16 July, 2012
Drug law reversing onus of proof on way
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.
The Cabinet paper and the regulatory impact statement can be found at
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.