Pulse ·
High-THC medicinal cannabis: the evidence gap is wider than most GPs know
High-THC medicinal cannabis products (Category 5, THC concentrations 13–88%) now account for nearly half of all TGA Special Access Scheme applications — despite a rapid review of 9,969 studies finding no clinical evidence supporting concentrations above 22% THC.
Adverse events are mostly mild-to-moderate and dose-dependent rather than concentration-dependent. Over half of all TGA adverse event reports for medicinal cannabis involve Category 5 products. The RACGP, Pharmacy Guild, and RANZCP have all called current THC regulatory standards inadequate.
What just happened
A rapid review by the Monash Addiction Research Centre, published in Drug and Alcohol Review, screened 9,969 medicinal cannabis studies. The finding: only 15 met inclusion criteria. And across those 15 studies, there is no clinical evidence supporting the safety or efficacy of THC concentrations above 22%.
The market has moved dramatically past 22%. Category 5 unapproved medicinal cannabis products — with THC concentrations ranging from 13% to 88% — now account for nearly half of all TGA Special Access Scheme applications. That gap between what the evidence supports and what is most commonly being prescribed is substantial.
Additional data from the same reporting period:
- Over half of all TGA adverse event reports for medicinal cannabis (mid-2022 to mid-2025) involve Category 5 products. Leading adverse event categories: psychiatric disorders, nervous system disorders, respiratory disorders.
- Queensland issued 167,000 medicinal cannabis prescriptions — more than all other Australian states combined.
- Eight AHPRA-flagged practitioners issued more than 10,000 scripts in six months; one practitioner issued more than 17,000.
- Medicinal cannabis unit sales fell 30% following regulatory crackdowns on prescribing outliers.
The RACGP, Pharmacy Guild, and RANZCP have all stated publicly that existing THC regulatory standards are inadequate.
Both-and
The case for medicinal cannabis as a therapeutic category remains intact
Medicinal cannabis has a legitimate, evidence-supported role in specific clinical indications. For treatment-resistant epilepsy in paediatric populations, chemotherapy-induced nausea, spasticity in multiple sclerosis, and selected patients with chronic non-cancer pain who have not responded to other agents — the evidence is real, if modest in effect size.
GPs in Australia are increasingly managing referral requests, specialist letters citing cannabis products, and patients who have already started on prescription cannabis from another provider. A proportion of those patients are accessing medicinal cannabis for indications where it provides genuine benefit with a side-effect profile comparable to or better than the alternatives they have tried.
Dismissing the entire therapeutic category because of the high-THC prescribing problem would be an overcorrection. The Monash review finding is not that cannabis has no medical application. It is that the most commonly prescribed products have the least supporting evidence.
The high-THC prescribing pattern is a different conversation
The Monash rapid review describes a market in which product formulation has diverged sharply from the evidence base. Products with THC concentrations up to 88% — concentrations that have never been tested in a rigorous clinical trial — are being prescribed at scale, predominantly by a small number of very high-volume prescribers.
Adverse events in the TGA dataset are dose-dependent rather than concentration-dependent. The key finding from the review is not that high concentrations are linearly more dangerous — it is that there is no clinical evidence at all for concentrations above 22%. Not positive evidence. Not negative evidence. The evidence simply does not exist.
Psychiatric adverse events being the most reported category is worth pausing on. For a patient managing perimenopausal mood disturbance, pre-existing anxiety, or a history of psychosis — the risk-benefit calculation for a high-THC formulation is not the same as for a patient without those risk factors. Those are not interchangeable, and they should not be treated as such when writing or approving a referral.
The prescribing outlier data — 17,000 scripts from one practitioner in six months — describes a business model, not a clinical practice. The regulatory response (AHPRA flagging, crackdowns, 30% fall in unit sales) suggests the system is beginning to respond. But the evidence gap the review identifies is a structural problem the current regulatory framework has not closed.
The contested framing
Some proponents of medicinal cannabis characterise the Monash review and the RACGP/RANZCP position as inherently anti-cannabis. The review methodology — screening 9,969 studies for those meeting rigorous inclusion criteria — is standard rapid review practice, not a biased process. Finding 15 eligible studies from nearly 10,000 screened is itself a signal about the quality of the evidence base in this space.
The constructive framing: if the clinical community believes high-THC products have therapeutic value at concentrations above 22%, the pathway is clinical trials to generate that evidence — not regulatory exemptions that allow market expansion to run ahead of it.
My two cents
GPs are now positioned as de facto gatekeepers at one point in a referral pathway that, in some cases, leads patients to prescribers operating as volume prescribers rather than clinicians.
The relevant clinical questions before approving or making a medicinal cannabis referral remain: What condition? What evidence tier is that indication at? What concentration range is the prescribing plan? Which prescriber, and do they have a structured review protocol and a plan for discontinuation if treatment goals are not met?
Medicinal cannabis is not a homogeneous category and should not be assessed as one. A low-THC/high-CBD product for a patient with treatment-resistant chronic pain who has exhausted guideline-concordant options is a different clinical decision from a Category 5 high-THC product prescribed by someone issuing thousands of scripts per month. The regulatory framework in Australia permits both; the clinical judgement required to distinguish between them sits with the GP.
Verdict: maybe — the evidence base for medicinal cannabis in specific indications is real and should be taken seriously. The evidence base for Category 5 high-THC products at concentrations above 22% does not exist. GPs need to hold that distinction actively when fielding referral requests.
Sources cited
- Talakovski A. High-THC cannabis products outpace evidence. The Medical Republic, 31 July 2026. https://www.medicalrepublic.com.au/high-thc-cannabis-products-outpace-evidence/127838
Frequently asked questions
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Is medicinal cannabis legal in Australia and can my GP prescribe it?
Medicinal cannabis is legal in Australia and can be accessed via the TGA's Special Access Scheme or an Authorised Prescriber pathway. GPs can prescribe it or refer to a cannabis clinic, depending on their prescriber authorisation. The regulatory framework allows prescribing — what varies is the quality of the clinical rationale behind each prescription, and the evidence base for the specific product and concentration being prescribed.
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My GP won't refer me for medicinal cannabis — what should I ask them?
The most productive conversation is a clinical one: what condition are you seeking to treat, what treatments have you already tried, what does the evidence say for medicinal cannabis at that specific indication and concentration, and which prescriber would provide structured review? GPs who are cautious about medicinal cannabis referrals are often responding to the prescribing patterns described in this piece — high-volume, low-clinical-rigour prescribers — rather than objecting to the therapeutic category as a whole.