Patient organisation or not? The EMEA defines its set of criteria

Has your patient organisation ever thought of being involved in some of the European Medicines Agency's (EMEA) activities? If so, you need to be aware of the criteria to be fulfilled by your organisation to be allowed to work in cooperation with the Agency.

“These criteria were recently created,” says Isabelle Moulon, Head of the newly created Medical Information Sector at the EMEA, “following a new Community legislation giving additional responsibility to the Agency, its Management Board, and its Committees to develop contacts with consumers and patients.” The EMEA wants to ensure that the patient organisations it collaborates with are legitimate to speak on behalf of their members, and that they are as transparent as possible. The Agency wants a dialogue with patient organisations based on trust and respect. “These criteria are important,” says Isabelle Moulon, “to clearly define patient organisations, not only for the EMEA, but also for the public.” Lesley Greene, Regional Development Manager, Climb (UK), and Eurordis' representative at the EMEA/CPMP Working Group with Patients' Organisations, says that “it is crucial that the EMEA is able to open up the discussions to a wide spectrum of patient groups. It brings new people, new blood, and fresh ideas to the collaboration. The criteria should allow this to happen on a transparent basis.”

The criteria originate in an initial recommendation by the EMEA/CPMP Working Group with Patients' Organisations, of which Eurordis is an active member, following its first meetings in 2003 and 2004. As a follow-up, the EMEA created a draft document that was submitted to the Working Group, which was able to give its feedback and expand the list of criteria before the Agency finally adopted the document on 28 September 2005. In the document, patient organisations are defined as not-for-profit organisations which are patient focused and include a majority of patients and/or carers in their governing bodies. These organisations can be general umbrella or European disease-specific organisations. The defined criteria include: legitimacy of the organisation in regards to its membership base; transparency of its missions and objectives; documented activities in the area of medicinal products; representativeness of patients at EU level; governing bodies elected by members; two-way dialogue with, and consultation of, members; and overall transparency of processes, sources of funding, and activities undertaken. Patient organisations should also be committed to taking an active part in the interaction with the Agency. Preference is given to European-wide organisations, but national ones can be considered in the case of a lack of a corresponding European organisation (for example, for discussion on a specific disease).

The importance of the creation of the list of criteria by the EMEA and the Working Group should not be underestimated. It is the first time that a drug agency has come up with such clearly defined criteria to characterise the kind of patient organisations they want to work with. As a consequence, these criteria can be used to determine which organisations are legitimate patient organisations to participate in a decision making process and which ones aren't. They can also be used to promote the quality of patient organisations. This new EMEA official policy about patient organisations, the first one of its kind, could be used in different areas in the future: regulatory and drug developments, as is intended, but also in new domains such as research and health policy developments.

Eurordis strongly encourages its members to assess their organisation against the set of criteria of the EMEA, whether they want to work with the Agency in the future or not. It will help them to analyse what kind of organisation they are; it will also give them a set of good practices to build up their credibility and implement the transparent processes and structures looked for by members and partner organisations alike.

This article was previously published in the January 2006 issue of our newsletter.

Author: Jerome Parisse-Brassens
Photos : © Eurordis
Graphics: © EMEA - European Medicines Agency