September 24th, 2020
Medical cannabis authorisations in Australia have been growing fast in the last two years. The openness in product ranges and facility to import has brought an immense expansion of supply which a recent report estimated at 150 products present in the market from 37 different suppliers, both domestic and from overseas.
The TGA picked the top 25 products by volume to conduct the tests in order to assess compliance with regulation TGO93 in the case of the products imported through the SAS-B pathway, the dominant way to access cannabinoid products in Australia. TGO 93 sets out the legal limits which stated cannabinoids can vary from those measured by the TGA and this varies for product types. The levels for flower must be within 80-120% of those stated on the bottle and within 90-110% for other formats including capsules and oral sprays. Three products were sold out so the final analysis was conducted over a sample of 22 products.
Five of the products were found to have significantly different cannabinoid profiles than stated in the companies’ declarations, namely:
- A flower strain by Dutch grower Bedrocan and an oil by Canadian LP Canopy were found with a lower THC content than on the label.
- Two oils imported from Canada by Althea were found to be over the stated CBD content.
- An oil produced by Little Green Pharma was found to be below the reported CBD levels.
Producers act to contain reputational damage
Despite the fact that no immediate risk to the patients was made apparent, consistency across batches for medicinal products is crucial, and failure to comply with this may entail reputational damage for the companies involved. Inconsistencies across batches can lead to variance in plasma concentration of drugs, affecting whether the drug is inside its therapeutic range or not. Stability and consistency has proven to be an issue for many producers as the cannabinoid makeup can be affected by factors such as the type of light during growing, as well as during drying and storage of the materials.
Following this news, affected products have been put under quarantine and producers are now puzzled, as they claim their own testing was well within the tolerance margin, and that the TGA went public before talks with the affected producers were concluded.
In a press release, West Australian company Little Green Pharma insists that their pre-market tests were conducted in a fully licensed GMP TGA-regulated lab, which is standing behind its results, methodology and testing standards. However, LGP has decided to switch laboratories to the same one that carried out part of the testing on behalf of the TGA, until the divergence of results is explained.
On the other hand, Althea is asking the TGA to improve their methodology for testing and to make their procedures public so as to align with industry standards.
This all occurs within the context of a global conversation on the best way to ensure standardised testing of cannabinoid content. For example, in 2018 Nature published a study examining the CBD and THC content of commercial cannabis strains in Washington. Researchers found that the same sample, tested rigorously by 6 different laboratories all yielded somewhat different results, as much as 20% for CBD levels in cannabis concentrates.
In Germany, another of the fastest growing international cannabis markets, at least three batches of products have been recalled during the summer, following both inconsistencies with labelling and contamination above acceptable levels.
The causes for inconsistencies in testing are still a topic of discussion, with potential solutions including more rigorous certification of laboratories, standardisation of testing protocol and robust measures to prevent THC and CBD levels altering over time due to effects of heat and light exposure.
Medical cannabis products in Australia
Despite the significant innovation in product formats in Australia, with wafers, patches, sprays and other formats reaching the pharmacy shelves, the dominant formats are oils and oral solutions, followed by a small presence of flowers and other formats such as capsules. This level of variety is unheard of in most international markets outside of North America.
50% of the analysed products contained more CBD than THC, while less than 30% had higher THC than CBD content. This can be explained by the higher doses usually employed with CBD and does not imply that a higher number of patients or revenue is being derived from CBD products, as pain, typically treated with THC, is the dominant indication in the country with 70% of the patients.
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