Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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^f1, and in particular Article 12(4)(b) and (c) thereof,

Whereas:

Commission Delegated Decision 2014/286/EU^f2 sets out the criteria and conditions that European Reference Networks (‘Networks’) and healthcare providers wishing to join such Networks must fulfil.

Pursuant to Article 12(4)(b) and (c) of Directive 2011/24/EU, the Commission is to decide the criteria for establishing and evaluating the Networks and the measures for facilitating the exchange of information and expertise on establishing and evaluating the Networks.

Networks should be established and healthcare providers approved as Members of the Networks on the basis of an open and transparent procedure. The procedure should include: (1) the call for interest; (2) Member States' endorsement of applications of their healthcare providers; (3) the submission of applications to the Commission; (4) the verification of the completeness of applications; (5) the technical assessment by an independent body of applications to form the Networks and of applications from individual healthcare providers wishing to be Members of a Network, to determine whether the applicants fulfil the criteria; (6) the communication of the assessment outcomes; (7) the approval of the Networks and their membership by Member States; and (8) the publication of the list of established Networks and of their Members.

In order to increase the coverage of the Networks, individual healthcare providers wishing to join a Network should be allowed to do so at any time. Their applications should be assessed according to the same procedure as that used to assess applications for the initial Network, including the endorsement of applications by the Member State in question.

In order to guarantee that the Network has genuine European Union added value and is big enough to enable the sharing of expertise and to improve access to care for patients across the Union, only applications from the minimum required numbers of healthcare providers and Member States, submitted in line with the call of interest, should be approved. If an insufficient number of healthcare providers apply or applications cover an insufficient number of Member States, the Commission should ask Member States to encourage their healthcare providers to join the proposed Network.

It might be difficult to reach the required minimum number of healthcare providers or Member States for some rare diseases or conditions due to a lack of expertise. It would therefore be a good idea to group healthcare providers that focus on related rare diseases or conditions in a thematic Network. Networks could also include providers of high technology services which usually require very high capital investment, such as laboratories, radiology services or nuclear medicine services.

Member States none of whose healthcare providers are Members of a Network should designate collaborative and associated national centres to encourage them to cooperate with the relevant Network.

Each Network's and healthcare provider's application, once their completeness has been established, should be technically assessed according to the criteria set out in Delegated Decision 2014/286/EU. The assessment should, on the basis of a common assessment manual, include an exhaustive documentation review and on-site audits of a selected number of applicants. It should be carried out by an independent assessment body appointed by the Commission.

Member States are invited to set up a Board of Member States which should decide on the approval of proposed Networks and on their membership. Member States' participation should be voluntary. Only a positive assessment issued by an assessment body should generally prompt Member States to approve the establishment of a Network and to grant membership of the Network.

Networks' Members should be licensed to use the ‘European Reference Network’ logo. The logo, owned by the European Union, should constitute the visual identity of the Networks and their Members.

Using a common evaluation manual, an independent evaluation body appointed by the Commission should periodically evaluate Networks and their Members. The evaluation should conclude with a technical evaluation report detailing the extent to which the objectives set out in Article 12(2) of Directive 2011/24/EU have been achieved and the criteria and conditions set out in Delegated Decision 2014/286/EU fulfilled. It should also describe the outcomes and performance of the Network and the contribution of its Members. A negative evaluation report should generally prompt Member States to approve the termination of a Network. Compliance with the requirement to have a minimum number of healthcare providers and Member States should be monitored after the evaluation so that the European Union added value of the Network can be maintained.

The assessment and evaluation manuals should be based on internationally recognised practices and contain the core principles and methodologies for carrying out assessments and evaluations.

The Commission should facilitate the exchange of information and expertise on establishing and evaluating the Networks. It should make general information on the Networks and their Members and the technical documentation and manuals on establishing and evaluating the Networks and their Members available to the public. It may offer to the Networks and their Members the use of specific communication media and tools. Conferences and experts meetings should be organised to provide a forum for technical and scientific debate among Networks.

The personal data related to establishing and evaluating the Networks should be processed in compliance with Regulation (EC) No 45/2001 of the European Parliament and of the Council^f3 as appropriate.

The measures provided for in this Decision are in accordance with the opinion of the Committee set up under Article 16 of Directive 2011/24/EU,

HAS ADOPTED THIS DECISION: