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ERNs in a crucial phase of enlargement

date:  05/12/2019

841 new clinical units in hospitals across Europe requested to become members of the European Reference Networks.  The call closed on the 30 of November and the full evaluation process is now starting to determine which of the applicants, will eventually join the ERNs. The ERNs already count 953 members and have recently included 247 Associated National Centres and 4 National Coordination Hubs as Affiliated Partners.

The ERN call for membership gives the possibility to the clinical units of European hospitals with appropriate expertise to join the current networks, especially in countries where the ERNs are not yet represented by full members. This is mainly the case in Eastern Europe and smaller countries, where participation is more limited or in certain cases absent.

The applications submitted to the European Commission will now undergo a precise evaluation process (the “assessment programme”).The assessment programme, which was set up to select the members of the ERNs, was developed by the European Commission in consultation with the Member States and key stakeholders. It was applied for the first call for ERNs launched in 2016 and has recently been updated taking into account some changes contained within the Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU. The assessment programme is based on a combination of a peer reviewed and third party independent assessment model and refers to best practices used by other recognised accreditation, certification or assessment bodies in the European Union (EU) and at global level.

The assessment of the application consists of several steps. First, the European Commission will conduct an eligibility check of all submitted applications, which will take about a month and a half. Then, the Board of the ERNs will have up to three months to assess all the eligible applications for their Network. In the case of an unfavourable opinion, the applicant will have a month to respond to the comments. The Board of the ERN will then issue its final opinion within one month. Afterwards, the applications with favourable ERN decisions will be provided to the Independent Assessment Body that will have up to six months to conduct an independent assessment. The final phase is formal approval of each candidature by the ERN Board of Member States, which will take up to two months. It should be emphasized that the final number of new members will only be known at the end of the whole assessment process, which is expected to be at the end of 2020.

The geographical coverage of the ERNs already underwent a first phase of enlargement earlier this year, with the inclusion of “Affiliated partners” between June and November 2019. The purpose of the Affiliated partner designation is to allow clinical units in hospitals in Europe that do not meet all the criteria required to become full members, to be associated to the work of the ERNs. Therefore, allowing patients and their doctors to access the expertise of the networks. Thanks to the inclusion of Affiliated partners, the geographical coverage of the ERNs in Europe was increased from 44% to 74%, through recent inclusion of 247 Associated National Centres and 4 National Coordination Hubs (created 311 links to the ERNs). Presently, Affiliated Partners represent around 25% of the total clinical units participating in the ERNs.

The enlargement of the ERNs requires a strong coordination at the level of the Networks themselves in order to fully integrate the new members and affiliated partners and manage the whole system. It also requires a relevant effort from the National Authorities to structure national referral procedures in order to organize and allow access to the networks at national level.