Dáil Éireann Debate, Tuesday - 29 January 2019
310. Deputy Clare Daly asked the Minister for Health the reason HIQA in its health technology assessment, HTA, report on extending the HPV vaccine to boys published in December 2018 used a Norwegian definition of a serious adverse reaction instead of the EU/EMA/HPRA definition of a serious adverse reaction as set out in guidelines (details supplied). [3765/19]
View answer311. Deputy Clare Daly asked the Minister for Health the reason HIQA or his officials consider Norwegian data to be more accurate or relevant than HPRA data; and if he will make a statement on the matter. [3766/19]
View answerI propose to take Questions Nos. 310 and 311 together.
The Health Information and Quality Authority, HIQA, has advised that, in relation to its HTA report on extending the HPV vaccine to boys, a comprehensive, independent safety assessment was conducted by it. A systematic review of all relevant international literature was performed that encompassed 70,000 trial participants and surveillance of many millions of individuals in cohort studies, and had a follow up of up to ten years. Ireland-specific safety data from the Health Products Regulatory Authority, HPRA, were reported in the HTA.
A Norwegian definition of, "serious adverse events", was not used in HIQA’s safety assessment of HPV vaccines. The review noted that a single agreed definition of serious adverse event is not applied across safety studies. Consistent with all national adverse reaction reporting schemes, HPRA safety data must be interpreted with caution, as they relate to "suspected" adverse events that are not always medically confirmed. In the absence of validated Irish data on hospitalisation rates for HPV-associated adverse events, Norwegian data was used to inform estimates of these costs in the economic model.
