As the EU’s general pharmaceutical legislation enters a decisive phase, Retina International joins more than 70 patient organisations in supporting the joint call by EURORDIS–Rare Diseases Europe and the European Patients’ Forum (EPF) to safeguard strong and meaningful patient involvement at the European Medicines Agency (EMA).
A key concern is the retention of patient voting rights in the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance and Risk Assessment Committee (PRAC). The European Commission’s original proposal represented a significant step forward in formalising patient participation in EU medicines regulation. It introduced provisions for four patient representatives with voting rights on the CHMP and two on the PRAC. However, the Council agreement adopted on 4 June falls short of this ambition, weakening key provisions and threatening to roll back decades of progress in patient inclusion.
For over 25 years, patient representatives have contributed vital lived experience to the regulatory process—ensuring that medicines are not only clinically effective, but also aligned with real-world patient needs. Their role is not symbolic; it is expert, informed, and essential.
Read the full statement here.
Avril Daly, CEO of Retina International, stated: “Retina International strongly supports the call to safeguard patient voting rights at the EMA. These rights are not symbolic – they are essential to ensuring that EU medicines regulation reflects real-world needs. Weakening patient involvement would undermine trust and progress. We urge policymakers to enshrine meaningful, equitable participation in the final legislation.”
Retina International is proud to stand with EURORDIS, EPF, and the wider patient community in calling on EU policymakers to ensure that the final pharmaceutical legislation preserves robust, equitable patient representation.
We believe that any framework for medicines regulation must recognise the unique insights that patients bring—as equal partners in shaping decisions that affect their health and lives. The coming trilogue negotiations are a pivotal moment. Patient organisations across Europe are united in their message: #KeepPatientsVoting.
