Psychedelia.dk

New Zealand: Prove recreational drug is safe, then you can sell

(CNN) -- The New Zealand government wants to make sure your high is safe.

In an attempt to tackle the popularity of new-generation synthetic party drugs -- sold widely in convenience stores and blamed for triggering a spate of mental health issues -- New Zealand authorities have taken a radical new tack.

A new law shifts the onus to the makers of synthetic recreational drugs, forcing them to conduct clinical tests to prove their products are safe -- similar to the way pharmaceuticals are regulated.

It's the first nation to take a dramatically different approach to psychoactive substances like party pills and synthetic marijuana -- which the United Nations has flagged as an alarming drug problem. Some psychoactive substances go by names like bath salts, spice or meow-meow.
In a 119-to-1 vote on Thursday, the country's parliament passed the Psychoactive Substances Bill, establishing a framework for testing, manufacturing and selling such recreational drugs.
The new law does not apply to non-synthetic drugs like marijuana, cocaine or magic mushrooms.

In a country that prides itself as a "social laboratory," New Zealand has become "a laboratory in every sense: for the approval of new recreational drugs," according to an editorial in the New Zealand Herald.

The drug law enjoyed broad support although there was debate over whether animal testing would be required in the clinical tests.

"While other countries are still blindly banning drug after drug, the Psychoactive Substances Bill will put New Zealand ahead of the industry's game," said Ross Bell, the New Zealand Drug Foundation's executive director in a statement in support of the law. "It is a comprehensive, pragmatic and innovative approach to address a complex problem."

This contrasts with countries where substances are legal until the governments ban them. Chemical concoctions come out fairly routinely -- far outpacing efforts to control them.

When one product is banned, "there are two or three or four replacements in the market," said Bell.

And authorities can't prevent the drug makers from selling new concoctions.

"You can't ban what yet doesn't exist," Bell said. "The government isn't in the position to pre-empt these things."

New Zealand is unique because of its remote geography, he added.

"It's because we're a small remote country," he said. "Drugs like heroine don't make their way to New Zealand. What we've become good at doing is making our own drugs."

Psychoactive substances have raised concerns over their ingredients and effects. Some are known to cause paranoia, hallucinations, convulsions and psychotic episodes.

"In lots of ways, this synthetic cannabis is way worse than the real stuff with a number of people who are becoming psychotic as a result," said Dr. Mark Peterson, the chair of the New Zealand Medical Association.

Under the law, new psychoactive drugs cannot be sold unless they pass health regulations. That process will be determined by the country's Ministry of Health.

The new regulation "has to be rigorous and robust enough to stand up to public scrutiny. To be licensed, to be legal, it has to pass testing like new medicine in the market," said Grant Hall, general manager of the advocacy group, The Star Trust, which represents members of the legal high industry in the country.

The industry wants to "be recognized as other highs" such as alcohol and tobacco, he added.

Hall said he expects the industry to take a hit on profits as they'll now have to submit costly and lengthy applications to be be sold on the market. But he views it as an investment.

"You have take a long term view," Hall said. "It's a legitimate industry that provides certified low-risk product so people can enjoy them safely. That's a much better business model than the better cat-and-mouse game the industry plays with the government."

Here is what else the Psychoactive Substances Bill entails:

- Restricts where and how psychoactive drugs are sold

- Prohibits sales to minors

- Restricts labeling and packaging of products

- Gives existing products a grace period to begin application process

Ideen er da god nok. Men hvordan har de tænkt sig, det skal fungere i praksis? Hvis de virkelig skal gå gennem alle de tests, som medicin gennemgår, er der aldrig noget af det der blir godkendt. At få et drug godkendt til klinisk brug kan snildt koste over 1 milliard kr. Og det tror jeg alligevel aldrig, at nogen rc shop på nettet kan eller vil diske op med. Der er vist nemmere måder at tjene sine penge for små firmaer.

I praksis tror jeg, at loven kommer til at betyde et totalforbud.

Meaning of psychoactive substance

In this Act, unless the context otherwise requires, psychoactive substance—

(a) means a substance, mixture, preparation, article, device, or thing that is capable of inducing a psychoactive effect (by any means) in an individual who uses the psychoactive substance; and

(b) includes—

(i) an approved product:

(ii) a substance, mixture, preparation, article, device, or thing that is, or that is of a kind or belonging to a class that is, declared by the Governor-General by Order in Council made under section 81 to be a psychoactive substance for the purposes of this Act; but

(c) does not include—

(i) a controlled drug specified or described in Schedule 1, 2, or 3 of the Misuse of Drugs Act 1975:

(ii) a precursor substance specified or described in Schedule 4 of the Misuse of Drugs Act 1975:

(iii) a medicine as defined in section 3 of the Medicines Act 1981 or a related product as defined in section 94 of that Act:

(iv) a herbal remedy (as defined in section 2(1) of the Medicines Act 1981):

(v) a dietary supplement (as defined in regulation 2A of the Dietary Supplements Regulations 1985):

(vi) any food (as defined in section 2 of the Food Act 1981):

(vii) any alcohol (as defined in section 5(1) of the Sale and Supply of Alcohol Act 2012) unless the alcohol contains a psychoactive substance within the meaning of paragraph (a) or (b) that is not alcohol:

(viii) any tobacco product (as defined in section 2(1) of the Smoke-free Environments Act 1990) unless the tobacco product contains a psychoactive substance within the meaning of paragraph (a) or (b) that is not tobacco:

(ix) a substance, mixture, preparation, article, device, or thing that is, or that is of a kind or belonging to a class that is, declared by the Governor-General by Order in Council made under section 81 not to be a psychoactive substance for the purposes of this Act.

Psychoactive Substances Expert Advisory Committee

(1) This section establishes the Psychoactive Substances Expert Advisory Committee.

(2) The functions of the advisory committee are—

(a) to evaluate, with regard to the results of preclinical and clinical trials, psychoactive products to assess whether they should be approved for use by individuals; and

(b) to advise the Authority about whether a psychoactive product should or should not be approved for use by individuals; and

(c) to increase public awareness of the advisory committee's work in relation to psychoactive substances, for example, by the timely release of papers, reports, and recommendations.

(3) The advisory committee may comprise up to 6 members who between them must have appropriate expertise in—

(a) pharmacology:

(b) toxicology:

(c) neurosciences:

(d) medicine:

(e) any other areas the Authority considers relevant.

(4) The Authority may appoint members of the advisory committee on any terms and conditions that the Authority thinks fit.

(5) The Authority must appoint 1 member as chairperson of the advisory committee.

(6) The Authority must consult the Minister before making an appointment to the advisory committee.

(7) The Authority may give terms of reference—

(a) on the advice that the advisory committee provides to the Authority:

(b) on the use of external experts to assist the advisory committee.

(8) The advisory committee may, subject to any provision of this Act or regulations, determine its own procedure.

The approval process for each product is expected to take between one and two years. It will cost companies $180,000 just to apply and an estimated $1 million to $2 million for the tests. Current products can stay on the shelves only if they apply to be tested within the first month.

Fed up with the industry's trickery, Dunne has changed tactics with a world-first law change that will force drug manufacturers to prove their products are low-risk before they can go on sale. His Psychoactive Substances Bill, expected to become law by August 1 or earlier, will require drugmakers to pay for a series of clinical trials, including tests on human subjects. The approval process for each product is expected to take between one and two years. It will cost companies $180,000 just to apply and an estimated $1 million to $2 million for the tests. Current products can stay on the shelves only if they apply to be tested within the first month.

Dunne describes the law change as a knockout blow to an industry that has proved time and time again that it cannot be trusted. At the very least it should wipe out the corner dairy drug trade, putting an end to politically embarrassing news stories as the Government heads into election year.

Documents obtained by the Herald last year under the Official Information Act show Dr Stewart Jessamine, head of the Government's medicine safety regulator, Medsafe, worried that the requirements could be portrayed as a de facto ban - a phrase echoed by Norml (National Organisation for the Reform of Marijuana Laws) campaigner Chris Fowlie in his submission to the select committee. Online drug-seller MindFuel predicted the trade would die off, as no manufacturer would be prepared to spend $2 million and wait up to two years to win approval for a product so mild that few people would buy it.

Hall says drugmakers are willing to accept the setback if the high standard is based on scientific evidence, not political prejudice. But he says if the bar is set too high, possibly by politicial interference, the bill will fail because drug users will turn back to the gangs and the black market.

Dunne agrees that the number of approved substances is likely to be low and successful products could be on the mild side, precisely because they must be low-risk. He acknowledges that might drive some users to buy illicit drugs for a bigger high.

"That's always possible, but what do you do? If you go for a complete prohibition - even if that were possible to achieve given the nature of the substances - that's exactly what you drive up. If you simply let the status quo prevail, you've got a totally intolerable situation. If you say we'll just ban dangerous substances, then we're forever chasing our tail. So we need a circuit-breaker and I see this legislation very much as that."

Hall says drugmakers are willing to accept the setback if the high standard is based on scientific evidence, not political prejudice. But he says if the bar is set too high, possibly by politicial interference, the bill will fail because drug users will turn back to the gangs and the black market.

kom RCerene ikke på banen fordi at de narturlige stoffer gav enorme straffe nogen steder.. jeg mener er det ikk mere logisk at frigive naturen, end at lovliggøre kemikalier som tilfældigvis virker lidt som naturen?
sjovt de narturlige ikke ka få licensen, for mange ville gå lige igennem.. da de regler som forbyder dem er yderst forældede..

9 mio for at få et stof godkendt lyder som meget, meget lidt i forhold til alm drug udvikling. Men det er nok alligevel en del for et lille rc firma. Det jo heller ikke sikkert, at det blir godkendt. Og så har de lige smidt 9 mio ud ad vinduet.



Der er ingen grund til at tro, at et naturstof vil være mindre skadeligt end et syntetisk. De mest giftige og kræftfremkaldende stoffer der findes kommer fra naturen. Med det sagt, så er det gode ved noget som cannabis og svampe, at folk har taget dem i årevis uden problemer. Men det er en misforståelse, at naturstoffer er mindre giftige eller skadelige end syntetiske.