Dáil Éireann Debate, Thursday - 19 February 2026
609. Deputy Ken O'Flynn asked the Minister for Health whether her Department has conducted any value-for-money or cost-comparison analysis between maintaining automatic substitute reimbursement mechanisms during shortages and operating the current discretionary case-by-case approval model; and if she will provide details of any such analysis undertaken since 2020. [13658/26]
View answerMy Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.
Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.
Ireland has a multi-stakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders. Details of this framework can be found at: www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals/medicines-shortages
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market.
