Dáil Éireann Debate, Tuesday - 16 June 2026
949. Deputy Mark Ward asked the Minister for Health the reason the State is not pursuing fair pricing on an EU-wide basis regarding the topic of givinostat therapy for Duchenne muscular dystrophy; the reason this is only being considered in the context of the Irish market; if precedence for EU-wide negotiation has been used for drug pricing; and if she will make a statement on the matter. [45404/26]
View answerThe pricing and reimbursement of medicines is a matter for individual EU Member States. While medicines are authorised at EU level, pricing decisions remain a national competence.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines.
The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement, in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and,
(9) The resources available to the HSE.
The HSE is currently assessing the pricing and reimbursement application for givinostat (Duvyzat®) in line with the criteria detailed in legislation.
The commercial proposal along with other relevant information was progressed to the Drugs Group on 9th June 2026, who assessed all the information, including submissions by patient representative organisations, and have prepared a recommendation for the HSE Senior Leadership Team. No decision has been made by the HSE Senior Leadership Team, which has final statutory decision making authority for the reimbursement of medicines in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE will continue to assess and progress the application as efficiently as possible.
