The head of the Therapeutic Goods Administration (TGA) has confirmed the regulator is "exploring mechanisms" to strengthen patient safety around medicinal cannabis, while signalling it has no intention of cutting off access for patients who depend on it.
In a letter addressed to Queensland representatives of the Australian Medical Association (AMA), the Royal Australian and New Zealand College of Psychiatrists (RANZCP), and the Pharmacy Guild of Australia, Professor Tony Lawler said the TGA is working alongside other health regulators to, where needed, tighten controls around online prescribing.
The TGA is also working with the Medicinal Cannabis Expert Working Group (MCEWG) to consider introducing additional controls — the specifics of which have not yet been outlined — into the current patient access framework.
Even so, while acknowledging the "steep increase" in medicinal cannabis prescriptions and describing the matter as a "high priority" for the TGA, Lawler gave no indication the regulator was willing to back calls for medicinal cannabis to be removed from the Special Access Scheme (SAS).
The letter was a response to concerns those organisations raised last November that "inadequate controls" existed to shield patients from inappropriate prescribing and from accessing "highly potent" THC products.
To the alarm of the industry, those bodies had called for medicinal cannabis to be withdrawn from the SAS entirely.
While reminding the three organisations that the TGA does not oversee the clinical practice of individual health professionals, Lawler said he recognised the "importance of timely access to unregistered therapeutic goods to address the medical needs of patients, in clinical circumstances where there are limited or no approved treatment options".
"The prescribing of an unregistered medicinal cannabis product through the SAS, as with any unregistered therapeutic good, requires the prescribing clinician to comply with good medical practice, the principles that characterise ethical and professional conduct expected of doctors by their professional peers and the community," he wrote.
Lawler added that developing clinical guidance falls "generally" outside the TGA's scope, and said it would be "highly valuable" for peak medical and pharmacy bodies to produce "best practice clinical resources… in conditions where medicinal cannabis is being prescribed in high volumes, such as for the management of chronic pain and anxiety".
He also pointed to the establishment of the Rapid Regulatory Response Unit by the Australian Health Practitioner Regulation Agency (AHPRA), which will examine issues of concern and non-compliance within the medicinal cannabis sector.
In a column referencing the letter, solicitor and MPhil candidate at NICM Health Research Institute Andrew Proudfoot called on the industry to mount a stronger defence of its position in 2025.
