Stephen Donnelly (Wicklow, Fianna Fail)
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Department 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.

Denis Naughten (Roscommon-Galway, Independent)
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290. To ask the Minister for Health the steps that are being taken to increase the volume of generic medicines used to fulfil prescriptions to achieve the European Union average of 70%; the estimated savings to the annual drug bill as a result; and if he will make a statement on the matter. [35122/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Pricing and Supply of Medical Goods) Act 2013 provided for Interchangeability/Substitution, informed by the HPRA list of interchangeable products for medicines with a generic equivalent.

Under the 2013 Act, pharmacists are obliged to offer the lowest cost product on interchangeable list. The HPRA maintains a list of interchangeable products to enable substitution in this way.

Under the 2013 Act, the HSE sets a common reimbursement price for all medicines in any group of interchangeable products (internal reference pricing).

The HSE Medicines Management Programme was established in 2013 and continues to implement measures to assist prescribers in cost-effective prescribing.

Under the 2013 Act, the HSE has statutory responsibility for the administration of the community drug schemes, including data concerning prescribing and reimbursement; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.