Michael Fitzmaurice (Roscommon-Galway, Independent)
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1281. To ask the Minister for Health if he will give the approval for the drug givinostat to be permitted for treatment to patients suffering with Duchene muscular dystrophy; and if she will make a statement on the matter. [29042/25]

Barry Ward (Dún Laoghaire, Fine Gael)
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1638. To ask the Minister for Health the position regarding the introduction of the medication called givinostat to treat patients with Duchenne muscular dystrophy; the actions she will take to expedite this issue; and if she will make a statement on the matter. [30679/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 1281 and 1638 together.

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 medical 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 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 medicines. The Corporate Pharmaceutical Unit (CPU) is the unit within the HSE that is responsible for accepting and processing pricing and reimbursement applications from the pharmaceutical industry. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items covered under community drugs schemes and arrangements / funded via hospitals. In order to submit a formal application, the medicine must hold a marketing authorisation.

The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU via the centralised procedure.

The Health Products Regulatory Authority (HPRA) is the competent authority responsible for the regulation of human medicines in Ireland. A company can submit an application for a marketing authorisation directly to the HPRA if the product in question is not required to be approved through the centralised procedure.

On 25th 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. The European Commission is the authorising body for all centrally authorised medicines, who makes a legally binding decision based on the EMA's recommendation. Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States. The marketing authorisation for givinostat (Duvyzat®) is awaited from the European Commission.

To date neither the EMA nor the HPRA have granted marketing authorisation for Givinostat(Duvyzat®) for any indication.

As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.