We don't know whether any cannabis business has applied to the TGA to have its product registered and been rejected due to failures on the safety, efficacy and quality side.
So far, big pharmaceutical companies have not shown significant interest in low-dose CBD. They may not be sure low-dose drugs will be recommended by doctors, or be waiting for more research. They may not judge CBD to be a potential blockbuster compared with other therapies in their pipelines.
In Australia, it became legal to purchase products containing low-dose (less than 150 milligrams a day) CBD over the counter after the TGA down-scheduled the substance from a Schedule 4 (prescription medicine) to a Schedule 3 (pharmacist-only medicine).
What could low-dose CBD be good for?
They also need to understand the legal, professional and regulatory obligations placed on prescribers and dispensers. If products are being bought at the chemist, they may interfere with other drugs or foods. Companies who want to sell such products in Australia will need to focus on bringing their drug development into line with regulatory standards. Time will tell how many can do that.
Christian Read insists while medical medicinal cannabis can't cure him of the pain he experiences, it grants him some relief.
CBD is a chemical found in the cannabis plant. Like tetrahydrocannabinol (THC), also found in cannabis, it does have psychoactive effects. It can make people sleepy and affect the brain's electrical signals. Unlike THC, it won't get you "high" or induce other psychotic effects.
Here's a first look at how many Australians are taking medicinal cannabis
From a patient-safety perspective, regulating formulation and ensuring safety and quality data has met the TGA bar is imperative. Proving effectiveness is reasonable too. By down-scheduling and yet insisting on ARTG approval, the use of illicit CBD products may decrease – a win for population health if it transpires.
If we are using cannabis as a medicine, we should make the same demands we do of other medicines to protect patient safety. This requires good manufacturing practice, good laboratory standards of measurement, appropriate labelling, and sufficient clinical information for informed patient consent.
The TGA says there is scientific evidence to support the use of CBD capsules to treat chronic pain, anxiety and sleep issues, but any over-the-counter medicines will have to provide robust evidence that they work for one particular ailment.
Under the new rules, cannabis medicines in this category are classified as “schedule 3” medicines and can be sold in pharmacies without the need for a prescription. However, no Australian products currently fit the criteria for an over-the-counter medicine, meaning drug developers must set up clinical trials for new products and show that they work before anything can be sold to consumers.
“We know we are targeting a major unmet need in psychological distress,” he said.
In February, the country’s medicines regulator – the Therapeutic Goods Administration (TGA) – agreed to change the classification for certain products containing small amounts of cannabidiol (CBD), an active ingredient in the cannabis plant that does not get the user high but is used in therapeutic products.
It also bought a cannabis brand called Satipharm earlier in 2021. Satipharm already provides CBD capsules under Australia’s special access scheme, which lets doctors prescribe cannabis medicines to patients in certain circumstances for a range of illnesses, including chronic pain.
“The schedule 3 [pharmacy] product is going to take things to another level.”
“The interest in medicinal cannabis is strong, and it continues to grow,” said chief executive of ASX-listed cannabis company Cann Group, Peter Crock.