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 reimbursed and available to patients in Ireland, compared with 64 per cent in Germany. Across all medicine categories, Ireland’s availability rate stands at 32 per cent against an EU average of 45 per cent.

Average access timelines for all medicines have risen to 685 days from 645 days, while for cancer treatments the deterioration is sharper still, with timelines climbing to 730 days from 644 days.

A separate survey published alongside the W.A.I.T. data offers a partial counterpoint: 66 per cent of newly authorised medicines from EFPIA member companies have now been submitted for pricing and reimbursement consideration in Ireland, a 15-percentage-point increase since 2025 that brings the country broadly in line with the EU average of 69 per cent.

Improved submission rates

However, improved submission rates have not translated into faster access for patients, underscoring what the IPHA has previously identified as systemic inefficiencies beyond the point of submission.

Oliver O’Connor, IPHA chief executive, acknowledged the seriousness of the data while pointing to a recently concluded framework agreement as the basis for improvement. “The Framework Agreement is a critical step forward in supporting patients in Ireland to gain faster access to innovative and life-changing new medicines,” he said.

“It reflects a shared recognition by the State and industry that delays are unacceptable and that meaningful reform is required.” The focus must now turn to implementation, he added: “By delivering on the commitments within the Agreement, we have a real opportunity to significantly reduce timelines, improve patient outcomes, and empower clinicians to provide the best care available.”

Ireland’s health department told Euractiv the government was committed to timely access and pointed to significant recent investment. Backed by €158mn in funding across Budgets 2021–2025, it said Ireland has delivered access to 263 new medicines, 72 of them for rare diseases. A spokesperson said ‘Budget 2026’ has allocated a further €217mn for medicines, including €30mn for new treatments.

The department cautioned, however, that upfront allocations do not reflect the full cost burden of newly approved therapies. Once medicines are approved for reimbursement, the spokesperson said, “the full cost of providing them can reach multiples of this initial cost as their uptake increases” – a consideration that partly explains the measured pace of approvals.

New supply and pricing agreements

In March, Dublin signed two new Framework Agreements with Medicines for Ireland and IPHA on the supply and pricing of medicines. The department said the agreements balance fostering innovation with maintaining financial sustainability while providing greater certainty for industry.

Both include a structured commitment to achieve the 180-day reimbursement timeline enshrined in the Health Act 2013 – a target the current data shows the system running more than four times over. The department said the Health Service Executive (HSE) would meet that target on a net basis by the first quarter of 2029, supported by an implementation plan, process improvements and investment in additional capacity.

Industry’s parallel commitment to submit applications within six months of marketing authorisation would further support patient access, the spokesperson added.

The State and the sector have also agreed to develop a future strategic partnership, which will include a piloted early access programme for rare diseases in line with Programme for Government commitments.

Officials offered some context around the headline figures, noting that stop-clock periods – agreed pauses in the assessment timeline – are not captured in the W.A.I.T. data, and that international comparisons are complicated by significant variations in national reimbursement systems.

The department also noted that Ireland’s relatively small market size means some pharmaceutical companies do not prioritise it in the early stages of marketing a new medicine, a structural constraint that affects submission timelines upstream of the reimbursement process itself.

For patients with rare diseases – many of whom have no alternative treatments – the practical consequences of delay are severe. Postponed access can mean disease progression, diminished quality of life and missed opportunities for early intervention.

[VA]