Mary Seery Kearney (Fine Gael)
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l raise an issue in respect of which Senator Ahearn campaigned all through last year in order to make sure that the product in question was on the funding list. It is now on the funding list but it may as well not be. The provision is completely impotent. I refer to the alleged reimbursement for Cariban. This product is for women who suffer severe illness and vomiting during pregnancy. The condition for its reimbursement under the scheme is that it must be prescribed by a consultant. However, the reimbursement is subject to the drug payment scheme meaning that the person for whom it is prescribed must pay the first €80. A woman may only see a consultant when she is well advanced in the first trimester, if not at the very end going into the second trimester, so she has to fund the medicine for the first 12 weeks. Even when a person qualifies for the scheme, there is no retrospective reimbursement.

When this matter was raised in the Dáil, the response was from the Minister for Health - I note that the Minister of State here is not in that Department, which is a bit of a disappointment but which is no reflection on him personally - was to implore the drug companies to apply for the licence. However, the drug companies and practitioners are operating lawfully because we have an exempt medicinal product list. The point of that is that it is not necessary to apply for a licence or authorisation but if a consultant underwrites it, and, in other words, takes the risk away from the State in the prescribing of this matter, then where the consultant takes on the risk and carries the legal burden then it will be all right.

Rather than Ministers standing up and calling on the drug companies to apply for this and ensure that it is on the list, it would be better to reappraise the exempt list and assess whether it is suitable. Women can be sick all the time for the duration of the nine months of their pregnancies. The State purports to provide them with financial support but, in actual fact, it does not do so; it provides them with the very minimum. In that context, they might get a box and a half of Cariban capsules every four weeks.

Niall Collins (Limerick County, Fianna Fail)
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I am here on behalf of the Minister for Health. I thank Senators Seery Kearney and Ahearn for raising this matter and appreciate that it will be a concern for many women in Ireland.

Hyperemesis gravidarum is a severe form of nausea and vomiting during pregnancy that affects some women and that must be diagnosed and treated appropriately. The Government is keen to ensure that anyone experiencing this condition receives the support they need. As part of budget 2023, the Minister for Health announced €32.2 million in funding for women's health this year. That includes dedicated funding for Cariban, a medicine used to treat hyperemesis gravidarum. As of January, 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 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. There are three medicines containing doxylamine or pyridoxine that are licensed in Ireland.These are listed in the reply. Two of them are gastro-resistant tablets and one is modified-release hard capsules. To date, the market authorisation holder of Xonvea has not progressed the pricing and reimbursement application further with the HSE. The market authorisation holders for Exeltis and Navalem have not submitted pricing and reimbursement applications to the HSE. Therefore, to address the unmet needs of patients with hyperemesis gravidarum, the HSE's medicines management programme was asked to review the evidence available on the unlicensed exempt medicinal product Cariban, and to make a recommendation on the appropriateness and feasibility of an exceptional patient-specific process for access to the product.

Following the recommendations of the medicines management programme, an exceptional arrangement has been put in place to support the reimbursement of Cariban. Cariban is now available under the community drug schemes on an individual patient basis for the treatment of nausea and vomiting during pregnancy where consultant obstetrician-initiated. While the initial prescription for Cariban must be issued by a consultant, further prescriptions can be issued by the patient's GP. Consultant initiation is the case for all unlicensed exempt medicinal products under the community drugs schemes. The HSE advise that where a drug is not licensed, the expertise of a specialist in the relevant field is necessary to ensure safe usage. However, if a licensed product was approved for reimbursement this arrangement could then be reviewed or revised. The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, and other healthcare professionals to encourage the market authorisation holders of the available licensed medicinal products to progress with the formal pricing and reimbursement process in Ireland.

Mary Seery Kearney (Fine Gael)
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I thank the Minister of State. With due respect, putting the onus on drug companies to make the application when they are part of a for-profit industry - and let us be very clear about what it is - is absolutely farcical. It is not a patient-led response nor is it a citizens-of-the-Republic-led response. The fact is that what we are about is deferring the risk and the legal burden onto a practitioner or a consultant. The person who pays the cost in the middle of that is a woman who either does not get her prescription, does not get her funding, or may in fact be hospitalised at a cost to the State. The cost includes the hospitalisation, the woman's health, the bed that is unnecessarily taken up, and a woman on a drip in a hospital, as some of the patients who need treatment have told me. To be quite honest, the whole arrangement of an exempt list and our funding relationship with that needs to be reviewed and needs to be patient-centred.

Niall Collins (Limerick County, Fianna Fail)
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On behalf of the Minister for Health, I thank the Senators for raising this important matter today. Progressing women's health is a priority for this Government. A strong commitment to promoting women's health was made in the programme for Government. We are fully committed to the development and improvement of women's health services and to working with women and girls to improve their health across the whole lifecycle. The funding of €32.2 million for the women's health budget in 2023 will help continue making progress in the area for the coming year. This includes the dedicated funding for Cariban. The Minister for Health is pleased that this treatment is now available to those women who need it, and hopes it will make a meaningful difference to their well-being.

The Minister understands the frustration that exists around the fact that the medicine is only accessible via a consultant prescription in the first instance. This is because Cariban is an unlicensed exempt medicinal product, and therefore the expertise of a specialist in the field is necessary to ensure safe usage. The HSE's managed access protocols for Cariban lay out appropriate clinical protocols that must be followed to ensure safe usage. I will relay and reflect the concerns of both Senators to all of the Ministers in the Department of Health.

Mary Seery Kearney (Fine Gael)
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With respect, I am getting texts from a woman who has been waiting for over a month for the consultant to sign that form so that she can then get to a place where she will get some small intervention. The system just is not working and it is not all right. If one is in the public system, one really is at the mercy of the State.