Therapeutic Goods Administration Australia has issued a paper for public consultation, in which they will collect feedback from the general public on their experiences and opinions about unapproved cannabis-based medicinal products.
We reported last week that the TGA was launching a consultation with the public after concerns about risks of such products were growing in healthcare as well as the general population.
The consultation paper was launched this week, focusing on whether there is sufficient regulatory oversight of unapproved medicinal cannabis products accessed legally through Australia’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, and their safety risks — particularly with high potency THC products.
The TGA has no intention of removing access to cannabis-based medicinal products. says the consultation paper. “Rather than focusing on the quality of products, we want to be sure there’s confidence in their safety, effectiveness and performance. And, further research is being done to validate legitimate therapeutic use.”
Consultation feedback will guide future regulatory reforms. But, before any changes are made to the framework, further consultations will take place with key stakeholders.
The Australian Medical Association, (AMA), has welcomed this consultation.
The health landscape in Australia has changed significantly, and it’s important that we review our current regulatory frameworks to see what can be done, especially in the area of medicinal cannabis. said AMA President Dr Danielle McMullen.
The AMA is also concerned about unapproved medicinal cannabis products being prescribed at ‘alarming rates’ through direct-to-consumer telehealth models.
“Telehealth is an important mechanism to improve access to health services — but these direct-to-consumer, single-issue models lack clear referral pathways or a feedback loop to GPs and as the TGA has acknowledged, this requires much broader consideration by government,” said Dr. McMullen.
TGA’s consultation on Telehealth does not include its impact, as this is out of the Administration’s scope.
You can provide feedback using the online submission form herePlease submit your application by Tuesday, 7th October at 5 pm. Submissions are published on TGA’s website, unless confidential.