Hard News by Russell Brown

22

Is the Ministry of Health acting outside the law on medical cannabis?

The key barrier to the use of medical cannabis – or to even discovering what its uses might be – has long been marijuana's illegality under the Misuse of Drugs Act. But what if it transpired that a key component of cannabis is not, and has never been, controlled by the act? And that heavy restrictions on its use and importation are in fact taking place outside the law?

This may sound to you like one of those conspiracy theories your embarrassing friend posts on Facebook, but it's quite serious. And it's the subject of an intended legal challenge notified by Nelson lawyer Sue Grey. You may recognise her name: she's the lawyer who won Rebecca Rieder the right to walk through New Zealand Customs with a jar of raw cannabis prescribed to her in Hawaii.

Grey's intention, and its legal and scientific basis, is summarised in a letter sent to the Ministers of Health and Customs at the beginning of this month. I've uploaded the letter here – it's admirably clear in its language and worth reading.

The substance in question is cannabidiol (CBD), the principal cannabinoid in raw cannabis apart from THC. It's proper to be cautious about its medical potential, but a 2012 review in the British Journal of Clinical Pharmacology found that it was "a potential medicine for the treatment of neuroinflammation, epilepsy, oxidative injury, vomiting and nausea, anxiety and schizophrenia, respectively." No Cochrane reviews have focused on CBD per se, but advocates point to multiple recent studies investigating its application in treating a wide range of conditions, from pain and inflammation to anxiety.

CBD is present in a 50-50 concentration with THC in Sativex, currently the only approved medical cannabis product in New Zealand. It was also approved for use (as Elixinol) by the doctors treating Alex Renton, the Nelson teenager suffering from status epilepticus in 2015 – but only after approval from the Associate Minister of Health, Peter Dunne.

Ministerial approval was required because CBD was deemed to be controlled under the Misuse of Drugs Act – and Regulation 22 of the Misuse of Drugs Regulations demands the approval of the minister (even Sativex, an approved medicine, can't simply be prescribed and each use must go through and be rubber-stamped by Ministry of Health officials).

But CBD isn't explicitly scheduled under the act, and the contention of Ministry of Health officials that it is covered as an isomer of THC is flatly rejected by ESR scientist Dr Keith Bedford in an affidavit obtained by Grey on behalf of her client, a man with terminal cancer. (The affidavit reiterates the official view of ESR itself.)

And neither should it be, given that it's not psychoactive (although it does seem to moderate the "high" of THC) and poses no known individual or social harm that would meet the test posed in Section 3A of the act.

"The Ministry of Health want CBD to be covered by the Misuse of Drugs Act, but they can't get any experts that will say that it is," Grey told me when I spoke to her yesterday. "They keep getting advice from ESR that says it's not, and they've been looking around through their own staff trying to find somebody with some qualifications to say that it is."

This is a battle that has spilled over into the Expert Advisory Committee on Drugs, where Dr Bedford, a founding member, sits along MoH officials. The issue arose at the EACD's meeting in April last year, of which Grey's letter says:

The minutes of the EADC’s April 2016 identify no scientific or legal reason why Dr Bedford’s view is wrong. It appears the different views relate solely to policy consideration and perhaps vested interests, although it remains unclear to me why some members of the committee would prefer to continue to treat CBD as if it is illegal. Clearly government policy cannot override the law that was written by Parliament, and in particular s3A of the Misuse of Drugs Act.

It was discussed again at the EACD's meeting in October – a meeting for which Grey is still unable to obtain minutes.

"They don't want to release them because they're having an internal disagreement about what to say," she said. "Reading between the lines, the Ministry of Health advisors on that committee are saying 'we want it to be covered by the Misuse of Drugs Act' and ESR and other representatives are say, well, legally it isn't."

The Ministry of Health may indeed have quietly given up its argument that CBD is controlled under the MoDA in favour of focusing on the issue of cross-contamination with small amounts of THC, which is typically present in tiny quantities in non-psychoactive strains of cannabis sativa: ie, hemp.

"There's a note in the April minutes saying their secretariat needs to do some research on it.," said Grey. "Well they've had nearly a year now and I don't understand why it's taken so long when Australia's come out loud and clear on it."

In 2015, Australia's Therapeutic Goods Administration (TGA) down-scheduled CBD to a Prescription Only Medicine “in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis”. It observed that such low levels of other cannabinoids were "not clinically significant" and that that there was "low risk of misuse or abuse as cannabidiol does not possess psychoactive properties."

Problem solved then, surely.

This brings us to another dimension of this story: which is that cannabidiol is about to be approved by a joint Australia-New Zealand regulator – as food. This process has been grinding on for a long time, but Food Safety Australia New Zealand's Final Assessment Report is clear and emphatic. Although hemp seeds and plant material will inevitably contain CBD, it says:

There are no public health and safety concerns associated with the use of food products containing derivatives of industrial hemp, provided there is compliance with the proposed maximum levels for THC in hempseed, oil derived from hempseed and other products derived from industrial hemp.

And:

Foods containing derivatives of industrial hemp do not produce any psychotropic effects, and cannot be used as a source of THC.

And furthermore:

The current prohibition on Cannabis spp. use in food, in the absence of identified public health and safety concerns, could be contrary to Australia’s and New Zealand’s obligations as members of the World Trade Organization.

In the most recent report I can find, from September, New Zealand's Food Safety minister Jo Goodhew said she supported the sale of low-THC hemp seed food as "a safe and nutritious food, which could potentially provide economic benefits for New Zealand."

So we're left with a strangely contradictory situation. Not to mention a confusing one.

"I think it's completely clear that CBD is not covered by the Misuse of Drugs Act," said Grey. "And then everything else follows: you can have hemp seed food, you can have a hemp industry, the whole industrial hemp regulations make sense. And ESR's analytical approach fits. Everything makes sense. The only thing that doesn't fit is the Ministry of Health trying to say that it's covered by the Misuse of Drugs Act."

It's tempting to conclude the some Ministry of Health officials have a hangup with CBD, but it's hard to think of a good reason why. It's already scheduled as a prescription medicine under the Medicines Regulations. Acknowledging that it is not controlled under the Misuse of Drugs Act would simply make it more straightforward to prescribe.

Grey would like to see "some criteria that are obvious and simple and make sense. So that hemp food can be sold as hemp food, so we can have benefits of the same hemp foods they have in North America and Europe. Then probably a category for the dietary supplements. And perhaps some category for the medicines, particularly if it's in combination with THC and other medical products."

Grey has received a response from Customs minister Nicky Wagner, explaining that Customs – which has been seizing medical CBD products at the border –  is guided by the advice of the Ministry of Health, which is that "CBD is a class B1 controlled drug as it is an isomer of tetrahydrocannabinol. Customs has acted on that basis."

"How long do we have to wait? We've got people who are sick now," Grey said. "They don't want to have to wait another six months or two years for the advisory committee to align itself with what the law already says.

"I'm still hoping that the Minister of Health will get some control over his officials and ask what are you guys doing, why don't we just listen to what the experts are saying and accept that it's not covered by the Misuse of Drugs Act and it doesn't need to be? Then we won't need to go to court. But if they don't come to that conclusion fairly quickly, then we will file in court."

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Although Sue Grey is acting on behalf of a client, her action is being supported by a wider group of advocates, caregivers, processors and growers, along with The Hemp Store and Norml NZ. Norml president Chris Fowlie, who told me:

"CBD could improve the lives of many people. It is not psychoactive, has no known side effects, and is widely used in the USA and Europe. They say we must follow the law. We just want them to follow the law too.

"CBD is not listed in the Misuse of Drugs Act, and we believe the Ministry of Health and Customs are acting unlawfully when they seize it, and when they tell doctors they need special Ministerial approval to prescribe it. In fact, any doctor can prescribe it to any patient, for any condition.

"It seems extraordinary that officials have disregarded advice of their own expert, Dr Keith Bedford, and have instead based policy on the opinion of a secret scientist, whose identity and qualifications they have redacted. This is unprecedented in public policy, and we believe it will not stand up in court."

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