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}
Date: 2008-07-02
Institutions: European Commission
Subjects: cross-border cooperation, free movement of persons, health policy, impact study, organisation of health care, patient's rights, provision of services, social security

EN 

EN 

   EN 

 
COMMISSION OF THE EUROPEAN 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 

   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  mobility  of  patients.  Although  patients  prefer 
healthcare to be available as close to where 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  receive  healthcare  abroad  can  be  of  enormous 
impact, but also for healthcare systems as a whole the consequences of cross-border 
care can be substantial. It can further stimulate innovation, it can contribute to more 
efficient  planning  and  use  of  resources  and  to  better  overall  quality  of  care.  Some 
challenges  have  nevertheless  been  identified.  Uncertainty  exists  about  the  general 
application  of  rights  to  reimbursement  for  healthcare  provided  in  another  Member 
State.  A  consultation  with  all  relevant  stakeholders  showed  that  uncertainty  also 
exists over how the necessary frameworks for safe and effective healthcare should be 
ensured for cross-border healthcare.  

2. 

CONSULTATION OF STAKEHOLDERS 

The  Commission  invited  with  the  publication  of  a  Communication1  all  relevant 
stakeholders to contribute to a consultation 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  healthcare  and  to  receive  input  concerning 
objectives and policy options. The 280 contributions to this consultation have been 
brought  together  in  a  summary  report2  The  individual  contributions  have  been 
published on the Commission website3. 

Overall,  contributors  welcomed  the  initiative  of  the  Commission  regarding 
Community  action  on  health  services.  The  majority  of  national  governments  and 
many other stakeholders expressed the wish 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)  emphasised  that  any  Community  action  that 

1 

2 

3 
4 

Commission  Communication,  Consultation  regarding  Community  action  on  health  services,  SEC 
(2006) 1195/4, 26 September 2006. 
Commission  document,  Summary  report  of  the  responses  to  the  consultation  regarding  "Community 
action on health services" (2007) 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm 
2733rd  Employment,  Social  Policy,  Health  and  Consumer  Affairs  Council  meeting,  Luxembourg,  1-2 
June 2006 

EN 

2 

   EN 

                                                 
affects  the  health  systems  should  respect  the  subsidiarity  principle,  referring  in 
particular  to  Article  152  of  the  Treaty  establishing  the  European  Community, 
although  others  argued  that  the  principle  of  subsidiarity  should  not  prevent  the 
application of EU fundamental freedoms.  

3. 

ADDITIONAL RESEARCH 

The Commission asked the European Observatory on Health Systems and Policies to 
carry  out  a  stocktaking  exercise  to  give  an  overview  of  trends  and  the  current 
situation concerning cross-border healthcare5. The study gives more insight in access 
to  healthcare,  experiences  with  cross-border  collaboration,  quality  and  safety  of 
healthcare in the European Union, as well as developments concerning patient rights. 
Differences in benefit baskets and tariffs between member states are also presented. 
The study gives insight in the impact of cross-border care on the basic objectives and 
functions  of  healthcare  systems  and  gives  an  overview  of  the  existing  cross-border 
healthcare data. 

The  Commission  also  conducted  a  EuroBarometer  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 healthcare6.  

4. 

SUBSIDIARITY 

It  is  primarily  the  responsibility  of  the  individual  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  country.  In  accordance  with  the  principle  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  achieved  by  the  Member  States  and  can 
therefore, by reason of the scale or effects of the proposed action, be better achieved 
by the Community.  

Community  law  already  provides  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 questions 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  different  way  compared  to  interpretation  by 
national  governments.  But,  as  emphasised  by  several  Member  States  during  the 
consultation,  also  after  the  Court  came  with  its  interpretation,  Member  States  still 
lack certainty about how these individual cases 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 

6 

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. 
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 

3 

   EN 

                                                 
of  secondary  legislation,  would  bring  the  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  possible.  Cross-border  healthcare  has,  as  the 
name  already  predicts,  many  Community-wide  transnational  aspects.  For  both 
patients  and  professionals,  there  is  a  crucial  difference  between  having  some 
confidence  in  the  applicable  rules  for  cross-border  care,  and  being  certain.  The 
legal  uncertainty  concerning 
potentially  very  serious  consequences  of  any 
responsibilities in cross-border healthcare settings are an important reason to act on 
this issue. When citizens cross borders to receive healthcare, it is important that it is 
clear which country is responsible for what. Currently that clarity is lacking. It is not 
possible  for  individual  Member  States  to  define  their  own  responsibility  without 
agreeing  on  these  responsibilities  with  other  involved  countries.  Therefore  also  to 
solve  this  issue,  agreement  concerning  responsibilities  is  needed  on  Community 
level. 

5. 

POLICY OPTIONS 

In the impact assessment report five options for Community action 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 have been assessed on the basis of existing data and by 
using  basic  modelling  tools.  The  work  of  the  European  Observatory  on  Health 
Systems  and  Policies  and  the  result  of  the  Eurobarometer  survey  were  used  as 
valuable input.  

The first option would be to do nothing on Community level. This baseline scenario 
would  leave  all  responsibilities  to  create  clarity  to  the  individual  Member  States. 
Under  the  second  option,  the  Commission would 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 detailed 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-border 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 cross-border care, and it would support activities to develop 
common data and indicators as an evidence base for policymaking on health services.  

The third option would mean, possibly in combination with the soft actions described 
under  option  2,  the  establishment  of  a  general  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 information to their own citizens about their 
rights to healthcare abroad.  

Under  option  three  two  sub-options  (3A  and  3B)  have  been  described  for  dealing 
with  the  issue  of  legal  uncertainty  regarding  financial  entitlements  and  prior 
authorisation  for  cross-border  healthcare.  Under  sub-option  3A,  the  existing 
framework for coordination of social security schemes would remain in place in its 

EN 

4 

   EN 

current  form.  In  addition  to  this  existing  structure,  the  new  directive  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-hospital)  that  they  would  have  been 
provided  and  reimbursed  at  home  and  be  reimbursed  up  tot  the  amount  that  would 
have been paid had they obtained that treatment at home. The patient would bear the 
financial  risk  of  any  additional  costs  arising.  Prior  authorization  of  hospital  care 
would remain possible. Under mechanism 3A Member State would need to provide 
evidence  that  the  outflow  of  patients  without  an  authorization  procedure  would 
undermine  the  financial  balance  of  their  social  security  system,  the  maintenance  of 
treatment capacity or medical competence 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  authorisation  for  cross-border  hospital  care.  As 
with  sub-option  3A,  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, but whereas for sub-option 
3A this directive would apply to the financial 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 framework of harmonising legal measures for 
issues as data collection, information provision to patients, criteria for authorization 
and  the  authorization  procedure,  standards  of  quality  and  safety,  patient  rights  and 
compensation  for  harm.  This  option  might  be  difficult  to  justify  in  the  light  of  the 
subsidiarity principle. 

6. 

IMPACT 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 clear 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  possibilities  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 legal 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  the  social  benefits  increase  with  more 
patients being involved. 

EN 

5 

   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  healthcare  through  direct  application  of  free 
movement  principles  have  been  established  in  theory.  Nevertheless,  without 
Community  action  these  rights  will  be  difficult  to  use  in  practice.  Without  a  clear 
framework  for  ensuring  minimum  requirements  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 healthcare. 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 guarantees that they will be reimbursed. 

With option two, there is some improvement. The key issue here is certainty; given 
the potentially catastrophic consequences for patients of problems with cross-border 
care,  merely  having  guidance  rather  than  legal  certainty  about  cross-border  care  is 
not  enough,  either  for  patients  or  professionals.  Option  three  provides  a  balance 
between  action  on  Community  and  national  level.  It  achieves  the  core  aim  of 
providing  sufficient  certainty  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  implies  a  degree  of  change  and  harmonisation  which  is 
not appropriate and not consistent with the principle of subsidiarity. 

Within  option  three,  the  key  choice  is  about  the  handling  of  cross-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 outweighs the overall costs of 
the system. For the long run, there is no reason to assume that planning and overall 
sustainability  will  be  disturbed  by  the  implementation  of  option  3A.  Both  sending 
and  receiving  countries  will  on  the  contrary  benefit  from  increased  efficiency  and 
quality both for cross-border and for domestic 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  option  is  therefore  option  3, 
sub-option 3A. 

EN 

6 

   EN 

 
Option  four  has  potentially  a  positive  outcome.  Nevertheless  the  additional 
administrative burden during the implementation phase, due to the harmonisation, is 
substantial. This option would undermine the subsidiarity principle. Member  States 
have different backgrounds and different healthcare systems. This diversity makes a 
detailed  'top  down'  approach  to  Community  action  as  the  case  in  this  option 
potentially unfeasible and ineffective in several instances. 

EN 

7 

   EN