Gabhaim buíochas leis an Aire as teacht chuig an Seanad inniu. I welcome her to Seanad Éireann. As she may be aware - I know she is because she put up a video on social media - last Saturday, 28 February marked rare disease day. It was very welcome to see Leinster House lit up in the colours of blue, pink and green in acknowledgement of this important day. While we mark and acknowledge rare disease day, it must not be lost on us that such diseases are not in fact so rare. That is something the Minister has pointed out as well. When we look at them in their totality, it is estimated that approximately 300,000 people, or one in 17 of all people living in Ireland, are living with a rare disease, with a significant, long-lasting and all too often life-limiting impact on their lives and the lives of their families.

People living with such rare diseases are being subjected to unacceptable waiting times for access to European Medicines Agency, EMA, approved orphan medicines designed for rare diseases affecting fewer than one in 2,000 people, with the average delay between EMA approval and availability in Ireland being 710 days. This is time that people living with rare diseases, unfortunately, just do not have to spare. That is why I am requesting an update on the programme for Government commitment to a review of the drugs reimbursement process in line with the 2018 Oireachtas health committee report on evaluating orphan drugs and calling for this review to begin as soon as possible in order that we can deliver on improving access to these life-saving medicines within the lifetime of this Government.

The 2018 Oireachtas health committee report on evaluating orphan drugs specifically called for a review of the national drugs reimbursement process highlighting the need for legislative reform to improve the accessibility and timeliness of drug reimbursement decisions. Between 2020 and 2023, Ireland only reimbursed ten of 46 EMA-approved orphan medicines. The barriers these medicines face in getting approval include limited data availability and small sample sizes, among other technical challenges. However, these medicines are approved by the EMA and our European colleagues in Germany, North Macedonia, Cyprus, Austria and Switzerland. They are approving and funding such treatments in under 300 days on average, while Irish patients are waiting an average of 710 days for access to life-changing and often life-saving treatments, that is, of course, if they are approved for reimbursement at all.

I welcome the commitment from the Minister to supporting the new rare disease strategy, which is a welcome development that will support early intervention for many rare diseases, particularly expanding the use of the heel-prick test to screen for more diseases and maintaining a national rare disease register. However, while early identification is important, this must be coupled with additional support for reimbursing orphan medicine treatments. This is why I am calling for the Department of Health to begin the review, committed to in the programme for Government, of the national drugs reimbursement process. It should begin soon to ensure it can be front-loaded in the lifetime of this Government and that changes can be implemented in the Government's lifetime. While it is welcome that the new rare disease strategy has been published, I also ask the Minister to give an update on when the implementation oversight group for the rare disease strategy will be constituted.

This will show real commitment from the Department to the implementation of the rare disease strategy, reassuring people living with rare diseases that the Government is committed to supporting them in accessing the life-saving treatments they need. I hope the Minister will work to ensure this review of the drugs reimbursement process is commenced as soon as possible. Delaying the review any further will only add unnecessarily to the delays that people living with rare diseases already face when compared with our European neighbours. There is an opportunity for us to develop a new pathway for access to orphan medicines with this review so that people living with rare diseases can access treatments and in order that the reimbursement process is clearer, more predictable and in line with the guidance of the European Medicines Agency and our European colleagues.

Sula mbogaim ar aghaidh go dtí an Aire, cuirim fáilte roimh na cuairteoirí san Áiléar inniu ó Irish Countrywomen's Association, Marlay Guild. Tá míle fáilte rompu.

I thank Senator Ní Chuilinn for raising this important matter. Supporting those living with rare diseases is a priority for me as Minister and for the Oireachtas. It is important to remember that 300,000 people, as the Senator said, are living with a rare disease. While the disease may be rare, the fact of living with a rare disease is not. On foot of that, the national rare disease strategy was launched in August 2025. The Department of Health will now ensure its implementation and its vision to ensure that all people living with a rare disease have fair, equitable, inclusive, safe and cross-sectoral care throughout their journey. An implementation oversight group has been launched. It met in February and that implementation work is under way. Work has begun on planning for the 11 recommendations. As implementation of the strategy progresses, it is of course intended that patient representation will be a key feature and will be embedded in all structures.

I have a couple of updates on the pricing and reimbursement system. There has been dramatically increased resourcing across the pricing and reimbursement system, with 34 new people hired to work in it. That is essentially a doubling of that team, which is very important. There is also the development of a tracker to increase transparency. Since the negotiation of the agreements in principle on the supply and pricing of medicines with the Irish Pharmaceutical Healthcare Association and Medicines for Ireland, those agreements will commence this year and last until the end of 2029. Those agreements work alongside and indeed supersede some of the other work because they provide the commitment and structured process towards achieving a 180-day timeline for completing the health technology assessment and the reimbursement decisions. That is a significant change from the current waiting period.

It is important to remember that there has been an additional €158 million in funding in the past four years. We have delivered access to 250 new medicines in that time, about 110 of which were for cancer and 69 were for rare diseases. While we have allocated another €30 million in funding specifically for new medicines, at the moment we spend close to €4 billion every year on drugs. The pressure of that on our budget is significant. That is nearly €4 billion, which is more than twice the complete spend on the Department of Defence. The Department of justice spends €6 billion in the whole year for all the salaries of An Garda Síochána and the justice system in its entirety. That is to put the €4 billion in context. It is a very significant amount of money. What are we spending . that on? We are spending it on medication people get in hospital, that people get through their pharmacist that is paid for by the State. Even where a person pays €80 in the pharmacy, it is not that the drugs cost €80, it is that the State pays for the rest of it. Those are benefits to the taxpayer and to people living in Ireland in the healthcare system. The pricing is an important part of the reimbursement decisions that will ultimately have to be made in respect of rare disease drugs, as every other drug, and the State has to try to get the best value for money to continue to support as many people as possible within the budget, even though that budget is expanding.

It is also important to say that, as part of the framework agreements to which I referred, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of sandboxed early access for rare diseases. That is a proof of concept initiative. It aligns with the commitments in the programme for Government. In parallel, my officials have examined reimbursement systems throughout the European Union. They will bring forward further proposals in the coming months. Those mechanisms are quite complex and the potential impacts have to be considered carefully. I thank the Senator for giving me the opportunity to discuss the matter.

I know how busy the Minister is and I appreciate her coming to the Seanad today with that update.

The 180-day target is obviously a huge improvement on the 710 days, and even an improvement on European best practice. When does the Minister expect that to be met?

It is very easy for us to forget, when we are talking about these figures and price agreements, that a lot of the time we are talking about children, because a lot of rare diseases will present in childhood. The unpredictable nature of these reimbursement processes at times leads to conditions worsening in children and to unsettled times for families. It is important to remember that.

The Minister mentioned the rare diseases strategy. It is brilliant that the committee met in February, which is very recent. I thank the Minister for the update. There was disappointment to see very vague comments within the strategy in relation to access to orphan drugs. There was no mention of the reimbursement review, which is needed to identify the problems with the current criteria as they relate to orphan medicines.

With regard to the pricing agreement, the Minister mentioned the IPHA. I would point out that there are other industry stakeholders outside of the IPHA that have intimate knowledge of the reimbursement process given that their respective companies specifically and only manufacture and develop rare disease treatments. These stakeholders are very happy to discuss access to orphan medicines with Department stakeholders and the Minister. It is something to bear in mind.

Certainly, if it is a 180-day target, that is very positive. Does the Minister have any information on when that might be met?

The Department would always be happy to speak with any other parties in the pharmaceutical sector. It is important to point out that the 180-day period is for the decision from the application through the HTA process to reimbursement. I know there is a bit of a disconnect here. Because something has been EMA-approved, there is an assumption that that consideration is happening in the HSE. That only happens if the drug company makes an application in Ireland and that is not always the case for a lot of different reasons. For example, in addition to the commitment on pricing and reimbursement decisions within 180 days, the IPHA member companies will aim to shorten their timeline to submit reimbursement applications in Ireland to within six months of formal authorisation by the EMA. That is another important part of the timeline.

Again, the State will always have to be acutely conscious of the pricing decision and that pricing decision is going to come at an earlier stage. The State has to have the opportunity to negotiate on behalf of the State and the taxpayer to get the best value. We want to make sure we have access to many medications for all forms of disease, but especially rare diseases, as part of the rare disease strategy.

It is very important that I set those pieces out. It is for the company to make the application. It is for us to respond to that in an appropriate and timely way. There is a price calculation at the end of that. I have set out the broad budgetary parameters around what we are spending on drugs at the moment. Of course, there is not a single person in the Oireachtas who does not want to support every person in the State. I am simply setting out some of the realities around some of the decisions that will ultimately have to be made at a later stage.