When the ERNs were established, it was agreed that an evaluation would be conducted every five years after their initial approval (or last evaluation) to determine the worth or significance of the work and actions developed by the ERNs.

The evaluation process will be transparent and independent from the policy making, and developed by a third party, the Independent Evaluation Body (IEB), to enhance credibility. The evaluation process is part of the AMEQUIS Framework, a continuous quality improvement cycle of actions integrating the monitoring system of the ERNs and the assessment and evaluation processes. This will include the already established annual Continuous Monitoring exercise.

Objectives of the evaluation process

The general objective of the evaluation process is to verify and assess:

  1. The fulfilment of the criteria and conditions set out in Delegated Decision 2014/286/EU
  2. The accomplishment of the objectives set out in Article 12(2) of Directive 2011/24/EU
  3. The outcomes and performance of the Network and the contribution of each Member
  4. The achievement of the objectives and quality of the deliverables produced within the ERNs Specific Grant Agreements (SGAs)

All these evaluation elements must be integrated into an evaluation report from both ERNs and HCPs. The agents involved in this process include:

  • European Commission (EC): The EC appoints the IEB that will conduct the evaluation, provides the institutional support, and oversees the whole process.
  • Board of Member States (BoMS): The BoMS receives information from the EC regarding D.3.2.2 | Page 9 European Health and Digital Executive Agency (HaDEA). Unit EU4Health/SMP Food. Tenders CHAFEA/2019/HEALTH/18 the evaluation process and has to approve any termination of a Network or loss of membership on account of a negative evaluation.
  • Independent Evaluation Body (IEB): The IEB carries out all the activities included in the external evaluation process, including organisational, managerial, and logistic issues, as well as the specific technical evaluation.
  • European Reference Network (ERN): At ERN level, the ERN coordinator as well as other members of the Board and the coordinators of the different work packages will have to provide information to the evaluation team during the process; ERN patient representatives will also be interviewed. At HCP level, the HCP representative and other members of the multidisciplinary team will be involved for the self-evaluation and the audits.