Dáil Éireann Debate, Wednesday - 15 April 2026
363. Deputy Ken O'Flynn asked the Minister for Health the governance structure underpinning the Medicines Criticality Assessment Group; the decision-making authority within that structure; and the level at which final determinations are made in relation to supply risk mitigation actions. [27517/26]
Amharc ar fhreagra364. Deputy Ken O'Flynn asked the Minister for Health whether formal escalation thresholds exist within the medicines shortages framework based on clinical risk levels; and if so, the criteria for escalation; and the actions triggered at each level. [27518/26]
Amharc ar fhreagra368. Deputy Ken O'Flynn asked the Minister for Health which body holds ultimate accountability for ensuring continuity of supply of clinically critical medicines at national level; and the oversight mechanisms in place to monitor performance against this responsibility. [27522/26]
Amharc ar fhreagraI propose to take Questions Nos. 363, 364 and 368 together.
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 enables collaborative work and system wide perspective on non routine, potentially high impact events.
Following notification of a supply issue from a relevant health service stakeholder (Department of Health, 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.
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.
