Dáil Éireann Debate, Wednesday - 15 April 2026
362. Deputy Ken O'Flynn asked the Minister for Health whether respiratory emergency medicines, including salbutamol nebules, are classified as clinically critical within any national prioritisation system; and if she will detail the specific safeguards applied to ensure continuity of supply for such medicines. [27516/26]
View answerIreland 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.
Under 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.
