Pádraig Mac Lochlainn (Donegal, Sinn Fein)
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1994. To ask the Minister for Health when a medication (details supplied) will be available again here, for prescription for patients of the menopause hub; and if she will make a statement on the matter. [59569/25]

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, 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 has been notified of current shortages of the following HRT products:

Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot has notified the HPRA of a shortage of Estradot 50 micrograms / 24 hours transdermal patches and Estradot 100 micrograms / 24 hours transdermal patches. These shortages were notified on the 28th July 2025 and the 10th June 2025 respectively, and are due to a manufacturing delay impacting multiple countries.

Sandoz Pharmaceuticals d.d are presently unable to advise of an exact date for resolution of the shortages of the two presentations currently notified as a shortage. Once the delivery date is confirmed by the company, the HPRA website will be updated accordingly.

The shortage of Estradot 75 micrograms / 24 hours transdermal patches was recently resolved.

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.

In the event that patients are unable to source a medicinal product due to supply constraints, they are advised to discuss possible alternatives with their healthcare professional pending the resumption of normal supply.

Albert Dolan (Galway East, Fianna Fail)
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1995. To ask the Minister for Health further to Parliamentary Question No. 766 of 21 October 2025, if she will provide a detailed update on the progress of the best value medicines programme in achieving its stated target of at least 80% of individuals being in receipt of the best value medicine; if she will provide a breakdown of uptake levels by each target area; and if she will make a statement on the matter. [59592/25]

Albert Dolan (Galway East, Fianna Fail)
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1996. To ask the Minister for Health if there are any policy proposals or changes planned that will assist how the best value medicines programme contributes to reducing the financial burden on the HSE’s medicines budget and assists in securing access for patients to new and innovative treatments; and if she will make a statement on the matter. [59593/25]

Albert Dolan (Galway East, Fianna Fail)
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1997. To ask the Minister for Health to outline the expected policy changes planned to achieve the Programme for Government commitment to “ensuring that patients have access to new innovative new medicines and treatments as quickly as possible”; and if she will make a statement on the matter. [59594/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 1995 to 1997, inclusive, together.

The Department of Health, the Department of Public Expenditure, Infrastructure, Public Service Reform and Digitalisation and the Health Service Executive (HSE) are now in formal negotiations with the Irish Pharmaceutical Healthcare Association (IPHA) and with Medicines for Ireland (MFI), as part of the process to agree successor Framework Agreements on the Supply and Pricing of Medicines (FASPM).

A record of over €3 billion, around €1 in every 8 of public funding spent on health, is now being spent on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines.

Sustainability remains a core priority for the Government. It is crucial, given high levels of expenditure growth across the health sector in recent years and the new challenging economic conditions, that medicines expenditure does not come at a cost to other health areas. Officials are at present, actively engaging with the pharmaceutical industry to secure successor multi-year Framework Agreements on behalf of the State.

In August 2024, the HSE Senior Leadership Team approved the Overview of Medicines Funding Governance Processes. This document clearly articulates the governance processes for the funding of medicines in the HSE. It clarifies that the authority to approve the expenditure of funds on new medicines or new uses of existing medicines across the HSE is reserved solely to the HSE National Senior Leadership Team.

The Medicines Sustainability Taskforce is co-chaired by the Department of Health and the HSE. Membership includes representatives of the Department of Health, the HSE's Medicines Management Programme, the National Centre for Pharmacoeconomics, the HSE's Primary Care Reimbursement Service, the HSE's Acute Hospitals Division, HSE Finance, and clinical experts. Under the direction of the Productivity and Savings Taskforce, it supports the HSE’s examination of medicines expenditure in the health service and to identify measures to maximise value from the resources within the medicines budget. The focus is on generating savings where possible and ensuring that the funding available provides the greatest level of access to medicines for as many patients as possible.

In line with the Productivity and Savings Taskforce targets, the Medicines Sustainability Taskforce aimed to achieve a minimum of €20m in savings in 2024 and this was exceeded by over €30 million.

Regular updates from the Medicines Sustainability Taskforce are published on the Department of Health website: www.gov.ie/en/department-of-health/collections/medicines-sustainability-taskforce/