I begin today by extending my and Sinn Féin's deepest sympathies to the family of Saoírse Ruane. She inspired all of us in this House. She also inspired the toy show appeal. She inspired all of us right throughout the State in her battle with her illness. Ar dheis Dé go raibh a hanam. I am thinking of all her friends and colleagues and, especially, her family today.

Before the referendums tomorrow, I also make a final appeal to voters to come out and vote. We see the proposed changes as small steps forward and, on balance, we have advocated for a "Yes" vote in both referendums. Whatever the results, however, this must be a catalyst for meaningful change for people with disabilities, those who need care and their carers. I appeal to the Government to deliver the long-overdue rights and supports badly needed in this context.

Cluineann muid go bhfuil comhdháil náisiúnta ag an IPHA inniu agus tá sé ag díriú aird arís ar an am atá á ghlacadh ag an bhfeidhmeannas sláinte le drugaí úra agus drugaí a thig leo tacaíocht a thabhairt do dhaoine agus beatha daoine a shábháil a thabhairt ar an margadh. Tá sé ag glacadh i bhfad an iomarca ama é seo a dhéanamh. Caithfidh athrú teacht air seo. Tá staidéar déanta fá dtaobh de agus tá muid ar chúl san Eoraip ina thaobh. The IPHA is holding its annual conference today and it has highlighted the length of time it is taking the health service to approve the availability of new drugs. This has the potential to make real life-changing differences to the lives of patients in all our constituencies in every part of this island. Many innovative and life-changing drugs that save lives are produced here in Ireland, in the Tánaiste's own home county of Cork and elsewhere. Many Irish patients, though, are among the last in Europe to receive these drugs. How is this fair? Drugs are being produced down the road, but we are some of the last in line in Europe to actually get access to them. Careful consideration of drugs is needed and a balance must always be struck when we are looking at the issue of new drugs, but for those who are cancer patients or those with a rare disease, though, the industry has very clearly said Ireland is a laggard in this regard. When we compare ourselves with our European partners, we are at the bottom of the list in relation to access to these life-changing drugs. To add injury to insult, we also have a two-tier system where patients who have private health insurance get rapid access to these drugs once they are approved by the EMA, while patients who do not have the money for private health insurance must wait on a long, drawn-out process for the HSE to approve these drugs. In some cases, this can take years.

We all know the human impact of this situation. We also know what the problem is here. We have seen the reports being published in relation to this issue. They refer to a process that is convoluted and beset by staff and capacity problems. If staff are not there to process these approvals, then the problems and the delays are going to continue. There is uncertainty about the future funding streams for drugs. We saw this in the context of the recent budget where the Government did not allocate any new money for the provision of new drugs. Sinn Féin, the industry and professionals called the Government out on this issue, and it had to do a U-turn on it. This is not the way to manage this crucial issue. The problem is we have a steady flow of new drugs coming on stream, but we do not have multiannual funding or adequate staffing to ensure patients can secure timely and life-saving access to them. The average wait time in this State is around two years for new drugs to be approved by the HSE and this is simply far too long. When the now Tánaiste was on this side of the House, I heard him raise these exact same issues. I refer, for example, to Orkambi and its use by cystic fibrosis patients. Nothing has changed, despite the Tánaiste and a Fianna Fáil Minister for Health being in government for four years. The Tánaiste, therefore, is well aware of the issues and the length of time involved in this regard.

I am sorry, Deputy, we are over time.

We are talking about life-changing drugs that can save the lives of people with rare diseases and cancer. There is great frustration. Will the Tánaiste ensure multiannual funding is allocated to provide a clear and predictable budget for the HSE to manage a continuous supply of new medicines? Will he also ensure the issue of staff capacity is addressed? It was pointed out to the Government last year and it has still not done anything about it. The staffing level has not been increased.

Go raibh maith agat. I thank the Deputy. We are over time.

People in my constituency and that of the Tánaiste are waiting over two years for drugs to be approved. If people have private healthcare, however, they can get them straight away.

I also take the opportunity to offer my deepest condolences to the family of Saoírse Ruane, her parents, Ollie and Roseanna, her sisters and all who knew and loved her. I was fortunate enough to meet Saoírse at Croke Park some years ago. I was very much struck by her radiant smile, her warm personality and her love of sports, including Gaelic games. Saoírse inspired so many people with her positivity and courage. She has left an extraordinary legacy through the RTÉ toy show appeal. Ar dheis Dé go raibh a hanam dílis.

Turning to the point made by the Deputy, it is worth recalling and pointing out that about €3 billion is spent by the State on medicines annually. This is an enormous sum of money. It is important that we always strive to get value for money in terms of the spending of that €3 billion and strive for the best outcomes for patients. The HSE has approved about 148 new medicines in the past three years from €98 million in new medicines funding. It is not true, therefore, to say that nothing has happened. I did raise these issues when I was in opposition, and since we came into government additional money has been allocated every year. In the last three years, this has amounted to €98 million, with 148 new medicines approved. The total expenditure in that basket was about €327 million, to the end of 2023. We also made €30 million available this year for new drugs. There has been €20 million in new Government investment and the HSE has been requested to identify €10 million in efficiencies, which will be reinvested in new medicines. This morning, the Minister announced an additional 35 staff for the corporate pharmaceutical unit in the HSE. It is very welcome news that positions are being filled that had been vacant as a result of people moving on to other areas. The Minister has also agreed to create a tracker to monitor the journey of a medicine through the administrative process.

The Irish Pharmaceutical Healthcare Association is the industry lobby group. That is fair. It lobbies on behalf of the industry in respect of new medicines and the pricing around them and it would say it has a good and robust relationship with the Minister. The health technology assessment, as the Deputy is aware, is carried out primarily by the National Centre for Pharmacoeconomics. The IPHA has said it has a good and robust professional working relationship with that aspect of the process too, although it is concerned about administrative delays. When a product comes out of the NCPE process, it moves to a group in the HSE that evaluates drugs in terms of value for money, etc. The idea here is to get this process speeded up. The IPHA's view is that this currently takes too long.

Taking last year as an example, it is estimated that if we had accepted the original prices the industry put forward for all the new drugs, we would have spent about €400 million extra. In reality, we spent €200 million. There is a need, therefore, for a fairly robust engagement here with the industry on an ongoing, annual basis in respect of drugs that come forward.

Deputies Pádraig O'Sullivan and Lahart and others have been very strong advocates in the area of rare diseases and orphan drugs. There has been significant progress on that with the establishment of the working group and so forth. We are anxious to work with industry to see if we can develop a more effective approach to offering medicines with a fast-track assessment process. That is under consideration.

The Tánaiste talks about frustration. I mentioned that there must always be balance and consideration. The approval of a new drug is supposed to take 180 days. The Tánaiste talked about people with rare diseases and cancer patients. We are at the bottom of the list in Europe for accessing these drugs. All through the term of this Government that has been the situation. Irish people are likely to be one of the last in the line to access these drugs, which are being produced in the main in Ireland, in some cases down the road from the Tánaiste. That only applies for a public patient. A private patient with money who can afford private healthcare can get rapid access to these drugs.

These are not just drugs of convenience; these are drugs that keep people alive. Lives have been saved by these drugs and other lives have been lost as a result of the delays in processing these drugs. I am not questioning whether we are making money available for new drugs or whether new drugs are coming on stream, but why is Ireland the laggard in Europe on this? The Government received an expert report last year and has now set up an expert working group. I am sure that when it reports to the Government, it will set up an expert Cabinet committee and then an expert implementation group.

I thank the Deputy.

However, throughout the term of the Government we have been the laggard in Europe in processing and approving drugs that can save lives for public patients.

The Tánaiste to respond. We are way over time.

That is not acceptable.

I do not accept that. At the outset, the Deputy said that there was no new money this year; there was. Some €30 million has been made available. He said nothing had changed since the Government came in.

I said the Government had been forced to do a U-turn.

In fact, €98 million of new money has been provided since this Government came in for new medicines. I refer to 148 new medicines in the past three years, as well as 39 new drugs or new uses of existing drugs with an orphan designation. By orphan, we mean drugs for rare diseases and they are termed orphan drugs because of that. We spend €3 billion a year on medicines. That is not inconsiderable and we are not the laggard across Europe. I do not accept that at all. In fact, we would be a laggard in the use of generic drugs relative to others across Europe.

So, we are not at the bottom of the table.

In the last three years there have been about 61 new drugs or new uses of existing drugs for use in oncology alone for cancer patients. It is a very rapidly moving area, particularly in terms of immunotherapy drugs and so on. The funding has gone up exponentially over time. We need a system to evaluate this and make sure we get best value for money. In principle, I am disposed to getting drugs to the people who need them as fast as possible.

The Tánaiste is missing the point that we are one of the slowest. Perhaps he is not missing the point but is ignoring it.