Dáil Éireann Debate, Wednesday - 15 July 2026
369. Deputy Pádraig O'Sullivan asked the Minister for Health whether she will bring forward legislative proposals to permit therapeutic substitution by pharmacists during medicine shortages; and if she will make a statement on the matter. [53754/26]
View answerMy Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly 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.
In addition to this, there are Legislative initiatives in development in 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 establish the steps needed to progress this, including an assessment of any potential patient safety risks.
