EMA committee launches pilot project to consult patients on benefits and risk of medicines

The European Medicines Agency has launched a pilot project to involve patients in the assessment of the benefits and risk of medicines in its Committee for Medicinal Products for Human Use (CHMP). The project aims to enrich the scientific assessment of a medicine by listening to patients’ concerns and experiences from their perspective.

The CHMP conducts the initial assessment of medicines for which a Europe-wide marketing authorization is sought, and considers whether the benefits of a medicine outweigh its risks. As part of the project, patients will be asked to present their views on medicines for which there is an unmet medical need, where the committee still has concerns or doubts. The patients may also be invited to give their views on cases where the committee is considering withdrawing, suspending or revoking a marketing authorization, or restricting the indication of an authorized medicine.

The pilot project will explore how patients can be integrated into oral explanations at the CHMP, and stems from a wider EMA strategy to better involve patients in its activities.