Tag Archives: production

Why Does GDPR Matter for The Cannabis Industry?

By Marguerite Arnold
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The global cannabis industry is hitting thorny regulatory challenges everywhere these days as the bar is raised for international commerce. First it was recognition that the entire production industry in Canada would basically have to retool to meet European (medical and food) standards. And that at least for now for the same reasons, American exports are basically a no go.

However, beyond this, the battle over financial reporting and other compliance of a fiscal kind has been a hot topic this year on European exchanges.

As of this summer, (and not unrelated to the other two seismic shifts) there is another giant in the room.

If you haven’t heard about it yet, welcome to the world of EU GDPR (European Union General Data Privacy Regulation).

The German version is actually Europe’s highest privacy standard, which means for the cannabis industry, this is the one that is required for operations here across the continent if you are in this business.

What is it, and what does it mean for the industry?

GDPR – The Elevator Pitch

Here is why you cannot ignore it. The regulation affects bankers as much as growers, distributors as much as producers and of course the entire ecosystem behind medical production and distribution across Europe and actually far beyond it. Starting of course, with patients but not limited to them. The law in essence, applies to “you” whoever you are in this space. That is why it becomes all that much more complicated in the current environment.

While this is complex and far reaching, however, there are a couple of ways to think about this regulation that can help you understand it and how to manage to it (if not innovate with it).

The first is, to American audiences at least, that GDPR is sort of like HIPAA, the federal American privacy civil rights statute that governs medical privacy law. Except, of course, this being Europe, it is far more robust and far reaching. It touches every aspect of electronic privacy including data storage, retention, processing and security that is applicable to modern life. And far, far, beyond just “patients.”

On the marketing side, GDPR is currently causing no end of headaches. Broadly, the legislation, which came into force this year, with real teeth (4% of global revenues if you get it wrong), applies to literally every aspect of the cannabis industry for two big reasons beyond that. Medical issues, which are the only game in town right now in Europe (and thus require all importers to also be in compliance) and financial regulatory requirements.

The requirements in Germany are more onerous than they are in the rest of Europe. Therefore, they also affect the cannabis industry in a big way, especially since there is at this point a great deal of European cultivation with the German (and now British) medical market in mind. Further Germany is becoming European HQ for quite a few of the Canadian LPs. That means German standards apply.

The UK, for those watching all Brexit events with interest, will also continue to be highly affected by this. Whether it stays in the EU or not, it must meet a certain “trusted nation” status to be able to transact with the continent in any kind of favoured nation status.

Bottom line? It is big and here and expensive if you screw it up. If considering doing any kind of business with European customers, start hitting the books now. Large mainstream media organizations in the United States and Canada right now are so afraid of the consequences of getting this wrong that they have blocked readership from Europe for the present. Large financial institutions also must not only be in compliance but compliance of companies also guides their investment mandates on the regulatory front.

For all of these reasons, the cannabis industry would do well to take note.

What Does This Mean for The Cannabis Industry?

The Canadian and rest of the global industry is still struggling with compliance and this will have some interesting repercussions going forward.patient data must be handled and stored differently

Immediately, this means that all websites that are targeted to German eyes (read Canadian LPs and international, even English-only press) should hire German side compliance experts for a quick GDPR audit. There are few European experts at this point, and even fewer foreign ones. It is worth a call around to find out who is doing this auf Deutschland and bite the bullet.

It also means that internally, patient data must be handled and stored differently. And furthermore, it is not just “patients” who have this right, but everyone who transacts with your electronic or other presence. That includes consumers, subscribers to email newsletters and other stakeholders in the industry.

As the cannabis industry also starts to embrace technology more fully, it will also have highly impactful influence on what actually passes for a compliant technology (particularly if it is customer facing) but not limited to the same.

On the marketing side, GDPR is currently causing no end of headaches. Starting with PR and customer outreach teams who are trying to figure out how much of their master mailing lists they can keep and which they cannot. On this front, Mail Chimp is undeniably the go-to right now and has also implanted easy to understand and use technology that is being adopted by European marketers and those targeting Europe.

Stay tuned for more coverage on GDPR as we cover how data protection and privacy regulations will impact cannabis businesses, their marketing and outreach, plus service design efforts (in particular to patients) and other areas of interest.

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Edibles Discussion Comes To Food Safety Consortium

By Aaron G. Biros
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The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.

Jenna Rice, Director of Operations at Gron Artisan Chocolates
Jenna Rice, Director of Operations at Gron Artisan Chocolates

The track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas.

Ben Gelt, board chair of the Cannabis Certification Council, is moderating a panel titled What’s In My Weed? that will delve into issues like supply chain, production and other difficulties in creating cannabis products and the challenges inherent in teaching consumers to be more discerning.

Ben Gelt, Board Chair of the Cannabis Certification Council
Ben Gelt, Board Chair of the Cannabis Certification Council

Panelists will include:

Kimberly Stuck, Founder of Allay Compliance Consulting
Kimberly Stuck, Founder of Allay Compliance Consulting

Ben Gelt and the Cannabis Certification Council orchestrated the development of this panel to help promote their #WhatsInMyWeed consumer awareness and education campaign. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”

Before Kim Stuck founded Allay Compliance Consulting, she was the first Marijuana Specialist for a public health authority in the nation, where she was working with regulators in Denver, Colorado. She is currently a cannabis food safety expert and a Certified Professional of Food Safety (CP-FS) through NEHA. She has helped Colorado and California develop cannabis food safety requirements. “I will discuss pitfalls we have experienced in the regulation of cannabis in Denver and what mistakes not to make,” says Stuck. “I’d also like to talk about how to be prepared for when those regulators start to come in to facilities.”

Kristen Hill, MIP Director at Native Roots Dispensary
Kristen Hill, MIP Director at Native Roots Dispensary

Kristen Hill is the MIP Director at Native Roots, arguably one of the largest dispensary chains in the world. She oversees 30 employees in Native Roots’ MIP facility where product testing and quality assurance of products are all led under her guidance. Her background includes managing quality assurance and regulatory compliance with FDA regulations, among other areas. She said she’s particularly excited to talk about implementing manufacturing best practices in the cannabis space. “Cannabis is maturing and is beginning to shape operations around long standing best practices in other industries,” says Hill.

Leslie Siu, Founder and CEO of Mother & Clone
Leslie Siu, Founder and CEO of Mother & Clone

Leslie Siu brings to the panel 17 years of liquor, tobacco and pharma marketing and operational oversight plus global digital and experiential campaigns. Her company, Mother & Clone, produces infused, sublingual cannabis sprays. Based in Colorado, Mother & Clone’s team of biochemists are Merck alumni, currently working towards GMP standards in preparation for Canada, slated to be on shelf in the spring of 2019. Her main consideration for cannabis product development comes from what she has learned from the FDA in traditional industries- what they will and will not tolerate.

To learn more about the panel, other topics presented and see the full agenda for the upcoming Food Safety Consortium, click here.

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Lab Accreditation Bodies To Meet At Food Safety Consortium

By Aaron G. Biros
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The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.

FSC logoThe track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas. One particular topic of interest in the quality and safety of cannabis products is laboratory testing. At the event this year, leading laboratory accreditation bodies in the country will sit together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.

Roger Muse, vice president at ANAB

Representatives from ANSI-ASQ National Accreditation Board (ANAB), the American Association for Laboratory Accreditation (A2LA) and Perry Johnson Laboratory Accreditation (PJLA) will host the panel on the morning of Wednesday, November 14.

Panelists will include:

  • Roger Muse, vice president of business development of ANAB
  • Christopher Gunning, life sciences accreditation manager with A2LA
  • Tracy Szerszen, president/operations manager, PJLA
  • Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)
Tracy Szerszen
Tracy Szerszen, president/operations manager, PJLA

Laboratories that are new to the industry and looking to get accredited should be aware of the new ISO/IEC 17025:2017 standard, which was released last year. According to Tracy Szerszen, labs that have already been accredited to the 2005 version will be required to transition to the 2017 version by November 29, 2020. “This can be done in conjunction with routine assessments scheduled in 2019 and 2020,” says Szerszen. “However, laboratories are cautioned to transition within a reasonable timeframe to avoid their 17025: 2005 certificate from lapsing prior to the transition deadline. Some of the changes to the standard include but are not limited to: the re-alignment of clauses similar to ISO 9001:2015 and other ISO industry standards, modifications to reporting and decision rules, the addition of risked based thinking and a new approach to managing complaints.” Szerszen, along with the other panelists, will go much more in-depth on changes to the new ISO 17025 and other topics during the panel at the Food Safety Consortium.

Some of the other topics the panel will discuss include:

  • ISO/IEC 17025 –what’s expected, benefits of accreditation, common deficiencies, updates to the new 17025 standard
  • Standards available for production facilities-GMPs & GFSI standards
  • How standards can be used to safeguard the quality of production and safety requirements
  • An open discussion with panelists from leading accreditation bodies on the state of cannabis lab testing
Christopher Gunning, life sciences accreditation manager with A2LA
Christopher Gunning, life sciences accreditation manager with A2LA

According to Chris Gunning, many states are requiring accreditation to ISO/IEC 17025, the standard used throughout the world in many other high-profile industries such as the testing of food and pharmaceuticals, environmental testing, and biosafety testing. “In an industry where there are few standard methods, where one hears that you can ‘pay to play,’ and where there are ‘novice’ laboratories popping up with little experience in operating a testing laboratory, it is extremely important to have an experienced, independent, 3rd party accrediting body evaluating the laboratory,” says Gunning. “This process confirms their adherence to appropriate quality management system standards, standard methods or their own internally developed methods, and can verify that those methods produce valid results. Ultimately, the process of accreditation gives the public confidence that a testing laboratory is meeting their state’s requirements and therefore consumers have access to a quality product.” He says most states with legal cannabis recognize the need for product testing by a credentialed laboratory.

Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)

Another important topic that the panel will address is the role of food safety standards in the cannabis industry. Lauren Maloney says cannabis product manufacturers should consider GMP and HACCP certifications for their businesses. “Food safety is important to the cannabis industry because although individual states have mandated several food safety requirements there still considerable risks involved in the production of cannabis products,” says Lauren Maloney. “Consumers want the assurance that the cannabis products are safe and therefore should be treated like a food product. Because FDA does not have oversight of these production facilities, third party certification is essential to ensure these facilities implement a robust food safety system.”

The panelists will examine these issues along with other topics in greater detail during their talk at this year’s Food Safety Consortium.

Marguerite Arnold

Are Global Cannabis Markets Moving In Synch?

By Marguerite Arnold
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Marguerite Arnold

In American political lingo, an “October Surprise” is an event or incident that is deliberately planned to impact a political election – usually during a presidential year.

The cannabis industry, of course, is still highly political – starting with reform itself.

So what to make of the fact that over the course of the summer, three major markets have started to align in terms of timing?

Canada, Germany and The UK Moving In Synch?

None of these things were original, publicly planned or announced, of course. During July, the Canadian government finally announced the recreational market start date, the German government issued its new cannabis cultivation bid (due in October), and of course, the British government announced that they would reschedule cannabis and create more access for British patients.Canadian companies, for example, are perfectly poised to enter both markets and dominate the industry

What is in the air? And could this, in any way, be a deliberate cannabis industry power play by political forces in motion right now?

The Canadian-German Connection

Planned or not, it is certainly convenient that the much stalled German cultivation bid will now be due right at the time that the Canadian rec market goes into hyper drive. Why? The largest Canadian LPs are currently dominating the European market. These companies are also widely expected to take home the majority of the tender opportunities and are already producing and distributing across Europe.

For this reason, it is unlikely that there will be any “shortages” in the market in terms of deliverable product. However, larger Canadian cannabis companies have already announced that a certain percentage of their stock will be reserved for medical use (either at home or presumably to meet contract commitments that now stretch globally). Inefficiencies in the distribution network will be more responsible, at least in the short term, for consumer “shortages” rather than a lack of availability of qualified product.

Regardless, the connection between these two markets will generate its own interesting dynamics, particularly given the influence of both the Canadian producers and the size of the German medical space on cannabis reform as well as market entry.

The German-British Connection

Germany and the UK are connected historically, culturally, and now on the topic of cannabis reform. While it is unlikely in the short term that German-produced cannabis would end up in the UK, British grown cannabis products are available across Europe, including Germany, in the form of drugs developed by GW Pharmaceuticals.

In the future, given the interest in all things “export” in both economies, this could be a fascinating, highly competitive market space. Whether or not Brexit happens.

The British-Canadian Connection

While not much has emerged (yet) from these two commonwealth countries now embarking on the cannabis journey, it could certainly be an interesting one. This starts with the major competition GW Pharmaceuticals now faces at home from external (Canadian in particular) companies looking to expand their reach across Europe.

Whether Britain Brexits or not could also impact the pace of market development here. Particularly as cannabis supplies can be flown in (via Heathrow), or shipped via the Atlantic, thus missing the Channel crossing point and literally parking lot delays on major motorways.GW logo-2

Canadian cannabis companies could also decide to build production sites as the market matures in the UK.

As it emerged earlier in the year, the UK is also the world’s top cannabis exporter – ahead still of the entire Canadian export market. Do not expect this to last for long after October.

However, in one more intriguing connection between the markets, Queen Elizabeth II in the UK must sign the final authorization for the Canadian recreational market to commence. With a new focus on commonwealth economies,if Brexit occurs, cannabis could certainly shape up to be a major “commonwealth crop.”

Much like tea, for that matter.

The common language between the two countries also makes international business dealings that much easier.

But What Does This All Mean For The Industry?

The first indication of this synching phenomenon may well be simply market growth on an international level unseen so far.

Canadian companies, for example, are perfectly poised to enter both markets and dominate the industry simply because this odd calendrical synching is also very convenient for business,

British companies coming online in the aftermath of rescheduling will also be uniquely positioned, no matter the outcome of the now looming divorce agreement between the parties. Whether the first market beyond domestic consumption is either commonwealth countries or the EU (or both in a best case scenario), the British cannabis market is likely to be even more globally influential than it already is.

The German market may also, depending on the pace of patient growth and cultivation space, become the third big rival, particularly with the near religious fervour all exports are worshipped here.

In the more immediate future, Germany is actually shaping up to be the most international market. Established companies from Canada to Israel and Australia are clearly lining up to enter the market one way or the other. And all that competition is starting to predict a seriously frothy, if not expanding, market starting now with connections that stretch globally.

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Food Safety Consortium To Address Cannabis Safety, Edibles Manufacturing

By Aaron G. Biros
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The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.FSC logo

The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:

  • Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
  • Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
  • Larry Mishkin, counsel to Hoban Law Group and partner at the law firm, Silver & Mishkin, which serves cannabis businesses in Illinois, will provide insights during the conference.
  • Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
  • Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.

The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.

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Aurora Expands Canadian (And Global) Footprint

By Marguerite Arnold
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With the summer season (and recreational reform) fast approaching and the continued growth of the European medical market, Canadian LP Aurora has continued to power forward with another corporate acquisition. This time, the firm is medical cannabis firm MedReleaf (TSE:LEAF). The price? $3.2 billion in stock.

Aurora shareholders will now own 61% of MedReleaf.

The firm has also, of course, solidified its place as a global leader in the cannabis space with production capacity of over 570,000 kilos of cannabis a year.This purchase will absolutely ensure that the company is in a strong position

According to a statement by chief executive Terry Booth, “Our complementary assets, strategic synergies and strong market positioning will provide us with critical mass and an excellent product portfolio in preparation for the adult consumer use market in Canada.”

It also does a bit more than that.

With the German cultivation bid in what appears to be at least a three to six month delay, exports, including from Canada, are the only real way into Europe’s largest cannabis market. And Aurora, with it’s on the ground partner, Pedianos, isright in the middle of it. This purchase will absolutely ensure that the company is in a strong position as the next level of cannabis reform begins to unfold particularly in Europe.

Cannabis Is SO Expensive!

In fact, per this report just produced by one of the leading German public health insurers, Aurora, via Pedianos, and MedCann (the company that became both Spektrum Cannabis and bought out by Canopy Canada), appear to be the two Canadian LPs supplying the vast majority of all reimbursed medical cannabis to German patients. Further the vast majority of product is still coming from Canada – not the satellite grow or production facilities now being built in Portugal (Tilray), Denmark (Aurora and Canopy), Spain (Canopy) or anywhere else in Europe where legal cultivations are being established.

Techniker Krankenkasse report
“The Cannabis Report” produced by Techniker Krankenkasse (TK) and the University of Bremen, p.20

However, this also makes for an expensive product here in Germany, land of the generic drug (and where most of them can be bought by consumers, with a prescription, at a regular pharmacy for about $12). In fact, this report was produced in part to underscore the still-evolving medical position on the use of medical cannabis and its efficacy. This highlights how much Germany’s import policy is now costing even public insurers.

What is even more intriguing about the TK report is that the Germans are clearly moving into new research territory. Sure AIDS, chronic pain and muscle spasms (in particular MS) are conditions for which the drug is increasingly being prescribed, but so is ADD. And research studies are now mushrooming around the country.

The Germans have engaged on the medical cannabis efficacy question. And while it is still unclear what doses and of what kind of cannabinoid, have yet to be standardized into protocols, such conversations are well on their way.

And Aurora is also, of course, right in the middle of them.

Another Aurora Acquisition

Given the importance and size of the German market, in particular, it is also no surprise to see another strategic Aurora acquisition coming less than a week after the announcement of this report in Berlin. Specifically, Aurora has also just sunk another 1 million in an investment in CTT– an Ontario-based firm leading the development of thin film wafers that can provide dose specific, smoke free delivery of medical cannabinoids.

The Teutonic cannabis market is clearly in the company’s sights. Not to mention absolutely driving investment and positioning strategy both at home and abroad.

PA flag

Pennsylvania Adjusts Medical Cannabis Program

By Aaron G. Biros
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PA flag

On Monday, Pennsylvania Health Secretary Dr. Rachel Levine announced plans to allow patients access to whole plant, dried flower, as well as more qualifying conditions. The move reverses the previous rule permitting dispensaries to sell only processed forms of cannabis, which some say limited access and kept costs high for patients.

According to the Marijuana Policy Project (MPP), the Department of Health approved changes to the program at a hearing on Monday, which were recommended by the Advisory Board last week. While smoking remains theoretically prohibited, patients can now access the flower for vaporization.

The medical cannabis program in Pennsylvania has only been functional for a few months now; patients began getting access to the drug back in February of 2018. In a press release, MPP says only a small number of cultivators and dispensaries are currently operating. This fact, coupled with the need to purchase processed forms of cannabis, has created product shortages and costly medicine for patients.

It is expected that this move could help alleviate some of those problems in the state’s new program. “Allowing cannabis in its natural, flower form and expanding the list of qualifying conditions will have a huge positive impact on seriously ill Pennsylvanians,” says Becky Dansky, legislative counsel for the Marijuana Policy Project, who helped lead the legalization effort in Pennsylvania’s legislature. “By being able to provide medical marijuana in plant form, producers will be able to get medicine into the hands of patients much more quickly and for much lower cost to patients,” says Dansky. “This is vitally important for patient access right now while the program is still getting off the ground and production is not yet at full capacity. We hope these rules are promulgated as quickly as possible so even more patients will be able to find relief.”

The qualifying conditions added to the list for patients seeking medical cannabis is set to include cancer remission therapy as well as opioid-addiction therapy, which are two very notable additions. With more qualifying conditions and a potentially cheaper form of medicine, these changes could improve the program’s efficacy in treating patients.

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MGC Pharma Makes Its Slovenian Moves More Final

By Marguerite Arnold
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mgc-pharma

Right now the map of Europe, from a cannabis cultivation perspective at least, is shaping up to be very much like a game of Risk. Throw the dice, move your armies (or more accurately line up your financing), and apply for federal import and cultivation licenses.

In the process, all sorts of interesting strategic plays are popping up. And as a result, here is a new and actually pretty cool “alternative” reality that is easy to verify in several different ways. Medical cannabis is being cultivated in multiple countries across Europe as of 2018, however unbelievable this was even four years ago. Even though it is still cleary just early days. And those cultivators are already international, operating across federal jurisdictions in Europe and across both the Atlantic and Pacific oceans.

With all the excitement and attention paid to the American hemisphere and the European moves of big Canadian LPs (and they are pretty amazing), there are still other moves afoot that are absolutely of note. Specifically, Australian firms and MGC Pharma in particular, have been moving steadily to establish both distribution and cultivation presence on the ground in Europe.

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

The latest news? MGC’s production facility in Slovenia was officially inspected by authorities and issued an interim license for its production plant in January, before presumably being given a green light of approval permanently. The company is also moving forward with the production of CannEpil, the company’s first pharmaceutical-grade medical cannabis product for the treatment of refractory epilepsy.

Refractory epilepsy affects about 30% of all those who suffer from the condition. Refractory is one of those words however, that hides its real meaning. Translation for those without an MD? This is “drug resistant” epilepsy. Resistant to all drugs before, of course, except cannabinoids.

And that is a welcome relief for patients domestically and throughout Europe. It is also a note to investors looking for savvy Euro plays right now.For all manufacturers now considering entering this market, this is a complicated environment to begin negotiating

This is a major win for MGC. Not to mention a vibrant medical market. No matter where specialty drugs are now going to be sourced from.

A Treatment-Driven “Branded” Pharma Market

What more traditional American pharmaceutical companies have known for a long time (certainly since the 1950’s) is now a fact also facing all cannabis brands coming to the European market and Germany in particular. The regulatory environment is hostile to the extreme for Auslanders in particular. Specifically, the development of “branded” or “name brand” drugs runs economically and philosophically counter to the concept of public health insurance itself even as their market accessibility is required by the same. This is even more the case for foreign firms with such ideas.

Here is the problem. Name brands are expensive. They are also usually outlier drugs for specific, relatively rare conditions. This is also the place where new drugs enter the market, no matter what they are.mgc-pharma

In an environment where the government negotiates bulk contracts for common drugs and these can be bought at every apotheke (pharmacy) for 10 euros and a doctors rezept (prescription), the chronically ill and those with drug resistant conditions are left out of the discussion. They face steep and usually inaccessible bills up front for all meds not in bulk purchase categories. And that as of last year in Germany specifically, includes cannabis. That is the case even though technically the government is now buying cannabis in bulk and making purchase commitments to foreign companies for the same. Insurance companies, however, are still forcing patients to pay the entire out of pocket cost up front and wait to reimbursed.

“Generic” Brands For Off label Chronic Conditions

However medical cannabis is clearly not just another drug. Cannabis falls on both sides of every fence in this discussion.

The first problem is that the providers (importers and soon to be domestic cultivators) are private companies. All of them are foreign helmed at this point, with a well-developed bench of branded products. That makes all cannabis drugs, oil and flower, by definition, fall into the “expensive” branded category immediately. The German, Italian, and Danish governments appear to be now negotiating bulk buys during a licensing season that is well on the way to domestic cultivation too. That alone will affect domestic prices and new products. But again, this is now several years behind other countries – notably MGC in Slovenia, Tilray in Portugal, all things now afoot in Denmark and clearly, Greece.

Next, cannabis’s status as a still imported, speciality, semi-trial status in the EU means it is in the most restricted categories of drugs to begin with (no matter the name or strength of the cannabinoid in particular). And because it can be bought as bud, in an “unprocessed” form as well as processed oils or other medicine, this is throwing yet another spanner into the mix.

Look for distribution deals all over Europe as a result, starting with PolandThen there is this wrinkle. Cannabis (even CBD) is currently considered a narcotic within the EU and even more specifically the largest continental drug market – Germany. The German regulatory system in particular, also imposes its own peculiarities. But basically what this means in sum is that the legal cannabis community including distributors and pharmas at this point, have to educate doctors in an environment where cannabis itself is a new “brand.” Who manufactures what, for the purposes of German law, at least, is irrelevant. It is what that drug is specifically for that matters.

For all manufacturers now considering entering this market, this is a complicated environment to begin negotiating. This is sure not how things are back home.

What this also means is that low cost, speciality cannabis products will continue to be imported across Europe for the German and other developing, regulated sovereign markets here as doctors learn about cannabis from condition treatments. And that is what makes the news about MGC even more interesting.

Look for distribution deals all over Europe as a result, starting with Poland. And, despite the many well-connected and qualified hopefuls from Canada, a little competition in the German market too.

MS is the only “on-label” drug at present for cannabis treatment in Germany. As a result, particularly when it comes to paediatric treatment for drug resistant epilepsy, this is the kind of strategic presence that will create a competitive source for highly condition-branded medication for a very specific audience of patients. It is also what the German market, for one, if not the EU is shaping up to be at least in the near term.

As this interesting abstract from 2006 clearly shows, this kind of epilepsy is also high on the German radar from a public policy and healthcare-cost containment perspective. The costs of treatment per patient were between 2,600 and 4,200 euros for three months a decade ago, and not only have those risen, but so have the absolute number of people in similar kinds of situations.

Further, with indirect costs far higher than direct costs including early retirement and permanent semi disability, MGC’s market move into an adjacent (and cheaper) production market might be just what the German doctors if not policymakers now looking at such issues, will order.

What Is Going On With Germany’s Cannabis Bid?

By Marguerite Arnold
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Germany is proceeding down the path to officially grow its own medical cannabis crops. Medical use became legal this year, along with a federal mandate for cheap access. That means that public health insurance companies, which cover 90% of Germans, are now firmly on the hook if not front line of the cannabis efficacy issue. As such, Germany’s medical market is potentially one of the most lucrative cannabis markets in the world, with a total dollar amount to at least challenge, if not rival, even California’s recreational market. Some say Canada’s too.

However, before “home grow” enthusiasts get too excited, this legislative move was an attempt to stymie everything but commercial, albeit medical production. Not to mention shut off the recreational discussion for at least another four years.

How successful that foray into legalization will be – especially given the chronic shortages now facing patients – are an open question. Not to mention other infrastructural issues – like doctor unfamiliarity with or resistance to prescribing cannabinoids. Or the public insurers’ so-far reluctance to cover it even though now federally mandated to do so.

Regardless, Germany decided to legalize medical use in 2017 and further to begin a sanctioned domestic cultivation for this market. The decision in the Bundestag to legalize the drug was unanimous. And the idea to follow UN regulations to establish this vertical is cautiously conservative but defendable. Very predictably German in other words.

Since then, however, the path has been far from smooth. Much less efficient.

Trouble in Germany’s Medical Cannabis Paradise

In April the government released its tender bid. And no matter how exciting it was to be in the middle of an industry who finally saw a crack of light, there were also clouds to this silver lining that promised early and frequent thunderstorms on the horizon.

By the time the tender bid application was due in June, it was already clear who the top firms were likely to beIn fact, by the end of the ICBC conference, which held its first annual gathering in Berlin at the same time the bid tender was announced, the controversy was already bubbling. The requirements of the bid, for a laughably small amount of cannabis (2,000 kg), mandated experience producing high qualities of medical marijuana in a federally legitimate market. By definition that excluded all German hopefuls, and set up Canada and Holland as the only countries who could provide such experience, capital and backlog of crop as the growing gets started.

The grumbling from Germans started then.

However, so did an amazingly public race to gain access to the German market directly – by acquisition or capital expenditures that are not refundable easily (like real estate or even buyouts). The common theme? They were large amounts of money being spent, and made by major Canadian Licensed Producers who had the right qualifications to meet the standards of the bid. In fact, by the time the tender bid application was due in June, it was already clear who the top firms were likely to be. They were the only ones who qualified under the judging qualifications.

And while nobody would commit publicly, news of the final decision was expected by August. Several Canadian LPs even issued press releases stating that they were finalists in the bid. But still no news was forthcoming about the official list.

Delay, Delay and More Delay

A month later, as of September, and there was still no official pronouncement. Nor was anybody talking. BfArM, the regulatory agency that is supervising this rollout as well as the regulation of all narcotic drugs (sort of like a German version of the FDA) has been issuing non-statement statements since the late summer. Aurora, however, one of the top contenders for cultivation here, was quietly issued an ex-im license by both Canadian and German authorities. Publicly, this has been described as an effort to help stem the now chronic cannabis shortage facing patients who attempt to go through legitimate, prescribed channels. On the German side, intriguingly, this appears to be a provisional license. Privately, some wondered if this was the beginning of a backdoor approval process for the top scoring bid applicants for cultivation. Although why that might be remains unclear.

Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Late in the month, rumours began to fly that there were now lawsuits against the bid process. Nobody had much detail. Not to mention specifics. But CannabisIndustryJournal can now confirm in fact that there have been two lawsuits (so far).

The summary of the complaints? It appears that two parties, filing with the “Bundeskartellamt” (or regulatory office focusing on monopolies and unfair business practices) did not think the bid process or scoring system was fair. And both parties also lost.

But as of mid-October, there is still no public decision on the bids. What gives?

Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Even though the plaintiffs failed, some have suggested that the German government might force a complete redo. Others hint that it will likely be slightly revised to be more inclusive but the regulatory standards must remain. If a redo is in the cards, will the German government decide to increase the total amount of yearly cannabis to be delivered? At this point, it is only calling for 2,000 kg per year by 2019. And that, as everyone knows, is far too little for a market that is exploding no matter the many other obstacles, like insurance companies refusing to compensate patients.

What Is Behind The Continued Delays?

There are several theories circulating the higher levels of the cannabis industry internationally right now even if no one is willing to be quoted. The first is that the total number of successful applicants, including the recent litigants, will be slightly expanded, but stay more or less the same. There is a high standard here for the import of medical cannabis that the Germans intend on duplicating domestically.

The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval.The second is that the German government will take its time on announcing the final winners and just open the doors to more imported product. This will not be popular with German insurers, who are on the hook to pay the difference. However with Tilray now on track to open a processing facility in Portugal and Canopy now aligned with Alcaliber in Spain, cross-continent import might be one option the government is also weighing as a stop-gap provision. Tilray, who publicly denied in the German press that they were participating in the cultivation license during the summer, just issued a press release in October announcing a national distribution deal to pharmacies with a German partner – for cannabis oil.

But then there is another possibility behind the delay. The government might also be waiting for another issue to resolve – one that has nothing to do with cannabis specifically, but in fact is now right in the middle of the discussion.

The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval. In fact, on September 19, a prominent German politician, Sigmar Gabriel of the Social Democrats (SPD) made a major statement about his party’s willingness to support Germany’s backing of the deal. It might be in fact, that the German government, which is supportive of CETA, got spooked about the cannabis lawsuits as test trials against not cannabis legalization, but a threat to the treaty itself.

Quality control, namely pesticides when it comes to plant matter, and the right of companies to sue governments are two of the most controversial aspects of this trade deal. And both appear to have risen, like old bong smoke, right at the final leg of closing the cannabis cultivation bid.

Will cannabis be seen as a flagship test for the seaworthiness of CETA? On a very interesting level, that answer may be yes. And will CETA in turn create a different discussion about regulatory compliance in an industry that has been, from the beginning of this year, decidedly Canadian-Deutsch? That is also on the table. And of great concern to those who follow the regulatory issues inherent in all. Not to mention, of course, the industry itself.

Conclusions?

Right now, there are none to be had.

However at present, the German bid process is several months behind schedule as Canadian producers themselves face a new wrinkle at home – the regulation of the recreational crop in the provinces.

It is also clear that there are a lot of questions and not a whole lot of answers. Not to mention a timeline when the smoke will clear.

Canopy Growth and Spektrum Cannabis Form Alliance With Spanish Alcaliber

By Marguerite Arnold
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Canopy Growth (based in Ontario, Canada) and its subsidiary, Spektrum Cannabis GmbH (in St. Leon-Rot, Germany) have been making waves all year.

As of early September, Canopy and Spektrum also announced their next strategic European move. They have just entered into a supply license agreement with Alcaliber, S.A., a leading Spanish pharmaceutical company. Alcaliber specializes in research, as well as the development, breeding and preparation of plant-based and other raw materials into narcotic medicine. More significantly, it is already a leading company in the global pharmaceutical and narcotic space.

According to Bruce Linton, chairman and chief executive officer of Canopy Growth, the partnership opens a lot of doors. “This agreement gives us additional resources to aggressively enter the European market where federally permitted by law, while we continue to work to establish our own complimentary production footprint for cannabis cultivation, value-add oil extraction and Softgel production in the European Union,” says Linton.

Bruce Linton, CEO of Canopy Growth
Photo: Youtube, TSX

Alcaliber is one of the largest producers of morphine in the world (27% of global production) and supplies 18% of its codeine. Cannabis is also considered a narcotic drug in Europe. This kind of track record is exactly what governments are looking for as they figure out how to integrate cannabinoids as medical products into existing pharmaceutical production and distribution. They are equally excited about the possibilities this partnership brings, according to Jose Antonio de la Puente, chief executive officer of Alcaliber. “There is a clear demand for pharmaceutical cannabis produced in accordance with pharmaceutical standards and the expertise we have developed manufacturing narcotic derivatives for over 40 years,” says de la Puente.

The agreement is also the first of its kind between a Canadian cannabis company and a separate, established, international pharmaceutical company. The fact that Alcaliber is located in Spain (albeit Madrid and not Barcelona) makes this new alliance even more interesting, and for several reasons. Not just in Europe or even Canada for that matter.

In the EU? GW Pharmaceuticals, the only other existing pharmaceutical manufacturer and grower of cannabis in Europe, and based in the UK, just got major European if not global competition.

And then of course, there is what is going on Down Under. Australian and Tasmanian companies moving into the game now (with pharma connections, background in opioids and a global footprint) as the medical market in Australia begins to take shape, are about to go head to head with the Canadian-Spanish-German alliance now forming on the other side of the world.

Cross-Continental Plays Are Now Forming

Just as in the U.S., Europe is turning out to be literally a state-by-state chess game of legalization, regulation and supply. Unlike the U.S., however, European countries are bound by both European law and in some cases, sub-regional agreements – like what exists in the so-called Schengen States.

However, even here, the new world is graduating into federal and regional law. And how that will play out in Europe, where the focus is still largely on medical use, is going to be interesting.

What does this mean for Canada’s largest LP? A strong, multi-country presence in the medical cannabis space that, strategically, is par to none other. There are other Canadian LPs who are planning production facilities in other EU countries of course. And some Canadian companies who appear to see Europe as one giant export market. Germany is just one of them. However, the German-Spanish connection is interesting for several reasons: The two most interesting markets globally right now from both a strictly medical perspective with a clear pathway to much broader acceptance as it transitions into some kind of recreational reform, are Spain and Germany. While the former has not signed up for full-boat medical acceptance, the recent independent assertion by the Catalonian government that they would formalize the cannabis club system is seen here as one more step towards the inevitable. So are ongoing and significant Spanish medical cannabis trials.

This move also gives Canopy and Spektrum something else: access to much cheaper Spanish labour and production. This means that no matter where they grow their crops in Europe, or process them, the company now has a two-country supply system for a multi-country medical market that is just waking up. And that is highly valuable right now.

Why?

It gives Canopy direct market entry into several European states, with federally approved, medical grade cannabis and medical products. Those who are coming to the rest of Europe from a Spanish base only, will not at this juncture meet strict medical growing requirements for the German market for starters. On the Spanish side of things, this also means that cannabis clubs might be pressured to stop growing their own (at least outside of Catalonia) and rely on more corporate entities to actually grow and process the plant.

What Does This Mean For Euro Industry Development?

Canopy, strategically, has been at the forefront of interesting strategic plays in the global industry for at least the last 18 months to 2 years. They have eschewed the American market (unlike other Canadian competitors) in lieu of other game elsewhere. However their current expansion strategy, geolocationally, has clearly also been at least 12 to 18 months ahead of just about everyone else.

The cross-country chessboard game is also something that other Auslander (foreign or international) companies are clearly trying to play, particularly in Europe. This is true of both actual cannabis production and distribution entities as much as tech. The hop-scotching of both Leafly and Weedmaps across the continent in search of a business strategy that makes sense is just another face of this. Advertising rules in Europe, including online, and especially for cannabis, are a lot different from say, California state law.

However what Canopy appears to be doing is establishing both a brand and production presence in a way that guarantees not only European entry, but potentially dominance in the medical market as the market here continues to expand and open up.

What they are also doing with this announcement is telling the German government, for one, that they can supply patients in the EU with EU-sourced product, even if not grown or produced in Germany itself. This alone will help keep prices down as German cannabis production gets underway over the next several years.

It will also help Canopy deal with what is expected to be at least supply pressure as of next year as the Canadian recreational market gets underway. There is a very good chance that Spanish grown cannabis might end up not only in the rest of Europe but will also be shipped back to Canada if the supply problems there are severe enough.

Whatever the end result, this is an interesting alliance, and coming at an interesting time for not only the German cannabis industry, but a regional market as well. And further, it is also clearly a play with not only hemispheric implications but global ones.