There is a strange, if yet so far undetected, regulatory hum in the air right now in Europe that will begin to increasingly occupy those who are in the certified industry here or looking to get in.
And no, it’s not imminent “recreational,” although it will also have vast impact on the same.
A little understood regulatory structure (so far at least within the cannabis industry) called EU-BIO is now firmly in the room.
What that is and how it will impact the industry is already starting to show up in a few places (see the new announcement by the Swiss that their recreational trial will be organic). This is of course before any dates have even been decided upon for said trial (although others have been set up in the country for about a year).
Beyond this, there are vast implications for every part of the industry, THC or CBD, medical or “lifestyle” focused.
What is EU BIO?
All food in the European Union is regulated on a “federal” level much like in the United States. The difference in Europe however, is that every European “state” or country (like Germany, Spain or Holland) also then has their own regulatory structure which is also equal to the federal standards of the U.S. – including via treaty on both the pharmaceutical and “consumer” side. In general, as a result, regulations, including in all things cannabis space related, are much stricter in Europe.
What this also means, generally, is that all food, cosmetic and human-use lebensmittel (to use the German word for everyday consumer goods like food, cosmetics and lifestyle products) must pass through regulatory agencies that are very much like the USDA and FDA in every country and on a regional European level before being approved on a national sovereign one. Where those are, and who handles what, however, is a patchwork of agencies across the continent. There is no homogenization, in other words, for an organic producer looking for the right agency to get certification from in Germany and Austria.
The distinctive green logo that is omnipresent in particularly German grocery stores also comes with a few high standards of its own. Namely that the logo must appear on all pre-packaged EU food products claiming to be organic within the EU and all member states as well as all imports. Even more importantly, the logo cannot be placed on “transition” projects – namely those which are hoping to fulfil the regulatory standards but are not there yet.
To complicate matters even further, of course all product that ends up as EU GMP must begin life as an organic product. Forget pesticides – radiated product is a hot topic right now as well as its certification in the German medical market.
And that also means, by definition, that all cannabis production in Europe as well as products hoping to be sold via relatively normal channels, must also meet these certifications.
The only other option of course, is what is called “Novel Food.” And even here, thanks to changes in EU BIO on the table for the next couple of years, those who hope to gain access via this kind of labelling, still need to pay attention to organic production. No matter where you are. Or what you want to sell.
Are All “Organics” Made Equal?
Just as in the medical industry and GMP, the strictures of “certified organic” are supposed to be fairly straightforward, but are interpreted by different countries and regions.
Generally speaking, however, national or even regional “organics” are not exactly the same. For example, Canadian “organic” is not the same as EU-BIO, starting with the fact that the plants in question are not necessarily of European origin (see the same logic here as behind Novel Food). In other words, there is no automatic equality, starting with the source of the seed. But there are also other issues in the room including processing.
That said, being organic is going to be the watchword of the industry. And in this, a bit surprisingly, the US will also have a lasting impact. Why? Because many countries want to export to the US (far from cannabis) and are required to adopt similar agricultural standards (see Latin America for starters).
Bottom line: it is better to be “green”, through and through, no matter where you are, or where you are from, in the global industry going forward. By the end of 2021, certified organic supply, at every level of the industry, won’t be a “choice” anymore.
There are obvious upsides and downsides to cannabis regulation. Gone are the days when it was a free for all, for outlaws growing in California’s hills, under the limited protections California’s medical cannabis laws provided. While there is no longer the threat of arrest and incarceration, for the most part, there are also a lot of hoops to jump through, and new rules and standards to contend with. This article highlights three areas in which your cultivation plan must necessarily change due to the new regulations.
1. Integrated Pest Management (IPM) is limited
In the new regulated market, products that were once widely used are now no longer allowed. Prior to regulation, in the days of Prop 215, you could spray your plants with just about anything, since there was no testing mandated for the products that were being sold. However, people unfortunately got sick and experienced negative reactions, with products like Eagle 20, which contains mycobutinol, and Avid, which contains bifenthrin. Accordingly, under new regulations there are thankfully much more stringent standards dictating what pesticides can be used. It’s ironic that for most of the “medical marijuana” era in California there were no mandatory testing requirements for the THC content of your cannabis, let alone testing for toxins, including pesticides, molds or heavy metals.
You need to have a very thorough pest management plan to make sure your bug populations are always in check. Given that there are a small number of allowable products for pest control in the regulated market, this can be tricky. You need to be extremely familiar with what is and isn’t allowed in today’s regulations. You must also make sure that someone who is certified to apply pesticides is applying them.
As a word of caution, there have been instances where approved pesticides were found to have old unused chemicals (that are not approved for use) from the manufacturing process in them. They may have only occurred in very small amounts, but they are harmful to humans and there is no lawful way to dispose of them.
Further, the presence of these harmful chemicals can cause your finished product to fail when undergoing mandated testing.
Rather than using risky chemicals, the best solution for (early detected) control of pests is the use of beneficial insects. Although they may not be the best solution for an infestation, predator bugs like Neoseiulus Californicus can efficiently control small populations of spider mites while ladybugs are good to limit aphids. Strategic planning of your IPM is one of the best ways to keep pest levels in check.
2. Plant size and plant count matter more than ever
Despite widespread legalization in the past few years for both the medical and recreational markets in the United States, the black market is still rampant and most cannabis is still being produced illegally in the US and internationally.
Generally speaking, in the black market, the less plants you have the better, as high plant counts lead to longer sentences of incarceration. With the passage of prop 215 in 1996, many growers, especially outdoor, started growing their plants as big as they possibly could because most limitations were based on plant counts. Some outdoor growers were able to cultivate plants that yielded over 10 pounds per plant. These days regulations are based on canopy measurements, meaning you can grow as many plants as you want within a defined, limited square footage area. This is where “light deprivation,” a method used to force plants into flowering, becomes favorable as it allows 2-4 harvests per year instead of just one. It is a much more intensive way of growing when you have tens of thousands of plants. While it is easier to plant, cultivate and harvest a larger number of smaller plants, it also requires a much more detailed level of planning and organization.
In order to achieve 4 harvests per year, you must have a well thought out cultivation plan and an all-star staff, but if you are able to accomplish this, you can increase your revenue significantly. Maximizing plant canopy space is essential to a profitable business in today’s market, and to do that will require more detailed planning, better organization and proper crop management.
3. How you grow and what equipment you use
With regulation comes liability for defects or injury. It is essential that all equipment used is approved for its intended use. Traditionally, cannabis was cultivated in secrecy in the black market. This led to many unsafe grow rooms being built by people who did not have the proper skills to be undertaking projects such as converting a garage into a grow room or handling the electrical and plumbing running into them. Accordingly, there were many instances of damages to property or injuries to people because of this. Now that counties and states permit cannabis cultivation facilities, the infrastructure and labor that is done must meet regulated building codes and general safety requirements. It is therefore imperative to know the codes and regulations and hire a professional that does, to ensure you meet the standards in order to avoid potential liability.
Larger scale cultivation requires bigger and more expensive equipment. Cultivation facilities are more likely to have sophisticated equipment, such as chiller systems, that are designed to control the grow room environment. While very efficient, some are not intended to be used specifically for cannabis cultivation, and can therefore be difficult to control and maintain. They perform very specific functions, and when not properly tuned to your conditions, can malfunction by prioritizing dehumidification over cooling. This can be a real challenge in warmer climates when temperatures rise, requiring cooling, but also necessitate removal of moisture from the cultivation space.
On the other hand, there is new technology that can make a huge difference in the success of your cultivation. I recently worked with two different companies that specialize in root zone heating systems. One manufactured equipment for root zone heating and cooling of 10k sq ft raised beds that had never been used in California previously. The other company specialized in root zone heating using radiant floor heat. They both worked as intended to maintain a constant root zone temperature, which increased plant health, and ultimately increased yield.
Many counties require data collection from your cultivation, requiring you to track the amount of water and nutrients used. Therefore, another useful tool you can use to increase efficiency, is data collection software that will allow you to collect different information about the amount of water and nutrients used, as well as specific information about the conditions in your grow medium. You can also record and display temperature and humidity readings in your grow room, in real time remotely through Wi-Fi, that you can then access from your phone or computer from anywhere in the world. This can be a useful tool when documenting information that your county, state or investors may require from you. Further, the ability to collect and analyze data will allow you to identify areas of inefficiency in order to correct and optimize your grow room’s potential. While you can achieve these same goals with simple in-line water meters, keeping track of nutrients and pesticides is not as easy. Data collection in the most basic form, using a pen and paper, can be an inaccurate and an inefficient use of time, and can easily be misplaced or ruined. Therefore, simple data software collection programs are the best solution to make the process simple and hassle free.
While it is nice to have state of the art equipment, if it does not work properly, or cannot be easily maintained, it will not be worth it in the long run and you will never see a return on your investment. Innovation comes with a price; using equipment that is cutting edge can be risky, but on the flip side, when done properly it can give you a big advantage over your competitors.
In switching from the black market to the regulated market, these three areas have proven to be the biggest areas of change and have presented the biggest challenges. It is important you consider these necessary changes, and make a solid plan before you begin your cultivation. This is where a cultivation consultant can help.
According to a press release published earlier this month, the U.S. Department of Agriculture (USDA) announced two new programs available for hemp growers to mitigate their risk.
The first is called Multi-Peril Crop Insurance (MPCI), which is a pilot hemp insurance program designed to cover against “loss of yield because of insurable causes of loss for hemp grown for fiber, grain or Cannabidiol (CBD) oil.” The second plan is Noninsured Crop Disaster Assistance Program, which protects against losses from lower-than-normal yields, destroyed crops or “prevented planting” where permanent crop insurance is not available.
Both of the programs are now accepting applications and the deadline to apply is March 16, 2020. “We are pleased to offer these coverages to hemp producers. Hemp offers new economic opportunities for our farmers, and they are anxious for a way to protect their product in the event of a natural disaster,” says Bill Northey, Farm Production and Conservation Undersecretary.
The MCPI program is available for hemp producers in 21 states, according to the press release. Th program is available in certain counties in Alabama, California, Colorado, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Montana, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Tennessee, Virginia and Wisconsin.
There are a handful of requirements to be eligible for that program, such as having one year of growing under their belt and have contracts in place for the sale of their crops. Hemp growers producing CBD must have at least 5 acres and hemp growers producing fiber must have at least 20 acres cultivated.
In 2021, the press release states, “hemp will be insurable under the Nursery crop insurance program and the Nursery Value Select pilot crop insurance program.” With those programs, hemp crops can be insured if grown in containers and in accordance with federal law.
To apply for any of these programs, hemp growers must have a license and must be totally compliant with state, tribal or federal regulations, or be operating under a state or university research plot from the 2014 Farm Bill. Growers need to report their hemp acreage to the Farm Service Agency, a division of the USDA.
The press release also mentions that if the crops have above 0.3% THC, the crop becomes uninsurable and ineligible for any of the programs.
By Aaron L. Hammer, David S. Ruskin, Nathan E. Delman No Comments
Two thirds of all states and the District of Columbia have, to varying degrees, legalized cannabis. With the recent addition of Illinois, eleven states now allow adult recreational use. But cannabis entrepreneurs’ rush of excitement and dreams of cashing in is met with fierce competition and economic risks that makes the dreams, which look so dank at first, end up going dark, or in other words, out of business.
This article discusses the available options for a cannabis business that finds itself on hard times and in need of reorganizing its debts or liquidating altogether. With the federal status of cannabis remaining illegal, cannabis businesses must clear significant hurdles to achieve success. Among the many other pitfalls traditional business owners experience, a cannabis business must navigate limited access to financial institutions and its related security concerns of keeping large amounts of cash on location. Also, they cannot deduct ordinary and necessary business expenses for federal income tax purposes. Turning a profit in legal cannabis can be a big challenge.
The first thought for a business facing insolvency is bankruptcy. However, bankruptcy courts have not been welcoming to cannabis businesses. Bankruptcy courts are courts of federal jurisdiction, and the federal government is represented by the United States Trustee Program (UST), which is the division of the Department of Justice responsible for oversight of Bankruptcy Courts. Since cannabis remains illegal under the Controlled Substances Act of 1970 (CSA) as a Schedule I controlled substance, it is unsurprising that the UST creates roadblocks for those seeking relief. In fact, the UST currently and steadfastly seeks dismissal of cases against cannabis businesses, cannabis employees and landlords of cannabis businesses.
But all hope is not lost. First, a change at the head of the DOJ could have a significant effect on how these cases are handled, even without a reclassification of cannabis. Second, recent caselaw shows a willingness by the courts to forge a path allowing cannabis cases to survive. Finally, if federal bankruptcy protection is not an option, other state remedies may be available to unsuccessful cannabis ventures.
The UST’s prosecutorial discretion has a strong influence in how a bankruptcy case can develop. While still very difficult to predict, a compelling analogy for cannabis cases can be seen in how the UST dealt with same-sex marriages in 2011. Nine years ago, the Defense of Marriage Act (DOMA) governed, and Section 3 of DOMA1 defined marriage as “a legal union between one man and one woman as husband and wife.” In In re Gene Douglas Balas and Carlos A. Morales, a same sex couple filed a Chapter 13 petition in California, and the UST filed a motion to have the case dismissed. The UST sought dismissal of the joint bankruptcy case, arguing the couple did not qualify for a joint petition under 11 USC § 302(a) because they were in a same-sex marriage. The bankruptcy court denied the UST’s motion. The bankruptcy court in Balas based its opinion partially on a letter from then United States Attorney General Eric Holder, with President Obama’s support, reasoning that Section 3 was unconstitutional as it applied to legally married same-sex couples. The UST appealed the case to the Ninth Circuit Court of Appeals, however, the UST did an abrupt about-face and dismissed its appeal. In fact, the UST took a further step by publicly stating it would not seek dismissal of any joint bankruptcy filed by a legally married same-sex couple. Similarly, if today’s executive branch decides not to enforce the CSA in bankruptcy court, cannabis businesses in compliance with state law would have access to bankruptcy courts.
Many businesses have pushed the bankruptcy courts to use a similar public policy approach to allowing cannabis businesses to seek debt relief, but it is proving to be a far stickier issue. Bankruptcy Courts have routinely dismissed cases with both direct and indirect relationships to the cannabis industry. The UST has taken a stance firmly against affording relief with any type of connection to cannabis. In an April 2017 letter to Chapter 7 and Chapter 13 trustees, the Director of the UST put it bluntly: “[i]t is the policy of the United States Trustee Program that United States Trustees shall move to dismiss or object in all cases involving marijuana assets on grounds that such assets may not be administered under the Bankruptcy Code even if trustees or other parties object on the same or different grounds.”
Indeed, one can fairly point out a significant difference between allowing a same-sex couple to file a joint bankruptcy. The practical significance of allowing same-sex couples to file jointly is the loss of a filing fee to the bankruptcy court, whereas a cannabis company’s liquidation creates a situation where a Chapter 7 trustee would have a fiduciary duty to liquidate a controlled substance, effectively violating federal law.
However, the UST shows equal hostility to cases involving downstream cannabis businesses such as landlords and even certain gardening suppliers, where there is no risk of cannabis itself becoming property of a bankruptcy estate. A Colorado District Court affirmed a bankruptcy court’s dismissal of a holding company for purported CSA violations.2 The Court reasoned that since the company owned stock for a large hydroponic gardening company, it willfully aided and abetted criminal activities.
While the federal executive branch is decidedly opposed to the cannabis debtor, one hope for reform lies with the judicial branch. To this end, the Ninth Circuit handed the biggest victory to date to a downstream cannabis business in Garvin v. Cook. Based on a microscopically close reading of the Bankruptcy Code, the Ninth Circuit held that a reorganization plan which relies partially on money from cannabis does not equate to a plan being “proposed by means forbidden by law” because the statutory text of one section cannot mean “all applicable law” or else the language in a closely related section that “the plan complies with the applicable provisions of this title” would be surplusage.
But this victory has not created much daylight for cannabis ventures seeking to utilize bankruptcy courts. Notably, Garvin could have gone a different direction if the UST had revived a motion to dismiss for gross mismanagement of the estate, which is how most Chapter 11 cannabis cases are dismissed. Indeed, in the weeks following the Garvin decision, two lower courts declined to blaze a new trail, and instead distinguished its cases from Garvin, dismissing debtors with equally indirect ties to cannabis.
Bankruptcy courts have shown significantly more latitude for legal hemp companies. In a promising decision, In re Royalty Properties, LLC, a Northern District of Illinois Bankruptcy Court took no issue with the legality of a debtor growing hemp seeds. The court took pains to distinguish hemp from its psychoactive relative marijuana and based its ruling on the 2018 Farm Bill which effectively legalized hemp. The court even denied as unnecessary an order to approve contracts to grow hemp, stating its approval was not necessary. Ultimately, the reorganization failed for reasons unrelated to growing hemp. Nevertheless, the case does show a step toward tolerance. Now that CBD giant GenCanna Global has filed a Chapter 11 in Kentucky, the UST’s tolerance will be put on full display.
Also, it is worth noting that the unwillingness of bankruptcy courts to take on cannabis cases cuts both ways. Creditors of cannabis businesses, already taking on a certain amount of risk for dealing with borrowers who cannot use depository institutions in a traditional way, also have been prevented from banding together and filing an involuntary bankruptcy against cannabis businesses.
Fortunately, legal cannabis businesses facing insolvency have options aside from federal bankruptcy to deal with debt issues.
An assignment for the benefit of creditors proceeding (ABC) presents one very workable option. In an ABC, a distressed company selects an “assignee” to liquidate the debtor’s assets via state law and distribute the proceeds to the creditor’s benefit. Depending on whether the assets include cannabis, the assignee will likely have to comply with applicable state law to be able to legally liquidate the asset. Nevertheless, an ABC might be the best solution currently available for cannabis companies seeking debt relief.
Another option is a corporate receivership where a disinterested third party, typically an attorney, is appointed to take control of an ailing business. The receiver takes over management of the company and can liquidate the company’s assets. Receiverships present certain advantages over bankruptcy proceedings. They allow for greater flexibility in decision making because the receiver is not bound by the confines of the Bankruptcy Code. Receiverships can be more cost effective, due to less court involvement and administrative expenses. For creditors, there is the advantage of potentially deciding on the receiver. Also, the receiver, unlike a Chapter 7 trustee, does not bear the imprimatur of any government, and is not a public officer within the meaning of a constitutional or statutory provision relating to public officers. Oregon and Washington have both amended their receivership statutes to ensure that cannabis businesses can effectively manage debt without receivers running the risk of violating the law. Ideally, other legal states will follow suit to ensure this remedy is available to cannabis businesses.
Finally, another bankruptcy alternative would be a friendly foreclosure under Article 9 of the Uniform Commercial Code (UCC). Unlike the Bankruptcy Code, the UCC is not federal law, but is adopted individually by each state. Again, considering the secured lender is required to comply with state law, this is another instance where amending state statutes could provide great assistance to a struggling cannabis business and its secured creditors.
Legal options for insolvent cannabis businesses is a new challenge. Society is trending in the direction of a more permissive attitude toward cannabis, so it should follow that the legislatures and courts accept this shift and afford distressed cannabis businesses the same opportunities to reorganize or orderly liquidate just like other legal business entities.
DOMA was ruled unconstitutional in 2013 US v. Windsor, 133 S. Ct. 2675 (2013).
See In re Way to Grow, Civil Action No. 18-cv-3245-WJM, 2019 U.S. Dist. LEXIS 207846 (D. Colo. Sep. 18, 2019)
According to a press release, the ANSI National Accreditation Board (ANAB) accredited Pure Labs, LLC to ISO/IEC 17025. The Phoenix, Arizona-based laboratory achieved the accreditation after demonstrating the ability to meet general requirements for the competence of testing labs.
The press release says that Pure Labs is one of the first cannabis testing labs in Arizona to achieve the ISO/IEC 17025 accreditation. According to R. Douglas Leonard, vice president of ANAB, they have seen a rise in demand for labs across the country. “Demand for competent testing laboratories is growing as many states have legalized medical and adult-use recreational marijuana,” says Leonard. “Testing by a laboratory accredited to ISO/IEC 17025 is necessary to demonstrate that cannabis products are safe for consumption and free from harmful levels of contaminants.”
Barbara Dow, CEO of Pure Labs, LLC, believes their scope of accreditation is the best in their state. “The ANSI National Accreditation Board welcomed us and our scope of accreditation, which is the most comprehensive scope in Arizona,” says Dow. “I am proud of our team and our success as one of the first ISO/IEC 17025 accredited laboratories in our state. This level of excellence was made possible by ANAB, our accreditation partner. It is an exciting time for our laboratory in this fast-paced industry.”
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.
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.
Previous 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.
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, 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 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.
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.
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.
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.
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.
Nepal’s parliament is debating cannabis reform. Even more interestingly, they are also considering cultivation as a way of curbing the harm done to the local population by the importation of distilled spirits. Namely, proceed with cultivation of cannabis and ban imported alcohol.
This is also the first time this specific discussion – alcohol vs. cannabis – has arisen in a national state legislature discussion about legalization quite like this anywhere in the world.
Specifically, instead of “legalize and tax” like alcohol – the mantra of many early American states like Colorado and Washington State, Nepal at least, is taking a directly different approach. Literally to accept cannabis as a drug and recreational substance while moving people away from distilled alcohol. And further doing so specifically as an act of public safety.
Western European nations if not North American ones, take note.
However, this is also a trend that is already showing up in the United States if not Canada all by itself. It is absolutely why the big beer and alcohol companies have invested early and big in this business.
Nepalese politicians clearly seem to want to make a different kind of statement right from the get go. Including potentially banning any cannabis company or funding that is directly tied to alcohol sales – or in the more likely inverse, giving a market alternative to global brands like Constellation. North American brands will sell well in a tourist market specifically there for outdoor sports, spiritual rejuvenation, or a bit of both.
Background on Nepal
Chances are you know about as much about Nepal as, well, most people do. It is a small, relatively open country on the edge of a much larger Tibet. Nepal and Tibet literally meet at the Himalayas and share Mount Everest. Tibet being the land of the exiled Dalai Lama and the site of that movie with Brad Pitt.
Nepal is also mostly Hindu, although there is a wide smattering of religious belief in the country that includes Buddhism, Islam, Christianity and Sikhism. And unlike Tibet, Nepal can be reached with a simple tourist visa.
It is for this very reason that such debates in the Nepalese parliament have taken on such an interesting geopolitical tint.
A Quick History of Cannabis and Nepal
Just like other countries touching the Himalayas, cannabis is hardly a “new” development. Indeed, this region of the world is likely to be home to many intriguing indigenous cannabis species – including of the intriguing “purple” kind. For those without a degree in cannabis cultivation, purple coloured cannabis, particularly in the wild, comes from areas that are cold at night – see Hindu Kush, albeit from Afghanistan.
Like other countries subjected to geopolitical forces of the early 1970s, the country was also forced to abandon its cannabis cultivation as part of the Cold War and War on Drugs that targeted this part of the world. Politicians are now calling for that to end.
Beyond tourism however, and local economic development (almost 50% of the economy is still subsistence farming), cannabis is deeply interwoven into local tradition and religion.
February 21 is known as the “Night of Shiva” – where millions of Hindus make religious pilgrimages to holy sites in the highest mountains in the world. Shiva is one of the three gods in the Hindu triumvirate.
Brahma is the creator of the universe. Vishnu is the preserver of it. Shiva, however is the destroyer of the universe in order to recreate it.
Coming as it does a month before the spring equinox, the ritual to Hindus is not one of violence but rather one of the rebirth of spring and renewal just around the corner. It makes sense that cannabis would be associated with the same.
In Nepal, in other words, there is a political and economic turning of the wheel for the new decade that is also spiritually motivated at least, by ancient and traditional Nepalese traditions that are quite literally, as old as time.
Information economics has existed for decades and drives much of how products, including cannabis, are marketed and purchased. One of the essential frameworks that guides information economics are the search, experience, and credence properties of a product (Patterson, 2017). Understanding these different product attributes is key to setting up a sustaining cannabis product, corporation, and industry.
The search attribute of a product is largely what we see prior to the purchase of a product. Images, claims, and packaging may all contribute to the search attribute of a product. You’ve got a good-looking, flower, pre-roll or edible, and it shows well on your insta page. Information is seemingly symmetrical between agency and consumer, what you see is what you get. In the developing cannabis industry, firms are investing a tremendous amount of resources into search attributes.
What is the effect of the product? There are two aspects of the experience attribute in information economics. Testimonials may be also considered experience attributes, as they give a user knowledge of how a product tastes, how long it takes to kick in, how long it lasts and descriptions of how others perceived the product’s deliverables. Despite testimonial power, experience is largely personal and occurs only after the product is consumed. Information is seemingly symmetrical; you get the experience that the agency planned and you anticipated. Advances in genetics, homogeneous production methods and potency testing demonstrate that the cannabis industry is investing in experience attributes.
A level playing field where transparency is at the forefront of all transactions will help solidify trust and drive sustainable growth. So, your product looks good, tastes good, and has very positive reviews. Customers can’t get enough; they are voting with their wallets for your product. But there is a third part of information economics you may be missing.
Credence attributes rely on information asymmetry. Think of used cars as a textbook example: sellers of used cars rely on asymmetry to motivate purchases. Highway miles, adult driven, oil changes every 3,000 miles, etc. are claims that can only be verified by the seller, the buyer has no way of knowing if these are true or not. Credence attributes can’t be verified by the seller due to lack of knowledge or expertise (Ford et al, 1988). The same goes for a consumable good like cannabis, only the grower or manufacturer knows what occurred in the “back of the house.” Product safety, therefore, is a credence attribute of cannabis products.
Investing in credence attributes in a young market may seem cost prohibitive. Many in the cannabis industry simply want to follow whatever the state they operate in dictates as the minimum allowable. In hemp we see states that require QR codes on each product that link to a COA, but many do not. Does the cost to produce the COA and QR code make a product more eye-catching or enhance the experiences? No, but those producing it may pay a hefty price if and when the product makes someone sick.
If a firm relies on fragmented, disparate regulatory bodies to dictate their investments in product safety, they will eventually face credence issues. Is smokable flower grown in Texas safer than that grown in Maine? We don’t have data to support either regulation’s effectiveness, so a firm or industry must dictate what the standard is and stick to it.
We need only look at the leafy green industry to see an example of a product that did not break any regulatory guidelines yet continued to sell a good with very negative credence attributes. How long were folks getting sick from leafy greens prior to them identifying the source? No one knows and that is what makes credence attributes so hard to pin down and develop an ROI formula for. Inputs that yield not-sick people aren’t known until someone gets sick. For leafy greens, they had an advantage – years of studies showing that they were good for you. Cannabis, unfortunately, doesn’t have that leg to stand on and faces an uphill battle gaining public trust.
As soccer moms (and dads) across the nation start to work cannabis into their play date wine sessions, the industry must ensure that they are investing in all avenues of information economics. A level playing field where transparency is at the forefront of all transactions will help solidify trust and drive sustainable growth.
Patterson, M. (2017). The economics of information. In Antitrust Law in the New Economy (pp. 39-60). Cambridge, Massachusetts; London, England: Harvard University Press. Retrieved February 7, 2020, from www.jstor.org/stable/j.ctvc2rkm6.6
Ford, G., Smith, D., and Swasy, J. (1988), An Empirical Test of the Search, Experience and Credence Attributes Framework, in NA – Advances in Consumer Research Volume 15, eds. Micheal J. Houston, Provo, UT : Association for Consumer Research, Pages: 239-244.
Maine’s Office of Marijuana Policy (OMP), the government agency in charge of regulating their cannabis industry, announced today a six-year contract for traceability software with Metrc LLC. According to the press release, the software will be used for the newly formed adult use market, which is just a few months away from going live with legal sales.
Maine’s OMP was previously under contract with BioTrackTHC as their software provider before switching to Metrc with this new contract. The software is cloud-based and uses radio-frequency identification (RFID) tags on plants and products to track cultivation and distribution of cannabis products throughout the state. The software is commonly used across the country in states that have legal cannabis markets. It essentially prevents diversion to the black market, allows for a transparent supply chain with clear chain of custody tracking and it increases recall readiness.
Erik Gundersen, Director of Maine’s OMP, says Metrc is helping to make a smooth launch of the adult use market. “We are excited to partner with Metrc,” says Gundersen. “Metrc is an industry leader, and their team is committed to delivering a product that will allow us to proceed with the launch of our adult use program later this spring.”
Over the next few months, Metrc and OMP plan on helping the industry familiarize themselves with the new software. The two organizations will go on the road in March, giving licensees training and answering questions. Metrc will then offer online training and evaluations followed by credentialing licensees showing they are proficient with the software.
Jeff Wells, CEO of Metrc, says they are excited to get to work. “We’re excited to partner with the OMP to help launch the state’s adult-use marijuana market,” says Wells. “2020 is another significant year for cannabis industry growth, and we look forward to serving the OMP, local cannabis businesses, and the people of Maine.”
The agreement is a six-year contract with a value of roughly $540,000. License holders pay a $40 monthly fee to access the system, which helps support training and technical support, according to the press release.
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