Medicinal Cannabis in Australia | Part 1: Available Products

by , , | May 4, 2022

Introduction

Medicinal cannabis is now widely available in Australia.  However, the vast majority of medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG).  Rather, they are unapproved therapeutic goods, i.e., products that have not been assessed by the Therapeutic Goods Administration (TGA) as meeting the various efficacy, safety and quality standards necessary for registration on the ARTG.

In this first part of a series on medicinal cannabis in Australia, we summarise the medicinal cannabis products currently available in Australia and how they may be accessed.

ARTG-registered products

Nearly all of the medicinal cannabis products registered on the ARTG are export only products.  These products are made from cannabis plants cultivated in Australia, from which cannabinoids are extracted and formulated into products.  Such products are required to be ARTG registered to ensure that Australia is not exporting sub-standard therapeutic goods.  Currently, 28 export only medicinal cannabis products are registered on the ARTG, generally in the form of oils or dried flowers.  Those products are shared between five sponsors: ABC Can Pty Ltd; ECS Botanics MC Pty Ltd; Cannim Australia Pty Ltd; MediPharm Labs Australia Pty Ltd; and Little Green Pharma Ltd.

Both medicinal cannabis products approved by the TGA for supply in Australia are sponsored by Chiesi Australia Pty Ltd under licence from GW Pharma Ltd, the developer of the products.

  • The first product, Sativex®, was ARTG registered in 2012. It is a mouth spray formulated from a cannabis extract referred to as nabiximols.  The principal active ingredients in nabiximols are delta-9-tetra-hydrocannabinol (THC) and cannabidiol (CBD).  Sativex is indicated for treating muscle spasticity in multiple sclerosis.
  • The second product, Epidyolex®, was registered on the ARTG in 2020, as reported in our 1 October 2020 article. It is an oral liquid that contains CBD as its active ingredient.  Epidyolex is indicated as an adjunctive therapy in the treatment of seizures in individuals with Dravet syndrome or Lennox-Gastaut syndrome.

Chiesi’s predecessor (Emerge Health Pty Ltd) was unsuccessful in obtaining Pharmaceutical Benefits Scheme (PBS) listing of Sativex in 2013.  In the view of the Pharmaceutical Benefits Advisory Committee (PBAC), there was insufficient evidence to support the sponsor’s claim of superior efficacy over the standard of care, and nabiximols appeared to be inferior to the standard of care in terms of safety.  Accordingly, Sativex is only available by private prescription in Australia, reportedly for around $100 per week of treatment[1].

Chiesi has had some success in listing Epidyolex on the PBS.  The PBAC recommended Epidyolex for the Dravet syndrome indication in November 2020 and it was PBS listed for this indication on 1 May 2021.  According to the Health Minister[2], its subsidised price is just over $40 per script, rather than potentially more than $24,000 annually.  However, in March 2022, Chiesi was unsuccessful in relation to the Lennox-Gastaut syndrome indication.  Although the PBAC considered CBD to be effective in treating seizures associated with Lennox-Gastaut syndrome, it was concerned by the unacceptably high price Chiesi would charge the Department of Health for Epidyolex.  The PBAC also noted that CBD was inferior to the standard of care in terms of safety.  Therefore, Epidyolex is PBS listed for the Dravet syndrome indication but not the Lennox-Gastaut syndrome indication.

Unapproved products

Significantly more medicinal cannabis products are available in Australia as unapproved therapeutic goods under the Special Access Scheme (SAS) or via an Authorised Prescriber (discussed below).  Although such products are not assessed by the TGA before they are able to be supplied, the TGA regulates unapproved products in other ways, which is the subject of Part 2 of this series.  Based on the TGA’s 8 April 2022 report, between 1 July and 31 December 2021, 228 distinct medicinal cannabis products by many different sponsors were supplied in Australia as unapproved therapeutic goods.  These products include oral liquids, capsules and tablets, dried herbs for vaporisation, and topical liquids.

Medicinal cannabis products can be separated into different schedules of the TGA’s Poisons Standard according to their cannabinoid composition, in particular the concentration of THC in the product.

  • A medicinal cannabis product is a schedule 3 medicine if it is ARTG registered, CBD makes up at least 98% of its cannabinoid content and THC no more than 1% of that content, provided the product is taken orally, no more than 30 days’ supply is provided and the recommended daily dose is no more than 150 mg. The significance of this is that Schedule 3 medicines may be dispensed by pharmacists without a prescription.  However, unless and until such a product is registered on the ARTG, patients will be unable to take advantage of this possibility.  The considerable effort and expense involved in satisfying the TGA’s efficacy, safety and quality standards is likely to be the hold-up.
  • Medicinal cannabis products are Schedule 4 medicines if CBD makes up at least 98% of their cannabinoid content and any other cannabinoid (such as THC) makes up no more than 2% of that content. Schedule 4 medicines are prescription only.  Medicinal cannabis products are Schedule 8 medicines if CBD makes up less than 98% of their cannabinoid content, i.e. if other cannabinoids (such as THC) make up more than 3% up to 100% of their cannabinoid content.  Schedule 8 medicines are controlled drugs subject to additional restrictions, for example, prescribing permits.

As noted above, patients may access Schedule 4 or 8 unapproved medicinal cannabis products under the SAS or via an Authorised Prescriber.  A medical practitioner can use the SAS to obtain TGA approval to supply an unapproved product to a single patient, whereas if a medical practitioner obtains Authorised Prescriber status from the TGA, they can supply an unapproved product to a class of patients (e.g. patients with particular medical conditions, such as chronic pain) without having to seek TGA approval each time.  See our separate article for further details.

Concluding remarks

Medicinal cannabis is now widely available in Australia by prescription of unapproved products.  It will only be a matter of time before sponsors register Schedule 3 products on the ARTG, after which pharmacists will be able to dispense medicinal cannabis to patients without a prescription.  However, obtaining PBS listing to subsidise the use of more expensive medicinal cannabis products will likely remain a greater challenge.

Alex May

Alex May

Senior Associate, Foreign Qualified Lawyer

Alex is an intellectual property disputes lawyer with twelve years’ experience and a track record of obtaining successful outcomes for clients. He specialises in advising pharmaceutical companies on patent litigation and related matters and has a technical background in genetics.

Emily Bristow

Emily Bristow

Graduate (Law), Trainee Trade Mark Attorney

Pearce IP’s law graduate Emily Bristow offers legal and intellectual property services, with particular focus on patents and trade marks.

Emily co-authors Pearce IP’s blogs including the biopharma focussed blog BioBlast®, and Pearce IP’s regular pharma/biopharma industry news updates, and ensures that Pearce IP’s life sciences clients are kept abreast of important industry and legal developments.

Naomi Pearce

Naomi Pearce

Executive Lawyer, Patent Attorney & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory.  Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

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