Teresa Costello (Fianna Fail)

A clear commitment is made in the programme for Government, on page 90, to be specific, to ensure patients in Ireland have access to innovative medicines and treatments as swiftly and effectively as possible. Several steps were promised. We pledged to increased clinical trials and to better support clinicians, researchers and healthcare staff in these efforts. We committed to reviewing the drugs reimbursement process and implementing the Mazars review recommendations so that the entire approval pipeline would be properly resourced. We promised to explore early access schemes, particularly for rare diseases, and to strengthen co-ordination with European partners like the Benelux agreement to enhance our negotiating power and speed of access. We committed to investing in breakthrough treatments, especially for cancer and other major diseases, to improve patient outcomes and to reduce the burdens that delay places on lives and the healthcare system.

The Irish Pharmaceutical Healthcare Association published a position paper in February and I have read its findings. Under the health Act 2013, the HSE is legally obligated to make decisions on new medical reimbursements within 180 days, exclusive of clock stops. A clock stop, as we know, is when the HSE formally requests additional information, but when delays occur without formal written requests due to internal bottlenecks or other inefficiencies, those are not clock stops under the law. They are simply delays and patients pay the price.Under the 2021 Irish Pharmaceutical Healthcare Association framework agreement, the HSE further committed to implementing reimbursement decisions within 45 days of approval. However, real-world experience shows a different picture. The corporate pharmaceutical unit, CPU, and the National Centre for Pharmacoeconomics, NCPE, play crucial roles in evaluating cost-effectiveness but this process can take up to a year, which is far too long when lives or quality of life are at stake. Families are waiting and in some cases, such as with Duvyzat, the wait is deeply painful. Duvyzat is a promising treatment that can slow the progression of Duchenne muscular dystrophy, a rare and devastating condition. It offers not just a treatment but a glimmer of hope, a chance at a better quality of life for patients and their families. Right now, however, those families in Ireland are receiving a substandard level of care compared with their counterparts in the UK, where Duvyzat is already available.

The European Medicines Agency, EMA, is expected to make a decision on marketing approval by June or July, yet unless our reimbursement scheme significantly accelerates, there is a real and urgent risk that Irish children will continue to suffer and deteriorate while waiting for access. I have seen at first hand the desperation and devastation the unavailability of Duvyzat has caused to little Archie Ennis and his family in Tallaght. I know that when the medicine is approved by the EMA, his family will be watching the clock on it becoming available in Ireland, as will I.

This is not solely a procedural issue. The impact of delays is significant. Disease progression leads to higher treatment costs, increased hospitalisations and avoidable suffering. Delayed access reduces health gains and can lead to lost quality-adjusted life years. It places a greater burden on the healthcare systems, requiring more long-term care and more intensive interventions, and ultimately, it creates an economic and emotional burden on patients and their families. The numbers tell the story. For orphan treatments, Ireland made nine medicines available in an average of 597 days, compared with 401 days in Scotland and a weighted European average of 403 days. This puts our system behind those of our European peers. Just 20% of all orphan drugs approved by the EMA are available in Ireland, as opposed to other countries such as the UK, which has access to more than 60% of all medicines approved by the EMA.

The Mazars review identified what patients of the industry already know, namely, that the reimbursement process in Ireland lacks transparency. Months can pass with no communication, visibility on timelines or clarity on the next steps. To address this, have the following reforms been considered: transparent indicative timelines for each stage of the reimbursement process, from rapid review to final HSE decision; structured accountability to ensure compliance with the 180-day statutory timeline; and clinician-led horizon scanning to prioritise high-impact new therapies and expedite submissions? Timely access to medications is not a luxury. It is a necessity.