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Dáil
‹ An tOrd Gnó - Order of Business

Drug approval delays

Summary

Colm Burke contrasted Ireland’s slow medicine approval times with Denmark’s and said patients were waiting too long. The Minister said dedicated funding had been secured for new medicines and he would ask the Health Minister to update the Deputy.

The European Federation of Pharmaceutical Industries and Associations produced a report which suggests that in Denmark from the date that a drug is approved by the European Medicines Agency, it will be available to people in the country within 176 days. The average time for this to happen in Ireland is 541 days. Orphan drug approval in Denmark takes 249 days whereas in Ireland it takes 870 days. The National Centre for Pharmacoeconomics, NCPE, is doing a good job in assessing the medication, but it appears that we are not able to assess them or send them on to the next step for approval under the drugs refund scheme in a timely manner. Will serious consideration be given to reviewing the process that is currently in place? The health committee produced a report back in 2018 but it has not been acted on. I ask that this would be reviewed.

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Catherine Connolly An Leas-Cheann Comhairle Independent

The Minister to respond.

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There is a huge delay in the availability of drugs.

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We have now provided a dedicated stream of funding for new medicines to be progressed through the system and, ultimately, to be made available to the patients who are impacted. That has been broadly welcomed by the industry. That is ring-fenced funding that has been secured. As the Deputy said, the NCPE does its job competently. I am aware of the committee report to which he referred, and a Private Members’ Bill that was tabled by Deputy Pádraig Ó Sullivan. I will ask the Minister for Health and come back directly to Deputy Burke on the up-to-date position.

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