At The Trough Of Australian Medicinal Cannabis, The Commonwealth, Complexity & Capitalists

Over the past few weeks we’ve seen a slew of articles indicating a huge rise in patient and product “approvals” in the Australian medical cannabis market but no real explanation as to where these numbers come from and what they actually mean.

The obvious answer is that it’s reporting season in Australia but there’s lot more to consider.

Our article will cover the following takeaways and will hopefully allow our readers to string together a more holistic understanding of what is and is not happening in  Australia’s world of regulated  medical cannabis.

Information isn’t so readily available in Australia as it is in the US and we’d suggest that there’s still far too much obfuscation in the market designed to confuse both investors and patients, not just from Federal & State government mind you, but also emanating from the private sector.

Key Takeways

  • Media
  • Lobbying & Federal Politics
  • The Therapeutic Goods Administration (Federal)
  • The Private Sector / Accessing Medical Cannabis
  • (i) Company Structures
  • (ii)Taxpayer Funding
  • (iii) Cannabis Clinics, The Medical Profession, Prescriptions
  • In Conclusion

Media

Here are a few examples of articles currently doing the rounds from media outfits you’ll most likely be aware of.

Articles

Hemp Gazette
https://hempgazette.com/news/tga-cannabis-applications-hg1236/
Prohibition Partners UK:
https://prohibitionpartners.com/2020/08/06/july-records-largest-single-month-patient-growth-in-australia-as-authorisations-surge/
MJ Biz

Australia sees record month for medical cannabis approvals

We have also noticed in the same period a rise in chatter about the Australian medicinal cannabis market. Whether it be deals, new clinics, media launches etc.

Again, here are a few examples.

Southern Cannabis Holdings to present at medical cannabis webinar on Tuesday
https://www.proactiveinvestors.com.au/companies/news/926092/southern-cannabis-holdings-to-present-at-medical-cannabis-webinar-on-tuesday-926092.html
Medical cannabis Australia: A look inside Australian Natural Therapeutics Group medical cannabis farm near Armidale
https://www.northerndailyleader.com.au/story/6868446/pharm-to-table-inside-australias-growing-medical-cannabis-industry/
Cannabis use ‘costing $4.5 billion a year’
https://www.canberratimes.com.au/story/6864554/cannabis-use-costing-45-billion-a-year/
Peel region patients now have better access to medical cannabis
https://www.busseltonmail.com.au/story/6863404/peel-region-patients-now-have-better-access-to-medical-cannabis/?cs=1435
Cann Global Limited (ASX:CGB) Quarterly Activities and Cashflow Report
https://au.finance.yahoo.com/news/cann-global-limited-asx-cgb-210600795.html
Emerald Clinics signs cannabis RWE contract with Canopy Growth’s UK subsidiary Spectrum Biomedical

Emerald Clinics signs cannabis RWE contract with Canopy Growth’s UK subsidiary Spectrum Biomedical

Cannabiz, Australia’s first legal cannabis industry media platform launches

Cannabiz, Australia’s first legal cannabis industry media platform launches

Hemp Gazette: WA Medical Cannabis Partnership Announced 

WA Medical Cannabis Partnership Announced 

These are just a few  examples of the slew of “writing” appearing online since the last week of July which immediately makes us at CLR do our best alert hare impersonation.

Yes it is true that the medical cannabis market has picked up in Australia in 2020, despite the pandemic, but this level of activity, is, as they say about everything this year, unprecedented.

Lobbying & Federal Politics

First up we  note that lobbying efforts are currently on the up with the Australian Medicinal Cannabis Industry Association announcing 20 July.

The MCIA is delighted to welcome the establishment of a Parliamentary Friends of Medicinal Cannabis Group in the Federal Parliament.

The group will provide a non-partisan forum for Members and Senators to meet with representatives of the Australian medicinal cannabis industry, medical experts and patient advocates to raise awareness of the applications of medicinal cannabis to Parliamentarians and within the broader community.

The MCIA is funded by the following companies according to their website. Some of these names North American readers will recognize others have slightly more opaque ownership structures.

Who are the politicans ?

Parliamentary Friends of Medicinal Cannabis of the 46th Parliament

To help you understand their politics we highlight them below by political persuasion with a little help for our North American readers as you’ll be confused by the fact that Australian liberals aren’t actually liberal and that in Australia  blues are reds and visa versa !

The Australian equivalent of the Trump base are called One Nation and their leader Pauline Hanson almost makes Sarah Palin seem an attractive option. Hanson has supported medical cannabis but interestingly is conspicuous by her abscence in the list with only one of her party signing up to the MCIA group.

Liberals (Think Republicans)

  • Dr John McVeigh
  • Ross Vasta
  • Ted O’Brien
  • George Christensen
  • Michelle Landry
  • Richard Colbeck

Labor (Think Democrats)

  • Dr Mike Freelander
  • Sharon Bird
  • Josh Burns
  • Carol Brown
  • Catryna Bilyk
  • Brian Mitchell
  • Joel Fitzgibbon
  • Dr Andrew Leigh
  • Warren Snowdon
  • Anne Urquart
  • Steve Georganas
  • Helen Polley
  • Luke Gosling
  • Chris Bowen
  • Susan Templemann
  • Maria Vamvakinou
  • Louise Pratt

Greens

One Nation (Trumpsters)

  • Malcom Roberts

Nationals (Republicans With A Country Base)

  • Warren Entsch
  • David Gillespie
  • Damian Drum

Independent

  • Helen Haines

We may be overpainting the canvas a touch by detailing the above but it is, we believe, of interest to note which politicians are aligning themselves with this lobbying body for the big end of town medicinal cannabis companies.

On the positive side it is good to note that there are a number of medical doctors on the list and unsurprisingly the left of politics appears to be keener on medical cannabis than the right.

An important omission to note is that no Green Party politician has yet joined the group and this we suggest may be due to the fact that according to their cannabis policy (last updated in 2019) they have less of a business related approach to the issue and for point of comparison see the Uruguayan model as a better route to go down.

Not an approach that will appeal much to the MCIA.

Here’s  what the Greens said in their 2019 drug policy pdf with regard to cannabis

LEGALISE AND REGULATE CANNABIS Every year in Australia, both the consumption of cannabis and arrests associated with its use continue to rise. 35% of Australians have used cannabis, and it accounts for the greatest proportion of illicit drug arrests across Australia.

Despite choosing to use it, millions of Australians are forced to buy cannabis of unknown quality or strength from criminal drug dealers, or grow cannabis plants at home illegally.

Creating a regulated legal market for cannabis – as many states of the US, Uruguay and Canada have done – would bust the business model of criminal drug dealers, ensure greater protections for vulnerable cannabis users, and allow for the revenue and the current vast expenditure on the criminal response to cannabis to be redirected to drug treatment, education, and other harm reduction programs.

In place of prohibition, the Australian Greens would create a tightly regulated adult use market for legal cannabis. At the heart of our plan is reducing harm, recognising that people choose to use cannabis.

Our plan would:

• Allow growth of up to six plants at home for personal use only;

• Establish cannabis retail shops which would: – Sell only to people aged over 18 years – Sell only plain packaged cannabis – Prohibit all advertising;

• Establish an Australian Cannabis Agency which would issue licenses for production and sale, carry out a program of monitoring and enforcement of premises of production and sale, and monitor the scheme to ensure that it continues to work as well as possible;

• The Australian Cannabis Agency would also act as the single wholesaler for cannabis – purchasing cannabis from the producers and selling on plain packaged product to the retail stores to ensure quality and consistency; • Impose strict penalties for the sale of unlicensed or black market cannabis and for anyone found to be driving under the influence of cannabis; • Review all of these regulations after 2 years.

TGA (The Therapeutic Goods Administration)

The Office Of Drug Control

The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989.

It is Australia’s TGA approval numbers that are engendering a flurry of excitement by a select group of parties in the Australian medical cannabis market, who, for one reason or another, wish to show to all and sundry,  a rapid growth of the country’s medical cannabis market over a short period of time. We presume in order to get those all important stock prices up.

But, the detail in most media reports has been somewhat lacking and a little more definition of what the numbers actually mean is needed to gain an understanding of why TGA approvals have recently risen.

A TGA spokesperson has provided Cannabis Law Report the following detail.

Firstly, as most with some knowledge of this market will already know.

Unapproved medicinal cannabis products may be accessed by Australian-registered medical practitioners for their patients through two main access pathways:

(i)The Special Access Scheme (SAS)

and (ii) Authorised Prescriber (AP):

  • The SAS enables a medical practitioner to apply to use an unapproved medicinal cannabis for an individual patient.
  • AP enables a medical practitioner to apply to use unapproved medicinal cannabis product/s for a class of patients.

Up to 31 July 2020, approximately 35,000 patients are estimated to have received approval to access a medicinal cannabis product through the Special Access and Authorised Prescriber Schemes for over 130 different conditions.

Here are just some of the conditions listed

The TGA has approved over 56,000 Special Access Scheme (SAS) Category B applications for unapproved medicinal cannabis products and there are 94 individual prescribers(Please note that the TGA does not release a list of Authorised Prescribers of medicinal cannabis products.)  with current authorised prescriber authorisations for medicinal cannabis.

Monthly statistics are also published on the TGA website at:

www.tga.gov.au/access-medicinal-cannabis-products-1

Approval data for 2020

Total SAS B approvals from 1 Jan-31 July 2020 (7 months) 28,313
Authorised Prescriber approvals from 1 Jan-31 July 2020 (7 months) 754

For comparison we asked the TGA for 2019 numbers to give readers a sense of market growth over the last 18 or so months

Approval data for 2019

Total SAS B approvals from 1 Jan-31 December 2019 (12 months) 25, 157
Authorised Prescriber approvals from 1 Jan-31 December 2019 (12 months) 144

These figures are correct at the 11th August 2020, however are subject to change in order to reflect updates due to subsequent application cancellations, withdrawals and amendments.

The Office of Drug Control website has also published a list of manufacturers and suppliers of medicinal cannabis products

This list is not exhaustive of all manufacturers and suppliers with products accessible through the unapproved product scheme and the Australian Government cannot guarantee availability or supply by any manufacturer or importer listed on the website.

Here is that list and remember they still fall in the category

“unapproved product scheme”

Manufacturers

Persons licensed under the Narcotic Drugs Act 1967 (ND Act) to manufacture medicinal cannabis products.

Note: Names and contact details are published with the manufacturers consent. Not all persons licenced to manufacture under the ND Act are included in this list.

Importers

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

Before we move onto discussing the picture that the industry players are building these would be our  comments on current TGA statistics.

Yes it is true that numbers are up and one could say significantly so.

But we would also err on the side of caution because the unavoidable fact is  that in a country of 25 million odd citizens there are only 94 individual prescribers with current authorised prescriber authorisations for medicinal cannabis and let’s not forget as mentioned earlier there seems to be no official listing detailing those allowed to prescribe.

Do the math and we’d suggest that makes access to medical cannabis not as easy as it might first appear.

Also; we know from various surveys, prescriptions from “unnapproved” suppliers only account for approximately 3-4% of people using cannabis medicinally in the country (the other 96% go to the black/grey market) and as yet we haven’t even got to the subject of process or cost to access medical cannabis.

We note for those who want to know more about the TGA in Australia and how it operates and is funded, or not as the case may be; hop over to new Australia Cannabis media outlet Cannabiz for their article Why government underfunding is putting Australian medical cannabis users at risk

In the second part of a three-part analysis of Australia’s legal cannabis landscape, Cannabiz chief correspondent Steve Jones examines the Office of Drug Control’s role in hampering the industry’s progress.

It’s been a schmozzle from day one. Basically, guff has been clogging up the scheme. That’s why we have so few locally cultivated products.

FRESHLEAF ANALYTICS PRINCIPAL CONSULTANT RHYS COHEN

It’s a well timed quote and article as we will  be returning to Cohen and “Freshleaf Analytics” in the following section.

The Private Sector / Accessing Medical Cannabis

(i) Company Structures

Now, this is where things get interesting, or, depending upon your point of view, the Australian medical cannabis private sector may well make you end up feeling like the image below.

Trying to unravel the Australian private sector for medical cannabis, we believe, is akin to reading Joyce’s Finnegan’s Wake .

A review of the novel in the Irish Times said in 1939…

“Nothing moves, or appears, or is said, as ever before in any book,

it is endlessly exciting in its impenetrability.” 

An analogy that would aptly (We’d knock out the word “exciting”!)  describe both, medical cannabis company structures in Australia and the endless inanity that patients have to hop through to access overpriced treatments.

(i) Company Structures

Let’s start with a simple example of company structures and to re-iterate we could pull many similar examples from the hat countrywide.

Freshleaf Analytics would be a great place to start.

Launched last year they analyse data, mainly patient numbers in Australia’s medical cannabis market.

Nothing wrong with that per se as we discover in some basic questions we asked of them late July.

When was Freshleaf Launched?
2018

How many and what reports have you produced up to July 2020 – what is their distribution both in numbers and geographically ,  are the reports free or is there a cost?
We have done 4 reports. Currently we do them every 6 months. The next one (Q3 2020) will come out in September. They are available online at no cost and are mostly used by players in the Australian industry to inform strategic planning.

What data do you request from your partners – how often is that data supplied.. daily? weekly” monthly?
We currently source data from industry players including product companies, pharmacies, clinics and the regulator (TGA) on an as needed basis for our reports and for client projects. This data is used in our internal models which forecast and describe patient numbers, attrition rates, industry revenues, product demand, and industry value-chains.

Your website indicates what companies are your partners … are you able to define the role of a “partner” and exactly what the relationship is?
Our website probably needs an update!! We source data on a non-commercial basis from the industry players as described above.  Our clients are generally product companies or government bodies seeking insight about the industry.

What is the ownership of fresh leaf ?
Freshleaf is part of Southern Cannabis Holdings which is a privately owned company that  includes investment from ASX listed MMJ Holdings.

Do partners pay to supply you with information for your reports and subsequent distribution?
No

Are any of your “partners” investors in Freshleaf
No 

Does Freshleaf have a, meeting, board, would it be possible to let us know who Freshleaf’s board members are
Freshleaf does not have a board.

If your partners do not contribute revenue for supplying information and there is no charge for the reports would it be possible to outline Freshleaf’s revenue model
Freshleaf is a consultancy. Our team includes experts in regulatory compliance, clinical research, policy, product innovation, marketing and project management. Our clients pay for strategic advisory services in the area of pricing anaysis, product strategy, go-to-market strategy, distribution strategy, regulatory compliance and other areas.
You’ll be glad to know.. surprise surprise  head honcho Tim Drury is doing a big push just as we write this article

Tim Drury – Director and CEO at Southern Cannabis Holdings

The company’s market intelligence arm, FreshLeaf Analytics, predicts a tripling of patient numbers and product volume in the near term.
We think that over the next couple of years the revenue per patient will decline, as there’s quite heavy downward pressure from a pricing perspective at the moment on products, so we do expect that average spend will decline.
“However, the rate of growth is going to outpace that substantially.
“We think the revenues will probably double in that period.”
They are based at an address 53 Walker Street North Sydney NSW Australia and are fully transparent about the 3 companies they currently own.(see image below)
What concerns us is the following. As a listed company should they really be working in research, providing clinical services and then also providing “analysis” all at the same time ?
Call us old fashioned but what others term as “vertical integration”  we’d suggest offers too many opportunities for unecessary grey areas that have already been complicated enough by state and federal government in Australia.
A privately owned company, yes we would understand the argument but not publicly listed companies

You Tube Southern Cannabis Holdings Promo Video

.…..builds, integrates and operates high value brands across the cannabis value chain. We are in a unique position to see new markets before others, capitalize on emerging opportunities first and unlock the potential of the largest value creation opportunity on the planet today
The Australian medical cannabis private sector is chock a block with these structures all entirely legal with the help of the professions and advisors but is it really what is needed to build a long term and transparent sector that serves the medical patient as its primary function?

(ii) Taxpayer Funding

Whilst Australian cannabis companies raise money from the markets and work towards vertical integration to capture as much of the market as possible they also aren’t averse to what the financial press love to call “public private partnership” and what we’d call using taxpayer dollars to increase the value of companies, their shareholders and executives.
3 February 2020 we reported on a press release issued by

Three medicinal cannabis cultivation and production facilities in  Victoria and South Australia have received major project status from the  Federal Government 3 February 2020.

Medicinal cannabis projects drive job creation
3 February 2020
Three medicinal cannabis facilities expected to create thousands of jobs in Victoria and South Australia have been granted Major Project Status by the Morrison Government.
Minister for Industry, Science and Technology Karen Andrews said the projects would help Australia continue to develop its medicinal cannabis industry.
“When you combine our world-renowned agriculture sector, with our trusted reputation for medical products, Australia is in a unique position to dominate the global medicinal cannabis industry,” Minister Andrews said.
“The Morrison Government is committed to making it as easy as possible for businesses to maximise those opportunities because we know these projects equal Aussies jobs.
“Each of these projects will also drive economic growth, including in regional areas.”
LeafCann is a biotech company which plans to produce high quality, pharmaceutical grade medicinal cannabis ingredients and medicines in Adelaide, South Australia as part of a $350 million investment.
When its state-of-the-art cultivation and production facility is fully operational it is expected to generate more than 1400 jobs, in addition to 850 during development.
Other projects include:
  • PhytoGro’s $140 million medicinal cannabis cultivation and medical device manufacturing facility in Melbourne’s inner west which is estimated to create around 300 new ongoing jobs at full capacity.
  • Cannatrek’s $160 million medicinal cannabis cultivation and manufacturing facility in Victoria’s Goulburn Valley region is expected to create 400 full time positions at full capacity.
Last year it was announced medicinal cannabis licence applications for projects granted Major Project Status were being prioritised within the Office of Drug Control’s licencing process.
Six medicinal cannabis projects have been given such status since then.
Major Project Status is the Commonwealth Government’s recognition of the strategic significance of a project to Australia. It provides companies with extra support from the Major Projects Facilitation Agency, including a single entry point for Commonwealth Government approvals, project support and coordination, and help with state and territory approvals.
For more information on the Major Projects Facilitation Agency and the full list of current major projects, visit www.mpaa.gov.au.

It would be interesting in August of 2020 to learn how much taxpayers money has been received by these companies, how that money has been invested and how many jobs have actually been created ?

Answers on a postcard to……….

It’s not just federal government, state governments are being equally generous with their taxpayers money.

Here’s just one example from the state of  Victoria…….

This from 2019

Australian medical cannabis company Cann Group (ASX:CAN) has been awarded a grant under the Victorian Government’s Regional Jobs Fund.

Cann Group is constructing a large-scale medical cannabis cultivation and production facility in Mildura with the potential to create 150 new permanent jobs. The company was last week awarded a grant for up to $1.975 million in connection with the project, with the funding to assist in electricity upgrades at the site.

Cann Group Australia Scoops Up Grant For Cannabis Facility

(iii) Cannabis Clinics, The Medical Profession, Prescriptions

With all of this money flowing, sophisticated company structures full of highly professional individuals there to serve the market you’d think that the most important part of the equation the medical cannabis patient would be able to get cheap and easily accessible medicines with the minimum of drama.

We would dispute that.

As we have already highlighted there are under 100 medical cannabis prescribing individuals or organisations and the private sector would have you believe it is all the fault of government and a overly conservative medical profession, both arguments which have some level of merit.

But and there is a big but, we see some classic obsfucation and price gouging of patients in Australia and you don’t have to go far to discover examples.

In February of this year the ABC (Australian Broadcasting Corporation) reported…..

Medicinal cannabis regulation costing patients $600 a month, forcing some to turn to the black market

“It’s only after you get accepted, they tell you the associated costs,” said Mr Arcuri, who was initially paying around $600 a month for medicinal cannabis.

There is currently no subsidy for cannabis products under the Pharmaceutical Benefits Scheme (PBS).

Melbourne mother Emma Broughan relies on cannabis to relieve chronic pain caused by a car accident in 2015.

“It would have ended up costing me a third of my income basically, my pension, to go on this medication,” she said.

Ms Broughan believes she is left with no other option than to purchases cannabis products from the black market, a practice which leaves her feeling judged.

While prescriptions for medicinal cannabis are available, Ms Broughan believes the high price means the product remains inaccessible for many Australians.

“It’s set up so we’d fail. Here it is, but we can’t have it. There is no way I could afford that product,” she said.

This article also details cost issues for patients in Australia

The private sector lays the blame with government and regulation but there’s  now a plethora of “clinics” acting as middlemen between the government and GP’s all with a standard home page of a generally  white male doctor ( well it is Australia!) wearing a white coat.

Here he is !

A recent  price chart publishd by honahlee.com gives you an idea what these clinics will charge patients for an initial consultation.

Seems very reasonable if you are from a certain urban mileau but those patients who may have a blue collar worker injury, end of term cancer, a child with severe epilepsy or live out in the back and beyond are going to find these prices untenable.

As with everything else about the system  we see cost and too many levels of middlemen accessing the patient’s hard earned money before they even get to actually paying for a imported drug that could cost them in the $1000’s per year.

Remember also, that these drugs are still defined as unapproved under Australian law.

In Conclusion

By this stage your brain like ours is probably reeling from the layers of complexity, confusion and laissez faire capitalists in the mix of the Australian medical cannabis market.

Australia loves her layer upon layer of federal and state legislation along with rules and regulations to test the patience of a saint and this way of thought is thoroughly ingrained in the country’s DNA.

This thinking has been applied in spades to medical cannabis (we hesitate to call it a market) and also, in the main, it is led by government(s) to the right of politics.  Structurally, certain groups of people and organisations benefit from the management of this complexity but the end patient is left in a sea of question marks and ever increasing bills.

For both the public and private sectors the only discussion is medical cannabis. Attitudes towards recreational cannabis reside somewhere in the 1950’s and benefit both aforesaid parties.

Australia as late as 1969 still declared  Roth’s “Portnoy’s Complaint” as a  “prohibited import”  and for those of you who know the subject of that title  will understand why we draw the comparison.

Unfortunately alea iacta est and nothing shall undo it, so, if you wish to enter the lion’s den…… as either a investor, patient, advocate or participant be wary be very wary.

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