Tag Archives: export

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.

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European Cannabis Summer Roundup

By Marguerite Arnold
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There have been many significant developments this summer in Europe that will shape the debate about reform and the legal cannabis market that trails it, for at least the next year. Here is Cannabis Industry Journal’sroundup of our biggest events and trends over the summer so far.

Medical Sales Across Europe Are Slow

In Germany, it is easy to maintain a fairly ballpark understanding of patient count. Find the number of prescriptions issued in the trade press and divide by four. Everywhere else, however, the true realization of what is going on across Europe is slowly starting to hit everyone outside producers wanting to know what is going on.Establishing territorial footprint has been what the race in Europe has been all about since mid 2016 for the Canadian LPs so far.

This is going to start to hit stock prices soon beyond the wobbles already evident in the market thanks to this summer’s breaking industry scandals (CannTrust, lawsuits in every direction) to lack of financial performance for investors (Bruce Linton’s firing from Canopy). It is becoming increasingly obvious to everyone that just because a public Canadian company issues a press release about a (cultivation, import, export or processing) “event” does not mean anything other than a slew of social media telling everyone about it. The frustration with “forward looking” statements has hit European investors big time, from the retail to the institutional kind.

Despite a lot of press releases in other words, which clearly show market penetration, there is not much else going on from the sales perspective when it comes to growing those first numbers. Establishing territorial footprint has been what the race in Europe has been all about since mid 2016 for the Canadian LPs so far.

However, from an industry, if not investor and of course, patient perspective, patient numbers are what really count. And unlike Canada, where patients remain the biggest existential threat to the industry, the same industry may not sign them up or ship to them directly in Europe. For several reasons.

Germany is still the only country in Europe with a significant patient count, and while growing, slowly, is still a group where 2/3 of patients obtain dronabinol. It should shock nobody that the most accurate patient count right now in the UK is hovering somewhere under 20. For the whole country, 9 months after the law changed. While the peculiarities of Brexit are also in the room, this is so far, compared to U.S. state markets, Canada, Israel and Germany before it, pathetic.

The Industry Says It Supports Patients…But Does It?

There are several levels to this debate which start with the still appallingly high level of price gouging in the room. 2019 and certainly this summer is a time when the Canadian companies are clearly learning that European governments negotiate for drugs in bulk. Even (and especially in the near future) this one. See the difference between the EU and the US.

UKflagThe level of industry promotion vs patient access recently reached a new nadir this summer when it emerged that despite a great deal of interest, more people showed up (by far) to the week-long cannabis industry conference (European Cannabis Week in London in June) than there are legitimate patients in the UK right now.

That is about to change, but so far, industry support for trials has not materialized. When the various trials now being planned do get going, look for new battles over a couple of issues, starting with patient access to and control of their medical data.

Novel Food: The Regulation That Keeps On Giving

The issues involved in this discussion are complex, certainly by North American standards. This of course starts with the fact that there is no such regulation on the continent. But also rapidly bleeds into puncturing the amount of hot air entrepreneurialism there is in the room.

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

The CBD market in Europe that everyone got so excited about in investor releases, in other words, is basically dead for the time being. Yes, there are a few smart niche players weaving around the regs, but it is a full-time job.

Here is the reality: Since Christmas last year when Austria put the kabosh on all products containing the cannabinoid CBD, several major countries have weighed in on the issue. It is not going away. And it is here to stay, even after recreational.

Political Advocacy Is Stirring In Europe

Whether it is the vagaries of Brexit, the discussion across the continent about how the EU will work together, right wing populist screeds about “too much regulation” or national elections, cannabis is in the room from now until the end of at least 2021 as one of the hottest global political issues under the sun. That includes of course, a discussion about global climate change, sourcing, pricing and resource use so far unaddressed but rapidly looming.

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Photo: Ian McWilliams, Flickr

Further, patients are still having a voice – whether it is making sure that their children obtain imported CBD, or that they can obtain their own THC prescriptions without going bankrupt or having to solicit in the black market.

Cultivation Bids Looming?

One of the surest signs yet that the German authorities at any rate, are in no mood to solve the cultivation issues still on the ground and the bid itself, is that the government just renegotiated, for the second time since last fall, the amount of medical cannabis to come over the Dutch-German border. Who is going to go next? With the Italian hybrid now done and dusted, Poland is likely to be next. And when that happens, expect a raft of similar initiatives across Europe. But probably not until then.

And in the meantime? Distributors are looking for product. The demand is clearly there. But across Europe this summer there is a clear sense that the hype machine that has been the industry’s mouthpiece is at minimum overenthusiastic about the bottom-line details behind it all.

Poland Pushes Forward On Reform

By Marguerite Arnold
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Given all the fuss about newly opened markets in Europe of late (see all the hullabaloo recently in the UK), it would be remiss for anyone in the industry to forget about Poland.

The Eastern European country that shares a large part of its border (if not recent history and long cultural influence) with Deutschland has been proceeding slowly into the cannabis space for the last couple of years.

There are a couple of similarities (and differences too) about the market development in the country to its Teutonic sister to the West as well as the emerging fight over access that is sparking patient revolutions all over the continent now.

A Brief History Of Polish Cannabis Reform

Like other culturally conservative places (see state reform in the United States in places like Georgia), Poland has moved towards reform in a way that may make political sense, but has left patients in much the same boat as British ones. Reform began happening without access as of late 2017.

Polish Flags Image: włodi, Flickr

Poland, or so the joke goes in Germany, is Deutschland’s “trailing sister,” on most things, and cannabis reform in some ways, is absolutely following that pattern. But it is not exactly analogous, starting with patient access. In fact, the first opening of the market did not touch import much less cultivation. It only authorized patients to cross borders in search of their medication. No matter the high cost involved. And of course, the still dodgy proposition of returning across a border with a highly stigmatized narcotic product.

Fast forward a year? Many of the major Canadian cannabis companies had achieved some sort of import (mostly of small amounts of the drug and mostly to single hospitals). See the announcement of Aurora last October on the same day that the Polish government announced a change in the law that they had imported in bulk to a hospital.

But what is going on now, particularly with a growth in acceptance of the medicinal impact of the drug across Europe? And will the Poles, like the Germans, launch a domestic cultivation bid anytime in the near future? Not to mention learn the lessons that so far have continued to stymie German domestic cultivation as well as frustrate a smooth supply chain if not operations on the ground?

The Market Is Coalescing

According to Andrew Makatrewicz de Roy, managing director of Bearstone Global, a market research and investigative firm moving into the cannabis space, Poland has one of the more progressive laws in Europe, but still is lagging behind other countries in terms of organisation and a political lobbying movement.

“There is a lot of vibrancy in the market, but we want to make sure that there is an initial forum where the market can meet and discuss the industry here”.There are also a few (low volume) transactions taking place.

However, as in other places (see the UK in particular), there is a lot of heat if no fire yet behind the scenes. Both individuals and companies are starting to appear who will help build a wider ecosystem in the cannabis space.

As in other countries in Europe, despite the market potential, there is still a general political lag in further development of the industry. Perhaps because of complications in the German market. And almost certainly because of complications with German reform and its own cultivation bid. There have been rumours of a Polish bid circulating for at least a year. Licensed cultivation is beginning to take place.

In response, Makatrewicz de Roy is moving to establish one of the first industry conferences in the country in October. In late July, he also held the first precursor to the same – an online streamed event that attracted 70 major thought leaders from the industry including many members of the political class, producers and distributors (including some of the biggest Canadian ones), doctors and patients.

“We want to build an ecosystem,” de Roy said. “There is a lot of vibrancy in the market, but we want to make sure that there is an initial forum where the market can meet and discuss the industry here”.

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.

Marguerite Arnold

UK Non-Profit Launches Project TWENTY21 To Register 20K Cannabis Patients

By Marguerite Arnold
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In late June, as more than a thousand people descended on the South Bank Center to attend the largest cannabis conference held so far in the UK, another development was taking place away from the headlines.

Drug Science, a non-profit research group founded to reform drug policies based on scientific evidence rather than politics or even economic considerations, launched an ambitious trial project in the UK.

The goal? To get medical cannabis to 20,000 British patients suffering from a range of conditions that the drug is well known to help treat.

Who Is Drug Science?

Founded by Professor David Nutt, the former chief drug advisor to the British government who was fired in 2009 for stating that ecstasy and LSD were less harmful than alcohol, the group itself is clearly not afraid to tackle controversy. The Project TWENTY21 initiative is an ambitious if not desperately needed undertaking.

Targeted patient groups include those suffering from chronic pain, PTSD, MS, Tourette’s and addiction.

Several cannabis companies have already signed up to support the effort which also includes the United Patients Alliance ,and academic researchers.

According to Abby Hughes, Head of Outreach for UPA, “Whilst a change in UK law has given clinicians the green light to prescribe medical cannabis, the majority of patients are denied access, some even being criminalised, whilst corporations are profiting from the same plant.”

UKflagHughes also noted that the goal of the project is to begin to ground patient demand in research and hard data. “We hope that by having a dataset that proves the efficacy of medical cannabis, thousands of patients will be able to access legal, affordable medicine, which may improve their quality of life,” she said.

What Is The Scope of Project TWENTY21?

It is the first-of-its-kind project in the UK where, 9 months after the law changed to allow prescription of cannabinoids as well as the medical importation of the same, there are less than 20 (legal) patients in the country. And all of the successful candidates so far have fought for the right and still do.

While important in its own right, the concept if not forward motion on the same, is also poised to create similar trials all over Europe. This is especially true in countries (like France) where the issue of reform has not moved at all. Or even in Germany (with well over 50,000 patients two and a half years after similar reform was passed by the Bundestag) where problems with access and questions about medical efficacy still frustrate the close to a million Germans who cannot access the drug. Switzerland and Luxembourg may yet prove to be similiarly interesting.

Why Is This Timely?

There has been an increased call for the need for widespread and sustained population trials across Europe as the cannabis industry has really begun to establish itself since mid-2016. This is the only way to help forward medical understanding of cannabinoids at a level that leads to mainstream acceptance. And more importantly, medical and payer mainstream approvals. Until that happens, despite all the press releases, overall sales across the continent remain low.

One of the most important issues beyond this – the extraordinarily high pricing seen in Europe until late last year – has also played a role of course. Payers (see the German “statutory” health insurers) on the front lines of uncertain medical efficacy are still reluctant to pay for a drug, in any form, they do not understand, do not have evidence for, and are still highly suspicious of.

There has been an increased call for the need for widespread and sustained population trials across Europe With cannabis companies agreeing to provide product (in this case potentially from Australia), a research organization with national chops and brave leaders is likely to take the conversation far. And not just in the UK.

While Drug Science is of course not the only British entity planning canna trials and in part supported by the Canadian industry (see The Beckley Foundation for starters), Project 2021 is also certainly likely to be a study with both local as well as regional and global implications.

In Europe, there are other regional trials now in the offing (see Switzerland, Germany and France). Only Germany of course, has a patient population that is starting to be large enough to be effectively studied, and of course, the majority of these patients are still receiving dronabinol.

It is also clearly a steady state march, rather than a discussion that is likely to see significant boosts in patient numbers any time soon. Unless of course, there are other contributing factors.

Regardless, unlike the U.S. and even Canada, the strict medical focus of Europe (including the UK) is finally moving the conversation to the next level. Large, regional and/or national medical trials – and further for conditions the drug is well-known to treat but are so far considered “off-label” for most Europeans will be the watchword here for the next several years.

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The Face Of Cannabis Education In Europe

By Marguerite Arnold
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More than a few cannabis “education companies” – mostly from Canada and the U.S. but some with Israeli ties, plus German and British efforts have targeted Europe as the next logical expansion plan in their global roadmap.

These include most recently Cannvas Medtech Inc., and several initiatives funded by Canopy Growth, including teaching children about the drug. It also includes training programs for frontline staff, launched by Organigram (although in this case it appears to be geared towards “brand education.”)

There are also doctor training programs launching in the UK.

In Germany, there are several efforts underway, helmed by both doctors and cannabis advocates generally, in several cities around the country.

But how effective is all of this “education” in both preventing illegal use, and promoting legitimate sales?

Particularly if such “education” platforms are exported from a foreign market for use in Europe?Canopy_Growth_Corporation_logo

Education Is Desperately Needed, But So Is Channel Penetration

Nobody is arguing that “education,” as well as trials and more information for payers and doctors are not required. The problem is that some education is more effective than other campaigns. And most of the talk in most places is more a discussion of the need for further regulatory reform, more trials and more investigation.

That has to get paid for somewhere.

That, at least in Europe is also tricky, as both early educational movers Weedmaps and Leafly have both found out, especially in medical only markets in the EU. Why? There are also highly limited opportunities for advertising either a drug, or to doctors.

Different Regulatory Environments Cause Bigger Issues

Even in Canada and the United States, there is an ecosystem of supplying the demand that has very much grown up customized by the strange paths to reform if not the first mover discussion.

That is not going to be the case in Europe, which in effect creates a brand-new ecosystem to educate, with new players, and every ecosystem participant group has a different kind of educational needs.

Here is one example of where this shows up. So far, in most countries, doctors are still highly resistant to prescribing the drug. Nurses, on the other hand, in both the United States and Canada at least, have proven to be a much more reliable source of converts for the cannabis cause. That approach of course is not possible in places like Germany where only doctors may issue prescriptions, including of the cannabis (and narcotic) kind.

european union statesAccess issues also play a big role in just about every country- from cost to privacy. And on the privacy front, it is not just foreigners who are getting used to new rules. So are German doctors.

The pharmacy discussion is also very much in the room – and this is not “just like” approaching a “dispensary” from North America. They are regulated chemists. Which causes a whole new set of issues and a serious need for new kinds of educational materials.

In Germany, for example, pharmacists are being recruited and trained by not only staff recruiters specializing in the same, but also sent on special training courses funded by the big Canadian companies (Tilray being the noticeable one recently). The brick and mortar vs. online discussion is also a big topic across Europe. Notably, where it is allowed and where it is, as in Deutschland, verboten.

And, of course, the big green giant in the room everywhere in Europe, in particular, is payer/insurance approvals, which are based on a kind of education called proven medical efficacy.

And that, so far, is in markedly short supply.

In the UK, it is so far the main reason that NHS patients (for example) cannot access coverage for the drug to treat conditions like chronic pain.

In the meantime, the most widespread “education” that is going on, is still mostly at the patient level. Especially when patients sue their insurers, or lobby doctors to prescribe.

The cannabis industry may be maturing, in other words, to be able to answer these questions – but there is also clearly a long way to go.

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Tilray Imports Medical Cannabis Oil In Bulk To UK

By Marguerite Arnold
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Tilray has managed to successfully import its first bulk supply of medical cannabis oil into the UK.

It was a Tilray product, in fact, that was not only confiscated at the border last year – but subsequently sparked media outrage over the denial of the same to one Billy Caldwell, an epileptic child. It was not the only outcry nor was Billy the only child endangered. And the British people, in fact, finally signalled that they had lost their stiff upper lip on this one last year.

All of this despite lingering and significant problems ever since. Not to mention an intriguing and well-timing market entry for Tilray right after things have been heating up on cannabis reform in Parliament of late.

The Tilray product, which will be imported from its new production facilities in Portugal, has already been distributed in other European countries, including Croatia and Germany.

tilray-logoWhat is significant in other words, is that the UK is starting to allow bulk orders in through customs- and they are coming not from Canada, but from Europe. Even if it is a Canadian company’s brand on the same, for now at least.

Tilray of course, is not the only company engaged in a race to get imports into the country. Right after Christmas last year, Canopy/Spektrum announced the same plans. Wayland has clearly been angling for a British outpost for some time. And of course, more locally initiated groups, including European Cannabis Holdings, have been working to initiate easier access to British markets for well over a year. Let alone more locally grown interests and pursuits now clearly lining up for market entry.

But this announcement, coming so shortly after all the recent activity on cannabis reform and calls for trials in the UK, clearly means that the doors are now opening fast for the largest players angling to get in.

Bottom line? Look for the biggest Canadians with an already established European presence, to begin making similar announcements this summer.

Being “Available” Is Only The First Hurdle

One of the biggest problems facing not only the “industry” but patients in the UK, much like elsewhere, is that doctors do not know or want to prescribe cannabis and cannabinoid medicines- and for reasons stemming from fear or ignorance about medical efficacy to insurance coverage.

Medical cannabis, in all its forms so far, however, is also highly expensive and out of reach for most unless they obtain an NHS approval (or as in Germany, statutory health insurer approval) to actually obtain the drug. And then have a place to obtain it.

This basically counts out everyone who cannot pay out of pocket and cannot find a willing doctor to sign them up via onerous and ongoing paperwork. And that, of course, is the majority of the sick people in the room.

It is this basic conundrum, which the bigger Canadians have yet to solve themselves (and it is becoming more of a recognized issue in the U.S. in the days, presumably, before the 2020 election which will hopefully set a timetable for federal reform) that has been in the room for the last two years thanks to Germany.

Image credit: Flickr

It is even more of an issue in the UK. Especially with a renegotiation in Britain’s diplomatic and trade relationship with the rest of the world.

That includes, as of mid-July, a downright, undiplomatic spat between the White House and Whitehall right now over leaked comments from the British Ambassador to Washington – and about matters of competency far from cannabis. Although of course, this issue is in the room.

For that reason, the Canadian as well as the European connection to imports right now (from not just Portugal but Holland) on the medical side of the ledger, spell an intriguing fall for not only cannabis, but the real shape and direction of British politics- and by extension- British trade.

Patients Are Taking It To The Streets And To Parliament

As much as patients have so far partnered with the big Canadian companies in the attempt to get the borders open, this is not the only game in town. Dutch imports, from Dutch companies, are already showing up in the UK (see Bedrocan). And both British and Irish growers are getting in on early action, even if for now “just” on the CBD side.

Furthermore, it is clear that patients are playing a large role in making sure that they are being heard, even to the point of putting pressure on doctors. In an extraordinary admission at the parliamentary level during the last week of June, lawmakers conceded that the British public was taking matters into their own hands. And furthermore, that the change in the law had led to clear expectations that were not being met.

Namely, British patients are literally demanding medical cannabis by prescription from their doctors.

And much like in Germany, with a mandate for coverage, the government is being forced to listen, and as best as it can in a severely crimped and politicized Brexit environment, respond.

While cannabis reform is hardly the Guy Fawkes, in other words, in a tinder match environment that British politics certainly is right now, it might be a kind of spark that drives a much wider conversation in the UK about current events.

Specifically the survival of a system that is poised to provide not only access to cannabis but comprehensive medical care beyond that, even for the old or chronically ill.

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Has Cannabis Reform Landed In The UK?

By Marguerite Arnold
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UKflag

The British have finally decided that cannabis reform is overdue. In London at least, 63% of the population believe that recreational reform is a good idea.  According to a poll by The Evening Standard, the rest of England too, is getting close to a majority when the idea of recreational reform is in the room.

It is, as usual, recreational reform that is the icing on a medical cake that has yet to be baked. But that spice brownie is well on its way to the oven too. According to the British Medical Journal as of the beginning of July, the idea of broader access to regulated medical supplies for patients is mandatory.

And in the ranks of the conservative party, Crispin Blunt founded the Conservative Drug Policy Reform Group last September to lead Parliament in a long overdue discussion about the use of both medicinal and recreational cannabis use in the UK that formally “launched” during the last week of June.

But how the industry will develop here is also a big question in the room right now, especially with a country poised on the edge of one of the biggest constitutional questions in the country’s history – to Brexit or not, and how.

Justice Minister Crispin Blunt (right)
Photo courtesy of The UK Ministry of Justice, Flickr

The North American Influence Is Controversial

While Blunt, for example, sees no issue with injecting North American capital into the debate, there are others who are not so sanguine. And while the idea of Canadian reform is popular here, including the freedom of patients (and others) to grow small amounts themselves, the idea of Canadian companies influencing national policy is not. From The Daily Mail to The Guardian, there have been front page headlines about the coming financial influence of “The North Americans.”

That this discussion is also going on at a time when the UK is considering a completely new trade agreement with the world, including on pharmaceuticals, is not insignificant. Where the country’s drugs come from, far from cannabis, is absolutely on the table. Not to mention how much they cost.

Questions of basic access are likely, in other words, to be in the room for a long time here. The barriers to obtaining and filling a prescription start at its expense – which is ₤1,100 (about $1,400) per prescription. There are few people, let alone those who are chronically ill, who can afford the same. This is far from a “normalized” drug- even of last resort- at the NHS.So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.

That said, it is a start. And for the first time, as of this summer, those with the money can in fact, obtain cannabis by prescription.

But what happens to those (the vast majority) who cannot? 

Patients Are Feeling Side-lined

Just as in national legalizing conversations in the United States and Canada so far, patients are being pushed aside for “the business” to take the conversation forward. But where does this business fall on matters of price and access?

So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.

While patient groups are organizing, and the earliest ones to gain national attention, usually families whose children have been directly in the line of fire, are getting commercial ambitions themselves, the fact remains that patient voices are not the loudest ones in the room. Although as Blunt announced last week, he does not see recreational reform happening in the UK for the next five years.

That also means that every Canadian company entering the market (in particular) will have to continue to sing the same medical song they have been humming across Europe- at least in public.

The UK is NOT Germany – But It’s Not Canada Or The US Either…

No matter how much more “liberal” supposedly, the English people are on the whole CBD question (there is already far more CBD for sale in the UK than just about anywhere else), the UK market is still far behind Germany. Why? Since March 2017, insurance companies auf Deutschland have been required to cover the drug – from sprays and pills to floss when prescribed by a doctor.

There are, by latest calculations about 50,000 German patients.

That said, it is clear that the British do not seem to give a fig about the entire “novel food” discussion and are literally, in some cases, daring the police to raid stores and shut down establishments. The idea of rebellion against EU rules seems very obvious on the CBD front.

Beyond this, however, it is also clear that “Canadian” much less “American” cannabis reform is not necessarily the only model in town.

As the British, in other words, do finally embrace the cannabis question, it is very likely that the face of the same will be of a unique Limey strain all of its own.

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

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

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

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

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Photo: Ian McWilliams, Flickr

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

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

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

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

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

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

The Cannabis Industry Cometh

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

Israeli Together bought into a large German distributor last summer.

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

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

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

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

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

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

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

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

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Germany Enters The Fray On Novel Food

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

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

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

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

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

What Exactly Does Novel Foods Regulation Cover?

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

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

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

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

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

Why Is The German Announcement So Cynical?

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

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

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

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

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

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