Long wait for over-the-counter cannabis Australia

Purchasing low-dose medicinal cannabis over the counter from pharmacies is years away from becoming a reality despite the national pharmaceutical watchdog de-scheduling the drug early this year.

Pharmacists can legally sell low-dose medicinal cannabis products that have cannabidiol (CBD) content of up to 150mg a day, however, the Therapeutic Goods Administration has not yet approved such products.

ECS Botanics Managing Director Alex Keach said “there was lots of hype around the de-scheduling of low dose medicinal cannabis from a Schedule 4 to an over-the-counter Schedule 3 drug but added that steps needed to be taken before such a drug hits the market.”

He said low-dose CBD products may not receive approval nor be available for sale across Australia for another two years.

“It’s like making lollies available but locking the cupboard,” he said.

“In order to bring CBD products to market, human trials need to be conducted on developed products, which may take a couple of years until the first product comes to market.”

There are also many scientific complexities and clinical rigours involved in the creation and approval of CBD products.
A study looking into the ethics of clinical trials involving medicinal cannabis noted that cannabis medicines come in a variety of preparations and concentrations of CBD, and may contain other cannabinoids and terpene combinations.

Researchers and ethics committees both should be aware that one cannabis medicine product, even if available in the same dose, formulation or concentration, may have vastly different potency or purity to another,” the study published in Trials wrote.

“Cannabis Australia medicine products may also have different absorption rates due to the variety of carrier oils, extraction methods and delivery systems available.”

Mr Keach said over the counter CBD needed to be 98 per cent pure. “Therefore the product has to be manufactured heavily to increase the potency per gram, and very few of the other cannabinoids or terpenes are allowed”

Over-the-counter pharmacy sales of low-dose medicinal cannabis, with up to 120 grams of CBD, is years away.

Written by: Isabel Bird, Examiner Launceston