Peter Cleere (Carlow-Kilkenny, Fianna Fail)
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2455. To ask the Minister for Health if she will provide an update on the shortages of several HRT products for women (details supplied); and if she will make a statement on the matter. [21118/25]

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 mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

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.

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: www.hse.ie/eng/about/who/cspd/medicines-management/guidance-on-shortages/prescribing-tips-and-tools-in-response-to-hrt-shortages.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 a shortage of Estradot transdermal patches (37.5 microgram/ 24 hour transdermal patch, 50 microgram/ 24 hour transdermal patch, 75 microgram/ 24 hour transdermal patch, and 100 microgram/24 hour transdermal patch). These shortages are due to a manufacturing delay which is impacting multiple countries, including Ireland.

The HPRA have been notified by Sandoz Pharmaceuticals d.d of an expected return date, reported as the 6th May 2025 for 37.5 microgram/ 24 hour transdermal patch and 100 microgram/24 hour transdermal patch. The resupply of the 50 microgram/ 24 hour transdermal patch and the 75 micrograms / 24 hours, transdermal patch is anticipated by the end of the year.

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.

Peter Cleere (Carlow-Kilkenny, Fianna Fail)
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2456. To ask the Minister for Health the reason unlicensed products are available for 50 mg patch but are not currently covered on GMS scheme, which results in patients having to pay privately for this; and if she will make a statement on the matter. [21119/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drug schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).