Medicinal Products

Dáil Éireann Debate, Tuesday - 16 June 2026

• Díospóireachtaí
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  • Díospóireachtaí na Dála
  • Díospóireachtaí an tSeanaid
  • Díospóireachtaí Coiste
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  • Vótálacha na Dála
  • Vótálacha an tSeanaid
  • Vótálacha Coiste
• Ceisteanna Parlaiminte
  • Ceisteanna scríofa
  • Ceisteanna ó bhéal
• Leideanna cuardaigh
• Nuair a bhíonn tionchar tromchúiseach ag aithrisí

Tuesday, 16 June 2026

Ceisteanna (823, 824, 825, 826, 832, 836, 839, 842, 852, 853, 864, 884, 898, 947, 966, 1017, 1030)

Paul Nicholas Gogarty

Ceist:

823. Deputy Paul Nicholas Gogarty asked the Minister for Health the actions she is taking in liaison with the HSE to ensure a timely pricing and reimbursement scheme for givinostat (duvyzat), given that it is a year since conditional marketing authorisation was granted and it is a year since she met with families of children with DM and MDI and six months since she spoke at a national conference (details supplied); and if she will make a statement on the matter. [44891/26]

Paul Nicholas Gogarty

Ceist:

824. Deputy Paul Nicholas Gogarty asked the Minister for Health the reasons provided by the HSE regarding the delay in processing the pricing and reimbursement application for givinostat, especially since 15 January 2026 when a full HTA dossier was submitted by a company (details supplied) to the NCPE; and if she will make a statement on the matter. [44892/26]

Paul Nicholas Gogarty

Ceist:

825. Deputy Paul Nicholas Gogarty asked the Minister for Health if she has been briefed by the HSE Drugs Group which was due to meet on 10 June 2026 to consider givinostat for reimbursement; if clear timelines for rollout have now been provided; if there will be proactive engagement with the HSE and clinical teams to ensure planning begins urgently, in order that implementation does not become a further barrier to access; and if she will make a statement on the matter. [44893/26]

Paul Nicholas Gogarty

Ceist:

826. Deputy Paul Nicholas Gogarty asked the Minister for Health the steps she has taken to ensure that eligibility criteria for givinostat are aligned with the NICE approach, ensuring access for boys who can walk or who can stand with or without support, in order that boys here are not disadvantaged compared to those in the Northern Ireland and receive equitable access to treatment; and if she will make a statement on the matter. [44894/26]

Claire Kerrane

Ceist:

832. Deputy Claire Kerrane asked the Minister for Health to provide an update on access to givinostat; and if she will make a statement on the matter. [44908/26]

Michael Fitzmaurice

Ceist:

836. Deputy Michael Fitzmaurice asked the Minister for Health the status of gaining access to givinostat for boys living with Duchenne muscular dystrophy; and if she will make a statement on the matter. [44919/26]

Shónagh Ní Raghallaigh

Ceist:

839. Deputy Shónagh Ní Raghallaigh asked the Minister for Health if she will ensure free access to givinostat for boys living with Duchenne muscular dystrophy; and if she will make a statement on the matter. [44935/26]

Michael Cahill

Ceist:

842. Deputy Michael Cahill asked the Minister for Health to ensure that all children within the State receive urgent access to givinostat (duvyzat) for Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [44945/26]

William Aird

Ceist:

852. Deputy William Aird asked the Minister for Health the current status of the reimbursement application for givinostat for the treatment of boys living with Duchenne muscular dystrophy; the timeline for a decision following consideration by the HSE Drugs Group; the steps being taken to ensure that there are no further delays in access should reimbursement be approved; whether eligibility criteria will be aligned with those applied by NICE in Northern Ireland to ensure equitable access for Irish patients; and if she will make a statement on the matter. [44974/26]

Willie O'Dea

Ceist:

853. Deputy Willie O'Dea asked the Minister for Health if she will expedite the approval and funding of the new drug givinostat to treat boys currently living with Duchenne muscular dystrophy (DMD) in Ireland; and if she will make a statement on the matter. [44978/26]

Roderic O'Gorman

Ceist:

864. Deputy Roderic O'Gorman asked the Minister for Health to provide an update on consideration of the HSE corporate pharmaceutical unit of reimbursement of givinostat for Duchenne muscular dystrophy; and if she will make a statement on the matter. [45076/26]

Mark Ward

Ceist:

884. Deputy Mark Ward asked the Minister for Health if givinostat will be made available for children with Duchenne muscular dystrophy; to provide an update on steps taken by the HSE since a commercial proposal was received from a company (details supplied); when this therapy will be made available to the public; and if she will make a statement on the matter. [45156/26]

Duncan Smith

Ceist:

898. Deputy Duncan Smith asked the Minister for Health when givinostat will be made available for boys with Duchenne muscular dystrophy; and if she will make a statement on the matter. [45208/26]

Ann Graves

Ceist:

947. Deputy Ann Graves asked the Minister for Health if she will give a commitment to expedite the approval of givinostat here (details supplied). [45399/26]

John Paul O'Shea

Ceist:

966. Deputy John Paul O'Shea asked the Minister for Health the current status of the reimbursement application for givinostat for the treatment of Duchenne muscular dystrophy; the timeline for consideration of the drug by the HSE Drugs Group and subsequent decision-making processes; the measures being taken to ensure that, should reimbursement be approved, access can be provided to eligible patients without unnecessary delay; and if she will make a statement on the matter. [45587/26]

Pádraig Rice

Ceist:

1017. Deputy Pádraig Rice asked the Minister for Health to provide an update on the position regarding a drug for people living with Duchenne muscular dystrophy (details supplied); the outcome of the HSE Drug’s Group meeting on 10 June 2026; and if she will make a statement on the matter. [45899/26]

Louis O'Hara

Ceist:

1030. Deputy Louis O'Hara asked the Minister for Health the steps her Department is taking to provide access to givinostat; and if she will make a statement on the matter. [45947/26]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 823, 824, 825, 826, 832, 836, 839, 842, 852, 853, 864, 884, 898, 947, 966, 1017 and 1030 together.

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 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.

Question No. 824 answered with Question No. 823.

Question No. 825 answered with Question No. 823.

Question No. 826 answered with Question No. 823.

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