Patient Access Data in Australia

By late 2023, the TGA had processed well over four million medicinal cannabis approvals since the framework opened in 2016. Four million. It is a figure that keeps pulling me back, not because it tells you everything, but because of how much it doesn't tell you without context.

Patient access data in Australia is public, quarterly-updated, and genuinely useful. It's also easy to misread. This article walks through what the TGA actually publishes, how the two main access pathways account for those numbers, and where the data has real gaps. If you want the regulator's own role laid out first, The Therapeutic Goods Administration (TGA) Explained is a useful companion, and the Wikipedia entry on the TGA gives a short general outline.

Two pathways, one set of totals

Almost all unapproved medicinal cannabis in Australia reaches patients through one of two regulatory mechanisms: the Special Access Scheme (SAS) or the Authorised Prescriber (AP) scheme. Both sit under the Therapeutic Goods Act 1989 and are administered by the TGA. The legal logic behind both is covered in Unapproved Therapeutic Goods: The Legal Basis.

Under SAS Category B, the more commonly used route, a doctor applies for a single patient to access a specific unapproved product. Each approval covers one patient, one product. The mechanics are set out in Special Access Scheme Category B, and the wider scheme is explained in Understanding the Special Access Scheme in Australia.

Under the AP pathway, a specialist gains approval to prescribe to a class of patients without needing individual TGA sign-off each time, so the approval volume those prescribers generate doesn't appear in the SAS figures at all. That distinction matters enormously when you're interpreting the quarterly statistics. A reader who treats the SAS count as the whole system is, in effect, counting one door and ignoring the other. More detail on the second door sits in The Authorised Prescriber Scheme.

The TGA publishes cumulative SAS approval counts, broken down by indication category (broad groupings like "pain", "neurological", "mental health") and by product type. What you don't see is the AP prescribing volume expressed the same way, because APs report to their institution or specialist college rather than generating individual TGA approval records. The true patient count is therefore higher than the SAS numbers alone suggest; meaningfully higher, once you factor in the AP prescribers operating in areas like chronic pain and sleep.

One terminology trap is worth flagging. "Approval" and "patient" are not interchangeable words. A single person can hold more than one approval, for example where a product changes, so a cumulative approval count is a count of administrative decisions rather than a headcount of people.

What the TGA's quarterly data actually shows

The TGA's medicinal cannabis access data dashboard, updated roughly every quarter on tga.gov.au, reports cumulative SAS approvals by financial year. Because the figures are cumulative, a rising line is almost guaranteed; the more informative question is how steeply it rises from one year to the next. A few things stand out from the published figures.

Growth has been steep. The scheme processed a handful of approvals in its first year (2016–17) and scaled exponentially through 2020–2023. The acceleration largely tracks two regulatory changes: the 2020 rescheduling of low-THC/high-CBD products from Schedule 8 to Schedule 4 under the Poisons Standard, and progressive TGA streamlining of the SAS online portal. The origins of the framework itself are covered in Australia’s 2016 Medicinal Cannabis Legalisation.

Pain is consistently the largest indication category by approval volume, followed by neurological conditions and mental health. That ordering has been stable for several years, though the mental health share has grown proportionally. Anxiety and PTSD sit under the mental health umbrella in the TGA's categorisation; they are separate from the psilocybin/MDAC pathways that opened under different scheduling decisions.

Product type data shows oils and capsules dominating, with flower products growing their share. This is partly a bioavailability and onset question, since different routes of administration produce different pharmacokinetic profiles, and partly a prescriber familiarity issue. Honestly, the rise of flower approvals surprised some observers who expected the oral-dominant trend to hold. For how products are grouped in practice, see Medicinal Cannabis Product Categories 1–5.

The ARTG and what "approved" means

Two things often get conflated here. The ARTG, the Australian Register of Therapeutic Goods, lists products the TGA has formally evaluated and registered or listed. A handful of medicinal cannabis products have achieved ARTG registration, which means they've cleared a full efficacy and safety evaluation and can be prescribed via ordinary script like any other prescription medicine.

The overwhelming majority of medicinal cannabis approvals, however, involve unapproved products accessed through SAS or AP. "Unapproved" in TGA language doesn't mean unsafe or unregulated. It means the product hasn't completed the full registration process, though it must still meet Good Manufacturing Practice (GMP) standards and the supplier must hold the relevant TGA licences. It's a process distinction, not a quality judgement, but it creates a two-tier system that can confuse patients and even some clinicians.

The practical lesson for anyone reading the statistics is to check which tier a number belongs to. A figure that blends registered and unregistered products, or that quietly covers only one of them, will tell a different story from one that keeps them apart. Common questions on this split are collected in Medicinal Cannabis Access in Australia: FAQ.

Reading gaps in patient access data honestly

I'll be direct about where the published data falls short, because I think the limitations matter.

First, approvals are not the same as dispensed prescriptions. An SAS approval is a TGA green light; whether the patient then fills the script at a pharmacy, whether the product was in stock, whether cost was a barrier, none of that is captured. The TGA isn't a pharmacy benefit management system. Data on what's actually dispensed sits with the PBS (which doesn't cover most medicinal cannabis) and private pharmacy systems, which are not aggregated publicly.

Second, the indication categories are broad. "Pain" covers an enormous clinical range. So does "neurological." You can't extract condition-level granularity from the published tables, which limits what researchers and policymakers can do with them.

Third, demographic data is thin. Age-band breakdowns exist in some TGA releases but are not consistently detailed. We know a lot about approval volumes and not nearly enough about who is actually holding those prescriptions; which postcodes, which age groups, which socioeconomic profiles. A 2022 report from the University of Sydney's Lambert Initiative for Cannabinoid Therapeutics pointed to geographic and economic access disparities, but the TGA's own data can't speak to that directly.

Fourth, state-level comparisons are tempting but slippery. The per-capita approval rates vary considerably between states, and the reasons aren't entirely obvious from the numbers. Prescriber availability, regulatory familiarity at the state health level, and cost all likely play a role. But the data doesn't let you separate those factors cleanly. State-by-state regulatory context is covered in Medicinal Cannabis Access in Victoria, South Australia, Western Australia and the Australian Capital Territory.

The Schedule 4 / Schedule 8 split and its significance

The 2020 rescheduling of certain cannabidiol-dominant products from Schedule 8 to Schedule 4 under the Poisons Standard is probably the single biggest structural shift in the access data. Schedule 8 products are controlled drugs; they require state/territory-level permits in most jurisdictions, specialist co-signatures in some, and pharmacy dispensing records that differ from standard prescription goods. Schedule 4 is prescription-only but doesn't carry those additional layers. The related policy debate is explored in CBD and Down-Scheduling in Australia.

The practical effect was that GPs, not just specialists, became able to prescribe lower-THC products without the administrative overhead that had discouraged many from engaging with the scheme at all. Approval volumes jumped. Whether that jump reflects improved access for patients who genuinely needed it, or some degree of over-servicing, is a question the current data genuinely cannot answer. I'd argue the honest position is: probably both, in proportions we don't yet know.

What researchers and the Lambert Initiative have added

The TGA data tells you about the regulatory system. Researchers have tried to fill in some of the clinical picture. The Lambert Initiative at the University of Sydney has published work on prescribing patterns and patient-reported outcomes. The Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE) has contributed real-world evidence studies. These are secondary to the TGA's administrative data but give it texture.

A consistent finding across several Australian real-world evidence studies is that patient-reported outcomes in chronic pain and sleep contexts have been positive in self-report surveys; but those studies carry significant methodological limitations: no control groups, self-selected populations, high dropout. Peer-reviewed researchers have been appropriately cautious about overstating them, and I think that caution is warranted. The TGA's approval numbers don't say anything about outcomes, and neither does real-world survey data without more rigorous design. The trade-offs between the two kinds of evidence are unpacked in Real-World Evidence vs Trial Data.

For readers wanting deeper background on the receptor-level pharmacology behind why cannabinoids are being studied at all, the endocannabinoid system page here gives a solid foundation, including the roles of CB1 and CB2 receptors that underpin most mechanistic research.

Where the data is heading

The TGA has indicated interest in improving the granularity of access data over time. Whether that translates into public-facing dashboards with condition-level or demographic breakdowns remains to be seen. There's also ongoing discussion in health policy circles about whether a national medicinal cannabis registry, similar to those in some European jurisdictions, would improve the evidence base. That's a significant infrastructure investment and not imminent.

For now, the quarterly SAS approval figures remain the best single public source. They're worth reading directly from tga.gov.au rather than through summaries, because the summaries often miss the SAS/AP split and the ARTG/unapproved distinction, two things that change the story considerably.

The four million figure is real and it reflects a genuinely significant shift in prescribing behaviour over seven years. What it doesn't do, on its own, is tell you whether the system is working well for patients. That question needs better data than we currently have.

Sources

• Medicinal Cannabis Access Data, Therapeutic Goods Administration (TGA)
• Real-world evidence for medicinal cannabis in Australia: a systematic review; NCBI / PubMed Central
• Medicinal cannabis regulatory framework, Therapeutic Goods Administration (TGA)
• Medicinal cannabis, Australian Government Department of Health

Marcus Hale, Regulatory researcher; TGA & access law