Seán Ó Fearghaíl (Kildare South, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

1665. To ask the Minister for Health the reason for the shortage of certain medicines (details supplied); and if she will make a statement on the matter. [11508/25]

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

Thank you, Deputy, for your question in relation to shortages of medicinal products.

In order to facilitate an answer to your question, my Officials were in contact with our medicines regulator, the Health Products Regulatory Authority (HPRA).

Companies are required to notify the HPRA of medicine shortages or potential shortages impacting the Irish market.

Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot, has notified the HPRA of a shortage of Estradot 37.5 micrograms / 24 hours, transdermal patch and Estradot 75 micrograms / 24 hours, transdermal patch. These shortages were notified on the 5th of February 2025 and the 22nd of January 2025 respectively and are due to a manufacturing delay which is impacting multiple countries.

The HPRA have been notified by Sandoz Pharmaceuticals d.d of an expected return date, reported as the 20th of March 2025 for Estradot 37.5 micrograms / 24 hours, transdermal patch and the company is currently unable to advise on an anticipated return date for Estradot 75 micrograms / 24 hours, transdermal patch.

Haleon Ireland Limited, the company responsible for supplying Caltrate 600 mg/400 IU, Film-coated Tablets, has confirmed that there are no current supply issues with this product. Haleon Ireland Limited did however notify the HPRA of a recent shortage of Caltrate 600 mg/400 IU, Film-coated Tablets due to an unexpected increase in demand and a quality issue, impacting Ireland only. The HPRA has been notified by Haleon Ireland Limited that Caltrate 600 mg/400 IU, Film-coated Tablets has returned to supply since the 26th of February 2025.

The HPRA maintains a shortages list on its , which is updated daily as we receive information from the companies that place medicinal products on the market.

Ennogen Healthcare (Europe) Limited the company responsible for supplying the Uniphyllin portfolio of medicines has informed the HPRA that it does not presently market authorised Uniphyllin medicines in Ireland.

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

Ireland has a multi-stakeholder Medicines Shortages Framework in place, operated by the 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.