Patients in Ireland now wait an average of 801 days for access to rare disease medicines

 

• The access timelines for rare disease medicines have increased to 801 days from 685 days as reported last year.
• Average access timelines for all medicines in Ireland have risen to 685 days, compared to an EU average of 597 days.
• The recently agreed IPHA Framework Agreement provides a clear pathway to address these challenges.

Tuesday 19^th May 2026

Patients in Ireland continue to wait longer than their peers in most Western European countries in terms of accessing life-enhancing new medicines after authorisation by the European Medicines Agency, according to a new report by data analysts IQVIA for EFPIA, the European pharmaceutical body.

For patients with rare diseases the wait time from EMA authorisation has significantly increased from 685 days to over 800 days. This is in stark contrast to the EU average of 614 days. Furthermore only 18 (27%) of a total of 66 rare disease medicines approved by the EU are publicly-reimbursed and available to patients in Ireland, compared to 64 in Germany. While this rate of availability represents a marginal improvement from last year (20%), the deterioration in access timelines for these medicines is concerning.

This new data from the EFPIA Patients WAIT Indicator, assesses the availability of 168 innovative medicines with EMA central-marketing authorisation between 2021 and 2024 across 36 countries. While the rate of availability of new medicines in Ireland remains similar to previous years – 32% against the EU average of 45% – the time it takes for patients to access these treatments continues to increase and remains significantly behind the European average.

More broadly, the data shows:

• Average access timelines for all medicines in Ireland have risen moderately to 685 days from 645 days as reported in 2025.
• However, for oncology medicines, timelines have increased to 730 days from 644 days since last year.

These delays have real and lasting consequences for all patients. For people living with rare diseases – many of whom have limited or no treatment options – delayed access can mean disease progression, reduced quality of life, and lost opportunities for early intervention.

Alongside the EFPIA W.A.I.T. Indicator Report released today, a further survey* shows that 66% of newly authorised medicines by EFPIA members have been submitted for pricing and reimbursement in Ireland — a 15% increase since 2025 — bringing Ireland broadly in line with the EU average (69%). However, while submission rates have improved, patient access timelines remain significantly out of step with Europe, highlighting persistent systemic inefficiencies beyond the point of submission, as identified in IPHA’s Faster and Fairer paper (2024).

However, the recently agreed IPHA Framework Agreement directly addresses these structural challenges by setting out a clear pathway to streamline processes, reduce delays across the system, and ensure faster, more predictable access to medicines for patients in Ireland. This includes a commitment to achieve 180 days as outlined in the Health Act 2013, over the lifetime of the current Agreement.

Oliver O’Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association said “The Framework Agreement is a critical step forward in supporting patients in Ireland to gain faster access to innovative and life-changing new medicines. 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. 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.”

IPHA emphasised that improving access to rare disease medicines must be a priority, given the disproportionate impact of delays on these patient populations.

“Ireland has the ambition to be a leader in life sciences and healthcare innovation. Ensuring timely access to medicines – particularly for rare disease patients – is fundamental to achieving this goal.”

ENDS

Notes to Editor:

Other Western European countries analysed with higher rates of availability include: Germany, Switzerland, Italy, Austria, Spain, Portugal, Luxembourg, France, England, Denmark, Finland, Belgium, Scotland, Sweden, Norway, Netherlands, Iceland.

*EFPIA/Charles Rivers Associates European Access Hurdle Portal

Both reports available below.

EFPIA Patients W.A.I.T. Indicator 2025 Final 180526

CRA EFPIA – European Access Hurdles Portal – Final 180526