Dáil Éireann Debate, Wednesday - 5 February 2025
1275. Deputy Sinéad Gibney asked the Minister for Health if her Department has been made aware of any shortages of hormone replacement therapy (HRT) products which are due to be included in the free HRT scheme; and if she will make a statement on the matter. [3293/25]
Amharc ar fhreagraDear Deputy
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 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.
The HPRA is aware of current shortages of the following HRT medicines:
• Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot, has notified the HPRA of a shortage of Estradot 37.5 micrograms / 24 hours, 50 micrograms / 24 hours, 75 micrograms / 24 hours, and 100 micrograms / 24 hours transdermal patches.
• The shortages of all of the above presentations of Estradot, except for Estradot 75micrograms/ 24 hours, are expected to be resolved on 10th February.
• Theramex Ireland Limited, the company responsible for supplying Evorel, has notified the HPRA of a shortage of Evorel 50 micrograms/24 hours transdermal patches due to an unexpected increase in demand. This shortage is expected to resolve on 15th February.
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.
The Department of Health engaged with both the Health Service Executive (HSE) and the Irish Pharmacy Union in relation to the practical rollout of this measure and is working to introduce it as soon as possible. On Tuesday, 5 November the Health Insurance (Amendment) and Health (Provision of Menopause Products) Bill 2024 passed all stages in the Oireachtas and was signed into law.
This legislation means that where a woman has been prescribed a Hormone Replacement Therapy (HRT) product by her healthcare provider to alleviate the symptoms associated with all stages of menopause*, the cost of the HRT medications or products will be met by the State. This will cover any HRT medications and products which are currently reimbursable by the HSE, which are prescribed for the purposes of alleviating the symptoms of menopause. The cost of GP consultation fees and pharmacy dispensing fees are not included in the measure.
*For the purpose of this measure, menopause means, in relation to a woman, the various stages for the treatment of menopause symptoms and includes perimenopause, post menopause, early menopause, premature menopause and medically induced menopause.
