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Luxembourg’s Government Triples Medical Cannabis Budget for 2020

By Marguerite Arnold
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While Luxembourg is a tiny country in the middle of Europe, it is beginning to play an outsized role in pushing all aspects of the cannabis discussion forward in the EU.

The country has steadily moved forward on integrating cannabis into the medical system. In 2018, medical cannabis was tested in a pilot project and is now available, on prescription, from a limited number of hospital pharmacies since February of this year. The program, at least from the Department of Health’s perspective, has been “very successful” so far in the words of Health Minister Etienne Schneier.

So, as a result, the next phase of the transition is going into effect. The budget for doctor training and medical cannabis purchases will be increased from €350,000 to €1.37 million next year. The drug will also be available from all pharmacies. Overall, the government has allocated a budget of €228 million for its cannabis “pilot” next year – an increase of €22m in 2019.

Canopy Growth Moves Into A Prime Position

Canopy_Growth_Corporation_logoCanopy Growth also announced last month that it has now become the exclusive supplier of medical cannabis to the country in a deal that extends through the end of 2021 (in other words presumably until recreational reform becomes legal). This is an interesting twist of events, given that Aurora announced it was the first company to import the drug into the country last year.

This is certainly a new chapter in the ongoing competition between the two Canadian companies who have, since 2017, essentially split Europe’s “first entries” between them (with the exception of Tilray in Portugal).

It also comes at a time when Aurora has just lost its third license in Italy to cultivate.

The clash of the cannatitans continues.

Why Is Luxembourg’s Cannabis Experiment So Interesting?

The increasingly strategic position of this tiny country on the cannabis discussion cannot be discounted.

aurora logoIn the summer of 2018, it was the government’s decision to change the law on medical cannabis use that preserved the ability of Germans to continue to buy cannabis stocks. Confused? The Deutsche Börse, in Frankfurt, the third largest stock exchange in the world, claimed that it could not “clear” stock purchases last summer because their clearing company, based in Luxembourg, could not close the transactions in a country where even medical cannabis was still off the table. When Luxembourg changed their law, in other words, the Deutsche Börse had to reverse course.

Since then, this tiny country has continued to challenge the cannabis discussion in the EU – also announcing that a full-boat recreational program will be enacted within the next two years (almost certainly by 2021). This aggressive timetable will also move the discussion in almost every EU regulation still on the table, and probably position the country as the only one in Europe where a fully integrated medical and recreational policy is in place. Even Holland does not cover medical cannabis these days. Dutch insurers stopped covering the drug in early 2017 – just as the German government changed its own laws.

Luxembourg, in other words, has now effectively pulled at least on par with Denmark and Germany in the cannabis discussion, with recreational now the agenda. And appears to be willing to preserve its medical program after recreational comes.

Who says size matters?

The “Colorado” Of Europe?

One of the reasons Colorado was such a strategic state in the cannabis discussion in the U.S. was undoubtedly its “purple” status – i.e. a state which politically swung both ways on a range of policy issues.

Luxembourg in fact, as the seat of the European Courts of Justice, may end up playing the same role in Europe – but on a national level.

In fact, the battle here increasingly resembles not Canada, but the U.S., as individual countries begin to tackle the cannabis question in their own way – both within and beyond the EU rubrics on the drug.

Will the United States legalize federally before the EU changes its tune? That is unknowable.

However, for the moment, the market leader in the EU to watch is undoubtedly Luxembourg, no matter its geographical size and population count.

As usual, cannabis reform enters through a crack, and widens from there. Luxembourg appears to be, if not the only crack, then certainly one of them that is turning into a decently sized crevice in the unyielding wall of blanket prohibition.

The Great European Cannabis Cosmetics Confusion

By Marguerite Arnold
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If the “recreational” discussion is off the table for now except in a few local sovereign experiments (Luxembourg, Switzerland, Denmark, Holland), and the medical discussion is mired in “efficacy” and payments (Germany, UK), where does that leave this third area of cannabis products?

Namely cosmetics.

The answer? Because this conversation involves cannabis, as usual, the discussion is getting bogged down in confusion even as industry groups press for clarification and guidelines.

The Problem

Cosmetics, including externally applied creams, lotions and potions, are of course subject to regulation and testing beyond cannabinoids. Think of your favourite cosmetic product and the notices about no animal testing (et al). Yet when the conversation comes to cannabis, of course, even of the hemp kind, the current discussion in the EU is mired in confusion, and of course ongoing stigma. Not science. Or even logic.

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

According to the EU Working Group on Cosmetic Products earlier this year, ingredients containing CBD (even derived from hemp) should be banned from cosmetics production because of the ban on cannabis as an illicit substance under the 1961 Single Convention on Narcotic Drugs. Guidance under the Cosing Catalogue (a database of allowed and banned ingredients)  gives individual EU member states a framework to set national rules for cosmetics.

To add to the confusion, the EU also added new entries to the EU inventory of cosmetic ingredients which outlaw CBD derived from extracts, tincture or resin. But – in a bizarre bureaucratic swerve, they did approve “synthetically produced CBD.”

Opponents of the ruling – including the European Industrial Hemp Association (EIHA) have of course opposed the newest guidelines on regs. CBD, as the EIHA has mentioned repeatedly, is not referenced specifically in the 1961 Convention.

The EIHA wants the EU to treat cosmetics like other CBD products – namely requiring that they have less than 0.2% THC.

The EIHA Proposal

The EIHA has its own proposal for setting guidelines under Cosing. Namely that extracts from industrial hemp and pure CBD should only be prohibited from use in cosmetic products if they are not manufactured in compliance with laws in the country of origin.

Further, the EIHA has also pointed out that the seeds and leaves of industrial hemp and any products derived from the same are also clearly excluded from the 1961 Convention.

However, and herein lies the rub – even within the EU, there is not yet harmonization on these standards between countries. So, what may pass for “legal” in the country of production may also not pass for products that are then exported – even within the EU and or in Europe.

EIHA also has proposed new wording for the definition of Cannabidiol based on the International Nomenclature of Cosmetics Ingredients (INCI), the most comprehensive and widely recognized international list of ingredients used in cosmetics and personal care products.

Where Does This Cross With Novel Food?

Of course there is also the confusion in the room about cannabis extracts as “novel food.” Cosmetics of course are designed for external application, but cannabis tinctures and extracts containing “CBD” are being put in that category right now by regulators in the EU. The fact that novel food is also in the room may in fact be the reason that regulators are apparently sanguine about synthetic CBD in cosmetics, but not that derived from the actual plant.

The cannabis discussion is going to be in the room for many years to come and on all fronts – from medication to food to cosmetics.Bottom line? There are, at present, no easy answers. This leaves the CBD industry in the EU, at all levels, as the planet barrels into the third decade of this century, in basically a state of limbo. If not absolute confusion.

What Is The Outlook?

While it may not be “pretty” right now, the industry is clearly moving through channels to pressure and challenge regulators at key international points and places.

What is increasingly obvious however, is that the problem with cannabis – at all levels – will not be solved soon, or easily. Even calls for “recreational reform” or even “descheduling” will not cure them.

Cannabis as a plant, if not a substance used in everyday living has been so stigmatized over the last 100 years that a few years of reform – less than a decade if one counts the organization of the industry since 2013 globally – will not come close to fixing if not ironing out the bugs.

The cannabis discussion, in other words, is going to be in the room for many years to come and on all fronts – from medication to food to cosmetics.

Doctors & Researchers Push Medical Efficacy Forward at 10th IACM

By Marguerite Arnold
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It is easy to forget as one steps inside this world-class medical conference (held this year in Berlin), that cannabis is disputed as medicine anywhere in the world.

Inside a packed conference hall in an upscale hotel in East Berlin, international researchers presented evidence that when taken as a drug, this simple plant can make a world of difference to patients suffering from a range of illnesses.

There were also doctors who talked about prescribing this as medicine (even to children), with dramatic and affirming results (if not heart-warming pictures).

In sum, as always, the IACM is the best place to find facts if not evidence galore to convince even the most hard-boiled egghead that this drug works – and across a broad range of so far “other” drug-resistant medical conditions.

As a participant in the IACM said after the opening remarks on the very first morning, it is so easy to ask the question – “Why are doctors still so afraid of if not resistant to this drug?”

Medical efficacy is no longer an unanswered question…

For those seeking affirmation and evidence, this year’s IACM did not disappoint. There were presentations on the drug’s impact on neurological, oncological and inflammatory conditions that while not all new, are increasingly impactful in an aging planet.

A full house of attendees for the patients panel

But that is not all that was discussed. The broader implications of adding cannabis into skincare, diets and medicine chests were also presented – from cannabis’ impact on lowering obesity and positively affecting acne to impacting the opioid epidemic.

Also intriguing this year was a far-reaching study on how polluted the CBD supply chain is in Europe, even for non-medical and nutraceutical products. Not to mention a socio-political plea for legalization of personal use in South Africa.

And that was just the presentations from the stage and in the poster hall.

The conversations swirling around were just as interesting. Because of course, nobody at this three-day gathering, for all the normalization on display, did forget that this gathering of doctors, scientists, cannabis companies and patients is still an anomaly.

The fact is that there are still too few doctors prescribing. And too few trials. And too many fights over efficacy still in the room.

As Alice O’Leary Randall (wife and former partner in activism with her late husband, Professor Randall who initiated the medical efficacy fight in the U.S. in 1975 over glaucoma) said to Cannabis Industry Journal, “It is hard to believe that we are still fighting the same fights all over again.”

Another “AIDS” Crisis?

There is a more dramatic sense of urgency at the IACM than other conferences that focus just on the “business.” In part, this is because the conference is made up of not only doctors and researchers who fight to prescribe the drug or get trials funded, but also patients on the front lines in a country where the drug is supposed to be covered by health insurance.

Dr. Franjo Grotenhermen (seen on the table) and others during a panel discussion

The patient panel, as a result, was an international face of accusation: To national authorities who still refuse to mandate cannabinoid care – across Europe and beyond. To medical establishments who are not demanding cannabinoid treatment be made mandatory in hospitals and emergency rooms in every country in the EU and beyond. To individual doctors who refuse to come to such conferences, where, if they wanted to, could learn how to begin prescribing the “next penicillin.” To payers and insurers who are still too slow to pick up the message if not the tab.

Indeed, one of the best panels of the conference was a gaggle of doctors, led by Grotenhermen, who discussed the particulars of approaching a new drug – for the very first patient and first time.

Act Up, Speak Out, Silence Equals Death

As the conference wrapped up with its awards dinner, there was of course, a sense of needing to go home with not wanting this to end. For those in the thick of this multi-generational fight, there of course were words of encouragement to colleagues from the industry, internationally. But there was also a new sense of needing to up the pace, if not create faster change.

The battles are far from over – in fact, they are just beginning in many places. As one questioner said of a panel about halfway through the conference – “We need to pick up the fight the same way the AIDS community did on this drug.”

That remark perhaps means less today than it did 20 to 30 years ago when an embattled LGBTQ subculture was the organized point of the spear that fought the early state legalization battles as pioneers for a cause that sought equality as much as it sought a cure.

The plea did not fall on deaf ears.

In the midst of studies, statistics and scientific evidence, in other words, there was a new sense of a need for a renewed fight – and from the medical and scientific community as well as patients.

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Italian Government Cancels One of Aurora’s Licenses

By Marguerite Arnold
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Aurora has just faced a rare setback in Europe. The Italian government has cancelled one of three tender cultivation lots to supply Italian patients it granted Aurora this summer (in July).

Aurora was the only company to win the bid after other companies were disqualified.

For this reason, the high-level parliamentary attention to the bid this fall is even more interesting. Most foreign cannabis is being imported from the Netherlands and Bedrocan. While Wayland (ICC) and Canopy are in the country (Wayland has established production facilities for CBD in fact), Aurora was the only foreign Canadian cannabis company to actually win government issued, cultivation slots.

What Is Going On?

In July, Aurora won the Italian bid, beating out all other companies for all three lots.

aurora logoYet in September, the third lot, for high-level CBD medical flower, was cancelled by the Ministry of Defense which oversees cannabis importing and production, for an odd reason. Specifically, the lot was suddenly “not needed.”

As of October 31, the Minister of Health responded to parliamentarians who wondered about this administrative overrule by saying that the rejected lot (lot 3, for high-level CBD) was in fact rejected because stability studies to define the shelf life of products were not being conducted.

EU GMP Standards Are In The Room In Europe

This is not really a strange turn of events for those who have been struggling on the ground in ex-im Europe to learn the rules.

For at least the second time this year, and possibly the third, a national European government has called stability tests and the equality of EU-GMP standards into question. As Cannabis Industry Journal broke earlier this fall, the Polish government apparently called the Dutch government into question over stabilization tests (albeit for THC imports) during the February to September timeframe.

european union statesIt is still unknown if there is any connection between these two events although the timing is certainly interesting. Just as it was also interesting that both Denmark and Holland also seemed to be in sync this summer over packaging and testing issues in July.

Aurora and Bedrocan are also the two biggest players in the Polish market (although Canopy Growth as well as other international, non-Canadian cannabis companies are also making their mark).

What is surprising, in other words, is that countries all around Germany are suddenly asking questions about stability tests, but German authorities, still are notably silent.

Why might this be? Especially with German production now underway, and imports surging into the market?

Is This A Strange EU-Level CBD Recreational Play In Disguise?

There are no real answers and no company is talking – but in truth this is not a failure of any company on the ground, rather governments who set the rules. If there are any cannabis companies in the room at this point who are not in the process of mandating compliance checks including stability tests, it is the governments so far, who have let this stand.

Notably, the German government. Nobody else, it appears, is willing to play this game.

Further however, and even more interestingly, this “cancellation” also comes at a time when novel food is very much in the room in Italy. Namely, it is now a crime to produce any hemp food product without a license. There is no reason, in this environment, why a national cultivator could not also produce locally a high-quality, high-CBD product for the nascent Italian medical market.

While nobody is really clear about the details, there is one more intriguing detail in the room. The government may, in fact, allow medical cultivation now by third parties.

Bremen Steps Up Its Cannabis Campaign As Other Groups Lobby For More Access

By Marguerite Arnold
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The German city of Bremen (perhaps you know it from the Brothers Grimm and the animal musicians) is determined to force the federal German government to play another tune when it comes to basic access within the city.

For those without the special geographic knowledge that comes with being a “local” this is also a deliberately strategic political move. Bremen, like Berlin, is a strange German hybrid, a city-state.

Change here, of course, like Berlin, would have wide impact on other German states.

It is not a new campaign of course. None of these city campaigns for home-grow really are. They are the result of efforts, at this point with elected officials involved, of literally decades of patient activists, who are still necessary. But this time, they have politicians involved. When the national ones don’t listen, the local ones are being dragged in.

That said, don’t expect any breakthroughs or miracles from Bremen or Berlin either right now for that matter. This experiment, in Bremen just like the country’s capital, is still at least several years off, no matter its regular recycling in news stories for the last several years.

The German city of Bremen
Image: Chaim Dönnewald, Flickr

Politically right now it is hard to understand the CDU’s continued reluctance to embrace the weed. The CDU is Germany’s strongest and largest “middle of the road” party. Particularly because they along with everyone else of alternative political persuasions are highly alarmed by the right wing AfD’s popularity and spread. It is not inconceivable that even Germany’s largest if not highly beleaguered party might use a little cannabis to stop that. And they are being pushed, hard now, by the fringes.

The Outpricing Of The Patient Movement

Talk to any cannabis-connected company right now and chances are you will hear the phrase “patient first.”

That means nothing in an environment where most patient groups are kept out of the room when legislation opening markets is being written (certainly in Europe). And of course, it is precisely the individuals that these groups represent who cannot afford the legal medication hitting the markets early.

Here, because of the focus on high-quality, GMP-certified product, the chances of a patient collective actually being able to afford a cultivation license (for example) are so far non-existent.

As a result, there is an active foment on the ground right now in almost every country in Europe. This is meeting other kinds of frustration right now and that can be a powerful weapon for change. However, without funded lobbyists in most European capitals and Brussels, there is more power and money behind the established industry right now to keep the (almost) status quo.

As strange as they seem to the cannabis industry right now, GMP certification is a standard pharmaceutical designation.

The boogeymen in the room right now, in other words, for every strong patient group, with its own grey market distribution channels, are the well-funded companies who are in fact getting the laws to change.

Patients, in these environs, as well as their concerns, are left out entirely.

The Strength of The European Gray Market

For this very reason, the gray market problem is going to be large in Europe for quite some time to come. Patients are effectively priced out of the legitimate market if they cannot get insurer approvals and for most that is still the biggest problem in the room.

Are there large gray market grows all over Europe? Yes. As one German activist told Cannabis Industry Journal recently, echoing the comments and practices of thousands of others, “Yes, they made me jump through the hoops, and I have packaging from all the big guys. That’s how I carry my home grow these days.”

Forget “patient cards” that some enterprising distributors are trying to get patients to carry.

The cops don’t challenge legit packaging. And every producer, distributor and patient knows that. Buy once, no matter how exorbitant, and that is all she wrote.

For that reason, “patient numbers” if not “sales” actually mean very little.

It does not matter, in other words, if a cannabis company announces its market entry in any country right now. What matters is that they can prove consistent supply and sales and real patient numbers – which if GDPR (European privacy legislation) is strictly followed, producers and distributors should never really know at a level that such sales are trackable per patient.

And that is where this all gets difficult down in the weeds.

Are there large gray market grows all over Europe? Yes. Are they all under the purview of the criminal black market? No. There are very organized patient non-profit networks locally in just about every city and town in Europe. If not other places.

And, where those fail, certainly in Germany, there is always the area around every local train station. If you are hard up enough and desperate enough, skunk and hash albeit of an indeterminate source, will cost you about $12 per gram.

There is no cannabis company in the room anywhere in Europe that can provide legit product via any pharmacy, for that price at point of sale. Yet. And therein, as always, lies the rub.

european union states

The Economics of Ex-Im In Europe

By Marguerite Arnold
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european union states

You have read the press releases. You may have heard about such ideas at a recent cannabis conference in and around the EU of late. Or you may have encountered new distributors coming into the game with a German presence and a decidedly interesting ex-im plan that sounds a bit, well, off the map.

No matter how geographically creative some of these plans are, the problem is that many of these ideas literally do not make economic sense. Either for the companies themselves (if not their investors), and certainly not for patients. Not to mention, truth be told, the looming price sensitivity issues in the European market that North Americans, for starters, seem to still just be waking up to.

Some Recent Examples….

Yes, exports from Denmark have been much in the news lately (including into both Germany and Poland). Truth be told, however, this makes about as much sense, economically, as importing ice to eskimos. Why? Denmark, for all its looser regulations and less-uptight approach to the cannabis discussion generally, is one of the most expensive labour markets in Europe. Fully automated production plants are one thing, but you can build those in other places too. Especially warmer climates, with lots of sunshine. German production, as it comes online, will also make this idea increasingly ludicrous.

Who on earth got on this bandwagon? It seems that the enthusiasm in the room began when Denmark began to import to Germany (where the disparities in wages in production are not so noticeable). However, lately, several Canadian companies with a Danish footprint have been eying Poland of late.

And on that particular topic – there are many who are doing the math and trying to figure out, as the alternatives get going, if even Canada makes much sense, or will in a few years.

Low Wage Markets With Sunshine Are Hotspots For European Cannabis Production

Like it or not, the European market is extraordinarily price sensitive – namely because it is not “just” consumers called patients picking up the tab but health insurance companies demanding proof of medical efficacy.

That starts, a bit unfortunately, with understanding wage economics across Europe. The warmer the climate, in other words and the further east on the map, wages drop precipitously. That is “good” for an industry looking to produce ever cheaper (but more compliant) product.

It is also good, at least politically, for countries whose elected leaders are being forced to admit that cannabis works, but are less than copacetic about encouraging local production. See Germany for starters, but places like Austria, Poland and most recently France (which has just embarked on a first of its kind medical cannabis trial).

Here, no matter the temporary buzz about Denmark, are the places that cannabis production makes sense:european union states

Portugal: The country is a newcomer in the cannabis discussion this fall, although in truth, the seeds of this reality were sown several seasons ago when Tilray began to build its production plant in the country in 2017. They are far from the only company who has seen the light, and these days, farmers are getting hip to the possibilities. Especially if they are already exporting crops throughout Europe.

Spain: The industry that can afford GMP certification is getting going, but everyone else is stuck in a limbo between pharmaceutical producers and the strange gray market (see the patient clubs in Barcelona). That said, political groups are beginning to discuss cultivation as an economic development tool, if not sustainable food and medication strategies.

Greece: The weather is warm, and the investment climate welcoming. Of all the countries in the EU, Greece has embraced the economic possibilities that cannabis could bring. How that will play out in the next years to come is an intriguing story.

Italy: The southern part of the country in particular is ripe for cannabis investment and it’s full of sunshine. However, as many have noted, organized crime in this part of the world is a bit fierce and starts with the letter M.

Malta: The island is a comer, but does importing cannabis from here really make economic sense? There are trade routes and economic treaties tying the island both to the apparently Brexiting British and Europe. Why not, right? Just remember that along with labour, transportation costs are in the room here too.

And Just Outside The EU…

The country now (sort of) known as North Macedonia and struggling to get into the EU if France would just get out of the way is also going to be a heavyweight in this discussion for years to come. Wages, of course, will increase as part of EU membership, but in general, this country just north of Greece is going to play a highly strategic role in exports throughout Europe.

Poland Gets Cracking (Sort Of)

By Marguerite Arnold
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One of the surest ways to understand that you are entering not just another country, but what is called an “emerging market” is when you travel from Germany to Poland by train.

There is only one “intercity” option from Berlin Hauptbahnhoff – a far cry from the modern, internet-connected, fast ICE trains that go West. This line is run by the Poles. By the time you reach Warsaw five hours later, however, it is clear at least some parts of this country are booming. The skyscraper construction in the center of town rivals London and Berlin.

Like every emerging market, there are vast disparities in wealth and income, if not opportunity here. And into this discussion, now is coming the entire cannabis discussion. Visiting, as an American, in particular, one is reminded of a city that could be East Berlin 15 years ago.

As a cannabis journalist, it feels, from this perspective, like every American state in the 1990’s. Reform is on the tip of everyone’s tongue. But not quite realized yet, except for a few elites. Beyond such realities which are common in the world of cannabis, how very, well, Iron Curtain.

The difference of course, these days, is that the conversation next door in Germany, as well as other places, is finally forcing the Polish government to face reality. But it is clear, from interviews with activists and patients in particular, as well as the nascent newcomers from abroad testing the cannabis waters, that this fight is not going to be easy on the ground.

Then again, when and where has it ever been?

The Patients….

As always, real reform and market opening is driven by the sheer numbers of sick people who brave arrest to gain access to the plant. Some do it for themselves. Many do it for their children (of all ages). An elderly, boomer couple who talked to Cannabis Industry Journal about their ordeal also see it as a form of justified struggle. And Poles are no strangers to that, far from the cannabis kind.

That ethic is much in the room among the nascent industry that is also struggling to find respect. The Polish side of the discussion is looking at hemp. And growing THC illicitly, just like elsewhere.

But the budding movement here is highly organized, including on the business end, with hundreds of thousands of members. How this translates into a legal industry (besides media and hemp products) is of course, still up for grabs.

That is very much in the minds of those who brave the struggle daily. The patient collective in Warsaw is also highly organized – providing free and non-profit product to those most in need. It is an impressive operation. And further one that is increasingly distrustful of foreigners seeking “market share.” If not the already floating “suits.” Just knowing how to speak Polish, as the activists are, at least realizing, is not a guarantee that they will not be dealing with cannasharks only interested in their contacts and mailing lists. Patients over profits is a phrase you hear a lot here. This has nothing to do with not wanting to support a legit, safe industry. But when you are poor, you find ways to improvise. Including getting your medication.

The Foreign Companies…

Aurora and Canopy Growth are already in the room and there are other Canadians lining up to follow. However, these two are the only ones so far who have been able to get their products registered locally and even then, availability is still in the offing.

european union statesThese are also highly expensive products. And do not begin to compete with producers now eying the Polish market from North Macedonia and the rest of Eastern Europe.

The foreign companies, in other words, are already broadly falling into two camps. North American curiosity seekers (at this point), and companies, mostly from the East and South, who are looking to Poland to be the “next Germany.” Especially because their product is so price and geographically convenient.

A Battle For Poland’s Emerging Market

It is clear that at least the Canadian companies are already lining up against more home grown and patient interests. Just as what happened in Germany and the rest of Europe so far. And not even on purpose, but more on matters of price.

Like other pre-commoditized markets, the Polish industry is still trying to be (relatively) equal and fair, as much as there is a huge amount of positioning already just below the surface. Everyone is tired of struggling. Dreams of cannabis riches are enticing just about everywhere.

Of course, add to that, patients are dying here, and that always sets the tone – especially when only the richest and lucky few can afford to access the drug through legitimate channels. Face pain, unpleasantness or death or buy in the black market? For the Polish industry on the forefront of the debate, in other words, the stakes are high, the government is moving glacially, and those on the ground are organizing to meet the winds of change.

Foment for another kind of Green Perostroika? Perhaps.

There will, almost certainly as a result of these forces, be a call for a Polish bid – and further one that allows for local producers to enter the medical market.

But the bottom line is that this strange, and exciting and certainly new market is going to be as volatile, and wild west as any in Europe for the immediate future. Expect interesting things, if not more of the same.

A Year In Review: Canadian Recreational Reform Year 1

By Marguerite Arnold
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There is certainly, in retrospect, much to be proud about in Canada – home of one of the most disruptive international cannabis industries in the world. And certainly an early mover.

That starts with having the national mojo to begin this journey in the first place, not to mention pivot and even admit faults along the way. For all the complaints and whinges, however on the ground, most Canadians are proud that they tackled the canna question at a federal level.

As the industry now does a bit of an annual review and revisit, what are some of the largest accomplishments, takeaways (and let’s be honest, major f*ckups) so far? And where is this all headed as the industry at least tries to gear up for another year, if not quite Cannabis 2.0?

The Big Bravos

Launching in the first place. Yes Full Monty Recreational was scary, and delayed a few months last year. And even though there have been many problems (retail outlets, online sales, privacy, supply chain issues in every direction, ex im, foreign markets and etc.), it is up and running.

In comparison, the Brits have been haranguing over Brexit for the last three years and are still not really there.

Further, it is also apparent that the agencies in charge of the new industry are themselves giving a bit of a shake after CannaTitanic (CannTrust). That was embarrassing for them too, although of course, while a bit of a negative compliment, the recall system seems to work.

Even if it needs a few jump starts via whistleblowing.

That in and of itself is a fact that is still in the room, although perhaps the pancaking of the stock price of most of the public industry of late was also another much needed wakeup call.

The Devil In The Details

Domestic Requirements. Health Canada is getting hip to the fact that the industry needs a bit more of a heavy hand. See the book thrown at CannTrust. No matter what, Canadians are demanding to know where their cannabis comes from, and further are also demanding that it be at least free of pesticides that can harm them.

Licensing. Many cannapreneuers are complaining, still, about the delays in licensing, particularly for retail outlets in the provinces who are taking the cannabull by the horns.  That said, there are still lots of enterprises who are perfectly happy to dodge the requirements all together and sell to the black or gray market. No licensing fees, and no taxes is a wonderful dream, but that is not exactly how regulated democratic capitalism works – at least at this level.

Supply Chain Logistics and Related Technologies. Canadians are struggling to implement a regulated industry in a country where patient home grow is constitutionally protected, and in an environment where who can sell what, and to whom including online, is still evolving. Predictably, no matter how groovy the solution works at home, (or the U.S.), no it will not fly in Europe. See GDPR regs, for starters.

Seed Culture (Aka Strain Protection). No matter how much the lawyers in the colonies are gearing up to sue each other over Huey’s Half Baked, in Europe, there are tomato and pepper farmers who are laughing, literally, all the way to the bank on this one. While hip to be a “strain defender,” the reality in a medical market looking for cheap cannabinoids is rather different. Effective, clean product, which can be reproduced reliably and cheaply, is the name of the game. Girl Scout Cookies, and such ilks will be a long time in coming as anything but highly expensive, niche products you can find in a Dutch Coffee Shop.

GMPDomestic Requirements Vs International Export. Canadian standards, so far, have been widely divergent in an environment where exports to Europe in particular are part of the story for the biggest companies. That said, GMP, and in particular EU GMP, has become at least a buzzword if not a standard to live up to.

Privacy. California might be considering its own form of GDPR (European privacy legislation) but so far, the industry has largely failed to protect consumers (from themselves). Ideas about owning huge data troves on cannabis users for someone else’s profit are still very much in the room. After all, data is the new oil, whether people know their data is being harvested or not. And just like big oil has done for most of its existence, those in the driver’s seat so far show little compunction about harvesting personal information, to become in the words of the now departed CEO of Canopy Growth Bruce Linton, “the Google of Cannabis.” Won’t happen. Starting with the fact that in not just Europe but now even California, people, far beyond pot users are tired of a world where privacy is a second class right.

While the issue first hit in Canada on the recreational side, the reality is that companies know who their clients and patients are in a way that is not only disturbing but increasingly being challenged.

A Second Chance: CannTrust To Destroy Inventory & Plants

By Marguerite Arnold
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The beleaguered CannTrust has been given a way out of the perilous mess that executive management created for the company – but such a salvation comes at a high cost. That said, the company was already in deep water with regulators and clients. Health Canada, in fact, cancelled the company’s license to produce and sell cannabis in September – essentially mandating mass returns two months after a whistleblower instigated what is probably the legal industry’s most egregious scandal to date.

Efforts to regain regulatory approval also include plans by the company to recover cannabis that was not authorized by its license, and improve inventory tracking – the full details of which will be delivered to Health Canada by October 21.

While the beleaguered pot company’s stock predictably surged again on the public markets, the question lingers: can CannTrust ever be trusted again? These were egregious violations.

A Changing Industry

As with most things in business, the issues plaguing CannTrust were not isolated to one company. This has ranged in the past from pesticide use to creative accounting. Not to mention all sorts of creative endeavors on the financial side that are, depending on which stock market you look at this from, less than legit or just this side of shady.

It was easy to throw the book at a company like this – not only for these specific violations, but also as a warning to others tempted to engage in similar tactics (or fail to clean those up that still exist).

CannTrust in other words, was a clarion bell about the change in the weather, driven not only by international treaties but the legitimization of the drug, on the ground. Globally. When large health insurers get involved (see Europe), the conversation begins to change. And it is, fairly drastically.

On the ground in Germany, there are two more cultivation sites underway with one now certified and functional. BfArM (the German equivalent of the FDA) is now on the front lines of a battle that so far, at least in Canada, has not been addressed at a level Europe requires. That said, this reality too is changing. One of the largest distributors in Germany, CC Pharma, now owned by Aphria, has started a supply chain compliance check that is overdue. And further, while focussed on the cannabis industry, in truth, is a problem that plagues pharma far from cannabinoids.

However, as this is the cannabis industry, the scandals that rip through headlines are that much more visceral.

Seed to sale traceability, and further in a model unseen in the industry so far, will also become a watchword that is still rippling through an international industry chafing at any sort of standards, let alone standardization required for pharmaceutical acceptance. The bar, in other words, has just been set much higher. And there are many who will not make the grade.

CannTrust, certainly, was a victim not only of internal mismanagement, but a shifting environment that is rapidly upgrading on a level not seen so far in the entire North American industry – with a few notable exceptions. 

Pharmaceutical Grade Is The Standard To Beat

Here is the reality now facing an industry coming into its own and on an international basis. The standards are tightening. The rules are not only being written but being enforced. And while there are sure to be a few more scandals along the way, the kinds of basic problems found at CannTrust are probably, finally, going extinct in the part of the industry that now knows it is being held accountable to far higher standards.

The reason? Medical grade and national food standards are in the room for every exporter now eyeing Europe. And that alone is resetting the debate everywhere. No matter how treacherous the path may be.

So no matter how harsh the penalties are now facing one company, even the regulators know that this is shifting territory. CannTrust, after all, is being given a second chance.

european union states

Safeguarding Your International Supply Chain: The Brave New World Of Cannabis Compliance

By Marguerite Arnold
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european union states

The CannTrust story may have shocked the uninitiated, but it hit almost every bogeyman the legitimizing industry has both feared and suffered from, particularly of late.

Here, generally, is the issue. Especially in Europe (even more especially in places like Germany, the UK and other emerging markets), budding cannapreneurs need each other. A distributor in Germany, for example, cannot get their final (federal) licenses allowing them to do business without establishing a relationship with an existing producer. That producer also needs relationships with established distributors to get their licenses.

In a fraught world, where all parties are evolving rapidly (and this also includes the “Big Boys” from Canada and several U.S. states including California), supply chain logistics, and even contract agreements if not licensing beyond that requires a level of honesty, integrity and transparency the industry, largely has not achieved yet.

That said, there are also parties, if not individuals and companies determined to set themselves on the straight and narrow – and play by the emerging “rules” – and then there are also clearly companies which, well, do not.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.What this brave new world of cannabis requires, however, and from everyone – from grower, to manufacturer, packager, distributor and service delivery – is that all ecosystem partners must be in compliance.

Ensuring that can be a full time job. But what it also means is that to have a fully compliant product, every party in the chain bears responsibility for upholding standards that so far have proved hard to reach for many.

The time has come, in other words, where that is no longer an option.

The First Step Is Certification…

GMPIn a world where every member of the diverse cannabis ecosystem requires certification, determining what, and from whom is the first hurdle – both for buyer and seller. If one has GMP-certified product, that is awesome. But there are also treaties in the room that only allow some GMP certifications to be considered equal to others. If you are in Lesotho right now, for example, far from Europe, your biggest concern is not just looking to the EU but figuring out a way to export your crop into your neighbouring (and surrounding) country – namely South Africa.

This example, while seemingly far away, in fact, is the biggest bugbear in determining who can sell to whom even within Europe (let alone countries just outside and far beyond the region).

Determining cert presence, if not validity, however, is only the tip of the iceberg. And depending on who you are, that path alone is not a one time dalliance with authorities, but multiple certifications that must all also be kept current.

But It is Not The Only One…

The second hurdle, of course, is also checking the verity of everyone you do business with. For a producer, this includes making sure that processing, packaging, and even transportation are in compliance. In Canada, of course, this has been short circuited by the ability of producers to ship directly to patients.

In Europe, however, this is far from the case. And that is also why the entire conversation is also getting not only much more granular, but expensive. Pharmaceutical regulations are actually what guide the rules of the road here.

european union statesWalking floors, and checking, in person, may or not be mandated by international treaties at this point. However, most of the young producers on the ground here are implementing policies of personal visits to their vendors. In Massachusetts of late, this is also on the drawing board. Albeit on a “state” level, the reality is that both federal, state and more local training is a watchword, if not a must, now on the roadmap.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.

And while that obviously is a challenge, companies must step up to the plate internally to commit to the same. It is too dangerous to ignore such steps. Including the easy to reach ones, like staff background checks and decent cybersecurity safeguards. The former has blown several enterprising cannadudes out of the driver’s seat already in Europe over the last few years. The latter is an emerging threat in a region that is also home to GDPR regulation (and growing fines).

For that very reason, certainly on the ground in Germany if not across Europe and in those countries and companies that wish to supply the same, supply chain verification, that is constant, consistent and verifiable, is the path for the industry both as of now and in the immediate future.