Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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The Minister of State has sat in a lot of parliamentary party meetings with me and I know this is an issue she is very familiar with because I have raised it every second week. I appreciate the Minister of State being here this evening. I do not mean to sound dismissive but I can almost predict the answer she will give to me. I half know the answers to some of the questions I have posed which relate to why we approve so few new cancer drugs, why there are delays in the system and the third part of my question, which is centred around proposals for the future and how we improve the process.

I will start by stating a couple of facts relating to today's publication from the European Federation of Pharmaceutical Industries Association. It published a report today which essentially gives a descriptor of what is going on in this country in regard to new cancer drugs, in particular, and a couple of facts stood out. First, 48% of all innovative medicines are unavailable in this country in comparison with our EU counterparts. Only 29% of those drugs are actually fully available in Ireland, the remainder being partially available or having some restrictions on them and varying from drug to drug. Second, the rate of availability for non-oncology - non-cancer - drugs is 22% compared with the EU average of 39%. Again, we are way behind the curve in comparison with our EU counterparts. Third, only 25% of non-oncology drugs are available in Ireland compared with our EU counterparts, where an average of 31% of those non-oncology drugs are available. Finally, 25% of the 56 new cancer treatments licensed by the European Medicines Agency since 2020 are available in Ireland, so only one in four cancer drugs available widely across Europe are available in this country.

I can nearly predict the answer from the Department of Health that the Minister of State will read. The problems are quite apparent for me. We have a system that is one size fits all, so when we assess drugs in this country, we assess them on a quality threshold, that is, the quality of years that is added to somebody's life. Unfortunately in this country, we also operate a quality threshold of €45,000, so if a drug costs more than €45,000 per patient, it is automatically rejected. However, it takes almost a year to find that out formally through the process, so a lot of time is wasted.

It takes the average orphan drug 710 days to get to market authorisation in Ireland. By comparison, for our EU counterparts, it is an average of 607 days.

I will leave the Minister of State with these two statements. Back in 2017, the then Minister for Health, Deputy Simon Harris, actually described this system as being broken. Predating that, the former head of the HSE, Mr. Tony O'Brien, commented that the system is producing the results it is designed to produce. What I see the system doing is essentially knocking industry and the Department of Health or the HSE into a protracted negotiation that takes somewhere between two and three years, if patients are lucky. Unfortunately, for me as a public representative, it is patients in the middle who get caught out and lose time in terms of treatment and improving their life chances, extending their lives in some cases.

I understand these drugs are expensive. There is nobody here expecting us to break the bank or break the State but other countries do it far better and far more efficiently than us. That has to be recognised, and we need to get to the crux of the matter. I welcome some inclusions in the programme for Government, which I might talk to the Minister of State about in the supplementary.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy and I acknowledge his constant advocacy with regard to new cancer drugs and drugs in general. I am taking this question on behalf of the Minister, Deputy Carroll MacNeill.

As the Deputy knows, the HSE has statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications that have been granted marketing authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds, and having regard to the advice of the National Centre for Pharmacoeconomics. There are formal processes that govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed or both.

An external review of this process, published in 2023, found it to be operating in line with international norms. In the same year, 50% of applications for reimbursement progressed following a rapid review without the need for a full health technology assessment. Recommendations made in the review have been implemented. These include the introduction of an application tracker to enhance transparency within the pricing and reimbursement process and enhancing the capacity across the process with the recruitment of 34 additional staff.

The timing of company applications for new medicine reimbursement in different countries can vary for several reasons, not least the available market share in each country. Once a company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country or countries of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list unless an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration. In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. In 2023, a record €3 billion of public funding was spent on medicines for patients in Ireland, so it is not that we are not spending a huge amount of funding on drugs. This €3 billion out of the full budget represents almost €1 of every €8 spent by the State on healthcare. In the last three years, over €645 million was spent on medicines to treat patients with cancer, and investment in such treatments continues to be a priority. I take on board the statistics the Deputy articulated at the start, and I will bring them to the attention of the Minister.

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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I thank the Minister of State. I will point out a few things relative to the script she has there. The first thing is that we are spending €3 billion on drugs. That is a fact; I cannot dispute it. It is likely to be €4 billion before too long and it is going to continue to increase as the innovations in drugs and treatment continue to progress. That should be a good thing because it saves people going into hospitals or into long-term care, and it saves us by giving people the opportunity to be productive in society and partake if their ailment is identified early enough and they can get the appropriate treatment. It is just a fact that we are going to spend more and more on drugs into the future. That needs to be embraced because with regard to the innovation that is out there, it is eye-opening to see what we can do and what we can treat.

The issue I have regards the assessments. I am surprised that the Department did not make any attempt at putting its own figures with respect to the figures I quoted. The truth of the fact is it does not have them, or if it does have them it never discloses them. It is concerning to me that the Department of Health would not have access to those timelines. If the Department is going to dispute the timelines here by the EFPIA, I would like to think it has its own statistics and waiting times but it does not have them, and I find that very concerning.

The one big difficulty I have with this is that whether people in this House know it or not, we are actually overseeing the implementation of a two-tier health system by proxy. What I mean by that is I am lucky enough to have private health insurance, and there are people in this country today who, depending on their provider and the cover they have, can access these very expensive drugs. People on the public system, if those drugs are still awaiting reimbursement, cannot access those drugs and that is not a health system we should be standing over. That is why, in the programme for Government, we were happy to see the inclusion of early access programmes for certain drugs for certain cancer sufferers, and we got a commitment that the overall reimbursement process for drugs would be reviewed. The one thing I would ask the Minister of State to take away to the Minister, Deputy Carroll MacNeill, tonight is to ensure that the commitments in the programme for Government are initiated now, and we are not having this conversation in two years' time again, trying to instigate them at that point.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy. The level of investment in recent years is unprecedented in supporting patients through the availability of the latest and wide-ranging medicines. Since 2020, €128 million has been made available to fund access to 217 new medicines, including 74 for treating cancer and 57 for treating rare diseases. For 2025, an additional €30 million will be made available to enable access to new medicines. This will come directly from efficiencies to be achieved by the HSE.

It is important to go back to the statement that once the company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country or countries of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages and that has to be taken on board.

Second, the pharmaceutical industry must also play its part. Ireland is open for business and encourages timely applications for reimbursement with reasonable pricing offers. We are confident this will support improved access to medicines in Ireland, including in the area of oncology. I thank the Deputy and I will bring what he has said back to the Minister.