Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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2575. To ask the Minister for Health the steps being taken to address the growing concern re the shortage of salbutamol. [40971/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly managing and mitigating medicine shortages is the subject of several workstreams across the Department and wider health service.

Medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. It is a global health problem, not unique to Ireland, and increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months, and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.

Ireland 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.

There has been intermittent supply of some salbutamol presentations over recent years, not just in Ireland but also in other countries. All shortages, including persistent shortages, are managed via the national Medicines Shortages Framework (MSF), coordinated by the HPRA. The MSF involves a multi-stakeholder approach to handling shortages of human medicinal products, and the HPRA engages with all such stakeholders, in all cases where it is required to, until such a time it is established that there is sufficient supply of medicinal products to meet the demand and continuity of care. In case of shortages with a significant public health impact, the HSE can issue clinical guidance to healthcare professionals, where appropriate, to mitigate the impact of a shortage.

The HPRA has been notified of current shortages of the following presentations that contain salbutamol as an active ingredient (includes where the presentation is marketed as a combination product):

• Teva B.V., the company responsible for supplying Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution, has notified the HPRA of a shortage of Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution due to an unexpected increase in demand impacting multiple markets. The company currently estimates that resupply will occur in November 2025.
• Teva B.V., the company responsible for supplying Salamol Steri-Neb 5mg/2.5 ml Nebuliser Solution, has notified the HPRA of a shortage of Salamol Steri-Neb 5mg/2.5 ml Nebuliser Solution due to a global manufacturing delay. The company currently estimates that resupply will occur in November 2025.
• Teva B.V., the company responsible for supplying Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution, has notified the HPRA of a shortage of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution due to an unexpected increase in demand impacting globally. The company currently estimates that resupply will occur in November 2025.
• Teva B.V., the company responsible for supplying Salamol Easi-Breathe CFC-Free Inhaler 100 micrograms Pressurised Inhalation (Suspension), has notified the HPRA of a shortage of Salamol Easi-Breathe CFC-Free Inhaler 100 micrograms Pressurised Inhalation (Suspension) due to a global manufacturing delay. The company currently estimates that resupply will occur in early October 2025.