Minister for Health Jennifer Carroll MacNeill has agreed to reform the medicines approval process to make new drugs available more quickly to Irish patients.
In a framework agreement with the Irish Pharmaceutical Healthcare Association (IPHA) – which represents all the drug developers operating in Ireland – the Minister agreed to put in place a “structured process towards achieving a 180-day timeline” for decisions on whether to approve a medicine for use in the Irish market and at what price.
A survey published by the industry body in 2024 found that it was taking 729 days, or two years on average, to get from application for reimbursement to the medicine being available in Ireland.
That is four times longer than the target set down in Irish legislation.
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The IPHA said it believed the new four-year framework would allow new medicines reach patients faster and was a positive step in supporting the life sciences industry in Ireland, establishing “a practical framework of process reforms to drive measurable improvement over its lifetime”.
It said the Minister’s assurance that the agreement should address “the explicit aim of achieving the timelines set out in legislation had been critical to the successful outcome of takes between the two sides.
“This marked the first time a Minister for Health confirmed a policy commitment to achieving the timelines in the 2013 legislation and is now the basis for this new agreement,” Ipha said.
Ms Carroll MacNeill said: “The agreement in principle with Ipha represents a major step forward in improving access to medicines for patients in Ireland.”
She added that it struck a balance between fostering innovation and maintaining financial sustainability.
The State spends about €3.3 billion a year on medicines, accounting for just over 13 per cent of overall health spending.
The frameworks signed by the Department of Health with IPHA and Medicines for Ireland, which represents manufacturers of generic off-patent medicines, are also designed to improve security of supply, reducing the risk of medicine shortages that have been an issue in recent years.
“Today’s announcement sends a strong message to patients and innovators that Ireland is a positive environment for industry that rewards innovation, affordability and the stable supply of generic and biosimilar medicines for the benefit of Irish patients,” the Minister said.
The two sides said they would work to complete the final wording of the four-year agreement on medicine pricing and supply over the next months.
