Sinéad Gibney (Dublin Rathdown, Social Democrats)
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796. To ask the Minister for Health for an update on the issue of hormone replacement therapy (HRT) medication shortages; the steps her Department is taking to address these shortages and mitigate the disruption to those who need HRT medication; and if she will make a statement on the matter. [13900/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Thank you for you query in relation to shortages of hormone replacement therapy (HRT) products.

The 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.

In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify our medicines regulator, the Health Products Regulatory Authority (HPRA) of medicine shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current and resolved 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.

Persistent medicinal product shortages across this therapeutic area (HRT) have been managed and continue to be 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 this is necessary, 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. There have been a number of such shortages where the HSE has issued clinical guidance as a mitigation measure, including HRT (see HSE Medicines Management Guidance issued in 2022).

The HPRA has been notified of current shortage of Estradot 75 micrograms / 24 hours, transdermal patch, due to a manufacturing delay impacting upon multiple countries, including Ireland. The expected return date for this product is pending.

Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot, has issued a letter to healthcare professionals advising of expected global supply constraints for Estradot throughout 2025. The HPRA will continue to engage with Sandoz, and the most recent supply information will be made available via the HPRA’s website: Medicine shortages .

The HPRA, along with other health service entities, is actively monitoring the national supply, and the current status is that other HRT medicines are generally available. The HPRA has engaged with relevant suppliers to understand the reasons for current reports and to examine opportunities for regulatory flexibilities to assist meeting current demand. There are a number of medicines authorised for use in Ireland as HRT for the treatment of symptoms of menopause. In the event that patients are unable to source a medicinal product due to supply constraints, they are advised discuss possible alternatives with their healthcare professional pending the resumption of normal supply.