Medicines Amendment Bill

Thank you, Madam Chair, and thank you to the Minister for her answer to that previous question from my colleague.

CHAIRPERSON (Hon Jacqui Dean): Order! Sorry, Chris Bishop. Just procedurally, I need to put—the question is that Part 1 stand part. [Interruption] No. The question is that Parts 1 and 2, the Schedule, and clauses 1 to 3 stand part.

Madam Chair, thank you. I was just trying to be helpful to the committee. Clearly, maybe not!

CHAIRPERSON (Hon Jacqui Dean): No, very helpful.

Oh thank you, Madam Chair, very kind. Thank you to the Minister for that answer to my colleague’s question. Following on from the comments from the Attorney-General in the second reading of the bill, I note his response to my question through my speech, which was basically two questions: what was the Government told and when were they told it? His answer was the first the Government knew about the possibility of a legal challenge to the roll-out of the Pfizer vaccine was when the court proceedings were filed which produced the judgment that has prompted this case, which begs a series of other questions, the first of which is: did the Government ask for advice in relation to the legality of the Pfizer vaccine roll-out prior to the court proceedings being filed; and, if not, why not?

I’d be very—just not sure if that is a question in relation to this bill, and I’m sure this will be canvassed thoroughly at future question times, when the Minister responsible will be available.

Point of order. Madam Chair, I think the Opposition have been very gracious and quite generous. We could be doing three readings and debating a committee stage on the parts, was it not for the fact that the Opposition have agreed to actually truncate this debate so that the Government can get more of its business done later in the day. Now, I wonder if you might consider asking the Minister to be a bit more candid in answers to her questions in return for that.

Thank you. On that point of order, it was my view that the question asked by Chris Bishop was in order; however, it is not to me, not up to the Chair, to determine the quantum or the quality of the Minister’s answer. And Mr Bishop has further opportunities, as does every member in this committee stage, to probe the Minister on that question.

Madam Chair, I think it’s a very serious question that my colleagues Chris Bishop and David Seymour have put to the committee. We have an unusual situation where we have a court ruling and we have the Government using the powers of this Parliament to overrule that court process. In many instances that I have seen Parliament do this, often it’s said that you would allow the benefit of the individual that’s taken the court action to get the benefit of that, and that is just unconscionable in the public health situation that we have in the world and in New Zealand, and that is why National is choosing to be so cooperative in what is a pretty extraordinary exercise of parliamentary power to override the decision of the court.

So I want to go back to the very real question that my colleague Chris Bishop has asked, and that is that—and our Government experienced similar such experiences when dealing with the earthquakes, both Kaikōura and—and had to take extraordinary action. And when we did, as I’m sure you would in a corporate, if I look at my colleague Chris Luxon—is that you’re dealing with a crisis and you’d be saying, “What’s the legal advice? How do I get the skills in place?” And making sure we’ve got all the ducks in a row.

Now, when I look at the court ruling, it seems blatantly clear that to use a provision that was intended for a relatively small group of people to be able to receive access to a medicine—to, effectively, provide for the authorisation of the vaccine—surely somewhere in the bowels of Government, in dealing with the big-list public policy issue that our nation’s faced at one of the biggest crises in our country’s history, somebody asked the question: is the vaccine lawful and the process proper?

So I go back and would ask the question that has been asked both by David Seymour and Chris Bishop. It does need to be addressed by the Government. Did the Government Ministers ask the question of the officials as to whether the provisions in the Medicines Act—that we’re seeking to amend—were adequate for a national roll-out of a vaccine as important as that for COVID?

I think you’ve heard from the Attorney-General already today that Ministers learnt of this problem at the time of the court action, and our view is that the ministry obviously believed that it was acting legally and in accordance with earlier practice, and you can see that from the fact that going back to 2012, other pandemic vaccines have been approved in this way.

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.

Thank you, that is a really important point for us to keep in mind as we develop the therapeutic goods bill. I think, just to be clear, the two influenza vaccines in the Schedule are pandemic influenza vaccines. The H5N1 is a bird flu vaccine and the other is a generic influenza A pandemic vaccine that does allow for that and it is currently, I understand, agnostic as to which specific strain of influenza A it is, so it can be updated. To me, it seems like that is an appropriate use of the provisional consent, which, of course, is time-limited. But I take the member’s points and concerns on board, and I’ll certainly raise them as we do the policy development around the next Act.

Thank you, Madam Chair. Just reflecting on the point that was raised by the Hon Michael Woodhouse, I would ask the Minister to confirm my understanding, if I’ve got it right, which comes from both the general policy statement and the explanatory note, which is that the effect of the amendment is, essentially, to remove the words from the current section 23 that the use has to be for “a limited number of patients”. This is made clear by considering the existing section 23(1), which says “Notwithstanding sections 20 to 22 [of this Act], the Minister may, by notice in the Gazette, in accordance with this section, give his”—as the member has said—“provisional consent to the sale or supply or use of a new medicine where he is of the opinion that it is desirable that the medicine be sold, supplied, or used on a restricted basis for the treatment of a limited number of patients.”

That’s replaced in this new bill by clause 4 of the bill, which replaces that section 23(1) with this subsection (1), which says, “Notwithstanding sections 20 to 22, the Minister may, by notice in the Gazette, in accordance with this section, give provisional consent to the sale or supply or use of a new medicine if the Minister is of the opinion that it is desirable that the medicine be sold, supplied, or used.” So other than making it gender-neutral language, the only change here is to remove the reference to “a limited number of patients”. That is the change, in effect, as I understand it, and that change is not just for the benefit of the listed consents that are being retrospectively validated; it also applies to other applications for provisional consents in the future, should they be made. Of course, that could all become overtaken eventually by the replacement in the therapeutic goods bill, but we don’t need that in order to have a functioning mechanism in respect of provisional approvals for new vaccines or other medicines. That was a question to the Minister as to whether my understanding is correct.

I can confirm that is my understanding.

I thank both the Minister and Mr Parker for that observation, which I agree with absolutely as a prefacing comment, although I would add that it wasn’t only the words on the treatment of “a limited number of patients” that’s being deleted. It’s sold, supplied, or used on a restricted basis, and so the legal framework was intended to restrict the dispensing of medicines under this section compared with those approved under sections 20 to 22.

I think my central point remains that there is a risk that we get into a potentially perpetual cycle of approvals under section 23 if the vaccine changes to such a degree that a new application is warranted. Therefore, we may never—that’s a slightly far-reaching sort of conclusion—actually approve a COVID vaccine under sections 20 to 22, and that was never the intention of this section. It’s an unusual situation, I think, where because of the potential rapid mutation of a virus, the medicine itself changes to such a degree that it’s no longer applicable to dispense it under the gazetting under section 23. I simply raise it as a policy question for the ministry, because it may well be that we need a third path of approvals.

Sorry, I thought my colleague Andrew Bayly was seeking a call, but, in fact, he’s skedaddling. So two questions following on from my previous remarks, and they relate to Part 1, or New Schedule 1AA, which amends Part 1 in relation to the validation. The first is, when the Cabinet was considering the roll-out of the COVID-19 vaccines, particularly the Pfizer vaccine in relation to the Cabinet papers, did those Cabinet papers identify any legal risk and was this prospect identified as a legal risk? And secondly, when did Cabinet first turn its mind to the possibility that the legislation that we’re debating might be required?

I just want to reinforce the importance of the Minister in the chair answering the essential question, because here is the part that has me dumbfounded: you would not need a law degree to say that when section 23(1) of the Medicines Act said it was to be used for “a limited number of patients”, and you were proposing to roll a vaccine out for 5 million New Zealanders, that you’ve got a mistake, that—

CHAIRPERSON (Hon Jacqui Dean): No. Order! Order! Not me.

That’s right; the Minister in the chair. It would not require a legal degree or a great deal of sense to realise that when section 23(1) requires that it may be used for “a limited number of patients”, and the Government was intending for a vaccine roll-out in the biggest public health crisis in a century, aiming it for 5 million people was never going to pass the legal test of a limited number of patients.

So the question that my colleague Chris Bishop asks is a question the Government must ask because it goes to the core of the competency. I want to remind the committee that we are overruling a court decision. We’re applying this law retrospectively. It is an issue that goes to the heart of the biggest issue that New Zealand has faced in many years: that there is a high expectation of a level of competency within Government. So we do require an answer to: how was it possible for a Government to be so incompetent to believe that it could approve a vaccine when the provision on which it was approving it explicitly said that it could only be used for “a limited number of patients”? That question needs to be answered by the Government.

In response to the member Chris Bishop’s first question, the answer is no, and to the second question, the answer is: last week. I think the last member to speak, the Hon Dr Nick Smith, asked a number of rhetorical questions about how this is possible. Well, the answer must be the same for this Government as it was for the Government in 2012 that approved two similar pandemic vaccines—

💬 Hon Dr Nick Smith: We weren’t rolling out a nationwide vaccine.

Well, why did you approve something you didn’t think—

CHAIRPERSON (Hon Jacqui Dean): Order! The Minister will not bring the Chairperson into the debate.

My apologies, Madam Chair. So this has been the practice in this area for some time—that conditional approvals have been not considered to be restricted with respect to people—and our legislation today updates the Act in order to make it reflect practice, and international best practice.

So summarising all of that from the last half an hour, 40 minutes or so, plus the second reading, is it reasonable to say the following: the Government was never told that there was a chance of a legal problem about the roll-out, the Cabinet papers did not identify any legal risk in relation to the roll-out, no one in the Government asked for advice about any legal risk to the roll-out, and that the first time the Government started to consider legislation to respond to any negative court ruling was last week?

I think the member has my answer about when consideration of this matter was initiated by Cabinet, which was in response to the court ruling. And no, I disagree. I think legal risk has been considered throughout the vaccine roll-out overall.

I wish to question further. The Minister has said that—

CHAIRPERSON (Hon Jacqui Dean): Order! Order! I call Dr Nick Smith.

The Minister’s answer actually requires further explanation. Earlier in the committee stage, the Minister indicated the Government knew that the Medicines Act was outdated. In fact, the Minister has said that the Government’s work programme was concerned that the Medicines Act was outdated. Now, the Minister has just said legal risks were assessed. Well, I’m sorry, the Minister has to give some explanation as to why, if legal risks were assessed and section 23 said that the vaccine could be used for only a limited number of patients, when the Government’s intent was to roll the vaccine out for 5 million New Zealanders—how could the legal risks have been assessed, when a person without any legal qualifications could see the mismatch between the law and the Government’s intention?

As I’ve mentioned, the ministry obviously believed it was acting legally and in accordance with practice.

The question is that Parts 1 and 2, the Schedule, and clauses 1 to 3 stand part.

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

House resumed.

The committee has considered the Medicines Amendment Bill and I report the bill without amendment. I move, That the report be adopted.

Motion agreed to.

Report adopted.

Third Reading