Delay in medicine approvals
Deputy Burke said Ireland's medicine approval process is too slow, especially for cancer drugs, and many EMA-approved medicines never get an Irish application. The Taoiseach said spending is already high, acknowledged delays, and said timelines should be improved.
The average time from when a medicine is approved by the European Medicines Agency to it being available in Ireland is 617 days. Between 2004 and 2025, 402 new medicines were approved by the European Medicines Agency, of which 71% had applications made in Ireland. In other words, for 117 medicines approved by the EMA, no licence or approval has been applied for here. It is the whole delay in the process. I fully accept additional staff are being taken on, but the period the process takes is far too long, especially for new cancer drugs, which are available at European level but not in Ireland. We need to fast-track them. What action will be taken, especially to make cancer drugs available in an early timeframe?
Comment on this
First of all, I think about €3 billion is now being spent on medicines. I can clarify that. There is an ongoing issue, and there will be, because of the rapidity of discovery and new drugs coming onto the market. Ireland has a very significant pharmaceutical presence. I have engaged with most of the CEOs of the pharmaceutical companies in respect of tariffs, trade and so on and domestically, the European Public Health Alliance, EPHA, has made representations in respect of this, as have patients, particularly as regards rare diseases and orphan drugs. The Deputy, Deputy Pádraig O'Sullivan and others have been looking at this for quite a while. The process we have through the pharmaceutical centre, headed by Professor Michael Barry, is diligent and so on. We need to look at it in terms of rare drugs, rare diseases and orphan drugs in particular, and new discoveries as well.
