16 December, 2020
TGA announces final decision on Cannabidiol (CBD) – minimum dose limit increased
Today the Therapeutic Goods Administration (TGA) announced a
Final Decision to down-schedule certain low-dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).
The decision allows for products approved by the TGA containing low-dose CBD:
– Containing up to a maximum of 150 mg/day
– For use in adults
– To be supplied over-the-counter by a Pharmacist without a prescription, provided that controls such as pack size (30 days), child-resistant closures and others are followed.
An implementation date of 1 February 2021 has been provided in the final decision – but people should be aware that this does not mean that any CBD products will be available from that date.
Public pressure successful in TGA lifting minimum CBD dose limit:
Although the TGA decision will not make CBD any more available to Australians in the short-term, in the final decision the TGA has increased the maximum daily dose proposed in the
Interim Decision from 60 mg/day to 150 mg/day,
offering greater promise of achieving successful clinical trials of efficacy.
The TGA’s originally-proposed dose of 60mg/day was sub-therapeutic. This meant it would be of little-to-no actual therapeutic benefit, which in turn meant that no companies would invest in expensive trials to test products they knew would be ineffective. In turn, this meant the public would not be able to access CBD products under the new ‘Pharmacist Only’ scheme – which would have represented nothing more than a ‘window-dressing’ exercise.
The outcome of raising the dose from 60 mg/day to 150 mg/day was strongly influenced by public feedback through the Your Health Your Choice (YHYC) campaign, which inundated the TGA with 5,399 public submissions in early 2020 – the largest public response the TGA medicines Scheduling Committee had ever received, by far.
A follow-up public campaign hosted by YHYC prior to the release of the TGA Interim Decision (which maintained the 60mg/day limit) resulted in over 15,000 emails sent to people’s Federal political representatives.
The added pressure worked.
No products currently meet the new TGA criteria:
People should realise that there are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the new Schedule 3 criteria.
It is highly unlikely that there will be availability of CBD in Pharmacies by the February 2021 implementation date, as the decision limits over-the-counter supply to those products that are approved by the TGA and included on the ARTG.
First, a product must be approved as an AUST R (registered medicine), based on clinical trials demonstrating efficacy for the labelled therapeutic indication/s. For this to happen, companies must conduct clinical trials and then apply to the TGA to conduct an evaluation of their proposed product/s.
The increase in dose from 60 mg/day to 150 mg/day now makes investment in clinical trials more viable and likely to occur, as the 150mg/day dose is more likely to have a therapeutic effect.
The increase in dose from 60 mg/day to 150 mg/day was based on concluding that the known adverse events of CBD at low doses were not serious and followed further consideration of safety information, the decision considering safety information, public submissions, expert Committee advice, and the earlier TGA safety review of low dose CBD.
Public pressure has advanced the CBD public agenda:
While the TGA Schedule 3 proposal is far from perfect and there is a long way to go for people to be able to access CBD products, public pressure has put this issue firmly on the political map and has accelerated the CBD/ medicinal cannabis public agenda.
In the case of CBD, the public campaign has resulted in the TGA revisiting the issue more consultatively and modifying its original proposal to make the likelihood of future patient access to affordable CBD more achievable.
Summary:
- Consumers will be able to access cannabidiol from their Pharmacists, where they are Registered medicines (AUST R) that undergo evaluation by the TGA with a maximum recommended daily dose of 150mg of cannabidiol.
- Preparations must contain 2% of less of cannabinoids including 1% or less of THC.
- The medicines must include the warning statements: Do not use if pregnant or likely to become pregnant; Do not use if breastfeeding or planning to breastfeed.
- Amounts above 150 mg/day, or for children under 18, or without child-resistant closures, or in larger pack sizes, or without the required warnings, will remain Prescription Only (Schedule 4) in accordance with the Schedule’s conditions.
- Currently, there are no medicines in this category, and the entry to the AUST R category will require suitable clinical evidence for a therapeutic indication suitable for OTC registered medicines as per the registered medicines guidance.
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