FREQUENTLY ASKED QUESTIONS
ERN-LUNG is currently made up of 60 Full Member reference centres in 12 countries and is organised into nine Core Networks representing the diversity of diseases and conditions affecting the respiratory system.
5 years, 1 March 2017 – 1 March 2022
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The 2019 call for new members to join existing ERNs is now CLOSED.
It is each Member State’s responsibility to assess the quality of their Reference Centers (HCP) and endorse their participation in an ERN application, according to their respective national legislation.
As part of the assessment process for ERN applications, the European Commission will assess the quality of each HCP in an application against the Delegated Decision’s general and specific conditions/criteria. This will ensure that HCPs participating in an application meet clear and robust quality criteria both at a national and EU level.
In addition, during the application process, the ERN itself will define the threshold or required level of disease-specific expertise or competency that HCPs will need to meet to be a member of an ERN. The ERN has to validate their application by providing evidence that the required level of expertise is met.
The final level of assurance is that each HCP within a network is required to verify that it continues to meet the required competency as defined by the legislation, throughout the 5 years that networks have been approved for operations. If one or more HCP, at any point in the five years, ceases to comply with the conditions and criteria set out in the Delegated Decision, they are required under the legislation to highlight this to the Network’s Board, whose members should then report this to the Board of Member States. At the end of the five years, these networks will be evaluated by the European Commission for a renewal of their network as an ERN.
ERN applications require strong cooperation between clinicians as this will reflect their ability to provide a functional and operational ERN if an application is successful.
There are significant benefits and opportunities in the creation of an ERN, which clinicians will respond positively too, including:
– Connecting up scattered expertise to increase understanding of rare diseases, natural history and increase in diagnosis and outcome to treatment
– Increased critical mass for research and ability to successfully secure research grants
– Improve access to high quality diagnosis and healthcare and reduce inequalities in care
– Share learnings and eHealth / IT platforms support
– Reduce ineffective treatment and inappropriate use of scarce resources
– Maximise integration and interoperability of EU and national strategic projects
– Provide a clear interface for industry, attracting investment opportunities and economic growth
There is significant interest from the clinical community to take part in these networks and an ERN application has a minimum requirement of 10 healthcare providers from 8 Member States. It is important to reach out to clinicians in your Member State and across the EU to work together to ensure that this minimum requirement is met and that HCPs are endorsed by their respective Member State.
For the rare disease community, sharing of knowledge and expertise and connecting up the clinical community will enable a levelling up of the knowledge of healthcare practitioners in the ERN, as well as to national, regional and local healthcare systems, bringing this expertise to the patient. This will see improvement to the outcome of diagnosis and treatments available in Member States.
It is expected that multi-system rare diseases will be supported in a number of relevant ERNs, with these networks working together to meet the needs of rare disease patients. The important aspect is to ensure that, by working with ERN applicants, the scope of an ERN application includes these diseases. Different ERNs are expected to work together for the benefit of patients living with a multi-system condition or disease.
It is unfeasible to create a separate ERN for every one of the over 6000 rare diseases that exist; ERNs will therefore be organised according to disease groupings. This grouping of diseases does not prevent a patient from being able to go to a disease-specific centre of expertise, nor from benefiting from the expertise of several ERNs.
The Withdrawal of the UK from the European Union is in effect as of January 1st, 2021. It has the following implications for ERN-LUNG:
• While UK healthcare providers have terminated exercising their role as members of the ERNs, patients and colleagues from the UK and all other European non-member states can continue to be actively involved in all activities of ERN-LUNG.
• UK healthcare providers cannot continue participating in the ERNs as members and they will no longer have access to the Clinical Patient Management System (CPMS) and other ERN IT tools and databases.
• Personal data of patients enrolled by a UK healthcare provider will be removed from the CPMS.
ON AFFILIATED PARTNERS
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.
There are two types of Affiliated Partners that may be designated at this stage:
Associated National Centres which establish a link with one specific Network 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: (i) clinics and departments/clinical units providing direct outpatient and/or inpatient services to patients; (ii) medical and genetic diagnostic laboratories; (iii) pathological laboratories; (iv) specific facilities for instrument-based diagnostics“.
National Coordination Hubs which establish at once a link with more than one Network 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: (i) a major national healthcare provider […]; (ii) a network of healthcare providers coordinated at national level; (iii) 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.
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.
Our understanding is that, while not having the level of expertise that would make them qualify for membership, 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).
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.
In the following links, you will find the documents agreed by the Board:
2016 Statement on Affiliated Partners
2017 Statement on the definition and minimum recommended criteria for Affiliated Partners
2018 Statement on the timeline for designation of Affiliated Partners
2018 Rules for termination of Affiliated Partners
2019 Strategy for the integration of Affiliated Partners
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.
You can view the network specific criteria here.
The Member States remain free to use or not such templates.
The designation letter will be sent by the Member States to the Commission’s functional mailbox: SANTE-ERN-AFFILIATED-PARTNERS@ec.europa.eu and to the Coordinator of the Network that this Affiliated Partner shall join.
Yes, this is allowed. Considerations related to the manageability and sustainability of the Networks should however be taken into account by the Member States.
As agreed at the November 2018 Board meeting, 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.
ERNs establish contact with the designated Affiliated Partner and if needed, request any further information that would be necessary to allow integration of the Affiliated Partner in the activities of the Network (always putting in copy the designating Member State). In case no further information is needed, the enrolment of the Affiliated Partner is finalised by establishing a bilateral cooperation agreement using the template provided (same template to be used for both types of Affiliated Partners, Associated National Centres and National Coordination Hubs). The text of the template should not be changed, however, areas of cooperation may be added or removed depending on Affiliated Partners’ level of expertise.
FOR PATIENT ADVOCATES
Patient organisations can engage with clinicians who are preparing an application to help shape the scope of rare disease ERNs and potential services provided by successful ERNs (but this is not a formal requirement in the legislation). The European Commission and Member States strongly encourage patient involvement in ERNs, as set out in the addendum to the EU Committee of Experts on Rare Diseases Recommendations on ERNs. EURORDIS has strongly advocated for full engagement of patient representatives in the ERN application process, governance and activities of ERNs.
ERNs have to demonstrate they are patient-centred and empower patients as defined in the European Commission Delegated Decision. Patients and patient organisations will play a critical role in rare disease ERNs due to their expertise in their rare disease. The Commission Expert Group on Rare Diseases Addendum gives a clear strategic message that ERNs should involve patient representatives to play an active role in the governance structures of ERNs. This includes:
– To advise on planning, assessment and evaluation of Centres of Expertise and European Reference Networks based on their experience, with a consistent approach
– To ensure transparency of quality of care, safety standards, clinical outcomes and treatment options
– To promote and encourage a path delivery of clinical care, service improvement and strategic development and decision-making
– To ensure all ethical issues and concerns for patients are addressed, balancing patients’ and clinical needs appropriately
– To ensure care is patient-centred and respects patients’ rights and choice
– To ensure the application of personal data protection rules, compliance of informed consent and management of complaints
– To ensure feedback on patient experience and the active evaluation of patient experience
This Addendum has been approved by members of the Commission Expert Group on Rare Diseases including Member States, the European Commission and the Joint Action partners, therefore providing a strong strategic direction for ERNs to act on.
In order to enhance patient representation and empower the patient representatives in each ERN, EURORDIS wants to facilitate and support patient organisations to participate in the ERN decision-making processes and activities through a structured and democratic approach.
EURORDIS is working with its members to establish a EURORDIS Patient Advocacy Group (EPAG) for each of the 24 ERN groupings. EURORDIS will gather elected patient representatives who will ensure that the patient’s voice is heard in the successful development of ERNs. Through these EPAGs, patient representatives will help organise and exchange information, contribute to the decision-making process within the ERN, take action to collect feedback from patient groups at local levels and from patients and families, and participate in the creation or maintenance of registries, best practices guidelines etc.
Collaborative and associated members are centres which can also be part of an ERN. There is no definition of these centres in the European Commission ERN Delegated acts and they are not assessed as part of an ERN application. Only HCPs that have been identified as expert in the Member State legislation can formally sit on the Network’s Board and be assessed against this EC legislation. It is the responsibility of Member States to identify and define the role and function of collaborative and associated centres in an ERN.
ERNs create a clear governance structure for knowledge sharing and care coordination across the EU. They are networks of centres of expertise, healthcare providers and laboratories that are organised across borders.
Patients will continue to visit their local hospital and not see any changes in how their care and treatment is given, but they will see improvements to the outcome of their treatment; the changes will be seen in the way in which, because of ERNs, clinicians will be able to liaise through a wider clinical network spanning Europe, connecting up with experts in specific rare diseases and getting advice or sharing knowledge of complex and rare cases that will ultimately improve the outcome of the care provided.
Patients have the right to choose where they receive care and need to liaise with their own national healthcare system to make an informed choice. ERNs support local provision of care to the patient where possible, and encourage experts to share their expertise and knowledge with national, regional and local healthcare systems. ERNs promote the sharing and mobility of expertise, rather than the movement of patients themselves across borders.
European Reference Networks are clinical networks that are being established to create a clear governance structure for knowledge sharing and care coordination across the EU. They are networks of centres of expertise, healthcare providers and laboratories that are organised across borders and not patient organisations networks.