‘No longer appropriate’: Watchdog flags medicinal cannabis strength limits amid boom

3 months ago 24

Australia’s medicines regulator has flagged a crackdown on the medicinal cannabis industry, pointing to a ballooning number of high-strength products issued through telehealth appointments.

The Therapeutic Goods Administration this week put the industry on notice, floating in a confidential consultation paper obtained by this masthead that it would gauge support for “significantly restricting or preventing access” to more than 1000 unapproved cannabis products now prescribed to hundreds of thousands of Australians.

Medicinal cannabis being grown in 2024 at a Victorian cultivator.

The wide-ranging review will canvass substantial changes to the system permitting access to the once-illegal drug, although the consultation paper specifically notes the federal government “is not intending to remove access to medicinal cannabis”.

The TGA review warns that the strength of cannabis extracts is not limited in Australia and has grown rapidly, with some now containing up to 88 per cent tetrahydrocannabinol (THC), the component in cannabis that makes users feel “high”.

One pro-cannabis MP said this was more than eight times as strong as the “pot” many people had smoked in previous decades.

Access to cannabis for medical purposes was legalised in Australia in 2016, and has sharply increased as many recreational users realise they no longer need to access the drug illicitly.

Cannabis use in Australia has not changed dramatically. The federal government’s Australian Institute of Health and Welfare found 13 per cent of Australians used cannabis in 2001 compared with 11.5 per cent in 2023. But the institute found that among people who used cannabis, the use of prescribed cannabis for medicinal purposes was on the rise.

In the past 12 months, this masthead has detailed the supercharged growth of corporate-backed telehealth cannabis clinics and the explosion in prescribing since 2016. Major companies have emerged supplying the drug. The biggest, Montu, turned over $263 million last year.

In the consultation paper, the TGA questions whether the primary access pathways it oversees – the special access scheme and authorised prescriber scheme – are failing. The schemes were designed to approve drugs needed only in “exceptional circumstances”.

“The unapproved pathways used by prescribers to access medicinal cannabis products, traditionally used as exceptional access mechanisms for unapproved goods, are no longer appropriate due to the high volume of patients accessing an ever-increasing range of products,” it said.

The two schemes run by the TGA had become the default gateways for an industry in which, the consultation paper said, more than 99 per cent of products had not been properly evaluated by federal health authorities for quality, safety or efficacy.

Despite this, the number of cannabis products being prescribed by Australian doctors has exploded – from just 153 approvals in 2017, the year after the drug’s legalisation for medical purposes, to 819,000 approvals last year.

Medicinal Cannabis Industry Australia, the organisation representing the sector, said it supported the TGA’s consultation process.

“The current patient access pathways were implemented nearly 10 years ago, so a review is in order,” a spokeswoman said. She added that her group would “promote this opportunity for industry to provide feedback on their knowledge, experience and observations”.

For the first time, the TGA also formally flagged the prospect of an upper limit on the potency of the main psychoactive component of cannabis, THC. The paper states that when access was liberalised in 2016, “a maximum upper limit for THC was not established”.

This has led to unapproved products being supplied in Australia with extracts that have concentrations of up to 88 per cent of their total weight – vastly higher than the 35 per cent the TGA said would be found in the strongest natural plant.

Victorian Legalise Cannabis MP David Ettershank said high-THC substances such as hashish had “been made for thousands of years” and that comparing strong cannabis in its flower form to modern cannabis extracts was like comparing whiskey to wine.

But some new forms of cannabis were incredibly strong compared with what many Australians had smoked in years gone by, he said.

“If you go back a decade, you were looking at 10 per cent THC levels – that was considered ‘good weed’. Today, 20 to 25 per cent is common,” Ettershank said. “This is a change that warrants priority research.”

Ettershank said the review must be “far-sighted because it is inevitable that the legalisation of cannabis will happen in Australia. The question is not if, but when”.

This meant there would ultimately need to be proper oversight of both cannabis prescribed for medical purposes and that used for recreational reasons, as in other countries. Ettershank said it was “absurd” that the consultation paper did not countenance this.

Among the most significant options being considered is a shift in legal and regulatory responsibility, by potentially moving the onus for product safety from prescribing doctors to the corporate “sponsors” of the cannabis products.

The consultation paper also acknowledges that “product-specific” telehealth services operating under “vertically integrated direct-to-consumer business models” are a primary issue of concern.

The TGA said its review would not focus on how telehealth appointments were working, as that was not a core part of its mandate.

The TGA said any outcomes from the review would depend on the outcome of the consultation, but noted that the entire industry relied first on supply of the products it regulated.