Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein) | Oireachtas source

I welcome the representatives from REGRET and the other health professionals who make up the panel. I would like to ask a number of questions about the patient information leaflet that comes with Gardasil when accessed across the counter. Is it still the practice that the same detail is not provided to parents in advance of their signing the consent form for their daughters to be vaccinated at school? If that is the case, could the officials explain why the information provided through the school vaccination programme falls short of that offered by the patient information leaflet?

Ms Cannon stated that there has been significant under-reporting of adverse reactions to the HPV vaccine. For the information of Ms Cannon and her colleagues, in a parliamentary reply I received on 5 November on this matter, which I have been pursuing for some time, it is advised that the Health Products Regulatory Authority, HPRA, had at that point received 919 reports of adverse reactions and events associated with the use of Gardasil in Ireland. That may, in the minds of some, be few in terms of the number of those who would have participated in the vaccine programme, but 919 reports of adverse reactions and events over what is a relatively short period is not insignificant, in my opinion. I am only offering that as additional information.

Would Dr. Bonner like to confirm to the committee that she did indeed convey the committee's view regarding a vaccine damage compensation scheme to her colleagues as undertaken at that time? Would she or anyone else like to comment on the potential for such a scheme to occur in the near future?

Regarding worldwide concerns, Deputy Kelleher has also made reference to Japan and Denmark. Who takes that into account? Is it the HPRA? We know the HPRA has indicated that it does not have the authority to withdraw the licence for the vaccine but can only make recommendations. Are we taking into account international concerns and evidence? I use the word evidence quite positively. What is the situation in Denmark? They have replaced it with an alternative vaccine. Have we such a choice? Is there any evidence to suggest the alternative vaccine is safer than Gardasil or that there are not the same concerns attributable to it? Is it an alternative, safer vaccine? Perhaps Dr. Bonner or Dr. Gilvarry could comment on that.

The decision of Japan to no longer recommend is not an insignificant decision on its part.

It is totally understandable that families are not coping financially. Ms Smyth made this point in her contribution. I advise the representatives from REGRET and any other interested party present that I raised this matter by parliamentary question this morning on the floor of the Dáil with the Minister, Deputy Varadkar in the area of disability allowance, medical card entitlement, etc. While the Minister's response was anything but encouraging - he kept referring to the criteria for qualification for medical cards - I reminded him that not so long ago medical cards were issued on the basis of medical need. The breach has happened and it is an important one. I asked the Minister to look at this particular cohort favourably, sympathetically and humanely. I would reference it to the representatives of REGRET. If they are not able to access the exchange, I would be happy to forward it to them afterwards.

Dr. Bonner, in her contribution, stated the signalled expectation was that the vaccine, Gardasil, could save the lives of up to 70% of women.