I thank both Deputy O'Sullivan and Deputy O'Hara for raising this important issue. I spoke on this in the Seanad a couple of weeks ago. I acknowledge Deputy O'Sullivan's advocacy on rare diseases in the past six years. As we all know, the State acknowledges the importance of access to new and innovative medicines for patients living with a rare disease. Budgets 2021 to 2025 included dedicated funding for new medicines of €158 million. Budget 2026 allocated an additional €30 million of funding available for new drugs. From 2021 up to March 2026, this has enabled the HSE to approve reimbursement for 263 new medicines, including 72 new medicines for the treatment of rare diseases. As Members are aware, the National Rare Disease Strategy 2025-2030 was launched last year. The strategy outlines a comprehensive framework designed to enhance diagnosis, treatment and support for people living with rare diseases, aiming to improve quality of life, promote equitable access to healthcare, and foster innovation in rare disease research and treatment. It also emphasises the importance of access to orphan medicines among its key recommendations. The State has signed two new framework agreements on the supply and pricing of medicines from 2026 to 2029, following successful negotiations with the pharmaceutical industry, that will provide stability and certainty to the sector. Building on this achievement, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandbox early-access programme for rare diseases. This will be a proof-of-concept initiative aligned with the commitments in the programme for Government and the national rare disease strategy. Regarding Skyclarys, I will provide some background for our colleagues and then address the Deputy's question. Omaveloxolone, sold under the brand name Skyclarys, is a medication licensed by the European Medicines Agency to treat Friedreich’s ataxia in patients aged 16 years and over. Friedreich’s ataxia is a rare inherited disease that causes damage to the nervous system. Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. The Act provides for a rigorous process for the assessment of new medicines for reimbursement. This ensures that the right medicines are chosen and that approval is at a sustainable price. The HSE received an application for pricing and reimbursement for Skyclarys from the applicant, Biogen Idec (Ireland) Limited, on 1 August 2024. After receiving a completed rapid review assessment report from the National Centre for Pharmacoeconomics, the HSE commissioned a full health technology assessment on 25 September 2024. A fully completed dossier, which is required to allow the NCPE to conduct a pharmacoeconomic assessment of the pricing and reimbursement application, was not received from Biogen until July 2025. The NCPE proactively engaged with the applicant company and submitted the finalised health technology assessment report to the HSE on 16 December 2025. It is important that we look at the timelines. This report included submissions made by patient organisations. These submissions will form part of the data that the HSE considers. The HSE invited the applicant to commence price negotiations and offered a range of dates to the company. The HSE has advised this meeting took place on 12 February 2026 and, as of the most recent update from the HSE in April, a commercial proposal from the company remains outstanding. I checked with the Minister's Department last night in this regard and I know the Taoiseach has engaged with her. Where we are at the moment is that a commercial proposal from the company remains outstanding, which I know is frustrating, but it is important to put the timelines on the record of the Dáil.

Sentiment score: 0.21

I concur with both Deputies. We are speaking about this really important drug and 200 people, their families and their parents want to know what is going to happen and are hanging on our every word. I take all that on board. While I know this has been going on for two years, the HSE did not receive the information from Biogen until July 2025. We are still waiting for the commercial proposal from the company. That remains outstanding. That is the situation at the moment. I am glad Deputy O'Sullivan has engaged with the company to see if we could get some movement on this. We have an agreement in relation to some drugs. We have the Benelux agreement, which allows us to get really good value in procuring drugs. However, it is different for drugs for rare diseases. You need a number of elements to work together. I agree with Deputy O'Sullivan about the overall system, the process and meaningful engagement. I will be speaking to the Minister about this again. The sooner the commercial proposal from the company comes in, the sooner a decision can be made. There is not a Deputy in the House who has not been touched by Aoife's case and those of others who are awaiting this drug. Did the Deputies get my response? Was it circulated?

Sentiment score: 0.21

I thank the Deputy for raising this again and for his continued advocacy in relation to this situation. It is one that I am very familiar with, as our two constituencies align along a border. I have met one of the nurses who works in the service and who has advocated strongly as well. I just happened to meet her one day. On behalf of my colleague, the Minister for Health, I thank the Deputy for raising this important issue, which he has highlighted a number of times. As the Deputy is aware from previous replies, every effort has been made to recruit staff to this service, but these efforts have not been successful to date. The HSE provides free optical services to preschool and national school children who are referred through child health and school health examinations and are identified as having sight problems. These services continue until a child reaches 16 years of age. In addition, the community ophthalmic services scheme, which has been in place since 1979, allows medical card holders aged 16 and over to access care from contracted ophthalmologists, community ophthalmic physicians, optometrists or dispensing opticians. The HSE has confirmed that the community ophthalmic post in south Tipperary - University Hospital Waterford - became vacant in October 2024 following a planned retirement. In 2025, the post was regraded to that of consultant in medical ophthalmology to align with the national clinical programme for ophthalmology. Permanent consultant posts are advertised through the Public Appointments Service, PAS. This process can take time, and the HSE ran two temporary recruitment campaigns in May and September 2025 to maintain services in the interim. Unfortunately, no appointment was made following these campaigns. The permanent post was advertised by the PAS in November 2025. As there were no applicants, the closing date was extended to January 2026. One application was received but following shortlisting, the candidate did not progress to interview. The post was advertised in the British Medical Journal. In parallel, the HSE has advertised clinical optometrist and orthoptist posts, a process that closed in January. Filling these roles will help support the resumption of optical services in south Tipperary. While recruitment to the consultant post remains ongoing, a multidisciplinary working group has been established involving consultants from University Hospital Waterford and the national clinical lead for ophthalmology. In addition, a targeted blitz clinic initiative is being processed to urgently address the significant waiting list backlog for patients in south Tipperary. I take on board every word that the Deputy said in relation to over 2,000 children waiting, with many of them under four years of age. That early intervention is absolutely crucial. We accept that. Sometimes, it is difficult for different reasons to get the specialist consultant into a particular area. That is what is proving difficult in this case. As Minister for State with responsibility for mental health, I have similar challenges in various areas. I was delighted to see a vacancy in south Kerry child and adolescent mental health services, CAMHS, that had been vacant since 2014 being filled only recently. It had been supported by locums up until that. The HSE has tried everything to try to get this post filled. It went out to the British Medical Journey. However, I am pleased to see that this targeted blitz clinic initiative is being progressed to urgently address the significant waiting list backlog for patients in south Tipperary. Hopefully, that will have an impact while the recruitment process is under way in parallel.

Sentiment score: 0.08

It is disappointing that a post that has been advertised for almost two years has still not been able to be filled for various reasons. It is important to note that recruitment to the consultant post remains ongoing. In parallel, a multidisciplinary working group has been established involving consultants from University Hospital Waterford. The national clinical lead for ophthalmology is that piece of the jigsaw that the Deputy mentioned as regards the Royal Victoria Eye and Ear Hospital. That would be the person. Across all definitions in health, we have a national clinical lead. To have the national clinical lead involved at this level is important. The targeted blitz clinic initiative is being progressed. We do not have the details here, but I would expect that would include public and private to try to get the waiting lists down. That would be normal. I will look for more information in relation to the blitz clinic initiative because I am a very conscious of the growing waiting list. I will revert to the Deputy. I will talk to the Minister.

Sentiment score: 0.01