You may have read last week that two years after the publication of regulations for medicinal cannabis – and three years after the enabling legislation – two local products from a local manufacturer have finally met the minimum quality standards for prescription. You may also be interested to know that it's not quite that simple.
The two products, both CBD oils and both from Auckland-based Helius Therapeutics, are indeed listed on the Medicinal Cannabis Agency website under the SubDrops brand. But their Active Pharmaceutical Ingredient (API) – the cannabidiol itself – is not produced in New Zealand, but imported as isolate from the Netherlands. The isolate powder is formulated – mixed with a carrier oil – at Helius's facility in East Tamaki.
It took some asking around to establish that, but not really because Helius is withholding the information. The rules around advertising of unapproved medicines are so strictly applied that Helius is not allowed to even put out a press release saying it has the products for sale, let alone provide background detail on them. (It did put a little announcement on its website.)
But the timing of the launch is extremely good news for cannabis patients, many of whom were facing sharply higher costs for prescribed CBD medicines after the twice-extended transitional period of the Medicinal Cannabis Scheme ended on October 1, meaning that imported products that had not met the minimum quality standards could no longer be prescribed. It's also a crucial face-saver for the Ministry of Health and Health minister Andrew Little, who are finally able to to point to a local company that has found a way through the regulatory thicket.
The pricing implications are significant. The Helius 100mg product is wholesaling for $115 for a 30ml bottle, meaning that patients should be able to get it for as little $160 from a pharmacy. The comparable product from the Canadian company Tilray is wholesaling for $377 for a 40ml bottle – and selling to patients for $500 or even $600 after pharmacy markup. (I want to emphasise that I did not get this information from Helius and they would be in trouble if I had.)
This is good for Helius too – it's got them into the market at a time when thousands of patients have been cut off from products imported by companies like Medleaf and Nubu and are anxiously looking around for options. But Helius isn't making much money out of this pricing – possibly none at all.
Helius apparently expects to swap out its imported API for a locally-produced one next year and launch a wider range of products, once it can get something past the quality standards. But producing GMP-grade CBD isn't cheap. Helius has a great show at grabbing market share right now – how long it can sustain this kind of pricing isn't clear.
Like Rua Bioscience, the only other local company to have achieved a GMP licence, Helius will be relying on the European export market to stay viable in 2022. Things may get tough for the other New Zealand producers established under the law if they can't get their GMP licences soon.
Meanwhile, minister Little made a weirdly unhelful contribution to the debate after the transitional period ended by telling the Herald's Derek Cheng that the industry, or "some at least importers who frankly didn't get off their asses and get their applications in when they should have done."
This is unfair bordering on actionable. I know that Medleaf at least has tried repeatedly to get products through the standards, and that when its application for one producer failed because its EU GMP licence wasn't recognised by our ministry, it offered to pay for a remote audit with a telepresence robot. The ministry said no. Medleaf has also repeatedly sought a meeting with Little to discuss its issues. The minister's office said no.
This all wound up in a fairly spectacular radio segment where the minister insisted that our regulations were no different those of countries like Germany. He was followed on air by Medleaf's Shane Le Brun, who explained various ways in which products accepted by Germany have been rejected here. Short version: New Zealand's regulators have taken the most maximal and least pragmatic path available to them at every step.
The regulations have been eased in a couple of ways recently, most notably in that local producers will no longer be required to do their product testing at GMP labs that literally don't exist in New Zealand. Turns out, ISO-accredited labs are fine. But a broader regulatory review has stalled and won't report until next year.
Little also said in the radio interview that individual prescribers would still be able to import the now-banned CBD products as unapproved medicines for individual patients under Section 25 of the Medicines Act (anything containing THC needs case-by-case ministry approval). Then Medsafe's Chris James went to the press to warn that this right should be used only "sparingly" and bulk imports would be investigated. It's just a bit of a mess.
But that's what's happening. One clinic is using Section 25 to prescribe its own-brand CBD products. Medleaf has also set up an offshore company to supply prescribers under Section 25.
Medleaf's CBD product will be broad-spectrum, which means it contains other compounds, such as terpenes and very low levels of other cannabinoids. Some patients and prescribers regard broad-spectrum products as important for their needs, so there's probably a battle looming over that. The MCS effectively doesn't recognise any role for terpenes or differences between strains, so it's not just a matter of interchangeable isolates.
The differences between the establishement approach to prescribing cannabis and the broader understanding of cannabis therapeutics are also evident in the long-awaited BPAC guidelines for prescribing cannabis, which are currently up for feedback.
The advice suggests chronic pain, spasticity and childhood epilepsy (CBD only) as primary indications, but warns that "in the absence of large and robust RCTs comparing medicinal cannabis with established treatments, medicinal cannabis products cannot currently be considered a first- line option for any indication." For neuropathic pain, it recommends that at least three other medications should have been tried before cannabis is prescribed and for malignant pain, two others.
Notably absent is any consideration of how patients might feel: as I've written recently, some pain patients simply find prescription opioids and gabapentinoids, which can be freely prescribed, unbearable and feel strongly that cannabis has helped them reclaim their lives. Dr Graham Gulbransen calls prescription cannabis an "exit drug" for that reason.
Yet the BPAC advice declares there is "no evidence that adjunctive use of medicinal cannabis reduces the use of opioids in patients with chronic non-malignant pain", citing a large four-year observational study that did indeed find "no evidence that cannabis use improved patient outcomes." But that study was included in a more recent evidence review that did find quite plentiful evidence of opioid use reduction with cannabis in qualifying studies, but failed it on some familiar basics of evidence quality: not least, what is a dose of cannabis anyway? See also: exactly which cannabis are we talking about?
The emphasis on clinical trial evidence is inevitable – and it does turn up something interesting. A graphic in the draft advice compares the efficacy of several treatments. For all the problems with funding and conducting high-quality cannabis research, gabapentin and pregabalin actually wash up only slightly better than cannabis does.
There's a kind of cultural gap here too. Anyone who has used cannabis understands that different strains do different things and it's reasonably well established that the respective effects of, say, cannabis sativa and cannabis indica strains are related to their respective terpene profiles, which are thught to modulate the effects of cannabinoids. But the advice to prescribers covers just two isolated molecues, CBD and THC. No other cannabinoids are mentioned, nor terpenes. The gulf between cannabis science and the clinical world still seems hard to bridge.
So it's a baseline for wary GPs, one with a creditable emphasis on conversations with patients and jointly-agreed treatment plans. But I suspect regular prescribers will look more to next year's Helius-sponsored MedCann summit, which will have a prescriber day. Helius is also a sponsor of the mcinfo.com site published by DataPharm, which provides a somewhat gentler introduction for prescribers and their patients.
Finally, I'm aware that the regulatory battles tend to drown out any good news stories the fledgling industry might generate. So let's focus on a really good news story.
Growing Dope, Wednesdays on Prime TV, tells the story of Rua Bioscience over four years (beginning as Hikurangi Enterprises) with warmth and authenticity. It's striking to grasp how much hope rides on this company and it only increased my respect for Manu Caddie and Panapa Ehau to see how patiently they've worked towards their kaupapa.
PS: Thanks so much to everyone who clicked the support button below the last cannabis issues post and kicked in a little via PressPatron. This stuff is important, but there's a limit to how much I can get in mainstream publications.