Ruth Coppinger (Dublin West, Solidarity)
Link to this: Individually | In context

2065. To ask the Minister for Health the steps being taken to address the lack of supply of a medicine (details supplied); and if she will make a statement on the matter. [44571/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

However, medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Issues surrounding security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years. The causes of such supply issues are multifaceted, ranging from supply chain issues, perennial shortages of raw materials, increases in demand and manufacturing delays.

Medicines shortages are managed through the Medicines Shortages Framework and immediate actions are taken by relevant stakeholders to mitigate the impact on patients. 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 and ipratropium 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.

As of 8th August 2025, the HPRA has not received any notification of a current shortage of products branded as ‘Atrovent’. The HPRA has been notified of current shortages of the following presentations that contain salbutamol and/or ipratropium 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 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 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 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 due to a global manufacturing delay. The company currently estimates that resupply will occur in early October 2025
• Teva B.V., the company responsible for supplying Ipratropium 250 micrograms / ml nebuliser solution (250mcg presentation), has notified the HPRA of a shortage due to a global manufacturing delay. The company currently estimates that resupply will occur in January 2026.
• Teva B.V., the company responsible for supplying Ipratropium 250 micrograms / ml nebuliser solution (500mcg presentation), has notified the HPRA of a shortage due to an unexpected increase in demand impacting globally. The company currently estimates that resupply will occur in January 2026.