Because of legislative changes, businesses in Australia can apply for a licence to cultivate cannabis for medicinal purposes, to manufacture medicinal cannabis products or to conduct medicinal cannabis related research under the Medicinal Cannabis Scheme.

The Victorian law reform report estimates that 750,000 Australians use cannabis every week, and that 35% of Australians over the age of 14 have used it within their lifetime.

Up to 31 July 2019, the TGA has approved over 11,000 SAS Category B applications for unapproved medicinal cannabis products.

The growth trajectory of medicinal cannabis users that we have seen so far in Australia is very similar to what was seen in Canada in the early days of commercial legalisation.

Fortunately, more GPs and medical specialists are starting to learn more about the benefits of medicinal cannabis as well as how to prescribe it to patients.

There has recently been a significant shift recently in how the medical profession views medicinal cannabis and its place in the health sector."

Australia's top 20 listed cannabis companies have a market capitalisation of $1.8 billion, but more than half of that comes from the top three - Elixinol Global, Cann Group and Althea, all of which have significant North American backing.

Current Importers in the Australian business segment

Persons licensed to import under the Regulation 5 of the Customs (Prohibited Imports) Regulations 1956.

· Adelaide Compounding Pharmacy (INT) Pty Ltd

· Anspec Pty Ltd

· Bod Australia Ltd

· Burleigh Heads Cannabis

· Cann Group Limited

· Cannatrek Medical Pty Ltd

· Cannvalate Pty Ltd

· Greenfield Medicinal Cannabis

· Health House International

· Herba Healthcare Australia

· HL Pharma Pty Ltd

· iX Biopharma Ltd

· Medcan Australia Pty Ltd

· Medicinal Organic Cannabis Australia (MOCA) Pty Ltd

· Medlab Clinical Ltd

· Novachem

· Bedrocan

· Pharmacann Pty Ltd

· Tilray AUS

· Althea Health and Wellbeing

· Canndeo

· Pro Pharmaceuticals Group

· The Cannabis Company

Reference

Patient Data in Australia as at June 2019

SAS Category B is an application pathway that can be accessed by medical or dental practitioners if patients do not fit the Category A definition and if the products is not authorized for supply under the SAS Category C notification pathway. Read more here.

SAS Category B is an application pathway that can be accessed by medical or dental practitioners if patients do not fit the Category A definition and if the products is not authorized for supply under the SAS Category C notification pathway.

The first cultivation license was granted in 2018.

Key Australian Laws and Regulations

• Narcotic Drugs Act of 1967 (and 2016 amendment)

• Therapeutic Goods Act of 1989

• Therapeutic Goods Regulations of 1990

• Special Access Scheme

Market Data

• As of June 2019, cumulative patient approvals topped 9,300 and although the number seems small, growth is faster than Canada’s medical marijuana program in its first year.

• Government Regulators have granted 27 licenses for medical cannabis cultivation and production so far.

• Seventeen licenses have been awarded for cultivation and production for research purposes.

• Twenty-four manufacturing licenses have been handed out.

Medical Cannabis Products Available in the Australian Market

Any product can be made available in Australia, provided it meets minimum quality and safety standards.

North American Companies in the Market

Several North American companies are present through local partnerships:

• Ontario-based Cronos Group launched the international hub Cronos Australia in Victoria.

• Alberta-based Aurora Cannabis is the largest shareholder in Melbourne, Victoria-based Cann Group.

• Ontario-based MedReleaf, which is wholly owned by Aurora Cannabis.

• Victoria-based cannabis producer and importer Althea has a supply agreement with Ontario-based Aphria.

• MedReleaf Australia in Queensland is a partner of

• British Columbia-based AgraFlora Organics International has a large-scale greenhouse project in Australia.

Big Picture

• Australian regulators include the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

• Licenses cover medical cultivation and production, research (production and cultivation) and manufacturing.

• Business opportunities currently exist in cultivation, import/export and the ancillary sector, but not retail, because medical cannabis is sold in pharmacies.

• Cultivation licenses are driven by demand, so currently there is no cap on the number of permits granted. However, the ODC released the following statement: “International experience from North America suggests that only a small number of licensed cultivators will be required to meet domestic demand.”

• Most medical cannabis supply in Australia has been imported as of mid-2019 whilst cultivation ramps up. However, as Australian licensed growers increase local production, the domestic industry is expected to be supplied locally.

• Australia eventually expects to be an export hub.

• Regulators have approved medical cannabis to treat the following conditions: refractory pediatric epilepsy, cancer pain, neuropathic pain, chemotherapy-induced nausea and vomiting, palliative care, spasticity from neurological conditions, anorexia and wasting associated with chronic illness (such as cancer).

• Cannabis products manufactured in Australia must be made under a Good Manufacturing Practice license.

Medical cannabis products listed on the Australian Register of Therapeutic Goods (ARTG), such as Sativex, are accessible to patients via prescription. Other “unapproved” medical cannabis products, such as oils, tinctures, vapes, capsules and other extracts, are available via prescription through the Special Access Scheme (SAS).