Tag Archives: European

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.

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International Supply Chains: Considerations for European Imports

By Marguerite Arnold
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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.

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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.

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Destination Cannabis Europe: Employment in the Industry

By Marguerite Arnold
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It is obviously not just at conferences but now on the ground in Germany and across Europe that Americans are heading to the industry here. And it is not just the “new” cultivation guys at Demecan in Berlin (currently hiring), or in Guernsey, but in truth, throughout the industry.

Wish you were here? Here is the broad skinny to actually getting (and keeping) a job in the industry in Europe.

Get A Job Before You Come

By far, the easiest and safest way to come to a new country, like Germany (or the UK for that matter) is to have pre-arranged employment. That is also beginning to happen, as large companies set up grow and manufacturing facilities throughout Europe. That said, these are hard to come by (there are many Germans and other natives vying for the same jobs). However so far, certain kinds of experience in the U.S. (or Canada) beats anything that has gotten going here so far from the cultivation side and many other aspects of the biz.

But – and this is a big one – you have to have the kind of experience that counts. Regulated industry participation is a must on your CV if this is your preferred route of travel. Pharmacists in particular, could have a fascinating career path here not open in the United States at all yet. So will doctors – but that certification has to be earned here to practice.

It is also far easier to deal with the paperwork that is required than it used to be ironically – in that there are new qualifications being set out for the same in both the UK and Germany at the moment. Understanding them, however is another matter, and interpretation at the immigration office is not something you want to sign yourself up for. In any language.

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Member states of the EU, pre-Brexit

However, immigration law is just the beginning on the regulation front. Regulations across the cannabis industry are also changing fast – and not just under the heading “cannabis.”

Nothing, really is “easy” about being an expat. You have to want to do this.

There are now starting to be numerous European job postings in the industry on Linked In. It is a great place to start. Having B1 Deutsch (third level, very hard to pass, intensive German language certification) is usually a must for employment (not to mention getting around in the country).

Disclosure: This journalist failed A1 German in Germany (introductory level) twice. Starting from scratch is not recommended, because the rest of your class (usually with previous German training) will kick your butt in numbers bingo by the end of the first week. Learning – including punctuation and spelling 50 new vocabulary words a week is pretty standard. And that is before the grammar. All taught in German too! Four hours a day, five days a week.

Yes, your class will laugh at you, even if they think you are otherwise cool as a North American.

It also helps if you have taken at least one German language course (as in college semester level) before you come. Otherwise you will hit unbelievably intimidating compound words that take up a great deal of space on a page and four different tenses that even native Germans do not really understand by the end of the second week (and it is mind-blowing). You learn to appreciate Mark Twain’s humour about the dratted language very quickly, not to mention that the umlaut is really the only thing you have any freedom of expression with.

Be prepared to sign up for language courses when you land with the local VHS (Volkshochschule) – which is sort of like German community college for anything you want to take classes in. It is also the cheapest deal on language courses around. The private ones are pricey.

That said, master the lingo, even passably, and Germans are super pleased about the same. No matter how badly you mangle the language, they are just happy to hear you try.

Student Visas and the Educational Path

By far, the easiest path to starting your journey overseas, is luck. The second one however, is actually one way to go if you are prepared to work yourself to the bone, and do it while learning German intensively. Plus get a university level or graduate degree along the way.

If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.Go first as a language student. That gets you two years, fairly easily, as long as you have €8k in your bank account at all times, and do not work at a German job. That is verboten. However, as an American, particularly in Germany, you still have the right to come here and learn.

There is also about to be a fairly ground-breaking immigration law that comes into effect as of March in Germany that allows highly skilled foreigners to earn their way to citizenship. There is a list of requirements that go along with this, of course. The path to being able to stay includes getting a higher German degree or special German training. Expect pretty much the same thing from post-Brexit Britain too – just in the same language.

You also have to have health insurance and a lot of other things taken care of. It is not a sudden move or jump. For all the amazing things that come with this, also be prepared to think about looking in the mirror at least a few times and thinking “am I stupid, what on earth have I done?”

Then there is location. A Kreuzburg address may impress the folks back home, but those are not cheap these days, and extremely hard to come by. Rent, in general, and not just in Berlin, is beginning to be a real issue in every German city. Finding an accommodation that you can afford in “starting out” circumstances – is not easy right now anywhere.

But it’s not just about rent or the buzz you might have heard. Don’t just put Berlin on the map (or even Munich, also a growing professional scene). Both cities are far from the center of the cannabis scene in Europe, much less Germany although there is a lot going on all the time there. Dortmund, and the Ruhrgebeit in the former “Rust Belt” of Germany are much cheaper, full of students, and popping with cannabis reform all over. Cologne is also a very interesting city right now. So are Bremen and Stuttgart.

The Differences Are Large Besides the Language

No matter what you think you can expect, the only thing you can rely on is that just about everything will not be the same. Yes, German beer fests and bratwurst are comfortingly familiar to be accepted easily. But when it comes to really immersing yourself in a country well enough to think of it as “home”, let alone understanding the vagaries of this business in particular? Just about everything is different. This ain’t Kansas, (or Colorado, for that matter) Dorothy.

Bottom line? If Cannabis Europe is your dream job and vocation, you will make it happen. Just don’t expect it to be easy, or just like anywhere else.

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European Cannabis is the Emerging Market to Attract North American Investment

By Mark Wheeler
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Europe continues to be the new frontier of medical and wellness developments in the cannabis industry, with various sources predicting that Europe will become the world’s largest legal cannabis market over the next 5 years. Key related statistics, include:

  • A population of over 740 million (over double US and Canada combined)
  • Total cannabis market estimated to be worth up to €123 billion by 2028 (€58bn medical cannabis (47%), €65bn recreational cannabis (53%))
  • Over €500 million has been invested in European cannabis businesses (including significant expenditure in research and development, manufacturing and distribution)

To reiterate this belief, this month, hundreds of industry experts and delegates will be attending Cannabis Europa in Madrid, to discuss the expansion of cannabis across Europe and the challenges facing the industry across the member states of the EU and the UK.

Global mainstream leans to European strength

Since late 2018, major global operators have made substantial moves into the cannabis sector. Anheuser-Busch InBev, the world’s largest beer company and maker of Budweiser, entered into a partnership to research beverages infused with two types of cannabis. Constellation, owner of Corona beer, announced a commitment for $4 billion investment in Canadian cannabis company Canopy Growth. BlackRock Inc, through five actively managed BlackRock funds, has invested into Curaleaf Holdings Inc, a dispensary operator, for a not too insignificant investment sum of $11 million (as at March 2019). Such international investments prove that cannabis has moved from the fringes and into the mainstream.

When considering the impact of mainstream cannabis, it should be recognised that major European countries have approved or are planning on implementing, legalisation of medicinal cannabis. The UK, Germany, Italy and the Netherlands already have legal systems in place for medicinal cannabis and France and Spain are currently reviewing key legislative reform to align themselves with international practices. At present the German market is the third largest cannabis market (in terms of size) behind the US and Canada.

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Member states of the EU, pre-Brexit

In addition to medicinal cannabis, several key European countries have systems in place, or are developing systems, or considering the reform of existing systems, to approve cannabis with THC content at a recreational level. The Netherlands already has a system and Luxembourg’s health minister in August 2019 announced the intention to legalise cannabis for Luxembourg residents. The Luxembourg government is lobbying EU member states to follow suit.

Whilst the EU has a labyrinth of laws in relation to edible CBD (as a novel food) which make the regulatory landscape complex, there has been an explosion of CBD products for vaping and cosmetics. Of course, with each of these products being subject to different local laws (some aligned between EU members states) in relation to vaping and cosmetic related regulations. The Brightfield Group has predicted a 400% increase in the European CBD market (including vaping liquid) from $318m in 2018 to $1.7 billion by 2023. There is also an expansion into applications for CBD with animals with many US manufacturers of CBD-infused pet food.

The European Parliament’s health committee has been calling for properly funded scientific research and there are motions to establish policies to seek to incentivise member states to advance the studies of medical cannabis, with a priority on scientific research and clinical studies – the first step necessary to drafting legislation, designed to better support the industry.

Where does the UK sit within cannabis?

Medicinal cannabis famously saw a legalisation, of sorts, by the then Secretary of State, Sajid Javid, who provided the authorisations for prescriptions for the high profile cases of Billy Caldwell and Alfie Dingley. Subsequently, on 1 November 2018, this was codified into law by an amendment to Schedule 2 of the 2001 Misuse of Drugs Regulations. This allows clinicians to prescribe cannabis as an unlicensed medicine.

There have, of course, been some high profile licensed medicines. The UK company, GW Pharmaceuticals, is the largest exporter of legal medical cannabis in the world, cultivating medical cannabis for production of cannabis-based medicines (e.g. Epidiolex & Sativex). Epidiolex (manufactured by subsidiary Greenwich Biosciences) became the first cannabis-derived medicine approved for use in the US for treatment of seizures caused by Lennox-Gastaut and Dravet syndromes (both severe forms of epilepsy).

When considering the level of research development and investment in the medicinal field, it is no surprise that the UK is the world’s largest producer and exporter of medical cannabis. Research published by the International Narcotics Control Board indicates that the UK produces over 100,000kg a year of medicinal cannabis.

UKflagPrevious guidance from the National Institute for Health and Care Excellence (NICE) indicated that further research is required to demonstrate the benefit of medicinal cannabis, citing its cost versus evidenced benefit. However, there is now renewed confidence in the UK following NICE’s approval of two cannabis-based medicines produced by GW Pharmaceuticals,  Epidiolex (cannabidiol) oral solution and Sativex (nabiximols), for routine reimbursement through the NHS.

Following the re-categorisation of medicinal cannabis in November 2018, a number of clinics have been established where specialised clinicians can start the process of prescribing cannabis based medicinal products (CBMPs). Whilst this route is not fast, and challenges are well documented as to the satisfaction of prescriptions made in the UK, there is momentum behind the development of this as a means for providing genuine and established medical care. A significant step in October 2019, was the CQC registration of one such cannabis clinic, Sapphire Medical Clinics Limited.

In November 2019, a project backed by the Royal College of Psychiatrists was announced with the aim to be the largest trial on the drug’s use in Europe with a target of 20,000 UK patients.

The UK medicinal cannabis sector is establishing a research-based approach to expand usage in the UK and across Europe.

How North America compares to Europe

Canada

Canada, as a first mover within the cannabis sector, has a multitude of large companies which are well-capitalised and have substantial international footprints. The Canadian exchanges have large listed companies looking to Europe with the intention of acquiring or investing into European operations. As of the date of writing, the 10 largest cannabis companies in Canada have an aggregate market cap of over $23.5 billion (and all registered cannabis companies in Canada having an aggregate market cap of over $46.5 billion).

Listed companies have had a tough time over the last 6-12 months with a slowdown in the market as a natural re-balancing occurs – part of which is due to rapid expansion and heavy investment into cultivation by all the major participants in the market. Over the next 6 -12 months we can expect to see management changes (some of which will be voluntary and some of which will be imposed by institutional pressure) to introduce different skill sets at board and senior management level to facilitate the oversight and leadership necessary for large pharmaceutical companies. Many operations have expanded into highly regulated products and complex supply chains whilst still operating with fundamentally the same team that established the operations with entrepreneurial efforts but, perhaps, a lack of experience in these sectors. The recent announcements by Aurora Cannabis and Tilray demonstrate that these restructurings and costs reductions have already commenced. However, with increased experience at board level and an improvement of profitability focused on sustainable business practices, should come new opportunities on a global scale for these North American operations.

The US

The US market, because of the complexity of state and federal laws not being fully aligned, is closer to its infancy than the Canadian market. This is not too dissimilar to the European market. That said, there are a number of well-funded and quite large US enterprises. A limited number of these, such as Tilray, are looking to expand into Europe.

Many of the companies in the US have, and continue to, expand quickly so we can expect to see a number of mergers and acquisitions. We are likely to witness Canadian and US entities merging with one another with the potential for acquisitions for operations within Europe. It is unlikely that the North American companies will risk their capital through organic growth so would be expected to be identifying “turnkey” solutions.

One of the major challenges facing US companies is the complexity of supply and distribution. This is largely a result of the complexities for state and federal laws interacting with one another as well as international importation and exportation with US states.

How you can invest within the UK and Europe

Developments in the fields of research and development are anticipated to add further weight to the lobbying of government and regulatory bodies across Europe.The UK remains, despite the events of Brexit, a major financial hub for Europe. The London market has seen the growth of several investment and operation cannabis companies. This includes private companies such as; EMMAC Life Sciences Limited and the operations formerly trading as European Cannabis Holdings (now demerged into several new entities including NOBL and LYPHE) as well as publicly listed companies; including Sativa Group PLC (the first publically listed cannabis specific company in the UK) and World High Life Plc, both operating on the NEX Exchange.

The Medical Cannabis and Wellness Ucits ETF (CBDX), Europe’s first medical cannabis ETF fund, domiciled in Ireland, and which has been passported for sale in the UK and Italy, has also caused a renewed stir within the market with a further platform for listed investment.

As the regulatory framework evolves further there is an anticipation that more medicinal cannabis and CBD related enterprises should have the opportunity to list on public exchanges, whether in the UK or in European countries.

Conclusion

Despite a period of slow down following the natural rebalancing of the fast-growing North American markets for the cannabis sector, there is renewed confidence in the expansion of the industry. Developments in the fields of research and development are anticipated to add further weight to the lobbying of government and regulatory bodies across Europe.

There is an increased push for a public dialogue and consultation in relation to medicinal and recreational cannabis in the UK, backed by several mainstream media platforms. This is likely to be shaped in some parts by national debates in Luxembourg and other European countries as they consider their own domestic laws.

With European parliaments across the EU (including the UK) hopefully having time freed up to discuss other political matters now that Brexit is progressing, the next 18 months should prove an exciting time within the European cannabis sector.

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German Medical Cannabis Imports Doubled in 2019. So What?

By Marguerite Arnold
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Germany, for all of the other developments going on right now (globally) is still chugging forward, in integrating medical cannabis. It is slow going – but certainly going.

In terms of overall numbers, there is certainly an interesting story to tell. The import of medical cannabis grade flowers also more than doubled last year over 2018.

Hooray.

But does the “average” German patient have easier access even with more product in the market?

Answer: There are certainly more Germans with more cannabis prescriptions. See the increase in imports and the numbers from the statutory health insurers.

But even though these are clearly positive signs, it has not necessarily gotten much easier so far. That said, it is about to get quite a bit cheaper.

The Mainstreaming of the German and EU Cannabis Market

National pride aside, the German government is in fact the entity which got this whole ball of wax rolling here, and it is they who still determine the pace of regulated change. The cultivation of medical cannabis is now fully underway in the country, with Demecan still in the most interesting position. Aurora has just gotten another certification and is back on the ground in pharmacies.

But many issues remain.

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Photo: Ian McWilliams, Flickr

On the ground, pharmacists cannot get enough product on a reliable basis. Patients are still caught in the never-ending merry-go-round of chasing down willing doctors, battling insurance companies for reimbursement and trying to have a good relationship with their local pharmacist. If, of course, they can afford both the drug itself, along with its outlying costs and frustrations to access, and their health insurance company plays ball.

Even then, chances are, the most seriously ill patients are still relying on “other” sources. A reference wholesale price (of €2.30 a gram set by the German government last year) is likely to stabilize the market if not pricing. For everyone – not just those on public healthcare.

The plant is becoming commoditized, even if slower than most people in the industry long to see.

On top of that, while certification is currently gaining steam in the industry, especially in Europe, there are many problems and issues remaining – on everything from processing of the flower to registration of products made from it. And in both the medical and recreational market.

Overall, in other words, markers are all good. But the process is going to be (very) slow if steady for the next several years.

Don’t Expect Continual Explosive Growth

Dronabinol is still at least a third of the public healthcare market. The majority of patients who receive the drug still fit the same overall treatment profile (chronic pain). And doctors are still highly reluctant to consider it as a more standard practice.

But the most important conversation, by far, is still basic legalization and regulation beyond that. That too will change. Not to mention the recreational discussion now absolutely on the table. Four years of a medical market only continue to open doors, not close them. And elsewhere, across the continent, reform is generating new producers from not only southern Europe but just about everywhere else on the globe where cannabis is becoming legit.

For the next year, however, as all of these issues continue to be debated, and at both a national and increasingly local level, don’t expect “explosive” anything.

Those who have established themselves are dug in. It is going to be trench warfare from now on out, barring a major surprise, for the next few years.

What Is Likely To Change The Equation?

CBD battles are absolutely strategic manoeuvres through the intricacies of this regulatory shift (legalization of the plant). This alone, particularly for the next few years, is likely to also move the conversation forward – and not just on the medical front.

It is also patently obvious that governments (starting with Italy) are beginning to again consider the topic of limited home grow and recreational reform.

But the most important conversation, by far, is still basic legalization and regulation beyond that. And until that happens, nothing will be “normal” about a market that is clearly being allowed to grow, in a market which is being carefully tended and managed.

“Explosive” in other words, is far from the agenda of anyone in authority who is making the decisions. And that includes regulated market growth and numbers for the next 48 months at least.

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THC Not AfD: Germans Protest on the Front Lines of Change

By Marguerite Arnold
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Braving the chill and rain, over 200 German activists gathered in the German dorf (small town or village) of Lahr on the first Saturday of Febuary, protesting for more comprehensive laws for the controlled distribution and legalization of cannabis. As the local media was quick to point out, this was the first demonstration of its kind in the town.

It was a strategically planned demonstration at a time when the rules are changing, and challenges from law enforcement and regulatory agencies, are growing in Germany. Just in other words, as police are challenging hemp sellers from Spain and Italy to France last year, the battle has come to pot shops and patients alike over the last four years.

The UK is in its just post-Brexit heyday, but the free for all so far on CBD is not likely to proceed without further police involvement. The rules are just not stable enough yet.

On the ground in Germany in early February, no matter how small or inconsequential it might have looked to outsiders, in other words, this protest also appears to have been carefully staged to bring attention to big issues that remain on the ground. In Europe generally, and Germany specifically.

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Photo: Ian McWilliams, Flickr

Chanting “Cannabis Normal” and “THC not AfD” (a reference to a far-right political group that has seen a rapid rise in Germany over the same period of time that cannabis has legalized here and who also opposes cannabis generally), the peaceful demonstration was upbeat, cheerful and polite with the same kinds of street theatre seen in local legalization marches since the 1960s.

As a result, and very much a populist as well as a political movement beyond the plant itself, cannabis protests and legalization have taken place within that environment in Germany so far, with some interesting hybrids.

In fact, the march organizers specifically thanked the police for their protection during the event (common at German hemp parades), and further specifically linked a legal cannabis industry to a safer, less violent society. One of the organizers, indeed was also there to promote the opening of his new CBD shop.

The specific link to peace and a peaceful society is a theme that has not yet seen much global conversation in the new cannabis industry, but it is here in spades in the German market. Particularly as Germans respond to the rise in terrorist attacks here over the last seven years by supporting the banning of a Neo Nazi terror group (Combat 18 on January 23 – the same day as the allies liberated Auschwitz 75 years ago).

A new hybrid approach that specifically links public activism and peaceful free speech about cannabis to legal economic activity.As the conversation about many of these themes auf Deutsch, including the strong Israeli and Jewish presence in the global cannabis industry, continues to expand, it is taking on a very interesting tenor. Yes, Germans are as keen as anyone to be entrepreneurial, and have extra money to spare on consumer goods. But core to the German soul is also a conservative, thrifty approach to all things. Cannabis is one of the few “consumer goods” if not “medication” that appears to be challenging the rules if not culture in ways Germans are still interpreting.

One of the most powerful things about cannabis is its ability to heal. Many different kinds of wounds. And at least to Germans that is the way things are moving politically if not in the world of business. If this plant, in other words, can lower the national healthcare bill, take better care of Germans and create tax revenue that keeps the trains running on time, not to mention somehow ties into “clean” and “green” living, Germans are all for it. And in ways that are certainly “populist.”

That conversation, however delayed by North American standards, is now fully underway auf Deutschland. However, within that, there are all kinds of shades of green, if not purple. From the leaves and buds of the plant, to the political persuasions of those who advocate for its final, full and equal introduction into society, this is also a revolution that is now fully underway and picking up supporters.

Even, en masse, in a tiny town on the edge of Bavaria and via a very interesting new hybrid approach that specifically links public activism and peaceful free speech about cannabis to legal economic activity.

Is 2020 the Year of New CBD Markets?

By Marguerite Arnold
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If you were at Davos this year, you heard alot about CBD. The cannabinoid will again be a headliner in business analysis and bottom line reports this year. But as the market matures, globally, what is the real temperature of the industry? And how fast will regional hiccups resolve?

Regulatory Issues Are In The Room

From the US state markets to the EU, hemp is coming into its own, even though almost everyone also refers to it as CBD (cannabidiol).

european union statesIn the United States, things are even more murky because of a lack of federal reform and the individual rules and regs of existing state markets. To an extent, the market is being “federalized” on the testing front (see ISO for example) and GMP (at the federal pharmaceutical level), producers are beginning to be able to get certified on a global scale. However, the vast majority of the U.S. market is not anywhere close to the regulatory muster now required of even the most-humble commercial hemp farmer anywhere in the EU.

In Europe, the entire cannabis discussion is already far more defined, and as a result, very much likely to set the rulebook globally, especially as so many people want to import here. And this is going to be a bugbear for the next two years. The rules on EU Bio for starters, are still in flux. And where this ties into GMP downstream, those who brave such waters are in for choppy seas for the time being.

Tie this into Novel Food, and this is an area right now that should only be charted by the most experienced navigators, and not just using the stars.

The Battle Is On – Both On The High Seas And The High Streets

For all the desire to bring “whole plant” into the room, (in other words recreational cannabis and medical cannabis with the THC still attached), CBD fever at least has spread in Europe faster than any pending flu epidemic from China.

There are positives and negatives that come with this discussion. Namely, the ever pounding need to commercialize the legal industry and remove all Drug War stigma and barriers from the discussion.

CBD-only legalization is also a powerful answer to those who claim that if CBD is legit, then the police will not chance busting people, no matter how much THC is or is not in the offending substance in question.

These are also the same people frequently who also have a stake in some level of the industry as it legalizes. And this is also where some of the fiercest battles for regulatory control and definition have also begun to happen.

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

Where they have come to a head (see Italy), it appears that governments are indeed reconsidering the whole “insurance” if not “home grow” discussion. Not to mention, as a result, recreational after that. The conversation in Italy, of all places, right now, is a good indication of this trend. It is a conservative country in every way, yet it is the first to not only cancel a government controlled monopoly license, but also the largest country in Europe to again tinker with limited home grow of cannabis plants.

Ironically this is also the place where the most dedicated “CBD revolutionaries” have also hit. In places like the UK right now, the lack of appetite for EU regulatory control generally (see Brexit) has resonated, particularly with a pro cannabis crowd sick and tired of more delay on a topic whose day in the sun has finally come. If not more government wobbles on discussion on the medical side (see the recent NHS decision to ignore cannabinoids and chronic pain).

In other places like Europe however, and this certainly showed up at Davos, CBD is a hardy foot soldier if not cannaguerilla from the hills that is beginning to chalk up discussions if not yet wide-ranging sovereign victories.

This is absolutely clear to see in places like the African market (and Lesotho is about to become a hot ticket globally if not within the African continent). Indeed, the first seeds were sown several years ago).

Yes, it is ridiculous that CBD is being banned. And it is also obvious that governments are unwilling to be bankrupted over medical cannabis of any kind or THC concentration, and know they must also seek other ways to deal with the issue.

CBD, in other words, is a kind of Che Guevara that is going to take down a few of the established orders in this revolution that is now global. And for that very reason, taking on a character if not place at the table all of its own.