Woodhouse MichaelHon MICHAEL WOODHOUSE (National): Thank you Madam Chair. I think it's a measure of the age of the legislation that if one reads section 23 it's very masculine—it talks about how the Minister may give his" provisional consent and on giving his provisional consent the Minister may do lots of things. Well we have a female the Associate Minister of Health who has that power and I think the Medicines Act certainly does need updating if for that reason alone. But one of the other things that I think—and we're not going to be able to do it in the time that requires us to make lawful the question that the High Court has determined but I read with interest in the judgment that Pfizer were asked by the ministry in addition to their provisional consent to actually table a full consent under section 20 or 21. Now that raises the perception and clearly the authorities believed that a provisional consent wasn't sufficient to satisfy all of the questions that it had regarding—certainly—efficacy because of course with the vaccine roll-out one wouldn't know the efficacy of the vaccine until the end of the product. But it also talked in the court judgment that Pfizer were also asked to continue to provide other information including that around safety. Now this raises an interesting question of the degree to which the lifting of the limit on the number of people the class of people that could benefit from a new medicine is then going to mean that any vaccine may never get full consent under section 21 because we now know the seasonal influenza vaccine has probably been captured by the court judgment. So I want the Government even if the Minister can't answer the question today to consider the degree to which there may need to be a new process for vaccines and inoculations more generally because the risk is that if there's a two-year window the likelihood is that a new assay a new type of vaccine is going to be required at least to be updated and then new provisional consent needed. In fact that's a question that I would have of seasonal influenza vaccines because we're now gazetting them under I think—yes H5N1 influenza vaccine is notified in the Gazette 2018-go576. So we've now got the situation where we could be in this endless loop of provisional approvals for vaccines that are continually changing. At some point I think it's either necessary to say that–to confirm that—or say that that requires a different process. It may be that and I will go to the right clause—ah yes it is sections 20 and 21 that isn't appropriate for the vaccine.So I would encourage the Minister to think about whether or not theirs is necessary—almost like a third way a third pathway for the approval of medicines that for proven patent medicines that for provisional experimental medicines which section 23 was designed to cover and then a third class now for the perpetual approval of things like influenza and COVID vaccines because I think we're going to be doing this for years. And if the virus is going to act in the way that we think it is—it's going to mutate it's going to need a new vaccine we're probably going to need booster injections in a couple of years—I worry that if the authorities felt that it was necessary for Pfizer to do a full application on this they now don't need to do that. Well one could argue that by the time that's complete a new provisional approval will be necessary for a new vaccine.I hope I've made myself clear on that; it's a bit jumbled in my thinking. But I do think there's some homework for the ministry and for Medsafe to do."