According to the European Commission Expert Group (EUCERD) patients and patient representatives should play an active role in the decision and opinion making process of the European Reference Networks (ERNs) and be involved in structural and clinical network activities. The Expert Group recommended that ERNs demonstrate meaningful patient involvement, patient-centeredness and empowerment through recognition of the role of patients, as experts by experience and co-producers of knowledge, in the ERNs structural and clinical activities and therefore demonstrate meeting the legal requirements in the Delegated Acts. 

These rules for patient engagement aim at facilitating the effective involvement of patient representatives in the activities of ERKNet. They are based on the governance framework developed by EURORDIS for patient engagement in the ERNs and contain specific provisions to adapt them to the governance structure of ERKNet.

The ERKNet European Patient Advocacy Group (ePAG) has appointed at least 2 ePAG advocates to be involved in each of the ERN work streams. This policy does not preclude other patient organizations registered in Europe, patient organizations registered outside Europe and individual patients and family members referred to in Sections 16 to 18 from collaborating on specific projects by invitation of the ERKNet the ePAG in agreement with the Network Board.

The position of ePAG advocate is a voluntary position and does not involve any financial compensation. Travel and accommodation expenses will be reimbursed according to the ERKNet policy on reimbursement for travel expenses.

ERKNet European Patient Advocacy Group (ePAG) is comprised of patient advocates that represent and are endorsed by a patient organization following the process described in Sections 11 and 12.

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. To achieve this goal, the ePAG role is to: 

• Represent the voice and interests of patients and families within ERKNet

• Ensure a patient-centric approach in the collaborative activities of ERKNet in the areas of care, education and training, knowledge sharing and research.

• Support the identification of ERKNet strategic priorities.

• Provide input on ethical issues.

• Support the Network in the dissemination of its activities and information to the wider patient community to ensure transparency.

ePAG advocates are patient representatives that are active in the ERN https://www.erknet.org

including the Network Board, work streams and working groups. The ePAG advocates role is to:

• Work in partnership with other patient advocates, clinicians and researchers involved in ERKNet

• Champion the diversity of views of the ERKNet patient community, and not just to represent their own disease area nor their own experience;

• Support ERKNet to disseminate information, primarily to the patient community, but as appropriate to other communities (e.g. healthcare providers, health authorities, clinicians and medical professionals and their professional bodies)

• Contribute to the development of patient information, clinical practice guidelines, other clinical decision support tools and referral pathways;

• Contribute to the development of research priorities and ensure the needs of patients and families area taken into consideration;

• Provide input on ethical issues, and balance patient and clinical needs appropriately;

• Scout for or make recommendations for new patient organizations to cover under-represented disease groups or patients from other EU countries.

All ePAG advocates will be required to:

• Participate in ERKNet working groups (depending on interests, expertise and availability).

• Participate regularly in the majority of the ePAG calls, and send apologies in advance if unable to attend.

• Report regularly in the ePAG calls and meetings on the progress of the work and projects in which they are directly involved in ERKNet. If unable to attend, the report should be sent by email ahead of the meeting or call. 

• Participate in the ERKNet annual meetings, where possible. Travel and accommodation expenses will be reimbursed subject to the ERN budgetary rules.

• Contribute to identify and develop the ePAG annual objectives and work program.

• Contribute to the assessment of new applications for membership of the ePAG.

• Respect the confidential nature of the discussions when it is made clear that this is a requirement by the person who is chairing a call or meeting.

• Comply with the ERKNet conflict of interest policy.

• Adhere to the terms of the mediation agreement in the case of a mediation process described in the EURORDIS ePAG Constitution and Rules of Procedure.

All ePAG advocates also commit to adhering to the following set of core values:

• Respecting the mission of the ERKNet (https://www.erknet.org/about-us/about-erknet)and its governance structure;

• Listening to the opinions and requests of others;

• Showing solidarity, mutual respect and support;

• Adhering to the principles of equity and social justice;

• Conducting themselves with professionalism in engaging with the clinical, research leads and fellow patient advocates;

ePAG advocates may nominate an alternate from his/ her own patient organization to attend specific ERN or ePAG meetings. The ERN Coordinator or the ePAG lead shall validate the participation of such alternates in the ERN or ePAG meetings, respectively. Alternates must comply with the ERKNet conflict of interest policy and with the core principles lay down in Section 4 when attending ERN or ePAG meetings.

ERKNet has one ePAG Chair and one ePAG Co-Chair, who are jointly responsible for coordinating and leading both the ePAG Group they represent and the broader ePAG Community within the ePAG Board.
In addition, each ERKNet disease-specific Working Group (WG) includes an ePAG WG Coordinator, who oversees ePAG-related activities within their WG and supports internal communication.

Responsibilities of the ePAG Chair and Co-Chair

In addition to the general roles and responsibilities of ePAG Advocates outlined in Section 5, the ePAG Chair and Co-Chair are responsible for:

• Represent the voice of ERKNet ePAG advocates and the ePAG Community to the ERKNet ePAG Board and network meetings.

• Share important news and update the other ERKNet ePAG advocates and the ePAG Community on ERKNet activities as appropriate.

• Consult with the other ERKNet ePAG advocates and the ePAG Community on relevant issues and feedback information to the ERKNet Network Coordinator.

• Ensure the sustainability of the ePAG advocates group.

• Assign ePAG advocates to WGs.

• Monitor ePAG advocates activities in the WGs.

• Coordinate the activities of the whole group, and report shared vision with ERN Coordinator/steering Committee 

• Coordinate the activities of the whole group, and report shared vision with EURORDIS Steering Committee/ Transversal Group etc.

Decisions within the ePAG group are made by consensus. In cases where consensus cannot be reached, a vote may be held. If disagreement persists, the ePAG Chair’s decision prevails.

The ePAG Chair and/or Co-Chair are also responsible for administrative coordination of the ePAG group, including:

• Welcoming new ePAG Advocates and Community members.
• Organising regular ePAG meetings (preparing agendas, minutes, and follow-up actions).
• Disseminating relevant information and ensuring effective communication within the group.

Responsibilities of ePAG Working Group (WG) Coordinators

In addition to the role and responsibilities of the ePAG advocates mentioned in Section 5, the ePAG WG Coordinators have the following responsibilities:

• Welcome new ePAGs in their WG

• Monitor the activities within the WG

• Presenting the ongoing ePAG activities at the WG and ePAG meetings

• The ePAG WG Coordinator can also delegate specific tasks within the group

• Encourage active participation of ePAG members and ensure that the patient perspective is effectively represented in WG discussions and outputs.

Individuals cannot apply on a personal basis. Prospective applicants must be formally endorsed by a patient organization that meets the following requirements: 

• Is legally registered and operates in Europe (48 countries as defined by EURORDIS based on definitions by the EU, the Council of Europe and the WHO-Europe). This registration requirement can be waived in exceptional cases, due to the particularity of patient-driven organizations and of rare diseases, as well as for historical or contextual reasons. 

• 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).

• Holds non-profit status.

• Has proven activities such as patient support and/or advocacy activities and/or research (https://www.erknet.org/about-us/conflict-of-interest-policy).

In exceptional cases, such as those involving ultra-rare conditions or countries/regions with very small patient populations, organizations that do not fully meet all standard eligibility criteria may still be considered. To be eligible under such circumstances, they must:

• Demonstrate structured and meaningful patient involvement in decision-making processes, and

• Provide clear documentation on the interests and communities they represent.

All exception requests will be jointly reviewed by the ERKNet Coordination Team and the ePAG Chairs, who will assess whether sufficient safeguards are in place to ensure independence and meaningful patient representation.

Required skill and experience:

• Have knowledge of, or experience of living with, one of the rare and complex conditions included in the scope of ERKNet.

• Willingness and motivation to get involved, contribute actively to the discussions and work of the ePAG and the ERN WGs ;

• Ability to work effectively, constructively with other patient representatives and clinicians from different EU countries;

• Ability to represent the interests of all represented diseases that are under the scope of the ERN, beyond their own disease.

• Ability to bring independent judgment from a patient representative perspective;

• Have an awareness of, and commitment to, equality, diversity and inclusiveness;

• High level of organization and self-motivation;

• Understand the need for confidentiality;

• Able to communicate in English to be able to follow and contribute to meetings.

• Have computer skills and equipment to communicate through email, webinars, and videoconferences.

• It is desirable to have experience working in a committee setting with clinicians and patient representatives.

ePAG advocates will be required to attend ePAG calls approximately every two months that will generally take place during working hours. 

They will also be required attend the calls of the ERN WGsin which they decide to be involved, as well as the ERN annual meeting, which  is usually a full day meeting.

In addition, they will need to dedicate time to review and read documents ahead of the meetings and calls. This implies a commitment of typically 2 days per month and can increase to approximately 5 days per month for ePAG Chairs. 

ePAG advocates role and position in the ERNs give these representatives the possibility to: 

• Work closely with clinicians, researchers and other patient representatives to transform healthcare services and accelerate research for people living with a rare disease in Europe.

• Participate firsthand in the development of the ERN objectives and infrastructure to ensure that it remains driven by patients’ needs.

• Gain international exposure and expand their international network, specifically across Europe.

• Acquire a good understanding of healthcare models across Europe and European Reference Networks.

• Develop soft skills such as communication, public speaking, conflict resolution, etc. acquired through trainings such as the ones provided by EURORDIS through its Open Academy, EUPATI and others, and through active participation in the ePAG.

• Share and learn from other ePAG advocates and build their own capacities as patient representatives, broadening knowledge both within their own field of rare diseases and beyond.

Prospective applicants should complete and sign the Application Form: https://form.jotform.com/eurordisforms/epag-application and send it together with the Endorsement Letter signed by the legal representative of the patient organization.

If the Coordination Team (the ERKNet ePAG Chair, and ERKNet Coordination office) considers necessary, additional supporting documentation may be requested. These may include, but are not limited to, the following:

• Statutes of Association/Constitution
• List of the Board of Directors, indicating for each member whether they are a patient or a family member of a patient.
• Most recent Annual Report, including the financial statements.

Once received, the applications are processed as follows: 

1. EURORDIS ePAG manager shares the application and accompanying documents with the ERKNet ePAG.

2. The ERN staff will review the information pertaining to the patient organization to ensure that the requirements described in Section 7 are met.

3. The application is reviewed and discussed by the ePAG chairs and ERKNet coordination office. Applicants will be assessed against the required skills and experience outlined in Section 8. Selection will be made on the basis of the content of the application form and accompanying documents.

4. The ePAG may request further information or arrange an informal call with the prospective applicant to get additional information on his or her skills, experience and motivation. 

5. Priority will be given to prospective applicants that represent a country or a disease not currently represented in the ERKNet ePAG.

6. Approval of new ePAG advocates is through agreement in the ePAG and in consultation with the ERN Coordinator. 

7. All applications will receive a successful or unsuccessful notification. 

The appointment of a new ePAG advocate is initially for a six-month period. During this period, the new ePAG advocate will have the opportunity to get familiar with the activities and with his/her role and responsibilities. After this period, the ERKNet ePAG, in consultation with the Network Coordinator, will validate the appointment of the new ePAG advocate.

ERKNet will request that all new ePAG advocates complete an interactive online induction session delivered by EURORDIS on a quarterly basis. This webinar lasts an hour and a half and will provide some background information to the European Reference Networks and European Patient Advocacy Groups and the work that they do. 

In addition, new ePAG advocates will also receive an induction on the work of ERKNet delivered by one of the seasoned ePAG advocates. 

The mandate of ePAG advocates expires at end of each five-year funding period of the ERNs. The mandate of ePAG advocates appointed for a given 5-year period may be renewed for another 5 years by reconfirming their willingness to continue and submitting a written notification (e.g. via email) from their patient organization, addressed to the ePAG Chairs and ERKNet Coordination, confirming continued endorsement. ePAG advocates who joined the last year of any 5-year ERN period, will not be required to renew their mandate.

Appointment of the ePAG Leads is for a period of 2 years, their mandate may be renewed with the agreement of ERKNet ePAG and in consultation with the ERN Coordinator and the ERKNet Working Group HCP Chairs and Co-chairs.

The mandate of an ePAG advocate shall terminate in any of the following cases:

1. The ePAG advocate sends a notice of resignation to the ERKNet ePAG, the ERN Coordinator and to EURORDIS.

2. The Patient Organization withdraws the endorsement given to the ePAG advocate. 

3. The ePAG advocate does not respond to emails, attend meetings or does not contact the ePAG group in a period of 3 months.

4. Mutual agreement between the ePAG, ERN Coordinator, EURORDIS and the ePAG advocate that his or her involvement is not in the best interests of the ERN.

In the circumstances referred to in points 3 and 4 above, before any decision is made to remove someone from being an ePAG advocate:

• the ePAG advocate, his/her endorsing Patient Organization and EURORDIS must be informed of the reasons why it is proposed to remove them (this includes an opportunity for open discussion), and

• at least one month should be allowed for mediation and any concerns raised to be addressed.

At any time, ePAG advocates can send a notice of temporary suspension to ERKNet, the ePAG chairs, the ERN Coordinator and to EURORDIS, in case they would like to voluntarily step down for a period of time.

External patient organizations registered in Europe that do not have a formal representative in the ePAG may wish to engage with the ERKNet ePAG. This wider community of patient organizations may be willing to collaborate on specific tasks (e.g. respond to surveys), help to disseminate information about the ERN across their wider patient community, be consulted occasionally for feedback, and be kept informed on the development of the ERN activities. 

These patient organizations do not have a representative formally involved as an ePAG advocate in the ERKNet work streams or WGs , but they represent an important component of the ePAG accountability and proper functioning.

Any rare disease patient organization meeting the following two requirements can contact the ePAG Chairs or ERKnet Coordination office to express their interest to collaborate and/or receive updates from the ePAG and the ERKNet. They will then be invited by the ERKNet Board in agreement with the ePAG to collaborate with the group and/or receive updates:

• Is registered in Europe as a patient organization. This requirement can be waived in exceptional cases, due to the particularity of patient-driven organizations and of rare diseases, as well as for historical or contextual reasons.

• Operates in Europe representing patients and families living with a rare disease that belongs to the scope of the ERKNet

• Further details on the diseases covered by ERKNet are available at: https://www.erknet.org/disease-information

Patient organizations that meet the above requirements and are invited to collaborate should indicate a contact person who will receive the ePAG notifications and act as the liaison between the patient organization and the ePAG. Such individuals will not be formally involved in ERKNet as ePAG advocates. However, when engaging in the ePAG or ERN activities and projects, they must comply with the ERKNet conflict of interest policy and the core principles lay down in Section 4.

The ERKNet ePAG is responsible for maintaining the list of the external European patient organizations with whom they engage and sharing this list with their ERN Coordinating team.

External patient organizations registered and operating outside of Europe representing patients and families living with a rare disease that belong to the scope of ERKNet want to collaborate with the ePAG on specific tasks and projects. Where appropriate, the ERKNet Board in agreement with the ePAG may invite these patient organizations to contribute to a specific project or activity within a specific timeframe. 

Once invited by the ERKNet Board, the patient organization will contact the ePAG Chair to indicate a contact person who will receive the ePAG notifications and act as the liaison between the patient organization and the ePAG. Such individuals will not be formally involved in ERKNet as ePAG advocates. However, when engaging in the ePAG or ERN activities and projects, they must comply with the ERKNet conflict of interest policy and the core principles lay down in Section 4.

The ERKNet ePAG is responsible for maintaining the list of the international patient organizations with whom they engage.

Individual patients or family members may want to volunteer their time to collaborate with the ePAG on specific tasks or projects. Where appropriate, the ERN Board in agreement with the ePAG may invite these persons to contribute to a specific project or activity within a specific timeframe. Such individuals are formally involved in ERKNet as supporting partners. However, when engaging in the ePAG or ERN activities and projects, they must comply with the ERKNet conflict of interest policy and the core principles lay down in Section 4. 

The ePAG on annual basis will make the necessary amendments to ensure they remain fit for purpose. 

Nothing in this document removes the rights of the ERKNet Network Board to interpret and/or amend its content in the best interest of the Network or to comply with relevant directives or guidance from the European Commission.