Medicinal Products Seanad Éireann — 2026-03-25 ============================================================ Mary Butler (FF), Waterford I thank Senator Kyne for raising this issue today and highlighting Aoife's case in the Seanad. I am taking this Commencement matter on behalf of the Minister for Health, Deputy Carroll MacNeill, and I will make sure she knows from the Senator’s advocacy the impact that Friedreich’s ataxia has on Aoife and her family. I was struck by some of the statements the Senator made about how her life has changed and how every day brings further loss and her future seems frighteningly limited. How brave she was to focus on her exams in 2021 and get them out of the way. The State acknowledges the importance of access to innovative medicines for patients in Ireland. The Government is committed to providing timely access to new and innovative medicines and has made considerable investments in recent years, with annual expenditure on medicines now exceeding €3 billion. It is actually closer to €4 billion. The level of investment is unprecedented in supporting patients through the availability of new and innovative medicines. Budgets 2021 to 2025 have included dedicated funding for new medicines of €158 million. This year, we have a record budget for medicines, which has increased by over €200 million, with €30 million ring-fenced to support access to the latest medicines. The HSE has approved 263 new medicines, or new uses for existing medicines, since 2021, including 107 for treating cancer and 72 for rare diseases. Friedreich's ataxia is a rare, inherited, progressive neurological disorder. It causes progressive ataxia, which is a neurological condition that causes problem with co-ordination, balance and movement, and neuropathy or nerve damage that disrupts normal nerve signalling. The Government acknowledges the importance of access to medicines and the Minister is particularly aware of the challenging circumstances faced by patients with Friedreich's ataxia. The Minister attended a briefing in Leinster House on Friedreich's ataxia last month. I think that was the briefing to which the Senator referred. It was organised by Deputy Peter 'Chap' Cleere and was led directly by people who had been diagnosed with Friedreich's ataxia and their family members. They spoke with great courage and conviction about their lived experience. I take this chance to acknowledge and thank them, including Aoife, for sharing their perspective with us. [ Omaveloxolone ], sold under the brand name Skyclarys, is an orphan medicine used to treat Friedreich's ataxia in adults and adolescents aged 16 years and over. The HSE received a pricing and reimbursement application for the drug in August 2024 for the treatment of Friedrich's ataxia in adults and adolescents aged 16 years and older. The HSE commissioned a health technology assessment in September 2024 and this was submitted by the applicant company to the National Centre for Pharmacoeconomics, NCPE, in July 2025, nine months after it was commissioned. The NCPE concluded its assessment and provided a recommendation to the HSE in December 2025. The HSE corporate pharmaceutical unit, CPU, is the interface between the HSE and the pharmaceutical industry in relation to medicine pricing and reimbursement applications. The CPU recently met with the company to discuss this application and is awaiting a commercial proposal. As the House will appreciate, this is now subject to commercial engagements and I am not in a position to say anything further on this part of the process. Once the commercial proposal is received and engagements conclude, the proposal and the NCPE reports, along with patient group submissions received, will go to the HSE drugs group. The HSE drugs group considers all of the evidence and makes a recommendation to the HSE senior leadership team, which holds final decision-making authority. The HSE has advised that the application remains under consideration and cannot make any comment on possible outcomes from the ongoing process at the moment. --- Source: Houses of the Oireachtas. Licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). The Official Report is revised after first publication; the fetch timestamp below identifies the version quoted. Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-03-25/debate/main Retrieved: 2026-08-14T04:54:46+00:00 Sitting date: 2026-03-25