There is someone the Tánaiste knows very well in the Public Gallery. She is the unstoppable and heroic Cara Darmody. Cara has just completed her third 50-hour protest outside the Dáil, calling for real action for children and young people waiting for an assessment of need. It is high time that the Government did the right thing, as Cara has asked for. In fact, the Tánaiste might take the opportunity to meet with her before she leaves Dublin.

People in wheelchairs gathered outside Leinster House on Tuesday. They are people living with Friedreich's ataxia. This is a progressive degenerative neurological disease. They were here at the Dáil because they have been waiting two years for access to Skyclarys, a drug that can slow down the relentless progression of their condition. Their hopes were very high that the HSE drugs committee would finally approve Skyclarys, but those hopes were to be dashed. The committee decided against approving the drug. Instead, it referred it to a rare disease review group. In other words, one committee passing the buck to another committee. That means more delay and more time wasting - time that these people simply do not have because this condition does not slow down. It does not pause. It does not stop for the summer holidays or recess, it just gets worse. It robs people of their ability to stand, walk and swallow. It can rob them of their sight and their speech. When Friedreich's ataxia strikes a person's body, it invades every facet of them. Time just changes for a person. Time moves far more quickly, and time is running out from many of these people. This cruel condition moves relentlessly, ravaging their bodies and their lives, 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. Two years on, it is available in France, Germany, Portugal, Italy, Spain and Czechia. It is available in Britain, Canada and the United States of America, but not here. The people who gathered on Tuesday outside Leinster House see people in other countries getting help while they are left to deteriorate. Emily Felix is one of these people. She is now 28. She has been living with Friedreich's ataxia since she was 12. She says the system is telling her that her life is not worth saving. Craig Coady from Cork lost 13-year old Rory to this condition last September. Now he watches as Paudie, his other son, aged 16, deteriorates with the same disease. He says Paudie does not have weeks to wait. He says, "I can't lose him [too]. He is all I have left." That is what is at stake here. This is urgent. Caithfidh an Rialtas an rud ceart a dhéanamh dóibh siúd a bhfuil Friedreich's ataxia orthu. Ní tráth moille é.

Of course medications have to be properly assessed, but it has been going on for two years. Decisions have to be taken and time is running out. The Tánaiste can fix this. He can bring the pace and urgency that is necessary. The Taoiseach says he will not bring that. Right now, today, people living with Friedreich's ataxia are watching this exchange. They want the Tánaiste to intervene. They do not have weeks or months. They are now counting on him to do something to make this right. What is the Tánaiste going to do?

Hear, hear.

Gabhaim buíochas leis an Teachta McDonald. I thank her for the question. First, I join with her in welcoming Cara Darmody back to Dáil Éireann. It is good to see her again. While she continues her campaign in relation to improvements around assessments of need and disability services in general, it is also worth noting that she 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. My colleague, the Minister of State, Deputy Higgins, who is here, along with the Minister, Deputy Foley, are committed to bringing forward legislation on the assessment of need process. We look forward to engaging with her on that soon. She is very welcome back. I look forward to seeing her soon.

I thank Deputy McDonald for raising what is genuinely an important issue. I do take the point that when we talk about this in the abstract or from a process point of view in here, that for people watching this is their real lived experience. I know there are people across this House, including Deputy McDonald, who have engaged with patients and families on this drug. I fully understand that it is a worrying and anxious time for them. Today, my colleague, the Minister of State, Deputy Higgins, met with Muscular Dystrophy Ireland. As the Deputy can imagine, this was an issue it quite rightly highlighted as well. I think there might have been officials from the Department there as well.

I accept that this is frustrating for people at home, but I still need to say it: there is an ongoing process under way. That is a process guided by science. It is a clinically led process. The HSE is currently assessing this medication. Deputy McDonald is right: there was consideration by the HSE's drugs group on 14 July and it made the decision to seek additional advice from the rare diseases technology review committee. Where I somewhat disagree with her emphasis is that I do not see that as passing a file from one committee to the other; I actually see it as an opportunity to bring together the experts. The purpose of this is to bring in national clinical experts in this condition, crucially with patient representatives, so as to have 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. Referral to a rare disease committee is intended to ensure that every possible opportunity is given to a medicine to demonstrate its effectiveness for patients.

I take the Deputy's point in relation to 2024. I would just make the point - this does not matter a huge amount to patients, but it is the truth - that the commercial proposal was actually received from the company in Ireland on 27 May 2026, so it is not a question of 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-----

That was there on the 21st.

I do not know who said that-----

It was the 21st.

-----but I am just relaying in good faith the information.

Deputy Newsome Drennan should allow the Tánaiste to speak.

The 27 May 2026 is when the information came in versus 2024, but I accept the seriousness of this matter. Again, this is also just the truth: there are mixed views on the science in relation to this. A number of European countries have said "No". Some 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 and the patient advocates, to hear their voices and views, if they did not want to give this every possible chance.

I take the point about timelines. That is why it is important that there is a four-week period now to hear those voices, to hear that lived experience and, crucially, to hear from the doctors. I am not one. We must hear from the clinical experts who specialise in this condition in Ireland about the effectiveness of this drug. We will continue to monitor the outcome of that very closely.

So we are clear, it is not that all of this is frustrating for those living with Friedreich's ataxia; it is actually terrifying for them. I met Emily three or four weeks ago and I was speaking to her again on Tuesday. Even in that short time span, she told me that her swallow and speech had disimproved. We are on the clock here. Time is of the essence. Of course the science is important. We have to lead with clinicians and science, but it has been two years since this was cleared by the European Commission. This therefore is a process not so much guided by science as stalled and delayed by bureaucracy and indecision. I am appealing to the Tánaiste. I never take Leaders' Questions on a Thursday. I never have. I am standing before him 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 leave terrified people. In Emily's case she is 28. In another case, Oisín is 27. Paudie is 16. They are terrified. They want their clinicians to have access to this drug.

It can levitate their deterioration in some cases by as much as 50%. I am appealing to the Tánaiste. I am actually begging him to intervene and to do it now. I ask him not to stall or not to delay because these young people, others and their families are now relying on you, Simon Harris, to do the right thing.

Hear, hear.

It is always good to see the Deputy on a Thursday. I take the fact that she is here as a sign of her seriousness on this issue. I mean that genuinely. I thank her for that. I also take the seriousness of the issue. There is no disagreeing. We can use different words to describe this situation but there is no disagreement that it is a very worrying and stressful time for these families. That is a statement of fact. It is also a statement of fact that the process - and the Deputy knows it very well - is clear in law as how this goes. It is not a question of the Government stalling, or me, anybody over here or over there stalling. The process is very clear. The HSE drugs group looks at this. If the HSE drugs group feels it can benefit from the expertise of people in rare diseases - the people who treat the very patients the 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. That is an appropriate thing to do. The Deputy referenced summer recess. I do not want anyone at home to think that there is any effect, with the Dáil not being in session. This is a HSE drugs group led by clinicians.

I wish to make a broader point because we-----

Will the Tánaiste intervene?

I will make sure the process is carried in the expeditious timeline that has been set out in terms of that-----

When they will know?

It has said it will do that within four weeks.

Deputy McDonald, allow the Tánaiste to answer.

I wish to make one point because I am conscious that we are on the clock. The Deputy made another point around delays and bureaucracy. I have to make the point back that sometimes those delays are not on the side of the State. We need to have full root and branch review of how medicines are assessed in this country. My colleague, the Minister, Deputy Carroll MacNeill, is entirely committed to that. Even in the House today, debating when the application came in or when the full business came in, there has to be a better way and more efficient way of assessing drugs applications more generally. We can return to that. On this-----

In the meantime, these people are deteriorating in real time.

Allow the Tánaiste to conclude.

-----specific issue, the rare diseases group, which is made up of not politicians-----

I know what it is made up of.

-----and not of bureaucrats but of doctors who treat these patients.

I am aware of that.

As am I. The group and the patient representatives will meet through this structure to assess this drug.

Are the doctors in Germany, England and France all different then?

I call Deputy O'Callaghan.

Are the all doctors-----

Deputy Gould, Deputy O'Callaghan is next.