Gary Gannon (Dublin Central, Social Democrats)
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I thank the Office of the Ceann Comhairle for providing time for this Topical Issue on the urgent need for accessible and affordable medical care for those suffering from hyperemesis. The women's health task force and the medicines management programme were recently tasked with finding a solution when it comes to the treatment of hyperemesis with the drug Cariban. Cariban is the first stage in the treatment algorithm for hyperemesis in our national guidelines but it is unlicensed in Ireland and unavailable for reimbursement, with treatment costing more than €3,000 in some cases over the course of a pregnancy. Yesterday some welcome news was reported from the Fianna Fáil Parliamentary Party meeting. I would very much like to hear the detail of what was proposed and the impact this will have for those suffering with the condition.

Anne Rabbitte (Galway East, Fianna Fail)
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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.

Gary Gannon (Dublin Central, Social Democrats)
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I sense the Minister of State's frustration in the response. When I give my response back it is not aimed at the Minister of State, Deputy Rabbitte, it is aimed at the lack of urgency in addressing the issue.

When the Minister for Health, Deputy Stephen Donnelly, was in opposition in 2018 he raised this very issue. Back then he would have brought it to the Heath Products Regulatory Authority much quicker than last month.

The effects of hyperemesis are not insignificant for pregnant women. It takes an extreme toll on the mental and physical health of the pregnant person. I want to thank the work of Hyperemesis Ireland and everyone who has shared their story on just how debilitating, isolating, and needlessly financially devastating this condition can be. I acknowledge also the domino effect that this on our health care system. In 2019 there were 3,237 day patients and inpatients as a result of dehydration and for hyperemesis treatment. In 2020, at a time when maternity services, like all health care services, were severely impacted a result of Covid, the figure was 3,007. How many women would not have needed such hospital intervention at the height of the pandemic had Cariban been available to them?

I will come off script now and say to the Minister of State that I believe there is a shared need for urgency around this issue. The Minister for Health, Deputy Stephen Donnelly made a statement last that was picked up in the media, captured attention and got people excited. Can we please just bring some finality to this? Women are suffering as a consequence of an absence of action on the issue. This medication costs more than €45 per week and people just cannot afford it. Let us get some urgency behind it. It does not have to be an issue of the Opposition versus the Government. I believe we share the same goal in this regard. I trust that the Minister of State would take this frustration, which we both seem to share, back to the Minister for Health. I ask that the Minister of State would put a bit of fire under him for it.

Anne Rabbitte (Galway East, Fianna Fail)
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I will take this back after I leave the meeting later on. I do know that the Minister, Deputy Stephen Donnelly, has put a priority on women's health. The priority means that if something was said last night, let us get clarification on that. As a woman who has given birth three times, I also suffered. I cannot say it was with hyperemesis but I know what morning sickness is like. I cannot imagine what that level of illness is like and I would not want any woman to go through it. I will talk to the Minister, Deputy Stephen Donnelly about this. As I have said it is a priority and it is a shared priority of all of in here to ensure that nobody has to go through that unnecessarily.