Tag Archives: schedule

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British Government Agrees To Loosen Rules on Prescribing Medical Cannabis

By Marguerite Arnold
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After a year of embarrassing missteps and revelations, along with two well-run advocacy campaigns by the parents of children with drug-resistant epilepsy, the British government is finally throwing in the towel on medical cannabis.

Sadly, politics rather than science has driven the pace of British cannabis legalizationIn the last week of July, a mere two weeks after announcing his review of the issue against mounting domestic pressure and outrage in the media, Sajid Javid, the home secretary, announced that cannabis medications will be rescheduled by the fall, allowing doctors to prescribe them more widely.

“Fall,” it should be noted, is not only when the Canadian government moves ahead with its own fully recreational market, but also when the German bid respondents need to file their paperwork to participate in the country’s first grow bid, Round II.

A Political Embarrassment Beyond Brexit

Sadly, politics rather than science has driven the pace of British cannabis legalization, just like it has in other places. However the UK is one of the best examples of how far medical knowledge has outstripped the pace of political change, and in this case, exposed bare the banal reason.

News broke this summer, as two families mounted a highly successful battle in the public for medical access, that the Prime Minister herself has personally profited from a status quo that is only now slowly going to change.

How and why?

Theresa May, Prime Minister of the UK
Theresa May, Prime Minister of the UK
Image: Annika Haas, Flickr

It was bad enough in May that the publicly anti-pot reformer Victoria Atkins, the cabinet level British drugs minister, was married to the managing director of British Sugar, the company with the exclusive right to grow cannabis in the British Isles. British Sugar is also the sole cultivator for GW Pharmaceuticals, the only company with the license to produce cannabis medications in the UK (and export them globally). In June, however, it emerged that Prime Minister Theresa May’s husband, Phillip May, is employed by Capital Group– an investment firm that is also the largest shareholder in GW Pharma. This is against the backdrop of news that broke earlier this year that GW Pharma had made the UK the single largest exporter of cannabis-based medicine annually. Globally. Even more than all of the Canadian firms combined currently exporting to Europe and beyond. Even as the drug is largely denied to British residents.

You don’t even have to be British to think the entire situation is more than a bit of a sticky wicket.

Vested, If Not Blueblood Interests

This development also came to light right as GW Pharma’s newest focal epilepsy drug faltered to failure in Eastern European trials and as Epidiolex, the company’s drug for certain kinds of childhood epilepsy, was given the green light in the U.S. by the government as the “first” cannabis-based medication to be allowed for sale in America.Epidiolex-GW

No one has yet defined exactly what kind of cannabinoids will be allowed to be prescribed in the UK come fall, but here is the most interesting development of all that still hangs over the British Isles like stale smoke: Will competitors to GW Pharma be allowed to sell their products to medical customers in the UK or will this new opening for patients just create more of a monopolized windfall for one company whose profits, at least, lie in “pharmatizing” the drug rather than creating greater access to the raw plant or its close derivatives? And those profits flow to women (and men) with the greatest political control over the development of the industry in the country.

Is This Really A “Legalization” Victory?

In the short term, no matter how limited, the answer is actually yes. Rescheduling the drug is a step that has not even been taken in the U.S., and will serve, medically, to reset the needle if not the debate about the circumstances under which cannabis should be used for patients.GW logo

It will also move the punishment discussion in a way that still has not happened in places like Germany where, technically, the drug has not yet been decriminalized even though doctors are prescribing it and public health insurers cover the costs for increasing numbers of patients. Large numbers of Britons, just like everywhere else, are incarcerated every year or obtain black marks on their records for mere possession that in turn can affect lives.

Finally, it will put recreational reform in the room, even if still knocking at the door. This discussion too has been gaining in popularity over the past year in particular as reform moves elsewhere. Like Germans, like Canadians and like Americans, reform in Colorado and Washington set loose a global revolution, which will clearly not be stopped.

Even if in places like the UK, it is still moving far slower than it should be. For political and business reasons, not driven by science.

Operational Inefficiencies in Commercial Cannabis Cultivation

By Drew Plebani
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From the perspective of sustainable cannabis cultivation models, it seems clear that outside of the particular cultivation methodology adopted, that operational efficiency and the implementation of lean manufacturing principles will be necessary for successful and truly “sustainable” businesses, in the current, ever growing, cannabis space.

Implementing lean manufacturing principles as an integral part of the cannabis cultivation facility just makes sense- it is a manufacturing operation after all. From a lean perspective, doing away with the non-value-added costs in the supply chain and production model are quite important.

Let’s look at this case study as evidence for the necessity of operational efficiency:

A 300-light flowering, indoor cultivation facility in Colorado.

The system was purchased with ongoing pest/disease issues, recent updates to Colorado’s approved pesticide list, had prompted the implementation of an updated integrated pest management (IPM) program, which had been moderately successful in developing an albeit short-term solution to keeping ongoing root aphids, powdery mildew, and botrytis, to name a few, at bay.

This existing facility was producing roughly 60 pounds of trimmed cannabis per week, equivalent to almost $6M annual gross, however they were losing a percentage of their yields to product that did not pass Colorado’s contaminant testing requirements.

It is important to note that any deviation from the existing manufacturing schedule and system would create a change to the potential productivity of the system, for better or worse.

At the most basic level, one would hope that a new operator taking over an existing facility would analyze the system and implement incremental or perhaps major changes to create more efficient and profitable outcomes. That being said, currently the average grower likely doesn’t have much understanding of the lean manufacturing process. That will undoubtedly change.

When we look at basic manufacturing facility operations, on an annual gross potential basis, each daily task not completed on the existing manufacturing timeline is, at least, a 0.3% (1/365) loss in potential productivity. In monetary terms, for this particular facility, each 0.3% equates to a potential $18,000 in lost productivity.

The information that follows is taken from observations during the first week of this facility ownership transition and below is a generalized outline representing just one aspect of the operational inefficiencies (created or existing) that were observed :

  • Plant group A put into flowering 4 days behind schedule (4 days x 0.3%) =1.2%
  • Plant group B transplanted 3 days behind =0.9%
  • Plant group C transplanted 7 days behind =2.1%
  • Plant group D (clones) taken 7 days behind =2.1%
  • IPM applications not completed for 7+ days

That equals a 6.3% loss in potential annual productivity, which translates into a rough estimate of up to $378,000 in lost revenue.

Changes to the nutrient program in the midst of the plant’s life cycle had created nutrient deficient plants in all stages of vegetative and flowering growth, coupled with changes to the existing IPM program, all add to the potential losses incurred. Deviations in the plant nutrition program and IPM scheduling are hard to quantify mid-cycle, but will certainly be quantifiable when the hard numbers come home to roost.

These inefficiencies, once compounded, could potentially equal more than a 20% loss in potential productivity during the subsequent 3.5 month plant cycle. The current 60 pounds-per-week would likely be reduced for the next 2 months, down to roughly 50 pounds, or even much less, per-week. This could become a loss upwards of $500,000 in annual potential revenue in the first quarter of operation alone.

These seemingly small and incremental delays in the plant production cycle are all greatly compounded. The end result is that each subsequent cycle of plants is slightly smaller due to delays in transplanting and less days at maximized vegetative growth, etc. Undoubtedly, the cumulative effect of these operational inefficiencies creates a significant drop in the existing level of productivity, with the end result being a significant, undesired loss of revenue.

The sum of the lessons learned from this cultivation facility, is this: a sustainable operation, in the most pragmatic sense, is an efficient one both in terms of productivity and in terms of the carbon footprint and waste generated. The more streamlined and successful the operations are, the greater likelihood of success. Perhaps all of this is to say don’t forget about all the little parts that make up the whole, and strive to create a work environment/corporate culture that empowers your employees, your managers and all involved to participate and contribute to the process of improving the operations for mutual benefit.

Lessons learned from the aerospace manufacturing industry: Even the smallest zip tie on a spaceship matters! Some food for thought: If it’s truly beneficial it should stick around… If it is beneficial and it’s not sticking around, then there are limiting factors in the system that need to be addressed.

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A Case To Not Reschedule Cannabis

By Tyler Dautrich
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As many probably already know, last month the DEA announced that the organization was going to reconsider its position on cannabis and would come to a decision about whether or not to reschedule cannabis on The Controlled Substance Act (CSA) by June of this year. Many would say this is long overdue, considering the DEA has cannabis listed as a Schedule I drug, the same as heroin and LSD.

Rescheduling cannabis to Schedule II would place it in the same category as Vicodin, cocaine, methamphetamine, Adderall, oxycodone, and many more. These substances are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. However, they are recognized as having some potential medical benefits.

If cannabis were to become a Schedule II drug, it would allow further research on the plant. This could be beneficial to the industry because further medical research would finally provide the scientific validation that cannabis does have medical benefits and that it should be accepted as a form of medicine.

Those benefits come with a steep cost.

If cannabis becomes Schedule II it means the federal government finally sees cannabis as a plant (drug) that can provide some medical value. Which, at face value, is good because that is what many advocates have been fighting for. On the other hand, the only reason that larger pharmaceutical companies have largely kept out of the industry so far is because it is a Schedule I drug and the government did not officially recognize that it had any medical value. If this were to change, there is no reason for those pharmaceutical companies to continue watching from the sidelines. There is also no industry better fit than the pharmaceutical industry to run, manufacture, control, and profit from medical cannabis. The infrastructure is already in place.

There is also not another industry that has the money and the historical relationship with the FDA like the pharmaceutical industry. If the FDA were to regulate cannabis, it would have to regulate every single product on the shelf of every single dispensary, which would require more stringent lab testing guidelines. Just because one of your brownies made it through the FDA regulation process, does not mean the cookie next to it will. Entering into this process would take companies years to complete and cost more than $1 billion per product. Think about how many products some dispensaries have. Think about the number of different strains that dispensaries carry. That requires years of testing and multiple billions of dollars, just for the strains.

Big Pharma is positioned perfectly to come in and take control of the entire process if this happens. It will be a mad rush from all pharmaceutical companies to come in and quickly obtain market share. I know that as an industry we think we are seeing a lot of money in sales and profit, but compared to the pharmaceutical industry, it is merely a drop in the bucket. These companies will easily, and willingly, out-spend every company currently in the industry to the point where we can no longer compete. All the work that advocates and business professionals have put in to get the industry to where it is today could be lost.

Schedule II status would also turn the adult-use industry into utter chaos. The only reason we are able to have an adult-use market right now without the interference of the FDA is because cannabis is federally illegal. If cannabis is moved to Schedule II it will be recognized by the government, which means the FDA will have to come in and start the approval process for every product on the shelf. How smoothly do you think that will go for the adult-use retail centers in the industry? The cost alone will force shops to close. There is also not another substance that has a Schedule II classification that we have an adult-use industry for. Could cannabis be the first? I would not want to take that chance with the government or have to go through that process as an adult-use cannabis business owner.

When discussing this matter with several colleagues, some would ask “But what about now? We are in direct violation of the federal law right now, and they are leaving us be.”

Yes, that is for the most part true, but it is true because cannabis is now a Schedule I, federally illegal drug. Meaning the government does not even recognize it. The FDA will not regulate anything that is not recognized by the federal government because they are a federal agency. If the FDA were to implement regulations and an approval process, that would mean that a federal agency is recognizing cannabis as a consumer product. Right now that goes directly against the government’s public stance on the issue. And pharmaceutical companies cannot start selling a drug that is federally illegal and has been classified by the government as having no medical value. But as soon as the government recognizes cannabis as a form of medicine, it opens the doors for these organizations to get involved because it is justifiable now.

If that were to happen all the money that has been generated in this industry, and has made several people very wealthy and successful, will slowly, but surely get stuffed into the pockets of Big Pharma, the FDA and the government.

That is a lot of individuals that stand to lose a very significant amount of money. This could be devastating for Colorado. Colorado’s entire economy is booming right now largely because of the cannabis industry. Colorado’s Real Estate market has seen tremendous growth since legal cannabis took effect with home values going up 13%, which is nothing compared to commercial properties. Cannabis is the driver behind half of Colorado’s tourism, and provided the state with $35 million to put into schools.

In my mind, rescheduling cannabis to a Schedule II substance will create more issues for the industry than it will benefits.

If the government were to take any stance on cannabis, it should completely declassify it. It should not be listed on any type of controlled substance list by the government. It is a natural plant, not a man-made substance. If the government will not declassify cannabis, I would rather them keep it as a Schedule I substance. At least this way it protects the industry and keeps it as is, belonging to the people.

Opportunities like the cannabis industry are once in a lifetime. It would be a shame to see it taken by Big Pharma, or controlled by the government.

For those that have made it this far down on this post, please understand that this is a worst-case scenario. A very drastic, but realistic outcome down one of the many paths the industry could go. But the motto in this industry since the beginning was, “prepare for the worst, and pray for the best.” I think we should follow those instructions now more than ever.


Editor’s Note: This article represents the opinion of the author, not necessarily that of Cannabis Industry Journal. We invite all readers who agree or disagree with the author’s opinion to join the conversation in the comments section below the article.