Hard News by Russell Brown


Approved by lunchtime

As you may have read in the news, Peter Dunne approved a medical cannabis product yesterday. Indeed, he received the application to use Aceso Calm Spray to treat a patient with severe Tourette's in the morning and had it approved by lunchtime. The interesting question is whether this product required approval at all.

The Aceso spray's chief active ingredient is a cannabnoid called cannabidiol, or CBD, which has promising, if not quite yet proven, applications in treating various conditions, from epilepsy to anxiety. CBD also is thought to mitigate some of the psychoactive effects of THC, which is the chemical in cannabis that get you high. It's present in 50-50 parts with THC in Sativex, the only approved cannabis-based medicine in New Zealand (this is a much higher ratio than in all but a handful of specialist strains of raw cannabis).

The statement from the minister's office says the Aceso spray was "chosen for its low THC content" and hence "its reduced psychoactive side effects." What it doesn't say is how low the THC content is.

Denver-based Dixie Brands, the manufacturer, says that because Aceso is refined from industrial hemp, it contains "little or no" THC  and "levels so low that the product is federally legal and can be shipped across the country" and this Company Week story says it's one of two product lines Aceso makes with "THC-free oil from Europe". The other is Therabis, which is for pets. Dixie also makes products containing THC, at a separate facility.

 Here's where it gets interesting. The Ministry of Health's medical cannabis page, which the statement from the minister's office links to, says this:

Cannabis products are Class B1 controlled drugs and Ministerial approval is required before these can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977.

But the Misuse of Drugs Act defines a "cannabis preparation" in quite a specific way.

... that is, any preparation containing any tetrahydrocannabinols, including cannabis resin (commonly known as hashish) and cannabis oil (commonly know as hash oil), produced by subjecting cannabis plant material to any kind of processing

CBD is not a tetrahydrocannabinol. A preparation containing only CBD is not a cannabis prepration under the law.

Now, you could be a stickler and and say that even a trace of THC is enough to class the Aceso spray as a controlled drug. And it seems likely that the spray contains a trace of THC. (There are products guaranteed to be 100% pure CBD, but they're expensive and produced as reference samples for drug-testing labs to calibrate with.) But that takes you down a strange road.

Because there are already products containing trace quantities of THC available in New Zealand. Foods, cosmetics, hemp oil. You don't even need a prescription to get them – you can just rock up to any shop that happens to stock them. The quantities are too small to be psychoactive, but if you consume the edible hemp products with sufficient enthusiasm, it's possible to register a positive drug test for marijuana.

 I doubt we're about to suddenly take these products off the shelves. But what if Aceso products were sold as hemp products? Or if the spray was marketed not as a drug, but as a breath freshener, or a spiritual cleanser? What would prevent it being stocked alongside all the other minimal-THC-containing hemp products?

I'm not proposing that. CBD is a chemical we still don't know all that much about and it ought to be treated as a drug in a therapeutic setting. [NB: Cannadidiol is regulated under the Medicines ACt – see note at the end of the post.] What I am saying is that the basis on which the ministry asserts it should be subject to such special controls is quite dubious.

Peter Dunne told me last night on Twitter (his accessibility and responsiveness there is very, very welcome) that "I assume MOH officials made that assessment when the application was received." I'd like to see the reasoning, but it might take another OIA request.

But basically the issue is this: how long are we going to be so hung up about any and every form of cannabis-derived medicine that we impose the burden of an application to the minister on every individual doctor and patient who wants to use it? It's worth noting that both the Director of Mental Health and the acting Director of Public Health had to have a word in the recommmendation to the minister.

The statement from the minister says this approval shows the criteria drawn up by senior officials to guide his decisions are "not an impediment to robust, clinician-led, assessment-based approaches”. Well, they clearly are, for reasons I've been through at length here already. That's why they're being reviewed. We are very much not there yet.

UPDATE: As Ross Bell points out, CBD is regulated under the Medicines Act. It's defined as a "prescription medicine". But the ministry's page refers to the Misuse of Drugs regulations – and, as noted above, it's doubtful whether the spray is in fact a "cannabis preparation" under the law. The basis for requiring ministerial approval for a drug already regulated as a prescription medicine seems even more dubious. This should be a one-off product approval, no more.

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