Governance

An important aspect of structured and sustainable patient partnership in the ERNs is a set of principles and rules that guide patient involvement. EURORDIS developed a governance framework – the ePAG Constitution – and governance templates to facilitate the effective involvement of patient representatives in the ERNs’ activities. These principles and rules ensure unitary, solidary, and equitable patient representation.

Recognising the heterogeneous nature of the rare disease patient community and its diverse needs, this framework to structure patient partnership in the ERN as well as the four governance templates can be adapted to 1) best meet the specific needs of each ePAG Community and for 2) the governance structure of the respective ERN.

The framework for patient partnership in the ERNs outlines 2 levels of patient engagement:

ePAG Constitution EURORDIS approach to structured patient partnership in the European Reference Networks.

Templates

Transversal working groups

The ERNs identified common areas of work, transversally impacting all of the networks. To favour peer learning, empower and support ePAG advocates’ participation, EURORDIS set up the following working groups (WG):

• ePAG Steering Committee

  ePAG Steering Committee provides advice to the ERNs, European Commission and Board of Member States (BoMs) on patient partnership and ensures a common approach to involving patients in the ERNs. The ePAG Steering Committee does this by being a bridge between EURORDIS and the 24 ePAGs.

• ePAG Clinical Practice Guideline and Care Pathways Taskforce

  ePAG Clinical Practice Guidelines and Care Pathways Taskforce supports ePAG advocates in engaging in the development of clinical practice guidelines and other clinical decision support tools.

• Patient Partnership framework for Clinical Trials in the ERNs Taskforce

  Within the ERICA project, EURORDIS is leading a deliverable on Patient Partnership Framework for Clinical Trials in the ERNs, co-created with the ERNs clinicians and ePAGs and the ERICA project partners.

• ePAG AMEQUIS Task Force

  ePAG AMEQUIS Task Force supports ePAG advocates’ engagement in monitoring, evaluation and quality improvement.

• ePAG Patient Partnership WG

  ePAG Patient Partnership WG brings together ePAG advocates and ERN Project Managers to support patient-professional partnerships and harmonise patient engagement and in the ERNs.

   

Learn more about the milestones achieved by these transversal working groups here

Get involved in the ePAGs

More than 300 patient advocates are already involved in the ERNs, and additional applications are welcome to cover existing gaps. If you are interested in becoming an ePAG advocate, have a look to our ePAG Induction call and Welcome Package factsheet and contact PEM-ePAGs@eurordis.org. For information on a specific ERN, please contact their respective ePAG advocates or ERN project managers to find out more: 

FAQs

• As a patient representative, can I participate in more than one ePAG?
  Yes, you can be part of one or more ePAGs
• Do ePAG advocates work for EURORDIS?
  No, they are independent and their sponsor organisations do not need to be EURORDIS members.
• Do ERNs need to dedicate resources to facilitate patient engagement?
  Yes, EURORDIS support to the ePAGs should be supplemented by additional resources and support from the ERN coordination teams so the patient representatives are integrated into the ERN governance structure and activities and are adequately supported to fulfil their role.
• Is EURORDIS responsible for facilitating patient engagement in all the ERNs?
  No, ERNs and patient representatives may request EURORDIS support or not.
• May I request EURORDIS to provide tailored support?
  EURORDIS support is through cross-ERN working groups, capacity building and development of resources for common use. Exceptionally EURORDIS may provide 1 to 1/tailored support when there is a special need. The request for tailored support may come from the ePAG and/or the ERN coordination team. EURORDIS always aligns with both to discuss the details and coordinate any action.
• Do ePAG advocates have to be admitted to EURORDIS Open Academy trainings?
  Being an ePAG advocate is one of the criteria that is considered when selecting candidates for the Open Academy Schools, but these trainings are open to the rare disease patient community at large.
• Why has EURORDIS developed governance templates to organise patient involvement in the ERNs?
  As a resource to help harmonised patient representation in the ERNs. Each Network may decide to use these rules, adapt them or adopt a different set of rules.
• What is the role of EURORDIS in the recruitment of new ePAG advocates?
  The application process and criteria to assess the applications of new ePAG advocates should be clearly described in the ERN bylaws and ePAG Terms of Reference. ERNs may request EURORDIS support to manage the application process. EURORDIS sends prospective applicants the application package and shares the application forms with the ePAG and the Coordination team for their consideration, decision and follow-up.
• If I have a problem with how things are working with my ERN or ePAG, can EURORDIS intervene?
  EURORDIS has a process in place to support informal or more formal mediation and will always try to help with support and advice, but this is a voluntary process and EURORDIS does not have the remit to make changes to the composition of an ePAG.

ePAG glossary of terms

• European Reference Network (ERN)

  A group of highly specialised healthcare providers that have been awarded with the membership of a given Network. Networks focus on rare or low prevalence and complex disease(s), condition(s) or highly specialised intervention(s) as regulated by article 12 of the Directive 2011/24/EU on patients’ rights in cross-border healthcare[1].

  [1] OJ L 88, 4.4.2011, p. 45, Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare

• Board of Member States (BoMs)

  A governing body consisting of representatives from Member States across EU Member States and European Economic Area responsible for the formal designation of European Reference Networks as provided in the Commission Implementing Decision 2014/287/EU[1]. The Board of Member States (BoMS) has the responsibility of approving European Reference Networks (ERNs).

  [1]OJ L 174, 17.5.2014, p. 79, Commission Implementing Decision 2014/287/EU of 10 March 2014 setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks

• Patient Organisations (PO)

  Non-profit organisations that are legally registered and operating in Europe (48 countries as defined by EURORDIS based on definitions by the EU, the Council of Europe and the WHO-Europe), representing patients and families living with a rare disease, has a governing board made up of a majority patients or of family members of patients, is financially independent, particularly from the pharmaceutical industry (max. 50% of funding from several companies) and has proven activities such as patient support and/or advocacy activities and/or research. Individual ERNs may waive some of these requirements in exceptional cases, due to the particularity of patient-driven organisations and of rare diseases, as well as for historical or contextual reasons.

• Patient partnership

  Patient partnership in the ERNs can be defined as a mutual relationship between patients and health professionals, where input from people living with a rare disease or caring for someone with a rare disease routinely and formally informs the Networks’ collaborative activities and decision-making. Patient partnership implies considering health professionals and patients involved in the Networks as equal partners in all ERN activities and domains (e.g. Network planning and evaluation, healthcare, training, education, outreach and information, and clinical research).

• ERNs Associate Partner – Patient Organisation

  Patient Organisation registered and operating in Europe that has been invited to partner with an ERN, complies with the requirements established by the ERN and has gone through the Network’s application process to designate a patient representative to be involved in the ERN activities as an ePAG advocate. An Associate Partner agreement is signed between the ERN and the Patient Organisation to establish the terms of this collaboration.

• ERN Supporting Partner – Patients

  Patient Organisation with a national, European or international remit with no designated patient representative in the ERN, individual patients and family members or social-media patient support groups that have been invited to collaborate with an ERN. A Supporting Partner Agreement is signed between the ERN and the Patient Organisation, individual or support group to establish the terms of this collaboration.

• ePAG Advocate

  A patient representative to a specific European Reference Network who has been endorsed by an ERN Associate Partner-Patient Organisation to be active in the ERN governance structure including its working groups. For the purpose of this framework, the terms ePAG advocate, patient representative and patient advocate are used interchangeably.

• European Patient Advocacy Group (ePAG)

  A patient group, specific to each European Reference Network, composed by patient advocates that have been endorsed by a Patient Organisation established by EURORDIS to optimise patient involvement in the ERNs’ decisions and activities. Some ERNs have formally recognised these groups as part of their governance structure. The overarching objective of the ePAG is to ensure that the needs of people living with rare and complex conditions covered by the ERN are included in its strategic and operational delivery.

• ePAG Steering Committee

  Transversal working set up and managed by EURORDIS composed by ePAG Advocates from the 24 ePAGs sitting in the ERNs Boards or Executive Committees to provide strategic advice, share experience and knowledge from the 24 ERNs.

• ePAG Transversal Topic Based Groups

  Transversal peer learning working groups set up and managed by EURORDIS composed by ePAG Advocates dedicated to a specific topic, e.g.: clinical practice guidelines and clinical decision support tools, communication and dissemination, research and registries, training and education, monitoring and evaluation.

• ERN Coordinator

  The person appointed as the Coordinator of the Network by the Member of a European Reference Network chosen as the coordinating Member as referred to in recital 3 and Article 4 of Delegated Decision 2014/286/EU.

• ERN Project Managers

  The persons in charge of coordinating the Networks’ collaborative activities, financial and technical reporting, monitoring and evaluation.

• Board of the ERN

  The coordination body for each Network responsible for its governance, as foreseen in the Commission Delegated Decision 2014/286/EU3 (Annex I)[1]. All members of the Network must be represented on the Board.

  [1] OJ L 174, 17.5.2014, p. 71, Commission Delegated Decision 2014/286/EU of 10 March 2014 setting out criteria and conditions that European Reference Networks and healthcare providers wishing to join a European Reference Network must fulfil.

• ERN Core Networks (or sub-thematic networks)

  ERNs are thematic networks covering a number of rare or complex diseases and/or highly specialised interventions or surgery, as defined in their ERN application scope. Each ERN is structured differently to reflect the needs and grouping of their rare diseases into a number of ‘Core Networks’, also known as Disease Specific Networks or Sub-Thematic Working Groups, (e.g.: ERN-Lung has 9 core networks including Cystic Fibrosis, Pulmonary Hypertension, etc). Each one of these networks have a clinical committee or board of experts in that specific field to coordinate and lead the ERN activities specific to this disease area.

• ERNs Coordinators Group

  A working group that brings together the Coordinators of the 24 ERNs to discuss common technical matters.

• ERN Transversal Working Groups

  Transversal working groups set up by the ERN Coordinators, sometimes jointly with the ERNs BoMs, to discuss on topics and activities that are cross-cutting all 24 ERNs e.g.: clinical practice guidelines and clinical decision support tools, legal and ethics, research, training and education, integration of ERNs into national health systems, monitoring and evaluation.

• ERN Healthcare Provider (HCP) Member

  Member States with no Member of a given Network may decide to designate healthcare providers with a special link to a given ERN, following a transparent and explicit procedure. Those providers might be designated as Associated National Centres focusing on the provision of healthcare, Collaborative National Centres focusing in the production of knowledge and tools to improve the quality of care or a National Coordination Hub who connects their national healthcare system with ERNs, coordinating information and referrals.

• ERN Affiliated Partner

  ERNs are thematic networks covering a number of rare or complex diseases and/or highly specialised interventions or surgery, as defined in their ERN application scope. Each ERN is structured differently to reflect the needs and grouping of their rare diseases into a number of ‘Core Networks’, also known as Disease Specific Networks or Sub-Thematic Working Groups, (e.g.: ERN-Lung has 9 core networks including Cystic Fibrosis, Pulmonary Hypertension, etc). Each one of these networks have a clinical committee or board of experts in that specific field to coordinate and lead the ERN activities specific to this disease area.

• ERN Supporting Partner

  Healthcare providers, medical societies, and any other entity or individual experts which, without having a commercial relation with the ERNs and their Full Members or Affiliated Partners, or with the European Commission, contribute in different ways to the work of the networks.

• EUCERD

  European Union Committee of Experts on Rare Diseases stablished to support EU policy on rare diseases, and specifically provide policy guidance on the effective implementation of the 2008 EU Commission Communication on Rare Diseases and the 2009 Council (of the European Union) Recommendation on action in the field of rare diseases. In 2013 it was replaced by the European Commission Expert Group on Rare Diseases (CEG –RED) whose mandate terminated in 2016. The EUCERD and CEG-RD brought together representatives from: the 28 EU Member States, Iceland, Norway, Switzerland, the EU Commission, the Committee for Orphan Medicinal Products of the EMA, industry, academia, eight individual experts as well as eight patient advocates.

   

Download  the ePAG Glossary of terms