Tag Archives: drug

Illinois Legislators To Introduce Legalization Bill

By Aaron G. Biros
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It is not news that Illinois Governor J.B. Pritzker favors recreational cannabis legalization. But State Senator Heather Steans (Chicago-D) and State Representative Kelly Cassidy (Chicago-D) introducing a formal bill to legalize recreational cannabis is certainly news. With what they hope will be bipartisan support in the legislature and a Governor on their side, Illinois seems poised to pass legislation legalizing recreational cannabis for adults.

According to the Herald & Register, State Sen. Steans says that public opinion polls show that roughly two-thirds of voters in Illinois favor recreational legalization. “We have a huge opportunity in Illinois to do this right and carefully,” Steans told an audience at a town hall meeting in Springfield, IL yesterday. From what the lawmakers told the public during that town hall meeting, the legislation sounds like it mirrors programs in other states.

Illinois Governor J.B. Pritzker

The bill “would allow Illinoisans 21 and older to purchase and possess up to 30 grams, or about 1 ounce, of marijuana,” Steans and Cassidy said. “Nonresidents would be able to buy and possess half that amount. Use of the drug in public wouldn’t be allowed.” The bill would expunge previous criminal records with respect to cannabis, make it harder for minors to access it and raise an estimated $350 million to $750 million, providing funding for “community development of impoverished neighborhoods,” says Cassidy. “If we don’t address the social-justice issues of this, if we don’t address the collateral consequences of the ‘war on drugs,’ we will have failed,” Cassidy added. The bill would also allow people to grow up to five plants at home, would not allow for public or social consumption, and municipalities, employers and landlords would be able to prohibit possession and use, according to the lawmakers.

In 2015, the state legalized medical cannabis and there are roughly 42,000 patients currently in the medical cannabis program, with roughly 40 qualifying conditions approved for use. Some critics have argued, according to the Chicago Tribune, that before the state legalizes recreational use for adults, they should first expand the list of qualifying conditions for patients. This would provide greater access to those in need while the state implements a regulatory framework for recreational use, which could take upwards of a year to establish the program.

Farm Bill Analysis: Is Hemp Legal Now?

By Aaron G. Biros
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On December 20, President Trump signed the Agriculture Improvement Act of 2018 (the Farm Bill) into law, which included an important change to the way federal agencies regulate hemp farming and production. The Farm Bill essentially removes hemp-derived cannabidiol (CBD) from the Controlled Substances Act in states that choose to regulate it. It strips the Drug Enforcement Agency’s (DEA’s) authority from outlawing hemp and gives states the ability to regulate hemp markets on their own, with approval from the United States Department of Agriculture (USDA).

This gives the USDA the authority to regulate hemp farming, providing for things like access to banks, insurance, grants, certifications and gets rid of the need for a pilot program, which was previously the case under the 2014 Farm Bill. It also defines hemp a little better, to include cannabinoids, derivatives and extracts.

According to Aaron Smith, executive director of the National Cannabis Industry Association (NCIA), the signing of the Farm Bill is a crucial step towards full legalization. “The lifting of the federal ban on non-psychoactive hemp is a concrete sign that the ‘reefer madness’ which first led to its criminalization is finally coming to an end,” says Smith. “This Farm Bill is a step in the right direction for comprehensive cannabis policy reform and will help fuel discussions in Congress about the best ways to end federal prohibition and create a regulated national cannabis market.”

FDAlogoHowever, one particularly important caveat needs to be mentioned: The Food and Drug Administration (FDA) still retains regulatory authority over CBD products. In a statement released the same day that the Farm Bill was signed, the FDA addressed their oversight capabilities. “We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” reads the FDA statement. “The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act [Federal Food, Drug and Cosmetics Act] because they were marketed as dietary supplements or because they involved the addition of CBD to food.”

The Farm Bill signing opened the doors for hemp cultivation and production in the United States.What the FDA said in their statement is crucial information for those developing hemp-derived products. They recommend that companies use traditional pathways to get approval from the FDA to market their products, providing the Epidiolex example where the drug manufacturer used clinical studies to prove the drug’s efficacy.

The FDA also notes that there are circumstances “in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” That means they are exploring opportunities for companies to develop, manufacture and market legal CBD products without going through the extensive drug approval process.States need to establish programs approved by the USDA and companies need to cooperate with the FDA, taking the necessary steps to get their products and marketing approved.

In the food ingredients realm, they have already taken steps to approve hulled hemp seeds, hemp seed protein and hemp seed oil as generally recognized as safe (GRAS). “Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims,” reads the FDA statement.

The Farm Bill signing opened the doors for hemp cultivation and production in the United States. It allows farmers to access the same goods and services extended to other commodities farming, it makes conducting business easier across state lines, it will pave the way for more research into hemp as an effective medicine and helps to end the debate over hemp’s legality. But this doesn’t mean any business can just start producing and selling CBD products. States need to establish programs approved by the USDA and companies need to cooperate with the FDA, taking the necessary steps to get their products and marketing approved.

In the coming months and years, we will see which states decide to develop hemp cultivation programs and how the proliferation of hemp-derived products will evolve under FDA regulatory oversight.

First Cannabis Clinical Trials All Set In UK

By Marguerite Arnold
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Beckley Canopy Therapeutics, based in Oxford, England has raised ₤7.4 million for the purposes of cannabinoid research and drug development. The new company is a unique partnership established between Canopy Growth Corporation and the Beckley Foundation, a research institute which examines the utilization of psychotropic drugs for the treatment of physical and mental conditions.

Studies focusing on the use of cannabinoids for the treatment of opioid addiction and cancer pain will be conducted in Europe, the UK and the US.

Why Is This Significant?

Here is the first reason: the woman behind it all. Her name is Lady Amanda Feilding, Countess of Wemyss and March. Born into a landed gentry family at Beckley Park (a Tudor hunting lodge with three towers and three moats) she also has a long history of engaging and supporting scientific endeavours that use stigmatized drugs in the treatment of both intractable disease and mental illness via the use of scientific research.

In 1998, Amanda Feilding set up the Beckley Foundation, a charitable trust which initiates, directs and supports neuroscientific and clinical research into the effects of psychoactive substances. She has also co-authored over 50 scientific papers in peer-reviewed journals.

The so-called “hidden hand” behind the rebirth of psychedelic science, Fielding’s contribution to global drug policy reform has been widely acknowledged in international drug policy circles. She was named as one of the bravest men and women in the history of science in 2010 by the British Guardian.

And here is the second reason: The foundation is now partnered with Canopy Cannabis, one of the leading cannabis firms in the world, which is also working closely with Spanish opioid manufacturer Alcaliber.

In other words, this coalition is almost the mirror opposite of the approach taken by the American Sackler family, makers of Oxycontin, who have fought cannabinoids as an alternative or even transition drug in multiple state legalization campaigns. Meanwhile the death rates from overdoses have quadrupled since 1999. In 2016, opioid-related drug overdoses killed about 116 people a day (or about 42,249 for the year). It is estimated that about 11 million people in the U.S. are currently misusing or dependent on opioids.

Amanda Fielding
Image credit: Robert Funke

Beyond The Politics of The Opioid-Cannabinoid War

While opioids clearly have a role particularly in chronic pain treatment, the question now at the global scientific table is this: Are cannabinoids a substitute for longer term chronic pain management? It is a fiercely battled scientific debate that has frequently, particularly in the U.S., crossed over into political drug reform questions.

The unique partnership of Beckley and Canopy is well placed both scientifically and culturally to take on a discussion which has languished for too long in the grass of political debate and reform.

Even better, it is taking place in a country where English is the first language, but outside the U.S. and further, in a country where cannabis has now been legally reclassified as a Schedule II drug.

Do not expect, in other words, the same trials and tribulations that faced noted U.S.-based researcher Sue Sisley, to slow down research, trials or findings.

Why Is A Cultural and Scientific Reset Required?

For the past forty years, since the end of the 1970s, cannabis in particular, has been pushed into a strange scientific territory in part, because of the culture surrounding the drug. This in turn, along with the schedule I classification of cannabis, has led to not only a dearth of research, but a reluctance on the part of prescribing doctors to examine its efficacy.

In the present, this means that doctors are still (beyond insurers who demand medical evidence before approving payment) the biggest hurdles in every medical system where cannabis is becoming legal. See the debate in Canada, the UK and of course, Germany, where patients frequently report asking for a drug their doctors refuse to prescribe.

This is exactly the kind of high-placed, societally influential effort in other words, that might finally break the medical taboo at the most important remaining logjam– at the point of prescription and approval for patients.

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The UK Starts Prescribing Cannabis

By Marguerite Arnold
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It is official. British doctors as of November 1, 2018, can now write prescriptions for medical cannabis. But what does that really mean? And is this truly a victory or merely an opening in the fierce resistance to and outright battle against cannabinoids as medicine?

A Real Victory Or Another Stall?

Many in the advocacy community in Europe are profoundly split. On one hand, yes, the British decision, like other sovereign medical cannabis reforms in Europe over the last two years, is a victory. The British government, like many before it, has thrown in the towel on denying basic access to medical cannabis. But what does this mean, especially in a country which may well be facing shortages of basic food products and other kinds of medications in under half a year if things continue to blow up on Brexit and there is no “people’s vote” to save the day?

Cultivated product would, normally, be slated to come from Portugal and Spain where Tilray and Canopy in particular have set up cultivation centers. If things continue to head to a negotiated Brexit, it is inevitable that imported cannabis would fall into the same category of everything else set to come into England by boat or lorry. It is highly unlikely that the NHS would authorize full payment for cannabis flown in from Canada. Especially with British Sugar’s existing cannabis plantations in Norfolk as well as the budding cultivation deals now finally flowering all over the country if not in Ireland.There are many who expect that medical cannabis will actually save public healthcare systems a great deal of money.

Brexit Is The Bigger Worry, So What About Cannabis?

It may also seem to some that access to cannabis is the least of the country’s worries. Actually this is a discussion deeply embedded in the politics and drama in London and Brussels right now. It is also at the heart of Brexit itself. Namely the propaganda associated with European divorce that ran along the lines of “saving the NHS.”

In fact, the legalization of medical use in the UK, just as it is in countries across Europe (Germany being the best and most current ongoing example) will do much to shine a light on how creaky and outdated the medical provision system really is here. Especially when it comes to approving new drugs for large numbers of people quickly. This was, ultimately the goal of public healthcare. See penicillin, not to mention most inoculation drugs or vaccines for childhood diseases (like Polio).

One of the great ironies of cannabis legalization in Europe of course is that it is also often shining a light on how far this concept, not to mention funds for proper delivery, has been allowed to lapse. There are many who expect that medical cannabis will actually save public healthcare systems a great deal of money. That is if it can finally make its way into widespread medical distribution.

UKflagAnd cannabis is a drug like no other. Why? Despite all the pharmacization of the plant that is going on right now as producers are being forced to produce pills and oils for the medical market, cannabinoid treatments will not be pushed so easily into “orphan” status – since whole plant products can treat a range of diseases. This is important in terms of supply and negotiated prices down the road. But in the short term, cannabis is falling into a couple of strange categories created by organized public healthcare, insurance mandates (both public and private), the demands being placed on producers in this space to act more like pharmaceutical companies, limited public spending budgets, and a changing demographic where chronic conditions treated by cannabis are a whole new ballgame. Namely patients are living longer, and not necessarily old.

So while it is all very well and good for British doctors to begin to write prescriptions for cannabis, merely having one does little good for most patients. In fact, this usually means the battle is only half won.

Why?

National Healthcare Is Still Functional In Europe

As foreign as it is to most Americans, most European countries operate more or less the same way when it comes to healthcare. First of all, all of the national systems in operation in Europe today, including the UK, were set up in the aftermath of WWII to recover from devastation most Americans, especially today, never experienced personally.

These healthcare systems were set up to first and foremost be inclusive. In other words, the default is that you are covered. 90% of populations across Europe in fact, including the UK, are covered by their national healthcare systems. “Private” health insurance actually only covers about 10% of the population and in some countries, like Germany, is mandatory once annual income rises above a certain level.

However this system is also based on a very old fashioned notion of not only medical care, but treatment of chronic conditions. Namely, that most people (the mostly well) face low prices for most drugs. Further, the people first in line to get “experimental” or “last use” drugs (as cannabis is currently categorized in Europe no matter its rescheduling in the UK), are patients in hospitals. With the exception of terminal patients, of course, that is no longer the case.

Patients in the UK can expect to face the same kinds of access problems in the UK as in Germany.That is why, for example, so many disabled people began to sue the German government last year. They could not afford treatment until their insurer approved it. Monthly supplies in legal pharmacies are running around $3,000 per month for flower. Or about 8 times the total cash budget such people have to live on (in total) on a monthly basis.

In fact, because of this huge cost, approvals for drugs like cannabis do not actually happen at the front line of the insurance approving process, but are rather kicked back to regional (often state) approvals boards. As a result, approval for the right to take the drug with some or all of the cost covered by insurance, is actually limited to a much smaller pool of people right now – namely the terminally ill in hospital care. In Germany, the only people who are automatically approved for medical cannabis once a doctor writes the prescription, are the terminally ill. For everyone else it is a crapshoot. Between 35-40% of all applications in Germany are being turned down a year and a half into medical legalization. Some patients are being told they will have to wait until next year or even 2020.

And once that prescription is actually approved? Patients in the UK can expect to face the same kinds of access problems in the UK as in Germany. Namely pharmacies do not readily stock the drug in any form.

In the meantime, patients are turning back to the black market. While the online pharmacy discussion is different in the UK than Germany, which might in fact make a huge difference for the right approvals system, most patients in the UK still face a long fight for easy and affordable access covered by public healthcare.


Disclaimer: Marguerite Arnold is now in negotiations for a pilot of her digital prescription and insurance pre-approvals and automization platform called MedPayRx in several European countries including the UK, Germany, and a few others.

World Health Organization November Meeting To Review Cannabis

By Marguerite Arnold
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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:

  1. Pure CBD should not be scheduled within International Drug Control Conventions.
  2. Cannabis plant and resin, extracts and tinctures of cannabis, Delta-9-THC and isomers of THC will all be reviewed in November.
  3. 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.

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GW Pharma’s Enormous Price for Epidiolex

By Marguerite Arnold
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Epidiolex-GW

In a fascinating early August conference call with Seeking Alpha, British-based GW Pharmaceuticals finally revealed their retail price point for CBD-based drug, Epidiolex, as it goes into distribution in the U.S.

The drug is designed for the treatment of certain kinds of childhood epilepsy – although not all kinds. Also notable of course, is that GW Pharma’s “other” drug for treatment of resistant epilepsy failed in late stage trials in Eastern Europe earlier this year. It also knocked off 5% of the price of the company’s stock.The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

British Advocacy Over Access And Pricing

The ineffectiveness of GW Pharma’s drugs for many patients (along with the cost charged for them) was responsible for pre-empting the entire access discussion in the UK this year. The mother of an epileptic British child tried to import a personal store of cannabis oil (produced by Canadian LP Tilray) only to have it confiscated at the airport this summer. Her son ended up in the hospital shortly thereafter.

The national uproar this caused pushed forward the country’s new medical cannabis policy– indeed drug rescheduling is due to go into effect in October. Conveniently, right as Epidiolex goes on sale in the U.S. (where cannabis remains a Schedule I drug).

The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

Price Tags and Politics

What is the price of Epidiolex? $32,500 per patient, per year. If that sounds high, the company insists it is pricing the drug to be “in line” with other drugs for this segment of the market.

The majority of this cost will not be picked up by private health insurers but rather the federal governmentActually, according to industry analysis, this is about 70% more than the price of one comparable drug (Onfi), and slightly more expensive than Banzel, the two competing (non-cannabinoid based) medications now available in the U.S. for this market.

Here is the other (widely unreported) kicker. The majority of this cost will not be picked up by private health insurers but rather the federal government, which is also not negotiating with GW Pharma about that high price  (unlike for example what is going on in Europe and the German bid).

Why the difference?

Two reasons. The first is that Epidiolex has obtained “orphan drug” status (a medication for a disease that affects fewer than 200,000 patients in the U.S.) The second is that the majority of the insurance that will be picking up this tab is Medicaid. The patient pool will be unable to afford this. As a result, the bulk of the money will remit not from private insurance companies but rather federal taxpayers. And, unlike in say, Germany, none of this is pre-negotiated in bulk.

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What is the price of Epidiolex? $32,500 per patient, per year.

Co-payments are expected to range from $5 to $200 per month per patient after insurance (read: the government) picks up the tab. This essentially means that the company plans to base participation at first at least on a sliding scale, highly subsidized by a government that has yet to reschedule cannabis from a Schedule I in the U.S.

Creating, in other words, a new monopoly position for GW Pharmaceuticals in North America.

A Hypocrisy Both Patients And The Industry Should Fight

The sordid, underhanded politicking that has created this canna monster is hardly surprising given the current political environment in both the U.S. and the U.K. right now. The people who benefit the most from this development are not patients, or even everyday shareholders, not to mention the burgeoning legitimate North American cannabis industry, but in fact highly placed politicians (like British Prime Minister Theresa May). Philip May, the PM’s husband’s firm is the majority shareholder in GW Pharma. Her former drugs minister (with a strong stand against medical cannabis) is married to the managing director of British Sugar, the company that grows GW Pharma’s cannabis stock domestically.

So far, despite a domestic outcry over this in the UK (including rescheduling), there has been no political backlash in the United States over this announcement. Why not?

Look To Europe For A More Competitive Medical Market

This kind of pricing strategy is also a complete no go in just about every other market – including medical-only markets where GW Pharma already has a footprint.

For example, German health insurers are already complaining about this kind of pricing strategy for cannabis (see the Cannabis Report from one of the country’s largest insurers TK – out earlier this year). And this in an environment where the government, in fact, does negotiate a bulk rate for most of the drugs in the market. Currently most German cannabis patients are being given dronabinol, a synthetic form of THC which costs far less.

GW logo-2On top of this, there are also moves afoot by the German government to begin to bring the costs of medical cannabis and medicines down, dramatically. And this too will impact the market – not only in Europe, but hopefully spark a debate in every country where prices are also too high.

The currently pending German cultivation bid for medical cannabis has already set an informal “reference” price of at most 7 euros a gram (and probably will see bid competitors come in at under half that). In other words, the government wholesale price of raw, unprocessed cannabis flower if not lightly processed cannabis oil is expected to be somewhere in the neighbourhood of 3-4 euros per gram come early next year. If not, as some expect, potentially even lower than that.

Processed Cannabis Medicine vs. Whole Plant Treatment

The debate that is really raging, beyond pricing, is whether unprocessed cannabis and cannabis oil is actually “medicine.” At the moment, the status quo in the U.S. is that it is not.

GW Pharmaceuticals, in other words, a British company importing a CBD-based derivative, is the only real “medical cannabis” company in the country, per the FDA. Everyone else, at least according to this logic, is placed in the “recreational camp.” And further, hampered still, with a lack of rescheduling, that affects everyone.

If that is not an organizing issue for the American cannabis industry, still struggling with the many issues inherent in the status quo (from insurance coverage and banking to national distribution across state lines) leading up to the midterms, nothing will be.

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FDA Approves GW Pharma’s Epidiolex

By Aaron G. Biros
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Epidiolex-GW

According to a press release, the U.S. Food and Drug Administration (FDA) approved GW Pharma’s drug Epidiolex for the treatment of rare forms of epilepsy. Just a few months ago, news broke of a very encouraging FDA panel assessment, which indicated a positive outlook for the drug’s approval.

In the press release, FDA Commissioner Scott Gottlieb, M.D appeared to indicate an open willingness to explore the medical benefits of cannabis. “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” says Gottlieb. “And, the FDA is committed to this kind of careful scientific research and drug development.” He went on to add:FDAlogo

Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

According to the press release, the drug was studied in three randomized, double-blind, placebo-controlled clinical trials with 516 patients who have either Lennox-Gastaut syndrome or Dravet syndrome, the two rare forms of epilepsy the drug is now approved to treat. Epidiolex is an anti-epilepsy drug, taken in a syrup form, with the main active ingredient being cannabidiol (CBD), and less than 0.1 % THC.

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Epidiolex Gives GW Pharmaceuticals Boost In Global Markets

By Marguerite Arnold
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GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.

The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States? 

So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.

The FDA Might be on the Verge of Approving its First Cannabis-Based Drug

It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.

Epidiolex-GWIf the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.

Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?

A Divergent and Highly Different Drug Market

Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.

GW logo-2But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.

That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.

That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.

What Will This Mean in the US vs Europe?

In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.

In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.

It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.

The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.

Ex-Im Europe: The Face of the Current Cannabis Market

By Marguerite Arnold
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In the United States, the idea of transporting cannabidiol (CBD), let alone medical cannabis across state lines is still verboten. As a result, a patchwork of very different state industries has sprung up across the map, with different regulatory mandates everywhere. While it is very clear that California will set the tone for the rest of the United States in the future, that is not a simple conversation. Even in-state and in the present.

In the meantime, of course, federal reform has yet to come. And everywhere else, there is a very different environment developing.

In Canada, “territorial” reform does mean there will be different quality or other regulatory guidelines depending on where you are. The main difference between the territories appears to be at point of retail – at least for now. Notably, recreational dispensaries in the East will be controlled by the government in an ABC package store model. That will not be the case across all provinces however. Look for legal challenges as the rec market gets underway.

EU flagIn Europe, the conversation is already different – and based on the realities of geopolitics. Europe is a conglomeration of federally governed nation-states rather than more locally administered territories, supposedly under federal leadership and control (as in the US). That said, there is common EU law that also governs forward reform everywhere now, just as it hindered national drug reform until a few years ago on the cannabis front.

However, now, because European countries are also moving towards reform but doing so in very different ways in an environment with open borders, the market here is developing into one of the most potentially fertile (and experienced) ex-im markets for the cannabis plant anywhere. On both the consumer and medical fronts, even though these labels mean different things here than they do elsewhere.

The Drivers

Medical reform in Europe basically opens the conversation to a regulated transfer of both non and fully loaded narcotic product across sovereign national borders. This is already happening even between nation-states where medical (read THC infused) cannabis is not federally legal yet, but it is has been accepted (even as a highly restricted drug). This means that Europe has already begun to see transfer of both consumer and medical product between states. In the former case, this is also regulated under food and cosmetic safety laws.

Cannabis in this environment is “just another drug.”While a lot of this so far has been via the strategic rollout of the big Canadian LPs as they attempt to carve up European cannabis territory dominance and distribution like a game of Risk, it is not limited to the same.

Pharmaceutical distributors across Europe are hip to the fact, now, that the continent’s largest drug market (Germany) has changed the law to cover cannabis under insurance and track its issuance by legal prescription. So is everyone in the non-medical CBD game.

As a result, even mainstream distributors are flocking to the game in a big way. Cannabis in this environment is “just another drug.” If not, even more significantly, a consumer product.

Game Time

The race for Europe is on. And further, in a way that is not being seen anywhere else in the world right now. And not just in pharmacies. When Ritter Sport begins to add cannabis to its famous chocolate (even if for now “just” CBD) for this year’s 4/20 auf Deutschland, you know there is something fundamental and mainstream going on. Lidl – a German discount grocery chain that stretches across Europe, has just introduced CBD-based cannabis edibles – in Switzerland.

As a result of this swift maturation, it is also creating from the beginning a highly professional industry that is essentially just adding cannabis to a list of pharmaceutical products already on a list. Or even just other grocery (or cosmetic) items.

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Spektrum, Alcaliber and Canopy are part of some of the larger deals in Europe

In general, and even including CBD, these are also products that are produced somewhere in Europe. As of this year, however, that will include more THC from Portugal, Spain and most certainly Eastern Europe. It will also mean hemp producers from across the continent suddenly have a new market. In many different countries.

This means that the industry itself is far more sophisticated and indeed used to the language and procedures of not only big Euro pharma, but also mainstreamed distribution (straight to pharmacy and even supermarket chains).

It also means, however, understanding the shifting regulations. In general, the focus on ex-im across Europe is also beginning to standardize an industry that has been left out of the global game, on purpose, for the last 100 years. Medical cannabis, grown in Spain under the aegis of Alcaliber (a major existing opioid producer) can enter Germany thanks to the existing partnership with Spektrum and Canopy, who have a medical import license and source cannabis from several parts of Europe at this point. It also means that regular hemp producers, if they can establish the right brand and entry points, have a new opportunity that exists far outside of Switzerland, to create cross-European presence.

And all of this industry regulation is also setting a timeline, if not deadline, on other kinds of reform not seen elsewhere, anywhere, yet.

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German Court Stops Pending Cannabis Cultivation Bid On Technical Fault

By Marguerite Arnold
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In a move that seems to shed more doubt than certainty on domestic cannabis cultivation and the date that it will start auf Deutschland, the Higher Regional Court (or OLG) in Dusseldorf formally stopped the pending bid procedure for the first crop on March 28th. BfArM, the federal agency in charge of regulating all narcotic drugs, initiated that procurement bid. The tender bid was launched after the German Parliament and federal legislators changed the law last year to mandate that cannabis be available via prescription, and further that public health insurers were required to cover it.

That bid announcement was supposed to come as early as last September. Criticisms about the process and requirements began immediately thereafter. For starters, the bid’s requirements excluded all German-only respondents to the bid and left both Canadian and Israeli firms in the front positions to obtain these valuable licenses. However, there were other gripes, including the fact that the amount of cannabis requested (about 6.6 tonnes) was far too low to even begin to meet real demand. Namely, there are easily 1 million German patients who could qualify for the drug.

In the space of the last year, in fact, the number of “official” German cannabinoid patients has shot up from 1,000 to about 15,000. That said, the top three covering insurers also report a mere 64% approval rate. This means that there are more doctors writing prescriptions than insurers are covering.

That, at least for patients and their advocates is a bit of good news despite the blow that any delay in domestic production has created. Doctor resistance to prescribing cannabinoids even when there are no other alternatives has been used as an excuse in many media reports for the speed of market development. That clearly is not true. The attitude on the ground in Deutschland is rapidly changing.

That bid announcement was supposed to come as early as last September. At that point, however,the agency was then forced to extend the response date, which it did, but apparently not for long enough.

Throughout the fall, it was impossible to understand, from any direction, what was going on. Four lawsuits against the bid were launched around September, each with differing complaints that ranged from criticizing the agency for the lack of extension and response time to monopolistic business practices.

The OLG dismissed all but the criticism about the extension.what this decision has done most clearly is slowed down the production of domestically grown medical cannabinoids

The one clear thing to come out of Düsseldorf? BfArM has been banned from awarding its contract to anyone to produce medical cannabis in Germany starting in 2019. The first letters to bid finalists announcing the bid had been canceledbegan arriving the day after the court’s decision.

Reading Between the Lines

There have been rumors since last fall that the bid would end up in such waters. However,all the major producers widely suspected to have applied for the bid also began announcing themselves as finalists in press releases. For this reason, the official line from everyone that the bid was still, in fact, on track.

Nobody could understand why anyone would want or even be able to halt the production of direly needed, locally sourced, high-gradecannabis. That includes BfArM, which made an impassioned response, via their attorney to the OLG in Dusseldorf. Attorney Heike Dahs warned the court that any interruption of the bid was “very bad for the care of patients.”  He was similarly pessimistic about the ability to begin production domestically by the previously set 2019 deadline.

In fact, what this decision has done most clearly is slowed down the production of domestically grown medical cannabinoids (although potentially not by much) while giving officials at BfArM a rather nasty black eye that might yet lead to further legal action.

It also means that there will be another bid process. In the meantime, the ex-im market is, if anything, taking off.

This is a Shock And Opportunity – but not a Surprise

No matter the opinionated emails and IM’ing going on in several languages all over the world right now about the implications legally in the future, the major producers are all taking this in stride. And appear to be well positioned to respond.

According to Dr. Pierre Debs, the managing director of Spektrum Cannabis (the global medical brand of Canopy and based just south of Frankfurt), who responded to CannabisIndustryJournal a day after the court decision, the company is not affected by this development. “Spektrum has a steady and constant supply and we do not anticipate any problems supplying patients through their pharmacies,” he says. Debs received the first German medical import license to bring Canadian cannabis into the country a mere two years ago and has continued to carve a leading path in the discussion across Europe. “In addition to our supply from Canopy Growth Corp, our partnership supply agreement with Alcaliber in Spain will see Spektrum importing sun-grown medical cannabis products starting towards the end of the summer,” says Debs.

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Dr. Pierre Debs, managing director of Spektrum Cannabis
Photo: ICBC, Berlin

But it is not just the big guys in the mix anymore. And there are many who see opportunityto a situation, which is frustrating.“As the second-largest country by population in Europe and a leader within the EU, the German market represents a new frontier for the cannabis industry in general in the region,” says Zlatko Keskovski, chief executive officer of NYSK Holdings, a Macedonian firm now in its second harvest of GMP-certified cannabis and holding EU export rights.

For such firms, even though NYSK is a surprise entrant to the conversation this year and outside the EU, the current situation represents an unbelievable chance to enter a market literally starving for qualifiedproduct. The firm is currently looking for German distributors who cannot access medical grade cannabinoids via other routes including attending the ICBC in Berlin in April. “This year’s ICBC looks to be a seminal moment for NYSK,” says Keskovski. “We have taken the appropriate steps to ensure our high-quality standards have led to products that our customers, and eventually patients, can rely on. We look forward to the chance to showcase our achievements that we’ve worked so hard for. The ICBC will also present us with the opportunity to meet with potential distributors and future partners.”

German Patients are Going to be on the Front Lines of This Discussion

The difficulties that German patients have already faced in obtaining a drug that is now legal in their own country for medical use (and even for recreational purposes across an open border in Holland) are legion. While to a certain extent, German patients are in the same boat as patients elsewhere and their problems, in fact, there are still huge access issues that remain. For starters, the drug is much more expensive here, so those without health insurance approval face bills of about $3,000 per month. Why the eye-watering price? All medical grade cannabis is still imported, although increasingly this is now just via other EU countries, not just from Canada.

“One of the reasons we organized the national German Patient Roundtable is to give patients a voice in all of this supply and demand discussion and to help BfArM and others formulate workable solutions for all,” responded Philip Cenedella IV when reached for a response by CIJ. Cenedella, an American expat and the organizer of the Roundtable, a nationally focussed, umbrella group that is kicking off its campaign this year, spoke for many who are far from court and boardrooms where the decisions are being made.

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Philip Cenedella, pictured left, at the Deutsche Hanfverband (DHV) conference in Berlin last November.
Photo: @MedPayRx, Instagram

“While there are very talented firms who will now take up this discussion with the government and reissue a response for the tender, what we continue to see on the ground is that patients simply do not have the access granted them in the law which was passed over a year ago,” Cenedella says, with more than a note of frustration. “We again are calling on all government officials, industry executives and patient advocates to band together to immediately establish workable protocols that directly help the patients.”

Indeed, despite the frustration and delay, if not new costs and opportunities that this decision creates, one thing is very clear on the ground here. The current status quo is unacceptable. That alone should also put pressure on the powers that be to remedy the situation as quickly as possible. And via several routes, including widening import quotas or even issuing new licenses as a new solution to domestic cultivation is implemented.

“Patients are not being served and do not have access to a medicine that has been proven to improve lives,” says Cenedella. “Our simple request is for BfArM to finally invite patients into their discussions, to work with patients to formulate workable cultivation and distribution solutions, and we humbly request that this happen now before they go down another dead-end road, ending in another court defeat, and resulting in even more delays to the patients that are still lacking the care afforded them by the German Federal Court’s decision of 2017.”