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

I thank the Minister of State for the response. I am conscious it is not his responsibility or area of expertise but there are some things I have an issue with in the response. One is that the HSE has approved 52 new medicines, including Zolgensma. Many of these new drugs were approved through the Benelux arrangement the Minister of State referenced in his response. He went on to say about 97 new medicinal indications including treatments for rare diseases will be approved by the EMA in Europe in the next five years but Ireland's track record in this is pitiful. Of the last 47 drugs approved by the EMA, only eight have been approved here. I do not say lightly that we are laggards among our European counterparts, but we are. All the facts point to it.

Later, the response the Minister of State has references the €45,000 quality assisted life year, QALI, threshold and the fact orphan drugs do not have a specific pathway for reimbursement. That is precisely what my Bill, which was introduced here a number of months ago, aims to achieve. It would provide a specific pathway for orphan drugs to be assessed. We must look at other countries. The Swedes can do it properly, as can the Scots and the Danes. What I advocate in my Bill is no different to what those countries have implemented, and it has not broken the banks. Specific to my legislation is a reference that any drug approvals for rare diseases would have to be done subject to budgetary constraints. It is there in black and white. What keeps coming from the Department of Health is that this will weaken our hand at the negotiating table with pharmaceutical companies or that it will cost the State an arm and a leg. That is nonsense. I have said it here before and have no problem reiterating it.

I get frustrated because the most difficult conversation I have ever had with a person was sitting at that kitchen table, as I referenced. The waiting times I referenced earlier are fact. They are from a parliamentary question put by Deputy Michael Moynihan a number of years ago. I gave the statistic at the start about the number of children with a rare disease aged under five years who die, which is 30%. Every year lost negotiating and prevaricating around the price of a drug means lives lost.

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