EU actions for cross-border healthcare : significant ambitions but improved management required. Special report No 07, 2019.
Date: 2019-09-02
Institutions: European Court of Auditors
Subjects: EU action, audit, cross-border cooperation, directive (EU), e-Health, exchange of information, health care, health care system, illness, medical computing, medical data, orphan disease, patient's rights, report, right to health

EN 

2019 

NO 07

Special Report  EU actions for cross-border 

healthcare: significant 
ambitions but improved 
management required

(pursuant to Article 287(4), second subparagraph, TFEU) 

 
 
 
 
 
Contents 

Executive summary 

Introduction 

Patients’ rights to cross-border healthcare 

Cross-border exchanges of health data 

Cross-border initiatives for rare disease patients 

Audit scope and approach 

Observations 

The Commission has ensured that the EU Cross-Border 
Healthcare Directive has been put into practice 

2 

Paragraph 

I-IX 

01-16 

02-07 

08-11 

12-16 

17-21 

22-65 

22-32 

The Commission has monitored and enforced transposition of the Directive 

23-25 

The Commission has reported on the operation of the Directive in a timely 
manner 

The Commission guided the National Contact Points in improving the 
information on cross-border healthcare 

Exchanging patients’ health data across borders: high 
expectations had not been matched by results at the time of the 
audit 

The 2018 eHealth Strategy did not include an implementation plan 

The Commission underestimated the difficulties involved in deploying EU-
wide eHealth Infrastructure 

The Commission overestimated the likely take-up of the eHealth Digital 
Service Infrastructure 

European Reference Networks for rare diseases are an ambitious 
innovation but their sustainability has not been demonstrated 

The Commission has not updated its framework for EU actions on rare 
diseases 

The Commission did not apply all lessons learned from the European 
Reference Networks pilots 

The Commission supported the establishment of 24 European Reference 
Networks but did not create an effective system to assess participants 

26-28 

29-32 

33-47 

34-37 

38-44 

45-47 

48-65 

49-51 

52-53 

54-57 

 
 
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58-62 

63-65 

66-72 

The EU budget does not contain a specific budget line for the European 
Reference Networks 

Despite delays, the Commission is now launching an EU wide platform for 
rare disease registries 

Conclusions and recommendations 

Annexes 

Annex I – Comparison of patients’ rights to cross-border 
healthcare under the Directive and the Regulation 

Annex II – State of play of planned deployment for cross-border 
health data exchanges in the EU 

Annex III – List of European Reference Networks 

Acronyms and abbreviations 

Glossary 

Replies of the Commission 

Audit team 

 
 
 
 
4 

Executive summary 

I While cross-border healthcare remains marginal in comparison to healthcare 
delivered domestically, in some situations, the most accessible or appropriate care for 
patients is available in a Member State other than their home country. Patients’ ability 
to make a free and informed choice to access cross-border healthcare can improve 
their healthcare. 

II The 2011 Cross-border Healthcare Directive seeks to guarantee EU patients’ right of 
access to safe and high-quality healthcare across national borders within the EU, and 
their rights to be reimbursed for such care. The Directive facilitates closer cooperation 
in a number of areas: notably the cross-border exchange of patients’ data and access 
to healthcare for patients with rare diseases. 

III Approximately 200 000 patients a year take advantage of the systems put in place 
under the Directive to receive healthcare treatments abroad: less than 0.05 % of EU 
citizens. In recent years, France reported the highest number of outgoing patients and 
Spain the highest number of incoming patients. The majority of patient mobility has 
been between neighbouring Member States. 

IV We examined whether the Commission has overseen the implementation of the 
Directive in the Member States well and provided guidance to the National Contact 
Points responsible for informing patients about their right to cross-border healthcare. 
We assessed whether the results achieved for cross-border exchanges of patients’ data 
were in line with expectations and demonstrated benefits to patients. We also 
examined key recent EU actions in the field of rare diseases focusing on the creation of 
the European Reference Networks. These networks seek to share knowledge, provide 
advice on diagnosis and treatment through virtual consultations between healthcare 
providers across Europe, and thus raise standards of care. 

V We conclude that while EU actions in cross-border healthcare enhanced 
cooperation between Member States, the impact on patients was limited at the time 
of our audit. These actions are ambitious and require better management. 

VI The Commission has overseen the implementation of the Cross-border Healthcare 
Directive well. It has guided the National Contact Points towards providing better 
information on cross-border healthcare, but there remains some scope for 
improvement. 

 
 
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VII At the time of our audit, no exchanges of patients’ data between Member States 
had taken place and no benefits to cross-border patients from these exchanges could 
be demonstrated. The Commission did not establish an implementation plan with 
timelines for its new eHealth strategy and did not estimate the volumes of potential 
users before deploying the cross-border health data exchanges.  

VIII The concept of European Reference Networks for rare disease is widely 
supported by EU stakeholders (patients’ organisations, doctors and healthcare 
providers). However, the Commission has not provided a clear vision for their future 
financing and how to develop and integrate them into national healthcare systems. 

IX Based on our conclusions, we make recommendations focusing on the 
Commission’s support for National Contact Points, the deployment of cross border 
exchanges of health data, and EU’s action in the field of rare diseases. 

 
 
 
 
6 

Introduction 

01 The Cross-border Healthcare Directive (“the Directive”)1:  

— 

sets out EU patients’ rights to access safe and high-quality healthcare across 
national borders within the EU, and their rights to be reimbursed for such 
healthcare; 

—  establishes National Contact Points to provide citizens with information on 

their rights to cross - border healthcare; 

— 

— 

seeks to facilitate closer cooperation on eHealth, including cross-border 
exchanges of patients’ data and   

seeks to facilitate patients’ access to healthcare for rare diseases, notably by 
the development of European Reference Networks (ERNs). 

Patients’ rights to cross-border healthcare 

02 Healthcare is a national competence and Member States finance, manage and 
organise their health systems2. The Directive sets out the conditions under which a 
patient may travel to another EU country to receive planned medical care which will be 
reimbursed under the same conditions as in their Member State. It covers healthcare 
costs, as well as the prescription and delivery of medications and medical devices, and 
complements the legal framework already set out in the EU Regulation on the 
coordination of social security systems3 (see Annex I for the comparison of patients’ 
rights under the Directive and the Regulation). The Directive aims to facilitate access to 
safe and high-quality cross-border healthcare based on the free and informed choice 
of patients, as in some situations, the most accessible or appropriate care for patients 
is only available in a Member State other than their home country. However, the 
Directive does not encourage patients to receive treatment abroad.  

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  Article 168 of the Treaty on the Functioning of the EU (TFEU). 

3  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). This 
Regulation is of relevance to cross-border healthcare in the context of labour mobility and 
tourism and their links between healthcare and social security systems. 

 
 
                                                      
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03 Patients seeking to receive healthcare in another Member State are entitled to 
relevant information on standards of treatment and care, on reimbursement rules and 
on the best legal pathway to use. Each National Contact Point should provide this 
information. Member States can require prior authorisation for certain types of 
healthcare, mainly for treatment which involves either an overnight hospital stay or 
the use of highly specialised infrastructure or equipment. They do so in around 1 % of 
cases.  

04 The Directive confirms that patients seeking healthcare abroad should be 
reimbursed for that healthcare by their home country, provided that they are entitled 
to that healthcare at home. The level of reimbursement for treatment abroad is set at 
the level of cost that would have been incurred by the home country. The requirement 
for upfront payment by patients, while intrinsic to the design of the Directive, is widely 
recognised as a significant challenge that patients face4. However, the Directive offers 
the option for Member States to provide patients with an estimate of healthcare costs. 

05 The number of citizens claiming reimbursement for medical care received abroad 
under the Directive is low (approximately 200 000 claims a year – fewer than 0.05 % of 
EU citizens) compared to those making use of the Regulation on the coordination of 
social security systems (approximately 2 million claims a year for unplanned 
treatments abroad). Expenditure on cross-border healthcare incurred under the 
Directive is estimated at 0.004 % of the EU-wide annual healthcare budget5. A 2015 
Eurobarometer survey reported that fewer than 20 % of citizens were aware of their 
rights regarding cross-border healthcare. The Commission has no recent data on the 
awareness of citizens regarding the Directive. 

06 The use of the Directive varies among the Member States. For cross-border 
healthcare services not requiring prior authorisation, France had the greatest number 
of outgoing patients (close to 150 000 patients in 2016), with Spain, Portugal and 
Belgium treating the highest numbers of incoming patients6. Table 1 shows patient 
mobility in all EU and EEA countries under the Directive in 2016, which covers both 

4  According to results by the survey of NCPs carried out by the Cross-border Healthcare 
Expert Group in May 2017 and confirmed by the ECA’s own survey of Cross-border 
Healthcare Expert Group members. 

5  Commission report on the operation of Directive 2011/24/EU on the application of patient 

rights in cross-border healthcare, COM(2018) 651 final. 

6  Annex B of Commission report on the operation of Directive 2011/24/EU, 

COM(2018) 651 final. 

 
 
                                                      
8 

cross-border healthcare services and products. The numbers include patient mobility 
for both, treatments not requiring Prior Authorisation (in total 209 534 patients) and 
those requiring Prior Authorisation (in total 3 562 patients). 

Table 1 – Patient mobility under the Directive in 2016 

Outgoing patients in 2016 

Incoming patients in 2016 

Country  
FRANCE 
DENMARK 
FINLAND 
NORWAY 
POLAND 
SLOVAKIA 
SLOVENIA 
UNITED KINGDOM 
IRELAND 
CZECHIA 
LUXEMBOURG 
ITALY 
CROATIA 
ROMANIA 
ESTONIA 
ICELAND 
BELGIUM 
LATVIA 
LITHUANIA 
CYPRUS 
SPAIN 
GREECE 
AUSTRIA 
BULGARIA 
PORTUGAL 
MALTA 
GERMANY 
HUNGARY 
NETHERLANDS 
SWEDEN 
Total 

Number of patients  
146 054 
25 343 
11 427 
10 301 
8 647 
6 110 
1 835 
1 113 
791 
401 
277 
201 
200 
130 
80 
53 
30 
27 
19 
13 
11 
10 
9 
5 
5 
4 
no data 
no data 
no data 
no data 

213 096 

Country 
SPAIN 
PORTUGAL 
BELGIUM 
GERMANY 
LUXEMBOURG 
CZECHIA 
ESTONIA 
ITALY 
POLAND 
SWEDEN 
GREECE 
HUNGARY 
AUSTRIA 
CROATIA 
NETHERLANDS 
UNITED KINGDOM 
ROMANIA 
BULGARIA 
IRELAND 
MALTA 
FINLAND 
FRANCE 
LITHUANIA 
NORWAY 
SLOVAKIA 
CYPRUS 
DENMARK 
LATVIA 
ICELAND 
SLOVENIA 
Total 

Number of patients  
46 138 
32 895 
27 457 
27 034 
12 530 
12 300 
10 044 
9 335 
6 545 
6 162 
5 639 
4 169 
2 437 
1 680 
1 653 
1 646 
1 003 
686 
674 
463 
403 
371 
369 
327 
259 
254 
198 
167 
141 
117 

213 096 

Source: ECA based on Report on Member State data on cross-border patient healthcare following 
Directive 2011/24/EU – Year 2016 available on the Commission’s website. 

07 The Commission supports cross-border cooperation in healthcare by means of 
numerous studies and initiatives, including via Interreg7, funded under the European 
Structural and Investments Funds. Member States are responsible for managing their 

7  European Territorial Cooperation (ETC), better known as Interreg, is one of the two goals of 
the EU cohesion policy and provides a framework for joint actions and policy exchanges 
between national, regional and local stakeholders from different Member States. 

 
 
 
                                                      
9 

health systems, and for any cooperation arrangements between Member States. Such 
cooperative arrangements often develop without the involvement of the Commission. 
The recent Commission study on activities and EU investment in cross-border 
cooperation in healthcare identified 423 EU-funded projects8 in support of cross-
border collaboration initiatives in healthcare in the period from 2007 to 2017. 

Cross-border exchanges of health data 

08 The Directive mandates the Commission to support Member States cooperation 
on eHealth and establishes a voluntary network of Member State authorities (eHealth 
Network) to support the development of common standards for transferring data in 
cross-border healthcare. eHealth is also a key part of the European Commission’s 
Digital Single Market strategy and its development in the EU is structured around the 
actions listed in the Commission’s Actions Plans for eHealth and in the 2018 strategy 
on eHealth9. The Commission also launched a Task Force in 2017 which is examining 
incentives and obstacles to achieve secure exchange of health data across the EU. 

09 The Commission, together with the Member States, is building an EU-wide 
voluntary eHealth Digital Service Infrastructure (eHDSI), to enable the exchange of 
patients’ health data – specifically ePrescriptions and Patient Summaries – across 
national borders. This project involves 22 Member States10 and aims at connecting 
their eHealth systems to the EU eHealth Infrastructure through a dedicated “portal” 
known as the National Contact Point for eHealth (NCPeH) (see Figure 1 showing the 
procedure for cross-border exchange of ePrescriptions). 

8  Study on Cross-Border Cooperation. Capitalising on existing initiatives for cooperation in 

cross-border regions – Commission study published in March 2018. The list of projects and 
their objectives as identified by the study may be accessed online here. 

9  Commission’s Communication on enabling the digital transformation of health and care in 

the Digital Single Market; empowering citizens and building a healthier society of 
25 April 2018, COM(2018) 233 final. The Communication resulted from the mid-term 
review of the Digital Single Market Strategy. 

10  Belgium, Czechia, Germany, Estonia, Ireland, Greece, Spain, France, Croatia, Italy, Cyprus, 
Lithuania, Luxembourg, Hungary, Malta, the Netherlands, Austria, Poland, Portugal, 
Slovenia, Finland, and Sweden. 

 
 
                                                      
Figure 1 – Cross-border exchange of an ePrescription 

10 

Source: ECA. 

10 In some Member States11, the use of ePrescriptions is common. Other Member 
States however have only recently started to pilot or implement ePrescriptions 
services. Reduced availability of eHealth services at national levels is one of the main 
challenges associated with the deployment of the EU-wide eHealth Infrastructure. In 
addition some Member States do not participate at all (e.g. Denmark – see Box 1 on 
eHealth applications for patients) or only participate in some of the services of the EU-
wide eHealth Infrastructure. 

Box 1 – eHealth applications for patients in Denmark 

The national eHealth portal – Sundhed.dk (https://www.sundhed.dk) allows Danish 
patients to access their medication profiles, view scheduled consultations with 
healthcare providers, and re-order certain medication themselves. In 2018, the 
Danish authorities were working on a pilot project to add further features to the 
eHealth portal so as to make it easier for patients who consult the doctor frequently 
(e.g. for chronic disease patients) to schedule their appointments. 

In addition, the “Medicinkortet” mobile application allows patients to request an 
extension for their existing digital prescriptions. All medical prescriptions issued in 
Denmark are digital. 

11  Ten Member States reported more that 90 % as national coverage for ePrescriptions in 
2017 (Croatia, Czechia, Denmark, Estonia, Finland, Greece, Italy, Portugal, Spain and 
Sweden). 

 
 
 
                                                      
11 

11 The EU finances eHealth Infrastructure through the Connecting Europe Facility 
building on a pilot project for cross-border exchanges of health data12. Member States 
that wish to start cross-border exchanges of health data need to go through a testing 
and auditing process following which a Member States Expert Group (eHMSEG) makes 
a recommendation. The eHealth Network then takes a final decision on which 
countries can ‘go live’ in cross-border health data exchanges.  

Cross-border initiatives for rare disease patients 

12 The Directive defines a rare disease as any disease affecting fewer than five 
people in 10 000. An estimated 6 000 to 8 000 rare diseases affect between 6 % and 
8 % of the EU population, i.e. between 27 and 36 million people. The specificities of 
rare diseases – a limited number of patients and a scarcity of relevant knowledge and 
expertise – led the Council of the European Union to single out cooperation in this field 
as “as a unique domain of very high added value of action at Community level”13. 

13 The Commission put forward a specific policy framework to tackle rare diseases, 
notably through the creation of the European Reference Networks, in its 2008 
Communication “rare diseases: Europe’s challenge”. The Directive mandates the 
Commission to support the Member States in the development of the ERNs. Figure 2 
shows successive policy developments leading to their establishment. 

12  epSOS – Smart Open Service for European Patients – project funded under the 

Competitiveness and Innovation Programme (CIP) theme 3: Sustainable and interoperable 
health services.  

13  Council Recommendation of 8 June 2009 on an action in the field of rare diseases. 

 
 
                                                      
12 

Figure 2 – Successive policy developments leading to the establishment 
of the European Reference Networks 

2004

High Level Group on 
health services and 
medical care 

Jan 2004-
Jun 2009

November

2005

2006

2007

Pilot ERNs

Between 
2007-2013

Communication on 
RD

2008

2009

November

Council 
Recommendation on 
RD

June

RD

Task Force

EUCERD 
Recommendations 
on RD

January

2013

Directive 2011/24/EU

October

PARENT Project

Cross-border Healthcare 
Expert Group

European Union 
Committee of 
Expert on RD 

November 
2009-July 
2013

2012

2011

2010

May 2012-
May 2015

March 
2012-
February 
2015

January

EUCERD Joint 
Action

Board of MS

2014

2015

2016

2017

February

March

June 2015-
May 2018

March

European Commission 
Expert Group on RD

Commission 
Implementing Decision

Launched 24 ERNs

Commission 
Delegated Decision

RD-ACTION Joint 
Action

2004-2017
Before the 
establishment of 
ERNs

Source: ECA. 

14 The ERNs are intended to reduce time to diagnosis and improve access to 
appropriate care for rare disease patients and provide platforms for the development 
of guidelines, training and knowledge sharing. 24 Networks were launched in 2017 for 
different classes of rare diseases. Each receives €1 million funding over five years from 
the EU Health Programme. The Commission also finances patient registries and 
support activities for the ERNs as well as the development of IT tools, notably through 
the Connecting Europe Facility (CEF). 

15 When a patient case is referred to an ERN, a “virtual” panel of medical experts is 
convened via the Clinical Patient Management System (CPMS), a web-based 
application provided by the Commission in November 2017. The application enables 
doctors to share information, data and images on individual patients, subject to their 
consent, and to get support in the diagnosis and treatment. 73 % of ERN members had 
registered to use the application and 333 panels had been created by December 2018 
(see Box 2 showing examples of rare disease patients’ cases consulted by the ERNs). 

 
 
 
13 

Box 2 – Examples of a rare disease patients cases consulted by a 
European Reference Network 

In 2018, the ERN for Paediatric Cancer was presented with cases concerning two 
Lithuanian children with rare paediatric cancer. Following advice received from 
specialists via the ERN, new treatments were provided to these children. 

In 2017, the ERN for Rare and Complex Epilepsy was presented with the case of a  
4-year-old Finnish boy who had a specific brain abnormality causing severe epilepsy. 
His doctor in Finland consulted the specialists in the ERNs to seek advice on the right 
treatment. Specialists from at least six other countries were involved in the 
discussions and knowledge sharing on the boy’s treatment.  

In both cases, the ERNs provided valuable advice on patient treatment.  

16 The Board of Member States for ERNs14 approves the creation and membership 
of the Networks. By the end of 2018 there were 952 healthcare providers (i.e. 
institutes, hospital units) in over 300 hospitals participating in the ERNs, spread out 
over the EU. No ERN covered more than 19 Member States. Figure 3 shows that the 
distribution of healthcare provider members of the ERNs varies across the EU. The 
highest number of HCPs participating in the ERNs comes from Italy. This Member State 
has a longstanding national strategy for rare disease actions and a national network of 
specialised hospitals and centres qualified to assist patients with rare diseases. 

14  The Board of Member States for ERNs was created by the 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). 

 
 
                                                      
Figure 3 – Distribution of healthcare provider members of European 
Reference Networks across the EU 

14 

Source: ECA based on data on health care provider members to European Reference Network per 
Member State provided by the Commission, February 2019. 

 
 
 
  
 
 
15 

Audit scope and approach 

17 One of the strategic goals of the European Court of Auditors (ECA) is to examine 
performance in areas where EU action matters to citizens15. Improving Europe's health 
infrastructure and services and their accessibility and effectiveness is an area in which 
EU action can add value for EU citizens. We launched our audit 10 years after the 
Commission approved its strategy on rare diseases and the main EU pilot project for 
cross-border exchanges of healthcare data started. Our audit sought to answer the 
following question: 

Do EU actions in cross-border healthcare deliver benefits for patients? 

18 We examined whether: 

(a)  the Commission oversaw the implementation of EU cross-border healthcare 

Directive in the Member States well; 

(b)  the results achieved so far in terms of cross-border exchanges of health data are 

in line with expectations; 

(c)  EU actions on rare diseases add value to Member States efforts to facilitate 

patients’ access to cross-border healthcare. 

19 Our audit covered the period from the adoption of the Commission’s rare disease 
strategy and the launch of the EU’s main pilot project for cross-border exchanges of 
health data in 2008. We performed the audit work between February and November 
2018 and held interviews with the Commission representatives form Directorate-
General for Health and Food Safety (DG SANTE), Directorate-General for 
Communications Networks, Content and Technology and Directorate-General Joint 
Research Centre (DG JRC) and with five Member States’16 authorities responsible for 
implementing the Directive. Our choice of Member States considered the main EU 
funded projects for cross-border exchanges of health data.  

20 We also surveyed all Member States’ representatives in the Cross-border 
Healthcare Expert Group to obtain their opinions on main developments and 
challenges hampering patients’ access to cross-border healthcare and representatives 
of the eHealth Network on their opinion on the Commission’s work on cross-border 

15  ECA strategy 2018-2020. 

16  Denmark, Italy, Lithuania, the Netherlands and Sweden. 

 
 
                                                      
16 

exchanges of patients’ data. We received 15 responses from the Cross-border 
Healthcare Expert Group and 10 from the eHealth Network.  

21 We audited EU funded projects which aimed to facilitate access to cross-border 
healthcare, including those for exchanging health data across borders and for 
developing and maintaining the European Platform on Rare Diseases Registration. We 
organised an Expert Panel to obtain independent advice on the EU’s rare disease policy 
and the European Reference Networks.  

 
 
 
 
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Observations 

The Commission has ensured that the EU Cross-Border 
Healthcare Directive has been put into practice  

22 In order to oversee the implementation of the Directive, the Commission needs 
to monitor and enforce its transposition by the Member States through completeness 
and compliance checks. The Commission also has to report on the operation of the 
Directive and appropriately guide the National Contact Points responsible for provision 
of information to patients on cross-border healthcare. 

The Commission has monitored and enforced transposition of the 
Directive  

23 Following the Directive’s transposition deadline of 25 October 2013 and the 
Commission’s completeness checks of the transposition by the Member States, the 
Commission opened 26 infringement procedures for late or incomplete notification of 
transposition measures. In addition, the Commission initiated 21 infringement 
procedures on late or incomplete transposition of the Implementing Directive on the 
recognition of medical prescriptions issued in another Member State17. After all 
Member States provided complete notifications of transposition measures, the 
Commission closed these procedures by November 2017. 

24 The Commission checks Member States’ legislation to establish whether they had 
correctly transposed the Directive’s provisions. In order to target these checks, the 
Commission identified four priority areas that act as barriers to cross-border patients: 
reimbursement systems, the use of prior authorisation, administrative requirements 
and the charging of incoming patients. Following these checks, the Commission 
opened 11 own-initiative infringement cases, four of which had been closed by 
November 2018, after Member States amended national transposition measures.  

25 We consider that the Commission’s checks has led to improvements in the 
systems and practices employed by the Member States. 

17  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). 

 
 
                                                      
18 

The Commission has reported on the operation of the Directive in a 
timely manner  

26 The Commission is required to draw up a report every three years, starting in 
2015, on the operation of the Directive18. These reports should include information on 
patient flows and the costs associated with patients’ mobility. While the Directive does 
not oblige Member States to collect data on patients’ flows, it specifies that they shall 
provide the Commission with assistance and all available information for preparing the 
report. In 2013, Member States agreed to provide specific data to the Commission on 
an annual basis. 

27 The majority of Member States were late in the adoption of the national 
transposition measures (see paragraph 23) and this delayed their provision of data to 
the Commission in 2015. In 2017, 26 Member States provided it but for six of them, 
data was incomplete. In addition, data was not comparable from one country to 
another as some Member States reported all reimbursements without specifying 
whether they were granted under the Directive or the Regulation on the coordination 
of social security systems. The Commission recognised the limited accuracy of data 
included in the reports. For example, the overview of patient flows was incomplete. 
Table 1 shows that four Member States did not provide data on outgoing patient flows 
in 2016.  

28 Despite these challenges, the Commission met its reporting obligation on time. It 
adopted its recent report in September 2018 and presented an overview of patient 
flows and of the financial impact of cross-border healthcare under the Directive.  

The Commission guided the National Contact Points in improving the 
information on cross-border healthcare  

29 The Commission supports and guides the National Contact Points with the aim of 
providing clear and comprehensive information on patients’ rights to cross-border 
healthcare. To do that the Commission published a number of relevant studies19. Prior 

18  Article 20 of the Directive. 

19  These studies include: 2012 Study on a best practice based approach to National Contact 
Point websites with recommendations to Member States and the Commission on how to 
provide the appropriate information on various essential aspects of cross-border healthcare 
through NCPs; 2014 Study on the impact of information on patients’ choice within the 
context of the Directive; 2015 Evaluative study on the operation of the Directive containing 
inter alia a review of NCP websites. 

 
 
                                                      
19 

to the Directive’s transposition deadline, in 2013 the Commission sent a guidance note 
to the Member States on cross-border healthcare treatment pathways available for 
patients: the Cross-border Healthcare Directive and the Regulation on the 
Coordination of Social Security systems. 

30 However, fewer than half of the National Contact Point websites explained the 
two different ways for patients to obtain healthcare in other countries20. In March 
2018, the Commission sought to address the potential for confusion between the two 
pieces of legislation by holding a capacity-building workshop for NCPs and by 
developing a practical toolbox to help NCPs pass the information on to patients. Our 
survey showed that the competent authorities in the Member States welcomed the 
toolboxes, but that further work is needed to help explain the difference to patients. 

31 A recent Commission study21 considered that the information available to 
patients on NCPs websites was generally adequate and met the requirements of the 
Directive, but that the websites could provide more information on incoming patient 
rights and on the reimbursement of cross-border healthcare costs for outgoing 
patients. In addition, a report on the Directive by the European Parliament noted that 
“in-depth information on patients’ rights was generally lacking on the NCPs 
websites”22.  

32 NCPs are not required by the Directive to include information on European 
Reference Networks on their websites. We found that some NCPs did provide such 
information, and others were considering how to do so. German, Irish, Estonian, 
Lithuanian and UK representatives have already expressed interest in liaising with the 
ERN Board of Member States for ERNs23. The rare disease experts that we consulted 
considered that NCPs should provide such information about the Networks.  

20  According to a survey of NCPs carried out by the Commission for its Report on the 

operation of the Directive. 

21  Study on cross-border health services: enhancing information provision to patients 

published on 20 July 2018. 

22  The report on the implementation of the Cross-Border Healthcare Directive of 

29 January 2019 by the Committee on the Environment, Public Health and Food Safety. 

23  The report from the meeting of NCPs of 5 May 2017. 

 
 
                                                      
20 

Exchanging patients’ health data across borders: high 
expectations had not been matched by results at the time of 
the audit 

33 Creating mechanisms to exchange patients’ health data within the EU requires a 
clear strategic and governance framework, supported by the Member States. Clear 
objectives should be set and performance monitored regularly. Before launching the 
large-scale projects, the Commission with the support of the Member States should 
estimate the volumes of potential users. Lessons should be learnt from the earlier pilot 
projects. 

The 2018 eHealth Strategy did not include an implementation plan 

34 The Commission’s eHealth Action Plans set out its approach to eHealth, including 
to cross-border exchanges of patients’ health data. The current Action Plan runs from 
2012 until 2020. In April 2018, the Commission adopted a new eHealth strategy24, 
which is broader in scope than the current Action Plan. It notably includes the possible 
expansion to cross-border exchange of electronic health records. 

35 In 2014, the Commission published an interim evaluation of the eHealth Action 
Plan25. While positive overall, the evaluation noted some weaknesses and 
recommended that the Commission should update the plan to include the most 
relevant issues, provide a clear governance structure and create a monitoring and 
coordination mechanism. 

36 The Commission implemented most of the actions foreseen in the eHealth Action 
Plan. It has not followed the 2014 evaluation recommendation to update its Action 
Plan nor revised it to reflect the 2018 eHealth Strategy. Therefore, the plan does not 
include relevant issues, such as the introduction of the General Data Protection 
Regulation. In addition, the Commission has not set out responsibilities for the plan’s 
implementation. 

24  Commission’s Communication on enabling the digital transformation of health and care in 

the Digital Single Market; empowering citizens and building a healthier society of 
25 April 2018, COM(2018) 233 final. The Communication resulted from the mid-term 
review of the Digital Single Market Strategy. 

25  Interim evaluation of the eHealth Action Plan 2012-2020, Deloitte study prepared for the 

Commission. 

 
 
                                                      
21 

37 The 2018 eHealth strategy refers to new challenges such as the introduction of 
the General Data Protection Regulation and cybersecurity threats. However, this 
strategy did not include an implementation plan with timelines for expected results 
and outputs that would show the Commission’s approach to implementing the eHealth 
strategy. When the Commission launched its 2018 strategy on eHealth the only 
evaluation of its 2012-2020 Action Plan dated from 2014. 

The Commission underestimated the difficulties involved in deploying 
EU-wide eHealth Infrastructure  

38 The Commission has worked on exchanges of patient health data between 
Member States in two stages: a pilot project (epSOS)26 from 2008 to 2012, costing 
€18 million and an ongoing deployment project (EU-wide eHealth Infrastructure) with 
a budget of €35 million27 launched in 2015. 

39 epSOS’s goal was to develop an Information and Communication Technology 
framework and infrastructure to enable secure cross-border access to patient health 
information. The pilot was to test the functional, technical and legal feasibility and 
acceptance of the proposed solution for cross-border health data exchanges. It was 
intended to “demonstrate the practical implementation of the solution in a number of 
settings in a number of participating states”.  

40 The project developed the definitions of data content of Patient Summaries and 
ePrescriptions (see paragraph 09) as well as mechanisms for testing, reviewing and 
approving exchanges of health data across borders. It has contributed to the 
development of eHealth interoperability specifications and guidelines. It has also 
provided common standards to foster these exchanges and demonstrated Member 
States commitment to cooperation in this area. 

41 The project planning phase did not set the scope and scale of testing required 
before practical implementation. Testing of the feasibility of the proposed solution 
consisted of 43 transfers of patient data. This meant that the project provided a 
limited practical demonstration of the proposed solution. In the final review of the 
project, external evaluators concluded that the number of real Patient Summaries and 
ePrescriptions was “too low to consider the epSOS services as operational and 

26  The total project budget was €38 million of which the EU agreed to co-finance €18 million. 

In total 24 countries participated in the project.  

27  The amount includes IT services for the ERNs.  

 
 
                                                      
22 

robust”28. However, this exchange, while limited, was considered by the Commission a 
sufficient proof of concept for the eHDSI. 

42 The Commission assessed the epSOS project in 2014. This assessment noted that 
“although the expectations about statistically relevant numbers of patients’ 
encounters have not been met in the epSOS project so far, the concept of the epSOS 
approach for cross-border interoperability has been proven to be valid”29. In addition, 
interoperability problems at legal, organisational and semantic levels had proven to be 
a greater challenge than expected. The Commission also identified ineligible costs 
claims from the project’s contractors, mostly linked to personnel costs. At the time of 
our audit, the Commission was in the process of recovering ineligible expenses, 
amounting to 42 % of financing provided. 

43 Despite these challenges, in 2015 the Commission decided to use this pilot 
project’s outputs as the basis for the development of the large scale EU-wide eHealth 
Infrastructure (eHDSI). The eHDSI architecture, technical and semantical specifications, 
legal, organisational and policy agreements among the participating Member States 
are based on epSOS deliverables. 

44 We identified weaknesses in the Commission’s preparation for this complex 
project, notably insufficient estimation of the volumes of potential users (patients and 
providers, i.e. pharmacies and hospitals) of the cross-border eHealth services that 
eHDSI provides and an insufficient assessment of the cost-effectiveness of these 
services before launching the eHDSI. Therefore, we find that the Commission 
underestimated difficulties involved in deploying an EU-wide eHealth Infrastructure. 

The Commission overestimated the likely take-up of the eHealth Digital 
Service Infrastructure  

45 Commission announcements on the likely level of health data exchanges across 
borders have been overoptimistic (see Box 3). 

28  Final technical review report of EpSOS of 12 November 2014 

29  In 2014, DG SANTE’s Information Systems Unit carried out an epSOS project assessment in 

order to obtain an overview of what the project delivered in terms of output and 
achievements and to summarise the conclusions about the maturity of the project for 
potential further large-scale implementation. 

 
 
                                                      
23 

Box 3 – The Commission’s announcements on the take-up of EU-wide 
eHealth Infrastructure 

In December 2017 the Commission announced that: “In 2018, twelve EU Member 
States will start exchanging patient data on a regular basis”30. 

On its website on eHealth Infrastructure governance, the Commission stated that “It 
is expected that towards 2019, the EU’s cross-border health data exchange starts to 
be an accepted practice of the national healthcare systems ...”31. 

When assessing its own performance, the Commission reported in 2017, 
ten Member States as “having capacity to the health data exchange and join the 
Cross-Border eHealth Information Services”32. This figure was based on Member 
States’ self-reporting on a question about the establishment of their national 
eHealth portals and included Member States which had only started to build their 
portals, but had not confirmed their readiness to exchange health data across 
borders. 

46 By the time of our audit (November 2018), exchanges of patients’ health data 
across borders had not yet started via the EU eHealth Infrastructure (see Annex II, 
which shows the planned ‘going-live’ deployment dates for cross-border health data 
exchanges in the Member States). By this time, the Commission had assessed the 
capacity of seven Member States33 to ‘go live’ in cross-border exchanges. Four of these 
Member States (Czechia, Estonia, Luxembourg and Finland) had undergone follow up 
checks. In October 2018, the eHMSEG recommended that they ‘go live’, provided that 
all corrective actions had been taken. Figure 4 presents the process by which Member 
States join the Cross-border eHealth Information Service and the 2018 state of play. 

30  Commission’s website: Cross-border digital prescription and patient data exchange are 

taking off. 

31  Commission’s website: eHDSI governance. 

32  Annex of the 2016 Annual Activity Report (AAR) – Health and Food Safety. In its 2017 AAR, 
the Commission reported nine Member States, as Denmark withdrew from the Cross-
Border eHealth Information Services (see paragraph 10 and Box 1). 

33  Czechia, Estonia, Croatia, Luxembourg, Malta, Portugal, and Finland. 

 
 
 
                                                      
24 

Figure 4 – The process of joining the Cross-border eHealth Information 
Service – state of play 2018 

CEF funding for 
national eHealth 
Infrastructure to join 
eHDSI in 2018-2021 

(Member States) 

Technical Testing & 
Checks 

(The Commission) 

Readiness for & 
admission to cross-
border service 
(eHMSEG & 
eHealth Network) 

‘Going live’ 
for cross 
border 
health data 
exchanges 

22 countries 
received CEF 
grants 

7 countries 
checked 

4 countries 
admitted  

Source: ECA based on information provided by the Commission. 

47 We also found that these four Member States were admitted to the EU-wide 
eHealth Infrastructure to operate different types of eHealth services. At the time of 
the audit, Finland was ready to send ePrescriptions, while Estonia could receive them 
(in early 2019 this was the only exchange of ePrescription available in Europe). 
According to the Commission, 550 ePrescriptions were settled this way between 
January and the end of February 2019. Czechia and Luxembourg were ready to receive 
Electronic Patient Summaries from abroad, but no Member States could yet send them 
via eHDSI. In addition, at the start only some national Healthcare Providers and 
pharmacies in these countries will use the system. Box 4 explains how patients could 
benefit from cross-border exchanges of ePrescriptions and Electronic Patient 
Summaries. 

 
 
 
 
 
 
25 

Box 4 – Cross-border exchanges 

ePrescriptions (the case of Finland and Estonia),  

When a patient with an ePrescription issued in Finland goes to an Estonian 
pharmacy to get their medicine, the pharmacy should register the patient’s ID. The 
pharmacy should then send the prescription data, provided patient consent is 
available, to the Estonian eHealth portal (NCPeH) which should forward it to the 
Finnish eHealth portal. After the medicine is dispensed to the patient by the 
Estonian pharmacy, the Finnish eHealth portal should be informed that the 
ePrescription has been processed (see Figure 1).  

and Electronic Patient Summaries. 

When an individual has a medical emergency or makes an unplanned visit to a 
healthcare provider abroad, medical personnel could electronically access basic 
medical information about the patient in the patient’s home country via the EU 
eHealth portal. The Patient Summary may include information on the patient’s 
allergies to medication and can facilitate patient’s diagnosis abroad.  

European Reference Networks for rare diseases are an 
ambitious innovation but their sustainability has not been 
demonstrated 

48 For the Commission to effectively support the Member States in the 
development of the European Reference Networks, such support needs to be provided 
in the context of the legal framework, and with a coherent strategy and a clear 
roadmap.  

The Commission has not updated its framework for EU actions on rare 
diseases  

49 The development of the European Reference Networks is part of the EU’s wider 
policy on rare diseases, which includes such elements as support for the development 
of national rare disease plans, improved standardisation of rare disease nomenclature 
and support for research on rare diseases. The Commission’s 2008 Communication on 
rare disease aimed to “encourage cooperation between the Member States and if 
necessary to lend support to their action”. The objective was to set out “an overall 
Community strategy for support to Member States”34 in tackling rare diseases. The 

34  Commission Communication “on Rare Diseases: Europe’s challenge”, COM(2008) 679 final. 

 
 
                                                      
26 

Council endorsed this approach in its Recommendation on an action in the field of rare 
diseases of 8 June 200935. 

50 The Commission published an implementation report on both, the 
Communication and the Council Recommendation in 2014. The report concludes that 
“by and large, the objectives of the Communication and the Council Recommendation 
have been reached”. These objectives included the establishment of a clear definition 
of rare diseases or improvement of their codification in the healthcare systems. The 
report does caution that “there is still a long way to go” to ensure rare disease patients 
across the EU get the care they need and points to the lack of rare disease strategies in 
some Member States as an area requiring further work. It lists 11 actions envisaged by 
the Commission including continued support for the European platform for rare 
diseases and for the development of rare disease plans.  

51 Despite the conclusion that the objectives had been reached, nine of the 
11 envisaged actions are a continuation of existing initiatives. The Commission has not 
updated its rare disease strategy since 2008, although it is managing important 
initiatives such as the Networks and the EU wide platform for rare diseases registries. 

The Commission did not apply all lessons learned from the European 
Reference Networks pilots 

52 The Commission funded ten pilot Reference Networks between 2007 and 
2013.The Commission’s consultative committee on rare diseases (EUCERD)36 evaluated 
these pilot ERNs and published a “Preliminary analysis of the outcomes and 
experiences of pilot European Reference Networks for rare diseases” in 2011. 
However, when the Commission set up the ERNs, they tackled only some of the issues 
raised in the 2011 evaluation e.g. support for patient registries, the need for a 
dedicated Information and Communication Technology tool and for each Network 
member to have quality control processes for its care practices. Outstanding issues 
include: 

— 

sustainability of the Networks beyond their initial funding period; 

— 

the development of a continuous monitoring and quality control system for the 
Network members; 

35  Council Recommendation of 8 June 2009 on an action in the field of rare diseases. 

36  European Union Committee of Experts on Rare Diseases (EUCERD) set up by the European 

Commission Decision of 30 November 2009 (2009/872/EC). 

 
 
                                                      
27 

— 

the administrative challenges and financial costs of expanding a Network and 

— 

sustainable support for patient registries. 

53 The Board of Member States for the Networks has, since its launch in 2014, 
continued to work on these outstanding points. It has made progress on continuous 
monitoring and quality control (for which in September 2018 it approved a set of core 
indicators collected by the ERNs). However, new issues such as the integration of the 
Networks into national healthcare systems and collaboration with industry have 
emerged and have yet to be resolved. Figure 5 illustrates the different challenges 
facing the Networks, which the Commission, the Board of Member States or the 
Networks Coordinators Group are currently trying to address. 

Figure 5 – Challenges to the European Reference Networks development 

Conti nuous
moni toring

Sus tainable 
funding

Col l aboration 
wi th i ndustry

Integration i nto
MS hea lthcare
s ys tems

ERN

Ma na gement
mode

Da ta  policy/ 
regi stries

Source: ECA, based on Board of Member States for European Reference Networks minutes. 

 
 
 
 
28 

The Commission supported the establishment of 24 European Reference 
Networks but did not create an effective system to assess participants 

54 The Directive mandated the Commission to establish specific criteria and 
conditions which Healthcare Providers must fulfil in order to join an ERN37. The 
Commission used a consultant to develop a set of guidelines for applicants as well as 
for the Independent Assessment Body (IAB), which evaluated the ERNs and individual 
Healthcare Provider applications. The Commission worked to raise awareness of the 
launch of the ERNs among relevant stakeholders and its initial objective to support the 
establishment of ten ERNs38 was exceeded as 24 were created (see Annex III showing a 
list of European Reference Networks).  

55 Figure 6 illustrates the assessment process of Healthcare Provider’s applications 
to join the ERNs. Before submitting an application, every Healthcare Provider had first 
to be endorsed by their Member State’s competent authority. The assessment 
procedure at the EU level was limited to an eligibility check of applications and the 
assessment of a sample of 20 % of individual applications.  

37  The Commission developed the framework for this work in the Implementing and 

delegated decisions of 10 March 2014. 

38  DG SANTE 2016 AAR (Annex A, p. 169) indicates an interim milestone of ten ERNs under the 

result indicator 1.5.A: number of established ERNs. 

 
 
                                                      
Figure 6 – Decision tree for the eligibility check and assessment process 
for Healthcare Provider (HCP) applications to join European Reference 
Networks 

29 

953
HCPs 
apply

European 
Commi ssion

El i gibility check 
of a l l applications

1 rejected

952 pa ss

~80 %
773 no revi ew

773 HCPs  
joi n the ERN

952
HCPs 
joined

~20 %

179 document revi ew 
i ncl uding 41 on-site checks

Positive Opinion: 
117 HCPs  join 
the ERN

Preliminary Negative Opinion: 
62 HCPs  a llowed to provide 
more i nformation

IAB rea ssess 
HCP a pplication

Positive Opinion: 
48 HCPs  joi n 
the ERN

2nd Interim Negative 
Opinion: 
14 HCPs  provi de further 
i nformation

Positive Opinion: 
14 HCPs  joi n 
the ERN

Source: ECA analysis based on documents provided by Consumer, Health, Agriculture and Food 
Executive Agency. 

 
 
 
 
30 

56 The Independent Assessment Body produced 62 negative preliminary reports. For 
all these cases, the applicants provided information39 on outstanding issues which 
enabled the Assessment Body to give a positive opinion. However, our examination of 
a sample40 of assessment reports found that in many cases, the Assessment Body 
awarded its final positive opinion on the basis of incomplete information. The final 
outcome of the assessment process was that 952 Healthcare Providers out of the 953 
that applied were accepted into the ERNs. We conclude in practice that this 
assessment process added limited value to the establishment of the ERNs. 

57 The sample-based system of assessment was not originally complemented by any 
other monitoring or assessment measures. The Commission has been working with the 
Member States representatives and ERN coordinators since December 2016 on 
developing a system of continuous monitoring by the Commission and periodic self-
evaluation for all ERNs members. However, at the time of the audit they had  not 
decided what measures should be taken if this monitoring system identifies under-
performing Healthcare Providers. The Commission also plans to evaluate the ERNs at 
the end of their five-year financing period41. 

The EU budget does not contain a specific budget line for the European 
Reference Networks 

58 The Directive required the Commission to support Member States in the 
development of the ERNs. The EU budget does not contain a specific budget line for 
the ERN costs. To support the ERNs’ operations, the Commission has provided funding 
from different spending programmes (Health Programme, Connecting Europe Facility) 
and through different spending mechanisms (calls for proposals and tenders). The 
Commission did not set out a comprehensive spending plan for the period 2017-2021 
and communicate it to the ERNs and budgetary authority. 

59 In November 2017, the Commission provided the Networks with the Clinical 
Patient Management System for sharing and consulting patients’ data (see 
paragraph 15). Patients’ consultations using this system is one of the significant 
aspects of the ERNs’ operations. However, the use of cross-border consultations 

39  Article 4(5) of Commission Implementing Decision 2014/287/EU. 

40  In our sample of 50 Healthcare Providers assessment reports from 23 ERNs, we found that 

30 Healthcare Providers did not provide information on clear action plan. 

41  Article 14 of Commission Implementing Decision 2014/287/EU of 10 March 2014. 

 
 
                                                      
31 

through CPMS highlighted the issue of recognising doctors’ time spent  on the 
diagnosis and treatment of patients in another Member State. Figure 7 shows the 
number of consultation panels created in the System per ERN between 
November 2017 and December 2018. 

Figure 7 – Consultation panels are a sign of ERN operation  

44

38

20

12

9

7

6

5

7

6

11

6

3

4

31

20

10

19

12 14

27

15

5

2

50
45
40
35
30
25
20
15
10
5
0

Source: Commission’s CPMS report 12.2018 

Number of panels

60 Each ERN coordinator currently receives €1 million over a period of five years in 
EU funding42 for administrative costs. There were often delays in the payment of the 
annual administrative funding to the ERNs. A Commission survey of ERN coordinators 
in January 2018, to which 20 ERNs responded, showed that sustainability of financing 
is one of the top two challenges facing the ERNs43. 17 of the 24 ERNs have included 
identification of other funding sources within their objectives or risk-mitigation 
strategies. 

61 In addition to this administrative funding the Commission provided grants to the 
ERNs to support the achievement of their objectives. It launched procurement 
procedures to develop activities to support the establishment and development of the 
Networks. By the end of 2018, these included: 

— 

— 

the use of the eHealth solutions, i.e. Clinical Patient Management System 
(€5 million allocated from the Connecting Europe Facility fund); 

the development of the Clinical Practice Guidelines (in total €4 million from the 
Health Programme); 

42  3rd Health Programme. 

43  Board of Member States for ERNs, 6 March 2018. 

 
 
 
                                                      
32 

— 

— 

— 

— 

the ERNs’ registries (in total €2 million for five ERNs in 2018 from the Health 
Programme); 

the provision of training and tools for ERN coordinators (call for tender to external 
company with estimated value: €400 000); 

the provision of secretarial support to the ERN coordinators Working Group (call 
for tender to external company with estimated value: €380 000); 

the development of templates of the ERNs’ documents (call for tender to external 
company with estimated value: €100 000). 

62 The ERN coordinators consider that participating in the numerous calls for 
proposals run by the Commission imposed significant administrative burden. 
Moreover, the long-term sustainability of the ERNs’ registries, currently financed with 
Health Programme funds, is unclear despite the Commission emphasising the risk of 
project based funding for registries in its 2008 Communication on rare diseases. 

Despite delays, the Commission is now launching an EU wide platform 
for rare disease registries 

63 In its 2008 Communication on rare diseases, the Commission highlighted the 
importance of databases and registries to enable epidemiological and clinical research 
on rare diseases. It further stressed the importance of ensuring the long-term 
sustainability of these systems. In response to this challenge, in 2013, DG JRC started 
to develop the European Platform for Rare Diseases Registries co-funded by the Health 
Programme44 and open to all European rare disease registries. The JRC’s platform aims 
to deal with the fragmentation of data contained in rare disease patient registries 
across Europe by promoting EU-level standards for data collection and providing 
interoperability tools for rare disease data exchanges. 

64 We found that, in parallel to the JRC platform, the Commission funded another 
project, RD-Connect from research and innovation funding programme (Seventh 
Framework Programme), which had as one of its objectives the creation of a directory 
of patient registries for rare disease research. Both projects have a similar aim of 
connecting registries in the EU to make it easier for researchers to access data on rare 
diseases. As a result, the Commission is funding two projects with potentially 
overlapping outputs. 

44  Based on the Administrative Agreement between DG SANTE and the JRC. 

 
 
                                                      
33 

65 At the time of the audit the JRC platform was due to go live in February 2019, 
more than two years later than initially planned. One of the reasons for the delay was 
that, the development of the JRC platform also included transferring two existing 
networks45 to the JRC, which required more time and resources than anticipated. We 
found that the original timing and budget allocation planned for the platform were 
unrealistic. Furthermore, DG SANTE’s funding provided to the JRC platform currently 
covers approximately 45 % of the costs of the work but there is no provision for the 
financial sustainability of the platform or planning to ensure that the platform is 
successful other than a dissemination plan drafted in the fourth quarter of 2017.  

45  The EUROCAT (European Surveillance of Congenital Anomalies) and SCPE (Surveillance of 

Cerebral Palsy in Europe). 

 
 
 
 
                                                      
34 

Conclusions and recommendations 

66 We examined the Commission’s oversight of the transposition of the Cross-
border Healthcare Directive in the Member States and the results achieved so far for 
cross-border exchanges of health data. We also assessed EU actions in the field of rare 
disease policy. We sought to answer the following question: 

Do EU actions in cross-border healthcare deliver benefits for patients? 

67 We conclude that while EU actions in cross-border healthcare were ambitious 
and enhanced Member States collaboration, they require better management. The 
impact on patients was limited at the time of our audit.  

68 We found that the Commission oversaw the implementation of the Directive in 
the Member States well (paragraphs 23 to 28), and supported the work of National 
Contact Points responsible for providing information for cross-border patients. It has 
recently developed a practical toolbox for the NCPs. However, EU patients still face 
challenges in accessing healthcare abroad and only a minority of potential patients are 
aware about their rights to seek cross border healthcare. The complexity of cross-
border healthcare treatment pathways available for patients under the Cross-border 
Healthcare Directive and Social Security Coordination Regulation makes it difficult to 
provide patients with clear information. NCPs give limited information about ERNs on 
their websites (paragraphs 29 to 32). 

Recommendation 1 – Provide more support for National 
Contact Points 

The Commission should:  

(a)  building on former actions,  support the work of National Contact Points, 

including on how best to communicate the relationship between the Cross-border 
Healthcare Directive and the Social Security Coordination Regulation pathways,  

(b)  provide guidance on presenting information about European Reference Networks 

on the National Contact Points websites; 

(c) 

follow up on the use by National Contact Points of the 2018 toolbox.  

Target implementation date: 2020 

 
 
35 

69 In 2018, the Commission adopted a new eHealth strategy without updating the 
current eHealth Action Plan. The 2018 eHealth strategy does not include an 
implementation plan committing to timelines for expected results and outputs 
(paragraphs 34 to 37). 

70 The work on cross-border exchanges of health data has resulted in the creation of 
interoperability standards. The Commission, in cooperation with the Member States, is 
building EU-wide infrastructure for these exchanges. The Commission did not estimate 
the likely numbers of users of the EU-wide eHealth Infrastructure before launching the 
project. The Commission’s forecasts of the likely take-up of cross-border exchanges of 
health data were overoptimistic. There were delays in the deployment of the eHealth 
Infrastructure and cross-border health data exchanges via eHealth Infrastructure had 
not started at the time of our audit (paragraphs 38 to 47). 

Recommendation 2 – Better prepare for cross border exchanges 
of health data 

The Commission should: 

(a)  assess the results achieved for cross-border exchanges of health data via EU-wide 
eHealth Infrastructure (for ePrescriptions and Electronic Patients Summaries); 

Target implementation date: 2021 

(b) 

in the light of this, assess the 2012 eHealth Action Plan and the implementation of 
the 2018 eHealth strategy, including whether these actions have provided cost-
effective and timely solutions, and meaningful input to national healthcare 
systems. 

Target implementation date: 2021 

71 The launch of the European Reference Networks is an ambitious innovation in 
cross-border healthcare cooperation, particularly as healthcare is a Member State 
competence. The Commission provided the ERNs set up with the Clinical Patient 
Management System to facilitate sharing of patient data. The ERNs were established in 
March 2017 and it is too early to assess their success in adding value to Member States 
efforts to provide better care to rare disease patients.  

 
 
 
36 

72 We found that the Commission has not taken stock of its progress in the 
implementation of the EU rare disease strategy since 2014 (paragraphs 49 to 51). The 
process of establishing the ERNs and the Commission’s on-going support for them was 
marked by shortcomings and the Commission did not set out a spending plan for the 
ERNs. The ERNs face significant challenges to ensure they are financially sustainable 
and are able to operate effectively within and across national healthcare systems. The 
Commission has therefore encouraged Member States to integrate ERNs into national 
healthcare systems (paragraphs 52 to 62). We also found that there were delays in 
launching the EU wide platform for rare disease registries (paragraphs 63 to 65). 

Recommendation 3 – Improve support to facilitate rare disease 
patients’ access to healthcare 

The Commission should: 

(a)  assess the results of the rare disease strategy (including the role of the European 
Reference Networks) and decide whether this strategy needs to be updated, 
adapted or replaced; 

Target implementation date: 2023 

(b) 

in consultation with the Member States set out ways forward to address the 
challenges faced by the European Reference Networks (including integration of 
the European Reference Networks into national healthcare systems, and patients’ 
registries); 

Target implementation date: 2020 

(c)  work towards a simpler structure for any future EU funding to the European 

Reference Networks and reduce their administrative burden. 

Target implementation date: 2022 

 
 
 
 
37 

This Report was adopted by Chamber I, headed by Mr Nikolaos MILIONIS, Member of 
the Court of Auditors, in Luxembourg at its meeting of 10 April 2019. 

        For the Court of Auditors 

Klaus-Heiner LEHNE 

        President 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
38 

Annexes 

Annex I – Comparison of patients’ rights to cross-border 
healthcare under the Directive and the Regulation 

Sector 

Public + Private 

Public only 

DIRECTIVE 

REGULATION 

Eligible treatments 

Treatments available under 
patients’ own country's health-
insurance 

Treatments available under the 
other country's national health-
insurance 

Prior authorisation 

Required under certain 
circumstances 

Always required for planned care 

Not required for emergency 
situations 

Costs covered 

Reimbursement up to the amount 
had the treatment been carried 
out in patients’ home country 

Complete funding (barring co-
payment charges) 

Reimbursement of co-
payment charges 

Up to the limit of the cost in the 
home country 

Yes (under certain conditions) 

Method of payment 

Patients pay up-front and are 
reimbursed at a later time 
(reimbursement-system) 

Between countries, no up-front 
payment from patients required 
(funding-system) 

Eligible countries 

All EU & EEA countries 

All EU & EEA countries + 
Switzerland 

Source: ECA based on the website ‘Healthcare beyond borders’. 

 
 
 
 
 
 
Annex II – State of play of planned deployment for cross-border 
health data exchanges in the EU 

39 

PS-s Patient summary (sending country)
PS-r Patient summary (receiving country)

eP-s ePrescription (sending country)
eP-r ePrescription (receiving country)

Planning changed to 2019

2018

eP-s

2019

2020

2021

eP-r

eP-s

PS-s PS-r

eP-r

PS-s PS-r
PS-r

PS-s

PS-s PS-r eP-s eP-r

PS-r eP-s eP-r PS-s

PS-s PS-r

eP-s eP-r
eP-s

PS-s PS-r eP-s eP-r

PS-r eP-s eP-r PS-s

PS-s

PS-r

eP-s eP-r

PS-s PS-r eP-s eP-r
PS-s PS-r eP-s eP-r
PS-s PS-r eP-s eP-r
PS-s

eP-s
eP-s eP-r

PS-s PS-r
PS-s PS-r
PS-s PS-r

eP-s eP-r
PS-s PS-r eP-s eP-r
eP-s eP-r

PS-r

Country
Finland
Estonia
Czechia
Luxembourg
Portugal
Croatia
Malta
Cyprus
Greece
Belgium
Sweden
Austria
Italy
Hungary
Ireland
Poland
Germany
France
Spain
Slovenia
Lithuania
Netherlands

Source: ‘Service Catalogue, Delivery and Overall Deployment – eHDSI – ePrescription and Patient 
Summary’ available on eHDSI website46. 

46  In November 2018, the eHealth Network granted permission to ‘go live’ in the cross-border 
exchanges of health data via eHDSI to four Member States: Finland can send ePrescriptions, 
while Estonia can receive them. Czechia and Luxembourg are now allowed to receive 
Electronic Patient Summaries from abroad, but no Member States can yet send them via 
eHDSI. Three Member States (Croatia, Malta and Portugal) plan to apply to ‘go live’ in the 
first quarter of 2019. 

 
 
 
 
 
                                                      
40 

Annex III – List of European Reference Networks 

ERN abbreviated 
name 

ERN full name  

Endo-ERN 

ERKNet 

ERN on endocrine conditions 

ERN on kidney diseases 

ERN BOND 

ERN on rare bone disorders  

ERN CRANIO 

ERN on craniofacial anomalies and ENT disorders 

EpiCARE 

ERN on rare and complex epilepsies 

ERN EURACAN 

ERN on rare adult solid cancers 

EuroBloodNet 

ERN on rare haematological diseases 

ERN eUROGEN 

ERN on urogenital diseases and conditions 

ERN EURO-NMD 

ERN on neuromuscular diseases 

ERN EYE 

ERN on eye diseases 

ERN Genturis 

ERN on genetic tumour risk syndromes 

ERN GUARD-Heart 

ERN on rare and low prevalence complex diseases of the heart 

ERN ERNICA 

ERN on inherited and congenital abnormalities 

ERN ITHACA 

ERN on congenital malformations and rare intellectual disability 

ERN LUNG 

ERN on respiratory diseases 

ERN TRANSPLANT-
CHILD 

ERN on transplantation in children 

ERN PaedCan 

ERN on paediatric cancer (haemato-oncology) 

ERN RARE-LIVER 

ERN on hepatological diseases 

ERN ReCONNET 

ERN on connective tissue and musculoskeletal diseases 

ERN RITA 

ERN-RND 

ERN Skin 

ERN on immunodeficiency, autoinflammatory and autoimmune 
diseases 

ERN on neurological diseases 

ERN on rare skin disorders 

MetabERN 

ERN on hereditary metabolic disorders 

VASCERN 

ERN on multisystemic vascular diseases 

 
 
 
 
41 

Acronyms and abbreviations 

AAR: Annual Activity Report 

CEF: Connecting Europe Facility 

CPMS: Clinical Patient Management System 

DG SANTE: Directorate-General for Health and Food Safety 

eHDSI: eHealth Digital Service Infrastructure 

eHMSEG: eHDSI Member States Expert Group 

epSOS: Smart Open Service for European Patients 

ERN: European Reference Network 

EUCERD: European Union Committee of Experts on Rare Diseases 

HCP: Healthcare Provider 

IAB: Independent Assessment Body 

JRC: European Commission’s Directorate-General Joint Research Centre 

NCP: National Contact Point 

NCPeH: National Contact Point for eHealth 

RD: Rare Disease 

TFEU: Treaty on the Functioning of the EU 

 
 
 
 
42 

Glossary 

Cross-border healthcare: healthcare provided or prescribed outside the insured 
person's country of affiliation 

eHealth: use of Information and Communication Technology in health products, 
services and processes combined with organisational change in healthcare systems 
and new skills. eHealth is the transfer of healthcare by electronic means 

Electronic Health Record (EHR): a comprehensive medical record or similar 
documentation of the past and present physical and mental state of health of an 
individual in electronic form, and providing for ready availability of these data for 
medical treatment and other closely related purposes 

ePrescription: a prescription for medicines or treatments, provided in electronic 
format with the use of software by a legally authorised health professional and the 
electronic transmission of prescription data to a pharmacy where the medicine can 
then be dispensed 

European Reference Networks (ERNs): virtual networks involving healthcare providers 
across Europe. They aim to tackle complex or rare diseases and conditions that require 
highly specialised treatment and a concentration of knowledge and resources 

ERN Coordinator: for each network, one member acts as coordinator. They facilitate 
cooperation between network’s members. Interoperability: capacity to make use of 
and exchange data between different health systems in order to interconnect 
information 

Rare Disease (RD): a disease or disorder is defined as rare in the EU when it affects 
fewer than 5 in 10 000 people 

 
 
 
 
 
REPLIES OF THE COMMISSION TO THE SPECIAL REPORT OF THE EUROPEAN 
COURT OF AUDITORS 

“EU ACTIONS FOR CROSS-BORDER HEALTHCARE: SIGNIFICANT AMBITIONS 
BUT IMPROVED MANAGEMENT REQUIRED” 

EXECUTIVE SUMMARY 

I. The Directive 2011/24/EU on the application of patients' rights in cross-border healthcare is seen 
as a major development in EU health policy. It clarifies and codifies the rights to healthcare which 
derive  from  individual  judgments  of  the  European  Court  of  Justice.  Moreover,  it  introduced  a 
number of significant  flanking measures to enable patients' rights to cross-border healthcare to be 
applied in practice. 

V.  The  EU  actions  in  cross-border  healthcare  encompass  innovative  infrastructure  solutions, 
supporting  Member  States  in  an  area  where  they  have  the  main  competence  and  where  the 
development of national infrastructure and use of services at Member State level is very different 
from one Member State to another.  

VI. A robust framework is in place to monitor systematically the application of patients’ rights in 
cross-border  healthcare.  The  Commission  works  with  the  National  Contact  Points  (NCPs)  to 
support  the  continuous  improvement  of  their  information  provision.  Furthermore,  it  published 
recently the Guiding Principles for the practice of National Contact Points under the Cross-border 
Healthcare  Directive  and  a  National  Contact  Point  toolbox  containing  a  range  of  checklists  and 
manuals to support a high quality, patient-oriented practice.  

VII. E-prescriptions issued in  Finland  are now accepted in  Estonia, with  over 550  e-prescriptions 
being  dispensed  between  end  of  January  and  the  end  of  February  2019.  The  exchange  of  patient 
summaries  could  save  lives  of  citizens  travelling  abroad  by  allowing  doctors  in  the  country  of 
destination to access the medical history of the patient and avoid wrong medications, allergies etc. 
This  is  particularly  relevant  for  countries  with  a  large  diaspora.  When  new  cases  will  be  added 
(images,  laboratory  results),  exchanging  this  information  may  bring  savings  to  the  healthcare 
systems, by avoiding the repetition of tests.  

Currently 2 million reimbursements are made every year for cross-border healthcare. There are 1.4 
million  cross-border workers and 17 million  EU citizens are living in  an  EU Member State other 
than their country of citizenship.   

The Commission has set up  an inter-service task force, which monitors the implementation of the 
2018 Communication on enabling the digital transformation of health and care in the Digital Single 
Market; empowering citizens and building a healthier society. 

VIII.  In  the  last  few  years,  the  Commission  developed  a  coherent  approach  in  supporting  the 
European  Reference  Networks  (ERN)  reflecting  the  innovative  nature,  the  complexity  and  the 
political sensitiveness of the ERN Initiative. Acknowledging the pioneer work on rare disease and 
the  innovative  nature  of  the  European  Reference  Networks,  in  2017  the  European  Ombudsman, 
Emily O'Reilly,  gave the first  Prize of the Award for Good Administration to  DG SANTE for its 
policy on rare diseases. 

INTRODUCTION 

1 

 
04. While the Directive offers the option for Member States to provide patients with an estimate of 
healthcare costs (a prior notification), it is not often used. 

09.  The  eHDSI  is  open  to  all  EU  Member  States  and  EEA  countries  and  several  Member  States 
have also announced their intention to join the project.  

10. The eHealth Digital Service Infrastructure (eHDSI) is the pioneering solution enabling the cross 
border exchange of health data between Member States. Once implemented in a Member State, the 
eHDSI becomes part of  the national  eHealth  system,  regulated in  national  legislation. The aim of 
the eHDSI is to empower patients with the access to their data within EU. The prerequisite to start 
exchanging  data  through  the  eHDSI  is  to  have  well  established  and  functional  national  eHealth 
systems. Member States improvements of their national eHealth systems enable exchange of better 
quality data. 

15. The number of panels created in CPMS between November 2017 and the end of February 2019 
was 471 and continues to increase. 

16. In addition to Italy other Member States such as France, Germany, Netherlands, Spain, Sweden, 
etc. are developing National Rare Diseases Plans. 

OBSERVATIONS 

23. The Commission welcomes the European Court of Auditors’ observation that it has monitored 
and enforced the transposition of the Directive and recognises the sustained effort committed over 
the years. The Commission will continue to assess Member States’ compliance with the Directive 
as part of its conformity checks. Cooperation will also continue with the National Contact Points to 
improve  the  information  provision  to  patients,  including  information  on  the  European  Reference 
Networks. 

24. The Commission will continue to address the identified priorities  – reimbursement conditions, 
the  use  of  prior  authorisation,  administrative  requirements  and  the  charging  of  incoming  patients. 
To achieve this, it will use the Cross-Border Health Expert Group, its bi-lateral structured dialogues 
with  the  Member  States  and,  where  necessary,  infringement  proceedings  to  achieve  correct 
transposition of the Directive for the benefit of the European citizens. 

26. The Commission agrees with the European Court of Auditors’ observations and will continue to 
urge Member States to submit completed data sets on patient flows and patient mobility. 

30. The Commission provided the National Contact Points with a toolbox which includes, inter alia 
manuals  for  patients,  information  on  reimbursement  rules  and  decision-making  trees  on  the  best 
legal pathway to receive healthcare in another EU country. This toolbox is publicly available on the 
Europa website. 

The  Commission  acknowledges  the  importance  of  continuous  and  sustained  guidance  to  National 
Contact  Points  on  the  complexity  of  the  two  instruments  (the  Social  Security  Coordination 
Regulations and the Directive) that offer two legal pathways to cross-border healthcare. In addition 
to the capacity-building workshop on 8 March 2018, the Commission published a National Contact 
Points  toolbox  in  March  2019,  including  practical  information  for  patients.  The  Commission  will 
continue to provide NCPs with advice regarding the relationship between the Regulations and the 
Directive. 

2 

 
31. The Commission agrees that more in-depth information could be made available on the NCPs 
website  in  an  accessible,  and  if  possible,  multilingual  format.  The  Commission  will  discuss  the 
matter with the National Contact Points. 

32. The Commission considers that information on the European Reference Networks is of utmost 
importance  for  patients  affected  by  rare  and  complex  conditions  and  will  work  together  with  the 
National Contact Points to offer comprehensive information on the ERNs. 

Common Commission reply to paragraphs 33 and 34:  

The  eHealth  Digital  Service  Infrastructure  is  an  innovative  infrastructure  solution,  supporting 
Member  States  in  an  area  where  they  have  the  main  competence  and  where  the  development  of 
national infrastructure and use of services at Member State level is very different from one Member 
State to another. The eHealth Digital Service Infrastructure has a solid governance structure in line 
with  the  requirements  of  the  CEF  programme  for  Digital  Service  Infrastructures  and  its  progress 
and performance is monitored, on a quarterly basis, via a set of 11 key performance indicators. In 
addition, following an audit on CEF Telecom governance finalised in January 2019 by its Internal 
Audit  Service,  the  Commission  will  better  clarify  some  elements  of  its  operational  arrangements 
and further develop the set of result-oriented KPIs. 

Almost half of the EU population has a European Health Insurance Card, and over 2 million request 
reimbursements  yearly. In 2017, there were 17 million EU citizens living in an EU Member State 
other than their country of citizenship and 1.4 million cross-border workers were active in the EU. 
All of them represent potential users of eHealth Digital Service Infrastructure. 

The exact number of e-prescriptions and patient summaries exchanged depends on the use of these 
services  at  Member  State  level,  and  a  gradual,  but  significant  development  is  expected  (see 
Commission reply to paragraph 41). 

34. The deliverables of the Communication are clearly spelled out in the text, although these are not 
accompanied by timelines. 

Common Commission reply to paragraphs 35 and 36. 

The Commission Communication included  an update of the objectives of the eHealth Action plan 
and  took  up  the  relevant  recommendations  from  its  interim  evaluation.  In  addition,  due 
consideration was given to new opportunities (e.g. in the context of the digital single market and the 
adoption  and  application  of  the  General  Data  Protection  Regulation,  Recommendation  on  a 
European  Electronic  Health  Record  exchange  format)  and  to  new  challenges  (e.g.  cybersecurity 
threats)). 

As  regards  the  actions  listed  on  the  eHealth  Action  Plan  2012-2020,  most  of  them  have  been 
delivered  or  taken  forward  in  the  Commission’s  Communication  on  enabling  the  digital 
transformation of health and care in the Digital Single Market. 

The  action  plan  is  specific  in  terms  of  actions  and  timeline.  The  responsibilities  for  the  plan’s 
implementation  stem  from  the  tasks  and  missions  of  each  Directorate-General.  The  actions  were 
coordinated  with  the  Member  States,  in  the  context  of  the  e-health  Network,  and  with  wider 
stakeholders, such as the research community. 

37.  The  Commission  has  set  up  an  internal  co-ordination  mechanism  (cross-DG  Task  Force)  in 
order to coordinate and oversee the implementation of the Communication. The deliverables of the 
Communication are clearly spelled out in the text. 

3 

 
Before the Communication was adopted, an interim evaluation of the Action Plan on eHealth had 
been undertaken, and the Commission assessed to which extent its actions had been delivered, as set 
out in the Commission reply to paragraphs 35 and 36. The interim evaluation was overall positive, 
as most of the activities foreseen in the Action Plan had been delivered. 

41. It is common practice for any business project to test its feasibility through a small scale "proof 
of concept" and then proceed with scaling-up the project to fit mass-deployment. The exchanges of 
test  data  implemented  within  the  epSOS  and  EXPAND  projects  were  sufficient  to  develop 
specifications and prove that the exchange of patient summaries and e-prescriptions is technically 
feasible.  The  validity  of  the  epSOS  project  conclusions  are  confirmed  by    the  fact  that  e-
prescriptions  issued  in  Finland  are  now  accepted  in  Estonia  (550  e-prescriptions  being  dispensed 
between end of January and the end of February 2019). This confirms that the exchange of test data 
within  the  ePSOS  project,  albeit  limited,  was  sufficient  to  put  down  the  basis  for  the  successful 
deployment of a large-scale cross-border data exchange. 

42.  The  Commission’s  2014  assessment  is  corroborated  by  the  successful  going  live  in  January 
2019 of the eHDSI. 

43.  The  epSOS  final  review  stated  that  an  impressive  basis  has  been  developed  for  the  Legal, 
Semantic  and  Technological  solutions  necessary  to  exchange  important  patient  data  between  the 
European countries. 

The  Commission  concluded  that  epSOS  had  laid  the  foundations  for  cross-border  exchange  of 
patient information. 

44. The cross-border exchange of electronic health data is based on voluntary cooperation among 
Member  States  (see  Article  14(1)  of  the  Cross-Border  Health  Care  Directive  (CBHD)).  Joining 
eHealth Digital Service Infrastructure is voluntary and requires a certain level of digital readiness, 
as well as trust between parties.  

An impact assessment was carried out in support of the provisions of the Directive, including the 
cross-border exchange of data, confirming the need for EU action in the area of cross-border health 
care. 

The potential users include over 2 million EU citizens that request reimbursements yearly for cross 
border healthcare, 1.4 million cross-border workers active in the EU, 17 million EU citizens living 
in  an  EU  Member  State  other  than  their  country  of  citizenship  and,  eventually,  the  population 
having a European Health Insurance Card.  

A gradual, but significant development is expected (see also Commission reply to paragraph 41). 

45.  In  its  public  communication,  the  Commission  used  the  timelines  indicated  by  each  Member 
State participating in the eHDSI1. 

Accurately estimating the time of completion of highly technological and innovative projects in an 
area where subsidiarity plays a major role is very difficult. Moreover, security of the exchange of 

1   Each Member State participating in the eHDSI received the funding from the CEF Telecom Programme to set up their National 
Contact Point for eHealth and start the cross border exchange of health data. The timeline of national implementation is part of a 
Grant Agreement signed by each Member State with the Commission. 

4 

 
                                                      
sensitive patient data had to be ensured, while respecting the voluntary nature of the initiative and 
building trust among Member States. 

46. The eHDSI is operational since January 2019 (see also Commission reply to paragraph 41). 

47. Member States join the cross border exchange of health data according to the readiness of their 
national  system  to  (1)  retrieve  the  data  from  national  infrastructure,  and  (2)  display  the  data 
(received from other Member States) to the healthcare professionals. 

Member  States  may  choose  to  gradually  deploy  different  services  (sending  and  receiving  e-
prescriptions and patient summaries)2. 

Common Commission reply to paragraphs 48 and 49: 

In  the  last  few  years,  the  Commission  developed  a  coherent  approach  and  a  clear  roadmap  in 
supporting the ERNs reflecting the innovative nature, the complexity and the political sensitiveness 
of  the  ERN  Initiative  related  i.a.  to  the  fact  that  the  provision  and  financing  of  healthcare  is  a 
Member  States'  competence  and  that  it  pertains  to  the  Member  States  to  decide  how  best  to 
integrate  the  ERNs  into  their  healthcare  systems.  The  progress  made  by  the  Commission  in 
developing  the  European  Reference  Networks  notably  influenced  the  decision  by  the  European 
Ombudsman, Emily O'Reilly, to award the first Prize of the Award for Good Administration to DG 
SANTE for its policy on rare diseases. In particular, as far as the long term financing is concerned, 
in  the  next  Multi-annual  Financial  Framework  the  Commission  proposed  to  simplify  the  ERNs 
financial support. 

49. Pursuant to Article 168(7) of the Treaty on the Functioning of the European Union3, EU action 
in  the  field  of  public  health  must  fully  respect  the  responsibilities  of  the  Member  States  for  the 
organisation and delivery of health services and medical care. In this context, the Commission can 
focus on coordinating EU action in areas related to rare diseases and on improving patient access to 
diagnosis, information and care.  

50.  Advancing  work  on  the  definition,  codification  and  registration  of  rare  diseases  has  been 
consistently  supported  by  the  Commission  via  a  series  of  projects  and  Joint  Actions.  This  is  an 
ongoing process that has made considerable progress in the five years following the implementation 
report  of  2014  quoted  by  the  European  Court  of  Auditors.  The  Commission's  endeavours  are 
channelled through work with Member States, EU funding mechanisms and Joint Research Centre 
contributions. 

2   The  four  countries  authorised  to  go-live  by  the  eHealth  Network  in  November  2018  plan  to  deploy  more  than  one  service 
(sending and receiving e-prescriptions are two different services). (i) Finland has started sending e-prescriptions and plans to start 
receiving them by the end of 2019. (ii) Estonia has started receiving e-prescriptions and plans to start sending them by the end of 
2019. (iii) The Czech Republic is ready to both send and receive patient summaries and plans to  start sending and receiving e-
prescriptions by the end of 2020. (iv) Luxembourg is ready to receive patient summaries and plans to start sending them by the 
end of 2019. It also plans to start sending e-prescriptions by the end of 2020. 

On  11  March,  Croatia  received  a  positive  recommendation by  the  eHealth  Member  State  Expert  Group  (eHMSEG)  to  go live 
with the exchange of e-prescritions (both sending and receiving) and patient summaries (receiving), once the auditors confirmed 
that the last pending corrective action has been successfully implemented. This recommendation has to be adopted by the eHealth 
Network in order to become effective.  

3   http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12012E/TXT&from=EN  

5 

 
                                                      
51. It is important to recall the innovative nature of the EU work on rare diseases, especially against 
the backdrop of the very limited EU's competencies in the public health policy area. Since 2009, the 
EU's  efforts  have  focused  on  developing  the  various  building  blocks  that  make  up  the  European 
response as described in the 2008 Commission Communication and 2009 Council Conclusion. This 
is still ongoing as can be illustrated by the recent launch of the European Platform on Rare Disease 
Registration in February 2019. 

Taking  stock  of  achievements,  lessons  learned,  and  persistent  challenges,  the  Commission  then 
plans to consult Member States and relevant stakeholders, and revise its rare disease strategy where 
appropriate and relevant4. 

52. The Commission has been developing a continuous monitoring and quality control system for 
the Network members. It has provided comprehensive proposals for the funding of the ERNs in the 
next  Multi-annual  Financial  Framework  and  it  is  engaged  in  a  dialogue  with  the  Member  States 
concerning the financial support that they should provide to the ERNs and their members. Moreover 
the  Commission  is  supporting  the  Member  States  and  the  Networks  in  addressing  the  challenges 
that the Networks are facing. 

53.  The  ERN  initiative  is  innovative  and  complex,  but  also  challenging  and  politically  sensitive, 
especially concerning the integration of the ERNs in the healthcare systems of the Member States, 
taking into account that healthcare provision is a Member States' competence. The Commission has 
been  supporting  the  Member  States  and  the  Networks  in  addressing  this  challenge  as  well  as  the 
others which are emerging in the first years of development of this complex initiative. 

56.  The  Commission  considers  that  the  assessment  was  carried  out  in  accordance  with  the 
Assessment Manual drafted in consultation with the Member States, and looked in detail of to the 
criteria and conditions that each ERN and each healthcare provider applying for membership had to 
fulfil.  An  explicit  scoring  system  was  included  in  the  methodology  and  the  outcomes  signalled 
explicitly in the final reports. 

57. The current legal framework already contains provisions related to the termination of Networks 
and loss of membership of the participant healthcare provider (see Articles 11 and 12 of the 2014 
ERN Commission Implementing Decision) which might be eventually triggered by the outcomes of 
the monitoring exercise. 

58. The Commission highlights that, while it cannot prejudge the final decision of the legislators, it 
has  made  concrete  proposals  for  the  smooth  financing  of  the  ERNs  in  the  next  Multi-annual 
Financial Framework.  

59. In line with the spirit and the letter of Article 12 of the 2011 Cross-border Healthcare Directive, 
the ERN initiative is the primary responsibility of the Member States, which are "supported" in their 
endeavour by the Commission. Therefore, while the Commission provides financial support to the 
ERNs, it can legitimately expect that the Member States actively participate in the financing of this 
initiative. The Commission has therefore notably engaged in a dialogue with the Member States to 
encourage  them,  depending  on  the  way  their  healthcare  systems  are  organised  and  clinical 

4   Notably:  1)  The  conclusions  of  the  Rare  2030  Pilot  Project  funded  by  the  European  Parliament  aims  to  support  future  policy 
decisions, examine the feasibility of new approaches and propose policy recommendations (results expected by early 2021); 2) 
the  evaluation  of  the  Third  Health  Programme  (expected  by  mid-2021);  3)  the  evaluation  of  Directive  2011/24/EU  on  the 
application of patients’ rights in cross-border healthcare (expected by the end of 2022); 4) the evaluation of the Horizon 2020 
Framework Programme for Research and Innovation (expected date still to be confirmed).   

6 

 
                                                      
procedures remunerated, to  ensure their support to ERN Members whose healthcare professionals 
participate in virtual consultation panels. 

61. 

First indent: The total allocated budget from 2015 to 2018 for the development of e-health solutions 
for the ERNs from CEF budget is more than €12 million. 

63. The European Platform on Rare Diseases Registration (EU RD Platform) was launched on the 
Rare Disease Day on 28 February 2019. The infrastructure and tools provided are open to all RD 
registries  and  make  registries'  data  searchable  and  findable.  It  will  facilitate  epidemiological, 
clinical, translational, pharmacological studies and research, fostering knowledge generation on rare 
diseases. 

The  development  of  the  EU  RD  Platform  could  not  be  achieved  within  the  initially  proposed 
timeframe due to the complexity and novelty of the project with its various stakeholders and unmet 
needs. The EU RD Platform has to be seen in its entirety, knowing that it is not one product, but the 
result  of  a  combination  of  many  individual  components,  each  of  which  had  to  be  developed 
separately and then integrated. 

64.  The  scope  of  the  EU  RD  Platform  is  different  from  the  one  of  RD-Connect.  RD-Connect 
focuses  on  genetic  data  and  considers  only  patients  having  genetic  data  resulting  from  specific 
diagnostic  methods  (a  minority).  The  EU  RD  Platform's  Directory  of  Registries  is  an  interactive 
tool  addressed  to  ALL  rare  disease  registries  in  Europe  independent  from  the  genetic  data  (the 
majority). 

When  mapping  the  needs  for  patient  registration  with  all  stakeholders  (registries,  national 
authorities,  patients,  regulators)  neither  RD-Connect,  nor  any  other  stakeholders  reported  that  the 
need  for  a  directory  of  registries  was  already  covered  by  RD-Connect  outputs.  This  indicated 
clearly that the need still existed and was not covered by RD-Connect. 

65. The timing of the go-live of the JRC platform could not be planned with precision from the start 
due  to  the  complexity  of  the  project.  Typical  for  infrastructure  projects,  the  planning  faced  a 
number of unknown factors to conceive, develop and deploy practical solutions for the interaction 
of many hundreds of rare disease registries in the EU, with very different structures, purposes, and 
functionalities,  to  adapt  to  new  data  protection  requirements  and  to  transfer  the  central  databases 
and coordinating activities of the two surveillance networks EUROCAT (European Surveillance of 
Congenital Anomalies) and SCPE (Surveillance of Cerebral Palsy in Europe) to the JRC. 

Both DG SANTE and the JRC are committed to financially sustaining the platform. 

CONCLUSIONS AND RECOMMENDATIONS 

67. eHealth DSI entered into its operational phase on 21 January 2019 when the first Member States 
enabled their citizens to make use of their health data in the cross border environment. Before that, 
eHealth DSI was still in the deployment phase, in which no real benefits could be realised. At the 
same time, good management of the project was proved by running the routine operations. 

The ERNs have already carried out almost 500 virtual consultations and are considered a success by 
all stakeholders. 

68.  The  Commission  agrees  with  the  European  Court  of  Auditors  that  there  remains  a  lack  of 
awareness  of  the  Directive’s  benefits  for  EU  citizens.  Raising  awareness  requires  cooperation 

7 

 
between  all  actors  involved  –  National  Contact  Points,  health  authorities,  health  insurers,  health 
providers  and  patient  organisations  –  at  local,  regional  and  national  level.  At  EU  level,  the 
Commission  publicises  the  Directive  and  its  benefits  on  the  Europa  website  of  the  Directorate-
General  Health and  Food Safety  and on the website “YourEUROPE”. The Commission  will  urge 
NCPs to provide information about the ERNs on their websites. 

Recommendation 1 – Provide more support for National Contact Points 

The Commission accepts recommendation 1(a). 

The Commission will build on its actions to support the work of the National Contact Points (NCP) 
including advice regarding the different legal routes for cross-border healthcare and make the NCP 
toolbox available to the wider public. The toolbox includes useful decision-trees for planned cross-
border treatment to guide patients to the best legal pathway (the Directive or the Regulations). 

The Commission accepts recommendation 1(b). 

Two Commission studies5 provide evidence that the uptake of information on European Reference 
Networks on the NCPs’ website increased over time. The Commission will provide guidance to the 
NCPs to encourage the provision of information on the European Reference Networks to all NCPs. 

The Commission accepts recommendation 1(c). 

The Commission has published the National Contact Point toolbox and will follow up on its use as 
part  of  the  exchange  of  good  practices  in  the  NCP  Sub-Group  meeting  organised  by  the 
Commission. 

69. As stated in paragraphs 36 and 37, when the Communication was adopted, an interim evaluation 
of the Action Plan on eHealth had been undertaken, and the Commission considered to which extent 
its  actions  had  been  delivered  (most  of  its  actions  have  been  delivered)  and  took  its  objectives 
forward  in  the  Communication  on  enabling  the  digital  transformation  of  health  and  care  in  the 
Digital Single Market, empowering citizens and building a healthier society. 

With respect to the implementation of the Communication, the Commission has set up an internal 
co-ordination  mechanism  (cross-DG  Task  Force)  in  order  to  monitor  and  coordinate  the 
implementation of the Communication. 

70. See Commission reply under paragraphs 33 and 44. 

Recommendation 2 – Better prepare for cross border exchanges of health data 

The Commission accepts recommendation 2(a). 

It will monitor and report the results achieved through the eHDSI governance structures. In order to 
provide  the  overall  assessment,  a  critical  mass  of  Member  States  is  needed  and  this  will  be 
achieved, at the earliest, by 2023. 

The Commission partially accepts recommendation 2(b).  

5    https://ec.europa.eu/health/sites/health/files/cross_border_care/docs/2018_crossborder_frep_en.pdf 

8 

 
                                                      
The Commission will monitor and assess the eHealth Strategy and the eHealth Action Plan and will 
consider  appropriate  follow-up  action.  The  focus  of  the  assessment  concerning  cost-effectiveness 
and meaningful input to national healthcare systems will be only on the eHDSI, which is the major 
element of the EU funding. The assessment will build upon the outcome of the actions undertaken 
under 2(a) after 2023. 

72.  The  ERN  initiative  is  very  innovative  and  complex,  as  well  as  politically  sensitive  notably 
because the provision of healthcare is a Member States' competence. The ERNs are financed under 
the  Health  Programme  and  CEF  and  the  Commission  has  made  comprehensive  proposals  to 
continue financing ERNs in the next Multi-annual Financial Framework. The Commission provides 
grants for the development of patient registries and finances a variety of support activities for the 
Networks such as the provision of logistic and secretarial support to the ERN Coordinators Group 
and its Working Groups, the development of taxonomy, of the templates for ERN documents, the 
support to the development of clinical guidelines, the mobility of healthcare professionals, etc. The 
Commission has also raised to the attention of Member States the issue of integration of ERNs in 
national healthcare systems. 

Even if the launch of the European Platform on Rare Diseases Registration (EU RD Platform) was 
delayed for the reasons presented in paragraphs 63 and 65, the JRC organised three training sessions 
(February-March 2018) on the structure and functions of the Platform for users from the ERNs, thus 
preparing the implementation of the Platform with ERN registries. 

Recommendation 3 – Improve support to facilitate rare disease patients’ access to healthcare 

The Commission accepts recommendation 3(a). 

The  Commission  will  assess  the  progress  made  as  regards  the  implementation  of  the  rare  disease 
strategy building on the outcomes of several processes that are currently ongoing or foreseen. 

Taking  stock  of  achievements,  lessons  learned,  and  persistent  challenges,  the  Commission  then 
plans to consult Member States and relevant stakeholders, and revise its rare disease strategy where 
appropriate and relevant by early 2023.  

The Commission accepts recommendation 3(b). 

The Commission works closely with the Member States and the Networks in the ERN Board, in the 
ERN  Coordinators  Group  and  in  various  thematic  working  groups  which  focus  on  the  different 
challenges  faced  by  the  networks  in  their  first  years  of  activities.  The  Commission  is  fully 
committed to supporting the Member States and the European Reference Networks. 

The Commission accepts recommendation 3(c). 

The  Commission  has made  proposals  to  simplify  the  financing  of  the  Networks  within  the  future 
Multi-annual  Financial  Framework,  but  it  cannot  commit  at  this  stage  on  the  outcomes  of  the 
ongoing  negotiations  with  the  co-legislators  concerning  the  future  Multi-annual  Financial 
Framework. 

9 

 
Audit team 

This ECA’s special reports set out the results of its audits of EU policies and 
programmes, or of management-related topics from specific budgetary areas. The ECA 
selects and designs these audit tasks to achieve maximum impact by considering the 
risks to performance or compliance, the level of income or spending involved, 
forthcoming developments and political and public interest. 

This performance audit was carried out by Audit Chamber I Sustainable use of natural 
resources, headed by ECA Member Nikolaos Milionis. The audit was led by ECA 
Member Janusz Wojciechowski, supported by Kinga Wiśniewska-Danek, Head of 
Private Office and Katarzyna Radecka-Moroz, Private Office Attaché; Colm Friel, 
Principal Manager; Joanna Kokot, Head of Task; Nicholas Edwards, Deputy Head of 
Task and Frédéric Soblet, Aris Konstantinidis, Anna Zalega, Michela Lanzutti, Jolanta 
Zemailaite, Auditors. Mark Smith provided linguistic support. 

From left to right: Frédéric Soblet, Kinga Wiśniewska-Danek, Aris Konstantinidis, 
Janusz Wojciechowski, Colm Friel, Joanna Kokot, Nicholas Edwards, Jolanta Zemailaite. 

 
 
Event 

Date 

Adoption of Audit Planning Memorandum (APM) / Start of audit 

7.2.2018 

Official sending of draft report to Commission (or other auditee) 

21.2.2019 

Adoption of the final report after the adversarial procedure 

10.4.2019 

Commission’s (or other auditee’s) official replies received in all 
languages 

16.5.2019 

PDF 

ISBN 978-92-847-1934-1 

doi: 10.2865/280048  QJ-AB-19-005-EN-N 

HTML 

ISBN 978-92-847-1903-7 

doi: 10.2865/946816  QJ-AB-19-005-EN-Q 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The 2011 Cross‐border Healthcare Directive seeks to ensure 
EU patients’ rights to access safe and high‐quality 
healthcare, including across national borders within the EU. 
These rights are also intended to facilitate closer 
cooperation between Member States on eHealth and the 
treatment of rare diseases. We concluded that although EU 
actions in cross-border healthcare enhance Member States’ 
collaboration, the benefits for patients were limited. We 
found that despite the progress made on providing EU 
citizens with information on cross-border healthcare, in 
some areas this information remains difficult to access. We 
identified weaknesses in the Commission’s strategic 
planning and project management. We make 
recommendations focusing on the Commission’s support 
for National Contact Points, the deployment of cross-border 
exchanges of health data, and EU’s actions in the field of 
rare diseases.

EUROPEAN COURT OF AUDITORS 
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Enquiries: eca.europa.eu/en/Pages/ContactForm.aspx 
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