Teresa Costello (Fianna Fail)

Today marks 15 days since families with children affected by Duchenne muscular dystrophy and I held a demonstration and information briefing in the audiovisual meeting room. We were supported by all parties and none. Fifteen days may not seem like much time to you and me, but to people whose children have DMD, that time flies by, and every day their children’s strength and abilities are failing.

To refresh memories, it is a progressive neuromuscular disease that causes the weakening of muscles over time. It almost exclusively affects boys, with symptoms typically appearing between the ages of one and three. It is a life-limiting illness, and givinostat provides hope and a lifeline to these boys, as it can stop progression of this illness, keeping the boys on their feet for longer. If they are wheelchair-bound, it can delay the progression to the lungs and heart, providing them with a better quality of life. Who would not want that for a child?

I appreciate that the Minister for Health is committed to a meeting on all of this. As it has now been 15 days and, as we know, time is muscle, I would appreciate if the Deputy Leader requested a timeline for when that meeting will go ahead. Can I be given a firm date? This meeting, which was to include some family representatives, other key stakeholders and me, was agreed to discuss a pathway forward. I cannot express how important it is that we not take the foot off the pedal in our pursuit of early access to givinostat.

Belgium is providing early access to givinostat through its compassionate use programme, CUP. This allows eligible boys to receive the drugs before formal EU approval, which is expected in July 2025, and national reimbursement. We already have EU approval. The CUP is overseen by Belgium’s FAMHP, ensuring safety while bridging the gap between clinical trials and full market access. Is this something we could do? I welcome the discussion in the Dáil this morning, during which my colleague Shane Moynihan raised the subject of givinostat with the Minister. I commend her activity to date, which includes speaking with the Italian Minister of Health and proactively engaging with the manufacturer. Her work is not limited to that; I welcome all the progress the Minister has made. Will the Deputy Leader convey to her my full support and gratitude for her work so far? I look forward to working with her on this matter and meeting her in the near future.