Tag Archives: Greece

By Michael Sassano

I have heard everything from “No one in their right mind would spend the energy in Europe when the U.S. has the most developed infrastructure in the world and $13 billion in sales” to “Is it even legal there?”. And yes, when you come from the West Coast cannabis world, it’s hard to imagine anywhere else but the West Coast of the U.S.A.

Europe has taken an infrastructural leap forward by starting off the pharmaceutical, medical and GMP supplements path. As an American-European from the West Coast cannabis world, remembering how the U.S. started/progressed, remaining patient and stretching the grey matter crossing the thresholds of pharmaceutical manufacturing, is serious.

Costs to Do Business

Which country you choose to begin operations in decides if cannabis is more or less expensive cap-x and opp-x to the U.S. And don’t forget the Euro conversion. Clearly, working near main cities like Berlin and Geneva will be expensive both for land and competition for talented staff. I chose Portugal, which greatly reminds me in terms of geography to a mini-California on the coast of Europe. Portugal also boasts the most progressive cannabis rules and is home to large cannabis producers like Tilray and Clever Leaves paving the way in the EU market. Greece is also one of our top locations, due to being cannabis friendly and another coastal country with great talent and reasonable costs to live and operate.

Excitement

All of Europe is buzzing with cannabis. Somai Pharmaceuticals tracks over 387 star-ups in cannabis around Europe, South America, Australia and Asia. The excitement when Colorado first announced cannabis legalization in 2014 is the same feeling in Europe now. Most groups are collaborative yet guarded at the same time with the uncertainty of how EU cannabis plays out. Patient demand exists, and similar government wills are at play, but all in the direct backyard of big pharma.

Right now you see huge companies that will always exist and small companies that will always be a part of competition. It’s likely that Europe will shake out to be 30% large to medium company mix and 70% medium to small companies. So, the feeling of room for everyone exists there. This is not surprising considering the legal market in the world is $17B in sales while the illegal market is estimated at ten times that market. And new demographics from around the world are opening up to cannabis for pain relief, sleep and other ailments for new age groups.

Brand New Infrastructure

Conforming to standard guidelines like pharmaceutical manufacturing, GMP supplement manufacturing and GACP farming is just plain normal. U.S. state-by-state expansions really missed the boat on this, and state rules without federal guidelines aren’t good for businesses left guessing or consumers. Eventually, with federal legalization, some infrastructure rebuilding will be needed to conform to standard procedures. I am unsure if the systems are even capable of handling tens of thousands of operating facilities with or without regulation, but starting off at the highest level of pharmaceutical grade is a good way to build consumer and regulator confidence. Learning pharmaceutical and supplement GMP manufacturing is a precise and studied endeavor coming from the U.S. cannabis market. The US hemp industry is embracing this on a supplement level. I now curl up to online courses and formulation books.

In time, all of Europe’s 741 million population will have access to cannabis related products. With standardized processes, new infrastructures and good-old fashioned entrepreneur energy Europe will be a massive market. Sure, the early adopters will need to struggle through regulations and rule creation, but the lifestyle in Southern Europe is the envy of West Coast USA, where laid-back lifestyle and organic food is the minimum standard.

August 10, 2020

Spanish Cannabis Approved for Import to Germany

By Marguerite Arnold

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It is official. BfArM, the German version of the Food and Drug Administration and the federal agency with oversight of the national cannabis program, has approved Spanish medical cannabis imports into the country. Indeed, three German companies are now finalizing their paperwork to allow the transfer to be completed.

As Cannabis Industry Journal has learned, at least one of the companies on the Spanish side of the equation is the ever-interesting Alcaliber (Linneo Health). So far, the privately funded company has made smart, strategic business moves through a challenging transition period. With one of the few EU GMP-recognized licenses in Spain, it is a logical choice for German distributors in search of foreign-produced, but up-to-snuff product.

This is a positive and widely predicted turn of events as Germany begins to institutionalize its cannabis program at the next level. As of this fall, three producers will begin to distribute domestically grown cannabis in Germany. However, there is a clear need for a vibrant import market here and there will be for a long time to come.

Domestically grown cannabis, by design at least so far, was never intended to serve the entire base of medical cannabis patients in Germany. And Spain has been, from the beginning of the discussion, along with Portugal, Greece, Poland, Eastern Europe and of course Italy, an attractive market to produce high quality cannabis for export to (at minimum) Germany.

The European Ex Im Market Is Opening

While the Canadians still have an outsize impact on this market, that is clearly a period of time that is coming to an end. Indeed, Canadian produced cannabis is being turned down at the German border for quality issues linked to certification.

This is not a new issue. It has haunted the German market since 2017 and the beginning of the discussion about the German cultivation bid. But now it is official. Beyond Holland, and even Canada, in other words, lower cost cannabis is now entering the German market and from other European countries.

While Portugal and Denmark beat Spain to the punch, however, this is likely to be an impactful development for not only patients, but the entire price discussion. Distributors are clearly on the front lines of not only obtaining high quality cannabis (from somewhere), but meeting a price that is increasingly on the downward slide, just from the pressures of domestic production and the price structure created around the same by the German government.

Producers have been feeling the pinch, no matter where they are based, for at least the last 12 months.

The Impact On The Spanish Cannabis Discussion

It is unlikely that this development will not be duplicated by other Spanish companies vying for entry into the European and German markets. Spain has a thriving grey market cannabis economy in the form of Cannabis Clubs. It also, like Holland, has allowed a semi legitimate market as well as a distribution network to spring up around the same.

However, the times are also clearly changing. Holland is in the midst of regulating even its coffee shop cultivation economy as it becomes one of the most important exporters of medical cannabis to Germany. Expect the same trend in Spain, especially as Europe increasingly comes to the same conclusion as everywhere else. The regulated medical cannabis industry is great for economic development, especially for countries like Spain, with great weather and perhaps an overreliance on the tourism industry.

The Other European Producers Now In View
Beyond Spain, Portugal and Denmark have the right to import medical cannabis to Germany. This list is expected to continue to expand as patient numbers grow. Because of the price restraints now placed on the entire market by the German government, however, entering the country with an attractively priced product that will pass muster, not only with regulators but doctors and insurers, is now absolutely the name of the game.

And that is of course, before the recreational and CBD topic even enters the discussion – and both are clearly on the agenda now, across Europe.

January 8, 2020

Italy Sets New Pace For Recreational Cannabis & Domestic Cultivation

By Marguerite Arnold

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The Italian Supreme Court seemed to take a page from both Israel and Thailand last year (who announced exports and reform legislation on Christmas Day 2018). In the dying days of 2019, on December 19, the court ruled in what is basically a landmark decision for not only the country but the continent, that small-scale domestic cultivation of cannabis (both of the CBD and THC kind) is legal.

Even more intriguingly, the ruling was ignored for several days in Italy before being picked up by news agencies. This in turn has apparently set off a much wider and predictable debate about the use of the plant in the country – either for medical and or recreational purposes. Many are doubtful that any legislation will pass formalizing the inevitable in the near future (one attempt has already been killed), but one can never know these days. This is an issue that perennially takes countries and politicians by surprise as populations warm quickly to the concept of medical reform.

That said, so far efforts to formalize the ruling into law have been slapped down by the center right Forza Italia Party. Further, if a right or center right coalition comes to power in Italy as widely expected, it is likely to try to overturn the court ruling legislatively which has been described at least in such circles as an “absurd verdict.”

It is important also to understand this distinction if not label and how it translates both internationally and domestically.

In Canada, reform was championed by economic liberals (who are basically centrist, globalists if not free traders) and libertarians more than any other label. However initially, reform was driven not by political campaigns but rather a national challenge to prevailing cultivation law at the supreme court. This then became the legal basis for reform legislation of both the medical and recreational kind.

In the U.S., cannabis reform is frequently championed by states’ rights advocates, who are from a European perspective, extreme right wing. Right down to opposing the federal imposition of not only civil rights but other kinds of regulatory law. Including in this space. This also includes absolute hostility to anything resembling “national” if not “single payer” federal healthcare.

The two issues obviously overlap, intersect and create many strange juxtapositions if not outright contradictions and paradoxes. And many strange bedfellows.

This disconnect of course is also what has held back a united front on passing federal reform no matter how much this has allowed recreational to now spread to 11 American states as of January 1 this year. As a result, for now and certainly for several years after the next presidential election, barring a surprise realignment of politics in the U.S., there is unlikely to be any progress on federal reform. But in the U.S., cannabis legalization is a “purple” issue. Trump, for example, still opposes any national change – although if the election is tight, look for a lot of promises from both sides.

Across the Atlantic however, what Italy’s new judicial stance on the subject means for the first time, is that there is potential for a real fight on the ground from a political grass-roots front in a socially conservative European state. This is also intriguing for another reason. Italy’s health ministry also just cancelled one of Aurora’s cultivation licenses. For all the naysayers on the significance of this development, this should not be discounted.

Kind of like a Canada or Mexico moment for the continent indeed.

Not to mention what this discussion does for the CBD discussion. Both in Italy and elsewhere.

Look Homeward Deutsch Angel

Advocates across the continent if not the UK, are of course, also watching closely. Germany in particular, tried to avoid this exact discussion three years ago, but it is unlikely that advocates at least, will let this continental victory rest. Starting with the fact that this is a debate that was firmly shut off in 2017 with the passage of the medical cannabis insurance coverage law to widespread patient frustration and huge patient issues with access ever since. Even though, in fact, Guenther Weiglein, the German patient who brought the suit, took it as far as he could legally. His right to domestic cultivation, along with the few patients who managed to avail themselves of the same right before the law changed, are no longer allowed to do so.

So of course, beyond charging the debate in Italy, this development will also increase pressure in Germany (for starters) as well as other European countries to reconsider what so far at least has been verbotten and largely because of Germany’s lead so far.

Even in places like Holland, Denmark, Portugal, Spain and Greece, the domestic cultivation discussion has been off the table. Luxembourg, and just outside the EU, Switzerland, has not raised this prospect.

That may well change in all of these countries plus others as the clock now starts to tick down to the end of 2021.

Regardless, early predictions about the pace of change as well as the size of the markets have largely been wrong.

So, for all the intriguing possibilities, this is not a slam dunk, but certainly a strong charge down the court in the right direction.

December 17, 2019

The European Cannabis Industry In Review: 2019

By Marguerite Arnold

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2019 opened with a strange vibe in the air on the cannabis front. Israel and Thailand set the stage with dramatic reform announcements last Christmas. And as the calendar counts down to 2020, the larger players all seem to be licking their wounds (if not stock prices).

But cannabis reform is not just about profits on the public markets. What has gone down and where and ultimately, has the year lived up to its promise?

Reform Marched On In Several Countries

At this point, reform is certainly “too big to fail.” There will be no going back anywhere no matter the laggards still in the room.

From the perspective of opening patient access (and markets beyond that), There were several big stories on the medical front this year – and – in a real first for the EU – of not only the medical, but recreational kind as well.

Germany of course is going, relatively speaking, like “gangbusters” on the medical front although supply, quality and supply chain issues are still in the room. Even more so now because the German government has also announced, for the first time, a public reference wholesale price per gram of floss. That alone is big news, although expect that too to drop (see Aurora’s pricing for Italy, for starters).

In the UK, the NHS finally got down to brass tacks and negotiated a bulk discount for GW Pharmaceuticals cannabis drugs for a very narrow band of patients (mostly child epileptics and MS patients). A tiny minority of the estimated 1.4 million daily British “medical” users including those suffering from chronic pain can afford imports. The rest is all black, or in the case of CBD, gray market.

In France, the country finally got on the reform bandwagon with a “medical trial.” This means that all the major countries in the region are finally on board with some kind of reform. That too is a meaningful move.

Poland is also opening – a good sign for the remaining conservative countries in Europe still on the fence.

And in a real first (although do not get too excited just yet), on the “recreational” front, it is not just Holland that is in the room any more. Both Denmark and Luxembourg announced that they were opening this conversation. In Denmark and Holland’s case, this is in the form of “trials” in places where operational grey markets have already been established. In Holland, this is of course, regulating the “coffee shop” trade in large cities like Amsterdam. In Denmark, the new “trial” will be on the grounds of a revived hippy experiment called Christiana, that morphed predictably into the control of gangs over the last generation.

Luxembourg, however, seems intent on setting the benchmark if not timeline and is moving aggressively in one direction. As a result, as of this year, the strategic “heart” of Europe is now on the schedule to go full monty by 2022. That said, it is a country of about half a million people. Further, no matter the inevitably hype on the way, don’t expect the country to turn into a big cannabis hub- nor encourage pot tourism even from neighboring Europeans.

The end of 2021 is the time to watch for all things recreational. In the meantime, including next year, look for increasing “experiments” in other places. Particularly of the Swiss variety (where both recreational and medical products are sold via pharmacies.)

THC Is Being Accepted As Having Medical Efficacy

No matter the controversy in the room, and the strange inclinations of the British NICE to try to undo forty years of medical knowledge about the impact of THC on chronic pain, medical cannabis and specifically medical cannabis with THC has made its global medical debut as of this year.

That said, the push is on to “pharmacize” the product.

Flower (floss) is in the room, in other words, but the future is looking towards oils and distillates – at least for the medical market long term. And a lot of that will also come increasingly to this market from places like Portugal, Spain, Greece and other European markets now moving into the cultivation space seriously.

Then again, there is still a lot of road to travel. Wags who predicted that German health insurers would never pay for floss cannabis just five years ago were wrong.

CBD Is Not All Its Cracked Up To Be

For all those who sang “Free the CBD” this year, Europe has taken a rather conservative and concerted push back. From Austria to Italy and Sweden to Poland, the path to market for any product containing CBD has been a tough one this year.

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

That said, perhaps it is a call for more standardization- no matter how painful that might be economically. At a presentation given at this year’s IACM medical conference in Berlin, a medical researcher revealed the results of a study he had conducted on the accuracy of labelling of these products in several European countries. The industry has not standardized, labelling is all over the place in terms of accuracy – and the claims about “medical efficacy” are hard to swallow for substandard over-the-counter product.

If the CBD-based part of the industry is to thrive here, it will have to find a way to establish and certify itself. That appears to be going on in Italy right now. It also impacts every cultivator from Portugal and Spain to Eastern Europe looking at the possibilities right now.

However, with labelling and other EU cross currents in the room, this route to the industry has been fraught this year with all the cross winds and those are not likely to dissipate next year or indeed for the next several.

The Cannabis Winds Of Trade Are In The Air

While it may be a bit ironic, given that international trade has pretty much always been a hallmark of the development of the modern cannabis industry, next year will undoubtedly be the year of “International Cannabis Trade.”

No matter the problems “back home,” as of this year, a German-based manufacturer of GMP-certified product got fully underway (see ICC/Wayland’s success this year). That, along with the final decision on the first German cultivation bid, has clearly shaped a market that is still changing. And that change is driven by the admission, even by authorities, that there is not enough legal cannabis grown in the country.

That means that the strength of the German market will continue to drive policy (see the recent announcements on wholesale pricing) as well as demand that will be met across the continent.

Along the way, cannabis reform is also being driven locally. And that means, no matter the trials and tribulations of the Canadian part of the sector, which perhaps can be considered aptly warned for getting a bit too big for its britches, and no matter how faulting, the winds of reform are still afloat. Just perhaps, on the cards for next year and those to come, blowing from many more points on the globe.

October 30, 2019

The Economics of Ex-Im In Europe

By Marguerite Arnold

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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:

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.

October 30, 2019

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.

These 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.

October 9, 2019

Cannabis Featured At Germany’s ExpoPharm For The First Time

By Marguerite Arnold

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Expopharm is a big deal in Germany and Europe beyond that. It is the largest expo for pharmacists on the continent.

This year, there were two firsts in a convention already looking to the future with digitalization – itself a huge issue in not only the European medical space, but Germany in particular. There is a national obsession with privacy auf Deutschland that does not exist anywhere else.

Beyond digitalization, however, medical cannabis was also a major theme this year. Many of the largest producers and distributors showed up in force. So did the smaller, newer ones. There are now 19 licensed importers in the country – and quite a few of them showed up in Dusseldorf last week.

Beyond that, the expo also saw the birth of the VCA – the Verband der Cannabis versorgende Apotheken e.V (German Cannabis Pharmacists Association). This is a group of pharmacists who are on the front lines of the medical cannabis revolution on its most complicated, expensive and paper-laden end, determined to make their voices heard.

the VCA ,German Cannabis Pharmacists Association

According to Tobias Loder, the owner of Luxe 99 Apotheke in Cologne and one of the organizers of the VCA, “There is huge interest in our association.”

For those of American extraction, at least, there has yet to be such a conference anywhere in the U.S. simply because of the lack of acceptance at the federal level of cannabis as medicine. In Canada, and elsewhere, national pharmacy chains are already getting into the action.

Germany, however, remains the strange, and as a result, most interesting exception.

In Düsseldorf this year, despite added traffic and a great deal of excitement, cannabis as medicine was, as the press attendant said as he handed out the Cannabis Industry Journal press pass, “par for the course” and “no big deal.” Even though of course, the generation of all the interest and intrigue.

The drug is, while still highly stigmatized, on its way to legitimacy here. And in a decidedly normal, Deutsch weg (way).

The Inside Skinny On What Is Changing For German Pharmacists

As revealed during the Denton’s medical cannabis conference in Berlin in late September (about a day before the news hit the expo floor in fact), things are indeed changing at the last mile of the regulated cannabis path. Why?

Several reasons.

Within the next thirty days, doctors will be able to prescribe up to 100 grams of floss (dried cannabis flower) or cannabis oil by the gram per patient prescription. That means that patients can indeed go to the doctor every three months – and that there are in fact more regular users in the system. This is also an indication that the supply chain is also beginning to normalize – although there is a huge demand so far unmet by supply. And as a result, while two of the three bid winners are now getting down to cultivation, imports are still the name of the game.

On this front, things are also changing. Cannabis just came into the country from Portugal. Other countries lining up to import include not only Canadian producers, but those from Spain, Malta, Greece, Australia, South Africa, Columbia and of course, Israel.

This is also a step towards international normalization on the pharma side. Schedule II narcotics in the American system are dispensed every 90 days.

The rules about pharmacy mark-ups are also in flux. One of the reasons, for example, that medical cannabis has been so expensive is that, up until now, at least, pharmacists were required to mark up such product 100%. That is also changing. In fact, the Federal Union of German Associations of Pharmacists (ABDA) and the National Association of Statutory Health Insurance Funds (GKV Spitzenenverand) have had to agree on a new surcharge that is expected to see significant and immediate savings of a projected 25 million euros.

It is not a casual argument or discussion. One of the reasons that the German pharmacy vertical has remained so strong and resistant to buyouts and consolidations is that by law, owners are limited to no more than three (and in so far one case discovered by CIJ in Bavaria) four brick and mortar pharmacies. The reduction in this preparation surcharge means that pharmacies will have to find ways to become more efficient. That is also a concern for the VCA, who, among other things, are looking to reduce their own overhead costs while gearing up to serve more patients.

Digitalization, innovation and more, in other words, is on the table. And German pharmacists, for one, are not only on the front line – but stepping up to the challenge.

June 20, 2019

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

By Marguerite Arnold

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

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

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

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

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

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

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

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

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

The Cannabis Industry Cometh

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

Israeli Together bought into a large German distributor last summer.

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

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

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

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

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

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

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

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

April 29, 2019

Why International Trade Agreements Are Shaping The Cannabis Industry

By Marguerite Arnold

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

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

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

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

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

What Are MRAs?

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

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

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

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

What Are Mutual Recognition Agreements All About?

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

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

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

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

A Specialized Map Of Global Medical Cannabis Exporters

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

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

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

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

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

The Biggest News?

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

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

April 22, 2019

How Germany Gets Its Cannabis

By Marguerite Arnold

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

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

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

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

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

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

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

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

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

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

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

What Are The Standards, Certifications, and Qualifications?

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

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

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

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

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

Caused By The Bid….and Likely Shorter Term Outcomes

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

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

The Plusses and Minuses of The News

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

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

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

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

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