Dáil Éireann Debate, Wednesday - 15 April 2026
366. Deputy Ken O'Flynn asked the Minister for Health whether national early warning or predictive monitoring systems are in place to identify potential shortages of clinically critical medicines in advance; and if she will outline the data sources and indicators used within such systems. [27520/26]
Amharc ar fhreagraIreland has a multi-stakeholder Medicines Shortages Framework in place, operated by our medicines regulator, the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages as they arise. Stakeholders in this framework include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies should notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current shortages on its website and is in regular contact with suppliers in relation to these shortages, with a view to minimising their duration and impact on patients. The webpage of the HPRA is updated daily as the HPRA receives new information related to ongoing and newly notified shortages. Shortages when published remain active until supply returns to an acceptable level to meet demand, irrespective of whether there is a suitable alternative supply available that is meeting that demand.
The Medicines Criticality Assessment Group (MCAG) is convened by the Department of Health and chaired by the Health Service Executive (HSE) to facilitate rapid assembly of relevant government and agency bodies to assess, address and resolve emerging medicinal product supply issues. Consequent to its deliberations and where the MCAG deems it necessary, the MCAG membership shall issue communication(s), to healthcare professionals and patients, among other actions. The Terms of Reference for MCAG is available on gov.ie.
