Michael Healy-Rae (Kerry, Independent)
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386. To ask the Minister for Health the plans that are in place regarding free HRT shortages (details supplied); and if she will make a statement on the matter. [27877/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My 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.

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 our medicines regulator, the Health Products Regulatory Authority (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 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 www.hse.ie/eng/about/who/cspd/medicines-management/guidance-on-shortages/mmp-guidance-for-prescribers-on-hrt-shortages-september-2022.pdf).

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. 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.

Sandoz Pharmaceuticals d.d. the company responsible for supplying Estradot, has notified the HPRA of shortages of Estradot 50 micrograms / 24 hours transdermal patch and Estradot 75 micrograms / 24 hours transdermal patch due to a manufacturing delay which is impacting upon multiple countries, including Ireland. These shortages are expected to resolve at the end of 2025.

The HPRA maintains a list of current and resolved shortages on its website (www.hpra.ie/find-a-medicine/for-human-use/medicine-shortages?data=eyJpZCI6bnVsbCwic2tpcCI6MCwidGFrZSI6MTAsInF1ZXJ5IjpudWxsLCJvcmRlciI6Imxhc3R1cGRhdGVkIERFU0MiLCJmaWx0ZXIiOiJBbGwifQ%3D%3D). The webpage is updated daily as the HPRA receives new information.