More efficient way of of assessing new drugs needed, says Tánaiste

By Bairbre Holmes, Press Association

A row over the length of time it is taking for a drug to treat a rare neurological condition to be approved shows the need for a review of how medicines are assessed in Ireland, the Tánaiste has said.

Opposition leader Mary Lou McDonald raised the issue of Skyclarys, which is used to treat Friedreich’s Ataxia, in the Dáil during Leaders’ Questions on Thursday.

At a meeting on Tuesday, the HSE Drugs Group did not recommend the drug for reimbursement and instead referred it to an expert committee comprising of consultants and patient representatives.

McDonald described this as “one committee passing the buck to another committee, more delay, more time wasting”.

She said Skyclarys was approved by the EU Commission in 2024 and is available in France, Germany, Portugal, Italy, Spain and Czechia, as well as the UK, Canada and the US.

The condition of many of those with Friedreich’s Ataxia is deteriorating quickly, she told Simon Harris and said, “decisions have to be taken, and time is running out. You can fix this. You can bring the pace and urgency that’s necessary”.

She said she was “begging” Harris to intervene.

Responding, Harris said: “It’s not a question that the Government, or indeed our representatives through the HSE or clinicians, have been in any way dilly-dallying on this.”

He said the commercial proposal for Skyclarys’ use in Ireland was received on May 27th, and the expert committee now has a four-week deadline to reach a decision.

We do need to have a full root and branch review of how medicines are assessed in this country

“There’s mixed views on the science in relation to this,” he said.

“There are a number of European countries that have said no, there are some that have said yes.”

The rare diseases expert panel was set up to “give this every possible chance”, he added.

However, he said, “I take the point about timelines”.

Later, he said that sometimes delays “aren’t on the side of the state”.

He continued: “We do need to have a full root and branch review of how medicines are assessed in this country”.

Minister for Health Jennifer Carroll MacNeill is “committed to that”, he said, as “there has to be a better way and a more efficient way of assessing drug applications more generally, and we can return to that on this specific issue”.

Last month Carroll MacNeill said an end-to-end review of the pricing and reimbursement system will be carried out, starting this year.