Dáil Éireann Debate, Tuesday - 28 April 2026
1274. Deputy Roderic O'Gorman asked the Minister for Health the reason imvaggis is not covered by the free HRT scheme; if consideration can be given to its inclusion in the scheme; and if she will make a statement on the matter. [30897/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines, which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013). The HSE must comply with the relevant legislation when considering investment decisions around new medicines.
The HSE must robustly assesses applications for pricing and reimbursement to ensure it can stretch available resources as far as possible, deliver the best value from each medicine, and ultimately, provide more medicines to Irish citizens and patients.
Formal processes govern applications for the pricing and reimbursement of new medicines and new uses of existing medicines to be funded and/or reimbursed by the HSE. Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the HSE list of reimbursable items or funded via hospitals. The decision by pharmaceutical companies to market licensed medicines in Ireland, i.e., whether or not to submit a formal application, is outside the control of the HSE.
As of the 27th of April 2026, the HSE has not received a pricing and reimbursement application for Imvaggis®(estriol) from the marketing authorisation holder. As outlined above, the national assessment and decision process cannot commence without a pricing and reimbursement application submission to the HSE.
