Dáil Éireann Debate, Wednesday - 25 March 2026
436. Deputy Mark Ward asked the Minister for Health will consider running a pilot orphan drug early-access programme in order that children with Duchenne muscular dystrophy can access givinostat; if a pricing and reimbursement application has been received by the HSE for givinostat; and if she will make a statement on the matter. [23049/26]
Amharc ar fhreagraI recognise the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. The Government is committed to investing in new medicines for patients, which has facilitated the introduction of 250 new medicines including 69 for rare diseases. For 2026, over €200m is available for medicines including €30 million for new medicines. The State has successfully negotiated new Framework Agreements with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stopclocks. In addition, suppliers will aim to shorten the timeline to submit medicine reimbursement applications in Ireland to within six months of formal authorisation by the European Commission. Together these measures will enable faster access for patients in Ireland. The Programme for Government contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this Government. As part of the Agreement talks, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases. This will be a proof of concept initiative, aligned with the commitments in the Programme for Government. As this work progresses, it will be essential that we take account of the views of patients, of industry, and of clinicians. The mechanisms involved are complex, and the potential impacts must be carefully considered to ensure any future system is fair, effective, and sustainable.
In parallel, my officials have commenced work examining reimbursement systems in use across the European Union. 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 and medical devices; therefore, the question of receipt of a pricing and reimbursement application for givinostat has been referred to the HSE for attention and direct reply to the Deputy.
