Therapeutic Goods Administration (TGA) chief medical adviser Professor Robyn Langham has delivered a blunt assessment of the industry, warning of the “abuse” of access pathways and escalating safety concerns linked to THC products.
The comments – delivered as the regulator finalises the first stage of its review into medicinal cannabis products – came during a University of Melbourne webinar titled Medicinal Cannabis and Regulatory Challenges.
Langham’s remarks will potentially unnerve the industry which is waiting for the first indications of what reforms may be thrust upon it.
On the issue of the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways, Langham said they were introduced in 1989 as a way for Australians to access very specific drugs which often came to the country late.
She added the framework – and how it has been applied to medicinal cannabis access in Australia – meant it had drifted significantly from its intended purpose.
“If there was a particular product that was needed for a patient, and this was often pointy-end cancer drugs or brand-new products that had been registered elsewhere, the SAS and AP was a way for you to access that in Australia,” she said.
“It was really anticipated for medicinal cannabis, back in 2015, that this would be very small numbers of practitioners for very specific clinical needs.
“But what’s happened in the last couple of years has been really an abuse of this access pathway. What we’re now seeing is patterns of recreational access to a drug rather than medical access.
“There are two products that have been registered as drugs. There are over 1,200 products that are not.”
Beyond limited visibility of prescription numbers under the AP pathway, which she described as “incredibly troubling”, Langham said the growth in Category 5 products – those containing more than 98% THC/other cannabinoids and less than 2% CBD – was a major issue.
“Category 5 outnumbers all of the other categories, and Category 5 is pretty much pure THC. Houston, we have a bit of a problem,” she said.
“The safety signals… [are] the biggest concern.”
She claimed that evidence for most commonly treated indications was “incredibly poor”, adding: “There is none, and that’s partly why we haven’t seen any other products come to us for registration.”
The TGA chief medical adviser also raised concerns about the telehealth clinic model, which she described as the “real elephant in the room”, arguing it was driving “low-value care” and contributing to the broader regulatory challenge.
Langham confirmed the TGA was reviewing the 794 submissions received in the initial consultation before a second round would take place.