Anne Rabbitte (Galway East, Fianna Fail) | Oireachtas source

I thank the Deputy for raising this matter. She has given me the challenge of using an awful lot of words that are very complicated, but I will do my very best.

On behalf of the Minister for Health, I thank the Deputy for raising this topic and appreciate that it will be of concern to many women in Ireland. Hyperemesis is a severe form of nausea and vomiting during pregnancy that affects some women 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. That included dedicated funding for Cariban, a medicine used to treat hyperemesis. As of January 2023, this medicine is now available to those women who need it. I take fully on board what the Deputy has just said; it comes with its own health warning.

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. There are three medicines containing doxylamine-pyridoxine which are licensed in Ireland. They are Xonvea, Exeltis and Navalem 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 need of patients with hyperemesis, the HSE's medicines management programme was asked to review the clinical 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 drugs schemes on an individual patient basis for the treatment of nausea and vomiting during pregnancy where consultant obstetrician-initiated. That is the crux of the issue. While the initial prescription for Cariban must be issued by a consultant, further prescriptions can be issued by a patient's GP. Consultant initiation is the case for all unlicensed exempt medicinal products under the community drugs schemes. The HSE advises that where a drug is not licensed, the expertise of a specialist in the relevant field is necessary to ensure safe usage. If, however, a licensed product were 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, Xonvea, Exeltis and Navalem, to progress with the formal pricing and reimbursement process in Ireland.

I feel there is a process being put in place but it is not solving the problem. I have to acknowledge that the Minister, Deputy Stephen Donnelly, did listen to the campaign. He worked really hard to ensure we could find a solution. Unfortunately, by the time you hit 20 weeks or 18 weeks, you are probably over the worst of your sickness and you also will not have seen your consultant, so there is a problem with waiting the 20 weeks to see the consultant.

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