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

I was not at yesterday's parliamentary party meeting. I am taking this matter on behalf of the Minister for Health, Deputy Donnelly. The Minister appreciates that hyperemesis is a debilitating condition for women and is anxious that our health service should support women with this condition in every way possible. Improving women's health outcomes is a key priority for the Minister and this 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. As part of the women's health agenda, officials supporting women's health in the HSE and the Department of Health are working with urgency to identify all of the available options to better support this cohort of women. In the coming weeks, the Minister for Health will be bringing a women's health action plan to Government. It will set out a wide range of initiatives to support women's health, including maternal health.

On the question of access to medicines to treat the condition, unfortunately the situation is not straightforward. As the Deputy is 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. The Minister for Health is advised by the HSE that the product Cariban, which is regarded as a beneficial treatment for hyperemesis, is classified as a food supplement rather than a medicinal product. It 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.

However, the Minister for Health understands that some hospitals prescribe and dispense Cariban free of charge to patients with severe nausea and vomiting in pregnancy. The prescribing of an unlicensed product in a hospital setting is solely at the discretion of the treating clinician. Two other products, Navalem and Xonvea, are authorised by the Health Products Regulatory Authority for the treatment of nausea and vomiting in pregnancy in women.

However, a pricing and reimbursement application has not been submitted to the HSE for Navalem. The HSE also advises that in late 2021, the company responsible for Xonvea advised that they are not in a position to launch the product in Ireland at this time. The HSE has developed a national framework for access to medicinal products not currently on the reimbursement list through discretionary hardship arrangements in exceptional cases. As Cariban is considered to be a food supplement rather than a medicinal product, it cannot be considered for reimbursement as an exempt medicinal product under the General Medical Services, GMS, scheme and community drug scheme, or reimbursement under the discretionary hardship arrangements. For this reason, the HSE's own internal medicines management programme was asked last month to review the clinical evidence available on Cariban, and to make a recommendation on the appropriateness and feasibility of an exceptional patient-specific process for access to the product. The Minister for Health is advised by the HSE that this evidence review has commenced and the results of the review, along with recommendations, should be completed in a matter of weeks. The Minister for Health appreciates that this is a worrying time for women suffering with hyperemesis and is hopeful that the HSE can arrive at a positive outcome with respect to Cariban and its availability under the community drug scheme in Ireland.

See this speech in context