On 16 March 2026, The Lancet Psychiatry published what the researchers describe as the largest-ever systematic review and meta-analysis of randomised controlled trials evaluating medicinal cannabinoids for mental health and substance use disorders. The analysis, led by Dr Jack Wilson, a postdoctoral research fellow at the University of Sydney's Matilda Centre for Research in Mental Health and Substance Use, reviewed 54 RCTs involving 2,477 participants, drawing on evidence spanning 1980 to 2025.

The headline finding, that the researchers found insufficient evidence to justify cannabinoids as a routine treatment for most psychiatric conditions, is significant and was widely covered. What the coverage failed to report, with near-uniform consistency, was a specific safety finding from the same dataset, one that materially complicates the prevailing media narrative around cannabis and psychosis.

What the Researchers Found

Writing in their own plain-language summary in The Conversation, the study authors stated that cannabis medicines were no more effective than a placebo at treating symptoms of psychotic disorders, anxiety, PTSD, anorexia nervosa, or opioid use disorder. Notably, the researchers found no randomised controlled trials at all examining cannabinoids for depression, despite depression being among the most common indications for which these medicines are prescribed in Australia.

On safety, the picture is more nuanced than most coverage conveyed. Participants receiving cannabinoids experienced significantly more adverse events overall compared with those receiving placebo, with the researchers calculating that one additional participant would experience an adverse event for every seven treated with cannabinoids. However, and this is the finding that received least attention: serious adverse events, including psychotic episodes, occurred at no higher rate in the cannabinoid group than in the placebo group. That distinction between all-cause adverse events and serious adverse events was not well communicated in most of the media coverage that followed.

The Pharmaceutical Journal noted that the analysis found no significant effects on psychotic disorders among the conditions examined. But noting the absence of a therapeutic effect on a condition is not the same as reporting the equivalence of serious adverse event rates between cannabis and placebo. The former describes what the medicine failed to treat. The latter describes its safety profile under controlled conditions relative to an inert control. Both findings are in the paper. Only one was consistently reported.

The Substitution

The psychosis claim that did appear in most coverage was drawn from a different body of literature entirely.

The NPR piece, syndicated across multiple public radio affiliates, referenced a well-documented link between cannabis use at a young age and an increased risk of psychosis. That claim is sourced to a separate review published in JAMA Internal Medicine earlier the same month, drawing on a broader mix of study designs including observational data. It is not drawn from the Lancet Psychiatry RCT dataset. The two are presented in close proximity in a manner that invites conflation. A reader who did not parse the passage carefully would reasonably conclude that the cannabis-psychosis link was supported by the controlled trial evidence under discussion. It was not. The controlled trial evidence under discussion found no significant difference in serious adverse events, including psychotic episodes, between cannabis and placebo.

The Pharmaceutical Journal covered the study with reasonable breadth, reporting positive findings alongside the negative ones and including a counter-perspective from Mike Barnes of the Medical Cannabis Clinicians Society, who argued that the RCT model is poorly suited to evaluating a pharmacologically complex plant and that real-world evidence would yield different conclusions. That is a legitimate methodological critique and its inclusion represents a more complete piece of coverage than most. The Pharmaceutical Journal article nevertheless did not report the equivalence of serious adverse event rates between cannabis and placebo, the same omission present across the broader coverage.

The clearest illustration of the substitution comes from within the study's own media cycle. In the University of Sydney press release accompanying the paper, Dr Wilson is quoted as saying: "Though our paper didn't specifically look at this, the routine use of medicinal cannabis could be doing more harm than good by worsening mental health outcomes, for example a greater risk of psychotic symptoms and developing cannabis use disorder, and delaying the use of more effective treatments."

The comment is clearly labelled as outside the scope of the paper, and Dr Wilson's general caution is understandable in a broader clinical context. But it handed media outlets a quotable psychosis concern that could be used without engaging with what the study's own controlled trial data showed. The result was that speculative comment explicitly placed outside the study's scope received prominent placement across the coverage, while the finding inside the study's scope, that serious adverse event rates including psychotic episodes were equivalent between cannabis and placebo, did not appear at all.

This is the structural problem. The study's methodological credibility as gold-standard RCT evidence is invoked to support the "cannabinoids are ineffective" finding, while a lower-grade evidentiary basis, including comment that explicitly acknowledges falling outside the study's scope, sustains the "cannabis causes psychosis" narrative.

What the Study Also Found

A balanced reading requires acknowledging where the researchers found positive signals, and where the study's own limitations are genuine.

The researchers found meaningful reductions in cannabis use and withdrawal symptoms among people with cannabis use disorder, with the effect driven specifically by pharmaceutical-grade mixed CBD and THC formulations administered orally. This is consistent with a harm-reduction model: patients substituting a standardised oral formulation for smoked high-THC cannabis may use less overall, with associated reductions in related health risk. Notably, the researchers also found that cannabinoids increased cocaine cravings among people with cocaine use disorder, a cautionary finding that qualifies any broad reading of the substance use disorder evidence.

The researchers identified a significant reduction in tic severity among those with Tourette syndrome, again only for combined CBD and THC formulations, not for either cannabinoid administered alone. Sleep time showed improvement among those with insomnia, though the researchers note this finding lost significance when high-risk-of-bias studies were removed from the analysis, placing it on less certain ground than some coverage implied. A reduction in autistic traits was observed, but subgroup analysis revealed that neither CBD alone nor combined CBD and THC showed individual significance, and both contributing studies had a high risk of bias.

The researchers characterise these as promising signals warranting further investigation, particularly given the scarcity of effective pharmacological options for cannabis use disorder and Tourette syndrome, but the certainty of evidence across these positive findings was rated as low to very low under the GRADE framework.

Two methodological caveats from the paper itself are directly relevant to Australian readers. First, most included trials used registered cannabinoid products, such as Sativex, rather than the unregistered high-THC products that dominate the Australian market. The safety and efficacy profile observed in the trials may not reflect what Australians are actually receiving. Second, the average treatment duration across the included trials was approximately five weeks, which the researchers acknowledge as a significant constraint: long-term harms are unlikely to be captured within that window.

The Australian Regulatory Context

The study lands at a consequential moment for Australian regulation. According to the paper, over one million prescription applications have been approved in Australia, and mental health conditions account for six of the ten most common prescribing indications. Around 700,000 Australians used cannabis for health purposes in the past year, with sales increasing four-fold since 2022. The majority of products prescribed are not registered with the TGA, meaning they have not undergone rigorous pre-market testing. The researchers explicitly state that their findings should inform the TGA's current review of medicinal cannabis prescribing.

Editorial note: The Conversation article co-authored by Wilson and Stockings states that sales have increased "four-fold" since 2022. The University of Sydney press release issued on the same day describes "a tripling of sales...over the past four years." The Lancet paper does not provide a sales multiplier figure. Both figures originate from the same research team and the discrepancy has not been resolved. This article uses the figure from the Conversation piece, as it carries the authors' names directly, but readers should be aware of the inconsistency pending clarification.

Two co-authors on the paper hold declared interests relevant to Australian regulatory context. Wayne Hall and Myfanwy Graham received consultation fees from the World Health Organisation; Hall additionally received payment for expert testimony on the risks of cannabis use. Graham is a member of the Medicinal Cannabis Expert Working Group at the Australian Department of Health, Ageing and Disability, and has received TGA funding for independent evidence reviews on medicinal cannabis. These disclosures, noted in the paper itself, do not impugn the study's findings. They are part of the complete public record. Most media coverage did not mention them.

The Evidentiary Pattern

The most important observation is the selective application of evidentiary standards.

When RCT evidence supports a cautionary or restrictive interpretation of cannabis medicine, it is presented as definitive. When the same RCT evidence contradicts a harm narrative established by decades of observational epidemiology, it is absent from the coverage and replaced, without acknowledgement, by observational evidence or speculative comment that explicitly falls outside the study's scope.

The relationship between cannabis use and psychosis in population-level data is documented across multiple cohort studies and should not be dismissed. However, population-level associations capture confounding variables that controlled trials are specifically designed to remove. The controlled trial data, on the specific question of whether pharmaceutical cannabinoids administered under clinical conditions produce serious adverse events including psychotic episodes at a higher rate than placebo, found no statistically significant difference. That is a finding. It belongs in the same coverage that cites the study's methodological credibility.

The source material is publicly available under a Creative Commons Attribution licence. Readers are in a position to assess the coverage for themselves.

Citation: Wilson J, Dobson O, Langcake A, Mishra P, Bryant Z, Leung J, Dawson D, Graham M, Teesson M, Freeman TP, Hall W, Chan GCK, Stockings E. 'The efficacy and safety of cannabinoids for the treatment of mental disorders and substance use disorders: a systematic review and meta-analysis.' The Lancet Psychiatry, 2026. DOI: 10.1016/S2215-0366(26)00015-5. Published under Creative Commons Attribution (CC BY 4.0) licence.

Editorial transparency note: This article was prepared with the assistance of Claude (Anthropic), an AI system used to locate and retrieve media coverage of the study, cross-reference claims against the primary Lancet Psychiatry paper and the authors' own Conversation summary, identify factual discrepancies between drafts and source material, and flag unsupported claims for removal across multiple revision cycles. All editorial judgements, interpretive framing, and final decisions regarding content and accuracy remain the responsibility of the human author. The primary source material, including the full text of the Lancet paper, was provided directly and verified against all substantive claims prior to publication.

This article discusses published research for informational and media literacy purposes. It does not constitute medical advice and should not be used as the basis for any clinical decision. Patients seeking information about medicinal cannabis treatments should consult a qualified healthcare professional.

In 2000, the country operated eight refineries. Today, just two remain: Ampol's Lytton refinery in Brisbane and Viva Energy's Geelong plant.

It is a fragile position at the best of times. In the current global environment, it borders on reckless.

US and Israeli strikes on Iran have effectively closed the Strait of Hormuz, a critical passageway carrying roughly 20 per cent of the world's oil supply, sending prices toward US$120 per barrel and triggering genuine alarm about global fuel availability. Australia imports more than 90 per cent of its refined petroleum products from Asian refineries that themselves rely heavily on Middle Eastern crude. A crisis in the Persian Gulf does not simply affect Australia indirectly through global markets; it also affects the refineries in Singapore, South Korea and Japan that produce the petrol, diesel and jet fuel Australians consume daily. The vulnerability sits two steps upstream in the supply chain.

Diesel powers the trucks that move freight across the country, keeps agriculture operating, supports mining and construction, and ensures emergency services can function. If those supplies are disrupted during a global shock, the consequences will be immediate and severe: supermarket shelves would empty, transport networks would stall, and regional communities would be hit hardest.

Against this backdrop, Australia's hemp sector is sitting on an underutilised answer, and a regulatory framework that makes it nearly impossible to scale.

The case for hemp derived biodiesel

Hemp (Cannabis sativa L.) is one of the most versatile oilseed crops on earth. Its seeds yield a cold-press oil that can be processed into biodiesel through standard transesterification, the same method used for canola and soy. Unlike fossil diesel, hemp biodiesel is carbon-cycling rather than carbon-adding, it is non-toxic, and it biodegrades rapidly. It can be blended with conventional diesel at varying ratios, meaning it does not require new engines, new infrastructure, or a wholesale rethink of Australia's transport fleet.

The agronomic case is equally compelling. Hemp is a fast-growing, low-input crop that improves soil health, suppresses weeds and requires significantly less water than comparable broadacre alternatives. It grows across a wide range of Australian climates, from the tablelands of New South Wales to the red soils of the Northern Territory. Research has consistently shown that rotating hemp into grain cropping systems can lift subsequent wheat yields by ten to twenty per cent, meaning the crop delivers value even before the seed reaches a press.

For Australian farmers already under pressure from volatile commodity prices, climate uncertainty, and the ongoing squeeze of input costs, a dual-purpose energy and rotation crop represents exactly the kind of diversification the sector needs.

The regulatory handbrake

Here is where Australia's sensible-sounding hemp framework becomes quietly absurd.

Industrial hemp is legal in Australia, but regulation is split across different government bodies, and rules vary by state and territory, a patchwork that can feel confusing fast. Each state and territory has its own legislation covering cultivation, processing and storage, with licence applicants required to provide national police history checks, and site inspections generally required. Every industrial hemp crop must be tested for THC at the grower's expense.

The fragmentation is not merely inconvenient. It is a structural barrier to the kind of scale required to make hemp biodiesel commercially viable. A farmer in Queensland operates under different rules than one in Victoria. A processor moving hemp across state borders navigates layered compliance obligations that would test a well-resourced legal team, let alone a farming family exploring a new enterprise.

Critically, there is no national industrial hemp policy framework, no dedicated biofuel incentive structure for hemp, and no government-coordinated research program connecting hemp cultivation to Australia's fuel security strategy. A crop that could be part of a sovereign energy solution is being administered primarily as a niche food and fibre commodity.

This is a policy failure hiding in plain sight.

What a serious response would look like

A coherent national approach would begin with the obvious: harmonising industrial hemp licensing across all jurisdictions into a single federal framework, administered efficiently, with appropriate but proportionate compliance requirements. It would include dedicated research funding for Australian hemp biodiesel production pathways, connecting agricultural extension services with energy policy. It would offer targeted incentives for farmers in suitable regions to trial hemp as a biofuel feedstock, with offtake arrangements connected to biodiesel blending mandates for heavy transport and agriculture, sectors that cannot easily electrify.

Analysts warn that with roughly a month of petrol and diesel available under normal conditions, the system functions only because imports arrive continuously. If the Hormuz crisis continues for weeks or spreads further, genuine shortages become plausible.

Australia cannot refinery-build its way out of this crisis quickly enough. But it can grow its way toward a more resilient position, if it chooses to. Hemp biodiesel will not replace crude oil. It was never going to. But it can displace a meaningful proportion of diesel consumption in agriculture, regional logistics, and heavy industry, precisely the sectors most exposed when global supply chains fracture.

The plant is ready. The farmers are interested. The technology is proven.

The only thing missing is the political will to stop treating hemp like a problem to be managed and start treating it like an opportunity.

This article reflects the views of the author. It does not constitute fuel or investment advice. Readers interested in industrial hemp cultivation should consult their relevant state or territory licensing authority.

A peer-reviewed study published in Frontiers in Pharmacology (February 2026) has shed new light on the potential role of the endocannabinoid system in managing the neurobiological overlap between Alzheimer's disease (AD) and chronic neuropathic pain, two conditions that frequently co-occur and share underlying biological pathways.

The research, conducted by scientists at Grigore T. Popa University of Medicine and Pharmacy in Romania, used preclinical animal models to investigate how an EU-GMP certified Cannabis sativa L. preparation interacted with these conditions in combination. The findings, while preliminary and not yet applicable to clinical practice, add to a growing body of scientific literature exploring cannabinoids as a multi-target pharmacological tool.

Why These Two Conditions Are Studied Together

Alzheimer's disease is the most common form of dementia, affecting more than 55 million people globally. Research has consistently shown that a significant proportion of people living with AD (estimated at close to half) also experience persistent pain. Yet managing pain in dementia patients is notoriously difficult: standard pain assessment tools rely on self-reporting, cognitive impairment can mask pain behaviours, and many conventional analgesics carry risks of adverse effects in this population.

Beyond the clinical challenge, there is growing scientific interest in whether chronic pain may itself accelerate cognitive decline. The two conditions appear to interact at a neurobiological level, involving overlapping mechanisms including neuroinflammation, oxidative stress, and disruption of the endocannabinoid system.

The endocannabinoid system, a network of receptors and signalling molecules distributed throughout the brain and body, plays a modulatory role in both pain processing and neurological function. It is altered in both Alzheimer's disease and chronic pain states, making it an area of active research interest.

What the Study Did

The researchers used a rat model designed to simulate the co-occurrence of these two conditions simultaneously: transient cognitive impairment induced by scopolamine (a drug that disrupts acetylcholine signalling, commonly used to model memory impairment), alongside chronic neuropathic pain induced by sciatic nerve ligation.

Treatment groups received either a Cannabis sativa L. preparation (an EU-GMP certified whole flower product, administered orally at 5 mg/kg), standard medicines including donepezil (a common Alzheimer's drug) and tramadol (an opioid analgesic), or combinations of these.

Outcomes were assessed through validated pain sensitivity tests, clinical monitoring, and detailed tissue analyses including immunohistochemistry, allowing the researchers to examine markers of neuroinflammation, neuronal cell death, and structural integrity in both brain tissue and peripheral nerve.

Key Findings

The study reported several notable findings in the animal model:

Analgesic effects. The cannabis preparation produced measurable, time-dependent reductions in thermal pain sensitivity. When combined with donepezil and tramadol, the combination produced longer pain response latencies than tramadol alone, suggesting a potential additive or synergistic interaction. Effects on mechanical pain sensitivity were less pronounced across all treatment groups.

Neuroprotective markers. Immunohistochemical analysis showed that the cannabis preparation, whether administered alone or in combination, was associated with the most pronounced reductions in markers of neuroinflammation and neuronal stress. Specifically, researchers observed reduced activation of astrocytes (GFAP) and microglia (Iba1), lower expression of the inflammatory cytokine IL-6, reduced Caspase-3 (a marker of programmed cell death), and better preservation of hippocampal neuron integrity and peripheral nerve structure.

Organ safety in animal models. Histological examination of internal organs found no significant tissue alterations in animals treated with the cannabis preparation across the study period. By contrast, the tramadol-only group showed detectable hepatic (liver) changes, a finding consistent with previously reported concerns about tramadol's hepatotoxic potential at clinical doses.

The researchers concluded that the multi-target action observed, spanning pain modulation, inflammation reduction, limitation of apoptosis, and preservation of neural architecture, supports the hypothesis that cannabinoids may offer a complementary approach when managing dementia with comorbid chronic neuropathic pain.

What This Research Does and Does Not Tell Us

It is important to contextualise these findings carefully.

This is a preclinical study conducted entirely in animal models. Results in rodent models do not reliably predict outcomes in humans, and no conclusions about treatment efficacy in people with Alzheimer's disease or neuropathic pain can be drawn from this research alone.

The study used a specific, EU-GMP certified whole flower preparation under controlled laboratory conditions and dosing protocols. This is not a basis for individuals to self-administer cannabis products in any form.

The authors themselves note that future studies will need to explore the molecular mechanisms underlying the observed effects, and assess long-term safety and efficacy across a broader range of neurodegeneration models and in clinical (human) settings.

The Broader Research Context

This study contributes to an expanding international literature on cannabinoids and neurodegeneration. Researchers have been increasingly investigating the endocannabinoid system as a potential therapeutic target in conditions involving neuroinflammation, a pathological feature of Alzheimer's disease, Parkinson's disease, multiple sclerosis, and various chronic pain syndromes.

The emphasis on EU-GMP certification in this study is also noteworthy from a scientific rigour perspective. GMP (Good Manufacturing Practice) certification ensures that the cannabis product used in research is produced to a consistent, pharmaceutical-grade standard, an important variable when interpreting and comparing cannabinoid research across different studies and product types.

In Australia, medical cannabis products approved through the Therapeutic Goods Administration (TGA) regulatory pathway are also required to meet pharmaceutical manufacturing standards, a framework that underpins their use within the healthcare system.

For Patients and Carers

If you or someone you care for is living with Alzheimer's disease, dementia, chronic pain, or any related condition, it is important to speak with a qualified healthcare professional before considering any changes to treatment.

Medical cannabis is a prescription medicine in Australia. It can only be legally accessed through a registered medical practitioner via the TGA's regulatory framework, including the Authorised Prescriber scheme or the Special Access Scheme. Eligibility, appropriate product selection, dosing, and monitoring are all clinical decisions that must be made in consultation with a doctor.

This article is intended for educational and informational purposes only. It does not constitute medical advice, and no claims are made about the efficacy of any product for any condition.

Source: Costachescu I, Gogu RM, Stanciu GD, et al. Therapeutic relevance of an EU-GMP certified Cannabis sativa L. strain in a dual in vivo model of cognitive impairment and chronic neuropathic pain. Front Pharmacol. 2026;17:1761426. doi: 10.3389/fphar.2026.1761426

The conflict of interest statement published with this study states that the research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

Imagine two veterans. Both served. Both are diagnosed with cancer this year. One received DVA-funded medicinal cannabis last year for a separate condition. The other is coming to the scheme for the first time.

Under the Department of Veterans' Affairs' updated Medicinal Cannabis Framework, announced today, those two veterans will not be treated the same.

The veteran already in the system keeps their existing arrangements — at least for now. The newly diagnosed veteran must find a Fellow of an AHPRA-accredited medical specialty to prescribe, attend an in-person consultation first, and navigate new THC concentration and dosage caps on dried herb products. All of this, effective immediately.

It is a two-tier system, created overnight, for people who may be facing some of the worst moments of their lives.

What DVA Has Actually Done

DVA has been funding medicinal cannabis for eligible veterans under the Repatriation Pharmaceutical Benefits Scheme (RPBS) since 2018, for conditions including chronic pain, chemotherapy-induced nausea and vomiting, palliative care, anorexia and wasting from chronic illness, spasticity from neurological conditions, and refractory paediatric epilepsy.

That list of conditions has not changed. DVA is not withdrawing funding for these indications. But for any veteran accessing the scheme for the first time from today, the rules are significantly different.

New patients must now be prescribed by Fellows of an AHPRA-accredited medical specialty, a requirement that immediately excludes the GP-led and telehealth-based prescribing models that have brought medicinal cannabis within reach of veterans in regional and remote Australia. The first consultation must also be in person.

Additionally, a daily dosage cap and THC concentration limit have been introduced for dried herb medicinal cannabis products for new patients, on the basis of what DVA describes as "increasing evidence of harm associated with high concentration THC products and/or high doses of THC, with insufficient evidence of benefit."

That framing, insufficient evidence of benefit, will raise eyebrows among clinicians and researchers who work in this space, particularly as it applies to patients in palliative care, where quality of life and symptom relief, rather than curative outcomes, are the measure of what works.

The Access Problem Nobody Is Talking About

Australia has a well-documented specialist shortage, and it is not evenly distributed. Veterans in metropolitan areas may be able to find a Fellow of an AHPRA-accredited specialty with relative ease. Veterans in rural and regional communities, who are disproportionately represented in the veteran population, face a different reality.

For a veteran in outback Queensland newly diagnosed with a terminal illness, "find a specialist and attend in person first" is not a neutral administrative requirement. It is a genuine barrier to care, arriving at the worst possible time.

The telehealth prescribing models that DVA is now effectively closing off for new patients were not a loophole, they were a considered response to the realities of Australian geography and veteran demographics.

A Grandfathering Period That Asks Questions of Its Own

Veterans already receiving DVA-funded products containing high-concentration or high-dose THC will continue under their current arrangements during a six-month grandfathering period, after which they will need to meet the new criteria.

DVA frames this as a transitional measure to allow "prescriptions to be adjusted in a safe way." That is a reasonable description of what it is. It is also a six-month countdown for some of the most vulnerable patients in the scheme, including those in palliative care, to restructure their treatment under new constraints.

If high-concentration THC products carry the risks DVA now cites, the question of why those patients were funded in the first place deserves an answer. If those patients' treating clinicians believe the current regimen is clinically appropriate, the question of why DVA's Framework now supersedes that clinical judgement also deserves an answer.

What DVA Isn't Funding — And Never Has

DVA has reiterated that it does not fund medicinal cannabis for mental health conditions. Given that PTSD remains one of the most prevalent and debilitating conditions in the veteran community, and given the volume of emerging research into cannabinoids and trauma-related disorders, that exclusion continues to represent a significant gap between the lived experience of veterans and the conditions DVA is willing to fund.

That policy has not changed today. But in a document full of changes justified by evidence, its absence without explanation is notable.

The Bottom Line

DVA says these changes are about ensuring it funds treatments that are "both safe and effective." That is an unimpeachable goal. Nobody disputes that prescribing standards matter, or that THC concentration deserves clinical oversight.

But policy intent and policy impact are not the same thing. The practical impact of today's announcement is that a veteran receiving a serious diagnosis from tomorrow onwards faces a harder, slower, more expensive path to the same funding their comrade next door has held for years, not because their need is lesser, but because of the date on their paperwork.

That is worth saying clearly.

This article reports on a government policy update and represents editorial commentary on that policy. It does not constitute medical advice. Decisions about medicinal cannabis treatments should be made in consultation with a qualified healthcare professional. More information on the updated Framework is available at dva.gov.au.

New research demonstrates that medicinal cannabis may help patients with advanced pancreatic cancer manage distressing symptoms such as pain, insomnia and appetite loss, with a favourable safety profile and high patient satisfaction.

Study Overview

A pilot randomised waitlist-controlled trial known as CanPan involved 32 patients with newly diagnosed locally advanced or metastatic pancreatic adenocarcinoma. The research was conducted through a partnership between investigators and the Minnesota Medical Cannabis Program, and was published in JCO Oncology Practice whilst being presented at the 2026 ASCO Gastrointestinal Cancers Symposium.

Patients in the study had a median age of 71 years, with 53% being women and 91% identifying as White. All participants experienced at least one burdensome symptom at study commencement. The trial randomly assigned participants in a 1:1 ratio to receive either early cannabis intervention (weeks 0–8) or delayed access (weeks 9–16).

The intervention consisted of medical cannabis programme certification, personalised education with dosing guidance, and provision of cannabis products at no cost. Patients in the early access group typically collected their cannabis products approximately 3 days after commencing chemotherapy, following a median of 5 days from enrolment to chemotherapy initiation.

Baseline Symptom Burden

At the study's commencement, participants reported significant symptom burdens:

• 85% experienced moderate-to-severe insomnia
• 77% suffered from moderate-to-severe pain
• 69% had moderate-to-severe appetite loss
• 46% reported moderate-to-severe anxiety
• 31% were already using opioid medications (mean baseline oral morphine equivalent of 7 mg)

Additionally, quality of life assessments indicated mild limitations in both physical and mental health domains.

Cannabis Use Patterns

Participants predominantly used oral cannabis formulations, with tablets being the most common choice. The median daily dose at 4 weeks was 10 mg of tetrahydrocannabinol (THC) and 5 mg of cannabidiol (CBD). By 8 weeks, the median daily THC use was 7.3 mg.

Participants made a median of two visits to dispensaries during the study period, with a median one-way distance of 11 miles from their homes. They used six different dispensary locations across the study. The estimated out-of-pocket cost (had participants been required to pay) averaged $807 USD over the 8-week period, with a range of $199–$3,079 USD.

Key Findings

After 8 weeks, patients who received early cannabis access showed numerically higher improvement rates compared to those in the waitlist group:

• Pain improvement: 44% versus 20% (P = 0.35)
• Appetite improvement: 56% versus 30% (P = 0.37)
• Insomnia improvement: 67% versus 30% (P = 0.18)
• Most severe baseline symptom improvement: 89% versus 50% (P = 0.14)

Importantly, the early access group experienced a numerically greater decrease in opioid use (mean change of –3 mg versus +17 mg oral morphine equivalent), though this was not statistically significant (P = 0.22).

Safety Profile

The early access group reported lower rates of worsening potential side effects compared to the waitlist group:

• Dry mouth: 11% versus 20% (P = 0.99)
• Dizziness: 11% versus 20% (P = 0.99)
• Concentration problems: 22% versus 50% (P = 0.35)

Researchers attributed the favourable safety profile to the education participants received emphasising a "start low, go slow" approach to dosing.

Only one adverse event (fatigue and confusion) was reported in the early arm and designated as possibly related to cannabis use. After discussion with clinical staff, the participant chose to discontinue cannabis. Both study arms showed steady increases in neuropathy severity over time, consistent with the neurotoxic effects of chemotherapy.

Patient Acceptability

Of the 10 early arm participants who completed study experience surveys:

• 100% would recommend using cannabis to other patients with similar needs
• 100% reported that study activities (enrolment, obtaining cannabis, completing weekly surveys) were easy
• 90% reported that using cannabis was easy, practical, helped their symptoms and wellbeing without negative health impacts

Participant feedback for improving future trials included clearer dosing instructions and further streamlining of electronic patient-reported outcomes and cannabis pickup logistics.

Study Feasibility

The study successfully met all three prespecified feasibility metrics:

• 74% enrollment rate among eligible patients (goal ≥20%)
• 81% compliance with random assignment through week 8 (goal ≥60%)
• 75% completion rate for weekly patient-reported outcomes (goal ≥50%)

These findings demonstrate that randomised interventional cannabis trials can be successfully conducted through partnerships with state cannabis programmes, overcoming significant regulatory barriers that have historically limited such research in the United States.

Limitations and Context

It's important to note several limitations of this preliminary research:

• The trial was small with only 32 participants
• The 8-week primary study period was relatively brief, precluding conclusions about longer-term benefits or safety
• Participants were predominantly from urban, White populations in Minnesota
• Results may not be generalisable across different state cannabis programmes and regulations
• The study was not powered for definitive efficacy testing—differences between groups were not statistically significant
• Only 59% of participants had complete symptom data available at both baseline and 8 weeks for efficacy analysis
• Blinding was not possible given the study design
• As a pilot study, the findings require validation in larger, multicentre trials

The study was supported by philanthropic funding to the HealthPartners Cancer Research Centre, with cannabis products provided by Vireo Health (GreenGoods, Minnesota).

Researcher Perspective

The study's lead author, Dr Dylan Zylla from HealthPartners Institute Cancer Research Centre in Minneapolis, emphasised that this research design offers a model for collaboration between investigators and state cannabis programmes to overcome regulatory barriers.

"Early access to medical cannabis was associated with improvement in certain symptoms, particularly insomnia, with minimal harms," Dr Zylla noted. The research team concluded that these encouraging preliminary results regarding efficacy and safety support further exploration into cannabis for managing cancer-related symptoms.

This trial builds upon Dr Zylla's broader research programme examining cannabis in oncology, which has included analysis of over 1,000 patients with cancer enrolled in Minnesota's medical cannabis programme since 2015. Previous work by the research team found that roughly 30–40% of patients reported clinically meaningful improvement in symptoms, with adverse effects being uncommon (10.5%) and generally mild.

Current Approaches Insufficient

The researchers noted that current symptom management approaches for pancreatic cancer remain insufficient. More than 80% of patients continue to report moderate-to-severe symptom burden over time despite supportive care interventions. Additionally, treatment for one symptom can worsen another—for instance, opioids used for pain may worsen somnolence, constipation and itching, and have been associated with tumour growth and decreased survival in some studies.

Regulatory Innovation

The successful completion of this trial represents an important advancement in cannabis research methodology. Cannabis is classified as a Schedule I drug in the United States, making interventional trials difficult to conduct. By partnering with a state-run medical cannabis programme and using standard-of-care cannabis products that participants could individually titrate to achieve personalised symptom control, researchers were able to conduct a real-world interventional trial whilst overcoming otherwise insurmountable regulatory barriers.

The trial design was fully remote with no additional in-person study-specific visits after the initial consent visit, minimising participant burden whilst allowing ongoing cancer care to continue uninterrupted.

Original paper link: https://doi.org/10.1200/OP-25-01165

Important Regulatory Information for Australian Readers

In Australia, medicinal cannabis is a prescription-only medicine regulated by the Therapeutic Goods Administration (TGA). It is available through the Special Access Scheme or Authorised Prescriber pathways for patients with conditions where conventional treatments have proven inadequate.

The TGA's regulatory framework differs substantially from state-based programmes in the United States. Australian patients interested in accessing medicinal cannabis must consult with their healthcare provider to discuss whether it may be appropriate for their individual circumstances. Only healthcare practitioners can determine eligibility and prescribe medicinal cannabis products approved for use in Australia.

This article is for educational purposes only and should not replace professional medical advice. The research discussed was conducted in the United States under Minnesota's medical cannabis programme. Always consult with a qualified healthcare practitioner before making decisions about treatment options.

The Victorian Government's world-first medicinal cannabis driving trial has completed recruitment of patients, marking a significant step forward in research that could eventually inform policy changes affecting thousands of Australians.

Trial Update

According to an update published on 6 January 2026 on the Victorian Government website, recruitment of adults with medicinal cannabis prescriptions has now concluded. The trial, conducted by Swinburne University of Technology at a closed-circuit track facility, will now commence recruitment of control participants in early 2026.

Researchers are assessing participants' ability to manage distractions and evaluating driving performance including steering, braking and speed control at METEC Driver Training in Bayswater.

The Road to the Trial: Fiona Patten's Advocacy

The pathway to this trial began in October 2020, when former Victorian MP Fiona Patten introduced a Bill to Parliament calling for medicinal cannabis patients to be treated like other prescription medication users. In response, the Victorian Government established the Medicinal Cannabis and Safe Driving Working Group, which included Patten herself alongside Victoria Police and other stakeholders.

Patten, who served as a Member of the Legislative Council from 2014 to 2022 for Reason Australia, established the medicinal cannabis taskforce and was the driving force behind the Inquiry into the Use of Cannabis in Victoria. She ran as the lead Senate candidate for Legalise Cannabis Australia in Victoria at the 2025 federal election.

The working group reported in July 2021, leading to government-funded research projects culminating in this $4.9 million trial announced in May 2024.

Why This Research Matters

Current Victorian law makes it illegal to drive with any detectable amount of THC, the principal psychoactive compound in cannabis. THC can remain detectable in a person's system for several days after taking prescribed medication, creating legal complications for patients who use THC-containing medicinal cannabis products.

The Victorian Government has acknowledged that significant gaps exist in understanding the impacts of prescribed medicinal cannabis on driving performance. This trial aims to determine whether Victorians prescribed THC-containing medicinal cannabis can operate a vehicle without compromising their safety or that of other road users.

Timeline and Delays

• 2016: Medicinal cannabis legalised in Victoria; Patten begins advocacy for driving law reform
• October 2020: Fiona Patten introduces Bill to Parliament; Government establishes working group
• July 2021: Working group releases report with recommendations
• May 2024: Trial announced with $4.9 million funding (18-month timeline)
• November 2024: First participant drive conducted (six months after announcement)
• January 2026: Patient recruitment concluded; control group recruitment to commence

The sequential progression suggests the trial will extend beyond its originally anticipated late 2025 completion. No revised completion date has been announced.

Implications for the Sector

The trial's findings may inform not only Victorian policy but also provide evidence relevant to other states and territories grappling with similar regulatory challenges. Currently, patients prescribed THC-containing products face a legal paradox: they can lawfully use their prescribed medication but may be breaking the law if they drive, even when not impaired.

Patients, healthcare providers and advocacy groups will be watching closely for outcomes that could shape the future of medicinal cannabis policy and road safety regulations across Australia.

Further updates are expected to be published on the Victorian Government website as the research progresses.

This article is for informational purposes only and does not constitute medical advice. Patients should consult their healthcare provider regarding their prescribed medicinal cannabis treatment and comply with all applicable laws regarding driving and medication use.

Historic directive fast-tracks cannabis rescheduling and expands CBD research as millions of Americans turn to cannabis for chronic pain relief

President Donald Trump has signed a sweeping executive order aimed at accelerating medical cannabis research and improving access to cannabidiol products, marking a significant policy shift in federal cannabis regulation. The order, signed on 18 December 2025, directs the Attorney General to expedite the reclassification of cannabis from Schedule I to Schedule III of the Controlled Substances Act.

A Long-Overdue Recognition

The executive order acknowledges what Australian cannabis advocates have long argued: decades of restrictive drug policies have stifled legitimate medical research. The directive specifically recognises that the FDA found scientific support in 2023 for cannabis's use in treating anorexia related to medical conditions, nausea and vomiting, and pain.

The numbers are staggering. Chronic pain affects nearly 1 in 4 United States adults and more than 1 in 3 United States seniors, and 6 in 10 people who use medical cannabis report doing so to manage pain. With 40 states plus the District of Columbia operating regulated medical cannabis programs, the federal government's Schedule I classification has created a stark disconnect between state-level medical acceptance and federal prohibition.

The Rescheduling Push

The path to rescheduling has been in motion since 2023, when the Department of Health and Human Services recommended moving cannabis to Schedule III. This recommendation was based on findings that more than 30,000 licensed healthcare practitioners across 43 US jurisdictions are authorised to recommend medical cannabis for over 6 million registered patients treating at least 15 medical conditions.

Schedule III classification would recognise cannabis as having accepted medical use and lower abuse potential than Schedule I or II substances. The Department of Justice issued a proposed rule in May 2024, which received nearly 43,000 public comments and is currently awaiting an administrative law hearing. Trump's executive order now directs the Attorney General to complete this rulemaking process "in the most expeditious manner."

CBD and the Hemp-Derived Cannabinoid Maze

The order also tackles the increasingly complex regulatory landscape surrounding CBD and hemp-derived cannabinoid products. One in 5 United States adults and nearly 15 percent of seniors reported using CBD in the past year, yet current regulations leave patients and healthcare providers navigating a confusing patchwork of rules.

A particular concern highlighted in the order is the quality and labelling of CBD products. Recent studies found that some commercially available CBD products were inaccurately labelled regarding their composition, creating safety risks for consumers. The directive calls for developing regulatory frameworks including guidance on THC limits per serving, per-container limits, and CBD-to-THC ratio requirements.

The order also addresses an upcoming complication: section 781 of Public Law 119-37 will reclassify some full-spectrum CBD products as controlled marijuana under the CSA due to THC content, adding another layer of complexity to an already tangled regulatory environment.

Bridging the Research Gap

For Australian observers, the executive order's emphasis on research infrastructure will sound familiar. The directive specifically calls for research methods utilising real-world evidence to assess health outcomes of medical marijuana and legal CBD products, with particular focus on long-term effects in vulnerable populations such as adolescents and young adults.

The order notes that inadequate research has left American patients and doctors without proper prescribing guidance. One patient survey showed that just 56 percent of older Americans using marijuana have discussed the usage with their healthcare provider, placing patients on multiple medications at increased risk of drug interactions or adverse events.

Implications for Pain Management

The executive order places particular emphasis on chronic pain management and alternatives to opioids. Research cited in the directive found that 20 percent of participating US veterans reported using fewer opioids as a result of their medical marijuana use. Evidence also suggests improvements in seniors' health-related quality of life and pain outcomes with medical marijuana use.

This focus on pain management alternatives resonates strongly with Australian cannabis policy discussions, where chronic pain represents a significant portion of medical cannabis prescriptions under the Special Access Scheme and Authorised Prescriber pathways.

Implications for State Programs and Home Cultivation

While the executive order represents a major policy shift, it's important to understand what it does and doesn't change for patients currently accessing cannabis through state programs. Rescheduling marijuana to Schedule III would not federally legalise medical cannabis, but it would significantly reduce legal risks and barriers.

Under Schedule III, marijuana would remain a controlled substance requiring prescriptions from licensed healthcare providers. This creates complications for existing state medical programs, which typically operate through "recommendations" rather than prescriptions due to federal restrictions. The transition period could create regulatory uncertainty for patients, dispensaries, and healthcare providers navigating between state and federal frameworks.

For home cultivation, the implications are mixed. Schedule III substances can only be possessed with a valid prescription, which would technically conflict with state-based home grow programs that operate outside the prescription model. However, federal enforcement priorities and prosecutorial discretion will likely play a larger role than the technical scheduling in determining how home cultivation is treated in practice.

The order's emphasis on working with Congress to update hemp-derived cannabinoid definitions could also affect home growers cultivating low-THC plants. Depending on how new THC limits and CBD-to-THC ratios are defined, some home cultivation practices currently considered legal hemp production might face reclassification.

State-based programs would also benefit from expanded research infrastructure. Better clinical data on dosing, efficacy, and safety could help healthcare providers within state programs offer more informed guidance to patients, potentially improving outcomes and reducing the current trial-and-error approach many patients experience.

What This Means

The executive order represents the most significant federal policy movement on medical cannabis in recent US history. By directing expedited rescheduling and calling for comprehensive CBD regulatory frameworks, the Trump administration is attempting to align federal policy with the medical reality experienced by millions of Americans.

For Australia's cannabis sector, the US policy shift could accelerate international research collaboration and provide valuable real-world evidence on medical cannabis outcomes. As the world's largest pharmaceutical market begins closing the gap between cannabis prohibition and medical acceptance, the ripple effects will likely be felt across global cannabis policy and research landscapes.

The order does not legalise recreational marijuana nor does it create immediate changes to current law. However, by prioritising research infrastructure and recognising the medical utility of cannabis, it marks a pragmatic shift toward evidence-based drug policy—something cannabis advocates on both sides of the Pacific have long called for.

Key Findings

A prospective cohort study published in JAMA Internal Medicine has found that participation in New York State's pharmacist-directed medical cannabis programme was associated with significant reductions in prescription opioid use amongst adults with chronic pain.

The 18-month study tracked 204 adults newly certified for medical cannabis who were already receiving opioid prescriptions. Participants dispensed a 30-day supply of medical cannabis experienced a reduction of 3.53 morphine milligramme equivalents (MME) per day compared to those not dispensed medical cannabis in any given month. Overall, participants' mean daily opioid dose decreased by 22% over the study period, from 73.3 MME to 57.4 MME.

Study Design

The Medical Marijuana and Opioids (MEMO) Study ran from September 2018 through July 2023, recruiting participants from Montefiore Medical Centre and nearby medical cannabis dispensaries in the Bronx, New York.

What makes this study particularly robust is its use of objective data from New York State's Prescription Monitoring Programme (PMP), which tracks all dispensed controlled substances including both opioids and medical cannabis. This allowed researchers to measure actual dispensation patterns rather than relying on self-reporting. The study also controlled for unregulated cannabis use, addressing a key limitation of previous research.

Who Participated

The study population reflected the demographics of chronic pain patients in urban New York. Most participants (55%) were female, with an average age of 57 years. The cohort was ethnically diverse and predominantly economically disadvantaged—78% were unemployed, 78% had only public insurance, and 58% lived below the federal poverty level.

Participants reported substantial pain burdens, rating their pain severity at 6.6 out of 10 on average. Mental health challenges were common, with 46% reporting moderate to severe depression and 37% experiencing PTSD symptoms.

What Patients Actually Used

Amongst the 142 participants who obtained medical cannabis during the study, dispensaries provided 2,832 products over 18 months.

Product preferences broke down as:

• 43% ingested (edibles) or oromucosal (tinctures, oral sprays)
• 33% oils or flower for vaporisation
• 22% flower for combustion

High-THC products dominated (78%), with balanced THC-CBD products (14%) and high-CBD products (8%) making up the remainder.

An important finding: 30% of certified participants never actually obtained cannabis from a medical dispensary, and participation declined over time amongst those who did.

The New York Model

New York's medical cannabis programme stands out for its highly medicalised approach. After physician certification, patients visit medical cannabis dispensaries where pharmacists independently evaluate them, review the certifying clinician's recommendations, and authorise specific products and supply durations.

All dispensations are recorded in the state's Prescription Monitoring Programme alongside other controlled substances. This creates an unusual level of oversight and tracking compared to many medical cannabis programmes globally.

Why This Matters

The 22% reduction in opioid use may seem modest, but researchers emphasise this aligns with current clinical recommendations for gradual opioid tapering over extended periods rather than rapid cessation.

This study stands out because it:

• Followed patients prospectively for 18 months rather than looking backwards
• Used objective prescription monitoring data rather than self-reporting
• Controlled for unregulated cannabis use—a critical factor often ignored in previous research
• Examined an actual medical programme with clinical oversight rather than just comparing states with and without legal cannabis

Limitations

The study's findings may not generalise to states with different medical cannabis laws, rural populations, or patients with acute rather than chronic pain. The research team notes their findings support a medicalised model with pharmacist involvement rather than models where medical and adult-use dispensaries are indistinguishable.

A placebo-controlled randomised trial is currently underway to provide more definitive evidence on whether medical cannabis reduces prescription opioid use.

Implications in an Australian Context

Whilst this study examined New York's specific programme structure, the findings contribute to the growing evidence base for medical cannabis as a potential component of chronic pain management strategies. The pharmacist-directed model and objective dispensation tracking may offer insights for jurisdictions considering programme design, though direct comparisons require careful consideration of differing regulatory frameworks.

Source: Slawek DE, et al. JAMA Internal Medicine, December 8, 2025
DOI: 10.1001/jamainternmed.2025.6496

After three years of rigorous field trials across nine sites spanning Australia's diverse climatic zones, the AgriFutures Industrial Hemp Variety Trials (IHVT) program has delivered its verdict: industrial hemp can thrive in Australia, but only if the industry confronts several critical systemic failures head-on.

The findings paint a picture of an industry with enormous potential being throttled by poor seed quality, regulatory uncertainty and infrastructure gaps. For growers, processors and investors, the data offers both a roadmap and a warning.

The Seed Quality Crisis: Australia's Achilles' Heel

The most alarming finding from the trials is the catastrophic variability in imported seed quality. Research on imported hemp seed revealed germination rates ranging from a dismal 13% to 92%, with some varieties averaging just 59% germination under controlled conditions.

In the field, the consequences were severe. At Katherine Research Station in the Northern Territory, four varieties (CRS-1, Fibror 79, X-59 and Orion 33) had to be written off in the early March sowing due to very poor germination and low plant vigour. Multiple trial reports documented similar catastrophic establishment failures across different sites and varieties.

When 40-87% of purchased seed is non-viable, growers face a double penalty: inflated input costs (requiring 2-3x normal seeding rates) and unpredictable crop establishment. This isn't a minor quality control issue; it's a fundamental supply chain failure.

The culprit? A combination of hemp seed's notoriously fragile viability and Australia's time-consuming biosecurity import processes. Seeds that might have been viable at harvest deteriorate during months-long quarantine delays.

Industry advocates are calling for fast-tracked domestic seed multiplication programs and reformed biosecurity procedures. Until then, growers must budget for significantly higher seed costs and accept establishment uncertainty as a cost of doing business.

Geography Is Destiny: Regional Specialisation Is Non-Negotiable

The trials definitively shattered any notion that hemp is a universally adaptable crop in Australia. Performance varied dramatically by climate zone.

Northern Australia (Tropical Powerhouse): The Katherine Research Station in the Northern Territory emerged as Australia's hemp grain production champion, with the Yuma variety achieving a remarkable 3.11 tonnes per hectare when planted in late April. Other high performers in tropical conditions included Han Cold, King Gee and Ruby, all late-maturing, dioecious Chinese varieties.

Southern Australia (Consistency and Quality): Tasmania and Victoria told a different story. In Tasmania's Epping Forest, European varieties CFX-2, X59 and CRS-1 dominated performance metrics. Victoria's Hamilton Smart Farm saw Fedora 17 emerge as the most reliable performer, averaging 2.5 t/ha across multiple sowing times.

The Strategic Split: Northern tropical regions can achieve yields 25-165% higher than southern sites, making them ideal for high-volume commodity production. Southern regions offer consistency and stable quality, positioning them for premium food-grade contracts.

The takeaway: attempting to grow European varieties in the Northern Territory or Chinese varieties in Tasmania will result in near-total crop failure. Variety selection must be matched precisely to local climate conditions.

Timing Is Everything: Miss the Window, Lose the Crop

The trials repeatedly demonstrated that planting date is as critical as variety selection. Missing the optimal window by even 4-6 weeks can halve yields.

In Katherine, early March sowings faced temperatures around 35°C and dry conditions, resulting in poor crop establishment. Late April emerged as the optimal planting time. Conversely, Tasmania's data showed that crops sown in early summer had shorter growing seasons and produced significantly less biomass and grain than late spring sowings.

The lesson is clear: growers cannot 'get ahead' by planting early. In hot climates, premature sowing decimates germination.

The THC issue

While most trial varieties stayed comfortably below the 1.0% THC legal limit, the regulatory risk remains an existential threat. Crops testing above 1% THC face mandatory destruction with zero salvage value, a binary outcome that can transform a profitable harvest into a total loss overnight.

Environmental stressors (heat, drought, nutrient deficiency) can push borderline varieties over the threshold. Chinese dioecious varieties, which performed exceptionally well in tropical trials, naturally test higher for THC and carry greater risk under stress conditions.

Conservative variety selection (proven European low-THC varieties like Fedora 17 and Futura 75) combined with regular pre-harvest testing is the only viable strategy. High-performing but higher-risk varieties should be reserved for well-monitored trial plots until THC stability is confirmed under local conditions.

Organic Hemp: Premium Play, Not Volume Strategy

The Stanthorpe, Queensland trial successfully demonstrated that industrial hemp can be produced using organic farm management strategies, with Fedora-17 emerging as the best-performing variety.

However, organic production comes with a significant yield trade-off. Industry experience suggests organic yields typically run 30-50% lower than conventional high-input systems.

Organic hemp is viable only when premium contracts compensate for lower volumes. This is the 'artisan coffee' model: high-margin, low-volume, marketed on soil health and environmental credentials. Growers pursuing organic production must secure premium off-take agreements before planting and accept realistic yield expectations of 1.0-1.5 t/ha versus 2.0-3.0 t/ha under conventional management.

The Infrastructure Gap: Fibre's Unrealised Potential

Dual-purpose hemp varieties consistently produced impressive biomass yields: up to 10 tonnes per hectare at Hamilton, Victoria, and 8.5 t/ha in South Australia. Yet this substantial fibre resource remains largely stranded.

Australia currently lacks adequate processing infrastructure to transform hemp fibre into value-added products. Without local processing capacity, biomass becomes waste or low-value mulch. Current economics heavily favour grain-only production, leaving thousands of tonnes of potential fibre revenue unharvested each season.

The Numbers Tell the Story

As of 2020, Australia cultivated approximately 2,000 hectares of hemp, yielding 2,000 tonnes per annum for grain and just 100 tonnes for fibre. AgriFutures aims to exceed $10 million in production at farmgate, modest numbers that underscore the industry's nascent stage.

The sector remains too fragmented to support significant processing infrastructure in every region. Success will require regional production clusters, shared processing facilities and coordinated supply agreements between grower groups and processors.

The Critical Path Forward

For Growers:

• Choose only varieties proven in your specific climate zone
• Source seed from reputable suppliers with germination guarantees
• Nail the planting window; this is non-negotiable
• Budget for 2-3x seed rates until domestic supply stabilises
• Secure off-take agreements before planting

For Processors and Investors:

• Focus on grain processing infrastructure first (food-grade facilities)
• Establish regional processing hubs, not scattered facilities
• Prioritise temperate south for food-grade contracts (consistency)
• Prioritise tropical north for volume/commodity products
• Fibre processing requires minimum 500+ hectare regional supply to justify infrastructure investment

For Policymakers:

• Streamline biosecurity seed import processes
• Support domestic seed multiplication programs
• Harmonise THC limits across states (currently inconsistent)
• Fund shared regional processing infrastructure

Bottom Line: Potential Meets Reality

The AgriFutures Industrial Hemp Variety Trials have provided the Australian industry with something invaluable: hard data. The trials prove hemp can be commercially viable in Australia, but only when grown with the right varieties, in the right regions, at the right time, with quality seed.

The industry's greatest challenges are not agronomic, they're systemic. Seed supply failures, infrastructure gaps, market fragmentation and regulatory uncertainty create execution risks that cannot be wished away.

For advocates who have long championed hemp as a transformational agricultural opportunity, the IHVT findings offer both validation and a reality check. The potential is real. The obstacles are equally real. Success will require regional specialisation, patient capital for infrastructure and the discipline to follow proven protocols rather than chasing shortcuts.

The 'easy money' phase of Australian hemp, if it ever existed, is over. The next phase demands professional, data-driven operations and coordinated industry development. The trials have mapped the path. Whether the industry can follow it remains the defining question.

The AgriFutures Industrial Hemp Variety Trials program evaluated hemp varieties across nine sites: Katherine (NT), Kununurra (WA), Manjimup (WA), Loxton (SA), Maaoupe (SA), Hamilton (VIC), Epping Forest (TAS), Narrabri (NSW) and Stanthorpe (QLD) from 2021-2024. Full reports are available at agrifutures.com.au.

New research shows growers can predict final cannabinoid yields weeks before harvest using non-destructive hyperspectral imaging

Australian researchers have developed a breakthrough method that could transform how cannabis cultivators manage crops, predict yields, and ensure regulatory compliance, all without damaging a single plant.

In a study published in Industrial Crops & Products, scientists from the University of Adelaide demonstrate that hyperspectral measurements of cannabis fan leaves taken during early flowering can accurately predict final cannabinoid concentrations in mature flowers.

The Game-Changing Technology

Using a hand-held hyperspectral device, researchers achieved prediction accuracies with R² values up to 0.89 for CBD, 0.77 for THC, and 0.8 for total cannabinoids. These results significantly outperform previous approaches.

The method works by measuring how light reflects off intact fan leaves at wavelengths invisible to the human eye. These spectral "fingerprints" correlate with the plant's biochemical composition. This allows machine learning models to predict what cannabinoid profile the flowers will ultimately produce.

Lead researcher Aaron Phillips and his team at the University of Adelaide's School of Agriculture, Food and Wine tested the technology across two cannabis cultivars under seven different lighting regimes. They took measurements both early and late in the flowering period.

Why This Matters for Australian Growers

The implications for Australia's emerging cannabis industry are substantial.

For Industrial Hemp Producers: Exceeding legislated THC levels necessitates destruction of entire crops, posing substantial economic risks. Early prediction enables identification and removal of non-compliant plants before they jeopardise an entire harvest.

For Medicinal Cannabis Operations: High-performing plants can be identified and prioritised early in the growth cycle. This minimises resources wasted on inferior genetics. The technology could also help optimise harvest timing to maximise cannabinoid yields.

For Breeders: Promising plants can be selected for crossing programmes before flowering even begins. This dramatically accelerates breeding timelines.

Completely Non-Destructive

Unlike previous methods that required removing inflorescences and leaves prior to measurement, this approach enables rapid, in-situ assessment of intact fan leaves. No sacrificial sampling or laboratory analysis is required.

This is crucial. There is evidence that wounding or removing plant material can alter cannabinoid profiles, potentially confounding predictions.

The hand-held device used in the study takes measurements directly in the growing environment, whether glasshouse or field. It provides instant analysis without the need for HPLC or GC-MS laboratory testing.

How It Works

The research team took hyperspectral measurements at two critical timepoints:

• Early: Two weeks after initiating flowering, before flowers emerged
• Late: Four weeks after flowering initiation

Measurements were taken from five fan leaves per plant across the vertical length of the canopy. The device captured wavelengths from approximately 350 to 2500 nanometres.

Machine learning models trained on these spectral profiles, combined with actual cannabinoid measurements from harvested flowers, learned to predict final concentrations with remarkable accuracy.

Beyond Cannabinoid Prediction

The technology offers additional benefits.

Hyperspectral measurements successfully differentiated between cannabis cultivars and lighting treatments, offering a tool for germplasm classification. This could help growers verify cultivar authenticity. Breeders could use it to select diverse parent genetics for crossing programmes.

Looking Forward

While the study focussed on controlled indoor environments, the technology shows promise for field applications. The researchers suggest that measurements taken from fan leaves proximal to sampled flowers may provide even better predictions. This opens avenues for further refinement.

For Australia's cannabis industry, navigating strict regulatory frameworks while pursuing economic opportunities in both industrial hemp and medicinal cannabis, this non-destructive, early-prediction technology represents a significant step forward. It promises more efficient, compliant, and profitable cultivation practices.

The research was conducted at the University of Adelaide's Waite Campus. The team collaborated with German analytics firm Compolytics GmbH and South Australian lighting company VAILO.

The study "Hyperspectral measurements of Cannabis sativa fan leaves during early floral development predict final cannabinoid yield" is available as open access in Industrial Crops & Products.

UK speciality pharma strengthens European position with landmark cannabinoid medicine

CNX Therapeutics completed its acquisition of the global Sativex (nabiximols) business from Jazz Pharmaceuticals on 31 October 2025, marking a significant milestone in the UK-based company's strategy to build a leading central nervous system (CNS) therapeutic portfolio across European markets.

The deal transfers worldwide rights to the cannabinoid-based medicine, which is approved in many markets for symptoms of moderate to severe spasticity in adult patients. The transaction includes marketing authorisations, commercial partnerships and manufacturing arrangements, with Jazz Pharmaceuticals providing transition support through a specified service agreement.

A Historic Cannabis Medicine

Sativex represents the first plant-derived cannabinoid medicine approved by a medicines regulator, a distinction that underscores its pioneering role in legitimising cannabis-based therapeutics. The drug is approved in the European Union, United Kingdom and other international markets for adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity treatments and who show clinically significant improvement during an initial trial.

Guy Clark, chief executive officer of CNX Therapeutics, emphasised the strategic importance of the acquisition, stating it strengthens the company's position as a provider of specialist CNS medicines across European markets and represents a significant milestone in their focused acquisition strategy.

Strategic Implications

For CNX Therapeutics, this acquisition represents a logical extension of an aggressive growth strategy. In 2023 and 2024 the business acquired two central nervous products from Eisai to treat psychological disorders and Parkinson's disease, as well as four hospital products from Clinigen and two central nervous products from Sanofi.

Ben Moore, CNX's corporate development vice president, noted that the company's established CNS infrastructure and deep therapeutic expertise made this acquisition a strategic fit as they continue building their European specialty portfolio.

Jazz's Portfolio Rationalisation

From Jazz Pharmaceuticals' perspective, the divestiture reflects a strategic refocusing of resources. Jazz acquired Sativex through its acquisition of GW Pharmaceuticals for $7.2 billion, which was completed in May 2021. However, Sativex's revenue came in at $13 million in 2021.

Additionally, the nabiximols oromucosal spray flunked a Phase 3 trial in 2022, coming up short in helping multiple sclerosis patients with spasticity. Over a 21-day span, the spray failed to improve lower limb muscle tone as measured by the Modified Ashworth Scale. Jazz Pharma subsequently announced it had completed its analysis of the nabiximols MSS1 trial and made the decision to discontinue the programme.

Australian Context and Implications

The acquisition has particular significance for Australian patients and healthcare providers. Sativex was approved by the Therapeutic Goods Administration (TGA) for the treatment of people with spasticity associated with MS, with the product being ARTG registered in 2012.

However, access remains challenging for Australian patients. Chiesi's predecessor (Emerge Health Pty Ltd) was unsuccessful in obtaining Pharmaceutical Benefits Scheme (PBS) listing of Sativex in 2013. In the view of the Pharmaceutical Benefits Advisory Committee (PBAC), there was insufficient evidence to support the sponsor's claim of superior efficacy over the standard of care, and nabiximols appeared to be inferior to the standard of care in terms of safety.

The absence of PBS listing means Sativex is available in Australia but it is not yet listed on the Pharmaceutical Benefits Scheme. It is available from selected pharmacies for approximately $700-800 for a 6-8 week supply, placing it beyond reach for many patients who might benefit from the therapy.

Both medicinal cannabis products approved by the TGA for supply in Australia are sponsored by Chiesi Australia Pty Ltd under licence from GW Pharma Ltd, the company that was acquired by Jazz. Chiesi Australia PTY LTD are the legally registered Sponsor for Sativex in Australia and New Zealand and are currently working with local health authorities to enable supply of Sativex in each country.

There were 33,335 people with MS in Australia in 2021, and the prevalence and incidence are increasing with time. The CNX acquisition raises questions about the future of Sativex in Australia, including whether CNX will maintain the existing licensing arrangement with Chiesi Australia, and whether the change in ownership might provide an opportunity to revisit PBS listing.

Market and Patient Impact

The acquisition is unlikely to disrupt patient access in established markets, with CNX explicitly committing to ensuring continuity of supply and support for patients and healthcare professionals.

The nabiximols spray failed its Phase 3 trial in 2022, and its subsequent transfer to a smaller specialty player suggests Sativex will likely remain primarily focused on existing approved markets rather than pursuing major expansion.

Broader Industry Context

CNX Therapeutics is backed by private equity firm Inflexion and has pursued multiple acquisitions to build its CNS and hospital products portfolio. The transaction represents one example of how specialty pharmaceutical companies are acquiring established products from larger firms.

References:

1. MS Australia: "Sativex (Nabiximols)"
2. Centre for Medicinal Cannabis Research and Innovation, NSW: "Product" information
3. Pearce IP Law: "Medicinal Cannabis in Australia, Part 1: Available Products" (21 September 2023)
4. PharmiWeb.com: "CNX Therapeutics acquires Sativex global business from Jazz Pharmaceuticals" (4 November 2025)
5. Pharmaceutical Business Review: "CNX Therapeutics expands CNS portfolio with Sativex acquisition" (4 November 2025)
6. PharmaTimes: "CNX Therapeutics acquires Sativex from Jazz Pharmaceuticals" (4 November 2025)
7. Fierce Pharma: "Trial failure for Jazz's cannabis-derived drug blunts goal to expand its use to US" (29 June 2022)
8. Business of Cannabis: "European Cannabis Stocks Review: Jazz Pharma Scraps US Sativex Trial" (1 March 2023)
9. Medical Journal of Australia: "Consensus recommendations on multiple sclerosis management in Australia and New Zealand: part 1" (10 February 2025)
10. MS Australia: "Multiple sclerosis rising and accelerating in Australia new data shows" (13 February 2023)

Australia's cannabis import quota has been slashed from 101 to 88.8 tonnes for 2025, the first major reduction since medical cannabis was legalised nine years ago. It's a stunning reversal for an industry that, by every metric, should be thriving.

Patient demand is exploding. Prescriptions have skyrocketed. The market is forecast to reach US$402.1 million in 2025. Yet behind the growth headlines lies an uncomfortable truth: Australia's domestic cannabis industry is collapsing under the weight of its own success, or rather, under the weight of everyone else's surplus.

The Import Flood That Changed Everything

The numbers tell a brutal story. Cannabis imports into Australia surged from just 7,306 kilograms in 2021 to 77,406 kilograms in 2024, a 959% increase in just three years. To put that in perspective, Australia imported more medical cannabis in 2024 than Germany, Europe's largest cannabis market.

Meanwhile, domestic production jumped 55% from 26,593 kilograms in 2023 to 41,328 kilograms in 2024. But here's the catch: by the end of 2024, Australian producers were sitting on 38,206 kilograms of unsold domestically grown cannabis inventory, nearly double the inventory from the year before. They're growing more but selling less of their own product.

The problem isn't demand. Australians spent approximately $402 million on medicinal cannabis in the first six months of 2024 alone, compared to an estimated $235 million for all of 2022. The problem is that patients and prescribers are overwhelmingly choosing imported products, particularly from Canada.

The Canadian Dumping Debate

"I have no issue with imports coming here; the issue is that because they have surplus product, they're dumping it here, which makes things difficult for local cultivators,"

Nan-Maree Schoerie, managing director of ECS Botanics, told the Sydney Morning Herald in October 2024. Her company is one of dozens of Australian producers struggling to compete.

In 2024, Australia imported 62,111 kilograms of cannabis from Canada, representing 80% of the country's total cannabis imports. Canada's cannabis industry faces massive oversupply in its domestic market. With nowhere else to sell ageing inventory, Canadian producers have turned to export markets like Australia, where they can offload large quantities at prices Australian growers simply cannot match.

Schoerie noted that while Australian growers could get around AU$6 per gram wholesale in 2023, that dropped to around $4-4.50 in 2024, a direct consequence of imports primarily from Canada. The Canadian advantage isn't just about surplus, it's about scale, genetic diversity, and a decade-long head start in commercial cultivation techniques.

Australian producers face a cruel catch-22: the domestic industry needs imports to meet patient demand and provide product variety, but the flood of cheap imports prevents the domestic industry from gaining the foothold it needs to become competitive. Chris Nasr at Nectar Brands noted that top-tier Canadian cannabis can be landed in Australia for a dollar less per gram than comparable Australian quality, with far more choice available.

The Regulatory Burden Nobody Talks About

If import competition were the only problem, it would be manageable. But Australian cannabis producers face regulatory costs that make competing nearly impossible.

Establishing a compliant cannabis cultivation facility in Australia takes between two and four years, with annual costs of around $50,000 just to maintain a licence, and inspections alone ranging from $4,800 to $12,800. In contrast, there are no fees required to import medicinal cannabis into Australia.

Australian growers aren't just competing with cheaper Canadian product, they're competing while operating under some of the world's strictest and most expensive regulatory frameworks. Cade Turland from Hale Farm noted that Canada had a sort of incubation period in which it could develop without outside pressure from imports, while Australian producers haven't had time to develop.

The Guild's Warning

The newly formed Australian Cannabis Cultivators Guild, representing around 80% of the country's licensed cannabis producers, recently sent a letter to federal health minister Mark Butler warning that without government assistance, the industry faces dire times in the near future.

The Guild says growers can't compete with products coming into the legal market from South Africa, Thailand, Colombia, Uruguay, Portugal, and Canada, not just because those countries can produce at lower costs, but because the regulatory burden in Australia tips the scales beyond recovery.

The letter warned of "catastrophic failures across local cultivators" unless imports are restricted, calling for a domestic-first policy aligned with International Narcotics Control Board rules.

Why The Quota Cut Matters

The reduction in Australia's import quota from 101 to 88.8 tonnes signals a policy shift, but it's unclear whether it represents genuine support for domestic producers or simply administrative housekeeping. The Office of Drug Control confirmed that delays were linked to over-forecasting by companies and unused permits tying up capacity.

In other words, companies were requesting more import permits than they actually needed, creating artificial scarcity. The quota reduction may simply reflect more accurate demand forecasting rather than a deliberate effort to protect domestic growers.

For Australian producers hoping this represents protectionist support, the reality is likely disappointing. The fundamental economics haven't changed. Canadian producers can still deliver triple-A and quad-A quality flower at prices Australian growers struggle to match, even after paying for international shipping.

What Went Wrong?

Nine years after legalisation, Australia's medical cannabis sector is experiencing remarkable growth, but almost entirely on the backs of foreign producers. Several factors converged to create this crisis:

1. Late Market Entry: By the time Australian producers scaled up, international suppliers had already established dominant market positions with proven products and trusted brands.

2. Regulatory Asymmetry: Australian producers face rigorous and expensive licensing standards, while international suppliers enter the local market with far fewer hurdles.

3. Import Over-Reliance: In 2023, 61% of medicinal cannabis sold in Australia was imported. This early dependence created prescriber and patient preference patterns that now favour foreign products.

4. Lack of Genetic Diversity: Canada offers extensive genetic variability and cultivars grown at scale, making high-quality triple-A and quad-A product extremely affordable to import. Australian producers are still developing competitive genetics.

5. Global Oversupply: Canadian producers facing domestic oversupply are using the export market to offload lower-quality products from stockpiling, distorting competition.

6. Lack of Reciprocity: Countries like Canada can export medicinal cannabis to Australia but do not allow Australian imports in return.

7. Industry Opposition to Patient Home Grow: By failing to support patient cultivation rights, the industry alienated potential political allies and reinforced the perception that commercial growers prioritise profits over access. This destroyed the goodwill needed when asking for government intervention against imports.

The Self-Inflicted Wound: What The Industry Didn't Say

Perhaps the most damaging factor in the industry's collapse has been its own political strategy, or more precisely, what it chose not to advocate for. The silence is damning when you examine what the industry actually submitted to government inquiries.

When Medicinal Cannabis Industry Australia (MCIA), the peak industry body representing licensed producers, made its submission to the 2020 House of Representatives inquiry into drug approval processes, it advocated passionately for its own interests: fast-tracked approvals for products already registered overseas, reduced regulatory burdens for research, easier access to novel delivery methods like vaporisers and transdermal patches, and government funding for industry R&D.

What MCIA didn't mention even once in its entire submission: patient home cultivation. Not a single word about the affordability crisis driving patients to the black market. Not one sentence supporting patient rights to grow their own medicine.

This wasn't an oversight.

It was a strategic choice that would prove catastrophic.

The 2020 Senate inquiry into barriers to medicinal cannabis access heard testimony about patients paying up to $100,000 per year for treatment, costs that witnesses described as "well beyond the reach of almost all patients." The inquiry received evidence that over 90% of medical cannabis users were obtaining their product from recreational dealers, illicit suppliers, friends, family, or self-cultivation precisely because legal commercial products were prohibitively expensive.

The Senate inquiry's final report recommended amnesty for possession and cultivation of cannabis for genuine self-medication purposes. The Australian Government explicitly rejected this recommendation, stating:

"The Government does not support the provisions of amnesties for possession and/or cultivation of cannabis through illegal sources, as there are straightforward legal means by which to obtain medicinal cannabis products on the prescription of medical doctor."

The industry's response?

Silence. No coordinated push for home grow rights. No public campaigns supporting patient cultivation. No submissions arguing that home grow would complement, not compete with, commercial products for those who could afford them.

You don't need to find evidence of the industry actively lobbying against home cultivation, the absence speaks louder than any position paper ever could. When patient advocates and research organisations were calling for home grow rights, when the Senate was recommending amnesty, the industry said nothing. Their silence was their position.

This strategic failure poisoned the well with the very politicians and patient advocates the industry now desperately needs. When the Australian Cannabis Cultivators Guild writes to the health minister warning of industry collapse and begging for import restrictions, what credibility do they have? They're asking taxpayers to protect businesses that never supported patient access when it mattered.

Compare this to Canada, where constitutional challenges established patient home cultivation rights years before commercial legalisation. Canadian patients can grow unlimited plants based on their prescription. When Canada's commercial industry developed, it had public support because patients had options.

The industry built goodwill by existing alongside, not against, patient rights.

In Australia, the industry's calculation was transparent: keep patients captive, maximise margins, let government handle the political heat. Now that calculation has backfired spectacularly. Politicians look at an industry begging for protection and see businesses that prioritised profits over patient access. Patient advocates see an industry that was silent when home grow amnesty could have helped millions of Australians afford their medicine.

The message is inescapable: This isn't an industry worth protecting. These are companies that want monopoly pricing power without market competition, not from imports, not from patients growing their own. Why should government intervene to save businesses that never fought for the patients they claim to serve?

The industry's 38 tonnes of unsold inventory isn't just an economic problem. It's karma.

The Path Forward

Australia now faces a choice: accept that its medical cannabis market will be permanently import-dependent, or implement policies that give domestic producers a fighting chance.

Some industry voices are calling for import taxes similar to those proposed in Israel, where the government threatened tariffs up to 165% on Canadian cannabis. Schoerie has stated that most growers don't want tariffs, but believes some form of tariff for low-cost producing countries may be the only way to level the playing field.

Others argue for a domestic-first policy where local growers supply as much of the government-approved cannabis quota as possible, with importers only filling remaining shortfalls.

The irony is bitter. Australia positioned itself as a potential global supplier of premium medicinal cannabis, with climate advantages, strong agricultural expertise, and quality control reputations. Instead, it's become a dumping ground for surplus product from more established markets.

The 12.2-tonne reduction in import quota may be symbolic, but symbols matter little to producers sitting on 38 tonnes of unsold inventory while prescribers continue ordering from overseas. Without structural changes to level the playing field, Australia's domestic cannabis industry risks becoming a cautionary tale: what happens when you legalise a market but fail to protect the local industry you hoped to build.

The sector hasn't just stalled, it's discovered that explosive market growth and domestic industry collapse can happen simultaneously. That's the paradox nobody predicted when medical cannabis became legal nine years ago.

References

1. Australian Government Office of Drug Control - Medicinal cannabis data and statistics
   • Cannabis import and production statistics (2021-2024)
   • https://www.odc.gov.au/medicinal-cannabis-statistics
2. Sydney Morning Herald - "Australian cannabis growers call for tariffs on international imports" (October 2024)
   • Nan-Maree Schoerie (ECS Botanics) quotes on dumping and pricing
   • Interview with Chris Nasr (Nectar Brands) and Cade Turland (Hale Farm)
   • https://www.smh.com.au/politics/federal/australian-cannabis-growers-call-for-tariffs-on-international-imports-20241017-p5kirj.html
3. Statista - Australia Medical Cannabis Market Report 2025
   • Market value projections (US$402.10m in 2025)
   • Growth forecasts and market analysis
   • https://www.statista.com/outlook/hmo/pharmaceuticals/cannabis/medical-cannabis/australia
4. FreshLeaf Analytics - Australian Medicinal Cannabis Market Reports
   • Q2 2024 spending data ($402 million in first six months)
   • 2022 annual spending comparisons
   • Patient and prescription statistics
   • https://freshleafanalytics.com.au/
5. Senate Community Affairs References Committee - "Current barriers to patient access to medicinal cannabis in Australia" (March 2020)
   • Recommendation 12: Amnesty for possession/cultivation for self-medication
   • Testimony on patient costs and access barriers
   • Evidence of 90%+ patients using illicit sources
   • https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Medicinalcannabis/Report
6. Australian Government Response - Response to Senate Inquiry on Medicinal Cannabis (October 2020)
   • Rejection of amnesty recommendation
   • Government position on legal access pathways
   • https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Medicinalcannabis/Government_Response
7. Medicinal Cannabis Industry Australia (MCIA) - Submission to House of Representatives Inquiry into Approval Processes (October 2020)
   • Industry priorities and advocacy positions
   • Notable absence of patient home cultivation support
   • https://www.aph.gov.au/DocumentStore.ashx?id=b80f99c0-4df7-4b74-b2f7-a078ac94fa66&subId=693432
8. Cannabis Health News - "Australian cannabis industry faces 'dire times' without government help" (October 2024)
   • Australian Cannabis Cultivators Guild letter to Health Minister
   • Industry warnings about catastrophic failures
   • Regulatory cost comparisons ($50,000 annual licensing, $4,800-$12,800 inspections)
   • https://cannabishealthnews.co.uk/2024/10/22/australian-cannabis-cultivators-in-dire-straits-without-government-help/
9. The Guardian Australia - Coverage of Israel's proposed cannabis import tariffs
   • 165% tariff proposals on Canadian cannabis
   • International market dynamics and protectionist measures
   • https://www.theguardian.com/
10. Australian Institute of Health and Welfare (AIHW) - National Drug Strategy Household Survey 2019
    • Cannabis use patterns and self-medication data
    • Patient access and acquisition methods
11. Therapeutic Goods Administration (TGA) - Special Access Scheme and Authorised Prescriber data
    • Approved conditions for medicinal cannabis (130+ conditions as of December 2019)
    • Regulatory pathways and requirements

Article drafted October 28, 2025, based on publicly available data, government submissions, industry statements, and market research reports.

Victorian medicinal cannabis producer slashes debt by 81% in landmark refinancing deal

Cann Group Limited(ASX:CAN) has announced a transformative debt restructure that will see the Mildura-based medicinal cannabis company reduce its debt burden by approximately $54.7 million, positioning the business for sustainable growth after years of financial pressure.

Major Debt Forgiveness Delivers Fresh Start

In a landmark agreement with National Australia Bank (NAB), Cann Group will settle approximately $70 million in outstanding loan balances—including capitalised interest—for $15.3 million as full and final settlement. The loan facilities total $69.96 million as at 15 October 2025. The major financier has agreed to release all security, discharge property mortgages, and close all loan facilities in exchange for the reduced payment.

The debt forgiveness of $54.7 million represents an 81% reduction in the company's debt and will increase Cann Group's net assets by approximately $60 million.

New Funding Structure

Complementing the NAB settlement, Cann Group's existing subordinated lender—a prominent Australian private credit fund—will contribute an additional $9 million loan and extend the maturity date on an existing $5.5 million facility (balance as at 30 September 2025). The combined $14.5 million loan will mature in two years and carries a 9.5% per annum cash interest rate, payable monthly, plus 3% per annum capitalised interest due at maturity.

The credit fund will also receive 63,439,600 options with a 1.46 cent exercise price, expiring upon loan maturity, and a 2% facility fee (capitalised and due upon maturity).

$9 Million Capital Raise

Cann Group has secured firm commitments for a $9 million capital raise (before costs), comprising:

• Institutional Placement: $6.5 million through the issue of 565,217,391 new shares at 1.15 cents per share, conducted via two tranches (Tranche 1: 120,395,238 shares raising approximately $1.3 million settling 30 October 2025; Tranche 2: 444,822,153 shares raising approximately $5.1 million, subject to shareholder approval at the AGM on or around 28 November 2025, settling 3 December 2025)
• Share Purchase Plan (SPP): $2.5 million minimum, with firm shortfall commitments from institutional investors for the full amount

The placement price represents a 17.9% discount to the last closing share price of 1.4 cents on 22 October 2025 and an 18.3% discount to the five-day VWAP up to and including 22 October 2025.

Eligible shareholders in Australia and New Zealand will be able to apply for up to $30,000 of new shares under the SPP, which opens on 30 October and closes on 17 November 2025. The SPP price will be the lower of 1.15 cents per share or a 2.5% discount to the five-day VWAP up to the closing date.

Significant Option Opportunity

In an attractive sweetener for investors, both placement and SPP participants will receive one free attaching option for every new share issued. These options are exercisable at 1.15 cents and expire on 15 June 2026.

Upon exercise, option holders will also receive one share plus one additional "piggyback option" exercisable at 2.85 cents, expiring 15 June 2028. This structure provides the company with the opportunity to raise up to $31.3 million if all options are exercised.

The options are subject to shareholder approval at an extraordinary general meeting scheduled for around 22 December 2025.

Strong Growth Forecast

With its balance sheet reset, Cann Group has provided guidance for FY26 showing revenue of approximately $17 million—representing 50% growth on FY25—and EBITDA of $0.3 million to $0.7 million, a significant improvement from the $5 million EBITDA loss in FY25.

The company attributes the forecast growth to strong demand for bulk flower and its branded Botanitech™ products.

Leadership Changes

Mike Ryan will join the board as chairman following completion of the transaction. Ryan brings over 40 years of financial services experience, including senior roles at Shaw and Partners, Goldman Sachs, and Morgan Stanley. He currently chairs Sequoia Financial Group and serves as a director of Energy One Ltd and PM Capital Global Opportunities Fund.

Current interim chair Doug Rathbone will revert to a non-executive director role.

CEO's Perspective

CEO and managing director Jenni Pilcher commented: "We are very pleased to have reached this landmark agreement, which represents a major step forward in strengthening our balance sheet and positioning Cann for sustainable growth. The settlement with our major financier eliminates approximately $70 million of their debt for a payment of $15.3 million, providing a clean foundation for the Company's next growth phase. We are equally encouraged by the continued support from our subordinated lender and the additional $9 million capital raising, which together provide the flexibility required to execute on our growth strategy.

"With a clear path to positive EBITDA and forecast FY26 revenue of $17 million, Cann is now well placed to capitalise on the strong demand for our bulk flower and Botanitech™ products."

About Cann Group

Cann Group operates a large-scale cultivation and GMP manufacturing facility near Mildura, Victoria, along with research facilities and corporate headquarters in Melbourne. The company supplies dried flower, oil products, active pharmaceutical ingredients, and extracts to customers in Australia and internationally. Cann Group also owns Satipharm and its patent-protected capsule technology.

Bell Potter Securities Limited acted as lead manager and bookrunner to the capital raising.

Germany's Cannabis Act, which came into force on April 1, 2024, provides a compelling case study in rapid market transformation. A major new survey of over 11,000 German cannabis consumers reveals that within the first year, 88.4% of regular users shifted to legal access routes, with homegrown cannabis becoming the dominant supply method.[1]

Meanwhile, Australia's medical cannabis system, now nine years into legalization (2016-2025), faces a regulatory crisis. The Therapeutic Goods Administration (TGA) just closed a major consultation in October 2025, receiving over 700 submissions. The consultation was triggered by mounting evidence that "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", and that "these products have not undergone any regulatory review or evaluation of their quality, safety, efficacy or performance."[2]

The contrast between Germany's success and Australia's stagnation raises a fundamental question: what structural differences enable one country to achieve rapid market transformation while another remains locked in gatekeeping and corporate control?

Australia's Medical Cannabis Crisis: The Evidence

Scale of Unapproved Supply

During the first half of 2025, over 1,000 distinct medicinal cannabis product entries were reported by sponsors in the TGA's mandatory six-monthly reporting system.[2] However, this figure includes different formulations, sizes, SKUs and brand variations of what may be the same underlying therapeutic product, and represents only products supplied during that specific reporting period. The TGA notes that inclusion in their product list does not guarantee the product is available and that products not supplied via SAS/AP or reports submitted after the required timeframe are not included.[2]

What is clear is that over 99% of medicinal cannabis products being prescribed to patients in Australia remain unapproved and therefore have not undergone any pre-market assessment by the TGA for quality, safety, efficacy or performance.[2]

The growth has been exponential. SAS B approvals for unapproved medicinal cannabis products increased from 57,711 in 2020 to 177,762 in 2024.[2] This explosion reflects a system where legal pathways exist but supply remains concentrated through gatekeeping mechanisms that benefit commercial interests.

The Structure: Vertical Integration and Business Model Exploitation

The AMA's submission reveals the structural problem: "The AMA is concerned that the Special Access Scheme (SAS) and Authorised Prescriber scheme (AP), originally designed for exceptional access, are being exploited as commercial pathways for unapproved products."[3]

The rapid expansion of medicinal cannabis prescribing, particularly through vertically controlled, direct-to-consumer telehealth models, has created a business structure where one corporate entity may own the telehealth clinic, control the prescriber, and operate the dispensary. This structure creates systemic incentives for high-volume prescribing, as each link in the chain benefits financially from volume. The AMA notes: "These models often bypass traditional safeguards, including in-person assessments, community pharmacy dispensing, and continuity of care."[3]

The AMA emphasizes: "While the regulation of direct-to-consumer (DTC) telehealth models falls outside the scope of this consultation, the AMA reiterates its longstanding concerns about the risks posed by vertically controlled entities that bypass traditional safeguards such as in-person assessments, community pharmacy dispensing, and continuity of care."[3]

Most tellingly: "Excessive prescribing and the proliferation of unapproved products are most safely addressed when medicinal cannabis is brought within Australia's established regulatory frameworks specifically, when products are listed on the ARTG and subject to robust oversight."[3]

Emerging Clinical Concerns

The AMA reports observations from clinical practice: "Our members working in emergency departments around Australia have reported increased demand for resources at public hospitals to manage presentations related to the use of high-THC concentration medicinal cannabis products, as well as cases of cannabis-induced psychosis, dependence, and cognitive impairment."[3]

These observations suggest that prescribing practices may not be appropriately matched to clinical evidence or patient selection. The underlying issue is not the availability of cannabis itself, but rather the incentive structure created by vertically integrated business models that profit from high-volume prescribing.

The Product Range Problem

During the first half of 2025, the most commonly accessed products fell within the TGA's Category 5 classification, which represents nearly half of all applications.[2] The regulatory categorization of these products is complex. The TGA's Category 5 classification is based on CBD-to-total-cannabinoid ratios rather than absolute THC content, meaning it encompasses both conventional high-THC flower and ultra-concentrated isolates as a single category.

"The concentrations of THC found in unapproved medicinal cannabis products supplied in Australia can vary considerably and can be much higher (>35%) than the amount found naturally in a cannabis plant."[2] Examples cited by the TGA include: extracts up to 88% w/w THC, herb dried up to 60% w/w THC, inhalation products up to 880 mg/mL, and oral liquid up to 50 mg/mL.[2]

Currently, patients have no option to access products with specific cannabinoid profiles they may prefer. If legal homegrow were permitted, patients could select or grow cannabis with the cannabinoid profiles and potency levels appropriate to their individual needs, rather than being limited to whatever the commercial market supplies.

The German Model: How Decentralized Legal Access Transformed Markets

In contrast, Germany's KonCanG survey data shows rapid, voluntary market transformation through fundamentally different regulatory design.

The Rapid Shift to Legal Access

Before April 1, 2024, only 23.5% of German regular cannabis users accessed cannabis through legal channels. After legalization, this figure jumped to 88.4% achieved entirely without legal retail dispensaries.[1] The shift was driven by three mechanisms:

• Home cultivation: 49% of users now use this as their main source
• Pharmacy access: 29.2% now obtain cannabis from pharmacies
• Cultivation associations: 1.9% use non-profit cooperative models[1]

Why Home Cultivation Mattered

The critical difference: Germany allowed personal homegrow. Homegrowing became the default with nearly half of surveyed consumers now provisioning themselves through personal cultivation. This eliminated artificial scarcity and destroyed the pricing power of corporate suppliers.

The data is revealing about who grew: "nearly all new homegrowers were men (90.1%), suggesting cultural and confidence factors shape adoption."[1] But crucially, homegrow required no medical justification. It was simply permitted as a legal right.

What This Prevented

By decentralizing supply, Germany prevented the vertical integration problem Australia is experiencing. When supply can only come from approved vendors with gatekeeping relationships to prescribers, those vendors can:

• Charge premium prices
• Incentivize high-volume prescribing
• Control patient access through integrated telehealth clinics
• Exploit regulatory gaps

When anyone can grow, these levers disappear. Price competition becomes impossible to avoid. Prescribing incentives evaporate because patients are no longer dependent on practitioner-prescriber-dispensary chains controlled by single corporate entities.

Before legalization in Germany, dealer supply accounted for a substantial portion of access. After legalization, this fell dramatically to only 5%.[1] This demonstrates how legal alternatives effectively displace illicit markets when supply is decentralized.

Why Australia's 2020 Senate Recommendation on Homegrow Was Ignored

In 2020, the Senate held an inquiry into barriers to medical cannabis access. The inquiry's explicit recommendation: enable patient home cultivation.

Yet five years later, no legal home cultivation pathway exists for Australian patients. No pilot programs. No risk assessment. Simply: prohibition maintained.

The absence of patient homegrow rights, despite Senate recommendation and clear evidence of international success, reveals where regulatory priorities lie. Home cultivation would:

• Enable patient autonomy over cannabinoid profile and potency
• Eliminate artificial scarcity propping up commercial prices
• Remove dependency on vertically integrated supply chains
• Create price competition
• Reduce prescriber gatekeeping power and financial incentives for high-volume prescribing

The prohibition persists because none of these outcomes benefit current market incumbents.

Comparative Structural Analysis

The Uncomfortable Truth: What the TGA Consultation Reveals

The TGA's August 2025 consultation paper itself exposes the regulatory breakdown. The agency states plainly: "The TGA shares these concerns and supports the call for regulatory change."[2]

The TGA identifies the core problem: "The ready access provided via these pathways [SAS/AP] has reduced or removed the incentive to collect the robust safety, efficacy and performance data necessary for the evaluation and registration of a medicinal cannabis product on the Australian Register of Therapeutic Goods (ARTG)."[2]

In other words: because the system rewards supplying unapproved products through gatekeeping pathways, companies have no reason to seek proper approval. The regulatory framework incentivizes the exact behavior it should discourage—high-volume prescribing of unapproved products through vertically integrated models.

The TGA further notes that only 2 medicinal cannabis medicines have been registered on the ARTG: Epidyolex (CBD) for certain epileptic conditions and Sativex (nabiximols) for multiple sclerosis symptoms. Four devices have been approved for supply. All other medicinal cannabis products prescribed remain unapproved.[2]

What Would Patient-Centered Reform Look Like?

Based on the evidence from Germany and the structural problems documented in the TGA consultation:

Enable patient autonomy:

1. Permit patient home cultivation for chronic conditions (as 2020 Senate recommended)
2. Allow non-profit cultivation cooperatives independent of commercial producers
3. Ensure patients can access products with diverse cannabinoid profiles, not only high-potency commercial options

Reform prescribing incentives:

1. Separate medical access from commercial licensing
2. Prevent vertical integration (prohibit single companies owning prescriber plus dispensary plus product)
3. Create transparent disclosure requirements for prescriber financial relationships

Improve information:

1. Mandate labelling showing ARTG registration status (registered vs. unapproved)
2. Require informed consent disclosing that products have not been TGA-evaluated
3. Enable data sharing between TGA and AHPRA to support continuity of care

The AMA specifically recommends that "labels clearly display THC and CBD content in milligrams and percentages per dose and per pack, include dosing instructions and storage requirements, and indicate ARTG registration status using plain language (e.g., 'Registered' versus 'Unapproved')."[3]

The Policy Choice Moment

The TGA consultation closing October 7, 2025, with over 700 submissions, represents a choice point. Regulators can:

Option A: Maintain the current gatekeeping system. Products remain unapproved and commercial, vertically integrated clinics maintain control, prices remain high, prescribing volume incentives persist.

Option B: Structural reform including enabling homegrow, permitting patient autonomy over cannabinoid profile, preventing vertical integration, and separating medical from commercial frameworks.

Germany chose something closer to Option B. The outcome: 88.4% of users voluntarily shifted to legal supply within one year, dealer markets collapsed, and rapid transformation occurred without retail infrastructure.

Australia's policymakers could have chosen similarly in 2016. They did not. The reasons are documented: regulatory capture, commercial interests, and misalignment of incentives between patient access and corporate profit.

The question is not whether reform is possible. Germany proves it is. The question is whether Australia's regulators will prioritize patient access and autonomy over the commercial interests that have shaped the current framework.

The 700+ TGA consultation submissions will provide an answer, not through their explicit recommendations, but through whose interests the final regulatory framework serves.

References

[1] Steimle, L., Werse, B., and Stallwitz, A. (August 2025). "Veranderungen fur Konsumierende von Cannabis durch das Cannabisgesetz (KonCanG): Projektbericht." Institut fur Suchtforschung, Frankfurt University of Applied Sciences and Evangelische Hochschule Freiburg. [English translation: "Changes for Cannabis Consumers through the Cannabis Act: Project Report"]

[2] Therapeutic Goods Administration (August 2025). "Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products." Version 1.0. Australian Department of Health. Available at: https://consultations.tga.gov.au/medicines-regulation-division/test-soms/user_uploads/final—consultation-paper—medicinal-cannabis-review—august-2025.pdf

[3] Australian Medical Association (October 7, 2025). "AMA submission to the TGA review into the safety and regulatory oversight of unapproved medicinal cannabis products." Available at: https://www.ama.com.au/sites/default/files/2025-10/AMA_submission_Reviewing_regulatory_oversight_of_unapproved_medicinal_cannabis_products_0.pdf

Sarah Chen* winces as she reviews her bank statement. Another $450 gone this month for her medical cannabis prescription—money she can barely afford on her disability pension.

Sarah's one of more than a million Australians now using medicinal cannabis, part of a staggering 5,455% increase since 2019. But while regulatory bodies focus on reining in questionable prescribing practices, patients like Sarah face a different crisis: the prohibitive cost of legal access.

This week, leading health organizations including the Royal Australian College of GPs, the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, and the Australian Medical Association united to call on the NSW Government to address serious concerns about medicinal cannabis prescribing and dispensing. Their joint letter to NSW Health Minister Ryan Park highlights troubling practices: doctors issuing prescriptions every four minutes, pharmacists dispensing thousands of products daily, and vertically integrated "closed loop" clinics that profit from both prescribing and dispensing.

The health bodies are right to sound the alarm about rogue operators. Evidence shows some clinics circumvent proper procedures, with patients learning the right answers to guarantee a script after brief consultations. One pharmacist dispensed 959,000 cannabis products in a single year. One doctor issued over 17,000 scripts in six months. These statistics paint a picture of an industry prioritizing volume over patient care.

But there's a crucial element missing from this regulatory conversation: why are patients flocking to these questionable clinics in the first place?

For many, it's not just convenience—it's economics. Medical cannabis products in Australia remain expensive, often costing patients hundreds of dollars monthly for conditions ranging from chronic pain to chemotherapy side effects. Unlike many prescription medications, these products receive no Pharmaceutical Benefits Scheme (PBS) subsidy, placing them out of reach for pensioners, low-income workers, and those whose conditions prevent them from working.

The regulatory framework compounds this problem. Of the nearly 1000 unregistered medicinal cannabis products currently available in Australia, none have been assessed for safety, quality, or efficacy by the Therapeutic Goods Administration. Only two products have achieved full TGA registration since legalization nearly a decade ago. This lack of registration means no PBS listing, which means no subsidies for patients who need them most.

The health organizations correctly note that "closed loop" systems—where telehealth prescribers send scripts to their own dispensaries—create perverse financial incentives. These clinics even charge surcharges if patients want to use their regular pharmacy instead. But this vertical integration also allows some operators to offer slightly lower prices through bulk purchasing and direct-to-consumer models, making them attractive to cost-conscious patients despite the fragmented care.

The call for reform raises valid patient safety concerns. Reports of inappropriate prescribing to people with opioid dependence and mental health issues are alarming. One patient who experienced a psychotic episode after receiving medicinal cannabis was then bombarded with messages about obtaining another prescription. Aggressive marketing using names like "Joker Juice" and "Gelato Sherbert" treats Schedule 8 substances like consumer products rather than serious medicines.

The solution proposed by health bodies—routing all prescribing through regular GPs and dispensing through community pharmacies—would certainly improve continuity of care and oversight. Dr. Rebekah Hoffman, RACGP NSW & ACT Chair, emphasized;

"patient care and safety must come ahead of profits."

But without addressing affordability, this reform risks pushing vulnerable patients further to the margins. Those who can't afford higher prices at traditional pharmacies may simply go without treatment, return to inadequate alternatives, or turn to unregulated sources.

Any meaningful reform must balance multiple imperatives: rigorous safety standards, continuity of care, professional oversight, and—critically—patient access. This means:

• Accelerating TGA assessment and registration of quality products
• Creating pathways for PBS subsidy of evidence-based medicinal cannabis treatments
• Ensuring community pharmacies can competitively dispense these products
• Maintaining GP involvement while acknowledging that many traditional doctors remain reluctant to prescribe
• Addressing the evidence gap through properly funded clinical trials
• Exploring home cultivation programs for medical patients

The Home Cultivation Solution

One option conspicuously absent from the Australian debate is medical home cultivation—a model successfully implemented in Canada that could simultaneously address affordability, over-prescribing, and vertical integration concerns.

Under Canada's Access to Cannabis for Medical Purposes Regulations (ACMPR), patients with prescriptions can register with Health Canada to grow their own cannabis, with the number of plants permitted calculated based on their prescribed daily dosage. The formula is straightforward: the higher the prescription in grams per day, the more plants a patient can legally cultivate.

This model offers several advantages for addressing the issues raised in the health bodies' letter:

It eliminates profit-driven over-prescribing. When a doctor knows their patient will be growing their own medicine, there's no financial incentive to prescribe excessive quantities. The patient bears the cultivation effort, creating a natural check on prescription amounts.

It breaks vertical integration. Home cultivation completely removes the closed-loop problem. There's no clinic-owned dispensary, no surcharge for using your regular pharmacy, no financial pipeline from prescriber to product sale. The profit motive that drives questionable clinic practices evaporates.

It dramatically improves affordability. While there are upfront costs for equipment and ongoing costs for electricity and supplies, home cultivation can reduce per-gram costs by 80-90% compared to pharmacy prices. For patients on fixed incomes like Sarah Chen, this could mean the difference between affording treatment and going without.

It encourages appropriate GP involvement. A patient seeking authorization to grow cannabis plants at home would naturally turn to their regular GP who knows their full medical history. This addresses the fragmented care concern where GPs remain unaware their patients are using medicinal cannabis.

It provides quality control transparency. Patients know exactly what they're growing and consuming. No questions about unregistered products or unclear supply chains. The concerns about products named "Joker Juice" become irrelevant.

The Australian context would require careful implementation. Safeguards would be essential: secure cultivation sites, plant count limits tied to legitimate prescriptions, restrictions on sale or diversion, and perhaps mandatory registration with health authorities. The model wouldn't suit every patient—many lack the space, ability, or inclination to cultivate plants. But for those who could and would, it offers a legitimate alternative that serves patient interests rather than corporate profits.

Critics might argue home cultivation risks diversion to the black market. Yet Canada's experience suggests this concern can be managed through proper oversight. And honestly, the current system—with doctors issuing scripts every four minutes and pharmacists dispensing thousands of units daily—hardly represents a bulwark against diversion.

The upcoming TGA review of the safety and regulatory framework for medicinal cannabis presents an opportunity to get this right. The explosive growth from 18,000 to over one million users in five years demonstrates genuine patient need. These aren't all people gaming the system—many are desperately seeking relief from debilitating conditions.

Sarah Chen shouldn't have to choose between questionable online clinics and going without treatment. Nor should she face financial hardship to access medicine that improves her quality of life.

Perhaps with a medical prescription and registration, she could legally grow her own plants—eliminating both the exploitation and the financial burden.

As regulators crack down on rogue operators—and they should—they must ensure the system that replaces this wild west doesn't simply price out the patients who need help most.

The conversation about medicinal cannabis in Australia has matured beyond whether these products should be available. Now we must ensure they're available safely, appropriately, and affordably. Home cultivation for medical purposes deserves serious consideration as part of that solution. It's worked in Canada. It could work here.

Anything less fails the million-plus Australians who have turned to these medicines, often as a last resort.

*Sarah Chen is not a real patient name. Privacy is important.