Tag Archives: European

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Frontline Pharmacy: The Battle For The Footprint of Medical Cannabis Europe

By Marguerite Arnold
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This summer, as new distributors continue to get into the cannabis game (in Germany, the UK and beyond), and at least two countries (Greece and Macedonia get GMP-certified), the battle is now on not just for cultivation and distribution licenses, but the end point of sale, pharmacies.

Pharmacies were always going to play a large role in cannabis distribution in Europe, starting with the fact that there will not be a separate “dispensary” system (as there is in the United States and Canada). Further, in some jurisdictions, notably Germany, the idea of the “apotheker” is one that is not going to go away anytime soon. No matter how intriguing the concept of online pharmacies actually are to everyone else (see the British).

Further, the shift to what is widely being referred to as “tele” or “digital” health is only going to increase in prevalence as discussions continue. Cost and access (to all medications, not just cannabis) are an issue near and dear to the average European. So is the right and consumer safety issues of being able to consult with a local pharmacist, who might even know you personally, and can advise on the health effects of the medicines they pass over the counter.

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Photo: Ian McWilliams, Flickr

Jens Spahn, the current Health Minister of Germany, is touting a move to personal management of health records and digital prescriptions by next year. However, nobody knows exactly what that means, much less the functionality of the same.

Further, the German pharmacy situation in particular is one that has implications across Europe no matter how aggressively “digital health” solutions are implemented here. By law, no more than three (in some rare cases four) brick and mortar pharmacies can be owned by the same owner. There is no such thing as “Boots” (a British chain) or “Walgreens” (an American one).

Doc Morris, the Dutch online pharmacy, has always been an option for Germans just across the border. The problem of course is that insurers so far have been refusing to pay for critical parts of this idea. The company is currently experimenting with working with insurers- but do not expect the average chronically ill person in any country to suddenly get expedited access. So far, the only innovations in this market have hit as the privileges of the privately insured.

Second class status (and significantly lagging behind those with private healthcare) is also very much in the room as a political issue- and cannabis access has only sped this up.

If the scenario in the EU two years ago could be described as the race for import licenses and cultivation rights, this year, the focus of the big guys is very much trying to mainstream their product and get it on as many “shelves” as possible.

In Europe, however, since nobody can ship straight to the patient (as in Canada), the next most obvious step is securing access to pharmacies.

The Cannabis Industry Cometh

Even before Aphria announced its purchase of CC Pharma (one of Germany’s largest distributors)  in a deal that finally closed in January of this year, the larger companies have been looking for a more efficient supply chain situation. Owning a distributor is certainly one way to go about this.

Israeli Together bought into a large German distributor last summer.

As of May 2019, Aleafia Health and its wholly owned subsidiary, Emblem, entered a JV with Acnos Pharma GmbH – with access and reach to 20,000 German pharmacies. And Wayland announced its merger with ICC, with pharmacies across the world.

As early as October 2017, Tilray and Cronos together tried to storm the German market (by inking a deal to reach the 20k plus pharmacies in the German system). Two years later, and this still has not made a huge difference in access.

Regardless of these larger industry players, however, or perhaps so far because of their statements and the resulting continued lack of access for most patients, it is also fact, particularly in both Germany and the UK, that merely having relationships with pharmacies is not enough. This year, there is also a fairly major price drop in the cards for the cannabis industry. And while the larger players may blanket the market with relationships, actually providing access to GMP-certified medical cannabis at a decent if not competitive price, is going to continue to have an impact on every market, particularly in those situations where compliant online access can be connected to indie distribution.

It is also an environment where the advantage still does not necessarily go to the “big guys” – a strategy that Wayland, for one, has been playing strategically for the better part of the last two years better than any other Canadian in the market. Especially when supply chain issues, beyond price, are still in the room.

Right now, pharmacies are well aware of their growing influence in this space in Europe. How much of an influence they will continue to have however, also rests on how effectively they preserve their right to have such an influence on the end consumer (as in Germany) or not (see the many discussions about this issue in the UK right now).

Further, as many of these entities are also realizing, and this is true far beyond the cannabis discussion, pharmacies are increasingly caught in the middle between consumer, doctor and insurer (this is certainly the case both for cannabis and also for all expensive orphan drugs).

How the pharmacies, in other words, begin to solve other issues, beyond just having a contractual relationship with a cannabis distributor/producer, is very much a part of the conversation right now. Access to cannabis via distribution deals with a Canadian or even Israeli partner certainly helps sales but it does not guarantee them.

One thing is for certain. The impact of new privacy legislation is having an effect, so even in an environment where a distributor/producer buys a pharmacy, what they can then do with customer information they also might have been interested in purchasing, is not only highly limiting, but in the future it may be the best approach to handling liability, and from multiple directions that includes everything to access to affordable, certified product to cyber security issues.

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A Cautionary Tale of Two British CBD Start-Ups

By Marguerite Arnold
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As cannabis reform finally begins to hit the UK, the same confusion, lack of standards and uneven application of the “law” reigns supreme.

Just like other places (notably Israel, the United States and Canada), in the early days after medical reform hits, the English situation is instructive if not reminiscent of other fights elsewhere – no matter how much individual stories may differ on the surface. Just like in Israel for example, sick children had to be hospitalized before anyone moved forward on reform.

Just like in the United States, Canada and Israel, the people who were able to get into the changing industry first and early had money and political connections.

And just like everywhere else, who survives and who gets hit with red tape, is largely a matter not of entrepreneurial savvy, but connections, inherited privilege, race, gender and of course, bank account. In a place like the UK, where “class” is still a valid force on its own (beyond access to money), this is already obvious. As a theme, it is one that is sadly, not over yet for too many in or affected by “the industry.”

There are still, per the estimates available, less than 100 legal patients in the UK. Those served by the NHS are also well aware of their “second class” status when it comes to healthcare. This one issue, after all, drove Brexit, and may yet cause it to fail, just on this one issue. Cannabis may be a side note in the debate. But it is also, by this time, clearly in the room.

A Chelsea Popup Shop Survives While A Brighton Eatery Fails To Open

In January, two graduates of Imperial Business School (a private, prestigious university in London) opened a “pop up shop” (kind of like a kiosk) in Chelsea. This is a part of the city frequented by Royals on the hoof, reality stars of a certain vintage, and a lot of highly priced real estate.

So far, with the predictable fawning press coverage, the almost too “cutely” named TheDrug.Store (which by its own admission is selling non-medical products) has been doing brisk business.

Meanwhile, in the historic if less slightly less elite but almost as expensive touristy seaside town of Brighton, The Canna Kitchen, a CBD eatery with the catchy slogan of “let food be thy medicine”, was closed by the police right before it was supposed to open at the end of May (although there is no mention of this or the negative press on the website, which despite having no telephone number, still allows visitors to “book a table.”) The owners, who also seem to be quite well-heeled millennials themselves, appear to be on the verge of “losing hundreds of thousands of pounds and laying off 15 staff,” to quote The Guardian story on the subject.

Never mind the irony that they also seem rather well positioned financially. Or that many, many more people, usually called poor patients, are still at risk of being hospitalized because they cannot get (or afford) their medication.

As the industry, such as it is, and patient rights group organize in earnest this summer, reform in the UK also hinges on whether and what the country decides to do in the fall.

And despite the huge disparities that exist in terms of who has access (let alone to entrepreneurial capital), or perhaps because of them, look for a healthy debate from patients about policy, access and fairness.

European Cannabis Week Kicks Off First Year In London

By Marguerite Arnold
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Hold your hats and book your seats! The Limeys, no matter what they are doing on Brexit, are getting organized on the cannabis front. A unique coalition of “home-grown” as well as cross-European, American and Canadian industry insiders are already making travel plans for London during the last week of June.

Unlike Trump’s recent visit to the British capital, however, they are likely to meet nothing but enthusiasm if not a growing understanding in the British populace at large that the Great Green Cannabiz Has FINALLY Landed.

Now the question is getting the entire industry mainstreamed (just on the medical side).

On the CBD “recreational” discussion, the entire enchilada is still being formed and reformed. A high-end CBD “pop up” shop opened in a ritzy part of London in January while a more crunchy CBD restaurant in the seaside town of Brighton was shuttered right as it planned to open. Just another innocent victim in all the fuss about novel food still working its way through the entire British conversation (as it is elsewhere in Europe, including most recently Germany and Italy), certainly, but hopefully one of the last.

However, for that very reason, enthusiasm is already high as organizers continue to add events even three weeks out.

What Is On The Agenda?

Check the event website for details and scheduling. There is also a lot that is not on the official website, but has clearly been organized around it. That includes a patient advocacy and policy formation gathering on Thursday being organized by the United Patients Alliance and other events not on the “official” ECW list (or website) but clearly all with the goal of networking, interacting and gaining ground (such as the internationally organizing Cannabis Tech Society).

The first two days are reserved (at least during the day) for Cannabis Europa – the “other” major European cannabis business conference that got its start in 2018 in London. Earlier this year, the event was also held to a standing room only audience in France. Organized by two of the leading cannabis consultancies in the UK who are making a clear play towards both North America and Europe- Prohibition Partners, and Hanway Associates, the event is primed to bring together those in the international industry curious about changing times and opening opportunities not only in the UK but across Europe.

The rest of the week, events are spread out across the city (and are already selling out). Of note on Wednesday is an investors conference as well as an introduction to the growing ranks of British doctors (one hopes for the future of nascent doctor training programs everywhere across Europe, without borders), even if nascent at the moment, who are joining the medical cannabis crusade.

Thursday’s planned events also include a focus on connecting women in the industry to investors – particularly of the medical kind – and MedPayRx’s third pilot to market workshop (Unveiling The Digital Prescription). It will also include a ground-breaking seminar about cannabis certification for doctors at King’s College (long known for its critical studies about the supposed connection between cannabis and a host of nasty mental illnesses and conditions starting with schizophrenia).

There is also a round of private parties, events, industry soirees and more that are invite only. However, as with most cannabis industry events, showing up and tagging along is one of the best ways to network and meet people.

It will be a busy week, for sure.The entire cannabis debate is absolutely hitting in this space in the UK in a way that it has not in other places

Why Is This Significant?

The British are finally kicking off their version of “the industry.” That said, problems abound, including of the kind seen in places like Germany, with the added whiff of further disruptions thanks to a still-pending Brexit. On the healthcare discussion at least, it is hard to find a fan of the NHS in the ranks of average cannabis patients (who are still struggling to get their numbers over 100 for the entire country six months after Schedule II prescriptions were authorized). However, it is also equally hard to find anyone in the ranks of the chronically ill at least, who would welcome a more U.S. style approach to healthcare provision – even if they can avail themselves of private healthcare coverage. That is just 10% of the population.

The entire cannabis debate is absolutely hitting in this space in the UK in a way that it has not in other places (including Germany). This is, beyond Brexit discussions, in part a testament to the creakiness of the British system, although the German one at present also leaves a lot to be desired.

Nobody wants an “American” system. And the Canadians in the room are also dealing with the problem that so far, Canadian public health insurance does not cover medical cannabis either.

Like it or not, this is also a theme that colors cannabis politics in Europe as much as the industry does not know how to channel and harness it. The Green Vest movement is certainly alive and well in the UK. Nor should it be underestimated. And that resentment at the moment also is hitting some of the biggest industry players who are the only ones allowed market entry where it counts (the regulated ones including medical).

On the CBD front, despite assurances by activists as late as last year, and certainly overflowing enthusiasm about the potential of this market, novel food still applies.

Where the conversation will certainly get interesting is the ability to distribute through online pharmacies (unlike in Germany where this is still verboten– and for all drugs, not just cannabis). But even here, don’t look for the UK to become just another Amazon outlet. New rules, including GDPR, still affect the UK and will continue to do so no matter what happens in the fall. This has to do with what is called “trusted nation” status that affects regulatory issues including pharmaceuticals but also financials (which is why the idea of the UK sailing off entirely on its own or as an American subordinate state is also ludicrous).

Not to mention of course, that supply and demand has yet to be effectively linked anywhere in Europe.

Cannatech, beyond distribution platforms, will also become more of a focus in climate change conscious Europe.

And of course, with a focus in London, there will be a much greater opportunity for both the concentration of specialty equity and the industry itself (in English) that will impact issues across the continent.

In a nutshell, in other words, the week-long events in London (held in conjunction with an equally interesting gathering now coalescing in Berlin just the weekend before) is proof positive that not only is the European cannabis industry in the middle of another seismic year, but the British and German movements are connecting, coordinating, cooperating, and driving change both at home and elsewhere across the region.


Disclaimer: European Cannabis Holdings and Prohibition Partners are sponsors of MedPayRx and a business relationship exists between them.

Marguerite Arnold

The Sale Of Cannabis Sativa Derived CBD Becomes A Crime In Italy

By Marguerite Arnold
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Marguerite Arnold

For all the excitement about the “CBD” or “Cannabis-Lite” possibilities in Europe thanks to Switzerland over the last few years, the reality as of 2019 is proving to be a little different.

As of the end of May, Italy’s top court, the Court of Cessation, ruled that selling derivatives of cannabis sativa (from the buds and leaves to oils and resins) is illegal. Hemp of course, is excluded from this decree. And in fact, this decision was intended to close a loophole that was created in 2016 for so-called “Cannabis-Lite.” In other words low THC, CBD products and extracts that are showing up in the market as is or as an ingredient in something else (from food to makeup).

While this development is certainly a blow to those who were not in the know already, it is hardly surprising– especially given current events next door. German authorities just declared that they could find no use for “CBD”. This of course confuses the issue even further (since CBD is obviously found in both hemp and cannabis sativa.) Austria did the same thing late last year- and further did so on a level unseen anywhere else in Europe (namely putting cosmetics on the list too).Novel food regulation, at its heart, is all about the source of the plant and how it is processed. 

In fact, and certainly in comparison, far from being nebulous, Italy appears to have taken, surprisingly, a rather scientific, if not clear-headed, approach to the issue in general. Not to mention a step that is absolutely in line with current EU policy on the same.

Novel food regulation, at its heart, is all about the source of the plant and how it is processed. This entire discussion about CBD falls squarely within that- although of course, hardly limited to just this one cannabinoid or in fact, plant genus.

What Should Investors Be Aware Of?

There is, as always, a hype around CBD. That is true in almost every legalizing market, but Europe, with a much stricter regional regulatory regime and at least a four-year path to recreational, has seen an odd twist in all of this for the last two years.

There is the potential for a CBD play in Europe, but it is niche, and country-by-countryIn the EU, the distinction between hemp and cannabis-derived cannabinoids (including but not limited to THC), is a well-known fact for those with any stripes in either the cannabis, or beyond that, mainstream food and drug industry. The largest confusion, in other words, is strictly at the lower rungs of the biz. Not to mention all foreigners.

Proof of the same? Purvey the contents of even the most wide-ranging Dutch Seed shop catalogue, and you will be hard-pressed to find non-hemp products. And even though such entities know how to get around loopholes themselves (starting with the online sale across Europe of cannabis seeds from all over the world), novel food is not a regulation even these cannabis entrepreneurs want to cross.

In other words, there is the potential for a CBD play in Europe, but it is niche, and country-by-country in an environment where both local and regional rules are shifting. And further are likely to do so for some time to come.

And in the meantime, those who make the grade, are certainly freed from one pressing if not looming question. The market in Italy is, in fact, not only far from “illegal,” but opening up both in terms of import and export to cannabis products from all over the world. Including of course, Canada and the United States.

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Germany Enters The Fray On Novel Food

By Marguerite Arnold
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The novel foods discussion in Europe is a thorny one- and further one very misunderstood by natives, let alone those who would take Europe by canna storm. Within Europe, this discussion has festered and percolated for the better part of two years. Last year, despite a huge bump in sales in certain regions (see Switzerland), police were directly involved on the ground in Spain and rumblings of the same possibility took place in Austria at the end of the year. Early this year, further indecision at the EU level has continued to confuse the entire discussion.

This year, while there have been recent blow-ups in the UK, and fights at the EU level, the main action has been in the DACH region of the EU. The DACH trading alliance includes Germany, Switzerland and Austria.

In fact, the debate in this region of the world may drive not only European but UN policy. For that reason, the road currently is a thorny one, with lots of drama shaking out along the way in policy fights that still, at least in many European countries, involve the fuzz and what has been ostensibly packaged and labelled as “health food.”

It is for that reason that the most recent move by the German Federal Office of Consumer Protection and Food Safety (or BVL), which said that CBD should not be sold in food at all, has gotten all the attention lately. Especially and more worrying for the nascent CBD industry across the continent, the agency also opined that it does not see a case where CBD-containing cannabis would be marketable in foods or health supplements.

european union statesLast month, on April 11, the European Industrial Hemp Association (IEHA) issued a sharp rebuttal to the same. As they have just been asked to serve in an advisory role in setting EU regulations on novel foods and hemp extracts, this is likely to move the conversation forward regionally. Including in the DACH region where this issue is all over the place.

What Exactly Does Novel Foods Regulation Cover?

Novel Foods regulation in Europe covers two things, and this is true far from cannabis. It is consumer rights legislation and guidelines that cover all plant-based food and supplements across the continent. It also covers beauty products (since the skin is the body’s largest external organ) although so far, this tiny part of a niche industry has largely escaped attention. Do not expect that to last.

Where this crosses with cannabis is an interesting discussion. Hemp and cannabis of course have been consumed in Europe for thousands of years. As such, food and extracts of the plant, from species that occur naturally here, normally would not raise a fuss. However, this discussion has also become complicated for a few reasons. Starting with the fact that the seeds and strains now being developed in the U.S. and Canada are not “native” to the European region.

In fact, the early exports across the Atlantic (and there have now been a few) are all on the hemp side of the equation. Currently hemp is the only plant containing CBD that is recognized as viable under novel foods. Cannabis sativa strains that are low in THC are where this whole discussion gets dodgy. The strain, Girl Scout Cookies, and its contents including CBD for example, would under this regime, never be allowed. Nor would cannabis strains bred for their low THC in the United States.

The second issue is how such plants are processed and the cannabinoids extracted. That is another issue that directly relates to how concentrates, tinctures and extracts are made in the first place. This is also in the room.

But that is also where the entire debate also spins off into other semantic hair-splitting that the industry so far has found not only tedious but largely impenetrable.

Why Is The German Announcement So Cynical?

Germany is following its DACH neighbour Austria to directly put the brakes on the CBD and THC discussion across the border with Switzerland. In contrast to its Teutonic trading partners, the Swiss have been experimenting with all kinds of CBD products, from all sorts of sources, and are now talking THC recreational trials (even if sold out of pharmacies).

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

In contrast, over the last six months, both Germany and Austria have come out with statements and official pronouncements not about hemp, per se, but rather CBD- a cannabinoid found in all instances of both hemp and cannabis sativa. While politically this might send a statement that both countries are not ready to engage the cannabis debate on the next level (beyond medical in other words), scientifically of course, this is a silly argument to make. A cannabinoid is a chemical compound that acts the same whether it comes from cannabis, hemp or synthetic sources (see the synthetic dronabinol).

In the meantime, CBD itself has not been declared a “novel food.” In other words, for all the legal regulatory “brakes” and excuses, the dust is starting to clear on the debate as both regional and international bodies finally take on the entire cannabis discussion, albeit in a plodding, multi-year way. That, however, is undeniably under way at this juncture.

In the meantime, look for political grandstanding about every cannabinoid under the sun and further such drama will not abate even with “recreational” reform. Even when Europe accepts full boat regulated, recreational, novel food regulation will still be in the room. Even if politicians no longer play games with individual cannabinoids.

That said, at this point, that is also unlikely. In other words, expect the battle on the novel food front to continue for the entire industry, and shift, when recreational comes, to merely another cannabinoid, unless policy makers address the bottom-line issues now.

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Why International Trade Agreements Are Shaping The Cannabis Industry

By Marguerite Arnold
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If you have wondered over the past several years, why the big Canadian companies (in particular) are following the global strategy they are, there is actually a fairly simple answer: Newly implementing trade agreements, particularly between Europe and North America.

More specifically, they are highly technical trade agreements that are also called Mutual Recognition Agreements, (or MRAs).

In fact, look at the schedule of the MRA agreements signed between the U.S. and individual EU countries over the last several years, and it also looks like a map of the countries that have not only legalized at least medical cannabis, but where the big Canadian companies (in particular) have begun to establish operations outside of their home country.

But what is going on is actually more than just CETA-related and also will affect cannabis firms south of the Canadian-U.S. border.

All of these swirling currents are also why the most recent MRA to come into full force in July this year, between the U.S. and Europe, is so interesting from the cannabis perspective. Even before federal reform in the U.S. If this sounds like a confusing disconnect, read on.

What Are MRAs?

MRAs are actually a form of highly specialized trade agreement that allow trading countries to be certain that the pharmaceuticals they purchase from abroad are equivalent to what is produced at home. This includes not only ingredients but processing procedures, production plant hygiene, testing, labeling and more.

When it comes to the  EU-US MRA agreement, this means that individual states of the EU can now recognize the American Food and Drug Administration (or FDA) as an effective federal regulator of American pharmaceutical production that is equal to the procedures in Europe. US GMP standards, in other words, will be recognized as equal to those of EU states.

This will now also, by definition, include GMP-certified medical cannabis formulations.

What is so intriguing, however, is how this development will actually place certain American (and Canadian) manufacturers in a first place position to import cannabis into Europe ahead of the rest of the American cannabis industry.

What Are Mutual Recognition Agreements All About?

One of the most important quality and consumer safety aspects of establishing a clean supply chain is tied up in the concept of GMPs (Good Manufacturing Practices). These are procedures, established by compliant producers of pharmaceuticals, to ensure seed (or source) to sale reliability of the medication they make. In the cannabis industry, particularly in the advent of Canadian-European transatlantic trade in cannabis, this has been the first high hurdle to accept and integrate on the Canadian side.

GMPIf European countries recognize a country’s GMP certifications are equivalent to its own, in other words, and cannabis is legal for export, a country can enter the international cannabis market without facing bans, in-country inspections and the like. In the interim, imported products still have to be batch tested until the agreements are fully accepted and operational.

Israel, for example, already had an MRA with the EU, and medical cannabis is legal in the country. However, Israel was prevented from selling cannabis abroad until a legislative change domestically, passed on Christmas Day.

That is why the MRA agreement between the US and EU with Canadian companies in the middle also put both Israeli and U.S. firms at an extreme disadvantage in comparison. Both in entering the market in the first place, and of course associated discussions, like the German tender bid. That is now changing- and as of this year.

A Specialized Map Of Global Medical Cannabis Exporters

Ironically, what the new US-EU MRA could also well do is create a channel for pharmaceutical cannabis from the United States to Europe (certainly on the hemp and CBD front) just as Israel is expected to enter the international cannabis export industry (later this summer or fall). It could well be also, particularly given the Trump Administration’s tendency to want to not only “put America first” if not pull off “a better deal” in general and about everything, that this is why President Trump offered the delay to Israel’s president Benjamin Netanyahu in the first place.

Regardless of the international individual developments and subtleties however, what is very clear that from the time the first bid stalled in Germany in the summer of 2017 until now, the U.S.-EU MRA has been in the room even if not named specifically as a driver.

For example, the FDA confirmed the capability of Poland and Slovenia to carry out GMP inspections in February of 2019.  It was only last fall that Aurora pulled off its licensing news in the former (on the same day licensing reform was announced by the government). Denmark was recognized in November of last year during the first year of its “medical cannabis pilot progam.” Greece was recognized in March 2018. Italy, Malta, Spain and the UK came online in November of 2017.

Overlay this timetable with a map of cannabis reform (and beyond that, cannabis production) and the logic starts to look very clear.

The upshot, in other words, is that while cannabis still may be “stigmatized” if not still “illegal” in many parts of the world, more generalized, newly negotiated and implementing, specialized global trade agreements between the US, Europe and Canada in particular have been driving the development of certain segments of the cannabis industry globally and since about 2013.

The Biggest News?

As of this year, as a result, expect at least from the GMP-certified front at least, that such international trade will also include medical cannabis from the U.S.

Want an example of the same? First on that list if not early in the game will now undoubtedly be Canadian-based Canopy Growth, with Acreage on board, headquartered in New York.

Marguerite Arnold

Canopy Growth Makes Multi-Billion Dollar Conditional Acquisition Deal

By Marguerite Arnold
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Marguerite Arnold

The first German cannabis bid may have come to an end more or less, and with a whimper rather than a bang (not to mention the inevitable still-to-be-settled legal challenges). However even as the dust settles, one of the biggest “names” in cannabis and the company formerly expected to win at least a few of the tender lots is looking elsewhere.

Namely Canopy Growth, which was a finalist in the first round of the tender, has not shown up as a finalist firm in Germany this time (at least not so far).

However, it is clear the firm has other intentions afoot, namely U.S. expansion.

In an unprecedented move, Canopy announced its intent to buy the largest U.S. based producer of cannabis, a firm called Acreage Holdings, just before Easter. The conditional deal is being consummated in both cash ($300 million) plus stock swaps, and will not finally close until federal reform has come in the U.S. In fact, the deal makes the bet that the entire issue of U.S. federal reform will be solved within the next decade.

Canopy_Growth_Corporation_logoIn the meantime, however, what this also does is place one of the world’s largest cannabis companies in the middle of what is largely seen as the world’s most valuable overall cannabis market. Further it does so in an environment where the company benefits from Acreage’s considerable market and political clout. Former speaker of the U.S. House of Representatives John Boehner (a fierce opponent of legalization until it was personally convenient and profitable) is on the board of Acreage.

But there are those who might still be confused about why this deal happened. Canopy after all is fond of saying that its first focus is the “more valuable” medical rather than recreational market. And the U.S. market has many challenges still, that stem from a lack of federal reform. In fact, Canopy has frequently said in the past that they would not enter the U.S. until federal reform occurs. What gives?

What The Deal Also Does…

It is not “just” entry into the U.S. recreational market, albeit still on a state level that is significant about the deal. That starts with its timing.

When trying to understand the motivations of Canadian cannabis companies, especially ones who have eschewed the U.S. market in the past (at least until federal reform passes), it is also necessary to understand that they operate in a shifting world of global strategy that is never as straightforward as one might think. And often has nothing to do with cannabis per se.

Namely, while this deal places Canopy in the middle of the U.S. state industry it also does something else. It positions Canopy as a U.S. producer just two months after a new international pharmaceutical trade deal went into force (on February 8) called an MRA.

MRA agreements, also known as Mutual Recognition Agreements, are essentially trade deals between countries to accept the equivalency of their pharmaceutical production and supply chain.

On the cannabis front, the existence of MRAs between existing countries as cannabis has become legal, has also largely dictated the new international cannabis trade (see Canada and Germany as a perfect example) although this has been held as a closely held secret by the largest cannabis company executives (some of whom have previously denied that this was driving their expansion across Europe).

However, thanks to the agreement on this MRA in February, as of July of this year, Europe and the U.S. will formally kick off a situation where the European and therefore German health authorities will formally recognize American GMP processes.

That means that on the pharma front, Canopy has also essentially re-entered the European market, albeit by a bit of a backdoor. It also means that Canopy can immediately start to import cannabis drugs at least, made in the U.S. into the European and by extension, German market.

Cannabis drugs have been going in the opposite direction across the Atlantic to the U.S. for at least a year now (see the GW Pharma’s Epidiolex adventure last year). And further over the U.S.-Canadian border if now only bound for academic research (see Tilray).

It also may mean that they can import medical cannabis itself to be used as “medicine” or processed into one in Europe.

Does This Mean That U.S. Federal Reform Is Imminent?

Not necessarily. In fact, keeping the U.S. market in general out of the global cannabis trade, while allowing the top companies to participate both in the cross-state market and the global pharmaceutical one benefits the biggest companies. Conveniently, this also allows U.S. cannabis “pharmaceutical” producers to enter the EU in force just as Israel is expected to (third quarter this year). This also puts the “deal” U.S. President Trump and Israeli President Netanyahu cut on the subject to delay Israeli sales in an entirely new light (and one that should outrage both Americans and Israelis in the industry on this front even more). Not to mention every European hopeful producer unaware of the larger game afoot.

That said, what federal U.S. legalization will do is drop the operating costs of the larger U.S. entities now engaged in multi-state operations.

Cannabis in other words is not likely to be legalized in the U.S. before the next presidential elections for reasons that have everything to do with the profits of a few – and for that reason will certainly be a major theme in the next national political race.

And in the meantime, the biggest companies, Canopy included, are not only laughing all the way to the bank (although their shareholders are another story), but setting themselves up to be at the ground floor DNA of the global cannabis business as it establishes itself in every country of the world.

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How Germany Gets Its Cannabis

By Marguerite Arnold
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german flag

The German cannabis cultivation bid may be mostly done and dusted (although the last four lots are now up for legal challenge) but the drama is only intensifying on the ground in Germany. Namely, where is the cannabis being consumed on the ground now actually coming from?

For the past several years (in fact since 2016 when a Frankfurt-based start-up called Medcann imported the first Canadian medical cannabis into the German market in partnership with Canopy Growth), the conventional wisdom has been that Holland and Canada were the only two countries allowed to import medical cannabis into the country.

Canopy_Growth_Corporation_logoAs is usually the case in the cannabis industry, when it comes to such things, there were also multiple and highly creative explanations about this strange state of affairs that sounded oddly exotic enough to be plausible. This is after all, the international cannabis business.

These explanations also usually referenced conventional industry “lore” including such tall tales as these two countries were not signatories to an international drug treaty (not true), to being European (nope) or even a member of the EU (also completely false).

Yet there was always something strange with such urban legends – perpetuated by insiders across the German industry. Starting with a deliberate vagueness about details. Especially as in the summer of 2017 when Tilray announced grow facilities in Portugal, and by the end of it, Canopy was moving into Spain, and later by early 2018 Denmark and more. Italybegan to appear on the radar of multiple big Canadian companies. Clearly all these big companies seemed to know something that those outside did not. See Greece. Not to mention the teeth-gnashing of the Israelis– repeatedly shut out of the German market by not being allowed to export by their own government until Christmas Day, 2018.

The mystery deepened in March in fact, as a furore rocked the German-based cannabis industry over the last weeks. Farmako, a new, Frankfurt-based distributor, not only announced that it was importing 50 tonnes of cannabis into the country– and from Poland (where production of such bulk has not even been seeded) – but then gave additional details on a Bloomberg appearance that appeared to indicate that in fact the medical cannabis they were already selling (sourced from other places) had come from Macedonia. 

Certification, and most certainly paperwork are the name of the gameIn fact, no such transfer of cannabis had occurred from the Macedonian side (yet), although the firm in question at the other end of the deal was subjected to considerable harassment in the German canna-specialty press in the meantime.

The news, that occurred right at a time when Tilray is clearly training pharmacists for the German market, the first bid is concluding, Greece issues even more cultivation licenses, Canadian companies are clearing still stepping up their production game, and South Africa is also getting into the formal licensing act, with all sorts of interesting things afoot in Uruguay, also set off what appears to be an official investigation of the firms involved at the governmental level.

Insiders are tight lipped and nobody is willing to talk on record. However, the distribution firm, Farmako, has subsequently reported that in the month of March, they became the top selling cannabis specialty distributor in Germany. And since they are not out of business, it is also clear that while their PR may have been a little premature if not easily misunderstood, the broader message is very obvious.

What is also very clear at this point, in other words, is that the German door for cannabis and the international industry appears to be opening to product sourced from many places. Further by extension, the German government is in the process of recognizing foreign GMP certification processes from multiple countries all over the world as being equal to its own – at least on the cannabis front.

In fact, this has been going on relatively quietly for the past six months or so.

What Are The Standards, Certifications, and Qualifications?

A press release from January of this year, issued from an Australian firm called MCA, announced they had accepted the first letter of intent to ship to a German firm (in 2020). The company is currently accepting pre-orders as it finishes construction and achieves EU GMP certification. The same (female founded) firm was also present at the ICBC in Berlin this year in March, reporting that German demand from a universe of local distributors was already greater than they could fill. The news that their first sale went to German firm Lexamed, the controversial German wheelchair distributor who helped bring down the first German bid, was also largely unremarked upon at the time by most of the industry press and in fact, ever since.

GMPIn truth, it appears that the countries and companies that have the right to import to Germany must first have their own national GMP certification recognized as being equal to German standards – or a so-called Mutual Recognition Agreement (or MRA) must exist between the importer and exporter nations. It still means that to be really EU-GMP compliant, inspectors have to walk your cultivation floors. But first your country has to have the MRA. And that is a matter for lawyers and regulators to decide.

In the Australian case, the GMP equivalence for cannabis production apparently became reality within the last six months although no one is giving exact dates. In the case of Macedonia, this is pending, with German inspectors now apparently scheduled to begin inspecting domestic cultivation facilities within the next month to six weeks.

The biggest news, of course, which makes even more sense on the heels of Canopy’s latest “record breaking” U.S. acquisition, is that the EU and the U.S. will enter into an MRA in July that was finally agreed to in February of this year. This will also mean that cannabis “medicines” potentially even beyond CBD, produced via U.S. GMP processes, will be allowed to enter Europe if not Germany in the near future – and from the U.S. for the first time. Ahead of federal legalization in the U.S.

It also means that Israeli and American firms will be allowed to enter the European and thus German market for the first time (on the ground with product) by at latest, the third quarter of this year.

Caused By The Bid….and Likely Shorter Term Outcomes

What the events of the last several weeks make clear is that the bid is not only insufficient for demand, but the authorities are officially, if quietly recognizing the same. There are already rumours about the next cultivation tenders in Germany, and there is a high likelihood that other countries (see Poland in particular) may also follow suit shortly.

Further, the difficulties in making sure that not only countries but the companies based in the same remain compliant with EU and further German sanctified EU- GMP processes (for one) is likely to be an issue that continues to bubble. Why? It is a problem already in the broader pharmaceutical market here.

The Plusses and Minuses of The News

The first thing that is also obvious is that even Wayland cannot source the entire German market with the product it has begun to grow here no matter who ends up with the last four cultivation licenses this time around. Further, that the other winning bid firms (Aphria and Aurora as known at this point) without cultivation on the ground, are sourcing from somewhere that is also probably at this point, not even Canada. No matter how much expansion is going on in Canada, in other words, what is now entering the German market may bear a Canadian brand but could just have easily been sourced from almost anywhere in the world.

That also means that enterprising firms (see Australian MCA) can skip the Canadian introduction to the German market and sell directly to local producers before they even have crops on the ground, as well as the burgeoning German cannabis distributors across the country.

For such firms now wanting to enter the market, however, it is not all clear sailing. The events of the last few weeks clearly show that the government is watching, including reading English language industry press, and willing to pursue any firms it deems are breaking the rules on both sides of national borders.

Certification, and most certainly paperwork are the name of the game, as well as greater accuracy in company intentions (even if in the near term).


Disclaimer: Nysk, the Macedonian firm referred to in this story, is a sponsor of the MedPayRx pilot to market program

Marguerite Arnold

Farmako Inks Deal To Import 50 Tonnes of Polish Cannabis Into Germany

By Marguerite Arnold
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Marguerite Arnold

The ex-im cannabis map of Europe has been promising to get interesting for some time. And in March, it’s long promised potential just bloomed a little more as Frankfurt-based Farmako announced a first-of-its kind import deal of 50 tonnes of medical cannabis (and from Poland no less) over the next four years.

Farmako was just founded in September 2018. They began distribution to German pharmacies this month. They also have an office in London and cross-European aspirations.

While Farmako is the first to announce such a unique cross-border production and distribution agreement, however, they are far from the only ones planning the same. In fact at least Tilray is expected to announce that their newly-minted Portuguese crop is being processed into oil bound for German pharmacies any day now. It is also not unrealistic to expect that (at least) Canopy Growth, of the big Canadian producers at least, will soon announce the same situation for their crops in countries across the continent, starting with Spain.

Outside Germany of course, this kind of entrepreneurial endeavour is already underway. In the UK, a new import group just announced the first bulk shipment of Dutch medical cannabis into the country, distributed directly to over 1,000 pharmacies nationwide.

There still are a couple of jaw-dropping things to consider about this new German development. Namely, that the amount of just this deal over the next four years between two (relatively new, non-Canadian) companies is approximately five times the amount currently called for in the still pending domestic cultivation bid in Germany.

The second, of course, is that the Polish company on the other side of the border and this ex-im deal, PharmaCann Polska, is a uniquely positioned conglomeration of individuals with apparently Canadian and Israeli market experience. This means that they are already positioned to access the biggest two production markets in the world and are certain to be looking to exploit other Eastern European connections (at minimum). If not ones further afield than that.

One thing is absolutely certain far beyond the particulars of this one deal. The current import limitations from Canada and the Netherlands into the German market appear to be a thing of the past. And the cross-border trade for medical cannabis is now clearly entering a new phase.

Implications

Farmako clearly intends to go after the existing Canadians in the market on price, which means both Canopy Growth and Tilray. But it also means Wayland, at this point is the largest domestic certified producer (albeit with Canadian roots and partners) and an entire licensed facility in eastern Germany ready to go. That is not an insignificant threat and sets up another looming question: Which will actually be cheaper in the long run? Domestically grown German cannabis, or that imported from adjacent countries with lower paying labor markets?

This announcement also means that the “cannabis shortage” in the country is officially over as of this spring. And that won’t just come from Farmako but others already in the market and those angling now to get in via other creative means.

Regardless, what that will do to overall sales, patient numbers and overall speed is another matter.

Other Looming Problems

There are two big issues that this development does not solve of course. The first is the ability of patients to find doctors willing to prescribe the drug, and further to make sure they spend the time filling out the paperwork and negotiating with the patient’s insurer, to make sure that patients can actually get it. Starting with affording medical cannabis in the first place. Most patients on what is known as “statutory” health insurance (90% of the country) cannot afford the out of pocket cost at pharmacies without insurance approvals. Once they get them, they pay up to $12 for a month’s supply (in the case of flower, about an ounce).

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Photo: Ian McWilliams, Flickr

The second issue is that it is currently unclear, mostly due to the lack of granularity provided by the country’s statutory health insurers, what is actually being prescribed for which kind of condition and to whom. Earlier this month, new information was made available about the overall growth of coverage of medical cannabis in Germany. While the total spending, and rough breakdown of flowers vs. product was provided, it is unclear beyond that, where this is going. There were also apparently just over 46,000 patients in Germany as of December 2018. And this is a growth trend that while clearly on an upward trajectory for the last three quarters is slow and steady as she goes. The sudden uptick in the market seen in the second quarter of last year appears to be an anomaly.

Further, understanding market price points is also hard. Flos and prepared pharmaceuticals such as Sativex are highly expensive right now. In the case of the Canadian firms, their medical exports are being sold at about twice the price of their domestic recreational sales points. Look for this to change dramatically as real competition heats up across Europe (and from more distributors than just this Frankfurt upstart).

What the news in other words about Farmako really signifies is that the price barriers in the medical market are about to come down at the point of sale- and hopefully in the short term, patients will not have to rely on the approval of their insurance companies to be able to access the drug because they will be able to afford it themselves. No matter what happens with the bid. Although this too will also serve to lower prices.

The great medical normalization race for medical cannabis in Europe is now officially “on.” And that is good news not only for patients, but of course, the industry.

British Barristers Take On Cannabis “Novel Food” Regulation In Brussels

By Marguerite Arnold
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The first thing to understand about the significance of the British barristers now challenging the EU’s classification of hemp extracts as a novel food is that this is like jumping into the middle of an action adventure by coming in at the second act. In other words, you miss the introduction and the first couple of car chases.

That said, this action movie also features a cannabis-flavored plot. Those used to the maddening hair splitting now going on just about everywhere as the industry gains legitimacy, in other words, are familiar with the larger story line.

Here are the “CBD Cliff’s Notes.”

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

It is highly significant that a major British cannabis trade organization, the Cannabis Trades Association, hired a leading law firm in London to go sue the EU over its recent decision to lump all CBD extracts into the same “novel” distinction. Up until now, only CBD sourced from cannabis had fallen prey to this strange regulation. Thus, the lawsuit. No Brexit themes involved. Yet. Although that too will play a role in all of this.

What Is This Really About?

If those in the CBD business are honest with themselves, the real reason for this segmented part of the cannabis industry to even exist in the first place is the race, desire and need to actually be allowed to operate in relative regulatory peace. No matter what the battles are on the THC front. CBD has been seen as a result, pretty much since the beginning of the new age of legalization, as the “safer” political and market entry choice by those in regions such as U.S. southern states and the burgeoning, can’t-wait-to-be-off-to-the-races, market in Europe. See the new federal hemp legalization bill in the United States as Exhibit A.

However, in Europe this has run into more than a few problems since the Swiss put “low THC” or “Cannabis Lite” on the map more locally. Starting with the whole discussion about licensing in general. And then, even more confusingly, about what to actually classify the plant. Especially when it is used in food and cosmetics as opposed to “medicine.”

Specifically, where does the cannabis plant in general, let alone its individual components, really fall when it comes to regulated human consumption?

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Member states of the European Union

For the time being- read last year when the industry in Spain was facing police busts over CBD cookies on the shelves at health stores- the conventional industry wisdom was that this whole furore was “just” over the use of concentrates, tinctures and other products made from cannabis-sourced CBD. However, given the noise that Austria managed to make over Christmas about the entire “licensing” issue (namely who has the right to produce, sell and package even CBD as a cannabinoid no matter where it is sourced), the EU also moved all CBD products and tinctures- even those made from good old hemp- into the novel food category.

This means in effect, that even CBD extracts produced from the hemp plant (which is actually the majority of such product in Europe) must now be regulated as a “novel food” too. Even though in poor old hemp’s case, it is certainly the case that health food nuts have been consuming the same in Europe long before (and certainly after) standing EU “novel food” regulations were put into place back in the late 90’s.

Thus, the lawsuit, launched from a country unsure of whether it will even be in the EU post-May (either the month or the current PM).

According to the EU at least for now, CBD itself is a “novel food” no matter from where it is sourced. And that, according to not only science but food history is an absolute fallacy.consumer safety, from factory to pharmacy or farm to table, is never far from the discussion

Likely Outcomes

Those who were hoping that CBD would remain unregulated in the EU should think again. It is highly likely that what will happen is that CBD production licensing is in the cards and just about everywhere. Think GMPs but with a consumer-food twist.

While indie producers might groan at the prospect of fees and licensing procedures, remember this is Europe. And consumer safety, from factory to pharmacy or farm to table, is never far from the discussion.

While this lawsuit, in other words, is likely to make the EU think more closely about regulating CBD in general, what is most likely to happen is that entire enchilada will be lumped under a regime to insure that high quality production, particularly of crops bound for consumption, is also extended to anything that ends up in either a food or cosmetic product.

CBD Producers Have To Keep Current On Regs

Given the current murkiness that exists, in other words at this point across Europe, in every country and for every CBD product, exports here from other places are still not a great idea.

There are labeling, licensing and of course, ultimately legislative issues that are all still in flux. And while the outcome of the lawsuit might eventually regulate and standardize things, the idea that a license-free CBD production industry is clearly now dead in the water.