Two companies running medicinal cannabis clinics have been fined almost $240,000 after allegedly targeting epilepsy patients with advertising on their websites and social media.
The TGA says the two companies, Australian Institute of Medicinal Cannabis and Biologics Research Institute Australia, used advertising with “unapproved references” to multiple serious conditions including epilepsy and cancer.
Some advertising also allegedly suggested or implied that particular medicinal cannabis products were recommended or approved by a government authority, the regulator said on Monday.
Biologics Research Institute Australia was fined $133,200 and treats patients in six states, with physical clinics in Sydney and Queensland under the CA clinics brand.
Australian Institute of Medicinal Cannabis opened its first combined clinic and pharmacy, branded MiDispensary, in Sydney last month. It was fined $106,560.
The move comes amid a broader crackdown on the industry and follows nearly $1 million in fines handed to three companies producing cannabis products back in September.
“While the TGA facilitates legal pathways for medical practitioners to prescribe medicinal cannabis products to patients, the medicinal cannabis products that are subject of these infringement notices are unapproved prescription-only medicines that cannot be advertised to consumers,” the watchdog said at the time.
“The use in advertisements, of claims about a serious disease or condition is also unlawful without express permission from the TGA because Australians facing a serious disease or condition are a particularly vulnerable consumer group.”
Research published this year revealed more than 250,000 medical cannabis scripts had been written in Australia since the drug was approved in 2016 under the TGA’s Special Access Scheme Category B.
The study, published in Frontiers in Pharmacology (link here), also suggested more than 200,000 scripts were now being written annually thanks to reforms allowing any doctor to prescribe the drug.
“The dramatic escalation of prescribing over time is unlikely to reflect greater population morbidity (with notable exceptions, vide infra), but is more likely to reflect improved patient access pathways and greater familiarity and acceptance of MC prescribing amongst HCPs,” the authors said.
In contrast, SAS-B applications for epilepsy showed downward trends, likely due to the registration of CBD-containing medicine Epidyolex in September 2020 – obviating the need for access under the scheme.
“Interestingly, the proportion of approvals for S8 products for epilepsy has increased since mid-2019, perhaps reflecting inadequate treatment responses in patients with S4 products,” the authors added.