Dáil debates
Wednesday, 7 May 2025
Saincheisteanna Tráthúla - Topical Issue Debate
Medicinal Products
10:15 pm
Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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.
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