Frequently Asked Questions
General questions on ERNs and call for proposal
A network connecting health care providers and centres of expertise of highly specialised healthcare, for the purpose of improving access to diagnosis, treatment and the provision of high-quality healthcare for patients with conditions requiring a particular concentration of resources or expertise no matter where they are in Europe. For clinicians who network widely already, the ERN will represent the formalisation of their networking structures/practices in highly specialized healthcare. For those without specialist networking communities at present, ERNs will promote expertise and support health care providers in order to bring local, regional and national provision of healthcare closer to the patients.
Before starting to set up an ERN, following suggestions might be helpful:
- Review the information on the Commission webpage which includes the current framework, the legislative proposal and a many frequently asked questions (FAQ)
- Contact your national representatives in the ERN Board of MS. They will provide you with more specific information on the national endorsement process
- Conceive a one page document with your network proposal and share it with the national and European medical societies as well as your national representatives
- Address a wide scope in your network proposal referring to thematic groups. An example of such possible groupings can be found in the Rare Disease European Reference Networks ADDENDUM To EUCERD Recommendation of January 2013.
The directive 2011/24/EU is intended to provide a legal framework within the European Union (EU) to facilitate cross-border care. Article 12 requires the European Commission to support the Member States in the establishment of the ERN. The process how to become a member of an ERN is clearly defined in the Implementing Acts: a healthcare provider (HCP) wishing to become a member of an ERN will have to pass an assessment process based on the criteria in Delegated Decision (2014/286/EU) Annex II and on the Implementing Decision (2014/287/EU). This assessment will be composed of several steps:
- the formal support/endorsement by the Member State in which the HCP is based (for further information an interested HCP should approach the relevant MS representative on the Board of Members States of ERNs and ensure they understand and abide by the agreed national process for endorsing HCPs (More information ).
- After passing an eligibility check a technical assessment composed of documentation review, teleconferences and on-site visits will follow.
- The final approval of the proposed ERN will take place by the Board of Member States.
Questions on procedure and timing
- How many calls will there be for ERNs?
- How will applications be assessed?
- Is there any list of potential candidate ERN available?
- When will affiliated partners join ERNs?
- Who does the conflict of interest policy cover?
- What will be the relationship between ERN and industry?
The 1st call will take place in 2016. After consulting the Member States, the Commission shall decide on the appropriate timing for the publication of subsequent calls for interest.
The applications will have to pass three steps - the eligibility check by the Commission and the independent assessment bodies, the technical assessment by the independent assessment bodies and the approval by the Board of Member State. For the application, each applicant member will have to secure the endorsement of their Member State. An Assessment Manual and Tool-Kit for applicant members will describe the assessment.
Since the call is still ongoing, no official list of candidate ERNs is available yet.
However your Board of Member States representative might have more relevant information in this regard.
Moreover in DG SANTE webpage, there is a find a partner tool available to explore further options.
As stated in the document “ERN Assessment Manual for Applicants 1.Description and Procedures”, page 17 “The addition of Affiliated Partners and the relevant 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. Therefore, only Healthcare Providers applying for full membership should be included as applicants in the Network proposal.” The ERN Board of Member States is currently discussing a potential common approach to this matter.
Conflict of interest goes much further than only industries; academia and research institutions. It should cover each stakeholder external to an ERN that interacts with the Network at any stage and at any governance level.
According to the legal basis, only healthcare providers who are endorsed by national authorities can be members of an ERN. Associated or collaborative national centres or hubs, also endorsed by national authorities, can be recognised as affiliated partners. There is no specific legal provision when it comes to the involvement of stakeholders, including industry stakeholders. Therefore, the Board of Member States has set up a specific working group to discuss this issue and further guidance will be published which will adhere to the following principles:
- Each candidate ERN should establish its own Conflict of Interest Policy, to ensure disclosure of all financial and non-financial conflicts of interest before any engagement commences.
- Conflict of interest policy should respect relevant national and European legislation and follow the recommendations and guidelines developed by independent organisations and recognised bodies.
Conducting research and in particular clinical trials will be an integral task of ERNs. Board of Member States supports ERN engagement with industry where appropriate and in an open and transparent manner.
- No industry stakeholder should have a place in the governance structure of an ERN
- There should be no direct industry funding of any ERN activity
- A complete transparency policy should apply to the relationship between ERNs and industry
- The responsibility of each HCP is to follow and respect the national legislation and by-laws on conflict of interest must be made explicit.
Questions on eligibility
- How many centres from each country might participate in an ERN?
- Can a third country be a full member of an ERN?
- Is there a limitation on the number of HCP that can apply per Network and/or per Country?
- If a centre is not endorsed for its participation in a Network by its MS authorities what are the options to participate in ERNs?
- If a centre does not meet the Criteria defined in the Delegated Act Annex II, what are the options to participate in ERNs?
- What are the criteria for Affiliated Partners (Associated National Centres, Collaborating National Centres and Coordination hubs)?
- If one on the centre does not fulfil the criteria, will it impact on the global ERN application (meaning that the ERN will not qualify) or the ERN application will still be valid and allowed to continue to the assessment process?
- To be eligible for application a proposed network has to consist at least of 10 HCP out of 8 member states. The Commission Implementing Decision provides the minimum but not the maximum of possible HCP. This will be agreed by the proposing network along with their considerations of the governance of the network. The possibility to include more than one centre of expertise of a member state by endorsement is in the responsibility of the member state.
- When considering the number of centres to network in any given ERN, it is important to remember that as per the Acts, one representative from each member will need to serve on the Board of that ERN - the larger the Board, the more challenging the governance.
The scope of the legal provisions of the Directive on patient rights to Crossborder healthcare and all legal measures related with the ERN implementation, are only applicable to the EU and EEA member states. That implies that third countries healthcare providers cannot participate as candidate for full membership of a European Reference Network neither as affiliated partners (collaborative or associated national centres or coordinating hubs). Nevertheless, one of the criteria that networks are asked to fulfil is to cooperate with centres and networks of expertise at international level. That would allow non EU or EEA countries to interact and exchange knowledge or participate in research or training projects. A direct contact between the centre of expertise in the third country and the relevant ERN (once approved) has to be established.
There is no official limitation. The Commission Implementing Decision provides the minimum but not the maximum of possible HCP. This will be agreed by the proposing network along with their considerations of the governance of the network.
However, there are a couple of rules to bear in mind:
- It is a bottom-up top-down process.
- Only HCPs which have received the endorsement certificate by their National Authorities are eligible as a member of a potential ERN.
- Each ERN can set its own rules and the governance of the network.
- Network coordinators have the responsibility to assess that each potential HCP belonging to its candidature respects all general and specific operational criteria
- The final decision on which HCPs will be accepted as applicant member of the candidate Network lays only with the Network Coordinator.
- Network coordinators are encouraged to carefully weigh the size of their candidate ERN. They should look for a number of HCPs that do not prevent a smooth governance of the ERN.
- Please bear in mind that a minimum of 10 HealthCare providers coming from at least 8 Member States must be involved.
If a centre is not endorsed for its participation in a Network by its MS authorities what are the options to participate in ERNs?
The MS has the full capacity and responsibility on the endorsement process and the EU legislation does not provide a legal base related with this matter.
If a centre does not meet the Criteria defined in the Delegated Act Annex II, what are the options to participate in ERNs?
For centres which will not meet the criteria but nonetheless could contribute to an ERN, the MS where the centre is located might take a strategic decision on the convenience to designate it as an Associated National Centre or a Collaborating National Centre
What are the criteria for Affiliated Partners (Associated National Centres, Collaborating National Centres and Coordination hubs)?
There are no specific criteria for each of these forms of affiliation to an ERN. It is a competence of Member States to designate their potential affiliated partners. The Board of Member States in its strategic paper issued in January 2016 includes the position of Member States on this regard:
“ERN applicants will be encouraged to liaise with National authorities, where appropriate, to iden-tify 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. The process for the development of networks will also include the enrolment of affiliated partners as well as of new full members at later stages.”
As formulated in the Delegated Decision "proposed networks must collaborate with Associated National Centres and Collaborative National Centres chosen by Member States with no Member in a given Network, particularly if the objectives of the Network are among those listed in Article 12 (2) (f) and (h) of the directive. The ERN should facilitate mobility of expertise virtually or physically and develop, share and spread information, knowledge and best practice and foster developments of the diagnosis and treatment of rare diseases, within and outside the networks. Further they should help member states with an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide highly specialised services of high quality."
If one on the centre does not fulfil the criteria, will it impact on the global ERN application (meaning that the ERN will not qualify) or the ERN application will still be valid and allowed to continue to the assessment process?
If the minimum requirements are still fulfilled after the exclusion of some HCP (10 providers in 8 Member States) there is no problem to continue the process. If the minimum requirements are not met, according to the legislation (art.2.5 Commission Implementing Decision) the application shall not be entitled to assessment and the Commission shall ask Member States to encourage their healthcare providers to join the proposed network in order to help reach the required number(s).
Questions on ERN Members, roles and structure
- How will coordination of an ERN be decided?
- Can there be more than one network coordinator in a proposed ERN?
- What is the role of the Board of MS?
- Some existing networks involve scores of partners across many countries - should coordinators of an ERN invite all these centres to join a proposal?
- Is there any recommendation on the governance structure an ERN should adopt?
- Are only rare diseases included in the scope of ERNs?
- The Acts state that the ERNs will be governed by a Board of each network, composed of representatives of each member HCP. One of these HCPs has to be designated as the coordinator of the proposed network and a single individual from this HCP will be named network coordinator.
- More details are (will be) found in the Assessment Manual and Toolkit.
No, according to the delegated decision only one coordinator of the network will be chosen from among the health professionals belonging to the staff of the coordinating member, who will chair the meetings of the Board and represent the network.
The Board of Member States (BoMS) has the responsibility of approving European Reference Networks (ERNs). The BoMS consists of representatives from across the EU Member States and European Economic Area (EEA). The Board's main roles and responsibilities are to:
- Develop and maintain rules of procedure for the Board of Member States (functioning and decision-making process);
- Review the assessment reports and recommendations from the Independent Assessment Body (IAB);
- Give final approval of applications for ERNs;
- Approve proposals to add one or more members to an existing ERN;
- Approve the termination of an ERN; and
- Decide on the loss of membership of one or more members of an existing ERN.
Some existing networks involve scores of partners across many countries - should coordinators of an ERN invite all these centres to join a proposal?
Coordinators will need to think carefully about possible memberships of HCPs especially considering the efficient governance of proposed networks. In these considerations they will have to include the eligibility check criteria for each applicant member of the proposed network. Alternative means of affiliation (such as Associated and Collaborating National Providers) may be of use here.
There are no rules or recommendations on the governance structure to be adopted by an ERN. It is up to the candidate ERN to decide on its own internal structure according to its needs and preferences.
The scope of ERNs as laid out in the legal basis is to provide highly specialised healthcare for "rare or low prevalence complex diseases or conditions". The intention is for Networks to improve access to diagnosis, treatment and the provision of high-quality healthcare to patients who have conditions requiring a particular concentration of resources or expertise. It is in this area where working together at EU level has clear added value.
Questions on the application form
- Will all members of a network need to submit membership applications?
- Where are the finalised documents and application forms available?
- If different wards/ units/ groups belonging to the same HCP wants to join the same ERN, can they together fill in the application forms as HCP X and then specify the different diseases they work on?
- Do we need to translate the supporting documentation for Networks application (Appendix B, Self-Assessment for Networks)?
- Do we need to translate the supporting documentation for HCP proposal (Appendix B, Self-Assessment for Healthcare Providers)?
- Updated - Who should sign the self-assessment checklist for Healthcare Providers and the Application of Healthcare Providers?
- Can a single HCP represent a multidisciplinary team or a consortium of different HCPs?
- With reference to question 7b page 16 of the Network application form: How detailed should the description be?
- With reference to question 12a page 29 in the Network application form: What it is meant by when applicable?
- Is it mandatory to use the new application forms for HCP and Network (doc format)?
- I need more space in the application, how can I add it?
- In the Network Application what is the difference between tables 8d and 8f?
- How should the third column “Minimum number of procedure / patient per year” of table 8g be completed?
- How detailed and comprehensive should the documents listed in the Appendix B of the Network Self-Assessment be?
- Can you explain question 21 in the Healthcare application?
- Are ERN coordinators expected to collect all HCP documents listed in annex B of the HCP Self-Assessment?
- Should we wait until the last day to submit our ERN application?
- In the Self-Assessment for Network Appendix A Self-Assessment Scoring Table the percentage calculation is not correct, what should we do?
Yes, each applicant member will need to submit an application in addition to the application of the proposed network as a whole.
All documents related to the ERN call for interested parties are available in the call for interest for ERN webpage available here.
If different wards/ units/ groups belonging to the same HCP wants to join the same ERN, can they together fill in the application forms as HCP X and then specify the different diseases they work on?
Yes if different units belonging to the same HCP (hospital) and will be applicants of the same thematic network, in that case they must fill only one application according to the criteria established by the candidate network. In case they are applying to different thematic networks, they must, then, fill one application for each network proposal.
Do we need to translate the supporting documentation for Networks application (Appendix B, Self-Assessment for Networks)?
All the list of documents required in the Self-assessment for the Network must be in English.
Do we need to translate the supporting documentation for HCP proposal (Appendix B, Self-Assessment for Healthcare Providers)?
Concerning the list of documents required in the self-assessment, the HCPs are requested to provide:
- for some document a full translation in English (EN)
- in some case a summary in English (EN_Sum) of the documents already available in the original language.
- when no specific indication is provided the documentations can be provided in the original language.
See table below:
Updated - Who should sign the self-assessment checklist for Healthcare Providers and the Application of Healthcare Providers?
The Self-Assessment for Healthcare provider should be signed both by the Network coordinator and the Healthcare Provider (HCP) representative.
The Application form for Healthcare Providers section V should be signed by the HCP's representative. However we will accept also HCP applications signed by the HCP CEO providing that the contact details of the CEO are the same specified in point 3 of the same application form.
Yes it is possible that only one HCP submits the application on behalf of a consortium or a multidisciplinary team including members belonging to different HCPs.
However, since the Independent Assessment Body will investigate the authenticity of this agreement both in the documentation review and during on-site visits, it will be the responsibility of the HCP's representative to provide proof of the real collaborative work among the consortium HCPs. Examples of this collaboration may include e.g. sharing resources (human or technical) and patients.
It is also very important for the HCP to explain in its application how this functional collaboration is running at the time of the submission of the application. The applicant Network Coordinator should be fully aware and acknowledge the collaborative and common multidisciplinary work of those consortia.
With reference to question 7b page 16 of the Network application form: How detailed should the description be?
The description should be comprehensive, covering the structure of the ERN, the structure of the Board sub-committees or advisory groups, and the organisation of work for the sub-thematic groupings. As some of these sub-committees or advisory groups would need further definition, there is no need to include all possible complementing structures to the board of the Network, neither the concrete details nor identification of external stakeholders that may be involved in the ERN governance.
With reference to question 12a page 29 in the Network application form: What it is meant by when applicable?
In this section you should explain how the Network envisages the interaction with, or involvement of, patient organisation within the ERN. However, as the identification or agreement with specific patient organisation may require extra time, it is not compulsory to list the specific details of the patient organisations.
Yes the latest word versions of these forms must be used, and the older application forms will no longer be accepted. The upgraded from is more user-friendly and several bugs have been fixed. We regret any inconvenience, but content provided in the old format can easily be copy-pasted into the new form.
To avoid any layout problem, please save your application in the word version: Word 97-2003 Document *(doc).
Should you need additional rows in the tables to be filled in the applications for ERN and HCPs applications just make a copy of the table and add it to the final application.
Whereas table 8f is for individual HCPs, table 8d is for a multi-disciplinary team within the Network - in other words, when more than one Healthcare provider is involved.
This exceptional circumstance may happen when the Network has to involve different HCPs to put together a multidisciplinary team. A concrete example is when an oncological centre does not offer proton therapy within its premises. In that case to create a multidisciplinary team both the Oncological centre and the institution offering proton therapy have to be engaged. Going back to table 8d, in this case it should list the sum of professionals and/or resources that could be located in the different settings).
How should the third column “Minimum number of procedure / patient per year” of table 8g be completed?
Since the column allows for a maximum of 5 characters we suggest that you indicate the number followed by the acronyms PA (patient per year) or PR (procedure per year).
How detailed and comprehensive should the documents listed in the Appendix B of the Network Self-Assessment be?
For the majority of measures, you are only required to provide a plan detailing how the measures will be implemented. Please refer to "Evidence of compliance" on page 5 of the manual and the specific explanations for each measure on pages 7 to 44.
In addition to respecting the requirements on the specificity, we ask that you also ensure the documents are clear, concise and well structured.
As 'clinical outcome' is a generic concept that should be adapted to each of the thematic networks, in table 21 of the HCP application, we ask that you list the specific clinical outcomes, as defined in your network proposal and in line with the diseases or conditions the Network will address (see table 9, section V of the ERN application).
In the ERN application form the Network coordinators should define the expected clinical outcomes and how they should be measured (e.g. concrete indicators they have in mind to check the quality of the healthcare provided), so in the corresponding table 21 the HCP should provide these expected clinical outcomes in a numbered list.
Are ERN coordinators expected to collect all HCP documents listed in annex B of the HCP Self-Assessment?
ERN Network coordinators are not expected to collect the documentations of all HCPs candidates of the ERN. HCP Representative should have all the documentation ready for the IAB evaluation.
The official deadline for submission of applications is the 22 July 2016. However, due to the important number of documents to be checked and send we strongly advise all Network coordinators' applicants TO DO NOT WAIT until the last days.
No applications will be accepted after the deadline of the 22 July 2016.
In the Self-Assessment for Network Appendix A Self-Assessment Scoring Table the percentage calculation is not correct, what should we do?
Should this happen, please insert a comment saying that the automatic calculation is not correct and that the correct score is X%.
We apologise for the inconvenience.
Thematic scope of the ERNs by disease area and respective specialisms
- Would a HCP be able to join an ERN if it does not possess expertise in aH the diseases that could fall under the thematic scope or grouping of a Network proposal?
- Who decides which category diseases fall 'under'?
- Why does the model for grouping RD for the purposes of ERNs not refer to specific procedures or specialities like by instance surgery , laboratory etc.?
- The model for grouping ERNs seems to be that a single network must care for both paediatric and adult patients - what if existing groups are only geared towards paediatric patients at present?
- How might cross-talk across ERNs be ensured?
The Commission Implementing Decision on ERN states that in order to guarantee that the Network has genuine European Union added value and is big enough to enable the sharing of expertise and to improve access to care for patients across the Union, only applications from the minimum required numbers of healthcare providers and Member States, submitted in line with the call of interest, should be approved. It might be difficult to reach the required minimum number of healthcare providers or Member States for some rare diseases or conditions due to a lack of expertise. It would therefore be a good idea to group healthcare providers that focus on related rare diseases or conditions in a thematic Network. Networks could also include providers of high technology services which usually require very high capital investment, such as laboratories, radiology services or nuclear medicine services.
Moreover, the Commission Expert Group on Rare Diseases has adopted an Addendum to the EUCERD Recommendations on Rare Disease ERNs. This Addendum espouses a model for grouping RD to enable all RD to 'find a home' within a manageable number of overarching ERNs.
Many clinical experts currently participate in disease-specific networks (for instance 'pilot' networks, established by EC funding in the past) or in networks dedicated to a relatively small number of diseases: is it possible for such networks to simply 'transform' into ERNs, retaining their current scope?
In principle, no, this is not the aim of ERNs which represent a collaboration in healthcare. Many former networks were collaborating in different fields of research. The goals and criteria established in the legal acts are mandatory and therefore the current pilot networks or groups wishing to apply as a Network proposal shall assess themselves and reach an agreement on how to fulfil those criteria. It would be advisable for the current narrow disease-specific networks to expand their focus and increase their networking associations in order to better reach the goals and minimum number of participants.
Would a HCP be able to join an ERN if it does not possess expertise in aH the diseases that could fall under the thematic scope or grouping of a Network proposal?
Yes a HCP could join a proposed ERN even though it does not possess expertise in all diseases under the scope of the proposed network.
It will be for the healthcare providers and stakeholders preparing a Network proposal to decide on this very important issue, to argue and defend its proposed ERN scope. The recommendation issued by the
Commission Expert Group on Rare Diseases on a model of grouping should give an orientation of what is intended, which means several disease entities are grouped together. Examining who takes care of a patient at present could be a useful way of approaching this. The specialists themselves are best-placed to determine which ERN grouping their disease falls under as this is something best addressed at the grass-roots level by those expert in the diseases. However, a mapping of some sort may be advisable during the ERN proposal preparation stage, in order to assess the sort of disease coverage desired by that ERN at the end of the strategic plan for ensuring comprehensive coverage of RD to address patient needs.
Why does the model for grouping RD for the purposes of ERNs not refer to specific procedures or specialities like by instance surgery , laboratory etc.?
Multidisciplinarity is the cornerstone of the Networks. Networks are not intended as a cooperation limited to one speciality but as a multidisciplinary approach to the diseases, including the participation of all possible healthcare professionals involved and all necessary procedures or techniques related to the diagnosis or treatment of the diseases covered by the ERN.
The model for grouping ERNs seems to be that a single network must care for both paediatric and adult patients - what if existing groups are only geared towards paediatric patients at present?
The proposed model of grouping serves as an orientation. It is acknowledged that it will be difficult to incorporate adult services into existing paediatric-focused highly specialised services: it will depend on how the networks will convey and argue their choice of specific criteria and conditions which may vary depending on the scope of the concrete area of expertise. Perhaps a stepwise development could be expected, of integrating adult care with paediatric care. The primary goal of the proposed scheme is inclusivity at the European level. Such inclusivity should also relate to the ages of patients as referred to in the Addendum to the EUCERD Recommendation of January 2013 adopted in June 2015. It is expected from the proposed network to have a business plan to improve over time and address the areas which are not incorporated at present.
The Commission should facilitate the exchange of information and expertise on establishing and evaluating the Networks. It should produce general information on the Networks and their Members and ensure the technical documentation and manuals on establishing and evaluating the Networks and their Members are available to the public. It may offer to the Networks and their Members the use of specific communication media and tools. Conferences and expert meetings should be organised to provide a forum for technical and scientific debate among Networks.
The added-value of ERNs
What will be the added-value of RD ERNs to those already running successful, disease-focused networks?
ERNs will provide for the first time a unique opportunity to work together in healthcare. The main goal is to support cooperation in healthcare where expertise is scarce and to facilitate access to high-quality diagnosis and medical care including the European added value by working cross border in this field. Proposed networks have to define how they want to communicate with each other (i.e. access to shared communication tools and assets to support e-health and teleconsultations) and what services they will offer such as sharing diagnostic tools etc. between collaborators within a single ERN.
Operations of ERNs
- What is the difference between ERNs and HCPs/Centres of Expertise? How do they relate to each other?
- What are the roles of healthcare providers/CEs in ERNs?
- What formalised structure will ERNs assume?
- Will ERNs be able to involve experts from outside of the EEA e.g. Serbia or Israel? How might these countries participate?
- How will be the disease-specific operational ('vertical' criteria of the Delegated Acts Annex II) defined for each ERN?
- How are the relationship between industries and ERN been addressed?
- Will DG SANTE provide the ERNs with a suitable IT platform allowing the correct functioning of ERNs?
What is the difference between ERNs and HCPs/Centres of Expertise? How do they relate to each other?
The ERN is a network composed of at least 10 healthcare providers from at least 8 different Member States with at least 3 out of 8 objectives defined in the Cross-Border Healthcare Directive. The main goal is to support cooperation in healthcare where expertise is scarce and to facilitate access to high-quality diagnosis and medical care in this field. The Network will operate at the European level and will be formally approved by the Board of Member States. It is for each National Authority to decide on the role and organisation at National level of their healthcare providers or centres of expertise. It would be advised that the HCPs/CEs endorsed and approved as member of an ERNs would act as the 'nodes' around which the ERN is centred and will continue to provide care for their patients with RD nationally, as they do at present .
An ERN is centred around highly specialised healthcare, first and foremost, and is expected to demonstrate:
- knowledge and expertise to diagnose, follow up and manage patients with complex diseases or conditions which necessitate highly specialized healthcare
- evidence of good outcomes o a multi-disciplinary approach to care
- capacity to produce good practice guidelines and to implement outcome measures and
- quality control o research, teaching and training
- collaboration with other centers of expertise and networks
In addition the Delegated Decision (Annex II) stipulates criteria for all ERN members to meet, with regards to:
- patient empowerment and patient-centred care o organisation, management and business continuity o research and training capacity
- exchange of expertise, information systems and e-health tools o expertise, good practices, quality, patient safety and evaluation
Health care provider applicants will be approved member of a European Reference Network which will have an institutional value. Networks' Members should be licensed to use the 'European Reference Network' logo. The logo, owned by the European Union, should constitute the visual identity of the Networks and their Members.
Will ERNs be able to involve experts from outside of the EEA e.g. Serbia or Israel? How might these countries participate?
In addition to the EU 28, the three EEA countries are eligible and indeed have the right to participate in the Board of MS for ERNs. The policy and legal documents state that members of ERNs are expected to collaborate with others centres and networks; however, it is not possible to include them as formal members as they cannot be included in any formal EU assessment of the centres and networks. Therefore, external participation and contributions are encouraged, but cannot be formalised.
How will be the disease-specific operational ('vertical' criteria of the Delegated Acts Annex II) defined for each ERN?
The Commission will approve in consultation with an Assessment Manual and Toolbox including a set of operational criteria according to those established in the legal base. Those criteria will apply to healthcare providers or networks in a generic way. There is the necessity for the Criteria to be transparent, measurable, objective and comparable to all kind of settings in highly specialised healthcare. There are the set of horizontal criteria and conditions on patient empowerment and centred care, organisational, management and business continuity, research and training capacity, exchange of expertise, information systems and e-health tools and expertise, good practice, quality, patient safety and evaluation to be fulfilled by all healthcare providers regardless of the field of expertise.
Further there are a set of specific criteria and conditions that may vary depending on the scope of the concrete area of expertise where the proposed Network has to propose and document its specific
criteria on the required competence, experience and activity of all possible members of the Network including the provision of evidence of good clinical care and outcomes in its field, describe the characteristics of human resources important for this thematic group of diseases, show the organisation and functioning in a multidisciplinary healthcare team, describe the specific equipment within the centre or easily accessible show communication strategies / interactions at a distance capacity for cross border health care. Those criteria would be used to assess the level of fulfilment of each of the applicant healthcare providers.
According to the operational criteria (Measure 1.7.1) for Network, each candidate ERN has to establish its own Conflict of Interest Policy, ensuring disclosure of all financial and non-financial conflict of interest related to the treatment or research activities.
Moreover, the Board of Member States is discussing the issue and has set a specific working group on this topic.
Will DG SANTE provide the ERNs with a suitable IT platform allowing the correct functioning of ERNs?
The European Commission will provide ERN with an IT platform including Communication and Networking tools in order to help the networks to fulfil their tasks (governance, clinical care, training, research, etc.).