Pádraig O'Sullivan (Cork North Central, Fianna Fail) | Oireachtas source

I thank everyone who has contributed on this debate. It is great to see that the Bill has universal support and I look forward to it going to Committee Stage. Deputy Colm Burke and our own Deputy Lahart are on the Committee on Health. They are passionate about this topic.

I will make a couple of comments in summary. There are a few inescapable truths. One is that these drugs are expensive. Of that, there is no doubt. The second inescapable truth is that we as a country make people wait much longer than they probably should, certainly compared to our European neighbours.

The Minister of State, Deputy Butler, has taken this debate on behalf of the Minister. In my opening speech, I referred to the fallacy of budgetary constraints, the concept that these drugs would be costly and that we would be opening a can of worms. That is precisely where I want this debate to move away from, as it is a fallacy. There is no truth to it and it is a myth. The Minister of State said: "The advice provided is that abandoning the methodology would potentially have added an additional €250 million cost over the next five years". I would love to see how that figured was arrived at. I imagine it assumes that all orphan drugs that went for reimbursement got approval. I am not asking for that, though. I know the process inside out at this stage. I know that not all orphan drugs get approval. That €250 million figure is not a true reflection and does not stand up to any scrutiny.

I agree with Deputy Cullinane on one point he made, in that this sector is moving at a fast pace.

My honest view is that this Bill is probably outdated already, insofar as it was initially put forward in 2018. I essentially replicated it, but in the meantime we have made significant progress in the area of genetics and gene therapy, for example. The Bill does not have those types of therapies included, and that is probably something that might emerge as a further amendment in the health committee. That is something I would welcome. Deputy Cullinane is correct in saying that this sector is moving fast. I hope the Bill will become legislation in a few years. There is no doubt that by the end of the debate, further provisions will be required.

I wish to put to bed the myth that if we abandon the €45,000 QALY threshold, costs are going to spiral out of control. We can look at a dozen countries across the EU that do not have that QALY threshold. I mentioned Sweden and Scotland, and Denmark is very similar to us in terms of population and size, but none of them operates a specific QALY threshold, be it for €45,000 or €100,000. They assess a drug on its efficacy and then they do a cost-benefit analysis in the process. All drugs get a fair chance. The fundamental issue here is that orphan drugs are not assessed as orphan drugs, which means if 1 million patients in a country need a new drug, there is a specific pathway for them, but as Deputy Colm Burke alluded to earlier, if there are ten or 20 patients needing a drug, obviously the cost will go up and there is no specific pathway or process for the drug to be analysed. It is analysed in the same way as a drug that is destined for 1 million patients, which is complete madness.

There should be a specific pathway, criteria and timelines because the reality, as per Deputy Michael Moynihan's parliamentary question, is that it takes 1,361 days on average for a drug to come into someone's possession. A total of 426 days are required for the initial application. When we drill down into the 426 days, any of the companies that are applying for reimbursement for orphan drugs know the answer to the application process already. They are going to be over the €45,000 threshold. It makes no sense for them to be assessed in the same way as a drug destined for 1 million patients. It is completely bonkers. In that respect, what we are trying to do here is to provide a statutory footing for orphan drugs. They do not have that at the moment. The intention is to provide hope for patients in the future that the drugs they require will be assessed on their individual merit and not with mainstream drugs or illnesses. That is the crux of the matter.

Other speakers have referred to the importance of pharmaceutical companies to us as a country. Deputy Colm Burke mentioned that nine of the ten largest pharmaceutical companies in the world are based here. It is unfortunate that drugs being made in Ringaskiddy, Little Island or wherever it might be are potentially unavailable here, but we are exporting them all over the Continent.

The Bill gives people a definite pathway and it also gives them hope and opportunity. I had only been a Deputy for two months when I had the hardest conversation I ever had around a coffee table outside Cork city. I was told that a person was one of a couple of dozen people in the country that suffers from amyloidosis. The Minister of State, Deputy Butler, mentioned it earlier. This person had already had a relative die of that disease. In the meantime, the person knew that for every year they did not have the drug, it was taking years off their life. Thankfully, after four years the system approved the drug, patisiran, to specifically treat amyloidosis. I befriended a number of people who suffer from the condition, which is especially prevalent in Donegal of all places. It is connected with a specific gene and a number of related families suffer from this very specific illness. There is relief for them now that they have a life and access to a drug.

As Deputy Gould mentioned, many people cannot afford these drugs. That is the simple reality. I know the detractors of the Bill will say that it will open a can of worms, as has been said previously, and that a bottomless pit of money will be required that we cannot provide. There is a specific provision in the Bill stating that it must operate within budgetary constraints. Nobody is suggesting for a moment that it would be otherwise. If a drug is effective and, following intense negotiations with a company, the State can get it at a reasonable price, it should be made available. That is what this Bill provides for.

Ireland is probably three to five years behind most of its leading counterparts in this regard. We are playing catch-up. Realistically, all the quantitative and qualitative data are already done in European countries. Those pharmaceutical companies will use the same data when they are selling these products to us. The reality is that because we are so far behind, we know the drugs work. If we were ahead of the game, we would be taking a greater risk, but we are not. We are years behind. In that respect, we are playing catch-up. We know that many of the drugs that will be sought for reimbursement work because they are being used across the Continent. The Bill enshrines in legislation that orphan drugs will have a specific pathway. That is all we can give to people. We cannot expect the Department to give drugs if we are dubious about their efficacy, but because we are so far behind, we know the drugs work elsewhere and are enhancing and improving people's lives all across the Continent.

I thank everybody for their support. I thank the Ministers of State, Deputies Butler and Rabbitte, as well. I met the Minister, Deputy Stephen Donnelly, last week on a Zoom call and I am grateful for his support of the Bill. I look forward to the Committee Stage debate on the Bill.

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