REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Commission Report on the operation of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare
Date: 2015-09-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: application of EU law, consumer information, cross-border cooperation, free movement of persons, health care, health expenditure, patient's rights, provision of services

EUROPEAN 
COMMISSION 

Brussels, 4.9.2015  
COM(2015) 421 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Commission Report on the operation of Directive 2011/24/EU on the application of 
patients’ rights in cross-border healthcare 

EN 

   EN 

 
 
 
 
  
 
Commission  Report  on  the  operation  of  Directive  2011/24/EU  on  the  application  of 
patients’ rights in cross-border healthcare 

Directive  2011/24/EU1  (hereafter  ‘the  Directive’)  on  the  application  of  patients’  rights  in 
cross-border  healthcare  came  into  force  on  24 April 2011.  It  was  due  to  be  transposed  by 
Member States by 25 October 2013. It clarifies the rights of patients to seek reimbursement 
for healthcare received in another Member State. 

Article 20(1) of the Directive requires the Commission to ‘draw up a report on the operation 
of  this  Directive  and  submit  it  to  the  European  Parliament  and  to  the  Council’  by 
25 October 2015,  and  every  three  years  thereafter.  The  report  was  to  include,  in  particular, 
information on patient flows, financial dimensions of patient mobility, the implementation of 
Article  7(9)  and  Article  8,  and  on  the  functioning  of  the  European  reference  networks  and 
national contact points. 

This report sets out the current state of play of transposition, and covers the most important 
and relevant provisions, such as the use of prior authorisation, the level of patient mobility, 
reimbursement practices, information to patients and cooperation under the Directive. It also 
report  on  the  use  of  delegated  powers  pursuant  to  Article  17(1)  of  the  Directive,  which 
requires the Commission to report on these by 24 October 2015. 

Chapter 1: State of play of transposition 
The transposition deadline for the Directive was 25 October 2013. Infringement proceedings 
were launched against 26 Member States on the grounds of late or incomplete notification of 
such measures. 

As of 1 July 2015, four infringement proceedings remained open, and all four Member States 
concerned had made firm commitments to address the outstanding issues.   

These infringements relate only to the completeness of transposition measures. The next stage 
for  the  Commission  is  to  assess  whether  Member  States  have  transposed  the  Directive 
correctly. 

 Chapter 2: Patient mobility 

2.1 Prior authorisation: background 

Article 8(2)(a) of the Directive allows Member States to use a system of prior authorisation 
for  healthcare  that  is  subject  to  planning  requirements  if  it  involves  overnight  hospital 
accommodation  or  if  it  requires  use  of  highly  specialised  and  cost-intensive  medical 
infrastructure or medical equipment. Articles 8(2)(b) and (c) also allow them to require prior 
authorisation  for  treatments  presenting  a  particular  risk  to  patients  or  the  population  or  for 

1 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of 
patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 

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care  provided  by  a  healthcare  provider  that  gives  rise  to  serious  concerns  relating  to  the 
quality and safety of care.  However, in practice, prior authorisation systems are based almost 
entirely on Article 8(2)(a), on which this report will therefore focus. 

Any system of prior authorisation must be necessary and proportionate to the objective to be 
achieved, and may not constitute a means of arbitrary discrimination or an unjustified obstacle 
to the free movement of patients. 

Article  8(7)  of  the  Directive  requires  Member  States  to  ‘make  publicly  available  which 
healthcare is subject to prior authorisation’. 

Member States have introduced prior authorisation systems as follows. 

Fourteen countries therefore use both the “overnight stay” and the “highly specialised” care 
criteria for requiring prior authorisation. 

None of the 14 countries which have used the ‘overnight stay’ criterion has specified which 
treatments are covered by this criterion. 

Several Member States require prior authorisation if the healthcare requires an overnight stay 
in the Member State of treatment. It is questionable whether this is in line with the criterion in 
Article  8(2)(a),  which  relates  to  the  way  treatment  is  provided  in  the  Member  State  of 
affiliation rather than the Member State of treatment. 

Nine of the 14 Member States have set out which treatments they consider to meet the ‘highly 
specialised’ criterion, whilst five have not. 

In these 14 Member States, therefore, it is unclear for patients exactly which treatments are 
subject to prior authorisation, since the use of at least one of these criteria — and sometimes 
both — has not been elucidated by national authorities.   

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Interviews with 20 health insurers as part of an evaluative study2 on behalf of the Commission 
found that 15 of them thought that patients in their country do not know whether a treatment 
is  subject  to  prior  authorisation  or  not,  and  that  patients  therefore  tended  to  request  prior 
authorisations even when this was not necessary. 

As  outlined  in  recital  43  of  the  Directive,  the  criteria  attached  to  the  grant  of  prior 
authorisation have to be duly justified. The data returns made by Member States, in general, 
do  not  suggest  that  extensive  systems  of  prior  authorisation  are  justified:  the  numbers  of 
people applying for authorisation are simply too small. It seems hard to argue, for example, 
that a treatment should be subject to prior authorisation when not a single person has applied 
for  authorisation  for  that  treatment  that  year  (with  a  possible  exception  for  extremely 
specialised  or  expensive  treatments,  of  course,  where  even  a  very  small  number  of 
reimbursement claims could have significant consequences). The data in Annex A shows that 
some  Member  States  with  prior  authorisation  systems  have  received  no  requests  for 
authorisation at all (and many others have received very few).   

2.2 Reimbursement and administration 

Article 7(9) permits Member States to limit the application of the rules on reimbursement of 
cross-border  healthcare  for  overriding  reasons  of  general  interest.  However,  Article  7(11) 
requires that such limitations be necessary and proportionate, and do not constitute a means of 
arbitrary  discrimination  or  an  unjustified  obstacle  to  free  movement.  Furthermore,  Member 
States  are  required  to  notify  the  Commission  of  any  decision  to  introduce  limitations  under 
7(9). 

Although the Commission has received no specific notifications, some of the ways in which 
Member States have transposed the Directive could be considered as limiting reimbursement. 

According  to  Article  7(4)  of  the  Directive,  the  reference  point  for  reimbursement  for  cross-
border healthcare should be the amount borne by the system when that particular healthcare is 
provided by a public or contracted healthcare provider (depending on the way a given health 
system is organised) in the Member State of affiliation. 

At  least  three  Member  States  have  adopted  reimbursement  practices  for  cross-border 
healthcare whereby the reimbursement tariff for patients is based on the costs that would be 
borne by  the  Member State of affiliation for  care received from a private or  non-contracted 
provider  (which  is  considerably  lower  than  the  rate  for  public  or  contracted  providers)  had 
this healthcare been provided in its territory. 

Three  Member  States  appear  to  require  any  patient  seeking  reimbursement  for  cross-border 
healthcare  to  demonstrate  why  it  is  medically  necessary  for  the  particular  episode  of 
healthcare to be received in another country. It is questionable whether this is in line with the 
principle of free movement of patients and with the criteria set out in Articles 7(9) and 7(11). 

2  http://ec.europa.eu/health/cross_border_care/docs/2015_evaluative_study_frep_en.pdf.   
A note on the evaluative study is attached in Annex B of this report. 

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Article  7(7)  of  the  Directive  allows  Member  States  to  impose  the  same  conditions  and 
formalities on patients seeking cross-border healthcare as they would impose if the healthcare 
were  provided  in  their  territory,  provided  that  these  are  not  discriminatory  and  do  not 
constitute an unjustified obstacle to free movement. 

Twelve  Member  States  have  used  this  provision  with  regard  to  their  ‘gatekeeper’  structure, 
which is a system whereby a referral from a GP or family doctor is required for a patient to 
access specialist healthcare. Therefore such referrals are also required in order for patients to 
be  reimbursed  when  they  access  such  specialist  healthcare  in  another  Member  State. 
According to  the principle of  mutual  recognition of  qualifications, however, Member  States 
should recognise decisions about clinical need and appropriateness provided by an equivalent 
professional in another Member State. Yet five of these twelve Member States explicitly insist 
that the referral must be from a professional in their country. 

At least four Member States require patients to provide a sworn translation of invoices (one 
even  requiring  patients  to  get  all  documents  certified  by  their  consul  in  the  country  of 
treatment). However, Article 10 of the Directive obliges National Contact Points to assist each 
other in understanding invoices. This requirement will therefore need to be analysed under the 
conditions of Article 7(7). 

The application of the Directive to ‘telemedicine’ (i.e. health services provided remotely) has 
led  to  a  certain  lack  of  clarity.  For  example,  some  Member  States  reimburse  or  provide 
consultations with general practitioners at a distance, whilst others do not. If a patient from a 
Member  State  where  such  consultations  are  not  provided  or  funded  has  a  consultation  via 
telemedicine with a GP in a Member State where such consultations are so provided, it is not 
clear whether the Member State of affiliation may, in such a case, refuse reimbursement. On 
the one hand, reimbursement for cross-border healthcare is to be provided if such healthcare is 
among the benefits to which the insured person is entitled in the Member State of affiliation 
(Article 7(1)) and the Member State of affiliation may impose, including in case of healthcare 
received through telemedicine, the same conditions and criteria of eligibility as for healthcare 
provided in its territory. On the other hand, Article 4(1)(a) lays down the principle whereby 
healthcare  is  provided  in  accordance  with  the  legislation  of  the  Member  State  of  treatment 
and, in the case of telemedicine, healthcare is considered to be provided in the Member State 
where the healthcare provider is established (Article 3(d)). One relevant issue here is how the 
‘basket of benefits’, i.e. the healthcare to which the patient is entitled, is defined. 

2.3 Patient flows 

For  this  report,  the  Commission  asked  Member  States  to  participate  in  a  data  collection 
exercise. Twenty-six Member States provided responses, covering the calendar year 2014.   

Patient flows for healthcare abroad under the Directive are low. Of the 21 Member States who 
introduced a system of prior authorisation, 17 were able to supply data on numbers of requests 
for authorisation specifically under the Directive. In these Member States there were a total of 
only 560 applications for authorisation  (of which 360  were granted).  Two  of  these Member 
States reported that they had neither refused nor granted a single request, two reported only 
one each, and only two had more than 100 requests. In addition to these 17 Member States, 

5 

 
 
France  reported  granting  57 000  authorisations;  however,  this  is  an  aggregate  figure 
combining authorisations under both the Social Security Regulations3 and the Directive.   

For  treatment  not  subject  to  prior  authorisation,  Finland,  France  and  Luxembourg  reported 
considerable  activity,  with  17142,  422680  and  117962  reimbursements  respectively.  
However,  again,  these  are  aggregate  figures  combining  data  from  both  the  Social  Security 
Regulations and the Directive.   

Twenty Member States reported data on reimbursement made exclusively under the Directive. 
For  these,  a  total  of  39 826  reimbursements  were  made,  of  which  31 032  were  reported  by 
Denmark  alone.  In  total,  only  four  of  these  Member  States  reported  more  than  1 000 
reimbursements. At  the  other  end  of  the scale, 14 Member States had  made fewer than 100 
reimbursements (of which six had made no reimbursements at all). This seems to be due to 
low numbers of claims rather than large numbers of refusals: the available data suggests that 
roughly 85 % of reimbursement claims are granted. 

This  generally  low  volume  of  patient  mobility  for  planned  healthcare  appears  to  be  equally 
the case for care under the Social Security Regulations. In 2013 there were 1.6 million claims 
for  reimbursement  for  unplanned  healthcare  but  only  30 172  applications  for  planned 
healthcare abroad under the Regulations (via the S2 form used in such cases). Of the latter, 
29 115 were accepted4 — 17 358 in Luxembourg alone. 

A  detailed  breakdown  of  data  may  be  found  in  Annex  A,  which  also  sets  out  various 
qualifications  regarding  the  data  collection  exercise,  not  least  that  the  Directive  was 
implemented at different times in different Member States and data may not therefore cover 
all of 2014).   

The  report  under  Article  20(3)  of  Directive  2011/24/EU  which  the  Commission  adopted  in 
early 2014,5 noted that the coming into operation of the Directive could affect the use of the 
Social Security Regulations. That report set out in detail the data which would be needed to 
assess  whether  this  had,  in  fact,  happened.  As  things  stand,  that  data  is  unavailable  and  the 
Commission is, therefore, unable to make any further analysis at this time. 

Chapter 3: National Contact Points and Information to patients 
Some  Member  States  have  different  National  Contact  Points  (NCPs)  for  ‘incoming’  and 
‘outgoing’ patients. Others have regional NCPs under one ‘umbrella’ NCP. Some NCPs are 
based  in  the  Ministry  of  Health,  others  in  the  healthcare  insurer,  and  others  in  independent 
bodies. 

3 Regulations (EC) No 883/2004 and No 987/2009 on the coordination of social security systems. 
4 Note that the data for planned healthcare via the S2 forms covers only 22 Member States as data for the others 
was not available. 
5 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0044&from=EN. 

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There  are  also  differences  in  the  communication  channels  used  by  NCPs,  as  the  following 
table (covering all 28 Member States and the separate contact points for England, Scotland, 
Wales, Northern Ireland, and Gibraltar)6 shows. 

This data is from the evaluative study, which also indicated significant variation in the activity 
of  the  NCPs.  Of  nine  NCPs  surveyed,  three  had  fewer  than  10  requests  for  information  per 
month, four had between 10 and 100 requests, and only two had more than 100 requests per 
month.  These  findings  are  in  line  with  the  data  reported  by  Member  States  on  information 
requests (contained in Annex A) 

This  is  not  surprising,  given  EU  citizens’  seemingly  low  awareness  of  their  rights  and  the 
existence of the NCPs. A recent Eurobarometer survey7 indicated that fewer than two out of 
ten citizens feel that they are informed about their cross-border healthcare rights: 

Whilst only one in ten knew about the existence of NCPs: 

6 The UK has no National Contact Point covering the whole UK, so it was necessary to examine the separate 
contact points. Other Member States also have regional contact points, but also one national NCP. 
7 http://ec.europa.eu/public_opinion/archives/ebs/ebs_425_sum_en.pdf. 

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Via a series of conferences organised on behalf of the Commission by the European Patients’ 
Forum,  patient  organisations  have  reported  their  concern  that  patients  are  faced  with  ‘a 
labyrinth of confusing, sometimes insufficient and sometimes too detailed information’ with 
regard to cross-border healthcare. They have identified NCPs as having a crucial role in the 
success  or  failure  of  the  Directive,  recommending  that  NCPs  could  provide  ‘checklists’  for 
individuals  considering  planned  care  abroad,  and  more  detailed  individual  timelines  of 
procedures,  costs  and  reimbursement  rates.  They  stressed  the  desirability  of  facilitating 
‘comparability and reliability of information provided to patients on quality and safety, across 
institutions and across Member States’. 

‘Patients  have  high  expectations …the  prevailing  sentiment  is  that  the  NCP  must  be  a 
gateway to healthcare, not a gatekeeper blocking access.’ — Patient organisation 

The  Directive  requires  Member  States  to  provide  information  on  their  quality  and  safety 
systems.  Some  Member  States  provide  links  to  different  legal  documents;  others  give  a 
general  description  of  quality  assurance  strategies;  a  few  provide  detailed  information 
(including  links  to  hospital  evaluation  systems  featuring  typical  safety  parameters,  e.g. 
mortality rate, number of cases treated with complications); others direct citizens to specific 
sources — websites or a named person. Some do not mention safety and quality at all. 

A  number  of  Member  States  continue  to  express  concern  about  communicating  the 
complexities  of  the  current  legal  situation,  where  cross-border  healthcare  is  covered  by  two 
distinct sets of EU legislation (the Directive and the Social Security Regulations), despite the 
stipulation in Article 2(m) of the Directive, whereby the former applies without prejudice to 
the Social Security Regulations (see also recitals 28-31 to the Directive). 

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Chapter 4: Cross-border cooperation 

4.1 Recognition of prescriptions 

Article  11  of  the  Directive  gives  effect  to  the  principle  of  mutual  recognition  of  medical 
prescriptions  between  Member  States  and  empowers  the  Commission  to  adopt  practical 
measures to assist such recognition. 

The majority of these measures were addressed in Implementing Directive 2012/52/EU8.  This 
Directive established a list of common elements to be included in cross-border prescriptions.  
This list includes, among other elements and with limited exceptions, the “common name” of 
the  product  (which,  in  practice,  means  the  International  Non-proprietary  Name  for  a  large 
majority of products).  

The  deadline  for  the  transposition  of  the  Implementing  Directive  was  the  same  as  that  for 
transposition  of  Directive  2011/24/EU,  i.e.  25 October 2013.  Twenty-one  Member  States 
either  failed  to  make  the  deadline,  or  transposed  the  Implementing  Directive  incompletely, 
leading  to  infringement  proceedings.  Two  of  these  infringement  cases  were  pending  as  of 
1 July 2015, the others having been closed on the grounds of subsequent transposition by the 
Member  States  concerned.  In  the  two  pending  cases,  the  Member  States  concerned  have 
committed to addressing the outstanding issues. 

4.2 European Reference Networks 

Article 12 of the Directive requires the Commission to support the development of European 
Reference Networks (ERNs) of healthcare providers and centres of expertise (in particular in 
the  area  of  rare  diseases)  by:  adopting  the  criteria  and  conditions  that  such  Networks,  and 
providers  wishing  to  join  Networks,  must  fulfil;  developing  criteria  for  establishing  and 
evaluating such Networks; and facilitating the exchange of information and expertise on the 
Networks.  In  March  2014  the  legal  framework  for  the  establishment  and  evaluation  of 
Networks (delegated9 and implementing decisions10) was adopted, with unanimous support of 
the Member States.  

The  Commission  has  since  begun  the  process  of  establishing  ERNs,  including  the 
establishment  of  the  Board  of  Member  States,  which  will  be  charged  with  approving 
proposals  for  ERNs.  The  first  call  for  networks  will  take  place  in  early  2016,  with  the  first 
networks expected to be approved during that year. 

The  Commission  is  working  with  healthcare  providers  and  authorities  to  raise  awareness  of 
the possibilities offered by ERNs, and to gather support for potential networks or members of 
networks. 

8 Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the 
recognition of medical prescriptions issued in another Member State (OJ L 356, 22.12.2012, p. 68). 
9   Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that 
European Reference Networks and healthcare providers wishing to join a European Reference Network must 
fulfil (OJ L 147, 17.5.2014, p. 71). 
10 Commission Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating 
European Reference Networks and their Members and for facilitating the exchange of information and expertise 
on establishing and evaluating such Networks (OJ L 147, 17.5.2014, p. 79). 

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4.3 eHealth 

The  Commission  adopted  Implementing  Decision  2011/890/EU  concerning  the  eHealth 
Network  on  22 December 2011.11.    The  eHealth  Network  aims  to  support  cooperation 
between national authorities.  It meets twice a year and is supported operationally by a joint 
action  under  the  Health  Programme  established  by  Regulation  (EU)  No  282/201412.    The 
work  of  the  eHealth  Network  is  supported  by  a  number  of  activities  carried  out  under  the 
eHealth Action Plan 2012 – 2020: Innovative healthcare for the 21st century13. 

Since  its  inception,  the  eHealth  Network  has  adopted  guidelines  on  patient  summaries  data 
sets and on ePrescriptions, and position papers on: electronic identification, interoperability, 
the  proposed  Regulation  on  data  protection;  and  eHealth  investment  to  be  supported  by  the 
Connecting Europe Facility (CEF). It is currently working on guidelines on effective methods 
for  enabling  the  use  of  medical  information  for  public  health  and  research.  Under  the  CEF 
Work  plan  2015,  EU  funding  has  been  allocated  to  implement  the  exchange  of  patient 
summaries, and ePrescriptions. The eHealth Network will review and, if necessary, update the 
guidelines in 2015-2016 in the light of the CEF experience. 

4.4 Health Technology Assessment (HTA) 

The rules concerning the HTA Network envisaged by article 15 of the Directive are set out in 
Commission  Implementing  Decision  2013/329/EU14    The  HTA  Network  aims  to  support 
cooperation  between  national  authorities,  including  on  the  relative  efficacy  and  short-/long-
term effectiveness of health technologies. It meets twice a year, and is supported on scientific 
and technical issues by a joint action under the Health Programme, called EUnetHTA. 

The  Network  adopted  a  Strategy  for  EU  cooperation  on  HTA  in  October  2014,  and  a 
reflection paper on reuse of joint HTA work in national activities in April 2015.15  

For  the  future,  the  HTA  Network  will  continue  its  strategic  role,  but  strong  and  efficient 
scientific cooperation will be essential. Member States have asked the Commission to propose 
measures to ensure long-term sustainability.16  

4.5 Cross-border collaboration 

The  Directive  requires  the  Commission  to  encourage  Member  States  to  cooperate  in  cross-
border  healthcare  provision  in  border  regions.  Initial  work  by  the  Commission  shows  that 
there  is  a  limited  number  of  existing  cross-border  projects  which  may  provide  valuable 
‘lessons  learned’  for  future  parties.  It  has also  identified  specific  areas  where  greater  cross-

11 http://ec.europa.eu/health/ehealth/docs/decision_ehealth_network_en.pdf. 
12 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.086.01.0001.01.ENG. 
13 http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52012DC0736. 
14 Commission Implementing Decision 2013/329/EU of 26 June 2013 providing the rules for the establishment, 
management and transparent functioning of the network of national authorities or bodies responsible for health 
technology assessment (OJ L 175, 27.6.2013, p. 71). 
15 http://ec.europa.eu/health/technology_assessment/docs/reuse_jointwork_national_hta_activities_en.pdf. 
16 Council conclusions on ‘innovation for the benefit of patients’ Employment, Social policy, Health and 
Consumer affairs Council meeting Brussels, 1 December 2014 
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/145978.pdf. 

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border collaboration could make a significant difference to patient outcomes, for example in 
access to critical care for myocardial infarctions. 

Successful cross-border collaboration requires significant buy-in from local-level actors, with 
the  support  of  national  authorities.  The  next  step  is  to  identify  those  EU  activities  and  best 
practices  which  will  help  implement  real  cross-border  collaboration  which  delivers  added 
value.  Geographical  areas  which  might  benefit  from  such  collaboration  also  need  to  be 
identified. 

Chapter 5: Conclusions 
Patient  mobility  for  planned  healthcare  —  under  both  the  Directive  and  the  Social  Security 
Regulations — remains low, whilst patient mobility in terms of unplanned healthcare seems 
to be considerably higher. France, Luxembourg, and possibly Finland and Denmark appear to 
be exceptions to this general observation. The level of use of planned healthcare elsewhere is 
far  below  the  potential  levels  suggested  by  the  number  of  people  indicating  in  the 
Eurobarometer survey that they would consider using cross-border healthcare. 

There are a number of reasons why this may be the case. Firstly, a number of Member States 
were late implementing the Directive, which will impact on the numbers able to use it during 
2014. 

Secondly, as also indicated by the Eurobarometer, the number of citizens  who are  aware of 
their general rights to reimbursement is extremely low. Even where citizens are aware of their 
rights, there are a number of Member States where it is difficult for patients to find out more 
about  how  to  use  these  rights  in  practice.  The  evaluation  study  cited  above  indicates 
considerable variation in the performance of National Contact Points in this regard. 

Thirdly,  whilst  some  Member  States  have  implemented  the  Directive  fully  and  are  making 
considerable  efforts  to  facilitate  patients’  rights  to  cross-border  healthcare,  there  are  a 
considerable number of Member States where the obstacles placed in the way of patients by 
health  systems  are  significant,  and  which,  in  some  cases  at  least,  appear  to  be  the  result  of 
intentional  political  choices:  some  of  the  current  systems  of  prior  authorisation  are  more 
extensive than the current numbers of requests would appear to justify; in many cases it is not 
clear  exactly  which  treatments  require  prior  authorisation;  lower  reimbursement  tariffs  than 
those  used  in  the  home  Member  State  are  a  clear  disincentive;  there  are  a  number  of 
burdensome administrative requirements which may well deter patients. 

It  may  be  that  that  the  natural  demand  for  cross-border  healthcare  is  relatively  low  for  a 
number of reasons: unwillingness of patients to travel (e.g. because of proximity to family or 
familiarity with home system); language barriers; price differentials between Member States; 
acceptable  waiting  times  for  treatment  in  the  Member  State  of  affiliation.  It  is  also  worth 
noting  that  some  of  the  demand  that  does  exist  may  be  catered  for  under  local  bilateral 
arrangements, which exist in some Member States. However, given the points set out above, it 
is  not  possible  to  conclude  now  that  use  of  cross-border  healthcare  accurately  reflects 
potential demand. 

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However,  the  impact  of  the  Directive  should  be  considered  more  widely  than  simply  cross-
border healthcare. It has contributed to a number of important discussions going on in many 
Member States regarding healthcare reform. 

Most  obviously,  the  Directive  contains  a  significant  number  of  provisions  relating  to 
transparency for patients on their rights, and on the quality and safety of healthcare services. 
This subject of which information patients need, and how it should be provided, is likely to be 
on  the  agenda  for  some  time  to  come.  This  is  not  due  to  the  Directive  itself,  but  reflects 
broader technological and societal changes: people’s expectations are radically different now 
than they were just a few years ago (and health services are unlikely to be immune from the 
impact of, for example, user-generated reviews). But the Directive does provide a ready-made 
space  (and  forum,  in  the  shape  of  the  network  of  NCPs,  which  meets  regularly)  for  the 
Commission and Member States to share ideas on how this challenge might be met. 

So far, it is clear that there are significant differences between NCPs in the way they operate 
and  the  quality  of  the  information  they  provide.  There  may  well  be  merit  in  exploring 
common approaches or guidelines for the work of NCPs in future discussions. 

Similarly,  the  pressures  faced  by  health  services  are  leading  to  increased  interest  in  making 
better use of resources via cross-border collaboration. Whilst the initial work undertaken by 
the Commission so far has thrown up some suggestions for action at EU level (e.g. sharing of 
best practice from successful projects; development of checklists for those considering cross-
border  collaboration),  it  is  clear  that  these  would  only  work  in  support  of  national  or  local 
activities. 

The  chapter  of  the  Directive  on  cooperation  between  health  systems  has  created  a  new 
framework  for  Member  States’  cooperation.  This  could  deliver  tangible  benefits  to  health 
systems  across  the  EU.  To  take  just  one  example,  the  European  Reference  Networks  could 
seriously  improve  access  to  care  for  rare  /  low-prevalence  and  complex  diseases  where 
expertise is rare. To realise this potential, ongoing support and commitment from all sides will 
be needed. 

The HTA strategy adopted by the HTA Network has demonstrated the interest in joint work 
by  the  Member  States  but  has  also  shown  the  need  for  permanent  and  well-founded 
arrangements.  Such  arrangements  would  need  to  facilitate  joint  work,  and  consequently 
enable Member States and other stakeholders to benefit fully from it. 

Finally,  the  advance  of  technology  means  that  ‘telemedicine’  services  (including  online 
pharmacies) are likely to become more common and more significant in the immediate future. 
It  may  therefore  prove  useful  to  consider  whether  and  how  the  applicable  rules  (e.g.  on 
applicable legislation; access to, and reimbursement for, treatment) need to be developed and 
clarified. 

12 

 
 
Chapter 6: Exercise of the power to adopt delegated acts conferred on the Commission 
pursuant to Article 17 of Directive 2011/24/EU on the application of patients’ rights in 
cross-border healthcare 

6.1 Introduction   

Article  11  of  Directive  2011/24/EU  concerns  mutual  recognition  of  prescriptions  between 
Member  States.  Article  11(5)  empowers  the  Commission  to  adopt,  by  means  of  delegated 
acts, measures to exclude specific categories of medicinal products or medical devices from 
the recognition of prescriptions, where necessary to safeguard public health. 

Article  12  of  Directive  2011/24/EU  concerns  the  development  of  European  Reference 
Networks  (ERNs).  Article  12(5),  read  together  with  Article  12(4)(a),  empowers  the 
Commission to adopt, by means of delegated acts, a list of the specific criteria and conditions 
that the ERNs must fulfil, and the conditions and criteria required from healthcare providers 
wishing to join such Networks, as envisaged in Article 12(4)(a). 

Article  17  of  Directive  2011/24/EU  confers  on  the  Commission  the  delegated  powers  for  a 
period  of  5  years  from  24  April  2011.  It  requires  the  Commission  to  prepare  a  report  in 
respect  of  the  delegated  powers  not  later  than  six  months  before  the  end  of  the  five-year 
period.    The  delegated  powers  shall  be  automatically  extended  for  periods  of  an  identical 
duration,  unless  the  European  Parliament  or  the  Council  revokes  them  in  accordance  with 
Article 18. 

6.2 Exercise of the delegation 

Regarding  Article  11(5),  a  meeting  of  Member  State  experts  was  convened  on 
14 February 2012  to  discuss  whether  there  was  a  need  to  exclude  specific  categories  of 
medicinal products or medical devices from the recognition of prescriptions. The conclusion 
of this meeting (and of the support study carried out) was that no exclusion was needed at that 
time. The Commission has therefore not yet used the delegated power. 

Regarding  Article  12(5),  the  Commission  worked  closely  with  the  Member  States  on  the 
content  of  the  delegated  act  before  adopting  it  on  10  March  2014  (see  reference  under  4.2, 
above). It entered into force on 27 May 2014. 

6.3 Conclusion 

The Commission is of the view that the delegated powers conferred by Directive 2011/24/EU 
should remain in force.   

The field of medicinal products and medical devices is one where change may occur rapidly. 
Although  exclusions  from  the  principle  of  mutual  recognition  of  prescriptions  are  not 
currently needed, such a need may arise in the future, and would need to be dealt with swiftly 
via a delegated act in order to safeguard public health. 

Regarding  ERNs,  the  first  Networks  will  be  established  in  2016,  and  will  then  need  to  be 
evaluated.  This  evaluation  is  likely  to  mean  that  it  is  desirable  to  adjust  the  content  of  the 
current Delegated Act in the future. 

13 

 
 
Data from Member States on the operation of the Directive 

ANNEX A 

A questionnaire was sent to all Member States in January 2015. The agreed final cut-off date 
for the exercise was 30 April 2015. The timeframe covered by the exercise was the calendar 
year 2014. 

A total of 26 out of 28 Member States provided data (no returns were received from Latvia or 
Malta). 

A  selection  of  the  data  reported  by  Member  States  is  presented  here.  A  number  of  points 
should be noted:   

Member States transposed Directive 2011/24/EU at different times and in many cases the data 
provided only cover part of 2014. Some Member States have difficulties dividing their cases 
between  Directive  2011/24/EU  and  the  Social  Security  Regulations  (Regulations  (EC)  No 
883/2004 and (EC) No 987/2009), particularly for claims for reimbursement of healthcare not 
subject to prior authorisation. 

It  has  proved  difficult  for  many  Member  States  to  provide  data  concerning  information 
requests to NCPs broken down by medium and issue. It is also likely that requests relating to 
cross-border  healthcare  outside  the  scope  of  Directive  2011/24/EU  have  sometimes  been 
included, e.g. questions relating to the European Health Insurance Card (EHIC) etc. 

Some Member States — particularly those with insurance-based systems — have experienced 
difficulties in collecting information from the component parts of their system. 

As this was the first time this questionnaire was used, a number of practical semantic issues 
were identified during the exercise (reflecting the variety of national situations and practices). 
Those  will  need  to  be  addressed  in  future  exercises,  as  they  affect  the  comparability  of  the 
data. 

The data is not, therefore, easily comparable between Member States: examples in this Annex 
are given by way of illustration only. 

Information requests received by National Contact Points 

Of  the  26  Member  States  who  responded,  all  but  Luxembourg  and  Sweden  were  able  to 
provide  data  on  the  total  number  of  unique  requests.  A  total  of  109 223  such  requests  were 
recorded in 2014. Five Member States had fewer than 100 requests for information (Portugal, 
for  example,  recorded  just  6).  Ten  Member  States  recorded  more  than  1 000  information 
requests.  Three  Member  States  alone  accounted  for  nearly  75 %  of  the  requests  recorded: 
Germany  (36 602);  Finland  (25 207);  and  Austria  (15 536).  These  much  larger  figures  are 
probably due to website visits being recorded as information requests in these three Member 
States. 

14 

 
 
 
Some Member States were able to divide their information requests by medium. In these cases 
the data indicate 74 050 via website (see point above), 15 461 via telephone, 5 436 via email, 
and 2 179 via face-to-face contact. 

Use of prior authorisation 

Twenty-one  Member  States  have  introduced  a  system  of  prior  authorisation  (Austria,  the 
Czech Republic, Estonia, Finland, Lithuania, the Netherlands and Sweden have not, although 
some of these have introduced legislation enabling them to introduce such a system at a later 
date,  should  they  so  wish).  Of  these  21,  Latvia  and  Malta  did  not  provide  data  returns. 
Germany  did  provide  a  data  return  but  was  unable  to  provide  data  on  the  use  of  prior 
authorisation. 

Of  the  18  Member  States  who  provided  data,  France  was  a  clear  outlier  with  57 000 
authorisations  granted;  however,  this  is  an  aggregate  figure  for  authorisation  granted  under 
both  the  Social  Security  Regulations  and  the  Directive.  The  number  of  requests  for  prior 
authorisation specifically under the Directive which were either authorised or refused in the 
remaining  17  Member  States  was  560,  of  which  360  were  authorised.  Two  Member  States 
(Poland  and  Greece)  reported  that  they  had  neither  authorised  nor  refused  any  requests  for 
prior authorisation in 2014 and two (Croatia and Portugal) received just one each. At the other 
end of the spectrum, Italy received 177 (103 authorised) and Slovakia 139 (121 authorised). 

Reimbursement for treatment not subject to prior authorisation17 

Of  the  26  Member  States  who  responded,  only  23  were  able  to  provide  complete  data  on 
reimbursements  made  for  treatment  not  subject  to  prior  authorisation  (Germany  and  the 
Netherlands could not provide data; Belgium could not provide complete data). Of these 23, 
Finland,  France  and  Luxembourg  provided  aggregate  data  for  the  Directive  and  the  Social 
Security  Regulations.  Finland  reported  17 142  reimbursement  claims,  France  422 680  and 
Luxembourg 117 962.   

In  the  other  20  Member  States,  a  total  of  39 826  reimbursements  were  made  specifically 
under the Directive: of this total Denmark alone accounted for 31 032. Four Member States 
made  more  than  1 000  reimbursements.  Fourteen  Member  States  made  fewer  than  100 
reimbursements,  of  which  six  (Austria,  Bulgaria,  Cyprus,  Estonia,  Greece,  and  Portugal) 
recorded no reimbursements under the Directive. 

Processing times 

Of  the  16  responding  Member  States  that  had  a  system  of  prior  authorisation  and  received 
requests  for  prior  authorisation,  nine  (Bulgaria,  Croatia,  Denmark,  Ireland,  France, 
Luxembourg, Slovakia, Spain, and the UK) reported average times to process requests as 20 
days  or  fewer.  Only  three  had  average  processing  times  of  30  days  or  more:  Hungary  (30 
days); Cyprus (40); and Slovenia (69). 

17 This data may include a limited number of claims for treatment which was supposed to be subject to prior 
authorisation but for which the claim was made retrospectively and ultimately reimbursed. 

15 

 
 
                                                            
Of the 19 responding Member States that actually received claims (and were able to provide 
the  requested  figures)  for  reimbursement  for  treatment not subject to prior authorisation, 15 
were  able  to  provide  data  on  the  average  times  for  processing  claims  (Belgium,  Lithuania, 
Greece  and  Romania  were  not  able  to  provide  this  data).  Of  these,  four  had  an  average  of 
fewer  than  20  days  (Denmark,  Hungary,  Luxembourg,  and  the  UK)  and  three  had  average 
times of more than 80 days: Finland (82); Slovakia (84.3) and Sweden (150) (NB the Finnish 
figure relates to both the Regulations and the Directive).18 

18 Reimbursement practices may vary considerably from Member State to Member State. For example, if a 
Member State decides to reimburse someone under the Regulations on the grounds that this is more beneficial to 
the patient, then the procedure for establishing the reimbursement amount can take several months. 

16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
The evaluative study on the Cross-border Healthcare Directive 

ANNEX B 

This study considers the effects of Directive 2011/24/EU. Its overall objective is to report on 
implementation to date on the basis of the sources at hand and to identify gaps and potential 
for improvement, as called for by Article 20(1) of the Directive. It draws on the situation on 
the ground and other valuable external sources (past studies, scientific literature, stakeholder 
input, etc.). 

Methodology 

In addition to desk research and a literature review, a detailed website review and widely used 
participatory research methods were used. 

Building on previous research efforts, a website analysis was carried out on all the websites of 
the  32  NCPs  (32  countries  or  territories  as  Scotland,  Wales,  England,  Northern  Ireland  and 
Gibraltar were analysed for the UK).  The analysis was carried out between 6 October 2014 
and 6 November 2014. 

The ‘pseudo-patient’ research method was used to take account of the ‘end-user’ perspective. 
NCPs  in  12  EU  Member  States  (Austria,  Belgium,  France,  Germany,  Hungary,  Italy, 
Lithuania,  Malta,  the  Netherlands,  Slovenia,  Spain,  and  Sweden)  were  approached  in 
November  2014  by  both  email  and  telephone  using  three  different  pre-designed  scenarios. 
These ‘focus countries’ are a representative sample, based on a host of criteria detailed in the 
report. 

Subjective, opinion-based data was also collected in the focus countries and at European level 
via  59  stakeholder  interviews  and  an  online  survey  addressed  to  the  12  NCPs  in  the  focus 
countries. Some 50 % of stakeholders contacted agreed to be interviewed over the four-week 
period. They represented a range of health insurance providers, healthcare providers, patient 
ombudsmen, national and regional authorities, patient groups, audit bodies, trade unions and 
frontline healthcare prescriber organisations. All NCPs completed at least a part of the online 
survey. 

A  SWOT  analysis  focusing  on  the  services  provided  to  the  patients  complements  the 
conclusions of the study. 

Limitations 

The study is not a formal evaluation. Complaints,  infringements  and  transposition  measures 
were  not  part  of  its  remit.  Given  the  recent  adoption  of  the  Directive  and  the  scarcity  of 
readily  available  data  on  patient  mobility,  a  formal  evaluation  of  the  Directive  would  have 
been  premature.  An  evaluative study  does, however,  deliver  a  meaningful, albeit qualitative 
contribution  to  the  baseline  assessment  and  to  future  evaluation  efforts,  in  line  with  the 
‘evaluate first’ principle. 

17