Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail) | Oireachtas source

I thank Senator Fitzpatrick for raising this important issue. I totally agree with her. I have spoken to the Minister, Deputy Carroll MacNeill, about this. Substantial progress has been made in recent years to support women through their menopause journeys. A number of medicines are authorised for use in Ireland as hormone replacement therapy for the treatment of menopause. Budget 2025 announced the intention to fund the cost of HRT products prescribed to women to help manage the symptoms associated with all stages of menopause. This is supported by a €20 million per annum investment by Government. This new measure aims to relieve some of the cost burden associated with HRT products. The legislation that has been passed means where a woman has been prescribed a 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 measure is for women who have been prescribed HRT by their healthcare provider. The measure applies to HRT products reimbursable by the HSE under the community drug schemes. The Department of Health and HSE have been engaging with the representative body for community pharmacists, the Irish Pharmacy Union, on the practical roll-out of this measure.

There is a medicines shortage framework in place which involves a multi-stakeholder approach to handling shortages of human medicinal products. This is the problem. Persistent product shortages across this therapeutic area of HRT have been managed and continue to be managed via the framework, operated by the Health Products Regulatory Authority, HPRA. Suppliers and manufacturers of HRT have notified shortages of HRT products due to manufacturing delays. The HPRA understands from recent meetings with HRT suppliers that shortages have been compounded by a significant increase in demand for HRT globally. Hence shortages of HRT products continue to be notified not just in Ireland but in other countries as well. The HPRA, with other parties across the health service, continues to monitor overall national supply of a single therapy and the current picture is that HRT medicines remain generally available, and this includes oral products.

The HPRA continues to engage with suppliers of medicines subject to persistent shortages to understand the responses of the company to meet the increase in demand and to introduce necessary measures to prevent shortages from occurring. This is the real issue now. Sandoz Pharmaceuticals, the company responsible for supplying Estradot, has notified the HPRA of a shortage of Estradot 37.5 mg, 50 mg, 75 mg and 100 mg patches.

The HPRA has been notified of an expected return date, as the Minister told me, of 7 March 2025 for the three presentations but is currently unable to advise on a date for the 37.5 microgram patch. The HPRA has also engaged with suppliers to explore opportunities for regulatory flexibility. I understand this is probably not the answer the Senator wanted. I understand the seriousness of this issue. Half our population is women but unfortunately this is where we are at the moment. I will continue to work with the Senator.