Applying for Participation in Rare Diseases European Reference Networks
Process for Health Care Providers
Directive 2011/24/EU on patients’ rights in cross border healthcare (Article 12)
According to the legislation the Member States Competent Authority is required to provide a written statement of endorsement for their Rare Disease Health Care Provider verifying that its participation in the proposal to establish a European Reference Network (ERN) is in accordance with its national legislation before the application is made to be assessed to join an ERN.
For the latest updates on ERNs and how to apply please refer to the following links
European Reference Networks
European Reference Networks Video Clip
To view the current ERN listing refer to the following link
List of European Reference Networks
Member States are responsible for:
- Defining their national process to assess applicant Rare Disease Health Care Providers for entry to ERNs;
- Ensuring that this process is transparent.
In addition, it is within the competence of the Member States to define national ‘Affiliated Centres’ that may also receive a letter of endorsement from the national competent authority. ‘Affiliated Centres’ are healthcare providers that provide multidisciplinary national expertise in rare diseases but may not have the capacity to fulfil all the criteria necessary for full membership of an ERN.
It will be within the remit of the specific ERN, when established, to describe its process to invite affiliated centres to join the ERN. It is proposed that affiliated partners will have access to services for treatment and diagnosis and opportunities to collaborate with development of guidelines, registries and research as deemed appropriate by the ERN Co-ordinating team, i.e. network proposals must describe pathways of how affiliated partners other than approved members of the network can interact, participate and contribute to the network.
Types of Health Care Providers that participate in ERNs
Health care providers (HCP) with expertise in rare diseases that may apply to participate in ERNs may include:
- Standalone centres that primarily provide rare disease multi-disciplinary (MDT) healthcare
- Networks of Health Ccare Providers that together provide co-ordinated MDT care for patients
- Smaller Health Care Provider sites that provide some or all of the multi-disciplinary care required for the management of rare diseases care
National Designation Process Ireland
All Health Care Providers wishing to apply to be put forward by Ireland for consideration for entry to ERNs must undergo an assessment process on their ability to meet specific criteria. These criteria are based on those set out by the European Union Committee on Expertise in Rare Diseases.
In Ireland there are two potential levels of ERN participation for Health Care Providers:
- Full membership
- Affiliated membership
Applicants must choose which membership level they wish to apply for and should review the process for Full Membership in the first instance. If approved by the HSE (Acute Hospitals Division) and the Department of Health through this process, this Health Care Provider can be nominated to join an ERN.
The call for full membership applications for the 2015-2016 call is now closed. The Acute Hospitals Division, supported by the National Clinical Programme for Rare Diseases (NCPRD) is reviewing the 2017 process for full membership and further information will be available shortly.
The majority of Health Care Providers with rare disease expertise in Ireland will not meet all the criteria set out in the Self-Assessment Template and, therefore, will be ineligible for full national designation. They may, however, apply for affiliated membership.
Affiliated membership status may be awarded based on meeting less stringent criteria than full membership. To apply for Affiliated Membership status, Health Care Providers must:
- Identify a Consultant clinical lead in a permanent role with the service
- Register the service on Orphanet as a Centre of Expertise www.orpha.net
The Orphanet Quality Criteria Form describes the information required to register the service.
- You can also read the guide for registering on Orphanet. If you cannot complete all sections at a minimum please complete the mandatory criteria.
Click here to see an example of a completed Orphanet Quality Criteria Form
To learn more about Orphanet read our Orphanet Overview for Clinicians
- Services registered on Orphanet are validated. Following validation HSE Acute Hospital Division will review the service as a potential affiliated centre of expertise.
- Affiliated centres of expertise will be issued with a letter of endorsement from the Department of Health. This letter is required for entry to ERNs.
More Information about Orphanet: The European Rare Diseases Portal
All rare disease health care providers, regardless of membership status, will be required to maintain an up to date registration of their clinical centre of expertise on Orphanet (http://www.orpha.net/consor/cgi-bin/index.php), including the completion of the Orphanet Quality questionnaire describing their multidisciplinary expertise in rare disease management. Assistance with registration is available through Orphanet Ireland (01 809 7448 or firstname.lastname@example.org )