Medicines Amendment Bill

The House in committee on the Medicines Amendment Bill. Members, we now come to the committee stage of the Medicines Amendment Bill. This bill will be debated in parts. We come first to Part 1, which includes the debate on clause 4, the amendment to the provisional consenting provision. The question is that Part 1 stand part.

Thank you, Madam Chair. I just have a fairly simple question for the Minister in the chair. New Schedule 1AA, inserted by clause 6, Part 1 clause 1(1) states, “The following provisional consents must be treated as having been given under section 23”, then lists a series of, I think, six medicines that are consented. Now, of course, we’re doing this under urgency. Parliament’s been taking up its time, not doing any other business, to get this right. Due to the, sort of, fast-moving and fluid and, dare I say it, haphazard nature of the process, can the Minister just assure everybody that in this list of six pharmaceuticals, these are the only ones that need to be treated in this way? It would be terrible to wake up to the news tomorrow and find that, actually, there was some other medicine or some other category of medicines that were caught so that we had to then go and do all this all again, especially on Budget day.

Yes, I can assure the member that these are the medicines that need to be treated in this way—though, of course, we’ve amended the Act so there is an opportunity for prospective applications for new medicines that fit the criteria for provisional consent to be made. It might be helpful for me to describe what the basis for other medicines listed there are and why they fit the provisional consent criteria, because I think it’s illustrative of what the provisional consent avenue seeks to achieve.

So the first one, labelled “(a)” there is, of course, the COVID-19 vaccine that we’re discussing. But there are five further ones: item (b) and item (e) are both oral contraceptive pills. And I think this is a really interesting illustration, because we experienced both issues with manufacturer problems with supply, and also supply chain disruption in the last year. That meant that there was a realistic possibility of there being no oral contraceptive pill available. Now, if we were only to have an emergency medicine authorisation process, I’m not sure if that would meet the definition of an emergency. But there is certainly a clear public health need for that. Both of those medicines were approved in other jurisdictions, and on that basis, and the basis of other data that was able to be provided to Medsafe, they were approved. Item (d) and item (f) are both influenza A vaccines, suitable for use in a pandemic, and they have both been subject to conditional approval since 2012—obviously with the two-yearly renewal of that status, as is required by all conditional approvals.

I note that we’re talking about the Schedule to the bill. So I seek leave for all parts to be taken as one debate.

Leave is sought for that purpose. Is there any objection? There is no objection.

Parts 1 and 2, the Schedule, and clauses 1 to 3