Mark Ward (Dublin Mid West, Sinn Fein)
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907. To ask the Minister for Health if she will consider running a pilot orphan drug early-access programme in order that children with Duchenne muscular dystrophy can access givinostat; and if she will make a statement on the matter. [32665/25]

Ivana Bacik (Dublin Bay South, Labour)
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938. To ask the Minister for Health her plans to improve policy in relation to orphan medicines; her plans to fulfil Programme for Government commitments in relation to access to new and innovative treatments; her views on the need to provide access to givinostat, in particular; and if she will make a statement on the matter. [32797/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 907 and 938 together.

The recently published Programme for Government (Securing Ireland's Future) contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this government.

In relation to the pricing and reimbursement status of Givinostat (Duvyzat®), 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 devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

The HSE must robustly assess 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.

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.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):

On 25^th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.On the 6^th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).

A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.