COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare
Date: 2022-05-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: application of EU law, consumer information, cross-border cooperation, delegated legislation, e-Health, free movement of persons, health care, health expenditure, medical device, patient's rights

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 12.5.2022  SWD(2022) 200 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the operation of Directive 2011/24/EU on the application of patients' rights in cross-border healthcare {COM(2022) 210 final}  
 
 
Table of contents 

1. 

INTRODUCTION ................................................................................................................................ 5 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? ....................................... 7 

Description of the intervention and its objectives .......................................................... 7 

The Directive’s Intervention Logic................................................................................. 9 

Legal Framework .......................................................................................................... 11 

Points of comparison .................................................................................................... 11 

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? ....................... 11 

Implementation in the Member States .......................................................................... 11 

Operation of the Directive 2015-2020 .......................................................................... 12 

4. 

EVALUATION FINDINGS ............................................................................................................... 17 

4.1.  TO WHAT EXTENT WAS THE INTERVENTION SUCCESSFUL AND WHY? .......................... 17 

Effectiveness.................................................................................................................. 17 

4.1.1.  How effective was the Directive in the area of patients’ rights? ................ 17 

4.1.2.  How effective was the Directive to  encourage cross-border cooperation in 
the EU?  27 

Efficiency ...................................................................................................................... 37 

Coherence ..................................................................................................................... 42 

4.2.  HOW DID THE EU INTERVENTION MAKE A DIFFERENCE? .................................................. 48 

4.3.  IS THE INTERVENTION STILL RELEVANT? .............................................................................. 49 

5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? ................................................. 53 

ANNEX I. PROCEDURAL INFORMATION ......................................................................................... 58 

ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED .............................................. 60 

ANNEX  III.  EVALUATION  MATRIX  AND,  WHERE  RELEVANT,  DETAILS  ON 

ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) .................................... 65 

ANNEX IV. OVERVIEW OF BENEFITS AND COSTS ....................................................................... 90 

ANNEX V. STAKEHOLDERS CONSULTATION – SYNOPSIS REPORT ....................................... 95 

ANNEX VI. EUROPEAN REFERENCE NETWORKS ...................................................................... 109 

ANNEX  VII.  INFORMATION  ON  HEALTHCARE  UNDER  THE  CBHC  DIRECTIVE 
AND  THE  REGULATIONS  ON  THE  COORDINATION  OF  SOCIAL  SECURITY 
SYSTEMS ........................................................................................................................................ 110 

1 

 
 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

Competent  Member 
State 

Member State under whose social security system the patient 
concerned is insured at the time of the cross-border treatment. 

Cross-border 
healthcare  

Cross-border healthcare refers to medical treatment outside the 
patient’s country of residence, whether or not insured under the 
social security legislation of another Member State. The 
treatment is considered to be cross-border when received in any 
EU/EEA Member State or (but only in case of the application of 
the Regulations) in Switzerland and the UK. 

CBHC Directive 

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. 

European  Economic 
Area (EEA) 

The European Economic Area includes the Member States of 
the European Union and three countries of the European Free 
Trade Association: Iceland, Liechtenstein and Norway. 

European 
Insurance 
(EHIC) 

Health 
Card 

Free card, issued by the national health insurance institution that 
allows the patient to receive medically necessary, state-provided 
healthcare during a temporary stay in another EU/EEA country, 
Switzerland or the UK, under the same conditions and at the 
same cost (free of charge in some countries) as the persons 
insured in that country. 

European  Reference 
Networks (ERNs) 

European Reference Networks are virtual networks involving 
healthcare providers across Europe, aiming to facilitate 
discussion on complex or rare diseases and conditions that 
require highly specialised treatment, and concentrated 
knowledge and resources  
(https://ec.europa.eu/health/european-reference-
networks/overview_en) 

Follow-up care 

Healthcare that may be required in the home country as a result 
of cross-border treatment or medical intervention with the 
purpose of providing aftercare or surveillance to ensure a good 
recovery.   

Home country 

The country where the patients reside and are entitled to 
sickness benefits, regardless of whether or not they are insured 
under the social security system of that country. 

Insured person 

Person or family member of a person who is subject or has been 
subject to the social security legislation of an EU/EEA Member 

2 

 
State or (but only in case of the application of the Regulations) 
of Switzerland or the UK. 

Member 
affiliation 

State 

of 

Member State which under the Regulations is competent to 
grant to the insured person a prior authorisation to receive 
appropriate treatment outside the Member State of residence and 
issue the S2 form. This will normally be the country under 
whose social security system the patient is insured. 

Member 
treatment 

State 

of 

Member State on whose territory the cross-border treatment is 
actually provided or in the case of telemedicine the Member 
State where the healthcare provider is established. 

National 
Points (NCPs) 

Contact 

Under Directive 2011/24/EU, all EU/EEA Member States are 
obliged to designate one or more National Contact Points which 
provide patients with information on all aspects of cross-border 
healthcare. 

Planned healthcare 

Healthcare provided during a temporary stay abroad of which 
the explicit purpose was to receive it there. 

Prior authorisation 

Authorisation that patients need to receive from their national 
health insurance institution/health insurer in advance of their 
travel abroad in order to be guaranteed reimbursement for cross-
border healthcare. 

the 
Regulations  on 
coordination  of  social 
security systems 

Regulation (EC) No 883/2004 of the European Parliament and 
of the Council of 29 April 2004 on the coordination of social 
security systems and Regulation (EC) No 987/2009 of the 
European Parliament and of the Council of 16 September 2009 
laying down the procedure for implementing Regulation (EC) 
No 883/2004 on the coordination of social security systems. 

Reimbursement 

Repayment to the patient by the national health insurance 
institution/health insurer, on certain conditions, of the costs 
incurred for cross-border healthcare services. 

Necessary 
(unplanned) 
healthcare 

Healthcare received by a patient in an EU/EEA country, 
Switzerland or the UK, which becomes necessary on medical 
grounds during a temporary stay in that State for work, study or 
leisure (i.e. without the initial purpose of the patient's travel 
being to receive treatment there) and that, taking into account 
the length of the stay, cannot wait until the patient returns home. 
This includes treatments provided in conjunction with chronic or 
existing illnesses. 
See explanatory note from the European Commission: 
https://ec.europa.eu/social/BlobServlet?docId=6481&langId=en  

3 

 
 
AEBR 

ANEC 

CBA 

CBHC 

CPMS 

DG 

Acronyms and abbreviations 

Association of European Border Regions 

European consumer voice in standardisation 

Cost-Benefit Analysis  

Cross-Border Healthcare  

Clinical Patient Management System 

Directorate-General 

DG SANTE  

Directorate-General for Health & Food Safety 

ECA 

EDF 

EEA 

EFTA 

EHDS 

EHIC 

ePAGs 

EPF 

EPHA 

EQ 

EQM 

ERICA 

ERN 

EU  

EUR  

EXPH 

IT 

JC 

European Court of Auditors 

European Disability Forum 

European Economic Area 

European Free Trade Association 

European Health Data Space  

European Health Insurance Card  

European Patient Advocacy Groups 

European Patients’ Forum 

European Public Health Alliance 

Evaluation Question 

Evaluation Questions Matrix 

European Rare disease research Coordination and support Action 

European Reference Network 

European Union  

Euro 

Expert Panel on Effective Ways of Investing in Health  

Information Technology 

Judgement Criteria / Criterion 

LGBTIQ 

Lesbian, gay, bisexual, transgender, intersex, and queer/questioning 

MS 

NCP 

OECD 

PGEU 

SWD 

TFEU 

ToR 

Member State(s)  

National Contact Point 

Organisation for Economic Co-operation and Development 

Pharmaceutical Group of the European Union 

Staff Working Document 

Treaty on the Functioning of the European Union 

Terms of Reference  

ZOAST 

Zones Organisées d’Accès aux Soins Transfrontaliers 

4 

 
 
1. 

INTRODUCTION 

Access to high quality health services is a priority for EU citizens. Directive 2011/24/EU 
on the application on patients’ rights on cross-border healthcare1 (the CBHC Directive 
or the Directive) aims to ensure patients with safe and high quality healthcare services in 
a  Member  State  other  than  the  Member  State  of  affiliation.  It  also  provides  a  legal 
framework  for  reinforcing  voluntary  cooperation  between  EU  countries  in  healthcare. 
While the Regulations on the coordination of social security systems have enshrined the 
right  to  receive  healthcare  in  another  Member  State  for  various  categories  of  insured 
persons since the beginning of the European integration2, the Directive is the first piece 
of EU legislation in  the area of health services.  At the same time, the organization and 
financing of health systems remain the responsibility of the Member States. 

Thanks to the application of the Directive, around 300,000 patients a year take advantage 
of the systems put in place under this Directive to receive (partial) reimbursement for the 
healthcare  costs  incurred  in  another  EU  country.  The  first  24  European  Reference 
Networks (ERNs) bring together highly specialised medical experts from 900 healthcare 
units located in 313 hospitals offering their expert advice on the diagnosis and treatment 
of thousands of patients with rare or low prevalence complex diseases. The Commission 
encourages cross-border cooperation in healthcare, particularly in border regions, where 
EU  funding  has  supported  an  estimated  400  cross-border  initiatives  to  cooperate  in 
healthcare3. European cooperation in health technology assessment and digital health has 
evolved significantly to meet new needs in healthcare across the EU.  

The purpose of this evaluation is to assess how well the CBHC Directive has performed, 
a  decade  after  its  adoption  in  2011  and  eight  years  since  its  transposition  deadline  in 

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). 

2  One  of  the  first  measures  ever  taken  by  the  European  Community  were  Regulations  No.  3  and  4 on  social 
security  for  migrant  workers  (OJ  30,  16.12.1958),  which  entered  into  force  on  1  January  1959.  On  1 
October 1972, these Regulations were completely revised and replaced by Regulation  (EEC) No 1408/71 
(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 (OJ L 149, 5.7.1971, p. 2)) 
and  its  Implementing  Regulation  (EEC)  No  574/72  (Regulation  (EEC)  No  574/72  of  the  Council  of  21 
March  1972  fixing  the  procedure  for  implementing  Regulation  (EEC)  No  1408/71  on  the  application  of 
social security schemes to employed persons and their families moving within the Community (OJ L 74, 
27.3.1972,  p.  1)).  Since  1971,  these  Regulations  were  the  subject  of  several  amendments  in  order  to 
accommodate trends in national legislation and progress resulting from the rulings of the Court of Justice. 
On 1 May 2010, a new set of Regulations, Regulation (EC) No 883/2004 (Regulation (EC) No 883/2004 of 
the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems 
(OJ  L  166,  30.4.2004,  p.  1))  and  its  Implementing  Regulation  (EC)  No  987/2009  (Regulation  (EC)  No 
987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure 
for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (OJ L 284, 
30.10.2009, p. 1)) became applicable. On 13 December 2016, the Commission proposed a revision of the 
EU social security coordination rules. The proposal is currently under negotiations. 

3  EU  funded  projects  from  2007-2017  (Bobek,  J.  et  al.  (2018).  Study  on  Cross-Border  Cooperation 
regions”, 
for 

cross-border 

cooperation 

initiatives 

in 

“Capitalising 
on 
http://dx.doi.org/10.2875/825256).  

existing 

5 

 
                                                 
2013. Its objective is to check whether the Directive is still relevant and “fit for purpose” 
to  meet  current  and  future  patient  needs.  It  also  identifies  where  the  Directive  was  not 
applied  effectively  and  draws  conclusions  based  on  the  evidence  gathered  for  future 
policy decisions on the Directive. 

This report assesses two key parts of the CBHC Directive using the evaluation criteria of 
effectiveness, efficiency, relevance, coherence and its EU added value. First, the CBHC 
Directive’s provisions (Articles 1-9) covering the responsibilities of Member States with 
regard  to  cross-border  healthcare,  including  the  National  Contact  Points  (NCPs). 
Secondly, 
the  recognition  of 
prescriptions  issued  in  another  EU  country  (Article  11  and  Implementing  Directive 
2012/52/EU4), the mutual assistance and European cooperation between regions (Article 
10) and, in  the area of rare  and low prevalence  complex diseases, the setting up of the 
ERNs (Article 12 including the Commission Delegated and Implementing Decisions5). 

the  provisions  governing 

this  evaluation  covers 

The evaluation covers the CBHC Directive’s application in the EU-276 and EEA EFTA 
States Norway, Iceland, Liechtenstein from the period 2015, the time by which most EU 
countries had transposed the Directive into national law7, until the end of 2020. 

The CBHC Directive’s provisions on eHealth (Article 14) have been evaluated separately 
as  part  of  the  work  on  the  Commission’s  proposal  for  a  Regulation  on  the  European 
Health  Data  Space  (EHDS).  Following  the  adoption  and  entry  into  force  of  the 
Regulation  on  cooperation  in  health  technology  assessment  in  2021,  the  CBHC 
Directive’s  relevant  provision  (Article  15)  was  repealed  and  therefore  not  part  of  this 
evaluation. 

This  evaluation  largely  draws  on  the  evaluation  study  conducted  by  an  external 
contractor, the replies received to the Commission’s public consultation, which ran from 
May  to  July  2021,  as  well  as  several  events  organised  by  the  Commission  to  gather 
feedback  on  the  CBHC  Directive.  An  important  limitation  was  that  little  research  has 
been conducted on the Directive and that there is insufficient comparative research across 

4  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). 
5  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), Commission Implementing Decision 2014/287/EU of 10 March 
2014 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)  and  Commission  Implementing  Decision  (EU)  2019/1269  of  26 
July  2019  amending  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 200, 29.7.2019, p. 35). 
6 Although  the UK ceased to  be an EU Member State on 1 February 2020, the Directive still applied in  that 
State transitionally until 31 December 2020. Thus, this report includes the UK patient mobility data  (see 
below Section 3). 

7  Infringement  proceedings  were  launched  against  26  Member  States  on  the  grounds  of  non-notification  or 
incomplete  notification  of  transposition  measures.  After  the  Member  States  notified  such  measures,  the 
infringement proceedings were closed: three proceedings closed in 2014, 19 – in the first half of 2015, one 
– end of 2015, two – in 2016 and the last one – in 2017. 

6 

 
                                                 
countries on the impact of the Directive. The engagement of some stakeholders was also 
low: the researchers found it difficult to contact and engage the stakeholders during the 
course of the Covid-19 pandemic. In addition, there was evidence of stakeholder fatigue, 
as there were many concurrent activities in the area of healthcare.  As not all sources of 
evidence  are equally robust,  consideration was  given as to  when  and how the  evidence 
was collected and whether there was any bias or uncertainty in it. The contractors used 
triangulation of data from the different data collection as a method to arrive at robust and 
evidence-based  results  that  could  be  confirmed  by  more  than  one  source.  More 
information on the methodology and process to  carry out this evaluation is available in 
Annex II and can be found on the Commission’s dedicated webpage for the evaluation of 
the Directive8. 

This  evaluation  is  part  of  the  Commission’s  regulatory  fitness  and  performance 
programme (REFIT9). It refers to the opinion of the Fit for Future platform adopted on 10 
December 202110. 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? 

Description of the intervention and its objectives 

EU  legislation  to  facilitate  cross-border  healthcare  in  the  European  labour  market  has 
been  in  place  since  195811.  Currently,  Regulation  No  883/2004  on  the  coordination  of 
social security systems ensures the reimbursement for healthcare that becomes necessary 
on  medical  grounds  during  an  insured  person’s  temporary  stay  in  another  EU  country 
using  the  European  health  insurance  card  (EHIC).  It  also  covers  planned  healthcare 
subject to prior approval by the EU country where the citizen is insured. 

In  1998,  the  Court  of  Justice  of  the  EU  (the  Court  of  Justice)  clarified  principles  for 
cross-border healthcare reimbursement through its rulings in two cases12. Over the next 
decade,  there  were  further  Court  rulings  on  the  principles  on  the  freedom  to  provide 
health services based on Article 56 of the  TFEU. The case law has made clear that the 
TFEU  provisions  on  free  movement  apply  to  the  reimbursement  of  health  services 
regardless  of  how  they  are  organised  and  financed  at  national  level.  To  provide  legal 
certainty of the 10-year case law on the freedom to provide health services in the EU and 
to  give  effective  application  of  the  citizens’  rights  in  the  EU  internal  market,  the 
Commission  proposed a Directive on the  application  on patients’ rights  in cross-border 
healthcare  in  200813.  The  CBHC  Directive  was  adopted  on  9  March  2011  and  entered 

8 https://ec.europa.eu/health/cross-border-healthcare/evaluation-cross-border-healthcare-directive_en  
9 

https://ec.europa.eu/info/law/law-making-process/evaluating-and-improving-existing-laws/refit-making-eu-
law-simpler-less-costly-and-future-proof_en  

10 Fit for Future Platform Opinion, ref. 2021/SBGR3/14, available here:  
https://ec.europa.eu/info/sites/default/files/final_opinion_2021_sbgr3_14_patient_rights.pdf 
11 See footnote 2.  
12 Judgments of 28 April 1998, Decker, C-120/95, EU:C:1998:167; and Kohll, C-158/96, EU:C:1998:171. 
13 Proposal for a directive of the European Parliament and of the Council on the application of patients' rights in 

cross-border healthcare, 2.7.2008, COM(2008) 414 final. 

7 

 
                                                 
into  force  on  24  April  2011.  It  was  due  to  be  transposed  by  the  Member  States  by  25 
October 201314. It is important to bear in mind that the CBHC Directive came into being 
at a time of economic recession with huge impacts on healthcare budgets in the EU. 

The CBHC Directive’s main aim was therefore to provide sufficient legal certainty for 
citizens  wishing  to  use  cross-border  healthcare.  It  does  this  by  setting  out  patients’ 
rights,  including  the  rules  on  reimbursement  for  cross-border  healthcare  costs  in 
accordance with the Court of Justice’s rulings, to ensure that EU citizens could use those 
rights  in  practice15.  The  legal  provisions  put  in  place  complemented  the  existing  legal 
framework  for  cross-border  healthcare  provided  by  Regulation  (EC)  No  883/2004  by 
removing certain  obstacles to  cross-border healthcare and by  aiming to  give citizens  in 
certain instances the right of choice to healthcare services in the internal market. While 
both these EU instruments are about cross-border healthcare, their approaches differ: the 
Directive  centres  around  patients’  rights  and  encouraging  cross-border  cooperation  in 
healthcare  whereas  the  focus  of  the  Regulation  is  coordinating  social  security  systems. 
The Directive was not intended to replace the rights to cross-border healthcare under the 
Regulations nor to deprive patients of the more beneficial rights guaranteed therein when 
the conditions are met. 

The  second  objective  of  the  CBHC  Directive  was  to  make  sure  that  the  necessary 
requirements  for  high  quality  and  safe  cross-border  healthcare  were  respected 
throughout  the  EU.  The  Commission’s  impact  assessment  accompanying  the  legal 
proposal16 recognised that while citizens prefer healthcare to be available close to where 
they live and work, there are certain situations where the citizen may wish to be treated 
abroad. This is the case for highly specialised care requiring resources or expertise that is 
not available in every EU country such as for rare diseases, as well as where the nearest 
appropriate healthcare  provider may  be  across the border or where the local services are 
unable to provide the  appropriate healthcare  yet there is capacity in another EU  country. 
Some citizens may wish to be treated abroad to be close to their family, who may live in 
another EU country, or to seek a better quality or a cheaper procedure in another Member 
State.  At  the  same  time,  patient  flows  between  Member  States  were  expected  to  remain 
limited. 

The CBHC Directive also intended to promote EU cooperation between health systems 
in several  areas where economies of scale of coordinated action between  Member States 
could bring significant benefits to national health systems. EU countries were encouraged 
to  provide  mutual  assistance  and  to  cooperate  in  border  regions  to  improve  access  to 
healthcare for patients and using resources more efficiently. In the area of rare and low 
prevalence complex diseases, the aim of the ERNs was to provide healthcare to patients 
who have  conditions requiring a  particular  concentration  of  resources  and to act  as focal 

14 The Directive was due to be transposed by the EEA EFTA States by 1 August 2015. 
15 See proposal for a directive referred to in footnote 13. 
16  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, 2.7.2008, SEC(2008) 2163. 

8 

 
                                                 
points  for  medical  training  and  research,  information  dissemination  and  evaluation.  A 
European  network  exchanging  information  to  assess  health  technology  could  provide 
important  evidence-based  strategic  advice  to  policy-makers  and,  lastly,  in  the  area  of 
eHealth, where different  and incompatible formats and standards hampered the provision 
of eHealth services, a network of national authorities could work together to improve the 
interoperability of systems. 

The Directive’s Intervention Logic 

The Commission’s impact assessment accompanying the legal proposal did not develop an 
intervention logic model to describe how the CBHC Directive was expected to work at 
the  outset.  The  Commission,  with  the  support  of  an  external  contractor17,  therefore 
developed an intervention model retrospectively by analysing available document sources. 
This  analytical  work  shows  the  different  steps  involved  in  the  implementation  of  the 
Directive and highlights the expected cause and effect relationship regarding patient rights 
and  rare  diseases.  The  intervention  logic  in  Figure  1  excludes  health  technology  and 
eHealth for the purposes of this evaluation. 

17 Study on enhancing implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient 
rights  in  the  EU,  https://ec.europa.eu/health/publications/study-enhancing-implementation-cross-border-
healthcare-directive-201124eu-ensure-patient-rights-eu_en. 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Figure 1: Intervention Logic of Articles 1-13 of the Directive 

Source: Study on enhancing implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient rights in the EU 

10 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Legal Framework 

The CBHC Directive’s framework for ensuring patients’ rights in cross-border healthcare 
applies to all health services provided by health professionals to patients, excluding organ 
transplants, public vaccination programmes and long-term care the purpose of which is to 
support people in need of assistance in carrying out routine, everyday tasks. It ensures that 
all citizens who are insured in a Member State are eligible to receive treatment in another 
Member  State  and  be  reimbursed  for  it  from  the  social  security  system  of  their  own 
Member  State.  It  sets  out  the  responsibilities  of  the  Member  State  of  treatment  and  the 
Member  State  of  affiliation.  It  requires  Member  States  to  have  complaint  procedures  in 
place and sets out the rights of patients, such  as the right to information and the right to 
follow-up care back home. It establishes the NCPs for cross-border healthcare to provide 
information  to  patients  and  it  covers  the  administrative  procedures  for  patients  seeking 
healthcare  in  another  EU  country.  Moreover,  the  Directive  encourages  voluntary 
cooperation on healthcare between Member States. Its provisions ensure the recognition of 
prescriptions  for  medicinal  products  and  medical  devices  issued  in  other  countries  under 
the conditions established therein. It puts in place the legal framework for the creation of 
the  ERNs  in  the  area  of  rare  and  low  prevalence  complex  diseases  and  promotes 
cooperation  in  the  areas  of  health  technology  assessment  and  eHealth.  It  also  requires 
Member States to provide mutual assistance as is necessary for the implementation of the 
Directive  and  encourages  cooperation  in  the  provision  of  cross-border  healthcare  at 
regional and local level, particularly in neighbouring countries and in border regions. 

The  CBHC  Directive  co-exists  with  the  Regulations  on  the  coordination  of  social 
security systems. 

Points of comparison 

This evaluation uses the Commission’s first evaluative study on the Directive of 2015 as 
the point of reference18 as most EU countries had transposed the Directive’s provisions 
by then. Also since 2015, Member States provided the Commission with data to monitor 
the Directive’s application in the EU. 

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

Implementation in the Member States 

The CBHC Directive came into force on 24 April 2011 and was due to be transposed into 
national law in the Member States by 25 October 2013. However, transposition was not 
completed  until  2015  following  infringements  proceedings  against  26  Member  States 
(and 21 Member States in the case of Implementing Directive 2012/52/EU). More than 
five  hundred  national  measures  transposing  the  Directive  were  notified  to  the 
Commission. The large number of national laws involved was partly due to the fact the 

18 European Commission (2015). Evaluative Study on cross-border Healthcare Directive 2011/24/EU, available 

here: https://ec.europa.eu/health/system/files/2016-11/2015_evaluative_study_exsum_en_0.pdf  

11 

 
                                                 
Directive regulated a number of issues which fell under regional competences and were 
subject  matter  of  separate  pieces  of  national  legislation.  The  Commission’s  conformity 
checks  focused  on  the  application  of  the  Directive  in  four  key  areas  with  the  greatest 
potential  to  act  as  barriers  to  patients  seeking  cross-border  healthcare:  the  systems  of 
reimbursement,  the  use  of  prior  authorisation,  the  administrative  requirements  and 
charging  incoming  patients.  Infringement  proceedings  started  against  three  Member 
States – Finland, Austria and the Netherlands – for a breach of the Directive in relation to 
the reimbursement of cross-border healthcare costs. 

The Directive’s provisions have been subject to four preliminary rulings of the Court of 
Justice that further clarified its rules on reimbursement of cross-border healthcare costs, 
also in light of the TFEU and the Charter of Fundamental Rights of the EU, as well as on 
recognition of prescriptions issued in other Member States19. 

Operation of the Directive 2015-2020 

The Commission triennial reports describe how the operation of the CBHC Directive has 
progressed  since  201520.  The  Commission  reported  in  2015  and  2018  on  cross-border 
patient  flows,  the  financial  dimension  of  patient  mobility,  the  limitations  on  the 
application of the rules for reimbursement and the application of prior authorisation and 
the  functioning  of  the  ERNs  and  the  NCPs21.  The  Commission’s  third  report,  due  by 
October  2021,  was  postponed  until  April  2022  so  as  to  include  the  key  findings  of  the 
Commission’s evaluation of the Directive as described in this staff working document22. 

In summary, the Commission reports conclude that the Directive has improved the legal 
certainty for cross-border patients as well for domestic patients over their rights, however 
there  remain  important  shortcomings  in  the  application  of  the  Directive  in  the  EU  as 
described in the evaluation findings in Section 4 below. In terms of patient flows, in the 
countries  that  provided  data  for  all  reference  years  2016-202023,  the  number  of  prior 
authorisation requests received and granted peaked in 2018 followed by a modest decline 
in 2019 and a larger decrease in 2020 (in view of Covid-19). Similarly, in countries for 

19 Judgments of 18 September 2019, VIPA, C-222/18, EU:C:2019:751; of 23 September 2020, WO, C-777/18, 
EU:C:2020:745; of 29 October 2020, A, C-243/19, EU:C:2020:872; and of 28 October 2021, Y, C-636/19, 
EU:C:2021:885. 

20 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. 

21 Commission Report on the operation of Directive 2011/24/EU on the application of patients' rights in cross-
border  healthcare,  COM(2015)  421  final,  4.9.2015  and  Report  from  the  Commission  to  the  European 
Parliament and the Council on the operation of Directive 2011/24/EU on the application of patients' rights 
in cross-border healthcare, COM(2018) 651 final, 21.9.2018. 

22  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  operation  of  Directive 

2011/24/EU on the application of patients' rights in cross-border healthcare, COM(2022) 210 final. 

23 This concerns 15 Member States (BE, BG, DK, ES, FR, EL, HR, IE, IT, LU, MT, PL, RO, SI, SK) and the 

UK. 

12 

 
                                                 
which there is  complete data24, the number of requests for reimbursement received and 
granted saw a steady increase until 2018 and a slight decline in 2019 and 2020. 

The total numbers of prior authorisation and reimbursement requests received by all the 
countries are illustrated in Figures 2 and 325. 

Figure  2:  Number  of  prior  authorisation  requests  received  and  granted  for  all 
countries that provided data, 2016-2020 

 8.000

 7.000

 6.000

 5.000

 4.000

 3.000

 2.000

 1.000

 -

7.279 

6.935 

5.220 

5.409 

4.718 

6.236 

5.902 

3.942 

4.048 

3.886 

2.955 

3.028 

3.076 

2.184 

2.067 

3.667 

2.152 

1.646 

1.370 

760 

2016

2017

2018

2019

2020

Received

Authorised

Received of which by France

Authorised of which by France

  The  totals  excluding  the  UK  are  as  follows:  in  reference  year  2016:  6,009  prior 
authorisation  (PA)  requests  received  and  3,822  granted;  in  2017:  5,471  PA  requests 
received  and  3,727  granted;  in  2018:  6,301  received,  4,447  granted;  in  2019:  5,352 
received, 3,291 granted; and in 2020: 5,218 received, 3,542 granted. 

Source: Questionnaires on Directive 2011/24/EU reporting on patient mobility 

24 This concerns 17 Member States (BG, CZ, DK, EE, ES, FR, EL, HR, IE, IT, LT, LV, MT, PL, RO, SI and 

SK), the UK and NO. 

25  FR  was  not  able  to  separate  between  the  data  for  cross-border  healthcare  under  the  Directive  and  the 
Regulations  on  coordination  of  social  security  systems  or  under  parallel  schemes.  In  light  of  this,  the 
numbers for FR are highlighted separately in Figures 2 and 3. 

13 

 
 
 
 
 
 
 
 
                                                 
Figure  3:  Number  of  requests  for  reimbursement  without  prior  authorisation 
received and granted for all countries that provided data, 2016-2020 

 300.000

271.565 

283.719 

 250.000

240.443 

235.548 

226.834 

238.937 

 200.000

198.145 

194.876 

 150.000

162.137 

143.479 

147.807 

130.073 

177.863 

170.872 

157.585 

148.263 

 100.000

 50.000

 -

191.079 

155.517 

110.910 

92.390 

2016

2017

2018

2019

2020

Received

Granted

Received of which by France

Granted of which by France

The totals excluding the UK are as follows: in reference year 2016: 238,680 reimbursement 
requests  received  and  197,152  granted;  in  2017:  233,508  reimbursement  requests  received 
and 193,803 granted; in 2018: 269,006 received, 225,186 granted; in 2019: 280,594 received, 
236,891 granted; and in 2020: 188,013 received and 153,960 granted. 

Source: Questionnaires on Directive 2011/24/EU reporting on patient mobility 

The most prominent patient flows have remained stable over the years and the majority 
take place between neighbouring countries and North European citizens using healthcare 
during short-term stays in the South. In 2019, the largest flows were from Ireland to the 
United Kingdom, France to Germany, France to Spain and from Norway and Sweden to 
Spain26. 

In addition, the Commission reports that the period 2018-2020 saw significant progress 
to  enhance  cross-border  cooperation  in  healthcare  with  the  adoption  of  EU 
implementing and delegated acts,  paving the way  for the creation of the ERNs in  2017 
followed  in  2021  by  the  adoption  of  a  new  EU  Regulation  on  health  technology 
assessment with the subsequent repeal of Article 15 from the Directive. 

26  Olsson,  J.,  De  Smedt,  L.  and  De  Wispelaere,  F.  (2021).  Data  on  patient  mobility  under  Directive 

2011/24/EU: Trend report reference years 2018-2020. 

14 

 
 
 
 
 
                                                 
In  2017,  the  ERNs  were  established  on  the  basis  of  Article  12  of  the  Directive, 
Commission Implementing Decision 2014/287/EU and Commission Delegated Decision 
2014/286/EU. Currently there are 24 ERNs on rare or low prevalence complex  diseases 
(see Annex VI). 

By 2021, the ERNs were bringing together more than 900 highly-specialised healthcare 
units from over 300 hospitals in 26 EU countries and Norway. As of January 2022, the 
existing  ERNs  have  been  joined  by  620  new  members,  bringing  the  total  number  of 
members  to  almost  1,500  and  covering  all  the  EU  Member  States  and  Norway.  The 
members of the existing ERNs currently treat more than 1.7 million patients with rare or 
low  prevalence  complex  diseases.  The  Commission  launched  a  continuous  monitoring 
system of the ERNs based on the set of 18 agreed key performance indicators in 2020. 
The analysis of the collected data is on-going. 

Other  EU  institutions  and  bodies  have  drawn  up  reports  on  the  implementation  of  the 
CBHC Directive. In 2018/2019, the European Court of Auditors (ECA) carried out an 
audit  on  the  Commission’s  work  overseeing  the  Directive’s  implementation  and  EU 
actions in cross-border healthcare. Its special report concluded that, while EU actions had 
enhanced cooperation between Member States, the impact on patients was rather limited. 
The ECA recommends improving information provided by the NCPs to patients and calls 
for  more  EU  actions  on  eHealth  and  rare  diseases27.  Both  the  Council28  and  the 
European  Parliament  supported 
the  ECA’s  recommendations.  The  European 
Parliament  called  for  simpler  administrative  procedures  and  improving  access  to 
healthcare 
the  European  Committee  of  the  Regions 
recommended more support for the authorities to comply with the Directive’s obligations 
and recognised the value of prior notification of reimbursement costs and the use of prior 
authorisation  to  protect  national  health  systems30.  The  Fit  for  Future  Platform 
Opinion31  recognizes  the  same  obstacles  to  the  Directive  and  makes  eight  concrete 
suggestions how to make it easier for European patients to understand their care options 
and access the best possible treatment and care. 

to  patients29.  In  2020, 

The  CBHC  Directive  has  had  an  unexpected  positive  impact  on  domestic  healthcare 
systems according to evidence from the literature review. It has acted as a driver for the 
development  and  greater  transparency  of  patients’  rights  as  well  as  leading  to  the 
introduction  or  adaptation  of  mandatory  professional  liability  insurance  and  the 
implementation  of quality  indicators  and standards32.  Examples include  the adoption of 

27  ECA  Special  Report  7/2019  EU  actions  for  cross-border  healthcare:  significant  ambitions  but  improved 

management required, 4.6.2019. 

28 Council conclusions in response to the ECA Special Report 7/2019, 12913/19 FIN, 23.10.2019. 
29  European  Parliament  Resolution  on  the  implementation  of  the  Cross-Border  Healthcare  Directive, 

2018/2108(INI), 12.2.2019. 

30  ECR  Opinion  Implementation  and  future  perspectives  for  cross-border  healthcare,  CDR  4597/2019, 

14.10.2020. 

31 Referred to in footnote 10. 
32 Azzopardi-Muscat, N., Baeten, R., Clemens, T., Habicht, T., Keskimäki, I., Kowalska-Bobko, I., Sagan, A. 
and van Ginneken, E. (2018). The role of the 2011 patients' rights in cross-border health care directive in 

15 

 
                                                 
 
explicit benefit packages in Malta and Finland; reimbursement of telemedicine services 
in  Belgium;  the introduction of mandatory professional liability insurance in  Malta and 
Poland  (and  expected  in  Estonia);  and  the  adaptation  of  this  liability  insurance  in 
Germany. Some efforts to  lower waiting times for healthcare in  Poland and Malta may 
also  be  attributed to  the  influence of the Directive.  In addition,  other studies show that 
the  Directive  encouraged  Member  States  (such  as  Austria,  Belgium,  Finland,  Hungary, 
Latvia,  Luxembourg,  Malta,  Norway,  Poland,  Spain)  to  be  more  transparent  about 
patients'  rights  in  general  and  that  existing  national  rules  on,  for  example,  informed 
consent, privacy and access to medical records apply to cross-border patients in the same 
way as for domestic patients33. Another change that can be attributed to the Directive is 
related to private clinics in Belgium, which will be made subject to quality standards that 
previously only applied to hospitals as from 2022. There are also examples of countries 
(as mentioned above) which have introduced explicit statements of what is included in a 
patient’s benefit basket, and those which have introduced or adapted mandatory liability 
insurance for professionals34. 

Secondly, there is  evidence that  medical tourism agencies, for example in  Ireland and 
Poland, have emerged since the CBHC Directive was adopted35. However, there is a lack 
of  data  on  the  actual  extent  of  usage  and  reimbursement  of  these  services,  both  within 
and outside the framework of the Directive.  

With regard to external factors, due to the temporary restrictions on the free movement of 
people  in  response  to  the  Covid-19  pandemic36,  patient  mobility  under  the  Directive 
dropped  significantly  from  283,719  applications  for  reimbursement  without  prior 
authorisation received in 2019 to 191,080 in 2020. 

The  Commission  has  published  all  the  above  reports  and  external  studies  on  the 
implementation of the CBHC Directive on its website37. 

4.  EVALUATION FINDINGS 

4.1.  To what extent was the intervention successful and why? 

Overall  the  evaluation  found  that  the  Directive  has  been  successful  in  delivering  its 
objectives  to  a  certain  extent.  It  has  brought  additional  legal  clarity  on  the  rights  of 
patients  to  use  healthcare  services  anywhere  in  the  EU  and  it  has  enshrined  important 

shaping  seven  national  health  systems:  Looking  beyond  patient  mobility. Health  Policy, 122(3),  pp.279-
283. 

33  European  Commission  (2016).  Patients’  Rights  in  the  European  Union  Mapping  eXercise,  available  here: 

https://limo.libis.be/primo-
explore/fulldisplay?docid=LIRIAS1950327&context=L&vid=Lirias&search_scope=Lirias&tab=default_ta
b&fromSitemap=1   

34 European Observatory on Health Systems and Policies (2019). Everything you always wanted to know about 
available  here: 

European  Union  health  policies  but  were 
https://apps.who.int/iris/bitstream/handle/10665/328267/9789289051767-eng.pdf   

ask,  2nd 

afraid 

ed., 

to 

35 Ibid. 
36 Frontier workers were exempted from these border restrictions. 

16 

 
                                                                                                                                                 
patient  rights,  such  as  equal  treatment  of  EU  and  domestic  patients.  It  has  achieved  a 
more consistent approach at EU level to reimbursement of cross-border healthcare costs 
for  EU  citizens.  It  has  acted  as  a  driver  for  patient  rights  in  general,  increasing 
transparency  on  treatment  prices  and  bringing  about  changes  in  various  national  health 
systems  to  the  benefit  of  patients.  EU  citizens  are  making  use  of  their  rights  and  the 
reimbursement  mechanisms  provided  by  the  Directive,  although  their  numbers  remain 
small. The general public has largely benefited from the Directive’s provisions regulating 
the recognition of prescriptions.  

The  Directive  has  made  a  significant  contribution  in  the  area  of  rare  diseases  with  the 
creation  of  the  ERNs  to  support  the  diagnosis  and  treatment  of  rare  disease  patients.  It 
has also played a crucial role to deepen European cooperation between health systems in 
the  area  of  health  technology  assessment,  leading  to  the  adoption  of  a  separate 
Regulation in 2021, and also in eHealth, leading to  the proposal for a Regulation on the 
EHDS. 

Effectiveness 

4.1.1.  How effective was the Directive in the area of patients’ rights? 

The  CBHC  Directive  has  facilitated  access  to  safe  and  high  quality  cross-border 
healthcare  to  some  extent  by  clarifying  the  responsibilities  of  the  Member  States  with 
regard  to  cross-border  healthcare  and  the  rules  on  reimbursement  of  costs  of  such 
healthcare.  

To enable citizens to make an informed choice regarding healthcare abroad, the Directive 
obliges  Member  States  to  ensure  that  citizens  receive  the  relevant  information  and  sets 
out  other  important  responsibilities  with  regard  to  cross-border  healthcare.  Among  the 
responsibilities  of  the  Member  States’  of  treatment  are  the  obligations  to  ensure  that 
patients  from  other Member States are treated equally with  domestic patients  regarding 
access to treatment, that standards and guidelines on quality and safety laid down by that 
Member  State  and  EU  legislation  are  ensured,  as  well  as  that  the  healthcare  providers 
apply  the  same  scale  of  fees  for  services  for  patients  from  other  Member  States  as  for 
domestic  patients  or  that  they  charge  a  price  calculated  according  to  objective,  non-
discriminatory criteria if there is no comparable price for domestic patients. The Member 
State of affiliation is required, among other things, to ensure the same medical follow-up 
as would have been available if the healthcare at issue had been provided on its territory. 

Unequal access to health services in the Member State of treatment has not been reported 
as encountered by patients. The same is true regarding the different quality of healthcare 
in  the  Member  State  of  treatment  for  domestic  and  cross-border  patients.  Nor  has  the 
Commission  identified  that  healthcare  providers  are  setting,  or  are  allowed  to  set, 
discriminatory  prices  for  patients  from  other  Member  States.  This  evidences  certain 
success of the CBHC Directive in ensuring patients’ rights. 

37 https://ec.europa.eu/health/cross-border-healthcare/overview_en  

17 

 
                                                                                                                                                 
However,  the  CBHC  Directive  is  perceived  as  less  effective  in  creating  legal  certainty 
and clarity over the patients’ rights to cross-border healthcare based on the replies of the 
majority  of  public  consultation 
respondents,  particularly  patients  and  patient 
organisations. Conversely, 34% of healthcare authorities, providers and insurers consider 
the  Directive  has  achieved  clarity  and  certainty  to  a  limited  extent.  Insufficient  and 
unclear  information  on  cross-border  healthcare,  multiple  interpretations  of  the  relevant 
rules and uncertainty over the level of reimbursement were among the reasons cited. The 
gaps  in  information  for  patients  about  their  rights  alongside  with  financial  burdens  are 
considered as the most important problems resulting from cross-border healthcare. 

By codifying the case law, the CBHC Directive has ensured a more consistent approach 
at EU level to reimbursement of cross-border healthcare costs for EU citizens compared 
to the situation where Member States were to comply directly with the TFEU provisions, 
as interpreted by the Court of Justice. At the same time, recognising the organisation and 
delivery  of  healthcare  as  a  national  competence,  the  Directive’s  provisions  are 
formulated in a way that leaves sufficient room for manoeuvre for Member States to limit 
certain  patients’  rights  on  overriding  reasons  of  general  interest,  if  the  principle  of 
proportionality  is  respected.  However,  the  conformity  checks  undertaken  by  the 
Commission show that this resulted in quite a divergent implementation of the Directive 
across EU countries and each restrictive national measure has to be assessed on a case-
by-case  basis38.  This  also  essentially  means  that  patients’  rights  to  cross-border 
healthcare cost reimbursement might differ in each Member State and full clarity about 
the content of these rights could only be ensured on a national level. 

EU citizens are using the CBHC Directive to seek healthcare across borders as a result of 
the Directive removing some obstacles to cross-border healthcare. Patient mobility data 
from 2015-202039 shows that reimbursement cases for treatment in another EU country 
under  the  Directive  steadily  increased  until  2018  and  then  declined  in  2019  and  2020. 
Patient  mobility  under  the  Directive  remains  low  with  around  300,000  requests  for  the 
reimbursement  of  cross-border  healthcare.  However,  taking  into  account  the  data 
robustness and that several countries fail to report patient flow data40, the Directive has to 
some extent met the expectations of the Commission’s impact assessment accompanying 
the legal proposal41, which anticipated an estimated 390,000-780,000 patients annually to 
benefit  from  the  preferred  option.  Moreover,  while  the  Directive’s  impact  on  patient 
flows is  rather limited, the promotion of cross-border healthcare is  not  the objective of 
the Directive.42 At the time of the adoption of the Directive, it was expected that patient 
flows would remain limited43. Stakeholders indicated that most patients prefer to receive 
healthcare close to home and that going abroad is very difficult and costly. Even if they 

38 See COM(2022) 210 final. 
39 See the report referred to in footnote 26. 
40 DE, NL and LI have not been able to provide data on patient flows due to structural reasons. 
41  Commission  Impact  Assessment,  referred  to  in  footnote  16,  Table  1  “Comparing  the  Options”  (preferred 

option 3A 780,000 patients and sub-option 3b 390,000 patients).  

42 Recital 4 of the CBHC Directive. 
43 Recital 39 of the CBHC Directive. 

18 

 
                                                 
do  go  abroad,  in  most  instances  they  prefer  to  do  so  under  the  Regulations  on  the 
coordination of social security systems or any existing parallel schemes as there might be 
no or less out-of-pocket expenses for the patient to bear. 

Information to patients on cross-border healthcare 

Limited  access  to  information  for  patients  about  their  rights  was  highlighted  by  public 
consultation respondents as a key reason why the CBHC Directive do not meet patients’ 
needs adequately44. According to a 2021 Eurobarometer survey45, EU citizens still do not 
feel well informed about their healthcare rights, indicating that many are not able to make 
an  informed  choice  about  cross-border  healthcare:  25%  of  EU  citizens  surveyed  felt 
“well-informed”  about  what  healthcare  they  have  the  right  to  receive  and  to  be 
reimbursed for in another EU country compared to 17% in 2015; however 72% felt “not 
well  informed”  compared  to  78%  in  2015.  Survey  findings  by  country  shows  a  higher 
awareness  of  rights  in  Northern/Western  Europe  over  respondents  in  Southern/Eastern 
Europe. 

The  NCPs  for  cross-border  healthcare  play  a  key  role  in  enhancing  patients’ 
opportunities  to  seek  healthcare  abroad.  By  2016,  all  Member  States  had  established  a 
NCP for cross-border healthcare to  provide clear and accessible information to  citizens 
about cross-border healthcare in accordance with Article 6 of the Directive. Through the 
creation  of  the  NCPs,  the  Directive  has  effectively  contributed  to  the  gradual 
improvement of patients’ awareness  of their rights.  However, awareness  remains rather 
low with just over half of the public consultation respondents aware that NCPs existed. 
Those  that  found  information  on  the  NCPs  websites  ranked  it  higher  for  clarity  and 
quality  rather  than  completeness.  Overall,  information  on  cross-border  healthcare  has 
improved between 2015 and 2021 according to an analysis of NCPs websites in 201846 
and  in  202147.  A  Commission  study  in  201848  considered  the  information  adequate. 
Nonetheless,  many  stakeholders,  particularly  patient  organisations,  highlighted 
information  gaps,  which  hinder  the  effectiveness  of  the  Directive  to  facilitate  access  to 
healthcare in another country. The European Patients’ Forum states in its position paper 
that  clear  information  about  patients’  entitlements,  even  within  the  domestic  healthcare 
system, was a gap. When it comes to receiving treatment abroad, financial implications 
of  the  choices  available  are  quite  important  to  know  in  advance49.  The  Fit  For  Future 

44 21% of public consultation respondents. 3rd most popular issue raised in the consultation response.  
45 Standard Eurobarometer 95 - Spring 2021, available here:  
https://europa.eu/eurobarometer/surveys/detail/2532  

46  European  Commission  (2018).  Study  on  Cross-border  health  services:  enhancing  information  provision  to 
patients,  available  here:  https://ec.europa.eu/health/publications/final-report-study-cross-border-health-
services-enhancing-information-provision-patients_en   

47 Study on enhancing implementation of the Cross-Border Healthcare Directive 2011/24/EU to ensure patient 
rights in the  EU, available  here:  https://ec.europa.eu/health/publications/study-enhancing-implementation-
cross-border-healthcare-directive-201124eu-ensure-patient-rights-eu_en 

48 See the study referred to in footnote 46.  
49 The European Patients' Forum (EPF) Response Statement “Public consultation on Cross-border Healthcare – 
https://www.eu-

11.2.2021, 

evaluation 

available 

patients’ 

rights”, 

here: 

of 

19 

 
                                                 
 
Platform also highlights how the NCPs are generally not known as information point for 
healthcare abroad and there is a lack of awareness at regional level50. 

Information  on  healthcare  providers  has  increased  considerably  when  comparing  the 
results  of  2021  with  those  of  2015  and  2018,  although  there  are  significant  differences 
between  countries.  Gaps  were  identified  particularly  in  relation  to  the  provision  of 
contact details and the provision of search tools to help patients find specific healthcare 
providers.  

Particularly important for patients is information on whether to seek healthcare under the 
CBHC Directive or the Regulations on the coordination of social security systems, and to 
know whether prior authorisation is a pre-requisite for reimbursement of medical costs. 
A  2021  Commission  study  found  that  out  of  the  22  Member  States  and  EEA  EFTA 
countries  having  prior  authorisation  system  in  place,  only  17  NCPs  websites  provide  a 
specific list of treatments subject to prior authorisation in their country51. Other countries, 
both  in  their  implementing  legislation  and  on  the  NCPs  websites,  only  refer  to  general 
criteria of healthcare that could be made subject to prior authorisation in accordance with 
Article  8(2)  of  the  Directive  thereby  undermining  legal  certainty  for  patients  about  the 
exact content of their rights to healthcare abroad. Moreover, less than half the NCPs were 
found  to  provide  information  on  the  distinction  between  the  Directive  and  the 
Regulations, according to an analysis of NCP websites52. The ECA noted that this issue 
affected patients’ choice for reimbursement of healthcare.  

While for 20 out of 30 NCPs information on reimbursement costs improved, information 
on  pricing  of  treatments  is  generally  lacking.  This  is  due  to  a  lack  of  information  at 
national level.  

Only 10 out of 31 websites provided options for people with decreased sensory functions. 
The  European  Disability  Forum  (EDF)  report53  stated  that  patients  with  disabilities 
seeking cross-border healthcare face difficulties finding information on their rights under 
the  CBHC  Directive,  due  to  the  lack  of  options  for  people  with  decreased  sensory 
functions and due to the amount of information being limited.  

To  improve  the  information  provision  to  patients,  the  Commission  developed  and 
published  a  multi-lingual  toolbox  for  NCPs  with  the  support  of  the  EPF.  This  includes 
guiding principles for the practice of NCPs under the CBHC Directive (see Box 1) and a 
Manual for Patients54. While sixteen NCPs have published the toolbox on their websites, 

patient.eu/globalassets/events/old/2014/2014_cbhc_gr/presentations/day2/epf_cbhc_consultation-
feedback_final.pdf  

50 See the opinion referred to in footnote 10. 
51 Study supporting the evaluation of the Directive, Annex 1.5.8. 
52 Ibid, Annex 1.5.5. 
53 European Disability Forum (2021). Report on access to cross-border healthcare by patients with disabilities 
the  European  Union,  available  here:  https://www.edf-feph.org/content/uploads/2019/08/EDF-

in 
report_on_health_revised-accessible.pdf  

54 https://ec.europa.eu/health/cross-border-healthcare/toolbox-cross-border-healthcare_en  

20 

 
                                                                                                                                                 
respondents  to  a  survey  of  patients’  organisations,  healthcare  insurers  and  healthcare 
providers showed that they are not very familiar with the toolbox55. 

Box 1: Guiding Principles for the Practice of NCPs 

General Principles: 

  Principle of visibility 
  Principle of accessibility 
  Principle of transparency 
  Principle of inclusion 

Information provision in accordance with Directive 2011/24/EU: 

  Principle of duality 
  Principle of information to outgoing patients in accordance with the Directive 
  Principle of information to incoming patients in accordance with the Directive 

Cooperation: 

  Principle of information to healthcare providers 
  Principle of cooperation 

The  CBHC  Directive  has  contributed  to  some  extent  to  enhance  transparency  and 
comparability of healthcare (regarding safety, quality, costs and waiting times) across the 
EU, according to interviewees. In many cases, it has acted as a driver for Member States 
to make information on patients’ rights and quality of care more transparent and to adapt 
professional  liability  standards  for  health  professionals.  However,  this  has  not  been 
systematic  across  all  Member  States.  Moreover,  according  to  an  analysis  of  NCPs 
websites56, there are persisting gaps in the provision of information regarding safety and 
quality standards, costs, waiting times etc. Only 9 NCPs websites provide information on 
national laws regarding patient safety. 

The  Directive  requires  that  NCPs  consult  with  key  stakeholders.  However,  a  2021 
Commission  funded study57  showed that, in  total,  only 16, 19  and 21 of the NCPs had 
such consultations arrangements (informal or formal) with patient organisations, insurers 
and healthcare providers respectively. Moreover, where they are in place, the NCPs  are 
in contact with these stakeholders on an irregular or rare basis.  

Obstacles to access healthcare abroad 

Citizens  continue  to  face  important  obstacles  hindering  the  effectiveness  of  the  CBHC 
Directive  to  meet  its  main  objectives.  The  public  consultation  responses  identified  the 
five  biggest  barriers  (out  of  20  listed)  as  paying  for  healthcare  costs  upfront,  extensive 

55 See the study referred to in footnote 17. 
56 Study supporting the evaluation of the Directive, referred to in footnote 51. 
57 Ibid.  

21 

 
 
 
 
                                                 
use  of  prior  authorisation,  complex  administrative  procedures  and  uncertainty  over 
reimbursement and information to patients.  

Paying for healthcare costs upfront represented the biggest barrier to healthcare abroad 
according  to  the  public  consultation  respondents  (117  out  of  169  respondents)  and 
interviewees.  While  the  Directive  provides  a  mechanism  for  citizens  to  seek  (partial) 
reimbursement  from  their  health  insurer,  patients  must  pay  upfront  for  their  treatment 
abroad and face additional costs for travel and accommodation as usually these are often 
not  reimbursed  in  Member  States  (nor  is  this  required  under  the  Directive).  Because 
patients  are  reimbursed  at  the  same  level  of  costs  as  if  treated  where  they  are  insured, 
patient organisations in particular take the view that the Directive increases inequalities 
in  healthcare,  as  there  is  a  discrepancy  in  tariffs  for  healthcare  services  between  EU 
countries.  Patients  from  countries  with  lower  tariffs  for  healthcare  have  to  pay  a  large 
difference  out  of  their  own  pocket  if  treated  in  a  country  with  higher  tariffs/prices  and 
seek  reimbursement  under  the  Directive,  thereby  undermining  the  Directive’s  aim  to 
facilitate access to healthcare EU-wide. Paying costs upfront also impacts those unable to 
afford to pay in advance for healthcare abroad. The issue of access becomes particularly 
acute  for  patients  with  rare  and  low  complex  diseases  whose  only  option  may  be  to 
receive care and life-saving treatment via a specialized centre in a different country.  

In this context, it is important to recall the objectives of the Directive to facilitate cross-
border  healthcare:  first,  it  complements  the  Regulations  on  the  coordination  of  social 
security systems. In cases such as for rare disease patients where highly specialised and 
cost-intensive  care  is  necessary,  the  Regulations  offer  a  more  favourable  route  to 
treatment  in  another  country  as  the  social  security  bodies  are  responsible  for  the 
reimbursement of the treatment costs and in most instances, the patient will not need to 
pay costs upfront58. Secondly, under the Directive, patients pay costs upfront as it is the 
only viable way to empower the citizen to choose a healthcare provider, whether public 
or  private,  in  another  EU  country  without  prior  approval  outside  the  circumstances 
coordinated under the Regulations for the coordination of social security systems while 
also giving the patient the right to reimbursement of (some) costs by their health insurer. 

The  extensive  use  of  prior  authorisation  to  access  cross-border  healthcare  and 
associated application processes prevents the realisation of the Directive’s full potential 
and  hampers  its  effectiveness.  In  line  with  case  law  of  the  Court  of  Justice,  making 
reimbursement  of  costs  for  cross-border  healthcare  subject  to  prior  authorisation  is  a 
restriction to the free movement of services59. Therefore, as a general rule, the Member 
States  should  not  require  prior  authorisation60.  Indeed,  the  highest  added  value  of  the 
Directive’s  route  for  cross-border  healthcare  reimbursement  compared  with  the 

58 Cross-border healthcare under the Regulations on the coordination of social security systems in general and 
the prior authorisation requirement for planned treatment abroad under the Regulations in particular is out 
of the scope of this evaluation. 

59 See, e.g., judgment of 23 September, WO, C-777/18, cited in footnote 19, paragraph 58 and the case law cited 

therein. 

60 Recital 38 to the Directive. 

22 

 
                                                 
Regulations is the reduction of administrative burden for patients in that they can choose, 
for example to have outpatient treatment or a day surgery in another country without the 
need  for  prior  authorisation  and  be  reimbursed  for  the  costs  according  to  the  domestic 
tariff where they are insured. The Directive only allows Member States to use a system 
of  prior  authorisation  for  the  categories  of  healthcare  and  under  specific  conditions  set 
out  therein,  including  with  due  respect  to  the  principle  of  proportionality.  However, 
currently,  only  seven  EU  Member  States  and  one  EEA  EFTA  State61  have  no  prior 
authorisation  system  in  place,  giving  patients  freedom  to  choose  a  healthcare  provider 
abroad  and  reducing  administrative  burden.  Other  countries  have  introduced  a  prior 
authorisation system mainly for cross-border healthcare that involves overnight hospital 
accommodation  and/or  for  major  non-hospital  healthcare.  The  Member  States’  lists  of 
healthcare subject to prior authorisation also differ significantly in the extent to which the 
healthcare is further specified and in the number of the separate items on the lists62. At 
the  same  time,  a  steady  very  low  number  of  prior  authorisation  requests,  as  well  as  a 
relatively  low  number  of  reimbursement  requests  for  healthcare  that  is  not  subject  to 
prior  authorisation,  having  marginal  impacts  on  national  healthcare  budgets,  do  not 
generally point to a need of extensive prior authorisation systems under the Directive. 

Complex  administrative  procedures  for  prior  authorisation  for  cross-border 
healthcare  and  reimbursement  are  hampering  the  effectiveness  of  the  Directive  to 
facilitate the access to  cross-border healthcare to  the benefits of patients.  The Directive 
requires  that  administrative  procedures  relating  to  prior  authorisation  requests  and 
reimbursement must be based on objective, non-discriminatory criteria that are necessary 
and proportionate. Yet 66 out of 169 respondents to the public consultation, from most 
stakeholder groups, particularly patients and citizens, selected administrative procedures 
to cross-border healthcare as a key barrier. In 2018, the Commission in its triennial report 
identified  administrative  procedures  as  a  key  area  with  potential  to  act  as  barriers  to 
healthcare63  and  the  European  Parliament  report  refers  to  “unduly  burdensome  and/or 
restrictive”  systems  implemented  at  national  level64.  Recent  research  into  national 
administrative  procedures  for  cross-border  healthcare  confirm  that  some  national 
requirements  may  pose  disproportionate  barriers  to  patients  seeking  healthcare  in  other 
EU countries.  

Box  2:  Examples  of  potentially  disproportionate  administrative  requirements  for 
cross-border healthcare65 

Requirements for prior authorisation: 

61  CY,  CZ,  EE,  FI,  LV,  LT,  SE  and  NO  have  not  chosen  to  introduce  a  prior  authorisation  system  or  have 
decided  to  remove  it.  In  addition,  NL  has  not  introduced  a  prior  authorisation  system  in  its  national 
legislation,  but  where  persons  insured  under  the  NL  social  security  system  have  access  to  cross-border 
healthcare, prior authorisation seems to be required by the health insurers. 

62 Mapping and Analysis of Prior authorisation lists: analytical report, see the study referred to in footnote 17. 
63 COM(2018) 651 final, referred to in footnote 21. 
64 European Parliament resolution of 12 February 2019, referred to in footnote 29. 
65  See  further  Mapping  and  Analysis  of  Administrative  Procedures:  analytical  report,  the  study  referred  to  in 

footnote 17. 

23 

 
                                                 
 

 

 

 

 

 

In  three  countries,  patients  have  to  submit,  together  with  the  application, 
documentation  issued  directly  by  the  foreign  healthcare  provider,  either 
confirming  information  on  the  healthcare  to  be  received  abroad,  or  on  the 
healthcare provider and/or its availability to provide the requested service. 
In one country, patients  have to submit the calculation of expected costs for the 
planned healthcare abroad prepared by the foreign healthcare provider which will 
provide healthcare. 
In  nine  countries,  the  patient  seems  to  be  required  to  provide  in  the  application 
information concerning the availability of the healthcare and/or the waiting time 
for  the  service  in  the  country  of  affiliation.  For  example,  in  one  country,  it  is 
required  to  provide  a  certificate  from  at  least  two  hospitals  confirming  that  the 
proposed  healthcare  cannot  be  provided  in  that  country  within  a  medically 
acceptable period. 
In  one  country,  it  is  required  to  provide  a  document  issued  by  the  NCP  in  the 
country  of  treatment  showing  that  the  healthcare  provider  does  not  give  rise  to 
serious  and  specific  concerns  relating  to  the  observance  of  the  standards  and 
guidelines  regarding  the  quality  of  medical  assistance  and  safety  of  patients, 
including provisions regarding supervision. 
In  seven  countries,  the  practitioner  whose  referral  is  necessary  for  prior 
authorisation  must  be  a  national/contracted  doctor,  whilst  in  other  twelve 
countries,  the  sources  consulted  do  not  seem  to  provide  any  indication  on  the 
country  affiliation  of  the  practitioner,  thus  the  legal  certainty  is  not  ensured  for 
patients. 
In  two  countries,  official/certified  translations  of  supporting  documents  have  to 
be provided together with the application. 

Requirements for reimbursement: 

 

 

 

 

 

In one country, a certificate from the treating doctor regarding the legal status of 
the  institution  of  treatment  must  also  accompany  the  request.  In  addition,  all 
documentation shall be legally issued and certified by the consulate and officially 
translated. 
In  one  country,  the  reimbursement  request  should  include  an  evaluation  of  the 
national treating physician on the effectiveness of the treatment abroad. 
In  two  countries,  patients  are  required  to  inform  whether  they  have  applied  for 
reimbursement  at  a  private  insurance  company  or  whether  they  have  travel 
insurance with medical coverage. 
In  one  country,  flight  tickets  must  be  submitted  as  a  proof  of  travel  abroad  to 
substantiate reimbursement applications. 
In  seven  countries,  patients  might  be  required  to  provide  official  translation  of 
documents. 

Uncertainty about the amount that the health insurer will reimburse for healthcare 
abroad  was  among  the  biggest  barriers  to  cross-border  healthcare  identified  by 
respondents to the public consultation. While the system of voluntary prior notification 
is believed to be a useful way of reducing the financial risk for patients, providing them 

24 

 
 
 
 
with an estimation of the amount to be reimbursed after being treated abroad, only eight 
countries66 apply this system.  

The  uncertainty  about  the  reimbursable  amount  is  due  to  several  factors,  such  as  the 
disparities  in  Member  States’  healthcare  baskets  and  their  transparency,  complicated 
systems  on  assumption  of  costs  for  healthcare  in  certain  Member  States,  lack  of 
transparency  of  the  public  tariff  applied  for  the  purposes  of  reimbursement,  varied 
medical coding systems etc. 

The uncertainty  about  the prices  charged by healthcare providers in other EU countries 
was  another  barrier  mentioned,  but  this  was  ranked  in  the  eleventh  place.  The  Fit  For 
Future Platform recalls that, in general, information on the applicable fees is not readily 
available  and  urges  healthcare  providers  and  hospitals  to  supply  patients  with  cost 
estimates.  

Problems with the continuity of care after treatment abroad was pointed out by 84 out 
of the 181 respondents (46%) in public consultation, mostly concerning patients, citizens 
and  HCPs,  with  54  respondents  describing  problems,  which  mainly  concerned 
unrecognised medical prescriptions/referrals, lack of effective transfer of medical records 
between  treating  doctors  and  difficulties  in  accessing  follow-up  treatment67.  Patients 
continue to face challenges in continuity of care, according to 46% of public consultation 
respondents,  often  arising  from  differences  in  health  systems  between  their  country  of 
treatment and of affiliation. Administrative and language issues also play a role as does a 
lack of effective data-sharing. While 46% of respondents  said  that healthcare providers 
transferred medical records or a patient summary to the healthcare provider back home to 
a  great  or  to  some  extent,  41%  said  this  was  done  to  a  limited  extent  or  not  at  all.  An 
organisation representing health professionals noted that continuity of care raised issues 
of  professional  liability  as  health  professionals  from  different  countries  are  responsible 
for the treatment and the aftercare and healthcare is to be provided in accordance with the 
legislation, standards and guidelines of different countries68. 

Recognition of prescriptions 

The  CBHC  Directive  provides  for  the  mutual  recognition  of  prescriptions  in  the  EU  to 
make it easier for patients to receive a prescribed medicinal product or medical device in 
a Member State different from where the prescription originated. Implementing Directive 

66 DK, EE, EL, IE, IT, PL, SE and NO. 
67 See Study supporting the evaluation of the Directive, referred to in footnote 51. See also Footman, K, Knai, 
C,  Baeten,  R,  Glonti,  K,  McKee,  M.  (2014).  Cross-border  health  care  in  Europe,  Policy  Summary  14, 
available  here:  https://www.euro.who.int/__data/assets/pdf_file/0009/263538/Cross-border-health-care-in-
Europe-Eng.pdf  

68 In this context, it could be mentioied that under Article 4(2)(c) of the CBHC Directive, if patients suffer harm 
arising  from  cross-border  healthcare,  they  must  seek  remedies  in  accordance  with  the  legislation  of  the 
Member State of treatment.  This  might represent an additional deterrent  for patients  from other Member 
States to seek cross-border treatment. However, neither the public consultation respondents, nor complaints 
received  from  citizens  highlight  this  as  one  of  the  most  important  obstacle  to  cross-border  healthcare  in 
practice. 

25 

 
                                                 
2012/52/EU gives effect to the principle of mutual recognition of medical prescriptions 
and  lays  down  measures  for  uniform  implementation  in  the  EU  by  setting  out  a  non-
exhaustive  list  of  contents  to  be  included  in  cross-border  medical  prescriptions  that 
should  enable  health  professionals  to  verify  the  authenticity  of  prescriptions  issued  in 
other Member States. National authorities interviewed noted that the mutual recognition 
of prescriptions is an example of where the Directive has worked to decrease barriers for 
citizens.  The  Pharmaceutical  Group  of  the  European  Union  (PGEU)69  highlighted 
persisting issues with regards to the mutual recognition of medical prescriptions despite 
the  issuing  of  rules  and/or  guidance  for  the  recognition  of  foreign  prescriptions  at 
European level and at national level in several countries.  

Patients continue to experience issues in relation to the verification of prescriptions 
in another EU country. Four in ten public consultation respondents (38%) said that they 
were  aware  of  problems  with  pharmacists  in  another  EU  country  not  recognising 
prescriptions and three in ten said they were not aware of problems (another 31% did not 
provide  an  opinion  on  this).  Issues  commonly  identified  by  respondents  included 
pharmacists  refusing  prescriptions  provided  by  a  doctor  in  another  EU  country;  a 
pharmacist  not  being  able  to  verify  whether  the  prescription  was  issued  by  a  doctor 
legally  entitled  to  do  this  in  another  EU  country;  or  a  pharmacist  who  could  not 
understand the language of the prescription. To a lesser extent, respondents reported the 
inability  of  the  pharmacists  to  understand  the  doctor’s  handwriting  or  the  failure  to 
provide  for  a  substitute  medicine  to  that  prescribed  in  the  home  country,  and  “other” 
situations such as the lack of a standardised format of prescriptions across countries, the 
variation  of  packages  and  dosages  across  Member  States,  the  presence  of  different 
medical product names and the different legislative obligations regarding who can issue 
prescriptions.  

Patients  may  also  face  challenges  in  having  prescriptions  prescribed  as  part  of 
cross-border treatment recognised by their home country. In an open question related 
to  problems  that  patients  may  face  when  seeking  follow-up  care  at  home,  the 
unrecognised  medical  prescriptions  from  abroad  was  one  of  the  most  frequent  issues 
mentioned  by  the  public  consultation  respondents.  They  are  sometimes  presented  with 
prescriptions written in a language they do not understand and are often unable to contact 
the prescriber.  

The  PGEU  contribution70  notes  that  many  patients  might  not  be  aware  of  their  rights 
under  the  CBHC  Directive  and  the  need  to  inform  prescribers  about  their  intention  to 
present  any  prescriptions  for  medicines  or  medical  devices  to  a  pharmacist  in  another 
country, allowing the prescribing healthcare provider to issue the prescription in line with 
the  guidelines  for  cross-border  use.  The  public  consultation  results  revealed  that  six  in 
ten respondents were aware of the possibility of having their prescriptions recognised by 

69 

PGEU 

feedback 

on 

the 

Commission’s 

evaluation 

roadmap, 

available 

here: 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12844-Cross-border-healthcare-
evaluation-of-patients%E2%80%99-rights/details/F1670930_en. 

26 

 
                                                 
a  pharmacist  in  another  EU  country,  whereas  a  third  (31%)  were  unaware  of  that 
possibility71.  However,  citizens  were  significantly  less  aware  of  this,  with  only  38% 
being  aware,  compared 
the 
EU/international (79%) or national (66%) level. 

representing  organisations  working  at 

those 

to 

The issues identified by the PGEU are the same as those highlighted in the Commission’s 
impact assessment accompanying the legal proposal72, the academic papers reviewed and 
the  targeted  survey  of  pharmacists  conducted  in  2021.  This  indicates  that,  despite  a 
reduction  in  the  rate  of  non-dispensation  of  prescriptions,  the  CBHC  Directive  and 
Implementing Directive 2012/52/EU did not completely resolve the issues (language, 
verification and authenticity problems) that continue to hamper the recognition of 
prescriptions  in  Member  States.  According  to  the  PGEU  and  several  national 
authorities, the ongoing initiatives to develop the interoperability of systems facilitating 
the  cross-border  provision  of  electronic  healthcare  services,  including  the  exchange  of 
ePrescriptions,  has  the  potential  to  strongly  improve  the  recognition  of  prescriptions 
across the EU and overcome the barriers. 

4.1.2.  How effective was the Directive to encourage cross-border cooperation in the 

EU? 

The  CBHC  Directive  provides  the  legal  framework  for  voluntary  cooperation  in 
healthcare  between  Member  States  and  regions  as  well  in  the  areas  of  ERNs,  rare 
diseases, health technology assessment and eHealth (the latter two are outside the scope 
of this evaluation).  

Cross-border cooperation between regions and neighbouring countries 

The  CBHC  Directive  requires  the  Member  States  to  provide  mutual  assistance  and  to 
facilitate  cooperation  in  cross-border  healthcare  between  neighbouring  countries  and 
border regions. The Commission is to encourage such cooperation. 

Well-functioning  healthcare  in  cross-border  regions  contributes  to  the  well-being  of 
populations  and  is  essential  from  the  perspective  of  economic,  social  and  territorial 
development  and  the  sustainability  of  these  regions73.  A  specific  objective  of  the 
Directive is to  facilitate  healthcare  for  citizens living in  border regions  where adequate 
healthcare  services  may  be  lacking  and  the  nearest  healthcare  provider  is  across  the 
border.  Multiple  layers  of  cooperation  and  mechanisms  exist  to  address  the  structural 

70 Ibid. 
71 9% did not know or had no opinion. 
72  Referred  to  in  footnote  16.  The  Impact  Assessment  found  that  the  recognition  of  prescriptions  issued  in 
another  Member  State  was  hampered  by  the  fact  that  effective  recognition  was  limited  to  prescriptions 
issued only in certain countries depending on the country of the dispensing pharmacist, and that it was not 
always possible to verify the validity of the prescriber prior to dispensing, as required by local law. 

73  Sivonen,  S.,  &  Büttgen,  N.  (2021).  Is  the  EU  Patient’s  Rights  Directive  fit  for  providing  well-functioning 
here: 

An 
healthcare 
https://cris.maastrichtuniversity.nl/ws/portalfiles/portal/76750571/EN_FD21_dossier_4_healthcare_final_
met_kaft_1_.pdf  

cross-border 

assessment, 

available 

regions? 

ex-post 

in 

27 

 
                                                                                                                                                 
need  for  healthcare  in  border  regions  and  between  neighbouring  countries,  which  pre-
date the Directive. An assessment of the Directive in the EU region Meuse–Rhine found 
that the Directive does not necessarily address the unique demographics, characteristics 
and needs of patients seeking healthcare across the borders of Belgium, the Netherlands 
and  Germany.  The  use  of  the  Directive’s  mechanism  for  cross-border  healthcare  is 
hampered by prior authorisation and reimbursement procedures as well as differences in 
health  systems  and  healthcare  baskets.  On  the  other  hand,  the  Directive  explicitly 
encourages  Member  States,  particularly  between  neighbouring  countries,  to  conclude 
agreements between themselves with more favourable and flexible conditions adapted to 
the  healthcare  needs  in  border  regions.  The  ZOAST  framework  agreement74  along  the 
French-Belgian  border  represents  a  benchmark  for  good  practice  of  healthcare 
cooperation  in  the  EU  by  providing  conditions  more  favourable  than  those  in  the 
Directive.  In  this  way,  ZOAST  overcomes  the  obstacles  of  prior  authorisation  and 
upfront payment as well as reducing costs in healthcare. The Committee of the Regions 
“Regional Hubs” found that few “regional hubs” were monitoring patient flows75 as did 
the Association of European Border Regions’ (AEBR) study on patient mobility in four 
case studies carried out in border regions76. It also found that few regions monitor patient 
flows and therefore the extent of cross-border healthcare in border regions is unknown. 
However,  the  AEBR  study  concludes  that  the  Directive  provides  an  additional 
framework to share information and cooperate in healthcare at regional level. This view 
is  borne  out  by  the  public  consultation  respondents  where  six  in  ten  believe  that  the 
exchanges  of  information  and  good  practices  promoted  by  the  Directive  have  at  least 
somewhat  supported  cross-border  healthcare  cooperation  in  between  neighbouring 
countries.  

The  ECA  report77  highlighted  positively  how  the  Commission  has  encouraged  and 
financially  supported  cooperation  in  cross-border  healthcare  between  neighbouring 
countries and border regions by means of studies, projects and partnerships as provided 
by  the  Directive.  A  2018  Commission  study  provided  a  picture  of  423  EU-funded 
projects supporting regional cooperation in healthcare and implemented over the period 
2007-201778,  the  large  majority  of  which  took  place  between  countries  with  similar 
welfare  state  traditions  to  share  knowledge  in  treatment  and  diagnosis  of  patients. 
However,  there  is  no  evidence  to  support  to  what  extent  the  Directive  can  be  credited 

74 

Zones 

Organized 

for 

the 

Access 

to 

Cross-border 

Healthcare 

(ZOAST): 

https://futurium.ec.europa.eu/en/border-focal-point-network/good-practices/developing-cross-border-
complementarities-health-french-belgium-observatory  

75  European  Committee  of  the  Regions  (2020).  Network  of  Regional  Hubs  for  EU  Policy  -  Implementation 
Review  -  Implementation  Report  -  Third  Consultation,  on  Cross-border  Healthcare,  available  here: 
https://cor.europa.eu/en/engage/Documents/RegHub/report-consultation-03-cross-border-healthcare.pdf 

76  AEBR 

(2021).  Cross-border  patient  mobility 

in 

selected  EU 

regions, 

available  here: 

https://ec.europa.eu/health/publications/cross-border-patient-mobility-selected-eu-regions_en 

77 Referred to in footnote 27.  
78 European Commission (2018). Study on Cross-Border Cooperation - Capitalising on existing initiatives for 
here: 

Care, 
cooperation 
https://op.europa.eu/en/publication-detail/-/publication/52088b97-3234-11e8-b5fe-
01aa75ed71a1/language-en   

Cross-border. 

cross-border 

available 

regions: 

in 

28 

 
                                                 
with the promotion of regional cooperation in healthcare by the Member States and the 
Commission.  

European Reference Networks 

This  evaluation  provides  a  preliminary  assessment  of  how  the  ERNs  are  meeting  their 
objectives with the support of the Commission and the Member States as required by the 
CBHC Directive. An in-depth  performance assessment and evaluation  of all ERNs and 
their members in line with the requirements of Article 14 of Commission Implementing 
Decision 2014/287/EU will start in 2022.   

The Directive aims to ensure the right of EU citizens, including people living with a rare 
disease, to  have  access  to treatment  in  another EU country.  Article 12 sets  out  that the 
Commission  shall  support  Member  States  in  the  development  of  the  ERNs  to  pool 
knowledge  and  expertise  in  the  area  of  rare  diseases.  The  ERNs  are  required  to  work 
towards a number of aims to improve prevention, diagnosis, treatment, care and research 
in  this  area.  Besides  the  Commission’s  financial  support  for  the  ERNs  as  described  in 
more  detail  below,  the  Commission  supported  the  ERNs  system  by  preparing  their 
establishment and then ensuring secretariat support and policy input for the work of the 
ERN  Board  of  the  Member  States  and  the  ERN  Coordinators  Group.  The  Commission 
(DG  SANTE)  also  supported  the  work  of  the  ERN  working  groups  on  specific  topics. 
They  include  the  working  group  on  ERN  knowledge  generation  and  dissemination,  a 
working group on the ERN monitoring, a working group on legal, ethical and stakeholder 
issues,  the  ERN  IT  advisory  group,  working  group  on  the  ERN  integration  in  national 
healthcare  systems  and  working  group  on  ERN  research  (including  a  task  force  on 
patient registries). Research activities of the ERNs are also supported via several projects 
under the EU research and innovation funding programmes. 

The evaluation findings show that the CBHC Directive has been effective in meeting its 
objectives  in  the  area  of  cooperation  in  rare  and  low  prevalence  complex  diseases, 
bearing  in  mind  that  it  has  been  less  than  five  years  since  the  24  ERNs  were  set  up  in 
2017.  The  rare  disease  patient  community  claims  that  the  ERNs  “are  the  greatest 
achievements  that  the  rare  disease  community  as  a  whole  has  ever  accomplished”79 
(while  also  highlighting  shortcomings  in  the  Directive’s  objective  to  ensure  access  to 
treatment  for  rare  diseases  patients  with  regard  to  information,  prior-authorisation  and 
reimbursement). The public consultation showed that respondents who were aware of the 
ERNs  were  quite  positive  about  the  extent  to  which  the  ERNs  helped  healthcare 
providers  provide  diagnosis  and  treatment  options  for  patients  with  rare  and  low 
prevalence  complex  diseases,  and  contributed  to  the  delivery  of  and  access  to  high-
quality healthcare by patients. 

79 EURORDIS. An empty promise: accessing cross-border healthcare for people living with a rare disease, July 
here: 

2021, 
https://download2.eurordis.org/documents/pdf/CBHC_evaluation_standalone_response.pdf   

available 

29 

 
                                                 
There  has  been  a  continuous  growth  of  the  ERNs  patient  population,  with  1.7  million 
patients  being  treated  by  the  ERNs  members.  There  is  increasing  involvement  from 
patient organisations and patient representatives participating in the ERN activities80 and 
being  represented  in  the  governance  structure  of  all  ERNs.  Many  ERNs  have  also 
developed  action  plans  to  foster  an  operational  collaboration  with  different  patient 
associations  European  Patient  Advocacy  Groups  (ePAGs)  have  been  developed  by 
EURORDIS for each ERN disease group so patient organisations are able to participate 
in the ERN decision making. 

The ERNs have been effective in  providing healthcare providers with  access  to  a large 
pool  of  expertise  and  knowledge  to  help  rare  disease  patients  with  diagnosis  and 
treatment  options.  85%  of  respondents  to  a  targeted  survey  of  the  ERN  representatives 
carried out for this evaluation agreed that ERNs effectively contributed to the exchange 
of  knowledge  and  best  practices  in  rare  diseases  (43%  strongly  agree  and  42%  agree). 
87% of survey respondents agreed that the Directive has been effective in supporting the 
diagnosis  and  treatment  of  patients,  including  through  the  virtual  consultation  panels. 
Similarly, the majority of respondents to the public consultation who were aware of the 
ERNs (mostly NGOs but also public authorities, businesses, EU citizens) believe that the 
ERNs help health professionals provide diagnosis and treatment options for patients with 
rare and low prevalence complex diseases to at least some extent (6% completely, 21% to 
a  great  extent  and  48%  to  some  extent)81.  Interviewees  also  pointed  out  that  the 
effectiveness of the ERNs varied between the ERNs and that, in the initial years of their 
existence,  the  networks  had  mainly  focused  on  setting  up  the  ERNs  and  therefore  had 
less time available to treat and diagnose patients.  

For the time being, the impact of the ERNs’ collaboration is likely to be more important 
in improving diagnosis and treatment of rare diseases patients by knowledge generation, 
the  development  and  sharing  of  best  practices  and  guidelines  with  practitioners  within 
and  beyond  the  ERNs,  and  in  advancing  research  on  rare  diseases  than  in  providing 
diagnosis and treatment  to  individual patients through the Clinical  Patient  Management 
System (CPMS). This is partly due to the fact that only the most complex cases should be 
submitted to the CPMS and the lack of clear national pathways for patient referral to the 
ERNs  (to  be  developed  under  national  law).  Nor  is  the  ERN  process  often  fully 
understood  by  the  patients  and  health  professionals.  Both  the  ERNs  and  NCPs 
stakeholders  consulted  noted  the  lack  of  readily  available  information  for  patients  and 
doctors  on  the  ERNs.  To  address  this  shortcoming  some  stakeholders  suggested  that 
NCPs  could  in  the  future  play  a  more  proactive  role  in  assisting  patients  and  health 
professionals beyond just making the standard information about the ERNs available on 
their websites.  

80  Minutes  of  the  ERN  Board  meetings  and  outcome  from  ERN  monitoring  exercise,  available  here: 

https://ec.europa.eu/health/european-reference-networks/board-member-states_en   

81 Less than a fifth of participants thought ERNs helped to a limited extent (15%) or not at all (3%). Finally, 7% 

did not provide an answer. 

30 

 
                                                 
The CPMS, supported and financed by the Commission82, is increasingly used by health 
professionals in the ERNs for the diagnosis and treatment of patients with rare and low 
prevalence  complex  diseases  through  virtual  expert  panels  and  it  is  seen  as  a  positive 
development by stakeholders. However, only 2,100 patients’ cases have been dealt with 
through  the  CPMS  so  far.  This  relatively  low  number  is  due  to  the  combination  of 
factors, including the fact  that the CPMS currently handles only the most  complex and 
very  rare  patient  cases,  which  require  the  consultation  of  experts  from  different 
specialisations in different EU countries. Another issue affecting the effectiveness of the 
clinical collaboration through the ERNs is the fact that healthcare providers are often not 
reimbursed for the time that their health professionals dedicate to providing their medical 
advice  on  foreign  patient  cases  through  their  participation  on  the  virtual  panels. 
Clinicians  highlighted  the  lack  of  clarity  regarding  resourcing  responsibilities  for 
ERNs83.  They  noted  that  whereas  payment  schemes  for  physical  cross-border  patient 
referrals were well established, no reimbursement system exists for virtual consultations 
via the CPMS. Although the Directive’s rules on reimbursement do apply to cross-border 
telemedicine, its mechanism for cross-border healthcare cost reimbursement entails that 
patients pay for healthcare directly to the foreign healthcare provider and then are being 
reimbursed up to the public tariff in their Member State of affiliation, bearing the price 
difference. Thus, this mechanism does not represent a viable solution for reimbursing for 
the CPMS consultations with a panel of medical specialists from different countries. 

Lastly, some issues with the CPMS related to the system itself were identified as limiting 
its use and effectiveness. 20% of the respondents who were aware of the ERNs saw the 
non-interoperable IT facilities as an issue. The CPMS is quite burdensome with regard to 
the amount of information that needs to be entered onto its database for each patient and 
the time required to set up and use the CPMS virtual panels. A modification of the CPMS 
is already underway to improve its user-friendliness and to provide a mobile version of 
the tool in addition to the existing desktop version. 

Financing and sustainability of ERNs 

Article 12 of the CBHC Directive requires the Commission to support Member States in 
the  development  of  ERNs  between  healthcare  providers  and  centres  of  expertise.  The 
Commission  has  supported  the  ERNs’  operations  with  funding  from  different  spending 
programmes (primarily the Third Health Programme and the Connecting Europe Facility 
(CEF) and the EU Research and Innovation (R&I) programme Horizon 2020 for research 
activities84. Over the period of 2016-2019 the overall funding contribution  provided by 
the  Commission  to  the  ERNs  amounts  to  just  under  EUR 31  million  under  the  Third 

82 The CPMS is dedicated IT platform and telemedicine tool developed by the Commission to enable healthcare 
providers  from  the  ERNs  to  work  together  virtually  to  diagnose  and  treat  rare  diseases  patients, 
https://cpms.ern-net.eu/login/  

83  European  Commission  (2018).  EXPH  Report  on  Application  of  the  ERN  model  in  European  cross-border 
here: 

healthcare 
https://ec.europa.eu/health/system/files/2019-11/021_erns_en_0.pdf   

cooperation 

available 

diseases 

outside 

area, 

rare 

the 

84 ECA Special Report, referred to in footnote 27.  

31 

 
                                                 
Health  Programme  and  around  EUR 12 million  under  the  CEF.  The  Commission’s 
support  includes  grants  for  ERN  coordination  and  management  activities,  grants  for 
establishment  of  ERN  patient  registries,  grants  for  ERN  IT  related  activities  (such  as 
CPMS Helpdesk services, data collection for ERN monitoring exercise or maintenance of 
ERN registries), funding for an independent assessment body to conduct the assessment 
of ERNs at the time of their establishment and of new members wishing to join existing 
ERNs,  support  for  the  ERN  clinical  guidelines  programme,  support  for  the  ERN 
professional mobility programme or support for development of ERN integrated quality 
improvement  system  (AMEQUIS).  The  ERNs  are  also  important  beneficiaries  of  the 
research projects such as the European Joint Programme Rare Diseases, SOLVE-RD or 
ERICA funded under Horizon 202085. 

The  consultation  highlighted  the  importance  of  continuous  financing  to  ensure 
sustainability of the ERNs and therefore its future effectiveness.  A Commission  survey 
of  the  ERN  coordinators  showed  that  sustainability  of  financing  is  one  of  the  main 
challenges facing the ERNs86. Currently the grant application, management and reporting 
under the EU Health Programme  entail  a high administrative workload for the ERNs87. 
The ECA recommended that the Commission should “work towards a simpler structure 
for  any  future  EU  funding  to  the  European  Reference  Networks  and  reduce  their 
administrative  burden”88.  The  Commission  intends  to  address  this  recommendation  by 
streamlining the existing funding sources for ERNs under the Health Programme with the 
launch of new direct grants for ERNs under the new EU4Health Programme. 

In the context of ERN funding with regard to other activities such as drug development, 
knowledge  building,  collaboration  with  the  private  sector  (pharmaceutical  and  medical 
devices  industry)  has  been  considered,  for  example,  in  the  area  of  the  ERNs’  research 
and clinical trials on rare and low prevalence complex diseases (while taking appropriate 
transparency  and  conflict  of  interest  management  measures)89.  Recognising  the 
importance  of  the  role  of  industry  to  improve  the  knowledge  of  rare  conditions  and  to 
develop diagnostics tools and therapies, the Board of Member States for ERNs adopted 
“Statement  on  ERNs  and  industries”90  in  2019  that  provides  general  principles  for  this 
future collaboration. 

Integration into national healthcare systems 

85 The EU has supported the field extensively through its research and innovation framework programmes, with 
more than €1.8 billion made available - just from the two past programmes - under the Seventh Framework 
Programme (FP7) and Horizon 2020, to more than 320 projects on interdisciplinary research in the area of 
rare  diseases,  see  https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-
innovation/rare-diseases_en  

86  Minutes  of  meeting  of  the  Board  of  Member  States  for  ERNs  of  6  March  2018,  available  here: 

https://ec.europa.eu/health/european-reference-networks/board-member-states_en 

87  Tumiene,  B.  et  al.  (2021).  European  Reference  Networks:  challenges  and  opportunities,  Journal  of 

Community Genetics. 

88 ECA Special Report, referred to in footnote 27. 
89 Tumiene, B. et al. (2021), referred to in footnote 87. 
90  ERNs.  Statement  of  the  ERN  Board  of  Member  States  on  ERNs  and  industry,  25.6.2019,  available  at: 

https://ec.europa.eu/health/system/files/2020-03/statement_industry_conflictofinterest_en_0.pdf  

32 

 
                                                 
The CBHC Directive requires Member States to facilitate the development of the ERNs. 
All interviewees representing the ERNs stressed the importance of integrating the ERNs 
into the national healthcare systems to increase their visibility and, more importantly, to 
ensure appropriate referral and reimbursement mechanisms for rare and low prevalence 
complex  disease  patients.  The  Board  of  Member  States  for  ERNs  addressed  this  key 
issue in 2019 with a statement encouraging Member States to facilitate the integration of 
the  ERNs  into  national  healthcare  systems91.  However,  feedback  from  the  consultation 
(17% of public consultation respondents) clearly shows that the general principles set out 
by  the  Board  of  Member  States  for  ERNs  have  not  yet  been  fully  implemented  in  the 
Member States. An additional reported barrier is the lack of awareness or knowledge on 
how to access the ERNs among healthcare providers which are outside the networks. The 
Commission intends to further support Member States in their efforts to better integrate 
the ERNs into their national healthcare systems by launching in 2022 a Joint Action on 
ERN integration under the EU4Health Programme. 

ERNs’  role  in  knowledge  generation  and  information  sharing  on  rare  and  low 
prevalence complex diseases 

Beyond  the  general  support  for  the  ERNs’  coordination  and  management  activities 
(including training programs or conferences organised within the respective ERNs), the 
Commission  supported  the  ERNs  in  the  area  of  knowledge  generation  and  sharing 
through various specific projects including the ERN clinical  guidelines programme, the 
ERN  professional  mobility  programme  or  EU  high-level  ERN  conferences.  The  ERNs 
have  organised  workshops  and  webinars  to  increase  capacity  building,  and  surveys  to 
identify educational gaps in medical knowledge on patients with rare and low prevalence 
complex  diseases.  The  ERNs  have  also  invested  in  enhancing  highly  specialised 
knowledge  about  rare  diseases  through  various  dissemination  activities  (websites, 
newsletters, scientific journals, conferences etc.). 

The  majority  of  stakeholders  and  respondents  to  the  public  consultation  agree  that  the 
ERNs have been effective in  developing knowledge sharing activities to  support health 
professionals,  in  enhancing  professional  training  and  mobility  of  expertise  in  this  area 
and in facilitating exchange of knowledge and best practices. According to interviewees, 
effective knowledge sharing is one of the areas where the objectives of the networks are 
being best achieved.  

The level of awareness provides an important indicator to assess the extent to which the 
use  of  the  ERNs  and  the  knowledge  sharing  has  been  effective.  In  relation  to  this,  the 
public  consultation  results  showed  that  a  majority  of  respondents  were  aware  of  the 
ERNs and the possibilities to seek diagnosis and treatment of rare diseases in another EU 
country  with  prior  approval  from  their  healthcare  insurer  (11%  completely,  16%  to  a 
great extent and 25% to some extent). However, both the ERNs and NCPs stakeholders 

91 ERNs. Statement of the ERN Board of Member States on Integration of the European Reference Networks to 
at: 
Member 

the 
https://ec.europa.eu/health/system/files/2019-07/integration_healthcaresystems_en_0.pdf  

25.6.2019, 

healthcare 

available 

systems 

States, 

of 

33 

 
                                                 
consulted also noted the lack of coordination between the NCPs and the ERNs resulting 
in  a  lack  of  clear  information  for  patients  on  how  to  access  the  ERNs  services  and  on 
how to get from the national system to the ERNs. They noted that doctors are often not 
aware of the existence of the ERNs and are not always willing to bring patients into these 
networks. 

The ERNs’ role in research on rare and low prevalence complex diseases 

With  regard  to  the  impact  of  the  ERN  collaboration  on  the  research,  knowledge 
sharing  and  networking  activities  within  the  ERNs  have  resulted  in  increased 
collaboration  between  experts  and  directly  contribute  to  the  research  on  rare  and  low 
prevalence  complex diseases. The interviewees  considered that  collaboration  in  various 
cross-ERN  expert  groups  has  been  quite  fruitful  and  pointed  out  that  many  important 
research  initiatives  have  emerged  from  the  ERNs,  such  as  the  EU-funded  ERICA 
project92,  which  is  a  “Coordination  and  Support  Action”  for  coordinating  clinical 
research  efforts  of  the  24  ERNs.  ERNs  are  also  important  beneficiaries  of  the  research 
projects  such as the large European Joint Programme on Rare Diseases93 (EJP RD, co-
fund with Member States research funding agencies) and the Solve-RD project94 closely 
cooperating  with  several  ERNs.  It  is  important  to  keep  in  mind  that  many  other  EU-
funded  research  projects  are  relevant  and  involve  ERN  clinicians  and  researchers  from 
specific  ERNs  (for  example  ImmunAID95  for  ERN  RITA),  thus  also  enhancing  the 
research  potential  of  the  ERN  community  as  a  whole.  Other  EU-funded  projects 
involving ERN clinicians  and researchers  are:  Conect4Children (C4C)96, Screen4Care97 
(both  funded  under  the  IMI  joint  undertaking  thus  with  public  (H2020)  and  private 
funding) or Rare203098, led by the patients organisation EURORDIS. 

In  addition,  with  the  financial  support  from  the  Commission,  all  24  ERNs  have 
established or they are in the process of setting up or consolidating ERN patient registries 

92 European Rare Disease Research Coordination and Support Action (ERICA, 2021-2025). Total budget: EUR 
2,3  million  (EU  funding:  EUR  2,3  million),  all  24  ERNs  are  represented  in  the  project.  See 
https://cordis.europa.eu/project/id/964908 and https://erica-rd.eu/  

93 European Joint Programme co-fund on Rare Diseases (EJP RD, 2019-2023). Total budget: EUR 100 million 
(EU  funding:  EUR  55  million),  more  than  140  partners,  all  24  ERNs  are  represented.  See 
https://cordis.europa.eu/project/id/825575 and https://www.ejprarediseases.org  

94  Solve-RD  -  Solving  the  unsolved  Rare  Diseases  (2018-2022).  Total  budget  (=  EU  funding):  EUR  15,4 

million. See https://cordis.europa.eu/project/id/779257 and https://solve-rd.eu/  

95 ImmunAID - Immunome project consortium for AutoInflammatory Disorders (2018-2023). Total budget (= 

EU funding): EUR 15,8 million. See https://cordis.europa.eu/project/id/779295  

96 Conect4children (C4C, Collaborative Network for European Clinical Trials For Children), 2018-2024. Total 
budget  EUR  182  million,  EU  funding  of  EUR  67  million.  See  https://www.imi.europa.eu/projects-
results/project-factsheets/c4c and https://cordis.europa.eu/project/id/777389  

97  Screen4Care  (Accelerating  Rare  Disease  diagnosis  by  using  newborn  genetic  screening  and  digital 
technologies),  2021-2026.  Total  budget  EUR  25  million,  EU  funding  of  EUR  11,9  million.  See 
https://www.imi.europa.eu/projects-results/project-factsheets/screen4care  

98 Rare 2030 (2019-2021) is a foresight study that gathered the input of a large group of patients, practitioners 
and key opinion leaders to propose policy recommendations leading to improved policy and a better future 
for  people  living  with  a  rare  disease  in  Europe.  The  project  ended  in  a  presentation  at  the  European 
Parliament  with 
the  most  critical  areas  needing  sound  policy.  See 
https://www.rare2030.eu/  

recommendations  on 

34 

 
                                                 
in order to create a critical mass of patients’ data. These are essential building blocks for 
advanced  research  in  the  area  of  rare  and  low  prevalence  diseases.  Furthermore,  the 
ERNs  have  facilitated  large  clinical  studies  to  improve  understanding  of  diseases  and 
develop new drugs by gathering a large pool of patient data99. Patients participated in 732 
clinical  trials  within  the  ERNs.  162  new  clinical  practice  guidelines  were  drafted  by 
ERNs as well as the development of 143 clinical decision making  tools. Moreover, 405 
observational studies were conducted within the ERNs.  

When  asked  to  assess  the  contribution  of  the  ERNs  in  several  areas,  six  in  ten 
respondents  to  the  public  consultation  believed  that  the  ERNs  had  helped  to  exploit 
innovation in medical science and health technologies completely (9%), to a great extent 
(15%) or to some extent (36%). The same proportion agreed that the ERNs had helped to 
collect, analyse and make available health data completely (6%), to a great extent (16%) 
or to  some extent (38%). Overall,  a majority  (79%) of respondents  who  were  aware of 
the ERNs believed to at least some extent that the ERNs helped to generate knowledge 
and contribute to research on rare and low prevalence complex diseases in the EU (9% 
completely, 23% to a great extent and 47% to some extent)100.  

Cooperation in Rare Diseases  

Article 13 of the CBHC Directive has strengthened existing European cooperation in rare 
diseases  supported  by  the  Commission.  Between  2010  and  2015,  a  series  of  activities 
were  carried  out  to  support  the  development  of  Orphanet  as  a  European  portal  for 
information of rare diseases and orphan drugs, to enhance the visibility and recognition 
of  rare  diseases,  the  development  and  dissemination  of  knowledge  and  support 
improvements  in  access  to  quality  services  and  care.  As  of  2015  this  was  followed  by 
further  support  to  Member  States  to  promote  implementation  of  recommendations  on 
policy,  information  and  data,  and  to  implement  the  European  rare  diseases  codification 
system,  as  well  as  to  Orphanet.  Between  2010  and  2021,  financial  support  for  these 
efforts totalled nearly EUR 12.5 million via funds provided through subsequent European 
health programmes.  

The registration of rare diseases across Europe is supported by the European Platform on 
Rare  Disease  Registration  (EU  RD  Platform),  set  up  in  2019  by  the  European 
Commission’s Joint Research Centre101.  

The  EU  RD  Platform  facilitates  information  exchange  on  rare  disease  patients  and 
supports registries at national, regional and local level as well as the ERNs to collect and 
share information. 

99  European  Commission  (2015).  Report  of  the  EXPH  on  Cross-border  Cooperation,  available  at: 

https://ec.europa.eu/health/system/files/2019-11/009_crossborder_cooperation_en_0.pdf  

100 An additional 11% believed  this  was to a limited extent and 2% not at all.  Lastly, 9%  did not provide an 

answer. 

101 https://eu-rd-platform.jrc.ec.europa.eu  

35 

 
                                                 
The  EU  RD  Platform  makes  rare  diseases  patient  data  searchable  and  findable  -
something  that  so  far  was  not  possible-  and  is  available  for  patients  as  well  as  for  the 
community  of  researchers,  healthcare  professionals  and  policymakers.  While  the 
Platform's  infrastructure  is  openly  accessible  and  training  is  being  provided  for  people 
working  in  existing  registries  or  willing  to  create  new  registries,  it  also  sets  EU-wide 
standards for data collection and exchange.  

The  pillars  of  the  EU  RD  Platform  are  1)  the  European  Directory  of  Registries,  2)  the 
Central  Metadata  Repository  and  3)  the  Pseudonymisation  Tool,  which  makes  sure 
patient  data  is  held  under  a  pseudonym,  thus  not  traceable  back  to  the  individual  but 
permitting the cross-border or cross-registries data exchange.  

The EU RD Platform collaborates closely with the ERNs supporting the creation of ERN 
registries  and  aims  at  linking  patients’  clinical  data  with  other  health-related  data  like 
genomic data and biobanks. 

Interviewees  representing the ERNs, the ERN Board of Member States and researchers 
in  the  field  of  rare  diseases,  noted  that  ERNs  are  an  appropriate  tool  that  fit  well  with 
initiatives  such  as  the  Orphanet  database,  the  European  Joint  Programme  on  Rare 
Diseases. With support from the Commission and Member States, this is creating a rare 
diseases research eco-system in Europe, bringing together researchers and practitioners. 
The programme has generated important ties with health professionals who are and who 
are not involved in the ERNs. With regard to Orphanet particularly, stakeholders working 
in the field highlighted the synergies with the ERNs which helped develop, for example, 
the  ORPHAcodes.  Another  area  of  good  synergies  with  the  ERNs  mentioned  in  the 
interviews is the EHDS, for which the networks will be a building block.  

ERNs  and  Orphanet  thus  constitute  a  unique  European  framework  dedicated  to  rare 
diseases with  key  complementary roles. ERNs  have the clinical  and scientific expertise 
on  rare  diseases  and  Orphanet  has  the  expertise  on  databasing  and  standardisation. 
Through the objectives outlined in Article 12 (on ERNs) the CBHC Directive takes into 
account  this  complementary  role  and  supports  the  existing  framework  on  rare  diseases 
not  only  by  promoting  these  tools  under  Article  13,  but  also  by  reinforcing  their  role 
through shared objectives. 

Efficiency 

The evaluation on the efficiency of the CBHC Directive focuses on the actual costs and 
benefits  associated  with  the  implementation  of  the  Directive  as  well  the  administrative 
burden linked to it102.  

102  See  Annex  IV  for  further  information  on  the  cost/benefit  analysis  and  Annex  II  on  the  availability  and 

robustness of the data.  

36 

 
 
 
                                                 
Cost/benefits on Member States 

The additional costs arising from cross-border treatment under the CBHC Directive 
have  had  a  very  minor  impact  on  national  healthcare  budgets.  Based  on  data  received 
from  Member  States  as  well  as  data  from  Eurostat,  the  Commission’s  2022  report103 
estimates  that  the  share  of  the  amount  reimbursed  under  the  Directive  on  the  total 
government  expenditure  on  healthcare  corresponded  to  0.01%.  This  estimate  is  in  line 
with the ECA estimate104 and also corresponds to feedback received from stakeholders. 
They  also  noted the Directive’s  very modest impact  on public health funding. National 
health  insurers  and  health  ministry  representatives  interviewed  for  the  evaluation 
confirmed that the costs of treatment are low as the Directive provides that patients are 
reimbursed up to the same level of costs that would have been assumed by the Member 
State  of  affiliation  if  they  had  been  treated  domestically  and  therefore  the  financial 
burden  is  negligible.  Member  States’  reimbursements  to  cross-border  patients  grew 
between 2016 and 2019, from EUR 67 million to EUR 92.1 million, while remaining low 
in  absolute  terms105.  It  is  important  to  note  that,  as  pointed  out  in  the  Commission’s 
patient  mobility  data  trend  report  2018-2020,  the  countries  which  provided  data  on 
reimbursements  differ  between  the  reference  years.  In  the  countries  for  which  there  is 
complete  data  for  all  reference  years  2016-2020106,  the  total  amount  of  reimbursement 
peaked in 2019 (EUR 41.0 million), with a substantial drop in 2020 (EUR 29.2 million).  

The exact  magnitude of  the costs  arising  from the implementation  of the  Directive, for 
example,  processing  prior  authorisation  and  reimbursement  requests  is  not  known  as 
Member  States  countries  do  not  collect  this  cost  data.  Moreover,  while  resources 
apportioned for cross-border authorisation and reimbursement cannot be easily calculated 
as  health  insurance  staff  are  usually  also  processing  domestic  reimbursements,  no 
stakeholder reported that the Directive has created excessive or disproportionate costs for 
public authorities or health insurers.  

In  terms  of  benefits  for  health  systems,  the  CBHC  Directive  has  not  yet  delivered 
efficiency  gains  for  national  health  systems  as  the  volume  of  cross-border  healthcare 
cases  facilitated  remains  negligible  in  most  Member  States  with  an  estimated  6  out  of 
10,000  people  across  the  EU  receiving  reimbursement  for  cross-border  healthcare 
treatments  under  the  Directive107.  Even  when  allowing  for  variances  in  the  use  of  the 
Directive across Member States, the benefits remain very minor. However, qualitatively, 

103 COM(2022) 210 final. 
104 ECA Report, referred to in footnote 27. 
105 EUR 82.3 million, excluding the UK. For 2020, the total amounts to EUR 77.5 million (EUR 74.9 million 
excluding the UK). Given the Covid-19 related restrictions in 2020, the figures of 2019 are considered for 
the analysis (see the report referred to in footnote 26, as well as COM(2022) 210 final). 

106 It concerns 17 Member States (BE, BG, CZ, DK, EE, ES, FI, EL, HR, IT, LT, LV, MT, PL, RO, SI, SK), the 

UK and NO. 

107  Calculations  by  contractor  Tetra  Tech  based  on  Commission  (2019).  Member  State  data  on  cross-border 
at: 

patient 
https://ec.europa.eu/health/system/files/2021-03/2019_msdata_en_0.pdf  

2011/24/EU, 

healthcare 

following 

Directive 

available 

37 

 
                                                 
the  Directive  has  enabled  comparisons  between  health  systems  and 
transparency.  

increased 

Nor  is  there  evidence  that  the  CBHC  Directive  provided  direct  benefits  for  health 
systems  during  the  Covid-19  crisis.  For  example,  while  several  regions  in  Germany 
provided  life-saving  assistance  for  Covid-19  patients  to  alleviate  the  burdens  of 
overstretched hospitals across borders, these acts of European solidarity are attributable 
to  existing  regional  cooperation108.  However,  responding  whether  the  Directive  could 
tackle the backlog of postponed treatments arising from the pandemic, out of 184 public 
consultation respondents, 28% considered the Directive could help to a large extent and 
20% to some extent.  

Costs/benefits to the patient 

The  total  quantitative  benefits  for  patients  using  the  Directive’s  reimbursement 
mechanism  is  marginal  due  to  the  low  cross-border  patient  mobility  flow  of  around 
300,000 reimbursements per year. Less than 1% of citizens on a waiting list benefit from 
faster  treatments,  however  there  is  no  data  available  on  the  reduction  of  waiting  times 
overall.  The  Regulations  on  the  coordination  of  social  security  systems  are  generally 
more favourable route to healthcare abroad as the patients do not normally bear the costs 
of treatment and are being reimbursed based on the level of the tariff in the Member State 
of treatment. For example, in the reference year 2020, Member States and EFTA States 
issued  23,400  Portable  Documents  (PD)  S2109  for  planned  cross-border  healthcare  and 
received  around  1.9  million  claims  to  be  settled/reimbursed  for  necessary  cross-border 
healthcare based on the EHIC110. 

However,  in  terms  of  qualitative  benefits,  patients  with  rare  and  low  prevalence 
complex  diseases  have  benefitted  from  the  Directive,  particularly  through  the 
intermediate  outcomes  of  better  diagnosis  and  understanding  of  treatment  options 
available by health professionals  participating in  the ERNs. For physical  treatment  in  a 
healthcare  facility  abroad,  the  Regulations’  route  represents  a  better  option  in  most 
instances,  as  explained  above,  because  where  the  Member  State  of  treatment  provides 
benefits-in-kind  to  its  insured  persons,  cross-border  patients  also  have  access  to  such 
benefits under the same conditions. 

There  is  no  quantitative  data  available  on  the  use  of  the  Directive  by  different  patient 
groups. However, qualitative evidence shows that several patient groups benefit from the 
Directive’s rules  on cross-border healthcare cost  reimbursement. These include patients 

108  Communication  from  the  Commission.  Guidelines  on  EU  Emergency  Assistance  in  Cross-Border 

Cooperation in Healthcare related to the COVID-19 crisis, C(2020) 2153 final, 3.4.2020. 

109 PD S2 certifies the entitlement of the  insured person to planned health treatment in a Member State other 

than the competent Member State. 

110 Cross-border healthcare in the EU under social security coordination – Reference year 2019 and Reference 

year 2020, Table 1 and Table 4. Available here:  
https://ec.europa.eu/social/main.jsp?pager.offset=5&advSearchKey=ssc_statsreport2021&mode=advanced
Submit&catId=22&doc_submit=&policyArea=0&policyAreaSub=0&country=0&year=0 

38 

 
                                                 
who  need  an  outpatient  treatment  that  is  quicker  to  access  or  cheaper  abroad;  patients 
who travel frequently to other EU countries for work  or family purposes; patients from 
smaller  countries  or  for  whom  the  closest  facility  is  in  another  Member  State;  tourists 
who  need  necessary  treatments  which  they  cannot  access  under  the  Regulations  on  the 
coordination  of  social  security  systems111;  pensioners  who  live  part  of  the  year  abroad, 
but  do not qualify as residents of that country;  patients  who are expats  who wish to be 
treated in their country of origin.  

For  certain  groups  of  patients  the  costs  of  using  the  Directive  can  be  substantial.  This 
financial barrier is  hindering the effectiveness  of the Directive as described above. The 
patient pays  the  costs of treatment  directly to  the healthcare provider  and then requests 
reimbursement  back  home.  If  the  public  tariff  (or  a  price  calculated  under  Article  4(4) 
first  paragraph  of  the  Directive)  is  higher  in  the  country  of  treatment  than  where  the 
patients are insured, they cover the difference out-of-pocket. Moreover, the Directive is 
without  prejudice  to  national  legislation,  which  allows  healthcare  providers  to  set  their 
own  –  private  –  prices,  if  they  do  not  discriminate  against  patients  from  other  EU 
countries.  Cross-border  patients  under  the  Directive  are  also  charged  private  prices  in 
some Member States where public/contracted healthcare providers providing benefits-in-
kind  in  the public system  can  also  act  in  private capacity. Thus,  the difference that the 
patient  has  to  cover  out-of-pocket  can  in  certain  instances  be  even  higher  than  the 
difference between the public tariffs in the Member States of treatment and affiliation. 

In addition, in the vast majority of Member States, patients bear costs for travelling and 
accommodation abroad, or extra costs, which persons with disabilities might incur, as the 
Directive does not oblige the Member States to  reimburse such costs, even where prior 
authorisation  is  issued  for  healthcare  abroad.  Furthermore,  as  highlighted  above  in 
Section 4.1.1, burdensome administrative procedures in many countries add to the costs 
for  patients.  Processing  times  are  slow  and  varied  ranging  from  three  weeks  up  to  six 
months  for  prior  authorisation  applications  and  from  one  month  up  to  six  months  for 
reimbursement requests. In several  countries, processing times are not laid down in the 
national legislation112. Patients might also bear indirect costs related to the administrative 
procedures, such as postage costs, where applications cannot be submitted by electronic 
means (as illustrated in Box 2, in certain instances certified translation is required)113. In 
addition, patients might also be required to provide translation of the medical records, for 
the purposes of accessing treatment abroad or receiving follow-up treatment back home. 

Nor are the costs of the Directive borne proportionately by different patient groups. The 
costs can be particularly significant for those from lower income countries, for patients 
with lower socio-economic status or patients requiring access to more expensive highly 
specialised treatment as is particularly the case for patients with rare and low prevalence 
complex diseases.  

111 For example, in certain countries, the healthcare provider at issue has exceeded the limit of consultations per 

month free of charge. 

112 Mapping and Analysis of Administrative Procedures: analytical report, the study referred to in footnote 17. 

39 

 
                                                 
Data  gathered  for  the  cost/benefit  analysis  are  insufficient  to  estimate  the  costs  across 
different stakeholder groups and thus prevent an assessment on whether the costs of the 
Directive are proportionate to the associated benefits for these patient groups.  

On the other hand, as mentioned above, the Directive’s rules on reimbursement of cross-
border  healthcare  costs  supplement  the  relevant  rules  under  the  Regulations  on  the 
coordination of social security systems. Thus, in particular in those instances where the 
Regulations  do  not  apply  or  where  cross-border  patients  failed  to  ascertain  and  pursue 
their  rights  under  the  Regulations  (for  example,  where  the  healthcare  provider  did  not 
consider  the  treatment  as  “necessary  care”  under  Article  19  of  Regulation  (EC)  No 
883/2004) the Directive’s rules allow them to  receive  reimbursement of  at  least  part of 
cross-border healthcare costs (compared to zero reimbursement under the Regulations). 

With regard to the ERNs, a quantitative assessment of the cost effectiveness of the ERNs 
is  challenging  as  only  data  on  the  EU  level  funding  is  available  while  there  are  no 
estimates  for  the  total  funding  from  the  ERN  coordinating  centres  and  hospital  hosting 
the  ERNs.  Similarly,  data  on  the  funding  from  private  donors,  patient  organised 
campaigns and Member States is not available and not all costs incurred by the ERNs are 
taken into account. As a result, it was not possible to quantitatively assess the extent to 
which  the  costs  of  the  ERNs  and  their  tools  were  justified  and  proportionate  given  the 
objectives achieved and benefits obtained. 

To  support  the  ERNs’  operations,  the  Commission  has  provided  funding  through 
different  funding  mechanisms.  These  amount  to  just  under  EUR  31  million  under  the 
Third  Public  Health  Programme  and  EUR  12.4  million  under  the  Connecting  Europe. 
The  co-funding  provided  by  the  ERN  coordinating  centers  is  estimated  at  EUR  12.4 
million (40% co-funding of the grants provided). This brings the estimated total cost of 
the  ERNs  to  EUR  48.2  million.  However  this  estimate  does  not  take  into  account  all 
costs incurred by the ERNs. Nor does it take into account research activities of the ERN 
members. 

With regard to the objectives achieved, the ERNs have improved the care of patients with 
rare and low prevalence complex diseases across the EU through diagnosis and treatment 
(diagnosing patients and ensuring access to and delivering high-quality healthcare). The 
members  of  the  ERNs  treat  1.7  million  patients  with  rare  and  low  prevalence  complex 
diseases, including almost 600,000 new patients referred to the ERN healthcare providers 
with  a  diagnosis  of  diseases/conditions  that  fall  within  the  scope  of  expertise  of  the 
ERNs.  The  ERNs  have  also  contributed  to  research  and  innovation  by  generating 
knowledge,  exploiting  innovation  in  medical  science  and  health  technologies,  and 
collecting,  analysing  and  making  available  health  data.  The  ERNs  have  also  provided 
support to healthcare systems by developing quality and safety benchmarks and helping 
EU countries with an insufficient number of patients with a particular medical condition, 
or lacking technology or expertise, to provide highly specialised services of high quality. 

113 Ibid. 

40 

 
                                                                                                                                                 
52% of respondents to the public consultation believe that the ERNs have helped to make 
cost-effective  use  of  resources  within  EU-wide  networks  to  reduce  the  burden  and  fill 
gaps  at  national  level  to  at  least  some  extent;  while  19%  reported  that  the  ERNs  have 
contributed on this matter to a limited extent or not at all. The relatively high cost at the 
development  and  initial  implementation  stage  of  the  ERNs,  especially  in  the  IT 
organisational infrastructure, were to be expected at this early stage of the ERN project. 
This  is  supported  by  the  findings  from  the  public  consultation  whereby  81%  of 
respondents  believed  the  costs  of  the  ERNs  and  their  IT  tools  to  be  justified  and 
proportionate to at least some extent, given the objectives achieved and benefits obtained. 
However, the absence of a mechanism for reimbursement of healthcare providers’ costs 
incurred  as  part  of  the  ERNs  services  was  also  highlighted  as  an  issue  potentially 
affecting the cost-effectiveness of the ERNs. 

In addition, the ERNs provide the framework allowing rare and low prevalence complex 
disease  patients  to  receive  diagnosis  and  treatment  without  necessarily  physically 
transporting  the  patient  to  another  Member  State.  Therefore,  and  as  highlighted  during 
the EU Health Programme Conference in 2019, the ERNs are more cost effective as they 
save  the  patient  or,  as  the  case  might  be,  the  health  insurer  the  expense  of  travelling 
abroad  for  a  diagnosis  (including  related  costs  of  accommodation,  cost  of  family 
members moving with the patient etc.). This assessment of the cost-effectiveness of the 
ERN  model  was  supported  to  at  least  some  extent,  by  75%  of  the  ERN  members 
consulted  as  part  of  the  ERN  targeted  survey.  By  shortening  the  time  of  diagnosis  and 
improvements  in  treatment  through  virtual  consultations,  knowledge  sharing  or 
development of clinical guidelines, the ERNs produce cost-savings in the long run. This 
is particularly significant as patients with rare diseases tend to remain undiagnosed (for 
many years) or to be misdiagnosed114 resulting in a higher number of hospital visits and 
accompanying  costs  per  rare  diseases  patient  compared  to  the  general  patient 
population115.  Interviewees  noted  however  that  given  the  relatively  low  uptake  of  the 
virtual consultations in the first years since the establishment of the ERNs, specific data 
on cost-savings were limited so far. In addition, research takes time and given the ‘young 
age’ of ERNs, their research potential is not yet fully deployed. 

Coherence 

The evaluation of coherence involves assessing whether or not different actions related to 
the  CBHC  Directive  work  well  together.  It  helps  highlighting  areas  where  there  are 
complementarities  or  synergies,  which  improve  overall  performance;  or  sheds  light  on 
issues 
the 
complementarities  or  overlaps  between  different  provisions  of  the  Directive  (internal 

that  are  contradictory  or  cause 

the  evaluation, 

inefficiencies. 

In 

114  Genetic  Alliance  (2016).  The  Hidden  Costs  of  rare  Diseases:  A  Feasibility  study,  available  at: 

https://www.geneticalliance.org.uk/media/2502/hidden-costs-full-report_21916-v2-1.pdf  

115 Imperial College Health Partners (2018). A preliminary assessment of the potential impact of rare diseases 
on  the  NHS,  available  at:  https://imperialcollegehealthpartners.com/wp-content/uploads/2019/05/ICHP-
RD-Report-Nov-2018-APPROVED-002.pdf   

41 

 
                                                 
coherence), as well as the alignment with other inter-related EU policies and initiatives 
(external) has been assessed. 

Internal coherence 

The evaluation has not revealed any specific issues relating to the internal coherence of 
the CBHC Directive. The feedback from different stakeholder groups suggested that the 
Directive is well structured and that its objective to facilitate the access to safe and high 
quality  cross-border  healthcare  has  largely  translated  into  legal  provisions.  However, 
there  are  some  issues  with  regard  to  the  application  of  the  provisions  of  the  Directive 
across  the  EU,  most  importantly,  around  the  level  of  reimbursement  of  cross-border 
healthcare  costs,  the  prior  authorisation  systems,  administrative  procedures  for  cross-
border healthcare and  reimbursement of telemedicine.  In addition,  as mentioned above, 
in  recognition  of  national  competences,  the  Directive’s  provisions  allow  the  Member 
States to introduce certain limitations based on overriding reasons of general interest, if 
the principle of proportionality is respected. As a result, each restrictive national measure 
has to be assessed on a case-by-case basis. 

Level of reimbursement of cross-border healthcare costs: Member States use different 
methods to define “the level of costs that would have been assumed by the Member State 
of affiliation, had this healthcare been provided on its territory”. For example, it has been 
established  that  three  Member  States116,  with  varying  conditions  and  extent,  use  the 
levels  of  reimbursement  for  cross-border  healthcare  that  apply  to  healthcare  received 
from private/non-contracted healthcare providers within their own territory. Those levels 
are  lower  compared  to  the  level  of  reimbursement  within the  public  healthcare  system. 
The  Commission  considered  this  not  being  in  line  with  the  Directive  and  as  a  result, 
initiated  proceedings  for  failure  fulfil  the  obligations  under  the  Directive  against  those 
Member  States.  In  this  context,  it  is  also  questioned  whether,  and  to  which  extent, 
Member  States  are  allowed  to  apply  deductions  for  administrative  costs  to  the 
reimbursement requests for cross-border healthcare. 

Prior authorisation systems: Only seven EU Member States and one EEA EFTA State 
have  no  prior  authorisation  system  in  place.  The  main  reason  for  introducing  prior 
authorisation  systems  for  the  Member  States  was  the  protection  of  their  healthcare 
systems. At the time the Directive was transposed in the national legislation, its effect on 
the healthcare systems was uncertain and the introduction of prior authorisation for some 
countries was  a means to monitor this effect117. The Member States’ lists of healthcare 
subject to prior authorisation also differ significantly in the extent to which the healthcare 
is further specified and the number of the separate items on the lists. The main concern 
here is whether the option to make cross-border healthcare subject to prior authorisation 
is overused, as this would be regarded as an unjustified restriction of the free movement 
of  services118  and  would  not  allow  the  Directive  to  reach  its  full  potential.  Another 

116 FI, AT, NL. 
117 Mapping and Analysis of Administrative Procedures: analytical report, the study referred to in footnote 17. 
118 Recital 38 of the CBHC Directive. 

42 

 
                                                 
identified concern is the insufficient level of legal certainty and transparency for patients 
about  which  treatments  in  Member  States  are  made  subject  to  prior  authorisation.  The 
CBHC Directive allows the Member States sufficient room for maneuver, if the general 
principles  of  EU  law  related  to  the  restriction  on  fundamental  freedoms  are  respected. 
This  however  results  in  quite  divergent  prior  authorisation  systems  under  the  Directive 
across EU countries and each limiting national measure should be assessed on a case-by-
case basis, also in light of changing circumstances in that Member State. 

In  addition,  there  had  been  some  doubts  whether  Member  States  could  apply  prior 
authorisation requirement with regard to urgent treatments undergone by insured persons 
in other EU countries, as the Directive does not contain concrete provisions to this effect. 
However,  this  has  now  been  clarified  by  the  Court  of  Justice,  which  established  that 
national  legislation  that  excludes  the  reimbursement  without  prior  authorisation  of  the 
costs connected to urgent treatment undergone by an insured person in another Member 
State is not consistent with the free movement of services principle and the Directive119. 

Administrative  procedures  for  cross-border  healthcare:  Some  Member  States  had 
introduced administrative procedures for cross-border healthcare, which are questionable 
regarding their justified purpose, necessity and proportionality, such as requirements for 
certified  translations  of  medical  documentation  to  obtain  prior  authorisation  or 
reimbursement120.  In  addition,  under  Article  7(7)  of  the  CBHC  Directive,  the 
proportionality test also applies with regard to the requirements that are set for healthcare 
provided on the territory of the Member State and that, at the same time, apply for cross-
border  healthcare.  Here  also  the  Directive  allows  Member  States  to  impose  such  non-
discriminatory  requirements  based  on  the  reasons  listed  in  that  provision,  thus  the 
relevant  national  requirements  might  differ  from  one  EU  country  to  another  and  their 
compliance with the Directive should be assessed on a case-on-case basis.  

Telemedicine: The Directive has clarified some issues concerning the provision of cross-
border  telemedicine.  In  particular,  it  has  specified  that  in  the  case  of  telemedicine, 
healthcare  is  considered  to  be  provided  in  the  Member  State  where  the  healthcare 
provider  is  established.  This  means  that  cross-border  telemedicine  is  to  be  provided  in 
accordance with the legislation and standards and guidelines on quality and safety of the 
Member State of establishment of the healthcare provider (Articles 3(d)  and 4(1)). The 
Directive  makes  it  clear  that  cross-border  healthcare  costs  incurred  using  eHealth 
services are also to be reimbursed121. Article 7(7) of the Directive specifically mentions 
telemedicine when it allows the Member States to impose on an insured person the same 
conditions,  criteria  of  eligibility  and  regulatory  and  administrative  formalities,  as  it 
would impose if this healthcare were provided in its territory, if these  comply with  the 
principle of proportionality. 

119 Judgment of 23 September 2020, WO, C-777/18, cited in footnote 19, paragraph 85. 
120 See Section 4.1.1 above. See also Mapping and Analysis of Administrative Procedures: analytical report, the 

study referred to in footnote 17. 

121 Recital 26 of the CBHC Directive. 

43 

 
                                                 
However, the Directive does not aim to solve all legal issues related to the provision of 
cross-border  health  services  in  the  EU122,  such  as  Member  States’  limitations  on  the 
exercise  of  telemedicine  activities  (including  their  inclusion  in  the  scope  of  national 
health  insurance  systems),  data  protection  or  jurisdiction  and  applicable  law  in  case  of 
damage.  In  2008  and  2012,  the  Commission  assessed  the  applicability  to  telemedicine 
services  of  the  EU  legal  framework  existing  at  the  time.  This  assessment  showed  that 
legal  questions  related  to  the  provision  of  telemedicine  go  far  beyond  the  CBHC 
Directive123.  

With  the  Covid-19  pandemic,  Member  States  have  started  opening  up  financing  and 
reimbursement  of  telemedicine  services  on  the  national  level.  In  light  of  the  Directive, 
benefits  to  which  insured  persons  are  entitled  domestically  have  to  be  reimbursed  if 
received  cross-borders,  including  telemedicine  services.  There  is  currently  no  case  law 
clarifying conditions under which Member States can limit the reimbursement of cross-
border telemedicine costs in line with the Directive, thus the newly developing rules in 
the Member States might result in varied approaches. 

Coherence with other EU legislation 

a. Regulations on the coordination of social security systems 

There  are  two  routes  for  reimbursement  of  healthcare  costs  in  another  Member  State: 
under  the  Regulations  on  the  coordination  of  social  security  systems  and  under  the 
CBHC  Directive.  The  Regulations  and  the  Directive  overlap  in  terms  of  personal  and 
material  scope,  but  are  not  identical.  Therefore,  one  of  the  Directive’s  objectives  is  to 
clarify  its  relationship  with  the  Regulations.  The  aim  is  that  these  two  systems  are 
coherent  and  clear  in  the  sense  that  either  the  Regulations  apply  or  the  Directive 
applies124. 

In  many  cases,  the  Regulations’  route  to  cross-border  healthcare  is  more  beneficial  to 
patients.  For  example,  under  the  Regulations,  where  the  Member  State  of  treatment 
provides  benefits-in-kind  to  its  insured  persons,  cross-border  patients  should  also  have 
access  to  such  benefits  under  the  same  conditions  (see  Annex  VII).  Thus,  patients 
(insured persons) should not be deprived of the more beneficial rights guaranteed by the 
Regulations  when  the  conditions  are  met125.  In  light  of  this,  under  Article  8(3)  of  the 
Directive, the Member State of affiliation shall grant prior authorisation under Regulation 
(EC)  No  883/2004  where  the  conditions  laid  down  therein  have  been  met  unless  the 
person  specifically  requests  otherwise.  However,  no  provisions  of  the  CBHC  Directive 

122 Commission staff working document on the applicability of the existing EU legal framework to telemedicine 
services, Accompanying the document Communication from the Commission to the European Parliament, 
the  Council,  the  European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions  eHealth 
Action Plan 2012-2020 – innovative healthcare for the 21st century, SWD(2012) 414 final, 6.12.2012.  
123 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social Committee and the Committee of the Regions on telemedicine for the benefit of patients, healthcare 
systems and society, COM(2008)689 final, 4.11.2008 and SWD(2012) 414 final. 

124 Recital 30 of the CBHC Directive. 
125 Recital 31 of the CBHC Directive. 

44 

 
                                                 
ensure that patients benefit from the more beneficial rights under the Regulations in other 
circumstances. 

This  is  in  particular the case with  regard to  care, which becomes necessary on  medical 
grounds  during  the  insured  person’s  stay  in  another  Member  State  (Article  19  of 
Regulation (EC) No 883/2004). Whether such cross-border healthcare will be reimbursed 
under  the  Regulations  or  the  Directive  might  depend  in  practice  on  several  conditions: 
how  the  individual  healthcare  provider  assesses  the  (initial)  intention  of  the  person  to 
travel abroad126, as well as on the choices made by the person, or on the advice they may 
have received, in particular when they are directed to private providers or charged private 
prices  within  public/contracted  healthcare  providers  for  necessary  treatment.  Whereas 
pursuant  to  the  Directive,  the  patients  have  the  right  to  reimbursement  of  costs  of 
necessary treatment provided by a private healthcare provider, they have to bear the price 
difference, as the Member State of affiliation is only obliged to reimburse such costs up 
to  the  level  of  public  healthcare  tariff  in  that  Member  State  (Article  7(4)  of  the 
Directive). Although the exact extent to which patients are reimbursed for necessary care 
under the Directive’s provisions is not known, the lack of information about their rights 
under  the  Regulations  at  the  national  level  and  the  resulting  failure  by  cross-border 
patients to ascertain and pursue these rights in practice can lead to the application of less 
beneficial rules under the Directive. 

Complex issues related to the Directive’s relationship with the Regulations concern prior 
authorisation  and  reimbursement  of  costs  of  cross-border  healthcare  to  insured  persons 
and  their  family  members  residing  outside  the  competent  Member  State.  The  issue  of 
whether such persons benefit from the Directive’s rules of reimbursement if they are not 
insured under the compulsory sickness insurance scheme of the competent Member State 
has even been subject to a preliminary ruling of the Court of Justice127. In some cases, the 
Member State in which the persons at issue have to ask for prior authorisation under the 
Directive and under the Regulations is not the same. Thus, it cannot be ensured that the 
prior authorisation is issued to them under the more beneficial set of EU rules. 

Moreover, where, under the Directive, healthcare is not subject to prior authorisation, the 
Member State of affiliation (where the patient is insured) is not obliged to check whether 
the  terms  laid  down  in  the  Regulations  are  met  for  planned  healthcare  abroad.  Thus,  it 
will  depend  on  the  patients  to  get  acquainted  with  their  rights  and  to  choose  between 
going  abroad  using  the  Directive’s  route  for  cost  reimbursement  or  applying  for  prior 
authorisation under the Regulation. 

126  FreSsco.  Analytical  Report  2016  Access  to  healthcare  in  cross-border  situations,  p.  35-37  and  40-43 
file:///C:/Users/janecru/Downloads/FreSsco_AR2016_Cross-
(available 
borderHC_20170210FINAL%20(3).pdf)  where  it  is  pointed  out  that  it  is  not  always  easy,  and  in  many 
cases, impossible to determine the purpose of a journey or a patient’s actual intentions in order to establish 
tablwhether they should be reimbursed for necessary care under the Regulations. 

at: 

127  Judgment  of  28  October  2021,  Y,  C-636/19,  cited  in  footnote  19.  Moreover,  judgments  of  23  September 
2020,  WO,  C-777/18  and  of  29  October  2020,  A,  C-243/19,  both  cited  in  footnote  19,  also  provide 
additional clarity on the relationship between those two instruments. 

45 

 
                                                 
In  2012,  the  Commission  services  provided  to  the  Member  States  (Administrative 
Commission128) Guidance note aimed to ensure the coherent application of the Directive 
and the Regulations by the Member States with regard to social security aspects, which 
are  covered  by  both  instruments129.  The  Commission  has  also  produced  guiding 
principles  for  the  practice  of  NCPs,  a  toolbox  for  cross-border  healthcare,  including  a 
Manual  for  Patients  to  clarify  the  two  cross-border  healthcare  routes130.  It  has  also 
organised  several  workshops  aimed  at  increasing  capacity  of  the  Member  States  in 
applying  the  patients’  rights  in  cross-border  healthcare  and  clarifying  the  relationship 
between the Directive and the Regulations131. 

However,  public  and  stakeholder  consultations  suggest  that  the  complex  legal 
relationship  between  the  Directive  and  the  Regulations  is  very  difficult  for  citizens  to 
understand, as well as for health insurance institutions to communicate to patients. The 
complexity  of  the  systems  for  reimbursement  of  cross-border  healthcare  costs  and  the 
challenges  in  providing  clear  information  to  patients  led  several  Member  States  to 
introducing voluntary prior notification systems for cross-border healthcare (Article 9(5) 
of  the  Directive)132  or  advising  patients  to  seek  counsel  at  the  respective  institution 
before  engaging  in  a  cross-border  treatment.  An  analysis  of  NCPs’  websites  in  2021 
found  that  fewer  than  half  websites  provided  information  on  the  distinction  of  the 
patients’ rights under the CBHC Directive and the Regulations. Although the provision 
of such information is required under Article 5(b) of the Directive, some NCPs claimed 
not  providing  it  for  reasons  of  simplicity  for  patients.  Stakeholder  consultation  raised 
questions  whether  providing  full  information  about  the  relationship  between  the 
Directive and the Regulations would be necessary, if the patients were ensured access to 
the  route  that  is  the  most  beneficial  to  them.  The  European  Parliament  has  noted  the 
complexity  of  the  current  legal  situation  deriving  from  the  interaction  between  the 
Directive  and  the  Regulations  and  has  invited  the  Commission  to  further  clarify  it, 
including  by  means  of  comprehensive  public  information  campaigns,  as  well  as  to 
establish  guidelines  for  implementation,  especially  on  the  areas  where  those  two 
instruments interact133. 

For  the  respondents  to  the  public  consultation,  the  main  obstacles  to  cross-border 
healthcare were the financial problems and the fear of an incomplete reimbursement, as 
well  as  the  lack  of  clarity  for  patients  about  their  rights.  The  expert  reports  and 
complaints received from citizens suggest that patients find the EU schemes challenging 
to navigate. As illustrated above, in many instances, the burden in choosing the route that 

128  The  Administrative  Commission  for  the  coordination  of  social  security  systems  established  pursuant  to 

Article 71 of Regulation (EC) No 883/2004. 

129  European  Commission  (2012)  AC  246/12,  Guidance  note  of  the  Commission  services  on  the  relationship 
between Regulations (EC) Nos 883/2004 and 987/2009 on the coordination of social security systems and 
Directive 2011/24/EU on the application of patients' rights in cross border healthcare; and Appendix to the 
Guidance note of 2013 (ref. Ares(2013)1443508).  

130 https://ec.europa.eu/health/cross-border-healthcare/toolbox-cross-border-healthcare_en  
131 Workshops in 2016 and in 2018 for national experts and NCPs; training in 2021 to SOLVIT centers. 
132 Mapping and Analysis of Administrative Procedures: analytical report, the study referred to in footnote 17. 
133 European Parliament resolution of 12 February 2019, referred to in footnote 29. 

46 

 
                                                 
is  more  beneficial  is  left  on  patients134  with  some  resorting  to  private  contractors 
specialised in assisting in cross-border healthcare. In this context, it is important to note 
that in many cases, the patient’s “choice” will have financial consequences that could not 
be fully corrected by applying the more beneficial set of rules at the reimbursement stage. 
This  is  due  to  the  fact  that,  although  the  Directive  gives  patients  the  right  to  choose  a 
private healthcare provider abroad, it also means that these patients might be charged by 
healthcare  providers  –  even  in  certain  instances  public/contracted  providers  –  private 
prices whereas both under the Directive and the Regulations, the Member States are only 
obliged to cover expenses up to the level of the public tariff. 

All  the  above  raises  doubts  as  to  whether  the  coherence  of  the  Directive  with  the 
Regulations  on  the  coordination  of  social  security  systems  has  been  achieved  for  the 
benefit of patients. 

b. Directive 2005/36/EC on the recognition of professional qualifications 

Recital  50  of  CBHC  Directive  explains  that  it  is  without  prejudice  to  Directive 
2005/36/EC.  The  evaluation  has  not  established  incoherence  between  the  CBHC 
Directive and Directive 2005/36/EC. 

Title  II  of  Directive  2005/36/EC  regulates  services  provided  on  a  temporary  or 
occasional basis in another Member State than the Member State of establishment of the 
service provider, including health professionals. 

The CBHC Directive only concerns healthcare provided or prescribed in a Member State 
other  than  the  Member  State  of  affiliation  (Article  3(e)  of  the  CBHC  Directive). 
Telemedicine  is  to  be  considered  to  be  provided  in  the  Member  State  where  the 
healthcare provider is established (Article 3(d) of the CBHC Directive). Under Recital 50 
of the CBHC Directive, cooperation between Member States may concern, e.g. practical 
mechanisms to ensure continuity of care or practical facilitating of cross-border provision 
of healthcare by health professionals on a temporary or occasional basis.  

On the other hand, provision of healthcare services provided by health professionals on 
the  territory  of  another  Member  State  on  a  temporary  and  occasional  basis  is  not 
addressed  in  the  CBHC  Directive.  It  thus  does  not  specify  which  quality  and  safety 
standards should apply to such healthcare services, whether the systems  of professional 
liability insurance should extend to such services and how the costs of such cross-border 
services  should  be  reimbursed  to  patients  (or  the  health  professionals).  These  issues 
should therefore be assessed under the TFEU, Directive 2005/36/EC and/or national laws 
of the Member States, as appropriate. 

134  Judgment  of  23  September  2020,  WO,  C-777/18,  cited  in  footnote  19,  paragraph  37,  where  the  Court  of 
Justice noted that, in order for the Regulations on the coordination of social security systems to apply, it is 
necessary for the healthcare in question in the main proceedings to have been dispensed to the patient by 
the private provider in the Member State of treatment in accordance with the social security legislation of 
that Member State. 

47 

 
                                                 
3. Interaction with other European structures: the Civil Protection Mechanism  

The  Civil  Protection  Mechanism  is  an  example  for  the  CBHC  Directive’s  relationship 
and  good  interplay  with  existing  European  structures  related  to  the  Covid-19  crisis.  As 
described in the Commission guidelines on EU emergency assistance in cross-border 
cooperation  in  healthcare135,  the  Directive  provided  clarity  on  patients’  rights  across 
borders, while the Civil Protection Mechanism was used to provide emergency assistance 
to  regions  to  alleviate overburdened hospitals and the coverage of healthcare  costs was 
governed by the Regulations on the coordination of social security systems.  

4.2.  How did the EU intervention make a difference? 

The CBHC Directive has made a difference in a number of ways based on the evidence 
gathered for this evaluation:  

The Directive provides that  patients  have  equal  access  to  treatment  in  another Member 
State and the right not be discriminated with regard to the price.  

Patients  have  been  able  to  benefit  from  the  Directive’s  rights  to  choose  a  public  or 
private healthcare provider to meet their medical needs better and to be (at least partially) 
reimbursed the medical costs. This applies particularly for citizens accessing healthcare 
in  neighbouring  countries  and  in  border  regions  where  the  nearest  medical  facility  is 
across the border or waiting lists are long in the country of residence as evidenced by EU 
annual patient mobility data and the case study findings of the AEBR136. 

The  highest  added  value  of  the  Directive  for  cross-border  healthcare  reimbursement 
compared with the Regulations is the reduction of administrative burden for patients, 
although some of burdens still persist. As a general rule, the Member States should not 
make  reimbursement  of  costs  for  cross-border  healthcare  subject  to  prior  authorisation. 
Whereas  under  the  Regulations,  prior  authorisation  is  always  necessary  for  planned 
healthcare abroad. 

In  addition,  the  Directive  requires  that  administrative  procedures  for  cross-border 
healthcare  are  based  on  objective,  non-discriminatory  criteria  which  are  necessary  and 
proportionate to the objective to be achieved. In accordance with the general principles of 
EU  law,  the  same  rules  also  follow  with  regard  to  the  administrative  procedures  for 
cross-border  healthcare  under  the  Regulations.  However,  contrary  to  the  Directive,  the 
former do not contain concrete provisions to this effect. At the same time, further efforts 
are  necessary  to  ensure  that  prior  authorisation  system  is  not  overused,  that 
administrative procedures are not  too  restrictive  and that legal  certainty is  thus  ensured 
for patients. 

The  Directive  has  enshrined  other  patients’  rights  in  cross-border  healthcare.  The 
most  important  of  those  are  equal  access  to  health  services,  equal  quality  and  safety 

135 Guidelines referred to in footnote 108.  
136 See the study referred to in footnote 76. 

48 

 
                                                 
standards,  non-discriminatory  prices  in  the  Member  State  of  treatment,  the  right  to 
follow-up  care  back  home  and  the  right  to  information  provision  on  cross-border 
healthcare.  

A  number  of  stakeholders  recognise  that  the  Directive  has  provided  a  very  good 
framework  to  reinforce  patient  rights.  It  has  acted  as  a  catalyst  for  patients’  rights, 
bringing about changes in a number of national health systems to the benefit of patients, 
for  example  increasing  transparency  of  pricing  and  professional  liability  of  health 
professionals. 

The creation of the ERNs in the area of rare and low prevalence complex diseases 
are  considered  by  stakeholders  to  provide  the  highest  added  value  of  the  Directive 
through  the  better  diagnosis  and  treatment  of  patients  by  facilitating  the  exchange  of 
knowledge  and  best  practices  among  medical  specialists  cooperating  in  the  24  ERNs. 
These  outputs  would  not  have  been  as  effective  without  the  pooling  of  expertise  and 
patient data at the EU level. The ERNs could help Member States lacking the technology 
or expertise to meet the needs of patients with a particular medical condition, to provide 
highly specialised services of high quality. 

Information on patients’ rights to cross-border healthcare: the creation of the NCPs 
has  increased  the  provision  of  relevant  information  to  patients  about  cross-border 
healthcare,  including  healthcare  under  the  Regulations  on  the  coordination  of  social 
security systems.  

Cross-border  recognition  of  prescriptions:  steps  taken  under  the  Directive  have 
increased  the  recognition  of  cross-border  prescriptions,  although  several  areas  for 
improvement remain. 

4.3. 

Is the intervention still relevant? 

The CBHC Directive is still relevant as its key objective to facilitate access to healthcare 
in another EU country remains important and its legal framework is largely adequate for 
ensuring EU citizens’ rights in line with the TFEU, as interpreted in the case law of the 
Court of Justice.  

The Directive is highly relevant in ensuring EU patients’ rights to equal treatment with 
domestic patients in the Member State of treatment, as well as the same medical follow-
up  back  home.  In  addition,  based  on  the  Directive,  patients  are  ensured  access  to 
information  about  cross-border  healthcare,  including  under  the  Regulations  on  the 
coordination of social security systems. 

Evidence  shows  that  EU  citizens  are  still  willing  to  travel  abroad  for  healthcare  for  a 
variety of reasons137. Moreover, EU citizens continue to use the Directive’s mechanism 

137  According  to  ANEC  survey,  47%  respondents  considered  they  would  travel  abroad  for  their  healthcare. 
ANEC  (2018).  Cross-border  healthcare  Accessing  medical  treatment  in  other  EU  countries:  Consumer 

49 

 
                                                 
 
for cross-border healthcare reimbursement, although there has been a slight decline in the 
number  of  reimbursement  cases  since  2019  as  a  result  of  the  Covid-19  pandemic.  The 
public  consultation  views  were  divided  on  the  extent  to  which  the  Directive  has  met 
patient needs with around half of healthcare authorities, healthcare providers and insurers 
believing  the  Directive  met  needs  completely  or  to  a  great  extent  compared  patient 
organisations,  citizens  and  NGOs  who  felt  needs  were  met  to  some  or  limited  extent. 
Implementation  issues  were  cited  as  an  important  reason  why  the  Directive  was  not 
meeting  patient  needs.  This  view  is  supported  by  the  stakeholder  interviews  as  well  as 
the reports on the implementation of the Directive138. 

The Directive’s reimbursement mechanism is not seen as relevant for many stakeholders, 
in  particular  patient  organisations,  including  cancer  patients,  and  the  rare  disease 
community. This is because certain treatments, including gene therapy, are highly costly 
and therefore not possible to pay in advance and therefore out of reach for patient in need 
of  specialist  treatment  is  only  available  in  a  few  specialised  health  clinics  in  the  EU. 
However,  as  explained  above,  the  Directive  was  not  intended  to  replace  the  rights  to 
cross-border  healthcare  under  the  Regulations  on  the  coordination  of  social  security 
systems nor to deprive patients of the more beneficial rights guaranteed therein when the 
conditions  are  met.  Thus,  in  the  above-cases,  the  patients’  needs  could  be  better  met 
under  the  Regulations  under  which  patients  do  not  have  to  pay  for  healthcare  upfront 
where  the  social  security  system  of  the  country  of  treatment  provides  such  benefits  to 
their own insured persons139.  

On  the  other  hand,  the  Directive  continues  to  be  highly  relevant  for  the  pooling  of 
knowledge  and  expertise  as  well  as  for  structuring  much  needed  research  activities  to 
support the treatment and diagnosis of rare and low prevalence complex diseases through 
the ERNs as described above.  

70% of public consultation respondents viewed the Directive as relevant at least to some 
extent in ensuring that patients have better access to high quality healthcare services for 
rare and low prevalence complex diseases; 77% of respondents viewed the Directive as 
relevant at least to some extent in giving healthcare providers across the EU access to the 
best expertise and timely exchange of life-saving knowledge.  

Most of the respondents to the original 2013 public consultation on the implementation 
of the ERNs pointed out that the ERNs should focus on complex, highly specialised and 
rare  diseases  for  which  expertise  is  scarce140.  In  addition  to  rare  diseases,  some  ERNs 
have also  been established for other conditions  which require complex procedures (e.g. 

attitudes 
studies/ANEC-TS-2017-SERV-008.pdf  

experiences, 

and 

available 

here: 

http://www.anec.eu/images/Publications/technical-

138 See COM(2015) 421 final and COM(2018) 651 final. 
139 The prior authorisation requirement for planned treatment abroad under the Regulations is out of the scope 

of this evaluation. 

140  European  Commission  (2013).  Summary  Report  of  the  replies  on  the  public  consultation  on  the 
here: 

implementation 
https://www.uems.eu/__data/assets/pdf_file/0005/1499/cons_ern_report_en.pdf  

Reference 

Networks 

European 

available 

(ERNs), 

of 

50 

 
                                                                                                                                                 
ERN TransplantChild, which focuses on paediatric transplantation or ERN eRUOgen on 
rare uro-recto genital diseases and complex conditions). A 2018 expert panel assessment 
found this appropriate and saw no need to extend the ERNs model to other areas such as 
healthcare  in  remote  areas,  border  regions,  the  development  of  new  medicines  or 
interventions, or other specific areas such as the care of homeless people, for which they 
felt there were better mechanisms141.  

The  ERNs  may  further  serve  patient  needs  by  improving  research  collaboration  in 
relation to rare conditions. While rare and low prevalence complex diseases collectively 
present a significant burden on the healthcare systems, the small number of cases in each 
country may mean that certain conditions do not receive a significant amount of research 
funding  or  attention  in  the  healthcare  settings.  The  increasing  visibility  of  different 
conditions  as  a  result  of  the  ERNs  could  help  justify  further  allocation  of  funding  to 
research  and  help  build  research  economies  of  scale142  and  inform  the  EU  research 
agenda for which rare diseases have been a priority area as shown by the establishment in 
2011  of  the  International  Rare  Disease  Research  Consortium  (IRDiRC)  by  the 
Commission and the US National  Institute of Health143. A survey carried out as part of 
the mid-term evaluation of the third Health Programme found that the majority (75%) of 
the 39 ERNs experts that took part in the survey expect that the initiatives supported in 
the  post-2020  period  may  reasonably  contribute  to  increasing  the  amount  of  research 
being  produced  through  cooperation  within  the  ERNs144.  In  particular,  the  ERNs  have 
started  to  facilitate  large  clinical  studies  to  improve  understanding  of  diseases  and 
develop new drugs by gathering a large pool of patient data through registries.  

The Covid-19 pandemic and the scale of its impact has clearly shown the importance of 
cross-border  cooperation  in  healthcare.  Six  in  ten  public  consultation  respondents 
agreed  that  the  Directive  could  help  health  systems  tackle  a  possible  backlog  of 
postponed  treatments  arising  from  the  pandemic  either  completely  (12%),  to  a  great 
extent (28%) or to some extent (20%). In practice, this would wholly depend on domestic 
waiting lists and hospital capacity to receive cross-border patients. Populations in border 
regions  have  different  demographics  and  needs  as  described  above  (Section  4.1.2)  and 
their  weaknesses  and  vulnerabilities  were  re-affirmed  by  the  Covid-19  pandemic. 
According  to  the  AEBR,  the  Directive  remains  relevant  as  an  additional  instrument  to 
enable access to healthcare across borders and to encourage cross-border cooperation in 
healthcare145. 

In terms of the Directive’s relevance to meet future healthcare needs, trends in unmet 
need for healthcare within Member States provide an indicator for such future needs. The 

141 EXPH Report referred to in footnote 83.  
142 European Commission (2017). Mid-term Evaluation of the Third Health Programme (2014 – 2020), Annex 
https://ec.europa.eu/health/other-pages/basic-page/mid-term-evaluation-3rd-health-

available 

B, 
programme-2014-2020_en  

at: 

143 EXPH Report referred to in footnote 83. 
144 Mid-term Evaluation of the Third Health Programme (2014 – 2020), Annex B, referred to in footnote 142.  
145 See the study referred to in footnote 76. 

51 

 
                                                 
European Statistics on Income and Living Conditions (EU-SILC) 2020 survey shows that 
most  healthcare  needs  are  met  in  most  countries,  but  some  significant  unmet  needs 
remain.  Access  to  healthcare  can  be  limited  for  a  number  of  reasons,  including  cost, 
distance  to  the  closest  health  facility  and  waiting  times,  which  means  the  Directive’s 
objective to provide access to healthcare EU-wide remains relevant.  

Europe’s  digital  transformation  is  a  long-standing  Commission  priority  and  the 
digitalisation of healthcare was already included in the scope of the Directive ten years’ 
ago. Its provisions created a voluntary eHealth network to develop common standards to 
facilitate  the  electronic  transfer  of  data  in  healthcare.  Europe’s  Digital  Decade  sets  a 
target  of  100%  of  citizens’  having  access  to  electronic  health  records  by  2030146.  The 
Commission’s  proposal  for  a  Regulation  on  the  EHDS  is  expected  to  help  deepen  this 
cooperation.  

The Covid-19 pandemic has accelerated the trend towards tele-consultation in the light of 
social  distancing,  although  in-person  consultations  remain  the  norm.  Before  2020,  only 
few countries had policies or legislation that defined the reimbursement of digital health 
services. With the pandemic, new national policies have emerged to facilitate the use of 
digital  health tools,  including the opening  up of financing and reimbursement for these 
services 
invoices  and  prescriptions.  These 
developments  are  reducing  burdens  and  costs  for  patients,  health  professionals,  health 
insurers and administrations alike. However, the literature suggests there is still relatively 
little  formal  adaption  of  the  regulatory  framework  for  digital  health  tools  across 
Europe147. 

the  digitalisation  of 

together  with 

In  light  of  this  trend  on  the  national  level,  as  well  as  with  the  proposed  EHDS,  the 
Directive  will  become  more  prominent  with  regard  to  telemedicine  services  provided 
cross-border.  The  Directive  is  relevant  to  address  the  increasing  use  of  cross-border 
telemedicine in the sense that it sets out some important rules relating to  the applicable 
legislation, standards and guidelines on quality and safety and makes it clear that cross-
border  healthcare  costs  incurred  using  eHealth  services  are  also  to  be  reimbursed. 
However,  it  does  not  aim  to  solve  all  legal  issues  related  to  the  provision  of  (cross-
border)  telemedicine  in  the  EU,  as  the  EU  legal  framework  applicable  to  telemedicine 
services goes far beyond the CBHC Directive148.  

The Directive thus remains relevant to meet patient needs. As explained in Section 2.2, if 
the  Directive  did  not  exist  or  if  it  were  to  be  repealed,  there  would  no  EU  legal 
framework  for  ensuring  a  consistent  approach  to  reimbursement  of  cross-border 
healthcare costs as set out in the rulings of the Court of Justice.  

146 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social  Committee  and  the  Committee  of  the  Regions.  2030  Digital  Compass:  the  European  way  for  the 
Digital Decade, COM(2021) 118 final, 9.3.2021. 

147 Study supporting the evaluation of the Directive, referred to in footnote 51. 
148 See Section 4.1 above. 

52 

 
                                                 
5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? 

The  performance  of  the  CBHC  Directive  must  be  viewed  within  the  wider  context  as 
there  are  several  options  open  to  the  EU  citizen  to  access  healthcare  in  another  EU 
country  whether  under  the  Regulations,  the  Directive  or  bi-lateral  and  multilateral 
agreements at national or regional level.  

Moreover,  this  evaluation  highlighted  the  large  data  gaps  to  assess  the  wide  range  of 
impacts of the Directive. Data on patient mobility remains incomplete and inconsistent, 
with  data  lacking  from  important  Member  States.  It  was  not  possible  to  document  the 
type  of  services  more  frequently  used  under  the  Directive  as  Member  States  are  not 
required to provide this data under the Directive and most do not collect this data.  

Within  this  context,  this  evaluation  draws  the  following  conclusions  regarding  the 
Directive’s effectiveness, efficiency, coherence, relevance and added value which offer a 
number of  lessons  for the future improvement of the Directive’s implementation  in  the 
EU: 

Effectiveness 

The  Directive  has  been  moderately  effective  in  delivering  its  objectives  to  facilitate 
access  to  safe  and  high-quality  healthcare  in  another  EU  country.  It  has  contributed  to 
removing  obstacles  to  cross-border  healthcare  and  to  the  free  movement  of  healthcare 
services  by  bringing  additional  legal  certainty  in  relation  to  patients’  rights  in  cross-
border  healthcare  and  establishing  a  legal  framework  that  enables  citizens  to  exercise 
those rights. It enshrined patients’ rights in cross-border healthcare, such as equal access 
to  health  services,  equal  quality  and  safety  standards,  non-discriminatory  prices  in  the 
Member State of treatment, the right to follow-up care back home and the recognition of 
prescriptions.  The  Directive  has  been  somewhat  effective  in  regulating  these  matters, 
although some issues persist. The Directive has also acted as a driver for patients’ rights 
in general, increasing the transparency on treatment prices, bringing about changes in a 
number of national health systems to the benefit of patients. 

In  addition,  the  Directive  has  ensured  a  more  consistent  approach  at  EU  level  to 
reimbursement of cross-border healthcare costs for EU citizens compared to the situation 
where Member States were to comply directly with the TFEU provisions, as interpreted 
by the Court of Justice. At the same time, the Directive recognises the Member States’ 
competences and leaves sufficient room for manoeuvre to limit patients’ rights to cross-
border  healthcare  cost  reimbursement  which  has  resulted 
in  quite  divergent 
implementation  of  the  Directive  across  EU  countries.  For  example,  the  evaluation 
showed that not enough Member States help reduce the financial risk for patients by 
making  use  of  the  voluntary  prior  notification  system,  currently  used  by  only  eight 
countries,  to  confirm  the  amount  to  be  reimbursed  as  provided  by  the  Directive.  In 
addition,  it  was  acknowledged  by  stakeholders  and  the  Fit  for  Future  Platform  that 
making  information  available  about  the  prices  charged  for  treatment  abroad  and  tariffs 

53 

 
for reimbursement back home is of utmost importance to reduce uncertainty for patients 
wishing to be treated abroad. 

While  the  Directive  is  used,  cross-border  healthcare  reimbursements  remains  low  with 
around  300,000  requests  for  reimbursement  annually.  The  Directive’s  potential  for 
improving  access  to  cross-border  healthcare  are  undermined  by  important  barriers:  the 
low level of awareness over patients’ rights to cross-border healthcare, disproportionate 
administrative  burdens  and  uncertainty  over  reimbursement.  Patient  organisations,  in 
particular,  criticise  the  requirement  for  patients  to  pay  upfront  for  treatment  abroad  as 
creating inequalities in access to healthcare with only those who can afford it using the 
Directive for healthcare in another EU country.  

Raising  awareness  on  patients’  rights  to  cross-border  healthcare  and  improving 
information for patients are critical factors for easing access to healthcare abroad. The 
creation  of  the  NCPs  has  made  information  to  patients  on  cross-border  healthcare 
available  where  none  had  previously  existed.  Despite  improvements  and  continuous 
efforts  by  many  NCPs,  information  gaps  persist  in  relation  to  the  availability, 
completeness,  clarity  of  information,  and  also  on  the  accessibility  of  information  for 
people with disabilities. Moreover, the role of the NCPs remains limited, partly as there 
is  no  obligation  under  the  Directive  to  promote  cross-border  healthcare  and  therefore 
there  is  a  lack  of  awareness  that  they  exist.  This  finding  shows  the  importance  of  the 
NCPs’  consultation  arrangements  with  patient  organisations,  health  professionals  and 
health  insurers  to  raise  awareness  and  share  information,  however  these  remain  under-
developed  in  most  Member  States.  In  addition,  the  information  the  NCPs  provide  is 
drawn from  national  legislation implementing the Directive, which sometimes does  not 
ensure  legal  certainty  for  patients.  For  example,  while  the  NCPs  are  obliged  to  make 
transparent  the  categories  of  healthcare  for  which  prior  authorisation  is  required,  the 
availability and clarity of that information depends on national rules.   

The  Commission  has  effectively  encouraged  cooperation  in  cross-border  healthcare 
between  neighbouring  countries  and  border  regions  by  means  of  studies,  projects  and 
partnerships  between  these  countries  and  regions  as  provided  by  the  Directive.  While 
there is  some evidence that  the Directive provides an additional instrument  to  facilitate 
healthcare in border regions, there is no robust data to assess to what extent the Directive 
has promoted cooperation over and above pre-existing regional cooperation arrangements 
in  healthcare.  Despite  the  importance  of  cross-border  healthcare  in  border  regions,  the 
diversity  of  health  systems  in  invoicing  and  reimbursement  systems  may  result  in 
administrative  and  financial  burdens  for  the  patient.  This  is  why  several  regional 
cooperation  projects  along  border  regions  joined  forces  to  find  solutions  to  overcome 
these  differences.  The  Covid-19  pandemic  has  shown  that  citizens  in  border  regions 
could  benefit  greatly  from  structured  regional  cooperation  in  healthcare  and  show  that 
good  practice  examples  exist  to  show  how  to  overcome  differences  in  national  health 
systems to meet patients’ needs in those regions. Within the context of Covid-19, special 

54 

 
exemptions from restrictions to free movement were agreed for persons living in border 
regions and travelling across the border on a daily basis149. The Directive could help to a 
large or to some extent to address the backlog of postponed treatments arising from the 
pandemic. 

The  Directive  has  been  very  effective  with  regard  to  cooperation  in  rare  and  low 
prevalence  complex  diseases.  The  ERNs  have  contributed  to  considerable  progress  in 
knowledge  sharing  and  in  research  on  rare  diseases  find  solutions  for  patients 
encountering  diagnosis  difficulties  or  diagnoses  for  one  of  estimated  6000-8000  rare 
disease  with  no  treatment  option150.  Bearing  in  mind  that  the  ERNs  have  only  existed 
since  2017,  there  are  still  important  issues  to  address  including  the  complex  and 
sometimes  non-interoperable  IT  facilities,  the  complexity  of  the  ERN  funding,  the 
absence  of  reimbursement  mechanism  for  cross-border  virtual  expert  panels,  the 
insufficient  integration  of  the  ERNs  in  the  national  health  systems  and  the  absence  of 
clear patient pathways on how to access the ERNs at the national level.  

Efficiency 

The  Directive  has  had  important  benefits  in  providing  legal  certainty  for  cross-border 
healthcare,  enhancing  cross-border  cooperation  in  healthcare  between  neighbouring 
countries  and  border  regions  and  in  the  field  of  rare  and  low  prevalence  complex 
diseases, as well as indirectly acting as a driver for the development of patients’ rights in 
some  Member  States  and  greater  domestic  transparency  on  treatment  prices,  rules, 
procedures and standards. For Member States, the overall costs including reimbursement 
and  treatment  costs  under  the  Directive  are  minor.  The  Directive’s  financial  impact  on 
national healthcare budgets has been marginal. On the other hand, for patients opting for 
the  Directive’s  route,  costs  are  potentially  significant.  The  costs  of  the  Directive  are 
therefore  not  borne  in  a  proportionate  manner  by  EU  citizens  within  and  between 
countries.  

Patients with rare or low prevalence complex diseases have particularly benefitted from 
the existence of the ERNs under the Directive. 

Coherence 

The  Directive’s  legal  framework  is  well  structured  and  the  evaluation  has  not  revealed 
any specific issues regarding its internal  coherence. The ERNs are  coherent  with  wider 
EU policy objectives in rare diseases and the Directive has reinforced existing tools such 
as  Orphanet.  However,  there  are  important  issues  with  regard  to  the  consistent 
application  of  the  provisions  of  the  Directive  in  the  Member  States,  most  importantly, 
around  the  level  of  reimbursement  of  cross-border  healthcare  costs,  the  prior 

149 Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction 
of free movement in response to the Covid-19 pandemic (OJ L 337 14.10.2020, p. 3). The consolidated text 
available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02020H1475-20210202  
https://ec.europa.eu/info/research-and-innovation/research-area/health-research-and-innovation/rare-

150 

diseases_en  

55 

 
                                                 
authorisation  systems,  administrative  procedures  for  cross-border  healthcare  and 
reimbursement of telemedicine.  

In  terms  of  the  Directive’s  external  coherence,  the  complex  legal  relationship  between 
the  Directive  and  the  Regulations  of  the  coordination  of  social  security  systems  is 
difficult for citizens to understand and for the NCPs and health insurers to communicate 
to  patients.  Patients  cannot  easily  navigate  the  cross-border  healthcare  pathways  under 
the Directive and the Regulations on the coordination of social security systems. These 
mechanisms  are  not  perceived  as  “user-friendly”  for  patients  seeking  sometimes  very 
urgent  treatment  for  their  medical  condition.  At  the  same  time,  in  many  instances,  the 
responsibility in choosing the route that is more beneficial is left to patients with ensuing 
financial  implications  that  could  bring  scepticism  about  cross-border  healthcare  in 
general.  This  raises  doubts  as  to  whether  the  clarity  of  the  relationship  between  the 
Directive and the Regulations has been achieved for the benefit of patients.  

However,  the  evaluation  has  not  established  incoherence  between  the  CBHC  Directive 
and Directive 2005/36/EC on the recognition of professional qualifications. 

EU added value 

The Directive has provided EU added value in that it brought about a more consistent EU 
level  approach  to  patients’  rights  in  cross-border  healthcare,  including  the  right  to 
reimbursement  of  cross-border  healthcare  costs  and  to  the  mutual  recognition  of 
prescriptions in the EU. It reduced administrative burden for patients  accessing planned 
care in other Member States compared with the Regulations on the coordination of social 
security systems. Through the creation of the NCPs the patients have access to relevant 
information  about  cross-border  healthcare,  including  healthcare  under  the  Regulations. 
Rare disease patients have benefitted from the establishment of the ERNs. Repealing the 
Directive would remove the legal certainty the Directive’s objectives sought to provide. 
There  is  some  evidence  that  the  Directive  provides  an  additional  instrument  for  people 
living in border regions who have particular need to access “structural” healthcare if the 
closest medical facility is across a border. 

However, the problems raised in this evaluation mean that the full EU added value of the 
Directive is not currently being realised. 

Relevance 

Despite  persisting  problems  with  regard  to  implementation,  the  Directive  remains 
relevant  to  the  needs  of  EU  citizens  to  facilitate  access  to  cross-border  healthcare  as 
citizens  continue  to  use  its  mechanism  for  the  (partial)  reimbursement  of  their  medical 
costs for treatment abroad. The Directive also remains relevant to address the increasing 
use of telemedicine, a major development in recent years, however some elements need 
further  examination.  The  ERNs  remain  relevant  to  meet  the  needs  of  rare  and  low 
prevalence complex diseases patients.  

56 

 
 
57 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX I. PROCEDURAL INFORMATION 

Lead DG  

The European Commission's Directorate-General (DG) for Health and Food Safety is the 
lead DG for this evaluation (PLAN/2021/10183 and Commission Work Programme 2021 
COM 2020/690) 

Organisation and timing  

The Commission published a roadmap on the evaluation of patients’ rights on 15 January 
2021 that was open for feedback until 11 February 2021. A public consultation ran for 12 
weeks from 4 May until 27 July 2021 with 193 responses received in total. 

An  interservice  steering  group  (ISSG)  was  established  on  20  January  2021  involving 
representatives  from  DG  Employment,  DG  Communications  Networks,  Content  and 
Technology,  DG  Internal  Market,  Industry,  Entrepreneurship  and  SMEs,  DG  for 
Regional  Policy,  DG  for  Research  and  Innovation,  Joint  Research  Centre,  DG  Justice, 
DG for European Civil  Protection and Humanitarian Aid Operations, the Legal Service 
and the Secretariat-General. The  ISSG contributed to  the evaluation  and ensured that it 
met the necessary standards for quality, impartiality and usefulness. Five meetings were 
held. 

Exceptions to the Better Regulation Guidelines  

None. This evaluation was not selected for scrutiny by the Regulatory Scrutiny Board. 

Evidence, sources and quality  

This evaluation report drew on the following sources of evidence: 

  Study  supporting  the  evaluation  of  Directive  2011/24/EU  on  patients’  rights  in 

cross-border healthcare 

  Study  on  the  Better  Implementation  of  the  Directive  2011/24/EU  to  ensure 

patients’ rights in the EU 

  Study on patient mobility in selected EU border regions 
  Commission report on patient mobility data 2020 
  Submissions to the online public consultation from May-July 2021 and the factual 
summary  report  of  these  as  well  as  the  synopsis  report  of  all  consultation 
activities in Annex V  
Input from a stakeholder event on 9 November 2021 and a summary report of this 
event  

 

  Meetings with stakeholders and the minutes of these meetings  
  Meeting with the cross-border healthcare expert group and the National  Contact 

Points and the minutes of those meetings 

  Opinion of the Fit for Future Platform  

58 

 
Annex  II  of  this  report  describes  the  data  collection  tools  used  to  gather  the  relevant 
information  including  a  document  review,  stakeholder  interviews,  Commission  public 
consultation, targeted surveys, case studies, workshops and contracted studies.  

59 

 
 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED 

Study design 

A  consortium  led  by  Tetra  Tech,  carried  out  a  support  study  to  provide  input  for  this 
evaluation.  The  study  was  delivered  over  a  period  of  eight  months  and  the  public 
consultation was available between 4 May and 27 July 2021.  

There were no major changes made to the original plan set out in the roadmap. However, 
mitigating measures were taken, to adjust to unforeseen conditions. Firstly, as there were 
only  193  respondents  to  the  public  consultation,  the  study  team  conducted  additional 
targeted  consultation  activities,  reaching  to  a  total  of  287  stakeholders.  Secondly,  the 
study  team  took  several  mitigating  measures  to  ensure  the  reliability  of  the  data,  as 
presented below. 

Limitations and reliability of data  

The public consultation was launched on 4 May 2021 and remained open for 12 weeks 
until  27  July  2021.  There  were  a  total  of  193  respondents.  The  respondents  were  re-
categorised to better reflect the stakeholder categories in the Commission’s consultation 
strategy for the Directive151. Substantial efforts were made to engage stakeholders from 
all the categories identified in the stakeholder engagement strategy and across the study 
countries. While overall this objective was achieved, some sectors were less engaged in 
the  study  than  what  was  desirable  Response  rates  from  healthcare  providers  to  the 
targeted  questionnaire,  from  pharmacists  to  the  dispensers’  survey  in  some  study 
countries  and  from  national  health  insurers  invited  to  the  interviews  were  particularly 
low.  Two  main  reasons  have  been  identified  for  this  result.  Firstly,  many  targeted 
stakeholders have been occupied in the response to the Covid-19 pandemic and were not 
always  available  to  answer  the  evaluation  team’s  requests.  Secondly,  there  have  been 
several concurrent research activities on this topic area (or in related topics), which may 
have  led  to  some  stakeholder  fatigue.  It  is  also  important  to  note  that  key  stakeholders 
were  distributed  among  several  categories,  which  means  that  for  some  answers,  the 
qualitative data comes from a small number of individuals. To overcome this limitation, 
the presentation of the preliminary findings in different fora (virtual workshop, meeting 
of the ERN coordinators group, meeting of the cross-border healthcare expert group) has 
allowed to validate some of the main conclusions presented in this report. As the number 
of  responses  were  relatively  low  and  spread  across  many  different  categories  of 
respondents,  the  evaluation  team  grouped  the  (re)categorised  respondents  into  two 
categories, contribution type and organisation type, to enable different cross-tabulations.  

Methodology, sources of information and data analysis  

The methodology for this support study was based on: 

60 

 
  Desk-based  research,  including  a  literature  review  which  reviewed  and 
extraction  of  evidence  from  the  following  types  of  documents:  EU  legislation, 
Staff Working Documents; reports and documents produced by the Commission 
and  available  on  the  DG  SANTE’s  dedicated  website;  additional  academic 
papers, articles, theses and chapters. Through the different sources consulted, 236 
documents  were identified for abstract  and/or full text  screening, with  a total  of 
121 academic papers and reports included in the analysis. The desk research also 
included  a  web-analysis  of  the  information  provided  by  the  NCPs.  In  order  to 
carry out the desk research, the study team made use of different legislative acts, 
studies and data. The sources of information used included: 

 

Impact  Assessment  of  the  Directive  2008  on  patients’  rights  in  cross-
border healthcare, 

  Commission Reports 2015 and 2018 on the operation of the Directive on 

patients’ rights in cross-border healthcare,  

  Special Eurobarometer 425 Patients’ rights to cross-border health services 

in the EU,  

  Studies carried out by the European Commission available on the Europa 

website,  

  Commission  reports  on  Member  States’  data  on  cross-border  patient 

mobility,  

  Preliminary rulings of the Court of Justice and citizen complaints,  
  Special Report by the ECA, the Resolution of the European Parliament on 
the  implementation  of  the  Directive  &  the  Outlook  Opinion  of  the 
Committee of the Regions.  

 

In addition, the study made use of the Commission’s annual collection of data on 
the  budgetary  impact  of  cross-border  planned  healthcare  used  to  quantify  the 
regulatory  costs.  It  examined  the  costs  and  benefits  of  cross-border  treatment, 
using  available  healthcare  data  to  identify  any  unintended/unexpected  effects  of 
the  Directive.  Field  research,  including  surveys  and  requests  of  information, 
interview programme, one case study on the recognition of medical prescriptions 
and a public consultation. 
  Targeted  consultations:  285  stakeholders  engaged 

targeted 
consultation  activities in the form of interviews,  surveys and questionnaires. 
They  were  categorised  into:  the  European  Commission,  national  authorities, 
EU-level organisations, ERNs, national level stakeholders and others.  
  Analysis  of  quantitative  and  qualitative  data,  from  which  conclusions  and 

through 

recommendations were formulated.  

The evaluation was based on the evaluation criteria – effectiveness, efficiency, relevance, 
coherence and EU-added value. 

151 The new categories used were: individual citizens, patient organisations, NGOs representing specific groups, 
public  authorities  (national,  regional  and  local,  including  NCPs),  healthcare  providers,  health  insurers, 
industry, research organisations, organisations or projects promoting regional cooperation and ERNs. 

61 

 
 
                                                                                                                                                 
The study did  not  mention specific models used, however the statistical  analysis of the 
public  consultation  responses  were  conducted  through  different  analytical  approaches. 
The  public  consultation  dataset  is  composed  of  qualitative  consultations  as  well  as 
quantitative  data.  For  the  quantitative  data  coming  from  38  questions,  the  evaluation 
team  used a descriptive  statistical  analysis.  It entailed a cross-tabulation  of variables to 
check whether there were differences across different groups of respondents; frequencies 
of  satisfaction,  revealing  trends  in  the  degree  to  which  the  Directive  has  achieved  its 
intended goals; and averages in terms of responses across respondents. 

Robustness of results 

The evaluation was designed to ensure the robustness of the data and analytical results of 
the supporting studies. However, there are some limitations to the robustness of certain 
data identified in the supporting study. Overall, evidence was structured according to the 
judgment criteria (JC) and indicators presented in the evaluation matrix (Annex III). As 
not  all sources of  evidence are  equally robust,  consideration was  given as to  when  and 
how the evidence was collected and whether there was any bias or uncertainty in it.  

The study team used triangulation of data from the different data collection activities as a 
method to  arrive at  robust  and evidence-based results that could  be confirmed by more 
than one source. The evaluation triangulated at three different levels: 

  Triangulation  of  data:  primary  data  from  stakeholder  consultation  activities  and 

secondary data derived from the desk research. 

  Triangulation  of  respondent  groups:  NCPs,  patient  representatives,  national  and 

regional authorities, healthcare providers, the medical community, etc.  

  Triangulation  of  methods:  desk-based  research,  surveys,  interviews,  public 

consultation, workshops, case studies. 

There were several cases where the public and targeted consultation and literature review 
did  not  produce  enough  robust  evidence  to  provide  a  complete  answer  to  evaluation 
questions, including 

- 

- 

- 

limited  evidence  to  assess  the  functioning  of  the  system  of  prior  notification  in 
the reduction of administrative burden and improved patient experience (EQ 7); 
limited quantitative data on cross-border cooperation in healthcare (e.g. meetings, 
events, exchange of information/best practices, etc.); 
important data gaps on patient mobility and the use of the Directive compared to 
the Regulations and other parallel mechanisms in border regions (EQ 8); 

-  no  quantitative  data  on  the  use  of  the  Directive  by  different  patient  groups 

(EQ10); 

-  not enough evidence on the effectiveness of the Commission in supporting MS in 
cooperating  in  the  development  of  diagnosis  and  treatment  of  rare  diseases  by 
making health professionals  aware of the possibilities offered by the Regulation 
on the coordination of social security systems 883/2004 for the referral of patients 
to other Member States; 

62 

 
-  no evidence regarding the reimbursement of cross-border healthcare provided by 
foreign doctors treating patients  in  the state of the patients’ insurance affiliation 
(EQ 26); 

- 

- 

insufficient  information  to  assess  the  extent  to  which  the  Directive  is  coherent 
with the Directive on the recognition of professional qualifications with regard to 
the regulated professions in the healthcare sector (EQ36); 

insufficient  information  to  assess  whether  there  have  been  any  problems  with 
regard to the application of the professional rules for the health service provider 
(in  the  context  of  a  temporary  and  occasional  cross-border  service  provision) 
(EQ37). 

In addition to these gaps, a general limitation that can be highlighted is that, despite the 
Directive’s impact on all Member States, little research has been conducted on the topic 
and there is insufficient comparative research across multiple Member States. Therefore, 
there  are  important  gaps  in  the  knowledge  and  evidence  available,  with  most  research 
dating back several years.  

Quality of analysis  

To  prepare  the  dataset  for  analysis  of  the  public  consultation  responses,  the  evaluation 
team  assessed  the  quality  of  the  data  obtained.  This  data  clean  up  included  a  missing 
values  clean-up,  a  test  for  consistency  and  plausibility  a  clean-up  of  cases  with  high 
partial non-response. None of the answers were moderated and therefore all contributions 
were taken into account in the analysis. The cleaned-up dataset became the basis for the 
analysis. 

The  study  team  merged  and  compared  data  sets.  The  study  team  quality-reviewed  the 
public consultation dataset to check whether different respondents’ assessments could be 
analysed in combination to provide a more detailed analysis of views and perceptions of 
patient’s  rights  in  terms  of  cross-border  healthcare.  The  following  aspects  were 
integrated  into  their  approach:  comparing  and  contrasting  different  respondent  groups, 
meaning  that  there  is  a  risk  that  groups  that  bear  no  resemblance  or  relevance  to  each 
other.  This  could  be  compared  as  if  they  were  in  fact  similar  and  as  such,  that  their 
responses  were  comparable,  without  taking  into  account  their  fundamental  differences. 
Therefore, a minimum set of meta-data must be present in order to judge aspects such as, 
respondent sector (e.g. whether the respondents were receivers of the healthcare services 
or  healthcare  providers/organisers/payers).  In  sum,  merging  data  to  provide  a  basis  for 
analysis  must  take  place  under  strict  conditions  of  quality  assurance,  since  the  data 
quality may vary (e.g. number of respondents from a particular group or to a particular 
question, etc.). 

Critical assessment of work carried out by external contractor 

The work carried out by the contractors is of good quality in the light of the evaluation’s 
time  constraints  and  the  limitations  described.  There  is  a  logical  progression  from  the 
evidence  gathered  to  the  analysis  and  conclusions.  The  Commission  services  agree 

63 

 
broadly with the conclusions presented as these address the key issues arising from the 
evaluation.  

64 

 
 
 
 
 
ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

The table below presents the final Evaluation Questions Matrix (EQM), outlining the evaluation questions assessed as part of the study, judgment criteria, 
quantitative and qualitative indicators, the quality of the evidence and the data sources. For the assessment of the quality of the evidence, the study team 
has applied the following grading system: 

  High: The evidence collected allows to confidently answer the evaluation question. 

  Moderate: The evidence collected only allows to have moderate confidence in the answer to the evaluation question. 

  Low: The evidence presented only allows to have limited confidence in the answer to the evaluation question. 

  Very low: The evidence presented only allows to have little confidence in the answer to the evaluation question. 

Evaluation Questions Matrix 

EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

Effectiveness 
2.  To  what  extent  has  the 
Directive contributed to 
removing  obstacles  to 
access  to  healthcare  in 
another  Member  State 
and  to  free  movement 
of  health  services  more 
generally in practice? 

the  Directive 
a.  Since 
entered 
force,  what 
factors  help  or  hinder  such 
access and movement? 

into 

JC 2.1: The Directive has 
contributed  to  removing 
obstacles 
to 
healthcare in another MS 

to  access 

JC 2.2: The Directive has 
free 
contributed 
health 
movement 
services  

of 

to 

 

Incoming  and  outgoing  patients 
per MS per year 

the 

Directive 

  Evidence  on  existing/overcome 
obstacles to access CBHC; ways in 
which 
has 
contributed  to  free  movement  of 
health  services;  other  factors  that 
to 
have  helped/hindered  access 
CBHC  and  movement  of  health 
services 

JC 2.3: There are factors 
that  have  helped  or 
hindered such access and 

  Stakeholders’ 

on 
clarity of responsibilities regarding 
CBHC;  clarity  of  reimbursement 

perceptions 

65 

to 

responded 

Rating of the evidence: Moderate 
There  are  gaps  and  limitations  in  the  data 
presented  in  the  annual  patient  mobility  reports. 
The  data  from  2015  to  2018  is  incomplete,  with 
reference  year  2019  being  the  first  time  that  all 
countries 
for 
information.  Nonetheless,  even  in  2019  many 
countries  were  only  able  to  provide  limited 
information  and  not  all  countries  differentiated 
between 
the 
Coordination Regulations or under bilateral cross-
border agreements.  
This data limitation was caveated through the use 
the 
of 

the  Directive, 

cases  under 

quantitative 

presented 

request 

data 

the 

in 

of 

healthcare 

Literature review 
Survey 
providers 
Interviews  of  the  European 
Commission’s 
officials, 
national  authorities  (CBHC 
expert 
ERNs, 
group), 
healthcare 
patients, 
providers/ 
professionals, 
healthcare insurers 
Public consultation  
Virtual workshop  

 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

movement 

that 

been 

3.  How  effective  has  the 
in 
Directive 
ensuring 
clear 
information  is  available 
and 
to 
accessible 
patients  about  cross-
border  healthcare  from 
providers 
healthcare 
National 
the 
and 
Contact Points? 

a.  To  what  extent  are 
citizens aware of their rights 
and  entitlements  to  be  able 
to  make 
informed 
an 
choice? 

b.  What  factors  hinder  the 
provision  of 
and 
transparent  information  to 
patients? 

clear 

JC 3.1: The Directive has 
contributed  to  ensuring 
that  clear  information  on 
cross-border  healthcare 
is 
and 
available 
to  patients 
accessible 
from 
healthcare 
providers and NCPs 

JC  3.2:  Citizens  are 
aware  of  their  rights  and 
entitlements  on  cross-
border  healthcare  to  be 
able to make an informed 
choice 

JC 3.2: There are factors 
hindering  the  provision 
of  clear  and  transparent 
to  patients 
information 
by  MS 
(healthcare 
providers and NCPs) 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

further 

interviews  and 

In 
through 

years  2018-2020”. 

Commission’s report on “Data on patient mobility 
under  Directive  2011/24/EU:  Trend  report 
addition, 
reference 
targeted 
qualitative  data  collected 
the  workshop 
questionnaires, 
discussion  provided 
and 
evidence 
validation of the findings.  
Rating of the evidence: High 
The  NCP  websites  of  all  EU  MS,  Norway, 
Iceland  and  Liechtenstein,  were  analysed.  There 
were  no  limitations  in  the  data  collected  and  the 
methodological  approach  adopted  was  the  same 
approach used in the 2015 Evaluative study on the 
cross  border  healthcare  Directive  (2011/24/EU) 
and  the  2018  Study  on  enhancing  cross-border 
health services. This ensured comparability of the 
data. 
In  addition,  triangulation  of  evidence  collected 
from  the  different  data  collection  tools  (desk 
consultation, 
research, 
workshop)  and 
stakeholders  provides  high 
confidence on the validity results obtained. 

interviews, 

public 

analysis  of  NCPs 

Literature review 
Web 
websites 
Interviews  with  patients, 
national  authorities  (CBHC 
expert  group),  healthcare 
providers/ professionals 
Information 
to 
request 
national patient ombudsmen 
Virtual workshop  
Public consultation 

rules on CBHC costs 

  Extent  and  clarity  of  information 
provision  by  NCPs  and  healthcare 
providers (rights and entitlement) 

and 

quality 

provided 

  Accessibility 
of 
information 
to 
citizens/patients by MS (healthcare 
providers  and  NCPs)  on  cross-
border  healthcare,  incl.  on  their 
rights and entitlements 

 

Improvements  to  the  information 
provided  to  patients  by  NCPs, 
including their websites 

  Citizens/patients’ 

of 
awareness of their rights on cross-
border healthcare  

level 

  Factors  hindering  the  provision  of 
clear  and  transparent  information 
to 
by  MS 
(healthcare providers and NCPs)  

citizens/patients 

4.  To  what  extent  has  the 
information  provided  to 

JC 4.1: Transparency and 
of 
comparability 

  Extent  and  clarity  of  information  Rating of the evidence: High 

As per EQ3. 

Literature review 
Web 

analysis  of  NCPs 

66 

 
 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

under 

patients 
the 
Directive  contributed  to 
transparency 
enhanced 
and  comparability  of 
healthcare 
(regarding 
safety,  quality,  costs, 
etc.) 
times, 
waiting 
across the EU?152 

a.  To  what  extent  have 
Member  States  made 
the standards for quality 
and 
safety  of  care, 
applicable standards for 
professionals 
health 
transparent 
for  EU 
citizens?153 

5.  To  what  extent  have  the 
National  Contact  Points 
implemented 
consultation 
arrangements  with  patient 
organisations, 
healthcare 
providers  and  healthcare 
insurers  and  how  effective 
have these been? 

as 

healthcare 
regards 
safety  standards,  quality, 
costs, waiting times have 
been enhanced across the 
EU since the adoption of 
the Directive 

citizens  on 

JC  4.2:  MS  (healthcare 
providers 
and  NCPs) 
provide clear information 
to 
their 
standards  for  quality  and 
safety of care, as  well as 
applicable  standards  for 
health professionals 

JC  5.1:  NCPs  have 
implemented 
consultation 
with 
arrangements 
patient 
organisations, 
healthcare  providers  and 
healthcare insurers 
Information 
5.2: 
JC 
collected 
through 
consultation  of  patient 
organisations,  healthcare 
providers  and  healthcare 
insurers  has  helped  to 

provision  by  NCPs  and  healthcare 
providers  on  standards  for  quality 
and  safety  of  care,  as  well  as 
applicable  standards  for  health 
professionals 

improvements 
provided 

  Evidence  on 
to 
on 
information 
transparency  and  comparability  of 
healthcare 
standards, 
safety 
quality, costs, waiting times across 
the  EU  since  the  adoption  of  the 
Directive.  

  Evidence 

on 

with 

consultation 
arrangements 
patient 
organisations, healthcare providers 
insurers 
and 
implemented  by  NCPs  (incl.  ways 
in  which  the  information/opinions 
collected were used) 

healthcare 

websites 
Public consultation 
Interviews  of  the  European 
Commission’s 
officials, 
national  authorities  (CBHC 
expert  group),  healthcare 
professionals, 
providers/ 
healthcare insurers, patients 
Information 
to 
national patient ombudsmen 

request 

of 

another 
Subject 
commissioned 
study: 
Mapping  NCP  consultation 
key 
arrangements  with 
stakeholders:  draft  analytical 
report  (Study  on  Enhancing 
implementation of the Cross-
Border  Healthcare  Directive 
2011/24/EU to ensure patient 
rights in the EU)  

a  mapping 

exercise  on 

Rating of the evidence: High 
The  assessment  was  based  on  evidence  provided 
consultation 
by 
patient 
between  NCPs 
arrangements 
organisations,  healthcare  insurers,  and  healthcare 
providers  conducted  by  Ecorys.  The  evidence  of 
that  study  was  collected  through  1)  written 
inquiries with NCPs and 2) online questionnaires 
with  patient  organisations,  healthcare  insurers, 
and healthcare providers. 

and 

152 The wording of this question was slightly amended. The original question in the ToR read: “To what extent has the enhanced transparency and comparability of healthcare (with regard 

to safety, quality, costs, waiting times etc.) been enhanced across the EU?” 

153 In the ToR, this sub-question was presented as part of EQ3. However, the study team considered it was more appropriate to answer it together with EQ4. 

67 

 
 
 
 
                                                 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

Rating of the evidence: Moderate 
As per EQ2. 
No quantitative data available on the continuity of 
care  between  MS  after  cross-border  treatment 
across  the  EU  from  2012  to  2020;  therefore  the 
indicators was excluded. 

of 

healthcare 

Literature review 
Survey 
providers 
Interviews  with  CBHC 
expert 
patient 
group, 
organisations, 
healthcare 
providers/professionals, 
healthcare insurers 
Public consultation  

regard 

to 
6.  With 
administrative 
procedures 
for  cross-border  healthcare 
and  reimbursement  has  – 
and  how  –  the  Directive 
proven  to  be  effective  to 
ensure  that  these  are  based 
on 
non-
objective, 
criteria 
discriminatory 
which  are  necessary  and 
proportionate 
the 
objective to be achieved? 
a.  To  what  extent  did  the 
Directive  ensure  continuity 
of  care  between  Member 
States 
cross-border 
treatment? 

after 

to 

for 

services 

improve 
provided by NCPs  
JC 6.1: There are several 
ways 
the 
in  which 
Directive has contributed 
that 
ensuring 
to 
administrative 
procedures 
cross-
border  healthcare  and 
reimbursement  are  based 
non-
objective, 
on 
discriminatory 
and 
proportionate criteria 
JC 6.2: The Directive has 
ensured  continuity  of 
care  between  Member 
States  after  cross-border 
treatment 

on: 

with 

Quantitative 
prior 
data 
authorisation procedures per MS; prior 
vs non-prior authorisations requests per 
MS (received, refused, and authorised); 
processing  time  for  reimbursement  of 
access 
costs; 
citizens/patients’ 
to/satisfaction 
information 
available  on  waiting  times  for  cross-
border healthcare requests. 
Qualitative  evidence  on  administrative 
procedures  followed  by  MS  for  cross-
border  healthcare  and  reimbursement 
(e.g. waiting times, assessment criteria, 
etc.);  criteria  applied  by  MS 
in 
administrative  procedures  for  cross-
border  healthcare  and  reimbursement; 
ways  in  which  procedures  and  criteria 
applied  changed  since  the  adoption  of 
the  Directive; 
to  which 
citizens/patients  are  provided  with 
information on waiting times; extent to 
which  continuity  of  care  has  been 
ensured  by  MS  after  cross-border 
treatment 
Indicators 
analysis: 

excluded 

extent 

from 

the 

Quantitative  data  on  the  continuity  of 
care  between  MS  after  cross-border 
treatment  across  the  EU  from  2012  to 
2020 

68 

 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

7.  To  what  extent  have 
Member  States  applied  the 
system  of  voluntary  prior 
notification  on  the  amount 
to  be  reimbursed  and  the 
cost  of  treatment  and  did  it 
the  administrative 
reduce 
burden?  What  was 
the 
patient experience? 

JC  7.1:  A  number  of 
Member  States 
have 
the  system  of 
applied 
prior 
voluntary 
notification 
the 
amount to be reimbursed 
and the cost of treatment 

on 

JC  7.2:  The  system  of 
voluntary 
prior 
notification  has  reduced 
the administrative burden 
on  patients,  healthcare 
providers 
health 
insurers 

and 

8.  To  what  extent  has  the 
Commission 
encouraged 
cooperation  in  cross-border 
between 
healthcare 
neighbouring  countries  and 
border  regions  as  provided 
by  the  Directive?  Can  the 
Directive  be  credited  with 
cross-border 
increased 
cooperation 
in  healthcare 
and if yes, how? 

JC  8.1: The  Commission 
encouraged 
has 
in 
cooperation 
cross-
healthcare 
border 
neighbouring 
between 
countries 
border 
and 
regions 

JC 8.2: There are several 
ways 
the 
in  which 
Directive has contributed 
to  increased  cross-border 
cooperation in healthcare 

of 

system 

voluntary 

Quantitative  data  on  the  application  of 
the 
prior 
notification  (number  of  MS  having 
introduced the system) 
Stakeholders’  perceptions  on 
the 
effects  of  the  prior  notification  system 
the  administrative  burden  of 
on 
patients,  healthcare  providers  and 
health insurers 
Indicators 
analysis: 

excluded 

from 

the 

Quantitative data  on prior notifications 
(where  implemented)  per  MS  on  the 
amount  to  be  reimbursed  and  the  cost 
of treatment 
Qualitative  evidence  on  the  effects  of 
the  prior  notification  system  on  the 
administrative  burden  of  patients, 
healthcare 
health 
insurers 
the 
Qualitative 
evidence 
Commission’s  actions 
to  encourage 
cooperation  in  cross-border  healthcare 
and results of these actions 

providers 

and 

on 

increased  cooperation 

Evidence  on  the  extent  to  which  there 
is 
in  cross-
border  healthcare  and  how  it  was 
achieved 

Indicators 
analysis: 

excluded 

from 

the 

Quantitative  data  on  cross-border 
(e.g. 
cooperation 

healthcare 

in 

69 

Rating of the evidence: Low 
Very limited quantitative data available relating to 
the  use  and  effects  of  the  system  of  voluntary 
prior  notification  on  administrative  burden  and 
patient  experience  (two  indicators  had  to  be 
excluded from the analysis for this reason). 
To the extent possible, the answer to this EQ was 
based  on  stakeholders’  perceptions  collected 
through interviews  with representatives from MS 
applying the system of prior notification. 

Literature review 
Interviews 
of 
authorities 
group) 

national 
(CBHC  expert 

Subject 
another 
of 
commissioned  study:  Cross 
Border  Patient  Mobility  in 
Selected EU Regions 
Literature review 
Public consultation 

Rating of the evidence: Moderate 

to 

encourage 

Limited  data  available  on  concrete  actions 
cross-border 
implemented 
cooperation  in  healthcare,  as  well  as  important 
data  gaps  on  patient  mobility  and  the  use  of  the 
Directive  compared  to  the  Regulations  and  other 
parallel mechanisms in border regions (see EQ2).  

These 
limitations  were  addressed  by  using 
evidence  from  the  public  consultation  and  the 
findings  of  the  AEBR  research  project  on  Cross 
Border  Patient  Mobility  as  well  as  with  broader 
literature  review  such  as  Bobek,  J.  et  al.  (2018) 

 
 
 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

meetings, 
events, 
information/best practices, etc.) 

exchange 

of 

study  on  Cross-Border  Cooperation  “Capitalising 
on  existing  initiatives  for  cooperation  in  cross-
border regions”. 

and 

9.  How  effective  were  the 
Directive 
the 
Directive 
Implementing 
2012/52/EU  to  regulate  the 
recognition  of  prescriptions 
across EU borders? 
a.  What 

if 
factors, 
to 
any,  continue 
the 
prevent 
of 
recognition 
in 
prescriptions 
another  Member 
State? 

the 

JC  9.1:  The  Directive 
and 
Implementing 
Directive  were  effective 
the 
in 
regulating 
recognition 
of 
prescriptions  across  EU 
borders 

JC9.2:  There  are  factors 
that  continue  to  prevent 
the 
of 
recognition 
prescriptions  in  another 
MS 

  Quantitative data on: 

- 

- 

 The number of foreign prescription 
presented in the EU 
the recognition rate of prescriptions 
across EU borders 

  Qualitative evidence on: 

-  ways  in  which  the  Directive  and 
Implementing  Directive  regulated 
the  recognition  of  prescriptions 
across EU borders 

-  extent  to  which  these  rules  are 
being  applied  across  the  EU,  incl. 
challenges/barriers 
in 
applying them 
factors  that  continue  to  prevent  the 
recognition  of  prescriptions 
in 
another MS 

faced 

- 

Literature review 
Interviews/surveys  of 
the 
Commission’s 
European 
officials,  national  authorities 
group), 
(CBHC 
expert 
healthcare 
providers, 
healthcare insurers 
Case 
pharmacist targeted survey) 
Public consultation  

(including 

studies 

to 

sent  by 

responses 

submitted 

follow-ups 

Rating of the evidence: Low 
The robustness of the findings of the prescription 
case study is limited, as the analysis is based on a 
total  of  158 
the 
questionnaires  and  948  prescription  observations 
(compared  to  996  questionnaires  and  11,952 
in  2012).  Despite 
prescription  observations 
several 
the  national 
associations  at  the  request  of  the  PGEU  to 
encourage  a  higher  response  rate,  pharmacists’ 
engagement was very low. This was likely due to 
the  difficult  time  in  which  the  survey  was 
implemented. Indeed, representatives of the sector 
that  pharmacists  have  been  under 
indicated 
the  pandemic, 
considerable  pressure  under 
cross-border 
vaccines, 
delivering 
prescriptions  are  very  marginal 
for  most 
pharmacies.  
To  complement  the  limited  quantitative  data, 
where  possible,  additional  quantitative  and 
qualitative  data  was  collected  via  desk  research 
(e.g.,  on  total  prescriptions  dispensed  across  the 
EU  and  number  of  pharmacies).  While  the  low 
response  rate  affect 
the 
the 
quantitative analysis, the case study still provides 
useful 
problems 
on 
associated  with 
recognition  of 
the  mutual 
prescriptions across the EU.  

robustness  of 

information 

existing 

while 

10.  Are 
patient  groups 

there 

specific 
that  are 

are 
JC  10.1:  There 
specific  patient  groups 

Qualitative  evidence  on  patient  groups 
that have benefited more / less from the 

Rating of the evidence: Moderate 
No  quantitative  data  available  on  the  use  of  the 

Literature review 
Interviews  of  CBHC  expert 

70 

 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

particularly  benefiting  from 
the patients’ rights in cross-
border  healthcare  as  set  out 
in the Directive? 

particularly 
that 
are 
benefiting 
the 
from 
patients’  rights  in  cross-
border healthcare 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

in 

rights 

patients’ 
cross-border 
healthcare  since  the  adoption  of  the 
Directive and reasons for this. 
Stakeholders’  perceptions  on  why  / 
how  specific  patient  groups  have 
benefited more / less from the patients’ 
rights in cross-border healthcare. 
Indicators 
from 
analysis: 

excluded 

the 

limitation  was  addressed 

Directive by different patient groups. 
This 
the 
triangulation  of  qualitative  data  collected  during 
interviews, the public consultation and the review 
of  existing  and/or  related  literature  on  the  topic 
(i.e.  SOLVIT  survey,  ANEC  survey,  EXPH 
study, EPHA report etc.). 

through 

group,  healthcare  providers/ 
professionals, 
healthcare 
insurers, patient 
Public consultation 

rare 

to  support 

11.  How  effective  was  the 
Directive 
the 
diagnosis  and  treatment  of 
patients  with 
and 
complex  diseases,  including 
through  virtual  consultation 
panels?  To  what  extent  is 
of 
absence 
the 
reimbursement 
for 
professionals 
healthcare 
discussing  cases 
the 
(in 
the  patient) 
absence  of 
impacted on the provision of 
virtual  panels  and  on  the 
care for these patients? How 
be 
can 
improved;  what  kind  of 
reimbursement  mechanism 
would  be  adequate 
for 
similar situations? 

situation 

the 

JC  11.1:  There 
are 
several  ways  in  which 
has 
Directive 
the 
supported  the  diagnosis 
and  treatment  of  patients 
with  rare  and  complex 
diseases 

JC  11.2:  The  absence  of 
reimbursement 
for 
healthcare  professionals 
discussing  cases  (in  the 
absence  of  the  patient) 
the 
has 
impacted  on 
provision 
virtual 
panels  and  on  the  care 
for patients with rare and 
complex diseases 

of 

JC  11.3:  There  are  ways 
in  which  support  for  the 
diagnosis  and  treatment 
of  patients  with  rare  and 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
surveys, 
consultation, 
workshop)  and 
stakeholders  provides  high 
confidence on the validity results obtained. 

interviews, 

public 

Quantitative  data  on  patient  groups 
benefiting from cross-border healthcare 
across the EU from 2012 to 2020 
Quantitative data on: 

-  ERNs  established,  members  and 
affiliated  partners  represented  in 
them 

-  Rare/complex  diseases  covered  by 

ERNs 

-  MS  with  healthcare  providers  in 

ERNs  

-  Patients  treated  by  members  of 

ERNs  

-  ERN virtual consultation panels  
-  healthcare 

professionals 

participating in ERNs 

-  Hospitals  and  healthcare  providers 
participating in ERNs (total and per 
MS)  

-  ERN registries established 

Evidence on: 

-  ways  in  which  the  Directive  has 
and 

supported 

diagnosis 

the 

71 

by 

the 

Literature review 
Data 
provided 
European Commission’s 
Survey of ERN members 
Interviews  of  ERNs  patient 
representatives, 
industry, 
researchers 
Public consultation 
Virtual workshop  

 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

complex 
diseases, 
including  through  virtual 
consultation  panels,  can 
be improved 

12.  How  effective  was  the 
knowledge  sharing  on  rare 
diseases 
complex 
and 
healthcare 
EU 
among 
professionals 
to 
ERNs? 

thanks 

12.1:  Knowledge 
JC 
sharing 
activities 
organised  by  ERNs  have 
healthcare 
supported 
professionals 
least 
(at 
within  the  networks)  in 
diagnosing  and  treating 
patients  with  rare  and 
complex diseases 

treatment  of  patients  with  rare  and 
complex diseases 

-  extent of participation of healthcare 
professionals in cross-border virtual 
consultation panels, and factors that 
enable/hinder participation 

-  ways  in  which  the  cross-border 
diagnosis  and  the  effects  of  the 
absence  of  reimbursement  on  the 
provision of virtual panels  

Quantitative data on: 

-  Number  of  educational  activities 
accruing  educational  credits,  aimed  at 
healthcare  professionals  organised  by 
the ERN 

-  Number  of  new  clinical  practice 
guidelines written by the ERN 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
consultation, 
surveys, 
workshop)  and 
stakeholders  provides  high 
confidence on the validity of results obtained. 

interviews, 

public 

-  Number  of  educational  activities  not 
accruing  credits  aimed  at  healthcare 
professionals  delivered  by  the  ERN 
healthcare 
coordination 
provider members of the ERN 

team 

or 

-  Number  of  congresses/  conferences/ 
meetings  at  which  the  ERN  activities 
and results were presented 

in 

-  Number  of  accepted  peer-reviewed 
publications 
journals 
regarding  diseases  within  the  scope  of 
the  ERN  and  which  acknowledge  the 
ERN reviewed publications 

scientific 

72 

by 

the 

Literature review 
Data 
provided 
European Commission’s 
Survey of ERN members 
Interviews  of  ERNs  patient 
representatives, 
industry, 
researchers 
Public consultation 
Virtual workshop  

 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

13.  What  has  been 
the 
impact  of  the  ERNs  on  the 
research  on  rare  and  low 
prevalence 
complex 
and 
diseases? 

JC  13.1:  There  ERNs 
have  had  an  impact  on 
the  research  on  rare  and 
low 
and 
prevalence 
complex diseases 

Qualitative  evidence  on  if  /  how  the 
sharing  activities  have 
knowledge 
supported  healthcare  professionals  in 
diagnosing  and  treating  patients  with 
rare and complex diseases 

Stakeholders perceptions on the effects 
of  the  knowledge  sharing  activities  on 
healthcare professionals’ diagnosis and 
treatment  of  patients  with  rare  and 
complex  diseases  (e.g.  in  terms  of 
enhanced knowledge among healthcare 
professionals) 

Quantitative data on: 

of  Clinical  Practice 
-  Number 
Guidelines  and  other  types  of  Clinical 
Decision  Making  Tools  adopted  for 
diseases within the scope of the ERN 

-  Number  of  new  clinical  practice 
guidelines written by the ERN 

- Number of Clinical Decision Making 
Tools (clinical consensus statements or 
consensus recommendations) 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained. 

Literature review 
Interviews  of  ERNs  patient 
representatives, 
industry, 
researchers 
Public consultation  
Virtual workshop  

-  Number  of  clinical 
observational 
within the ERN 

prospective 

trials  and 
studies 

in 

-  Number  of  accepted  peer-reviewed 
publications 
journals 
regarding  diseases  within  the  scope  of 
the  ERN  and  which  acknowledge  the 
ERN reviewed publications 

scientific 

73 

 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

14. To what extent is the use 
of  ERNs  and  knowledge 
sharing  effective  to  allow 
patients with rare diseases to 
receive 
and 
need, 
treatment 
including 
potentially 
healthcare  in  another  EU 
Member State? 

diagnosis 
they 

JC  14.1:  The  use  of 
ERNs  and  knowledge 
sharing  have  allowed 
rare 
with 
patients 
diseases 
receive 
to 
diagnosis  and  treatment 
they 
including 
potentially  healthcare  in 
another MS 

need, 

Qualitative  evidence  on 
impact  of 
ERNs  on  research  on  rare  and  low 
prevalence and complex diseases 
Stakeholders perceptions on the impact 
of  the  ERNs  on  the  research  on  rare 
and 
low  prevalence  and  complex 
diseases  (e.g.  in  terms  of  volume, 
quality  and  coverage  of  research,  and 
importance of ERNs registries)  

Quantitative  data  on  the  use  of  ERNs 
and  knowledge  sharing  activities  by 
healthcare 
(see 
quantitative indicators in EQ12) 

professionals 

Qualitative evidence on ways in which 
the  use  of  ERNs  and  knowledge 
sharing activities have allowed patients 
with  rare  and  complex  diseases  to 
receive  diagnosis  and  treatment  they 
need,  including  potentially  healthcare 
in another MS 

Stakeholders’  perceptions  on 
the 
impact  of  ERNs  and  knowledge 
sharing  activities  on  granting  patients 
with  rare  diseases  with  the  diagnosis 
and treatment they need 

15.  How  effectively  has  the 
supported 
Commission 
in 
Member 
cooperating 
the 
development  of  diagnosis 
rare 
and 
diseases  by  making  health 

States 
in 

treatment 

of 

15.1: 

The 
JC 
has 
Commission 
cross-border 
supported 
the 
cooperation 
development 
of 
diagnosis  and  treatment 
rare  diseases  by 
of 

in 

health 

Quantitative data on actions undertaken 
by 
to 
the  European  Commission 
increase 
professionals’ 
awareness of tools and rules applicable 
to  cross-border  cooperation 
the 
and 
development 
treatment  of  rare  diseases,  as  well  as 

diagnosis 

of 

in 

74 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained. 

Literature review 
Interviews  of  ERNs  patient 
representatives, 
industry, 
researchers 

Public consultation  
Virtual workshop  

Rating of the evidence: Moderate 
Limited  evidence  on  concrete  actions  undertaken 
by the European Commission in supporting MS in 
cooperating  in  the  development  of  diagnosis  and 
treatment  of  rare  diseases  by  making  health 
professionals aware of the possibilities offered by 
the  Regulation  883/2004  for  the  referral  of 

Literature review 
Targeted survey of ERNs 
Interviews  of  ERNs,  CBHC 
expert 
patients, 
group, 
researchers, industry 
Public consultation  
Virtual workshop  

 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

professionals  aware  of  tools 
available  to  them  at  Union 
the 
(in  particular 
level 
Orphanet  database  and  the 
ERNs)  and  the  possibilities 
offered  by  the  Regulation 
883/2004  for  the  referral  of 
patients  to  other  Member 
States? 

16.  Has 
the  Directive 
triggered  any  unexpected  or 
unintended effects? 

making 
professionals aware of: 

health 

- 

- 

and 

tools  available 
to  them  at  EU 
level 
(e.g. 
Orphanet 
database 
ERNs) 
possibilities 
offered  by  the 
Regulation 
883/2004 
for 
the  referral  of 
patients  to  other 
Member States? 
JC  16.1:  The  Directive 
has had some unexpected 
or unintended effects 

data  on 
the  health  professionals’ 
awareness and use of the tools and the 
referral of patients to another MS 

Qualitative evidence on ways in which 
the  European  Commission  has  made 
healthcare  professionals  aware  of  the 
tools available at Union level 

Stakeholders’  perceptions  on  the  level 
of  awareness  and  use  of  healthcare 
professionals  of  the  tools  available  for 
the  diagnosis  and  treatment  of  rare 
diseases 

Quantitative  data  collected  for  other 
EQs  on  patients’  mobility  across  the 
EU  and  cross-border  healthcare  (e.g. 
EQ2) 

Qualitative 
any 
evidence 
unexpected or unintended effects of the 
Directive  (vis-à-vis  the  objectives  it 
was meant to achieve) 

on 

Stakeholders’  perceptions  on  any 
unexpected or unintended effects of the 
Directive 

patients to other Member States. 
This limitation was addressed through stakeholder 
consultation,  including  the  ERNs  targeted  survey 
which addressed that specific question. 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

Literature review 
of 
Interviews/surveys 
European 
Commission’s 
officials,  national  authorities 
(CBHC 
group), 
expert 
ERNs,  healthcare  providers/ 
healthcare 
professionals, 
insurers, 
researchers, 
industry 
Public consultation  

Efficiency 
17.  To  what  extent  are  the 
and 
justified 
costs 
proportionate 
the 
effects  observed/objectives 

given 

JC  17.1:  The  costs  are 
and 
proportionate 
considering 
justifiable 
identified 
the 

to 

Quantitative data on: 

-  reimbursement  claims  received  and 
in 
granted  for  healthcare  provided 

Rating of the evidence: Low 
Limitations of the patient mobility data (see EQ2) 
Limited  quantitative  data  on  the  administrative 
costs  related  to  applying  the  Directive  for  MS, 

Literature review 
of  European 
Interviews 
Commission’s 
officials, 
national  authorities  (CBHC 

75 

 
 
 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

achieved/benefits obtained? 

benefits/achievements  of 
the Directive. 

18.  How  proportionately 
the 
the  costs  of 
were 
Directive  borne  by  different 
groups 
stakeholder 

JC  18.1:  The  costs  of 
the 
implementing 
Directive 
were 
proportionately  borne  by 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

another MS 
- aggregate amount reimbursed per MS 
per  year  (for  CBHC  with  and  without 
prior authorisation) 
-  administrative  waiting 
to 
process requests for prior authorisation 
and reimbursement 
- 
patient 
administrative procedures 
Stakeholders’ perceptions on: 

complaints 

about 

times 

- administrative  burden  on  patients, 
healthcare  providers  and  healthcare 
insurers (n.b. administrative burden to 
be  defined  as  additional  to  national 
situations) 

Indicators 
analysis: 

excluded 

from 

the 

Quantitative data on: 

(FTEs) 
for 

for 
-  administrative  costs 
handling 
prior 
applications 
authorisation, and reimbursement (incl. 
translation costs, assimilation to health 
system and calculation of amount to be 
reimbursed) 
-  other  administrative  costs  (FTEs)  re. 
compliance, monitoring and reporting 
-  incoming  and  outgoing  patients  per 
MS per year 
Comparison  of  qualitative  data  on 
administrative costs and benefits of the 
Directive 
different 
stakeholder groups, including: 

borne 

by 

76 

group), 

expert 
healthcare 
healthcare insurers, ERNs 
Public consultation  

patients, 
providers, 

European  Commission  and  other  stakeholders. 
There  have  been  several  concurrent  research 
activities  on  this  topic  area  (or  in  related  topics), 
which may have led to some stakeholder fatigue.  
These  limitations  have  been  addressed  through 
interviews  and 
qualitative  data  collected 
literature 
through  desk  review  of  available 
including  the  European  Commission’s  report  on 
patient  mobility  (“Trend  report  reference  years 
2018-2020”)  and  Ecorys  and  Spark  2021 
and  Analysis  of  Administrative 
Mapping 
Procedures  (Study  on  Enhancing  implementation 
of 
the  Cross-Border  Healthcare  Directive 
2011/24/EU to ensure patient rights in the EU.)  

in 

Rating of the evidence: Low 
The  limited  data  available  did  not  allow  to 
calculate  or  estimate  aggregate  costs  across 
the  different 
different  cost  categories 

for 

Literature review  
of  European 
Interviews 
Commission’s 
officials, 
national  authorities  (CBHC 

 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

considering  the  distribution 
of the associated benefits? 

stakeholder 
different 
the 
groups  considering 
benefits  experienced  by 
each group. 

in  costs 

19.  If  there  are  significant 
differences 
(or 
benefits)  between  Member 
States,  what 
is  causing 
them? 
How  do  these  differences 
link to the intervention? 

costs 

is 
19.1:  There 
JC 
significant  variability  in 
levels  of 
and 
benefits 
by  Member 
State. 
JC  19.2:  The  reasons 
why 
significant 
differences  (should  they 
exist)  can  be  identified, 
as  well  as  how  they  link 
to the intervention 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

- national authorities (including NCPs) 
- patients 
Indicators 
analysis: 

excluded 

from 

the 

Quantitative  data  on  administrative 
the  Directive  borne  by 
costs  of 
different stakeholder groups 
Degree  of  proportionality  of  costs  and 
benefits by stakeholder group 

Analysis of quantitative and qualitative 
data relating to administrative costs per 
Member State  
Qualitative  data  on 
influence 
achieved by MS (see EQ20) 

that 
the  costs  and  benefits 

factors 

expert 
ERNs 

group), 

patients, 

Literature review  
of  European 
Interviews 
Commission’s 
officials, 
national  authorities  (CBHC 
patients, 
expert 
group), 
providers, 
healthcare 
healthcare insurers, ERNs 

thus  prevented 

stakeholder  groups  and 
the 
assessment  of  whether  the  costs  of  the  Directive 
were  proportionate  to  the  associated  benefits  for 
each stakeholder group. 
This limitation  was addressed through  interviews 
with  stakeholder  groups  and  desk  review  of 
available literature including EPHA report on the 
Implementation  of  the  Cross-border  Healthcare 
Directive  and  Ecorys  and  Spark  2021  Mapping 
and Analysis of Administrative Procedures (Study 
on  Enhancing  implementation  of  the  Cross-
Border  Healthcare  Directive  2011/24/EU 
to 
ensure  patient  rights  in  the  EU  (publication 
forthcoming).) 
Rating of the evidence: Low 
Limited  quantitative  data  on  administrative  costs 
related  to  applying  the  Directive  for  MS  and  on 
patient mobility (see EQ2) 
These 
through 
limitations  were 
qualitative  data  collected  in  interviews  and  desk 
review  of  available 
the 
Commission’s report on patient  mobility (“Trend 
report  reference  years  2018-2020.”)  and  Ecorys 
and  Spark  2021  Mapping  and  Analysis  of 
Administrative  Procedures  (Study  on  Enhancing 
implementation  of  the  Cross-Border  Healthcare 
Directive  2011/24/EU  to  ensure  patient  rights  in 
the EU (publication forthcoming).)  

addressed 

including 

literature 

Which 

20. 
factors 
influenced the  cost  side and 
which  ones  influenced  the 
benefit  side  and  to  what 
extent? 

JC  20.1:  It  is  possible  to 
identify main cost drivers 
and factors that enhanced 
or limited the benefits 
JC  20.2:  The  identified 
cost  drivers  and  limiting 

Quantitative  and  qualitative  evidence 
of  factors  related  and  unrelated  to  the 
Directive and their level of significance 
on costs, i.e. 

-  Estimated MS costs (treatment 
costs,  compliance  costs  and 

Rating of the evidence: Low 
The limited cost data available for MS, European 
Commission  and  patients  did  not  allow 
to 
quantitatively  identify  the  main  cost  drivers  in 
cross-border healthcare. In turn, the extent of the 
and  other 
contribution  of 

the  Directive 

Literature review 
of  European 
Interviews 
Commission’s 
officials, 
national  authorities  (CBHC 
patients, 
group), 
expert 
providers, 
healthcare 

77 

 
 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

to 

To  what  extent  were  these 
factors 
the 
linked 
Directive? 
To  what  extent  were  there 
external 
that 
influenced the results? 

factors 

to 

the 

relate 

factors 
Directive. 
results 
JC  20.3:  The 
achieved  were  enhanced 
limited  by  other 
or 
factors 
directly 
not 
related to the Directive. 

specific admin burden) 

-  Estimated patients' costs (non-
reimbursable  costs  and  admin 
burden),  

Qualitative  feedback  on  factors  that 
the  benefits 
reduced 
enhanced  or 
treatment 
to 
in 
achieved, 
relation 
benefits, 
social 
benefits, 
patient 
benefits,  benefits  for  MS  and  other 
stakeholders. 
Indicators 
analysis: 

excluded 

from 

the 

European  Commission’s 
support the Directive 

costs 

to 

Costs for other stakeholders 

21.  How  significant  is  the 
for 
administrative  burden 
specific  stakeholders caused 
by  the  Directive  compared 
to  the  situation  before  it 
came into force? 
Has  the  Directive  led  to  a 
reduction  in  administrative 
burdens  on  patients 
in 
cross-border 
relation 
to 
and 
healthcare 
reimbursement of costs? 
What 
burdens 
patients? 
Where  is  there  room  for 
simplification? 

administrative 
for 

exist 

still 

21.2:  There 

JC  21.1:  The  level  of 
administrative  burden  is 
significant  for  different 
when 
stakeholders 
the 
compared  with 
situation 
the 
before 
Directive. 
is 
JC 
increased 
evidence  of 
efficiency 
/ 
simplification  over  time 
for  patients  using  cross-
border  healthcare  and 
seeking 
reimbursement 
of their costs. 
JC 21.3: Certain types of 
burdens 
administrative 

availability/access 

evidence 

Quantitative 
improved 
information, 
increased 
reimbursement  of  costs 
complaints. 

confirming 
to 
speed 
of 
/  handling 

Patient  associations,  NCPs/  CBHC 
expert  group,  health 
insurers,  etc. 
confirm  main  sources  of  persistent 
administrative burden for patients and. 
Qualitative  feedback  confirm  main 
sources 
and 
opportunities to increase efficiency. 
Indicators 
analysis: 

simplification 

excluded 

from 

the 

of 

Comparative  analysis  of  data  on  costs 

78 

influencing  factors  over  costs  could  not  be 
assessed.  
These limitations were addressed, where possible, 
through desk research, qualitative findings and by 
means of estimations and assumptions in the cost-
benefit analysis (see EQ17). 

healthcare insurers, ERNs 

Rating of the evidence: Low 
Lack  of  data  on  cost  and  administrative  burden 
(same  limitations  and  measures  to  address  these 
limitations as under EQ 18, 19 and 20). 

Literature review 
of  European 
Interviews 
Commission’s 
officials, 
national  authorities  (CBHC 
patients, 
expert 
group), 
healthcare 
providers, 
insurers,  ERNs, 
healthcare 
researchers, industry 
Public consultation  

 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

still  exist  in  relation  to 
specific  aspects  of  the 
Directive. 
JC  21.4:  There  is  scope 
to 
increase  efficiency 
through  simplification  of 
current processes. 
JC  22.1:  The  costs  of 
a 
providing 
comprehensive 
ERN 
system  supported  by  a 
range 
are 
appropriate  to  the  level 
of  additional  benefit  that 
has been achieved 

tools 

of 

tools 

22.  To  what  extent  are  the 
costs  of  ERNs  system  and 
justified  and 
their 
the 
proportionate 
objectives 
and 
benefits obtained? 

given 
achieved 

diagnosis 

23.  To  what  extent  is  the 
model  of  ERNs  allowing 
rare  disease  patients 
to 
and 
receive 
treatment without physically 
transporting  the  patient  to 
State 
another  Member 
virtual 
the 
to 
(thanks 
consultations, 
knowledge 
sharing,  development  of 
clinical  guidelines, 
etc.) 
more (or less) cost-effective 
to  patients 
as  compared 
being physically transported 

JC  23.1:  The  direct  and 
indirect  costs  associated 
with 
virtual 
ERN’s 
diagnosis  and  treatment 
are  lower  than  would  be 
required  to  performance 
physical consultations. 
are 
JC  23.2:  There 
specific 
circumstances 
when  the  provision  of 
virtual  diagnosis 
and 
is  not  cost-
treatment 
because 
effective 
is 
physical 

presence 

and  benefits  per  specific  stakeholder 
group  (as  identified  in  EQ  18)  with 
equivalent  data  from  the  2008  Impact 
Assessment 

Costs for the European Commission for 
implementation,  development  of  tools 
and annual allocation. 
Quantitative  data  on  administrative 
costs  (FTEs)  re.  establishment  and 
running  of  ERNs,  monitoring  and 
reporting. 
Quantitative  data  on  results/benefits  of 
the  ERN  system  collected  for  the  EQs 
on effectiveness (e.g. EQ13, EQ14) 
Stakeholders perceptions on balance of 
costs and benefits of the ERN system 

Quantitative  data  on  administrative 
costs collected in EQ 22 
Stakeholders’ perceptions on: 
-  costs  and  benefits  associated  with 
physical consultations 
- Other cost-saving elements 

79 

Rating of the evidence: Moderate 
Limited  data  on  the  funding  that  ERNs  received 
from coordinating centres, private donors/patients 
organisations, and from MS.  
To address these limitations, both qualitative and 
quantitative  evidence  were  used  to  assess  the 
costs  of  ERNs.  In  addition,  the  funding  form  the 
coordinating  centers  was  estimated  based  on  the 
EU funding (i.e. coordinating center co-fund 40% 
of the EU funding) 

the 

Literature review 
Data 
by 
provided 
European Commission 
Interviews  of  the  European 
Commission’s 
officials, 
national  authorities  (CBHC 
expert 
patients, 
group), 
ERNs, researchers, industry 
Survey of ERNs 
Public consultation  

Rating of the evidence: Moderate 
Limited  quantitative  data  on  the  costs  associated 
with  patients  being  physically  transported  to 
another  member  State  and  receiving  healthcare 
there as well as on the cost of ERNs (see EQ 22) 
This limitation was addressed through qualitative 
feedback  from  stakeholders’  consultation  as  well 
as quantitative estimates.  

Literature review 
national 
Interviews 
of 
authorities 
(CBHC  expert 
group),  ERNs,  researchers, 
industry 
Survey of ERNs 

 
 
 
 
  
EVALUATION 
QUESTION 

to another MS and receiving 
healthcare there? 
Relevance 
the 
24.  How  well  do 
Directive’s 
specific 
objectives  still  correspond 
to  the  current  and  future 
needs  of  EU  citizens  for 
cross-border healthcare? 
Has  the  Directive  allowed 
citizens/patients  to  make  a 
preferred 
for 
treatment in another MS? 

choice 

JUDGEMENT 
CRITERIA 

required. 

JC  24.1:  EU  citizens 
continue 
to  need  and 
seek  planned  healthcare 
and  access  to  healthcare 
in  other  MS  now  and  in 
the 
the 
future  under 
common  principles  and 
entitlements  set  out  in 
the Directive 

JC 24.2: Citizens/patients 
have  been  enabled 
to 
preferred 
their 
select 
treatment 
another 
in 
Member States 

Are 

new 

there 

25. 
developments 
(technological154, 
policy, 
etc.)  since  the  Directive’s 
entry into force, which have 
implications  on  patients’ 
rights 
cross-border 
to 
healthcare? 

in 

JC  25.1:  Changes 
in 
policies, 
healthcare 
systems,  and  capacity, 
light  of 
also 
the 
Covid-19, 
had 
implications  on  patients’ 
rights 
to  cross-border 
healthcare 

have 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

Extent  that  common  principles  and 
responsibilities  of  MS  and  healthcare 
providers  for  cross-border  healthcare 
correspond to current and future needs 

Extent of  the clarify of entitlements of 
patients  to  have  healthcare  in  another 
MS 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained. 

Extent  that  rights  to  reimbursement 
for 
(under 
healthcare  abroad  can  be  used 
in 
practice 

conditions) 

certain 

Literature review 
the 
Interviews/surveys  of 
European 
Commission’s 
officials,  national  authorities 
group), 
(CBHC 
expert 
healthcare 
providers/ 
professionals, 
healthcare 
insurers, patients,  
Public consultation  
Virtual workshop 

Extent 
efficient  cross-border  healthcare 
ensured 

that  high-quality,  safe  and 
is 

Ensure  that  continuity  of  care  between 
Member  State  of 
treatment  and 
Member State of affiliation is ensured 

Evidence  on  new/changed  health 
insurance /provision policies /Covid-19 
influencing  access  to  and  take  up  of 
CBHC  and 
the  needs 
influencing 
addressed by the Directive  

the 
feedback 
Qualitative 
introduction of new technologies in the 

on 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

Literature review 
Interviews  of  the  European 
Commission’s 
officials, 
national  authorities  (CBHC 
ERNs, 
expert 
group), 
providers/ 
healthcare 
healthcare 
professionals, 
consumer 
insurers, 

154 EQ29 focuses on technological developments. Therefore, these were not addressed in this evaluation question. 

80 

 
 
 
 
 
 
 
 
 
                                                 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

How  do  they  impact  on  the 
Directive’s relevance? 

26.  Has  the  Directive  had 
any 
its 
effects  beyond 
scope,  for  example  on  the 
reimbursement  of 
cross-
border  health  care  provided 
by  foreign  doctors  treating 
patients  in  the  state  of  the 
patients’ 
insurance 
affiliation? 

meeting 

27.  Are 
the  National 
Contact  Points  still  relevant 
for 
patient 
information needs?  
What  could  be  improved  as 
regards NCPs? 

25.2: 

Identified 
JC 
changes 
or 
reduce  the  relevance  of 
the Directive 

enhance 

JC  29.2:  There  are  other 
technological 
new 
developments  which  are 
expected 
influence 
to 
cross-border  healthcare 
in the future 

JC  26.1:  The  Directive 
has  had  effects  beyond 
its scope  

JC  26.2:  The  Directive 
has  had  effect  on  the 
reimbursement  of  cross-
care 
health 
border 
foreign 
by 
provided 
doctors  treating  patients 
in 
the 
the 
patients’ 
insurance 
affiliation 

state  of 

27.1: 

JC 
Patients 
continue to refer to NCPs 
for  information  and  to 
support  their  access  to 
cross-border healthcare 

JC  27.2:  NCPs  have 
capacity  to  consistently 
and  adequately  respond 
to  all  patient  enquiries 

provision of cross-border healthcare  

Quantitative  and  qualitative  evidence 
that  identified  new  technologies  made 
it  easier  for  patients  to  take  up  their 
rights to cross-border healthcare 

Answer  to  JC  26.1  combined  with 
EQ 16 

Indicators 
analysis: 

excluded 

from 

the 

Quantitative  and  qualitative  data  on 
foreign  doctors  treating  patients  in  the 
state  of 
insurance 
the  patients’ 
affiliation 

Answer  to  the  first  part  of  the  question  (i.e., 
has  the  Directive  had  any  effects  beyond  its 
scope, JC2.1) is provided under EQ16.  
Rating of the evidence for JC26.2: Very low 
the 
No 
reimbursement 
healthcare 
provided  by  foreign  doctors  treating  patients  in 
the state of the patients’ insurance affiliation. 

evidence  was 

cross-border 

regarding 

found 

of 

Quantitative  data  confirming  numbers 
and type of enquiries 

Qualitative 
and 
feedbacks confirmed that: 

data 

stakeholder 

-  types  of  patients’  information  needs 
being met by NCPs  

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

expectations 

- 
improvements to delivery channels 

and 

possible 

81 

organisations, 
industry 
Public consultation 

researchers, 

Literature review 
national 
Interviews  with 
authorities 
(CBHC  expert 
group),  healthcare  providers/ 
patients, 
professionals 
healthcare insurers 

national 
(CBHC  expert 
healthcare 

Literature review 
Interviews 
of 
authorities 
group), 
providers/professionals, 
healthcare insurers, patient 
Public consultation  
Analysis of NCP websites  

 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

received 

JC  27.3:  There  are  ways 
to  further  enhance  how 
NCPs  provide  support 
and  the  type  of  support 
that they provide 

JC  27.4:  NCPs  have 
capacity  to  consistently 
and  adequately  respond 
to  all  patient  enquiries 
received. 

JC  27.5:  There  are  ways 
to  further  enhance  how 
NCPs  provide  support 
and  the  type  of  support 
that they provide.  

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

- consistency in the approach taken by 
NCPs across the MS 

- that NCPs add value to the landscape 
of  other  information  providers  in  the 
MS 

-  accessibility  of  NCP  information  by 
disadvantaged groups 

- need to broaden the role of the NCPs, 
for example, into advocacy services for 
their own patients 

Evidence  that  information  materials  in 
the public domain and levels and types 
of  accessibility/delivery  channels  meet 
patients’  expectations  also  regarding 
social media 

Indicators 
analysis: 

excluded 

from 

the 

Quantitative  data  and 
stakeholder 
feedback on whether there is a conflict 
of  interest  if  the  NCP  is  a  payer 
organisation 

28.  Which  provisions  have 
proven  to  be  significant  for 
the  Directive’s 
relevance 
and which are less adequate 
to  meet  the  needs  of  cross-
border patients? 

Which factors explain this? 

JC 28.1: There is demand 
additional/revised 
for 
provisions 
the 
in 
Directive 

Evidence  of  significant  variation  in 
demand for and provision of healthcare 
relating  to  specific  provisions  of  the 
Directive 

JC  28.2:  Patients  and/or 
those 
the 
involved 
provision  of  healthcare 
persistent 
experience 
fully 
problems 

not 

in 

Stakeholders’  perceptions  on  areas  of 
most  relevance,  as  well  as  aspects 
which  could  be  reinforced  and  or 
reasons / situations which influence the 
adequacy of provisions in the Directive 

82 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained 

Literature review 
Interviews  of  the  European 
Commission’s 
officials, 
national  authorities  (CBHC 
expert  group),  healthcare 
providers/ 
professionals, 
patients  
Virtual workshop  
Public consultation  

 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

addressed 
Directive 

by 

the 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

/systemic 

JC  28.3:  It  is  possible  to 
define  specific  issues  / 
situations 
/ 
historic 
cultural 
and 
reasons,  which  explain 
variations 
the 
relevance  of  different 
provisions 
the 
Directive  (should  these 
exist) 

of 

in 

Are 

there 

29. 
any 
technological  developments 
which  have  implications  for 
the  Directive  since  its  entry 
into force? 

Answer combined with EQ25 

N/A 

N/A 

JC 29.1: New technology 
has  been  integrated  to 
enhance the organisation, 
provision  and  access  to 
cross-border healthcare 
JC  29.2:  There  are  other 
technological 
new 
developments  which  are 
expected 
influence 
to 
cross-border  healthcare 
in the future 

the  ERNs  still 
30.  Are 
relevant 
the 
for  meeting 
needs  of  patients  with  rare 
and complex diseases? 

JC  30.1:  ERNs  improve 
the 
and 
diagnosis 
treatment  of  rare  and 
complex diseases 

are 
JC  30.2:  There 
that 
factors 
the 
limit 
that  ERNs  can 
extent 
enhance 
the  diagnosis 
and treatment of rare and 

Relevance of ERNs for meeting patient 
needs 

Quantitative  data  on  the  number  of 
patients 
ERNs 
benefiting 
(including  data  on 
the  number  of 
patients treated in the CPMS) 

from 

Factors that enhance / limit supply and 
demand for services 

83 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

Desk  review  of  available 
reports  studies  and  statistics 
on ERNs  
Interviews  with 
authorities 
group), 
representatives, 
researchers 
Survey of ERNs 

national 
(CBHC  expert 
patient 
industry, 

ERNs, 

 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

complex diseases 

31. Is there any difference in 
relevance  and  adequacy  of 
the  Directive’s  provisions 
depending 
territorial 
on 
dimension  (i.e.  for  border 
regions)? 

JC  31.1:  The  provisions 
under  the  Directive  meet 
patients' 
cross-border 
health  needs  consistently 
irrespective  of  where 
they  reside  and/or  where 
they 
healthcare 
support 

seek 

JC  31.2:  Cross-border 
provision 
healthcare 
between  border  regions 
the  same/different 
has 
requirements 
than 
provision  between  non-
bordering 
Member 
States/regions 

Coherence 
32. To what extent have the 
specific  objectives  of  the 
translated 
Directive 
unambiguously 
legal 
provisions to apply patients’ 
rights 
cross-border 
healthcare?  Identify  where 
more clarity is necessary. 

into 

in 

to 

JC  32.1:  The  specific 
of 
objectives 
the 
Directive 
translated 
unambiguously into legal 
apply 
provisions 
patients’  rights  in  cross-
border healthcare. 
JC  32.2:  There  is  a  need 
to  enhance  clarity  of 
legal provisions to ensure 
specific 
that 

the 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

Public consultation 

Literature review 
national 
Interviews  with 
authorities 
(CBHC  expert 
group),  healthcare  providers/ 
professionals 

Rating of the evidence: Moderate 

Limited  data  available  on  concrete  actions 
implemented in terms of cross-border cooperation 
since  the  Directive’s  adoption  (see  EQ  8)  and 
important  data  gaps  on  patient  mobility  and  the 
use of the Directive compared to the Regulations 
and  other  parallel  mechanisms  in  border  regions 
(see EQ 2).  
These 
the 
findings  of  the  AEBR  research  project  on  Cross 
Border  Patient  Mobility  as  well  as  with  broader 
literature  review  such  as  Bobek,  J.  et  al.  (2018) 
study  on  Cross-Border  Cooperation  “Capitalising 
on  existing  initiatives  for  cooperation  in  cross-
border regions” 

limitations  were  addressed  with 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained 

Literature review 
national 
Interviews  with 
authorities 
(CBHC  expert 
group),  healthcare  providers/ 
healthcare 
professionals, 
insurers 

Public consultation  

Indicators 
analysis: 

excluded 

from 

the 

Gaps  in  rare  diseases  and  complex 
conditions not covered by the ERNs 

Evidence  on  levels  of  cross-border 
healthcare provision  

Stakeholders’ perceptions related to the 
territorial dimension 

Qualitative evidence on the application 
of  the  provisions  of  the  Directive 
across the EU  
Qualitative  evidence  on  the  alignment 
between  the  specific  objectives  and 
legal  provisions  of  the  Directive  and 
reasons  underlying  any 
identified 
misalignments/divergences/gaps 
Stakeholders’  perceptions  on  extent  to 
the 
which 
Directive address its specific objectives 

legal  provisions  of 

the 

84 

 
 
 
 
 
 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

the 

33.  To  what  extent  has  the 
legal 
application  of 
framework 
by  Member 
States  been  coherent  with 
for 
regard 
to 
healthcare?155 
Identify 
inconsistencies and resulting 
problems for patients. 

costs 

the 

objectives 
of 
Directive are met. 
JC  33.1:  The  application 
of  the  legal  framework 
by  Member  States  has 
coherent  with 
been 
for 
costs 
to 
regard 
healthcare 
JC  33.2:  Inconsistencies 
in  the  application  of  the 
by 
framework 
legal 
Member  States 
have 
identified  which 
been 
have 
in 
problems for patients 

resulted 

clarified 
with 

the  Directive 
34.  Has 
its 
sufficiently 
the 
relationship 
existing  framework  on  the 
coordination 
social 
security  systems  (the  Social 
Security 
Coordination 
Regulations)  with  a  view  to 
patients’ 
of 
application 

of 

JC 34.1: The Directive is 
sufficiently clear on how 
the 
interacts  with 
it 
existing  framework  on 
the coordination of social 
security  systems,  leaving 
no room to uncertainty to 
patients, health providers 
security 
and 

social 

and areas where more clarity is needed. 

on 

the 

from 

costs, 

relating 

number 

excluded 

on 
the 

the 
evidence 
Qualitative 
relationship 
legal 
between 
application of the Directive by MS and 
the costs for healthcare, as  well as any 
identified inconsistencies 
Indicators 
analysis: 
to 
MS  quantitative  data 
of 
treatment 
claims/forms  received  and  issued,  and 
amounts reimbursed by MS  
Quantitative 
the 
evidence 
application  of  the  provisions  of  the 
Directive across the EU  
Stakeholders’ perceptions on the extent 
to  which 
the 
Directive  by  MS  has  been  coherent 
with  regard  to  costs  for  healthcare, 
including any inconsistencies identified 
For  the  purpose  of  consistency  and  to 
avoid  overlap,  EQ34  and  EQ35  have 
been combined. 
Quantitative  evidence  on  patients’ 
application  for  cross-border  healthcare 
under  the  Directive  and  the  Social 
Security Coordination Regulations 
Qualitative  evidence  on  how 
Directive  and 

the 
the  Social  Security 

the  application  of 

Rating of the evidence: Moderate 
Limitation  in  the  data  available  in  regard  to 
treatment costs, number of claims/forms received 
and issued, and amounts reimbursed by MS.  

Literature review 
national 
Interviews  with 
authorities 
(CBHC  expert 
group),  healthcare  providers/ 
healthcare 
professionals, 
insurers 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained 

with 

Literature review 
the 
Interviews 
Commission’s 
European 
officials,  national  authorities 
group), 
(CBHC 
expert 
healthcare 
providers/ 
professionals, 
healthcare 
insurers, patients 
Virtual workshop 

155 The wording of this question has been modified. The original question in the ToR read: “To what extent have Member States applied the legal framework been coherent with regard to 

costs for healthcare? Identify inconsistencies and resulting problems for patients.” 

85 

 
 
 
                                                 
EVALUATION 
QUESTION 

rights? 

JUDGEMENT 
CRITERIA 

institutions  on  how  to 
apply these rules  

between 

35.  To  what  extent  is  there 
overlap 
the 
the  Social 
Directive  and 
Security 
Coordination 
Regulations  and  how  has 
this  influenced  the  patients’ 
choice for reimbursement of 
healthcare  costs  and 
the 
response  by 
the  Member 
State of affiliation? 

is  a 
JC  35.1:  There 
certain degree of overlap 
between 
the  Directive 
and  the  Social  Security 
Coordination 
which 
Regulations 
influences 
patients’ 
choices  and  the  response 
of MS. 

36.  To  what  extent  is  the 
Directive  coherent  with  the 
Directive on the recognition 
professional 
of 

JC  36.1:  The  Directive 
the 
aligns  well 
the 
Directive 
of 
recognition 

on 

to 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

Coordination  Regulations  interact  with 
each  other,  from  both  a  legal  and 
practical perspective 
Stakeholders’  perceptions  on  extent  to 
which  the  patients,  health  providers 
and  Social  Security  bodies  understand 
the  relationship  between  the  Directive 
and  the  Social  Security  Coordination 
Regulations  and  how  to  apply  them  in 
practice  
For  the  purpose  of  consistency  and  to 
avoid  overlap,  EQ34  and  EQ35  have 
been combined. 
Qualitative evidence on: 
-  how  the  Directive  and  the  Social 
Security  Coordination  Regulations 
interact with each other, from both a 
legal and practical perspective 

-  reasons  for  patients’  choice  of  each 
scheme  for  the  reimbursement  of 
cross-border healthcare costs 

-  MS’ responses to the reimbursement 
of  cross-border  healthcare  costs 
under the different schemes 

Stakeholders’  perceptions  on  how 
patients’  choices  and  MS’  responses 
are influenced by the existing overlaps 
between  the  Directive  and  the  Social 
Security Coordination Regulations 
Qualitative  evidence  on  (mis)match 
between the provisions of the Directive 
and  those  of  the  Directive  on  the 
professional 
of 
recognition 

86 

Public consultation  

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation,  workshop)  and 
stakeholders  provides  high  confidence  on  the 
validity of results obtained. 

with 

Literature review 
the 
Interviews 
European 
Commission’s 
officials,  national  authorities 
group), 
(CBHC 
expert 
providers/ 
healthcare 
professionals, 
healthcare 
insurers, patients 
Virtual workshop 
Public consultation 

Rating of the evidence: Moderate 
Limited information to assess the extent to which 
the Directive is coherent with the Directive on the 
recognition  of  professional  qualifications  with 

Literature review 
Interviews  with 
national 
(CBHC  expert 
authorities 
group),  healthcare  providers/ 

 
 
INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

qualifications with regard to 
the  regulated  professions  in 
the healthcare sector? 

professional 
with 
qualifications 
regard  to  the  regulated 
professions 
the 
in 
healthcare sector 

to 

regard 

qualifications  with 
the 
regulated  professions  in  the  healthcare 
sector 
Stakeholders’ perceptions on: 
-  extent  to  which  the  provisions  of  the 
Directive and those of the Directive on 
professional 
recognition 
the 
qualifications are aligned. 

of 

of 

37.  Have  there  been  any 
problems  with  regard  to  the 
application 
the 
professional  rules  for  the 
health  service  provider  (in 
the  context  of  a  temporary 
and  occasional  cross-border 
i.e. 
service 
provision), 
to 
related 
difficulties 
determining  which 
rules 
apply  or  how  to  access  the 
professional’s 
liability 
insurance? 

contribute 

38.  To  what  extent  did  the 
Directive 
to 
activities on rare diseases in 
into 
particular 
account  relevant  legislation 
and the Orphanet database? 

taking 

JC  37.1:  The  application 
of  the  professional  rules 
for 
the  health  service 
provider  (in  the  context 
of 
and 
temporary 
occasional  cross-border 
is 
service 
clear 
not 
generated any difficulties 

provision) 

and 

has 

a 

other 

JC 38.1: The activities on 
rare  diseases  under  the 
Directive  are  coherent 
relevant 
with 
legislation 
data 
protection  in  relation  to 
the CPMS) 
JC 38.2: The activities on 
rare  diseases  under  the 
Directive  are  coherent 

(e.g. 

Qualitative evidence on the application 
of  the  professional  rules  for  the  health 
service  provider  (in  the  context  of  a 
temporary  and  occasional  cross-border 
service  provision),  incl.  any  identified 
difficulties in applying the rules 
Stakeholders’ perceptions on: 
-  how  the  professional  rules  for  the 
health  service  provider  (in  the  context 
of  a  temporary  and  occasional  cross-
border  service  provision)  are  being 
applied in practice, incl. any difficulties 
identified in applying the rules 

Qualitative  evidence  of  the  Directive 
coherence  with  other  EU  policies  and 
activities 
Stakeholders’ perceptions on the extent 
to  which  activities  on  rare  diseases 
under  the  Directive  are  coherent  with 
other  activities  in  the  field  such  as  the 
Orphanet database 

87 

in 

the 

the  regulated  professions 

regard 
to 
healthcare sector. 
This  limitation  was  addressed  to  the  extent 
possible  through  stakeholder  consultations  (who 
did  not  raise  any  points  of  incoherence  between 
the  two  Directives,  or  stated  that  they  were  not 
aware  of  any  problems)  and  desk  review  of 
available literature such as Ecorys 2017 study on 
cross-border  health  services,  which  examines  the 
free movement of healthcare providers in practice 
through specific examples in national contexts. 
Rating of the evidence: Low 
Insufficient 
to  assess 
information  available 
whether  there  have  been  any  problems  with 
regard to the application of the professional rules 
for the health service providers (in the context of 
a  temporary  and  occasional  cross-border  service 
provision),  i.e.  difficulties  related  to  determining 
which 
the 
rules  apply  or  how 
professional’s liability insurance 

to  access 

professionals 

Literature review 
Interviews  with  healthcare 
providers/ professionals 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different data collection tools (desk research, and 
interviews)  and  stakeholders  provides  high 
confidence on the validity of results obtained 

Literature review 
Interviews 
of 
authorities, 
researchers, industry  

national 
ERNs, 

 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

with  other  activities  in 
the  field  such  as 
the 
Orphanet database 
JC  39.1:  The  Directive 
and 
enhances 
complements 
other 
European 
existing 
structures  such  as 
the 
Civil 
Protection 
Mechanism 

39.  To  which  extent  does 
the  Directive  enhance  and 
complement  other  existing 
European  structures  such  as 
the 
Protection 
Mechanism  in  line  with  its 
objectives? 
EU added value 

Civil 

Qualitative  evidence  on  synergies/ 
complementarities 
the 
objectives of the Directive and of other 
existing  European  structures  such  as 
the Civil Protection Mechanism 

between 

Rating of the evidence: Low 
Beyond  discussion  on 
the  Social  Security 
Coordination  Regulations,  stakeholders  were  less 
engaged  with  or  aware  of  relevant  existing 
structure  impacting  on  and/or  impacted  by  the 
Directive 

Literature review 
national 
Interviews 
authorities 
(CBHC  expert 
group),  healthcare  providers/ 
professionals 

in 

and 

40.  In  what  ways  has  the 
Directive  provided  added 
value  in  terms  of  patient 
cross-border 
rights 
patient 
healthcare 
choice 
healthcare 
services in the EU compared 
to  what  could  reasonably 
have been expected from the 
Member States acting in the 
absence of the Directive? 

of 

41.  How  effective  was  the 
facilitating 
Directive 
in 
between 
cooperation 
in  cross-
Member  States 
border healthcare at regional 
and  local  level  since  its 
entry into force? 

of 

choice 

The 
JC 
40.1: 
the 
achievements 
terms  of 
in 
Directive 
patient  rights  in  cross-
border  healthcare  and 
patient 
of 
healthcare services in the 
to 
EU  are  additional 
what 
have 
could 
occurred  from  the  MS 
acting  in  the  absence  of 
the Directive 
JC  41.1:  The  Directive 
necessary 
set 
the 
to  facilitate 
provisions 
between 
cooperation 
Member  States  in  cross-
border 
at 
regional and local level 

healthcare 

Quantitative  and  qualitative  evidence 
on  the  achievements  of  the  Directive 
collected for other EQs 
Stakeholders’  perceptions  on 
the 
benefit  of  support  provided  by  the  EU 
to patients with regard to CBHC 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

Quantitative  and  qualitative  evidence 
on  extent  of  cooperation  between  MS 
in  cross-border  healthcare  at  regional 
and  local  level  (collected  for  other 
EQs) 
Stakeholders’  perceptions  on  ways  in 
which  the  Directive  has  facilitated 
cooperation  between  MS  at  regional 
and  local  level  (collected  for  other 
EQs) 

88 

in 

with 

collected 

Evidence 
previous EQs 
the 
Interviews 
European 
Commission’s 
officials,  national  authorities 
(CBHC 
group), 
expert 
ERNs,  healthcare  providers/ 
healthcare 
professionals, 
insurers,  patients,  consumer 
organisations, 
researchers, 
industry 
Public consultation  
Evidence 
previous EQs 
Interviews  of  the  European 
officials, 
Commission’s 
national 
authorities, 
healthcare 
providers/professionals, 
healthcare  insurers,  patients, 
consumer 
organisations, 
researchers, industry 

collected 

in 

 
 
 
 
 
EVALUATION 
QUESTION 

JUDGEMENT 
CRITERIA 

INDICATORS  

QUALITY OF THE EVIDENCE  

DATA SOURCES 

42. 
the 
In  what  ways 
Directive  (and  therefore  the 
ERNs  established  by 
the 
Directive)  provide  an  added 
value  for  patients  with  rare 
and 
diseases 
compared  to  the  national 
situation alone? 

complex 

of 

The 
JC 
42.1: 
the 
achievements 
Directive 
terms  of 
in 
patients  with  rare  and 
complex  diseases 
are 
additional  to  what  could 
have  occurred  from  the 
MS acting in the absence 
of the Directive 

Quantitative  and  qualitative  evidence 
on  the  achievements  of  the  Directive 
collected for other EQs, particularly  in 
relation to rare and complex diseases 
Stakeholders’ perceptions on the added 
value  the  ERNs  have  beyond  national 
actions by MS 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained 

in 

collected 

Public consultation  
Evidence 
previous EQs 
Interviews  of  the  European 
officials, 
Commission’s 
national 
authorities, 
healthcare 
providers/professionals, 
healthcare  insurers,  patients, 
consumer 
organisations, 
researchers, industry 
Public consultation  

consequences 

43. What would be the most 
likely 
of 
the  Directive’s 
repealing 
patients’ 
provisions 
rights 
cross-border 
in 
healthcare? 

on 

JC 43.1: The Directive is 
unique/fundamental 
in 
setting  out  the  rights  for 
patients  in  cross-border 
healthcare 
JC  43.2:  Effects  of 
repealing the Directive 

Quantitative  and  qualitative  evidence 
of  the  achievements  (and  gaps,  if  any) 
of the Directive collected for other EQs 
Stakeholders’  perceptions  on 
the 
effects  of  repealing  the  Directive  on 
patients’ 
cross-border 
healthcare 

rights 

in 

Rating of the evidence: High 
Triangulation  of  evidence  collected  from  the 
different  data  collection  tools  (desk  research, 
interviews,  public  consultation)  and  stakeholders 
provides high confidence on the validity of results 
obtained. 

in 

collected 

Evidence 
previous EQs 
Interviews  of  the  European 
Commission’s 
officials, 
national 
authorities, 
healthcare 
providers/professionals, 
healthcare  insurers,  patients, 
consumer 
organisations, 
researchers, industry 
Public consultation  

89 

 
 
 
ANNEX IV. OVERVIEW OF BENEFITS AND COSTS 

Citizens/Consumers/156  

Businesses157 

Administrations158  

Others: ERNs 

Quantitative   Comment 

Quantitative  

Comment 

Quantitative  Comment  

Quantitative 

Comment 

Costs  

Administrative costs 
Reimbursement  procedures  and 
reimbursement costs 

Recurrent 

Reimbursement 
procedures  to  access 
care 
prior 
and 
authorisation 
perceived 
impediments; 
data 
administrative costs 

as 
no 
available  on 

Cross-border 
reimbursements 
average  processing 
time:  
3 weeks to 6 months 
prior 
without 
authorisation;  one  to 
6  months  with  prior 
authorisation159 

N.A. 

EU  contribution  
over 
years  
5 
from 
CHAFEA/HAD
EA via the Third 
Health 
Programme; 
EUR 
30.932.113,11 

EU  contribution 
over 
years 
3 
from  Connecting 
Europe Facility 
EUR 
12.003.969,00 

156 Including patients. 
157 Including healthcare professionals and hospitals (public and private). 
158 Including national public authorities, insurance (public and private). 
159 9 countries have not introduced prior authorisation. See Commission study “Enhancing the Implementation of the Directive 2011/24/EU, analytical report on “mapping administrative 

procedures”, February 2022.  

90 

 
                                                 
 
 
 
 
     
 
                   
 
 
 
 
 
 
 
 
 
Compliance costs 

Cost  of  implementing  necessary 
systems 
to  administer  cross-
border  healthcare  and  provide 
information to patients 

One-off  & 
recurrent 

Implementation  and  operational 
costs of the ERNs 

Compliance costs of the ERNs  Recurrent 

Enforcement costs 

Recurrent 

Benefits 

Compliance  costs 
estimated 
to  be 
minor by MS: most 
NCPs 
have 
between  1  and  3 
FTE staff 

Estimate  cost  of 
at 
least  EUR 
12.4  million  in 
co-funding 
(2017-2020) 

N.A. 

N.A. 

N.A. 

91 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Direct benefits 
Estimated  number  of  patients 
benefiting 
healthcare 
from 
abroad 

Recurrent 

Estimated  number  of  patients 
with  rare  diseases  benefiting 
from ERNs 

patient 
329,589 
mobility 
cases 
estimated  across  30 
countries 

Patients  in  particular 
patients 
profiting: 
living 
border 
in 
regions  and  patients 
with  some  specific 
condition  

Less 
than  1%  of 
citizens  on  a  waiting 
list 
from 
benefit 
faster  treatments;  no 
data  available  on  the 
reduction  of  waiting 
times 

1.7  million  patients 
treated 
by  ERN 
members 

2,100  virtual  expert 
panels  opened  in  the 
CPMS   

Patients  participated 
to  732  clinical  trials 
within the ERNs 

Almost  1500  ERN 
members 
(hospital 
units)  and  more  than 
200  ERN  affiliated 
partners  across  EU 
and Norway 

92 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Indirect benefits  

Reduction  of 
access to healthcare  

inequalities 

in 

Recurrent 

Potential 
ERNs 

beneficiaries 

from 

Recurrent 

Social impacts of the 
Directive  could  not 
be 
determined 
quantitatively.  Only 
anecdotal  qualitative 
evidence is mixed 

future 
Potential 
Patients 
patients: 
profiting 
from 
treatments  tested  in 
the 732 clinical trials 

Increased  efficiencies  in  care 
pathways 

Recurrent 

and 

Research 
generation, 
knowledge and best practice 

exchange 

knowledge 
of 

Recurrent 

Costs  saved  from 
avoiding 
misdiagnosis 
inefficient 
treatment  of  rare 
disease 
patients 
thanks to ERNs 

or 

Costs 
from 
saved 
avoiding misdiagnosis 
inefficient 
or 
rare 
treatment 
of 
disease 
patients 
thanks to ERNs 

Better  understanding 
of  diagnosis  and  of 
treatment  options  by 
healthcare 
professionals: 

ERNs 
and 
results 
activities  presented  at 
1183 
congresses/ 
conferences/ 
583 
meetings; 
educational  activities 

93 

162  new  clinical 
practice 
guidelines  written 
by the ERN 

143 
Clinical 
Decision  Making 
Tools  developed 
by ERNs 

732  clinical  trials 
(before 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
by 

aimed  at  healthcare 
professionals 
the 
organised 
ERN; 
1,446 
educational  activities 
aimed  at  healthcare 
professionals 
delivered by the ERN 
coordination  team  or 
HCP  members  of  the 
ERN 

medicine/treatmen
t  is  approved  and 
on 
the  market) 
conducted  within 
the ERNs 

405  observational 
prospective 
studies 
(once 
medicine/treatmen
t  is  approved  and 
the  market) 
on 
conducted  within 
the ERN 

94 

 
 
 
ANNEX V. STAKEHOLDERS CONSULTATION – SYNOPSIS REPORT 

INTRODUCTION  

This  synopsis  report  provides  an  overview  of  the  results  of  the  consultation  of 
stakeholders  that  was  conducted  as  part  of  the  study  supporting  the  evaluation  of  the 
Directive 2011/24/EU. The report is structured as follows:  

  Consultation strategy (Section 1); 
  Consultation results (Section 2). 

1.  CONSULTATION STRATEGY 

1.1.  Overview of consultation activities 

In  line  with  the  European  Commission’s  stakeholder  consultation  strategy,  the  study 
entailed the following consultation activities: 

  public consultation launched by DG SANTE in May 2021; 
 
 
  online  survey  of  pharmacists  conducted  in  the  context  of  a  case  study  on  the 

in-depth interviews with stakeholders at EU and national level; 
targeted surveys, questionnaires and information requests to stakeholders; 

recognition of medical prescriptions in four countries; 

  presentations  of  study  progress  and  preliminary  findings  to  ERN  coordinators 

group and the Cross-border Healthcare expert group; and 

  virtual workshop with stakeholders, held on 9 November 2021.  

The study engaged a total of 287 stakeholders through these activities. Further details on 
the specific groups of stakeholders who provided data, views and experiences for the ex-
post evaluation of the Directive are provided below.  

The study then conducted a quantitative and qualitative analysis of data gathered through 
the  different  consultation  activities.  The  quantitative  analysis  included  a  descriptive 
statistical  analysis  of  the  results  of  the  public  consultation  and  targeted  surveys. 
Furthermore,  all  views  provided  in  the  interviews  and  the  open  questions  of  the  public 
consultation  were  analysed  using  qualitative  data  analysis  techniques.  Where  answers 
were  provided  in  languages  other  than  English,  these  were  translated  to  English  and 
integrated to the evidence base for coding and analysis. 

The analysis of the evidence from consultation activities was conducted first at the level 
of  individual  data  collection  tools.  Then,  the  contractor  triangulated  the  data,  and 
contrasted it with data coming from the literature review, to produce the answers to the 
study’s 
and 
recommendations. These were presented in the study’s (draft) final report. 

and  developing  overarching 

evaluation  questions 

conclusions 

1.2. 

Stakeholders consulted 

95 

 
 
Table  “Stakeholders  engaged  per  consultation  activity”  provides  an  overview  of 
stakeholders  consulted  as  part  of  the  study.  The  breakdown  of  stakeholders  evidences 
that  the  consultation  aimed  to  collect  different  perspectives  on  the  issues  under 
assessment. A choice was made so that the most relevant consultation tool was selected 
for  each  stakeholder  group  and  that  the  topics  of  the  consultation  reflected  the  profile, 
knowledge, experience, and interest of each group. 

Stakeholders engaged per consultation activity 

Consultation 
activity 

Public 
consultation 

Exploratory 
interviews 

or 

Interviews 
written 
contributions 

Targeted 
surveys, 
questionnaires 
or 
requests 

information 

Stakeholder group 

EMPL); 

contractors 

Non-governmental 
organisations  (NGOs);  EU 
and  non-EU  citizens;  public 
authorities; 
academic/research 
institutions;  company  and 
organisations; 
business 
business 
associations; 
consumer 
organisations; 
trade unions; other 
Commission  DGs  (SANTE 
and 
EU-level 
representatives  of  health 
insurers  and  pharmacists; 
of 
external 
previous  studies  on  cross-
border healthcare 
EU-level  representatives  of 
healthcare 
providers/professionals; 
insurers;  health 
research and consumers 
National health authorities 
National-level 
providers/professionals 
Patients 
National-level 
insurers 
representatives 
ERN 
(coordinators  and  Board  of 
Member States) 
ERN patient representatives 
Healthcare 
providers/ 
professionals 
Patient ombudsmen 
Pharmacists  (case  study  – 
dispensers’ online survey) 

healthcare 

industry; 

health 

96 

of 

Nr 
stakeholders 
targeted 
N/A 

Level 
engagement 

of 

Medium 

of 

Nr 
stakeholders 
responding 
193  responses 
and 
21 
position 
papers 

8 

12 

11 
8 

12 
8 

10 

3 
N/A 

8 

9 

9 
8 

12 
4 

8 

3 
7 

High 

High 

High 
High 

High 
Low 

High 

High 
Low 

12 
(50  per 
250 
study country) 

7 
(PL);  55 
72 
(FR); 26 (NL); 

Medium 
High 
and 

in  PL 
FR; 

 
 
Consultation 
activity 

Stakeholder group 

of 

Nr 
stakeholders 
targeted 

of 

Nr 
stakeholders 
responding 
4 
(DK) 

(DE); 

1 

Virtual 
workshop 
Feedback 
the 
roadmap 

on 
evaluation 

64 
84 

63 

ERNs 
N/A 
Stakeholders from all groups  117 

(registered) 
N/A 

NGOs;  EU  and  non-EU 
citizens; 
business 
associations; 
company/business 
organisations;  trade  unions; 
public  authorities;  research 
institutions 

Level 
engagement 

of 

in 
in 

Medium 
NL;  Low 
DE and DK 
Medium160 
High 

Medium 

1.3.  Consultation challenges  

Some challenges emerged during the consultation activities. These can be summarised as 
follows: 

  Stakeholder engagement: Substantial efforts were made to engage stakeholders 
from  all  the  groups  identified  in  the  Commission’s  stakeholder  consultation 
strategy  and  across  countries.  While  overall  this  objective  was  achieved,  some 
groups  were  less  engaged  in  the  consultation  activities.  For  instance,  response 
rates  from  healthcare  providers  to  a  targeted  questionnaire,  from  pharmacists  in 
some countries to the dispensers’ online survey, and from national health insurers 
invited to participate in interviews were particularly low. This was mainly due to 
some  stakeholder  fatigue  (as  several  concurrent  research  activities  were  taking 
place  at  the  time  of  the  study)  and  unavailability  because  of  the  Covid-19 
pandemic (many stakeholders of the health sector were occupied in the response 
to the pandemic and were less available). 

  Analysis of public consultation results: The reasons mentioned above are likely 
to  have  affected  responses  to  the  Commission’s  public  consultation  also. 
Although  the  number  of  responses  received  (193)  was  sufficient  to  conduct  a 
robust  analysis  of  general  results,  it  was  not  high  enough  to  allow  sub-groups 
analyses. To mitigate this, respondents were (re)grouped in broader categories to 
allow  some  comparison  (e.g.,  receivers  and  organisers/providers/payers  of 
healthcare  services).  Differences  in  the  views  of  these  broader  groups  were 
reported only when they were statistically relevant. 

160 The evaluation team targeted all 24 ERNs and ask them to respond to a questionnaire in the most suitable 
way  to  them,  either  providing  responses  from  coordinators  or  the  wider  ERN.  Although  the  number  of 
individual responses was high, the ERNs responding to the survey were seven; therefore, it was considered 
a medium-level of engagement. 

97 

 
 
                                                 
  Evidence  provided  by 

stakeholders:  Stakeholders  were  not  always 
knowledgeable  of  the  issues  under  evaluation  and/or  reported  that  no  data  was 
available  on  certain  topics.  As  a  result,  the  consultation  activities  produced 
limited evidence on some issues including: the functioning of the system of prior 
notification;  cross-border  cooperation  in  healthcare  (incl.  in  diagnosis  and 
treatment of rare diseases); the use of the Directive compared to the Regulations 
and other parallel instruments in border regions; use of the Directive by different 
patient  groups;  reimbursement  of  cross-border  healthcare  provided  by  foreign 
doctors  treating  patients  in  the  state  of  the  patients’  insurance  affiliation; 
coherence of the  Directive with  the Directive on the recognition  of professional 
qualifications; and the application of the professional rules for the health service 
provider. 

The challenges  emerging from the public and targeted consultations were addressed by 
discussing and validating the study findings with experts and stakeholders. For instance, 
the  preliminary  findings  of  the  study  were  presented  in  different  fora  such  as  a  virtual 
workshop  with  stakeholders  organised  by  the  study  team,  a  meeting  of  the  ERN 
coordinators group, and a meeting of the cross-border healthcare expert group.  In these 
other  consultations,  stakeholders  indicated  that  they  agreed  with  most  of  the  results, 
which they considered to be in line with their knowledge and views on the performance 
of the Directive. 

2.  CONSULTATION RESULTS 

The  results  of  the  various  stakeholder  consultation  activities  are  presented  below  per 
overarching question.   

2.1.  To  what  extent  is  the  Directive  relevant  for  meeting  patients’  needs  to  cross-
border healthcare and what is the patients' awareness of their rights to cross-
border healthcare? 

The  first  part  of  this  question  refers  to  the  relevance  of  the  Directive  in  relation  to  the 
needs of patients. According to stakeholders across all sectors, the Directive continued to 
be  relevant  to  the  cross-border  healthcare  needs  of  EU  citizens,  and  in  particular  of 
patients  with  rare  diseases.  However,  some  needs  remained  unaddressed,  which 
constituted barriers for traveling abroad for healthcare. 

Stakeholders  at  EU  and  national  level,  including  national  authorities,  healthcare 
providers, insurers, and patients, recognised that the Directive provided a clear common 
framework  to  guarantee  patients’  rights  to  cross-border  healthcare.  Moreover,  for  ERN 
representatives  (including  patient  representatives),  the  objectives  of  the  Directive 
corresponded to the current and future needs of patients with rare and complex diseases. 
Adding  to  this,  over  half  of  public  consultation  respondents  who  were  aware  of  the 
possibility  of  getting  reimbursed  for  healthcare  costs  incurred  in  another  EU  country 
under  the  existing  EU  schemes  (i.e.,  the  Directive  and  the  rules  on  Social  Security 
Coordination) believed that the EU schemes met patients’ needs either completely (4%), 

98 

 
to a great extent (20%), or to some extent (33%). The perspective of the receivers of the 
healthcare  services  (citizens,  patient  organisations  and  NGOs  representing  specific 
groups161) was more negative though, than that of the organisers/providers/payers of the 
services: while 51% of the latter believed that patients’ needs were met either completely 
or to a great extent, just 19% of the former agreed. Six in ten of these felt that needs were 
met either to some extent (36%) or to a limited extent (24%). 

Stakeholders referred to some financial, mobility, language and specific needs of patients 
with  rare  diseases  that  remained  unaddressed  and  that  constituted  barriers  for  traveling 
abroad for healthcare. Stakeholders across all sectors highlighted financial needs as a key 
barrier  to  being  able  to  access  healthcare  abroad.  For  instance,  69%  of  public 
consultation  respondents  identified  the  need  to  pay  upfront  for  treatment  costs  as  the 
main  barrier 
to  cross-border  healthcare.  Stakeholders  representing  people  with 
disabilities  referred  to  the  fact  that  the  Directive  contained  no  specific  obligatory 
provisions to support the needs for those less able to travel (for example, elderly people) 
or people with  disabilities.  Language barriers were identified as one of the five biggest 
barriers to cross-border healthcare by 52% of respondents to the public  consultation.  In 
relation  to  patients  with  rare  diseases,  representatives  of  patients  and  workshop 
participants noted that there were delays in securing prior authorisation for these patients 
given  that  the  doctors  may  not  have  the  knowledge  on  rare  conditions  required  to 
perform the clinical evaluation.  

In terms of future needs, it is worth noting that six in ten public consultation respondents 
agreed  that  the  Directive  could  help  health  systems  tackle  a  possible  backlog  of 
postponed  treatments  arising  from  the  pandemic,  either  completely  (12%),  to  a  great 
extent (28%) or to some extent (20%). 

The second part of this overarching question looks at patients' awareness of their rights to 
cross-border  healthcare.  In  the  public  consultation,  the  receivers  of  the  healthcare 
services were significantly less positive about this than the organisers/providers/payers of 
the healthcare services. While just over a quarter of the receivers (27%) considered that 
they were informed completely or to a great extent about their rights to seek healthcare 
abroad,  this  was  three  quarters  (74%)  among  the  organisers/providers/payers  of  the 
healthcare  services.  Moreover,  citizens  were  significantly  less  likely  to  know  about  the 
reimbursement  possibilities  under  the  two  existing  EU  schemes  (Directive  and  Social 
Security Coordination Regulations) than respondents representing organisations with an 
EU/international or national scope of work (65% said they were aware of this, while this 
was 97% and 85% in the other two groups). Most respondents (52%) also reported that 
patients did not receive information from their healthcare provider on treatment options 
in another EU country. From the patients and patient organisations consulted, there was 
evidence that many citizens did not know their rights and may either go abroad without 

161 Consumers, elderly, disabled, LGBTIQ, and socio-economically disadvantaged groups. 

99 

 
                                                 
checking the procedures for reimbursement and amounts first with NCPs or their health 
insurance or not even apply for reimbursement after being treated abroad. 

Key  to  patients’  awareness  of  their  rights  are  the  NCPs;  however,  awareness  of  NCPs 
remained low among citizens, as revealed in the public consultation162 and other targeted 
consultations. In the public consultation, the receivers of the healthcare services tended to 
be  much  more  negative  about  the  completeness,  clarity  and  quality  of  the  information 
provided  by  NCPs,  and  generally  considered  it  more  difficult  to  find  information,  than 
the  organisers/providers/payers  of 
In  general,  patients,  patients’ 
representatives  and  organisations  representing  specific  groups  pointed  to  the  need  of 
enhancing completeness and accessibility of the information provided by NCPs, as well 
as  the  provision  of  information  in  a  suitable  format  for  people  with  disabilities  and 
covering the LGBTIQ community. ERNs representatives and NCPs who participated in 
the  workshop  also  noted  the  lack  of  readily  available  information  on  ERNs  services 
targeted at patients with rare diseases and doctors treating these patients.  

the  services. 

National  authorities  were  more  positive  about  the  performance  of  NCPs  though, 
indicating  that  NCPs  had  received  an  increasing  number  of  queries  and  that  in  general 
patients  recognised  them  as  the  agency  responsible  for  cross-border  healthcare  in  their 
country. National authorities also stressed that information provision on patients’ rights 
by  NCPs  had  improved  significantly  in  the  last  years.  However,  other  stakeholders, 
including  patients/citizens,  considered  that  information  on  aspects  such  as  safety  and 
times  had  not  been  provided 
quality  standards, 
systematically or in a comparable format across NCPs. In particular, healthcare providers 
noted  that  information  on  these  aspects  (and  especially  information  on  treatment  costs) 
could not always be provided to patients given that in many Member States this was not 
even available at central level. 

treatment  prices  and  waiting 

2.2.  How effectively does the Directive operate in practice and what barriers remain 

to patients seeking cross-border healthcare?  

The first part of this question refers to the practical implementation of the Directive. In 
the  interviews  and  additional  targeted  consultations,  stakeholders  across  all  sectors 
agreed that the Directive had brought improvements for patients to make their preferred 
choice  for  treatment.  They  considered  that  the  Directive  had  contributed  to  removing 
some  obstacles  to  accessing  healthcare  in  another  Member  State,  including  for  patients 
with rare and complex diseases patients. For them, the clear legal framework had made 
an  important  contribution  to  facilitate  access  to  cross-border  healthcare.  Also,  the  fact 
that patients did not need, for the most part, approval to receive care abroad or that they 

162  69%  of  those  responding  to  the  public  consultation  as  citizens  said  they  were  not  aware  of  the  NCPs, 

compared to 74% of people representing EU/international organisations who said they were aware. 

100 

 
                                                 
were able to access private care were mentioned by most national authorities consulted as 
facilitators of cross-border healthcare. 

In  relation  to  the  system  of  voluntary  prior  notification,  which  enables  the  patient  to 
receive  a  written  confirmation  of  the  amount  to  be  reimbursed  based  on  an  estimate, 
national  authorities  and  health  insurers  from  the  Member  States  that  have  applied  this 
system163  considered  the  system  to  be  positive  as  it  reduced  patients’  uncertainty 
regarding reimbursement amounts. They noted that, although the system did not provide 
definite  assurance  of  the  cost  for  the  patient,  it  provided  certainty  that  the  treatment 
abroad  was  covered  by  the  national  healthcare  system  and  that  an  amount  of  the  costs 
would  be  reimbursed,  therefore  reducing  the  financial  risk  for  the  patient.  This  was 
considered by stakeholders to be of great importance for patients. 

Another  aspect  of  the  practical  implementation  of  the  Directive  is  the  recognition  of 
prescriptions  across  EU  borders.  For  national  authorities,  the  mutual  recognition  of 
prescriptions  was  an  example  of  where  the  Directive  had  worked  to  decrease  barriers. 
However,  pharmacists  and  representatives  of  pharmacists  also  highlighted  some 
persisting  issues  on  this  matter.  They  stated  that  in  some  Member  States,  rules  on 
recognition of prescriptions had not yet been duly integrated into national legislation, and 
in countries where they had, pharmacists occasionally faced difficulties to ascertain the 
authenticity and validity of prescriptions issued by a prescriber in another Member State. 
Language  was  identified  as  another  barrier  accounting  for  non-dispensation.  Adding  to 
this,  four  in  ten  public  consultation  respondents  (38%)  said  that  they  were  aware  of 
problems with pharmacists in another EU country not recognising prescriptions. 

Last,  in  relation  to  the  establishment  of  ERNs,  representatives  of  ERNs,  national 
authorities,  representatives  of  patients  with  rare  diseases,  health  professionals  and,  in 
general, stakeholders from the rare diseases sector agreed that the Directive, through the 
ERNs, had been effective in supporting the diagnosis and treatment of patients with rare 
and  complex  diseases.  Moreover,  in  the  ERNs  targeted  survey,  81%  of  respondents 
agreed that ERNs had effectively impacted research and knowledge sharing on rare and 
complex  diseases  among  EU  healthcare  professionals.  According  to  stakeholders, 
effective knowledge sharing was one of the areas where the objectives of the ERNs were 
being best achieved. ERNs had proceeded at different pace on this but most of them now 
had  regular  webinars,  education  sessions,  seminars,  etc.  where  they  spread  knowledge 
and  had  high  attendance  rates.  Generally,  stakeholders  consulted  indicated  that  the 
effectiveness of ERNs varied between ERNs and that many were still at an early stage of 
development.  

163 DK, EE, EL, IE, IT, PL, SE and NO. 

101 

 
                                                 
The  establishment  of  the  virtual  consultation  panels  through  the  Clinical  Patient 
Management System (CPMS) was generally positively assessed by stakeholders and was 
highlighted  as  being  increasingly  used  for  the  diagnosis  and  treatment  of  patients  with 
rare  diseases.  As  highlighted  by  representatives  of  ERNs,  patient  registries  had  an 
enormous  potential  in  improving  patients’  care  and  were  raising  the  interest  of  the 
pharmaceutical  industry,  as  they  allowed  to  create  cohorts  of  patients  necessary  for 
research  on  new  therapies.  Several  stakeholders  also  stressed  that  ERNs’  patient 
registries  were  being  developed 
their 
interoperability.  Moreover,  nearly  six  in  ten  respondents  to  the  public  consultation 
indicated that ERNs had helped to increase professional training, to at least some extent. 
Representatives  of  ERNs  noted  that  this  was  particularly  relevant  for  junior  physicians 
interested in the treatment of rare diseases. 

in  a  much  harmonised  way 

to  ensure 

The second part of the questions refers to  barriers which prevent  patients from  seeking 
healthcare  abroad.  Over  half  of  public  consultation  respondents  agreed  that  there  were 
persisting  barriers  to  patients  seeking  healthcare  in  another  EU  country,  with  53%  that 
either completely agreed or agreed to a great extent with this. For instance, stakeholders 
reported that there were gaps in relation to the availability of information for patients to 
make  an  informed  choice  on  cross-border  healthcare  (as  discussed  in  the  previous 
question).  Patients’  representatives  and  health  insurers  mentioned  that  there  was  a 
persisting confusion of patients on how to access care under the Directive and the Social 
Security  Coordination  Regulations.  Moreover,  healthcare  providers  indicated  that  the 
most  common  areas  where  information  was  lacking  were  in  relation  to  prior 
authorisation, treatment prices, and quality and safety standards. 

Language  barriers  were  also  identified  as  one  of  the  main  barriers  to  cross-border 
healthcare by respondents to the public consultation. Patients, patient representatives, and 
health  insurers  reported  that  in  some  cases  patients  were  required  to  provide  certified 
translations of healthcare documentation in order for their healthcare systems to process 
their  reimbursements  (as  discussed  below).  Workshop  participants  highlighted  that 
certified  translations  of  medical  records  were  justified  in  many  cases,  as  they  had 
financial risks for the national healthcare systems providing the reimbursement, as well 
as clinical risks for the  doctors that had to interpret  the document. Certified translation 
therefore mitigated this risk. 

Stakeholders across all sectors highlighted financial barriers as a key barrier to being able 
to  access  healthcare  abroad. They  referred  to  the need to  pay upfront, as well as travel 
costs.  Moreover,  national  authorities  and  representatives  of  healthcare  providers  at  EU 
level  highlighted  the  discrepancy  in  tariffs  for  medical  services  between  countries, 
meaning that patients from countries with lower tariffs for services (primarily in Eastern 
Europe) would have to pay the difference from their own pocket if travelling to countries 
with higher tariffs. 

102 

 
Other barriers highlighted by public consultation respondents included: the difficulties in 
transferring  medical  records  between  systems;  the  lack  of  follow-up  care  in  the  home 
country;  uncertainty  about  prices  and  reimbursements;  difficulties  in  accessing  public 
healthcare providers/treatment options abroad; the translation of medical documents and 
invoices  required  by  health  insurer;  and  difficulties  in  accessing  healthcare  and 
insufficient  support  for  those  with  disabilities,  including  the  lack  of  information  on  the 
accessibility of hospitals. 

National  authorities  and  health  insurers  also  noted  that  patients  generally  preferred  to 
receive  care  close  to  home  and  most  were  not  eager  to  go  abroad  even  if  they  could 
afford  it.  They  agreed  with  other  stakeholders  that  going  abroad  was  difficult  as  there 
were  language  barriers,  costs  associated  with  travel,  patients  may  not  have  relatives  or 
friends to rely on while they are abroad, or they may not have a place to stay. 

Last,  national  authorities,  health  providers  and  health  insurers  mentioned  that  patients 
may  face  challenges  in  continuity  of  care,  often  arising  from  differences  between  the 
healthcare system of the country of treatment and of affiliation. For example, one health 
insurer noted that difficulties could arise if a particular medical service required as part of 
the follow-up care was not available in the country of affiliation. One representative of 
health providers noted that continuity of care also raised issues of professional liability, 
as different healthcare professionals and systems are responsible for the treatment and the 
aftercare. Challenges could arise also from the application of standards of care between 
the two countries or if the patient comes back to his home country with a device that was 
not used there. In the public consultation, almost half of respondents (46%) reported that 
they were aware of administrative issues for patients receiving follow-up care at home. In 
a  targeted  questionnaire,  healthcare  providers  said  that  they  did  provide  follow-up 
treatments  to  patients  who  had  been  treated  abroad  and  that  they  ensured  continuity  of 
care, but that there were still some challenges (as outlined above). 

In  relation  to  barriers  pertaining  to  ERNs,  representatives  of  ERNs  mentioned  that  the 
virtual panels were quite burdensome regarding the amount of information that needed to 
be entered for each patient and that it took time to set up and use the CPMS. However, 
they also acknowledged that a simplification of the CPMS was already ongoing and the 
expectation  was  that  it  would  increase  its  use  considerably.  They  also  noted  that  there 
was  a  weak  integration  of  ERNs  in  the  national  health  systems  and  a  lack  of  care 
pathways of referring patients to the ERNs was not clear. In the absence of referral routes 
and considering a general lack of awareness among professionals outside the field of rare 
diseases  on  how  to  access  the  ERNs,  the  stakeholders  consulted  demanded  increased 
teamwork  between  NCPs  and  ERNs  in  relation  to  provision  of  information  to  patients 
and  practitioners.  Another  issue  reported  which  was  affecting  the  effectiveness  of  the 
ERNs was the fact  that hospitals were not  reimbursed for the time that their healthcare 
professionals  spent  treating  foreign  patients  on  virtual  panels.  Thus,  when  doctors 
allocated time to virtual consultations, they did it outside of their working hours and/or 

103 

 
take time away from their national patients. Last, in the public consultation, respondents 
referred  to  some  additional  barriers  including  the  non-interoperable  IT  systems  and 
administrative burden.  

2.3.  To  what  extent  has 

the  expected  benefits  at 
proportionate costs, and what have been the administrative burdens for patients 
seeking healthcare in another Member State?  

the  Directive  delivered 

The  first  part  of  the  question  addresses  the  efficiency  of  the  Directive.  Stakeholders 
across  all  sectors  generally  agreed  that  the  impact  of  the  Directive  on  national  health 
budgets  arising  from  patients  wishing  to  access  cross-border  healthcare  was  marginal. 
Some  national  authorities  pointed  out  that  there  was  a  concern  before  the  Directive’s 
adoption that it would cause a large flow of financial resources to  finance cross-border 
healthcare services. However, they considered that, in practice, the financial impact had 
been  modest  so  far.  No  stakeholder  reported  that  complying  with  the  Directive  created 
any  excessive  or  disproportionate  costs  for  public  authorities  and  national  insurance 
bodies or other health insurance providers.  

National  authorities  and  health  insurers  explained  that  the  Directive  states  that  patients 
have the right to be reimbursed for the care received abroad, up to the value of the same 
care  in  their  home  health  system.  For  them,  this  provision  of  the  Directive  was  key  to 
limiting the costs arising from the Directive for Member States, particularly for Eastern 
European  countries  where  tariffs  were  lower  than  in  other  parts  of  Europe.  Moreover, 
they stressed that the burden or cost of applying the Directive was comparable to that of 
the Social Security Coordination Regulations, under which in most cases, Member States 
reimbursed each other for the entire cost incurred by the Member State of treatment. 

Furthermore,  stakeholders  agreed  that  with  the  limited  number  of  patients  accessing 
cross-border  healthcare  via  the  Directive,  the  benefits  of  the  Directive  had  also  likely 
been  modest  across  the  Member  States.  National  authorities  and  health  insurers 
mentioned  that  the  Directive  could,  in  theory,  contribute  to  greater  efficiency  in 
healthcare provision across the EU. 

In terms of benefits, there was agreement across all stakeholder groups that patients with 
rare or complex diseases were a clear patient group benefiting from the Directive, given 
the improvements in the diagnosis and treatment of rare diseases made possible through 
the establishment of the ERNs. 

Stakeholders  of  the  rare  diseases  sector  considered  that  the  establishment  of  the  ERNs 
had entailed a relatively small investment from the European Commission, compared to 
the  size  of  the  network  and  the  number  of  healthcare  providers  that  were  involved. 
Representatives of ERNs indicated that they could finance most of the activities with the 

104 

 
existing  funding;  however,  they  also  mentioned  that  more  financial  resources  were 
needed to  ensure the sustainability of the ERNs.  ERNs representatives  emphasised that 
the system relied on experts dedicating part of their working hours or overtime to work 
on ERN activities, without appropriate compensation mechanisms. They pointed to some 
“hidden costs” to the participation of experts, which are borne by their employers or by 
themselves. 

For  ERN  representatives,  there  was  considerable  administrative  burden  coming  from 
their participation in the networks. They mentioned that ERNs had been operating under 
different  grants,  which  meant  they  had  to  deal  with  different  applications,  reporting 
obligations, and numerous deadlines. Moreover, they pointed to the significant time spent 
in inputting data into the CPMS and setting up the system for virtual consultations, which 
was not accounted for anywhere. 

ERN  representatives  welcomed  the  announced  changes  to  the  grant  system  which  they 
understood  would  entail  a  100%  of  funding.  There  was  agreement  across  stakeholders 
from the rare diseases field that integrating the ERNs to the national health system would 
help  to  increase  sustainability,  as  well  as  professionalise  the  participation  of  experts  in 
the ERNs. 

ERNs  representatives  also  considered  there  was  room  to  improve  the  network’s  cost-
effectiveness in the future. Some ERN tools, for example, the CPMS had still not shown 
the extent to which it can be a more cost-effective solution than the physical movement 
of  patients  to  specialised  centres.  According  to  them,  the  ERNs  had  lot  of  potential  to 
produce cost-savings in the future. Collaboration and virtual consultations could not only 
avoid transportation costs but could also help to minimise the risk of misdiagnosis, which 
in  rare  diseases  was  very  high.  On  stakeholder  provided  an  example:  a  misdiagnosed 
pediatric kidney cancer could cost up to EUR 2 million.  

The second part of the questions refers to the administrative burdens for patients seeking 
healthcare abroad. According to stakeholders that replied to the public consultation, the 
Directive  had  contributed  to  some  extent  to  removing  obstacles  to  cross-border 
healthcare.  Nevertheless,  they  also  highlighted  persisting  administrative  difficulties  or 
burden,  especially  for  patients,  such  as  complex  administrative  procedures  for  prior 
authorisation and reimbursement. One stakeholder specifically noted that it could take up 
to 20 days for patients to receive acknowledgement from the administrative body dealing 
with  reimbursement  of  receipt  of  the  request,  and  even  more  time  to  process  it.  Other 
stakeholders  representing  healthcare  providers  and  public  authorities  mentioned  that 
often  patients  lacked  the  documents  requested  to  be  attached  to  their  reimbursement 
requests and documents had to be retrieved from the healthcare provider in the treating 
country.  In  some  cases,  additional  forms  were  required  when  the  treatment  exceeded 
certain  costs  (e.g.,  over  EUR  200  for  dental  treatment).  Patient  representatives  warned 

105 

 
that administrative burdens were a deterrent to patients and were more important than the 
quality  and  safety  of  the  healthcare  for  the  patient  when  deciding  about  receiving 
healthcare abroad. 

insurers  also  pointed 

to  persisting  administrative  burdens 

to 
Health 
reimbursement  claims  stemming  from  the  need  to  translate  certain  documentation,  to 
review and process the submitted medical documentation, and to follow-up with patients 
who  may  not  have  all  the  documentation  needed  to  process  the  reimbursement.  The 
missing  information  may  bring  delays  in  processing  the  reimbursement  request.  Also, 
additional  information  or  documentation  required  is  sometimes  difficult  to  obtain  from 
healthcare providers due to privacy reasons.  In some Member States, each cross-border 
healthcare claim required a case-by-case assessment by health insurers. 

related 

2.4.  How does  the Directive interact  with other  legislation, such as the Regulation 

on the coordination of social security systems? 

A  majority  of  stakeholders  agreed  that  the  Directive  had  brought  improvements  for 
patients to make their preferred choice for treatment. They viewed as generally positive 
that  there  is  a  legal  framework  for  cross-border  healthcare  that  includes  both  the 
Directive and the Social Security Coordination Regulations. However, they also pointed 
out that the two parallel  EU schemes (in addition to national, bilateral,  and multilateral 
schemes  or  agreements)  create  some  confusion  and  it  is  difficult  for  patients  to 
understand and providers/insurers to manage. Both patients and healthcare professionals 
often  are  unaware  that  different  rules  apply,  for  example  for  planned  and  unplanned 
healthcare,  or  if  the  care  is  provided  by  public  or  private  providers.  Moreover,  some 
health  insurers  indicated  that  they  work  on  a  case-by-case  basis,  investigating  which  is 
the  most  appropriate  or  beneficial  route  for  each 
individual  patient  seeking 
reimbursement of cross-border healthcare costs. Workshop participants agreed with this 
and  emphasised  that  patients  find  the  different  pathways  confusing.  They  were  of  the 
view  that  the  responsibility  for  navigating  these  pathways  should  be  of  the  healthcare 
authorities,  rather  than  the  patients,  although  patients  still  need  information  about  their 
rights and entitlements to effectively engage with authorities’ advice. 

This  was  confirmed  also  in  consultations  of  patients  (and  organisations  representing 
patients).  For  instance,  there  were  references  to  cases  where  patients  had  travelled 
abroad,  paid  up  front,  obtained  partial  reimbursement  of  costs  and  then  learned  that  it 
could  have  been  done  through  the  Regulations  with  full  reimbursement.  Healthcare 
providers have also pointed out that the dual system is sometimes also confusing to them. 

Adding to this, most respondents to the public consultation (81%) said they were aware 
of the possibility of getting healthcare costs incurred in another EU country reimbursed 
under  the  existing  two  EU  schemes;  among  which  71%  said  that  they  were  aware  of 
problems  resulting  from  them  and  referred  to  the  administrative  burden  and  slow 
authorisation and/or reimbursement procedures.  

106 

 
In the field of rare diseases, stakeholders of this sector were of the view that the activities 
on  rare  diseases  under  the  Directive  were  coherent  with  other  relevant  legislation  and 
policies  and  that  there  were  no  major  incompatibilities.  ERNs  and  Member  States 
representatives, as well as researchers in the field of rare diseases, noted that ERNs were 
an appropriate tool that fit well with other initiatives such as the Orphanet database, the 
European Joint Programme on Rare Diseases, which, with support from the Commission 
and Member States, aimed at creating a rare diseases research eco-system in Europe and 
bring together researchers and practitioners. Specifically, on Orphanet, the synergies with 
the  ERNs  and  the  importance  of  their  work,  for  example  in  the  development  of  the 
ORPHAcodes  were  highlighted  by  stakeholders  working  in  this  field.  This  was  also 
highlighted at the virtual online workshop where a participant explained the importance 
of  adopting  the  ORPHAcodes  as  a  building  block  for  the  description  of  rare  diseases 
across Member States. 

2.5. 

In  what  ways  has  the  Directive  provided  EU  added  value  in  terms  of  patient 
rights  to  cross-border  healthcare  and  patient  choice  of  healthcare  services  in 
the EU?  

Stakeholders from all sectors generally agreed that the Directive had provided EU added 
value in cross-border healthcare by providing a framework in which to implement cross-
border coordination mechanisms. They referred mainly to improvements in the provision 
of  information  to  patients  through  the  NCPs,  cross-border  recognition  of  prescriptions, 
mechanisms  for  reimbursement,  and  diagnosis  and  treatment  options  for  patients  with 
rare and complex diseases. 

National authorities, health insurers, health providers and patient representatives saw the 
Directive  as  a  very  good  instrument  which  reinforced  patients’  right  to  seek  healthcare 
abroad. However, they  were of the view that more needed to  be done to realise its full 
potential in practice. Often as a result of low awareness among citizens and practitioners, 
some  instruments  or  rights,  such  as  NCPs  or  the  recognition  of  prescriptions,  were  not 
being used as much as they could.  

In relation to the EU added value of the ERNs, 85% of respondents to the ERNs targeted 
survey  considered  that  the  ERNs  had  effectively  provided  an  added  value  for  patients 
with  rare  diseases,  compared  to  what  could  have  been  achieved  at  the  national  level 
alone.  In  the  public  consultation  and  interviews,  stakeholders  from  all  sectors  also 
stressed the strong added value of the ERNs and the collaboration in rare diseases. They 
pointed  out  that  through  the  ERNs  network  there  was  quicker  access  for  patients  to 
specialised  advice.  They  also  noted  that  the  ERNs  had  offered  EU  added  value  by 
helping  health  professionals  provide  diagnosis  and  treatment  options  for  patients  with 
rare diseases, facilitating the exchange of knowledge and best practices among healthcare 
professionals,  helping  EU  countries  with  an  insufficient  number  of  patients  with  a 
particular  medical  condition,  or  lacking  technology  or  expertise,  to  provide  highly 
specialised services of high quality, and helping to generate knowledge and contributing 
to research on rare diseases in the EU. 

107 

 
ERNs  coordinators  referred  also  to  ERNs  added  value  during  the  Covid-19  pandemic. 
They explained that thanks to the ERN structure, they were able to respond to questions 
from patients with rare diseases. Moreover, coordinators were able to work together and 
agree  very  quickly  which  patients  should  get  priority  for  vaccination  and  for  which 
patients vaccination would not be advisable. Without the ERNs this process would have 
taken  much  more  time.  Another  benefit  mentioned  was  that  through  the  ERNs,  health 
professionals  could  connect  to  and  hold  discussions  with  other  areas  outside  of  their 
expertise.  To  illustrate  these  contributions  of  ERNs,  as  well  as  areas  for  improvement, 
one stakeholder said: “ERNs are a diamond, but they still need to be cut and formed, to 
become more accessible for patients and professionals”. 

108 

 
 
 
 
 
 
 
 
 
 
ANNEX VI. EUROPEAN REFERENCE NETWORKS 

Name  
Endo-ERN  

ERNICA  

ERKNet  

ERN 
ITHACA  

Description/Disease 
European 
Reference 
Network  on  endocrine 
conditions 
European 
Network  on 
and 
anomalies  

Reference 
inherited 
congenital 

Name  
ERN 
EuroBloodNet  

ERN RITA  

on 

Reference 
kidney 

European 
Network 
diseases  
European 
Reference 
Network  on  congenital 
malformations  and  rare 
intellectual disability  

ERN 
eUROGEN  

ERN-RND  

ERN BOND   European 
Network 
disorders  
ERN LUNG   European 

Reference 
bone 

on 

ERN 
NMD  

EURO-

ERN Skin  

ERN EYE  

Reference 
on 

Reference 
on 

Description/Disease 
European 
Network 
haematological diseases  
European 
Network 
immunodeficiency, 
autoinflammatory 
autoimmune diseases  
European 
Reference 
Network  on  urogenital 
diseases and conditions  
European 
Reference 
Network  on  neurological 
diseases  

and 

European 
Reference 
Network on neuromuscular 
diseases  
European 
Reference 
Network on skin disorders  

European 
Network on eye diseases  

Reference 

ERN 
CRANIO  

ERN 
PaedCan  

ERN 
EpiCARE  

ERN  RARE-
LIVER  

ERN 
EURACAN  

ERN 
ReCONNET  

Reference 
Network  on  respiratory 
diseases  
European 
Reference 
Network  on  craniofacial 
and  ENT 
anomalies 
disorders  
European 
Reference 
Network  on  paediatric 
(haemato-
cancer 
oncology)  
European 
Network on epilepsies  

Reference 

Reference 
on 

European 
Network 
hepatological diseases  
Reference 
European 
Network 
adult 
cancers (solid tumours)  
Reference 
European 
Network  on  connective 
tissue 
and 
musculoskeletal diseases  

on 

Source: https://ec.europa.eu/health/ern/networks_en  

109 

ERN 
TRANSPLANT-
CHILD  

European 
Reference 
Network on transplantation 
in children  

ERN 
GENTURIS  

MetabERN  

ERN  GUARD-
HEART  

VASCERN  

on 

Reference 
genetic 

European 
Network 
tumour risk syndromes  
European 
Reference 
Network  on  hereditary 
metabolic disorders  
European 
Reference 
Network on diseases of the 
heart  
Reference 
European 
Network  on  multisystemic 
vascular diseases 

 
 
 
ANNEX VII. INFORMATION  ON  HEALTHCARE  UNDER  THE CBHC DIRECTIVE  AND  THE  REGULATIONS  ON  THE  COORDINATION  OF SOCIAL SECURITY 
SYSTEMS 

Type of healthcare provider 

The Directive gives you the right to treatment by both 
public and private healthcare providers. 

The  Regulations  give  you  the  right  to  treatment  by 
public healthcare providers only. 

Directive  

Regulations 

Payment for cross-border healthcare services  

Under the Directive, you have to pay upfront for the 
healthcare  services  you  use  and  you  will  be  fully  or 
partially reimbursed afterwards. 

Reimbursement 
healthcare 

of 

costs 

for 

cross-border 

Price for healthcare  

You  can  claim  the  costs  you  had  for  healthcare 
services in another EU/EEA country from your health 
insurance institution. It will reimburse the costs up to 
the level that would have been paid in your country of 
residence  (without  exceeding  the  actual  costs  of 
healthcare received). 

Private  healthcare  providers  and,  in  certain  cases, 
public  healthcare  providers  are  allowed  to  set  their 
own  prices  or  apply  "private"  prices  for  your 
healthcare as for a domestic patient. 

However,  they  cannot  discriminate  against  patients 
from other EU/EEA countries. 

110 

Under the Regulations, you are entitled to healthcare 
in another EU/EEA country (as well as in CH, and the 
UK)  as  if  you  were  insured  there:    under  the  same 
conditions  and  at  the  same  cost  (free  in  some 
countries) as people insured in that country. 

Costs of the benefits in kind are reimbursed under the 
conditions  and  reimbursement  rates  applicable in  the 
Member  State  of 
the 
treatment. 
reimbursement procedure shall take place between the 
institutions of the countries involved. However, if the 
person  has  borne  the  cost  of  the  treatment,  s/he  can 
request  reimbursement  either  in  the  country  of 
treatment or when returning home. 

In  principle, 

The  prices  charged  are  the  same  as  for  persons 
covered  by  the  social  security  system  of  the  country 
where you received your treatment. 

 
 
 
 
 
 
 
 
 
 
 
authorisation 
of 

required 
for 
is 
Prior 
reimbursement 
healthcare.  Prior 
planned 
authorisation  for  planned  healthcare  (PD  S2)  is 
granted by the health insurance company. 

always 

Prior authorisation  

The  general  rule  is  that  you  do  not  need  prior 
authorisation 
for  cross-border  healthcare.  Your 
country  of  insurance  may  require  prior  authorisation 
for  certain  healthcare  treatments  and  equipment. 
Many  EU  countries  do,  so  it  is  important  to  check 
before  going  if  your  treatment  is  among  treatments 
for which prior authorisation is necessary. 

111