Teresa Costello (Fianna Fail)
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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.

Marian Harkin (Sligo-Leitrim, Independent)
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I thank Senator Costello for raising this issue. I will be answering on behalf of the Minister for Health, Deputy Carroll MacNeill.

The State acknowledges the importance of faster access to new medicines for patients. The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications that have been granted marketing authorisation by the EMA or the Health Products Regulatory Authority, HPRA. In making a reimbursement decision, the HSE is required under the Act to have regard to a number of criteria, including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds and having regard to the advice of the NCPE. Formal processes govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed.

The Senator mentioned the external review of the pricing and reimbursement process, the Mazars review, which was published in 2023. While this determined that the pricing and reimbursement process operated in line with international norms, a number of recommendations were made on foot of its findings.In the same year, 50% of applications for reimbursement progressed following a rapid review without the need for a full health technology assessment. Furthermore, 90% of generic and biosimilar medicines were approved for reimbursement within 90 days.

A number of these recommendations have now been implemented. One of the key recommendations of this review was enhancing the capacity across the pricing and reimbursement system, with significant funding allocated for 34 additional staff within the system. These 34 new staff have now been hired, of which 16 additional new staff were recruited and are now in place within the NCPE. This is a significant investment by the State and reflects the Government's commitment to providing access to new and innovative medicines to patients faster. The full impact of additional staffing within the NCPE on the speed of assessment of new medicine applications will become evident in the coming months. This additional capacity will significantly enhance and support the ability to appraise the increased volume and complexity of submissions from pharmaceutical companies for new drugs that are coming through the application process.

Another recommendation from this review was greater transparency for all stakeholders. A key focus was the implementation of a pricing and reimbursement medicines tracker to be developed by the HSE. The tracker has now been launched, with the initial iteration available since December 2024. In real time, this will show the status of a reimbursement application for a new medicine, from rapid review to a final decision by the HSE. Senator Costello asked about this. The HSE national service plan will continue the trackers' development with the introduction of indicative timelines for each step of a medicine's assessment process. That was the question the Senator specifically asked.

Teresa Costello (Fianna Fail)
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I thank the Minister of State for her reply. I welcome the recruitment of 34 new staff because time is of the essence when it comes to getting the necessary medication to people. As I said, time is something patients with certain rare illnesses do not have. I fully welcome the 34 new staff and I will be keeping a close eye on the progression and real life impact the additional staff will have in terms of a reduction in timelines.

Marian Harkin (Sligo-Leitrim, Independent)
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I am pleased to hear the Senator welcomes the 34 new staff who have been put in place and the efforts made to enhance and improve the pricing and reimbursement system, including the significant additional staffing to which we have referred. To fully benefit patients, the pharmaceutical industry must also play its part. Ireland is open for business and encourages timely applications for reimbursement with reasonable pricing offers - that is really important. We are confident that timely engagements and applications from industry for new and innovative medicines to be reimbursed will support faster and improved access to medicines for patients in Ireland.

The State has made considerable investments in new medicines in recent years. In 2023, more than €3.2 billion was spent on medicines by the State. That represents nearly one in every eight euro of public money that is spent on health. I think the Senator can see the level of commitment from the Department on this.