George Lawlor (Wexford, Labour)
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167. To ask the Minister for Health if she will address the ongoing shortage of estradot (estradiol transdermal) patches in Ireland; if she is aware that women are frequently having to change pharmacies, travel to Northern Ireland, or arrange private courier services to access their prescribed hormone replacement therapy (HRT); if she will comment on reports that general practitioners are reluctant to rewrite prescriptions to suit different pharmacy stock levels; the specific steps being taken by the Department and the HPRA to stabilise the HRT supply chain and protect continuity of care for women reliant on these; and if she will make a statement on the matter. [26168/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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.

Ireland has a multi-stakeholder Medicines Shortages Framework (MSF) in place, operated by our medicines regulator, the Health Products Regulatory Authority (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.

Shortages are a global issue experienced by all countries regardless of size or economic status. 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.

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 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 is updated daily as the HPRA receives new information.

Persistent medicinal product shortages across this therapeutic area (HRT) have been managed and continue to be managed via the national MSF. 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.

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.

Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot, has notified the HPRA of a shortage of Estradot transdermal patches (50 micrograms/ 24 hours transdermal patch, and 75 micrograms/ 24 hours transdermal patch). These shortages are due to a manufacturing delay which is impacting multiple countries, including Ireland.

The resupply of these patches is anticipated by the end of the year.

The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.

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.