Skip to main content

Italian Health Ministry Reverses Course On CBD “Narcotic”

If you are confused about the state of regulation in the EU, don’t feel bad. Everyone is as the rules and regulations do a few 360’s in public in Italy over the course of mere days

As frustrating as the drama is in the EU over the classification of cannabinoids, notably CBD, as a “narcotic,” the soap opera unfolding in Italy in the last few days is almost a welcome bit of humour. Call it the Spaghetti Western of cannabis reform, with a focus on the spaghetti side.

A Brief Timeline of the Canna-Flavoured Dolce Vita Afoot

For those who are confused, here is the brief timeline of events. The humour is clearly seen by reviewing it backwards.

On October 30 last week, the Ministry of Health officially declared that CBD is not a narcotic. 

A mere two days before, the same agency suspended the decree in force previously, with the stated intent of studying whether higher concentrations of CBD impact its supposed “narcotic” effect. Given what went down two days later, it seems the Italians can be efficient at some “studies” when they want to be.

And a mere five days before that, the Ministry of Health had outlawed CBD for the commercial market, singing a song out of the European Commission’s hymn book. But also effectively killing the very same “Cannabis Lite” industry that has continued to flourish in hard Pandemic hit Italy. 

Oops. Funny about that.

The Pharmaceutical Conversation Is Confusing A lot Of The Debate

Here is the first thing to understand. Beyond any muddles about scientific evidence proving efficacy, established pharmaceutical company lobbyists have done their jobs well. Namely confuse the situation, and for their benefit.

Here is one of the biggest culprits.

GW Pharmaceuticals, based in the UK, has sold the story to European regulators that one of its drugs, Epidiolex, is a “narcotic.” Naturally, calling a CBD extract mixed with berry flavoured syrup as such, justified the high price tag along with the exclusion of similar, perhaps more effective tinctures from reaching British patients (see Billy Caldwell). Not to mention a whole bunch of European ones.

Theresa May’s husband would not be so interested in holding the majority of shares of any company that failed to meet earnings expectations after all.

However, the well-placed political shareholders of GW Pharma are not the only reason this conversation has continued to stay so stupid for so long. Many regulators really do not understand the differences between cannabinoids. Much less have apparently ever been exposed to a patient who consumes THC on a regular basis and does not live life on a couch. And by this point, that fault lies in the stars of the cannabis industry itself.

At least in Italy, the Health Ministry did not put off the CBD discussion, much like what happened also last week just across the border in Germany. Not to mention Emmanuel Macron’s continued politically expedient contortions in France. 

That all of this confusion occurred almost simultaneously to what was happening as France accedes to medical utility and German Bundestag failed to move forward on a recreational cannabis reform bill while bemoaning how outdated Prohibition has become, demonstrates clearly how much the entire debate is in flux across the continent. And further, on the totality of the plant itself – not just the parsing of cannabinoids. 

It also clearly signals that the entire conversation is also ramping up a notch across Europe. No matter the short term mixed signaling going on even within the same federal agencies of countries, let alone at the Parliamentary level and certainly across borders.

Big things are happening in Europe on the cannabis front. Be sure to book your tickets to the next International Cannabis Business Conference, landing in Europe again, post-Covid, in 2021.

European Parliament Votes In Favor Of Raising Hemp THC Limit

The hemp industry is booming across the globe. Many international farmers have cultivated the hemp plant for years for the purpose of creating textiles, however, in recent years many hemp farmers have cultivated the plant for another purpose – CBD.

Hemp farmers, especially new ones, are scrambling to produce as much raw hemp to sell to companies that will take the raw biomass and turn it into CBD oil and other CBD products.

Many countries have updated their laws recently to permit legal hemp cultivation and to try to distinguish hemp cannabis from non-hemp cannabis.

The legal difference between the two cannabis varieties hinges on a THC threshold. If the cannabis tests above the THC threshold, then it is legally deemed to not be hemp, and if it tests below the THC threshold then it is legally considered to be hemp.

Members of the European Parliament recently voted to raise the THC limit in its policies, as reported by Hemp Today:

The European Parliament has voted in favor of increasing the authorized THC level for industrial hemp “on the field” from 0.2% to 0.3%, a critical step in the process of re-establishing that level of THC for European hemp.

The proposal, long advocated by the European Industrial Hemp Association (EIHA), was included in the Common Agricultural Policy (CAP) reform adopted by the Parliament today.

“This is an historic moment for our industry, for our farmers, for a green future and for all Europeans,” said EIHA President Daniel Kruse. “Finally, the EU has a level playing field again with the global industrial hemp sector.”

While it is good to see the THC threshold increased, a 0.3% THC threshold is still very low. Many hemp industry observers have stated publicly that a threshold of 1% makes more sense.

For instance, Switzerland has a hemp THC limit of 1% that applies to CBD products sold within its borders.

Despite having a THC threshold that is over 3 times greater than many other countries, including the United States which also has a 0.3% limit, Switzerland has not experienced any issues.

Open Call For French Medical Cannabis Suppliers

The French government is officially looking for suppliers for its medical cannabis trial. Applications are due by November 24. Applicants may also submit questions until November 18.

What The French Are Looking For

The government is looking for GMP certified providers who can provide up to 3,000 French patients with different qualities of both raw and extracted products for free during the duration of the trial.

This includes not only the provision of the medicine itself but all costs related to import and distribution. It also includes, for floß cannabis, the requirement that the supplier provides a vaping device (per patient).

How Does This Differ From The German Bid?

The French appear to be looking for a larger cannabis producer who can bear the cost of not only medicine provision and distribution, but also of import (required) and additional equipment (vapes).

There are few companies that are in a position to meet this challenge – not only from a quality perspective, but also from a cost perspective. Even the biggest companies right now are suffering from cash flow issues.

And even though the German bid required that cannabis companies spend a great deal of money to apply for a bid that was delayed twice by legal challenges, they could at least create revenue for themselves by selling the drug in the country in the meantime.

France is indeed challenging the industry to step up – and like the German government before it only looking for “established” companies.

The question is, outside a big French pharma right now, who is willing to step into this role?

How Does This Differ From Other Countries Steps Into Legalization?

The French foray into medical acceptance actually appears to be unique. No other country has launched a national trial like this to begin its foray into normalization.

It is also clear that the French are determined to push the onus back onto the industry itself to help prove its efficacy – and further do so in a way that may help build “infrastructure” in the form of creating a distribution network with an established French company – but no more.

This is not a bienvenue, but rather a révolution à contrecœur (reluctant change of heart).

The Upside

Clearly, the focus from the beginning in France is a GMP only market where the government is not on the hook for paying for the cost of the trial – and further that any cannabis company outside the country willing to engage in the same must have either a standing or in process partnership negotiated with a French pharmaceutical company capable of fulfilling the technical requirements of narcotic distribution within France.

For the latest on the changing market picture in Europe, be sure to attend the International Cannabis Business Conference when it returns to the continent next year.

Billy Caldwell Receives First NHS-Funded Cannabis, Opens Door For Other British Patients

The long two-year battle is over for Billy Caldwell, one of the UK’s most famous cannabis patients. The National Health Service (NHS) has agreed to provide him with government-funded cannabis for the rest of his life.

Now 15, Caldwell became an international media sensation after his mother, also an advocate and participant in the industry, went public with the fact that the supplies she was trying to bring into the country to treat her sick son were confiscated by the government at Heathrow airport.

Even more intriguingly? The prescription that Caldwell uses is not produced in the UK but rather produced in Canada, imported internationally, and paid for by the NHS. That said it is not clear that this exact model will be duplicated by the Belfast Trust, who is responsible for implementing the care plan, for other patients. Or any other NHS trust for that matter.

What Is Likely To Happen Next?

That this is a precedent-setting case is obvious – but what is the precedent likely to be?

As a subtext to all of this is that the NHS has finally admitted that the products that are produced domestically by GW Pharmaceuticals are not going to cut it for a lot of British patients.

The question on the table now, however, is where should the bulk of this “other” cannabis come from?

Buy British?

The logical caveat of course is that if locally produced cannabis oil meets muster on the regulatory side, is this, finally, the birth of the home-grown British industry? The Caldwell precedent, combined with a widely predicted ruling from the Food Safety Authority (FSA) that errs on the side of sanity from a novel food perspective, is actually really good news. And logically, the answer to that question is from a cost perspective, the answer, surely, must be yes.

While the raw products may not hail from the British Isles for a demand that is likely to be enormous on both the medical and consumer side, there are in fact companies on the horizon, established in the U.K. who are absolutely in a position to step up.

The local production of cannabis and its extracts into both food and medicine is a hot topic, particularly in Europe and even more particularly post Covid.

With such developments, it is not inconceivable that cannabis is well on its way post Brexit, to becoming as British as well, tea.

For the latest developments on the European cannabis market as well as the UK, be sure to stay tuned to our post-Covid conference schedule!

Poll Shows Overwhelming Support For New Jersey Cannabis Legalization Measure

Election Day is only two weeks away in the United States, and voter turnout is shaping up to be record-breaking. That is good news for states that are voting on cannabis reform measures.

Historically, a higher voter turnout tends to help the chances of cannabis reform measures passing on Election Day. Conversely, having a cannabis reform measure on the ballot has contributed to greater voter turnout rates because people that may have stayed home actually show up and vote since cannabis reform is on the ballot.

One state that will be voting on adult-use cannabis legalization is New Jersey. The legalization effort in New Jersey has been going on for many years, and in 2017 when current New Jersey Governor Phil Murphy was elected it was expected that New Jersey would legalize fairly quickly.

As the sessions continued to pass and the New Jersey Legislature failed to follow through on getting legalization approved, it became obvious that the issue would be better decided by voters.

New Jersey lawmakers referred a legalization measure that will appear on the ballot for voters to decide. If current polling is accurate, the measure will win by a landslide, as reported by Marijuana Moment:

New Jersey voters support a marijuana legalization referendum that’s on their ballots by a nearly three-to-one margin, according to a new poll released on Friday.

The Stockton University Polling Institute survey found that when likely voters were asked whether they “support or oppose a constitutional amendment legalizing marijuana in New Jersey,” 66 percent were in favor, compared to 23 percent in opposition.

If New Jersey voters approve legalization, it will likely result in a domino effect in the surrounding area. Cannabis legalization is closer than ever in New York and Connecticut, and pressure is especially high right now with Massachusetts already having legal adult-use sales occurring.

If/when legalization wins in New Jersey on Election Day, states like New York and Connecticut will have to decide very quickly if they want to see even more cannabis tax revenues going to other states or if they want to finally get on the right side of history and see those dollars stay within their borders.

German Patients Continue To Have To Sue Insurers/Claim Approvers

Without a doubt, Germany is the largest medical cannabis market in Europe (so far). There have been approximately 100,000 applications so far to the public health insurers. And there are, depending on whose estimate you are using, about 60,000 “legitimate” patients. But again, nobody is sure.

Here is what it is much easier to understand. Patients are still going through huge amounts of paperwork, stress and multiple rejections to obtain government/public health insurer-reimbursed cannabis. So much so that they are still suing (and winning). And further – many of the cases now expected to come to fruition were in fact launched almost immediately after Germany changed the law.

Two and a half years into the “German cannabis experiment” and some of these cases are now seeing their day in court if not the appeals process – which are (no surprise) coming down on the side of the patients who are bringing them.

The latest case to make the news is a Gen X woman, born in 1974. She is both on reduced earning capacity and was prescribed not even bud cannabis but dronabinol by her physician two years ago. Coverage of the same, however, has been repeatedly denied by her insurer in no small part by the botched oversight and review of the regional approver (known as the Medizinische Dienst der Krankenversicherung or MDK). All public health insurers send cannabis prescriptions to the MDK, which is why this case is also so impactful.

Initially, when the patient took the MDK to court, she lost, with a judgement against her this March.

Regardless, on appeal to the Social Court, the plaintiff was found to be within her rights to claim coverage for the drug. Further, the court found that the MDK had grossly misrepresented the plight of the patient and had written four “expert” opinions on the case without accurately describing not only the case, but also ignoring the patient’s and doctor’s rights to prescribe such a drug by focusing on perceived “negative health effects” such as an impact on appetite to dissuade coverage.

In an even more intriguing piece of fallout, the court ruled that the woman’s insurer must not only pay for the cost of the drug for a year but further, must continue to do so if she can prove a positive impact – even before the overall case has finally been decided. Not to do so would violate her basic rights (of being German).

It Still Sounds Like All Greek (if Not German) 

Here is the underlying importance of the case and why this is also likely to further force not only health insurers but all regional MDKs to get a bit more hip on medical cannabis.

  1. The first is that a woman who is severely disabled – enough for it to impact her income – has a health condition that clearly fits her eligibility for medical cannabis currently.
  2. The second is that her insurer turned her down because of (repeated) badly written coverage reports from the regional approver.
  3. The third is that the court has decided that this decision is actually in the hands of the doctor (first) not the MDK – and since the original prescriber had justifiably prescribed the drug, it was not the right of the MDK to try to sidestep the professional opinion of the primary doctor. Nor within the purview of the insurer to rely on the MDK rather than the doctor to try to deny coverage.
  4. The precedent set here is also important – namely that the insurer must pay for the drug for a year to determine if it will make a difference – and further on an interim basis while the entire discussion of medical cannabis is being examined by authorities (more generally).

Overall Longer-Term Impact – Good News For Patients

The decision is basically an escalation to the Landessozialgericht (regional social court) from the first interaction with a local one (which has now been overruled) – and further before a final regional ruling has been made. It is significant because this should (as the judges no doubt intended) stop local MDK’s from slowing down the approval of cannabis-related drugs specifically – if all other factors justify the prescription.

Logically, this should also now break a bit of a dam free in prescribing and obtaining approvals for cannabis under German healthcare. Starting with the fact that the regional approvers may not slow down the process of mandating covered payment for a drug originally prescribed (rightly) by the patient’s doctor and further for a rare condition for which no other drug could treat.

For the best update on all industry developments, be sure to book your tickets to the International Cannabis Business Conference when it returns to Europe in 2020

Cannabis y Libertad – Will Mexico’s Recreational Coup Be A Bloodless One On Both Sides Of The Rio Grande?

For those who know their Mexican history, the slogan of the country’s revolution between the years 1910-1920 was Tierra y Libertad (land and freedom).

This century is about to see a bit of a repeat. Including a restriction imposed by that revolution (the illegality of cannabis itself) that is about to go down in flames.

The Mexican Supreme court ruled on October 31, 2018, that current laws in the country prohibiting the recreational use of cannabis are unconstitutional. Further, the court ruled that the government must implement laws to essentially begin the process of regulating the industry by March 2019. 

Previously, the Supreme Court had ruled in 2015 that the prohibition of personal cultivation and use was also unconstitutional as it violated the human right to the free development of one’s personality. Limited medical reform was then implemented in 2017 by the government.

So far, essentially, however, this is an uncomfortable can that has been kicked down the road repeatedly by the nation’s lawmakers.

That is about to change.

The country’s legislators have a new deadline – December 15 – to pass cannabis legislation of the recreational kind.

The question still on the table is what kind of legal market this might look like – and if indeed the market will be protected or opened to foreign investors and companies.

Rec Reform “South Of The Border”?

Realistically, particularly with continued political delay north of the border (even in a Biden presidency), the development of a Mexican marijuana market that is recreationally legal is likely to start a massive influx of capital into the region – even if just to displace traditional “landed” interests that might have previous experience in the drug industry in the country – but not from the legal side of the world.

And in an irony of history, Mexico will lead drug reform north of the border, by legalizing a market and industry on a federal level that the U.S. at least, for all of its forward reform at the state level, has yet to embrace.

A revolution indeed. And further one that will undoubtedly become, beyond state reform domestically, the final nail in the coffin of prohibition in the U.S. as well.

For the latest updates on the global cannabis industry, be sure to attend the International Cannabis Business Conference when it returns to live conferences!

New Zealand Cannabis Legalization Campaign Wins The Twitter Battle

New Zealand could become the third country to legalize cannabis for adult use. Currently, cannabis is legal for adult use in Uruguay and Canada, and New Zealand could join that list if voters approve a legalization measure this month.

Election Day is technically on October 17th in New Zealand, although early voting is already underway. The election was originally scheduled for last month but was delayed due to a coronavirus outbreak.

Only time will tell if the measure ultimately passes, however, a study was recently conducted that sheds some light on the level of support for the measure, at least on social media.

Twitter is an extremely popular social media platform that is often harnessed for political purposes. Whether it’s by an official campaign or just a single voter, many New Zealand-focus tweets have involved the legalization measure.

A coalition of researchers based in Australia, the United States, and New Zealand examined Twitter data to gauge the level of support and opposition for New Zealand’s cannabis legalization measure.

Specifically, the researchers “conducted a sentiment analysis of all historic cannabis‐related tweets and referendum‐specific tweets written in New Zealand.”

The researchers didn’t just look at the data in recent months. They went all the way back to July 2009 and identified 304,760 tweets about cannabis legalization and New Zealand.

“Overall, the tweets were predominantly positive (62.0%) and there was a higher proportion of positive tweets written in 2020 (65.3%) compared to negative or neutral tweets. Similarly, for referendum‐specific tweets, the 2020 data reveal a generally positive view of cannabis (53.5%).” researchers concluded.

Twitter is obviously not the same as the ballot box.

For the sake of those that were harmed by cannabis prohibition in New Zealand, and countless others that are at risk of prosecution because of their cannabis use, hopefully voters approve the measure and get New Zealand on the right side of history.

The world will find out soon enough!

European Cannabis Reform Inching Forward Despite Covid

Does the expected WHO decision on cannabis this December have anything to do with it?

A funny thing is happening across Covid-stressed Europe. Governments are either inching forwards reluctantly on aspects of the cannabis question, or they are being challenged to change the law in court. Regardless, it is clear that cannabis is on the agenda, even if reluctantly, just about everywhere.

Indeed in the last month, these individual developments have inched forwards across the continent:

Spain: The Canary Islands Parliament just voted to move full reform forwards. While far off the Spanish mainland if not far from Catalonia (the Spanish autonomous “state” that is also home of Barcelona aka home of the vast majority of cannabis clubs), and closer to the coast of Africa than Madrid, this small archipelago of 4 million people could well help put pressure on the central Spanish government to finally begin to federally regulate the industry at all levels. In the meantime, one of the heroes of the club movement is challenging the legitimacy of the federal Spanish law in European Human Rights Court.

Italy: Quietly published in August, the Agriculture Ministry has included the extract of hemp flower in an official list of agricultural products that can be used for medical purposes.

France: On October 7, the French released news of the much-promised medical trial finally being instituted in the country no later than March 31, 2021, and to run for a period of two years. This comfortably puts any French cannabis experiment absolutely in line with one apparently established internationally by globally moving forces. See the UN.

European Countries Seem To Be Aligning With A Medical Outlook

With the increased formalization of the German market (namely BfArM has now chosen a distributor for domestically produced crops), the writing is absolutely on the wall that at a diplomatic, nosebleed level, countries across Europe have now absolutely fallen into line on accepting cannabis as a legitimate medical plant if not product.

This is a victory, no matter how incomplete. For those who remember the days before 2016, no matter how slow change has sometimes seemed, it is also one achieved in almost record time, all things considered. 

The Next Steps

There is nobody in the industry, let alone those who seek to regulate and shape it externally, who believes that this is all “over.” Even after the WHO makes what is widely predicted to be its landmark announcement in December. 

Too many patients remain outside care. And both hemp and recreational reform beyond that are now also absolutely on the horizon, no matter how many years and countless fights remain.

Be sure to book your tickets to the only European cannabis industry conference that keeps you up to date if not on the cusp of developing trends across the industry. The International Cannabis Business Conference returns to Europe in 2021!