Dáil Éireann Debate, Tuesday - 13 January 2026
2303. Deputy Liam Quaide asked the Minister for Health the current status of supply of estradot (estradiol transdermal) patches in the State; the duration and cause of any supply disruptions affecting this product in 2024 and 2025; the steps taken by her Department and the HSE to mitigate these shortages; and whether she will provide a timeline for full restoration of supply; and if she will make a statement on the matter. [75026/25]
Amharc ar fhreagraAs of 12th January, no current shortages have been notified to the HPRA for Estradot 50mcg / 24-hour transdermal patch, Estradot 75 micrograms / 24 hours transdermal patches, or Estradot 100mcg / 24-hour transdermal patch. All Estradot shortages have been recently resolved.
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.
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 on its website.
The HPRA, along with other health service entities, is actively monitoring the national supply, and the current status is that 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.
There has been intermittent supply of some hormone replacement therapy (HRT) presentations over recent years, not just in Ireland but also in other countries, due to a significant increase in demand and manufacturing issues which are limiting the ability to meet this increased demand. Persistent 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 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.
