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Shades Of Cannabis Reform & Confusion Across Europe Seem To Mirror US Progress

By Marguerite Arnold
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Cannabis reform is proceeding globally right now in some interesting places, and in an oddly syncopated schedule yet again.

Namely, in the last few weeks, change has been moving forward not only in the U.S., but Europe too. That this effort in the EU came literally weeks before the American presidential election where as of now, no matter who will occupy the White House, even more states move into the adult use camp is also surely no accident. Particularly given the results.

In South Dakota’s case, voters agreed to legalize both a medical and recreational market in a single election. In New Jersey, the referendum that passed authorized a market that is moving quickly to get implemented. This is equally intriguing. Namely that to the average person right now, no matter where they are, the continued delays and gridlock to get going, no matter the problems along the way, are increasingly unpopular politically. That too, is showing up at the ballot box.

Indeed, cannabis reform is now absolutely one of the most pressing and yet unaddressed issues in several countries at present. See New Zealand (where the voter mandate for adult use reform failed during their Presidential election last week).

Europe Seems To Be Following New Zealand’s Caution As Germany Delays Further Reform But…

Last week, a proposal on adult use cannabis reform failed in the German Bundestag (Parliament). With the exception of the far right Alternativ für Deutschland (AfD), every other political party agrees that there needs to be forward motion on the topic, but nobody seems to want to fully address it. This is no surprise. Indeed, the recent appointment of a former German minister last month to a Swiss cannabis company seems, certainly in retrospect, to presage the same. As well as the many protest votes on the topic emanating from Berlin, one way or the other.

However, in the aftermath of what is expected to be a widely influential medical case here (namely the regional approvers may not interfere with a doctor’s right to prescribe to qualified patients), it may be that the government wants more time to grow its medical program while Denmark, Holland and Luxembourg (if not Spain) figure out the logistics on the ground.

French flags blowing in the wind in Le Havre
French medical trials expected to begin Q2 of 2021

Given that France has finally committed to a national medical trial to begin no later than the second quarter of next year, and further one where it punts the majority of the cost onto the industry itself, this would create a solid “medical cannabis” bloc in Europe’s most affluent states. Not to mention the first real, nationally authorized patient trial in Europe that is not commercial.

But even this is not the whole story. While dickering about the certifications and scheduling of the plant go on now at the highest international levels, let alone federal ones domestically, hemp products are clearly entering the consumer market here – from upscale CBD stores in city centers to hemp seed oil and hemp-infused mayonnaise appearing on the shelves of German mainstream grocery stores. Not to mention hemp infused alcohol of at least the vodka, gin and rum varieties.

And then of course there is Italy.

The Italian Market May Be The Dark Horse In Europe Everyone Has Been Waiting For

Within literally the month of October, all in public view, the Italian government circled on the topic of legalizing the CBD/hemp market. As of last week, the Ministry of Health finally decided that cannabidiol sourced from hemp is not a narcotic.

CBD in Italy went from widely available to banned and back to available again.

Given the fact that home grow now is not illegal, and medical cannabis is technically available, it would seem that Italy is positioning its hemp market to survive if not thrive at least domestically and further thread the needle of industry continuity against fluid and further rapidly changing European and international regulation right now.

In the meantime, like Germany, however, the country is clearly angling to create an industry infrastructure – and further beyond the pharmaceutical vertical – via “other” channels before taking the final plunge. Cannabis Lite fits that bill perfectly.

What Does This Mean For 2021 And Beyond?

No matter the official denials, it is very clear that recreational cannabis reform at the American and Canadian ballot box is moving the conversation forward globally, even if at a different pace.

With the WHO now poised to weigh in on the issue, more American states signing up, an expanding medical market across the world and adult use upstarts everywhere, 2021 is absolutely sure to be a meaningful year just about everywhere on the cannabis front.

Former Vice Chancellor of Germany Joins Swiss Company Board

By Marguerite Arnold
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Dr. Philipp Rösler, the former federal Minister of Economics and Technology and Vice Chancellor of Germany from 2011-2013 has just joined the board of Swiss cannabis company Pure Holding AG.

The move is interesting for a number of reasons, not the least of which is that it signals how political currents are moving in Germany, if not Europe beyond that.

To American eyes, Pure Holding looks like a very organized, corporate farm and cannabis manufacturer, organized to produce and test high quality cannabis, extracts and white label products for the coming storm of interest – no matter where European regulatory winds may temporarily go on hemp extracts.

Geopolitics At Play
The fact that the farm is on the Swiss side of the border is also a signal that many Germans (at least) expect the EU to drag its feet on what kind of animal even low-THC and THC-free cannabinoids are while consumers vote with their pocket books across the continent and buy online imports.

The fact that Rösler is politically associated with the Free Democratic Party (FDP) of which he was also chair, is another indication that Germans in general are deeply upset about the slow movement of the CDU party (the Christian Democratic Union) on this issue (just like many others).

The FDP, like all other parties (except the extreme right wing Alternativ für Deutschland or Afd) has been much more forward about cannabis reform. That said, the party currently at the helm of the ruling coalition (CDU) has also been repeatedly accused of dragging its feet on the issue – no matter that medical cannabis was approved here as a therapy mandated for coverage by public health insurers.

The difficulties however that most patients have had to go through is not over. Reform has come here, but still for most, in name only.

The fact that Rössler was also a cardiothoracic surgeon before his stint in national politics is also a sign that the medical community is taking notice of the health effects of cannabis. That he was also federal minister of health of Germany (between 2009 and 2011 in Angela Merkel’s second cabinet) is also a clear indication that the topic of more cannabis reform is on the agenda at home in Germany, including Europe beyond that.

Even if, right now, certainly compared to what is developing in the UK, on a much slower boat to at least commercially accessible, low THC reform.

Philipp Rösler, former vice chancellor of Germany

The Current Debacle Over Hemp In The EU

It is unclear what the fate of hemp is in the EU at present. With the region’s administrators coming to a legally non-binding and decidedly non-scientific holding pattern on “CBD,” (namely that it is a narcotic) it could very well be that the Swiss, English and importers from the rest of the world bring in flower, extracts and products that the region cannot keep out, but is not quite copacetic about embracing, just yet.

That said, with major health food producers now stocking hemp seed extract on the stores of major German grocery stores, it is clear that the worm is turning, one former politician and now board member at a time.

Why The Fuss Over Hemp At All?

The bigger debate is actually a scientific one. It boils down to parsing cannabinoids from the same plant correctly, while also understanding the role that they play together.

That this is now happening, roughly twenty years after the discovery of the human endocannabinoid system – and the recognition that the human body itself creates cannabinoids that are mimicked by external phyto (or plant sourced) cannabinoids, is a victory, even if a late one.

It also signals that at a high level, the debate about cannabis as a drug if not a tool for maintaining overall body wellness, is not abating, but indeed proceeding even as the debate stymies politically at a country-by-country if not regional level.

What Will Reform In The EU Look Like?

While the analogy is not exactly the same, and for a variety of reasons starting with the fact that European countries are sovereign and independent states of Europe and not part of a single federal country, it appears that cannabis reform will look very similar to the progress of the same as it has unfolded so far in the United States.

The Growing Influence of Certified Organic in the European Cannabis Industry

By Marguerite Arnold
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There is a strange, if yet so far undetected, regulatory hum in the air right now in Europe that will begin to increasingly occupy those who are in the certified industry here or looking to get in.

And no, it’s not imminent “recreational,” although it will also have vast impact on the same.

A little understood regulatory structure (so far at least within the cannabis industry) called EU-BIO is now firmly in the room.

What that is and how it will impact the industry is already starting to show up in a few places (see the new announcement by the Swiss that their recreational trial will be organic). This is of course before any dates have even been decided upon for said trial (although others have been set up in the country for about a year).

Beyond this, there are vast implications for every part of the industry, THC or CBD, medical or “lifestyle” focused.

What is EU BIO?

All food in the European Union is regulated on a “federal” level much like in the United States. The difference in Europe however, is that every European “state” or country (like Germany, Spain or Holland) also then has their own regulatory structure which is also equal to the federal standards of the U.S. – including via treaty on both the pharmaceutical and “consumer” side. In general, as a result, regulations, including in all things cannabis space related, are much stricter in Europe.

What this also means, generally, is that all food, cosmetic and human-use lebensmittel (to use the German word for everyday consumer goods like food, cosmetics and lifestyle products) must pass through regulatory agencies that are very much like the USDA and FDA in every country and on a regional European level before being approved on a national sovereign one. Where those are, and who handles what, however, is a patchwork of agencies across the continent. There is no homogenization, in other words, for an organic producer looking for the right agency to get certification from in Germany and Austria.

The European Union’s logo that identifies organic goods.

The distinctive green logo that is omnipresent in particularly German grocery stores also comes with a few high standards of its own. Namely that the logo must appear on all pre-packaged EU food products claiming to be organic within the EU and all member states as well as all imports. Even more importantly, the logo cannot be placed on “transition” projects – namely those which are hoping to fulfil the regulatory standards but are not there yet.

To complicate matters even further, of course all product that ends up as EU GMP must begin life as an organic product. Forget pesticides – radiated product is a hot topic right now as well as its certification in the German medical market.

And that also means, by definition, that all cannabis production in Europe as well as products hoping to be sold via relatively normal channels, must also meet these certifications.

The only other option of course, is what is called “Novel Food.” And even here, thanks to changes in EU BIO on the table for the next couple of years, those who hope to gain access via this kind of labelling, still need to pay attention to organic production. No matter where you are. Or what you want to sell.

Are All “Organics” Made Equal?

Just as in the medical industry and GMP, the strictures of “certified organic” are supposed to be fairly straightforward, but are interpreted by different countries and regions.

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Member states of the EU, pre-Brexit

Generally speaking, however, national or even regional “organics” are not exactly the same. For example, Canadian “organic” is not the same as EU-BIO, starting with the fact that the plants in question are not necessarily of European origin (see the same logic here as behind Novel Food). In other words, there is no automatic equality, starting with the source of the seed. But there are also other issues in the room including processing.

That said, being organic is going to be the watchword of the industry. And in this, a bit surprisingly, the US will also have a lasting impact. Why? Because many countries want to export to the US (far from cannabis) and are required to adopt similar agricultural standards (see Latin America for starters).

Bottom line: it is better to be “green”, through and through, no matter where you are, or where you are from, in the global industry going forward. By the end of 2021, certified organic supply, at every level of the industry, won’t be a “choice” anymore.

Cannabis Featured at World Economic Forum in Davos, Switzerland

By Marguerite Arnold
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So, cannabis was at Davos, like a lot of Very Important People who paid to be seen. What does that mean, however, for 2020 if not beyond, particularly in Europe?

In general, the industry is setting itself up for the next round of “invasion” just about everywhere. In Europe this is going to be a very interesting next couple of years as cannabis as a crop is integrated into the mainstream via changing rules both on a national and regional level.

There are two possibilities for the now Brexited UK. Either the UK is also going to be an insane madhouse of cannabis innovation, set free from its EU “overlords” or the entire discussion is going to get bogged down in another kind of elite private room. Namely which British company gets mostly monopoly rights on what is left of NHS patients (see GW Pharmaceuticals), and which foreign (probably US or Canadian) company is going to be able to buy market accessone way or another to both the medical market that flows over from this discussion and the budding recreational one. See CBD for starters.

In the meantime, strange hybrids are going to enter markets. British distilled hemp infused rum showed up in German mainstream grocery stores just before Christmas. Chocolate makers are setting out stakes across European states with suppliers attached globally.

In Italy, home grow has entered the discussion again, and recreational count down calendars are also on the walls if not sales projections of everyone in the industry. That said, the strategies and ground covered between now and the beginning of 2022, must be strategically chosen. There is no easy, much less “one” path in. All things cosmetics and tinctures will be difficult paths for years to come – although lucrative markets.

CBD vs THC

This discussion is in the room as a political topic as well as an economic one. Technically, anyone with a working farm and used to producing standards demanded across the EU, should be able to enter the industry at this point. That said, getting in, and getting established is not only expensive but also time consuming. The many quirks and stigmas of the past are still in the room. And as fast as norms are establishing, the rules are changed again.

As much as anyone wants to set out even a stake (medical vs. recreational, THC Vs. CBD), the rules, if not debate is bunted again – certainly this has been the case in Europe over the past few years. In fact, the entire plant must be and always is in the room, even if in discussion with several agencies at a time.

2020, in other words, is going to be an interesting year for the industry, even if the most significant achievements, companies and people are not “seen” much less lauded in any spotlight.There is no way THC can be entirely left out of the discussion to begin with. Starting with alarmed reports about the fact that traces of THC in CBD products can show up in human bloodstreams. Until there is a real understanding about the tolerance levels of THC, and for whom in other words, the CBD market will always be haunted by this bugbear. And when they do, recreational reform of all kinds will also be much easier to support.

That said, you cannot pay overhead with promises about future reform. And in the short term, it is necessary to find your niche, and stick to it.

Europe also is a far more interesting regulatory market. Namely, there are more trials afoot, and more people are exposed to the idea of cannabinoids and how to use them.

How long will this take to resolve? It’s anyone’s guess, but the likelihood is that the next two years are set to be just as interesting as the last several have been, although the ground, as well as the goalposts are also just as clearly changing.

2020 in other words, is going to be an interesting year for the industry, even if the most significant achievements, companies and people are not “seen” much less lauded in any spotlight. Namely a general, mainstream and global population is now being introduced to a wonder if not miracle plant, and in a variety of ways.

That is surely, just in and of itself, perhaps the most important aspect of celebrating at a Swiss resort and playground of elites. Cannabis has “arrived” and taken its sophomore spin at the ball.

Luxembourg Announces Plans For Two Year Transition To Recreational Use

By Marguerite Arnold
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For those who have been watching, Luxembourg has played an inordinately influential role on the entire cannabis discussion in Europe for the past year.

This summer, the country announced that it had plans to implement recreational use (for residents only) within two years.

Last summer, the country not only changed its medical use policy as the Deutsche Börse tried to halt the clearances of cannabis trades made in Germany (Luxembourg is the place where the stock trades clear), but set a five-year mandate and timeframe as well.

This new announcement certainly is an attempt to signal at any rate, that the government is not going to run out the clock. But, realistically, with the extra six months already in front of the start date necessary to enshrine the legislation, plus whatever complications arise after that, Luxembourg could initiate its market on January 1, 2022.

Or, as is more likely, it could not. Including rolling delays caused by everything from EU objection and internal logistical hurdles of other kinds to lack of access to product.

Refom Redux?

Will Luxembourg be the “Colorado of Europe?” Probably not.

Will Luxembourg “be the next Canada?” Probably not either. However it is also worth noting that legislators and lawmakers from Luxembourg have drawn recent inspiration via numerous fact finding trips to Canada of late.

It is also worth remembering that even Canada’s great, green, “well-oiled” cannabis machine delayed its recreational market start by months last year. And that was a scenario already a generation in the making.

Further, as some would argue this summer, certainly post CannTrust, the relative “speed” with which Canada embraced its recreational market is again being criticized for not only being precipitous but a direct cause of problems in financial compliance and tracking.

The lack of regulatory muster, in other words, that even allowed a CannTrust to happen, will not fly in Europe. Certainly not in a country where regulations, including that of the European kind, are decided upon (the other center of EU regmaking is of course Brussels).

For that reason, no matter how exciting the news to an industry fighting an uphill battle on medical efficacy, there is plenty of room to temper enthusiasm.

Luxembourg is not going to be “just like” anywhere seen so far. The needle has moved. And the conversation is morphing if not moving on.

One of the most intriguing aspects of all of this, of course, is how insurers will treat the entire discussion.

Holland Round 2?

Here is what Luxembourg also won’t be. A new tourist mecca for out of towners. At least according to the current discussion. How the government will prevent that, is of course unclear. The same grey areas exist in the law behind Barcelona’s social clubs. The Dutch have tried for most of this decade to discourage this – and have largely failed.

What it very well might be, however, is a catalyst for change.  A before and after moment if you will.

european union statesThe Swiss are moving ahead with recreational and medical trials. The British, whatever their relationship with the world after Halloween, are too.

Luxembourg, whatever it ends up being, in other words, is well timed, if nothing else, to be a reference point if not conversation starter about real reform.

Including of course, medical impact, if not, beyond that, efficacy.

Here is where Luxembourg might in fact, be much closer to the Dutch experiment than any other place. Despite the fact the country has had a coffee shop culture for over 30 years, and Dutch medical cannabis is exported to countries all over the world, here is what is missing in Holland: Medical health insurance coverage for patients. In fact, Dutch insurers, en masse, stopped reimbursing the drug as soon as Germany changed its insurance rules in March 2017.

If that is on the agenda for Luxembourg, in other words, no matter how exciting a timeline for recreational is anywhere in Europe, this will be a pyrrhic victory indeed.

Sweden Joins Italy In Path To Defining CBD Oil Regulations

By Marguerite Arnold
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The highest court in Sweden has weighed in on the novel food, and the darling of the Swiss marketplace, CBD conversation. Further, it has done so in a move that seems predetermined to push the so-far escalating novel food debate EU-wide. Along, of course, with what constitutes “narcotic” cannabis.

Namely, Sweden’s highest court ruled in June that CBD oil with any concentration of THC falls under the narcotic jurisdiction.

Sound confusing? Welcome to the world of every CBD producer and purveyor on the “right”  side of the Atlantic.

Beyond The Lingo and Legal Mumbo Jumbo

When one follows the logic, there is one, hidden in the Swedish meatball of careful legal wording. Here is a translation, more or less of what the court intended.

The first is that the Swedes, along with the Italians (and expect this attitude to be reflected all over Europe) accept that cannabidiol when it comes from hemp, if not CBD oil derived from the same, generally, is excluded from the definition of cannabis (as a narcotic). Therefore it is not a narcotic drug.

However, according to the court, the loose definitions of what “CBD oil” is both legally and in the marketplace, no longer applies if the plant has been converted into a preparation containing THC. This is a clear shot across the bow of the “Cannabis Lite” movement that has been so popular across the continent for the last year or so and has absolutely electrified certain regions (see not only Switzerland but the UK and Spain).

This has added to the sky-high evaluations of the cannabis industry (or even the CBD part of it) in certain industry predictions, rosy scenarios and forward-looking statements.

However, in a nod to reality, the court also recognized that there is an exemption for trace amounts of CBD in the current frameworks, although it is indeterminate. In other words, this is a move to force regulators to determine what trace levels of THC are permitted. And further, to force regulation and licencing of the so-far, fairly free-wheeling industry that hoped, much like Holland, to establish itself in the grey spaces between the regulatory schematic of Europe.

Just some of the many CBD products on the market today.

No dice. See Holland of late. But also see Italy, Austria and Germany.

For those who still held out a vague dream of hope that this whole issue was going to go away, or get swept under the carpet of anti-regulatory Brexit mania (in the British case), think again.

In the Swedish situation, much like the Italian CBD caper, the individual at the heart of the court case was a man who escaped a minor drug charge for possession of CBD oil. However, the message is clear: Large scale distribution of CBD oil with “undeterminable” levels of THC (essentially all of it in the market until the rules are set), is courting a criminal drugs charge.

Look for licensing definitions soon.

What Does This Say About The CBD Future In Europe?

Much of this debate is also caught up in larger issues, namely labelling. The British, for example, have just seen recalls at some of the largest supermarkets in the country because of the same. It is a hot topic in several places.

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

Europeans, in general, and this includes the British, are generally also horrified at how Americans in particular, consume food and other products exposed to chemicals they know are toxic. However common chlorinated chicken is in the U.S., for example, this is a discussion as toxic to all Europeans, including the British, as well, chemically treated anything.

This is also a reflection of the much “greener” lifestyle Europeans aspire to lead (even with bizarre gross-outs like “fatbergs” in the Victorian recesses of London sewers). Even if they have not managed it yet, here. Climate change denial, especially in mostly air-conditioner free Europe, and especially this summer, is a rare concept indeed.

The novel food issue where it crosses with cannabis, in other words, has just popped up again, in Sweden. And given its proximity to not only recent legal decisions on the same, especially by their neighbors, if not on the calendar, the industry and all those who hope to chart its projections if not successfully surf its market vagaries, need to take note if not adjust accordingly.

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.

european union states

European Moves Signal Green Spring For Cannabis

By Marguerite Arnold
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european union states

It is hard to believe that two years have passed since the German government changed the law to mandate insurance coverage of cannabis by public health insurers. It is not so much the passing of time, but what has and what has not happened here on the ground during this stretch.

This is borne out by a quick overview of regional developments just in the last few weeks on the ground across the European Union.

Germany

The country that is still given credit for kicking off the whole medical cannabis enchilada discussion on a formal, federal level in Europe, still has not issued its first domestic cannabis cultivation tender. It will be two years this April since the initiative was first announced. Since then, several lawsuits have derailed the process, BfArM, the federal agency in charge of the tender, has admitted to a “technical fault,” and, presumably after the next round in court, the agency might be able to get on with business. The next date of note is April 10 (when the lawsuit will be heard in Dusseldorf).

german flag
Photo: Ian McWilliams, Flickr

Hopefully, this also means that the domestic cultivation of cannabis will finally begin (according to the agency) by, at latest, the fourth quarter of 2020. In the meantime, look for the awarding of bid finalists (or in the worst case, one more bid issuance after April) this year.

In the meantime, and even according to BfArM’s press statements, the import industry will fill in the gaps- meaning that by the time cultivation actually gets under way for real here, it will already be swamped, in terms of volume, by imports.

Where those imports will come from is another discussion. Right now, the only two countries with import rights for cannabis into Deutschland are Holland and Canada. Expect that to change this year, with Israel, Portugal, Spain and potentially even Greece all being very likely contenders.

Switzerland

Significantly, this tiny, non-EU but Schengen state is considering a pilot to study recreational cannabis. Namely, 5,000 recreational users could soon be recruited to help the government set the rules for a fully recreational market, presumably sometime in the near future.

Switzerland has led the discussion in the region on several fronts- notably setting the pace on CBD sales and continuing to air debates about how profitable the fully recreational industry will be for the public purse.

Bern, the capital of Switzerland
Photo: martin_vmorris

It is all very intriguing, particularly to neighbouring DACH state, Germany, but don’t expect the Swiss to do anything too outrageous on the legalization front- namely step too far out in front of either the UN or the European Parliament. Or anger their other DACH trade partner, Austria, who has taken the extreme polar opposite approach to all things CBD.

So to the extent that the Swiss have very much led the charge on the CBD front, such policies have not and will certainly not be copied across Europe (and has not been so far) any time soon. See the controversies over “novel foods” popping up not only in Austria, but Spain too.

Regardless, like Luxembourg, the Swiss are eyeing this new industry and proceeding cautiously in line with larger, international regulations that so far have led the pack on tweaking, testing and presumably changing in the next couple of years.

There are at least 200,000 people who currently use the fully leaded THC version of the drug illegally. Those who would qualify for the pilot study (only one of several proposed as the country considers the impact of cannabinoids from all angles) would have to be adults who already use the drug.

Stay tuned. This will certainly be one interesting trial.

Belgium

Belgium has also just announced the formation of its own “Cannabis Agency.” The new agency will, just as in Germany, oversee the development of the industry domestically- namely issuing licenses for production and import and overseeing quality.

Does this mean a Belgian cultivation bid is on the horizon? Could be. Although so far, no country except Greece has engaged in any large-scale cultivation effort commissioned by the government. And no country except Germany has so far issued a public tender. Even Italy proceeded with a unique hybrid last year when the military essentially turned over the domestic production it controlled over to Aurora.

This too is also likely to be an interesting space over the next few years.

A Belgian tender, right along with a Polish one (also expected after BfArM successfully executes at least one) may well be in the offing this year. This may also put additional heat on the German agency to bite the bullet and issue cultivation licenses by the end of 2019 no matter what happens in Dusseldorf in April.

Swiss Cloud 9 Begins Importing Cannabis From United States

By Marguerite Arnold
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For all the success of the cannabis market in the United States, there are two big issues that still confound the industry because of a lack of federal reform. The first, of course, is national recognition of an industry that still struggles with banking, insurance and selling products across state lines. The other is international trade.

However, it appears that one Colorado-based company, United Cannabis, has now successfully begun to navigate the complex regulatory and standards puzzle, and further, has set up trade and import agreements in both France and Switzerland. Even more interesting? It managed to do the same before the passage of the Farm Bill.

At present they are exporting to Europe from Florida – but the fact that they are exporting in the European direction at all is a feat still unmatched by many other American firms all looking to do the same thing.

Francis Scanlan, founder of Cloud 9 Switzerland

In Switzerland, they are also partnering with an equally intriguing firm called Cloud 9 Switzerland. We sat down with Francis Scanlan, founder of Cloud 9 Switzerland, to talk about what they are doing and how they are doing it- and from the European perspective.

The First Compliant Swiss Chocolate Maker

Cloud 9 is a start-up that is going head to head with the larger Canadian firms in innovative ways and in several directions. That includes the creation of food and beverage products. It also includes pharmaceuticals.

As of January 22, 2019, Cloud 9 also received approval from Swiss authorities to proceed with production of what will be, as Scanlan describes it, “the first EU-compliant hemp chocolate bar.” The hemp they are using contains a full spectrum hemp extract, which does not fall under the rubric of a so-called “novel food” because hemp has been a product in the consumer market here for a long time.

The product will be on Italian shelves as of the end of Q1 this year. Beyond the regulatory approvals necessary to get to market, it also took him about a year to find and convince a chocolate manufacturer in Switzerland to work with him.

Scanlan describes his year and a half old firm as the “value added” between suppliers, manufacturers and distributors. With a background in the corporate food and beverage industry including a stint at Nestlé, he and his team create the formulations and commercialize new products. And they keep a sharp eye on the regulatory bottom line in Europe.

Cloud 9’s corporate mission, Scanlan says, is to improve the quality of life and wellness of their customers. “We are not in the opportunistic marketing business” he says. “We want to create products that really benefit people. Our motto has always been Win-Win for both our partners and consumers.”

Bringing A Glaucoma Drug To The EU Market

However do not mistake Cloud 9 or even Scanlan himself as a kind of cannabis Willy Wonka one hit wonder. Or a firm that is solely operating in the wellness space. They are also now working to bring a Glaucoma drug into the EU where they will begin with medical trials to start the approval process. That said, Scanlan is confident about the success of this product as well. “It has a great dossier in its home country,” he says. “And that has also already caught the interest of doctors in Italy and Switzerland.”

Beyond that, there are other plans in the works, including the introduction of a transdermal patch that delivers cannabinoids through the skin. “The great thing about this kind of approach,” Scanlan says, “is that it allows people to get over their fear of orally ingested drugs. They don’t like the effect, they can just take it off.” He also noted that the patch uses a patented technology that allows a far more efficient delivery mechanism, which creates a time-delayed medication approach and allows for a 90% transfer of cannabinoids.

In other words, this small, privately funded start-up, using innovative approaches to a market Scanlan knows well, is absolutely in the ring and going to market. And further doing so with a European mindset and operating philosophy that incorporates not only hemp exported from the American hemisphere, but is mixed with a large dollop of good old “American” entrepreneurial gusto and inclinations.


Disclaimer: Cloud9 is a sponsor of the MedPayRx pilot to market program in the EU.

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Green Relief Enters European Market Via Switzerland

By Marguerite Arnold
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It is old news that Canadian companies are entering the European market. And it is also no stop-the-presses flash that Germany is a big prize in all of this. But there are other Euro markets to watch right now. Switzerland is one of them.

Look for the Canadian influx here too.

One of the more interesting entrants this month? Green Relief – a Canadian LP with a really unique twist. They are the only company in the world to produce cannabis oil from flower grown with aquaponics. This unique method creates unbelievably “clean” cannabis with no pesticides – and no residue of them.

It also sets the company up for a really unique market opportunity on the ground outside Canada. Especially as they have now just announced a partnership with two Swiss companies– Ai Fame GmbH and Ai Lab Swiss AG. Both companies have been leading European pharmaceutical companies since the turn of the century. The idea is to leverage all three company’s intellectual capital with Green Relief’s additional and first international investment with an eye to the entire European cannabis market. Ai Fame specializes in cultivation, manufacturing, sales and distribution to both the food and medical sectors. Ai Lab Swiss AG operates as a laboratory and testing facility.Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home.

From this unique perch in the Swiss canton of St Gallen, the three companies are setting up to conquer Europe.

Why Is Switzerland So Strategic?

Switzerland has been on the legalization track since 2011. As of this date, the Swiss government began allowing adults to buy and use CBD-only cannabis. Shops were allowed to obtain licenses. A trickle of sales began. However, rather suddenly, as reform hit Europe, the craze took off. Last year, for the first time, the industry generated a significant amount of revenue (close to $100 million). That is $25 million for the government via taxes- just on CBD sales. Even more intriguing for those looking for market opportunity across borders? Less than a week ago, the German-based budget discount store Lidl just announced they were carrying smokeable CBD  – in Swiss grocery stores. The leap across the border is imminent.

That has opened up other conversations, including the “legalize everything” push that makes an awful lot of sense to the ever tax-aware Swiss. This is a push afoot just about everywhere across the continent, including, of course, just across the border in Germany.

GreenRelief LogoThe cities of Zurich and the cantons of both Winterthur and St Gallen (home of the Swiss companies behind the new venture with Green Relief) have already indicated that they will not pursue possession fines for those busted with 10 grams or less– no matter what kind and even of the THC variety.

Read between the lines, and it is clear that the cannabinoid conversation locally has begun to attract the Canadians. And not just because of the many opportunities of the Swiss CBD market – but the huge medical and THC German and European opportunities now opening beyond that.

No matter which way Green Relief and their new partners slice it, they are now in the game – and across Europe – with a unique new play and product, and further one set to enter both the medical THC and “consumer,” albeit still CBD, market now burgeoning.

A Cross Market Play

Here is the truly interesting part about this new announcement. Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home. Cannabis Growth Opportunity Corporation also just announced an investment in Green Relief. The share purchase agreement netted Green Relief $750,000 in both cash and common shares.

With this, Green Relief seems to have set sail on its European expansion. Look for more interesting turns to this developing saga soon!