van Velden BrookeBROOKE VAN VELDEN (Deputy Leader—ACT): Thank you Mr Speaker. It's a pleasure to rise this afternoon on behalf of my ACT Party colleagues in support of the first reading of the Therapeutic Products Bill and we do so at the first reading to send the bill to select committee so that we can have proper scrutiny of this piece of legislation.This bill is a huge piece of legislation. I believe it requires at least six months at the select committee because if you look at it just in physical form you can see how much it wants to change our regulatory and legislative environment. But I really want to stress the point that's raised in Part 1 that in the equivalent jurisdiction of Australia where they have a regulator for medical products and all other therapeutic products there are approximately 2500 pages of secondary legislation plus regulations of 100 to 150 pages under each of the Australian State's Acts. So getting this bill right is crucial because it will lead to a huge regulatory compliance regime that will have flow-on effects for anybody involved in therapeutic products throughout New Zealand. So we need proper scrutiny of this new regulator through select committee.We also need to make sure there is adequate time for submissions to be made. I don't want to see this being rushed through at any point. I want submitters to have a full submission process. There will be people shutting down for Christmas. There will be people who have been really stressed with COVID in the pharmacy and medical space and have been really under the pump for the last few years and they will need a lot of time to actually look through this huge piece of legislation get their thoughts on paper submit them to the select committee and then have adequate time to then come and put their voice to Parliament. It's crucial that we get this right for everybody and not just the big players that you can expect to see come before the select committee. This touches on natural health products people who might sell at their local farmers markets people who might be involved in Chinese medicine in our community people who might be involved in Rongoā Māori in our community. Everybody needs to know that this is actually happening and they have adequate time to come and submit because it will change the way that people get their natural health products all the way up to how you get your hip-joint replacement. So it's very very important that we have adequate time to scrutinise this legislation.So what does the bill actually want to do? Well it's trying to get rid of the Medicines Act and the Dietary Supplements Regulations 1985 to put in place a comprehensive regulatory regime to regulate therapeutic products which are medicines medical devices natural health products and active pharmaceutical ingredients. That includes medicines made from biological components gene therapies and advanced cell and tissue therapies all the way through to medical devices that are software production systems whole organs and tissue grafts; and natural health products that are traditional and herbal in nature and all vitamins and minerals supplements. And so as you can see it's extremely comprehensive and requires the full time of this House. I believe though that it has missed a trick in one aspect. And we've already seen this play out in the media where the Minister of Health has acknowledged that while the Ministry of Health wanted to see pharmacy ownership regulations changed and liberated the Minister has no desire to change pharmacy ownership and hasn't put that forward in this bill even though the Ministry of Health said that it should be because under the current status quo pharmacists must own pharmacies. They have to have a majority share in a pharmacy. I don't think that's right. And the ACT Party doesn't believe that's right because if you look at an equivalent in the medical space of general practice clinics there is no requirement for a general practice clinic to be majority owned by a general practitioner or somebody with a medical licence. It is perfectly acceptable that you should be able to have the ability for a pharmacy to be owned commercially and operated by pharmacists in the same way that general practice clinics can be owned commercially and operated by general practitioners and I think that's right. There needs to be more flexibility—because without that flexibility we don't have innovation. And if we're having people in our communities wanting access to different forms of therapeutic products we need to know that they are getting them in a way that works in their best interests. So I would hope that at select committee we will have the ability to talk through that issue and have the pharmacists and other people involved in that industry have the ability to submit. I also hope that at select committee we go into depth on a couple of issues that have already been raised with me from people with concern in the industry and that's the concern of natural justice. You see this regulatory regime puts in place some pretty serious fines some pretty serious infringements—up to $1000000 if somebody doesn't get it right. And there's the issue of natural justice. Now people within the industry have asked that there is an ability for a discussion to be had so that it's not that you have just unknowingly not met all your requirements and you have no ability to explain and you're lumped with a huge massive fine of $1000000 or five years' imprisonment when you didn't think that you were doing anything wrong but that you have that ability to have a discussion with the regulator and say that you're sorry you didn't realise that you had messed up and you have an ability to make things right. So I think we need to go through that process at select committee and see whether or not there is natural justice in this bill. The second one is advertising. This one has been a bit of concern because clause 193 talks about not allowing some forms of advertising and it says (1) An advertisement for a therapeutic product means a communication made for the purpose of promoting the product. (2) A communication means a communication made in any way whatsoever (including for example by an individual in person using a physical object in print or using any kind of information or communications technology)." And you're not allowed to communicate about therapeutic products that aren't regulated in New Zealand already and the only people who have carve-out are the Ministry of Health Medsafe and Pharmac. Now if you think about it from the perspective of a patient advocacy group what impact will this really have on them? I hope we can flesh this out in select committee. We can think of people who have been in the last few years advocating for Trikafta for cystic fibrosis. That hasn't been regulated in New Zealand. We can think of the different types of Spinraza medications or spinal muscular atrophy or ustekinumab for people with Crohn's disease and colitis. These types of medications weren't funded by Pharmac. Is it possible that people who're trying to advocate for their own lives and their own children's lives for drugs that have been regulated overseas and not yet in New Zealand to find themselves in breach because they're communicating and advertising for their right to have those drugs and products in New Zealand? I think we need to hear from the select committee and the Government that that won't be the case because I don't believe that would be right.The third thing is: whether the costs outweigh the benefits and we need to make sure with any new regulatory body that we're not imposing such a heavy burden on anybody and essentially saying to them that they don't actually want to come to New Zealand and regulate their products here. In the case of some medical technology devices there might be only a few that get sold in New Zealand and we want to make sure that we're not putting in place such a burden that they decide to miss our market completely and that all New Zealanders miss out.So in conclusion the ACT Party will be supporting this bill at the first reading because we believe it needs a say. All New Zealanders need to have their voices heard and I hope that we have an adequate time at select committee and hopefully more than six months."