Medicinal Products
Dail Éireann — 2026-05-13
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Mary Butler (FF), Waterford

I thank Deputies Gallagher and Doherty for raising this matter. I will be answering on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill.
As stated, Duchenne muscular dystrophy is a rare and progressive disease affecting the muscle strength and function of boys almost exclusively, with approximately ten children diagnosed with the condition each year. The Minister, Deputy Carroll MacNeill, has engaged with representative groups and the parents of children suffering from this condition several times over the past year. The Minister has followed progress closely and will be meeting with patient groups again this week. 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 approaching €4 billion.
To move completely to givinostat, it is sold under the brand name Duzyvat, for the treatment of DMD in ambulant patients aged six years or older. It has recently undergone assessment by the European Medicines Agency, EMA. The European Commission granted conditional marketing authorisation for use of givinostat in this indication on 6 June 2025. The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In line with the Act, a company must submit an application to the HSE to have a new medicine added to the formal reimbursement list. Reimbursement is for licensed indications that have been granted marketing authorisation by the EMA or Ireland’s Health Products Regulatory Authority.
This is the importance piece. The Minister met with her Italian counterpart at the Employment, Social Policy, Health and Consumer Affairs Council, EPSCO, meeting in June 2025 in Luxembourg to ask him to encourage the company, Italfarmaco, to submit a timely pricing and reimbursement application to Ireland. On 6 August 2025, an application for reimbursement was received by the HSE and underwent a rapid review by the National Centre for Pharmacoeconomics.
Following the conclusion of a rapid review on 14 August 2025, a full health technology assessment, HTA, was commissioned by the HSE on 26 August. The assessment of the pricing and reimbursement application for givinostat could not proceed until the NCPE received the HTA from the company almost four months later, on the 15 January 2026. I need to set out the timelines clearly. The HTA has been completed and confidential commercial negotiations between the HSE’s corporate pharmaceutical unit and Italfarmaco have begun, with the receipt of a commercial offer from Italfarmaco on Friday, 8 May, which was last Friday. The HSE continues to engage with the applicant to progress this application in a timely manner. To be clear, the conclusion of the rapid of review was on 14 August. A full health technology assessment was commissioned by the HSE. The assessment of the pricing and reimbursement application for givinostat could not proceed until the NCPE received a full HTA from the company. That arrived on 15 January this year. The HTA has been completed now and confidential commercial negotiations are under way. A commercial offer was received from the company last Friday.
I thank the Deputy for sharing the stories of the two families who will want to understand exactly where the hold-ups are.

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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/2026-05-13/debate/main
Retrieved: 2026-09-14T01:01:03+00:00
Sitting date: 2026-05-13