Dáil Éireann Debate, Thursday - 19 February 2026
607. Deputy Ken O'Flynn asked the Minister for Health whether national clinical governance guidance has been issued by her Department or by the HSE in respect of reimbursement decision-making during shortages of time-sensitive respiratory medicines, including salbutamol nebules; whether such guidance addresses continuity of care, risk mitigation, and equity of access; and if she will make a statement on the matter. [13656/26]
Amharc ar fhreagraMy 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 Medicnes shortages on the HPRA website (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.
The HSE has advised that during a shortage of a medicine that medicines not on the formal Reimbursement List are considered on an individual patient basis. Community pharmacy contractors can contact PCRS Pharmacy Function Unit regarding reimbursement support. Individual applications can also be submitted by the dispensing pharmacy to: PCRS.IndividualRequest@hse.ie
Community pharmacy contractors can also submit queries relating to reimbursement of Exempt Medicinal Products (EMPs) to: PCRS.ExemptMed@hse.ie
