Frequently Asked Questions
The new call for Reference Centers to join existing ERNs is going to be open on the 30th of September 2019 until the 30th of November 2019.
*publication ID (End of July 2019)
*call for new ERN members (Sep-Nov 2019)
*eligibility check by European Commission (Nov-Dec 2019)
*opinion of the ERNs (Dec 2019-Apr 2020)
*IAB assessment (May 2020-Oct 2020)
*approval procedure by the ERN BoMS (Nov-Dec 2020)
Please also liaise with the National Coordinator(s) of your specific country to advise you in this process.
For more information and the network criteria email firstname.lastname@example.org.
A call for new ERNs should be launched in the incoming years, but it is not expected before 2019.
If the Reference Center has already been officially approved as a full member of Endo-ERN, extension of expertise to other MTGs or other MTG subthemes does not require that you apply again to the second call for ERN full membership .
What is required is 1) obtaining and/or demonstrating national endorsement for these additional subthemes, and with this, the center can apply to the ERN coordinator that will review the application according to the specific network criteria together with the respective MTG chairs. The forms can be provided by the Leiden Standing Office upon request.
The Withdrawal Agreement as agreed between the Parties in October 2019 will enter into force on 1 February 2020. It will have the following implications for the ERNs:
• UK healthcare providers can continue participating in the ERNs as members and they will continue to have access to the Clinical Patent Management System (CPMS) and other ERN IT tools and databases until the end of the transitional period (31 December 2020).
• Personal data of patients enrolled by an UK healthcare provider can be kept in the CPMS until the end of the transitional period (31 December 2020).
• UK healthcare providers will continue exercising their role of controllers of personal data of their enrolled patients in line with the GDPR and Union Law until the end of the transitional period (31 December 2020).
• As of 1 February 2020, UK authorities (i.e. ministry of health) will not participate anymore in the meetings concerning ERNs, e.g. the Board of Member States meetings, subject to the limited exceptions provided for in the Withdrawal Agreement.
• There will be no impact on the ERN Coordinators group meetings as all the UK coordinators have been already replaced by EU27 coordinators.
On Affiliated Partners
There are two types of Affiliated Partners that may be designated at this stage:
- Associated National Centres
Associated National Centres will participate in one Network only and, as defined in the 2017 Board Statement, are healthcare providers “with at least some special expertise matching the global thematic domain of a given reference network that concentrates primarily on the provision of healthcare directly related to the activities and services of this specific network, including any type of diagnostic contribution supporting this provision of healthcare. Associated National Centres can therefore comprise any of the following institutions:
- clinics and departments/clinical units providing direct outpatient and/or inpatient services to patients;
- medical and genetic diagnostic laboratories;
- pathological laboratories;
- specific facilities for instrument-based diagnostics”.
- National Coordination Hubs
National Coordination Hubs establish a link with more than one Network at once and, as defined in the 2017 Board Statement, comprise “any type of institution with the appropriate knowledge and the legal and organizational capacity to link the national healthcare system to a number or all European Reference Networks. National Coordination Hubs function as interfaces between the national healthcare system and those Networks where a given Member State is neither represented by a full member nor by an Associated National Centre. National Coordination Hubs do not need any specific medical expertise or knowledge and their composition might range from:
- a major national healthcare provider […];
- a network of healthcare providers coordinated at national level;
- a non-hospital based, specifically assigned institution as contact and coordination point linking the ERNs with the national system […]” such as the National Contact Points created by the 2011 Cross Border Healthcare Directive.
There are no specific criteria of affiliation to an ERN. It is a competence of Member States to designate their potential affiliated partners.
According to the Board of Member States: ERN applicants will be encouraged to liaise with National authorities, where appropriate, to identify a list of potential affiliated partners, for collaboration with the network from the outset. How-ever, for all potential affiliated partners (those identified before the ERN approval or those that will come up after the ERN approval) the affiliation process will take place only after the approval of the ERN by the Board and following the formal designation of each of the affiliated partners by its national authorities.
Find the complete text here.
Click here for more information from the European Commission.
In the following links you will find the documents agreed by the Board:
The Commission has prepared a template for designation, one for each subtype of Affiliated Partner.
The designation letter includes information on the Affiliated Partner and the Network(s) which they wish to establish a link with.
The Commission has also prepared an annex, one for each subtype of Affiliated Partner.
This gives a description of the designated Affiliated Partner, highlighting how the Affiliated Partner complies with the set of minimum recommended criteria identified in the 2017 Board Statement. At the same time, as stated by the Board in that document, “it is important to note that despite the mandatory requirement for some specific expertise within the thematic area covered by the respective network, Associated National Centres are not requested to meet these criteria to the same degree that is expected for full membership.”
As for National Coordination Hubs, the Board noted in the same document that
“With the broad range of non-specialized institutions eligible as National Coordination Hub, the minimum recommended criteria applicable to all are confined to general aspects only.” In this context, various Member States asked the Commission to publish the Network specific criteria to be complied with by the healthcare providers wishing to join a Network as members, established by each Network in their application to the 2016 Call.
The Member States remain free to use or not such templates.
Affiliated Partners are not members of the Networks. They are expected to establish a link to the Networks for those countries which do not have a member in a specific ERN thus addressing the concerns related to the geographic coverage of the Networks.
The Affiliated Partners will contribute to the Networks’ activities and benefit from their expertise, facilitating the sharing of knowledge across the EU. Most importantly, Affiliated Partners should act as entry points to ERNs for patients, improving the accessibility for patients across the EU. For that reason, the Affiliated Partners shall participate in the CPMS virtual consultation panels for those patients that they have referred to the Networks and may also attend some other virtual panels for their own learning purposes or to fill any knowledge gap, due to their specific expertise (e.g. in case of laboratories).
In some cases, Affiliated Partners may at a later stage, if they are healthcare providers and develop the required expertise, become ERN members. This would only happen in compliance with the procedures for membership applicable to any healthcare provider and NOT automatically or with a special procedure.
Please note moreover that an Affiliated Partner will lose its partnership i.a. if a healthcare provider from the same Member State joins the Network as a member.
The deadline for the designation (initially set for December 2018) was extended until the launch of the next Call for new Members joining existing Networks.