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This is a cruel, fast-moving disease and every month that passes Emma loses more of her independence. There is a treatment called Skyclarys which is approved across Europe and in the USA. Patients elsewhere are already benefitting but in Ireland Emma and others cannot access it despite … decline. I am asking for two simple things. Will the Minister of State intervene to ensure the HSE concludes reimbursement talks for Skyclarys? Do these delays reflect the access promised in the new rare diseases strategy? Emma and the FA community cannot be left behind while the rest

young people all suffer from Friedreich's Ataxia and they need the Government's help with regard to approving funding for the drug Skyclarys, which will make a huge difference to their lives. Today, their parents said, "Our kids don't have the luxury of time." They said … asking the Taoiseach and the Minister for Health to help these people and to urge the HSE to approve the funding for Skyclarys drug

with Duchenne muscular dystrophy or Friedreich's ataxia, those 800 days or so are time they do not have. This summer, we saw Skyclarys approved for Friedreich's ataxia after a long and exhausting campaign, so I welcome the early access scheme that the Department is devising

approved. What we cannot control is the conduct or participation of the drugs companies. The Deputy will be aware, particularly in relation to Skyclarys, that we were waiting for an extremely long time for the drugs company to submit the different pieces of documentation, including its commercial proposal

been 23 days since the drug Skyclarys was approved for roll-out to Friedreich's ataxia patients. To date, not one patient has been contacted in regard to how they can receive this life-changing drug. Can we have a debate in the Dáil today to clear that

Deputy's interest in this issue. I was very pleased with the decision of the HSE senior management to approve the reimbursement of Skyclarys for patients over 16 years of age with Friedreich's ataxia following substantive engagement and negotiations with the company. The company did come

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

matter has been raised twice already this morning, but it is hugely important. I will make a personal appeal to the Taoiseach regarding Skyclarys and the further delay that has now arisen. Yesterday, Emma O'Shea came to Leinster House from west Cork with her mother, father

Public Gallery and outside the gates of Leinster House for a peaceful protest. Can we have a debate on the current status of Skyclarys reimbursement and will these sufferers have positive news

outside the gates of the Dáil. They are, as the Taoiseach knows, waiting and waiting for confirmation that they will have access to Skyclarys, a drug that has the potential to be life-transforming for them. In the absence of it, however, far too many of them

industry, as well as patient advocates. There will be an important meeting of the HSE drugs group next Tuesday, which will discuss Skyclarys, and recommend it, hopefully, for approval for reimbursement. I do not expect the Minister to intervene or comment on that specific case, and we have

current age limits for school bus drivers and school buses used for school transport. Deputy Pádraig O'Sullivan - To discuss the reimbursement of SkyClarys. The matters raised by Deputies Connolly, O'Sullivan, O'Donoghue, Ó Súilleabháin, McGuinness and Newsome Drennan, and Neville have been selected for discussion

group of people living with Friedreich's ataxia, along with their families, were present in the Dáil as the urgently needed drug Skyclarys was being discussed on Leaders' Questions. It is important to acknowledge the hurt the Taoiseach caused that day when he gave incorrect reasons

coverage over the last few months is the disease called Friedreich's ataxia. There is a drug out there called Skyclarys. Citizens of a number of European countries are able to access that medicine. We have come here and families have come here and spoken about

speaking today on behalf of families living with Friedrich's ataxia who are running out of time while waiting for access to Skyclarys, the only approved treatment for this cruel disease. For these patients, every week that passes means more mobility loss, more independence gone and more heartbreak

State will know that we are working with Friedreich’s ataxia patients who are undergoing a similar process regarding reimbursement of the drug Skyclarys, which, I understand, will be deal with by the drugs group shortly. Still, here we are again. How many more patients' groups or cohorts

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

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

Deputy Barry Ward asked the Minister for Health the position regarding a timeline for the approval of skyclarys as a treatment for friedrich's ataxia; and if she will make a statement on the matter. [41995/26

Barry Ward asked the Minister for Health the position regarding meetings held between HSE or Department of Health officials with the manufacturers of skyclarys in relation to its' approval process for the treatment for friedrich's ataxia; and if she will make a statement on the matter. [41996/26

Deputy John Paul O'Shea asked the Minister for Health for an update on the process to have the drug skyclarys eligible for friedreich's ataxia patients in Ireland; and if she will make a statement on the matter. [43153/26

Deputy Niall Collins asked the Minister for Health if there are plans to approve skyclarys (omaveloxolone) for Friedreich's ataxia; and if she will make a statement on the matter. [43394/26

Deputy Colm Burke asked the Minister for Health the up-to-date position in respect of the application for pricing and reimbursement of skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older; and if she will make a statement

Deputy Pádraig O'Sullivan asked the Minister for Health the status of the progress of skyclarys through the drug reimbursement process; and if she will make a statement on the matter. [43773/26

Deputy Aengus Ó Snodaigh asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations, given that it is the only available treatment for this progressive disease, which currently can be classed as having an ‘unmet need

Health if any budget impact assessment, cost projection, prevalence estimate, or epidemiological model was prepared in advance of reimbursement consideration for omaveloxolone (skyclarys); and the details of same. [38847/26