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New Psychoactive Substances – a Legislative Response


Hon Peter Dunne
Associate Minister of Health
Speech

‘New Psychoactive Substances – a Legislative Response’
Address to the United Nations Commission
on Narcotic Drugs Roundtable
Vienna, Austria
Tuesday, 12 March 2013

Good morning.

We in New Zealand, as with many of you, face the challenge of how to respond to the rapid growth in new synthetic drugs.

Drugs such as those listed in the UN drug conventions are scheduled in the New Zealand Misuse of Drugs Act.

This legislation prohibits the importation, manufacture, cultivation, supply and possession of listed drugs and their analogues.

But this legislation, enacted in 1975, was never designed for an environment in which dozens of substances can be brought to market in a matter of weeks.

And, for drugs that are not listed in the Misuse of Drugs Act, there is no mechanism to prevent them appearing on the shelves of our corner stores alongside confectionery and milk and other every day products.

In New Zealand, as in other countries, unknown, untested and potentially dangerous substances are being sold without restrictions on their safety, their ingredients, or their manufacturing standards.

This situation poses a real risk of harm to our society and particularly to our young people – and it is out of step with the way we control other substances we consume, such as medicines and foods.

In order to add new substances to the Misuse of Drugs Act, an expert committee assesses the harm posed by a substance before making a recommendation to me for classification.

This process takes time and requires robust evidence for the committee to consider.

Going back to 2000, when GHB first came to New Zealand’s attention, in the time between this drug was first identified as potentially harmful and it being scheduled in the Misuse of Drugs Act (around two years), there was a death and dozens of hospital admissions just at one of our hospitals.

In the case of new synthetic drugs, it can take considerable time to collate evidence required to assess them when so little information is available.

And we would be in a worse position without our analogue provisions.

This means that any substance demonstrated to have a chemical structure similar to a drug listed in the Misuse of Drugs Act can by default be treated as a prohibited drug.

Substances such as mephedrone could never legally be sold in New Zealand, as they could in other jurisdictions, because they were already controlled as analogues of methcathinone.

While the analogue provisions have undoubtedly been useful, they still require a substance to be identified, tested and then shown to meet the definition of an analogue.

And because analogues need to be similar in structure (rather than similar in effect) the provisions also have the potential for some unusual substances to be captured such as blue cheese and ripe avocados! [They both contain hordenine, which is an analogue of methamphetamine]

The other measure that has been very successful in reducing the availability of new synthetic substances is temporary class drug notices.

Since their introduction in August 2011, we have placed 33 substances under the temporary bans.

If we hear of a new product and have reason to be concerned, then we have it tested, and once its chemical constituent substances can be identified and if there are concerns over those substances, then a ban can be put in place.

It is a very rapid response compared to the way drugs are normally controlled, but we are still looking at a window of around two months for unknown and potentially harmful substances to be sold.

That is two months too long.

The limitation with both the temporary bans and the analogue provisions, however useful they have been, is that we are still in the position of playing catch-up. As soon as one substance is banned another appears.
While we have placed more than 30 synthetic cannabis-like substances under temporary bans, but we are aware that there are potentially hundreds more that could replace them.
Last month, the New Zealand Government introduced new legislation into our Parliament that will end the game of catch-up once and for all.

We are going to reverse the onus of proof so the manufacturers of these products have to prove they are safe before they can bring them on to the market.

Currently, the onus is on the Government to identify the substances that are being sold, test them and prove that they warrant sufficient harm to be prohibited.

That approach has undermined our best efforts to keep our young people safe, and left the rather tawdry legal highs industry constantly one step ahead, despite our best efforts.

Under our proposed legislation, the Psychoactive Substances Bill, all psychoactive substances will be banned unless a manufacturer can prove that they pose no more than a low risk of harm.

Not only will the onus be on the manufacturer to prove safety, but importantly – and I think fairly – they will also bear the cost of all the safety testing.

After all, they are in business and making commercial decisions that should include such costs.

This pre-market approval scheme is consistent with our approach to food products, such as new food additives, and new medicines and hazardous substances.

And the testing regime that manufacturers will have to go through to get a substance approved will be similar to the process for approving new medicines.

The details of the tests and data requirements will be determined by regulations under the legislation.

An interim technical committee is currently being set up to establish what the threshold for approval will be.

There has also been a significant level of discomfort raised in New Zealand, and it is a sentiment I share, around the use of animal testing to determine the safety of recreational psychoactive substances.

While we are still in the process of determining what tests will be required under New Zealand’s regime to determine ‘safety’, I believe it is beholden on us all to strive for approaches to this and other such problems that remove the need for animal testing.

I welcome any developments that other delegations may have to contribute on this issue.

In addition to requiring manufacturers to meet safety standards for their products, they will also have to meet manufacturing standards and adhere to a number of retail restrictions.

The restrictions will include controls over purchase age, place of sale, advertising, and labelling.

Our definition of psychoactive substance is very broad and the legislation covers anything used for the primary purpose of inducing a psychoactive effect.

In fact, we have tried to future-proof our definition by ensuring that devices such as coils you put on your head to induce a psychoactive effect are covered.

However, there are a number of exclusions for substances that are already regulated such as alcohol, tobacco, food items such as caffeine, Misuse of Drugs Act drugs, and medicines.

We have previously found that some manufacturers of psychoactive substances have tried finding loopholes by claiming that their products are incense or plant food – and I understand that this has been a problem in other jurisdictions.

We have included a declaring power in the Bill so that a product can be declared to be a psychoactive substance and brought within the provisions of the Bill - even if manufacturers try to find ways to escape the legislation.

There are tough penalties – including substantial jail terms and heavy fines – for infringing against this regime, for acting without a licence, failing to notify adverse reactions, failing to comply with a notice to recall products, and supplying substances that have not been approved.

We believe that this legislation provides an enduring and effective mechanism to end the cat and mouse game we play trying to keep on top of the rapid growth in new synthetic drugs.

We are aware that New Zealand will be the first country to establish a regulatory regime of this nature.

We have therefore built in a provision to review the legislation after five years – we will try to get it right first time but with such a new approach we may need to do some tweaking along the way – and look to our colleagues overseas and see how they are tackling a problem we all share.

ENDS


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