EMA criteria

One of the best examples of good international practices certainly are the European Medecines Agency’s Criteria to be fulfilled by Patients’ and Consumers’ Organisations involved in EMA Activities:

The organisations should be established at European Union (EU) level, and should fulfil the following criteria:

• Legitimacy: the organisation should have statutes registered in one of the Member States of the EU. If it is an international organisation not registered in a EU Member State, additional information needs to be provided demonstrating EU focus and activities.•

– Mission/Objectives: the organisation should have its mission/objectives clearly defined and should agree to have it/them published on the EMEA website

– Activities: the organisation should 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).

– Representativity: the organisation should be representative of patients or consumers throughoutthe EU. Organisations already registered at Community level, e.g. in the EU Health Forum, the Council of Europe, are considered to adequately represent patients or consumers for involvement in EMA activities.

• Structure: the organisation should have governing bodies which are elected by their members, who shall be patients, their carers, or their elected representatives.

• 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: as a general rule, the organisation should be as transparent as possible, e.g. by regularly publishing, on its website, a report on the activities undertaken.
The organisation should also disclose its sources of funding both public and private by providing the name of the public and/or private bodies and their individual financial contribution in terms of percentage of the organisation budget. Any relationship with corporate sponsorship should be clear and transparent. Any conflict of interest should be disclosed to the EMEA. In case of umbrella organisations the list of member associations should be publicly available.

Please go to www.ema.europa.eu/ema to read the full information and download the application form.