Jerry Buttimer (Cork South-Central, Fine Gael)

I thank Senator Costello for raising this very important matter. I am taking it on behalf of the Minister for Health, Deputy Jennifer Carroll MacNeill. I thank the Senator for highlighting the case of a young boy from Tallaght. She is right that it is a race against time. I am conscious that my reply probably will not give her the answer that she needs and that the young boy deserves. I hope we can all work together to ensure we can progress the matter she has spoken about.

Duchenne muscular dystrophy is, as the Senator said, a rare disease affecting fewer than 200 people in Ireland. The State acknowledges the importance of access to medicines and is aware of the plight of patients with DMD.

The State has made considerable investment in new medicines in recent years. In 2023, the State spent over €3.2 billion on medicines, which represents nearly €1 in every €8 of public funding being spent on health. This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines. Senator Costello is right to highlight the challenges and the issues faced by people with DMD, and I thank her for doing so. The budgets of 2021 to 2024 have included dedicated funding for new medicines of €128 million. This has enabled the HSE to approve reimbursement for 194 new medicines or new uses for existing medicines, including 74 for treating cancer and 49 for treating rare diseases. Last year's budget allocated €30 million of funding for new drugs to be generated by efficiencies to be identified by the HSE.

Givinostat, which is sold under the brand name Duzyvat for the treatment of DMD in patients aged six years or older, has recently undergone assessment by the European Medicines Agency. The EMA is a centralised agency of the European Union 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. The company marketing this treatment applied for marketing authorisation from the EMA and its evaluation concluded with a recommendation that it be granted conditional marketing authorisation. The European Commission will consider this recommendation from the EMA and make a final decision on granting marketing authorisation for the treatment. At this time, givinostat does not have marketing authorisation in the EU.

The Health Service Executive has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In line with that 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 which have been granted marketing authorisation by the EMA or Ireland’s Health Products Regulatory Authority. As givinostat has not been granted marketing authorisation by the Commission, an application for pricing and reimbursement cannot be made to the HSE. If marketing authorisation is granted and the company chooses to apply, the HSE will give fair consideration to the application, with consideration for the criteria detailed in the 2013 Act.

I agree completely with Senator Costello that the process must be expedited. We cannot have this going on forever. There are people like the young boy the Senator mentioned and other families who need help and support. I thank Senator Costello for her advocacy and for raising this matter. She right to say that the clock is ticking. People are racing against the clock and I hope we can all see this matter expedited.