4.5 Cannabidiol (private application)

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26, November 2020)

4.5 Interim decision in relation to cannabidiol (private application)

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to cannabidiol.

Materials considered

In making this interim decision, the Delegate considered the following material:

• The application to amend the current Poisons Standard with respect to cannabidol;
• The 228 public submissions, including 20 written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26);
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of the substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Summary of Joint ACMS-ACCS advice to the Delegate

The Committee advised against amending the current Schedule 4 entry for cannabidiol to explicitly capture synthetic and semi-synthetic cannabidiol.

Members agreed that the relevant matters under section 52E(1) of the Therapeutic Goods Act 1989 included (a) risks and benefits of the use of the substance; (b) the purpose for which the substance is to be used and the extent of use; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of the substance; (e) the potential for abuse of the substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the advice included:

1. the risks and benefits of the use of a substance
   • Benefits:
     • Synthetic (-)-CBD has a similar safety profile when compared with naturally derived CBD, provided related substances and impurities are the same or excluded.
   • Risks:
     • (+)-CBD has been shown to have modest affinity at CB1 and CB2 receptors and therefore could potentially have psychoactive effects, however this is currently no substantive evidence that (+)-CBD causes THC-like psychoactive effects.
2. the purposes for which a substance is to be used and the extent of use of a substance
   • A number of emerging therapeutic indications for CBD including epilepsy.
3. the toxicity of a substance
   • Safety and tolerability of (-)-CBD is well established.
   • Pharmacological effects of (+)-CBD are uncertain. Potential for psychoactive effects but not demonstrated. Limited available clinical evidence for (+)-CBD products does not suggest significant psychoactive effects.
4. the dosage, formulation, labelling, packaging and presentation of a substance

   Nil

5. the potential for abuse of a substance
   • Limited potential for abuse of (-)-CBD containing products.
   • (+)-CBD may be psychoactive; whether there is a potential for abuse is unknown.
6. any other matters that the Secretary considers necessary to protect public health

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision not to amend the Schedule 4 entry for cannabidiol (CBD) to explicitly capture synthetic and semi-synthetic cannabidiol. The reasons for my decision are set out below.

I am of the view, that whilst not explicitly stated in the current Schedule 4 entry, both synthetic and non-synthetic forms of CBD are already captured under this entry. This is in line with Part 1 Interpretation section 1 (2) (a) of the Poisons Standard, which states "Unless the contrary intention appears a reference to a substance in a Schedule or an Appendix to this Standard includes that substance prepared from natural sources or artificially."

I note that CBD is normally taken to refer to the naturally occurring (-)-enantiomer extracted from cannabis, however the current Schedule 4 entry for CBD does not specify an enantiomer. I have considered currently available data on (-)-CBD and (+)-CBD and find, there is limited evidence of significant differences in pharmacological activity. For this reason, I have decided not to individually schedule the two CBD enantiomers.

I have considered the need to limit synthetic cannabinoid impurities in the Schedule 4 entry and find there is no justification for the inclusion of impurities in a synthetically derived CBD product. It is important to prevent presence of synthetic cannabinoids in CBD products as they are potentially of greater potency than those that are naturally occurring and at the 2% limit proposed in the application, could exert a psychoactive effect.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) risks and benefits of the use of the substance; (b) the purpose for which the substance is to be used and the extent of use; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of the substance; and (f) any other matters that the Secretary considers necessary to protect public health.