The European Medicines Agency (EMA) has informed ESMO that on 10 August 2012 ESMO was added to the list of healthcare professionals' organisations eligible to work with the Agency.
On 15 December 2011, the EMA published a list of criteria to be fulfilled by healthcare professionals' organisations wishing to be involved in the Agency’s activities. ESMO responded to the call and Dr Paolo Casali, Chair of the ESMO Public Policy Committee, submitted the application on behalf of ESMO in July 2012.
The list of organisations is intended for patients and healthcare professionals who may have questions related to a specific disease/illness and who could then contact the relevant organisation(s), who work with the European Medicines Agency.
The list can be accessed here
Further links to the list are also included in the EU Clinical Trials register, (https://www.clinicaltrialsregister.eu) which gives public access to information on EU clinical trials, and the Eudravigilance database (an EU database of suspected adverse reactions), with public access to aggregated data reports.
The criteria developed by the EMA relate to all aspects that a healthcare professionals’ organisation should fulfil in order to be involved in Agency activities. ESMO is proud to announce that it met the EMA’s criteria on legitimacy, mission/objectives, activities, representation, structure, accountability and consultation modalities, and transparency. The Agency carries out a full re-evaluation of eligibility every two years and evaluates the annual financial statements of each organisation. Organisations are encouraged to receive funding from as wide a selection of sources as possible.
European Medicines Agency definition of a healthcare professionals’ organisation
Healthcare professionals’ organisations are defined as not-for-profit organisations that have an interest in patient care, and where healthcare professionals represent a majority of members in governing bodies.
The given definition ranges from those organisations mainly centred on patient care to other associations such as learned and academic societies, focused on research activities, but which may have an interest in medicines and the Agency’s work, and which ultimately aim to benefit patients.
- European organisations representing national organisations or individual healthcare professionals (e.g. generalists or specialists in a specific disease area)
- European organisations that exist to promote a scientific discipline/profession
- General umbrella organisations (e.g. representing either European-specific disease organisations and/or national umbrella organisations)
European Medicines Agency criteria that ESMO fulfilled
The organisations shall be established in a Member State of the European Union (EU) or of the European Economic Area (EEA), and shall fulfil the following criteria:
Legitimacy: the organisation shall have statutes registered in one of the Member States of the EU/EEA. If it is an international organisation not registered in an EU/EEA Member State, additional information needs to be provided demonstrating EU focus and activities.
Mission/Objectives: the organisation shall have its mission/objectives clearly defined and should agree to have it/them published on the European Medicines Agency website.
Activities: the organisation shall have, as part of its activities, a specific interest in medicinal products which should be documented (e.g. through a report published on the organisation website).
Representation: the organisation shall be representative of healthcare professionals throughout the EU/EEA. Organisations already registered at Community level, e.g. in the EU Health Forum, the Council of Europe, are considered to adequately represent healthcare professionals for involvement in European Medicines Agency activities.
In case of a lack of European associations for a specific disease or treatment area, the involvement of national organisations may be considered, although preference will be given to European wide-associations. These associations will need to fulfill the same criteria apart from representation, which will be at national level.
If several similar associations exist in different Member States, a choice will be considered on a case-by-case basis.
International organisations can also be considered for eligibility as long as they have a European focus and representation, including EU/EEA based office(s).
Structure: the organisation should have governing bodies which are elected by their members, who shall be healthcare professionals.
Accountability and Consultation Modalities: statements and opinions of the organisation should reflect the views and opinions of its members and adequate consultation procedures with those members should be in place. In particular, the organisation should ensure that the appropriate flow of information is in place to allow dialogue both ways: from and towards its members.
Transparency: the organisation shall disclose to the European Medicines Agency its sources of funding both public and private by providing the name of the bodies and their individual financial contribution, both in absolute terms and in terms of overall percentage of the organisation budget. Any relationship with corporate sponsorship should be clear and transparent. This information shall be communicated to the Agency on an annual basis.
In case of umbrella organisations the list of member associations should be made available to the European Medicines Agency.
The EMA encourages organisations to be as transparent as possible, e.g. by publishing on the organisation website the registered statutes, together with financial information as specified above and information on the activities undertaken.
In addition, healthcare professionals’ organisations shall be committed to take an active part in the interaction with the EMA.
To facilitate communication, a contact person shall be identified.
In order to ensure transparency in this field, the EMA created a public registry of those healthcare professionals’ organisations with whom it interacts, following fulfilment of the above criteria.