob ility of patients. Although patients prefer 
healthcare to be available as close to wher e they live and work as possible, there are 
situations when cross-border healthcare can  be more appropriate. For the moment a 
limited amount of patients crosses borders to  receive care. But the extent of cross-
border healthcare is growing, and is likely to  continue to grow in the future. For 
individual patients the possibility to receiv e healthcare abroad can be of enormous 
impact, but also for healthcare systems as a whole the consequen ces of cross-border 
care can be substantial. It can further stimulate innovation, it can contribute to more efficient planning and use of resources a nd to better overall quality of care. Some 
challenges have nevertheless been identifi ed. Uncertainty exists about the general 
application of rights to reimbursement fo r healthcare provided in another Member 
State. A consultation with all relevant st akeholders showed that uncertainty also 
exists over how the necessary frameworks fo r safe and effective healthcare should be 
ensured for cross-border healthcare.  
2. C
ONSULTATION OF STAKEHOLDERS  
The Commission invited with th e publication of a Communication1 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) in the field of cross-border he althcare and to recei ve input concerning 
objectives and policy options. The 280 contribu tions to this consultation have been 
brought together in a summary report2 The individual contri butions have been 
published on the Commission website3. 
Overall, contributors welcomed the initiative of the Commission regarding 
Community action on health services. Th e majority of nati onal governments and 
many other stakeholders expressed the wi sh that any proposal of the Commission on 
health services should be based on the "Council Conclusions on Common values and 
principles in EU Health Systems"4. Many contributions (in particular from national 
governments, unions and purchasers) empha sised that any Community action that 
                                                 
1 Commission Communication, Consultation regarding Community action on health services, SEC 
(2006) 1195/4, 26 September 2006. 
2 Commission document, Summary report of the responses to the consultation regarding "Community 
action on health services" (2007) 
3 http://ec.europa.eu/health/ph_overview/co_oper ation/mobility/results_open_consultation_en.htm 
4 2733rd Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 1-2 
June 2006 
EN 3   EN affects the health systems should respect th e subsidiarity princi ple, referring in 
particular to Article 152 of the Treat y establishing the European Community, 
although others argued that the principle of subsidiarity s hould not prevent the 
application of EU f undamental freedoms.  
3. ADDITIONAL RESEARCH  
The Commission asked the European Observ atory on Health Systems and Policies to 
carry out a stocktaking exercise to give  an overview of trends and the current 
situation concerning cr oss-border healthcare5. The study gives more insight in access 
to healthcare, experiences with cross-bor der collaboration, quali ty and safety of 
healthcare in the European Union, as well as developments concerning patient rights. Differences in benefit baskets and tariffs be tween member states are also presented. 
The study gives insight in the impact of cr oss-border care on the ba sic objectives and 
functions of healthcare systems and gives an overview of the existing cross-border 
healthcare data. 
The Commission also conducted a EuroBarome ter about cross-border healthcare in 
the EU, in order to provide further insight  into the actual scope of patient cross-
border mobility, the willingness of patients to  go abroad for medical treatment and 
the advantages and challenges they foresee when going abroad to receive healthcare
6.  
4. SUBSIDIARITY  
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 these uncertainties it is difficult for Member States to manage their healthcare 
systems properly. Cooperation on Community level, for example by the development 
                                                
 
5 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. 
6 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 4   EN of secondary legislation, would bring th e requested clarity, which would not be 
realised with measures 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 
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. 
5. POLICY OPTIONS  
In the impact assessment report five optio ns for Community acti on are described to 
improve cross-border care, varying from no further action (the baseline scenario) to a 
detailed legal framework to improve legal certainty, clarity and cross-border cooperation. These options ha ve been assessed on the basi s of existing data and by 
using basic modelling tools. The work of  the European Observatory on Health 
Systems and Policies and the result of th e Eurobarometer survey were used as 
valuable input.  
The first option would be to do nothing on Co mmunity level. This baseline scenario 
would leave all responsibilities to create clarity to the individual Member States. 
Under the second option, the Commission wo uld provide guidance on cross-border 
healthcare issues, but would not propose additional binding legal measures. The 
Commission would come up with  a Communication with a de tailed interpretation of 
the implication of the Court of Justice's rulings. It would include recommendations 
on information to enable informed choices, plus principles or recommendations on 
ensuring quality and safety of cross-bor der care. The Commission would under this 
option establish a mechanism to bring Member States together to share ideas and best 
practice in the field of cro ss-border care, and it would support activities to develop 
common data and indicators as an evidence ba se for policymaking on health services.  
The third option would mean, possibly in comb ination with the soft actions described 
under option 2, the establishment of a genera l legal framework for health services, 
through a directive on health services. It would provide clarity about rights to be 
reimbursed for healthcare provided abroad. It would put a general requirement in 
place that Member States must provide info rmation to their own citizens about their 
rights to health care abroad.  
Under option three two sub-options (3A a nd 3B) have been described for dealing 
with the issue of legal uncertainty regarding financial entitlements and prior authorisation for cross-bor der healthcare. Under s ub-option 3A, the existing 
framework for coordination of social securi ty schemes would remain in place in its 
EN 5   EN current form. In addition to this existing structure, the new di rective would put in 
place a mechanism based on the principles  of free movement and building on the 
interpretation of the treaty by the Court of Justice. This would allow patients to seek any healthcare abroad (both hospital and non-hosp ital) that they would have been 
provided and reimbursed at home and be re imbursed up tot the amount that would 
have been paid had they obtained that trea tment at home. The patient would bear the 
financial risk of any additional costs ar ising. Prior authorization of hospital care 
would remain possible. Under mechanism 3A  Member State woul d need to provide 
evidence that the outflow of  patients without an aut horization procedure would 
undermine the financial balance of their soci al security system, the maintenance of 
treatment capacity or medical comp etence on their national territory.. 
Sub-option 3B takes the same approach as for sub-option 3A in all areas except for 
the financial entitlements and prior author isation for cross-borde r hospital care. As 
with sub-option 3A, the new directive on health services would put in place an 
alternative mechanism based on the principl es of free movement and building on the 
principles underlining decisions of the C ourt of Justice, but whereas for sub-option 
3A this directive would apply to the financ ial aspects of all cross-border healthcare, 
under sub-option 3B for financial aspects this directive would only apply to non-
hospital cross-border care. 
Under option 4 detailed legal rules would be established at European level. The 
Commission would propose a detailed framew ork of harmonising legal measures for 
issues as data collection, information provi sion to patients, criteria for authorization 
and the authorization procedure, standards of quality and safet y, patient rights and 
compensation for harm. This option might be difficult to justify in the light of the 
subsidiarity principle. 
6. I
MPACT OF COMMUNITY ACTION  
In the impact assessment five different types of impact have been analysed. First of 
all the impact on treatment costs and on treatment benefits due to patient mobility has been mapped. From table 1 it becomes cl ear that an increase of possibilities to 
receive healthcare abroad will create an increase in treatment costs. These costs 
remain nevertheless marginal compared to  the increased treatment benefits, which 
also increase with the increase of possi bilities to receive healthcare abroad. The 
compliance costs were also analysed. The impact assessment makes clear that with the creation of more legal certainty  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 health care system needs to be 
adapted to the new detailed rules. In the impact assessment report are also changes of 
administrative costs in each of the options analyzed. The more legal certainty is created, the more those administrative costs can be reduced. By creating more clarity 
about possibilities for cross-border care, more people will be able to receive the treatment they need quicker. Therefore th e social benefits increase with more 
patients being involved. 
EN 6   EN 7. COMPARING THE OPTIONS  
Table 1  Impacts of each option presented in financial terms 
 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 
Under option one, the current problems continue to exist. The rights to 
reimbursement for cross-border healthcar e through direct app lication of free 
movement principles have been estab lished in theory. Nevertheless, without 
Community action these rights will be difficu lt to use in practice. Without a clear 
framework for ensuring minimum requirement s for safe and efficient cross-border 
healthcare, uncertainty remains, also in this field. Moreover, no further action does 
not mean avoiding costs of cross-border h ealthcare. Rather, it means continuation of 
current trends, but accompanied by costs of managing these uncertainties. Social 
inequity will remain. The less well-off will be unwilling to advance the cost of 
healthcare without solid legal guarant ees that they will be reimbursed. 
With option two, there is some improvement. The key issue here is certainty; given 
the potentially catastrophic consequences fo r patients of problems with cross-border 
care, merely having guidance rather than le gal certainty about cr oss-border care is 
not enough, either for patient s or professionals. Option three provides a balance 
between action on Community and national level. It achieves the core aim of 
providing sufficient certaint y about the key issues in cross-border healthcare. It 
maximises the benefit of cross-border care overall, and does most to ensure social 
equity. This option provides certainty in  relation to reimbursement. In contrast, 
although option four provides a still greater degree of certainty, it involves wholly 
disproportionate costs and im plies a degree of change and harmonisation which is 
not appropriate and not consistent wi th the principle of subsidiarity. 
Within option three, the key choice is a bout the handling of cr oss-border hospital 
care. By maximising the potential access to cross-border care, option 3A is the only 
option where the likely value of  the benefits to patients ou tweighs the overall costs of 
the system. For the long run, there is no r eason to assume that planning and overall 
sustainability will be disturbed by the im plementation of option 3A. Both sending 
and receiving countries will on the contrary  benefit from increased efficiency and 
quality both for cross-border and for domes tic healthcare. Sub-option 3B has lower 
costs of treatment, but also provides lower benefits, and thus does not provide a clear 
net benefit over the cost of  the option. The preferred opt ion is therefore option 3, 
sub-option 3A. 
EN 7   EN Option four has potentially a positive outcome. Nevertheless the additional 
administrative burden during the implementa tion phase, due to the harmonisation, is 
substantial. This option would undermine the subsidiarity principle. Member States 
have different backgrounds and different he althcare systems. This diversity makes a 
detailed 'top down' approach to Commun ity action as the case in this option 
potentially unfeasible and ineffective in several instances.