Australia: Medical Cannabis in the Crosshairs of Authorities Following a Surge in Prescriptions

Faced with the’sharp increase in medical cannabis prescriptions, Therapeutic Goods Administration (TGA), the Australian regulator, plans to review the rules governing access to products that are not registered in the country. A key concern is so-called «closed-loop» systems, in which a single entity can prescribe, distribute, and supply products to patients.

An exceptional initiative that has become a major gateway

The Australian system is based, in particular, on the Special Access Scheme (SAS), originally designed to allow access, on a case-by-case basis, to certain unapproved therapeutic products.

But the scale of its use has changed significantly. According to TGA data, at least 148,388 SAS-B decisions were recorded between January and August 2026. The actual figure could be higher, as some data is withheld when it involves fewer than ten requests, but it already reveals a a sharp increase since medical cannabis became available.

In 2025, the regulator had recorded 207,980 decisions made public, compared with 177,762 for all of 2024. At the current rate, activity in 2026 will exceed that of the previous year by approximately 7%.

In his Business Plan 2026–27, the TGA has announced its intention to update the regulatory framework for therapeutic products that are not listed in the’Australian Register of Therapeutic Goods (ARTG).

The document specifically mentions «closed-loop supply chains,» as well as manufacturing and distribution to the point of pickup. Although cannabis is not mentioned directly, this wording potentially applies to integrated companies capable of managing multiple stages of the process, from prescription to dispensing.

These models are already raising questions among some healthcare professionals. In particular, commercial practices such as fees for filling prescriptions or directing patients to certain pharmacies have been reported. Domestic manufacturers are also complaining the excessive number of imports.

The issue, therefore, goes beyond mere access to products: the authorities are also seeking to determine the extent to which commercial interests can influence the course of care.

Stronger Oversight of Digital Companies

The announced reform comes after several red flags regarding the practices of certain prescribers and online clinics.

In 2024, the’Australian Health Practitioner Regulation Agency (AHPRA) had established a unit dedicated to monitoring new models of care, particularly with regard to online prescriptions. The following year, the organization reported prescribing trends it deemed concerning and noted that some practitioners were not fulfilling their professional obligations.

The TGA also plans to step up its efforts to combat violations related to advertising and therapeutic products marketed outside authorized channels. In particular, its plan sets a target of processing 65% of the relevant reports.

More than 165 notices of violation, representing more than 2.3 million Australian dollars, had already been sent to clinics for violations of advertising regulations over the previous two years.

A reform that could coincide with a regulatory deadline

The Australian schedule adds another element of uncertainty. The Narcotic Drugs Regulation 2016 and Narcotic Drugs (License Fees) Regulation 2016, which govern, among other things, the cultivation and manufacture of the relevant products, are set to expire on April 1, 2027, unless they are renewed.

A consultation on their renewal concluded in July 2026. The authorities must now incorporate the feedback received into the review process.  After supporting the market’s rapid growth, Australian authorities now appear to want to strengthen oversight and redefine the boundaries of a system that was originally intended to be a temporary measure.