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A Snapshot of The German Cannabis Market: Year 3

By Marguerite Arnold
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Despite the limitations and privations caused by the COVID-19 pandemic, Germany’s market is “up” in terms of sales and overall insurance approvals. For all the victories however, there are still many kinks along the way. That is of course, not just on the medical front (where flower is yet again in short supply this summer), but also in the CBD space.

There is also clearly a drumbeat for more reform afoot in a country which has bested the COVID-19 pandemic like few others in the world. And like France as well as other countries in Europe, the conversation across the region has turned to including cannabis in recovery efforts, and in multiple ways. That includes not only relying on a new crop and industry for economic revitalization, but also of course, on the topic of further reform.

A Brief Overview Of The “Modern” German Cannabis Market
Germany kicked off the entire cannabis discussion in a big way in Europe in the first quarter of 2017. The government got sued by patients and changed the law mandating that public insurers had to reimburse the drug. They also kicked off a cultivation tender bid which promptly became mired in several rounds of lawsuits and squabbles. The first German grown cannabis will hit pharmacies this fall, but it is not clear when, and the unofficial rumour is that the pandemic will delay distribution. The German distribution tender has been delayed three times so far this year.

In the meantime, the German market has developed into the world’s most lucrative target for global exporters, particularly (but not limited) to GMP and other certifiable high-grade cannabis (and in all its forms).

The German Parliament Building

Other Issues, Problems and Wrinkles

Nothing about cannabis legalization is ever going to be easy, and Germany has been no exception.

The first problem on the ground is that the supply chain here has had several major hits, from the beginning. This is even though the supply has come from ostensibly otherwise reliable sources. Companies in Canada and in Holland have all had different kinds of problems with delivery (for different reasons) throughout this period.

Right now, there is a major reorganization afoot in Holland which may also be affecting the recent decision on the Dutch side to reorganize how the government picks (private) German narcotics distributors. Aurora also had product pulled last fall because of labelling and processing issues. But these, no matter how momentous momentarily, are also just waves in a cannabis ocean that is still choppy. Domestic sales continue to expand and foreign producers can still find a foothold in a still fairly open market.

As a result, even with a new dronabinol competitor, Israel, Australia and South Africa as well as multiple European countries now in advanced export schemes, the supply problem is still a thorny one, but not quite as thorny as it used to be.

However, On The CBD Front…

Things have gotten even more complicated since the repeated decisions on Novel Food at the EU level. Namely, last year’s decision that the only CBD extract that is not “Novel” is extracted from seeds, has thrown the entire industry into a major fluff. Especially when such decisions begin to filter down via a federal and regional approach. This has begun to happen. Indeed, the city of Cologne, in Germany’s most populous state just banned all CBD that is not labelled per an EU (although admittedly) non-binding resolution on the issue.

This in turn is leading to a renewed push for the obvious: recreational cannabis.

Where Is the Recreational Discussion Auf Deutschland?
The recreational movement, generally, has been handed several black eyes for the last three years. Namely, that greater reform was not preserved in the first cannabis legalization that passed, albeit unanimously, in the German Parliament in 2017. However, as many recognized, the first, most important hurdle had just been broached. And indeed, that cautious strategy has created a steadily increasing, high quality (at least for the most part) medical market that is unmatched anywhere in the world except perhaps Israel.

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Photo: Ian McWilliams, Flickr

Now, however, there are other issues in the room. The CBD discussion is mired in endless hypocrisy and meddling at both the state country level and the EU. There are many Germans who are keen to try cannabis beyond any idea of cannabis as therapy. Remember that Germany has largely managed to contain the outbreak, despite the emergence of several recent but isolated hotspots of late. In Frankfurt, for example, with the exception of more people on kurzarbeit (which is not visible), most street traffic proceeds apace these days with masks on, but with that exception or two, feels pretty much back to “normal.” And of course, economic development in the form of exports is one of Germany’s favorite pastimes.

Beyond that, the needle has absolutely moved across Europe. Several countries, including Greece and Portugal as well as the UK’s Channel Islands, have already jumped on the cannabis economic development bandwagon, and this is only going to encourage the Germans as well as other similar conversations across the region. It has even showed up in France.

And of course, it is not like the implications of Luxembourg and Switzerland as well as recent efforts in Holland to better regulate the recreational industry there, have not been blatantly obvious to those in Europe’s largest medical market.

Look for new shoots and leaves, in other words of the next stage of cannabis reform to take hold auf Deutschland. And soon. It is inevitable.

Will Australia’s Cannabis Program Follow Canada’s Lead?

By Marguerite Arnold
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The news is intriguing in a world overwhelmed with pandemic news. THC Global, a Canadian-Aussie company now raising money and signing global deals, has just bought a “clinic network” of 30 prescribing physicians that will be able to supply up to 6,000 Australian patients this year.

In doing so, this entity is clearly beginning to establish a pattern of expansion in a new medical market not seen so far outside of Canada. Namely being able to obtain the all-important prescription for one’s brand at the doctor or prescriber’s office which is affiliated with a certain producer. Pharmacies and dispensaries downstream have no discretion for any other product to sell if the brand is written right on the prescription itself.

And this marks a new step in an industry frustrated with the high prices and high levels of red tape in other international environments where more widespread medical cannabis reform has come.

The Situation in Germany
Germany represents, so far at least, the destination market of choice for Canadian cannabis firms (for the last several years at least). This is for several very sound business reasons (at least in theory).

german flag
Photo: Ian McWilliams, Flickr

The German medical market is the largest in Europe. Health reforms which swept the country at the time of reunification also created a system that is in its own way a hybrid of the more European (and British) NHS and American healthcare. Namely, 90% of the German population is on the system, but it is tied to employment and income. Freelancers, even of the German kind, must use private healthcare as must all non-passport foreigners. If you make over a certain amount of money (about $65,000), you must also pay for private healthcare. As the cannabis revolution rolls forward, many cannabis patients are caught in changing rules and a great reluctance by public health insurers to allow fast entry of any new drug, including this one. This is based on “science” but also cost.

Bottom line? Yes, the market is lucrative and growing, and yes, cannabis is covered under public health insurance, but the ability of any producers to be able to maintain a reliable, steady market of “prescribers” is highly limited. Furthermore, unlike anywhere else in the world, pharmacists play an outsized role in the process – namely because there are no chains (more than four brick and mortar outlets are verboten). Prices and availability vary widely across the country.

There are also no “online” drug stores where patients can send prescriptions in the sense that this vertical has developed in other countries.

Hospital dispensation is, for all the obvious reasons, highly expensive and generally prohibitive for the long term, if not serving much larger numbers of patients.

The Problem in the UK
Like Germany, the UK decided to launch medical “cannabis” – or at least cannabinoid-related drugs under the purview of the NHS, but there are several issues with this.

Epidiolex-GWThe problems start with the fact that the system remains a monopoly for one British company, GW Pharmaceuticals. The medication produced by them, including Sativex and Epidiolex is expensive and does not work for many patients that it is produced “on label” for (such as MS or childhood epilepsy).

And then of course, the largest group of cannabis patients anywhere (chronic pain) have been explicitly excluded from the list of conditions cannabis can be prescribed for under public health guidelines in the UK. This, like Germany, has created a highly expensive system where those patients who obtain the drug on a regular (and legal basis) have to have both private healthcare and obtain help through private clinics. While there are several chain clinics now forming in the UK, this is not the same thing as “buying” patients in the thousands – the model seen in Canada from the beginning of 2014.

The market has a lot of potential, in other words, but like Germany, via very different paths to market than seen in Canada, in particular.

Why Is Canada Different?
The development of the medical market came through federal change in the law around the turn of the century. Namely, after patients won the right to grow for themselves, via Supreme Court legal challenge, patient collectives gradually formed to grow and sell cannabis that was more “professionally” cultivated. This, in turn, became the right of private companies and indeed household names in the Canadian market saw buying patient pools as their path to financing on the equity markets as of 2014.

This is not widely popular within the industry. Indeed, the last legal challenge mounted by the industry to ban non-profit patient collectives fell apart in 2016 – the year that the larger Canadian companies began to look abroad to Europe.

It is also undoubtedly why, beyond the red tape they face in Germany and the UK if not across Europe, Canadian firms are looking to hybridize a model which worked well for them at least in the early days of capitalization of the private industry. And maybe Australia will be “it.” Stay tuned.

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Why Europe May Serve as an Important Bellwether for Hempcrete Use in the United States

By Stephanie McGraw
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Hemp-based construction materials are an attractive option for achieving environmentally friendly goals in construction, including reduced emissions and conservation of natural resources. Hemp construction materials dating back to the 6th Century have been discovered in France and it has long been eyed with interest by hemp growers and manufacturers, as well as environmentalists in the United States and abroad. As the European Union moves forward with its 2019 European Green Deal, United States hemp, construction and limestone industries, as well as regulatory agencies, will be provided with an important preview of the benefits, risks and issues arising out of the use of hemp in construction.

The European Green Deal and Circular Economy Action Plan

Hemp applications in construction are gaining increased interest as the EU seeks to neutralize its greenhouse gas emissions by 2050. Much of the specifics for this transition to zero emissions are outlined in the EU’s “A New Circular Economy Action Plan,” announced on March 11, 2020. According to the EU, “This Circular Economy Action Plan provides a future-oriented agenda for achieving a cleaner and more competitive Europe in co-creation with economic actors, consumers, citizens and civil society organisations.” The plan aims at accelerating the transformational change required by the European Green Deal and tackles emissions and sustainability issues across a number of industries and products, including construction.

Construction in the EU accounts for approximately 50% of all extracted natural resources and more than 35% of the EU’s total waste generation. According to the plan, greenhouse gas emissions from material extraction, manufacturing of construction products and construction and renovation of buildings are estimated at 5-12% of total national greenhouse gas emissions. It is estimated that greater material efficiency could save 80% of those emissions. To achieve those savings, the plan announces various efforts to address sustainability, improve durability and increase energy efficiency of construction materials.

How Hemp Could Help Europe Achieve Neutral Emissions

Hemp, and specifically hempcrete, is being eyed with heightened interest as the EU enacts its plan. Indeed, recent mergers and acquisitions in the European hemp industry signal just how attractive this hemp-based product may be as international, national and local green initiatives gain momentum. But how would hemp be utilized in construction and what types of legal issues will this industry face as it expands?

Image: National Hemp Association

The primary hemp-based construction material is “hempcrete.” Hempcrete is typically composed of hemp hurds (the center of the hemp plant’s stalk), water and lime (powdered limestone). These materials are mixed into a slurry. The slurry petrifies the hemp and the mixture turns into stone once it cures. Some applications mix other, traditional construction materials with the hempcrete. The material can be applied like stucco or turned into bricks. According to the National Hemp Association, hempcrete is non-toxic, does not release gaseous materials into the atmosphere, is mold-resistant, is fire– and pest-resistant, is energy-efficient and sustainable. To that last point, hemp, which is ready for harvest after approximately four months, provides clear advantages over modern construction materials, which are either mined or harvested from old forests. Furthermore, the use of lime instead of cement reduces the CO2 emissions of construction by about 80%.

Watching Europe with an Eye on Regulation and Liability Risks

Hempcrete indeed sounds like a wünder-product for the construction industry (and the hemp industry). Unfortunately, while it may alleviate some of the negative environmental impacts of the construction sector, it will not alleviate the threat of litigation in this industry, particularly in the litigious United States. The European Union’s experience with it will provide important insights for U.S. industries.

Hempcrete blocks being used in construction

Because hemp was only recently legalized in the United States with the passage of the 2018 Farm Bill, it is not included in mainstream building codes in the United States, the International Residential Code, nor the International Building Code. Fortunately, there are pathways for the consideration and use of non-traditional materials, like hempcrete, in building codes. However, construction applications of any form of hemp, including hempcrete, at this point would likely require extensive discussions with local building authorities and an application showing that the performance criteria for the building are satisfied by the material. Such criteria would include standards and testing relating to structural performance, thermal performance, and fire resistance. Importantly, the ASTM does have a subcommittee working on various performance standards for hemp in construction applications. European progress on this front would pave an important regulatory pathway for the United States, as well as provide base-line standards for evaluating hempcrete materials.

Insights into regulation and performance standards are not the only reason to watch the EU construction industry in the coming decades. Introduction of hempcrete and hemp-based building materials in the United States will likely stoke litigation surrounding these materials. Although there is no novel way to avoid the most common causes of construction litigation, including breach of contract, quality of construction, delays, non-payment and personal injury, the lessons learned in Europe could provide risk management and best-practice guidance for the U.S. industry. Of particular concern for the hemp industry should be the potential for product liability, warranty, and consumer protection litigation in the United States. The European experience with hempcrete’s structural performance, energy efficiency, mold-, pest- and fire-resistant properties will be informative, not just for the industry, but also for plaintiff attorneys. Ensuring that hempcrete has been tested appropriately and meets industry gold-standards will be paramount for the defense of such litigation and EU practices will be instructive.

The United States construction industry, and particularly hempcrete product manufacturers, should pay close attention as the EU expands green construction practices, including the use of hempcrete. The trials and errors of European industry counterparts will inform U.S. regulations, litigation and risk management best practices.

 

The British Isles Sees Cannabis as an Economic Development Pathway

By Marguerite Arnold
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Cannabis as a tool of local or even regional economic development has rapidly gained traction in many jurisdictions within the United States and Canada. It has also caught on particularly in the poorer states of the EU (see Greece) and those countries hoping to enter the Union (North Macedonia).

These days, the concept is also spreading even to the UK, where reform has lagged significantly behind other countries both in North America and Europe. Indeed, two island communities are now investing heavily in the idea that cannabis is not only here to stay, but may invigorate communities and the economic health of islands looking for a new path, post-Brexit.

Cannabis so far, certainly in the United States and Canada, has proved to be a job creator just about everywhere for the past five years. Indeed, despite a few large corporate restructurings (see Aurora and Canopy Growth) of late, the industry itself has not slowed down, even with bumps in the road in terms of full and final legalization and the new challenges of a global pandemic.

House Of Green, Guernsey
This project is moving along, with its first harvest set for later in the year. The ₤2 million facility plans to be able to process up to 800 pounds every eight-hour day. Raw product is being grown at vineyards on the island itself by independent farmers and partners from other islands. Indeed, it is a unique facility on the European side of the Atlantic.

The company plans to process cannabis into tinctures, balms and salves as well as alkaline waters.

The idea is to create the base ingredients from which other products – bound both for the medical and recreational market – can be made.

Vecticanna, Isle of Wight
Just off the southern coast of the UK, Vecticanna is also embarking on an ambitious project – a fully solar-powered facility which plans to eventually employ 60 people. Their mission? To “unlock the therapeutic potential of cannabis” for the treatment of Fibromyalgia and related conditions.

Vecticanna has partnered with several large institutions, including the University of Southampton, and CAR Laboratories in Cambridge, and plans to produce its products in an R&D and research setting with the ambitious hope of furthering the potential of cannabinoid-based healthcare.

Where Goes UK and European Reform?

Reform across Europe has indeed been frustratingly slow. This includes the many hiccups in the German cultivation bid, which was first launched in 2017, and will only see the first nationally produced cannabis in the country sometime this fall. That amount is far too little for the patients who have already obtained prescriptions, and certainly will not be enough to serve the expected million plus patients in market here in just a few short years. Indeed, medical cannabis distributors in Germany are scouring the planet right now for properly certified product that comes from other European countries as well as South Africa, Australia, and even Latin America.

In the meantime, a new generic producer of dronabinol (synthetic THC) has just gained access to the German market.

In the UK, reform so far has also been torturously tortoise-like, with the National Health Service (NHS) favouring local producer GW Pharmaceuticals and forcing all other patients and their families to import pricey product from the Netherlands or Canada. While, it should also be added, excluding chronic pain patients.

Why Are The UK’s Island Cannabis Projects So Intriguing?

With a few exceptions (see Greece and Malta), European cannabis development remains mired in complications that include everything from a lack of reform and high prices to fights over basic regulations, including whether cannabis is a “novel” substance or not. This has slowed down the ability of growers to obtain the right certifications, find financing and actually go into business.

With two new producers on islands close to Europe and the UK however, there appear to be projects on the horizon which have jumped the regulatory queue, and are lining up for an intriguing future, supported from the ground up, by local policies that are looking at two simple things: the efficacy of the plant itself, and the economic well-being of their neighbors.

Turning Over A New Leaf: Faces of Courage In A Pandemic

By Marguerite Arnold
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The cannabis industry is not immune from global setbacks. Discussions about how resistant the vertical is to this (next) setback have been widely disseminated, from mainstream news to the blogosphere.

Yes, the UN punted global reform down the pike another 9 months – affecting the international industry. And so far, the entire vertical has been left out of the relief bill in the United States (although there are lobbying efforts everywhere to correct the oversight on subsequent bills now almost inevitably in the legislative hopper).

However, there are signs that the industry is actually gaining credibility if not forging new victories during a time likely to go down as this century’s “Great Depression.”

Here is a look at some of the trends afoot that are already bearing fruit and bringing relief.

Cannabis Business Is Essential Business

Some important battles have been won in many states in the U.S. as well as several other countries (including but not limited to Canada). This starts with the designation of the industry as “essential,” at least on the medical side. The issue of delivery and cashless payments have been on the front burner just about everywhere. And this time, there are few if any objections with a national lobby to voice said concerns.

In Europe of course the conversation is also different depending on where you are, but there are still signs that things are clearly changing.

In the UK, authorities have made it easier for cannabis importing. In Germany, pharmacies are on the front line in a way unseen just about anywhere else.

And in Spain, with most patients reliant on cannabis clubs, the lockdown and subsequent hardship for the most vulnerable has led to widespread calls to make deliveries a possibility. Even if the clubs are not functioning as “lounges,” their operators might not get fined for opening their doors, much less “importing” product from the outskirts of town to a central distribution point.

Pivoting To Respond In Times Of Crisis

It is impossible to forget that the emergent industry has been on the forefront of the medical industry and certified production for a long time, even if that, at least up to this point, has received little respect.

Health Canada has asked testing labs to repurpose their activities for Covid-19 testing.

Canadian and American producers are also on the front lines of providing PPE (personal protective equipment) that can be multi-purposed. Masks, gowns and gloves have all been donated from multiple companies. Others are literally repurposing ethanol used for extraction to make hand sanitizer for vulnerable populations. More than a few, including in Europe, have directly been involved in helping to fundraise for foodbanks.

GMP Licensing and Other Developments Still Cooking

While some companies waiting for certification have been stymied because of a lack of foreign travel (EU-GMP requires German inspectors to travel to Canada for example), there are other indications that global companies are finding the way through anyway.

GMPNew deals are being inked all over the planet, including international provision deals from unlikely places. This is in part because new export and sales channels are being forged – literally out of desperation. See the story of Little Green Pharma and Astral Health, an Australian company now exporting to the UK (a first). Or the New Mexico company Ultra Health, which just started to export to Israel. Not to mention the source of Israel’s other international purchase of cannabis this month –  from Uganda of all places.

Down under, things are certainly developing in an interesting way during the crisis. Indeed, New Zealand decided to proceed with its own cannabis cultivation, with signs that more reform is on the agenda for later in the year.

Back in the Northern Hemisphere, North Macedonia, home of one of the most developed cannabis economies adjacent to Europe, is literally one amendment away from entering the European and global business with flower as well as extracts (which is on the table this month as the government begins to reconvene.)

In summary, while times are tough, everywhere, the entrepreneurs who have forged their way through laws of man to create reform, are also showing up to battle against this century’s so far most emergent threat.

UN Votes to Delay Rescheduling of Cannabis for Second Time in Two Years

By Marguerite Arnold
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For the second time in two years, the United Nations Commission on Narcotic Drugs (CND) has delayed a critical vote on the reclassification of cannabis. The CND met in Vienna, Austria from March 2-6. The vote is now expected to happen in December 2020. The discussion about reclassification of the plant, however, has been going on for a little longer than that.

WHO Recommendations

There are several recommendations that are on the table (even if far from perfect). See the full text of the recommendation here.

  1. Delta 9 Tetrahydrocannabinol should be added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
  2. Delta 9 Tetrahydrocannabinol should be removed from the 1971 Convention on Psychotropic Substances.
  3. The six isomers of tetrahydrocannabinol chemically similar to Delta 9 THC should be classified similarly to Delta 9.
  4. Extracts and tinctures made from cannabis should be removed from Schedule I of the 1961 Single Convention but that they should also be classified per the act. In other words, extracts with THC should be considered narcotics with medical purpose and all dealt with per a single rule.
  5. Cannabidiol products containing no more than 0.2% of Delta 9 THC should not be under international control.
  6. Preparations with THC that are made as pharmaceutical products should be reclassified as Schedule III drugs per the 1961 Convention. (Note – Dronabinol is already classified this way in the United States and has been since 2010).

What Does This Really Mean?

Given the impending lockdown of whole industries right now, but a wartime footing for certain pharmaceutical drugs and medical equipment makers, on one hand, this seems like the obvious and safest thing to do. The world needs a vaccine and direct treatments and to focus research, manpower and money in that direction.

Further, and this should hopefully galvanize the industry internationally, what this also does is keep the consumption of the plant itself basically illegal while putting the focus on professionally prepared pharmaceutical drugs.

This is short-sighted. Cannabis is unlike other medications. Further, the high cost of pharmaceutical drugs makes wider treatment policy options extremely expensive to implement.

Further, this approach continues to define cannabis – specifically Delta 9 and THC – as a narcotic.

While it is undeniably true that for recreational users, there are narcotic effects, most long term patients do not react to the drug this way – particularly if they suffer from chronic pain due to neurological issues (including movement disorders), inflammatory diseases like rheumatoid arthritis and those that destroy the body’s immune response, like HIV.

There is a need for regulation, normalization of supply chains globally and of course, medical trials.The definitions of this plant, in other words, need to change. And not just for the benefit of pharmaceutical companies, but for patients as well.

Further, in a world that is quickly headed for a global recession unseen since the Great Depression, highly priced medications are not the best Rx.

As the German government responded to President Donald Trump recently, as he tried to offer a German company a billion dollars to only develop a vaccine for use on Americans, there are clearly limits to capitalism.

The Good News

It is highly unlikely by December, nine months into a global public health crisis which is widely expected to last for at least the next two years, that the UN will delay the vote again come December. There is a need for regulation, normalization of supply chains globally and of course, medical trials.

Beyond that, recreational reform also looms at a federal level in many countries and regions.

However, given the discussions so far, it is also clear that beyond the redefinition of cannabis, there will be greater legal opportunities to expand an industry too long stigmatized by old fashioned understandings and definitions of what cannabinoids are.

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Access to Cannabis Is About to Get Easier in UK

By Marguerite Arnold
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As of March 2, right before the UN punted on reclassification of cannabis at the international level for another nine months, the UK government eased import restrictions for people in search of the drug.

Specifically, licensed wholesalers will now be able to import larger quantities of cannabis-based products and hold supplies for future use by patients with prescriptions.

Previous restrictions meant that patients had to wait for weeks or months to obtain the still highly expensive drugs (an import license from Canada can take 8 weeks).

Essentially, while welcome, this also means that every single potential cannabis patient who does not suffer from epilepsy or MS must import, via private means, a drug that is still unbelievably expensive. Those with the means are subjected to high prices and bureaucratic complications (like a regular thirty-day review of the prescription).

Cynical Cannabis Moves

While those who can afford to pay approximately $1,000 a month now have options, this is not exactly cannabis reform that is inclusive. Indeed, the entire conversation appears to be about making sure that private companies make profits rather than scientific advancement.

While the government is planning to engage with patients and to participate in trials to figure out how the NHS can utilize the drug, this is little help for sick patients now. Particularly in the middle of a global pandemic and almost as surely, global recession.

Soundbites by government ministers are also putting a cheery face on a situation that is dire, not just because of access but because of cost.

Per British Health and Social Care Secretary Matt Hancock, “We still have a long way to go. We need more research into the quality and safety of these medicines, and to do all we can to cut down the costs and remove barriers so that, when appropriate, patients can access it, including on the NHS.”

How long that might be, however, is anyone’s guess. This discussion has now stuttered on for the last several years domestically.

Why all the Delay?

As recent events, including not only Brexit and cannabis reform, but indeed the now global pandemic have proven, healthcare systems globally are not up to the kinds of threats now thrown in their direction. Designed mostly after WWII, with a far different tax and economic base to support them, as well as far different demographics, most are also clearly not up to the rigors of the 21st century.

It is not just the supply chains for cannabis or even pharmaceuticals that are in the mix of course. Food security in the UK is now also, according to one international expert, Tim Lang, World Health Organization advisor, “in serious trouble.”

The Covid-19 pandemic, in other words, caught the world with its pants down, despite numerous warnings and even models predicting almost exactly this situation as recently as last year. Just like the AIDS crisis. This time, however, there are options available.

The question is, will governments and international organizations rise to the challenge to meet them?

A New World Drug Order

The British, while behind the Germans, are unfortunately, delaying a decision which has been already extended for too long. Relaxing drug import rules are one thing. But recommendations about the uses of the drug are still very narrow in the UK (even more stringent than in Germany).

Beyond that, overall food and drug security (supply chain) issues are in the room and for drugs far from cannabis. As many have begun to point out, cannabis is now prescribed for patients (and in many countries) and these patients are the most vulnerable to a virus like Covid-19. They are vulnerable not just because their immune systems are weak, but frequently because they are also economically exposed.

As the world battles another retrovirus pandemic, perhaps it is time that the lessons of the past be learned by those with the power to make decisions that will ultimately affect billions of people globally.

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Australian Producer MGC Pharma Gains Access To Polish Pharmacies

By Marguerite Arnold
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Publicly listed Australian firm MGC Pharma has now entered Poland. The company just announced a commercial wholesale agreement with a local NGO called Cannabis House Association. CHA is also pairing with the Forensic Laboratory of the Faculty of Law and Administration at the University of Lodz. The plan is to support a large-scale research project in Poland.

This is a first of its kind situation in Europe, even more interesting that it is happening here (as opposed to say Germany). The idea is to examine the societal, financial, medical and public health ramifications of the use of cannabis.

There are approximately 15,000 pharmacies in Poland, most of which are authorized to dispense cannabis. Indeed, estimates of how many Polish patients there are ranges from between 300,000 – 600,000. Numbers could also be well higher.

Poland does not represent the only European landing of late for MGC. Indeed, the company also began importing cannabis into Ireland – as of December, 2019.

CannEpil MGC
CannEpil, the company’s first pharmaceutical-grade medical cannabis product for the treatment of refractory epilepsy.

While it is based in Australia, MGC also has a production facility in Slovenia.

What Does Polish Reform Look Like on the Ground?

Poland is in an interesting position in the cannabis debate right now. Policy tends to follow Germany on many issues. However much the situation is different here than Germany, there are also obvious similarities – starting with the reluctance of authorities to encourage anything but imports into the medical market.

However, while the situation facing patients is not exactly analogous to Germany (it is more like Ireland or the UK right now), the country is clearly moving into a strategic position in the global cannabis economy.

Poland is also clearly at least beginning to implement reform that appears to track its larger neighbor next door.

A Short History of Polish Cannabis Reform

For the past few years, ever since 2017 in fact, when Poland “legalized” medical use, patients have been stuck with few options. Indeed, the only real access route to obtaining the plant or cannabinoid medicines legally is literally crossing the border, in person, in a place like Holland or Germany. Obtaining the drug in another country and then making the border crossings to get it home is not an attractive situation for anyone. This option, obviously is prohibitive for almost everyone. And dangerous for caretakers and patients alike, and clearly not sustainable.

Like Germany, in other words, Poland appears to be moving cautiously to implement the idea of cannabis reform starting with imports first. Even though there is a burgeoning local hemp industry in the country with hopes to not only to supply domestic patients, but also to export over the border into higher wage economies. See Germany, for starters.

Starting in 2018, Canadian companies began to enter the market. Aurora and Canopy Growth in particular, targeted Poland aggressively. But they are far from the only companies eyeing the country as a lucrative market. Macedonian, Czech and Israeli firms are all eyeing the ground.

Developing Market Issues

Poland is however on the front lines of this debate in a way that its richer European neighbors are not. With an exchange rate that is roughly 4 zloty to 1 euro, expensive cannabis imports will be even further out of reach for patients than they are in say Germany.

mgc-pharmaFurther, there is an active and enthusiastic burgeoning domestic cannabis economy on the ground already – although locally, capital is scarce.

MGC’s experiment, in other words, represents a first step not only in business development for their own products, but a potential opening of a national acceptance about the use of this drug – not to mention who pays for the same – and where it is produced.

In the aftermath of COVID-19 hitting Europe, German ministers (for one) are already suggesting that the country secure its pharmaceutical supply chain by producing more drugs in the country rather than relying on supply chains that reach to Asia for more conventional products.

It is likely that this conversation will also begin to expand to cannabis, not only in Germany of course, but also Poland.

In the meantime, MGC Pharma has managed to go where no other private cannabis company has gone in Europe so far – and in a way that will pay off not only for them, but the entire cannabis conversation.

How Coronavirus is Affecting the International Cannabis Industry

By Marguerite Arnold
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Frankfurt: Germany right now is not the worst place to be as a global pandemic closes borders and leads predictably to mass change overnight, which is unparalleled during peacetime. But it is still eerie. Berlin and Cologne are starting to close public spaces (like restaurants, bars and clubs).

The grocery stores and pharmacies are still stocked and open however- it is a national priority.

On Germany’s borders, Europe is closing in a way it has not since WWII. The EU is considering banning all non EU “foreigners” from entering the region for nonessential reasons for the next 30 days – albeit in an environment where leaders are also concerned about making sure supplies get through to those who need them.

It also feels like wartime – only this time the “enemy” is a virus. It is called COVID-19, and it is spreading. It cannot be “stopped” although authorities are now doing everything they can to slow it down. At risk are not only populations but also vulnerable health care systems. The goal here is to prevent masses of sick people showing up at hospital. There will not be enough space for everyone if the rapid spread of the virus is not stopped, starting with beds and ventilators. In Italy, doctors are already triaging patients (deciding, in an overwhelming influx of sick patients, who has a chance of living and who does not), because there is a shortage of staff, beds and medical devices for those who need the most care.

The German government, in particular, is clearly prioritizing slowing down the spread and mitigating the load on a system that is strong, but also vulnerable to this kind of existential overload. Jens Spahn, Germany’s health minister, sounded the alarm early about mass gatherings. The country’s Chancellor, Angela Merkel, has promised to throw “Germany’s arsenal” (funding) to help German organizations hit hardest.

But that is just one country. Italy is in lockdown, Spain is on its way this week, and many others are closing borders. In Switzerland, as of this weekend, the only shops that were open were pharmacies and grocery stores. To get in, you must wait in line outside, spaced 1 meter from other people, and use hand sanitizer as you enter.

These are not privations that any generation alive today remembers viscerally. The closest is stories, perhaps second or third hand, of what life was like here during wartime.

Both China and now Germany have sent medical supplies to Italy (the worst affected country in Europe so far), and a German company is on the front lines of producing a vaccine which is likely to be ready for human trials as of June.

What Is The Impact On The Cannabis Industry Specifically?

But how does all of this impact the global cannabis industry, especially as it is an industry still very much and by design, built on international imports? Throughout the world, including the United States, cannabis-related trade shows, expos and conferences are all being either cancelled or rescheduled to June at the earliest. President Trump also instituted a European travel ban, although this will not have much effect on the industry here, since Germany imports cannabis from Canada, not the U.S. for its medical market.

The connection to the industry from the threat of the virus itself is also on display. In Illinois, for example, some dispensaries are giving priority to their medical patients, shutting the doors to recreational customers. Just months after legalizing recreational sales, the state is now telling dispensaries to discourage crowds and prevent customers from lining up. That is not so far the case in Europe where cannabis is slowly being normalized into the regular pharmacy system. But pharmacies are also on the front lines of this epidemic – not only in that they serve front-line customers, but also deliver medicines to retirement homes.

German authorities have already suggested that they nationalize medical supply chains from Asia for vital medical supplies, including presumably vaccines and other medications as well as medical equipment, like ventilators.

Clinical trials, fast-tracked vaccine production and new drug approvals are evidence of how quickly governments can work to produce new treatment options. Countries still hampered by the slow pace of cannabis reform should look at how a global health crisis has allowed governments to bypass certain areas of red tape, untethered by high prices in developing supply chains. While cannabis reform is indeed not the same as a global pandemic, it has the ability to save lives regardless. That ability should be enough impetus for quick reform, much like actions taken by governments so far during this crisis. Not to mention the fact that many cannabis patients are also the demographic of who is most vulnerable in this epidemic – the chronically ill and the elderly.

The International Cannabis Business Is Built on Global Supply Chains

In the U.S. right now, there is a significant concern about sourcing of the vaping industry (the vast majority come from Asia). In Europe this is of course far less of an issue. The only vapes of medical designation produced here are made by German Storz and Bickel.

However, there are other considerations. Right now, more cannabis is being imported than grown in Germany legally, Europe’s still largest medical market. And so far, most of the cannabis here is coming in from Canada, Holland or Portugal although domestic production has now been seeded from Greece and Malta to countries further east. There is only one entity (the former Wayland in partnership with the German Demecan) who is now even certified to produce in Germany.

Wash your hands, limit social interaction and cancel large events. Stock markets around the globe are in free fall as investors fear the crisis will plunge the global economy into a recession. This obviously affects publicly traded companies, as well as companies looking for capital. Expect the larger cannabis companies to continue taking bigger hits on their stock price.

But while borders are being closed all over Europe to people, emergency medical supplies and the like will increasingly be given priority.

How countries begin to view cannabis in this kind of epidemic is another question. It is certainly a drug of last resort right now, highly expensive and in many cases going to the elderly and those in palliative care. For this reason alone, cannabis companies need to step up to the plate. This industry is being built to serve the chronically ill. In other words, those people who are already most vulnerable to this virus.

But how to do that? Dronabinol (manufactured in Germany) is no longer the only option now available. It was patented as a direct response to the AIDS crisis in the early 1980s. But in a country with other options now, this is also on the plate.

So what can cannabis companies do during this time of crisis? For starters, read the guidelines on how companies can do their part to mitigate the spread of disease. Wash your hands, limit social interaction and cancel large events. Consider using in-store pickup or delivery options, where legal. And use telecommunications platforms like Skype or other remote cloud solutions to manage your workforce remotely.

Cannabis companies ought to have the wherewithal to do their part in mitigating the spread of COVID-19. As the global pandemic continues to spread outside of China (the only place where new infections are now levelling off), it’s increasingly important to monitor the situation and take extra precautions to mitigate the spread.

european union states

International Supply Chains: Considerations for European Imports

By Marguerite Arnold
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european union states

The recent decision in Germany on the reclassification of CBD (kudos to the European Industrial Hemp Association) as something other than “novel” has now opened an interesting new discussion in Germany and by extension, Europe.

It basically means that hemp plants, if they are European in origin, can be grown (under the right regulatory structure starting with organic) and even extracted without ever being considered a “novel food.”

Look for (hopefully) similar discussions now across Europe and the UK where the Food Safety Authority is also examining similar policies.

What this ultimately means, however, is that the market is clearly opening on the CBD front, but only for products that make the grade.

What should the average producer or manufacturer from North America think about when setting up a supply chain for export?

Regulations

Thanks to the new treaties in place between the United States, Canada and Europe right now, there are market openings in the cannabis industry in Europe. Starting with the fact that the cannabis bug has clearly hit the continent, but there is actually not enough regulated product to be found yet and just about anywhere.

This is keeping prices high right now, but do not expect that to last.

european union states
Member states of the EU, pre-Brexit

Regardless, pricing of imports will not be like anything you have experienced if your background is state or even national market in the U.S. or Canada. There are higher regulations in every direction in Europe. Understanding how to translate the same into equivalencies that do not bankrupt you, overprice your products, or worse, get you in trouble with authorities is a critical first step, and not one to be taken lightly.

Get professional guidance from the country you are hoping to export to, at minimum. And that includes the legal kind. Every step of the way, you have to be certified with, at minimum, federal if not at an international certification.

No matter what cannabinoid is in the mix, this is ultimately a plant-based product. All rules one would normally think about when talking about other food products (for starters) are in the room.

While it is far from “this easy” (although thanks to the USDA’s decision about hemp, not to mention the FDA update on its own deliberations, there are now federal standards), think about the problem this way: If you were the world’s best chocolate bar, or even tomato juice, how would you hit Europe right now?

They have tomatoes here, and unbelievably great chocolate already. What is it about your offering that can stand out?  This is the million-dollar question. There are a few people and companies doing this right now, but it takes experience, and understanding the multiple regulatory guidelines involved. Once you figure that out, then you need to look at your supply chain, piece by piece and literally from the plant through end production for where you fit, and where you might not, into the regulatory discussion and market you hope to enter.

The Medical Discussion

There is now the possibility of exporting medical grade hemp and hemp extracts from the United States to Europe. However, everything must be GMP-certified to a medical standard, from organic production on up. This is an international standard, not an American one.

GMPThat qualification does not exist much in the cannabis industry in the United States (although ISO very much is) yet. Although it is dawning. On the Canadian side, there are plenty of companies in the discussion, because there is already a beaten path to export.

As the German cultivation bid proved, European certification, certainly is a high barrier to reach. Indeed, it is not only GMP certification in the room on the medical side but also rules about the import of all plant products.

From this perspective, it is also easier to import “finished” product rather than plant.

The Recreational Discussion

Before anyone gets too excited about recreational reform, the reality is that Europe is not going to step ahead of the UN (which has now pushed its next deliberation on the topic to the end of 2020). Yes, there are trials in a couple of places, but far from earth-shaking (recreational trials in the land of the coffee shop anyone?)

More interesting, of course, is what has just happened on the CBD side. But before American hemp farmers get too excited about this, they have hemp and farmers in Europe. And quite a few people have seen the light on this one already.

Sure New York state exports to Europe are probably in the offing, but so are hemp exports from the Southern states where the weather is warmer and the labor cheaper.

The European Union’s logo that identifies organic goods.

Certified labs, processing and extraction, and labelling are all in the mix. And every step must be documented as you go.

How to Proceed?

Whatever your crop or product is, take stock of the certifications you have now. If your plant was not organic, forget export anywhere. You are out of the international game.

However, with this taken care of, look at the certification requirements in Europe for extraction, processing and import of food and plant products and obtain production partners with the same – either in the US or abroad.

With luck, patience, skill and knowledge, yes, the doors are slowing opening, even to U.S.-based cannabis trade of the international kind.

Just don’t expect it to be easy, and leave lots of time for workarounds, pivots and even re-engineering at every point of the way.