Dáil Éireann Debate, Thursday - 30 June 2022
289. Deputy Joe Carey asked the Minister for Health when he expects uromune to become available in Ireland for the treatment of recurrent urinary tract infections given that it is currently available through various special access programs in countries around the world, including the UK, the Netherlands, Sweden, Norway, Spain, Australia and New Zealand; and if he will make a statement on the matter. [35116/22]
Amharc ar fhreagraDepartment officials have consulted with the Irish medicines regulator, the Health Products Regulatory Authority (HPRA), on this matter. The HPRA has advised that Uromune is not authorised nationally in Ireland, nor is it centrally authorised by the European Medicines Agency. The HPRA has also advised that, while there are some international clinical trials investigating the use of Uromune in the context of urinary tract infections, it has not received any application to conduct a clinical trial with this medicine in Ireland.
If the safe and efficacious use of Uromune in the treatment of recurrent urinary tract infections is demonstrated through successful clinical trials, the marketing authorisation holder may choose to apply to the European Medicines Agency or the HPRA to place the medicine on the market. The decision to make such an application can only be made by the marketing authorisation holder. It is important to note that, as Minister for Health, I have no role in the authorisation process for medicinal products.
