The purpose of this paper is to clarify the role of representatives of patient and healthcare professional organisations within the different EMA scientific committees, focusing in particular on their role as members of such committees. The aim is to provide guidance to current members as well as those who are considering applying for membership of a committee at the EMA. For this purpose, this document addresses the role, workload, challenges and the added value of the patients and healthcare professional representatives in the committees. It also covers the work involved outside of the committee and other related aspects.
This paper has been prepared in collaboration with patients and healthcare professional
representatives members of the Human EMA scientific committees, based on their experience to date. Analysis of the experience acquired demonstrated that participation of patients and healthcare professional representatives in the scientific committees improves the quality of the opinion given by the scientific committees. It is also acknowledged that their contribution increases transparency and trust in regulatory processes and develops mutual respect between regulators and the community.
In accordance with Community legislation, patients and healthcare professional representatives are included as members in four of the six human EMA scientific committees: the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), the Committee for Advanced Therapies (CAT) and the Pharmacovigilance and Risk Assessment Committee (PRAC) (Annex I)…