Avecho CEO Dr Paul Gavin warns the road to over-the-counter CBD may be a long one, but it will be a journey worth making for both patients and the industry.
The decision by the Therapeutics Goods Administration (TGA) late last year to down-schedule low-dose cannabidiol (CBD) preparations to Schedule 3 status signalled a new milestone in the advancement of the medicinal cannabis industry in Australia.
In its quest to curb unregulated consumption of CBD products and the market’s growing reliance on the special access pathway (SAS-B), the TGA has also presented the sector with the opportunity to prove itself beyond the ‘nutraceutical’ label, and evolve into a mature contender within the drug-development sector.
However, while the starting gates have opened for patients to access low-dose CBD products over the counter, industry players should heed caution as they hurtle headlong in the race for S3 registration.
What remains abundantly clear is that pharmacy shelves are not yet flooded with CBD products. Not even close.
In setting the scene for making CBD available in pharmacies, the TGA has set some specific requirements to ensure that low-dose Schedule 3 CBD products meet standards of quality, safety and efficacy – demanding the same rigour applied to other drugs in development, but coupled with somewhat subjective conditions along the way.
In short, all low-dose Schedule 3 products will need to be approved by the TGA and listed on the Australian Register of Therapeutic Goods (ARTG).
This is uncharted territory for both the Australian industry and the TGA. To be successfully listed on the ARTG, companies will need to approach the development of their CBD product as they would a pharmaceutical product.
Drug development is a complex and costly process, involving clinical trials to prove that products are both safe and efficacious. This requires scientific rigour, a deep understanding of the clinical indication being treated, an appreciation of the complexities of the clinical trials process, and very deep pockets. Suffice to say, there are few companies who will be prepared for this.
To those who have already commenced on the path to gathering clinical data, congratulations on having the foresight to start planning early. It can be a protracted process and take many years to collect the necessary evidence for registration.
For those unfamiliar with the regulatory frameworks that underpin the TGA’s decision making, it pays to seek advice from those with experience and expertise. The TGA should facilitate this process, but there are no shortcuts.
As an industry, we need to be striving for excellence, and building confidence among patient cohorts who can benefit from quality Australian CBD products. This can’t be achieved without putting in the work.
But even with this hard work under our belts, the ride isn’t over. Once the major hurdle of submitting clinical findings to the TGA for approval is done, the waiting game begins.
The TGA has indicated that it may take over 300 days to assess whether the product meets their requirements. At any time during this assessment, the TGA may request further information or reject the application, which means the process could take even longer.
Optimistically, even under the best of circumstances, patients are unlikely to see any CBD products on pharmacy shelves until 2023, at the earliest.
So why bother? The answer is simple. The Australian medicinal cannabis industry is sitting on a product with enormous therapeutic potential. But we owe patients the right to use CBD products knowing they are safe and effective for the condition that ails them.
The truth is, we still have a lot to learn about this product. Drug development is a long game, and as an industry, we should be striving for more. More scientific rigour. More accountability. More credibility.
We have an opportunity to differentiate our industry from the ‘wellness’ gurus peddling hope to vulnerable patients, and build an industry that not only believes in the medicinal value of cannabis products, but which puts the patient first.
No matter the pathway to market, what will be critical is the commitment of regulators and drug developers to work together efficiently and cohesively to get these products into patients’ hands.