Patients in Ireland with rare diseases now wait an average of 801 days from European regulatory approval to access new medicines, up sharply from 685 days recorded last year and well above the EU average of 614 days, according to new data. The figures raise fresh questions about the pace of reform in one of Europe’s leading pharmaceutical manufacturing hubs.
The data, drawn from the annual EFPIA Patients W.A.I.T. Indicator compiled by IQVIA, cover 168 innovative medicines with central marketing authorisation from the European Medicines Agency across 36 countries. They show Ireland falling further behind its European peers on access timelines even as submission rates improve – a disconnect that industry groups say points to persistent structural inefficiencies within the reimbursement process itself.
Bridging the gap
The gap with comparator countries is stark. Of the 66 rare disease medicines approved by the EMA between 2021 and 2024, only 18 – 27 per cent are publicly…
