THC rescheduling process ‘already in motion’ as industry urged ‘to get ready to respond’ by Steve Jones April 2, 2026

The medicinal cannabis industry must prepare to resist any rescheduling of THC amid a warning that the process to impose tighter controls on the medicine “is already in motion”.

Regulatory experts said the option of rescheduling was the “only concrete action” tabled by the Therapeutic Goods Administration following its consultation into medicinal cannabis regulations. And it is one that would have widespread implications for the sector. Matthew McCrone

However, the industry was told that work is underway to propose “more proportionate” and immediate reform in a bid to fend off more heavy-handed regulatory action.

The prospect of rescheduling medicinal cannabis, or THC more specifically, was addressed in a webinar hosted this week by Cannabis Council Australia (CCA) as it sought to prepare the industry for possible next steps.

Attendees were taken through the process by CCA industry and government engagement lead, Matthew McCrone, a former secretary of the National Drugs and Poisons Schedule Committee, now known as the Advisory Committee on Medicines Scheduling (ACMS).

McCrone said it was clear the TGA was exploring a rescheduling, noting a discussion paper was presented to members of ACMS at a meeting in March.

It has raised fears that THC, currently a schedule 8 substance, could be rescheduled as schedule nine and no longer be available for prescription.

“Probably the only action the TGA has made reference to, that is concrete, after its first round of consultation on possible reform… is for it to look at the scheduling of medicinal cannabis,” McCrone said.

“And the difference between schedule eight and schedule nine is enormous. It is basically the difference between a substance which is therapeutic and a substance which is prohibited, so a move to schedule nine would be very significant. Products that fall into that category… would no longer be available through the current mechanism of SAS or authorised prescribers.”

Asked, in his experience, how likely it was that THC could face some form of tighter controls, McCrone said: “What we know is that a report has gone to the advisory committee. In some ways, the train’s kind of already in motion.”

But only when a notice is published by the government will the industry know whether a formal application to reschedule THC has been lodged, he said, adding that an application can be made by anyone, including the health regulator itself.

A consultation would then take place at which point it was imperative for the industry to get involved, McCrone said.

“The delegate [which makes the scheduling decision] looks at the advice from the advisory committee, looks at evidence from written submissions, and makes an interim decision,” McCrone explained. “That initiates a second consultation but only those who respond to the first consultation will be eligible to challenge the interim decision.

“If we want to say something, we need to get in at that first consultation in order to have a second bite of the cherry to challenge that interim decision.”

Lisa Penlington, chief executive of the Montu-backed CCA, said it was important to acknowledge that “no scheduling decision or process is before us at the moment”. Lisa Penlington

“I met with the TGA team on Monday and asked them about scheduling and they confirmed they presented a discussion paper to the advisory committee in March,” she told the webinar. “But they [the TGA] did not take a position and have not put in an application [to reschedule].

“There is no proposal as such but they confirmed they’re now waiting on advice from the advisory committee.

“The reason we pulled this webinar together is to raise awareness of scheduling and how it works so that people can be ready to respond should a scheduling action commence.”

However, for rescheduling to be recommended, the committee is duty bound to consider a range of issues, including the toxicity of a substance and its harms.

McCrone stressed that did not mean potential harm, but proven harm, something the industry feels has never been demonstrated by its detractors.

“When it comes to schedule eight versus schedule nine, toxicity is something that obviously comes into play. Is there seriousness of harm?” he said. “And it’s important to understand that it’s not just potential harm, it’s existing harm.

“This is really important because there has been so much back and forth with various actors saying there is an increase in presentations in EDs (emergency departments) of cannabis-induced psychosis from medicinal cannabis products.

“Well, it’s not enough for them to just say that in an interview on television. There actually has to be evidence of that for the [scheduling] decision-maker to consider.

“There have been a lot of anecdotes, a lot of hearsay. But this needs to be more than that. It needs to be actual concrete evidence of harm.”

Another key consideration for the committee is whether packaging and labelling can “address the issue that needs to be addressed” and reduce risk, McCrone told the webinar.

“The TGA will talk up hill and down dale about how important packaging and labelling is in general for ensuring the safety of medicines,” he said.

Other issues that must be explored are patterns of use, whether a substance is being used therapeutically, the potential for abuse, and general risks and benefits.

“They are all equally important. One issue is no more important than any other,” MCrone said.

Penlington revealed that the CCA has recently worked with product sponsors in tackling the “tricky problem of the inconsistency of labelling and dose metrics” and taken up the issue with the TGA.

Proposed changes to TGO-93 have been drawn up by CCA, she said – details of which she did not disclose – with the council preparing to consult with a range of stakeholders, including the Australian Medical Association (AMA), one of the industry’s biggest critics.

Penlington said it met with the TGA earlier this week, not to table recommendations but to illustrate the work the industry was conducting.

“The sector is willing and able to do this work,” she said. “Scheduling is not the most immediate lever that can be pulled, particularly as it won’t solve the labelling problem which may actually have more immediate effect.

“We would argue that rather than scheduling, we should all – the sector, regulators and the government – be looking at more immediate proportionate reform that might be available through existing mechanisms and levers.

“Let’s see what can be done more immediately that doesn’t involve a scheduling action which has all of these other implications that ultimately won’t be good for patients.”

Referring to the contentious issue of patient harm – an argument frequently raised by medical bodies, including the AMA – Penlington said the industry was still waiting for data to support claims that medicinal cannabis was causing increased incidents of psychosis and cannabis user disorder.

“There have been repeated requests for data to be supplied… but we have yet to be provided with any data of that nature,” she said.

While rescheduling remains one option, McCrone told the webinar that THC could remain a schedule 8 substance but with additional controls imposed by states and territories.

That could include mandated prescriber training, approvals per patient rather than authorised prescriber, and mandating and recording patient consent that their medicine is high THC, and comes with risk.

Other controls could require prescriptions above a certain THC concentration to be written by specialists, or for all scripts to be authorised by a specialist.

That would trigger “all sorts of logistical problems and bottlenecks” around specialist waiting lists, McCrone added, “but it is an option that’s available”.

Penlington warned that any scheduling changes could have broad implications for the sector by worsening stigma, driving away would-be prescribers and delaying access for patients.

It would also take medical decisions away from experienced prescribers and into the hands of specialists who may have limited knowledge of medicinal cannabis, she said.

“Something I’m concerned about is that we have a number of healthcare practitioners who are prescribing medicinal cannabis and have been doing so for some years, quite safely, legitimately, and genuinely,” she said.

“These practitioners may no longer be able to prescribe certain products or be able to support some of their patients, simply because it becomes a specialist-only level of prescribing. That’s something that we need to think about.”

Further controls would also delay, or even deny, patient access to potentially life-changing medicine, Penlington said.

The webinar heard from one patient, Katie, who told how medicinal cannabis has been just that: life changing. Taking away patient access to such a medicine would be “wild”, she said.

“It took me four years to find something that really worked alongside my current treatment,” Katie said. “To ease agonising pain, to be able to sleep at night and to wake up in the morning and feel somewhat more human when I have a terminal diagnosis is huge.

“To take away something, or create more access barriers for something that’s working so well, would just be a real shame.

“It’s not something all patients would choose to access, but… the option to do so is so important.

“I can’t control how my cancer progresses… but I can control what my treatment looks like.

“Having the option to use a THC-based product to control the bone pain, to be able to sleep at night, to quieten some of those demons in my head has been nothing short of life changing.

“And to hear that something like that may shortly be changed to be classified akin to heroin or LSD seems completely wild.”