The industry has broadly welcomed the Therapeutic Goods Administration’s decision to down schedule low-dose CBD – with some important caveats.
On Wednesday, the TGA announced a significant change in its final decision, with the maximum dose increased to 150mg/day, up from the 60mg/day it signalled in its interim decision in September.
The implementation date of the down scheduling was also brought forward from June 1 to February 1, 2021.
Medicinal Cannabis Industry Australia (MCIA) welcomed the change as providing the industry with the flexibility to develop products for the Schedule 3 registered pathway.
However, it said it would continue to work with the TGA with a view to lifting the dose to 300 mg/day as “this is the threshold at which higher quality evidence accumulates around CBD efficacy, in the absence of significant safety concerns”.
MCIA chair Peter Crock added: “Down-scheduling CBD will benefit patients by allowing them to move from the illicit market and providing easier and more affordable access to high-quality products.”
While noting products will require TGA approval and inclusion on the Australian Register of Therapeutic Goods (ARTG), along with a number of other restrictions, Crock said the decision will provide a pathway for the industry to develop products for this market.
“If fewer consumers seek out illicit CBD products, which have unknown content and quality, then this move ultimately promotes greater safety for patients, which has to be the priority,” he added.
The Australian Medicinal Cannabis Association (AMCA) also welcomed the decision, but noted no medicines currently meet the criteria for a Schedule 3 medicine.
It cited the example of Epidyolex, a CBD-containing product currently registered on the ARTG which contains cannabidiol in a concentration of 100mg/ml, but with a stated starting dose of 2.5mg per kilogram twice daily, which equates to 300-350mg per day for a 60-70 kilogram adult.
AMCA secretary Teresa Nicoletti added: “That being the case, Epidyolex remains a Schedule 4 medicine at its starting dose or higher, and patients will not be able to access it as a Schedule 3 medicine. Based on the requirement for ARTG registration, no CBD medicine is currently available which could be supplied [over the counter].
“Ultimately, Schedule 3 CBD medicines will only be available if companies invest in generating the comprehensive data packages of quality, safety and efficacy that would be required to support registration on the ARTG.
“In the meantime, we anticipate patients will continue to access CBD as a Schedule 4 medicine, while the industry waits to see whether companies have any interest in working towards ARTG registration.”
Elixinol Global executive director and group CEO Oliver Horn described the TGA’s decision to increase the maximum daily dose as a “big surprise for the better”, but said it still left Australia lagging behind the rest of the world when it comes to consumer access.
He said: “The good news is that more people will have access to safe and effective CBD products now. However, the TGA’s approach is not reflective of the overall global trend and in particular the regulatory frameworks recently confirmed by the European Commission, which classifies CBD as food.
“Under the EU’s ruling, product suppliers have to demonstrate stringent safety standards but not efficacy. Even under the new TGA ruling, and with an increased dosage, proving efficacy for specific indications will prove challenging and will increase the barriers to entry into the Australian market.
“The vast illegal supply of CBD products from online suppliers into Australia will continue to exist simply because it’s more convenient, easily accessible and likely to be cheaper.
“The TGA ruling misses an opportunity to create a compliant, legal and buoyant domestic CBD market by demanding proof of efficacy and over-regulating the market. It’s a step forward, but global markets are moving forwards faster.”
Bod Australia revealed it has established a medical advisory board to explore the possibilities created by the down scheduling, with Lambert Initiative academic director Iain McGregor and head of neurology at Gold Coast University Hospital, Arman Sabet, among the board members.
Chief executive Jo Patterson told Cannabiz the company would initially pore through academic and medical literature to see if there is material supporting efficacy at 150mg.
She said Bod already has a CBD isolate targeting stress, anxiety and sleep disorder that it will look to register on the ARTG.
“Our ambition is to get a product to market as soon as possible,” Patterson said. “We will sit down with the TGA in the new year and discuss what sort of indication we are looking at for a registration.
“If there is enough literature in the public domain then the task of clinical trials may not be required. But if we do have to go down the clinical path trial, we will. We already have trials designed so if we need to go to phase 2 or phase 3 trials we are ready.”
Bod already has data from observational trials that provided “good insights into dosage and efficacy”, she added.
The listed company said it would also explore opportunities for its consumer-focused CBD and hemp products.
FreshLeaf Analytics regulatory specialist Tony Whittaker warned there were still hurdles for the industry to jump. He said: “The TGA has exacting standards, which will present a significant challenge to this young industry. We look forward to working with TGA to clarify the requirements for over-the-counter CBD products and navigating the path to approval and commercialisation.”
Tim Drury, the director of Southern Cannabis Holdings, which owns FreshLeaf, added: “Low-dose CBD has the potential to become a significant market in Australia for cannabis products. Companies wanting to compete in this space need to overcome substantial challenges – demonstrating safety, efficacy and quality of manufacturing – but the first to do so will be best positioned to succeed in a market that will, by our estimation, exceed A$200 million per annum.”