Medicinal Products Dail Éireann — 2026-04-29 ============================================================ Mary Butler (FF), Waterford I thank both Deputy O'Sullivan and Deputy O'Hara for raising this important issue. I spoke on this in the Seanad a couple of weeks ago. I acknowledge Deputy O'Sullivan's advocacy on rare diseases in the past six years. As we all know, the State acknowledges the importance of access to new and innovative medicines for patients living with a rare disease. Budgets 2021 to 2025 included dedicated funding for new medicines of €158 million. Budget 2026 allocated an additional €30 million of funding available for new drugs. From 2021 up to March 2026, this has enabled the HSE to approve reimbursement for 263 new medicines, including 72 new medicines for the treatment of rare diseases. As Members are aware, the National Rare Disease Strategy 2025-2030 was launched last year. The strategy outlines a comprehensive framework designed to enhance diagnosis, treatment and support for people living with rare diseases, aiming to improve quality of life, promote equitable access to healthcare, and foster innovation in rare disease research and treatment. It also emphasises the importance of access to orphan medicines among its key recommendations. The State has signed two new framework agreements on the supply and pricing of medicines from 2026 to 2029, following successful negotiations with the pharmaceutical industry, that will provide stability and certainty to the sector. Building on this achievement, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandbox early-access programme for rare diseases. This will be a proof-of-concept initiative aligned with the commitments in the programme for Government and the national rare disease strategy. Regarding Skyclarys, I will provide some background for our colleagues and then address the Deputy's question. Omaveloxolone, sold under the brand name Skyclarys, is a medication licensed by the European Medicines Agency to treat Friedreich’s ataxia in patients aged 16 years and over. Friedreich’s ataxia is a rare inherited disease that causes damage to the nervous system. Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. The Act provides for a rigorous process for the assessment of new medicines for reimbursement. This ensures that the right medicines are chosen and that approval is at a sustainable price. The HSE received an application for pricing and reimbursement for Skyclarys from the applicant, Biogen Idec (Ireland) Limited, on 1 August 2024. After receiving a completed rapid review assessment report from the National Centre for Pharmacoeconomics, the HSE commissioned a full health technology assessment on 25 September 2024. A fully completed dossier, which is required to allow the NCPE to conduct a pharmacoeconomic assessment of the pricing and reimbursement application, was not received from Biogen until July 2025. The NCPE proactively engaged with the applicant company and submitted the finalised health technology assessment report to the HSE on 16 December 2025. It is important that we look at the timelines. This report included submissions made by patient organisations. These submissions will form part of the data that the HSE considers. The HSE invited the applicant to commence price negotiations and offered a range of dates to the company. The HSE has advised this meeting took place on 12 February 2026 and, as of the most recent update from the HSE in April, a commercial proposal from the company remains outstanding. I checked with the Minister's Department last night in this regard and I know the Taoiseach has engaged with her. Where we are at the moment is that a commercial proposal from the company remains outstanding, which I know is frustrating, but it is important to put the timelines on the record of the Dáil. --- 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/dail/2026-04-29/debate/main Retrieved: 2026-09-21T01:01:08+00:00 Sitting date: 2026-04-29