Australia's medicines regulator has not investigated the safety of most medicinal cannabis products despite receiving hundreds of "adverse event" reports ranging from coughing to psychosis in the past three years.
The ABC can reveal there were 615 reports made to the Therapeutic Goods Administration (TGA) involving unregistered medicinal cannabis products between July 1, 2022 and June 1, 2025.
A TGA spokesperson said it had the power to investigate unapproved cannabis medications when "safety signals" — red flags for possible safety concerns —were identified.
"To date, no such signals for specific unapproved medicinal cannabis products have been identified and no investigations have occurred," the spokesperson said.
There are more than 1,000 different medicinal cannabis products currently available in Australia.
Apart from two products — which are listed on the Australian Register of Therapeutic Goods — the TGA has not approved or assessed any for quality, safety or efficacy.
While health professionals are required to report adverse events for unregistered products, the TGA generally keeps these reports on an internal database used for "general safety monitoring".
The TGA said when clinicians prescribed an unapproved medicine, they assumed responsibility for the "efficacy and safety of that good".
Psychiatrists say companies prioritising profit over safety
Chair of the Queensland branch of the Royal Australian and New Zealand College of Psychiatrists (RANZCP) Brett Emmerson believed the 615 adverse events reported between July 2022 and June 2023 were the tip of the iceberg.
Last year, Professor Emmerson told the ABC his colleagues had seen a significant increase in people hospitalised with psychosis after being prescribed medicinal cannabis.
"The industry continues to market medicinal cannabis for a wide variety of conditions for which there is no evidence that it works," he said.
"They market it because people take it and that's their business.
"The medicinal cannabis companies are just like the tobacco companies — they want people to use their product, that's how they make their money and their profit."
Professor Emmerson is calling for greater regulatory oversight of medicinal cannabis.
He said companies should be required to prove specific products were safe and effective treatment for conditions before the medication could be prescribed.
"This is not a drug that can be just regarded as a natural product," he said.
"It's a drug of dependence with serious side effects and it's having a tragic impact on a large number of people in this country."
(For complete story ABC News 10th September 2025thABC News 10th September 2025)