Patient organisations warn against EU rollback on patient involvement in medicines regulation
March 2025Monday 10 March, Brussels – Leading patient organisations EURORDIS-Rare Diseases Europe and the European Patients’ Forum (EPF) are calling in this joint position statement on EU Member States to protect meaningful patient involvement in the European Medicines Agency (EMA), warning that ongoing negotiations on the revision of EU pharmaceutical legislation risk undermining decades of progress in patient-centred regulation.
As part of the current Council of the EU negotiations, key provisions of the European Commission’s proposal to strengthen patient involvement in EMA decision-making are at risk of being discarded or significantly weakened. In particular, the proposal to grant four patient representatives voting rights on the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance and Risk Assessment Committee (PRAC) is under threat.
The removal of these voting rights would diminish the influence of patient expertise and reduce patient representatives to mere observers rather than active contributors to decisions that directly impact the health, quality of life, and needs of the communities they represent.
The EMA has long recognised the added value of patient engagement in medicines regulation. Over the past 25 years, patient representatives have played a critical role in reinforcing trust in the regulatory system, making sure that medicines reflect the real-world needs of the people they are intended to serve, and contributing valuable insights into the safety, efficacy, and impact of treatments.
Stripping patients of their voting rights within the EMA is not just a step backwards – it is an outright dismissal of the very people these decisions impact most. Patient expertise is not a ‘nice-to-have’, but an essential safeguard for better, more inclusive healthcare. We call on policymakers to do the right thing: restore and reinforce patient representation at every level of decision-making.
Valentina Bottarelli, Head of Policy and Public Affairs, EURORDIS
Patients are not mere observers. A meaningful patient involvement in EMA decision-making must be protected and strengthened in the context of the revision of the EU pharmaceutical legislation. To ensure that the new legislation is truly patient-centred, to make the most of the expertise patients bring and to serve the public health interest, we must preserve their crucial role in regulatory decision-making, including a right to vote in the CHMP and PRAC. Policymakers should keep this at the forefront of their decisions.
Anca Toma, Executive Director, EPF
The revision of the pharmaceutical legislation represents a once-in-a-generation opportunity to strengthen a patient-centred regulatory framework. EURORDIS and EPF urge EU governments, policymakers, and Members of the European Parliament to uphold their commitments to public health and patient involvement by ensuring that the final legislation preserves patient voting rights in CHMP and PRAC (Articles 148 and 149 of the Regulation proposal).
The upcoming vote in the Working Party on Pharmaceuticals is a critical moment to take a stand for patient engagement in EU healthcare policy. A failure to protect patient representation now would set a dangerous precedent, weakening the role of patients in shaping the regulatory decisions that directly affect their lives.
About EURORDIS-Rare Diseases Europe
EURORDIS-Rare Diseases Europe is a unique, non-profit alliance of over 1,000 rare disease organisations from 74 countries that work together to improve the lives of the 30 million people living with a rare disease in Europe. By connecting people, families, and rare disease groups, as well as by bringing together all stakeholders and mobilising the rare disease community, EURORDIS strengthens the patient voice and shapes research, policies, and services.
About the European Patients’ Forum
The European Patients’ Forum (EPF) is an independent non-profit, non-governmental umbrella organisation of patient organisations across Europe and across disease areas. Its 78 members include disease-specific patient groups, active at EU level and national coalitions of patients. Read about our vision, mission, and strategy.
Contact
Julien Poulain
Communications Manager
EURORDIS-Rare Diseases Europe
Julien.poulain@eurordis.org
Flavia Topan
Communications Manager
European Patients’ Forum
flavia.topan@eu-patient.eu