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Gaetan Duport: The Next Challenge for Patient Involvement at EMA

Gaetan Duport/LinkedIn

Mar 24, 2026, 16:33

Gaetan Duport: The Next Challenge for Patient Involvement at EMA

Gaetan Duport, User Representative on the Economic and Public Health Committee (CEESP) at French National Authority for Health, shared on LinkedIn:

”EMA’s 2024–2025 stakeholder report is worth reading closely from a patient involvement perspective.

Patient participation at EMA is becoming more embedded in procedure, not just consultation.

The Agency revised its CHMP public assessment report template to reflect patient input and patient experience data, introduced a form to capture patient input in scientific advice, and expanded the PCWP from 22 to 25 organisations.

But the report also confirms something patient organisations know very well: meaningful participation is resource-intensive.

In 2024, 70 patients and carers contributed to 67 procedures; in 2025, 53 contributed to 53.

By December 2025, EMA had 42 eligible patient and consumer organisations.

That is real influence — but it also points to a small, highly mobilised ecosystem carrying a heavy operational load.

This is why the 2025 mobilisation on voting rights mattered.

More than 70 additional patient organisations joined EPF and EURORDIS in calling for meaningful patient involvement and retention of voting rights.

EMA’s Management Board minutes later noted with satisfaction that patient priorities, including voting rights, had been included — while also warning that participation depends on a very small pool of people and requires adequate support.

The real issue in 2026 is no longer only recognition in principle.

It is follow-up: capacity, continuity, support, and the ability of patient organisations to remain present where decisions are actually shaped and budget cut.

The General Pharmaceutical Legislation is expected to come into late 2026, followed by a Lon transition period.”

Gaetan Duport: The Next Challenge for Patient Involvement at EMA