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Dunne: legal highs regime costs and penalties announced
Wednesday, 10 October 2012, 1:43 pm
Press Release: New Zealand Government
Hon Peter Dunne
Associate Minister of Health
10 October 2012
Dunne: legal highs regime costs and penalties announced
Legal high manufacturers will face estimated $180,000 application fees plus $1 million to $2 million in testing costs for each product they want to sell, and up to eight years in prison for selling banned substances, Associate Health Minister Peter Dunne said today in announcing details of the permanent psychoactive substances regime.
“I make no apologies for setting the bar high on public safety and putting in place a regime with the process costs squarely on the legal highs industry, and not the taxpayer,” Mr Dunne said of the regime which should be in place by the middle of next year.
“I have said all along that this regime will be fundamentally based on reversing the onus of proof so those who profit from these products will have to prove they are as safe as is possible for psychoactive substances.
“We will no longer play the cat-and-mouse game of constantly chasing down substances after they are on the market.
Penalties under the new regime will include up to eight years in prison for importing, manufacturing, supplying or possession with intent to supply analogues of controlled drugs that come under the Misuse of Drugs Act, and up to two years for import, manufacture, supply or possession with intent to supply unapproved substances.
Other key features of the new regime that have been approved by Cabinet include:
• Personal possession of an unapproved product will incur a $300 fine.
• There will be a minimum purchase age of 18.
• No advertising except at point of sale.
• Restrictions on outlets, including barring dairies from selling such products, and labelling and packaging requirements.
Mr Dunne said the $300 personal possession fine is deliberately not being legislated as a criminal offence.
“What we are trying to do is actually protect young people, not criminalise them and thereby jeopardise their job and travel prospects. The approach we are taking is similar to that used with alcohol infringements,” he said.
Labelling and packaging requirements will require all products to have a label listing their active ingredients, the phone number for the National Poisons Centre and contact details for the product’s New Zealand manufacturer or supplier.
‘To date, there has been no ingredient information, so no one who buys these products has the first clue what is in them, which is as ridiculous as it is dangerous and irresponsible,” Mr Dunne said.
“We have had considerable success with the Temporary Class Drug Notices that we instituted in August last year. They have taken 28 substances and more than 50 synthetic cannabis products off the market, but that was always a temporary measure until we could get this regime in place,” Mr Dunne said.
He said he will introduce the required legislation later this year and it is expected to be in place by the middle of next year. In the meantime, all existing temporary notices will be rolled over so they remain in effect until the permanent regime is in place.
The Cabinet paper and Regulatory Impact Statement can be found at www.health.govt.nz/about-ministry/l...new-regulatory-regime-psychoactive-substances
Psychoactive Substances Regime 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 is the Government bringing in a psychoactive substances regime?
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 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 stealthy 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.
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 which will be set in due course.
What happens when the legislation comes into force? Will everything be pulled from the shelves?
A transition period will follow enactment of the new regime. During the transition period, a sponsor will only be able to sell:
• products with an application pending approval by the regulator; and
• that have been legally on the market for at least six months prior to enactment of the new regime; and
• provided that there are no health concerns about the products concerned.
Will this just backfire and create a bigger black market?
No. We expect that having low risk psychoactive products legally available will make it less likely that consumers will resort to a black market.
ENDS
Wednesday, 10 October 2012, 1:43 pm
Press Release: New Zealand Government
Hon Peter Dunne
Associate Minister of Health
10 October 2012
Dunne: legal highs regime costs and penalties announced
Legal high manufacturers will face estimated $180,000 application fees plus $1 million to $2 million in testing costs for each product they want to sell, and up to eight years in prison for selling banned substances, Associate Health Minister Peter Dunne said today in announcing details of the permanent psychoactive substances regime.
“I make no apologies for setting the bar high on public safety and putting in place a regime with the process costs squarely on the legal highs industry, and not the taxpayer,” Mr Dunne said of the regime which should be in place by the middle of next year.
“I have said all along that this regime will be fundamentally based on reversing the onus of proof so those who profit from these products will have to prove they are as safe as is possible for psychoactive substances.
“We will no longer play the cat-and-mouse game of constantly chasing down substances after they are on the market.
Penalties under the new regime will include up to eight years in prison for importing, manufacturing, supplying or possession with intent to supply analogues of controlled drugs that come under the Misuse of Drugs Act, and up to two years for import, manufacture, supply or possession with intent to supply unapproved substances.
Other key features of the new regime that have been approved by Cabinet include:
• Personal possession of an unapproved product will incur a $300 fine.
• There will be a minimum purchase age of 18.
• No advertising except at point of sale.
• Restrictions on outlets, including barring dairies from selling such products, and labelling and packaging requirements.
Mr Dunne said the $300 personal possession fine is deliberately not being legislated as a criminal offence.
“What we are trying to do is actually protect young people, not criminalise them and thereby jeopardise their job and travel prospects. The approach we are taking is similar to that used with alcohol infringements,” he said.
Labelling and packaging requirements will require all products to have a label listing their active ingredients, the phone number for the National Poisons Centre and contact details for the product’s New Zealand manufacturer or supplier.
‘To date, there has been no ingredient information, so no one who buys these products has the first clue what is in them, which is as ridiculous as it is dangerous and irresponsible,” Mr Dunne said.
“We have had considerable success with the Temporary Class Drug Notices that we instituted in August last year. They have taken 28 substances and more than 50 synthetic cannabis products off the market, but that was always a temporary measure until we could get this regime in place,” Mr Dunne said.
He said he will introduce the required legislation later this year and it is expected to be in place by the middle of next year. In the meantime, all existing temporary notices will be rolled over so they remain in effect until the permanent regime is in place.
The Cabinet paper and Regulatory Impact Statement can be found at www.health.govt.nz/about-ministry/l...new-regulatory-regime-psychoactive-substances
Psychoactive Substances Regime 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 is the Government bringing in a psychoactive substances regime?
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 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 stealthy 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.
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 which will be set in due course.
What happens when the legislation comes into force? Will everything be pulled from the shelves?
A transition period will follow enactment of the new regime. During the transition period, a sponsor will only be able to sell:
• products with an application pending approval by the regulator; and
• that have been legally on the market for at least six months prior to enactment of the new regime; and
• provided that there are no health concerns about the products concerned.
Will this just backfire and create a bigger black market?
No. We expect that having low risk psychoactive products legally available will make it less likely that consumers will resort to a black market.
ENDS
