Mary Lou McDonald Demands Urgent Action on Skyclarys Delay

Thank you, Ceann Comhairle. Tánaiste, there's someone that you know very well in the public gallery. She is the unstoppable and heroic Cara Darmody. And Cara's just completed her third 50-hour protest outside the Dáil, calling for real action for children and for young people waiting for assessment of need. So it's high time, Tánaiste, that the government did the right thing as asked for by Cara. In fact, you might take the opportunity to meet with her before she leaves Dublin. Tánaiste, people in wheelchairs gathered outside Leinster House on Tuesday. They're people living with Friedrich's ataxia. This is a progressive degenerative neurological disease. And they were here at the Dáil because they've been waiting two years for access to Skyclaris, a drug that can slow down the relentless progression of their condition. And their hopes were very high that the HSE Drugs Committee would finally approve Skyclaris. But those hopes were to be dashed. The committee decided against approving the drug. Instead, they referred it to a rare disease review group. In other words, one committee passing the book to another committee. More delay, more time wasting, that these people simply don't have. Because this condition doesn't slow down. It doesn't pause. It doesn't stop for the summer holidays or recess. It just gets worse. It robs you of your ability to stand, to walk, to swallow. It can rob you of your sight and your speech. And when Friedrich's ataxia strikes your body, it invades every facet of you. And time just changes for you. Time moves far more quickly. And time, Tánaiste, is running out for many of these people. This cruel condition moves relentlessly, ravaging their bodies, their lives. And yet the system stands still, putting up obstacle after obstacle, forcing them to wait and wait as time slips by. This drug was approved by the EU Commission back in 2024. And two years on, it's available in France, in Germany, in Portugal, in Italy, in Spain, in Chechya. It's available in Britain. It's available in Canada. It's available in the United States of America, but not here. And so the people who gathered on Tuesday outside Leinster House see others in other countries getting help while they are left to deteriorate. Emily Felix is one of these people. She's now 28. She's been living with Friedrich's ataxia since she was 12. She says the system is telling her that her life is not worth saving. Craig Cody from Cork lost 13-year-old Rory to this condition last September. And now he watches as Pottie, his other son, aged 16, deteriorates with the same disease. He says Pottie doesn't have weeks to wait. He says I can't lose him to his all I have left. That's what's at stake here. This is urgent. And of course, medications have to be properly assessed. It's been two years for that. But decisions have to be taken and time is running out. You can fix this. You can bring the pace and urgency that's necessary. The Taoiseach says he won't bring that. And right now, today, people living with Friedrich's ataxia are watching. They're watching this exchange. They want you to intervene. They don't have weeks. They don't have months. And they are now counting on you to do something to make this right. I want to ask you, what are you going to do? Thank you for the question. Firstly, can I join with you in welcoming Cara Darmody back to Dáil Éireanns. Good to see you again. And whilst Cara continues her campaign in relation to improvements around assessments of needs and disability services in general, it is also just worth noting that Cara has already changed Ireland for the better with the creation of the fund that has made a real difference in terms of more children getting assessments. And my colleague, Minister Higgins, who is here, along with Minister Foley, are committed now to bringing forward legislation around the assessments of need process. And we look forward to engaging with you on that soon as well. So you're very welcome back. I look forward to seeing you soon. Thank you to Deputy MacDonald for raising what is genuinely an important issue. And I do take the point that when we talk about this in the abstract or from a process point of view, and here I agree with you that there are people watching in that this is their real lived experience. And I know there are people across this house, including you, who have engaged with patients, who have engaged with families in relation to this drug. And I fully understand that it's a worrying and anxious time for them. My colleague, Minister Higgins, today met with Muscular Dystrophy Ireland. And as you can imagine, this was an issue that they quite rightly highlighted as well. I think there might have been officials from the department there as well. I do need to say, and I accept that this is frustrating for people at home, but I still need to say it, that there is an ongoing process underway. That is a process guided by science. I do want to say this. It is guided by science. It is a clinically led process. So the HSE is currently assessing this medication. You're right, there was consideration by the HSE's drugs group on the 14th of July, and they made the decision to seek additional advice from the Rare Diseases Technology Review Committee. Where I somewhat disagree with you or disagree with your emphasis, I don't see that as passing a file from one committee to the other. I actually see it as an opportunity to bring together the experts. So the purpose of this is to bring in national clinical experts in this condition, crucially with patient representatives, with their voices as well, ensuring that their lived experience plus specialist expertise informs the assessment. There is a deadline given to this work of four weeks as well, and referral to a rare disease committee. It's intended to ensure that every possible opportunity is given to a medicine to demonstrate the effectiveness that it makes for a patient. I take your point in relation also to, I think you referenced 2024. I mean, I would just make the point that this doesn't matter a huge amount to patients, but it is the truth that the commercial proposal was actually received from the company in Ireland on the 27th of May, 2026. So it's not a question that the government or indeed our representatives through the HSE or clinicians have been in any way dilly-dallying on this. The application actually came in. I don't know who said that, but I guess the application came in. Okay, well, I'm just relaying in good faith the information. The 27th of May or May, 2026 is when the information came in versus 2020, 2024. But I take the seriousness of this matter. But we do need to, there is mixed, and again, this is also just the truth. There's mixed views on the science in relation to this. There are a number of European countries that have said no. There are some that have said yes. We would not have a situation where the HSE drugs group was deciding to set up a rare diseases expert panel to look at this, to bring together the national experts, to bring together the patient advocates, to hear their voices, to hear their views, if they didn't want to give this every possible chance. I take the point about timelines. That's why I think it is important that there is a four-week period now to hear those voices, to hear that lived experience, and to hear crucially from the doctors. I'm not one, but to hear crucially from the clinical experts who specialize in this condition in Ireland in relation to the effectiveness of this drug. We'll continue to monitor the outcome of that very closely. Dr. McDonald? Honestly, so we're clear, it's not that all of this is frustrating for those living with Friedrich ataxia. It's actually terrifying for them. I had met Emily, I'm going to say three or four weeks ago, and then I was speaking to her again on Tuesday, and even in that short time span she told me that her swallow had disimproved, that her speech has disimproved. We are on the clock here. Time is of the essence, and of course the drug, the science, we have to lead with clinicians and science, but there have been two years since this has been cleared by the European Commission. So this therefore is a process not so much guided by science as stalled and delayed by bureaucracy and indecision. And I am appealing to you, Tánaiste, I never take leaders' questions on a Thursday. I never have. I'm standing before you for one sole reason. I am terrified for these people. I do not think it is acceptable that we would rise for our summer recess and we leave terrified people who are 28 in Emily's case. In another case, Oisín, he's 27. Pádí is 16, and they're terrified. They want their clinicians to have access to this drug. It can alleviate their deterioration, in some cases by as much as 50%. I'm appealing to you, I'm actually begging you, Tánaiste, I am begging you to intervene and to do it now, not to stall, not to delay, because these young people and others and their families are now relying on you, Simon Harris, to do the right thing. It's always good to see you on a Thursday, and I take the fact that you're here as a sign of your seriousness, and I mean that genuinely, so thank you for that. I also take the seriousness of the issue, and there's no disagreeing. We can use different words to describe the situation, but there's no disagreement on the fact that it is a very worrying and stressful time for these families. That is a statement of fact. But it is also a statement of fact that the process, and you know it very well, Deputy, the process is clear in law as to how this goes, so it's not a question of the government stalling, or me, or anybody over here, or anybody over there. The process is very, very clear. A HSE drugs group looks at this. If the HSE drugs group feels it can benefit from the expertise of people in rare diseases, people who treat those very patients that you referenced, they bring in those experts and the patient voices in a short time of four weeks, and they get the best available evidence in terms of the effectiveness of the drug. I think that is an appropriate thing to do. You referenced summer recess. I don't want anyone at home to think that this is in any way linked, you know, there's any effect on the doll not being in. This is a HSE drugs group led by clinicians. I also want to make a broader point, though, because we can... Well, I will make sure that the process is carried out in the expeditious timeline that has been set out in terms of that program. Well, they've said that they will do that within four weeks, but can I make one point on that, not just around the clock, because the deputy makes another point around delays and bureaucracy. I just have to make the point back that sometimes those delays aren't on the side of the state. We do need to have a full root and branch review of how medicines are assessed in this country, and my colleague, Minister Carol MacNeill, is entirely committed to that, because even in the House today debating when the application came in or when the full business case came in, there has to be a better way and a more efficient way of assessing drugs applications more generally, and we can return to that on this specific issue, Deputy. The rare diseases group, which is made up not of politicians, not of bureaucrats, but of doctors who treat these patients, them, as am I, them and the patient representatives will meet through this structure to assess this drug.