2026-03-25

I thank the Minister of State for making himself available to deal with this matter. March, this month, is endometriosis awareness month. I am raising this issue to highlight a drug to which I will refer in this matter, namely, Ryeqo. It is available in over 27 countries across Europe. While it is available to purchase in Ireland, it is not available under the general medical services, GMS, scheme. In October 2025, the Minister for Health launched a national framework for the management of endometriosis in Ireland. The HSE, together with the Department of Health, has established a number of centres around the country, including in Tallaght University Hospital, Cork University Hospital, the Rotunda Hospital, the Coombe hospital, University Hospital Limerick, Galway University Hospital and the National Maternity Hospital. We have developed all of these centres to provide care for women. It is estimated that one in ten women will be affected by endometriosis. I know of the case of a 20-year-old girl who has undergone surgery. Two different consultants have recommended that she use the drug Ryeqo but she cannot afford it because it is not available to her under the GMS scheme. She is 20 years of age. She has gone through the surgery and the drug is not available. In 2022, the drug was submitted for approval under the drugs payment scheme, but it was turned down on the basis that it would not be economical to have it in the GMS scheme. I would argue with that. A huge number of women require care. It is not just surgical care. They also require the use of medication. This particular medication is not available but is being recommended by consultants. If you are lucky enough to have the income, you can purchase it, but if you do not, you are in difficulty, and in many cases there is no alternative. I ask for this matter to be reconsidered and given the priority it deserves. I fully understand that each year, there is a budget for the purchase of pharmaceuticals and drugs. However, 27 countries across Europe have this drug available under their health schemes but it is not available here in Ireland. In October 2025, the Minister set out a clear timeline to try to make all care available to women who had this medical condition. We have developed the surgical approach. For instance, we now have specialist units in Cork and Tallaght to deal with the condition, and other units are providing care across the country. It is wrong that we are able to provide surgical care now but are not prepared to provide the medication that is required either before the person is identified as requiring surgery or after surgery is completed. I ask that the matter be reviewed. We should go back into the negotiating process so that an agreement can be reached to have this drug made available. I ask for that to be done at the earliest possible date.

I thank the Deputy for raising the important issue of endometriosis. It is something that for too long we have not spoken about. There still is not enough awareness of what it is and the challenges and difficulties that women across Ireland face when they have this condition. There are women across Ireland living in severe pain because of endometriosis. There are woman across Ireland who experience heavy bleeding. There are women who have to undertake serious surgery to treat endometriosis, which is very painful and has a long recovery time. There are couples right across Ireland who, because of endometriosis, are facing incredible challenges with reproduction. These are all things that for far too long we have not spoken enough about publicly. We have not raised enough awareness about it. I am really heartened that Deputy Burke has raised the issue here today and that women right across Ireland are speaking out about it and about the necessity to treat it and, more important, to get access for women to treat this condition. That is the most important point. I commend the Minister, Deputy Carroll MacNeill, on tackling this issue head-on and putting it front and centre as something she wants to address. I just wanted to say that at the outset. In 2025 and earlier this year, the Minister engaged directly with women on a one-to-one basis through the patient voice forum and listened to their personal experiences of endometriosis. The national framework for the management of endometriosis in Ireland was published in October 2025. This marks a milestone in the evolution of women's healthcare in Ireland. The framework establishes, for the first time, a defined clinical care pathway for women and girls living with endometriosis. In conjunction with this framework, the Minister has written to all GPs, consultants and other clinicians to raise awareness of endometriosis in their clinical assessments. Moreover, the expansion of endometriosis services provided in Ireland is supported through the HSE's national service plan. Regarding Ryeqo, I will provide some background for our colleagues and then address Deputy Burke's question. Relugolix, estradiol and norethisterone acetate, marketed under the trade name Ryeqo, is a medicine used for the symptomatic treatment of endometriosis in women of reproductive age with a history of medical or surgical treatment for their endometriosis. The European Medicines Agency, EMA, granted marketing authorisation for this product in July 2021. The company marketing this medicine made an application for addition to the HSE's reimbursement list in May 2024. The HSE has statutory responsibility for medicine pricing and reimbursement decisions. HSE decisions on which medicines are reimbursed are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics, NCPE. Formal processes govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed. The HSE commissioned a health technology assessment, HTA, in July 2024. Just under a year later, in July 2025, the applicant submitted a full HTA dossier to the NCPE. Further engagement between the NCPE and the applicant has taken place in the interim, and the application remains under consideration. The HSE cannot make any comment on possible outcomes from the ongoing process. The Deputy can see from those milestones that it took considerable time for the State to receive the necessary dossier. We cannot progress reimbursement applications without timely engagement. We strongly encourage all pharmaceutical companies to apply for reimbursement here in Ireland and to submit fully prepared HTA dossiers in a timely fashion.

I thank the Minister of State. My information is that it was in February 2022 that the NCPE concluded that there was insufficient evidence of cost-effectiveness for the drug to be approved for reimbursement by the Health Service Executive. Obviously, there is a new application in. The Department of Health has taken decisions previously where the NCPE turned down a particular drug because of its cost-effectiveness, but it is about far more than just cost-effectiveness. There is also the issue of patient care. Sometimes when we look at cost-effectiveness, we look at the immediate cost of the drug rather than the long-term benefit. If having a drug available means we will reduce the number of times a person has to go to their general practitioner or consultant or to hospital, then that is a cost saving in real terms. All the evidence that has been presented to me clearly indicates that if this drug was made available, it would be beneficial to women who have this medical condition. The example I gave is a true and accurate one of a 20-year old who has no other drug available except ordinary painkillers, which are not really adequate for the difficulty she has. She has gone through surgery. This is the recommendation of two consultants but she cannot get access to this drug. This is a time when we need to be really pragmatic about taking a decision on something. Sometimes an issue may cost more than what it seems on paper, but in real terms there is a real saving for the State.

As I said, the HSE cannot comment on the outcome of this application. That is fair enough. There is a process to go through. I can probably comment more freely. I agree with Deputy Burke. There are obviously different levels of endometriosis but the surgery is costly and painful and there is a long recovery time. I am not a doctor, but the surgery does greatly increase the success rate for reproduction. Nevertheless, endometriosis can come back. If there is a treatment that can prevent that, it should be looked at and it should be accessible. I agree with Deputy Burke in that regard. In fairness, the statement says this is under consideration. The HSE probably cannot comment any further on the outcome, but I agree with the Deputy's request that the result of this application should be made known as soon as possible so that women like his constituent and women right across Ireland know where they stand, and so that we can address this hidden condition, which for too long has meant women have lived in severe pain with excessive bleeding and reproductive challenges, and address it head-on. I again thank Deputy Burke for raising this issue.

I thank the Minister of State.