why Australia’s medicinal cannabis system needs urgent reform

In 2024 alone, Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), authorised at least 979,000 prescription applications for medicinal cannabis through its specialised access pathways.

These “specialised access” mechanisms were originally designed for occasional, case-by-case use of unapproved drugs. But they have become mainstream.

As more and more people receive medicinal cannabis prescriptions, we’re left with a system that is misaligned with its original purpose.

The current prescribing landscape for medicinal cannabis is confusing for doctors, inequitable for patients, and difficult to regulate.

The Australian Health Practitioner Regulation Agency (Ahpra) recently announced it’s going to crack down on unsafe prescribing. But this doesn’t go far enough. The system needs urgent reform.

What is medicinal cannabis used for?

Medicinal cannabis was legalised in Australia in 2016. Products come in different forms including oils, liquids, capsules, gels (which can be applied to the skin), dried flower (which can be inhaled using a vapouriser) and gummies.

Key ingredients include THC (tetrahydrocannabinol) and CBD (cannabidiol). THC is the main psychoactive compound in cannabis, and is responsible if a “high” is experienced.

When it was first legalised, medicinal cannabis was intended for patients with complex needs and severe, treatment-resistant conditions.

The TGA clearly indicated medicinal cannabis should not be considered a first-line treatment for any condition, and should be administered with a “start low, go slow” dosage approach.

Patients for whom it might be deemed appropriate included those receiving palliative care, or suffering with intractable epilepsy, multiple sclerosis, nausea and vomiting from chemotherapy, or chronic pain unresponsive to standard care.

But over time, prescribing has expanded well beyond these cases. Today, most medicinal cannabis prescriptions are given for relatively common conditions such as chronic pain, anxiety and sleep disorders.

What does the evidence say?

The evidence remains inconsistent. Chronic pain – the most common reason medicinal cannabis is prescribed in Australia – offers a key example.

According to a recent TGA review, some randomised trials suggest medicinal cannabis may help a subset of patients achieve moderate reductions in pain. However, many studies are small, of variable quality, and don’t account for long-term effects.

And like all medicines, medicinal cannabis carries risks. Products containing THC have been linked to side-effects such as sedation, dizziness and cognitive impairment.

While generally better tolerated, CBD is not risk-free. For example, both CBD and THC can interact with certain medications, heightening the likelihood of adverse effects.

Access over evidence

In Australia, approved medicines undergo rigorous clinical testing before they’re registered. Drug manufacturers’ applications to the TGA normally include detailed data on efficacy as well as long-term safety monitoring and quality controls.

But driven by patient advocacy, political responsiveness, and commercial momentum, medicinal cannabis has come to reflect a different model.

Most medicinal cannabis products – bar two which have TGA approval – lack the evidence demonstrating safety, quality and efficacy required of registered pharmaceuticals.

In other words, the majority are not subject to the rigorous trials or data standards required for formal registration with the TGA’s Australian Register of Therapeutic Goods.

For many doctors, whose prescribing has traditionally been guided by strong trial data and rigorous regulatory review, this doesn’t sit well.

Doctors are often flying blind

While companies can legally sell cannabis products via access schemes without investing in clinical research, doctors are expected to prescribe without consistent information on what works, for whom, and at what dose.

The TGA oversees access pathways but is neither resourced nor mandated to provide clinical oversight or direct support to prescribers, leaving many clinicians to navigate the system alone.

Prescriptions are frequently granted via telehealth and posted to patients.

Growing concerns have emerged that some care models – particularly high-volume telehealth services – are prioritising patient throughput over clinical judgment, and not spending enough time with patients.

For example, Ahpra reported eight practitioners issued more than 10,000 medicinal cannabis scripts in a six-month period, while one appeared to have issued in excess of 17,000.

The surge in prescribing has been further shaped by active marketing from some cannabis companies, outpacing the development of coordinated clinical guidance and safety monitoring infrastructure.

Access and affordability: a system failing patients

Some people, including those living in rural and remote areas, can find it difficult to navigate medicinal cannabis prescribing processes. This can be due to limited digital access and fewer opportunities for follow-up with a local GP. These challenges make it harder for people to make informed decisions about their care.

Cost is also a major issue, particularly where bulk billing is unavailable or multiple consultations are needed. This is on top of the cost of the products.

One of the two TGA-approved medicinal cannabis products, Sativex, used to treat muscle stiffness in multiple sclerosis, is not currently subsidised by the Pharmaceutical Benefits Scheme. This means patients pay the full cost, which ranges between A$700 and $800 for a 6–8 week supply.

Read more: We looked at 54 medicinal cannabis websites to see if they followed the rules. Here's what we found

What needs to change?

Australia’s medicinal cannabis system is based on a fragmented evidence base and a fast-growing market operating with limited visibility into how products are used or evaluated. Addressing these challenges will require coordinated reform across multiple fronts.

1. Capture real-world data

Most urgently, we need robust, real-world data. To deliver safe and equitable care, we must know how medicinal cannabis is being prescribed, for what conditions, under what circumstances, and with what outcomes.

Without this, we cannot answer the most basic questions about clinical benefits or track adverse events.

Real-world data, such as de-identified health information from clinics, could help inform better clinical and policy decisions.

2. Build a national accreditation model

Australia needs a national prescriber accreditation model for medicinal cannabis, developed in collaboration with clinicians, regulators and professional bodies.

Such a model would help ensure prescribing is clinically appropriate, evidence-informed, and consistent with evolving standards of care. In practice, this would mean health professionals would need to complete specific training before prescribing medicinal cannabis.

This approach is not without precedent. For example, some health professionals must undergo immuniser accreditation before they can administer vaccines independently.

3. Tackle inequity

Finally, we must confront persistent access inequities. That includes exploring government subsidies for TGA-approved medicinal cannabis products. No one should have to choose between financial hardship and safe access.