A victory for common sense, but there’s still a difficult road ahead

Cannabiz editor-at-large Rhys Cohen unpacks the TGA’s decision to down schedule CBD.

The Therapeutic Goods Administration (TGA) has confirmed that clinically-proven CBD products registered on the ARTG will be eligible for Schedule 3 over-the-counter sale at pharmacies at doses of up to 150mg per day as of February 1st 2021. 

This is a significant increase from the much-critiqued interim decision to limit the daily dose to 60mg per day.

The interim decision recommended an implementation date of June 1st 2021, which has now been moved forward to February 1st 2021. So not only have we seen the recommended daily dose more than double, but this decision will be implemented four months sooner than previously expected.

The surprising announcement has been loudly welcomed by many patient advocates, companies, and industry commentators. And there are good reasons to be excited, although there is still an uncertain and difficult road ahead.

Not just a dose increase

The 150 mg dose increase was not the only difference between the interim and final decision. 

As with the Schedule 4 prescription-only CBD entry, the cannabinoid content of these products must be at least 98% CBD. But Schedule 3 products will have the additional restriction of no more than 1% THC content. In light of the dose increase, this decision was made to avoid unintended intoxication with THC.

In a big win for common sense, the Schedule 4 entry for CBD was expanded to include CBD for not only human therapeutic use, but also for analytical and scientific research purposes. 

Up until now, laboratories had to treat CBD as a Schedule 9 prohibited substance, which imposes unnecessary administrative and storage requirements. Further discussions between industry and the TGA to more sensibly regulate the analytical and scientific use of other cannabinoids are ongoing.

Reading through the final decision, I get the impression that earlier in the year there was significant uncertainty on behalf of the Delegate regarding the potential safety and appropriate management of CBD products. But particularly thanks to the engagement of key industry and scientific groups, many of those concerns have been addressed.

The Delegate made special mention of several academic medical, scientific and policy papers covering the safety, efficacy and availability of CBD which were published throughout the year. As well as a ‘confidential report’ on safety and efficacy.

This confidential report – which is likely either one commissioned by Medicinal Cannabis Industry Australia and written by the Lambert Initiative for Cannabinoid Therapeutics, or one commissioned by a group of product companies and written by Applied Cannabis Research – seems to have been instrumental in swaying the Delegate to reconsider the 60mg daily dose limit.

(I should disclose both the Lambert Initiative and the sister company of Applied Cannabis Research are clients of mine, but hopefully I don’t have a reputation for throwing around unwarranted praise).

Amusingly, the Delegate also conceded that the initial lower daily dose was partially determined by the incorrect assumption that the average weight of an Australian adult was 60kg (it’s actually 72 kg for females and 87kg for males). But then, the interim decision also mis-spelled cannabidiol, so they clearly weren’t paying too much attention at the time.

The difficult road ahead

Increasing the daily dose from 60mg to 150mg will make it comparatively easier for product companies to demonstrate efficacy and get their products on to pharmacy shelves. But this will still be a long and difficult road, and there is no guarantee that any products will successfully run the gauntlet of traditional pharmaceutical-level drug registration.

The final decision maintains the restriction on unregistered and compounded products. This means companies will still need to conduct rigorous clinical trials that prove 150mg of CBD is effective for treating a specific indication. I am not aware of any Schedule 3 drugs which have been registered on the ARTG without placebo-controlled clinical trials.

The indications appropriate for Schedule 3 drugs must also be taken into account. For example, a CBD product that has been proven to treat a serious medical condition which would normally be diagnosed and treated by a doctor is unlikely to be made available over-the-counter, regardless of the dose.

According to Professor Iain McGregor, Academic Director of the Lambert Initiative, although 150mg is comparatively more likely to produce a therapeutic effect than 60mg, there is “little compelling evidence of efficacy at CBD doses below 150mg, largely reflecting a lack of definitive, well-designed studies. Therapeutic benefits of CBD (across a range of indications) became more clearly evident in the current literature at doses of 300 and 400mg.”

Product companies pursuing Schedule 3 CBD registration in Australia were always going to be shooting in the dark due to the general absence of high-quality clinical research on low-dose CBD. 

Targeting 150 instead of 60mg will increase the likelihood of finding a therapeutic signal, but it does not guarantee that 150mg will prove to be effective or that low-dose CBD products will actually become available over-the-counter at all.

For more industry reaction to the TGA’s decision, click here.