NZ bans all legal highs unless proven safe

By davestate · Jul 17, 2012 · Updated Jul 20, 2012 · ·
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  1. davestate
    Cabinet has agreed key details of new psychoactive substances drug legislation that will require distributors and producers of party pills and other legal highs to prove they are safe before they can sell them, Associate Health Minister Peter Dunne announced today.

    “As promised, we are reversing the onus of proof. If they cannot prove that a product is safe, then it is not going anywhere near the marketplace,” Mr Dunne said. “The legislation will be introduced to Parliament later this year and be in force by around the middle of next year. ‘In the meantime, the Temporary Class Drug Notices – the holding measure we have successfully put in place – will be rolled over as required so there is no window of opportunity for any banned substances to come back on the market before the permanent law comes in,” he said.


    “The new law means the game of ‘catch up’ with the legal highs industry will be over once and for all. “I have been driving this for a considerable time. None of these products will come to market if they have not been proven safe – and the cost of proving that will be on those who make and sell them, as it should be,” he said. “Quite simply they will now have to do what any manufacturer of any product that is consumed or ingested already has to do – make sure it is safe.”


    Mr Dunne said that in the past year the Government had put a serious dent in the synthetic cannabis market with the Temporary Class Drug Notices. “We have seen a 75 percent fall in the number of emergency call incidents around synthetic cannabis products according to National Poisons Centre data.
    “That decline began the very month the Notices came into effect,” he said. “We have banned more than 28 substances and effectively taken more than 50 products that contain them off the market. The latest four substances were just banned on Friday.


    “We are winning the battle and we are about to deliver the knockout blow with this legislation,” he said.
    Mr Dunne said Cabinet has agreed to establish a new regulator within the Ministry of Health which will be responsible for issuing approvals. “Companies wishing to sell these products will need to apply to this regulator with scientific data similar to that which is required for the assessment of new medicines.
    “For example, they would need to provide toxicology data and results of human clinical trials,” Mr Dunne said. These tests will prevent products which cause common adverse reactions from being approved for legal sale.



    “However, in the end these are pharmacologically active substances, and there is always some degree of risk in taking such products because people can have varying reactions to them,” he said.
    Even once approved, any such products are likely to be subject to retail restrictions which will further reduce their potential to cause harm, he said.


    “The details of these restrictions have not yet been agreed, but I fully expect that they will involve a legal minimum purchase age and restrictions on the types of premises where they can be sold. “The legislation will be introduced later this year and will be in place by August 2013. In the meantime all of the existing Temporary Class Drug Notices will be rolled over for a further 12 months so there will be no slippage between them and the coming legislation,” Mr Dunne said.


    Peter Dunne 16/07/2012

    xxx.beehive.govt.nz/release/drug-law-reversing-onus-proof-way

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  1. davestate
    Re: Drug law reversing onus of proof on way

    Questions and Answers


    What are low risk psychoactive substances?
    This refers to new psychoactive substances for which the risks are low enough that they meet the approval criteria set by the regulatory. We say 'low-risk' to avoid implying that they will be entirely safe, as there will always be some risk. This is because different people have different reactions to pharmacologically active substances.

    Why are we doing this?

    We are doing this because the current situation is untenable. Current legislation is ineffective in dealing with the rapid growth in synthetic psychoactive substances which can be tweaked to be one step ahead of controls. Products are being sold without any controls over their ingredients, without testing requirements, or controls over where they can be sold. The government must prove a risk of harm before controlling a substance. The new regime will require a supplier or manufacturer to apply to a regulator for a safety assessment before any product can be sold.

    Are we legalising drugs?

    No. The regime will provide stronger controls over psychoactive substances. At the moment, these products are unregulated, with no control over ingredients, place of sale, or who they can be sold to. Because they are synthetic substances, there are a huge number of potential ingredients, which makes it unfeasible to deal with them individually.
    It will be illegal to sell any product which has not been through an assessment. There will be strict restrictions on where products can be sold, the purchase age, and marketing restrictions.

    What would it cost a manufacturer to take a product through the approval process, and how long would it take?

    Based on initial proposals, it is estimated that the cost of testing any product will be in the range of $1 million to $2 million and will take between one and two years.

    What will the implications of the new regime be for cannabis?

    The legal status of cannabis will not change. This is because the regime will only cover new psychoactive substances that are not already classified under the Misuse of Drugs Act 1975.

    Why don’t you just ban everything?

    Legislation should not be used to restrict behaviour that cannot be proved to be harmful. Products that meet the approval criteria will be approved. However, our position will still be that not using these products is the safest option.

    Is this a stealth way of banning everything and never approving any product?

    No. Clear testing requirements are being established to determine the risks of psychoactive products. Products that meet the approval criteria will be approved.

    How will risk/safety be determined?

    Consistent toxicological and behavioural testing will be required for every product seeking approval. A new regulator will be established to consider the data from this testing for each product. Products that meet the approval criteria will be approved.

    What do you mean by the regulator?

    A regulator will need to be established for psychoactive substances. This regulator will oversee the approval of products, monitor for compliance with post market restrictions, and reassess products in light of any new evidence of harm that might arise.

    How many drugs will get approved?

    We don’t know this yet. Products that meet the approval criteria will be approved. This will require toxicological and behavioural testing.

    How much will this cost?

    Modelling of the start-up costs for the new regime is currently being worked on. A detailed report on fee-setting and costing will be provided to Cabinet by 1 October 2012.
    We expect that over time, the costs of this regime will be recuperated through applications fees paid by industry.

    Who will do the risk assessments?

    The new regulator will consider toxicological and clinical data for each product.

    Does this mean the Government is endorsing drugs?

    No. At the moment these products are available without any information regarding their risks to health. We are changing the system to require industry to prove they do not pose a greater than a low risk of health before they may be sold.

    Will there be controls to stop children buying these drugs from dairies?

    Yes, it is intended that there will be restrictions on where substances can be sold and a minimum purchase age. I will provide Cabinet with full details of these restrictions by 1 October 2012.

    What happens when the legislation comes into force? Will everything be pulled from the shelves?

    Decisions have not been made on this yet but there will likely be a lead in time for industry to obtain the testing results needed.

    Will this just backfire and create a bigger black market?

    No. We expect that having low risk psychoactive products legally available will discourage consumers from using the black market.
  2. imyourlittlebare
    Re: Drug law reversing onus of proof on way

    Wow. I see two scenerios with this. Either very stringent rules where experts for hire are used to disprove the findings of the company's studies based on other evidence or quite possibly a change in attitude towards these substances. Perhaps drugs like modafinal, where I have read they use in place of amphetamines to increase alertness, can become available to students who wish to have an edge for the pursuit of their degree.

    I am really curious to see how this turns out and whether the United States would ever consider something along these lines. My hope is that at least certain drugs, those that could help increase productivity or people trying to make it through medical school, could become available so the reliance on illicit substances and illegal activity might be deterred. This just seems semi-subjective though in how safety will be rated. If a drug alters perception, it might lead to this and thus is harmful. If a drug is available in this dose, what if a person takes this dose and causes this you did not meet the criteria.

    I hope it goes the positive way for helping those who want to occasionally have a help with work or party have legal options.
  3. Calliope
    Re: Drug law reversing onus of proof on way

    The New Zealand Government announced plans on Monday to ban the use of drugs offering so-called 'legal' highs unless manufacturers can provide clinical evidence that they are safe.

    Associate Health Minister Peter Dunne described the move as a knockout blow to the market for products such as synthetic cannabis and legal "party pills", which mimic the effects of drugs like ecstasy without using illicit substances.

    Mr Dunne said current legislation was failing because as soon as regulators banned a synthetic drug, manufacturers simply tweaked its formula slightly and relaunched it in the marketplace.

    "The new law means the game of catch-up with the legal highs industry will be over once and for all," he said.

    At the moment, authorities must prove a synthetic drug is harmful before ordering it off the shelves.
    Mr Dunne said that under the new law, all synthetic psychoactive drugs will be illegal until their producers can provide clinical proof, such as toxicology reports and evidence from human trials, that they are safe.

    AFP July 16, 2012.

    http://www.abc.net.au/news/2012-07-16/an-new-zealand-drugs-ban/4134280
  4. TheBigBadWolf
    Now lets see how long it will take until coffee will be banned from NZ shelves. to ban anything until proven harmless is the same turd as running past the RC industry.
    When o when will they awake to see the war on drugs is lost as long as they keep on banning substances.

    Ban Dihydrogenmonoxide next!
    </satirical remarks>

    TBBW
  5. Alfa
    Since legal highs often contain caffeine, this ingredient will probably have to be proven safe for sale. Unless the law includes some kind of white list. This could become interesting.

    I think that this new law might hold a lot of promise. Because this might pave the way to legal highs that are clinically proven safe. It would become very difficult for a government, no matter if its EU, AU, US, or whatever, to ban a drug that has been clinically proven to be safe.
  6. davestate
    They are forever mentioning "products" as opposed to chemicals in the FAQ I posted, do you think they will force manufacturers to seek a license to sell for every product, as opposed to merely giving the green light to a specific chemical? Combinations of certain chemicals can be more dangerous than the separate constituents alone after all

    I'm still on the fence on this one.

    On one hand it forces legal high manufacturers to rigorously test products to make sure they are safe. It will also allow them to drop the "not for human consumption" facade and provide detailed ingredient lists and complete guides to dosage, effects, side effects and dangers on their products. It will also allow health professionals to know what to do in the event of an overdose.

    On the other hand if the laws defining what is safe are overly draconian/ludicrous and the price to get a product tested and license are too high, all it will do it compound the current problem, that is pushing the legal highs market further underground, futher endangering lives etc etc

    Time will tell, certainly one to watch and an initiative not really seen before by a govt
  7. Alfa
    Considering that the US legal highs industry tried to counter the US federal cannabinoid with financial data proving that the annual sales of only 1 distributor was over 80 million a year, it seems to me that the legal high industry is more than capable to cough up several million.
    The JWH-018 (Spice) ADME Toxicology Studies show that they are. ADME toxicology studies costs run into 5 figures already.

    What would be interesting, is if the NZ government would allow legal high vendors to prove safety for products that have already been banned. The JWH-018 study is a pretty solid foundation.
  8. Joe Duffy
    I wonder if this new legislation will also apply to well known long time legally addictive dangerous hard drugs like alcohol, and would the alcohol vendors also have to try and prove their products are safe before they can sell them again.
  9. Alfa
  10. (NS)-M-Lo-Reason
    I hesitate to believe that any world government went to bed prohibitive and woke up reasonable. I think that this is the most effective way for the NZ government to ban legal highs without appearing to do so, and this pissing off an industry with millions of dollars in the bank. I don't feel that any of these products will be proven safe, especially since any full cannabinoid agonist HAS been proven, through the trials on unsuspecting consumer subjects, to be potentially dangerous. I mean look at the countless threads regarding long term damage such as migraines and mental disorders, along with the acute effects of vomiting, panic and in some rare cases convulsions. These drugs AREN'T safe, now whether or not they're more dangerous than any other recreational psychoactive is up for debate. But do you really think the government would have put these controls in place if they didn't already have some idea that these products were harmful to the consumer?

    On a related note, I remember reading that some products were found to contain phenazepam, and that the manufacturer played the "oh my God how could this happen? We will find the cause and deal with it!" My manticore once played the same card when PCP was found in his outpatient urine sample. So let's assume, for the sake of not being idiots, that they knowingly and willingly included phenazepam, probably to offset cannabinoid induced anxiety as phenazepam is effective when smoked and my manticore knows this first hand. They can be held responsible for ruining the industry, especially because of their evasive and patronizing response to governmental inquiries. Fuck these people. And I don't want to hear anyone bad mouthing the government for making this move. These "legal high" bozos are trying to make as much money as possible before they sink the market for good. They don't care about the longevity of the industry or keeping these products available for future generations. I foresee an end to all of this, and I encourage any users of these products to mail in thank you notes to your favorite legal high distributers. Ridiculous.
  11. Alfa
    The NZ government has been extremely reasonable with their legal high policies over the years. NZ is the only country that has a class D for legal highs, which allows legal highs to be sold to adult while regulating sales.

    It has been some legal highs bozos who proved themselves to be completely untrustworthy to the point that the NZ government had to realize this and take a new approach. This new law is the direct effect of an industry which is unable to regulate itself.
  12. (NS)-M-Lo-Reason
    I was unaware of that fact, but good to know. All the more reason to be furious with these leeches. They had a good thing and had to ruin it, probably BECAUSE they knew of potential problems for consumers and instead of endeavoring to find alternative ingredients less likely to induce panic attacks, they included an ingredient with a whole slew of probable issues surrounding its use. That is assuming that the phenazepam was included to offset the anxiety, which I think is a fairly safe assumption.
  13. Alfa
    Phenazepam could well be in the smoke blend for its recreative effects. And since phenazepam has a 60 hour halflife this proves without any doubt that the producer is careless about consumer health at best and recklessly dangerous at worst.
  14. donxijote
    they are doing what they did with
    marijuana tax stamps, to prove the rc is safe you would need to be in possesion of it meaning youre breaking the law. this is a trick forget about rcs people let them win this one. its a ridiculous family of drugs that people have not learned to respect. this is why this is happening. imho i prefer natural drugs like the 100%illegal ones. lets see the crackers stop those drugs with laws lol
  15. donxijote
    by the way swim thought this was in the us, but its in new zealand my above post still applies guys. the multi million producers should approach this subject with great caution.
  16. davestate
    Except this has to do with the sale of legal highs, not the possession, so your analogy is incorrect. And leave the racists slurs out, yeah?
  17. Phenoxide
    The red herring in all of this is that human clinical trials that will be prerequisites to demonstrate safety are likely to require government licensing, and there's no reason to believe that such licenses will be granted to these grey market companies. There's also no reason that even in the face of compelling evidence that the government couldn't turn around and still deny any product license to market after the company has spent millions in development. Many such compounds also infringe upon existing international patents which would make licensing an issue. The NZ government could also easily schedule any substance while it's mid-way through the trials on other grounds (e.g. if it is marketed in other countries and linked to injuries or deaths), and just use this to buy time to outlaw new substances before they reach the NZ market.

    To me this looks like a step back rather than forward. It's an effective way of turning the game on its head. Before the RC industry operated in a grey area that made it difficult for drug law to be enforced against them. This snuffs out the grey area and makes it difficult for the RC distributors to operate. It forces them to become legitimate, but knowing full well that the terms and conditions in the fineprint will make this unviable for such companies.

    Well they've already stated that existing controlled substances will not be revisited so this one is a non-starter. The JWH-018 study was also nowhere near the level of information they'll likely demand once these laws are fully drafted (weird that they announce this and even project costs when the criteria aren't even finalized). While it was interesting preliminary data it was by no means a conclusive indication that the product was safe for human consumption, especially knowing that any such consumption may involve polydrug use.

    As you say that JWH-018 ADME study was a fraction of what is being pitched here both in terms of time and cost. I'd also say 2 years and $2 million is a significant underestimation of the true cost considering that when the final legislation is drafted the criteria for approval are likely to fall very close to the standards required for pharmaceuticals. That could well run into tens of millions of dollars and drag on for years if the licensing body drags their feet, which for a market the size of New Zealand and with an uncertain legal landscape simply isn't a risk worth taking. I think it'll just drive the RC market back to other countries with less restrictive laws.
  18. donxijote
    @davestate crackers means cops dude lol take it easy im not racist.
  19. imyourlittlebare
    @Phenoxide: What compounds would infringe on international patents? Its my understanding that slight alterations in chemical structures? I wish I could find this research study from the U.S. database on evaluating the efficacy of a drug very similar to tramadol with slightly altered chemistry. I guess other instances include extended release of old drugs like trazadone or alprazolam? Or on the flip side, pharmaceutical companies typically wont invest in old drugs where there is no ability to patent the medicine like ibogaine. Legal high dealers wouldn't care as much. It would be legal profit and probably the companies that survive having a lot more to do with marketing, word of mouth from consumers, and pricing. There would be competition for sure but it seems like it would end up being like OTC compounds where there were multiple suppliers and it just depends on what one prefers.

    But I agree with your statement regarding the ultimate decision. I could see a company proving that their drug is safe in human trials with risk factors being similar to those of prescription drugs. All compounds are going to have some risks. Its up to interpretation how those risks will be evaluated. For goodness sake, the gold standard should be that the drug does not carry as much risk as alcohol or tobacco and evaluate it in on a dimensional, rather than categorical, manner. If they do not, one could say the legal high is not safe due to its similarity to drug class x.

    There would have to be legislation regarding these compounds as similar to the herbal OTC preparations which carry variable and significant side-effects but one can buy them without the advisement of a doctor. Or like I said, on a dimensional basis comparing it to legally available drugs/herbal OTCs which contain various chemicals in them with active compounds.

    If this works, I hope the U.S. would consider this. But I sincerely doubt it for a number of reasons. Thanks Alfa for the info on New Zealand. I am curious how their laws and regulations differ from those of the U.S. and other countries.
  20. DiabolicScheme
    Unfortunately I think this is where other countries are headed, eventually the government will get sick of playing catch-up and either a)give up, b)ban psychoactive substances all together...obviously they aren't going to pick a).
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