Over the previous few weeks we’ve seen a slew of articles indicating an enormous rise in affected person and product “approvals” within the Australian medical hashish market however no actual rationalization as to the place these numbers come from and what they really imply.

The apparent reply is that it’s reporting season in Australia however there’s lot extra to contemplate.

Our article will cowl the next takeaways and can hopefully permit our readers to string collectively a extra holistic understanding of what’s and isn’t taking place in  Australia’s world of regulated  medical hashish.

Information isn’t so available in Australia as it’s within the US and we’d recommend that there’s nonetheless far an excessive amount of obfuscation available in the market designed to confuse each buyers and sufferers, not simply from Federal & State authorities thoughts you, but additionally emanating from the non-public 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 just a few examples of articles presently doing the rounds from media outfits you’ll almost definitely pay attention to.

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 additionally seen in the identical interval an increase in chatter in regards to the Australian medicinal hashish market. Whether or not it’s offers, new clinics, media launches and so forth.

 

Again, listed here are just a few examples.

Southern Cannabis Holdings to current at medical hashish 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 hashish Australia: A glance inside Australian Natural Therapeutics Group medical hashish farm close to 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 area sufferers now have higher entry to medical hashish
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 indicators hashish 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 authorized hashish business 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 only a few  examples of the slew of “writing” showing on-line because the final week of July which instantly makes us at CLR do our greatest alert hare impersonation.

 

 

Yes it’s true that the medical hashish market has picked up in Australia in 2020, regardless of the pandemic, however this stage of exercise, is, as they are saying about every part this yr, unprecedented.

 

 

Lobbying & Federal Politics

First up we  observe that lobbying efforts are presently on the up with the Australian Medicinal Cannabis Industry Association asserting 20 July.

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

The group will present a non-partisan discussion board for Members and Senators to fulfill with representatives of the Australian medicinal hashish business, medical specialists and affected person advocates to boost consciousness of the purposes of medicinal hashish to Parliamentarians and inside the broader group.

The MCIA is funded by the next firms in response to their web site. Some of those names North American readers will acknowledge others have barely extra opaque possession constructions.

 

Who are the politicans ?

Parliamentary Friends of Medicinal Cannabis of the 46th Parliament

 

To allow you to perceive their politics we spotlight them beneath by political persuasion with a bit of assist for our North American readers as you’ll be confused by the truth that Australian liberals aren’t truly liberal and that in Australia  blues are reds and visa versa !

The Australian equal of the Trump base are known as One Nation and their chief Pauline Hanson virtually makes Sarah Palin appear a sexy possibility. Hanson has supported medical hashish however apparently is conspicuous by her abscence within the record with solely one among her celebration signing as much as 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)

 

Nationals (Republicans With A Country Base)

  • Warren Entsch
  • David Gillespie
  • Damian Drum

 

Independent

 

We could also be overpainting the canvas a contact by detailing the above however it’s, we imagine, of curiosity to notice which politicians are aligning themselves with this lobbying physique for the massive finish of city medicinal hashish firms.

On the constructive aspect it’s good to notice that there are a selection of medical medical doctors on the record and unsurprisingly the left of politics seems to be keener on medical hashish than the correct.

An essential omission to notice is that no Green Party politician has but joined the group and this we recommend could also be on account of the truth that in response to their hashish coverage (final up to date in 2019) they’ve much less of a enterprise associated method to the difficulty and for level of comparability see the Uruguayan mannequin as a greater path to go down.

Not an method that can enchantment a lot to the MCIA.

Here’s  what the Greens mentioned of their 2019 drug coverage pdf with regard to hashish

LEGALISE AND REGULATE CANNABIS Every yr in Australia, each the consumption of hashish and arrests related to its use proceed to rise. 35% of Australians have used hashish, and it accounts for the best proportion of illicit drug arrests throughout Australia.

Despite selecting to make use of it, hundreds of thousands of Australians are pressured to purchase hashish of unknown high quality or power from felony drug sellers, or develop hashish vegetation at dwelling illegally.

Creating a regulated authorized marketplace for hashish – as many states of the US, Uruguay and Canada have accomplished – would bust the enterprise mannequin of felony drug sellers, guarantee better protections for weak hashish customers, and permit for the income and the present huge expenditure on the felony response to hashish to be redirected to drug remedy, schooling, and different hurt discount packages.

In place of prohibition, the Australian Greens would create a tightly regulated grownup use marketplace for authorized hashish. At the guts of our plan is lowering hurt, recognising that folks select to make use of hashish.

Our plan would:

• Allow progress of as much as six vegetation at dwelling for private use solely;

• Establish hashish retail outlets which might: – Sell solely to individuals aged over 18 years – Sell solely plain packaged hashish – Prohibit all promoting;

• Establish an Australian Cannabis Agency which might concern licenses for manufacturing and sale, perform a program of monitoring and enforcement of premises of manufacturing and sale, and monitor the scheme to make sure that it continues to work in addition to attainable;

• The Australian Cannabis Agency would additionally act as the only wholesaler for hashish – buying hashish from the producers and promoting on plain packaged product to the retail shops to make sure high quality and consistency; • Impose strict penalties for the sale of unlicensed or black market hashish and for anybody discovered to be driving beneath the affect of hashish; • Review all of those rules after 2 years.

 

 

TGA (The Therapeutic Goods Administration)

The Office Of Drug Control

The Therapeutic Goods Administration is the regulatory physique for therapeutic items in Australia. It is a Division of the Australian Department of Health established beneath the Therapeutic Goods Act 1989.

It is Australia’s TGA approval numbers which can be engendering a flurry of pleasure by a choose group of events within the Australian medical hashish market, who, for one cause or one other, want to present to one and all,  a speedy progress of the nation’s medical hashish market over a brief time frame. We presume to be able to get these all essential inventory costs up.

But, the element in most media reviews has been considerably missing and a bit of extra definition of what the numbers truly imply is required to achieve an understanding of why TGA approvals have just lately risen.

A TGA spokesperson has offered Cannabis Law Report the next element.

 

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

Unapproved medicinal hashish merchandise could also be accessed by Australian-registered medical practitioners for his or her sufferers via two principal entry pathways:

(i)The Special Access Scheme (SAS)

and (ii) Authorised Prescriber (AP):

  • The SAS permits a medical practitioner to use to make use of an unapproved medicinal hashish for a person affected person.
  • AP permits a medical practitioner to use to make use of unapproved medicinal hashish product/s for a category of sufferers.

Up to 31 July 2020, roughly 35,000 sufferers are estimated to have obtained approval to entry a medicinal hashish product via the Special Access and Authorised Prescriber Schemes for over 130 totally different circumstances.

Here are simply a number of the circumstances listed

The TGA has accepted over 56,000 Special Access Scheme (SAS) Category B purposes for unapproved medicinal hashish merchandise and there are 94 particular person prescribers(Please note that the TGA does not release a list of Authorised Prescribers of medicinal cannabis products.)  with present authorised prescriber authorisations for medicinal hashish.

Monthly statistics are additionally printed on the TGA web site at:

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

Approval information 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 comparability we requested the TGA for 2019 numbers to provide readers a way of market progress over the past 18 or so months

Approval information 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 appropriate on the 11th August 2020, nevertheless are topic to vary to be able to replicate updates on account of subsequent software cancellations, withdrawals and amendments.

 

The Office of Drug Control web site has additionally printed a list of manufacturers and suppliers of medicinal cannabis products

This record isn’t exhaustive of all producers and suppliers with merchandise accessible via the unapproved product scheme and the Australian Government can’t assure availability or provide by any producer or importer listed on the web site.

Here is that record and keep in mind they nonetheless fall within the class

“unapproved product scheme”

 

Manufacturers

Persons licensed beneath the Narcotic Drugs Act 1967 (ND Act) to fabricate medicinal hashish merchandise.

Note: Names and speak to particulars are printed with the producers consent. Not all individuals licenced to fabricate beneath the ND Act are included on this record.

Importers

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

 

Before we transfer onto discussing the image that the business gamers are constructing these could be our  feedback on present TGA statistics.

Yes it’s true that numbers are up and one might say considerably so.

But we’d additionally err on the aspect of warning as a result of the unavoidable truth is  that in a rustic of 25 million odd residents there are solely 94 particular person prescribers with present authorised prescriber authorisations for medicinal hashish and let’s not neglect as talked about earlier there appears to be no official itemizing detailing these allowed to prescribe.

Do the mathematics and we’d recommend that makes entry to medical hashish not as straightforward as it would first seem.

Also; we all know from numerous surveys, prescriptions from “unnapproved” suppliers solely account for roughly 3-4% of individuals utilizing hashish medicinally within the nation (the opposite 96% go to the black/gray market) and as but we haven’t even obtained to the topic of course of or price to entry medical hashish.

 

We observe for individuals who need to know extra in regards to the TGA in Australia and the way it operates and is funded, or not because the case could also be; jump over to new Australia Cannabis media outlet Cannabiz for his or her article Why government underfunding is putting Australian medical cannabis users at risk

In the second a part of a three-part evaluation of Australia’s authorized hashish panorama, Cannabiz chief correspondent Steve Jones examines the Office of Drug Control’s position in hampering the business’s progress.

 

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

FRESHLEAF ANALYTICS PRINCIPAL CONSULTANT RHYS COHEN

 

It’s a effectively timed quote and article as we’ll  be returning to Cohen and “Freshleaf Analytics” within the following part.

 

 

 

The Private Sector / Accessing Medical Cannabis

 

(i) Company Structures

Now, that is the place issues get attention-grabbing, or, relying upon your viewpoint, the Australian medical hashish non-public sector might effectively make you find yourself feeling just like the picture beneath.

 

 

Trying to unravel the Australian non-public sector for medical hashish, we imagine, is akin to studying Joyce’s Finnegan’s Wake .

A evaluate of the novel within the Irish Times mentioned 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 might aptly (We’d knock out the phrase “exciting”!)  describe each, medical hashish firm constructions in Australia and the countless inanity that sufferers must hop via to entry overpriced therapies.

 

 

(i) Company Structures

Let’s begin with a easy instance of firm constructions and to re-iterate we might pull many related examples from the hat countrywide.

 

Freshleaf Analytics could be an amazing place to begin.

Launched final yr they analyse information, primarily affected person numbers in Australia’s medical hashish market.

Nothing flawed with that per se as we uncover in some primary questions we requested of them late July.

 

When was Freshleaf Launched?
2018

 

How many and what reviews have you ever produced as much as July 2020 – what’s their distribution each in numbers and geographically ,  are the reviews free or is there a price?
We have accomplished Four reviews. Currently we do them each 6 months. The subsequent one (Q3 2020) will come out in September. They can be found on-line without charge and are largely utilized by gamers within the Australian business to tell strategic planning.

 

What information do you request out of your companions – how typically is that information equipped.. each day? weekly” month-to-month?
We presently supply information from business gamers together with product firms, pharmacies, clinics and the regulator (TGA) on an as wanted foundation for our reviews and for consumer tasks. This information is utilized in our inner fashions which forecast and describe affected person numbers, attrition charges, business revenues, product demand, and business value-chains.

 

Your web site signifies what firms are your companions … can you outline the position of a “partner” and precisely what the connection is?
Our web site most likely wants an replace!! We supply information on a non-commercial foundation from the business gamers as described above.  Our shoppers are usually product firms or authorities our bodies in search of perception in regards to the business.

 

What is the possession of contemporary leaf ?
Freshleaf is a part of Southern Cannabis Holdings which is a privately owned firm that  consists of funding from ASX listed MMJ Holdings.

 

Do companions pay to provide you with info on your reviews and subsequent distribution?
No

 

Are any of your “partners” buyers in Freshleaf
No 

 

Does Freshleaf have a, assembly, board, wouldn’t it be attainable to tell us who Freshleaf’s board members are
Freshleaf doesn’t have a board.

If your companions don’t contribute income for supplying info and there’s no cost for the reviews wouldn’t it be attainable to stipulate Freshleaf’s income mannequin

Freshleaf is a consultancy. Our staff consists of specialists in regulatory compliance, medical analysis, coverage, product innovation, advertising and undertaking administration. Our shoppers pay for strategic advisory companies within the space of pricing anaysis, product technique, go-to-market technique, distribution technique, regulatory compliance and different areas.

You’ll be glad to know.. shock shock  head honcho Tim Drury is doing an enormous push simply as we write this text

Tim Drury – Director and CEO at Southern Cannabis Holdings

The firm’s market intelligence arm, FreshLeaf Analytics, predicts a tripling of affected person numbers and product quantity within the close to time period.
We assume that over the subsequent couple of years the income per affected person will decline, as there’s fairly heavy downward strain from a pricing perspective in the intervening time on merchandise, so we do count on that common 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 primarily based at an tackle 53 Walker Street North Sydney NSW Australia and are totally clear in regards to the Three firms they presently personal.(see picture beneath)

What issues us is the next. As a listed firm ought to they actually be working in analysis, offering medical companies after which additionally offering “analysis” all on the similar time ?

Call us quaint however what others time period as “vertical integration”  we’d recommend provides too many alternatives for unecessary gray areas which have already been sophisticated sufficient by state and federal authorities in Australia.

A privately owned firm, sure we’d perceive the argument however not publicly listed firms

 () has welcomed information that its funding Southern Cannabis Holdings (SCH) has formally began operations in Australia and the United Kingdom.

SCH is a multinational firm that builds, integrates and operates companies in pharmaceutical hashish markets.

Initial SCH firms embrace Cannabis Access Clinics, Australia’s first and largest community of medicinal hashish clinics, Applied Cannabis Research, a specialist contract analysis organisation devoted to aiding medicinal hashish firms, and FreshLeaf Analytics, Australia’s main supply of information and details about the medicinal hashish business.

Source: https://www.proactiveinvestors.com.au/companies/news/907031/mmj-group-s-investment-southern-cannabis-holdings-launches-globally-907031.html

 

 

You Tube Southern Cannabis Holdings Promo Video

.…..builds, integrates and operates excessive worth manufacturers throughout the hashish worth chain. We are in a singular place to see new markets earlier than others, capitalize on rising alternatives first and unlock the potential of the most important worth creation alternative on the planet at the moment

The Australian medical hashish non-public sector is chock a block with these constructions all completely authorized with the assistance of the professions and advisors however is it actually what is required to construct a long run and clear sector that serves the medical affected person as its major operate?

(ii) Taxpayer Funding

Whilst Australian hashish firms elevate cash from the markets and work in direction of vertical integration to seize as a lot of the market as attainable in addition they aren’t averse to what the monetary press like to name “public private partnership” and what we’d name utilizing taxpayer {dollars} to extend the worth of firms, their shareholders and executives.

3 February 2020 we reported on a press launch issued by

Three medicinal hashish cultivation and manufacturing services in  Victoria and South Australia have obtained main undertaking standing from the  Federal Government 3 February 2020.

Medicinal hashish tasks drive job creation

3 February 2020
Three medicinal hashish services anticipated to create 1000’s 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 mentioned the tasks would assist Australia proceed to develop its medicinal hashish business.
“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 mentioned.
“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 firm which plans to supply prime quality, pharmaceutical grade medicinal hashish components and medicines in Adelaide, South Australia as a part of a $350 million funding.
When its state-of-the-art cultivation and manufacturing facility is totally operational it’s anticipated to generate greater than 1400 jobs, along with 850 throughout growth.
Other tasks embrace:
  • PhytoGro’s $140 million medicinal hashish cultivation and medical gadget manufacturing facility in Melbourne’s internal west which is estimated to create round 300 new ongoing jobs at full capability.
  • Cannatrek’s $160 million medicinal hashish cultivation and manufacturing facility in Victoria’s Goulburn Valley area is anticipated to create 400 full time positions at full capability.
Last yr it was introduced medicinal hashish licence purposes for tasks granted Major Project Status have been being prioritised inside the Office of Drug Control’s licencing course of.
Six medicinal hashish tasks have been given such standing since then.
Major Project Status is the Commonwealth Government’s recognition of the strategic significance of a undertaking to Australia. It supplies firms with further help from the Major Projects Facilitation Agency, together with a single entry level for Commonwealth Government approvals, undertaking help and coordination, and assist with state and territory approvals.
For extra info on the Major Projects Facilitation Agency and the complete record of present main tasks, go to www.mpaa.gov.au.

 

It could be attention-grabbing in August of 2020 to learn the way a lot taxpayers cash has been obtained by these firms, how that cash has been invested and what number of jobs have truly been created ?

 

Answers on a postcard to……….

 

It’s not simply federal authorities, state governments are being equally beneficiant with their taxpayers cash.

Here’s only one instance from the state of  Victoria…….

 

This from 2019

Australian medical hashish firm Cann Group (ASX:CAN) has been awarded a grant beneath the Victorian Government’s Regional Jobs Fund.

Cann Group is setting up a large-scale medical hashish cultivation and manufacturing facility in Mildura with the potential to create 150 new everlasting jobs. The firm was final week awarded a grant for as much as $1.975 million in reference to the undertaking, with the funding to help in electrical energy upgrades on the website.

Cann Group Australia Scoops Up Grant For Cannabis Facility

 

(iii) Cannabis Clinics, The Medical Profession, Prescriptions

With all of this cash flowing, refined firm constructions stuffed with extremely skilled people there to serve the market you’d assume that a very powerful a part of the equation the medical hashish affected person would be capable of get low cost and simply accessible medicines with the minimal of drama.

We would dispute that.

As we have now already highlighted there are beneath 100 medical hashish prescribing people or organisations and the non-public sector would have you ever imagine it’s all the fault of presidency and a overly conservative medical occupation, each arguments which have some stage of benefit.

But and there’s a huge however, we see some traditional obsfucation and worth gouging of sufferers in Australia and also you don’t must go far to find examples.

In February of this yr 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,” mentioned Mr Arcuri, who was initially paying round $600 a month for medicinal hashish.

There is presently no subsidy for hashish merchandise beneath the Pharmaceutical Benefits Scheme (PBS).

Melbourne mom Emma Broughan depends on hashish to alleviate persistent ache brought on by a automotive accident in 2015.

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

Ms Broughan believes she is left with no different possibility than to purchases hashish merchandise from the black market, a follow which leaves her feeling judged.

While prescriptions for medicinal hashish can be found, Ms Broughan believes the excessive worth means the product stays inaccessible for a lot of 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 mentioned.

This article additionally particulars price points for sufferers in Australia

 

The non-public sector lays the blame with authorities and regulation however there’s  now a plethora of “clinics” performing as middlemen between the federal government and GP’s all with an ordinary dwelling web page of a usually  white male physician ( effectively it’s Australia!) sporting a white coat.

Here he’s !

 

 

A current  worth chart publishd by honahlee.com offers you an concept what these clinics will cost sufferers for an preliminary session.

Seems very cheap if you’re from a sure city mileau however these sufferers who might have a blue collar employee damage, finish of time period most cancers, a toddler with extreme epilepsy or dwell out within the again and past are going to seek out these costs untenable.

As with every part else in regards to the system  we see price and too many ranges of middlemen accessing the affected person’s hard-earned cash earlier than they even get to really paying for a imported drug that would price them within the $1000’s per yr.

Remember additionally, that these medicine are nonetheless outlined as unapproved beneath Australian regulation.

In Conclusion

By this stage your mind like ours might be reeling from the layers of complexity, confusion and laissez faire capitalists within the mixture of the Australian medical hashish market.

Australia loves her layer upon layer of federal and state laws together with guidelines and rules to check the endurance of a saint and this manner of thought is completely ingrained within the nation’s DNA.

This considering has been utilized in spades to medical hashish (we hesitate to name it a market) and in addition, in the primary, it’s led by authorities(s) to the correct of politics.  Structurally, sure teams of individuals and organisations profit from the administration of this complexity however the finish affected person is left in a sea of query marks and ever growing payments.

For each the private and non-private sectors the one dialogue is medical hashish. Attitudes in direction of leisure hashish reside someplace within the 1950’s and profit each aforesaid events.

Australia as late as 1969 nonetheless declared  Roth’s “Portnoy’s Complaint” as a  “prohibited import”  and for these of you who know the topic of that title  will perceive why we draw the comparability.

Unfortunately alea iacta est and nothing shall undo it, so, in case you want to enter the lion’s den…… as both a investor, affected person, advocate or participant be cautious be very cautious.

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