Rose Conway-Walsh: Urgent call to approve Skyclarys now
Rose Conway-Walsh calls for urgent access to Skyclarys for people living with Friedreich's ataxia and urges reform of Ireland's medicines approval and reimbursement process. Speaking in the chamber, she highlights EMA approval on February 24 and warns that bureaucratic delays cost patients irreplaceable function and time.
All-island approach and clinical trials.
Rose Conway-Walsh argues for an all-island approach to orphan drugs and clinical trials, saying a larger population would make trials more efficient and strengthen negotiating leverage. She links this to discussions under the Good Friday Agreement on an all-island national healthcare system.
The human cost and Skyclarys approval.
She outlines the human impact: more than 200 people in Ireland live with Friedreich's ataxia and families face irreversible loss while waiting for HSE funding decisions. Skyclarys was approved by the European Medicines Agency on February 24 and is available in several countries, yet access in Ireland remains delayed.
International comparison and backlog.
Conway-Walsh notes Ireland ranks 23rd out of 27 EU countries for the speed of rare disease reimbursement and says that ranking is unacceptable. She welcomes the recent reimbursement decision for Givenstat but warns many families remain trapped by slow processes.
Demand for systemic reform.
While she acknowledges the Minister has begun reforms, she insists six months can be too long for people with progressive degenerative conditions. She presses for an urgent decision on Skyclarys and fundamental reform of the entire approval and reimbursement pathway so families do not lose more time.
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Go raibh maith agat. I was really pleased to see this on the agenda. It's very important that we have this discussion in the chamber today because it really matters. And first to say overall on orphan drugs and clinical trials and indeed having that negotiation power to lever for the leverage that we need. I think it's really important that we address this on an all-island basis, that we have an all-island system because we've been looking at this within the Good Friday Agreement as well in terms of an all-island national healthcare system and it's clearly coming through that were we to have an increased population for all of the island that it would make it much easier and much more efficient to have those clinical trials. So I think it's important to note that going out from here today. Now Minister I want to raise the urgent need for access to SkyClars and I know it's been raised many times in the chamber here. I was watching in on the screens but there's over 200 people living with Friedrich's Anataxia in Ireland and for those diagnosed with this devastating rare condition, this drug represents far more than another medicine. It offers hope for slowing progression, preserving mobility and maintaining independence and giving families precious time together and yet many families in Mayo and across Ireland are forced to watch their loved ones deteriorate while waiting for the decision on funding through the HSE and every month that past passes means a lost function that can never be regained and time matters enormously for people with progressive degenerative conditions. So SkyClars was approved by the European Medicines Agency on February 24 and is available to patients in the US, in the UK, in France, in Germany and in Austria and in other countries and meanwhile here in Ireland we continue to lag behind. We rank 23rd out of 27 EU countries for the speed at which we reimburse treatments for rare diseases and that is simply not good enough. Countless families in Mayo and indeed many other diagnosed themselves have contacted me directly pleading for SkyClars to be approved. One email came from a 32 year old man who has lived with Friedrich's Anataxia his whole life and he's been in a wheelchair since he was 17. Now he and his family should not have to spend their days campaigning, fundraising and begging for access to medicine that could change the course of his illness and Friedrich's Anataxia is only one example. Boys living with Duchenne muscular dystrophy who are waiting over a year for a decision regarding Givenstat only received the positive news last week that this drug would be reimbursed and I certainly welcome that but there are so many families trapped in similar situations while bureaucratic processes drag on. So Minister we need an urgent decision around SkyClars but beyond that we need fundamental reform of the entire medicines approval and reimbursement process. I'm glad the Minister has started that but six months is a long time for some of these families.
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