David Cullinane: We Can't Let Patients Wait on Skyclarys

leaders questions. We are not going to regain any of the abilities we've lost but Skye Clarris will give us time. Time when you're dealing with our progressive relentless disease is everything. We all deserve time with our loved ones. Taoiseach, those are the words of Emily Felix, a 28 year old trainee solicitor from Kilkenny who is living with Friedrich's ataxia. It is a rare progressive and life-limiting neurological condition. It gradually takes away mobility, speech and independence. Emily was diagnosed at 12 and since then she has completed her degree, pursued postgraduate study and begun training as a solicitor and she is doing everything she can to protect her health and her future. But the disease Taoiseach continues to progress. Yesterday as you know the HSE drugs group met to consider reimbursement of Skye Clarris the first approved treatment that can slow the progression of Friedrich's ataxia. Patients hoped for a positive decision and this process has been ongoing for years. Instead the drug was referred to a rare disease technical review group for further consideration. This group is not a standing body and must now be convened and this could mean further delays and potentially months before a final decision is made and for patients that delay is unbearable. It can mean losing the ability to walk, to speak clearly, swallow safely or live independently. Skye Clarris is not a cure but it offers something precious, more time with mobility, working, communicating and living independently. Dr. Richard Walsh, consultant neurologist and co-director of the National Ataxia Clinic has described this drug as a groundbreaking development. He has said that he would prescribe it if it was available in Ireland and that it may reduce the rate of disease progression. Skye Clarris has been approved across the European Union since February 2024. It is already publicly funded or accessible in several European countries but yet Irish patients Taoiseach are watching people with the same condition receive treatment elsewhere while they continue to deteriorate without it and I think that is cruel. Yesterday those living with Friedrich's ataxia gathered at Leinster House waiting for good news and their hopes were high but advocates and campaigners were left waiting with no communication. They were left desperately making phone calls, checking for updates, asking journalists, asking politicians if they had heard anything and I believe they were treated appallingly Taoiseach and then when the news did eventually filter through they were left devastated. Craig Cody from Cork who has already lost his 13 year old son Rory to Friedrich's ataxia now watches as his older son Potti deteriorates from the same condition and he took to social media to express his anger and he said this is the worst news for my son. The government is kicking the can down the road. We don't have that time because Potti is getting worse every day. I am so upset and disgusted. Taoiseach medicines must be properly assessed and I get that I do but the patient cannot be lost in the process and that's what happens. In fact in your own program for government you committed to reviewing that process because it was accepted it doesn't always work. The technical review group obviously now needs to be convened and needs to meet urgently because Emily cannot afford more delays. She is a young woman with a career, ambitions, a family and a future that she is fighting to protect and the same Taoiseach is true of every single person living with Friedrich's ataxia in this state. They cannot be left waiting any longer and they deserve better. So Taoiseach do you accept that those living with Friedrich's ataxia were treated appallingly yesterday, that they deserved to be treated with respect and should have been properly communicated with and do you recognize that this is a matter of urgency for them and that they cannot continue to wait and wait while time is running out. First of all just could I at the outset take a moment as this is my last Leader's Questions this term. I just want to thank Joachim Corle and all deputies in the house for your cooperation throughout the year to the entire team that work here, ushers and all the team staff in catering and so on for the manner in which they look after all of us on an ongoing basis. We deeply appreciate that and for deputies whilst we disagree on many issues I think this is parliamentary democracy in action and long may it continue. So I just want to say that. I thank Deputy Conan for raising this issue. I do accept that this is a matter of urgency for those with the condition of Friedrich's ataxia. I have met with Craig Cody, I've met with others as well who have the condition and it's extremely worrying for them to say the least. It's extremely traumatic the experiences that they and their families are going through whilst awaiting the assessment of this drug. And I would say that in the first instance and I appreciate you saying that there has to be a process, you know there has to be a scientific input in terms of whether medicines are effective or not or whether they're suitable for reimbursement. It did take a length of time. I think the company was slow over the last two years in responding to the HSE originally and all the timeline is there and I know you've kept in close contact with the Minister on that and the commercial proposal was received from Biogen ultimately on the 27th of May and it went through a lot of interactions before that which could have been quicker in my view and on the part of the company. But that said it then there's a process there where the first of all there was a health technology assessment published in December of 2025 and I think that's public and that wasn't that strong in terms of its assessment of Skycars at the time. So there was a clear recommendation from that but then that got moved on to the HSE drugs group. I would say in passing we need to perhaps, there are issues in terms of how this gets communicated, I accept that. But also up to now since the 2013 Act there hasn't been a practice whereby you know there's a sort of a political parallel operation if you like whilst this group is meeting monthly. So in previous drugs, so 70 rare disease drugs would have been approved in the last four years I think from about 21 to 25 and it wasn't the case of every month people were waiting. So that's something we've got to just be conscious of. I understand it but I think that we need to work around the constitution or the communication of all of that. These are scientists and people with expert knowledge, they're not politicians who meet to assess drugs. So we have to protect that process too in terms of their assessment of the efficacy of drugs and so forth in relation to conditions. This year alone 26 drugs for rare diseases have been approved and many, many more drugs then outside of that. So it is a very serious and urgent situation for the families. Our hearts go out to them. I mean it is progressively a disease that progresses, that has very severe impacts on those with the condition. It has now been referred to the Rare Diseases Technology Review Committee and the Minister is taking steps to establish that or get that established as quickly as possible to assess this. That has some of the national expertise and practicing consultants in this field, my understanding is would be on that group and I would hope that we can get an outcome to that as quickly as possible. Deputy Colin. Taoiseach, I met many of those patients and people with the illness yesterday myself. There was many of them here in Leinster House and they have told me, as they have in the past, that they cannot walk, they cannot swallow and as you acknowledge it's also very difficult for their families who have to watch on as their condition worsens and the disease progresses. And this drug was approved by the European Union in 2024 over two years ago. It is publicly available in many European countries and yet again Ireland lags behind and we're not providing this drug. And I see it very simply Taoiseach, this is about empowering the clinicians because at the moment clinicians who are treating those patients don't have the option of prescribing that drug. We should enable them to have that option because this is an issue for clinicians and patients to work out what is the best treatment for those patients. That is an option that is available in Italy, in Germany, in other countries, it's not available in Ireland. So I'm asking when is that group going to be convened because those people who were here yesterday were really obsessed, there was no communication, making phone calls and they fear months more of delay before a decision is made. First of all I accept the devastation for families yesterday on receiving that news. I accept that. This is not the news that they wanted to hear. The previous month a drug was approved and that was welcomed across the floor and so over across the house. But the very same group made that recommendation in respect of that drug. So there is an urgency attached to this and we're prepared to work with members of the house also in terms of the processes here. But I think we all accept that ultimately there has to be a science perspective on this. I do accept also there has to be those who are clinically at the front line in respect of this condition for example or in the neurological field more generally that there is a role also for those in terms of treating people with this condition. And many drugs have an evolutionary process in other words they can get better as they're refined and improved upon in the research and there's much more in terms of clinical trials and so on that we have to which the Minister has published a strategy on to get developed.