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}
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

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COMMISSION OF THE EUROPEAN 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} 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. 

Organisation and timing 

In  2003  health  ministers  and  other  stakeholders  invited  the  Commission  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  the  internal  market  at  the  start  of  2004  therefore  included 
provisions  codifying  the  rulings  of  the  Court  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  technical  complexities, 
sensitivity for public opinion and major support from public funds. The Commission 
therefore developed a policy initiative specifically 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 and does not prejudge the 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 discuss involvement of different DGs in the 
process. The second meeting took place in April. 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  discussed,  as  well  as  the  draft  stocktaking 
exercise  carried  out  by  the  European  Observatory  on  Health  Systems  and  Policies 
(see also  paragraph 1.2.3.2). A fourth meeting  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  representatives  had  a  meeting  with  the  board, 
which  sent  its  written  opinion  concerning  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. 

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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 chapter 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  concerning  stakeholder  consultation  have 
been  met.  Stakeholders  have  been  extensively  involved  in  Commission  activities 
regarding patient mobility and health care over many years, in particular through the 
High  Level  Reflection  Process,  the  Open  Forum3  and  the  High  Level  Group  on 
Health Services and Medical care4.  

Consultation  on  the  specific  initiative  described  in  this  report  started  formally  in 
September  2006  with  the  publication  of  a  Communication5,  inviting  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)  and  to  get  input  concerning  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  this  consultation  from  a  wide  range  of 
stakeholders.  From  individual  EU  citizens,  health  professional  organisations, 
healthcare  providers,  national  and  regional  governments,  insurers,  individual 
citizens,  the  industry  etcetera.  A  wide  range  of  issues  related  to  (cross-border) 
healthcare in Europe was raised. These are included where appropriate elsewhere in 
the  impact  assessment.  All  contributions  have  been  published  on  the  Commission 
website7 

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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. 
The  last  Open  Health  Forum  attracted  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  legislation,  because  subsidiarity  is  not  a  sufficient 
guarantee  of  meeting  the  promise  of  universal  access  to  high  quality  healthcare.  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  the  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). 
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  representatives  from  civil  society  have  also  been 
involved in the work of this group; Report on the work of the High Level Group on Health Services and 
Medical Care in 2006, European Commission (2006). 
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 

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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 instruments 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  patient-centred  approach;  evidence-based 
standards;  the  right  to  appeal  against  refusals  of  authorisation;  and  exceptions  for 
border  regions.  Greater  clarity  was  also  sought  over  pricing  for  cross-border  care, 
and the definition of 'health services' within 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  and  international  patient  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 support to national authorities in achieving 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 ensuring continuity of care included systems for exchanging 
patient  data,  an  EU  standard  discharge  letter  and  Europe-wide  prescriptions.  Many 
contributors also argued that there should be greater clarity over patients' rights. 

There is also broad consensus that the provider of treatment should 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 building on existing networks such as SOLVIT), requiring 
mandatory  insurance  for  healthcare  providers,  or  the  establishment  of  the  Europe-
wide no-fault compensation system. 

Some  contributors  were  concerned  about  the  potential  for  cross-border  care  to 
undermine the provision of healthcare within their countries, in particular with regard 
to  how  to  prioritise  different  patients  and  setting  fair  prices  for  cross-border  care 
provided. On the other hand, some contributors felt that increased cross-border care 
could have a positive effect on domestic care provision.  

Many  contributors  felt  that  there  was  a  need  for  better  monitoring  of  health 
professional mobility. Issues were also identified 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  establishment  of  healthcare  providers  in  other 
Member  States  was  also  sought  by  a  few  contributors,  with  particular  regard  to 
pharmacies  and  dentists.  However,  most  contributions  were  more  concerned  about 
practical  issues  in  cross-border  pharmacy  services,  and  made  suggestions  such  as 
developing  ePrescriptions.  Information  and  communication  technology  solutions  in 

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general  were  identified  as  a  key  area  for  the  future  by  many  contributors,  though 
teleradiology was seen as a priority challenge where more analysis was needed. 

Some contributors identified particular issues related to the practical operation of the 
existing regulations on coordination of social 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  potential  investment  in  healthcare  through 
the  structural  funds.  However,  many  contributors  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  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"8.  Many  contributions  (in 
particular  from  national  governments,  unions  and  purchasers)  emphasised  that  any 
Community  action  that  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.  

On the overall approach, the majority view of contributors was that a combination of 
both  "supportive"  tools  (such  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 any legal measures. In terms of the 
preferred approach for any legal instrument there were clearly two main approaches 
preferred  by  different  contributors.  Some  contributors  preferred  to  include  any 
changes within the Regulations on the coordination 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  nevertheless  that  the  nature  of  the  services 
directive was inappropriate to the health sector, hence their exclusion. Both Council 
and  Parliament  have  since  again  called  for  specific  proposals  on  health  services, 
considering that this is the best way forward 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 with various reports. In April 2005 a report on Community 

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2733rd  Employment,  Social  Policy,  Health  and  Consumer  Affairs  Council  meeting,  Luxembourg,  1-2 
June 2006 

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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 health services ensuring clarity for European citizens about 
their rights and entitlements when they move 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,  patient  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 respecting  the  primary responsibility of 
the Member States for the organisation, financing and delivery of health services and 
medical care. Member States and the Parliament have expressed concerns about what 
the  margin  for  manoeuvre  is  for  national  and  regional  authorities  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 proposals must take into account, 
and  it  is  also  part  of  the  reason  for  support  for  proposals,  both  Council  and 
Parliament considering that these issues should 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  external  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  EU13,  in  order  to  provide  better  insight  into  the  actual  scope  of 
patient  cross-border  mobility,  the  willingness  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  have  been  interviewed  about  possible 
reasons  to  go  abroad  for  medical  treatment  (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 

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A6-0129/2005 final 
B6-0098/2007 
A6-0173/2007 final 
10173/06 SAN 168 SOC 302 MI 132 
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. 

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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 another 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  are  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  necessary  treatment  would  also  be  important 
motivating  factors  for  patients.  The  42%  who  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  EU15  zone  would  prefer  to 
remain in their own country as they are satisfied with their domestic services, and the 
convenience  of  local  treatment,  while  those  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 Systems and Policies provided an independent 
expert analysis in support of this impact assessment taking stock of developments on 
health care in Europe, focussing on seven aspects of cross-border health care14: 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  understanding  of  cross-border  health  care 
from different national health systems perspectives on the above mentioned aspects 
and  describes  how  current  legal  and  non-legal  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 affected, in what ways, and to what extent. 

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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. 

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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  majority  of  cases,  the  health  systems  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  particular  concentration  of  resources  or 
expertise  that  is  beyond  the  capacity  of  every  Member  State  to  provide,  such  as 
for rare diseases; 

–  for  border  regions,  where  the  nearest  appropriate  healthcare  provider  may  be 
across the border in another Member State, 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 capacity 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 another Member State to work or retire may 
prefer  to  return  to  their  country  of  origin  for  healthcare,  even  if  the  healthcare  in 
question could also be provided in the country where 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 abroad 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  security  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  Card15.  The  regulations  also 
provide for patients to be able to seek healthcare in another EU country, subject to 
prior authorisation from their own system. That authorisation must be granted if the 
care cannot be provided within a medically justifiable 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  European  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-employed  persons  and  to  members  of  their  families  moving  within  the 
Community. OJ L 149, 5.7.1971, p.2 

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healthcare  abroad.  As  outlined  in  the  Commission's  communication  consulting  on 
these issues in 2006, in 1998 the Court established new principles through its rulings 
in two cases16 regarding direct application 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 services are provided for remuneration, they 
must  be  regarded  as  services  within  the  meaning  of  Treaty  and  thus  relevant 
provisions on free movement of services apply. The Court also ruled that as a result 
measures making reimbursement of costs incurred in another Member State subject 
to  prior  authorisation  are  barriers  to  freedom  to  provide  services,  although  such 
barriers  may  be  justified  by  overriding  reasons  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 reimbursement provided by their own system. 

–  Any hospital care to which they are entitled in their own Member State they may 
also seek in any other Member State provided 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  years,  it  is  clear  that  there  is  as  yet  no 
comprehensive data about cross border healthcare. 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  exercise,  and  was  broadly  confirmed  by  the 
responses from Member States and other contributors, with similar proportions both 
of expenditure and numbers of patients moving.  

The  total  GDP  of  the  European  Union  is  €  12,149  billion18.  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 . 

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Case C-158/96 Kohll [1998] ECR I-1931 and Case C-120/95 Decker [1998] ECR I-1831. 
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. 
EU economic data pocketbook 1-2007, Eurostat (2007) 
Europe in figures – Eurostat yearbook 2006-07, Eurostat (2007) 

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However,  respondents  to  the  consultation  underlined  that  cross-border  healthcare 
varies, and can be significantly larger in certain circumstances20. Factors influencing 
the impact of cross-border healthcare include: 

–  Border regions: The impact of cross-border healthcare is likely to be greater for 
European  citizens  living  in  border  regions,  and  the  associated  hospitals  and 
providers. One contributor argued that as soon as more than 5% of patients treated 
in  a  hospital  are  from  abroad,  the  planning  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  cross-border  agreements  on  provider,  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 the financial impact may be much more significant. For 
example,  in  Luxembourg,  up  to  7%  of  the  healthcare  budget  has  been  spent  on 
cross-border care in recent years. In addition, it was argued that it is not possible 
to provide some forms of highly specialized 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. Luxembourg, Malta, Cyprus), which simply do not 
have  enough  patients  to  justify  having  certain  institutions  or  technologies 
available in the country. In particular, patients with rare diseases may need to rely 
more on cross-border care to obtain appropriate treatment than patients with more 
common conditions.  

–  Areas  attracting  large  amounts  of  tourists:  Areas  attracting  large  numbers  of 
tourists,  such  as  parts  of  southern  Europe  and  the  Mediterranean  islands,  face 
some specific impacts. If capacities are intended only for the number 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  also  form  part  of  the  infrastructure  which 
makes those areas an attractive 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 numbers of patients thus planning to receive 

20 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm 

These contributions are all published on the Commission website:  

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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  has  grown  in  recent  years,  and  is  likely  to 
continue to grow in the future; see data on cross-border healthcare collected through 
the regulations on social security annexed. Many contributors to the consultation also 
expect  a  noticeable  increase  of  cross-border  healthcare  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 increasing tendency for people to travel 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 noticeable 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  consumers  stated  that  they  expect  that 
travelling long distances for healthcare services will be normal in 2020 (yes: 57%, it 
depends:  28%,  no:  14%;  do  not  know:  1%)  (Health  Consumer  Powerhouse).  The 
Eurobarometer  underlines  this  potential,  with  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 healthcare when it is quicker, 
better,  cheaper  or  more  convenient  for  them.  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 consider seeking healthcare abroad.  

(EU-SILC) 

survey  provides 

The extent of unmet need for healthcare within Member States is therefore a crucial 
factor in projecting likely future need. The European Statistics on Income and Living 
Conditions 
longitudinal 
multidimensional  microdata  on  income,  poverty,  social  exclusion  and  living 
conditions. This includes data on unmet healthcare 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 

cross-sectional 

and 

21 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/results_open_consultation_en.htm 

These contributions are all published on the Commission website: 

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who  have  a  clear  unmet  need,  and  are  aware  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 circumstances, 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 they are paying some or all of its cost. One 
common  example  is  dental  treatment,  as  identified  above.  And  indeed,  the 
percentage  of  people  identified  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 healthcare abroad can be applied in practice. The 
second  concerns  how  to  ensure  that  when  cross-border  healthcare  is  provided,  it  is 
safe and efficient. 

2.3.1.  Uncertainty  about  general  application  of  rights  to  reimbursement  for  healthcare 

provided in other Member States 

Many contributors to the consultation 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 that in many Member States patients are not 
aware of the possibilities and their entitlement 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  unsure22. 
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 their 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. However, it is necessary to improve clarity to ensure a more 
general and effective application of these rights 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  uncertainty  and  confusion  about  the  general 
application  of  rights  to  reimbursement  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  difficult  for  patients  to  use  their  rights  in 
practice,  as  those  responsible  will  be  reluctant  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 
23 

http://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co147.pdf 
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. 

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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  significant  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 difference through their own expenditure 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  (delivery  of  service  from  the  territory  of  one 
Member State into the territory of another); such as telemedicine services, remote 
diagnosis and prescription, laboratory services; 

–  Use  of  services  abroad  (ie:  a  patient  moving  to  a  healthcare  provider  in  another 

Member State for treatment); this is what is referred to as 'patient mobility'; 

–  Permanent  presence  of  a  service  provider  (ie:  establishment  of  a  healthcare 
provider in another Member State), such as local clinics of larger providers; and, 

–  Temporary presence of persons (ie: mobility 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  authorization  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  frameworks  for  safe  and  effective  healthcare 

should be ensured for cross-border healthcare 

Linked  to  the  problem  described  in  the  previous  section  but  broader  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 safety of the healthcare that is provided; 

–  continuity of care between different treating professionals and organisations; 

–  and  mechanisms  to  ensure  appropriate  remedies  and  compensation  for  harm 

arising from healthcare. 

24 

See the Eurobarometer results referred to above. 

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Within  Member  States,  different  structures  have  been  put  in  place  to  ensure  these 
elements  at  local,  regional  or  national  level,  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 through the regulations on 
coordination  of  social  security  systems  or  whether  it  is  in  application  of  the 
additional free movement rights 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 cases 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 explanation 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 planning mechanisms. As cross-border care often 
takes place outside of those mechanisms, quality and safety control is at risk in the 
cross-border context.  

Several  reports  highlight  problems  with  continuity  of  care  in  cross-border  settings. 
One  study  analysed  in  detail  the  weaknesses  in  the  care  chain  of  Dutch  patients 
treated in Belgian hospitals25. 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  reports  also  mention  problems  with  the 
availability at home of drugs and medical devices that were prescribed abroad26. This 
may  not  just  be  a  question  of  quality  and  safety  structures  being  lacking,  but 
problems  with  overlapping  and  potentially  conflicting  systems  being  applied  from 
both the country where care is provided and the 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 other countries may create additional risks 
rather than helping to ensure quality and safety. 

Ensuring  quality  and  safety  in  healthcare  depends  not  just  on  the  skills  and 
qualifications of an individual professional. Rather, it depends on the functioning of 
an entire system: the individual professional; the team of professionals dealing with 
the  particular  patient;  the  overall  providing  organisation;  and  the  applicable 
regulatory framework. It is precisely at the borders between each of these elements 
that risks increase, and thus cross-border healthcare (as healthcare involving borders 
between  all  of  the  systemic  elements  responsible  for  ensuring  healthcare)  raises 
greater risks than healthcare within a single Member State. 

25 

26 

Engels  EL,  Grenzeloos  geketend?  Explorerend  onderzoek  naar  de  transnationale  zorgketen  tussen 
Nederland  en  België,  Maastricht,  Universiteit  Maastricht,  Faculteit  der  Gezondheidswetenschappen 
(2003). 
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, Brussels, Observatoire Social 
Européen (2005) 

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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 for seeking information in the language of 
the patient about different treatment or provision options, their cost and availability 
in  practice,  or  their  outcomes  and  success  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 healthcare are that apply. For example, through 
which  country's  error  reporting  systems  should  they  report  mistakes  or  issues 
arising, and in what language 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  issues  outlined  above.  For  example,  if  a 
patient  from  one  country  is  referred  to  another  country  for  specialist  treatment, 
should their home country check the quality 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  another  country  where  they  are  present 
monitors  standards  through  a  specific  inspectorate,  whose  reporting  structures 
should monitor them? 

–  Temporary presence of persons: again, this initiative does not address where the 
professional is registered nor the conditions for being registered (which is already 
addressed  separately  through  the  directive  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  allergic  to  aspirin  but  the  country  where 
they  are  temporarily  providing  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  reimbursement  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 services, 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. 

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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 safety 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 problems with cross-border healthcare, both 
in  terms  of  uncertainty  over  the  general  application  of  rights  to  reimbursement  for 
healthcare provided in another Member State, and over the necessary frameworks for 
safe and efficient healthcare provision. 

2.4.1.  The necessity test 

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  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  Treaty,  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  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 
potentially  very  serious  consequences  of  any 
legal  uncertainty  concerning 
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 

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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. 

2.4.2.  Link with the Treaties  

The  European  Court  of  Justice  has  confirmed  that  even  though  Member  States  are 
primarily responsible for the organisation and delivery of health services and medical 
care, health systems must comply with the provisions of Community law, including 
internal  market  rules.  Both  the  European  Parliament  and  the  Council  of  Health 
Ministers have asked the European Commission 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  sufficient  clarity  about  patient's  rights  to  be 
reimbursed  for  healthcare  provided  in  other  Member  States  and  other  aspects  of 
cross-border healthcare so that 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 the possibility to contribute to Member 
States'  efforts  and  to  support  their  national  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 several occasions, health services fall within 
the  scope  of  the  EC  Treaty,  and  in  particular  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 outside such an environment. Article 95 of 
the Treaty foresees adoption of measures the 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  framework  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  protection  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 Community action shall respect Member States' 
responsibilities for the organisation 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 such, they contribute to the quality of life of 
European  citizens  and  are  one  of  the  essential  pillars  of  the  European  model  of 
society. Article 16 of the EC Treaty requires 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 fulfil their missions. In addition, Article 86(2) 
of the EC Treaty allows reconciling the rules of Community law, including rules on 
competition  and  internal  market,  with  the  fulfilment  of  the  mission  of  general 
economic interest by making undertakings entrusted with the operation of services of 
general economic interest subject to the rules contained in the EC Treaty in so far as 
the application of such rules does not obstruct the performance, in law or in fact, of 
the particular tasks assigned to them. 

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Article 95(3) of the Treaty further stipulates that the Commission, in its proposals for 
the establishment and functioning of the internal market concerning health, shall take 
as a basis high level of protection of health, taking account in particular of any new 
development based on scientific facts. The 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, alternatively to the new framework for cross-border healthcare 
created under article 95 of the Treaty, continue to have the rights arising from rules 
based on article 42 of the Treaty and in particular the regulation on the application of 
social  security  schemes  to  employed  persons  and  their  families  moving  within  the 
Community  (1408/71).  In  particular,  where  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 any additional financial costs being borne by 
their social security scheme in accordance with the provisions of that Regulation. 

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3. 

OBJECTIVES 

3.1. 

Overall objective: A clear framework for 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  within  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 rights to be realised in practice; 

–  and  ensure  that  the  necessary  requirements  for  high-quality,  safe  and  efficient 

healthcare are also ensured 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  their  rights  to  reimbursement  for  healthcare 
abroad  in  practice.  This  should  not  amend  the  existing  regulations  coordinating 
social  security  systems,  nor  the  mechanisms  that  they  provide  for  emergency  care 
whilst abroad or prior authorisation for healthcare abroad. Rather, it should ensure a 
clear framework for the additional free movement rights provided by the Treaties to 
have  access  to  healthcare  abroad,  the  principles  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 efficient cross-border healthcare 

It is the objective of this initiative to ensure that the necessary requirements for high-
quality,  safe  and  efficient  healthcare  are  also  respected  for  cross-border  care.  This 
initiative  should  stipulate  the  general  common  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 clarify what those responsibilities mean in practice.  

3.3. 

Operational objectives 

3.3.1.  For reimbursement for healthcare abroad: 

For  the  additional  free  movement  rights  provided  by  the  Treaties  to  have  access  to 
healthcare  abroad,  the  principles  of  which  have  been  established  by  the  Court,  the 

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operational  objectives  under  this  heading  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 healthcare abroad and the information to be 
provided to enable patients to be aware of the option of cross-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 efficient cross-border healthcare 

The  operational  objectives  under  this  heading  are  to  ensure  that  the  essential 
requirements  for  high-quality,  safe  and  efficient  healthcare  are  also  guaranteed  for 
cross-border healthcare, in particular:  

–  that  people  can  have  access  to  information  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 the country where treatment is provided; 

–  that  the  necessary  transfer  of  information  to  ensure  continuity  of  care  between 
different  treating  professionals  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  objectives  of  ensuring  a  clear  framework  for  cross-border 
healthcare,  this  initiative  will  also  contribute  to  the  overall  goals  of  the  health 
systems  of the Member States, and to  the growth, competitiveness and cohesion of 
the Union as a whole.  

3.4.1.  Contribution to the overall goals of the health systems of the Member States 

In addition to the direct objectives outlined above, putting in place a clear framework 
for cross-border healthcare will also contribute to the overall shared 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  healthcare  that  patients  seek  can  best  be 
provided in another Member State. Putting 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 

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20 

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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 variations in the mortality amenable to 
healthcare throughout the Union28. This is not a simple correlation with resources 
invested – rather, there are significant issues with inappropriate use of procedures, 
under-use  of  generally  accepted  and  widely  known  treatment  standards,  and 
medical  errors,  linked  to  overall  systemic  causes29.  In  addition  to  facilitating 
access  to  high-quality  care  where  this  can  best  be  provided  in  another  Member 
State,  a  framework  for  cross-border  healthcare  will  also  help  to  facilitate 
cooperation  and  comparison  between  Member  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  provision  can  be  provided  in  cooperation  across 
more  than  one  Member  State,  either  because  of  the  geographical  proximity,  or 
because of the concentration of specialist resources and patient volumes necessary 
cannot  be  provided  as  efficiently  and  safely  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  projected  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  future  costs  are  very  sensitive  to 
changes in costs of providing a given package of care. The key to sustainability 
for  healthcare  systems  is  therefore  controlling  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-border  healthcare  can  therefore  help  to 
maximise the overall efficiency of healthcare provision and thus help to ensure the 
financial sustainability of health systems as a whole. 

27 

28 

29 

30 

and 

references 

http://ec.europa.eu/health/ph_information/dissemination/hsis/hsis_14_en.htm 

See 
provided for additional information. 
Take  the  example  of  bladder  cancer;  although  survival  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 relative survival rate ranged from 60% in Slovakia to 82.6% in Sweden – 
see  Coleman  M.P.  et  al.,  EUROCARE-3  summary:  cancer  survival  in  Europe  at  the  end  of  the  20th 
century in Annals of Oncology 14 (supplement5):v128-v149, 2003.  
For more information, see "Towards High-Performing Health Systems", the final report of the OECD 
Health Project, OECD 2004, ISBN 92-64-01555-8. 
The  impact  of  ageing  on  public  expenditure:  projections  for  the  EU25  Member  States  on  pensions, 
health  care,  long-term  care,  education  and  unemployment  transfers  (2004-2050),  European  Economy 
Special Report 1/2006, produced by DG ECFIN. 

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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  largest  service  industries, 
the  health  sector  represents  one  of  the most important economic sectors in the  EU. 
Currently its output is estimated to account for about 7.7 % of GDP in the EU, larger 
than the roughly 5 % accounted for by the financial services sector or the retail trade 
sector. And around 9 % of all workers in the 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  performance  measures  in  economies  as  a 
whole.  

Moreover, the performance of the health sector will affect the competitiveness of the 
overall  economy  via  its  effect  on  labour  costs,  labour  market  flexibility  and  the 
allocation of resources at the macroeconomic level. 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. 

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4. 

POLICY OPTIONS 

This section sets out four main policy options, 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 three or four, where appropriate. 

4.1. 

Option 1: No further action, the baseline scenario 

This option would mean not taking any further Community action on health services. 
There would be no additional legal measures at Community level beyond the rulings 
of the European Court of Justice and existing rules, in particular the regulations on 
the  coordination  of  social  security  systems.  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  European  Court  of  Justice  to 
continue  to  develop  principles  at  Community  level  through  rulings  at  Community 
level. 

Regarding non-legal measures, there would be no additional coordination or support 
action  at  Community  level  beyond  those  already  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  States  on  an  individual  or  inter-governmental 
basis.  

4.2. 

Option 2: Soft action 

Under  this  scenario,  the  Commission  would,  in  addition  to  existing  mechanisms, 
provide guidance on cross-border healthcare issues, but would not propose additional 
binding legal measures. This option would envisage the following set of actions: 

–  Guidance  on  cross-border  healthcare  issues  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-border  healthcare  and  application  of  existing 
rules on harm and liability in a Commission communication. This communication 
would also include recommendations on information to enable informed choices, 
plus principles or recommendations on ensuring 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  system  and  to  make  the  national  procedures 
related  to  the  cross-border  healthcare  more  transparent  and  objective.  The 
Commission  would  also  provide  technical  advice  and  assistance  to  the  Member 
States  to  facilitate  their  efforts  to  implement  these  principles.  This  would  be 
further  re-enforced  by  initiating  infringement  proceedings  against  individual 

32 

See http://ec.europa.eu/health-eu/care_for_me/mobility_in_europe/index_en.htm. 

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Member States that do not effectively  comply  with  the  principles  established  by 
the Court of Justice. 

–  Another action under this option would include establishing a mechanism to bring 
Member States together to share ideas and 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  reference  networks,  patient  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  would  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  Party  on  Health  Indicators  which  also 
deals with indicators and their implementation.  

–  The European Commission would also continue its current financial support to the 
projects aiming at cooperation between Member States and networking in the area 
of healthcare systems from the current and future Public Health Programme and 
for  research  cooperation  on  delivery  of  care  and  health  systems  under  the 
current7th Research Framework Programmes. Under 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  action  points  would  be  widely  disseminated 
through a dedicated European website. This would help to make patients aware of 
their rights and obligations, especially with 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  legislative  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 the following areas: Common principles 
underpinning health systems in the EU: The directive would establish the general 
principle  that  Member  States  are  responsible  for  ensuring  that  the  healthcare 
provided on their territory is safe and of high quality (i.e. provided according to 
clear  standards  for  quality  and  safety,  to  be  defined  by  each  individual  Member 
State);  quality  and  safety  is  regularly  monitored;  patient's  right  to  complain  and 
right to redress  and  compensation  is  guaranteed; privacy and data protection are 
respected;  and  the  requirement  that  these  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 

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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 responsible in any given situation, to avoid 
gaps or overlap, and to clarify what those 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 entitlements 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 financial coverage that is provided for cross-
border  healthcare,  based  on  the  principle  that  patients  are  entitled  to  obtain 
reimbursement up to the amount that would have been paid had they obtained that 
treatment  at  home;  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.  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  information  on  cross-border  healthcare  being 
made available at the EU Health Portal; 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  Court  of  Justice,  but  still  leave  flexibility  for  the 
Member  States.  More  details  regarding  the  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  should  be  liable  for  any  harm  arising  through  cross-border 
healthcare, including when treating patients from other Member States. However, 
this would not prevent Member States from covering patients referred abroad with 
their  normal  domestic  compensation  system  (as  some  already  do,  such  as 
Sweden). 

–  Practical  cooperation  on  healthcare  systems:  With  the  directive  a  framework 
would  be  established  to  support  further  cooperation  in  the  areas  including 
European  reference  networks,  health  technology  assessment,  data  collection  and 
quality  and  safety,  in  order  to  enable  the  potential  contribution  of  such 

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cooperation  to  be  realised  effectively  and  on  a  sustained  basis,  and  to  agree  on 
overall  directions  for  difficult  issues  (ie:  data  standards,  handling  of  new 
technologies or techniques) to promote effective 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  healthcare.  Under  both  options  a  comitology 
committee  would  be  created  which  would  adopt  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  for  financial  aspects  of  cross-border 
healthcare (both hospital care and non-hospital care) 

As  set  out  above,  there  are  currently  two  different  routes  for  financial  aspects  of 
cross-border  healthcare:  the  regulations  on  coordination  of  social  security  systems. 
and  direct  application  of  the  free  movement  rights  provided  by  the  Treaties  on  the 
basis  of  the  recent  jurisprudence  of  the  Court.  These  routes  are  summarised  in  the 
following table. 

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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 
"hospital care" 

for 

Obligatory 

May be required by the 
Member States 

No prior authorisation 

Prior  authorisation 
"non-hospital care" 

for 

Means of payment 

Obligatory 

Not needed 

No prior authorisation 

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. 

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 MS of treatment.  

According to the rules of 
the patient's home MS.  

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 

In any event, only actual 
costs of the treatment are 
reimbursed (i.e. a patient 
cannot make profit)  

There  are  two  key  differences  about  these  systems  from  the  perspective  of  the 
patient.  The  first  is  about  the  process  for  going  abroad:  under  the  existing 
regulations, the prior authorisation requirements are stricter, 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  another  Member  State  will  cost  more  than  at 
home:  under  the  Court  judgements,  the  patient  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 the authorisation was refused and it was subsequently established that 
the refusal was unfounded(see also point 130 watts) 

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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  use  either  of  these  routes? 
There are two main reasons why they might prefer healthcare abroad: 

–  the healthcare that they need is just not available 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 treated differently. If a 
patient has to go abroad to get the healthcare they need because they cannot have it 
domestically, they should not lose out financially by doing so. But if they could stay 
at  home  and  they  just  prefer  to  have  the  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  treatment  will  be  covered  by  public  funds;  the 
mechanism  for  this  is  already  in  place  through  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 wish, to receive the treatment 
– but they would have to pay for any additional costs above what would have been 
covered at home.  

In practical legal terms, this 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  the  regulation  883/04)  with  all  the  general 
principles  on  which  the  regulations  on  coordination  of  social  security  schemes  are 
based, including putting the patient receiving 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  authorisation  being  granted 
where the care cannot be provided domestically 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 have been provided at 
home  without any prior authorisation and  be  reimbursed  not  more  than  the  amount 
that  would  have  been  paid  had  they  obtained  that  treatment  at  home.  The  patient 
bears the financial risk of any additional costs arising.  

Also  consistent  with  the  Court's  jurisprudence,  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 consulting a specialist, to which receipt of the 
same health services is made subject also on their territory. So if Member States have 

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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  example,  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 for a system of prior 
authorisation for assumption by their social security system of the costs of hospital 
care provided  in another  Member State. The 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 sector in order to avoid hospital 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  territory.  Such  a  prior  authorisation  system 
should then be limited to what is necessary and proportionate in order to ensure these 
objectives and shall not constitute a means of arbitrary discrimination.  

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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 
"hospital care" 

for 

No prior authorisation, Member States 
may require prior authorisation by way 
of derogation.  

Obligatory, in accordance with 
regulation 1408/71 

Prior  authorisation 
"non-hospital care" 

Means of payment 

for 

No prior authorisation 

No prior authorisation 

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. 

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) 

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. 

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 through 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 financial entitlements and prior authorisation for cross-border 
hospital care. As set out above, in its direct 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 equate the prior authorisation that may thus be 

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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 interpretation generally taken hitherto.  

Under this option, therefore, the directive envisaged under option three would only 
deal  with  the  direct  application  of  Article  49  for  financial  aspects  of  non-hospital 
cross-border  healthcare.  For  hospital  care,  patients  would  follow  the  existing 
mechanism  for  coordination  of  social  security  schemes,  with  the  conditions  and 
requirements stipulated therein.  

In  practical  terms,  this  would  mean  that  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 within 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  State,  an  additional 
reimbursement covering that difference).  

In  legal  terms,  as  with  sub-option  3A  this  again  would  require  no  changes  to  the 
existing  framework  for  coordination  of  social  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  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.  

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 measures, but rather a detailed framework of harmonising 
legal measures under Community law for all cross-border healthcare 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. Such a detailed legal framework could be 
set out in a detailed regulation and also include a legally binding 'Charter of patient 
rights'.  

These binding measures would provide: 

–  Detailed  rules  on  which  data  about  cross-border  healthcare  should  be  collected 
and  on  how  and  how  often  these  data  should  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; 

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31 

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–  explicit  criteria  for  authorization  and  the  authorization  procedure,  the  maximum 
waiting time during the procedure etc., without leaving the possibility for Member 
States to adapt it to their national circumstances; 

–  explicit  standards  for  quality  and  safety  defined  at  the  European  level,  and 
detailed description of minimum requirements for Member States and individual 
healthcare  providers  concerning  those  standards,  how  compliance  should  be 
monitored and in which situations which 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  choice  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 healthcare, adapting existing provisions of the 
international  private  law  to  the  specificities  of  the  cross-border  healthcare. 
Detailed level and requirement for compensation for harm would be also defined. 
These  detailed  legislative  provisions  would  provide  greater  certainty  over  the 
specific  issues  arising  from  the  Court's  recent  jurisprudence,  but  also  over  all 
wider  issues  as  raised  in  the  consultation.  This  would,  however,  represent  a 
significant degree of harmonisation of healthcare issues in Community law, which 
with regard to certain aspects can not be justified 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. 

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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  Commission  proposal,  compared  to  other 
options  or  no  further  action.  This  assessment  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 impacts described therefore are also broad 
descriptions,  but  are  sufficient  to  evaluate  the  overall  costs  and  benefits  of  the 
different  approaches.  Overall  cross-border  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.  This  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 healthcare treatment for public funds; 

–  additional benefits from cross-border healthcare 

–  overall cost of compliance 

–  specific administrative burden 

There  are  also  wider  macro-economic  impacts  to  be  considered.  Through  enabling 
cooperation and comparison, action in the field 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  substantial,  and  thus  these  improvements  can  be 
expected  to  help  contribute  to  the  sustainability  of  health  systems  and  overall 
economic  growth  and  development.  However,  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  additional  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 healthcare abroad, the Court has made clear that that the 
patient  can  only  be  reimbursed  for  costs  of  healthcare  abroad  up  to  the  amount  to 

EN 

33 

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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 another 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 entitled 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 should be no additional 
costs arising for patients who are 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  obtained  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 difference between spending funds at an earlier or 
later  point  in  time  can  be  represented  by  the  interest  applicable  to  the  funds  in 
question. To get a general impression of these 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  represented  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  unmet  medical  needs  due  to  waiting  lists  is 
calculated, weighted for the 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,  which  is  equivalent  to  approximately  7.8 
million  EU  citizens.  However,  evidence  about  take-up  of  cross-border  healthcare 
suggests that in practice, most people will still prefer to have healthcare at home. For 
example, when the Health Insurance Institute of Slovenia (HIIS) offered patients on 
the  national  waiting  list  for  cardiac  surgery  the  opportunity  to  receive  treatment 
abroad,  less  than  10%  decided  to  take  up  the  offer35.  We  therefore  assume  that  at 

34 

35 

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. 
Cross-border care in the south: Slovenia, Austria and Italy in Rosenmöller, M., McKee, M. Baeten, R., 
Patient Mobility in the European Union, Learning from experience, World Health Organisation (2006). 
This study is part of the project Europe for Patients, an EC FP6 funded research project. 

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34 

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most  10%  of  people  waiting  will  seek  cross-border  care  in  practice  on  this  basis. 
Although  data  about  comparisons  of  costs  between  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  elective  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  few  months,  as  otherwise  the  delay  in 
treatment will be sufficient to justify access to cross-border healthcare not under the 
direct application of free movement rights being assessed in this proposal, but under 
the existing regulations on the coordination of social security, the costs of which fall 
outside the scope of this impact assessment. 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 treatment. Thus for hospital care, taking our 
estimated average treatment cost of €7000, the additional cost to the patient's home 
system would be €70. For non-hospital care, taking our estimated average treatment 
cost of €800, the additional cost to the 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  involve  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 

37 

38 
39 

Based  on  research  on  health  baskets  and  tariffs  in  different  member  states,  Observatory  mapping 
exercise  and  HealthBASKET(www.ehma.org/projects/healthbasket.asp).  HealthBASKET  –  Health 
Benefits  and  Service  Costs  in  Europe  –  is  a  project  funded  by  the  European  Commission  within  the 
Sixth Framework Research Programme. 
Based  on  data  provided  through  HealthBASKET,  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. 
The OECD Health Project, Towards High-Performing Health Systems, OECD (2004) 
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. 

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35 

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5.1.1.2.  Additional benefits from cross-border care 

Of  course,  being  treated  more quickly abroad does not simply 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 references or weights called utilities, one for 
each possible health state. These utilities reflect 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  benefit  to  them  can  be 
represented by a 0.1 increase in quality-adjusted 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 earlier than at home. 

The remaining element is how much a QALY is worth. Estimates vary widely, and 
of course any such average figure cannot fully 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 care of quicker treatment as being that the average patient is 0.1 
QALYs healthier for a period of three months (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 
41 

42 

43 

What is a QALY?, Hayward Medical Communications, Hayward Group plc. (2003) 
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 Series, University of Sheffield (2007)) 
For the specific example of eye surgery the QALY increase might be slightly higher. However, as this 
is  an  example  case  intended  to  represent  the  general  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. 
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  healthcare  and  stated  that  not  more  than  €  80.000  should  be  spent  on 
healthcare to save one QALY. 

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Again,  the  different  options  involve  different  assumptions  about  how  many  people 
are  likely  to  seek  such  cross-border  healthcare  in  practice,  and  the  consequent 
estimated benefits under this model are given 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  cross-border  care,  such  as  additional  systems 
for paying for such care, estimating how much the care in question would have cost 
had it been provided domestically, and ensuring appropriate monitoring of care and 
continuity between domestic providers and 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 European Court of Justice on the application of 
free movement rights in order to have access to healthcare abroad. 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 size 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  qualifications,  however,  and  based  on  the  experience  of  existing 
cross-border  cooperation  projects,  we  estimate  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 involved44. 

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 report, 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, NZI (research institute), 1999. 

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5.1.1.4.  Administrative burden 

In the context of impact assessment, administrative 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 again, the size and nature of these costs will 
vary  according  to  the  different  organisations  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  inform  citizens  about  cross-border  care, 
drawing on comparisons with existing initiatives 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 information; for this, we take the results of 
the  Eurobarometer  in  terms  of  the  number  of  citizens  receiving  cross-border 
healthcare,  and  assume  that  at  least  twice  as  many  people  will  make  information 
enquiries as actually go abroad, giving a total 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  administrative  burden  of 
Community action in this area, and the directions 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 option we then estimate in what direction 
such information provision activities would 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  these  direct  impacts  related  to  the  direct 
objectives of the initiative, Community action 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 cohesion of the Union as a whole. Although 
it  is  not  possible  to  quantify  this  contribution,  the  types  of  impacts  and  the  likely 
relative magnitude of impact between the different options 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  the  different  options  to  have  any  major 
environmental  impacts.  We  briefly  indicate  however  the  likely  direction  of  change 
for two groups of environmental impacts: efficient use of natural resources (as part of 

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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 assessed for the different options are: 

–  different impacts for different social groups; 

–  longer-term  consequences  for  health  systems  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  additional  choices  to  patients  in  particular. 
However,  this  choice  is  clearly  not  without  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 several 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 come from a variety of sources45, including in particular: 

–  lower expectations of good health or the 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 patient’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 inequality in the use of medical care in 
21 OECD countries”, conducted by van Doorslaer, 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  specific  issue  of  patients  exercising  choice 
between providers. An evaluation of a patient choice scheme in London showed no 
significant difference in the numbers of patients exercising choice by socioeconomic 

45 

46 

See in particular “Is greater patient choice consistent 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. 
For more information see http://www.oecd.org/dataoecd/14/0/31743034.pdf 

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status.47  In  fact,  by  providing  a  mechanism  that  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 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  instead48.  However,  unequal  levels  of  knowledge 
about the options available cross-border care has been clearly identified as key issue 
by  stakeholders,  and  is  likely  to  be  a  major  factor  in  determining  the  impact  on 
equity  of  different  options.  By  increasing  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  obtain  cross-border  care  will  clearly  have  an 
impact  on  equal  access,  in  particular  as  the  direct  application  of  free  movement 
principles  will  normally  involve  the  patient  paying  for  care  initially  and  being 
reimbursed.  The  extent  to  which  people  will  be  able  to  do  so  will  depend  on  the 
resources they have available. Also the degree 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  focus  of  analysis  of  the  impact  of  the 
different  options  by  socio-economic  group.  However,  as  has  been  described  above 
with  regard  to  economic  impacts,  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  Court  of  Justice  in  any  event,  regardless  of 
whether there is any new legislative proposal by the Commission or other action, All 
of  the  policy  options  therefore  involve  some  such  impacts  on  equity  for  different 
socio-economic groups, including the 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-border healthcare on health system as a whole 

Some  contributors  to  the  public  consultation  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 

48 

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.  
Techniker  Krankenkasse  (TK),  Medizin  in  Europa:  Ergebnisse  der  TK-Mitglieder-Befragung  2003 
(2003) 

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–  would  pressures  from  cross-border  healthcare  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 any 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 cross-border care would not justify any such 
wider restructuring; 

–  would cross-border healthcare create inefficiencies in healthcare provision which 
would  undermine  overall  planning  and  provision?  On  the  contrary,  the  evidence 
available,  described  in  this  section,  suggests  that  a  clear  framework  for  cross-
border care will improve efficiency in healthcare, both for the healthcare provided 
abroad and through transferring best practice into domestic care; 

–  would there be unsustainable additional costs 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  additional  costs  from  cross-border  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 created 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 integrated into domestic provision 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 would 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 maintain health care services in less densely 
populated  areas.  Also  without  using  the  possibilities  that  cross-border  care  could 
give,  Member  States  are  now  already  able  to  withhold  regions  from  healthcare 
facilities by only allocating healthcare facilities to the more densely populated areas. 
There  is  no  indication  that  an  increase  of  possibilities  concerning  cross-border 
healthcare would lead to a growth of inequality between regions.  

•  Denmark has had a system of 'extended free 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 outside  Denmark  on  an  equal  footing  with 
those inside Denmark in providing such treatment. On the basis of the use made of 
this  system  up  to  2006,  however,  the  impact  for  the  system  as  a  whole  has 
remained low; only 1.5% of patients have made use of their extended free choice, 

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and  only  0.02%  received  that  treatment  abroad49.  However,  even  with  this  low 
take-up of 'extended  free choice', the SILC data on unmet medical need in  table 
8.1 show that over 98% of the Danish population considers that their health needs 
are met, and thus there is no reason to think that this pattern is not sustainable for 
the future; 

•  Malta: the smallest Member State faces some of the greatest challenges in terms 
of  providing  specialised  care  in  particular,  and  has  had  an  arrangement  for 
referring  some  patients  for  specialist  treatment  to  the  United  Kingdom  for  30 
years50. This is used for specialised treatments such as bone marrow transplants, 
complex  major  spinal  surgery,  and  specialist  paediatric  cases,  for  which  it  is 
neither clinically nor economically appropriate to develop services in Malta, with 
the  investment  cost  being  too  high,  there  being  too  few  patients  and  full-time 
professional  staff  providing  such  services  would  quickly  become  deskilled.  The 
number of patients referred through the system is stable at around 300 a year (or 
around 0.06% of the Maltese population). Again, 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  medical  need  -  over  96%  of  the  Maltese 
population  considers  that  their  health  needs  are  met,  and  estimates  of  people 
seeking  treatment  abroad  outside  the  formal  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  planned  care  than  most  other  Member 
States,  in  particular  with  Dutch  patients  being  treated  in  Flanders  through 
contracts  between  Dutch  health  insurers  and  Belgian  providers51.  In  this  case 
study, the researchers consider that as well as being convenient for patients, this is 
more  efficient  for  both  the  Dutch  insurers  (providing  care  that  is  faster  and 
cheaper, as well as being perceived as being technologically advanced and of high 
quality) and the Belgian providers (helping to overcome overcapacity in the acute 
hospital  sector  by  treating  patients  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  are  very  large  variations  in  efficiency  of 
supply within Member States. The HealthBasket project52 compared costs for some 
typical treatments between nine different systems, and the overall cost and variations 
for the specific case of hip replacement are shown below53 

49 

50 

51 
52 

53 

See  consultation  response  R-039  from  the  Danish  Regions;  additional  data  on  overall  hospital  usage 
from Eurostat (comparison year 2003, as the most recent available). 
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. 
Ibid, Chapter 7. 
For 
http://www.ehma.org/projects/default.asp?NCID=112&NID=91. 
The  small  dots  show  the  unexplained  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% confidence 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 

information 

project, 

reports 

more 

and 

full 

see 

the 

the 

of 

EN 

42 

   EN 

 
                                                 
Without going into the detail of the analysis, this illustrates the overall finding of the 
project,  that  while  differences  in  average  costs  were  significant  between  countries, 
within-country  variation  was  also  unexpectedly  large  –  in  some  cases,  larger  than 
between-country variation. These differences are partly due to different accountancy 
standards,  but  also  due  to  prices  per  input  unit  and,  most  importantly,  due  to  large 
and  apparently  real  differences  in  practice  (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 mortality within countries being as large 
as the differences between countries. 

does 

bar 
horizontal 
http://www.ehma.org/_fileupload/File/Projects/WP10%20REPORT_31_Jan-07_revised.pdf 

cross 

more 

axis. 

For 

explanations, 

not 

the 

EN 

43 

see 

   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  cannot  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  improve  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 demand for health care is better satisfied as 
supply is increased, it also serves as a strategy to warn national providers that they 
could  lose  patients  and  contracts  as  purchasers  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  the  English  NHS,  cross-
border  contracting  aimed,  for  instance,  at  putting  pressure  on  the  domestic  private 
sector  to  lower  their  prices  for  contracts  with  the  NHS;  cross-border  care  reduced 

EN 

44 

   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  decreased  significantly  (to  a  few  weeks) 
compared to another hospital located in the middle of the Netherlands where people 
were waiting six months. Another Dutch sickness fund had clear indications that the 
local  hospital  was  performing  much  better  in  terms  of  waiting  lists,  while  also 
striving  to  become  more  patient-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  social  impacts  for  countries  ‘sending’  and 
‘receiving’  patients  through  cross-border  care,  for  sending  countries,  there  is  a 
potential social impact through differential take-up of this possibility for cross-border 
care,  as  outlined  in  the  previous  section.  But  as  also  outlined  above,  cross-border 
care  can  provide  an  additional  choice  that  allows  all  citizens  to  ‘exit’,  which  for 
cross-border care will be particularly relevant 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 who do not move. There is also potentially 
the  issue  of  'supplier-induced'  demand,  where  the  possibility  of  additional  supply 
from  outside  the  country  could  bring  about  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  the  relatively  low  elasticity  of  demand  for 
healthcare,  and 
treated 
the  already-identified  preference  of  patients 
domestically in any case.  

to  be 

For  receiving  countries,  there  are  potentially  both  advantages  and  disadvantages.  If 
providing  cross-border  care  undermined  domestic  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  such  effects  in  practice,  even  for  systems 
which have had significant volumes of cross-border healthcare for many years. 

There are also potential advantages: healthcare provision requires a critical mass of 
patients  to  enable  high-quality  services  and  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 service planning and provision 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 therefore are unlikely to seek healthcare abroad. 

The  impact  of  cross-border  healthcare  is  therefore  not  likely  to  bring  about  major 
changes to health systems overall, given that the size of cross-border healthcare will 
remain marginal, despite its importance to the individuals concerned. 

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45 

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5.1.3.3.  Analysis by inequalities between Member States 

As set out above, additional choice through cross-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  domestic  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  standards  elsewhere  may  help  to  improve  the 
quality of health services overall, both for 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  throughout  the  Union.  As  set  out  above,  this 
route  involves  greater  financial  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  Member  States  will  involve  a  significant 
additional financial cost.  

This  represents  more  fundamental  regional  disparities  in  healthcare  overall.  The 
Community  is  acting  to  address  these,  in  particular  through  investment  through 
structural funds, including specifically for health 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 any event. All of the policy options 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 action, the baseline scenario 

The key issue with this option is that it would leave the problems set out in chapter 2, 
and would not provide a Commission response to the clear requests for action from 
the  Parliament,  the  Council  and  other  stakeholders.  It  would  provide  flexibility  to 
Member States to address cross-border healthcare issues according 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 Community action on health services show a 
variety  of  interpretations  and  understandings  of  the  current  position,  which  are 
therefore  likely  to  persist  under  this  option.  It  is  clearly  difficult  for  individual 
Member States to address uncertainty over interpretation of Community law on their 
own,  with  the  consequence  of  the  continued  problems  identified  in  chapter  2. 
Moreover, continued uncertainty over who is responsible for ensuring the necessary 
requirements  for  safe  and  efficient  healthcare  in  the  case  of  cross-border  care  will 
compound reluctance to implement rights to reimbursement in practice.  

EN 

46 

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The  European  Commission  develops  and  backs  many  initiatives  to  improve  cross-
border  care  and  to  strengthen  European  cooperation.  Important  examples  are  the 
further  improvement  of  the  legislation  on  the  coordination  of  social  security  in 
Europe and the legislation on the recognition 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  identified  in  chapter  two.  In  particular,  the  updating  of  the  social 
security  coordination  regulations  covers  only  publicly-funded  healthcare  through 
statutory social security schemes, not other types of healthcare; it does not cover the 
direct  application  of  free  movement  rights  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 ensure a common standard of initial professional training 
for  health  professionals,  they  do  not  address  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  framework,  nor  do  they  ensure  clarity  over  which 
authority is responsible for ensuring monitoring and oversight 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  additional  treatment  costs  due  to  non-hospital  care,  as 
(assuming that Member States apply the Commission’s current interpretation of the 
Court’s  rulings)  hospital  care  will  be  dealt  with  through  the  regulations  on 
coordination of social security. We therefore 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-hospital 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-border 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 States in terms of costs of an individual 
treatment  and  possibility  for  citizens  to  afford  treatment  abroad  is  not  taken  into 
account. When patients use the possibilities of cross-border care created on the basis 

54 

Although the regulations could be considered to address 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 

47 

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of  the  free  movement  principle,  they  will  only  have  the  costs  reimbursed  up  to  the 
level of the costs of the treatment 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 
the 
the 
treated 
corresponding  increase  in  quality-adjusted  life  years  can  be  equated  to  a  monetary 
value of approximately € 98 million. 

through  cross-border  care, 

total  benefit  estimated 

through 

5.2.1.3.  Cost of compliance 

As stated earlier, the total compliance burden of no further action is estimated to be 
approximately € 500 million per year.  

Without any action to make the authorization 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 care is likely to remain at this level. 

5.2.1.4.  Administrative burden 

Under  this  option,  Member  States  will  still  need  to  provide  information  about  the 
principles set out by the Court, and how they can be exercised in practice, although 
without additional Community guidance about how to do so. Uncertainty over cross-
border  healthcare  combined  with  the  high  levels  of  potential  interest  from  citizens 
shown  above  will  result  both  in  a  high  demand  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  total  administrative  burden  for  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 scale of the administrative burden of Community action in 
this area, and the directions 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. 

5.2.1.5.  Wider economic impacts 

With no further action at Community level, the potential contribution of cross-border 
healthcare to national and European 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  reference  networks  will  lack  a  consistent 
framework of minimum requirements for safe and efficient healthcare, and are thus 
unlikely to realise their potential in practice.  

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5.2.2.  Environmental impact 

This option does not entail any significant environmental impacts, as it would mean 
only continuation of the existing system. There would be some additional transport 
use  for  cross-border  healthcare  (although  this  might  in  some  cases  represent  less 
distance travelled, where the nearest provider is in another Member State). However, 
as  outlined  above,  this  option  is  unlikely  to  realise  the  potential  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  means  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  would  be  no  additional  clarity  or  information  about  cross-
border  care  provided  at  Community  level.  The  lack  of  such  information  has  been 
clearly  identified  as  a  major  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 procedures 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 involved. 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 particularly the case for patients from lower socio-economic 
groups55. 

5.2.3.2.  Impact on health system as a whole 

As  outlined  above,  cross-border  care  can  provide  an  additional  choice  for  patients 
that  can  provide  an  additional  signal  to  help  bring  about  improvement  of  services. 
Given  the  likely  inequalities  in  use  of  cross-border  healthcare  described  above, 
however,  this  option  is  correspondingly  less  likely  to  bring  about  such  changes  in 
practice for ‘sending’ countries.  

For  receiving  countries,  the  lack  of  any  additional  clarity  about  the  tools  that 
Member States can use to manage their own systems and integrate cross-border care 
risks  undermining  domestic  planning  and  prioritisation,  with  a  corresponding 
negative effect on the equity and accessibility of health services overall.  

55 

Techniker  Krankenkasse  (TK),  Medizin  in  Europa:  Ergebnisse  der  TK-Mitglieder-Befragung  2003 
(2003); and Eurobarometer; and Eurobarometer 

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5.2.3.3.  Impact on inequalities between Member States 

As set out above, additional choice through cross-border care can act as a signal to 
focus attention on improving services, in particular for specialised services with little 
domestic  contestability.  The  lack  of  additional  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 interpretation 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  achieve  the  objectives  set  out  above.  This  is 
underlined by continued uncertainty on the specific 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  rights  to  healthcare  under  Community  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  State  without  prior  authorisation,  and  be 
reimbursed up to the level of reimbursement 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 Member 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 least 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 authorisation for care in another Member State, 
the reimbursement levels that will apply 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 stakeholders 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 suggests 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 

50 

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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 over 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 providing guidance at Community is unlikely to 
provide sufficient this certainty in practice. 

Feedback  from  all  relevant  stakeholders, 
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  stakeholders  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 current interpretation of the Court’s rulings) 
hospital  care  will  be  dealt  with  through  the  regulations  on  coordination  of  social 
security. Nevertheless, we assume that providing guidance at Community level will 
somewhat increase the take-up of cross-border 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.  Taking  the  example  of  eye 
surgery,  our  model  suggests  that  the  total  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-border 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  quality  of  life  is  then  (re-)gained  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. 

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51 

   EN 

 
If  we  continue  to  assume  that  this  option  will  lead  to  270,000  extra  patients  to  be 
treated outside their country of affiliation, total 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  would  be  a  way  to  slightly  reduce  the 
compliance  costs  related  to  the  authorisation  procedure  and  quality  control 
mechanisms for cross-border care. Member States would be able to exchange good 
practices and learn from each other to reduce the compliance costs. We assume that 
the  total  administrative  burden  of  the  actual  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  cooperation  on  Community  level  concerning  information 
provision might be a slightly more efficient and lead to more appropriate results, it is 
assumed  that  this  option  would  therefore  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 total administrative burden for the Union as 
a whole of around € 100 million per year, reduced by 20% to € 80 million per year.  

5.3.1.5.  Wider economic impacts 

With only soft action at Community level, the potential contribution of cross-border 
healthcare  to  national  and  European  objectives  is  unlikely  to  be  fully  realised  in 
practice.  Even  though  some  potential  economies  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 particular for planning purposes, when looking 
years ahead to plan necessary facilities, health 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  use  for  cross-border 
healthcare (although this might in some cases represent less distance 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 clear framework for safe and efficient cross-
border care, and thus will not enable the most efficient use of natural resources. 

EN 

52 

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5.3.3. 

Social impact 

5.3.3.1.  Impact on socio-economic groups 

This  option  would  provide  some  additional  information  to  patients  about  cross-
border care, and would thus address 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  application  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  guidance  at  Community  level  is  unlikely  to 
represent  a  sufficient  degree  of  certainty  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  terms,  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  Member  States  encounter  concerning  cross-
border care will continue to exist. For receiving 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  Member  States  to  improve  their  healthcare 
systems  and  to  reduce  differences  in  quality  between  Member  States.  The 
introduction  of  more  soft  action  would  further  facilitate  such  processes  and  thus 
contribute to a reduction 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  services.  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 impact 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 practice. As outlined above, 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  potentially  very 

EN 

53 

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serious  consequences  of  any  problems  for  cross-border  care  means  that  certainty 
about the applicable rules is likely to make them much 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 would leave flexibility to Member States 
to  implement  these  principles  in  practice  according  to  local  circumstances.  For 
reimbursement  issues,  this  option  would  ensure  a  clear  binding  set  of  rules  to  help 
ensure that free movement rights provided in principle by the Court can be realised 
in  practice.  These  rules  complement  the  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 described in sub-options 3a and 3b below). 

This  option  would  also  create  clear  binding  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  efficient  cross-border  healthcare  can  be 
achieved  by  having  that  healthcare  properly  integrated  into  existing  systems  of  the 
Member States, based on the principle of the country responsible being the country 
where the treatment is provided, with any specific 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  Community  provisions,  as  there  is  no  such 
framework  at  Community  level,  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 social 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 additional costs and benefits of increased cross-
border  healthcare  are  taken  into  consideration.  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  examinations.  Increasing  cooperation  in  cross-
border care could result in a further 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 overall option there are two sub-options which 
have  different  costs  and  benefits  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 allowed to go abroad, and any additional costs 
of  treatment  will  be  covered  by  public  funds  through  the  existing  regulations  on 
coordination  of  social  security  systems.  However,  sub-option  3A  would  also  allow 
patients  to  use  cross-border  care  for  hospital  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  above  what  would  have  been  covered  at 

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54 

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home.  Sub-option  3A  therefore  has  both  higher  costs  arising  from  cross-border 
treatment than sub-option 3B, and higher benefits through greater take-up. 

5.4.1.2.  Additional costs of cross-border healthcare treatment for public funds 

To  evaluate  the  additional  costs  of  cross-border  healthcare  treatment  for  public 
funds, we apply the model set out in section 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  replacement).  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  treatment  of  sub-option  3A  for  non-hospital  care 
would therefore be € 3.1 million (390,000 patients multiplied by an additional cost of 
€8  per  operation  through  earlier  reimbursement).  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  hospital  care  would  be  roughly  €  5.6  million,  for 
Poland  €  2,7  million;  for  Hungary  €  285,000;  and  for  Ireland  approximately 
€100,00056 

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 total 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 from 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  this  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  legal  framework  at  Community  level  is  likely  to  reduce  the 
overall compliance cost in comparison with the current situation. By providing legal 

56 
57 

For a more detailed calculation see paragraph 5.2.1 of this report. 
Again, for a more detailed calculation see paragraph 5.2.1 of this report. 

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55 

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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  provide  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  care.  In  a  formula  this  calculation  would 
have the following shape (where T1 = compliance 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 concerned and TC = total 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 continuity 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 costs 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 current situation. We therefore assume that 
these costs reduce by a similar proportion as with 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  increasing  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  fulfil  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  should  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 quality care will provide sufficient basis for 
patients  and  providers  to  take  full  advantage  of  the  potential  of  cross-border  care 
where  this  is  appropriate,  with  consequent  contribution  to  cooperation  and 

EN 

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comparison between Member States that will contribute to improving access, quality 
and financial sustainability.  

5.4.2.  Environmental impact 

With  this  option,  one  has  to  also  look  more  closely  at  the  potential  environmental 
impacts, in particular related to the increased 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 cross-border healthcare would take place in 
the border regions (i.e. patients travelling a shorter distance across the border rather 
than  travelling  to  a  major  city  in  their  Member  State)  would  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  advantage  of  economies  of  scale  from  cross-
border  care,  this  option  would  also  contribute  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  different  resources  of  different  socio-
economic groups will clearly be a factor in affecting 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  issue  will  be  more 
important  for  more  expensive  care,  clearly).  However,  the  certainty  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  contest  these  formally  through  legal  proceedings, 
that  their  legal  rights  are  clear.  By  providing  this  legal  certainty,  this  option  will 
therefore  help  to  improve  the  equity  of  cross-border  care  through  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  alternatives,  which  is  also  likely  to  be 
particularly important for hospital care. By providing such a mechanism for all socio-
economic groups, increasing choice for hospital 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 help to improve equity overall.  

The  impact  of  a  legal  framework  in  requiring  information  provision  and  itself 
helping  to  raise  awareness  of  the  option  of  cross-border  care  will  help  to  address 
unequal levels of knowledge between different social groups. 

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5.4.3.2.  Impact for health systems as a whole 

Although  this  option  would  establish  a  legal  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’  endorsed  by  the  Council,  this  legal  framework 
should  not  add  additional  obligations,  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  separate  specific  set  of  obligations  for  cross-
border  care,  this  approach  therefore  ensures  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 set 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  restructuring  of  demand  control 
mechanisms.  Also  as  set  out  above,  the  experience  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 control of costs, there is a difference 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 reimbursed (the costs are reimbursed up 
to  the  level  of  the  cost  of  the  same  treatment  at  home).  Without  an  authorisation 
procedure, the costs are not limited by restricting patients to go abroad. Nevertheless, 
as explained above, total financial impact of this option will be limited. Under option 
3B,  the  public  authorities  partly  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 Member 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  control  for  Member  States  for  cross-border 
hospital  care,  but  as  already  set  out  above,  evidence  to  date  suggests  that  the  total 
impact  of  cross-border  hospital  care  will  remain  low  in  the  long  term.  Ultimately, 
patients  prefer  to  have  healthcare  (especially  hospital  care)  as  close  to  home  as 
possible.  Provided  that  all  Member  States  continue  meet  the  needs  of  the  vast 
majority  of  their  population  within  their  own  systems,  the  overall  impact  of  cross-
border hospital care will continue to be low, even if the absolute numbers concerned 
are likely to rise somewhat and despite its importance for the individuals concerned.  

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5.4.3.3.  Impact on inequalities within and between Member States 

By  helping  to  realise  the  full  potential  of  cross-border  care  and  thus  maximising 
access for patients for whom cross-border care is more geographically appropriate, or 
patients  requiring  particularly  specialised  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  framework  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.  However,  this  would  represent  a  significant 
degree  of  harmonisation  of  healthcare  issues  in  Community  law,  which  would 
include a significant additional administrative 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  health  care  systems,  given  the  limits 
provided  by  the  Treaty  (art.152.5  EC).  Member  States  have  different  backgrounds 
and  different  healthcare  systems.  This  diversity  makes  a  'top  down'  approach  to 
Community action as the case for this option potentially unfeasible and ineffective in 
several instances. This is especially true for harmonising healthcare systems, because 
of  the  difficulty  of  achieving  consensus  about  what  direction  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  many  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  compromise,  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 stakeholders will be difficult to obtain. It is 
therefore unlikely to be appropriate or desirable to oblige Member States to follow a 
uniform organisation of health systems, which may not be the most appropriate for 
that specific country. 

5.5.1.  Economic impacts 

As  regards  economic  impacts,  this  option  would  provide  a  detailed  framework 
applicable  throughout  the  Union,  which  would  increase  confidence  of  the  patients 
also in healthcare provided in other Member States. This, together with appropriate 
information,  would  enable  them  to  make  informed  choices  and  increase  the 
opportunities  to  benefit  from  the  cross-border  healthcare.  However,  it  would  be 
extremely difficult to implement this detailed binding system in a short term, due to 
the  existing  great  variety  of  organisation,  financing  and  delivery  of  healthcare 
services  among  (and  also  within)  the  Member  States.  This  option  would  also  not 
allow  flexibility  to  take  into  account  particular  regional  or  local  needs  and 
circumstances. 

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5.5.1.1.  Additional treatment costs due to cross-border care 

The  financial  impact  of  this  option  would  be  comparable  with  option  3A.  By 
increasing clarity and certainty through the introduction of a new detailed regulation 
and  by  improving  information  about  advantages  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  would  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 comparable with option 3A. Higher quality 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 financial terms this means, compared to no action, 
a reduction of costs of € 400 million from € 500 to € 100 million.  

However, such a detailed pan-European system would undoubtedly also significantly 
raise the compliance costs for the Member States, 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 effort in bringing their healthcare systems up to date, this 
option  would 
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 healthcare 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.  

therefore  have  adverse  effects  on  regional 

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  environment  for  Member  States  with  regard  to  providing 

58 

For a more detailed calculation see paragraph 5.4.4 of this report. 

EN 

60 

   EN 

 
                                                 
information  than  the  current  situation.  We  therefore  assume  that  these  costs  reduce 
by a similar proportion as with the overall costs 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 implementing such a system, as outlined above. 

5.5.1.5.  Wider economic impacts 

This  option  would  have  a  positive  contribution  to  wider  objectives  by  enabling  the 
full potential of cross-border care to be realised, and thus to maximise the potential 
contribution from economies of scale and sharing best practice through comparison 
and cooperation. However, it would come at a high cost, with major expenditure and 
systemic  change  required  to  implement  detailed  harmonising  requirements  at 
European level. Given those high costs, it seems unlikely that this option would be of 
overall benefit to health systems as a whole or to the overall economy, the potential 
benefits of cross-border care being outweighed by the costs of substantial regulatory 
harmonisation of health systems across Europe. 

5.5.2.  Environmental impact 

As this option would enable patients to make informed choices involving also cross-
border healthcare, one may expect increased mobility of patients and health services 
providers  and  thus  the  increased  demand  for  transport,  as  with  the  previous  two 
options. However, volume of patient mobility would always be limited due to factors 
such  as  inconvenience  for  sick  people  to  travel,  distance  from  the  relatives  or 
language barrier. Moreover, a large proportion of cross-border healthcare would take 
place  in  the  border  regions,  so  patients  do  not  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 would provide guarantees to the patients about 
quality and safety of health services and 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 quality 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  towards  significant 
European harmonisation. 

If there were a clear 'correct' model of health system organisation and there could be 
reasonable  grounds  for  assuming  that  European  harmonisation  would  help  to  make 
progress  towards  such  a  model,  then  it  might  be  possible  to  envisage  long-term 
benefits  in  achieving  overall  health  system  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 

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others.  Moreover,  as  all  EU  health  systems  seek  to  constantly  improve  their 
efficiency and effectiveness, the variety of approaches taken within the EU provide a 
unique  resource  of  comparison  and  mutual  learning  of  the  advantages  and 
disadvantages of the various approaches taken toward shared goals.  

Substantive  regulatory  harmonisation  at  European  level  would  therefore  lose  the 
benefits of current comparison and mutual learning, without any guarantee of putting 
in  place  a  'better'  system,  but  with  certain  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 contribute most to a decrease of inequalities 
between  Member  States  in  the  long  term.  However,  this  option  would  require 
fundamental changes in the national healthcare and social security systems. Although 
the healthcare systems across the European Union share certain common values and 
principles, the practical ways in which these values and principles are implemented 
in the national health systems vary significantly59 These diverse systems are based on 
different national traditions, geographic organisation of each Member State, different 
distribution  of  competences  between  central,  regional  and  local  authorities  and 
different modes of healthcare funding. The attempt to achieve uniform application of 
detailed European rules among those national 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 regulatory harmonisation of health systems would 
place a particularly heavy burden on the poorer Member States. Given their existing 
limited healthcare budgets and administrative capacity, also because they need to put 
already much effort in bringing their healthcare systems up to date, this option would 
therefore have adverse effects on regional inequalities in the short term, at least. 

59 

See the Council statement on common values and principles. 

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62 

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6. 

COMPARING THE OPTIONS 

Table 6.1 Impact of each option presented in financial terms60 

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 

On the basis of table 6.1 it is possible to compare the different options in financial 
terms. The calculations and modelling on which 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  will  create  an  increase  in  treatment  costs. 
The  more  patients  receiving  healthcare  abroad,  the  larger  the  increase  of  treatment 
costs will be. Where under option 1, the baseline scenario with only a very limited 
increase in cross-border care, additional treatment 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 remain nevertheless marginal compared to 
the increased treatment benefits, which also increase with the increase 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  impact  assessment  makes  clear  that  with  the 
creation  of  more  legal  certainty  and  clarity  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 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  costs.  By  creating  more  clarity  and  legal 
certainty,  information  provision  becomes  cheaper  and  easier.  By  creating  more 
clarity about possibilities for cross-border care, 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. 

EN 

63 

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Table 6.2 Comparison of the impacts of each of the options in qualitative terms 

Advantages 

Disadvantages 

Flexibility  for  Member  States  to  tackle  identified 
objectives themselves.  

Difficulty for Member States to develop action on 
their  own,  because  of  the  scope  and  nature  of  the 
problem.  

Likely costs of treatments low, and outweighed by 
benefits; though overall costs of administering the 
system outweigh the likely benefits to patients. 

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. 

Flexibility  for  Member  States  to  increase  legal 
clarity  and  certainty  concerning  cross-border 
healthcare,  combined  with 
some  additional 
guidance at European level.  

Guidance  unlikely  to  provide  sufficient  certainty 
for  either  patients  or  professionals,  given  the 
importance of the issues at stake. 

Some  improved  realisation  of  the  potential  of 
cross-border care; likely costs of treatment remain 
low.  

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 
the 
estimated benefits to patients.  

than 

EN 

64 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4

Ensures  sufficient  binding  clarity 
to  enable 
patients and professionals to take full advantage of 
cross-border  care,  whilst  avoiding  a  significant 
additional burden for Member States.  

Will  set  binding  obligations  on  health  services 
overall  at  European  level,  though  these  reflect 
already-agreed political principles.  

Does  most  to  overcome  social  inequality  in 
utilisation  of  cross-border  care  by  minimising 
financial 
guaranteeing 
reimbursement.  

through 

risk 

Enables full potential of cross-border healthcare to 
support  wider  health  system  objectives  through 
comparisons and cooperation 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: 
treatment than sub-option 3A.  

lower  additional  costs  of 

Highest  possible  legal  clarity  and  uniformity  for 
all 
cross-border 
healthcare.  

stakeholders 

concerning 

Guarantees for patients about quality and safety of 
health services. 

Maximum 
Member States. 

reduction  of  disparities  between 

Sub-option 3B: lower benefits to patients, with no 
clear net benefit comparable to the overall costs of 
the system. 

to  adopt 
No  flexibility  for  Member  States 
community 
in  national 
circumstances  and  makes  it  therefore  difficult  for 
them to implement. 

to  differences 

rules 

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 
information 
provision  for  patients  and  collection  of  data  on 
cross-border healthcare.  

reimbursement 

rules, 

Preferred Option 

Under option one the current problems identified in chapter two continue, with rights 
to  reimbursement  for  cross-border  healthcare  through  direct  application  of  free 
movement  principles  established  in  theory  but  difficult  to  use  in  practice,  and  no 
clear  framework  for  ensuring  minimum  requirements  for  safe  and  efficient  cross-
border  healthcare.  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  the  uncertainties  identified  in  chapter  two  in 
practice, compounded by social inequity in how the limited benefits 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 catastrophic consequences of problems with cross-border care, 
merely having guidance about cross-border care is not enough, either for patients or 
professionals.  So  the  costs  of  cross-border  care  continue  but  without  its  potential 
benefits being fully realised. 

EN 

65 

   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 equity in its usage by providing certainty of 
reimbursement  to  compensate  for  differences  in  initial  resources,  whilst  also 
allowing  citizens  to  exercise  as  much  choice  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  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. As set out in chapter four, under either sub-option if the appropriate 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 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 hospital care if it suits them better, provided 
that  they  are  willing  to  cover  any  additional  costs  above  what  would  have  been 
covered at home. By maximising the potential access to cross-border care, this sub-
option  is  the  only  one  where  the  likely  value  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  benefits,  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. 

MONITORING 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. There is a general consensus that 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 problem. It is therefore important that this 
initiative  contains  a  proposal  to  strengthen  the  data  availability.  Only  with  more 
structural data available, it will be possible to see whether the solutions implemented 
have the effect hoped for. Data are not only 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  reason.  On  that  basis  they  can  plan  their 
healthcare service better and adjust the availability of healthcare services within the 
border of the country. 

7.2.  Monitoring mechanism 

Parallel  to  that,  the  Commission  will  develop  a  monitoring  mechanism  to  monitor 
whether  this  initiative  is  appropriately  implemented  in  each  of  the  Member  States. 
Within  3  years  after  the  date  the  initiative  enters  into  force,  the  Commission  will 

EN 

66 

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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 Member States, collect data 
on the actual amount of citizens receiving healthcare abroad. It will also periodically 
measure  the  awareness  of  EU-citizens  concerning  their  rights  and  the  possibilities 
concerning cross-border care. The Commission will, in cooperation with the Member 
States, investigate how in each country citizens are informed about 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  comitology  committee.  This  committee  will 
adopt  measures  necessary  for  the  implementation  of  the  directive.  For  example 
mechanisms will have to be developed for the collection of appropriate information 
and data on cross-border healthcare, as mentioned in the directive. Detailed rules will 
have to be agreed upon concerning requirements for Member States to send regularly 
appropriate  data  on  cross-border  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 general and in the context of the forthcoming 
EP-Council  Regulation61  on  Community  statistics  on  public  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 
62 

COM(2007)46 final 
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. 

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Table  8.1  Main  reasons  for  unmet  need  for  medical  examination  and  treatment 
(2005)

Country 

Could not afford 
(too expensive) 

Too far too travel / 
no transportation 

Waiting list 

Other* 

No unmet need 

Austria 
Belgium 
Cyprus 
Czech Re p 
Germany 
Denmark 
Estonia 
Spain 
Finland 
France 
Greece 
Hungary 
Ireland 
Italy 
Lithuania 
Luxembourg 
Latvia 
Malta 
Ne therlands 
Poland 
Portugal 
Sweden 
Slovenia 
Slovakia 
United Kingdom 

0.23%** 
0.68% 
2.95% 
0.32%** 
6.69% 
# 
2.74% 
0.41% 
1.41% 
1.24% 
3.44% 
2.44% 
1.06% 
3.14% 
3.65% 
0.35%** 
17.01% 
1.01% 
# 
7.13% 
3.77% 
0.50%** 
# 
2.52% 
# 

# 
# 
# 
0.47%** 
0.14%** 
# 
0.81% 
0.19% 
# 
# 
0.45% 
0.37% 
# 
0.09%** 
0.39%** 
# 
0.62%** 
# 
# 
0.44% 
# 
# 
# 
0.19%** 
# 

# 
# 
# 
0.40%** 
1.74% 
# 
2.15% 
0.70% 
0.98% 
0.21%** 
0.62% 
0.73% 
0.65% 
1.36% 
2.32% 
# 
1.72% 
0.50%** 
0.28%** 
2.26% 
0.77% 
2.02% 
# 
0.34%** 
2.14% 

1.57% 
0.24%** 
2.76% 
5.95% 
7.93% 
0.81%** 
2.55% 
4.87% 
0.93% 
2.10% 
1.66% 
12.56% 
0.51% 
2.11% 
2.89% 
4.30% 
10.27% 
2.12% 
0.97% 
6.32% 
0.77% 
12.38% 
0.19%** 
4.80% 
2.96% 

98.04% 
99.04% 
94.13% 
92.86% 
83.49% 
98.94% 
91.75% 
93.84% 
96.62% 
96.42% 
93.83% 
83.90% 
97.67% 
93.30% 
90.75% 
95.23% 
70.38% 
96.35% 
98.57% 
83.85% 
94.56% 
85.00% 
99.48% 
92.15% 
94.77% 

Source:  EU-SILC  (2007);  *“Other”  includes:  (1)  Could  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  example,  17%  of  Latvians  state  that  they 
could not afford at least one medical examination or treatment they needed (in 2005). 
Other  figures  that  stand  out  in  this  respect  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  the  introduction  of  €10  co-payments  for 
every first visit to a physician in 2004. Polish data do not correlate with the official 
co-payment  requirements  (officially  none  for  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 care 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  the  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 population is currently on a waiting list, which 
is equivalent to approximately 7,8 million EU citizens. 

EN 

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It  is  stated  that  some  Member  States  use  waiting  lists  as  an  instrument  to  contain 
costs.  When  legal  clarity  concerning  cross-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 avoid waiting lists. Some argue that Member 
States will in that case use other instruments 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.  Dental  treatment  is  a  healthcare  field 
subjected  to  many  cost  sharing  policies  already.  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  existence  of  waiting  lists  and  introduction  of  co-payment  are 
reasons for increased cross-border mobility of patients. This increase of cross-border 
healthcare,  a  specific  from  of  health  tourism,  is  not  linked  to  the  discussion  about 
clarity and legal certainty aspects of authorization and reimbursement of cross-border 
care, nevertheless the quality and safety aspects of this type of cross-border care need 
to be stressed. 

Table 8.2 Main reasons for unmet need for dental examination and treatment in 2005 

Country 

Austria 

Belgium 

Cyprus 

Czech Re p 

Germany 

Denmark 

Estonia 

Spain 

Finland 

France 

Greece 

Hungary 

Ireland 

Italy 

Lithuania 

Luxembourg 

Latvia 

Malta 

Ne therlands 

Poland 

Portugal 

Sweden 

Slovenia 

Slovakia 

United Kingdom 

Hurdle 3: Could not 
afford (too 
expensive) 

Hurdle 4: Too far 
too travel / no 
means of 
transportation 

Hurdle 6: Waiting 
list 

Other* 

No unmet nee d 

0.23%** 

# 

# 

# 

0.54% 

# 

0.29%** 

# 

1.39% 

0.14%** 

0.17%** 

0.38% 

0.25%** 

0.75% 

1.00% 

# 

0.57%** 

# 

# 

1.52% 

0.27%** 

0.39%** 

# 

0.26%** 

4.09% 

1.38% 

1.14% 

6.99% 

4.34% 

5.47% 

2.54% 

1.28% 

4.59% 

2.30% 

2.76% 

1.83% 

7.83% 

1.48% 

3.43% 

1.49% 

3.55% 

5.78% 

2.73% 

5.24% 

5.05% 

2.21% 

5.95% 

# 

3.23% 

1.35% 

97.48% 

97.20% 

86.84% 

94.84% 

87.75% 

95.48% 

86.48% 

91.20% 

93.42% 

93.77% 

92.84% 

85.18% 

96.58% 

89.71% 

88.53% 

95.71% 

70.85% 

95.93% 

93.28% 

83.51% 

89.58% 

87.44% 

99.37% 

92.43% 

93.75% 

0.85% 

1.56% 

5.92% 

0.51%** 

6.13% 

1.76% 

11.63% 

4.07% 

2.82% 

3.24% 

5.00% 

6.51% 

1.64% 

6.03% 

8.85% 

0.69% 

22.60% 

1.19% 

1.25% 

9.77% 

7.85% 

6.16% 

# 

4.03% 

0.73% 

# 

# 

# 

# 

0.12%** 

# 

0.32%** 

0.11%** 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

# 

0.15% 

# 

# 

# 

# 

# 

69 

   EN 

EN 

 
 
 
 
 
 
 
 
 
 
Source:  EU-SILC  (2007);  *“Other”  includes:  (1)  Could  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  cross-border  healthcare  undertaken  through  the 
regulations on coordination of social security. These data are presented in table 8.3. 

Table 8.3 Claims for/on countries under Council Regulation (EEC) No.1408/71 in €,  
% of total and € per capita for 2004 

Country 

Austria 
Belgium 
Switzerland 
Cyprus 
Czech Re public 
Denmark 
Estonia 
Finland 
France  
Ge rmany 
Greece  
Hungary 
Iceland 
Ireland 
Italy 
Lithuania 
Luxembourg 
Latvia 
Malta 
Ne therlands 
Norway 
Poland 
Portugal 
Sweden 
Spain 
Slovenia 
Slovakia 
Unite d Kingdom 
Total 

Claims from other countries (de bt) 
% 
€ (1000) 
1.99 
24.321 
9.19 
112.084 
1.01 
12.321 
0 
0 
0.01 
174 
0.53 
6.440 
0 
1 
0.80 
9.802 
8.52 
103.927 
24.20 
295.232 
5.17 
63.067 
0 
14 
0.05 
569 
0.52 
6.303 
12.95 
157.961 
0 
5 
6.03 
73.537 
0 
2 
0 
0 
6.07 
74.006 
0.91 
11.161 
0.01 
131 
4.80 
58.552 
0.78 
9.483 
3.06 
37.349 
0.02 
281 
0 
52 
13.36 
163.001 
100 
1.220.194 

€ / capita 
2.96 
10.73 
1.66 
0 
0.02 
1.19 
0 
1.87 
1.72 
3.58 
5.69 
0 
1.94 
1.53 
2.70 
0 
161.62 
0 
0 
4.54 
2.42 
0 
5.56 
1.05 
0.87 
0.14 
0.01 
2.72 
2.59 

Claims on other countries (cre dit) 
% 

€ (1000) 

72.255 
66.564 
73.514 
0 
0 
1.634 
0 
3.173 
346.235 
154.068 
8.693 
0 
750 
0 
130.452 
0 
58.48 
0 
15 
42.651 
1.191 
218 
40.182 
17.179 
155.772 
1.989 
0 
45.011 
1.220.194 

5.92 
5.46 
6.02 
0 
0 
0.13 
0 
0.26 
28.38 
12.63 
0.71 
0 
0.06 
0 
10.69 
0 
4.81 
0 
0 
3.50 
0.10 
0.02 
3.29 
1.41 
12.77 
0.16 
0 
3.69 
100 

€/ capita 
8.80 
6.37 
9.91 
0 
0 
0.30 
0 
0.61 
5.72 
1.87 
0.78 
0 
2.55 
0 
2.23 
0 
128.90 
0 
0 
2.62 
0.26 
0.01 
3.82 
1.91 
3.62 
1.00 
0 
0.75 
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  outstanding  claims  under  the  regulation  on 
coordination of social security at the end of 2004. These figures represent only a part 
of  total  cross-border  healthcare.  There  are  several  reasons  why  the  figures  in  the 
above  mentioned  table  are  an  underestimation  of  the  actual  dimensions  of  cross-
border healthcare: 

63 

EN 

In: 
Belges, 
http://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co83.pdf 

Commission 

contribution 

consultation 

Mutualités 

70 

see 

   EN 

 
 
                                                 
–  The  data  may  (often)  exclude  those  patients  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 report utilisation and cost data; 

–  Several  public  payers,  maintain  cross-border  collaborations  outside  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 'travel insurance' for their holiday; or 

–  Patients  may  deliberately  choose  (under  the  "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-border  services/goods  and  then  ask  for 
(partial) reimbursement. 

A  survey  among  insured  members  of  the  German  TK  sickness  fund  showed  that  a 
relatively  low  percentage  of  patients  has  been  able  to  use  their  E111-form  (now 
EHIC),  when  they  were  in  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,  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) 

–  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  social  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 

71 

   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. 

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