Tag Archives: europe

Greece Gets Growing

By Marguerite Arnold
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The Greek government changed the law on medical cannabis as recently as February of this year. Now it has issued its first cultivation license.

Who Is The First Beneficiary?

The lucky (first but far from last) firm to receive a cultivation license? Intriguingly, a South American-Canadian cultivation company called ICC Cannabis Corp.

The most recent agreement received from the Greek government supersedes and augments its previous hemp cultivation license in the country. The license, however is not final yet but rather a conditional pre-approval for medical cannabis cultivation.Things in Greece are proceeding fast with no internal or external opposition.

The company already has secured a 16 acre grow facility in Northern Greece. ICC also has a distribution network of over 35,000 pharmacies spread across 16 countries which it says will “complement” its current Greek victory.

ICC will pay USD $200,000 in connection with the license issuance, pay a finder’s fee and issue 12 million shares.

Company executives are quick to point out that the success is a result of staff cultivating close relationships with local politicians.

The ICC of course is not the only company now engaged in solidifying their business opportunities in Greece. Hexo, a Canadian LP with about a million feet of grow space at home by end of 2018, in partnership with local Greek QNBS, is also rapidly moving to establish a 350,000 square foot growing facility in country as well. With a similar eye, it should be added on the European medical market.

European Legal Cultivation Is Exploding

Medical cultivation, in other words, is getting underway regionally, with authority. And the bulk of such crops not consumed locally, are already being primed for export to more expensive labour markets across the continent with increasing demand for high quality, low cost, medical grade.

Not only is this procedural development fast and relatively efficient, it sets up a serious competitor within the EU to provide cheap flower, oil and other processed cannabis products to a continent that is now starting to place bulk orders as individual countries struggle with the issue of how much local cultivation to allow and what patient conditions should be covered.

Even more interesting, at least so far, are a lack of punitive punishments being meted out to the country from the EU for considering this economic route to self-sufficiency again. That is not true for Albania, in direct contrast, which is being penalized with its membership to the Union on the line, for the level of black market cannabis grown in the country.

That said, it might also be the progress of Greek cultivation that has caused such a furore – led by France in Brussels within the EU. A country far behind regional leaders on reform it is worth noting. Even on medical.

A Quick History Of Cannabis Reform In Greece

Greek politicians decided fairly early as the cannabis ball got rolling in Europe that the industry was the perfect cash injection to an economy still emerging from troubled times and massive financial defaults. In fact, Greek officials are estimating that legalizing the medical industry here will inject approximately USD$2 billion into the country’s economy.

It could be, of course, much higher. Especially when exports are added to medical tourist consumption.

The amazing thing so far, for all the other issues in just about every other legalizing country within the EU of late? Things in Greece are proceeding fast with no internal or external opposition.

Who Is ICC?

The firm used to be known by the hard to pronounce Kaneh Bosm Bio Technology and Shogun Capital Corp. The firm has an interesting footprint with production in Uruguay but already exporting CBD and other derivatives to the Canadian market, including via a deal with Emblem Cannabis.

The company began trading on the TSX Venture exchange in November 2016. In late September, the company announced that it was also securing a 55-acre grow facility in Denmark, with other Canadian cannabis heavyweights like Canopy, Aurora and Green Dutchman Holdings.

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Focus on Canopy Growth: International Pioneer On A Global Mission

By Marguerite Arnold
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Read the glossy website or encounter their expensive marketing materials and lush swag at any upscale international cannabis business conference these days and you get a certain kind of impression. The new, modernist, chic European HQ in central Frankfurt, for example, with its floor-to-ceiling windows and breath-taking view of the city, river and mountains, continues to give that perspective far from home.The company has been at the forefront of the Canadian cannabis industry since 2013 and has subsequently weathered several mergers, buyouts and creative partnerships of all kinds.

But what’s of great interest about Canopy is that its highly slick corporate image is backed up by a solid performance elsewhere to date– and on a number of important, and globally impactful levels. Further, the company’s willingness to think strategically, globally, and take calculated, well-timed risks at the same time proves to be effective.

The Canadian Beginnings

The company has been at the forefront of the Canadian cannabis industry since 2013 and has subsequently weathered several mergers, buyouts and creative partnerships of all kinds. In the process it has also made financial history in the cannabis industry, becoming the first publicly listed cannabis company in the world a year after its founding.

Canopy_Growth_Corporation_logoSo much of its iconic corporate history is in fact, ironically fading in the rapid birth of the full on recreational market at home. However, here is the elevator pitch. Born as Tweed, in 2013, in an abandoned former Hershey chocolate plant and the recipient of one of Canada’s first medical cultivation licenses, the company rapidly expanded with increased market access that reform brought. Inevitably, its success also spawned one of its closest competitors (Cannabis Wheaton Income Corp) after co-founder Chuck Rifici was ousted by a unanimous vote of the Canopy board.

In 2018, Canopy Growth still maintains its reputation as the first Canadian cannabis unicorn, even though its stock price is just half that of close competitor, Tilray.

In Canada, the company has long expanded adroitly beyond its central HQ with strategic partnerships and buyouts that range the gamut of grow and branding opportunities that are becoming increasingly as mainstream as, well, beer. These days, Canopy is well-poised to take advantage of the shifting Canadian regulatory landscape on several fronts.

The first is undeniably medical. The company has made patient access a cornerstone of its continuing market development strategy. In fact, current CEO and original cofounder, Bruce Linton, has recently told the press that in his view the medical market globally is the company’s first and most profitable focus.

No matter how many beer companies come calling. And that is also one of the company’s more notable, if not newsworthy accomplishments.

International Aspirations

However it is on the international side that the company has really distinguished itself. That starts with the early (relatively speaking) and active interest in what was going on far from Canadian shores. Initially in Europe (but not limited to it). And even more centrally, how and where the company expanded its global medical reach.Canopy has spread its influence widely throughout Europe already

That started, from the Canopy perspective, with the decision to buy the small German GmbH called MedCann (now Spectrum Cannabis, the global medical brand of Canopy). Located just south of Frankfurt, an international but small team of globally experienced entrepreneurs managed to obtain the first import license for medical flower from Canada into Germany in the summer of 2016. Guided by the industry knowledge and business savvy if not entrepreneurial zeal that so often leads to naught, Pierre Debs and team faced a market still sceptical of medicinal cannabis domestically, and the burden of being “first.” Canopy was not yet in Europe, but they had more ready access to the market and capital. The Canopy buyout of MedCann was accomplished on December 12, 2016, six months before the first iteration of the German cultivation bid was announced. Canopy later announced that it had become one of the top ten finalists in the first iteration of the now restarted German cultivation bid.

Beyond Germany however, this unique team with deep local and global knowledge also began an immediate expansion policy in Europe and beyond that is still unfolding. Apparently in similar strategy adopted at home in the Canadian provinces, Canopy has spread its influence widely throughout Europe already. With an enormous supply contract from Spain’s Alcaliber and operations in Denmark, the Czech Republic, Poland, Italy and a few more (still currently unnamed) operations rolling out any day, the company is clearly building a solid, strategically dispersed infrastructure that reaches far beyond Europe, with global impact and influence.

Exhibit A? In April of this year, the company launched Spectrum Australia with support from the Victorian government.

Controversies

The biggest controversy facing the company so far, albeit indirectly, involves pesticides. This issue occurred during the acquisition of an outside company called Mettrum. In other words, Canopy inherited the production liabilities of a purchased company. The acquisition, however, which passed the buck to Canopy to fix, was actually an opportunity for Canopy to implement its own high internal production and quality controls throughout Mettrum facilities.

This was not inexpensive or of small impact (it affected 21,000 medical users). In addition to taking a leadership role in addressing their acquisition’s production issues, CEO Linton publicly apologized to affected patients.

The company has also been on the forefront of the banking and financing regulatory problems that have plagued the industry (so far successfully).

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A Who’s Who List Of The Top Movers & Shakers In The German & EU Cannabis Markets

By Marguerite Arnold
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This collection of leaders in the European cannabis market is by no means completely neutral. Much less comprehensive. It is however, German and European centric, because these people, by definition and geography, are now sitting at the nexus of a global, and even within Europe, international industry. Europe for that reason, will be the place, and for some time, where the global cannabis industry comes to make deals across borders, meet the high levels of compliance required here that is setting global standards and push the medical revolution forward for (at least) the next five to ten years.

For that reason, the people listed below carry influence far beyond one country or even region, by definition. But they are also not the only people redefining an industry.

Most notably, of course by their exclusion, are women, although there are some exceptions to that and women are increasingly establishing their place at high executive levels although not yet founder or cofounder or, auf Deutsch, Geschäftsfüherin– (Managing Director) at any of the establishing global companies with European presence. That said, they are beginning to make their appearance in every place and career path within the industry.

Movers and Shakers

Dr. Pierre Debs, Ph.D. An American expat with a German Ph.D., and twenty five plus years’ experience in stem cell research, including endocannabinoid system function. Debs is also the often uncredited individual who opened the current medical market in Germany in particular, but with immediate impact throughout Europe. As the scrappy start up MedCann, Debs, his cofounders and a skeleton team based just south of Frankfurt, not only got into the game first, they beat other established companies to obtain the first import license for Canadian flower in the summer of 2016. Including and most notably Tilray. MedCann GmbH at that point became the only other company besides Bedrocan, the perennial Dutch provider for the last twenty years to be able to provide medicinal, GMP-certified flower to the German market. That market distinction of course, did not last long as other companies quickly jumped into the ring but as the medical brand of Canopy, Debs has continued to lead industry development across Europe. Today, as the Geschäftsführerof Spektrum Cannabis GmbH (as MedCann was renamed after its purchase by Canopy sometime in Q4 2016-Q1 2017) and as Canopy Growth Corp Managing Director Europe, Debs has not only established but currently oversees operations in multiple European countries as Canopy Cannabis expands its global medical brand. From, it should also be added, its swanky new digs in central Frankfurt.

Tjalling Erkelens, Bedrocan founder and CEO. Bedrocan is the legacy cannabis player here in a game that is rapidly changing as it expands. The first exporter of medical cannabis in the world, the family owned company currently produces five different cannabis strains bound for the medical market, and is expected to be the beneficiary of the newly expanded import quota into Germany from Holland for medical grade flower, as well as place well in the German cultivation bid. 

Gerhard Muller of the Wayland Group
Gerhard Muller of the Wayland Group

Gerhard Müller. The unassuming Chair of the Audit Committee of Wayland Group, the cannabis company formerly known as Maricann. Müller is less often in the English-speaking press than Ben Ward, company CEO. However, Müller is a force to be reckoned with as Wayland begins to unfold its usually understated strategy in Germany and Europe from its Munich HQ base. Müller is the former head of Ernst and Young’s GSA Tech Practice, also adding household names like Birgit Homburger and Christopher Peterka to Wayland’s German Advisory Board. Also of note is GM for Wayland Germany Josef Späth now tasked with bringing his connections and previous experience as a top, internationally experienced clean tech architect and engineer to the build out of Wayland’s infrastructure. This includes previous work with NASA Jet Propulsion Lab alumni to develop new techniques for harvesting and processing of cannabis. German ingenuity and engineering at its best!

Patrick Hoffmann, CEO of Aurora Deutschland (formerly Pedianos). This firm too, was one of the early start-ups to get into the distribution and cultivation game and so far they have proven to be adept at navigating the complex path to winning cultivation rights. Aurora placed in the top ten finalists for the last German cultivation bid. As Pedianos, the firm won the first distribution and cultivation deal for Italy, sourced via Berlin. They have already proven to be highly skilled at finding market advantages in an exploding European market puzzle.

David Henn, CEO of Cannamedical Pharma
David Henn, CEO of Cannamedical Pharma

David Henn, CEO of Cannamedical Pharma. The millennial at the front of the cannabis import and distribution craze in Germany, founded his start up in November 2016. Henn then obtained one of the first issued licenses for trading and ex-im of medical cannabis just as the law changed in Germany officially to mandate insurance coverage of medical cannabis by prescription. Since then, the fiercely independent entrepreneur has turned down multiple acquisition offers from companies in Canada, Israel and Australia. The Cologne-based company supplies a growing network of German pharmacies and entered into off-take agreements with major companies in Europe, Canada and Australia. Bolstered by its cash flow in the existing distribution business, Cannamedical is continually expanding and has already established European subsidiaries that are in the progress of obtaining additional production and distribution licenses for the company.

Peter Homburg. Partner, Denton’s Law Firm. Peter has already had an established career as a high-powered partner and the head of the firm’s Life Sciences Division. Yet like many people of different paths and persuasions, he began to explore the world of the legal end of the business several years ago. These days, albeit based in Frankfurt, he has helped establish the firm’s reputation internationally as a leading law firm in the cannabis space.

Rob Reid, co-founder of European Cannabis Holdings
Rob Reid, co-founder of European Cannabis Holdings

Rob Reid. Reid wears several influential hats based out of his offices in London. As the director of publicly listed, SOL Investments Corp (formerly Scythian), he invests in the U.S.-based cannabis industry. He is also the co-founder of European Cannabis Holdings (ECH), which is investing in a portfolio of private medical cannabis companies on this side of the pond. He is also the co-founder of Prohibition Partners, the increasingly prolific market intelligence and consultancy firm, and Cannabis Europa, a conference and networking platform. Finally, he is involved in a number of cultivation JVs around the world.

Marla Luther. As co-director for Tilray Europe (along with Sean Carney) and based in Berlin, Marla has the most senior leadership title of any woman in the cultivation and distribution industry in Europe. She has also been in the position for the last several years.

Alex Rogers. As the founder of the International Cannabis Business Conference (ICBC), Alex has established perhaps the first truly international cannabis conference brand catering to the professional end of the regulated industry but retaining the soul of the advocacy movement. The Berlin conference going into its third year in 2019, literally reset the standards if not stage for the next upgrade of the industry conference concept. Within a year of its first international conference in Berlin, Alex and his team had also established conferences in Canada and are establishing the B2B conference of Spannabis under their rubric in Barcelona as of next year.

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The Battle Over CBD Regulation Hits Europe

By Marguerite Arnold
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With all the attention on the pending regs for the recreational industry in Canada plus the huge medical market under construction in the EU, it is easy to forget the other cannabis discussion in the room right now. Namely CBD in commercial food ingredients and supplements. Battles in the beauty space, while surfacing, are still much less avidly fought.

As a result, edible CBD is also rapidly becoming (another) big green elephant in the room. Globally. Starting with all the changing rules about mostly medical use of cannabinoids in general.

This is underway, sort of, in the United States, driven by state regulations and consumer protection initiatives, but delayed on a federal level by the fact that CBD is still scheduled, like THC, as a Schedule I drug.

In Europe, however, this is already a different animal.

The regulatory hammer also appears to be coming down in strategic country markets, with strange hybrid fights and issues emerging as a result.

For example, as cannabis crops (designed for both markets) begin to flourish in Spain buoyed by both the clubs in Barcelona and the growth of legitimate medical and other kinds of cannabis cultivation across the country – and much of that for export, authorities are cracking down on a federal level about labelling of not cannabis bound for clubs, but the CBD used in edibles.

In the last month, CBD industry blogs are reporting that the Spanish government is sending both warning letters to distributors and the police are apparently taking products off of shelves directly.

For all the direct showdowns about the cannabis plant this year, not to mention CBD, including British children ending up in hospital, this has got to make the top five list.

A Brief Modern History Of CBD Controversies On The Continent

The current complications have their roots in both the regulation of medical cannabis, health supplements and what are called “novelty” food items.

The food issue has been cooking for several years and for botanicals and additives far from cannabidiol. This year, on January 1, however, the entire EU brought in a new directive about the use of certain plants in food which seems to be affecting the edible cannabis conversation all over the continent. That said, countries are interpreting the same at different speeds and with different enthusiasm.

The EU looks poised to hop on the legalization train

Switzerland (not a member of the EU) is actually the only country on the European continent where so far, things have gone relatively smoothly. Their lack of EU membership is actually why. This also does not mean they have overcome some of the larger problems inherent in this entire discussion, but, if things go to form, it will be relatively drama free.

That is not the case in other places.

For example, at the end of 2016, British authorities made a splash about medical labelling with the Medicine and Health Care products Regulatory Agency (MHRA) also leaving the entire edibles discussion in limbo. Technically, low strength CBD can be sold in the UK but it must be labelled as a food product if not specifically made for the medical market. That flap is likely to take off again with the direct competition now of not only Tilray but Namaste and the changing scheduling of cannabis in the UK to a Schedule II in October. See the recent furore over the “unauthorized claims” supposedly made by the nascent Cannabis Trades Association in meeting, lobbying if not “working” with local authorities. The organization has literally blossomed within the last 18 months to over 300 members and 1,200 sellers in part to figure out what exactly the rules are, as authorities grapple with changing times.

tilray-logoNow jump the channel to Spain. The international focus of late has not been just the medical cannabis now sprouting in greenhouses owned by established pharmaceutical companies, or that bound for semi medical use in Barcelona, but the entire CBD edibles discussion.

Why?

On some levels, it is clearly an attempt to continue to set less than grey rules for the Spanish cannabis industry, which even in the club scene is regulating. But beyond that, this fight is altogether more complicated, and far from just regional, or even just a Spanish conversation.

European Food Regulation Meets The Cannabis Industry

CBD in edible products will, according to European regulation, make it a novel food or “additive” – namely that products containing the cannabinoid have not been used “safely”. Translated into English that crosses cultural boundaries, this definition really means that the substance in question must have been part of a regulated federal procedure – for at least 25 years in any third country. As such, it will have to be tested and regulated accordingly.In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

One does not have to be an industry analyst to know this clearly excludes all parts of the cannabis plant. Everywhere. This is why the situation now unfolding in Spain is all the more worrying for the industry across Europe.

In Spain at least, the crackdown appears to be on any food item containing cannabis, which, according to European-wide regulations, has yet to be classified as a “novel food.” Namely, a food product which has not been consumed in a significant degree in the EU before May 15, 1987. See the guide for new applicants here.

In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

Where Does This Leave The CBD Industry Across Europe?

As any manufacturer or vendor in any EU country could technically be required to register their new food, this means that cannabis producers and distributors in Europe need to be on their toes for the next several years as the regulatory schemata is worked out. Bottom line? Expect as much hullabaloo over this sector of the market as other places (even if over other issues).Both producers and distributors could easily face labelling problems

Here is the critical take-away. Regulation is coming to the entire industry in Europe in a way unseen in both Canada and the U.S. and from a much more granular perspective.

What “reigns in Spain” in other words right now, is a wake-up call for CBD producers across the continent, even if not involved in the medical space. Not to mention both U.S. and Canadian producers (in particular) looking for profitable market entry strategies. Labelling and standards, in other words, are clearly on the way, and beyond the drawing board, for all cannabinoids, not just those of the “medical” kind.

In the meantime, edible CBD products in Europe and in every country are ripe for the institution of new guidelines that are, as yet, formalized. Both producers and distributors, therefore, could easily face labelling problems for all their CBD products and product lines for the next several years.

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Tilray Enters Both U.S. & UK Markets

By Marguerite Arnold
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Tilray has long been seen as one of the market leaders in the global cannabis space. They are strategically placed in several critical areas to continue to do well, and put up major competition for just about everyone else (including German market entry first Canopy, plus the other big players in both Canada and Europe) ever since. See Aurora, Maricann and Aphria, to name a few. On the EU front, they are also certainly giving Dutch Bedrocan (with not only existing government contracts, but a newly increased ex-im medical allowance across the open Schengen border) a run for its money. And appear to have broached a monopoly long held by GW Pharma in the UK. 

But first things first. Here is a brief list of accomplishments on the corporate CV so far.In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Long (relatively speaking) before Europe was on the map for anyone but a couple of Canadian LPs, the company was exporting to Croatia (in 2016). Even the initial hiccups in delivery (a batch arrived in broken bottles), did not stop their foreign expansion plans. 

When the first German cultivation bid was due, the company also, at least according to their spokesperson in Berlin at the time, considered applying. However, by late summer last year, Tilray was actually the first to publicly tip their hands that not only were they bowing out of the German tender, but had rather decided to import to Germany from cheaper EU climes. See their production facilities in Portugal. Plus of course a mass distribution deal to German pharmacies via local distribution.

Then there is their social media presence on Leafly, which also competes with Weedmaps as both an information portal and dispensary finder in key markets (California and Canada). The German version of the website (Leafly.de), has created a reality, no matter where the server is located, of also connecting directly to patients in a market still finding its way. 

tilray-logoAdd all these elements together, and that puts the company behind it all in an unbelievably strong position to continue to gain both market access and market growth in multiple jurisdictions while carefully moving at literally the change if not bleeding edge of the law.

How much long term impact this will have, however remains to be seen. Why? The times are changing fast. And not everyone is following a policy of promotion timed around other large events (see Canadian recreational legalization and the timing of the company’s IPO). 

Here is another example: the company’s most touted recent double victory, on each side of the Atlantic. Why? This is a place where cannabis companies are starting to compete. And while notable, particularly in it’s timing, is clearly indicative of the next stage in the development of the legitimate medical cannabis industry– not just Tilray.

Trials As Market Entry Tools

Medical trials in both the United States and Europe right now (including the UK for now at least), are the best way for cannabis companies to enter and gain market share. In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Last week, Tilray also announced that they had essentially become the first Canadian LP to successfully challenge GW Pharmaceuticals on its home turf in the UK, even if for now limited to one patient application at a time. That won’t last, nor will such a tight monopoly.From a medical point of view, it is a very positive sign, at least for now.

That cross-Atlantic connection is even more interesting, however, given U.S. market entry recently for GW Pharmaceutical’s product, Epidiolex. 

From a medical point of view, it is a very positive sign, at least for now. How it will end up in the future is anyone’s guess, including stock valuation. 

Most advocates, of course, still hope for a medical market where patients are not restricted from deciding between the whole plant, oils or even the pharmaceutical products they choose to take.

Tilray of course is also not the only large LP engaged in medical trials. They are going on all over Europe right now (even if not as well strategically publicized). Health Canada is also committing to trials in Canada over the next five years.

However, what this very clearly demonstrates is that the global medical market is now ripe pickings for companies who approach the entire discussion from a “pharmacized” product point of view. Even if that means in Europe, and including for Tilray, entering the German and other medical markets with flower, oils and medical products.

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GW Pharma’s Enormous Price for Epidiolex

By Marguerite Arnold
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In a fascinating early August conference call with Seeking Alpha, British-based GW Pharmaceuticals finally revealed their retail price point for CBD-based drug, Epidiolex, as it goes into distribution in the U.S.

The drug is designed for the treatment of certain kinds of childhood epilepsy – although not all kinds. Also notable of course, is that GW Pharma’s “other” drug for treatment of resistant epilepsy failed in late stage trials in Eastern Europe earlier this year. It also knocked off 5% of the price of the company’s stock.The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

British Advocacy Over Access And Pricing

The ineffectiveness of GW Pharma’s drugs for many patients (along with the cost charged for them) was responsible for pre-empting the entire access discussion in the UK this year. The mother of an epileptic British child tried to import a personal store of cannabis oil (produced by Canadian LP Tilray) only to have it confiscated at the airport this summer. Her son ended up in the hospital shortly thereafter.

The national uproar this caused pushed forward the country’s new medical cannabis policy– indeed drug rescheduling is due to go into effect in October. Conveniently, right as Epidiolex goes on sale in the U.S. (where cannabis remains a Schedule I drug).

The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

Price Tags and Politics

What is the price of Epidiolex? $32,500 per patient, per year. If that sounds high, the company insists it is pricing the drug to be “in line” with other drugs for this segment of the market.

The majority of this cost will not be picked up by private health insurers but rather the federal governmentActually, according to industry analysis, this is about 70% more than the price of one comparable drug (Onfi), and slightly more expensive than Banzel, the two competing (non-cannabinoid based) medications now available in the U.S. for this market.

Here is the other (widely unreported) kicker. The majority of this cost will not be picked up by private health insurers but rather the federal government, which is also not negotiating with GW Pharma about that high price  (unlike for example what is going on in Europe and the German bid).

Why the difference?

Two reasons. The first is that Epidiolex has obtained “orphan drug” status (a medication for a disease that affects fewer than 200,000 patients in the U.S.) The second is that the majority of the insurance that will be picking up this tab is Medicaid. The patient pool will be unable to afford this. As a result, the bulk of the money will remit not from private insurance companies but rather federal taxpayers. And, unlike in say, Germany, none of this is pre-negotiated in bulk.

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What is the price of Epidiolex? $32,500 per patient, per year.

Co-payments are expected to range from $5 to $200 per month per patient after insurance (read: the government) picks up the tab. This essentially means that the company plans to base participation at first at least on a sliding scale, highly subsidized by a government that has yet to reschedule cannabis from a Schedule I in the U.S.

Creating, in other words, a new monopoly position for GW Pharmaceuticals in North America.

A Hypocrisy Both Patients And The Industry Should Fight

The sordid, underhanded politicking that has created this canna monster is hardly surprising given the current political environment in both the U.S. and the U.K. right now. The people who benefit the most from this development are not patients, or even everyday shareholders, not to mention the burgeoning legitimate North American cannabis industry, but in fact highly placed politicians (like British Prime Minister Theresa May). Philip May, the PM’s husband’s firm is the majority shareholder in GW Pharma. Her former drugs minister (with a strong stand against medical cannabis) is married to the managing director of British Sugar, the company that grows GW Pharma’s cannabis stock domestically.

So far, despite a domestic outcry over this in the UK (including rescheduling), there has been no political backlash in the United States over this announcement. Why not?

Look To Europe For A More Competitive Medical Market

This kind of pricing strategy is also a complete no go in just about every other market – including medical-only markets where GW Pharma already has a footprint.

For example, German health insurers are already complaining about this kind of pricing strategy for cannabis (see the Cannabis Report from one of the country’s largest insurers TK – out earlier this year). And this in an environment where the government, in fact, does negotiate a bulk rate for most of the drugs in the market. Currently most German cannabis patients are being given dronabinol, a synthetic form of THC which costs far less.

GW logo-2On top of this, there are also moves afoot by the German government to begin to bring the costs of medical cannabis and medicines down, dramatically. And this too will impact the market – not only in Europe, but hopefully spark a debate in every country where prices are also too high.

The currently pending German cultivation bid for medical cannabis has already set an informal “reference” price of at most 7 euros a gram (and probably will see bid competitors come in at under half that). In other words, the government wholesale price of raw, unprocessed cannabis flower if not lightly processed cannabis oil is expected to be somewhere in the neighbourhood of 3-4 euros per gram come early next year. If not, as some expect, potentially even lower than that.

Processed Cannabis Medicine vs. Whole Plant Treatment

The debate that is really raging, beyond pricing, is whether unprocessed cannabis and cannabis oil is actually “medicine.” At the moment, the status quo in the U.S. is that it is not.

GW Pharmaceuticals, in other words, a British company importing a CBD-based derivative, is the only real “medical cannabis” company in the country, per the FDA. Everyone else, at least according to this logic, is placed in the “recreational camp.” And further, hampered still, with a lack of rescheduling, that affects everyone.

If that is not an organizing issue for the American cannabis industry, still struggling with the many issues inherent in the status quo (from insurance coverage and banking to national distribution across state lines) leading up to the midterms, nothing will be.

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The Awakening Green Giant: China and Cannabis

By Marguerite Arnold
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There are many ironies along the path towards global cannabis legalization. Too many to count. But surely one of the oddest was always going to be the reacceptance and relegalization of cannabis in China.

The path so far has been, at a minimum, tortured.

Ritualistic, religious, and medical use of cannabis is mentioned in Chinese texts as early as 3,000 years B.C. and medical literature for the last 2,000 years. Fast forward through Imperial dynasties, the western Age of Empire and exploitation, a cultural and political revolution and two world wars, and it took China until 1985 to actually declare cannabis “illegal.”

Flag_of_the_People's_Republic_of_China.svgDuring the 19th Century British occupation, the majority Muslim Xinjang region of the country was a major cannabis producer (and exporter) to British India.This was done legally and under tariff until 1934 when the communist government cut off legal trade.

Currently,punishment for possession yields10-15 days jail time and a 2,000-yuan (approximately $300) fine. Illegal sales, however, carry the death penalty. Last year, China executed 10 people convicted of drug trafficking in a public space to send a strong statement about the launch of a new anti-drug campaign. It certainly sent a message.

But to Westerners, in particular, a highly confusing one.

So where is the “market?” And how and where is cannabis being slowly reintroduced to the country in the age of global reform?In 2003, they issued regulations to normalize the industry.

Hemp Is Widely Farmed

Farmers in the northerly province of Heilongjiang province, near Russia, are producing hemp legally these days – bound for industrial, medical and edible commercial use. The crop is highly profitable for farmers – bringing in about USD $1,500 per acre.This is far more than other crops like corn. Chinese authorities had, until earlier this century, turned a blind eye to its production. In 2003, they issued regulations to normalize the industry.

This production region also accounts for half of all farmland currently under legal hemp production, globally.

That is not a typo.

More Than Half Of Global Cannabis Patents Are Chinese

During the 20th Century,as cannabis reform moved on, not to mention western medical knowledge expanded about the plant, no surprise, the Chinese government began to lend support to a burgeoning industry and medical research. That also began surprisingly early. During the Chinese involvement in the Vietnam War during the 1970’s, the government needed a source of cheap clothing material for soldiers. They also needed cheap, accessible medicines with strong anti-bacterial properties, particularly in the humid jungle.

Given the highly politicized nature of the plant itself, not to mention current geopolitical developments shaping the global industry, Chinese exports are likely to stir a global conversation.Approximately half of the world’s 600 cannabis patents are now held in China, rivalling the potential of Israel on both the cannabinoid medicine and medical device front.

These days, there is a greater appreciation than ever for “traditional” Chinese medicine,long stigmatized by Western approaches to the same, far from China. The discovery of the so-called “endocannabinoid system” of the body by Israeli scientists at the turn of the century also supports this sea change. Including not only the use of cannabisbut other natural herbs and procedures like acupuncture to stimulate it.

The Chinese domestic medical cannabis trade, in other words, is ready to take off in the world’s largest greying population. The horse has, obviously, left the barn in the West.

But what does all this mean for non-Chinese competitors not only in Chinabut outside of it, as the drug heads for export crop status?

Cannabis Trade Wars Are In The Offing

Given the highly politicized nature of the plant itself, not to mention current geopolitical developments shaping the global industry, Chinese exports are likely to stir a global conversation.

President Donald Trump’s administration, it should be remembered, allowed a British CBD import to enter the U.S. pharmaceutical market this summer (while still banning all U.S. producers from entering the same thanks to delays on rescheduling domestically). It is not an unreasonable prediction to make, certainly after Trump also struck a deal with Israeli President Benjamin Netanyahu to delay the date of Israeli medical cannabis to the rest of the world in exchange for political support in moving the nation’s capital from Tel Aviv to Jerusalem.

A U.S. “ban” on Chinese-sourced cannabis would be one of the most natural responses in the world for the current American administration, which has not only used the cannabis trade card before (Israel, UK) but has yet to move on rescheduling the drug at home.

What To Expect If Considering Importing

Tread carefully. While Europe (at least to North Americans) has its eccentric quirks when it comes to international business, the situation in China is far different.Tread carefully, and find local partners where possible. 

Beyond appalling penalties for getting the paperwork (or etc.) wrong, there aremany differences in business, medical and even broader culture that are completely foreign to Westerners (in particular).

Tread carefully, and find local partners where possible. Where to meet Chinese partners?

Chinese investors are beginning to enter particularly European markets via conferences. In the past several years, while they are still a trickle, Chinese doctors, investorsandscientists have begun appearing in the West. Particularly in more medically oriented forums in Europe.

Marguerite Arnold

Are Global Cannabis Markets Moving In Synch?

By Marguerite Arnold
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Marguerite Arnold

In American political lingo, an “October Surprise” is an event or incident that is deliberately planned to impact a political election – usually during a presidential year.

The cannabis industry, of course, is still highly political – starting with reform itself.

So what to make of the fact that over the course of the summer, three major markets have started to align in terms of timing?

Canada, Germany and The UK Moving In Synch?

None of these things were original, publicly planned or announced, of course. During July, the Canadian government finally announced the recreational market start date, the German government issued its new cannabis cultivation bid (due in October), and of course, the British government announced that they would reschedule cannabis and create more access for British patients.Canadian companies, for example, are perfectly poised to enter both markets and dominate the industry

What is in the air? And could this, in any way, be a deliberate cannabis industry power play by political forces in motion right now?

The Canadian-German Connection

Planned or not, it is certainly convenient that the much stalled German cultivation bid will now be due right at the time that the Canadian rec market goes into hyper drive. Why? The largest Canadian LPs are currently dominating the European market. These companies are also widely expected to take home the majority of the tender opportunities and are already producing and distributing across Europe.

For this reason, it is unlikely that there will be any “shortages” in the market in terms of deliverable product. However, larger Canadian cannabis companies have already announced that a certain percentage of their stock will be reserved for medical use (either at home or presumably to meet contract commitments that now stretch globally). Inefficiencies in the distribution network will be more responsible, at least in the short term, for consumer “shortages” rather than a lack of availability of qualified product.

Regardless, the connection between these two markets will generate its own interesting dynamics, particularly given the influence of both the Canadian producers and the size of the German medical space on cannabis reform as well as market entry.

The German-British Connection

Germany and the UK are connected historically, culturally, and now on the topic of cannabis reform. While it is unlikely in the short term that German-produced cannabis would end up in the UK, British grown cannabis products are available across Europe, including Germany, in the form of drugs developed by GW Pharmaceuticals.

In the future, given the interest in all things “export” in both economies, this could be a fascinating, highly competitive market space. Whether or not Brexit happens.

The British-Canadian Connection

While not much has emerged (yet) from these two commonwealth countries now embarking on the cannabis journey, it could certainly be an interesting one. This starts with the major competition GW Pharmaceuticals now faces at home from external (Canadian in particular) companies looking to expand their reach across Europe.

Whether Britain Brexits or not could also impact the pace of market development here. Particularly as cannabis supplies can be flown in (via Heathrow), or shipped via the Atlantic, thus missing the Channel crossing point and literally parking lot delays on major motorways.GW logo-2

Canadian cannabis companies could also decide to build production sites as the market matures in the UK.

As it emerged earlier in the year, the UK is also the world’s top cannabis exporter – ahead still of the entire Canadian export market. Do not expect this to last for long after October.

However, in one more intriguing connection between the markets, Queen Elizabeth II in the UK must sign the final authorization for the Canadian recreational market to commence. With a new focus on commonwealth economies,if Brexit occurs, cannabis could certainly shape up to be a major “commonwealth crop.”

Much like tea, for that matter.

The common language between the two countries also makes international business dealings that much easier.

But What Does This All Mean For The Industry?

The first indication of this synching phenomenon may well be simply market growth on an international level unseen so far.

Canadian companies, for example, are perfectly poised to enter both markets and dominate the industry simply because this odd calendrical synching is also very convenient for business,

British companies coming online in the aftermath of rescheduling will also be uniquely positioned, no matter the outcome of the now looming divorce agreement between the parties. Whether the first market beyond domestic consumption is either commonwealth countries or the EU (or both in a best case scenario), the British cannabis market is likely to be even more globally influential than it already is.

The German market may also, depending on the pace of patient growth and cultivation space, become the third big rival, particularly with the near religious fervour all exports are worshipped here.

In the more immediate future, Germany is actually shaping up to be the most international market. Established companies from Canada to Israel and Australia are clearly lining up to enter the market one way or the other. And all that competition is starting to predict a seriously frothy, if not expanding, market starting now with connections that stretch globally.

european union states

International Summer Cannabis Roundup

By Marguerite Arnold
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european union states

As August comes to a close, it is clear that it has been one busy quarter for market development – all over the place. Developments in the UK and Germany in particular, however, have been dramatic. In turn, this is also starting to bring other countries online – even as potential producers move in on the market and before real domestic medical reform has occurred (in countries ranging from Turkey to Spain).

And, say no more, Canada finally announced its “due date” in October.

How all three markets will move forward is also very interesting. They are all interrelated at this point, and even more intriguing, increasingly in synch.

This trend is also one advocates should take note of to push forward on further legislative and access issues going forward.

The EU looks poised to hop on the legalization train

In the future, no matter what happens with Brexit, developments in both the UK and Germany will continue to push the conversation forward in the EU, a region that is now the world’s most strategic (and globally accessible) cannabis market. Advocates, particularly in Canada and the U.S. right now, can also do much to support them.

Germany

Events here, while they may seem “slow” to outsiders, are in fact progressing – and as Cannabis Industry Journal has been reporting – quite fast even if the developments haven’t been (initially at least) quite as public. As this ‘zine wrote, breaking the news in July, the Federal German Drugs and Medical Devices Agency (BfArM) quietly posted the revised bid in July on a European tender site after refusing to confirm that it had sent out (undated) cancellation letters to previous hopefuls.  Applicants for the new tender have until October 22 to respond. It is expected, given the new focus on “coalitions” that there will be many more applicants from global teams.

Even more interesting is the informal “reference price” that BfArM is appearing to set for bid respondents (7 euros per gram) and the impact of that on all pricing going forward across the continent.

german flag
Photo: Ian McWilliams, Flickr

Within a week, it also emerged that the Deutsche Borse, the organization that regulates the German stock exchanges, and working via its third party clearing arm, refused to clear any trades of any publically listed North American cannabis company that are also listed in Germany. This is an interesting development for sure – particularly now. How it will impact the biggest companies (read publicly listed Canadian LPs) is unclear, particularly because they can now raise capital via global capital markets – including the U.S.

Earlier in the summer, one of the largest public or “statutory” health insurance companies in Germany issued the “Cannabis Report.” It showed that cannabis has now moved out of “orphan drug territory” in Germany, and over 15,000 patients are now prescribed the drug. That said, over 35% of all claims are still being rejected. Most patients at this point, are also women older than 40.

The UK

It seems to be less than coincidence that the other big mover this quarter (and in fact most of the year) has been the UK. These two countries are linked by history and trade more than any other in Europe.

Epidiolex-GWAs of October, the country will not only reschedule cannabinoid-derived medicine to a Schedule II drug, but also allow more patients to access it. It is unclear how fast reform will come to a country in the throes of Brexit drama, but it is clear that this discussion is now finally on the table. What is also intriguing about this development is how far and fast this will open the door for other firms to compete, finally, with the monopoly enjoyed by GW Pharmaceuticals in the British Islands since 1998.

In one of the quarter’s biggest coups that stockholders loved but left the domestic industry with few illusions about the fight ahead, GW Pharmaceuticals also announced that it had managed (ahead of all U.S.-based producers and firms and even rescheduling in the U.S.) to gain U.S. federal government approval to import a CBD-based epilepsy drug (Epidiolex) into the United States from the UK and thus gain national distribution.

Canada

While it was more inevitable (and planned for) than developments in Euro markets, Canada also moved forward this quarter. There is now a set date for a recreational market start.

What is even more interesting is that the next formal “steps” in all three markets are now timed to coincide within weeks of each other in October this year.

Canadian producers of course are in the leading position to enter both German and British markets. Further their production centers now springing up all over Europe are supplying both their source markets and will be available for international distribution.

UKflag

British Government Agrees To Loosen Rules on Prescribing Medical Cannabis

By Marguerite Arnold
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UKflag

After a year of embarrassing missteps and revelations, along with two well-run advocacy campaigns by the parents of children with drug-resistant epilepsy, the British government is finally throwing in the towel on medical cannabis.

Sadly, politics rather than science has driven the pace of British cannabis legalizationIn the last week of July, a mere two weeks after announcing his review of the issue against mounting domestic pressure and outrage in the media, Sajid Javid, the home secretary, announced that cannabis medications will be rescheduled by the fall, allowing doctors to prescribe them more widely.

“Fall,” it should be noted, is not only when the Canadian government moves ahead with its own fully recreational market, but also when the German bid respondents need to file their paperwork to participate in the country’s first grow bid, Round II.

A Political Embarrassment Beyond Brexit

Sadly, politics rather than science has driven the pace of British cannabis legalization, just like it has in other places. However the UK is one of the best examples of how far medical knowledge has outstripped the pace of political change, and in this case, exposed bare the banal reason.

News broke this summer, as two families mounted a highly successful battle in the public for medical access, that the Prime Minister herself has personally profited from a status quo that is only now slowly going to change.

How and why?

Theresa May, Prime Minister of the UK
Theresa May, Prime Minister of the UK
Image: Annika Haas, Flickr

It was bad enough in May that the publicly anti-pot reformer Victoria Atkins, the cabinet level British drugs minister, was married to the managing director of British Sugar, the company with the exclusive right to grow cannabis in the British Isles. British Sugar is also the sole cultivator for GW Pharmaceuticals, the only company with the license to produce cannabis medications in the UK (and export them globally). In June, however, it emerged that Prime Minister Theresa May’s husband, Phillip May, is employed by Capital Group– an investment firm that is also the largest shareholder in GW Pharma. This is against the backdrop of news that broke earlier this year that GW Pharma had made the UK the single largest exporter of cannabis-based medicine annually. Globally. Even more than all of the Canadian firms combined currently exporting to Europe and beyond. Even as the drug is largely denied to British residents.

You don’t even have to be British to think the entire situation is more than a bit of a sticky wicket.

Vested, If Not Blueblood Interests

This development also came to light right as GW Pharma’s newest focal epilepsy drug faltered to failure in Eastern European trials and as Epidiolex, the company’s drug for certain kinds of childhood epilepsy, was given the green light in the U.S. by the government as the “first” cannabis-based medication to be allowed for sale in America.Epidiolex-GW

No one has yet defined exactly what kind of cannabinoids will be allowed to be prescribed in the UK come fall, but here is the most interesting development of all that still hangs over the British Isles like stale smoke: Will competitors to GW Pharma be allowed to sell their products to medical customers in the UK or will this new opening for patients just create more of a monopolized windfall for one company whose profits, at least, lie in “pharmatizing” the drug rather than creating greater access to the raw plant or its close derivatives? And those profits flow to women (and men) with the greatest political control over the development of the industry in the country.

Is This Really A “Legalization” Victory?

In the short term, no matter how limited, the answer is actually yes. Rescheduling the drug is a step that has not even been taken in the U.S., and will serve, medically, to reset the needle if not the debate about the circumstances under which cannabis should be used for patients.GW logo

It will also move the punishment discussion in a way that still has not happened in places like Germany where, technically, the drug has not yet been decriminalized even though doctors are prescribing it and public health insurers cover the costs for increasing numbers of patients. Large numbers of Britons, just like everywhere else, are incarcerated every year or obtain black marks on their records for mere possession that in turn can affect lives.

Finally, it will put recreational reform in the room, even if still knocking at the door. This discussion too has been gaining in popularity over the past year in particular as reform moves elsewhere. Like Germans, like Canadians and like Americans, reform in Colorado and Washington set loose a global revolution, which will clearly not be stopped.

Even if in places like the UK, it is still moving far slower than it should be. For political and business reasons, not driven by science.