Hon Peter Dunne
Associate Minister of Health

26 February 2013

Dunne: Psychoactive Substances Bill a ‘game-changer’

The Psychoactive Substances Bill introduced to Parliament today will mean legal highs have to be proved safe before they can be sold, Associate Health Minister Peter Dunne has announced.

“The Bill will be a complete game-changer in terms of party pills and other legal highs,” Mr Dunne said.

“It is about moving from constantly playing catch-up with this industry on each new product they produce, to reversing the onus of proof – now they will have to prove every product is safe before it goes on sale.

“This legislation will clean up what has been a highly irresponsible legal highs industry to date.

“Producers of products such as synthetic cannabis and party pills will no longer be able to play with the health of young New Zealanders,” he said.

He said that the law is expected to be in place by August to seamlessly replace the current temporary class drug notices regime, which has taken more than 30 substances and 50 products off the market.

“The drug notices have done their job, but they were always a temporary solution until we could get this legislation in place,” Mr Dunne said.

The Bill will include provisions for:

• A regulatory authority within the Health Ministry to
o consider and approve or decline psychoactive substances
o issue a manufacturing code of practice
o issue importation, manufacturing and sale licences
o conduct post-marketing monitoring, audit and recall functions
• Establish an expert advisory committee to provide the authority with technical advice
• Set offences and penalties under the Bill, including up to two years’ imprisonment for some offences, and fines of up to $500,000
• Restrict sale of products to those under 18, and place restrictions and prohibitions on places of sale; and
• Establish an appeals committee

Questions and Answers on the Psychoactive Substances Bill

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 this Bill?
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.

Is this just 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?
We start from the presumption that 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 and best option for any individual.

Is this a stealthy way of banning everything and never approving any product?
No. Clear testing requirements will be 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 is the position over animal-testing?
A number of possible alternative tests have been identified and Health Ministry officials will be advising the Minister if a combination of these tests will be effective in demonstrating the safety of psychoactive substances. An expert committee is being established and one of its roles will be to progress this work. Consistent with New Zealand’s animal welfare legislation , the Government’s preference id to avoid animal testing.

What do you mean by the regulator?
A regulator will 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?
This cannot be known at this point. Products that meet the approval criteria will be approved.

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, 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

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