The Commission launched in December 2022 the evaluation of the European Reference Networks (ERNs), which is an opportunity to learn and improve the existing system. It will also identify lessons learnt and areas for improvement, and ultimately if the ERNS are delivering the expected benefits for patients.
According to the Commission Implementing Decision 2014/287/EU, all networks and their members must be periodically evaluated by a Commission-appointed body at least five years after their approval or last evaluation and every five years after that, if applicable. The evaluation process and methodology are based on the Implementing Decision 2014/287/EU provisions, as specified by the Evaluation Manual and the Toolbox.
The aim of the evaluation is to verify and assess:
- the fulfilment of the criteria and conditions set out in Delegated Decision 2014/286/EU;
- the accomplishment of the objectives set out in Article 12(2) of Directive 2011/24/EU;
- the outcomes and performance of the network and the contribution of each member.
Timeline
The evaluation process will take about a year, from the appointment of the Independent Evaluation Body to the issue of the final evaluation reports.
Key phases of the evaluation process:
- Preparation for the set-up of the evaluation and information of ERNs members and organisation of tasks.
- Self-evaluation of ERNs and their Health Care Provider members, which includes an internal validation of the self-evaluation results by the ERN Coordinator and verification and confirmation by the Independent Evaluation Body.
- Technical evaluation by the Independent Evaluation Body:
- Network Technical Evaluation, which includes a document review, a virtual interview with the ERNs, the Work-Package coordinators, and the Patient Representatives.
- Health care providers technical evaluation, which includes a document review, and an on-site audit of a sample-of selected health care providers.
- Evaluation results which includes drafting and finalising the Evaluation Reports, one per network and health care provider. This process involves receiving feedback and making amendments and improvements.
Legal Framework
According to the Commission Implementing Decision 2014/287/EU, all networks and their members must be periodically evaluated by a Commission-appointed body at least five years after their approval or last evaluation and every five years after that, if applicable. The evaluation process and methodology are based on the Implementing Decision 2014/287/EU provisions, as specified by the Evaluation Manual and the Toolbox.
The aim of the evaluation is to verify and assess:
- the fulfilment of the criteria and conditions set out in Delegated Decision 2014/286/EU;
- the accomplishment of the objectives set out in Article 12(2) of Directive 2011/24/EU;
- the outcomes and performance of the network and the contribution of each member.
The results of the evaluation will be made publicly accessible on this website.
Evaluation process
Independent Evaluation Body
The assessment will be carried out by an Independent Evaluation Body (IEB), an expert and independent assessment organisation appointed by the Commission following an open call for interest. The Independent Evaluation Body will evaluate networks and healthcare providers externally.
General description of the process
The process to evaluate ERNs was established in February 2022 employing the Independent Evaluation Body. All the relevant stakeholders (e.g. Board of Member States, ERNs, and patient organisations) were consulted on numerous occasions.
The evaluation process includes some preparatory tasks and 4 main steps:
- Preparatory tasks:
- Done by the Independent Evaluation Body: organisational, managerial, and logistical arrangements, like training the evaluators, adapting the IT platform, etc.
- Done by the ERNs coordinators: they inform the members and patient representatives about the procedure, and agree on responsibilities, activities, and deadlines.
- Self-evaluation: One self-evaluation is expected from each ERN and its members. These self-evaluations will help determine whether and to what extent the ERNs have met their original objectives.
- Technical evaluation: done by the Independent Evaluation Body, including interviews, a documentation review and on-site /online audits.
- Results: reports for each network, for each Health Care Provider (HCP) and for the ERNs system.
The ERN-LUNG has called a meeting of its HCP members to review and offer remedies for the enhancement suggestions made by IEB. Each HCP’s draft report had recommendations, which were collected and debated in order to come up with a solution for each. This was done to aid members in their preparation for putting any improvement into their HCP.
