{"id":495079,"date":"2026-06-11T23:15:08","date_gmt":"2026-06-11T23:15:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/495079\/"},"modified":"2026-06-11T23:15:08","modified_gmt":"2026-06-11T23:15:08","slug":"minister-details-plan-to-review-system-for-approving-new-drugs","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/495079\/","title":{"rendered":"Minister details plan to review system for approving new drugs"},"content":{"rendered":"

Minister for Health Jennifer Carroll MacNeill says she has signed off on a plan for an end-to-end review of Ireland’s system for approving access and funding for new drugs and medical treatments.<\/p>\n

The announcement follows sustained criticism from families affected by rare diseases, who say that access to treatments can take too long, as degenerative conditions worsen.<\/p>\n

Speaking on RT\u00c9’s Prime Time, Minister Carroll MacNeill said she approved the tender details for the review last week and said it would examine how the system could be made more efficient.<\/p>\n

“The system needs to be improved. I’ve just begun a whole end-to-end review of how this system works and how we can make it tighter and how we can make it better on the HSE side,” the minister said.<\/p>\n

The intention to undertake such a review was included in the 2025 Programme for Government.<\/p>\n

Minister Carroll MacNeill said she expected the review to take around six months and that it would form part of wider efforts to ensure medicine reimbursement decisions are made within 180 days of an application being submitted by pharmaceutical companies.<\/p>\n

The minister acknowledged that delays can occur on both the HSE and pharmaceutical sides but said additional resources had been put in place to speed up assessments and existing processes.<\/p>\n

She added that the Government is also working on an early access programme for rare disease treatments, aimed at helping patients access medicines sooner while reimbursement processes are ongoing.<\/p>\n

The review comes as families affected by Duchenne muscular dystrophy (DMD) welcomed a recommendation to approve Givinostat, a drug that could slow the progression of the condition.<\/p>\n

The HSE Drugs Group recommended the drug for approval on Wednesday, bringing children with DMD a step closer to accessing the medication in Ireland.<\/p>\n

Families affected by DMD have run a high-profile campaign for access to the drug, supported by several members of the Oireachtas, including Fianna F\u00e1il TD P\u00e1draig O’Sullivan. DMD is a muscle wasting disease which predominantly affects young boys.<\/p>\n

The recommendation to approve Givinostat still needs to be considered by the HSE’s senior leadership team as part of the finalisation of the approval process.<\/p>\n

When asked when patients could expect to receive the drug, Minister Carroll MacNeill said “I very much hope that it is weeks,” adding that timelines will depend on supply and final approval steps.<\/p>\n

Among those who have been campaigning for access to the treatment is the family of nine-year-old Archie Ennis from Tallaght, Co Dublin. Archie was diagnosed with DMD two years ago after his parents noticed he was struggling to climb stairs.<\/p>\n

Read more: ‘Give us some hope’ – Families seek access to rare disease drugs<\/a><\/p>\n

His mother, \u00dana Ennis, told Prime Time that while she welcomed the recommendation to approve Givinostat, she said wider concerns remain about the system for drug approval.<\/p>\n

“The system for rare diseases in this country is shocking. Our campaign is not going to stop at Givinostat. We want to fix the system.” Ms Ennis said, “and we don’t want any family to go through what we have been through.”<\/p>\n

Ms Ennis said families are now focused on ensuring that all children who could benefit from the drug are able to access it.<\/p>\n

\"\u00dana
\nArchie Ennis’ mother \u00dana said the system for rare diseases in Ireland is “shocking”<\/p>\n

She called on the HSE to adopt eligibility criteria similar to that used in Northern Ireland, where children can access Givinostat if they are able to walk or stand, either independently or with support.<\/p>\n

“We cannot stress the urgency to get this medication into our homes as soon as possible, because this time last year, we had boys with us that were walking. They have now lost the ability to walk, and they cannot access this medication,” Ms Ennis said.<\/p>\n

“There’s 120 boys approximately in Ireland with Duchenne, and we want to give it to as many of them as possible,” she added.<\/p>\n

\"Archie
\nArchie Ennis was diagnosed with DMD two years ago<\/p>\n

Ms Ennis said her son Archie had taken the news about Givinostat in his stride. Asked about his reaction, she said “He was like: ‘Ok Mammy, can I go on my playdate now?’<\/p>\n

“He’s sheltered in all of this,” Ms Ennis added, “and I want to keep him my little boy.”<\/p>\n","protected":false},"excerpt":{"rendered":"Minister for Health Jennifer Carroll MacNeill says she has signed off on a plan for an end-to-end review…\n","protected":false},"author":2,"featured_media":495080,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[61,60,43],"class_list":["post-495079","post","type-post","status-publish","format-standard","has-post-thumbnail","category-ireland","tag-ie","tag-ireland","tag-news"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/495079","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=495079"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/495079\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/495080"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=495079"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=495079"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=495079"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}