Dáil debates

Wednesday, 18 June 2025

Ceisteanna ar Pholasaí nó ar Reachtaíocht – Questions on Policy or Legislation

 

6:10 am

Photo of Colm BurkeColm Burke (Cork North-Central, Fine Gael)

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?

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