Development of European Reference Networks (ERNs): New page on the Assessment Process

Development of European Reference Networks (ERNs): New page on the Assessment Process

The European Commission (EC) is supporting Member States into developing European Reference Networks (ERNs) in an initiative that will link existing highly specialised healthcare providers across the European Union.

Healthcare providers both willing to form a Network and having the endorsement of their Member States, are invited to apply for the call for ERNs. The assessment process for proposing Networks and memberships is based on the regulatory framework of the European Commission Delegated Decision (2014/286/EU) and Implementing Decisions (2014/287/EU) of 10 March 2014. These include compulsory criteria and conditions ERN applicants have to fulfil.

Here you will find documents that provide further information regarding the assessment process.

Mapping exercise

A mapping exercise was done to get valuable information concerning the state of play and methodologies related with the EU and national models and practices of designation and assessment of highly specialized healthcare providers.

It consisted of four specific elements: a) systematic literature review, b) review of benchmark procedures, standards, criteria, scoring systems, policies, procedures, processes, award or decision guidelines, audit processes and methodologies, c) written consultation questionnaire survey of Member States and d) on-site visits to a sample of 10 Member States.

Key findings of the exercise included broad variation in the organisation of services of highly specialised healthcare providers, centres of expertise and their supporting clinical networks in existing national or regional healthcare systems, and that the maturity of the existing assessment programmes within each health system vary widely. Therefore care pathways and coordination, expertise, clinical competency, quality data and measurements, patient safety and governance are among the key themes that must be addressed in the assessment of the ERN.

Further information can be found in the following documents: ERN Literature, ERN EU-National designation and assessment practices.

• Stage 1: Call for interest
• Stage 2: Application Process
• Stage 3: Determining Eligibility for the Assessment
• Stage 4: Technical Assessment of Proposed ERNs and Member Applicants
• Stage 5: Transfer of Assessment Report to the European Commission
• Stage 6: Approval of Proposed ERN and Member Applicants
• Documents

Further information can be found in the following documents:

Call for interest

For the approval of the networks a public call for interest was launched by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) in 2016.

Application Process

Healthcare providers interested in forming a European Reference Network (ERN) are invited to respond to the call for interest by the European Commission (EC). To be considered for the establishment of an ERN, a minimum of 10 Member Applicants from a minimum of 8 Member States (MS) are needed to participate in the application in line with the Commission Implementing Decision, Article 2 (2014/287/EU).

Self-Assessment for Proposed ERN and Member Applicants

Self-assessment is a valuable step that can be conducted before the call for ERNs. Allowing both the Proposed ERN and Member Applicants the opportunity to assess themselves against the specific legislated criteria and conditions before submitting their application to the EC.

The completion of the self-assessment is additionally a part of the application form and process. There would be two self-assessment tools: one for the Proposed ERN and one for each Member Applicant, in accordance with the requirements outlined in the Implementing Decision 2014/287/EU Annex I (b) that would be published in due time.

Determining Eligibility for the Assessment

In accordance with the Implementing Decision 2014/287/EU Article 4 (2) and Article 4 (3), there will be two eligibility checks: a) first by the European Commission (EC) and b) secondly by the Independent Assessment Body (IAB). Both are responsible for determining the eligibility of applications for Proposed ERNs and Member Applicants.

Passing the eligibility check represents the first important step on the approval of the proposed network.

Technical Assessment of Proposed ERNs and Member Applicants

After the eligibility checks follows the technical assessment. The purpose of this technical assessment is to assess compliance with the Operational Criteria for Proposed ERNs and Member Applicants in line with Article 4 (2) (d) and (e) in the Commission Implementing Decision (2014/287/EU). The assessment is composed of a documentation review for the proposed network and each individual applicant, virtual interviews and on-site visits of a chosen sample of individual applicant healthcare provider. The result of the technical assessment is a final report of the network proposal with summaries of the report of each applicant healthcare provider and a final technical Network assessment report.

Passing the technical assessment represents the second important step on the approval of the proposed network.

Transfer of Assessment Report to the European Commission

The Independent Assessment Body (IAB) will provide the European Commission (EC) with all the assessment reports for the Proposed ERN and Member Applicants.

Approval of Proposed ERN and Member Applicants

To be finally approved as a European Reference Network, the European Commission will forward the final reports of the technical assessment of the positively assessed proposed networks to the Board of Member States. The Board of Member States will take the final decision of approving the European Reference Network according to the rules of procedures.

Documents

Here you will find the supportive documents regarding the assessment process.