The head of the Therapeutic Goods Administration (TGA) has confirmed the regulator is “exploring mechanisms” to shore up patient safety around medicinal cannabis but indicated it was not about to jeopardise access for those who need it.
In a letter 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 with other health regulators to, where necessary, strengthen the “online prescribing landscape”.
It is also collaborating with the Medicinal Cannabis Expert Working Group (MCEWG) to potentially weave additional controls – as yet unspecified – into the existing patient access framework.
But while recognising the “steep increase” in medicinal cannabis prescriptions, and labelling it a “high priority” for the TGA, Lawler made no suggestion the regulator was prepared to support a recommendation to withdraw medicinal cannabis from the Special Access Scheme (SAS).
The letter came in response to concerns raised by the bodies last November that “inadequate controls” were in place to protect patients from inappropriate prescribing and from accessing “highly potent” THC products.
To the consternation of the industry, they called for medicinal cannabis to be withdrawn from the SAS.
While reminding the AMA, RANZCP and Pharmacy Guild that the TGA does not regulate the clinical practice of individual health practitioners, Lawler said he acknowledged 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 said the development of clinical guidance is also “generally” outside the remit of the TGA, adding it would be “highly valuable” for peak medical and pharmacy bodies to draw up “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 noted the creation of the Rapid Regulatory Response Unit by the Australian Health Practitioner Regulation Agency (AHPRA) that will investigate matters of concern and non-compliance in the medicinal cannabis industry.
Referring to the letter in a column for Cannabiz, solicitor and MPhil candidate at NICM Health Research Institute, Andrew Proudfoot, urged the industry to start fighting back in 2025.
