Call to protect and strengthen meaningful Patient Involvement in EMA Decision-Making
The European Patients' Forum (EPF) and EURORDIS - Rare Diseases Europe (EURORDIS) are urging EU Member States to uphold strong and meaningful patient involvement in the European Medicines Agency’s (EMA) regulatory decision-making. This call comes in the wake of ongoing Council negotiations on the revision of EU pharmaceutical legislation, which may significantly weaken the role of patient representatives in regulatory decisions.
EPF and EURORDIS express deep concern over proposals that would remove or diminish key provisions from the European Commission's proposal, particularly those ensuring four patient representatives with voting rights in the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance and Risk Assessment Committee (PRAC).
A Critical Phase for Patient Representation
EPF and EURORDIS emphasise that meaningful patient representation, including voting rights, must be enshrined in the legislation, particularly in Articles 148 and 149 of the Regulation proposal. Removing these rights would reduce patient representatives to mere observers, wearing away their ability to influence decisions that directly impact public health and quality of life.
For over 25 years, patient involvement in regulatory decision-making has proven invaluable in enhancing transparency, trust, and the quality of scientific evaluations. Patients bring first-hand expertise and lived experience, providing essential insights into the benefits and risks of medicines. Their involvement ensures that regulatory decisions better reflect the real-world needs of the communities they serve.
A Call to Action for EU Decision-Makers
EPF and EURORDIS call on EU Member States to safeguard and reinforce patient involvement in EMA decision-making by:
- Embedding the EMA definition of “patient organisation” in the legislation to formally recognise and strengthen the important role of patients in accordance with high governance standards;
- Consulting patients in drawing up the Union's list of critical shortages and critical medicines;
- Enabling patient representatives to contribute to muti-national assessment teams (MNAT) in the evaluation of marketing authorisation applications;
- Including patient representatives in the Coordination Group for Mutual Recognition and Decentralised Procedures for human medicines (CMDh).
- Providing adequate training and remuneration from the Agency's budget to enable them to make a meaningful contribution, especially when undertaking extensive and very time-consuming tasks.
The revision of EU pharmaceutical legislation presents a once-in-a-generation opportunity to strengthen a patient-centred regulatory framework. Patient engagement must remain a pillar of Europe’s public health strategy, ensuring that regulatory decisions lead to the development of safe, effective, and high-quality medicines that address the true needs of patients.