Patient and consumer organisations believe they are making a positive contribution to the work of the European Medicines Agency, and say they have been “very impressed with the great willingness of the EMEA Management Board” and the agency’s Working Party with Patients’ and Consumers’ Organisations “to take into account the comments made by patient representatives.”

However, the groups also say that they would welcome further involvement in the agency’s work, pointing out that it still conducts its product evaluation and guideline preparation activities without any systematic involvement with the relevant patient organisations.

Their comments were made in response to an EMEA survey, the first conducted by the agency since it began systematically involving PCOs in its core activities, to discover how satisfied the groups have been with such interactions.

21 PCOs participated in EMEA activities last year, and more than 92% of their representatives told the survey that they were either “satisfied” or “very satisfied” with their overall interactions with the EMEA. They were particularly positive about the consequences for their organizations of this involvement, for example being able to pass on information to patients about available new medicines and treatment options, and improved relations with health authorities and health care professionals.

They also felt, overall, that the agency does take account of their comments and other contributions to its activities.

The EMEA points out that it has engaged in a dialogue with PCOs ever since it was created in 1995. “As end-users of the medicines that the EMEA evaluates, PCOs have specific knowledge and expertise to offer. This makes them key stakeholders in the work of the EMEA, and the agency is therefore committed to maintaining a strong working relationship with them,” it says. To this end, in December 2005, the EMEA Management Board endorsed a Framework of Interaction between the agency and the PCOs.

The PCOs participating in EMEA activities in 2007 included both general umbrella associations and groups focused particularly on a single disease area, such as HIV/AIDS, Alzheimer’s or cancer. The activities in which they are involved include reviewing public summaries of scientific assessment reports and package leaflets, to ensure the information is comprehensible, and providing their insight as users of medicines to EMEA scientific bodies.

The survey results were welcomed by the EMEA Management Board at it meeting this month, which also agreed that actions would be proposed to address the PCOs’ request for further involvement during product evaluation and guideline preparation.

The agency added that it will “continue to work towards the provision of high-quality information adapted and oriented to patients,” and that patients will continue to be involved in this work. In this respect, procedures already in place – such as the review of European Public Assessment Report (EPAR) summaries and package leaflets – will be scrutinised, “in order to introduce the necessary improvements and to extend the current scope of the exercise.”

This year's PharmaTimes Great Oxford Debate draws on the theme of patient information with the stirring motion: 'This House believes it is madness pharma can't talk to patients'. Debaters include Former Deputy Commissioner of the FDA Dr Scott Gottlieb, the EMEA's Executive Director Thomas Lonngren and Dr Fiona Godlee, Editor in Chief of the BMJ. Don't miss out on this entertaining and unique occasion, click here to book.