‘We know it works’: Cannabis oil firms chase approvals as over-the-counter CBD sales are legalised
Low dose cannabis oil can be bought over the counter at pharmacies from Monday for the first time, but don’t expect to find any for at least six months as none has been approved for sale yet.
Manufacturers are working at a “lightning” rate to get products approved for sale in pharmacies, the former president of the Pharmacy Guild of Australia, Kos Sclavos, said.
A worker on the first farm licenced in NSW to produce medicinal cannabis prunes a plant. CREDIT: JANIE BARRETT FreshLeaf Analytics, specialists in the Australian medicinal cannabis industry, said the first company to get its product on chemists’ shelves will have a significant advantage in a market estimated to exceed $200 million a year.
The Therapeutic Goods Administration (TGA) announced in December that it would “down-schedule” some low dose cannabidiol (CBD) preparations of up to 150 mg a day to allow pharmacists to dispense this medicine without a prescription.
The Australian Medical Association opposed the proposal to sell cannabidiol over the counter. A spokesperson said it had not changed its position.
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Cannabidiol is an active ingredient in cannabis that doesn’t make a user high. A review by the World Health Organisation found it didn’t lead to drug abuse or dependence.
Clinical research has shown it can help reduce anxiety, insomnia, post-traumatic stress disorder and pain, said Dr Ben Jansen, the director and founder of Cannabis Doctors Australia.
Dr Jansen said his practice specialising in medicinal cannabis was passionate about CBD because it was life-changing for about a quarter of patients. Far from being a “demon drug” as it was thought of in the past, he said, “we know it works, but we want to find out how well it works.”
He said it would take “at least two million dollars and the appropriate data before (a product) can be registered for use for distribution by a pharmacist.”
Cannabis oil can be legally sold over the counter from Monday. CREDIT: SAKCHAI LALIT Contrary to stereotypes, the vast number of CBD users were middle-aged women who took the medicine for pain relief, such as inflammatory arthritis, he said. FreshLeaf’s analysis of the TGA ruling said many products prescribed by medical practitioners - after gaining special approval because the drug is currently unapproved - will meet the criteria for sale over the counter.
“History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating the industry today,” said Cassandra Hunt, managing Director of FreshLeaf.
Mr Sclavos, a pharmacist who has specialised in medicinal cannabis, said the decision to allow pharmacies to dispense cannabidiol without a prescription was a major move forward for a “whole cohort of patients”.
The first company to start producing cannabis oil will have an advantage in the highly lucrative market. CREDIT: JANIE BARRETT
He had seen first-hand the “incredible improvement in the quality of life” that medical cannabis could deliver to a range of patients including epileptics.
Compared with other medicines, the response of each individual to CBD varies enormously among individuals, Mr Sclavos said. That meant that pharmacists will have a “bigger say” in adjusting the dose.
The TGA decision only applies to products that are on the Australian Register of Therapeutic Goods (ARTG).
To register a product, a company must demonstrate that the products are high quality, safe, and efficacious. This is a time-consuming process, said Freshleaf. Products may not appear on shelves until next year. Originally published here: https://www.smh.com.au/national/we-know-it-works-cannabis-oil-can-be-legally-sold-over-the-counter-from-monday-20210129-p56xyd.html