Therapeutic Products Bill

Members, good morning. The House is resumed in committee. When we suspended last evening, we were considering Part 6 of the Therapeutic Products Bill, and I’m seeking a call.

Thank you, Madam Chair. So last night, before we rose, we were having a discussion about the potential provisions that could be in the bill to better support our medical professionals and patients, and I wanted to draw attention to Supplementary Order Paper (SOP) 383 under my name, particularly the bit that talks about Part 6.

As Dr Shane Reti alluded to, there is a growing call by medical professionals and experts around the need to ban direct consumer advertisement for prescription medicines. It’s one of those issues that, I think, we’ve become an outlier, alongside the US. In the US, we do have a great example of how things can go terribly wrong, where big pharmaceutical companies can dominate a market in terms of aggressive advertising to their communities. While that may not be reflected so much here, I think we leave ourselves vulnerable to huge power dynamics between different pharmaceutical companies—who, as has been acknowledged by the experts, their intent in advertisement is not necessarily grounded in public health so much as it is to make profit, and therefore there are concerns by the medical community about whether the advertisements, in and of themselves, actually support public health outcomes or whether they are clogging the healthcare system and adding pressure to general practitioners.

I acknowledge that the Minister wants to put this in regulations, and I guess my question around this would be about her level of confidence in being able to resource the departments who then would be in charge of those regulations to take into account the multiple dynamics that would exist and tensions that would exist in terms of the lobbying that would end up happening by pharmaceutical companies to prevent banning of direct consumer advertisement for prescription medicines, because there is an opportunity to just put it in primary legislation and follow international evidence and international best practice with this SOP. I have to acknowledge that, for me, it’s not so much about which SOP that does this is the one to choose; it’s more about getting the outcome that medical practitioners and our community wants, right?

So to just summarise, my question would be around the level of confidence around being able to get the regulations right—particularly concerned because we have seen what happens with the medical cannabis regime in terms of tensions around properly resourcing our departments to make good decisions and understanding that then there’s going to be a lot of lobbying going on. With this one, I do think it’s quite crystal clear in that there hasn’t been evidence overseas to suggest that this type of advertisement supports public health outcomes. So I’m keen to get a sense of the Minister’s confidence about how she thinks leaving it to regulations will deliver the outcome that I think many of us actually want and that medical professionals want.

Thank you very much, Madam Chair. Minister, I hope to raise an issue with you regarding clauses 193 and 194 regarding advertising. An issue’s been brought to my attention by Business Events Industry Aotearoa about the effect that can have on medical conferences. I’m advised that under section 20 of the Medicines Act 1981, which these clauses, I understand, largely replicate, Medsafe New Zealand restricts trade shows attached to a conference from displaying or discussing medicines that have not been licensed in New Zealand but are licensed in some parts of the world and therefore have relevance to delegates who may not be locally registered doctors.

Obviously, these trade shows are important for bringing others to New Zealand, and they think there’s probably about $90 million worth of business and direct spend that’s potentially at risk here if we can’t attract people here. I have had examples brought to my attention where, for example, Australian-based sponsors are nervous about coming to New Zealand and holding scientific conferences due to this issue. Additionally, there are Australia-based clients who will not even consider New Zealand when the Australian delegates cannot be given the same information they’d expect to get in an Australia-based meeting. So I’m wondering if the Minister could clarify the intention of this and whether it will have that impact from his perspective.

Thank you, Madam Chair. I just rise briefly to contribute on this discussion regarding Supplementary Order Paper (SOP) 383, in the name of Ricardo Menéndez March, and SOP 372, in the name of Dr Shane Reti.

I’d just like to hear the Minister’s input into the concept of banning such advertising. I’d like to know if the Minister has considered any unintended consequences around this, such as a lack of information that can be provided to consumers, to patients. Perhaps they might go to the GP with a request that’s not quite right but at least they’re getting some more information and they’re becoming aware of these treatments. I reflect on something on the news last night; there was a new treatment undergoing trials, very successful trials, for Alzheimer’s disease. Could something like that be caught up in this where coverage is restricted, or at least when something gets approved, they can then not actually educate the public? So what are the Minister’s thoughts on this? Thank you.

Thank you very much, Madam Chair. I want to start by acknowledging the two contributions around direct-to-consumer marketing. There have been concerns raised by medical experts about the role that direct-to-consumer advertising can have in appropriate use of medicines and the harm and wasted resource that may occur from that. That evidence and those calls were what led the Government to amend the bill to include a provision for a regulation that is strengthened in my Supplementary Order Paper (SOP) to enable prohibition of direct-to-consumer advertising. So I’d just like to reiterate the difference: the Government’s SOP allows prohibition of direct-to-consumer advertising in regulation whereas SOP 372 from Dr Reti and 383 from Mr Menéndez March puts that into legislation. So, in essence, those members from those parties and the Government are in agreement that there is a case here for harms from direct-to-consumer advertising, and it is appropriate that we seek to prevent that through our legislation.

I want to be clear—interestingly, the other two contributions made in the Chamber this morning illustrate the risks that may be present in this approach. Mr Mooney made a contribution about restrictions on advertising at trade shows of unapproved medicines and a concern that why would scientific meetings or trade shows occur in New Zealand if certain medicines that were at the cutting edge but not yet approved here couldn’t be regulated? When the select committee considered the bill, those sorts of unintended consequences from restrictions on advertising were considered, and that’s why clause 193 has been amended in the bill in the form it returned to the House in order to address that potential risk in unintended consequence. There is no intention of stopping experts from knowing about the advancements in science that occur in pharmaceutical science.

It is the risk of unintended consequences by a blanket ban in the legislation, in the bill, that gives the Government pause when considering whether or not to vote for these SOPs, and it is these types of unintended consequences that became clear at select committee that mean a blanket ban on direct-to-consumer advertising is not the Government’s preferred position. Instead, we have the opportunity to develop proposals, take advice on them, consult on them, address the New Zealand Bill of Rights Act issues that have been raised—that I have been advised on by both the Ministry of Health and the Ministry of Justice—and then make a decision and make a prohibition or other regulation in secondary legislation. That is the Government’s preferred approach.

This is not an area where we want to rush our legislative approach. There is a risk of unintended consequences, as the select committee identified when it went into this area of restrictions on advertising. The select committee was very concerned about potential bans on forms of communication about medicines that we consider appropriate in a free society, such as Givealittle pages, such as advocacy, such as satire.

Thank you, Madam Chair. Given that contribution, has the Minister seen overseas evidence where most jurisdictions—apart from ourselves and the United States—believe that the harms caused by direct-to-consumer advertising outweigh any perceived or real unintended consequences, and certainly any New Zealand Bill of Rights Act - like implications?

I take a brief call, mostly for the purposes of allowing the Minister to have time to respond to my colleague’s contribution. I suppose, just to pick up on Dr Reti’s point regarding New Zealand Bill of Rights Act (BORA) implications; for the uninitiated, of course, our New Zealand Bill of Rights Act includes that section 14, “Freedom of expression”: the right to impart, but also the right to receive opinions and information, and so forth. And no doubt my learned colleague, who obviously knows much more about things medical as well as other fields than me, presumably refers to the fact that it would be helpful to ensure, within reasonable limitations or justified limitations in terms of NZ BORA, that people have the ability to make informed decisions on their own account.

I thank the members for their contribution. In response to Dr Reti’s contribution: yes, I have been advised that Australia has a ban on direct-to-consumer advertising. I’m advised the European Union has a directive, but individual members of the European Union vary widely in how that directive is implemented—and there are numerous reports of how pharmaceutical companies escape that regulation. So I think to cast the international picture as black and white is perhaps not totally accurate. My role as Minister is to make sure that I have diligently considered the implications in terms of the New Zealand Bill of Rights Act (BORA), and the fact is that there needs to be, in my view, further consideration of that because the bill that went to select committee did not have a proposal for direct-to-consumer advertising. There is an opportunity to evaluate a concrete proposal when secondary legislation is developed, and to have that evaluated for its BORA implications.

I’d like to go back to the contribution of Mr Menéndez March about the resourcing and prevention of undue influence on the Government’s decision process. I hope Mr Menéndez March is reassured by the widespread concern across parties in the House about this issue that there is support for Government, of any form, to be able to regulate in this area. But the issue he raises reminds me of the legislation, the work we’ve done in regulating tobacco in New Zealand—another area where lobbying and inappropriate influence of regulatory processes and legislation is an area of concern. I have a lot of confidence in the ability of the Ministry of Health officials to protect their regulatory processes from that type of influence, and I think, as you can see, there are numerous—both in the conversation we’re having today and the conversation we previously had on tobacco control—

CHAIRPERSON (Hon Jacqui Dean): Order. I’m just going to have to rule on this, because it is out of order for any member to impute any influence on the Government of the day. Now, I will review Hansard, and if such a comment was made, then the House should view that very seriously. So I would appreciate it in the meantime if the Minister just steered away from that.

I’m confident that the regulatory process will be resourced so as to make sure that all the appropriate considerations are taken into account.

The Therapeutic Products Bill has been in progress for many months now. Can I ask the Minister, then, if she has sought a New Zealand Bill of Rights Act opinion on direct-to-consumer advertising from Crown Law?

I am advised that a New Zealand Bill of Rights Act vet is only provided on the bill, not a Supplementary Order Paper.

Just in the spirit of helpfulness, I think it might be helpful to point out that a New Zealand Bill of Rights Act vet can be provided, or a further opinion can be provided—it’s not required; the Minister’s right to say that it need not be, but it could be. I suppose if I could take the liberty of refining my colleague’s question to ask if she’s had any conversations with the Attorney-General or anyone else who would be helpful in the space of determining whether the Supplementary Order Paper might fall foul at, admittedly, a later stage of the legislative process.

I thank that member for that contribution. Yes, I am confident I have thoroughly tested the advice about whether or not there are New Zealand Bill of Rights Act issues to be explored. I’ve heard from health officials and other officials that that is indeed the case. That was very influential in my decision to have the Supplementary Order Paper written as it is.

I move, That the question be now put.

Motion agreed to.

Dr Shane Reti’s amendments to Part 6 of Supplementary Order Paper 368 set out on Supplementary Order Paper 384 are out of order as being inconsistent with a previous decision of the committee.

The question is that the Minister’s amendments to Part 6 set out on Supplementary Order Paper 368 be agreed to.