Dáil Éireann Debate, Wednesday - 15 April 2026
360. Deputy Ken O'Flynn asked the Minister for Health whether her Department has established a formal, national definition of “clinically critical medicines”; and if so, the criteria used to determine such classification; and if she will provide the current list of medicines designated under this definition. [27514/26]
View answer361. Deputy Ken O'Flynn asked the Minister for Health whether a formal risk-assessment or stratification model is in place to categorise medicines by clinical criticality and patient safety risk; and the methodology used within such a model; and if she will outline how it is applied in practice across the health service. [27515/26]
View answer369. Deputy Ken O'Flynn asked the Minister for Health the preparatory steps that have been taken to align national policy with the forthcoming European Union list of critical medicines; and whether an interim national list is in operation pending the introduction of EU measures. [27523/26]
View answerI propose to take Questions Nos. 360, 361 and 369 together.
In the proposed revision of the EU Pharmaceutical legislation the European Commission has proposed further strengthening measures and specific initiatives, such as the introduction of the Union list of critical medicines and the requirement for medicine suppliers to have in place shortage prevention plans (‘SPP’). Such measures are anticipated to further improve supply chain resilience and promote continuity of supply. My department, together with the Health Products Regulatory Authority (HPRA), is committed to continuing its active involvement at European level to maximise the effectiveness of this work and translate it into tangible national improvements.
Several initiatives have been taken over recent years at a European level to improve security of medicine supply and address supply chain vulnerabilities that are common to multiple markets. These include an expansion of the mandate of the European Medicines Agency (EMA) to optimise the management and prevention of shortages at European level.
Addressing 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 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.
