Jennifer Whitmore (Wicklow, Social Democrats)
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This is not the first time I have raised this issue. In fact, I have been raising it for more than two years now, during which time many people have had to suffer unnecessary and avoidable difficulties in pregnancies because of hyperemesis gravidarum.

It is not just difficulties, which is such a light word to use when it comes to what hyperemesis can do to people who are pregnant. I have spoken to pregnant women who have said that it leaves them vomiting hundreds of times a day. They vomit so much and so hard that they burst blood vessels in their eyes. They rip their oesophagi. Some of them suffer and have to terminate much-wanted pregnancies because they do not believe they can go through the whole pregnancy without support. Some also consider and contemplate suicide. It is an incredibly difficult condition to have to go through. There is relief. Relief can be found in medications such as Cariban. I recognise that inroads have been made on the side of the Government and that Cariban was made available under the drugs payment scheme in the new year. This was very much welcomed at the time but the system that has been put in place by the HSE means, essentially, that it is impossible for the majority of women to access this drug through the scheme. Rather than just getting it from their GP, which is what would happen if they were paying directly and privately, they must have a consultant sign off on the first prescription. For the majority of women they will not see the consultant for the first 14 or 15 weeks of pregnancy, by which time if they are suffering from hyperemesis, they are in dire straits.

When I raised this previously with the Minister for Health, he told me a number of things, one being that because this is an unlicensed medication the HSE cannot include it under the drugs payment scheme to be prescribed in the first instance by a GP. I have spoken to GPs, and there are many, many drugs that are unlicensed but have been given a drug code, which makes them notified medications. A GP can, therefore, prescribe them. There are a number of them, including the antibiotic Chloramphenicol, Scopoderm and a melatonin medication for children called Kidnaps. These are all unlicensed products but they can be prescribed by a GP. We ask that the HSE applies the same conditions as those other notified medications, and assists women to get this medication when it is needed.

The Minister also said that the HSE was going to review the policy and the process. That was two months ago. Will the Minister of State please bring some sense of urgency to this? On a daily basis women are suffering badly with this condition. It is completely unnecessary. Will the Minister of State give the House an update on that review? If it is not finalised, when does he anticipate it will be? It is important that this be communicated. I have asked that the Minister to meet with Hyperemesis Ireland, which he said he would do once the review was conducted. I ask that he would at least reply to their emails. I know that they have been in contact with him.

I really hope that the Minister of State has a good news update for me today, that he will be able to tell me the HSE has conducted the review and this medication for hyperemesis sufferers will be made available from GPs and under the drugs payment scheme as soon as possible.

Peter Burke (Longford-Westmeath, Fine Gael)
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I thank the Deputy for raising this very important issue. Again, I must give apologies for the Minister for Health, who obviously would be more aware of this topic and the review at the moment.

Hyperemesis gravidarum is a severe form of nausea and vomiting during pregnancy, which the Deputy articulated very well. It affects approximately 1% of the pregnant population and must be diagnosed and treated appropriately. The Government is keen to ensure that anyone encountering this condition receives the support they need.

As part of budget 2023, the Minister announced €32.2 million in funding for women’s health in 2023. This included general dedicated funding for Cariban, a medicine used to treat hyperemesis gravidarum. As of January 2023, this medicine is now available to those women who need it. Unfortunately, reaching this point has not been straightforward. Under the Health (Pricing and Supply of Medical Goods) Act 2013, only medicines that are licensed and have marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority can be added to the HSE’s formal reimbursement list. Cariban is not licensed and, therefore, cannot be added to the reimbursement list. It is instead classed as an exempt medicinal product.

Three medicines containing doxylamine pyridoxine are licensed in Ireland: Xonvea, Exeltis and Navalem. The respective market authorisation holders of these three products have not, however, progressed with a pricing and reimbursement application to the HSE under the 2013 Act. The HSE, therefore, encourages clinicians, along with the Institute of Obstetricians and Gynaecologists, the National Clinical Programme for Obstetrics and Gynaecology and other healthcare professionals to encourage the market authorisation holders of these licensed medicinal products to progress with the formal pricing and reimbursement process in Ireland.

Following the recommendations of the HSE medicines management programme, reimbursement support for Cariban to women suffering with hyperemesis gravidarum was made available from 1 January 2023 under an exceptional arrangement. The exceptional arrangement requires that treatment be consultant initiated, which is a long-standing governance practice in respect of exempt medicinal products. However, women would only need to see a consultant in order to be initiated on the product, and thereafter it can be prescribed by their GP. This exceptional arrangement has been put in place to ensure that women suffering from hyperemesis gravidarum have access to Cariban.

As of 27 March 2023, 847 applications for Cariban had been received and 825 women had been approved for the product. As the Minister recognises that women suffering from hyperemesis gravidarum may need access to Cariban before their first scheduled consultation with their specialist obstetrician, and in light of the fact that GPs prescribe it for private patients without an initial prescription from a specialist, the Minister has asked that the HSE review the current arrangement and report back to him.

I will raise the Deputy's issue about the timing of the review. She said that she had raised it with the Minster prior to this. I will ask him to also revert to her urgently with an update on the review. I do not have that information to hand.

Jennifer Whitmore (Wicklow, Social Democrats)
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I thank the Minister of State. I understand that this is not within his remit but it has taken the Minister two months to come up with a response that he gave me two months ago. It is an absolute disgrace.

I would also like to point out that I cannot recall the last time the Minister for Health came into this Chamber to respond to a Topical Issues matter and gave the Members raising these issues respect. It is not only for us as Deputies, but for all the women who are suffering from this. It is absolutely disgraceful that the Minister did not even provide an update on the review. It just goes to show the contempt that he shows to all of the women who are suffering. With all due respect, the Minister of State has been put into a very difficult position here. The Minister should have given him a considered and proper reply. We come across women who are considering suicide and terminations because of this condition. This is a BS response, if the Chair will excuse the language.

The Minister talks about an exceptional arrangement that has been put in place to ensure that women suffering from hyperemesis have access to the medication. The only exceptional thing about this system is that it is exceptionally bad. Women cannot access the drug under the drugs payment scheme unless they see their consultants, and that is an impossibility in the current medical system. It takes 16 weeks to see the consultant. It is okay for women who can afford to pay for it, but this is not acceptable. It is a very poor policy that has been put in place.

The Minister of State referred to exempt medicinal products and the need to see a consultant but that is not true. There are many other drugs, some of which I read out. There are dozens of exempt medicinal products that a person can get from their GP where the person does not need to see a consultant first. I ask that the Minister would put some time and effort into talking through those potential solutions. This is what women need. They need him to put solutions in place that will work for them and not something where he can just issue a big press release at Christmastime saying that he is giving this drug free to all of these women, and then putting these barriers up so that they cannot actually access it.

Bernard Durkan (Kildare North, Fine Gael)
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The Deputy is being supported here by Deputy Martin Kenny.

Martin Kenny (Sligo-Leitrim, Sinn Fein)
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But I cannot come in.

Bernard Durkan (Kildare North, Fine Gael)
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We cannot let everybody in as it may set a dangerous precedent.

Peter Burke (Longford-Westmeath, Fine Gael)
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I will refer back to the Minister for Health on the issues Deputy Whitmore has raised quite rightly.

I hear the Deputy's frustration in regard to this issue. She has articulated the points. I outlined the significant funding for women's health, which the Government takes as a significant priority in regard to the programme for Government. However, I will raise this with the Minister, Deputy Donnelly, in terms of the review and where it is at. I will ask him to revert back to Deputy Whitmore urgently because I understand the issue. As a father, I absolutely hear how important this issue is for women.