Medicinal Products
Seanad Éireann — 2026-03-03
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Jennifer Carroll MacNeill (FG), Dún Laoghaire

The Department would always be happy to speak with any other parties in the pharmaceutical sector. It is important to point out that the 180-day period is for the decision from the application through the HTA process to reimbursement. I know there is a bit of a disconnect here. Because something has been EMA-approved, there is an assumption that that consideration is happening in the HSE. That only happens if the drug company makes an application in Ireland and that is not always the case for a lot of different reasons. For example, in addition to the commitment on pricing and reimbursement decisions within 180 days, the IPHA member companies will aim to shorten their timeline to submit reimbursement applications in Ireland to within six months of formal authorisation by the EMA. That is another important part of the timeline.
Again, the State will always have to be acutely conscious of the pricing decision and that pricing decision is going to come at an earlier stage. The State has to have the opportunity to negotiate on behalf of the State and the taxpayer to get the best value. We want to make sure we have access to many medications for all forms of disease, but especially rare diseases, as part of the rare disease strategy.
It is very important that I set those pieces out. It is for the company to make the application. It is for us to respond to that in an appropriate and timely way. There is a price calculation at the end of that. I have set out the broad budgetary parameters around what we are spending on drugs at the moment. Of course, there is not a single person in the Oireachtas who does not want to support every person in the State. I am simply setting out some of the realities around some of the decisions that will ultimately have to be made at a later stage.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-03-03/debate/main
Retrieved: 2026-08-14T04:54:42+00:00
Sitting date: 2026-03-03