As of March 2, right before the UN punted on reclassification of cannabis at the international level for another nine months, the UK government eased import restrictions for people in search of the drug.
Specifically, licensed wholesalers will now be able to import larger quantities of cannabis-based products and hold supplies for future use by patients with prescriptions.
Previous restrictions meant that patients had to wait for weeks or months to obtain the still highly expensive drugs (an import license from Canada can take 8 weeks).
Essentially, while welcome, this also means that every single potential cannabis patient who does not suffer from epilepsy or MS must import, via private means, a drug that is still unbelievably expensive. Those with the means are subjected to high prices and bureaucratic complications (like a regular thirty-day review of the prescription).
Cynical Cannabis Moves
While those who can afford to pay approximately $1,000 a month now have options, this is not exactly cannabis reform that is inclusive. Indeed, the entire conversation appears to be about making sure that private companies make profits rather than scientific advancement.
While the government is planning to engage with patients and to participate in trials to figure out how the NHS can utilize the drug, this is little help for sick patients now. Particularly in the middle of a global pandemic and almost as surely, global recession.
Soundbites by government ministers are also putting a cheery face on a situation that is dire, not just because of access but because of cost.
Per British Health and Social Care Secretary Matt Hancock, “We still have a long way to go. We need more research into the quality and safety of these medicines, and to do all we can to cut down the costs and remove barriers so that, when appropriate, patients can access it, including on the NHS.”
How long that might be, however, is anyone’s guess. This discussion has now stuttered on for the last several years domestically.
Why all the Delay?
As recent events, including not only Brexit and cannabis reform, but indeed the now global pandemic have proven, healthcare systems globally are not up to the kinds of threats now thrown in their direction. Designed mostly after WWII, with a far different tax and economic base to support them, as well as far different demographics, most are also clearly not up to the rigors of the 21st century.
It is not just the supply chains for cannabis or even pharmaceuticals that are in the mix of course. Food security in the UK is now also, according to one international expert, Tim Lang, World Health Organization advisor, “in serious trouble.”
The Covid-19 pandemic, in other words, caught the world with its pants down, despite numerous warnings and even models predicting almost exactly this situation as recently as last year. Just like the AIDS crisis. This time, however, there are options available.
The question is, will governments and international organizations rise to the challenge to meet them?
A New World Drug Order
The British, while behind the Germans, are unfortunately, delaying a decision which has been already extended for too long. Relaxing drug import rules are one thing. But recommendations about the uses of the drug are still very narrow in the UK (even more stringent than in Germany).
Beyond that, overall food and drug security (supply chain) issues are in the room and for drugs far from cannabis. As many have begun to point out, cannabis is now prescribed for patients (and in many countries) and these patients are the most vulnerable to a virus like Covid-19. They are vulnerable not just because their immune systems are weak, but frequently because they are also economically exposed.
As the world battles another retrovirus pandemic, perhaps it is time that the lessons of the past be learned by those with the power to make decisions that will ultimately affect billions of people globally.
It is easy to forget as one steps inside this world-class medical conference (held this year in Berlin), that cannabis is disputed as medicine anywhere in the world.
Inside a packed conference hall in an upscale hotel in East Berlin, international researchers presented evidence that when taken as a drug, this simple plant can make a world of difference to patients suffering from a range of illnesses.
There were also doctors who talked about prescribing this as medicine (even to children), with dramatic and affirming results (if not heart-warming pictures).
In sum, as always, the IACM is the best place to find facts if not evidence galore to convince even the most hard-boiled egghead that this drug works – and across a broad range of so far “other” drug-resistant medical conditions.
As a participant in the IACM said after the opening remarks on the very first morning, it is so easy to ask the question – “Why are doctors still so afraid of if not resistant to this drug?”
Medical efficacy is no longer an unanswered question…
For those seeking affirmation and evidence, this year’s IACM did not disappoint. There were presentations on the drug’s impact on neurological, oncological and inflammatory conditions that while not all new, are increasingly impactful in an aging planet.
But that is not all that was discussed. The broader implications of adding cannabis into skincare, diets and medicine chests were also presented – from cannabis’ impact on lowering obesity and positively affecting acne to impacting the opioid epidemic.
Also intriguing this year was a far-reaching study on how polluted the CBD supply chain is in Europe, even for non-medical and nutraceutical products. Not to mention a socio-political plea for legalization of personal use in South Africa.
And that was just the presentations from the stage and in the poster hall.
The conversations swirling around were just as interesting. Because of course, nobody at this three-day gathering, for all the normalization on display, did forget that this gathering of doctors, scientists, cannabis companies and patients is still an anomaly.
The fact is that there are still too few doctors prescribing. And too few trials. And too many fights over efficacy still in the room.
As Alice O’Leary Randall (wife and former partner in activism with her late husband, Professor Randall who initiated the medical efficacy fight in the U.S. in 1975 over glaucoma) said to Cannabis Industry Journal, “It is hard to believe that we are still fighting the same fights all over again.”
Another “AIDS” Crisis?
There is a more dramatic sense of urgency at the IACM than other conferences that focus just on the “business.” In part, this is because the conference is made up of not only doctors and researchers who fight to prescribe the drug or get trials funded, but also patients on the front lines in a country where the drug is supposed to be covered by health insurance.
The patient panel, as a result, was an international face of accusation: To national authorities who still refuse to mandate cannabinoid care – across Europe and beyond. To medical establishments who are not demanding cannabinoid treatment be made mandatory in hospitals and emergency rooms in every country in the EU and beyond. To individual doctors who refuse to come to such conferences, where, if they wanted to, could learn how to begin prescribing the “next penicillin.” To payers and insurers who are still too slow to pick up the message if not the tab.
Indeed, one of the best panels of the conference was a gaggle of doctors, led by Grotenhermen, who discussed the particulars of approaching a new drug – for the very first patient and first time.
Act Up, Speak Out, Silence Equals Death
As the conference wrapped up with its awards dinner, there was of course, a sense of needing to go home with not wanting this to end. For those in the thick of this multi-generational fight, there of course were words of encouragement to colleagues from the industry, internationally. But there was also a new sense of needing to up the pace, if not create faster change.
The battles are far from over – in fact, they are just beginning in many places. As one questioner said of a panel about halfway through the conference – “We need to pick up the fight the same way the AIDS community did on this drug.”
That remark perhaps means less today than it did 20 to 30 years ago when an embattled LGBTQ subculture was the organized point of the spear that fought the early state legalization battles as pioneers for a cause that sought equality as much as it sought a cure.
The plea did not fall on deaf ears.
In the midst of studies, statistics and scientific evidence, in other words, there was a new sense of a need for a renewed fight – and from the medical and scientific community as well as patients.
The German city of Bremen (perhaps you know it from the Brothers Grimm and the animal musicians) is determined to force the federal German government to play another tune when it comes to basic access within the city.
For those without the special geographic knowledge that comes with being a “local” this is also a deliberately strategic political move. Bremen, like Berlin, is a strange German hybrid, a city-state.
Change here, of course, like Berlin, would have wide impact on other German states.
It is not a new campaign of course. None of these city campaigns for home-grow really are. They are the result of efforts, at this point with elected officials involved, of literally decades of patient activists, who are still necessary. But this time, they have politicians involved. When the national ones don’t listen, the local ones are being dragged in.
That said, don’t expect any breakthroughs or miracles from Bremen or Berlin either right now for that matter. This experiment, in Bremen just like the country’s capital, is still at least several years off, no matter its regular recycling in news stories for the last several years.
Politically right now it is hard to understand the CDU’s continued reluctance to embrace the weed. The CDU is Germany’s strongest and largest “middle of the road” party. Particularly because they along with everyone else of alternative political persuasions are highly alarmed by the right wing AfD’s popularity and spread. It is not inconceivable that even Germany’s largest if not highly beleaguered party might use a little cannabis to stop that. And they are being pushed, hard now, by the fringes.
The Outpricing Of The Patient Movement
Talk to any cannabis-connected company right now and chances are you will hear the phrase “patient first.”
That means nothing in an environment where most patient groups are kept out of the room when legislation opening markets is being written (certainly in Europe). And of course, it is precisely the individuals that these groups represent who cannot afford the legal medication hitting the markets early.
Here, because of the focus on high-quality, GMP-certified product, the chances of a patient collective actually being able to afford a cultivation license (for example) are so far non-existent.
As a result, there is an active foment on the ground right now in almost every country in Europe. This is meeting other kinds of frustration right now and that can be a powerful weapon for change. However, without funded lobbyists in most European capitals and Brussels, there is more power and money behind the established industry right now to keep the (almost) status quo.
As strange as they seem to the cannabis industry right now, GMP certification is a standard pharmaceutical designation.
The boogeymen in the room right now, in other words, for every strong patient group, with its own grey market distribution channels, are the well-funded companies who are in fact getting the laws to change.
Patients, in these environs, as well as their concerns, are left out entirely.
The Strength of The European Gray Market
For this very reason, the gray market problem is going to be large in Europe for quite some time to come. Patients are effectively priced out of the legitimate market if they cannot get insurer approvals and for most that is still the biggest problem in the room.
Are there large gray market grows all over Europe? Yes. As one German activist told Cannabis Industry Journal recently, echoing the comments and practices of thousands of others, “Yes, they made me jump through the hoops, and I have packaging from all the big guys. That’s how I carry my home grow these days.”
Forget “patient cards” that some enterprising distributors are trying to get patients to carry.
The cops don’t challenge legit packaging. And every producer, distributor and patient knows that. Buy once, no matter how exorbitant, and that is all she wrote.
For that reason, “patient numbers” if not “sales” actually mean very little.
It does not matter, in other words, if a cannabis company announces its market entry in any country right now. What matters is that they can prove consistent supply and sales and real patient numbers – which if GDPR (European privacy legislation) is strictly followed, producers and distributors should never really know at a level that such sales are trackable per patient.
And that is where this all gets difficult down in the weeds.
Are there large gray market grows all over Europe? Yes. Are they all under the purview of the criminal black market? No. There are very organized patient non-profit networks locally in just about every city and town in Europe. If not other places.
And, where those fail, certainly in Germany, there is always the area around every local train station. If you are hard up enough and desperate enough, skunk and hash albeit of an indeterminate source, will cost you about $12 per gram.
There is no cannabis company in the room anywhere in Europe that can provide legit product via any pharmacy, for that price at point of sale. Yet. And therein, as always, lies the rub.
One of the surest ways to understand that you are entering not just another country, but what is called an “emerging market” is when you travel from Germany to Poland by train.
There is only one “intercity” option from Berlin Hauptbahnhoff – a far cry from the modern, internet-connected, fast ICE trains that go West. This line is run by the Poles. By the time you reach Warsaw five hours later, however, it is clear at least some parts of this country are booming. The skyscraper construction in the center of town rivals London and Berlin.
Like every emerging market, there are vast disparities in wealth and income, if not opportunity here. And into this discussion, now is coming the entire cannabis discussion. Visiting, as an American, in particular, one is reminded of a city that could be East Berlin 15 years ago.
As a cannabis journalist, it feels, from this perspective, like every American state in the 1990’s. Reform is on the tip of everyone’s tongue. But not quite realized yet, except for a few elites. Beyond such realities which are common in the world of cannabis, how very, well, Iron Curtain.
The difference of course, these days, is that the conversation next door in Germany, as well as other places, is finally forcing the Polish government to face reality. But it is clear, from interviews with activists and patients in particular, as well as the nascent newcomers from abroad testing the cannabis waters, that this fight is not going to be easy on the ground.
Then again, when and where has it ever been?
As always, real reform and market opening is driven by the sheer numbers of sick people who brave arrest to gain access to the plant. Some do it for themselves. Many do it for their children (of all ages). An elderly, boomer couple who talked to Cannabis Industry Journal about their ordeal also see it as a form of justified struggle. And Poles are no strangers to that, far from the cannabis kind.
That ethic is much in the room among the nascent industry that is also struggling to find respect. The Polish side of the discussion is looking at hemp. And growing THC illicitly, just like elsewhere.
But the budding movement here is highly organized, including on the business end, with hundreds of thousands of members. How this translates into a legal industry (besides media and hemp products) is of course, still up for grabs.
That is very much in the minds of those who brave the struggle daily. The patient collective in Warsaw is also highly organized – providing free and non-profit product to those most in need. It is an impressive operation. And further one that is increasingly distrustful of foreigners seeking “market share.” If not the already floating “suits.” Just knowing how to speak Polish, as the activists are, at least realizing, is not a guarantee that they will not be dealing with cannasharks only interested in their contacts and mailing lists. Patients over profits is a phrase you hear a lot here. This has nothing to do with not wanting to support a legit, safe industry. But when you are poor, you find ways to improvise. Including getting your medication.
The Foreign Companies…
Aurora and Canopy Growth are already in the room and there are other Canadians lining up to follow. However, these two are the only ones so far who have been able to get their products registered locally and even then, availability is still in the offing.
The foreign companies, in other words, are already broadly falling into two camps. North American curiosity seekers (at this point), and companies, mostly from the East and South, who are looking to Poland to be the “next Germany.” Especially because their product is so price and geographically convenient.
A Battle For Poland’s Emerging Market
It is clear that at least the Canadian companies are already lining up against more home grown and patient interests. Just as what happened in Germany and the rest of Europe so far. And not even on purpose, but more on matters of price.
Like other pre-commoditized markets, the Polish industry is still trying to be (relatively) equal and fair, as much as there is a huge amount of positioning already just below the surface. Everyone is tired of struggling. Dreams of cannabis riches are enticing just about everywhere.
Of course, add to that, patients are dying here, and that always sets the tone – especially when only the richest and lucky few can afford to access the drug through legitimate channels. Face pain, unpleasantness or death or buy in the black market? For the Polish industry on the forefront of the debate, in other words, the stakes are high, the government is moving glacially, and those on the ground are organizing to meet the winds of change.
Foment for another kind of Green Perostroika? Perhaps.
There will, almost certainly as a result of these forces, be a call for a Polish bid – and further one that allows for local producers to enter the medical market.
But the bottom line is that this strange, and exciting and certainly new market is going to be as volatile, and wild west as any in Europe for the immediate future. Expect interesting things, if not more of the same.
Cannabis growers and distributors are “green” when it comes to cyber security. Unaware of the real risks, cannabis businesses consistently fall short of instituting some of the most basic cybersecurity protections, leaving them increasingly vulnerable to a cyber-attack.
Cannabis businesses are especially attractive to hackers because of the vast amount of personally identifiable and protected health information they’re required to collect as well as the crop trade secrets they store. With businesses growing by leaps and bounds, and more and more Americans and Canadians purchasing cannabis, cybercriminals are likely to increase their attacks on the North American market in the coming year. Arm your cannabis business with the following best practices for growers and distributors.
Distributor Risk = A Customer’s PII
Cyber risk is the greatest for cannabis distributors, required to collect personal identifiable information (PII), including driver’s licenses, credit cards, medical history and insurance information from patients. State regulatory oversight further compounds the distributor’s risk of cyber-attack. If you’re a cannabis distributor, you’ll want to make sure to:
- Know where you retain buyer information, and understand how it can potentially be breached. Are you scanning driver’s licenses into a database, or retaining paper files? Are you keeping them in a secure area off site, or on a protected network? Make sure a member of your management team is maintaining compliance with HIPAA and state statutes and requirements for cannabis distribution.
- Institute strong employee oversight rules. Every employee does not have to have access to every sale, or your entire database of proprietary customer information. Delegate jobs behind the sales desk. Give each employee the access they need to do their job – and that’s it.
- Distributors have to protect grower’s R&D information too. Most cannabis distributors have access to their grower’s proprietary R&D information so they can help customers understand which products are best for different medical symptoms/needs. Make sure your employees don’t reveal too much to put your suppliers in potential risk of cyberattack.
Grower Risk = Crop Trade Secrets
For cannabis growers, the risk is specific to crop trade secrets, research and development (R&D). If you’re a cannabis grower, you’ll want to:
- Secure your R&D process. If you’ve created a cannabis formula that reduces anxiety or pain or boosts energy, these “recipes” are your competitive advantage – your intellectual property. Consider the way you store information behind the R&D of your cannabis crops. Do you store it on electronic file, or a computer desktop? What type of credentials do people need to access it? Other industries will use a third party cloud service to store their R&D information, but with cannabis businesses that’s typically not the case. Instead, many growers maintain their own servers because they feel this risk is so great, and because their business is growing so fast, there are not yet on the cloud.
- Limit the number of people with access to your “secret sauce.” When workers are harvesting crop, or you’re renting land from farmers and planting on it, make sure to keep proprietary information in the hands of just the few who need it – and no one else. This is especially important when sharing details with third party vendors.
Cyber coverage is now ripe for picking
Although cannabis businesses are hard to insure – for just about every type of risk – cyber insurance options for cannabis companies have recently expanded, and come down in price. If you’ve looked for cyber coverage in the past and were previously unable to secure it, now is the time to revisit the market.
Know that cyber policy underwriters will do additional due diligence, going beyond the typical policy application, and ask about the types of proprietary information you collect from customers, as well as how you store and access it at a later date. Have this knowledge at your fingertips, and be ready to talk to underwriters about it when you’re bidding for a new policy – and at renewal time.
While enforcement of cannabis patents through litigation is common, there are other alternatives to litigation. Here we discuss some of the unique cannabis-related issues that could arise before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO).
The growth and evolution of the cannabis industry in the U.S. are not slowing. However, the cannabis industry – with its tremendous upside – is still beset with uncertainty and limited legal guidance curbing its full potential. Intellectual property law, including patent protection, has emerged from the murky legal and regulatory landscape as a reliable business strategy with developing certainty.
A pioneering cannabis patent case in Colorado has progressed without any indication that cannabis patents are to be treated differently than other patents. Relatedly, PTAB recently upheld the validity of a cannabis-related patent as part of a post-grant proceeding. However, although the courts and the USPTO are not discriminating against cannabis patents because of their illicit subject matter, the true strength of these newly issued patents could be suspect.
The fledgling nature of cannabis businesses and the fact that cannabis is just now emerging from its statutorily imposed dormancy combine to highlight certain weaknesses of the USPTO and its mechanisms meant to strike spurious patents.
For several reasons, it is possible that applicants are propelling cannabis patent applications of questionable validity through prosecution beyond the point that similar applications could proceed. The USPTO’s experience with cannabis patents is limited. The universe of prior art available to patent examiners is also limited. There are only about three thousand active cannabis patents, which would only account for 0.6 percent of the total issued patents in 2015. The legal status of cannabis has also likely deterred the broadcasting of public use as prior art, and enabling publications or other public disclosures covering cannabis (e.g., published scientific studies) are limited as well. Taken together, patent examiners considering applications for cannabis patents are at a disadvantage compared to other applications that the USPTO considers in other fields.
Additionally, the post-grant proceedings before PTAB established to review issued patents of questionable validity are not designed to handle the historical context and unique issues of cannabis patents. The difference in the procedural rules and requirements of two common inter partes mechanisms for challenging issued patents, post-grant reviews (PGRs) and inter partes reviews (IPRs), creates a gap in coverage that is particularly salient to cannabis patents.
Although the cannabis patent case in Colorado is first of its kind, we can expect more to follow in its wake.Where a PGR petitioner is free to challenge an issued patent on effectively any ground, an IPR petitioner is limited to validity claims for lack of novelty or non-obviousness based solely on patents and printed publications. However, the PGR petitioner must be diligent, because it only has nine months from the issue date of the challenged patent to file a PGR petition. After those nine months, the challenger will have to rely on litigation or an IPR, with its limited basis for invalidity.
What this means for a cannabis patent is that unless a challenger – likely, a competitor in the cannabis space – can timely file a petition for a PGR, the basis for challenging the patent before PTAB are limited to those types of prior art that are especially rare in the cannabis space: patents and printed publications. What is more, meeting the nine-month requirement to file a PGR is no trivial task. The cost and time required to research and prepare a petition for PGR are particularly problematic for the cannabis industry with its lack of access to traditional forms of business financing.
As a result, it is reasonable to question the validity of contemporary cannabis patents. Further, because of PTAB’s enforcement gap, a patent challenger will likely have to resort to litigation to bring its invalidity arguments unrelated to claims of lack of novelty and non-obviousness based on patents and printed publications. Such broader invalidity arguments could include lack of patentable subject matter – which is an appealing challenge for patents that stem from naturally occurring plants or products, such as cannabis – or lack of novelty and non-obviousness based on other prior art.
Although the cannabis patent case in Colorado is first of its kind, we can expect more to follow in its wake. And, because of the weaknesses at the USPTO and PTAB, invalidity arguments in these early cases will likely be of increased strategic importance than in typical patent cases.
There have been many significant developments this summer in Europe that will shape the debate about reform and the legal cannabis market that trails it, for at least the next year. Here is Cannabis Industry Journal’sroundup of our biggest events and trends over the summer so far.
Medical Sales Across Europe Are Slow
In Germany, it is easy to maintain a fairly ballpark understanding of patient count. Find the number of prescriptions issued in the trade press and divide by four. Everywhere else, however, the true realization of what is going on across Europe is slowly starting to hit everyone outside producers wanting to know what is going on.Establishing territorial footprint has been what the race in Europe has been all about since mid 2016 for the Canadian LPs so far.
This is going to start to hit stock prices soon beyond the wobbles already evident in the market thanks to this summer’s breaking industry scandals (CannTrust, lawsuits in every direction) to lack of financial performance for investors (Bruce Linton’s firing from Canopy). It is becoming increasingly obvious to everyone that just because a public Canadian company issues a press release about a (cultivation, import, export or processing) “event” does not mean anything other than a slew of social media telling everyone about it. The frustration with “forward looking” statements has hit European investors big time, from the retail to the institutional kind.
Despite a lot of press releases in other words, which clearly show market penetration, there is not much else going on from the sales perspective when it comes to growing those first numbers. Establishing territorial footprint has been what the race in Europe has been all about since mid 2016 for the Canadian LPs so far.
However, from an industry, if not investor and of course, patient perspective, patient numbers are what really count. And unlike Canada, where patients remain the biggest existential threat to the industry, the same industry may not sign them up or ship to them directly in Europe. For several reasons.
Germany is still the only country in Europe with a significant patient count, and while growing, slowly, is still a group where 2/3 of patients obtain dronabinol. It should shock nobody that the most accurate patient count right now in the UK is hovering somewhere under 20. For the whole country, 9 months after the law changed. While the peculiarities of Brexit are also in the room, this is so far, compared to U.S. state markets, Canada, Israel and Germany before it, pathetic.
The Industry Says It Supports Patients…But Does It?
There are several levels to this debate which start with the still appallingly high level of price gouging in the room. 2019 and certainly this summer is a time when the Canadian companies are clearly learning that European governments negotiate for drugs in bulk. Even (and especially in the near future) this one. See the difference between the EU and the US.
The level of industry promotion vs patient access recently reached a new nadir this summer when it emerged that despite a great deal of interest, more people showed up (by far) to the week-long cannabis industry conference (European Cannabis Week in London in June) than there are legitimate patients in the UK right now.
That is about to change, but so far, industry support for trials has not materialized. When the various trials now being planned do get going, look for new battles over a couple of issues, starting with patient access to and control of their medical data.
Novel Food: The Regulation That Keeps On Giving
The issues involved in this discussion are complex, certainly by North American standards. This of course starts with the fact that there is no such regulation on the continent. But also rapidly bleeds into puncturing the amount of hot air entrepreneurialism there is in the room.
The CBD market in Europe that everyone got so excited about in investor releases, in other words, is basically dead for the time being. Yes, there are a few smart niche players weaving around the regs, but it is a full-time job.
Here is the reality: Since Christmas last year when Austria put the kabosh on all products containing the cannabinoid CBD, several major countries have weighed in on the issue. It is not going away. And it is here to stay, even after recreational.
Political Advocacy Is Stirring In Europe
Whether it is the vagaries of Brexit, the discussion across the continent about how the EU will work together, right wing populist screeds about “too much regulation” or national elections, cannabis is in the room from now until the end of at least 2021 as one of the hottest global political issues under the sun. That includes of course, a discussion about global climate change, sourcing, pricing and resource use so far unaddressed but rapidly looming.
Further, patients are still having a voice – whether it is making sure that their children obtain imported CBD, or that they can obtain their own THC prescriptions without going bankrupt or having to solicit in the black market.
Cultivation Bids Looming?
One of the surest signs yet that the German authorities at any rate, are in no mood to solve the cultivation issues still on the ground and the bid itself, is that the government just renegotiated, for the second time since last fall, the amount of medical cannabis to come over the Dutch-German border. Who is going to go next? With the Italian hybrid now done and dusted, Poland is likely to be next. And when that happens, expect a raft of similar initiatives across Europe. But probably not until then.
And in the meantime? Distributors are looking for product. The demand is clearly there. But across Europe this summer there is a clear sense that the hype machine that has been the industry’s mouthpiece is at minimum overenthusiastic about the bottom-line details behind it all.
Given all the fuss about newly opened markets in Europe of late (see all the hullabaloo recently in the UK), it would be remiss for anyone in the industry to forget about Poland.
The Eastern European country that shares a large part of its border (if not recent history and long cultural influence) with Deutschland has been proceeding slowly into the cannabis space for the last couple of years.
There are a couple of similarities (and differences too) about the market development in the country to its Teutonic sister to the West as well as the emerging fight over access that is sparking patient revolutions all over the continent now.
A Brief History Of Polish Cannabis Reform
Like other culturally conservative places (see state reform in the United States in places like Georgia), Poland has moved towards reform in a way that may make political sense, but has left patients in much the same boat as British ones. Reform began happening without access as of late 2017.
Poland, or so the joke goes in Germany, is Deutschland’s “trailing sister,” on most things, and cannabis reform in some ways, is absolutely following that pattern. But it is not exactly analogous, starting with patient access. In fact, the first opening of the market did not touch import much less cultivation. It only authorized patients to cross borders in search of their medication. No matter the high cost involved. And of course, the still dodgy proposition of returning across a border with a highly stigmatized narcotic product.
Fast forward a year? Many of the major Canadian cannabis companies had achieved some sort of import (mostly of small amounts of the drug and mostly to single hospitals). See the announcement of Aurora last October on the same day that the Polish government announced a change in the law that they had imported in bulk to a hospital.
But what is going on now, particularly with a growth in acceptance of the medicinal impact of the drug across Europe? And will the Poles, like the Germans, launch a domestic cultivation bid anytime in the near future? Not to mention learn the lessons that so far have continued to stymie German domestic cultivation as well as frustrate a smooth supply chain if not operations on the ground?
The Market Is Coalescing
According to Andrew Makatrewicz de Roy, managing director of Bearstone Global, a market research and investigative firm moving into the cannabis space, Poland has one of the more progressive laws in Europe, but still is lagging behind other countries in terms of organisation and a political lobbying movement.
“There is a lot of vibrancy in the market, but we want to make sure that there is an initial forum where the market can meet and discuss the industry here”.There are also a few (low volume) transactions taking place.
However, as in other places (see the UK in particular), there is a lot of heat if no fire yet behind the scenes. Both individuals and companies are starting to appear who will help build a wider ecosystem in the cannabis space.
As in other countries in Europe, despite the market potential, there is still a general political lag in further development of the industry. Perhaps because of complications in the German market. And almost certainly because of complications with German reform and its own cultivation bid. There have been rumours of a Polish bid circulating for at least a year. Licensed cultivation is beginning to take place.
In response, Makatrewicz de Roy is moving to establish one of the first industry conferences in the country in October. In late July, he also held the first precursor to the same – an online streamed event that attracted 70 major thought leaders from the industry including many members of the political class, producers and distributors (including some of the biggest Canadian ones), doctors and patients.
“We want to build an ecosystem,” de Roy said. “There is a lot of vibrancy in the market, but we want to make sure that there is an initial forum where the market can meet and discuss the industry here”.
In late June, as more than a thousand people descended on the South Bank Center to attend the largest cannabis conference held so far in the UK, another development was taking place away from the headlines.
Drug Science, a non-profit research group founded to reform drug policies based on scientific evidence rather than politics or even economic considerations, launched an ambitious trial project in the UK.
The goal? To get medical cannabis to 20,000 British patients suffering from a range of conditions that the drug is well known to help treat.
Who Is Drug Science?
Founded by Professor David Nutt, the former chief drug advisor to the British government who was fired in 2009 for stating that ecstasy and LSD were less harmful than alcohol, the group itself is clearly not afraid to tackle controversy. The Project TWENTY21 initiative is an ambitious if not desperately needed undertaking.
Targeted patient groups include those suffering from chronic pain, PTSD, MS, Tourette’s and addiction.
Several cannabis companies have already signed up to support the effort which also includes the United Patients Alliance ,and academic researchers.
According to Abby Hughes, Head of Outreach for UPA, “Whilst a change in UK law has given clinicians the green light to prescribe medical cannabis, the majority of patients are denied access, some even being criminalised, whilst corporations are profiting from the same plant.”
Hughes also noted that the goal of the project is to begin to ground patient demand in research and hard data. “We hope that by having a dataset that proves the efficacy of medical cannabis, thousands of patients will be able to access legal, affordable medicine, which may improve their quality of life,” she said.
What Is The Scope of Project TWENTY21?
It is the first-of-its-kind project in the UK where, 9 months after the law changed to allow prescription of cannabinoids as well as the medical importation of the same, there are less than 20 (legal) patients in the country. And all of the successful candidates so far have fought for the right and still do.
While important in its own right, the concept if not forward motion on the same, is also poised to create similar trials all over Europe. This is especially true in countries (like France) where the issue of reform has not moved at all. Or even in Germany (with well over 50,000 patients two and a half years after similar reform was passed by the Bundestag) where problems with access and questions about medical efficacy still frustrate the close to a million Germans who cannot access the drug. Switzerland and Luxembourg may yet prove to be similiarly interesting.
Why Is This Timely?
There has been an increased call for the need for widespread and sustained population trials across Europe as the cannabis industry has really begun to establish itself since mid-2016. This is the only way to help forward medical understanding of cannabinoids at a level that leads to mainstream acceptance. And more importantly, medical and payer mainstream approvals. Until that happens, despite all the press releases, overall sales across the continent remain low.
One of the most important issues beyond this – the extraordinarily high pricing seen in Europe until late last year – has also played a role of course. Payers (see the German “statutory” health insurers) on the front lines of uncertain medical efficacy are still reluctant to pay for a drug, in any form, they do not understand, do not have evidence for, and are still highly suspicious of.
There has been an increased call for the need for widespread and sustained population trials across Europe With cannabis companies agreeing to provide product (in this case potentially from Australia), a research organization with national chops and brave leaders is likely to take the conversation far. And not just in the UK.
While Drug Science is of course not the only British entity planning canna trials and in part supported by the Canadian industry (see The Beckley Foundation for starters), Project 2021 is also certainly likely to be a study with both local as well as regional and global implications.
In Europe, there are other regional trials now in the offing (see Switzerland, Germany and France). Only Germany of course, has a patient population that is starting to be large enough to be effectively studied, and of course, the majority of these patients are still receiving dronabinol.
It is also clearly a steady state march, rather than a discussion that is likely to see significant boosts in patient numbers any time soon. Unless of course, there are other contributing factors.
Regardless, unlike the U.S. and even Canada, the strict medical focus of Europe (including the UK) is finally moving the conversation to the next level. Large, regional and/or national medical trials – and further for conditions the drug is well-known to treat but are so far considered “off-label” for most Europeans will be the watchword here for the next several years.