Garret Ahearn (Fine Gael)
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As we wait for the Minister of State, Deputy Murnane O'Connor, to take the next Commencement matter, I thank Senators Fitzpatrick and Ruane for facilitating the change to suit the Minister, Deputy Calleary.

Mary Fitzpatrick (Fianna Fail)
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I thank the Minister of State, Deputy Murnane O'Connor, for coming to the House. Déanaim comhghairdeas leis an Aire Stáit on her appointment. I am sure she will be very successful in her new position. I am disappointed that the senior Minister is not here to take this matter. but I genuinely appreciate the Minister of State's time and the support from the Department.

I am seeking two things. First, I am seeking clarity on what actions the Department and the Minister are taking to resolve the supply side shortages relating to hormone replacement therapy, HRT. Second, I am looking for an update on the provision of free HRT, which has been promised by the Government. It is not an overstatement to say that the supply side shortages relating to HRT are giving rise to significant issues for patients, doctors and pharmacists. This is causing significant distress, worry and expense for those who depend on HRT, for the physicians who prescribe it and for the pharmacists who dispense it. HRT is a lifeline for women. It is not an overstatement to say that it saves women's lives, protects their mental and physical health and saves their social and professional lives. In addition, HRT salvages and saves long-term relationships for many women and men. The importance of HRT cannot really be overstated.

Women comprise half the population. As a result, half of the population will go through menopause at some point in their lives. It is only right that this Government has committed to provide HRT free to those women. It is also right that the Government, the State and the Department take action to ensure there are sufficient supplies of HRT.

When women are prescribed HRT, it is not the case that one size fits all. Every woman's physiology is different. It can be an iterative process. Women who do not have medical cards have to pay for GP visits and prescription fees when it comes to HRT. The dosage can change. When a woman goes to her local pharmacy and the pharmacist does not have the prescribed dosage, there is then a need to try to make up the difference. The cut patches and prescribe gels instead of patches or tablets instead of gels.

It is creating great uncertainty, distress and expense, all the while undermining women's health and their ability to enjoy full and happy relationships, participate fully in the workforce and participate fully socially and culturally.

I hope the Minister of State has been sent to this House with an answer on the actions that are being taken to address the supply-side shortages, but also to ensure that free HRT is made available to everyone. The previous Minister, Stephen Donnelly, and the previous Government must be commended. The Minister of State and I worked on this and Fianna Fáil was the first political party to bring forward a women's health policy. We are very proud to have the proposals we made in that policy adopted by the previous Government, including free contraception and free IVF and fertility treatments and the establishment of menopause and gynaecological clinics. All of those were groundbreaking and historic innovations which were revolutionary for women's health. This Government must continue that work. I hope the Minister of State has been sent here today with word from the senior Minister in the Department that work is under way to address supply-side shortages and ensure the free roll-out of HRT takes place promptly.

Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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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.

Mary Fitzpatrick (Fianna Fail)
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I acknowledge the work being done by the Department, the Minister of State, the Minister and all of the stakeholders. It is good news. Women will be pleased to hear that there is a date of 7 March for Estradot transdermal patches. That in and of itself is really positive news. I ask the Minister of State to go back to the Department and ask for a date by which HRT will be made available for free. I appreciate a negotiation has to take place between the Department, community pharmacists and the Irish Pharmacy Union but I urge the Department to conclude those negotiations as soon as possible. It is almost discriminatory that women of menopausal age are not availing of free HRT in the same way women of a fertile age can avail of free contraception, as is right, and they get two free GP visits. Free HRT should be dispensed in the same manner as free contraception. It should be treated as just a continuum of women's fertility, health and journey. I urge the Minister of State in her new role to work to achieve that outcome.

Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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As I said, the HPRA has been notified by Xenon Pharmaceuticals of an expected return on 7 March. In relation to new HRT measures, the Minister for Health met the Irish Pharmacy Union on 11 February to discuss her objectives for expanding and reforming community pharmacy and to progress the HRT initiative in budget 2025. That is crucial. This was a constructive engagement and the Minister listened to issues raised by the IPU which committed to come back to her regarding the introduction of HRT measures. The IPU has now responded with further information which is being considered by the Department. The goal remains to introduce the measures as soon as possible; reimbursement supports will be available to participating pharmacies from that date and these measures commence. I agree with and thank the Senator for bringing this to my attention.

Garret Ahearn (Fine Gael)
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I thank the Senator. Before I ask Senator Ruane to speak on her Commencement matter, I welcome guests of the former Captain of the Guard John Flaherty. It is lovely to see him again. He and his guests are very welcome. They are in much better hands than a Senator or a TD bringing them around this building. They are in wonderful hands. It is great to see John.