472. Deputy Pádraig Mac Lochlainn asked the Minister for Health the current status of the reimbursement process for givinostat for children living with Duchenne muscular dystrophy; the steps being taken to ensure urgent access, clear timelines and no further delays; and if she will make a statement on the matter. [46503/26]

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 assessed 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 prepared a recommendation for the HSE Senior Leadership Team.

On foot of the Drugs Group recommendation, the HSE Senior Management Team, which holds final decision-making authority on the reimbursement of a medicine in line with the Health (Pricing and Supply of Medical Goods) Act 2013, has made a positive reimbursement decision and commissioned a Managed Access Protocol for givinostat.

All efforts will be made to expedite the implementation of the Managed Access Protocol and to ensure that an adequate stock of the medicine is available and delivered to patients as quickly as possible.