Neale Richmond (Dublin Rathdown, Fine Gael)
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I am grateful that the Minister of State has come to the House to take all these matters this morning. It is great credit to her own work ethic and commitment.

I raise a somewhat niche issue in that it only affects a small number of women in the country but it is serious. Hyperemesis is severe nausea, or morning sickness, during pregnancy. It affects 1% to 2% of pregnancies. In budget 2023, the Minister for Health announced that Cariban, which treats hyperemesis, will be reimbursed. This is welcome and long sought-after. However, to get a prescription for Cariban, the patient must first go to a consultant rather than her GP. This adds delay and cost and creates a great deal of distress to women who are extremely sick during a vulnerable time in their lives. It is hard to describe how badly hyperemesis can affect those who are unfortunate enough to suffer from it during pregnancy but it is debilitating. That they would have to wait for a consultant appointment and be seen before they may be prescribed this prolongs the misery.

A lady in my constituency was diagnosed with hyperemesis at eight weeks. She was losing 2kg a week. This was before it was placed on the drugs payment scheme and she was not eligible to get this so she had to go onto a less effective drug until she was six months' pregnant. She became pregnant again more recently and again fell foul of hyperemesis and, unfortunately, had to wait an additional three weeks to be seen and prescribed by a consultant rather than just being able to get an appointment with her GP the next morning. That was three weeks off work, losing weight and away from the care of the infant child she had simply because there is no joined-up thinking. I am asking for a little bit of common sense in the application of this important scheme for those who need it most.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy for raising this important issue. I am taking this matter on behalf of the Minister for Health. The Minister and myself appreciate that hyperemesis gravidarum, or severe nausea, is a debilitating condition for women. The Minister is anxious that our health service should support women with this condition in every way possible. Improving women's health outcomes is a priority for the Minister and the Government. We made a strong commitment to promoting women's health in the programme for Government and are fully committed to the development and improvement of women's health services.

We have made progress on women’s health issues. VAT has been removed from HRT, which has improved equality of access for women across the country. The free contraception scheme commenced this year and will be expanded to include women up to 30 years next year. IVF treatment will be provided in the public health system next year. We also intend to create additional women’s health hubs. These are all initiatives that will positively impact the lives of women in Ireland.

As part of the women's health agenda, officials supporting women's health in the HSE and the Department of Health worked with urgency to identify all of the available options to better support women with hyperemesis gravidarum. As part of budget 2023, the Minister announced €69.2 million in funding for women’s health in 2023, to include dedicated funding for Cariban. The dedicated funding for Cariban will help women who experience hyperemesis, a severe form of morning sickness, during pregnancy, which is difficult to deal with.

On the question of access to medicines to treat the condition, unfortunately the situation is not straightforward. As the Deputy will be aware, the HSE has statutory responsibility for medicine pricing and reimbursement decisions under the Health (Pricing and Supply of Medical Goods) Act 2013. Under the Act, only items that have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority can be added to the reimbursement list. However, that is not the question the Deputy has asked. His question relates to where patients must go to a consultant before they can get a prescription for Cariban. I did not realise that.

Neale Richmond (Dublin Rathdown, Fine Gael)
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To get it reimbursed.

Mary Butler (Waterford, Fianna Fail)
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Sorry, to get it reimbursed. However, I assume their doctor can prescribe it.

Neale Richmond (Dublin Rathdown, Fine Gael)
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But they have to pay for it.

Mary Butler (Waterford, Fianna Fail)
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Okay. The answer does not really deal with the question the Deputy is asking and, therefore, I will raise this with the Minister and his officials to see if anything can be done.

Perhaps the Deputy can clarify, in his response, if a patient must go to a consultant and pay for that appointment in order to get the prescription to claim the cost back.

Neale Richmond (Dublin Rathdown, Fine Gael)
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Just to clarify, it is an ever-changing issue. Unfortunately, there are situations like this with drugs and many different treatments all the time. The Minister of State deals with these issues on a daily basis, as does the Minister for Health. The situation, in this case, is that because of the nature of the drug and the regulatory environment with the European Medicines Agency, there is a requirement for patients to get a prescription from their GP, but they need to have a consultation with a consultant first.

I note and welcome the Minister of State's comments. I hope, following engagement with the stakeholders, we can find an opportunity to provide timely treatment for the 1% to 2% of pregnant women who suffer from this debilitating condition. I highlight that the HSE has discretion in the area of exceptional patient-specific processes. We have seen it in the implementation and roll-out of other drugs for many other illnesses. It is about getting around the system of waiting for EMA regulatory approval. We saw it with Covid vaccines and we have seen it with many other medicines. The important point is that the condition is extremely time-sensitive. Women do not know if they are going to get hyperemesis gravidarum before they get pregnant. Often, the patient does not present with symptoms until the eighth or ninth week of pregnancy. There is a need to work quickly to treat the condition, so having to attend a consultant appointment not only delays treatment by up to four weeks but imposes a major cost on the women who simply have to get access to this drug. I ask the Minister of State, when she goes back to the Minister or, more pertinently, the HSE, to ensure that a system is put in place whereby there is no requirement for women to attend a consultant appointment in order to get a reimbursement. They should be able to get access to the drug through a GP because this is a time-sensitive exceptional need. I think all of us agree that Cariban is recognised as a safe drug. It is seen as such. We must ensure we put in place the process to get ahead of the delay on a wider regulatory matter.

Mary Butler (Waterford, Fianna Fail)
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The Deputy is absolutely right that time is of the essence. If a woman is eight or nine weeks pregnant and is extremely sick, the last thing she wants to do is to get up and try to make a consultant appointment. Cariban, which is regarded as a beneficial treatment for hyperemesis, does not have a marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority and, therefore, cannot be added to the formal reimbursement list under the 2013 Health Act. I assume that is the reason women have to make a consultant appointment to access it. Of the €69.2 million in funding allocated for women’s health in budget 2023, €1 million is for the unlicensed medicine Cariban. As with the Minister for Health, I am hopeful that this medicine will make a meaningful difference to the well-being of pregnant women. There could be an opportunity for pregnant women to access the drug when they go for their regular check-ups and scans in a maternity hospital, without having to see a consultant privately. Perhaps that could be looked at and streamlined. I will certainly raise the issue with the Minister. By allocating the €1 million for Cariban in 2023, we can ensure that pregnant women who were not previously able to get Cariban can now access it. However, there seems to be one small barrier that we need to overcome. I will certainly raise the matter with the Minister. I thank the Deputy for bringing it to the House.