REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare
Date: 2025-12-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: application of EU law, consumer information, cross-border cooperation, delegated legislation, e-Health, free movement of persons, health care, health expenditure, medical device, patient's rights

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   EUROPEAN COMMISSION  Brussels, 12.12.2025  COM(2025) 757 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare  
 
 
1.  Introduction 

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 healthcare1 provides rules for facilitating access 
to safe and high quality cross-border healthcare in the European Union. To this end, patients 
are reimbursed for healthcare in accordance with the principles established by the European 
Court  of  Justice  of  the  European  Union  and  codified  by  the  Directive. At  the  same  time, 
Member  States  remain  responsible  for  providing  adequate  healthcare  in  their  territory. The 
Directive applies to cross-border healthcare without affecting the framework provided by the 
Social Security Coordination Regulations2. 

2.  Legal basis 

With this report, the Commission meets the reporting requirements established in Article 17 of 
Directive  2011/24/EU.  Pursuant  to  that  provision,  the  Commission  is  empowered  to  adopt 
delegated acts, as referred to in Article 17(1), with a view to: 

•  adopting  measures  to  exclude  specific  categories  of  medicinal  products  or  medical 
devices  from  the  recognition  of  prescriptions,  where  necessary  to  safeguard  public 
health, as provided for in Article 11(5); 

•  adopting specific criteria and conditions that the European Reference Networks (ERNs) 
must fulfil, and the conditions and criteria required from healthcare providers wishing 
to join such networks, including criteria for evaluating ERNs and for the exchange of 
information, as envisaged in Article 12(5). 

Pursuant  to  Article 17(1)  of  Directive  2011/24/EU,  the  power  to  adopt  delegated  acts 
concerning the matters listed in Articles 11(5) and 12(5) is conferred on the Commission for a 
period of five years. This power can be automatically extended unless the European Parliament 
or the Council revokes it in accordance with Article 18. 

3.  Exercise of the delegation 

Since the last report3, the Commission has not exercised the delegated powers conferred to it 
under Articles 11(5) and 12(5) of Directive 2011/24/EU. 

4.  Conclusion 

The Commission sees the need for an automatic five-year extension of the delegations of power 
provided  for  in Article 17(1)  of  Directive  2011/24/EU. The  rationale  for  the  delegations  of 
power has not changed. 

It is important to keep the possibility to:  

•  maintain the necessary flexibility in the legal framework;  
•  exclude  specific  categories  of  medicinal  products  or  medical  devices  from  the 

recognition of prescriptions, where necessary to safeguard public health; and  

1 OJ L 88, 4.4.2011, ELI: http://data.europa.eu/eli/dir/2011/24/oj. 
2 OJ L 166, 30.4.2004, ELI: http://data.europa.eu/eli/reg/2004/883/oj and OJ L 284, 30.10.2009, 
ELI: http://data.europa.eu/eli/reg/2009/987/oj.    
3 EUR-Lex - 52018DC0651 - EN - EUR-Lex. 

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•  amend the list of the specific criteria and conditions that the ERNs must fulfil, and the 
conditions  and  criteria  required  from  healthcare  providers  wishing  to  join  such 
networks, as envisaged in Article 12(4)(a). 

With  this  report,  the  Commission  complies  with  the  reporting  requirements  established  in 
Article 17(1) of Directive 2011/24/EU. 

The Commission invites the European Parliament and the Council to take note of this report. 

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