I now call Deputy Cullinane.

Sentiment score: 0.00

I think it was five weeks ago the Tánaiste suggested we do these statements and I commend him for that. I thank the Minister for being here. We have had many a discussion over the 18 months since the Minister was appointed. I wish to start by commending her. She has showed an awful lot of interest in this area since she has taken up office; far more, than many of her predecessors of the ten or 15 years prior, I might add. I commend her for that. The news of the review was kind of lost last week with the whole reimbursement or the positive recommendation of givinostat, which was obviously very welcome. It is not fully there but it is a positive recommendation nonetheless. What got lost in that was that the Minister had started this end-to-end review. This was a programme for Government commitment, as she alluded to in her speech and it is something that I and colleagues in my party have long asked for. We chased, harassed and harried our previous colleague, Stephen Donnelly, in relation to such a review and could not get it over the line. I genuinely give the Minister honest praise for that. It is appreciated by the families concerned at the centre of these campaigns. I do not want to repeat a lot of what was said. We all have constituency clinics and meet patient groups and people who have these rare diseases. They rank amongst the hardest stories I have listened to in my seven years up here. Many people will be familiar with Friedreich's ataxia, which I know the Minister obviously cannot speak about today in any great detail. The heartbreaking stories of those families and individuals such as Craig Coady and Emily Felix have been referenced here, as have those of many people we have brought into the House. What those people have to go through is dehumanising in a way. They have not had the best luck in the world with the disease they were diagnosed with, and to compound that further we have a system that unfortunately nearly encourages them to go on "Prime Time", "The Claire Byrne Show" and come in here and bare their souls to us and to the nation. To me that is fundamentally wrong, but, nonetheless, they felt they had to do it. I am heartened in the last few weeks with the progress on givinostat, as I have said. I am not the most religious person in the world but I am saying prayers every night before I go to bed in relation to the Skyclarys drug, which, despite what was said earlier, will be at the next drugs group meeting in July. There is also an attempt to bring that meeting forward. It is incredibly difficult. I am encouraged by the Minister's words on this review when she stated that: The aim of this work is clear: to identify where delays arise, where processes can be streamlined, and how we can ensure that decisions are made as efficiently and transparently as possible, while maintaining the necessary rigorous clinical and value assessments. That is fine. That is good. We have already had the transparency piece answered by Mazars. Mazars was a bit of a letdown for me and for many other people involved in the campaigns over the years. It solely and exclusively dealt with transparency. It has achieved an awful lot in that regard, but the challenge is around the process. Back in 2021, I published a Bill which would provide a separate pathway, like other people have referenced here. I do not think any system - I referenced this when I was on "The Claire Byrne Show" recently - that assesses a cough syrup or a medicine for migraines should be the same one that is used for these high-tech drugs. It makes no sense. The implementation of a quality threshold per quality-adjusted life-year added is €45,000. We know these drugs are going to cost in excess of that. Again, adherence to that in the assessment needs to be reviewed. I will not give the Minister a lecture about it because the review will be the review and she will have all the professionals in the country feeding into it. I do hope it differs from Mazars and that it provides a meaningful review and not something tokenistic. Mazars was the provision of an online transparency tracker and that was kind of it. If it is tokenistic like that, then unfortunately it will not have my support. However, I am optimistic because the Minister has approached this in a very forthright manner and, as such, I hope this will be a fruitful review. I get very frustrated listening to people from within the Department of Health appearing on radio and TV justifying delays. As the Minister rightfully said, in the case of givinostat, she was able to knock heads together, reduce timelines and get people around the table. That did cut some of the waiting times in comparison with other medicines. The biggest delay in the system is the health technology assessment, HTA, and the negotiation piece, and there is nothing to stop us having that negotiation piece while people are accessing medicines. That can happen retrospectively and that also needs to be looked at as part of any review. It happens in other countries. There is also the possibility of burden-sharing and risk-sharing with drugs. Again, I hope that will feed into the review. Many other countries do it. If a drug is effective, then a company can get reimbursed. If a drug is provided and it is not effective, the company gets a reduced amount or does not get reimbursed at all. Schemes like that need to be looked at because the fundamental thing here is to try to get medicines to people as quickly as possible. However, my concern is that the argument of the rare disease drugs and the new cancer drugs is getting lost in that €4 billion. The new drugs budget typically ranges from between €20 million and €50 million per annum over the last few years. I am saying it and nobody has contradicted me. If the Minister has evidence to the contrary, I would like to see it or hear it. That represents less than 1% of the total drugs budget and for me that is not a meaningful apportionment of the existing drugs funding that is there. If clarity could be brought to me on that, I would appreciate it. I wish to speak about the delays. Yes, the HSE is to blame for some of the delays. Probably more often, drug manufacturers are to blame. That needs to be acknowledged. It also needs to be acknowledged that many manufacturers do not want to come here not just because it is a small market but because they know they are going to feed into a system that will, as was alluded to earlier, take between five and 800 days in going through a HTA predominantly and a reimbursement process that is not fit for purpose. I do not blame them if they go to Romania, Slovakia and Slovenia. We are not talking here about France, Italy and big countries. We understand why manufacturers go to those bigger markets, but there are other smaller countries across Europe which have a higher proportion of reimbursed drugs than we do. That is a fact. The number increased recently. I acknowledge that we have reimbursed the bones of 50 drugs, give or take, over the last three years, which was a dramatic increase on the previous decade. However, it must also be said that only 30% of all EMA-approved drugs in Europe are available here, compared with an EU average of 45% or thereabouts. Even on that 15%, if we could just get ourselves on a par with our European counterparts we would be setting the bar quite high. I would like to see that happen. The reason I became involved in rare diseases six years ago is that I met a constituent and supporter of mine who was diagnosed with a disease called amyloidosis. It was a very rare genetic disease that predominately affected people in Donegal. This poor man below in Cork, due to his genetic history, was unfortunately diagnosed with it. That is how I became involved with it. We lobbied for a drug called patisiran at the time and we were successful in that. However, as I said at the start, I think it is dehumanising, whether it is amyloidosis, Friedreich's ataxia or Duchenne muscular dystrophy. It is dehumanising that we put people on that platform. I call it Groundhog Day. As I said to the Minister's colleague Deputy Aird when he first approached me about a constituent of his, this is just going to be repeated. All of the eggs are in the basket of this review. When this review is done, it will probably be the last attempt at a review for the next five or ten years. I really do hope it is meaningful and thorough. I will leave it on a positive note. I complimented the Minister at the start. She has gone above and beyond. She has met people privately in a personal capacity. She has met the families who are at the core of it. She said that the whole thing here is to provide hope. I know she has children. I also have children. Most people in this Chamber today have children. I always put myself in the position of their parents when they are fighting for these medicines and treatments. We would do anything for our children. Everybody in here would. We cannot blame the parents who are involved in these campaigns for doing the same. All the eggs are in the basket of this review. I hope there will be a positive outcome in the next six to nine months that gives people real hope.

Sentiment score: 0.09