Alzheimer Europe has joined more than 70 patient organisations in supporting a joint statement authored by Rare Diseases Europe (EURORDIS) and the European Patients’ Forum (EPF), calling for the safeguarding of meaningful patient involvement in the European Medicines Agency (EMA), as part of reforms to the EU’s pharmaceutical legislation. EURORDIS and EPF have warned that Council position risks removing patient representatives’ voting rights in the EMA’s Committee for Medicinal Products for Human Use (CHMP), as well as reducing the number of voting patient members in the Pharmacovigilance and Risk Assessment Committee (PRAC). The European Commission’s original proposal marked a milestone in formalising patient involvement in EU medicines regulation, introducing provisions for four patient representatives with voting rights on the CHMP and two on the PRAC.
However, the Council agreement adopted on 4 June significantly weakens these provisions. It falls short of both the Commission’s ambition and the European Parliament’s position adopted in April 2024 in terms of patient involvement. The statement notes that reducing patient involvement or removing voting rights would not only undo decades of progress, it would also send a damaging signal that patient perspectives are no longer valued in decisions that directly affect their lives. Trilogue negotiations between the Council, the Parliament and the Commission are set to begin on 17 June. The joint statement is available at:
https://www.eu-patient.eu/globalassets/joint-statement-epf-x-eurordis.pdf
