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Unpacking the New German Cannabis Reform Bill

By Michael Sassano
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Following the German cannabis reform movement is like watching a snowboard jump competition. We launch into the big jump with lofty promises, only to face the difficulty of gaining meaningful, immediate momentum at the bottom of the halfpipe. Nevertheless, we persevere through smaller political moves that set us up for more advanced regulatory jumps, all the while believing that broader cannabis legalization requires sacrifice and the skills to navigate the course properly.

The Cannabis Act is a significant step forward. Although we rarely get exactly what we want, it holds promise for the EU-GMP cannabis producers that have invested heavily in creating a global, pharmaceutical-grade market.

Reforms to Medical Cannabis in Germany

The Cannabis Act proposes reforms to how doctors prescribe cannabis, removing the narcotic designation that stigmatized prescriptions and created liabilities for doctors. If passed, doctors and telemedicine groups will be able to prescribe cannabis for almost any condition without fear of lengthy paperwork or the stigma of controlled substance liabilities.

This framework is reminiscent of early medical programs in the USA and Canada. In these countries, obtaining a prescription for cannabis became steadily easier as patient-driven demand took over. As we can see, the cannabis industries in these nations have flourished.

Home Cannabis Cultivation for German Citizens: A Small Step Forward

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Photo: Ian McWilliams, Flickr

Allowing citizens to grow three cannabis plants at home is not monumental. However, it is a strong symbolic statement about how accessible the cannabis plant should be to the broader population and is the first step toward a decriminalization bill.

This Act signals growing national acceptance from politicians and a shift toward treating the plant as a right for all Germans. Though small, this change needs applause from both institutional cannabis producers and the cannabis advocates that have fought so hard to bring it to fruition.

Cannabis Social Clubs in Germany

Social clubs are a completely unproven economic model, reminiscent of “coffee shop” models paired with small legal grows to service the club. These social clubs are a legal version of those around Barcelona and mirror proposals in Malta and Switzerland.

Though novel, the social club model is a positive shift toward a smaller-scale adoption of cannabis. It addresses a niche market for flower connoisseurs and appeals to cannabis entrepreneurs who want to explore their green thumb. The effect on the illicit market is yet to be seen, just like home grows, but progress here sets us up for the next move.

Looking Toward German Dispensaries

Cannabis institutional investors and producers are all looking towards the next step: American- and Canadian-style dispensaries that allow any adult to walk into a store and purchase a high-quality, regulated product. These establishments will likely compete directly with the illicit market and produce the capital necessary to push cannabis toward national legalization. Although not in the current text of the bill, all eyes are on the future as we celebrate our progress thus far.

The Cannabis Act Holds Promise for the Future

There is something for everyone in the latest Cannabis Act, whether you are a home enthusiast, advocate, members-only green thumb enthusiast or large-scale institutional player. This bill leaves little doubt that we are moving through the legalization course. There is much more work to come, but we are moving forward together and have hope for the future of regulated cannabis in Germany.

Innovations in Dosing Technologies: Getting an Accurate Hit, Every Time

By Michael Sassano
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Cannabis products and medicines are progressing rapidly, eating away at the market share of smokable flower. Currently, the general adult use cannabis market is split in three, in order of popularity: cannabis flower, vaporizers and ingestible products like edibles or capsules. In the medical market, flower is increasingly being replaced by alternative methods of delivery – and the same trend is now starting to be seen in the adult use market.

This is to be expected to some extent. Initially, only flower was available to medical cannabis users. On top of not everyone feeling comfortable with smoking, inhaling a combustible substance into the lungs is not the healthiest consumption method for those already suffering from a serious illness.

In the present day, there are new alternatives to smoking that come without the risk and actually have additional benefits. For example, there are now much more precise ways to measure your cannabinoid intake than weighing out the flower you’re about to burn. As technology develops, there is an expectation that – despite flower sales being fairly stable last year – we will see continued incremental growth in the non-flower category, especially on the medical side.

Oral Cannabinoid Delivery

Thankfully for those who want to use non-smokable products, there are a growing number of alternative oral products that are currently available in the market or are under development.

Some of the many infused products on the market today.

Cannabis edibles might be the first products to come to mind when you think about non-smokable products – but for many medicinal users, these are actually a fairly unpopular option. While having a cannabis-infused brownie or gummy might be quite discreet compared to smoking a joint, the need for patients to take in extra sugar or extra calories every time they need to take their medicine can be off-putting. Additionally, tradionally infused edibles can take between one to three hours to feel as the body needs time to digest.

Cannabinoid capsules or pills have recently emerged as an equally discreet alternative to edibles. These pills come in many forms, including hard capsules containing ground cannabis flower, softgel capsules containing measured doses of cannabis extract, and gelatin-free alternatives. Though these pills, like edibles themselves, do come with a relatively long onset time.

Cannabinoid capsules

Pills and edibles are also both affected by first-pass metabolism. This means that the active cannabinoids will be processed through the digestive system and the liver before passing onto the brain or the other organs. During this process, some amount of CBD or THC will likely be broken down by the body before it can make its effect felt, leading to inaccuracies between the labelled dose of a product and the active dose that reaches the brain or target area in the body.

To avoid these problems with first-pass metabolism, some have turned to use sublingual cannabis oils and tinctures. By placing a measured dose of oil under the tongue using a dropper, this theoretically allows for the fast absorption of THC or CBD into the bloodstream without the product being processed by the digestive system. However, in practice, these sublingual tinctures need to be held under the tongue for around ten minutes before they are fully absorbed. This is fairly difficult to do without accidentally swallowing some amount of the tincture, and so this still introduces some amount of uncertainty with dosing.

Fast-Acting Absorption

Fast-acting absorption techniques and nano emulsions are also gaining in popularity. Nanotechnologies and techniques have been developed by many firms, and boast claims of increasing absorption through the digestive system in order to effectively double the volume of cannabinoids absorbed into the body. Nano emulsions are also promising, which come with claims of up to four to five times more improved absorption. Such technologies rely on cannabis oils being immiscible with water-based substances, and process these cannabis oils in such a way that they become nanoscale droplets suspended in a larger mixture. Because of their size, these small pockets of cannabis oil are able to be absorbed rapidly through the gastrointestinal tract and into the bloodstream.

A drink additive, made by Splash Nano, that uses nano emulsion technology

Older liposomal and newer nano-liposomal combinations have also boasted similar claims. Liposomes are commonly used as a novel drug delivery system for pharmaceutical products to facilitate the absorption of drugs into the body, and the adaption of such techniques for the cannabis sector is also intended to dramatically improve the absorption of cannabinoids into the bloodstream. Given the marketing of these products, it can become confusing to know which is the best. The only way to know for sure is to have either a breath or blood analysis to see which style works and is best for the individual consumer.

As manufacturers progress from flower and basic products, the largest brands and more advanced medical companies are all producing ingestible products with fast absorption methods and additives. The difference is pronounced and significant enough that consumers and patients are starting to demand fast absorption products. As the market becomes more educated, you can expect that the market for fast absorption ingestible products will greatly outpace the older, more basic formulations. Of course, some emulsion additives will increase the operating costs for businesses, but over time, this difference will likely be fairly minimal.

Microencapsulation to boost cannabinoid absorption

Microencapsulation is another new method for producing drugs with high bioavailabilities, and the technique has recently made headlines in the cannabis industry.

Using a technique known as ionic gelation, or ionotropic gelation, scientists are able to trap drugs inside nano- or microscale capsules. These tiny capsules are robust enough to be able to protect the active drug ingredient–which in this case would be CBD or another cannabinoid–against the harsh environment of the gastrointestinal tract without necessarily limiting bioavailability.

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

Unlike the other oral dosing methods, cannabinoid microcapsules are not yet a commercially available product. However, there is early research indicating that this drug delivery technology could be a significant step forward in terms of improving cannabinoid bioavailability and absorption.

Published in the journal PLOS One, a new study from a team of Australian scientists reports that CBD microcapsules used in combination with a permeation-modifying bile acid can boost the peak concentration of CBD reaching the brain by 300 percent. These peak concentrations of CBD in the body also happened much earlier with the CBD microcapsules than with regular CBD oil, reflecting a faster absorption by the body.

This improved absorption and bioavailability addresses many of the limitations seen with traditional oral cannabinoid delivery. However, there is still potentially a very long road before these microcapsules are approved for general use in humans, making them an unrealistic option at present.

Metered Dose Inhalers

So far as innovative cannabis dosing technology that is currently available on the market goes, metered dose inhalers lead the way. Making up one-third of the market share, these devices are easy to use, discreet and are far less invasive than burning cannabis flower.

A metered dose inhaler by MÜV

Heating and vaporizing a purified cannabinoid also exposes the user to fewer potentially harmful combustion products than smoking flower. Using vapes, manufacturers are also able to adjust the formulation of vape oils in order to deliver a truly consistent product. This can help the consumer to truly measure their intake of beneficial cannabinoids.

Vaporizers for general adult use are very common now and come in many forms and flavors. Until recently though, there were very few vaporizers that met the specific needs of the medical market, like being able to deliver very controlled doses of cannabinoids. Now, innovation in the sector has led to a number of companies developing special metered dose inhalers for this purpose. These devices use smart technology to only heat and vaporize a pre-set controlled dose of cannabis oil from their compatible cartridges, allowing for intake to be tracked more precisely. This is different from regular vapes, where the amount inhaled can vary depending on how deeply a person inhales, or other environmental factors.

Recently, Syqe Medical received approval from Health Canada for their metered dose cannabis vaporizer. There is already a similar registration for approval in the US and Europe that looks promising for similar devices.

Recreational acceptance of products, like these high-tech vaporizers, drives up spending on innovations that would otherwise just be novel ideas. The cannabis industry has a wealth of creative talent, and with the market beginning to tear away from flower and towards novel and innovative products, like vaporizers and fast acting ingestible products, now is the time for the medical market to invest in this talent and follow the demand and the money.

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European Cannabis is Starting to Look Like the US Market 10 Years Ago

By Michael Sassano
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As the cannabis industry — now estimated to be worth more than USD 200 billion — continues to erupt around the world, Europe is about to take off.

This draws a parallel with the watershed legislative events of November 2012, when Colorado Amendment 64 and Washington Initiative 502 were implemented. These two bills kicked off a wave of medical and adult use acceptance in the United States. Europe’s medical referendums which started in 2017-2018 and the recent December 2020 United Nations acceptance of medical attributes of cannabis will do the same in that continental marketplace. Europe is following science and studying popular opinion about cannabis, just like the United States nearly a decade ago.

In many ways, the American “medical” market has been a political ploy, while the European market is truly medical in every way. Distribution through pharmacies and mainstream channels is the wave of the future. This method of distribution will both increase access and taxable bases quicker than the U.S. “medical” dispensary model. People who truly need cannabis should not be hindered by any rules or regulations to get the medicine, and the U.N. has paved the way for access while the U.S. still awaits rescheduling.

Markets in Europe require EU-GMP manufacturing for a variety of different products

The road to medical cannabis in Europe is more stringent than that of the U.S. and Canada. This is because most European markets have strict medical standards and medicines must be produced in European Union Good Manufacturing Practices (EU GMP) certified pharmaceutical manufacturing facilities. This is the same standard that all medical Active Pharmaceutical Ingredient (API) producers are held to.

Both Canadian companies, who have just launched extraction with Canada’s “Cannabis 2.0”, and American manufacturers alike are unfamiliar with pharmaceutical API production. Some argue that food-grade GMP standards are the most similar to already-existing systems in the U.S. and Canada. However, the meaning of “medical” is clear in Europe — it means medical. Improving access for patients to products will be the central challenge for Europe over the next few years as patient growth increases.

Europe is also embracing its potential adult use markets. First came Denmark, then Luxembourg, and now the Netherlands are all beginning to engage with the question of adult use cannabis legalization. We expect Portugal will soon join this list. After all, in a post-coronavirus world, every country will be looking for a means to grapple with a devastated economy and to boost employment to widen its taxable base.

The United States was supposedly founded by Puritans escaping gregarious Europeans. Now it’s likely America will legalize cannabis within the year and Europeans will be left asking, “Why them and not us?” And it will become harder to explain why such potential for growth in employment and increased tax revenue isn’t being taken advantage of as Europe begins to emerge from lockdown. It would be shrewd to expect a wave of European adult use kick-offs in 2022.

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It’s anyone’s guess what retail will look like for the cannabis market in Europe as it evolves

It is clear that 2021 is setting a blistering economic pace: from mergers and acquisitions to monster capital raises, to increased debt raises to the hot special purpose acquisition companies (SPACs) London Stock Exchange (LSE) up listings and initial public offering (IPO) fever. This year will be a cannabis-fueled explosion that Europe will not be able to ignore. With Canada, the U.S. and Mexico all likely to legalize cannabis in the near future, how long will it be before South and Central America follows suit? And then, how long for this wave to reach Europe?

The real answer is, it’s already here. Early adopters of cannabis overbuilt as the Canadians were given more money than they deserved, while the U.S. market was largely fueled by private equity and proved that it could be the biggest and best-run model. Europe will follow its own path by acknowledging the failures and successes of these markets, blending them to form its own unique European model.

The American dispensary will eventually pop up in Europe in a form similar to the current social clubs of Barcelona and coffee shops of Amsterdam. Possibly specialized pharmacies will carry more cannabis products, but it’s too early to call — countries are only just beginning to figure out how cannabis rules might be shaped to fit their needs and values.

2021 could be a decisive year for the European cannabis market

There are greater issues people are dealing with in the age of COVID-19, but that will change. Economic recovery, the need to provide medicine more quickly and affordably, social reform, green projects and many more pressing issues will become thematic of a post-COVID world; a set of themes for which a cannabis-shaped solution checks many of the necessary boxes.

There is a certain misrepresentation of cannabis as a panacea, able to cure every medical ailment and remedy every social problem if only it were legalized more broadly. While cannabis certainly is not a cure-all, it can fix many issues facing governments today. People were grateful for cannabis during these troubled times with cannabis stockpiling and usage through the roof in the early stages of the pandemic. As a result, 2021 has the potential to shatter old establishment perceptions as more consumers speak out.

Now, it is only a question of how the individual and collective European nations choose to regulate expansion across the continent. And the power to create a truly world-beating cannabis model is in their hands; without the international market differences and troubles that plague the North American sector, there will be virtually no limits to cannabis expansion throughout Europe if those in charge believe it to be so.

Cannabis Revival and Year of the SPAC’s: What’s To Be Expected the Rest of 2021?

By Michael Sassano
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The unusual nature of 2020 gave rise to a reciprocally roller-coaster-like cannabis market. Cannabis was cemented officially as an essential industry with the rise of COVID-19, and November elections resulted in even more United States markets welcoming medical and adult-use sales.

The stagnant cannabis stock market of 2019 became a thing of the past by the end of 2020. Throughout the course of last year, bag holders anxiously watched cannabis options creep back up. Now, nearly two years since market decline in 2019, the cannabis stock market is exploding with blank checks and buyout fever. Much of this expectant purchasing is due to Canadian companies considering U.S. market entrance. Combined with the recent surge in the use of special purpose acquisition companies (SPACs) to invest, this has led to an increase in asset prices.

A SPAC is defined as “a company with no commercial operations that is formed strictly to raise capital through an initial public offering (IPO) for the purpose of acquiring an existing company.” Though they have existed for decades, SPACs have become popular on Wall Street the last few years because they are a way for a company to go public without the associated headaches of preparing for a traditional IPO.

In a SPAC, investors interested in a specific industry pool their money together without knowledge of the company they’re starting. The SPAC then goes public as a shell company and begins acquiring other companies in the associated industry. Selling to a SPAC is usually an attractive option for owners of smaller companies built from private equity funds.

The U.S.-Canadian market questions that this rising practice asks are: Can Canadian companies enter a bigger market and be more successful? Is it advisable for U.S. companies to sell their assets to Canadian corporations whose records may be marred by a history of losses and a lack of proper corporate governance? Regardless — if both SPAC’s and Canadian bailout money is here, what comes next?

What is Driving this Bull Market?

Underpinning these movements are record cannabis sales internationally, making last year’s $15 billion dollars’ worth of sales in the U.S. look small in comparison. New markets have opened up in various states and countries throughout 2020, and that trend is only expected to continue. New demographics are opening up, especially among older age groups. This makes sense, as most cannabis sales — even in a recreational setting — are people treating something that ails them like insomnia or aches and pains.

Cannabis is set to take off, and we are entering only the second phase of its market expansion. The world is becoming competitive. Well-run companies that are profitable in key markets are prime targets for bigger, growing companies. At the same time, the world of SPACs will continue to drive valuations. Irrespective of buying assets, growing infrastructure is and will continue to be greatly needed.

The Elusive Profitability Factor

When Canada blew up, one of the biggest changes was companies began focusing the year on cost cutting and — most importantly — profitability. Profitability became the buzzword. But bigger companies are on the search for already-profitable enterprises, not just those that have the potential to be. However, profitability is currently still unobtainable in Canada. Reasonable forecasters should expect this year will show a few companies getting bailed out while many others will be forced to either merge for survival or declare bankruptcy.

An ideal company’s finances should highlight not only revenue growth, but also profitability. Attention should be focused on how well businesses are run, and not on how much money they have the potential to raise or spend. Over the years, there have been many prospective companies that spent hundreds of millions only to barely operate, and are now shells in litigation. Throwing money at any deal should have been a lesson learned in the past, but SPACs are tempting because they are trendily associated with new, interesting management styles and charismatic businesspeople.

Companies should be able to present perfect and clear financials along with maintenance logs for all equipment. In today’s day and age, books must be stellar and clean. As money pours into SPACs, asset valuations for all qualities of companies will rise. The focus instead becomes about asset plays, which will cause assets to continue rising as money is poured into SPACs.

Once upon a time, if number counters presented a negative review or had to dig too much, executives would turn a cold shoulder on investment. But in the age of SPACs, these standards of evaluation will be greatly undervalued. Aging equipment and reportability of every piece of equipment may or may not be properly serviced and recorded in a fast-moving market. Costs of repair or replacing equipment that isn’t properly maintained may be a problem of the past. Because when money comes fast, none care for the gritty details.

Issues for SPACs

Shortage of talent and training has become a big concern already in the era of SPACs. How many quality assets are out there? Big operators in the U.S. are content and don’t see Canada as an enticing market to enter. So, asset buys are likely to primarily be in the U.S. Large companies like Aphria may buy out some of the major American players, but most Canadian companies will use new funding rounds to pay down debts. Accordingly, they will then be forced to piece together smaller operators as a strategy.

A cannabis company’s personnel and office culture are very important when looking to integrate into a larger corporate culture. Remember, it’s not just the brick and mortar that is being invested into, it is also the people that run a facility. Maintaining employee retention when a deal occurs is always critical. Your personnel should be highly trained and professional if you want to exit. Easy to plug-in corporate structures make all the difference in immediately gaining from the sale or having to retool the shed and bring in all new people.

The rise of the SPAC-era and Canadian entry into the U.S. market will cause asset increases, but it is only the second chapter in the market expansion of cannabis. Proper buys will nail profitability, impeccable books, proper maintenance records and will have created an efficient corporate structure with talented personnel. The rest will be overpriced land buys that will require massive infrastructure spending. The basics of a well-run organization don’t change. The cannabis market is going to ROAR, but don’t worry if the SPACs pass you by- they are buying at the start of cannabis only.

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Being an American Cannabis Entrepreneur in Europe

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

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

Costs to Do Business

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

Excitement

The coast of Portugal

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

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

Brand New Infrastructure

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Member states of the European Union

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

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