AMCA OPINION

Response to the TGA final decision on down-scheduling of cannabidiol

AMCA supports the decision by the Scheduling Delegate to down-schedule CBD from a Schedule 4 medicine to a Schedule 3 medicine when administered at a dose of up to 150 milligrams per day.

AMCA notes, however, that the down-scheduling only applies to products administering 150 mg or less of CBD/day that are registered in the Australian Register of Therapeutic Goods (ARTG).

With that restriction in place, it is evident that any product containing CBD in a concentration of 150 milligrams per day or less that is a unapproved therapeutic good (whether it is a compounded therapeutic good or a therapeutic good that is imported or manufactured domestically in a GMP-accredited facility and supplied under the unapproved access schemes) remains a Schedule 4 medicine and cannot be supplied as a Schedule 3 medicine.

We note, further, that Epidyolex, which is a CBD-containing product that is currently registered in the ARTG, contains cannabidiol in a concentration of 100 mg/ml but with a stated dosage recommendation of 2.5 milligrams per kilogram as a starting dose taken twice daily (i.e. 5.0 mg/kg/day), which would amount to a dose of 300-350 milligrams per day for a 60-70 kilogram adult. That being the case, Epidyolex remains a schedule 4 medicine at its starting dose or higher, and patients will not be able to access that product as a schedule 3 medicine.

This means that based on the requirement for ARTG registration, no CBD medicine is currently available on the market which could be supplied a Schedule 3 medicine, i.e. there are no CBD medicines registered in the ARTG that have dosages of CBD of 150 mg/day or less.

Ultimately, Schedule 3 CBD medicines will only be available if companies invest in generating the comprehensive data packages of quality, safety and efficacy that would be required to support registration in the ARTG. In the meantime, we anticipate that patients will continue to access CBD as a Schedule 4 medicine in the short- to medium-term, while the industry waits to see whether any companies have any interest in working towards ARTG registration.

AMCA OPINION - 7 OCTOBER 2020

Department of Health considers making imported medical cannabis meet GMP standards

In response to a Cannabiz report that the Department of Health is considering taking steps to require all imported medical cannabis products to be manufactured according to Good Manufacturing Practice (GMP) quality standards (https://www.cannabiz.com.au/exclusive-department-of-health-considers-making-imported-medical-cannabis-meet-gmp-standards/), AMCA is cautiously optimistic that this could be the first significant step towards finally seeing fair treatment for Australian products vs imported products which currently only have to meet quality standard TGO 93, not production in a GMP-licensed facility.

We look forward to participating in consultations with the Department on behalf of our members and hope that the expected timeline of end-20 for such consultations is met.

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AMCA Opinion - 10 September 2020

TGA interim decision on down-scheduling of CBD

AMCA supports any government measures which legitimately facilitate access to medicinal cannabis. However, its view is that the interim decision of the Scheduling Delegate to down-schedule low-dose CBD (cannabidiol) will not lead to better access.

AMCA notes that the Medicines Scheduling Committee (Committee) did not support any down-scheduling of CBD but the Scheduling Delegate proposed, in an interim decision, to down-schedule CBD to schedule 3 on the following provisos (among others):

1. That CBD be limited to no more than 60 mg/day in oral dosage forms;

2. That the quantity supply be limited to a 30-day supply;

3. That the supply be restricted only to CBD medicines which have been entered in the Australian Register of Therapeutic Goods (ARTG).

The Scheduling Delegate has indicated that further advice will be sought from the Committee at the November meeting on whether the proposed addition to Appendix M of the Poisons Standard to restrict the supply of CBD as a Schedule 3 medicines only to medicines entered into CBD will sufficiently mitigate the concerns raised by the Committee about the safety of CBD.

However, the proposed addition to Appendix M will effectively negate any facilitated access that down-scheduling was intended to achieve. It means that pharmacists will be prohibited from compounding CBD as a Schedule 3, or from obtaining products which are not entered in the ARTG (but which nevertheless must meet certain quality standards), access pathways which are currently available for CBD as a Schedule 4 medicine and for all other Schedule 8 medicines (subject to approval under the Authorised Prescriber Scheme or Special Access Scheme).

AMCA does not agree that pharmacists would only be able to make “informed decisions” in relation to Schedule 3 CBD products that are ARTG-registered. Pharmacists have professional obligations in their practice of pharmacy, which include an obligation to satisfy themselves that the supply of any medicine to a patient is clinically appropriate.

The interim decision suggests that pharmacists are not sufficiently equipped to make decisions about the supply of CBD as an over-the-counter medicine unless that medicine is ARTG-registered.

AMCA strongly disagrees with that proposition; pharmacists who dispense medicinal cannabis products are knowledgeable on their quality, safety and the types of conditions for which they may be suitable. The other proposed measures that have been imposed on supply (60 mg/day dosing, not more than 30 days supply, adult use only, inclusion of mandatory warning statements and supply in child-resistant packaging) are more than sufficient to address any perceived safety concerns.

The requirement that all products need to first be registered in the ARTG, for specific indications, even at such a low dose, is also detrimental to the still-developing Australian industry. There is a paucity of sufficient data to demonstrate the efficacy of the 60mg/day dose proposed by the interim decision, and therefore to meet ARTG registration requirements, large and costly clinical studies would need to be conducted. This is neither feasible nor indicative of an approach intended to facilitate access.

AMCA encourages stakeholders to respond to the interim decision and provide further information to the Committee and Scheduling Delegate so that any further deliberations can refine the interim decision towards a final decision that actually does facilitate access.