European Medicines Agency Takes FDA to School on Patient Engagement | Pharmaguy's Insights Into Drug Industry News | Scoop.it

By: Nathalie Bere, MSc


I recently returned from a two-week fellowship at the FDA Headquarters in Silver Spring, Md. My mission was to learn about the FDA’s engagement with patients. And, at the same time, to share information on how we involve patients in our work here at the European Medicines Agency (EMA).


The EMA is responsible for the scientific evaluation primarily of innovative and high technology medicines developed by pharmaceutical companies for use in the 28 current EU member states as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Experts participate in the work of the EMA as members of its scientific committees, working parties, scientific advisory groups, or as members of assessment teams evaluating medicines. They are chosen on the basis of their scientific expertise. The patients and health care professionals’ voices are also fully integrated within the work at the EMA. 


DA could benefit from EMA’s experience of engaging with patients earlier during its discussions on specific product assessments. In the EMA’s system patient input can be regularly solicited throughout the medicine’s lifecycle, e.g. in all expert meetings, through written patient consultations, and by patients as voting members within committees.


Other areas that could benefit the FDA include: patient review of all package leaflets and safety communications, and the establishment of a permanent group of patient/consumer organizations that provide a platform for exchange of information on general issues within the EU system.