Shane Moynihan (Dublin Mid West, Fianna Fail)
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192. To ask the Minister for Health to outline her engagements with the HSE on access to givinostat for Duchenne muscular dystrophy; and if she will make a statement on the matter. [23725/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The HSE holds statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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 from either the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

The 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.

Givinostat, sold under the brand name Duvyzat®, is a medication used to treat Duchenne muscular dystrophy (DMD) in patients aged 6 years and older. It is not currently authorised in the EU.

On 25 April 2025, the EMA’s Committee for Human Medicinal Products (CHMP) recommended granting a conditional marketing authorisation in the EU for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are able to walk.

As per that statement the CHMP opinion will now be sent to the European Commission for consideration. In the event that the European Commission decides to authorise this medicine, the company will then need to apply to the HSE for pricing and reimbursement in Ireland.

To date neither the EMA nor the HPRA have granted marketing authorisation for Givinostat(Duzyvat®) for any indication at this time.

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

Grace Boland (Dublin Fingal West, Fine Gael)
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193. To ask the Minister for Health the work her Department has undertaken to engage with the manufacturers of HRT products to minimise any supply chain issues; and if she will make a statement on the matter. [24048/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

However, medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Issues surrounding security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years.

Shortages across this therapeutic area (HRT) have been managed and continue to be managed via the national Medicines Shortages Framework (MSF), coordinated by the HPRA on behalf of the Department of Health. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market.

The MSF involves a multi-stakeholder approach to handling shortages of human medicinal products, and the HPRA engages with all such stakeholders, in all cases where this is necessary, until such a time it is established that there is sufficient supply of medicinal products to meet the demand and continuity of care.

The HPRA meet relevant suppliers based on an ask by the DOH and were able to discern, from the information returned by suppliers of HRT products that supply is expected to be in keeping with company forecasted demand. The exception to this is transdermal patch presentations, where the company had already reported current demand is greater than supply leading to intermittent shortages. This is reported as a multi-market supply constraints requiring increasing manufacturing capacity

The HPRA, along with other health service entities, are actively monitoring the national supply, and the current status is that apart from patches HRT medicines are generally available.

In the event that patients are unable to source a medicinal product due to supply constraints, they are advised discuss possible alternatives with their healthcare professional pending the resumption of normal supply.