Dáil Éireann Debate, Wednesday - 15 April 2026
365. Deputy Ken O'Flynn asked the Minister for Health whether minimum stockholding requirements or buffer stock policies are in place for medicines deemed clinically critical; and the basis on which such levels are determined; and the mechanisms used to monitor compliance. [27519/26]
View answerAddressing medicines shortages is complex and requires input from multiple stakeholders. A Medicines Shortage Framework (MSF) has been in place since 2018 when the Department requested that the Health Products Regulatory Authority (HPRA) assume responsibility for its coordination. Since its inception, the framework has been of enormous benefit nationally. It has served to avoid the occurrence of potential medicine shortages and, where they have occurred, ensured appropriate mitigation is in place.
It is acknowledged that medicine shortages, when they occur, can be a challenge for patients and healthcare professionals. Each medicine shortage does not represent a defined risk to patients, and not all medicines shortages have the same potential impact on patients. In the case of medicines that are used most often in Ireland, there are typically multiple forms, strengths, brands, and generic medicines available from various sources.
Where some individual medicines are in short supply, alternative options such as alternative strengths, brands, and generic medicines remain available to ensure continuity of treatment. When a notification of a shortage is submitted to the HPRA an impact assessment is carried out and combines two main considerations - the availability of therapeutic alternatives and the expected impact on patient. In some cases where the medicine initially prescribed for the patient is unavailable, patients may be switched to a suitable therapeutic alternative following appropriate consultation with a healthcare professional. Regardless of patients being treated with suitable alternatives – a different brand for example – the shortage of each individual medicine will remain listed until supply returns to an acceptable level. The notification form also provides for a proposal from the MAH to handle a shortage, which may range from minimal activity in the case of low impact shortages, to a detailed management plan for high impact shortages.
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. Further detail on the scope and objectives of MCAG is available in a Terms of Reference (ToR) document on gov.ie.
