Willie O'Dea (Limerick City, Fianna Fail)
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616. To ask the Minister for Health if he is aware of a shortage of supply of hormone replacement therapy (HRT) products in Ireland; his plans to ensure a regular supply of these products; and if he will make a statement on the matter. [29168/23]

Mairead Farrell (Galway West, Sinn Fein)
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633. To ask the Minister for Health if he has been made aware of the current lack of supply of progesterone across pharmacies in the country; if he is taking action to rectify the supply issues; and if he will make a statement on the matter. [29209/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 616, 618 and 633 together.

Besins Healthcare Ireland Limited has advised of a shortage of Utrogestan Vaginal 200mg Vaginal Capsule, impacting multiple markets due to increased demand. The company anticipates resupply towards the end of June 2023. The company has stated that Exempt Medicinal Product (EMP*) is available to meet patient demand.

Laboratoires Besins International has also advised of a shortage of Imvaggis 0.03 mg Pessary, impacting multiple markets. The company stated the reason is manufacturing delays and supply is expected in early July.

Alternatives are available. Many Hormone Replacement Therapies (HRT) are authorised for use in Ireland in various formulations (e.g., oral tablets, transdermal patches, gels, and sprays) and strengths. For the vast majority of HRT products authorised, including transdermal patches and gels, the Health Products Regulatory Authority (HPRA) has not received any notifications of current shortages. This includes all but two of the above mentioned authorised products outlined in the HSE’s clinical guidance for HRT (hyperlink below).

MMP guidance for prescribers on HRT shortages – September 2022 (hse.ie)

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, to prevent, wherever possible, and to manage medicine shortages when they occur. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.

The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information.

*Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe a medicine as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.

As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.