Massively promising news for the cannabis industry today that many are calling historic: the Department of Health and Human Services (HHS) has sent a letter to the Drug Enforcement Administration (DEA), recommending that cannabis be rescheduled from Schedule I to Schedule III. The news was originally reported by Bloomberg, but further expanded on (and without a paywall we’ll add) by Marijuana Moment with comments from the DEA, HHS and the White House.
Many cannabis stocks across the market saw significant spikes in trading prices following the news of the recommendation. Industry stakeholders and trade organizations seem to share a similar sentiment across the board: Not quite exuberance and celebration, but cautious optimism. The move doesn’t mean the federal government is legalizing cannabis, but they are showing their willingness to work with the industry.
The current Schedule I status of cannabis means the DEA and the federal government see no medical value in it and a high potential for abuse, grouping it with heroin and cocaine. Moving it to Schedule III would mean the opposite, that they recognize cannabis does have medical value and does not have a high potential for abuse, which would put cannabis in the same classification as ketamine, testosterone and Tylenol with codeine.
Importantly, the move would remove the dreaded 280E tax burden that has plagued the cannabis industry with huge tax penalties. It would also lift many barriers to study cannabis that have hindered research for decades.
Last year, President Biden asked HHS to review the scheduling of cannabis, and this recommendation letter to the DEA appears to be the culmination of their review. It is only a recommendation and nothing happens instantly. The DEA still has to decide if they choose to reschedule cannabis.
Out of all the quotes and statements flooding the cannabis media today, Rep. Earl Blumenauer (D-OR) best summarized the feelings shared by many folks in the industry: “This is a step in the right direction but it is not sufficient. I hope it is followed by more significant reforms. This is long overdue.”
The cannabis industry operates in a legal gray area between federal restrictions and state legalization in a constantly changing regulatory environment. Maintaining payroll and HR compliance is a burden cannabis companies face that grows exponentially with geographic expansion of the workforce.
Würk allows cannabis companies to manage payroll, human resources, timekeeping, scheduling and tax compliance, minimizing compliance risks in the ever-changing cannabis regulatory environment. The company uses its expertise and trusted partnerships to provide guidance on 280E tax law, accounting and banking. Its platform is designed to scale nationally with the growth of the industry while incorporating the local laws and regulations unique to individual states. Their clients include Cresco Labs, Canndescent and NUG.
We caught up with Scott Kenyon to ask about Würk’s approach to human capital management, challenges facing cannabis businesses and industry trends. Scott sat on the Board of Würk before becoming its CEO and chairman. Prior to Würk, Scott held leadership roles at Dell and Phunware.
Aaron Green: How did you get involved in the cannabis industry?
Scott Kenyon, CEO and Chairman of Würk
Scott Kenyon: My wife and I were early investors in a few companies in Colorado and Nevada. From early on (this was back in 2015) we learned the hard way of cannabis and how difficult it is to run these businesses, especially in those early days. We’ve progressed a ton over the years, but it’s still very difficult to run cannabis businesses.
I joined Würk about five years ago as a board member. I came on as CEO at the beginning of 2021 after our founder and previous CEO Keegan Peterson, who was an early trailblazer in the industry, passed away. So, I’ve been CEO at Würk for about 18 months.
Green: Tell me about Würk and the main problems you’re trying to solve.
Kenyon: Early on we were focused on establishing getting out of the cash business for these cannabis companies. Allowing them to pay payroll, taxes and be tax compliant electronically was a huge early advantage for us as a company. Now, fast forward seven years later and a lot of different banks (credit unions) are in the industry and that is allowing people to move money. So, that’s not as big of an advantage for us anymore, but early on that was huge.
Our advantage now is the scars on our back, for lack of a better phrase, from what we’ve gone through over the last seven years. We anticipate. We prevent. And most importantly we’ve seen all those problems for our customers. Last year, a big thing of mine was being “Smokey the Bear.” We want everybody to be Smokey the Bear: prevent fires and prevent issues for our customers. When I came in, we were the world’s best firefighters. I didn’t want that title. I wanted to prevent issues for our customers. That takes you from being a vendor to a partner.
If you look at it, on our platform we have 80% of the enterprise cannabis market, about 60% of the mid-market and then low single digits in the small business space. We have that market share because we provide invaluable experience and guidance to our customers. The biggest MSOs have different challenges from a “Joseph and Scott” dispensary, or a “Mary and Jane” grow facility. We’re able to adapt to all those different segments.
At the core of our product, we offer payroll services and what we call HCM – human capital management. That’s everything from scheduling, applicant tracking systems processing and paying your payroll taxes. So, we have the full gamut of product offerings that any type of HCM or HRIS software system does, whether you’re outside of cannabis or inside of cannabis, we’re offering the same thing.
Green: How does Würk differ from say a Professional Employer Organization (PEO)?
Kenyon: We aren’t a PEO. We don’t manage employees. At a high-level, a PEO is basically managing HR for these companies. Our platform enables HR professionals to go out there and do that. PEOs are more popular down in the small business space, because people are not at the scale to hire an HR team. We’re similar in that we’re processing payroll and have all the software that these companies need, but we’re different in that we’re not running their HR for them.
Green: How do you work benefits into the mix?
Kenyon: We leave it to the client, and we integrate their benefits provider into our platform so it’s an easy one-stop shop. We have single sign-on for a lot of our integrations. For the HR organizations, we want them to log into our platform and everything they need will be there.
Green: How is SAFE banking going to affect the HR industry in cannabis?
Kenyon: It’s going to be great for the industry, obviously. For HR specifically, it’s going to bring in more providers of payroll and more competitors for us for sure. But also it’s going to bring in more providers of services that can come in and offer that right now because of the federal illegalization.
Green: How does 280E affect your business and your customers?
Kenyon: We don’t guide people around 280E because that’s a tax specific matter. We refer them to their tax experts. We process payroll tax, which is different than what 280E affects. I think 280E was a big challenge, it’s still a big challenge, but that’s mostly because people didn’t really understand it. I think 280E was a problem five to seven years ago. In the last two years most companies are very familiar with it. That doesn’t mean 280E is the right thing. I think 280E is an awful thing. And while I think I hope SAFE banking is the first thing to fall legislatively, I think 280E has a good chance of getting across first.
On any given day my opinion on which will go first changes. I just want something to get across the line.
Green: What are some unemployment and payroll challenges your customers face?
Kenyon: We really watch unemployment changes and changes in job descriptions or job codes. For example, if an unemployment rate changed, and that unemployed person moved to a different place, which happened a lot during COVID, that company needed to report that and they needed to collect the appropriate charges or taxes there.
Green: What geographies are you in right now?
Kenyon: As of January 1, we had people on our platform in 46 states and just under 600 different jurisdictions. So, even though cannabis isn’t legal in all those states, big companies have employees across the United States.
Green: How do you help your users manage compliance across multiple jurisdictions? That must be a complex undertaking.
Kenyon: Our platform automatically plugs into the states that have electronic notifications around laws, which most states do. In our tax department, we have certain group members that are experts, let’s say, in the west coast. So, we assign people to certain regions to ensure that they have the best knowledge.
From our support piece, where a lot of our customers come in, somebody might say, “Hey, I have a unique question for Utah” and we’ll say we have a person that is specialized in Utah, but we don’t force them there, we just give them the option. But in our tax queue, we actually direct the customer like, “Hey, here’s a Massachusetts Question, so that goes to a particular person because they are our Massachusetts expert.”
Green: How do you deal with timekeeping issues like overtime?
Kenyon: Well, our system does that automatically. Let’s say they’re working overtime in a state that’s difficult to keep time for like California. In the state of California, if they’re working overtime on a Saturday or Sunday or a holiday, that’s a whole different calculation than working longer on a Thursday night. So, our platform is made to automatically calculate that for our customers. There’s no manual adjustments or coaching happening there. We just follow the state law based on where the employees are.
Green: Are you seeing any unionization of employees within the cannabis industry?
Kenyon: There’s unionization in many of our states, I don’t know the exact number, but California being the biggest, there’s a lot of union representation. Illinois is probably the second biggest union state on our platform. I’m assuming New York will be once it becomes adult use.
Green: How does Würk approach cybersecurity?
“Cannabis customers don’t want to buy on the illicit market. They want to buy from a trusted source. It just takes time to make that happen.”Kenyon: Well, we approach it very seriously and I recommend everybody take cybersecurity seriously. We test our internal systems regularly. We test our employees through phishing scams. And we’re always just trying to educate our team on the risk that we have.
I can’t share specifically the prevention steps that we’re taking, but I can tell you we partner with some of the biggest experts and make sure that we’re following everything that they’re recommending. More importantly, we’re testing for human failures, because where most failures happen is with people.
Green: What trends are you following in the industry right now?
Kenyon: Any type of activity in Congress is going to be huge for this industry. So that’s something I always keep abreast of. The next thing that comes down the line which is tied to that is interstate commerce: How is interstate commerce going to really come into play? And how does that change this industry?
Within the industry, the big question is how do we combat the illicit market? Over the last five years, I’ve heard all kinds of different ideas. But in the end, I think we have to out-innovate the illicit market, and that’s what I’m most excited about.
There are new product categories, beverage being one that is starting to gain traction. How are these new products and new variations of the cannabis plant able to treat and help people in ways that we’ve never thought of? That’s part of out-innovation. I was reading an article today about new terpenes that were discovered and how 100 products could come from each one of those new terpenes. I think we’re just still at the tip of the iceberg of product innovation.
How do we fight the illicit market? I think that is just through coming up with new products that treat different illnesses and ailments, that allow customers to get away from pharmaceuticals. Cannabis customers don’t want to buy on the illicit market. They want to buy from a trusted source. It just takes time to make that happen. They’re not going to do it when there’s a huge price difference, but they will do it when there’s a huge product difference. And right now, our products are very similar to what you can find on the illicit market. You can find vapes, you can find gummies, you can find all that in the illicit market. We’ve got to out-innovate the illicit market.
Green: What in your personal life are you most interested in learning about?
Kenyon: I am the father of two teenagers right now and I really like to learn how to be a better parent to them because it’s really frickin’ tough!
As a strange year heads to a final, painful finish, there have been some major (and some less so) changes afoot in the global world of cannabis regulation. These developments have also undoubtedly been influenced by recent events, such as the recent elections in the United States, state votes for adult use reform in the U.S. and the overall global temperature towards reform. And while all are broadly positive, they have not actually accomplished very much altogether.
Here is a brief overview of the same.
The UN Vote On Cannabis Despite a wide celebration in the cannabis press, along with proclamations of an unprecedented victory by large Canadian companies who are more interested in keeping their stock prices high than anything else, the December 2 vote on cannabis was actually fairly indecisive.
Following the WHO recommendations to reschedule cannabis, the UN voted in favor of the symbolic move. Despite removing cannabinoids from Schedule IV globally, a regulatory label designed for highly addictive, prescription drugs (like Valium), the actual results on the ground for the average company and patient will be inconclusive.
The first issue is that the UN did not remove cannabinoids themselves, or the plant, from Schedule I designation. This essentially means that countries and regions will be on the front lines to create more local, sovereign policies. This is not likely to change for at least the next several years (more likely decade) as the globe comes to terms with not just a reality post-COVID-19, but one which is very much pro-cannabis.
In the meantime, however, the ruling will make it easier for research to be conducted, for patient access (for the long term), and more difficult for insurers to turn down in jurisdictions where the supposed “danger” of cannabis has been used as an excuse to deny coverage. See Germany as a perfect example of the same.
It is also a boon for the CBD business, no matter where it is. Between this decision and the recent victory in Europe about whether CBD is a narcotic or not (see below), this is another nail in the coffin for those who want to use semantic excuses to restrain the obvious global desire for cannabinoids, with or without THC.
That said, the vote is significant in that it is a test of the current trends and views towards big issues within the overall discussion, beginning with decriminalization and a reform of current criminal and social justice issues inherent in the same. The Biden Administration, while plagued with a multitude of issues, beginning with the pandemic and its immediate aftershocks, will not be able to push both off the radar. Given the intersection of minority rights’ issues, the growing legality of the drug and acceptance thereof, as well as the growing non-partisan position on cannabis use of both the medical and adult use kind, and the economy, expect issues like banking to also have a hope of reform in the next several years.
Cannabis may be taking a back seat to COVID, in other words, but as the legalization of the industry is bound up, inextricably, in economic issues now front and center for every economy, it will be in the headlines a great deal. This makes it an unavoidable issue for the majority of the next four years and on a federal level.
Prognosis in other words? It’s a good next federal step that is safe, but far from enough.
The European Commission (EC) Has Finally Seen The Light On CBD
This combined with the UN rescheduling, will actually be the huge boost the CBD industry has been waiting for here, with one big and still major overhanging caveat – namely whether the plant is a “novel” one or not. It is unlikely as the situation continues to cook, that Cannabis Sativa L, when it hits a court of law, will ever be actually found as such. It has inhabited the region and been used by its residents for thousands of years.
However, beyond this, important regulatory guidance will need to fall somewhere on the matter of processing and extraction. It is in fact in the processing and extraction part of the debate that this discussion about Novel Food actually means something, beyond the political jockeying and hay made so far.
Beyond this of course, the marketing of CBD now allowed by this decision, will absolutely move the topic of cannabinoids front and center in the overall public sphere. That linked with sovereign experiments on adult use markets of the THC kind (see Holland, Luxembourg and Denmark as well as Portugal and Spain right after that), is far from a null sum game.
Legal Challenges Of Note
The European Court of Human Rights
Against this changing regulatory schemata, court cases and legal decisions remain very important as they also add flavor to how regulations are interpreted and followed. The most important court case in Europe right now is the one now waiting to be decided in the Court of Human Rights at Strasbourg regarding the human rights implications of accessing the plant.
Beyond that, in Germany, recent case law at a regional social benefits court (LSG) has begun to establish that the cannabis discussion is ultimately between doctors and their patients. While this still does not solve the problem of doctor reluctance to prescribe the drug, barriers are indeed coming down thanks to legal challenges.
Bottom line, the industry has been handed a nice whiff of confidence, but there is a still high and thorny bramble remaining to get through – and it will not happen overnight, or indeed even over the next several years.
The United Nations Commission for Narcotic Drugs, based in Vienna, Austria, voted to remove cannabis for medical use from its Schedule IV status, the strictest drug classification where dangerous drugs like heroin are listed.
The vote comes after the World Health Organization submitted a number of recommendations to the commission regarding cannabis, all of which were rejected except for the Schedule IV removal, according to Kyle Jaeger at Marijuana Moment. The WHO first issued their recommendations to change the status of cannabis last year in 2019.
Dirk Heitepriem, vice president at Canopy Growth, told the New York Times the vote is a huge step forward. “We hope this will empower more countries to create frameworks which allow patients in need to get access to treatment,” says Heitepriem.
The much-delayed vote was close, with 27 in favor and 25 against, and Ukraine abstaining, but support from the United States was pivotal in getting it passed. Still though, the vote is largely symbolic – it doesn’t necessarily clear the way for countries to start legalizing cannabis and governments can still classify cannabis how they see fit.
The vote does, however, provide an important foot-in-the-door moment for cannabis advocates and businesses around the world. The commission’s decision to remove cannabis from Schedule IV means that the UN recognizes cannabis as an effective medicine, opening the door to future progress on the international level and possibly opening research opportunities along the way.
The South African government has taken a leap into the future (ahead also of the expected World Health Organization (WHO) decision on cannabis this December). Namely, it has begun to regulate hemp (more in line with Europe intriguingly, than the U.S.) and attempted to remove the THC part of the equation from a domestic list of plants and drugs with no medical use.
The notice was signed by South African Minister of Health Zweli Mkhize and published a week after a domestic moratorium on CBD expired. The moratorium permitted the sale of some kinds of CBD products.
This is an intriguing new development, although it will also undoubtedly cause headaches for the burgeoning industry in the region.
On The CBD Front…
South Africa’s new hemp guidelines – namely for the amount of THC allowed in legit hemp crops that are also regulated – are that plants contain no more than 0.2% THC. This makes the guidelines absolutely in line with what is generally developing across the EU. And even more intriguingly, below federal guidelines for most U.S. domestic hemp crops (which are 0.3% at a federal level and only differ in a few state cases where the amount is lower by state law).
However, there is also a unique twist to all of this: The South African government has now created a two-pronged regulatory schemata just for CBD. The default approach to the cannabinoid is that it is in fact medication, scheduled under South African internal and global drug guidelines as a “Schedule 4” drug.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
The other designation is reserved for CBD packaged in sizes of 600mg or less (and limited by instructions to no more than 20mg a day). This kind of CBD (despite the dubious understanding of cannabinoid science) will henceforth be labelled a “supplement” and on “Schedule 0”.
However, do not be fooled: This is not “descheduling.” This actually means that all CBD has been classified as a medical substance except in packets that are under a certain size, with portion suggestions on the outside of the wrapper or package.
That is hardly scientific. However, what is more burdensome is that any CBD cultivator in South Africa must also be GMP- (or internationally medically) certified (even if bound for the supplement market). By definition, in other words, it will make the cost of production for the supplement (commercial, food and cosmetic) part of the equation as expensive as pharmaceutical production. While from a purist’s point of view, having ultra clean cannabis in any product (at the level of pharmaceutical standards) is a wonderful idea, but this gets ridiculous when it comes to reality, and will ultimately never stand.
This development is also undeniably inconvenient (at minimum) for any who had envisioned outdoor hempires, which most of the cannabis grown in South Africa is. The only people who have the money to build indoor grows, starting with GMP certified greenhouses, are, for the most part, white people, foreigners or those who own property and have access to external, international equity.
The sins of Apartheid, in other words, are being writ large on the entire cannabis industry at present in South Africa. And CBD is contained right in the middle of the mix.
On The THC Front…
There are several interesting aspects to this.
The first is that THC has been removed from the South African “Schedule 7” which is roughly equivalent to the international “Schedule I” that cannabis also resides in until the WHO re- or deschedules the same.
However, this also means that all CBD as well as THC must be produced by those with pharmaceutical-grade facilities – and this of course includes more than just indoor, temperature-controlled greenhouses. It also includes a complex supply chain that is European and Western centric, starting with the requirement to access a rather large amount of capital to construct the same.
Global Re-Alignment Or Stopgap Measure?
This new regulation, in other words, specifically leaves the vast majority of what has already been seeded, or what is most likely to be, in the hands of a few Canadian and other companies who have been moving in this direction for the last several years.
It also implies, intriguingly, that the intra-African cannabis market is low priority at present for those writing the (health) rules. And that also means that eyes are being set more on creating an export market than for treating South African citizens.
It is not an unusual move, rather tragically so far. And almost certainly one that will be challenged, and in several directions, both by events, but also by firms caught up in the mix.
Why? For starters, the South African cannabis market also effectively controls the Lesotho cannabis regulatory scheme (namely all exports from Lesotho, which has seen quite a lot of cannabis investment over the last several years). All such crops must be labelled per South African guidelines if they, literally, can hit a port to be exported.
The vast majority of those grows, even with relatively decent foreign backing, are also outside – and of course as a result ineligible for GMP certification.
Of course given the fact that the UN is likely to clarify both the status of THC and CBD by the end of the year, this current situation in South Africa is also fairly clearly intended to be a stop-gap regulatory measure to last up until at least this time.
Where it may go after that is anyone’s guess. This measure, however, is also clearly being made to protect those who have invested in GMP-grade facilities as opposed to those who have been clearly angling for reform on the CBD front, starting with the beer market. Stay tuned. Interesting developments clearly ahead.
According to a press release published by the National Cannabis Industry Association (NCIA), the House Judiciary Committee approved the Marijuana Opportunity Reinvestment and Expungement (MORE) Act by a 24-10 vote. House Judiciary Committee Chairman Jerrold Nadler (D-NY) introduced The MORE Act (HR 2884), which now has 55 cosponsors. This marks the first time in history that a congressional committee approved a bill to legalize cannabis.
House Judiciary Committee Chairman Jerrold Nadler (Image credit: Ralph Alswang)
“Today’s vote marks a turning point for federal cannabis policy, and is truly a sign that prohibition’s days are numbered,” says Aaron Smith, executive director of NCIA. “Thanks to the diligent efforts of advocates and lawmakers from across the political spectrum, we’ve seen more progress in this Congress than ever before.”
A little bit of background on the bill: The MORE Act, if passed, would decriminalize cannabis completely on a federal level. It would remove it from the Controlled Substances Act, not reschedule it. If the bill were to pass, it would expunge all prior federal cannabis convictions. The bill provides for the establishment of the “Cannabis Justice Office,” which would develop a. program for reinvesting resources in those communities most affected by the war on drugs. That program would be funded by a 5% tax on cannabis commerce in states that have legal regulatory frameworks.
The bill also would allow the Small Business Administration to provide loans, grants and other support to cannabis-related businesses, as well as support state equity licensing programs. Through the bill, physicians in the Veteran Affairs system would be given permission to recommend medical cannabis to patients as well.
Aaron Smith, executive director of NCIA
“Supermajority public support for legalization, increasing recognition of the devastating impacts of prohibition on marginalized communities and people of color, and the undeniable success of state cannabis programs throughout the country are all helping to build momentum for comprehensive change in the foreseeable future,” says Smith.
According to NCIA, there was a recent amendment to the MORE Act that includes language from the Realizing Equitable & Sustainable Participation in Emerging Cannabis Trades (RESPECT) Resolution introduced by Rep. Barbara Lee (D-CA). That resolution is based on the white paper that NCIA’s Policy Council published back in March of 2019.
“There is still much work to be done, including the establishment of sound federal regulations for cannabis products,” says Smith. “This vote brings us one step closer to ending the disaster that is prohibition and repairing the harms it has caused while we continue the discussion in Congress about how to best regulate cannabis at the federal level. We urge lawmakers to move forward with this necessary bill without delay.”
In a sign that cannabis reform is now on the march at the highest level of international discussion, the World Health Organization (WHO) will be meeting in November to formally review its policies on cannabis. This will be the second time in a year that the organization has met to review its policies on the plant, with a direct knock-on effect at the UN level.
According to documents obtained by Cannabis Industry Journal, including a personal cover letter over the committee’s findings submitted to the Secretary-General Antonio Guterres by Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO, the November review will “undertake a critical review of the…cannabis plant and resin; extracts and tinctures of cannabis.”
What Exactly Will The WHO Review?
The November meeting will follow up on the work done this summer in June – namely to review CBD. According to these recommendations, the fortieth meeting of the Expert Committee on Drug Dependence (ECDD) in Geneva will include the following:
Pure CBD should not be scheduled within International Drug Control Conventions.
Cannabis plant and resin, extracts and tinctures of cannabis, Delta-9-THC and isomers of THC will all be reviewed in November.
Finally, and most cheeringly, the committee concluded that “there is sufficient information to progress Delta-9-THC to a critical review…to address the appropriateness of its placement within the Conventions.” In other words, rescheduling.
Industry and Patient Impact
Translation beyond the diplomatic niceties?
The drug war may, finally, and at a level not seen for more than a century, come to a close internationally, on cannabis.
Here is why: The WHO is effectively examining both the addictive impact and “harm” of the entire plant, by cannabinoid, while admitting, already that current scheduling is inappropriate. And further should not apply to CBD.
This also means that come November, the committee, which has vast sway on the actions of the UN when it comes to drug policy, is already in the CBD camp. And will finally, it is suspected, place other cannabinoids within a global rescheduling scheme. AKA removing any justification for sovereign laws, as in the U.S., claiming that any part of cannabis is a “Schedule I” drug.
What this means, in other words, in effect, is that as of November, the UN will have evidence that its current drug scheduling of cannabis, at the international level, is not only outdated, but needs a 21stcentury reboot.
International Implications
From a calendar perspective, in what will be Canada’s first recreational month, Britain’s first medical one and presumably the one in that the German government will finally accept its second round of cultivation bids, the world’s top regulatory body will agree with them.
This also means that as of November, globally, the current American federal justifications and laws for keeping cannabis a Schedule I drug, and based on the same, will have no international legal or scientific legitimacy or grounding.
Not that this has stopped destructive U.S. policies before. See global climate change. However, and this is the good news, it is far easier to lobby on cannabis reform locally than CO2 emissions far from home. See the other potentially earth-shaking event in November – namely the U.S. midterm elections.
The global industry, in other words, is about to get a shot in the arm, and in a way that has never happened before in the history of the plant.
And that is only good news for not only the industry, but consumers and patients alike.
British Home Secretary Sajid Javid appears to have become the most high ranking cannabis advocate in the British government. He has just launched a review into medicinal uses of cannabis in the UK. However, this dramatic change in policy has only come after a series of high profile campaigns and escalating battles for access waged by patients and their families against a government which has remained stubbornly intransigent in the face of growing evidence of medical efficacy and reform elsewhere. In fact, the cannabis “Battle of Britain” has come to resemble the contretemps in Israel over the same issue four years ago that led to a national review of medical use and greater patient access.
GW Pharma said their product Epidiolex (for the treatment of childhood epilepsy) is being considered by the European Medicines Agency
It is expected that this recent turn of events will open better access for more British medical users. The fact that the timing of all of this comes as GW Pharma has received the right to distribute Epidiolex in the U.S. as the first FDA-approved cannabis-based medicine is not only part of the irony but the underlying problematic politics surrounding all of this. Starting with the timing of who has access to what, and under what circumstances. As it stands, Epidiolex is also the only cannabis-based drug now eligible in the United States for healthcare coverage. The rest of the market is so-far excluded from it. Unlike, it should be pointed out the situation in the UK, the rest of the Commonwealth, and of course, the EU. Starting with Germany.
A Major Win for Patients
Celebrate one for Alfie! Alfie Dingley that is – the British 6 year old with epilepsy who has become one of the most well-known faces of medical justice for cannabis users in the UK. Dingley and his parents waged a battle since last fall over his right to consume low THC cannabis oil that allows him to manage his epilepsy. He has just been granted an emergency license to import the oil from the Netherlands.
But this is also a victory for Billy Caldwell, the twelve-year-old who ended up in emergency care in hospital recently after his medical oil (from Canada) was confiscated at the border. Video of border control agents at Heathrow Airport removing the oil from the Caldwells caused a national outcry in the UK. Caldwell’s mother, Charlotte, has also waged a high profile battle for access, including at the doors of the hospital her son was admitted to last week. She has also started her own CBD company named after her son.
Like the rest of Europe, which the UK still technically is part of until Brexit, the focus here has very much been on medical use.And of course, this new indication in change of policy is seen as a major victory if not step forward for literally thousands if not millions of Britains who suffer from chronic conditions that are still drug resistant (like Epilepsy but not limited to the same.)
As he addressed the House of Commons on the issue of medicinal cannabis use, Javid said “It has become clear to me since becoming home secretary that the position that we find ourselves in currently is not satisfactory…I have now come to the conclusion that it is time to review the scheduling of cannabis.” As in the US, cannabis is still considered a Schedule I drug in the UK – with supposedly no medical efficacy. This new development clearly challenges that scheduling – but where and how?
Recreational Is Still Not On The Table
Like the rest of Europe, which the UK still technically is part of until Brexit, the focus here has very much been on medical use. This is for several reasons, including a much better and more inclusive public health system – despite imminent fears about the longevity of the British National Health Service (NHS).
In the UK, however, further reform is not likely to move fast. Unlike anywhere else, cannabis production is essentially limited to one company – GW Pharmaceuticals – who themselves have high standing political connections that continue to oppose reform. This is not based on science but rather profit. Despite the fact that the British Isles are the largest exporter of medical cannabinoid pharmaceuticals in the world, British patients are still largely excluded from access. The only reason that these children and their parents were able to pierce the wall of privilege and profit that has driven the debate here since the late 90’s is that GW Pharmaceutical’s cannabinoid concoctions do not work on this kind of epilepsy. Plus the failure of a recent trial of their new drug (shamefully in Europe, not even conducted in the UK).
As a result, GW Pharmaceuticals and the well placed scions of British society who have profited directly and personally from this situation have little choice but to back down – but not by much. As soon as Javid announced his intention to do a review of British policy, former Tory (conservative) leader Lord William Hague called for full legalization. An initiative that as of June 19 was rejected by the government.
Is Medical Finally About To Get Its Due?
In Europe, politically, the frustration is clearly growing. And much like in the United States circa 2012, activists and advocates realize that medical access is the first step towards full reform. However here there is a marked difference to what is going on in both the U.S. and Canada. And in turn, this may bring a long overdue focus on the medical issue that has continually been obscured and overlooked by the industry itself as soon as recreational seems it is in reach.
When real and regulated medical markets are allowed to flourish, the first beneficiaries are both children and women, not middle-aged men. That is clearly the face of the “average” German patient now that the data of the first year has come in. It is also likely to be the case of the British patient as well as Europeans across the continent.In Europe, politically, the frustration is clearly growing
Further, as cannabis has become more of an accepted treatment, this is in turn forcing governments (and even the industry itself) to begin, for the first time, to consider funding widespread trials – and of the raw plant itself along with extracts and other forms the drug can be consumed in.
What does this really herald, in fact then besides relief for chronically ill patients? The first widespread scientific inquiry into the efficacy of cannabinoids outside of Israel.
And that too, is cause for celebration. Congrats Alfie and Billie! And all the people who helped move the issue forward.
On August 11, 2016, the widely anticipated Drug Enforcement Agency (DEA) announcement on federal cannabis policy yielded fairly anticlimactic results. According to the statement, the federal agency denied two petitions to reschedule cannabis under the Controlled Substances Act (CSA). The U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) conducted a scientific and medical evaluation that deemed cannabis “does not meet the criteria for currently accepted medical use in treatment in the United States, there is a lack of accepted safety for its use under medical supervision, and it has a high potential for abuse.” The announcement reiterates the agency’s previous statements on the matter, stating that they believe clinical trials under the investigational new drug (IND) applications and the drug approval process are how the FDA can assess the safety and effectiveness of cannabis-derived medicine.
This avenue for bringing a cannabis-based drug to market is extraordinarily cost-prohibitive, allowing only pharmaceutical companies with deep coffers in the space. The DEA did however make one announcement in the statement that has the potential to lift many barriers to researching the plant’s medical value. The policy change allows more institutions to grow cannabis for research, which was previously allowed only at the University of Mississippi under a contract with NIDA. This is a very significant policy change that could be viewed as a step in the right direction. There is plenty of research currently that proves cannabis’ medical value and its safety and efficacy, but allowing more research opportunities signals that the DEA could be open to revisiting a rescheduling recommendation in the future.
One can speculate endlessly about when the DEA may reschedule cannabis, but in reality, no one knows when that might happen, no one knows what a new administration would do, if Congress would act on it or if the courts would. It seems even the FDA and DEA are sitting on their hands as the federal government does what they do best– inaction.
However, one important ruling in the U.S. Court of Appeals for the 9th Circuit highlights the baby steps taken toward some form of federal acceptance of legal cannabis. The court ruled that the Department of Justice couldn’t prosecute individuals in states where cannabis is legal. More specifically, the court ruling “prohibits the Department of Justice from spending funds to prevent states’ implementation of their medical marijuana laws.” The ruling basically reaffirms the Rohrabacher-Farr amendment, which states that the DOJ cannot interfere with states where cannabis is legal, but this time also for those individuals complying with state law.
The DEA’s inaction on rescheduling cannabis should not be perceived as a loss to the legalization movement, rather as an upholding of the asinine status quo. Policy change in the United States is an arduous and very slow process. These things take time. One can look to the same-sex marriage movement and find striking similarities to the cannabis legalization movement. For example, Massachusetts and California were some of the first states to introduce legislation legalizing same-sex marriage and are also some of the first states that have introduced legislation legalizing cannabis. These states that are typically drivers of national policy have opportunities to pass important ballot initiatives this November that could have ripple effects throughout the country. Five states have ballot initiatives for recreational legalization and potentially up to eight states with initiatives for medical legalization, all being voted on this November.
What can the average citizen do to help with progress in cannabis legalization? For starters, you can vote. If you live in a state that has a ballot initiative for legalizing cannabis, show up at the polls and make your voice heard. If you live in a state where no such ballot initiative exists, you can still take action to get cannabis legalized. You can sign this petition or write your member of Congress to support the Compassionate Access, Research Expansion, and Respect States (CARERS) Act (S. 683). The CARERS Act, among many other important changes, would most notably reschedule cannabis to Schedule II.
So not all is lost with the DEA’s inaction. As more states legalize cannabis, we are seeing a rising tide lift all boats.
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Many cannabis stocks across the market saw significant spikes in trading prices following the news of the recommendation. Industry stakeholders and trade organizations seem to share a similar sentiment across the board: Not quite exuberance and celebration, but cautious optimism. The move doesn’t mean the federal government is legalizing cannabis, but they are showing their willingness to work with the industry.
Importantly, the move would remove the dreaded 280E tax burden that has plagued the cannabis industry with huge tax penalties. It would also lift many barriers to study cannabis that have hindered research for decades.
