 The best way to introduce our next speaker would be to say that he is New Zealand's leading legal expert on both the act and its application to the industry He probably works for the country's number one public law experts as well, and yes, he does and it's called Chen Palmer Ladies and gentlemen, please put your hands together for James Dunn Good morning everyone Grants asked me to as perhaps as a sort of a taster for the rest of the event to take everyone through the The the act the New Zealand solution how it came about What it means and where it fits where it fits into into the grand scheme of things? So I thought I'd start that by talking about the principles and the purpose behind the psychoactive substances act because in many senses They are the most revolutionary part of a part of legislation in in a New Zealand drug law and even a global drug law context So the purpose of the act and this is set out in section 3 is that it's to regulate the availability of psychoactive substances to protect the health of and minimize harm to individuals who use psychoactive substances So in there we've got a recognition the purpose of this legislation is regulation and we've got a recognition that individuals do use psychoactive substances And then moving on from there You then move to the principles behind the act and these are the principles which every decision maker under the act has to take into account That a psychoactive product that is approved for use by individuals should pose no more than a low risk of harm to individuals who use it and Before a psychoactive product that is approved for use Can be it's sorry can be approved for use by individuals the degree of harm posed by the product to individuals who use it Should be assessed by the authority on the basis of and this this is important this part on the basis of evidence and The advice of an expert advisory committee So we're not talking here about Whether the risk of harm should be assessed on the basis of what a politician thinks about it or what the media thinks about it Or even what the people who use the product think about it We're talking about evidence evidence meaning preclinical and clinical trials into the safety and efficacy of the product a psychoactive product that poses no more than a low risk of harm to individuals should be approved and A psychoactive product that poses greater than a low risk of harm to individuals should be prohibited and Finally a psychoactive product that has not yet been approved Should be prohibited on a precautionary basis until it has been assessed and the authority is satisfied that it poses no more than a Low risk of harm to individuals who use it So what we've got here effectively is a market clearance system if you want to enter the market You must provide reputable clinical evidence to the psychoactive substances regulatory authority that your product poses no more than a Low risk of harm and until you until you can do that you are not permitted to sell it One of the other things that's important to understand about the act and this underlies a lot of how the act fits together Is that the act draws a distinction between a psychoactive substance and a psychoactive product? A substance is your active ingredient and a product is that active ingredient packaged up and ready for retail sale And the reason that approach has been taken is what that means in terms of risk assessment Is that you're not looking at a substance and trying to work out every conceivable way that it might be used and every Conceivable concentration that it might come in and work out whether that's safe You're looking at a product a product when theory you should know how much it weighs how much it costs how it's packaged How it's supposed to be used how much stuff is supposed to be in there What the expected effects are going to be and that's really important in terms of making decisions on an informed evidence-based basis The act establishes a really detailed system of control at almost every level over over the market and psychoactive substances So the starting point in the New Zealand context is that the import of psychoactive substances requires a license At import the authority requires evidence that the substance you're importing is what you say it is The manufacture of psychoactive substances requires a license Increasingly now the code that there's a code of manufacturing practice that has been rolled out over the next two to three years That will move manufacturers towards Total GMP compliance status probably by the end of 2015 2016 In terms of wholesale that is what that also requires a license and finally retail licenses You know you must every retailer must have a license where they wish to sell online or through a physical store And off to the side a bit There's also a license for research which is really important because one of the concerns when the app came through Would be that it would actually represent a block on research because the way the app works is to blanket cover Every psychoactive substance that has ever been invented and in fact some that haven't It's important. There is an opportunity there that researchers who wish to research psychoactive substances Still have it still have a way to do that that it complies of the law Next question what exactly is a psychoactive substance? Quite important because it affects what the act apply what the act covers to the act defines a psychoactive substance And this is this is you will have questions about this. So just be there with me It's a substance mixture Preparation article device or thing that is capable of inducing a psychoactive effect by any means In an individual who uses that substance. So what you're looking at there is a very broad attempt to future-proof The act against anything people might come up with in the future to induce psychoactive effects in people now accepted from that definition We have controlled drugs Precursor substances, so we're looking at the precursors to for example methamphetamine medicines herbal remedies dietary supplements food alcohol tobacco and the catch all anything else the authority decides ought to be a psychoactive substance and this is to avoid the Kind of situation where somebody presents Something against for example fish flakes or CD cleaner or sticks not for human consumption on it But as soon as you look at it, you know that it's for human consumption. We all know the kind of products where we're thinking about here It's obviously one of the big gaps in that of course is that it doesn't apply to Currently control drugs those drugs remain illegal But there's a very broad range of substance that will apply to there is of course a legitimate question here about what? Induce a psychoactive effect means what the primary purpose of inducing a psychoactive effect means at the moment and so far We're only only eight months in It's the issue hasn't really come up every every product that's kind of come under the ambit of the act Everyone knows was always supposed to come under the ambit of the act But it probably will be an issue that will come up sooner or later particularly as the sort of an aligned piece of regulation coming through probably this year which will deal with Natural natural supplements and herbal remedies and that sort of thing and you might then start to see some some potential for Sorry some potential for a bit of a bit of back and forth that which regulatory regime a particular substance fits into So once you've got your substance and you've come up with your product, how do you go about getting it approved for sale? You have to make an application to the authority and as I've said that application will need to be supported by evidence That evidence will be then assessed by an expert advisory committee that committee is made up again not of politicians and Not even of sort of representatives of the general public It's made up of experts of experts in toxicology of experts in pharmacology of Experts who will assess the evidence you've put forward which is likely to involve both preclinical evidence I to be frank proof that the substance you want to put forward is not poisonous and Clinical evidence which will be around the effect the substance has on people how addictive is it? How much do they want to use it doesn't really deliver the effects you say it will deliver Unlike pharmaceutical medicine It's not likely that one of the real key tests there will be around efficacy and the reason for that frankly is that if you Want to go out and sell a psychoactive substance that doesn't work That's not the authorities problem. That's going to be your problem with your consumers In terms of enforcement the act Replicates the medicines act in many senses which is a public health angle So we're looking more at fines here which reflect the fact this is that these offenses are essentially regulatory So fines rather than imprisonment I think there is a term of two years for deliberately selling unapproved substance and at the very very bottom level if you're Found in possession of an unapproved substance you can get an infringement notice and a $500 fine now frankly I think that is a solution in search of a problem But at the concert committee when they put the legislation through felt very strongly that they needed to to send a strong message against something or other Once a product has been approved It's still subject to a range of controls but how it's packaged packaged and sold So the key one is that it has to be sold obviously in a licensed premise Licence premise in this context Will means one that's been granted a license kind of premises that are excluded from having access to a license petrol stations dairies anywhere that sells alcohol tents mobile vehicles And anywhere else the authority decides that perhaps it would be best not to have products sold from now Obviously the key thing that we're this reflects is concerned over the previous two or three years about these products being sold from dairies I'm not certain. It was ever a huge issue that was sold in petrol stations, but that's that's again That's in the legislation. So it's important to bear bear it in mind There are also controls on who these products can be sold to they can't be sold anyone at the age of 18 Products have to be packaged in particular ways They have to include health warnings increasingly. They'll have to include barcodes batch numbers all of the information about Ensuring that a substance is is is safe that people know what they're using they know what they're getting They understand the risks of using it and they know they know the consequences of doing so So how do we come to this legislation? We came to this legislation because we tried a range of other options in terms of controlling new psychoactive substances That if you would go anywhere else in the world, they're now trumpeting as new and innovative measures So we're looking here at for example analogs and emergency scheduling at at trying to impose blanket bands We've tried all of those over the last ten years Not one of them has worked in most cases. They haven't even worked for a day We had emergency scheduling of psychoactive substances between 2011 and 2013 and I don't think a day went past When psychoactive substances were not legally available in New Zealand So one of the advantages of this act is that it does represent as as Ethan said earlier a real breakthrough Because it's a recognition by a government That if effectively if you must use drugs Use these ones. We know these ones are low risk. We're not saying they're safe In fact under the act it's illegal to claim that your drug is safe But we do know they are low risk and we'd rather that you use these than dangerous drugs So we don't have control over the market. We don't know who's selling them. We don't know who they're being sold to So this act in many senses is all about control. It's about Admitting this market exists admitting that it will continue to exist no matter what we do and saying well if it must exist Let's take control over it. Let's understand how it works Let's establish a system where when every psychoactive substance enters the country We can track it through every manufacturer and retailer down to a granular level So if there is contamination if there is a risk of harm We can easily take that product off the market and protect the public and protect public health The act is interesting also because of these potential international Rantifications and some of these I think funnily enough are quite optimistically included in the legislation There's provision in the act for export certificates where the authority provides will provide a certificate for your for an approved product That says this is an approved product. We're satisfied it poses no more than a low risk of harm now in 2013 It's not quite clear what anyone else would actually do with that certificate But it might be that in the years to come as other countries catch up to us that you're looking there of us at a System of mutual recognition where having got a substance approved or product approved in New Zealand or Australia or elsewhere There will be some level of some ability to take it from country to country much in the same way as we do with medicines So there are real possibilities here for a realistic international reappraisal of where we sit where we stand on drugs As I've said one of the gaps is that there is no space for control for control met drugs in here They're not covered off and in the future It may be that a future government will decide that is a much more rational and sensible way of approaching the issue of controlled drugs then What we do with the misuse of drugs that which could be charitably described as sticking our head in the sand and Pretending that somehow if we ban these things hard enough, they'll go away And that's that's never worked and I'm not quite sure why it might work this time But it is it is it is this legislation creates a way through there that as you can see it avoids the extremes of total legalization And a free-for-all in the same way that we recognize that in an ideal world alcohol wouldn't be sold We know that it's dangerous. We know it is extremely dangerous We know it is so dangerous. It would never be approved for sale under the psychoactive substances act But we also know that we cannot now get it off the market. I mean the Americans tried that they spent the better part of a decade trying to Do it and it didn't work So it's better that if that market exists we control it in the same way In fact in a funny sort of way that we control we've realized that a free-for-all of tobacco was the wrong choice And if that market must exist it must be controlled So the act in that sense as Ethan says is an international breakthrough because it's a recognition by government that these markets can be controlled That the options are not just wave goodbye to public health or free-for-all There is a middle ground. There is a sensible solution and this is that sensible solution The last thing I wanted to cover off very briefly are the current interim arrangements These arrangements are designed to allow a sort of orderly transition so to speak into the new regulatory regime And basically what we've done there is we've frozen the market as it was in August 2013 And the intention is that over time as regulations come into force the interim licences will be replaced with full licences The interim product approvals which are currently more or less assessed for safety on the basis that nothing bad has happened so far Will be replaced with an assessment on the basis of here is your evidence that this product is low risk So that transition will happen over the next year or the next year and a half I mean we are in early days yet. I want to emphasize that. This is a very new act. It is eight months old It is far too early now to say whether it will work but all the evidence is good We've seen the number of outlets and there's a figure that the Ministry of Health quotes endlessly That they've taken the number of outlets from three to four thousand to a hundred and fifty Now we've got to bear in mind that three to four thousand. One of the problems was that is a guess Because we did not have control over the market. We didn't know how many outlets are selling these products Nobody did. Not even the industry knew because there was no way to tell. There was no central register No one could agree. So that control means yes there are far fewer outlets But now we know where they are. Now they're accountable Now we know they have to comply with the law. And the outlets that we do have now that are licensed are complying with the law Similarly with products there were somewhere in the region the Ministry of Health thinks of two to three hundred No one really knew what was in them. No one really knew what the effects were They would change on a weekly basis and all of this was actually driven by the regulatory regime at the time So the government effectively encouraged people to do this But we didn't know what was going on. We didn't have control And now under the cycle act of substance is that every approved product you can go on the website You can look it up. You can see what's in it. You can see how much it should You can see what it should look like. You can see how much it's how much is going to be there So you know exactly what you're getting and you can have confidence that when you buy it That's what you will get. You won't get some batch from last year You won't get some other product. You will get exactly what you want You want. Now as I say this act is new. This act has not bettered in yet But it is a genuine breakthrough I think in drug policy And to quote from Winston Churchill I don't think this act is the end and it's not even the beginning of the end But it may well be the end of the beginning