The Alpha-1 Europe Alliance is proud to support the joint position statement from EURORDIS and the European Patients’ Forum (EPF) calling on EU Member States to protect meaningful patient involvement in the European Medicines Agency’s (EMA) regulatory processes.
As the revision of the EU pharmaceutical legislation progresses, there is growing concern that key provisions aimed at strengthening patient participation—particularly those ensuring voting rights for patient representatives on the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance and Risk Assessment Committee (PRAC)—may be weakened or removed entirely.
“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.”
This would mark a serious setback in a 25-year history of patient engagement within the EMA, during which patient voices have enhanced trust, transparency, and the quality of scientific assessments. Patient representatives bring unique lived experience that complements scientific and clinical expertise, ensuring that the benefits and risks of medicines are evaluated from a real-world perspective.
The Alpha-1 Europe Alliance echoes EURORDIS and EPF’s call to enshrine patient voting rights in Articles 148 and 149 of the Regulation proposal and to strengthen the role of patient organisations across all levels of regulatory decision-making. We believe this is essential to ensure that medicines developed and approved in Europe truly meet the needs of the patients they are meant to serve.
"As a representative of the Alpha-1 community, I am deeply concerned about the potential rollback of patient involvement in EMA decision-making. For rare disease patients like those living with Alpha-1 Antitrypsin Deficiency, having a voice in regulatory processes is not a luxury — it is a necessity. Our lived experience brings unique and invaluable insights into the risks, benefits, and real-world impact of treatments. From an institutional perspective, we strongly support the initiative led by EURORDIS and EPF and urge EU policymakers to uphold and strengthen patient participation as a fundamental pillar of transparent, inclusive and patient-centred healthcare regulation."
This revision is a once-in-a-generation opportunity to build a patient-centred regulatory framework. The upcoming negotiations will determine whether Europe continues to lead in integrating patient voices into healthcare policy—or retreats from hard-won progress.
We urge policymakers to take a stand for public health by reinforcing—not weakening—the role of patients in shaping the future of medicine regulation.
