A public consultation opening next week could determine the direction of medicinal cannabis regulation across Australia.
The Therapeutic Goods Administration (TGA) has announced that from August 11, it will seek input from all interested parties in an effort to "ensure appropriate regulatory oversight and market controls are in place to provide assurance of the quality and safe use of medicinal cannabis products".
The TGA said the consultation was driven by "increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol (THC)".
"This is a significant regulatory reform consideration, and further consultations may be required to explore detailed and specific regulatory change options," the regulator added.
Although three concerns have emerged in recent months, the consultation will centre on two primary issues.
The first examines whether the regulatory oversight of medicinal cannabis accessed through the Special Access and Authorised Prescriber schemes is adequate.
The second addresses the safety risks tied to medicinal cannabis products, with a particular focus on those containing THC.
A third issue raised by health bodies — concerning "product specific" vertically integrated, or closed loop business models — will not be included in the consultation, as it falls outside the TGA's jurisdiction.
The announcement is unlikely to catch the industry off guard, given the considerable external pressure it has faced over the past 24 months.
Medical bodies have been sharply critical of what they view as overly open access to medicinal cannabis, and have not hesitated to raise those concerns with health ministers at both federal and state levels.
In announcing the consultation, the health watchdog said: "The TGA will be conducting a public consultation to gather information from stakeholders on their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia.
"This consultation, which will commence on 11 August 2025, has been prompted by increasing public and professional concern about the safety risks associated with unapproved medicinal cannabis products, particularly those containing higher levels of tetrahydrocannabinol (THC).
The regulator said the concern appeared to "correlate with the rapid growth in the number and type of these products being used and accessed in Australia by patients".
"The TGA seeks to understand whether current regulatory arrangements that enable patients to access medical cannabis via the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme provide adequate oversight for the more than 1000 unapproved products currently supplied in Australia.
"These schemes were initially designed to provide access to experimental products often used in clinical trials, or for exceptional circumstances at the discretion of the prescribing practitioner."
The TGA acknowledged that access to medicinal cannabis products is governed by "complex arrangements", with legal product access facilitated by the TGA, while prescribing and dispensing fall under the remit of AHPRA, the Medical Board of Australia, the Pharmacy Board of Australia, and relevant state and territory legislation.
More to follow.
