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what Independent Ireland believes should be delivered. I wish to ask the Minister of State about Friedreich's ataxia and the medication Skyclarys. Where are we in relation to getting patients access to Skyclarys? The brother of Emma O'Shea in west Cork died from this disease … weeks ago. One was a young lady who was devastated by what the disease was doing to her. Every second without Skyclarys medication is a death sentence. I ask the Minister of State, how can we in opposition help the Government? We are not here to blame

ataxia and Duchenne muscular dystrophy and to recognise the very brave patients and their advocates who have made this case in Leinster House. Skyclarys is the first and only approved treatment for Friedreich's ataxia which around 200 people live with in Ireland. This medication can slow … progression of their condition. The company that makes Skyclarys has put the official pricing proposal to the CPU and now the situation is fully in the hands of the HSE. Patients do not know how long it will take for the HSE to make its final decision

clinical trials. It is important to note that going out from here today. I want to raise the urgent need for access to Skyclarys. It has been raised many times in the Chamber. I was watching on the screens. There are over 200 people living with Friedrich … Every month that passes means a loss of function that can never be regained. Time matters enormously for people with progressive degenerative conditions. Skyclarys was approved by the European Medicines Agency in February 2024 and is available to patients in the US, UK, France, Germany, Austria and other

briefing. I was very glad to have the opportunity to meet those patients, as I have had the opportunity to meet other patients. Skyclarys has been authorised at European level for Friedreich’s ataxia. In Ireland, as with other medicines, any decision on reimbursement must follow the statutory … Deputies are familiar with. They are informed by clinical, economic, budgetary and other relevant considerations. No reimbursement decision has yet been made on Skyclarys. I really understand that for families this sort of process language can feel very distant from the reality of living with a progressive condition

must apply in this jurisdiction. At the same time, people living with Freidrich's ataxia, FA, are still waiting for a decision on Skyclarys. This is the first and only treatment for around 200 people in Ireland living with this progressive and life shortening disease. It is those … living with rare diseases and their loved ones who are forced to fight for access to treatment. Skyclarys has been shown to markedly improve neurological function in those with FA and they are still waiting for access. Their illness is not waiting; it is progressing every

weaker while waiting for access. I hope access is granted for whoever needs it as soon possible. On Friedreich's ataxia Skyclarys is the only drug that has been shown to slow the disease. It was approved by the EMA and is available in other European countries … will quote from a constituent: The NCPE issued a harsh verdict for Skyclarys on 17 December 2025. While I understand the HSE is still in discussions with the manufacturer, the delay is costing my niece time to slow this cruel disease. It is already heartbreaking watching her fade

answered a question on this already. Perhaps he would give us a timeline. Will he urgently intervene to ensure that the drug, Skyclarys, is included in the HSE's drugs group agenda for tomorrow, 10 June? I raised this issue in the Dáil a number of months … ataxia, a cruel and relentlessly progressive disease where every single month lost means a permanent loss of mobility and quality of life. Skyclarys is the first treatment proven to slow the condition. It is already approved and being provided in countries across Europe and the United States

family in Kilkenny, Oisín Pollard and his family in Carlow and many others have campaigned with huge dignity and courage for access to Skyclarys, the first treatment approved for this condition but unfortunately they continue to face delay and uncertainty while the disease continues to progress. Will … Taoiseach update the House on what the Government's position is on reimbursing Skyclarys? What message does he have for the young people and families who feel they are being asked to wait while an irreversible disease takes more and more from them every

been done; I am not sure of the timelines - and when these families can expect this medicine. I will raise, as others have, Skyclarys and the treatment of Friedreich's ataxia, a rare neurodegenerative disorder that progresses very quickly, resulting in neurological decline, the loss of bodily function … ultimately death. Approximately 200 people in Ireland have Friedreich's ataxia. I know the Minister met some of them earlier this year. Skyclarys is the only approved treatment for this condition. It was approved by the EMA in February 2024 and is available in many states across

recently in the context of heartbreaking battles to get people care and treatment. The drugs highlighted in the media recently are givinostat and Skyclarys. I congratulate my colleagues Deputy Pádraig O'Sullivan and Senator Teresa Costello on the strong and diligent work that they have done in relation … these two drugs. Thankfully, givinostat has been approved but people with Friedreich's ataxia are waiting for Skyclarys to be approved. This inequity is to be found across the entire healthcare sector, including in the areas of rare diseases and cancer. We have effectively developed a two-tier

with advanced Huntington's disease. Paudie's father, Craig, has said that he is in a race against time to secure access to Skyclarys, the first treatment shown to slow progression of this devastating illness. He has rightly stated that if there is a price tag on every … facing rare diseases cannot afford bureaucratic delays while conditions continue to progress. Will the Government commit to expediting the decision-making process on Skyclarys? Can the Minister give a clear timeline on when patients like Paudie will finally have access to this life-changing treatment

degenerative disease for which there is no cure. Until recently there was no effective treatment either but now there is. It is called Skyclarys and it is available elsewhere in Europe but not here in Ireland. People with Friedreich’s ataxia have been waiting since 1 August … days, for the HSE to make this drug available. Why is Skyclarys not on the agenda for the HSE drugs group meeting that will happen tomorrow? Further delay is intolerable and cruel because there is no pause in this disease. Every day lost has consequences. Emily Felix told

showed in meeting Paudie's father, Craig, in recent days and his commitment to do everything he can to help secure access to Skyclarys for Paudie and other patients who may benefit from it. I also acknowledge the strong advocacy of the Taoiseach's colleague, Deputy Pádraig … lost as a condition progresses. Will the Taoiseach exhaust all efforts to try to bring forward the HSE drugs group discussion on Skyclarys from July to June so that Paudie and his family are not waiting unnecessarily any longer

gone through is quite shocking. I have spoken to the Minister about this. We will do everything we can to accelerate consideration of Skyclarys provision. It was never scheduled for tomorrow but I think Givinostat is. However, we are hoping we can bring forward consideration of Skyclarys

July, but I know the Minister was trying to bring it forward a bit, in particular in consideration of key drugs such as Skyclarys and so forth. I will raise with the Minister the issue Deputy O’Hara brought up in respect of a PET scanner for University

well. It is very distressing, difficult and challenging for the families and for Emily, Oisín and their contemporaries who want access to Skyclarys as quickly as possible. Early on, there were issues in getting the material from the company and so on, but all that has been overcome

talk about access to medicines for rare diseases because it is an area that needs to be reformed. The Minister mentioned givinostat and Skyclarys. Delays in this area have an impact on patients. I think we all accept there must be a process to protect the taxpayer

deteriorate rapidly, not due to the lack of medical progress but due to what I can only call administrative neglect by the HSE. Skyclarys is a breakthrough drug for those over 16 with FA. It is widely used across European public health systems, yet it remains

deserve action and they deserve it now. When is the next HSE drug group meeting and will they be included on it? If Skyclarys cannot be introduced fast enough, can there be an interim access where they can get it, whether it is through Europe or if there

most religious person in the world but I am saying prayers every night before I go to bed in relation to the Skyclarys drug, which, despite what was said earlier, will be at the next drugs group meeting in July. There is also an attempt to bring that

things. He is looking at his friends growing into big strong men while he declines. Paudie should be given access to the drug Skyclarys under the compassionate access programme. We know this drug would have a huge positive effect on Paudie's quality of life. I know

acknowledge the pilot but while pilots are something, they are by their very nature exclusive. I noted the Minister's comments early on Skyclarys for Friedreich's ataxia. She has to know time is of the essence and every day counts. It is similar for boys with Duchenne

spoken about the positive news that we got regarding givinostat. However, we are still waiting for that good news when it comes to skyclarys in relation to Friedreich's ataxia. This something that the Government and the HSE must prioritise, particularly its corporate pharmaceutical unit because, as other

enough either. The process clearly needs to be improved, but I welcome the progress made and I encourage the approval of givinostat and skyclarys

That tells you how painful this disease is. There is some hope, however, and that hope is in the form of the medication Skyclarys. It was approved by the European Medicines Agency in 2024. While it is not a full cure, the clinical guidelines show that it will

Deputy Albert Dolan asked the Minister for Health the reason skyclarys has not been included on the agenda for the recent HSE Drugs Group meeting held in June 2026; when the drug will be considered by the Drugs Group; the timeline for a decision on its prioritisation within … reimbursement process; and the measures being taken to ensure there are no further avoidable delays in progressing access to skyclarys for patients living with Friedreich’s ataxia; and if she will make a statement on the matter. [48540/26

Deputy Louis O'Hara asked the Minister for Health whether the reimbursement of the drug skyclarys was included in the agenda for the June meeting of the HSE's Drugs Groups; if not, the rationale for its exclusion; to provide an update on the process of adjudicating whether … cost of skyclarys will be reimbursed; and if she will make a statement on the matter. [46002/26

given that persons in the Friedreich’s ataxia community in Ireland are being left behind waiting for a decision regarding the skyclarys reimbursement, while patients across Europe gain access to skyclarys (details supplied). [43947/26

Deputy Niamh Smyth asked the Minister for Health if she will provide an update on the reimbursement process for skyclarys for the treatment of Friedreich's Ataxia; the meetings that have taken place to date regarding the application; when a final decision is expected; and if she will

Deputy John Brady asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations; if she will commit to the inclusion of the drug on the agenda of the next HSE drugs group meeting

Deputy Natasha Newsome Drennan asked the Minister for Health when the commercial proposal request to include skyclarys on the agenda for the June HSE Drugs Group meeting was received by the HSE; and if she will make a statement on the matter. [46675/26

Deputy Pádraig Rice asked the Minister for Health if the consideration of skyclarys for the treatment of Friedreich's ataxia will be prioritised; the date on which the drug will be on the agenda for a meeting of the HSE Drugs Group; and if she will make

Deputy Réada Cronin asked the Minister for Health the reason skyclarys is not included on the agenda for the upcoming HSE Drugs Group meeting; and if she will make a statement on the matter. [46373/26

Deputy Conor Sheehan asked the Minister for Health the reason Skyclarys is not included on the agenda for the upcoming HSE drugs group meeting; if this drug will be put on the agenda for this meeting; and if she will make a statement on the matter. [44885/26

Deputy Eoghan Kenny asked the Minister for Health if her Department has further considered the inclusion of Skyclarys (omaveloxolone) as of June 2026, which is a treatment for Friedreich's ataxia in a reimbursement scheme given the cost of the drug and the fact that other European countries

ensure that the HSE recognises and responds to the time-critical nature of Friedreich's ataxia during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [44928/26

Deputy Roderic O'Gorman asked the Minister for Health the reason consideration of reimbursement for skyclarys was not included in the agenda for the 10 June 2026 meeting of the HSE's corporate pharmaceutical unit; and if she will make a statement on the matter. [45086/26

Deputy Michael Cahill asked the Minister for Health if she will ensure Skyclarys is covered by the HSE as it is the only drug approved to treat Friedreich's ataxia; and if she will make a statement on the matter. [45121/26

Deputy Marie Sherlock asked the Minister for Health for an update on the reimbursement process for Skyclarys for persons living with Friedreich’s ataxia; and if she will make a statement on the matter. [45289/26

Deputy Michael Fitzmaurice asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations (details supplied); and if she will make a statement on the matter. [44724/26

Deputy Michael Fitzmaurice asked the Minister for Health if the current delay a to the skyclarys reimbursement negotiations aligns with the "equitable access" promised in the newly launched National Rare Disease Strategy 2025-2030; and if she will make a statement on the matter. [44725/26

Health the status of price negotiations between the Health Service Executive Corporate Pharmaceutical Unit and the manufacturer regarding the reimbursement of omaveloxolone (skyclarys) for the treatment of Friedreich's ataxia; if she will address concerns regarding the omission of this life-altering therapy from the immediate agenda

Deputy Michael Cahill asked the Minister for Health to make skyclarys available to people living with Friedreich’s ataxia in Ireland (details supplied); and if she will make a statement on the matter. [44828/26

Deputy Pat Buckley asked the Minister for Health to provide urgent access to skyclarys for persons living with Friedreich’s ataxia (FA) here. [44859/26

Deputy David Cullinane asked the Minister for Health the current status of negotiations regarding pricing for reimbursement for skyclarys. [44200/26

Deputy Roderic O'Gorman asked the Minister for Health for a timeline on the skyclarys reimbursement negotiations, following the submission of a proposal by an organisation (details supplied) to the HSE's Corporate Pharmaceutical Unit; and if she will make a statement on the matter. [41813/26

Deputy Ryan O'Meara asked the Minister for Health for an update on the pricing and reimbursement application for omaveloxolone (skyclarys); if the commercial proposal has been received from the company; and if she will make a statement on the matter. [41821/26

Deputy Barry Ward asked the Minister for Health the position regarding the approval process for skyclarys as a treatment for friedrich's ataxia; and if she will make a statement on the matter. [41992/26

Deputy Barry Ward asked the Minister for Health her views on if delays in the approval of skyclarys as a treatment for friedrich's ataxia aligns with the "equitable access" as outlined in the National Rare Disease Strategy 2025-2030; and if she will make a statement

Deputy Barry Ward asked the Minister for Health the position regarding the commercial proposal in relation to the approval process for skyclarys as a treatment for friedrich's ataxia; and if she will make a statement on the matter. [41994/26