Dáil Éireann Debate, Thursday - 19 February 2026
637. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains a formal medicines supply resilience strategy addressing strategic stockholding, diversification of supply chains, early warning mechanisms and substitution protocols; if so, when it was last reviewed; and if she will outline the key policy measures currently in force [13763/26]
View answerMy Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, and mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.
Medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. It is a global health problem, not unique to Ireland, and increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months, and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.
To address these challenges in Ireland, a Medicines Shortages Framework, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health, has been established. This aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages across the health service as they arise. The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.
Additionally, within my Department a number of working groups have been established to specifically deal with medicine shortages. The Medicines Criticality Assessment Group (MCAG) is a collaborative working group of relevant government, regulatory and healthcare agency bodies that is convened by the Department of Health and chaired by the Health Service Executive (HSE) to facilitate ad hoc rapid assembly of nominated representatives to assess and address emerging human medicinal product (prescription and non-prescription) supply issues. MCAG was established in 2018 as part of a whole of government response to Brexit and has since evolved to its current form.
Following notification of a supply issue from a relevant health service stakeholder (DOH, HSE, HPRA and/or PSI) that is requiring more extensive and more immediate cross health-service input and is considered necessary to effectively prevent and/or mitigate a high impact supply issue, the Secretariat liaises with the Chair of the Group to convene an MCAG. This group will assist in the development of clinical guidance for mitigation of impact of specific medicinal product supply issues, as necessary, and where appropriate to do so. This workstream will be led by relevant HSE clinical personnel who will hold responsibility for final output.
The Strategic Medicines Access and Availability Group (SMAAG) is a working group established by the Department of Health in November 2025 to help shape national policy on medicines shortages, access and availability. The group will investigate, examine and pursue all appropriate measures that could improve the availability of medicines in Ireland by strategically addressing medicines shortages and gaps in availability, encourage an increase in the number of authorised and marketed medicines in Ireland and reduce our national reliance on Exempt Medicinal Products(EMPs).
In addition to this, there are legislative initiatives in development within the Department, via the Health (Miscellaneous Provisions) Act 2024, including Medicine Substitution Protocols, and reporting requirements for actors in the medicines supply chain. The Medicine Substitution protocols will act as an authorisation for registered pharmacists to supply an alternative medicinal product, for the medicinal product that is in short supply, without the need for a further prescription. The Department is liaising with relevant leads in the HSE to progress this, including an assessment of any potential patient safety risks.
