Dunne: drug law reversing onus of proof on way
17 July 2012
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
www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances