I propose to take Questions Nos. 1128, 1129, 1138, 1141 and 1142 together.
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.
Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.
Ireland has a multi-stakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders 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 are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current and resolved shortages of products containing salbutamol on its website.
Noridem Enterprises Limited has notified the HPRA of the shortages of Brodilaten 2.5 mg / 2.5 ml nebuliser solution and Brodilaten 5.0 mg / 2.5 ml Nebuliser solution. These shortages were notified on the 10/12/2025 and the 11/12/2025 because of an active pharmaceutical ingredient (API) shortage / unavailability in multiple countries. Both products have an expected return date of the 28/02/2026.
Teva B.V. has notified the HPRA of the shortages of Salamol Steri-Neb 2.5 mg / 2.5 ml nebuliser solution and Salamol Steri-Neb 5 mg / 2.5 ml Nebuliser Solution. These shortages were notified on the 03/04/2025 and the 11/07/2025 because of an unexpected increase in demand in multiple countries and a global manufacturing delay. Both products have an expected return date of the 16/02/2026
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. There have been several such shortages where the HSE has issued clinical guidance as a mitigation measure, including in this therapeutic area.
In the event that patients are unable to source a medicinal product due to supply constraints, they are advised to discuss possible alternatives with their healthcare professional pending the resumption of normal supply.
In terms of medical card holders, under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have also asked the HSE for an update in this matter.
The HSE has confirmed that they are aware of ongoing supply issues in relation to inhaled nebule presentations of short-acting bronchodilators including salbutamol. Reimbursement is supported for alternative exempt medicinal products of inhaled nebule presentations of short-acting bronchodilators under Discretionary Hardship Arrangements for individuals with a medical card and under Drugs Payment Scheme (DPS) for those with established DPS eligibility.
The provision of medicines which are not on the reimbursement list can be made by the HSE under Discretionary Hardship Arrangements for medical card holders. All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient. The processing of applications is a matter for the HSE.
The patient’s community pharmacy should contact the PCRS if they have any queries in relation to reimbursement of these alternatives.
