Tag Archives: medical

margueriteICBC

The Face Of Cannabis Education In Europe

By Marguerite Arnold
No Comments
margueriteICBC

More than a few cannabis “education companies” – mostly from Canada and the U.S. but some with Israeli ties, plus German and British efforts have targeted Europe as the next logical expansion plan in their global roadmap.

These include most recently Cannvas Medtech Inc., and several initiatives funded by Canopy Growth, including teaching children about the drug. It also includes training programs for frontline staff, launched by Organigram (although in this case it appears to be geared towards “brand education.”)

There are also doctor training programs launching in the UK.

In Germany, there are several efforts underway, helmed by both doctors and cannabis advocates generally, in several cities around the country.

But how effective is all of this “education” in both preventing illegal use, and promoting legitimate sales?

Particularly if such “education” platforms are exported from a foreign market for use in Europe?Canopy_Growth_Corporation_logo

Education Is Desperately Needed, But So Is Channel Penetration

Nobody is arguing that “education,” as well as trials and more information for payers and doctors are not required. The problem is that some education is more effective than other campaigns. And most of the talk in most places is more a discussion of the need for further regulatory reform, more trials and more investigation.

That has to get paid for somewhere.

That, at least in Europe is also tricky, as both early educational movers Weedmaps and Leafly have both found out, especially in medical only markets in the EU. Why? There are also highly limited opportunities for advertising either a drug, or to doctors.

Different Regulatory Environments Cause Bigger Issues

Even in Canada and the United States, there is an ecosystem of supplying the demand that has very much grown up customized by the strange paths to reform if not the first mover discussion.

That is not going to be the case in Europe, which in effect creates a brand-new ecosystem to educate, with new players, and every ecosystem participant group has a different kind of educational needs.

Here is one example of where this shows up. So far, in most countries, doctors are still highly resistant to prescribing the drug. Nurses, on the other hand, in both the United States and Canada at least, have proven to be a much more reliable source of converts for the cannabis cause. That approach of course is not possible in places like Germany where only doctors may issue prescriptions, including of the cannabis (and narcotic) kind.

european union statesAccess issues also play a big role in just about every country- from cost to privacy. And on the privacy front, it is not just foreigners who are getting used to new rules. So are German doctors.

The pharmacy discussion is also very much in the room – and this is not “just like” approaching a “dispensary” from North America. They are regulated chemists. Which causes a whole new set of issues and a serious need for new kinds of educational materials.

In Germany, for example, pharmacists are being recruited and trained by not only staff recruiters specializing in the same, but also sent on special training courses funded by the big Canadian companies (Tilray being the noticeable one recently). The brick and mortar vs. online discussion is also a big topic across Europe. Notably, where it is allowed and where it is, as in Deutschland, verboten.

And, of course, the big green giant in the room everywhere in Europe, in particular, is payer/insurance approvals, which are based on a kind of education called proven medical efficacy.

And that, so far, is in markedly short supply.

In the UK, it is so far the main reason that NHS patients (for example) cannot access coverage for the drug to treat conditions like chronic pain.

In the meantime, the most widespread “education” that is going on, is still mostly at the patient level. Especially when patients sue their insurers, or lobby doctors to prescribe.

The cannabis industry may be maturing, in other words, to be able to answer these questions – but there is also clearly a long way to go.

UKflag

Corporate CBD Production Gets Underway in UK

By Marguerite Arnold
No Comments
UKflag

Any thought that established British and Canadian growers were not already cooperating and in the throes of establishing a UK cannabis production base was put to bed in early July.

Namely, the news that Sundial, an Alberta based Canadian company, is buying Bridge Farms, the winner of the Overall UK Grower of the Year Award in 2017, is a sign that the age of British cannabinoid production (and in bulk) is here. The agriculture group has a 75-acre production facility in Lincolnshire (strategically on the border with Norfolk) and a recent ₤18 million equity injection.

This also means that large-scale CBD production in the UK is now underway with authority.

What it also means, however, is that the winds of trade, even if historically, are already cultivating some interesting partners as the entire British cannabis discussion gets underway.

Sundial Growers also almost simultaneously filed documents to list on the Nasdaq in the U.S. In this, they look remarkably similar to Tilray.

British Sugar Is Now Not The Only Game In Town

The links to the cannabis industry in this part of the UK are not new. Namely, the county of Norfolk (the east-coast “bump” of the British coastline just south of Lincolnshire) is home to British Sugar, the cultivator for GW Pharmaceuticals cannabis crop.

GW logoThis part of the world is also historically associated not only with major international British trade, but in the past at least, of the German kind in particular. See the port of Kings Lynn and the Hanseatic trading route that put the eastern town on the global shipping map until the advent of the railroads in the UK leached its importance south, to London in the 19th century.

Foreign investment in agriculture, in other words, in this part of the world is not new. Nor is shipping the final product elsewhere.

What Does This Mean For The British Market?

That is an interesting question on the advent of a potential Brexit. Is this newly constructed agricultural centre designed, like Canopy’s newest hempire in New York State, for domestic consumption, and-or overseas trade?

For that reason, a fully automated CBD production facility in such a strategic and historic part of the country seems to indicate the commercial production of CBD has begun at a level virtually unseen in any other European country so far. And further, that its backers have an international, not just domestic market, in mind.

What Does This Mean For the European Market?

Unless the UK is planning on eviscerating all worker safety and pay regulations, it is unlikely that British-grown cannabis will be price competitive with what is going on in Europe right now. The German market, in fact, is a very good precursor to the kinds of growing pains the UK is likely to see in this regard.

european union statesExports, in other words, are highly unlikely, at least to Europe.

What this does mean however, is that licensed producers, with international roots and global financing, are clearly moving into the more or less corporate production market that is slowly getting going in Britain.

And just like elsewhere, post Canada, there is no chance, at this point at least, for any “mom and pop” industry to develop.

Given a lack of patient access at this point that is also not likely to fly politically for long.

Regardless, as of the summer of 2019, there are beginning to be the signs that large scale production of both THC and CBD, is getting going in Britain.

No matter where their customers are located.

Soapbox

Medical Cannabis in Georgia: Federal Policy Effects on State Industries

By Reggie Snyder
2 Comments

Under the U.S. Drug Enforcement Administration’s (DEA) Controlled Substance Act (CSA), drugs are classified into five distinct schedules depending upon their acceptable medical use and their overall potential for abuse or dependency. The DEA currently lists cannabis as a Schedule I drug, which the CSA defines as drugs having no currently accepted medical use and a high potential for abuse. It appears, however, that the DEA may soon reconsider its current Schedule I classification of cannabis.

This article considers how the DEA’s potential reclassification of cannabis potentially could affect Georgia’s medical cannabis industry. Specifically, the article discusses: (1) how Georgia medical cannabis distributors would operate within this new regulatory framework; (2) how this change would affect registered Georgia patients who are either currently purchasing medical cannabis or are planning to do so; and (3) whether this reclassification would cause big pharmaceutical companies to enter Georgia’s medical cannabis market, and if so, how.

The DEA’s Reclassification of Cannabis Would Likely Affect the Regulatory Framework of Georgia’s Medical Cannabis Industry

On April 2, 2019, Georgia became the 34th U.S. state to legalize cannabis for medicinal use when the Georgia Legislature passed House Bill 324 (“HB 324”), which recently took effect on Monday, July 1, 2019. In Georgia, medical cannabis is defined as a “low-THC oil” that contains 5% or less of tetrahydrocannabinol (THC)—the psychoactive chemical in cannabis that causes a “high.”

Georgia State Flag

If the DEA reclassifies cannabis, the regulatory framework of Georgia’s medical cannabis industry under HB 324 would likely be affected. For instance, depending on how the DEA elects to reclassify cannabis, low-THC oil products manufactured and sold in Georgia could become subject to the U.S. Food and Drug Administration’s (FDA) costly, complicated and time-consuming drug approval process. Then, any low THC oil products that the FDA approves will be subject to federally mandated quality, efficacy and potency standards for FDA-approved drugs. Also, any federal standards that stem from the DEA’s reclassification of cannabis will trump any conflicting provisions in HB 324 or any other conflicting rules, regulations or procedures established by the Georgia Access to Medical Cannabis Commission (GAMCC), the seven member state agency responsible for promulgating and implementing the state-based rules, regulations and procedures necessary to produce and distribute low-THC oil in Georgia, and the Georgia State Board of Pharmacy (Pharmacy Board). However, even if the DEA reclassifies cannabis, the following state regulatory framework established by HB 324 will remain unaffected:

  • The GAMCC will likely continue to oversee the state’s medical cannabis industry.
  • The following two different types of dispensary licenses issued under the legislation will still likely remain: retail outlets (issued by the GAMCC) and pharmacies (issued by the Pharmacy Board).
  • Licensed dispensaries will still likely not be located within a 1,000-foot radius of a school or church, and licensed production facilities will still not be located within a 3,000-foot radius of a school or church.
  • Pharmacists who dispense low-THC oil will still likely have to review each registered patient’s information on the state’s Prescription Drug Monitoring Program (PDMP) database to confirm that they have been diagnosed with one or more of the 17 approved conditions and diseases. The legislation does not require retail outlet dispensaries to review patient information on the PDMP database or employ a pharmacist to dispense the drug.
  • Registered patients will still likely be prohibited from vaping low-THC oil or inhaling it by any other electronic means. The legislation does not expressly prohibit the use of other, non-electronic delivery methods of low THC oil such as pills or nasal spray.
  • All licensed dispensaries (and all licensed production companies) will still likely be subject to an “on-demand” inspection when requested by the Georgia Bureau of Investigation (GBI), the GAMCC, the four-member Medical Cannabis Commission Oversight Committee (MCCOC), or local law enforcement. The GAMCC and the Georgia Drugs and Narcotics Agency (GDNA) will also still likely be able to conduct one, annual inspection of dispensary locations. And, upon request, licensed dispensaries will still likely be required to immediately provide a sample of their low-THC oil for laboratory testing to the GBI, GAMCC, MCCOC, GDNA or local law enforcement.
  • All licensed dispensaries (and all licensed production facilities) will still likely be required to utilize a GAMCC-approved seed-to-sale tracking software.
  • All licensed dispensaries (and all licensed production companies) will still likely be prohibited from advertising or marketing their low-THC oil products to registered patients or the public. However, they will still likely be allowed to provide information about their products directly to physicians, and upon request, physicians will still likely be allowed to furnish the names of licensed dispensaries (and licensed production companies) to registered patients or their caregivers.

The DEA’s Reclassification of Cannabis Would Likely Affect the Availability of Low THC Oil

To date, approximately 9,500 Georgians are registered with the state’s Low-THC Registry, which allows them to purchase low-THC oil from licensed dispensaries. Since the legislation’s passage, the number of registered patients has increased significantly and continues to steadily rise. If the DEA reclassifies marijuana, this patient number will likely increase at an even faster rate because the public will likely perceive reclassification as an acknowledgement by the federal government that marijuana possesses health and medicinal benefits. If that occurs, statewide demand for low THC oil could quickly outstrip the supply.

Georgia Gov. Brian Kemp
Image: Georgia National Guard, Flickr

Under HB 324, the GAMCC is tasked with ensuring that the state has a sufficient number of retail outlet dispensaries across the state to meet patient demand but is limited to issuing only six production licenses. As the number of registered patients continues to grow, the GAMCC may be forced to recommend amendments to the statute allowing it to issue additional production licenses to increase the state’s supply of low THC oil, and depending on how many additional patients are added to the state’s Low-THC Registry, the GAMCC may also have to issue additional dispensary licenses to keep up with patient demand by relaxing the geographic limitations on locating dispensaries.

Thus, the DEA’s reclassification of cannabis likely would affect the amount of low THC oil available to registered patients in Georgia.

The DEA’s Reclassification of Cannabis Would Likely Cause Large Pharmaceutical Companies to Enter Georgia’s Medical Cannabis Market

Large pharmaceutical companies typically manufacture, market, sell and ship their products on a national and international scale. Given cannabis’ current status as a Schedule I drug under the CSA, these companies have largely steered clear of the burgeoning medical marijuana industry because of the inherent risk of violating federal law. If the DEA reclassifies cannabis, that risk will be diminished greatly, and the companies therefore will likely decide to enter the market by acquiring existing medical marijuana companies with established national or state-level medical cannabis brands.

If the DEA reclassifies cannabis, Georgia’s medical cannabis market will likely be affected in multiple ways.Depending on how the DEA reclassifies cannabis, low-THC oil in Georgia could be subject to stringent federal standards, including the FDA’s complex and expensive drug approval process. Georgia medical cannabis companies will likely not be accustomed to complying with such federal regulations. Large pharmaceutical companies, on the other hand, are very accustomed to dealing with the federal government, including FDA drug approval. So, if the DEA reclassifies marijuana, pharmaceutical companies will likely view reclassification as a tremendous opportunity to enter the Georgia market by leveraging their experience and institutional knowledge dealing with federal law to acquire or partner with a licensed Georgia cannabis company that has an established brand of low -HC oil.

Entering Georgia’s medical cannabis market won’t be easy, however, because HB 324 prohibits licensees from transferring their licenses for five years and requires that the original licensee be a Georgia business. But, HB 324 does not prohibit them from selling their businesses, which necessarily includes any licenses the business owns. Purchasing a licensed Georgia medical cannabis company requires payment of a production license business transfer fee. The fee for the first sale of a business with a Class 1 production license is $100,000 and the fee for a Class 2 license is $12,500. The fee for the second sale is $150,000 for a Class 1 production license, and $62,500 for a Class 2 license. The fee for the third and fourth sales is $200,000 for a Class 1 production license, and $112,500 for a Class 2 license.

Conclusion

If the DEA reclassifies cannabis, Georgia’s medical cannabis market will likely be affected in multiple ways. Specifically, depending on how the drug is reclassified, the regulatory framework for medical cannabis companies likely will change to include both state and federal requirements, potentially including the FDA’s complex drug approval process. Also, the amount of low-THC oil available for registered patients to purchase likely will be diminished precipitating the need for the GAMCC to modify the statute to allow for issuing additional production licenses and relaxing the geographic limitations on locating dispensaries. Finally, large pharmaceutical companies likely will attempt to enter Georgia’s medical cannabis market by purchasing existing, licensed Georgia companies that have established low-THC oil brands.

tilray-logo

Tilray Imports Medical Cannabis Oil In Bulk To UK

By Marguerite Arnold
1 Comment
tilray-logo

Tilray has managed to successfully import its first bulk supply of medical cannabis oil into the UK.

It was a Tilray product, in fact, that was not only confiscated at the border last year – but subsequently sparked media outrage over the denial of the same to one Billy Caldwell, an epileptic child. It was not the only outcry nor was Billy the only child endangered. And the British people, in fact, finally signalled that they had lost their stiff upper lip on this one last year.

All of this despite lingering and significant problems ever since. Not to mention an intriguing and well-timing market entry for Tilray right after things have been heating up on cannabis reform in Parliament of late.

The Tilray product, which will be imported from its new production facilities in Portugal, has already been distributed in other European countries, including Croatia and Germany.

tilray-logoWhat is significant in other words, is that the UK is starting to allow bulk orders in through customs- and they are coming not from Canada, but from Europe. Even if it is a Canadian company’s brand on the same, for now at least.

Tilray of course, is not the only company engaged in a race to get imports into the country. Right after Christmas last year, Canopy/Spektrum announced the same plans. Wayland has clearly been angling for a British outpost for some time. And of course, more locally initiated groups, including European Cannabis Holdings, have been working to initiate easier access to British markets for well over a year. Let alone more locally grown interests and pursuits now clearly lining up for market entry.

But this announcement, coming so shortly after all the recent activity on cannabis reform and calls for trials in the UK, clearly means that the doors are now opening fast for the largest players angling to get in.

Bottom line? Look for the biggest Canadians with an already established European presence, to begin making similar announcements this summer.

Being “Available” Is Only The First Hurdle

One of the biggest problems facing not only the “industry” but patients in the UK, much like elsewhere, is that doctors do not know or want to prescribe cannabis and cannabinoid medicines- and for reasons stemming from fear or ignorance about medical efficacy to insurance coverage.

Medical cannabis, in all its forms so far, however, is also highly expensive and out of reach for most unless they obtain an NHS approval (or as in Germany, statutory health insurer approval) to actually obtain the drug. And then have a place to obtain it.

This basically counts out everyone who cannot pay out of pocket and cannot find a willing doctor to sign them up via onerous and ongoing paperwork. And that, of course, is the majority of the sick people in the room.

It is this basic conundrum, which the bigger Canadians have yet to solve themselves (and it is becoming more of a recognized issue in the U.S. in the days, presumably, before the 2020 election which will hopefully set a timetable for federal reform) that has been in the room for the last two years thanks to Germany.

Image credit: Flickr

It is even more of an issue in the UK. Especially with a renegotiation in Britain’s diplomatic and trade relationship with the rest of the world.

That includes, as of mid-July, a downright, undiplomatic spat between the White House and Whitehall right now over leaked comments from the British Ambassador to Washington – and about matters of competency far from cannabis. Although of course, this issue is in the room.

For that reason, the Canadian as well as the European connection to imports right now (from not just Portugal but Holland) on the medical side of the ledger, spell an intriguing fall for not only cannabis, but the real shape and direction of British politics- and by extension- British trade.

Patients Are Taking It To The Streets And To Parliament

As much as patients have so far partnered with the big Canadian companies in the attempt to get the borders open, this is not the only game in town. Dutch imports, from Dutch companies, are already showing up in the UK (see Bedrocan). And both British and Irish growers are getting in on early action, even if for now “just” on the CBD side.

Furthermore, it is clear that patients are playing a large role in making sure that they are being heard, even to the point of putting pressure on doctors. In an extraordinary admission at the parliamentary level during the last week of June, lawmakers conceded that the British public was taking matters into their own hands. And furthermore, that the change in the law had led to clear expectations that were not being met.

Namely, British patients are literally demanding medical cannabis by prescription from their doctors.

And much like in Germany, with a mandate for coverage, the government is being forced to listen, and as best as it can in a severely crimped and politicized Brexit environment, respond.

While cannabis reform is hardly the Guy Fawkes, in other words, in a tinder match environment that British politics certainly is right now, it might be a kind of spark that drives a much wider conversation in the UK about current events.

Specifically the survival of a system that is poised to provide not only access to cannabis but comprehensive medical care beyond that, even for the old or chronically ill.

UKflag

Has Cannabis Reform Landed In The UK?

By Marguerite Arnold
No Comments
UKflag

The British have finally decided that cannabis reform is overdue. In London at least, 63% of the population believe that recreational reform is a good idea.  According to a poll by The Evening Standard, the rest of England too, is getting close to a majority when the idea of recreational reform is in the room.

It is, as usual, recreational reform that is the icing on a medical cake that has yet to be baked. But that spice brownie is well on its way to the oven too. According to the British Medical Journal as of the beginning of July, the idea of broader access to regulated medical supplies for patients is mandatory.

And in the ranks of the conservative party, Crispin Blunt founded the Conservative Drug Policy Reform Group last September to lead Parliament in a long overdue discussion about the use of both medicinal and recreational cannabis use in the UK that formally “launched” during the last week of June.

But how the industry will develop here is also a big question in the room right now, especially with a country poised on the edge of one of the biggest constitutional questions in the country’s history – to Brexit or not, and how.

Justice Minister Crispin Blunt (right)
Photo courtesy of The UK Ministry of Justice, Flickr

The North American Influence Is Controversial

While Blunt, for example, sees no issue with injecting North American capital into the debate, there are others who are not so sanguine. And while the idea of Canadian reform is popular here, including the freedom of patients (and others) to grow small amounts themselves, the idea of Canadian companies influencing national policy is not. From The Daily Mail to The Guardian, there have been front page headlines about the coming financial influence of “The North Americans.”

That this discussion is also going on at a time when the UK is considering a completely new trade agreement with the world, including on pharmaceuticals, is not insignificant. Where the country’s drugs come from, far from cannabis, is absolutely on the table. Not to mention how much they cost.

Questions of basic access are likely, in other words, to be in the room for a long time here. The barriers to obtaining and filling a prescription start at its expense – which is ₤1,100 (about $1,400) per prescription. There are few people, let alone those who are chronically ill, who can afford the same. This is far from a “normalized” drug- even of last resort- at the NHS.So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.

That said, it is a start. And for the first time, as of this summer, those with the money can in fact, obtain cannabis by prescription.

But what happens to those (the vast majority) who cannot? 

Patients Are Feeling Side-lined

Just as in national legalizing conversations in the United States and Canada so far, patients are being pushed aside for “the business” to take the conversation forward. But where does this business fall on matters of price and access?

So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.

While patient groups are organizing, and the earliest ones to gain national attention, usually families whose children have been directly in the line of fire, are getting commercial ambitions themselves, the fact remains that patient voices are not the loudest ones in the room. Although as Blunt announced last week, he does not see recreational reform happening in the UK for the next five years.

That also means that every Canadian company entering the market (in particular) will have to continue to sing the same medical song they have been humming across Europe- at least in public.

The UK is NOT Germany – But It’s Not Canada Or The US Either…

No matter how much more “liberal” supposedly, the English people are on the whole CBD question (there is already far more CBD for sale in the UK than just about anywhere else), the UK market is still far behind Germany. Why? Since March 2017, insurance companies auf Deutschland have been required to cover the drug – from sprays and pills to floss when prescribed by a doctor.

There are, by latest calculations about 50,000 German patients.

That said, it is clear that the British do not seem to give a fig about the entire “novel food” discussion and are literally, in some cases, daring the police to raid stores and shut down establishments. The idea of rebellion against EU rules seems very obvious on the CBD front.

Beyond this, however, it is also clear that “Canadian” much less “American” cannabis reform is not necessarily the only model in town.

As the British, in other words, do finally embrace the cannabis question, it is very likely that the face of the same will be of a unique Limey strain all of its own.

Illinois Legalizes Cannabis

By Aaron G. Biros
1 Comment

Illinois just became the first state to legalize and regulate adult use cannabis through the legislature.

Earlier this month, the House passed HB 1438 in a 66-47 vote, with bipartisan help. Roughly 24 hours before that, the same bill cleared the Senate in a sweeping 38-17 vote. Governor J.B. Pritzker signed the Cannabis Regulation and Taxation Act (CRTA) into law on Tuesday, making Illinois the 11th state in the nation to legalize adult use cannabis and the first to do so via the legislature.

Illinois Governor J.B. Pritzker campaigned and won the election on this issue and helped design HB 1438. Sponsors of the bill, Senator Heather Steans (Chicago-D) and Representative Kelly Cassidy (Chicago-D), along with Governor Pritzker, have been viewed as the architects of this piece of legislation.

Illinois Governor J.B. Pritzker

Back in January, the sponsors of the bill announced their plans, backed with full support from the Governor’s office. Then in early May, the coalition announced the formal introduction of the bill.

Some supporters say the state legalizing cannabis in this particular fashion will have shockwave effects throughout the rest of the country. Not only did Illinois pass this legislation, but they did so with social equity and public health in mind. Back when the sponsors of the bill announced their intentions in January this year, Sen. Steans told a town hall meeting in Springfield, “We have a huge opportunity in Illinois to do this right and carefully… 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.”

The Marijuana Policy Project (MPP) has a handy overview of the legislation that breaks down exactly what was legalized. An MPP press release says this legislation is, “the most far-reaching social equity provisions ever included in a legalization law. It includes reinvestment in communities disproportionately harmed by cannabis prohibition, broad expungement provisions, and measures to ensure the industry includes communities that have been targeted by cannabis enforcement.”

You can find more information about the bill, proposed rules, licensing processes and regulations here.

european union states

Frontline Pharmacy: The Battle For The Footprint of Medical Cannabis Europe

By Marguerite Arnold
1 Comment
european union states

This summer, as new distributors continue to get into the cannabis game (in Germany, the UK and beyond), and at least two countries (Greece and Macedonia get GMP-certified), the battle is now on not just for cultivation and distribution licenses, but the end point of sale, pharmacies.

Pharmacies were always going to play a large role in cannabis distribution in Europe, starting with the fact that there will not be a separate “dispensary” system (as there is in the United States and Canada). Further, in some jurisdictions, notably Germany, the idea of the “apotheker” is one that is not going to go away anytime soon. No matter how intriguing the concept of online pharmacies actually are to everyone else (see the British).

Further, the shift to what is widely being referred to as “tele” or “digital” health is only going to increase in prevalence as discussions continue. Cost and access (to all medications, not just cannabis) are an issue near and dear to the average European. So is the right and consumer safety issues of being able to consult with a local pharmacist, who might even know you personally, and can advise on the health effects of the medicines they pass over the counter.

german flag
Photo: Ian McWilliams, Flickr

Jens Spahn, the current Health Minister of Germany, is touting a move to personal management of health records and digital prescriptions by next year. However, nobody knows exactly what that means, much less the functionality of the same.

Further, the German pharmacy situation in particular is one that has implications across Europe no matter how aggressively “digital health” solutions are implemented here. By law, no more than three (in some rare cases four) brick and mortar pharmacies can be owned by the same owner. There is no such thing as “Boots” (a British chain) or “Walgreens” (an American one).

Doc Morris, the Dutch online pharmacy, has always been an option for Germans just across the border. The problem of course is that insurers so far have been refusing to pay for critical parts of this idea. The company is currently experimenting with working with insurers- but do not expect the average chronically ill person in any country to suddenly get expedited access. So far, the only innovations in this market have hit as the privileges of the privately insured.

Second class status (and significantly lagging behind those with private healthcare) is also very much in the room as a political issue- and cannabis access has only sped this up.

If the scenario in the EU two years ago could be described as the race for import licenses and cultivation rights, this year, the focus of the big guys is very much trying to mainstream their product and get it on as many “shelves” as possible.

In Europe, however, since nobody can ship straight to the patient (as in Canada), the next most obvious step is securing access to pharmacies.

The Cannabis Industry Cometh

Even before Aphria announced its purchase of CC Pharma (one of Germany’s largest distributors)  in a deal that finally closed in January of this year, the larger companies have been looking for a more efficient supply chain situation. Owning a distributor is certainly one way to go about this.

Israeli Together bought into a large German distributor last summer.

As of May 2019, Aleafia Health and its wholly owned subsidiary, Emblem, entered a JV with Acnos Pharma GmbH – with access and reach to 20,000 German pharmacies. And Wayland announced its merger with ICC, with pharmacies across the world.

As early as October 2017, Tilray and Cronos together tried to storm the German market (by inking a deal to reach the 20k plus pharmacies in the German system). Two years later, and this still has not made a huge difference in access.

Regardless of these larger industry players, however, or perhaps so far because of their statements and the resulting continued lack of access for most patients, it is also fact, particularly in both Germany and the UK, that merely having relationships with pharmacies is not enough. This year, there is also a fairly major price drop in the cards for the cannabis industry. And while the larger players may blanket the market with relationships, actually providing access to GMP-certified medical cannabis at a decent if not competitive price, is going to continue to have an impact on every market, particularly in those situations where compliant online access can be connected to indie distribution.

It is also an environment where the advantage still does not necessarily go to the “big guys” – a strategy that Wayland, for one, has been playing strategically for the better part of the last two years better than any other Canadian in the market. Especially when supply chain issues, beyond price, are still in the room.

Right now, pharmacies are well aware of their growing influence in this space in Europe. How much of an influence they will continue to have however, also rests on how effectively they preserve their right to have such an influence on the end consumer (as in Germany) or not (see the many discussions about this issue in the UK right now).

Further, as many of these entities are also realizing, and this is true far beyond the cannabis discussion, pharmacies are increasingly caught in the middle between consumer, doctor and insurer (this is certainly the case both for cannabis and also for all expensive orphan drugs).

How the pharmacies, in other words, begin to solve other issues, beyond just having a contractual relationship with a cannabis distributor/producer, is very much a part of the conversation right now. Access to cannabis via distribution deals with a Canadian or even Israeli partner certainly helps sales but it does not guarantee them.

One thing is for certain. The impact of new privacy legislation is having an effect, so even in an environment where a distributor/producer buys a pharmacy, what they can then do with customer information they also might have been interested in purchasing, is not only highly limiting, but in the future it may be the best approach to handling liability, and from multiple directions that includes everything to access to affordable, certified product to cyber security issues.

Food processing and sanitation

Key Points To Incorporate Into a Sanitation Training Program

By Ellice Ogle
No Comments
Food processing and sanitation

To reinforce the ideas in the article, Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table, the main goal of sanitation is to produce safe food and to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing rapidly, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.

GMPSanitation is not an innate characteristic; rather, sanitation is a trained skill. To carry out proper sanitation, training on proper sanitation practices needs to be provided. Every cannabis food manufacturing facility should require and value a written sanitation program. However, a written program naturally needs to be carried out by people. Hiring experienced experts may be one solution and developing non-specialists into an effective team is an alternative solution. Note that it takes every member of the team, even those without “sanitation” in their title, to carry out an effective sanitation program.

Sanitation is a part of the Food and Drug Administration’s Code of Federal Regulations on current Good Manufacturing Practices (GMPs) in manufacturing, packing or holding human food (21 CFR 110). Sanitation starts at the beginning of a food manufacturing process; even before we are ready to work, there are microorganisms, or microbes, present on the work surfaces. What are microbes? At a very basic level, the effects of microbes can be categorized into the good, the bad, and the ugly. The beneficial effects are when microbes are used to produce cheese, beer or yogurt. On the other hand, microbes can have undesirable effects that spoil food, altering the quality aspects such as taste or visual appeal. The last category are microbes that have consequences such as illness, organ failure and even death.In a food manufacturing facility, minimizing microbes at the beginning of the process increases the chance of producing safe food.FDAlogo

Proper sanitation training allows cannabis food manufacturing facilities to maintain a clean environment to prevent foodborne illness from affecting human health. Sanitation training can be as basic or as complex as the company and its processes; as such, sanitation training must evolve alongside the company’s growth. Here are five key talking points to cover in a basic sanitation training program for any facility.

  1. Provide the “why” of sanitation. While Simon Sinek’s TEDx talk “Start with why” is geared more towards leadership, the essential message that “Whether individuals or organizations, we follow those who lead not because we have to, but because we want to.” Merely paying someone to complete a task will not always yield the same results as inspiring someone to care about their work. Providing examples of the importance of sanitation in keeping people healthy and safe will impart a deeper motivation for all to practice proper sanitation. An entertaining illustration for the “why” is to share that scientists at the University of Arizona found that cellphones can carry ten times more bacteria than toilet seats!
  2. Define cleaning and sanitizing. Cleaning does not equal sanitizing. Cleaning merely removes visible soil from a surface while sanitizing reduces the number of microorganisms on the clean surface to safe levels. For an effective sanitation system, first clean then sanitize all utensils and food-contact surfaces of equipment before use (FDA Food Code 2017 4-7).
  3. Explain from the ground up. Instead of jumping into the training of cleaning a specific piece of equipment, start training with the foundational aspects of food safety. For example, a basic instruction on microbiology and microorganisms will lay down the foundation for all future training. Understanding that FATTOM (the acronym for food, acidity, temperature, time, oxygen and moisture) are the variables that any microorganism needs to grow supplies people with the tools to understand how to prevent microorganisms from growing. Furthermore, explaining the basics such as the common foodborne illnesses can reinforce the “why” of sanitation.

    Food processing and sanitation
    PPE for all employees at every stage of processing is essential
  4. Inform about the principles of chemistry and chemicals. A basic introduction to chemicals and the pH scale can go a long way in having the knowledge to prevent mixing incompatible chemicals, prevent damaging surfaces, or prevent hurting people. Additionally, proper concentration (i.e. dilution) is key in the effectiveness of the cleaning chemicals.
  5. Ensure the training is relevant and applicable to your company. Direct proper sanitation practices with a strong master sanitation schedule and ensure accountability with daily, weekly, monthly and annual logs. Develop sanitation standard operating procedures (SSOPs), maintain safety data sheets (SDS’s) and dispense proper protective equipment (PPE).

Overall, sanitation is everyone’s job. All employees at all levels will benefit from learning about proper sanitation practices. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.

UKflag

A Cautionary Tale of Two British CBD Start-Ups

By Marguerite Arnold
No Comments
UKflag

As cannabis reform finally begins to hit the UK, the same confusion, lack of standards and uneven application of the “law” reigns supreme.

Just like other places (notably Israel, the United States and Canada), in the early days after medical reform hits, the English situation is instructive if not reminiscent of other fights elsewhere – no matter how much individual stories may differ on the surface. Just like in Israel for example, sick children had to be hospitalized before anyone moved forward on reform.

Just like in the United States, Canada and Israel, the people who were able to get into the changing industry first and early had money and political connections.

And just like everywhere else, who survives and who gets hit with red tape, is largely a matter not of entrepreneurial savvy, but connections, inherited privilege, race, gender and of course, bank account. In a place like the UK, where “class” is still a valid force on its own (beyond access to money), this is already obvious. As a theme, it is one that is sadly, not over yet for too many in or affected by “the industry.”

There are still, per the estimates available, less than 100 legal patients in the UK. Those served by the NHS are also well aware of their “second class” status when it comes to healthcare. This one issue, after all, drove Brexit, and may yet cause it to fail, just on this one issue. Cannabis may be a side note in the debate. But it is also, by this time, clearly in the room.

A Chelsea Popup Shop Survives While A Brighton Eatery Fails To Open

In January, two graduates of Imperial Business School (a private, prestigious university in London) opened a “pop up shop” (kind of like a kiosk) in Chelsea. This is a part of the city frequented by Royals on the hoof, reality stars of a certain vintage, and a lot of highly priced real estate.

So far, with the predictable fawning press coverage, the almost too “cutely” named TheDrug.Store (which by its own admission is selling non-medical products) has been doing brisk business.

Meanwhile, in the historic if less slightly less elite but almost as expensive touristy seaside town of Brighton, The Canna Kitchen, a CBD eatery with the catchy slogan of “let food be thy medicine”, was closed by the police right before it was supposed to open at the end of May (although there is no mention of this or the negative press on the website, which despite having no telephone number, still allows visitors to “book a table.”) The owners, who also seem to be quite well-heeled millennials themselves, appear to be on the verge of “losing hundreds of thousands of pounds and laying off 15 staff,” to quote The Guardian story on the subject.

Never mind the irony that they also seem rather well positioned financially. Or that many, many more people, usually called poor patients, are still at risk of being hospitalized because they cannot get (or afford) their medication.

As the industry, such as it is, and patient rights group organize in earnest this summer, reform in the UK also hinges on whether and what the country decides to do in the fall.

And despite the huge disparities that exist in terms of who has access (let alone to entrepreneurial capital), or perhaps because of them, look for a healthy debate from patients about policy, access and fairness.

A Case for Digital Cultivation Management in the Cannabis Industry

By Allison Kopf
No Comments

The steady destigmatization and legalization of medical and recreational cannabis at the state level continues to propel a large and fast-growing industry forward. In 2018, the legal cannabis industry grew to $10.4 billion in the U.S., employing more than 250,000 people according to New Frontier Data. 

The mass production of anything that humans consume is invariably accompanied by an increased concern for safety and accountability—especially in the case of cannabis, which the federal government still deems a Schedule I substance. Each U.S. state has its own mix of laws based on the will of its voters, spanning the spectrum from fully legal to fully illegal.  

While the mix of legality in states can be hard to keep up with, all states with any form of cannabis legalization have one thing in common: the need to regulate this new industry. Last year, the federal government issued a Marijuana Enforcement Memorandum that allows federal prosecutors to decide how to prioritize enforcement of federal marijuana laws, so states are at risk.

If you are a public official involved in state cannabis regulation, or anyone involved in the supply chain from cultivator to dispensary, chances are you are using some kind of seed-to-sale tracking technology to monitor things like plant inventory, sales volume, chain of custody—and to hedge against federal encroachment by having a legitimate form of accountability.

Mandatory Request For Proposals (RFPs) issued by states for compliance solutions have spawned an entire sub-industry of seed-to-sale tracking, and point-of-sale hardware and software vendors, with large multi-million dollar contracts being awarded. Metrc’s RFID (Radio Frequency Identification) plant and packaging tags are gaining wide usage, and 11 states plus DC have adopted the technology.

While states are taking the right steps to keep their legal cannabis industry legitimate and accountable, there is actually a major gap that existing systems don’t cover: cultivation management. Most of the existing RFPs and platforms focus on the post-harvest side of the business (processing, packaging, distribution) and may have some cultivation management capability, but are not geared for the cultivation operation, which is where a lot of the risk actually lies for both growers and state regulators. 

As a state official or a cultivator, what could be more damaging to business than a massive product recall—especially after the product has been distributed and consumed? This is the fastest way to get shut down or audited by the state as a grower or invite federal investigation if you’re a state. And these recalls cost growers millions of dollars and possibly their license. There is massive risk involved by not addressing the cultivation side.

PlantTag
A plant tagged with a barcode and date for tracking

With current tracking systems, it’s possible to see where the product came from in the event of such a recall, but nearly impossible to pinpoint and see what actually happened and when the recall happened. This makes it almost impossible to stop the same problem in the future and puts consumers at unnecessary risk.

The reason most seed-to-sale systems are difficult for growers to use is because they were designed for regulators to address the most obvious regulatory questions (are growers abiding by the law? Who is selling and buying what and how much? Is the correct tax amount being levied?). They were not designed for growers and in many cases, cultivation teams are using two systems—their own ERP and/or spreadsheets and seed-to-sale tracking mandated by regulators.

This means there is a huge missing link in data that should be captured during the cultivation process. In many cases, growers are tracking crop inventory during the growth stage with pen and paper, or at best, in Excel. Cultivators need a tool designed for them that helps both run better operations and identify hazards to their crop health before it’s too late, and regulators need complete traceability along the supply chain to reduce risk to consumers.

To fill this critical data gap, there is a strong case for states in their RFPs and ongoing regulatory capacity, to adopt and encourage cultivators to use Cultivation Management Platforms (CMPs) alongside any existing seed-to-sale and ERP solutions for complete traceability.

As more states move to legalize medical and recreational cannabis, mitigating risk as part of a larger regulatory framework will only become more important. Adopting and using a CMP empowers growers to focus on not just tracking data, but making that data accessible and functional for growers to drive efficiency and profits all while ensuring security and regulatory compliance in this rapidly evolving industry.