Medicinal cannabis licences: Federal Government to cut red tape

The federal government is attempting to reduce the red tape and speed up the granting of licences for medicinal cannabis. Health minister Greg Hunt said the federal government would boost the nation's medicinal cannabis industry by prioritising projects that have been granted major project status (MPS).

Hunt said projects which will make a “significant contribution in the areas of exports, jobs and industry development, particularly in rural and regional areas” will be classified as a MPS. The prioritisation will start on 1 September.  

So far the government has granted 69 licences to cultivate, produce or manufacture medicinal cannabis: 24 for cultivation of cannabis for medicinal use; 16 for cultivation for research; and 23 for manufacture of medicinal cannabis products. 

Minister for industry, science and technology, Karen Andrews said: “The projects will still have to meet all of the approvals required, but this arrangement will make sure that they are not being held up by unnecessary delays.”

Elixinol extraction plant in Colorado
Elixinol extraction plant in Colorado

In May, the then CEO of Australian cannabis and hemp manufacturer Elixinol Global Paul Benhaim said it had been waiting for its licence for more than a year (Food & Drink Business, 08/05/2019). 

(On 16 July Elixinol announced Benhaim was moving to chief innovation officer and Stratos Karousos stepping into the CEO role.)

In July the company’s wholly owned subsidiary, Nunyara Pharma was granted a licence to manufacture medicinal cannabis for extracts and tinctures of cannabis and cannabis resin, but was still waiting for approval of its medicinal cannabis licence, which would allow the company to cultivate and produce cannabis for medicinal purposes.   

Karousos said: “The granting of the Manufacture Licence is extremely exciting and we look forward to also being granted our Medicinal Cannabis Licence shortly which will complete our licence application process for Nunyara.” 

Elixinol's extraction plant in Colorado
Elixinol's extraction plant in Colorado

Meanwhile, the company continues to grow its business in the US and Europe. 

On 29 July, Elixinol announced a partnership between its wholly-owned Dutch subsidiary and PharmaCare's Naturopathica brand. A CBD capsule range will be sold through UK health and wellness retailer, Holland & Barrett's 800 stores. Elixinol is already fulfilling a second order of 60,000 units.

Yesterday (8 August) it announced a manufacturing and supply agreement with Altmed Pets, trading as Pet Releaf. The brand is the market leader in hemp-derived CBD oils, topicals and treats for pets. It is sold in more than 4000 pet stores around the world and online. Elixinol has exclusively produced and supplied CBD extract to Pet Releaf since its inception in mid-2014. In April, Elixinol acquired a 25 per cent interest in Pet Releaf. 

The initial 18 month term of the agreement sees Pet Releaf purchase a minimum US$18 million worth of product over the term. Karousos says the deal ensures Pet Releaf's products will have "scalability and ongoing quality of supply". 

Government agrees to Narcotics Act review recommendations

A review of the Narcotics Drugs Act 1967 has recently been completed, with 26 recommendations made by independent chair Professor John McMillan. McMillan recommends congestion reducing initiatives for medicinal cannabis cultivation and manufacturing to apply to the whole sector. 

 Hunt said the Government has agreed in principle to adopt all 26 recommendations.

Two proposed changes would simplify the administration of the medicinal cannabis scheme and remove impediments to developing the Australian medicinal cannabis industry, he said.

Changes to the Narcotic Drugs Regulation 2016 will reduce the regulatory burden on licence applicants, and reduce the time it takes to apply and what level of detail is required.

As of 30 June 2019, over 10,000 prescriptions have now been written in Australia for medicinal cannabis products.

Approximately 7196 patients have been authorised to access a medicinal cannabis product through the Special Access and Authorised Prescriber Schemes.

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