Tag Archives: legal

israel flag

Israel’s Cannabis Export Plans Evaporate in Fire and Fury

By Marguerite Arnold
No Comments
israel flag

Trump Administration-Israeli relations had the distinct whiff of cannabis to them in the first week of February. In a development potentially just as impactful as transplanting Israel’s capital to Jerusalem, it has now emerged that Israel’s president, Benjamin Netanyahu, has effectively scotched, at least temporarily, the country’s budding medical cannabis international export plans on the eve of finally launching them.

Why? To appease the U.S. president.

What this latest act of international “diplomacy” will eventually impact in the long run is anyone’s guess. There will, however, be winners and losers out of this situation, both now and in the long term.

Who Wins

On the surface (and to gentiles) it might be hard to understand why Israel effectively shot itself in the foot from a global perspective. But cannabis falls into complicated geopolitical and religious crevices at home too. Bibi, as Netanyahu is referred to by an international Jewish audience, has just scored political points over the Jerusalem showdown. Why rock the boat over a plant that has so recently gained legitimacy just in Israel? Remember the country only partially decriminalized recreational use in 2017. However, Israel has explored legal medical cannabis for quite some time, and Tikun Olam, the country’s flagship producer, has been growing cannabis since 2007.

Tel Aviv, Israel, where Tikun Olam has a dispensary

The quote from Netanyahu that has been widely circulated in the press says a great deal. “I spoke with Trump and he told me about his general opposition to the legalization of cannabis, and I’m not sure Israel should be the export pioneer.”

The fact that apparent encouragement of this policy came from the Israeli Finance Ministry only underscores the gravity of the impact for the losing side – and what was also probably threatened. Uruguayan pharmacies, who began distributing medical cannabis legally, walked away from customers last year after their banks were first informed by U.S. partners that they would either have to cut off the pharmacies or sever ties and access to the entire U.S. banking system. The cannabis trade was estimated to be worth between $1-4 billion per year to Israeli firms.

That said, this will also be a short-lived hiccup. Netanyahu apparently wants to see more medical evidence before moving forward with the plan. That means Israel will be in the race, but not for the next 12 to 18 months (minimum).

Prime Minister Benjamin Netanyahu (Bibi)
Image: Kjetil Elsebutangen, UD

This will also not affect the cannabinoid-related export of intellectual property, where Israel has also led the cannabinoid discussion and for several generations now. Recipes, breeding instructions and even seeds cross borders more easily than plants. If anything, it will merely sharpen and shape the start up nation’s many budding cannapreneurs in a slightly different focus.

Canadian, Australian and a few other exporters also win. As of 2018, there will also be multiple European countries and EU-based firms importing and exporting (even if it is to each other).

Who Loses

The U.S. legal state cannabis movement has just been served a two fisted punch in the face by the White House. The Trump administration, in fact, has doubled down, in the space of less than five weeks, on its views towards cannabis legalization.

This also means that there will be no U.S. firms in any position to join a now global and exploding legitimate cannabis industry that stretches from the American hemisphere north and south of the U.S. itself. Not only will American producers not be able to get export approvals themselves from the U.S. government, but they may well be facing federal prosecution back home.israel flag

It will also be interesting to see whether this heralds any post-Cole memo prosecutions of the many Israeli entrepreneurs already operating in the U.S. state cannabis space. American and Israeli entrepreneurs with IP to protect are also the losers here, no matter how much this is being fought on the California front right now. That is just a state battle. IP must be protected federally.

Investors in the U.S. who had already been tempted to invest in the Canadian cannabis industry, now have little incentive to invest domestically or in Israel, no matter how big and bad California is. There is clearly budding (and less politically risky) competition elsewhere.

It goes without saying, of course, that this decision also hurts consumers – both recreational consumers and medical patients.

Bottom Line

This is clearly sabre rattling of the kind intended to make news both internationally and abroad. However, in direct terms, it will have little impact to the overall growth of the industry, no matter who is doing the growing, distributing and ex-im. The cannabis industry will also clearly not stop being a political business for the near term.

Look for prosecutions this if not next year in the U.S. – potentially in California or another high profile “impact” state. We might see pressure on Netanyahu at home, and probably from abroad as well, to get Israel into the cannabis game globally.

HACCP

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 1

By Kathy Knutson, Ph.D.
No Comments
HACCP

Hazard Analysis and Critical Control Points (HACCP) Defined

Farm-to-fork is a concept to describe the control of food safety starting in the fields of a farm and ending with deliciousness in my mouth. The more that is optimized at every step, the more food safety and quality are realized. Farm-to-fork is not a concept reserved for foodies or “eat local” food campaigns and applies to all scales of food manufacture. HACCP is like putting the last piece of a huge puzzle in the middle and seeing the whole picture develop. HACCP is a program to control food safety at the step of food processing. In states where cannabis is legal, the state department of public health or state department of agriculture may require food manufacturers to have a HACCP plan. The HACCP plan is a written document identifying food safety hazards and how those hazards are controlled by the manufacturer. While there are many resources available for writing a HACCP plan, like solving that puzzle, it is a do-it-yourself project. You can’t use someone else’s “puzzle,” and you can’t put the box on a shelf and say you have a “puzzle.”

HACCP is pronounced “ha” as in “hat” plus “sip.”

(Say it aloud.)

3-2-1 We have liftoff.

The history of HACCP starts not with Adam eating in the garden of Eden but with the development of manned missions to the moon, the race to space in the 1950s. Sorry to be gross, but imagine an astronaut with vomiting and diarrhea as a result of foodborne illness. In the 1950s, the food industry relied on finished product testing to determine safety. Testing is destructive of product, and there is no amount of finished product testing that will determine food is safe enough for astronauts. Instead, the food industry built safety into the process. Temperature was monitored and recorded. Acidity measured by pH is an easy test. Rather than waiting to test the finished product in its sealed package, the food industry writes specifications for ingredients, ensures equipment is clean and sanitized, and monitors processing and packaging. HACCP was born first for astronauts and now for everyone.HACCP

HACCP is not the only food safety program.

If you are just learning about HACCP, it is a great place to start! There is a big world of food safety programs. HACCP is required by the United States Department of Agriculture for meat processors. The Food and Drug Administration (FDA) requires HACCP for seafood processing and 100% juice manufacture. For all foods beyond meat, seafood and juice, FDA has the Food Safety Modernization Act (FSMA) to enforce food safety. FSMA was signed in 2011 and became enforceable for companies with more than 500 employees in September of 2016; all food companies are under enforcement in September 2018. FSMA requires all food companies with an annual revenue greater than $1 million to follow a written food safety plan. Both FDA inspectors and industry professionals are working to meet the requirements of FSMA. There are also national and international guidelines for food safety with elements of HACCP which do not carry the letter of law.

The first step in HACCP is a hazard analysis.

Traditionally HACCP has focused on processing and packaging. Your organization may call that manufacturing or operations. In a large facility there is metering of ingredients by weight or volume and mixing. A recipe or batch sheet is followed. Most, but not all, products have a kill step where high heat is applied through roasting, baking, frying or canning. The food is sealed in packaging, labeled, boxed and heads out for distribution. For your hazard analysis, you identify the potential hazards that could cause injury or illness, if not controlled during processing. Think about all the potential hazards:

  • Biological: What pathogens are you killing in the kill step? What pathogens could get in to the product before packaging is sealed?
  • Chemical: Pesticides, industrial chemicals, mycotoxins and allergens are concerns.
  • Physical: Evaluate the potential for choking hazards and glass, wood, hard plastic and metal.

The hazards analysis drives everything you do for food safety.

I cannot emphasize too much the importance of the hazard analysis. Every food safety decision is grounded in the hazard analysis. Procedures will be developed and capital will be purchased based on the hazard analysis and control of food safety in your product. There is no one form for the completion of a hazard analysis.

HACCP risk matrix
A risk severity matrix. Many HACCP training programs have these.

So where do you start? Create a flow diagram naming all the steps in processing and packaging. If your flow diagram starts with Receiving of ingredients, then the next step is Storage of ingredients; include packaging with Receiving and Storage. From Storage, ingredients and packaging are gathered for a batch. Draw out the processing steps in order and through to Packaging. After Packaging, there is finished product Storage and Distribution. Remember HACCP focuses on the processing and packaging steps. It is not necessary to detail each step on the flow diagram, just name the step, e.g. Mixing, Filling, Baking, etc. Other supporting documents have the details of each step.

For every step on the flow diagram, identify hazards.

Transfer the name of the step to the hazard analysis form of your choice. Focus on one step at a time. Identify biological, chemical and physical hazards, if any, at that step. The next part is tricky. For each hazard identified, determine the probability of the hazard occurring and severity of illness or injury. Some hazards are easy like allergens. If you have an ingredient that contains an allergen, the probability is high. Because people can die from ingestion of allergens when allergic, the severity is high. Allergens are a hazard you must control. What about pesticides? What is the probability and severity? I can hear you say that you are going to control pesticides through your purchasing agreements. Great! Pesticides are still a hazard to identify in your hazard analysis. What you do about the hazard is up to you.

german flag

Head of German Police Union Calls for Official Decriminalization of Cannabis

By Marguerite Arnold
No Comments
german flag

Facing the same conundrum as police everywhere after the start of a medical market only this time with federal authorization, the head of the German police union has called for recreational use of cannabis to also be decriminalized.

On the first Monday of February, the head of the BDK – the Association of German Criminal Officers told The Bild (sort of like the New York Post but a national “tabloid” here) that his group, the largest organized union of German police officers, favoured a change in German cannabis laws. Andre Schulz argued that the current laws stigmatized those charged with minor amounts and created opportunities for “criminal careers to start.”

“The prohibition of cannabis has historically been seen as arbitrary and has not yet been implemented in an intelligent and effective manner,” says Schulz. “My prediction is that cannabis will not be banned for long in Germany.”

Why this sudden pronouncement? It is actually not all that sudden and has been long in the offing. One of the largest contingents at both the ICBC and the IACM last year (the biggest cannabis-focussed business and medical conferences in Germany) were police officers from California and Deutschland. And all were singing the same tune.

André Schulz
André Schulz, chairman of the BDK

However beyond a realistic assessment of changing political reality, there are actually several other concrete reasons for not only the statement but the timing of it. In a country where patients can now pick up bud cannabis from the local apotheke (which is that easy for some, although it is still hard for most), the police have the unappetizing prospect of potentially arresting patients. On top of that, the idea of someone being arrested for CBD flower (rather than THC) gives the German polizei plenty of pause. Not to mention that they face this possibility at a time when many of them potentially could be patients themselves (or their families). The idea of arresting an activist in this situation is also one the police do not relish. Legalization rallies here get formal police protection when they march. Ask the average beat cop what they think about cannabis legalization and they tend to roll their eyes.

Then there is this: In stark contrast to the wars over prescribing medical cannabis at a state level in California in the late 90’s, here in Germany, there is a cultural commitment to the concept of sick people having a moral and civil right to obtain the medication they require. The idea of the police arresting them in the process of obtaining the same or because they might be recreational users, is as antithetic to core German sensibilities as the concept of Donald Trump as U.S. President. So is the idea of branding someone a “criminal” if not “drug user” for possession of a drug that is now used as medicine in Germany.

As has been rumoured for some time now, one of the few things that all political parties in Berlin can agree on is a change on the current cannabis laws.As a result, the very idea of both arresting the sick or labelling someone for the rest of their life with a police record for a drug “crime” that nobody considers as such anymore, causes a shock to the system. In many ways, German culture is far more conservative than the U.S. On another, there is a deeply humanistic, liberal strain to German life that also allows nudity, alternative healthcare and lifestyles to flourish (and not just all in Berlin). The current situation over cannabis, in other words, is becoming a political and legal embarrassment even to the beat officers who have to implement such laws.

And then of course there is this: One of the country’s top judges, Andreas Müller, a man well-known to the senior level of BDK, has recently written a book about the horrible situation that faces his own brother because of drug laws in Germany called “Kiffen und Kriminalität.”

Cannabis also falls into this crevice of cultural questioning if not the national zeitgeist of the moment, in multiple ways. It is, beyond the stigma, a natural medicine that is now federally recognized as such and one that the statutory health insurers (public healthcare) is required to cover. No matter that only 64% of submitted rezepts have been formally approved 11 months into Germany’s foray into this world. There are doctors writing them. And there are insurers picking up the tab.

It also means that there are at least 10,000 legal medical cannabis patients that der polizei have no wish to bother. And 10,000 German patients, who look the same as anyone else, are already too many legal users for current laws to stay in place.

Decriminalization, Cultivation & Changing Culture

There are some who say that Europe is “backwards” if not slower than the United States. Certainly those who experience German culture as Auslanders are struck by the procedural requirements of everyday life. Things do move slower here.

However when things do move, they are determinative shifts. Right now, it is impossible to live in the country and not be aware that Kiffen – a slang term for pot auf Deutsch – is legalizing in the U.S., Canada, the rest of Europe and of course other places. Further, Germans with their distrust of bureaucracy and authority and certainly currently rebellious mood, are looking to a way forward for the country in a sea of uncertainty both locally and regionally not to mention globally on any issue, no matter how “symbolic.”

As has been rumoured for some time now, one of the few things that all political parties in Berlin can agree on is a change on the current cannabis laws. The idea of decriminalization, now suggested by one of the country’s top cops, is a natural solution to political deadlock, if not a changing society.

The idea that other countries are also moving on this topic, from the now Brexiting UK to France next door, not to mention all the cultivation focused reform in many European countries, seems to indicate that decriminalization and even recreational reform are coming and now officially on the schedule, and not just to Germany but the entire continent.

Laura Bianchi
Soapbox

Jeff Sessions’ Latest Moves Should be a Wake-Up Call for the Cannabis Industry

By Laura A. Bianchi
1 Comment
Laura Bianchi

The legal cannabis industry was recently rocked to its core by the announcement that Attorney General Jeff Sessions would be rescinding the so-called “Cole memo” and several other Obama-era legal directives suggesting the federal government would leave state-by-state cannabis reforms more or less alone. Suddenly, it seemed the entire cannabis movement was in jeopardy. Laws legalizing medical and recreational cannabis could be at risk. A booming industry predicted to be worth $50 billion annually by 2026 could instead be going down in flames.

Here’s the good news: As a business transactions attorney who’s been working in the cannabis industry for eight years, I don’t see any cause for panic. The Cole memo and the other directives the Justice Department are rescinding were not laws, orders or even legal precedents – they were simply legal guidance, and murky at that. The memos provided guidance to federal prosecutors regarding cannabis enforcement under federal law, suggesting that federal prosecutors not focus resources on state-legal cannabis operations that weren’t interfering with other federal priorities, such as preventing the distribution of cannabis to minors and preventing revenue from the sales from going to criminal enterprises, gangs and cartels. Yes, federal prosecutors could take Sessions’ recent moves to mean it’s open season on medical and recreational cannabis businesses. But with medical cannabis programs of one form or another up and running in 29 states and Washington D.C., and recreational cannabis now legal in eight states and Washington D.C., dismantling the entire legal cannabis industry would require a Herculean federal effort that would come at the expense of a cornerstone of the Republican Party now in power: The vital importance of states’ rights.The best way to stay on top of those rules? Form relationships with your state program regulators

In other words, I don’t see the termination of the Cole memos as the end of the nascent cannabis industry. But I do think the development should be a wake-up call for all those people in the cannabis industry who have been playing fast and loose with their business operations. After all, if federal prosecutors do decide to make examples of certain cannabis operations, they’re going start with those who are not operating within the confines of the applicable state rules and regulations.  Any business that smells even slightly of tax evasion, interstate trafficking or the allocation of cannabis-derived revenue to benefit a criminal enterprise will end up at the top of that target list.

So how should well-meaning cannabis operators stay off the feds’ radar? Simple: Follow all the rules.

Unless you want orange to be your new black, you can’t afford to be sloppy with your business structure and financial records.For starters, you need a CPA who’s not just at the top of their game, but who also understands the very specific – and potentially debilitating – nuances of cannabis-specific tax liabilities. That’s because thanks to a quirk in the tax code called IRS section 280E, cannabis companies are utterly unique in that they are not allowed to deduct expenses from their business income, save for the costs of goods sold. You want an accountant who thoroughly grasps this issue, so they can help you plan for and (to the extent possible) minimize your tax liability. And you want to address such matters before you start to realize positive revenue, so you’re ready to handle an effective tax rate that can be upwards of 70 percent. Last I checked, the IRS doesn’t consider “But I can’t afford to pay my taxes!” a valid excuse.

Along the same lines, you need a business corporate attorney who’s well-versed in the world of cannabis. That’s because while it might seem exciting to jump headlong into the cannabis green rush, you’re not going to get very far if you don’t deal with the boring stuff first. I’m talking about start-up financing strategies, business contracts and agreements, profit and loss forecasts, cash-flow analysis, and long-term financial plans. Properly structuring your business from the get-go isn’t just important if you ever plan to seek capital or sell your business. It’s also necessary if you want to keep the feds happy. In other industries, regulators might cut first-time business owners some slack. Not so in cannabis. Unless you want orange to be your new black, you can’t afford to be sloppy with your business structure and financial records.

Jeff Sessions and Eric Holder
AG Jeff Sessions (left), the man responsible for the recent uptick in worries

Finally, make sure you’re playing by all the cannabis rules, regulations and requirements of your state and jurisdiction. While this suggestion might seem like a no-brainer, far too often cannabis brands hire hotshots from Fortune 500 companies who don’t know anything about cannabis regulations and how they apply to their business.

The best way to stay on top of those rules? Form relationships with your state program regulators. Here in Arizona, I am in constant contact with our regulators discussing nuances and new business concepts for which the rules are unclear, convoluted or simply silent. Working with the enforcers might not come naturally to many folks in the cannabis business, but we’re dealing with a new and evolving industry where there’s little or no business, regulatory or judicial precedent. We’re all in this together.

It’s exciting to be at the bleeding edge of a bold and booming new industry like cannabis, but to do so safely and legally, cannabis industry pioneers need to make sure they’re striking the right balance between daring innovation and sensible business security.

We shouldn’t expect Jeff Sessions to launch a new army of prohibition agents around the country to kick down doors of cannabis businesses. But it wouldn’t be a bad idea for cannabis entrepreneurs to start acting like he might.

Vermont Becomes First State to Legalize Cannabis Through Legislature

By Aaron G. Biros
No Comments

On Monday, January 22nd, Vermont made history becoming the first state to legalize adult use cannabis via the legislature. Governor Phil Scott signed the bill, H. 511, into law, which legalizes adult possession and cultivation of cannabis, eliminating penalties for possessing one ounce or less and up to two mature marijuana plants and up to four immature plants for people 21 and older, beginning on July 1.

Vermont Gov. Phil Scott

According to the Marijuana Policy Project, they have been lobbying Vermont’s legislature since 2003 and they plan on working with the Vermont Coalition to Regulate Marijuana and the state task force to implement sensible and effective regulations for the state’s new industry. This makes Vermont the ninth state to legalize cannabis.

On Thursday, January 4th, the Vermont House passed this bill, sending it to the Senate for concurrence. On January 10th. The state’s Senate also passed the vote, sending it to Gov. Phil Scott’s desk to sign. Now that he signed the bill into law, Vermont is officially the first state to legalize cannabis through their legislature.

“After more than 15 years of hard work by MPP and our allies in the state, adults in Vermont no longer need to fear being fined or criminalized for low-level marijuana possession and cultivation,” says Matt Simon, New England political director for the Marijuana Policy Project. “This is a great step forward for the state and the whole region. Responsible adults will soon have the freedom to enjoy a safer option legally, and law enforcement will be free to concentrate on serious crimes with actual victims. We are looking forward to working with lawmakers and state leaders to continue improving marijuana laws in the Green Mountain State.”

Greece Moves Forward on Legalizing Medical Use

By Marguerite Arnold
No Comments

The Greek Parliament is finally expected to approve the medical use of cannabis – probably in the first weeks of February. The move is far from a surprise. Greek politicians announced last summer that this development was in the cards.

What is even more promising for the sector domestically, not to mention in terms of European reform, is the unflinching acceptance of this industry by the establishment and national politicians, and further as one with great economic development potential for a still-ailing economy.

A $2 Billion Injection of Capital

Deputy Agricultural Development Minister Yannis Tsironis (for one) has already publicly expressed his hope that the Greek medical program will attract beaucoups bucks from overseas.

However given the context in which this announcement has taken place, is this seriously a commitment to medical cannabis? Or is it an easy (if not slightly buzzy) way to attract foreign capital to a Mediterranean paradise still in dire need of a capital injection from any source it can get one?

Deputy Agricultural Development Minister Yannis Tsironis

Maybe it is a combination of both.

Many in Europe are forecasting that 2018 might finally be the light at the end of the tunnel for the Greek economy, which has been mired in austerity for the last decade. The Greek government is now in the process of moving forward with the final requirements of both labour reforms and receiving what is hoped to be the last bailout of its economy by foreign investors before it finally goes it alone by August 2018.

The Greek economy finally grew 1.5% last year. In 2018, in part thanks to the final package of reforms, the economy is expected to grow by 2.4%.

A foreign-financed medical cannabis business might be just what the economists have ordered. Especially if it is also open to visitors.

Medical Marijuana on Mykonos?

The development of a domestic medical cannabis industry in Greece is good news for not only medical reformers but also those who are looking for ways to expand the influence of the flower into the broader economy.

And Greece is one place where such ideas could easily and quickly take root in Europe.

Mykonos, the Greek island
Image: Maggie Meng, Flickr

Greece has long been the haven for a highly niche, international tourist audience. Tourism in general has also been on the uptick over the last two years again as particularly Europeans look for relatively cheaper beaches and sunshine. Over 30 million foreign tourists flocked to the country last summer – a number of people roughly three times the population of the country.

Again, mainstreamed medical cannabis would only add to the economic results in a way that is just as heady if not (economically) stimulating as a good sativa.

The idea of a medical tourism industry here, could also potentially create not only a Greek medical paradise, but potentially also have a growth impact on European cannabis programs too. Especially if reciprocal medical rights we

re also offered to EU citizens looking for an extended canna-friendly vacation.

Greek Cannabis Club Med?

Of all the countries in Europe, the Greek cannabis experiment offers the first real chance for a Canadian/American style cannabis industry to begin to flourish in Europe. In colder, more northern European countries, medical cannabis is still being treated as an expensive adjunct to traditional healthcare. And no matter how much citizens are moving towards acceptance of a recreational industry down the road, things are moving much slower in the rest of Europe. Germany, to put things in perspective, passed medical reform several months before the Greek decision to legalize medical use last summer. Yet now it appears that Greece might actually move into a full-fledged, domestically grown industry before its Teutonic neighbour to the north.

Parthenon, Athens, Greece
Photo: Kristoffer Trolle

And further, unlike Germany, Greece may well decide to develop its “medical cannabis industry” as an adjunct to its tourist industry.

Sure, Holland and Spain led the way in this part of the world if not internationally. Neither country, however, needs new industries now in the same dire way, nor is emerging from a national, decade-long recession.

All the elements are here, in other words, for the Greeks to turn a new page in their very long and documented history, and do something a little different.

German Media Reports Dramatic Increase in Cannabis Patients Covered by Insurance

By Marguerite Arnold
1 Comment

German media is now reporting that in the first 10 months of medical cannabis reform, over 13,000 applications for medical cannabis have been received by the largest three public health insurance companies. Most of the applications were received (and processed) by AOK who received 7,600 applications. Barmer received 3,200 applications. Krankenkassen Techniker (or TK as it is widely referred to here) received approximately 2,200 applications.

The reality is that most patients still rely on the black market.Between 62-64% of those who applied at the big three were also reimbursed. That means that there are already close to 10,000 patients, if not slightly more, covered under some kind of reimbursed cannabis scheme in Germany (where cannabis costs only $10 per month as a co-paid expense). When cannabis is not covered by health insurance, however, patients must pay out of pocket for the drug which can run as much as $3,000 for a single month’s supply.

This information is also being released, fascinatingly, not from the government, insurance companies or even advocacy groups. Instead it comes from a report produced by local media (the Rheinische Post in Dusseldorf). The media outlet surveyed the three top largest health insurance companies on the number of cannabis-as-medicine applications they have received since the cannabis law was reformed last year.

Home cultivation and recreational use, except in a few city trials now underway in places like Bremen, is still outlawed on a federal level. The new law also specifically prohibits patients from growing their own. And since the reform law passed last year, the prevailing story from patients is the difficulties they have had in not only finding a doctor willing to prescribe cannabis, but also getting their health insurers to reimburse them for huge out of pocket expenses that most of the chronically ill can never hope to afford.

The reality is that most patients still rely on the black market. It is still easier to get cannabis this way. And far cheaper – unless of course approved by health insurance.

What Does This Mean For The Bigger Picture?

Despite the fact that many in the mainstream German media are still highly sceptical of the medical efficacy of cannabis, the tide is turning here too, rather dramatically. According to recent polls, about 57% of the country is ready for recreational reform. That means in the last four to five years, the majority of public opinion has also shifted. It is also clear that medical cannabis cannot be as easily dismissed as it once was. Here or anywhere.

What makes this even more interesting is the impact this now moving situation will have on the debate, particularly domestically, but also internationally.

The first is that Germany clearly has a huge number of potential patients. Local advocates put the real number here north of 1 million for conditions the drug is commonly prescribed for in other places. At the present time, the only doctors who are allowed to prescribe the drug must also have a special license to dispense such restricted “narcotics” as cannabis is now classified auf Deutsch. And the only “on-label” condition for cannabis is still Multiple Sclerosis. That means that cancer, AIDS, chronic pain and movement disorder patients, along with those who manage to get approved for PTSD, ADD, depression and other “psychological” disorders only get the drug approved as a measure of “last resort.” In other words, after all other drugs fail. That is a high bar to pass.

The second, as a result, is that these numbers appear artificially low for another reason. The government claimed upon passage of the cannabis reform legislation last year that it expected only 10,000 new patients a year for the first few years (and before domestic cultivation began). As these results already prove, there are clearly far more patients who want the drug than those who can get it. There are also more patients whose doctors are willing to write prescriptions for the drug than are getting reimbursed by public health insurance.Bottom line? No matter how slow it is in getting started, the medical cannabis market has arrived in Germany. The numbers will only grow from here.

Third, this entire debate is now happening at a time when Germany is re-examining its own health insurance policies. While 90% of the country is on much cheaper public healthcare, 10% of the country, mostly the self-employed, foreigners and high earners, have private coverage. This is highly expensive, and ends up trapping even Germans in a system that is unaffordable as they age. In fact, the issue is a big one in Berlin right now as particularly the SPD is pushing Chancellor Merkel and the CDU to finally address a growing problem.

The law last year mandated that public health insurance must cover cannabis if prescribed under the right conditions. That means that private health insurers have to cover it too.

On the cannabis front specifically, what this may indicate, however, is that the public health insurers are being tasked to only approve a certain pre-identified number of patients nationally in the early part of the cannabis program. Especially as all of the medical cannabis in the country is still imported – and most of that is still coming from Canada.

What these numbers clearly show however, beyond all the caveats, is that demand is starting to pick up. Cannabis as medicine has not entirely caught on in the mainstream, although Germans are clearly interested in the idea. Especially given all the noise and news from abroad on this front.

It also means that no matter how “anaemic” these numbers may seem in early 2018, it is a respectable kick-off to what many in the industry view as one of the world’s most lucrative medical cannabis markets. Counting the approximately 1,000 patients who received medical cannabis before the law changed last year, it is safe to say that the market is now up and running.

Bottom line? No matter how slow it is in getting started, the medical cannabis market has arrived in Germany. The numbers will only grow from here.

How Does This Compare To Other Countries?

But how does the German patient ramp up compare to other countries after significant reform has been passed?

In Canada, the cannabis-as-medication discussion is clearly mainstream as the country prepares to launch its recreational program later this summer. The medical program began in 2014. The most recently released figures as of the beginning of January 2018, show that medical cannabis has clearly caught on. Health Canada’s most recent figures show that by September of last year, there were 235,621 registered cannabis patients in the country. Significantly, this is also up dramatically from 174,503 registered patients as of just April 2017. The previous year, the total number of cannabis patients literally tripled in 2016. To put this in “historical perspective,” as of Q1 2015, about a year into the new medical law in Canada, there were “only” 23,930 patients (or about twice the number in Germany as of now). This growth is all the more impressive when one considers that there is no mandate for insurance coverage of the drug in Canada. That said, cannabis is far cheaper in Canada. It is of course covered domestically. Plus the licensed producers can mail order it directly to patients.

Israel’s path to medical cannabis access has been slower off the ground in terms of overall numbers, but it is has still dramatically expanded over the past decade too. In 2012, there were about 10,000 cannabis patients in Israel. That number more than doubled by 2016 to over 23,000 patients. This will continue to increase too. Israel’s medical cannabis is covered under national health insurance and patients must pay about $100 a month for their meds.

What Is The Official German Government Response To This News?

Marlene Mortler, German drug commissioner for the federal government and affiliated with the CSU, has issued comments that seem to be supportive of the continued program in Germany. “The growing number of permits shows how important it was to launch this law last year,” she said, while warning that medical cannabis is not a panacea.

Vermont Legislature Votes to Legalize Cannabis

By Aaron G. Biros
No Comments

Vermont could become the ninth state to legalize recreational cannabis soon, and the first to do so via the legislature. The Vermont Senate just voted to pass H. 511, a bill that would legalize cannabis for adults. The bill now goes to Governor Phil Scott’s desk for his signature, and he has indicated previously that he will sign this bill into law.

On Thursday, January 4th, the Vermont House passed this bill, sending it to the Senate for concurrence. Now that the Senate has passed the bill and Gov. Scott is expected to sign it into law, it is beginning to look like Vermont will be the first state to legalize recreational cannabis through the legislature, which is a monumental accomplishment.

Vermont Statehouse, Montpellier, VT
Image: Tony Fischer, Flickr

This could also be an important milestone for the East Coast, as legislatures in New Hampshire, New Jersey, Rhode Island, Connecticut and Delaware are seriously eyeing legalization bills as well. New Hampshire lawmakers in the state’s House approved a similar bill recently.

Matt Simon, New England political director for the Marijuana Policy Project, sees this as a massive win for the legalization movement. “Vermont is poised to make history by becoming the first state to legalize marijuana cultivation and possession legislatively, rather than by ballot initiative,” says Simon. “We applaud lawmakers for heeding the calls of their constituents and taking this important step toward treating marijuana more like alcohol.”

H. 511, the bill the Vermont Senate just approved, would eliminate penalties for possession of up to one ounce of cannabis and remove penalties for having two mature plants and four immature plants. A task force appointed by the governor will work on a report to investigate how the state should tax and regulate sales by December of 2018.

Microbiology 101 Part Two

By Kathy Knutson, Ph.D.
No Comments

Microbiology 101 Part One introduced the reader to the science of microbiology and sources of microbes. In Part Two, we discuss the control of microorganisms in your products.

Part 2

The cannabis industry is probably more informed about patients and consumers of their products than the general food industry. In addition to routine illness and stress in the population, cannabis consumers are fighting cancer, HIV/AIDS and other immune disorders. Consumers who are already ill are immunocompromised. Transplant recipients purposely have their immune system suppressed in the process of a successful transplant. These consumers have pre-existing conditions where the immune system is weakened. If the immunocompromised consumer is exposed to viral or bacterial pathogens through cannabis products, the consumer is more likely to suffer from a viral infection or foodborne illness as a secondary illness to the primary illness. In the case of consumers with weakened immune systems, it could literally kill them.Bacteria, yeast, and mold are present in all environments.

The cannabis industry shoulders great responsibility in both the medical and adult use markets. In addition to avoiding chemical hazards and determining the potency of the product, the cannabis industry must manufacture products safe for consumption. There are three ways to control pathogens and ensure a safe product: prevent them from entering, kill them and control their growth.

Prevent microorganisms from getting in

Think about everything that is outdoors that will physically come in a door to your facility. Control the quality of ingredients, packaging, equipment lubricants, cleaning agents and sanitizers. Monitor employee hygiene. Next, you control everything within your walls: employees, materials, supplies, equipment and the environment. You control receiving, employee entrance, storage, manufacturing, packaging and distribution. At every step in the process, your job is to prevent the transfer of pathogens into the product from these sources.

Kill microorganisms

Colorized low-temperature electron micrograph of a cluster of E. coli bacteria.
Image courtesy of USDA ARS & Eric Erbe

The combination of raw materials to manufacture your product is likely to include naturally occurring pathogens. Traditional heat methods like roasting and baking will kill most pathogens. Remember, sterility is not the goal. The concern is that a manufacturer uses heat to achieve organoleptic qualities like color and texture, but the combination of time and temperature may not achieve safety. It is only with a validated process that safety is confirmed. If we model safety after what is required of food manufacturers by the Food and Drug Administration, validation of processes that control pathogens is required. In addition to traditional heat methods, non-thermal methods for control of pathogens includes irradiation and high pressure processing and are appropriate for highly priced goods, e.g. juice. Killing is achieved in the manufacturing environment and on processing equipment surfaces after cleaning and by sanitizing.

If you have done everything reasonable to stop microorganisms from getting in the product and you have a validated step to kill pathogens, you may still have spoilage microorganisms in the product. It is important that all pathogens have been eliminated. Examples of pathogens include Salmonella, pathogenic Escherichia coli, also called Shiga toxin-producing E. coli (STEC) and Listeria monocytogenes. These three common pathogens are easily destroyed by proper heat methods. Despite steps taken to kill pathogens, it is theoretically possible a pathogen is reintroduced after the kill step and before packaging is sealed at very low numbers in the product. Doctors do not know how many cells are required for a consumer to get ill, and the immunocompromised consumer is more susceptible to illness. Lab methods for the three pathogens mentioned are designed to detect very low cell numbers. Packaging and control of growth factors will stop pathogens from growing in the product, if present.

Control the growth of microorganisms

These growth factors will control the growth of pathogens, and you can use the factors to control spoilage microbes as well. To grow, microbes need the same things we do: a comfortable temperature, water, nutrients (food), oxygen, and a comfortable level of acid. In the lab, we want to find the pathogen, so we optimize these factors for growth. When you control growth in your product, one hurdle may be enough to stop growth; sometimes multiple hurdles are needed in combination. Bacteria, yeast, and mold are present in all environments. They are at the bottom of the ocean under pressure. They are in hot springs at the temperature of boiling water. The diversity is immense. Luckily, we can focus on the growth factors for human pathogens, like Salmonella, pathogenic E. coli, and Listeria monocytogenes.

The petri dishes show sterilization effects of negative air ionization on a chamber aerosolized with Salmonella enteritidis. The left sample is untreated; the right, treated. Photo courtesy of USDA ARS & Ken Hammond

Temperature. Human pathogens prefer to grow at the temperature of the human body. In manufacture, keep the time a product is in the range of 40oF to 140oF as short as possible. You control pathogens when your product is at very hot or very cold temperatures. Once the product cools after a kill step in manufacturing, it is critical to not reintroduce a pathogen from the environment or personnel. Clean equipment and packaging play key roles in preventing re-contamination of the product.

Water. At high temperatures as in baking or roasting, there is killing, but there is also the removal of water. In the drying process that is not at high temperature, water is removed to stop the growth of mold. This one hurdle is all that is needed. Even before mold is controlled, bacterial and yeast growth will stop. Many cannabis candies are safe, because water is not available for pathogen growth. Packaging is key to keep moisture out of the product.

Nutrients. In general, nutrients are going to be available for pathogen growth and cannot be controlled. In most products nutrients cannot be removed, however, recipes can be adjusted. Recipes for processed food add preservatives to control growth. In cannabis as in many plants, there may be natural compounds which act as preservatives.

Oxygen. With the great diversity of bacteria, there are bacteria that require the same oxygen we breathe, and mold only grows in oxygen. There are bacteria that only grow in the absence of oxygen, e.g. the bacteria responsible for botulism. And then there are the bacteria and yeast in between, growing with or without oxygen. Unfortunately, most human pathogens will grow with or without oxygen, but slowly without oxygen. The latter describes the growth of Salmonella, E. coli, and Listeria. While a package seals out air, the growth is very slow. Once a package is opened and the product is exposed to air, growth accelerates.

Acid. Fermented or acidified products have a higher level of acid than non-acid products; the acid acts as a natural preservative. The more acid, the more growth is inhibited. Generally, acid is a hurdle to growth, however and because of diversity, some bacteria prefer acid, like probiotics which are non-pathogenic. Some pathogens, like E. coli, have been found to grow in low acid foods, e.g. juice, even though the preference is for non-acidic environments.

Each facility is unique to its materials, people, equipment and product. A safe product is made by following Good Agricultural Practices for the cannabis, by following Good Manufacturing Practices and by suppressing pathogens by preventing them coming in, killing them and controlling their growth factors. Future articles will cover Hazard Analysis and Critical Control Points (HACCP) and food safety in more detail.