Tag Archives: Union

August 10, 2020

Spanish Cannabis Approved for Import to Germany

By Marguerite Arnold

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

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

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

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

The European Ex Im Market Is Opening

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

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

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

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

The Impact On The Spanish Cannabis Discussion

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

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

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

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

July 22, 2020

The Changing Landscape of CBD in the UK

By Mike Barnes

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Reports estimate that up to 8 million people in the UK use CBD for its variety of wellness benefits. The market is currently worth £300 million, a figure which is expected to more than triple in the next five years.

Sales of CBD already outstrip those of Vitamin C at £301 million vs £119 million and given that almost 90 percent of users in the UK purchase CBD online, new investments into omnichannel and e-commerce capabilities are likely to lead to even more growth.

Yet, for all this excitement, the truth is the UK’s CBD industry is facing a bit of a roadblock.

Until this year, CBD has been in a period of regulatory uncertainty and the industry faced understandable criticism when high profile cannabis probes found that over half of the most popular CBD oils did not contain the amount of CBD promised on the label. On February 13, 2020, the Food Standards Agency (FSA) unveiled new plans to better regulate the industry and announced a deadline of March 31, 2021 for the submission of a valid application for novel food licence for businesses selling food and food supplements containing CBD in the UK. Contained in the announcement was a warning to all CBD companies that failure to comply may result in products being taken off the shelves.

Consumers are also advised by the FSA to “think carefully” about taking CBD, and not to consume more than 70mg a day, making the UK the first country in the world to set recommended limits for CBD consumption, despite no scientific basis for the 70mg recommended limit.

Whilst it is undeniable that the CBD market requires some form of regulation and standards need to be raised for CBD products, to ensure consumers are receiving safe, legal and quality products, this will be a complex and costly process. CBD companies, particularly smaller CBD brands, will need to ensure they have the necessary infrastructure, expertise and resources to meet this deadline.

The deadline is fast approaching, and no extension has been granted despite of the difficulties caused by COVID-19. This will put all businesses under pressure, as the process for applying for Novel Food status requires supplying a large amount of data from rigorous testing. For larger players, this will likely be nothing more than a costly inconvenience, but for smaller, nascent businesses, these costs may put their longevity at risk. There are hundreds of CBD start-ups which have done great work to future-proof their businesses and create safe, high-quality products. Now, instead of preserving costs to try and stay afloat during the pandemic, these businesses must put a significant amount of precious resource and funds into finalising their applications in time.

Improving end user confidence in CBD products and understanding the process from seed to shelf is crucially important in this developing industry, however, I firmly believe these regulations are suffocating the market. I fear that on April 1, 2021, many smaller firms who haven’t managed to achieve Novel Food status yet have a superior product, will suddenly find themselves unable to legally trade.

On the other hand, there is the argument that the FSA ruling may increase the importation of CBD products from firms based outside of Europe. So far, the large cannabis firms in North America, which have the budget and expertise to meet FSA standards, have held back on importing CBD products to the UK. This may well have to do with the slightly dubious legal status CBD has so far had in the UK, so it will be interesting to see whether this changes in April next year and which players will enter the market. The CBD market will continue to grow and diversify but it will be essential that this leads to increasing consumer choice rather than confusion.

In my opinion, the only way the UK will be able to fully harness the potential of CBD is to create an independent, self-sufficient industry that not only helps consumers but contributes to the wider economy through jobs, skills and investment. The pandemic has done well to put a spotlight on the huge access issues cannabis patients face in the UK, bolstering the case to ‘onshore’ the industry.

Whilst this would require a streamlining and simplification of the licensing laws around growing cannabis, the development of a UK-based industry would have endless benefits. Not only would medical cannabis patients see improved access to their medication, CBD firms would no longer have to ship oil in from the dominating wholesale nations such as Poland, Czechia and Italy, this in turn having huge economic benefits. The development of a UK industry should involve the creation of a new regulatory system specifically designed for cannabis products and preferably for a new regulatory body, similar to the Office of Medicinal Cannabis in the Netherlands, to oversee all cannabis regulation, licensing, importation and approvals. This would mean a move away from the current solution of forcing CBD products into the Novel Food category and subjecting them to inappropriate regulations which will soon begin to smother the market with unnecessary red tape.

People are increasingly turning to more natural health and wellness solutions, so as Britons become better informed about CBD products and as the market matures, demand will certainly increase. Yet with both Brexit and standardisation of cannabinoid regulations occurring in parallel, the future and scale of the CBD market is still to be determined. A huge UK market could potentially help push it in a positive direction, facilitating processes for CBD producers.

The cannabis industry is resilient and until this point, has managed to grow at an exponential rate despite regulatory uncertainty. As acceptance and demand continues to increase, so the case for an independent UK industry will strengthen and regulatory roadblocks finally overcome.

July 22, 2020

Could CBD Standards Become Global?

By Marguerite Arnold

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Here is the good news: There are beginning to be regional- and country-specific guidelines on at least one widely grown cannabis crop internationally. This includes a range of regs on the medical side (GMPs) but they are also expanding for the “other” cannabis crop too. Namely, hemp.

Now, here is the bad news: The regulation that is developing in different regions is frustratingly not uniform, and can still differ greatly in critical areas. Most notably, for some reason, while the U.S. Farm Bill of 2018 created a new national standard for the amount of THC that could be contained in American hemp crops (0.3%), the same conversation in Europe during the same period of time led to a decision to set the level of allowable THC in hemp plants and products at a slightly lower one: 0.2%. As a further confusing muddle, Switzerland has set its THC limits at 0.1% (Switzerland is not in the European Union), and other countries across the region have also attempted to limit the THC in industrial hemp production to no more than this level, no matter what regulators rule at the EU level.

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

Beyond a lack of scientific reasoning obvious in the same, by definition, this creates a natural trade barrier between hemispheres. If U.S. farmers are looking for export opportunities to Europe (for example) not to mention other states, they have to worry about both local as well as destination standards – which on the surface at least, are currently incompatible.

It is also creating some frustrating issues for anyone who is in the market for hemp as either a buyer or seller.

Other Issues In The Mix
Markets are driven by many factors – including regulations but also cost and of course consumer demand for a product within a certain price range. Certainly, the CBD industry if not the recreational THC one right behind it (even in Europe now) desperately wants to attract those who are known euphemistically as “daily consumers.”

This means that both the price point and consumer opportunities must hit a mainstream distribution norm. While the recreational market will continue to be distorted by delayed, but inevitable discussions about reform across Europe, the medical market is beginning to set some groundwork that is also bleeding into the entire discussion. Namely, that extracts will play a large role here.

What does this wrinkle mean in a world where the agricultural cultivation standards are different?

Biomass And Extracts Are Gaining In Importance
For those in the strictly “flower” game, the market at least in the U.S., will remain a place where pretty flower crops will gain premium prices as long as they meet local spec.

However, this is a limited proposition, even now – especially in the CBD business. The edibles market, for one, has created a huge potential for vast quantities of industrially produced, outdoor grown hemp, bound for extraction and downstream, a vast variety of end products across a wide spectrum of niches – from wellness to purely cosmetic. So is the burgeoning medical market in Europe.

This means two things. The first is that consumer-facing products with any amount of cannabinoid (take your pick) can be produced to order, no matter the cannabinoid concentrations of the original plant. The second, by definition, means that biomass bound for extraction, particularly export, will gain an increasingly larger share of the wholesale market.

Does it really matter, in other words, to a European extractor, that the source product is of higher THC concentrate than is allowed for B2C sale in Europe? No. Indeed, all it means is that they have to buy lower amounts of biomass. The rest is merely a mechanical problem.

Playing The Regulatory Game
For an increasingly competitive hemp market in the United States, in other words, foreign exports are absolutely an intriguing option for revenue right now, and will continue to be as long as price competitiveness and overall quality issues remain high. Furthermore, there will be almost no pressure to regulate the market globally to the same standards, particularly if CBD itself is descheduled in December by the WHO.

In other words, the regulatory disconnect between the U.S. and Europe right now, and certainly for certain kinds of unfinished bulk product, could therefore open a new niche in the market that is unlikely to be “fixed” anytime soon.

July 14, 2020

Shakeups In The German Cannabis Market

By Marguerite Arnold

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As Germany begins to enter a summer where life seems ever more normal, there are fairly major shakeups underway in the German cannabis market. These are structural but will have a profound impact on the entire market going forward.

A Mass Of Distribution Licenses
It is an interesting metric to understand that before 2015, there were no specialty cannabis importer/distributors in Germany. As of July 2020, there are rumors that this number has now shot to close to 80 (either licensed or in the process to become licensed). That is a huge number. So was the last amazing number (40) as of the beginning of this year. Just the previous estimate would mean, literally, 1 specialty cannabis distributor for every 2 million Germans. That obviously is not sustainable. What it does indicate is the huge surge of interest in medical cannabis not to mention acceptance, as well as the amount of money actually now beginning to slosh around in the domestic market.

And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.How many of these distributors will survive is another question, particularly in an environment where the government is looking for just one to fulfil the needs of all of Germany’s pharmacies from what is grown domestically. This does not of course mean the end of specialty distribution. Indeed, far from it. There is not enough cannabis entering the market, presumably this fall, that is grown here to even come close to meeting demand.

No surprises here. This has been one of the enduring criticisms of the entire process, if not the bid itself since 2017.

However, one thing this does mean is that distribution fees, like pharmacy fees for processing the plant before them, are finally hitting a price adjustment phase.

This is also going to be good not only for patients, but also health insurers.

For all the standardization of the industry, including fees and mark-ups, one of the strangest things about the German cannabis market is how widely cannabis prices can differ even between pharmacies. This is as true of flower as it is of dronabinol.

The Wholesale Price Of Medical Cannabis Is Dropping
Again, no surprise here, the government will end up buying more cannabis than contracted for under the original bid. This was actually anticipated in the language of the contract that currently exists between the government and the three bid winners. Namely, an automatic 50% reduction in price is mandated for any cannabis sold beyond the 120% agreed upon qualities.

The growers domestically, in other words, who won the bid will be under a severe price restriction. This may have been the ultimate strategy of the government to begin with (namely to attract foreign capital and expertise but then begin to reign in the sky-high prices of medical cannabis so far.)

This means that the price of €2.30 a gram will undoubtedly fall. Where it will float is anyone’s guess, but right now it appears on course to hit about €1.87. Or about the same price that other governments across Europe (notably Italy) had previously negotiated with the big Canadian cannabis companies (notably on this one, Aurora’s military contract in Italy).

Implications For The Import Market
With domestic producers under the gun, this also means that all imports will begin to feel the price squeeze too. And that will also have a significant impact on point of sale cannabis prices.

And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.

July 2, 2020

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).

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.

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.

June 17, 2020

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).

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.

The 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.

June 17, 2020

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 6^th 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?

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.

May 15, 2020

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.

April 21, 2020

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.

New 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.

March 24, 2020

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.

Delta 9 Tetrahydrocannabinol should be added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
Delta 9 Tetrahydrocannabinol should be removed from the 1971 Convention on Psychotropic Substances.
The six isomers of tetrahydrocannabinol chemically similar to Delta 9 THC should be classified similarly to Delta 9.
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.
Cannabidiol products containing no more than 0.2% of Delta 9 THC should not be under international control.
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.