"We are not going to regain any of the abilities we've lost, but Skyclarys will give us time. Time when you're dealing with our progressive relentless disease is everything. We all deserve time with our loved ones." Those are the words of Emily Felix, a 28-year-old trainee solicitor from Kilkenny who is living with Friedreich'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. Since then, she has completed her degree, pursued postgraduate study and begun training as a solicitor. She is doing everything she can to protect her health and her future, but the disease continues to progress.

Yesterday, as the Taoiseach knows, the HSE drugs group met to consider reimbursement of Skyclarys, the first approved treatment that can slow the progression of Friedreich's ataxia. Patients hoped for a positive decision. 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. This could mean further delays and potentially months before a final decision is made.

For patients, that delay is unbearable. It can mean losing the ability to walk, to speak clearly, to swallow safely or to live independently. Skyclarys 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 ground-breaking development. He has said that he would prescribe it if it were available in Ireland and that it may reduce the rate of disease progression. Skyclarys has been approved across the European Union since February 2024. It is already publicly funded or accessible in several European countries. Irish patients are watching people with the same condition receive treatment elsewhere while they continue to deteriorate without it. That is cruel.

Yesterday, those living with Friedreich's ataxia gathered at Leinster House waiting for good news. 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 and asking politicians if they had heard anything. They were treated appallingly. Then, when the news did eventually filter though, they were left devastated.

Craig Coady from Cork, who has already lost his 13-year-old son, Rory, to Friedreich's ataxia, now watches as his older son, Paudie, deteriorates from the same condition. He took to social media to express his anger. 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 Paudie is getting worse every day. I am so upset and disgusted.

Medicines must be properly assessed, and I get that, but the patient cannot be lost in the process, and that is what happens. In fact, in the programme for Government the Government committed to reviewing that process because it was accepted it does not always work.

The technical review group obviously now needs to be convened and needs to meet urgently.

Emily cannot afford more delays. She is a young woman with a career, ambitions, a family and a future she is fighting to protect. The same is true of every single person living with Friedreich's ataxia in this State. They cannot be left waiting any longer and they deserve better.

Does the Taoiseach accept that those living with Friedreich's ataxia were treated appallingly yesterday, that they deserved to be treated with respect and should have been properly communicated with? Does he recognise that this is a matter of urgency for them and that they cannot continue to wait while time is running out?

As this is my last Leaders' Questions of this term, I thank the Ceann Comhairle and all Deputies in the House for their co-operation throughout the year. I thank the entire team that works here, the ushers, the 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. To the Deputies, while we disagree on many issues, this is parliamentary democracy in action and long may it continue. I just wanted to say that.

I thank Deputy Cullinane for raising this issue. I accept this is a matter of urgency for those with the condition of Friedreich's ataxia. I have met with Craig Coady and with others who have the condition. It is extremely worrying for them to say the least. The experiences they and their families are going through while awaiting the assessment of this drug are extremely traumatic. I appreciate the Deputy saying there has to be a process or a scientific input into whether medicines are effective or not, or suitable for reimbursement. It took a length of time. I think the company was slow over the past two years in responding to the HSE. The timeline is there. I know the Deputy has kept in close contact with the Minister on that. The commercial proposal was ultimately received from Biogen on 27 May. It went through a lot of interactions before that, which, in my view, could have been quicker on the part of the company.

That said, there is a process where first a health technology assessment was published in December 2025. That is public and was not that strong in terms of its assessment of Skyclarys at the time. There was a clear recommendation from that. That was then moved on to the HSE drugs group. I accept there are issues in terms of how this gets communicated. However, up to now since the 2013 Act, there has not been a practice whereby there is a parallel political operation while this group is meeting monthly. I think 70 rare disease drugs were approved in the four years between 2021 and 2025. It was not the case that people were waiting every month. That is something we have to be conscious of. I understand it but we need to work on the communication of all that. These are scientists and people with expert knowledge who meet to assess drugs. They are not politicians. We have to protect that process too in terms of their assessment of the efficacy of drugs and so forth with regard to conditions. This year alone, 26 drugs for rare diseases have been approved and many more drugs outside of that.

It is a serious and urgent situation for the families. Our hearts go out to them. It is a disease that progresses and has 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 get that established as quickly as possible to assess this. It is my understanding that some of the national expertise and practising consultants in this field would be on that group, and I hope we can get an outcome as quickly as possible.

I met many of those patients and people with the illness yesterday. Many of them were here in Leinster House. They told me, as they have in the past, they cannot walk and they cannot swallow and, as the Taoiseach acknowledged, it is also very difficult for their families who have to watch as their condition worsens and the disease progresses. 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 are not providing this drug. I see it simply. This is about empowering the clinicians. At the moment clinicians treating those patients do not 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 the best treatment for those patients. That is an option available in Italy, Germany and other countries. It is not available in Ireland.

When is that group going to be convened because those people who were here yesterday were really upset? There was no communication. They were making phone calls, and they fear more months of delay before a decision is made.

I accept the devastation for families on receiving that news yesterday. This is not the news they wanted to hear. The previous month a drug was approved and that was welcomed across the House. The very same group made that recommendation in respect of that drug. There is an urgency attached to this and we are prepared to work with Members of the House in terms of the processes. We all accept that, ultimately, there has to be a scientific perspective on this. I accept there is also a role for those at the front line clinically in respect of this condition, and in the neurological field more generally who are treating people with this condition. Many drugs have an evolutionary process. In other words, they can get better as they are refined and improved upon in the research. There is much more in terms of clinical trials and so on that the Minister-----

That concludes the question.