As trilogue negotiations on the EU’s pharmaceutical legislation begin this week, over 70 patient organisations are calling on the bloc’s policymakers to preserve their voice in medicines regulation.
The coalition, with the European Patients’ Forum (EPF) and EURORDIS–Rare Diseases Europe at the helm, has launched a campaign titled #KeepPatientsVoting. It aims to urge lawmakers to retain patient voting rights in the European Medicines Agency committees, and to ensure meaningful patient involvement across the regulatory lifecycle.
“We’ve joined forces – EPF, EURORDIS, and more than 70 patient organisations – to make sure that strong and meaningful patient involvement is not weakened, but strengthened,” the campaign statement reads. “The choices made now will shape the future of EU health governance for years to come. Let’s get it right with patients – now.”
A defining moment for representation
At the heart of the debate are two EMA committees: the Committee for Medicinal Products for Human Use and the Pharmacovigilance and Risk Assessment Committee. These bodies oversee the evaluation, authorisation, and safety of medicines in Europe. The European Commission’s original proposal aimed to appoint four voting patient representatives in the CHMP and two in the PRAC. The European Parliament backed this approach in its April 2024 position.
However, the Council’s mandate, adopted on 4 June under the Polish Presidency, weakens these provisions, removing voting rights and reducing the number of patient representatives.
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“Removing voting rights would undo decades of progress,” said Virginie Bros-Facer, CEO of EURORDIS. “Patient representatives are not symbolic figures. They are expert, committed partners who dedicate significant time and expertise to regulatory discussions.”
“Patients bring vital lived experience to EU medicines regulation,” added Avril Daly, CEO of Retina International. “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.”
“Patients must not be sidelined. This is not just about votes. It’s about ensuring that the medicines system serves those who rely on it. Without meaningful involvement, the legislation risks falling short of its goals.” – Marco Greco, President of European Patient’s Forum
Political support builds
The campaign is receiving strong backing from policymakers. MEP Stine Bosse (Renew/DEN) stated: “Nothing about patients without patients. As we policymakers negotiate the biggest reform of EU rules for the pharmaceutical industry in over 20 years, we must all remember that the rules we make are there for the patients: serving the needs of patients and ensuring patient access to life-saving medicines. We must protect the progress made in the past few years and say it clearly: patients are equal partners in shaping medicine regulation, and need to have a voice and vote, just like we policymakers do,” Ms Bosse stressed.
Despite the support, patient groups fear trilogue negotiations might curtail their role severely. “Patients must not be sidelined,” said Marco Greco, President of EPF. “This is not just about votes. It’s about ensuring that the medicines system serves those who rely on it. Without meaningful involvement, the legislation risks falling short of its goals.”
Further political concern is also clearly present in a recent EU Perspectives article. The team of MEP Tiemo Wölken (S&D/GER) emphasised that “Removing patients out of the process and taking away their voice is definitely nothing that we as S&D or Parliament should stand for.”
“We must protect the progress made in the past few years and say it clearly: patients are equal partners in shaping medicine regulation, and need to have a voice and vote, just like we policymakers do.” – MEP Stine Bosse
A question of consistency
The Council’s position has also raised questions of consistency in political messaging. On 4 June, Polish Health Minister Izabela Leszczyna hailed the agreed mandate. “The mandate agreed today is a vital step toward ensuring that all Europeans have timely and equitable access to safe, affordable, and effective medicines,” Ms Leszczyna said. “At the same time, it strengthens the competitiveness and sustainability of our pharmaceutical sector and supports improved regulatory conditions to boost clinical research and to address public health needs. We are building a healthier, more resilient Europe that leaves no one behind,” she noted.
Yet patient groups argue that by stripping voting rights from EMA committees, the Council is doing exactly that. If patients are reduced to observers in regulatory processes that directly affect their lives, the argument goes, how can we claim to be leaving no one behind?
A united voice
“This is precisely the objective of our joint campaign with EURORDIS. We want to demonstrate that the patient community firmly opposes the Council’s proposed changes,” said Solène Jouan, EPF Policy Officer. “These decisions would have concrete and serious consequences for patients and public health across Europe. Policymakers must keep this in mind as trilogue negotiations begin. Our collective voice sends a strong signal: patients must not be sidelined.”
She added: “It’s important to highlight that only the Council has proposed reducing the number of patient representatives in the PRAC committee and removing their voting rights in the CHMP. In contrast, the European Commission and Parliament have put forward some proposals that support meaningful patient involvement. During the compromises to be made in trilogue negotiations, weakening patient involvement must be a red line from both those institutions.”
Beyond the vote
“Voting rights are crucial, but many other elements also need to be strengthened to ensure meaningful patient involvement,” Ms Jouan continued. “Without systematic patient involvement, it is impossible to assess the real value and obtain a comprehensive, fully accurate picture of the benefit-risk balance of new products.”
“This is why patient-relevant outcomes should be included in the marketing authorisation dossier to oblige pharmaceutical companies to genuinely involve patients from the very start of development and in the design of research,” the EPF Policy Officer continued. She also emphasised that “The concept of ‘unmet medical need’ must be defined in cooperation with patients to foster patient-centred innovation and avoid ignoring important quality of life factors.”
Involvement in shortages
“Patients should also be involved in identifying shortages and critical medicines,” Ms Jouan added, “not only to improve data collection and understanding of the societal impact, but also to ensure that policy responses meet patients’ needs.”
“Currently, the proposal does not allow patient representatives to become co-rapporteurs in the evaluation of marketing authorisation applications. Given patient representatives provide valuable expertise based on lived experience and a practical understanding of new medicines’ research and development, some national competent authorities may want to work with patient representatives as co-rapporteurs in specific cases,” she said.
“This legislative revision is a once-in-a-generation opportunity to make the EU regulatory framework more patient-centred,” Ms Jouan concluded. “It can promote deeper patient engagement in the regulatory process, improve access to high-quality medicines, and foster innovation that genuinely addresses unmet medical needs. The decisions made now will shape patient involvement in EU health governance for years to come. It must be right.”
What happens next
The first trilogue meeting takes place on 17 June 2025, with further technical meetings and a second political trilogue expected during the Danish Presidency. A final political agreement could be reached by the end of 2025.
The revised Regulation and Directive will enter into force 20 days after their publication in the EU Official Journal. While the Regulation will apply directly, the Directive will require transposition into national law within 36 months. If adopted and published in 2026, the new framework would apply from 2029 at the earliest, though transitional provisions may delay full implementation.
In the meantime, patient organisations are urging policymakers to make one thing clear: participation is not an add-on. It is a right. Campaign signatories emphasise that they are not asking for a favour. They are seeking recognition of the unique expertise patients bring, underscoring that a truly resilient and equitable Europe must respect patients’ place in decision‑making.
