Tag Archives: patient

How ERP Tech Helps Companies Manage Traceability & Process Control

By Scott Deakins
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Commercial real estate took a dive last year as companies began to work from home, but changing regulatory environments have opened doors to a new industry in need of property: cannabis. Growing rapidly at both the medical and adult use levels, cannabis businesses have been eager to move into vacant buildings, quickly buying up space as more states adjust their laws regarding cannabis.

Cannabis businesses cannot go at it blindly, however. Legal cannabis firms of all sizes – from the smallest startup to the biggest enterprise – will face regulatory challenges, traceability requirements, process control standards and, ultimately, the right technology to keep them moving forward in this promising industry.

Use data to keep track of plants, patients and regulations 

As a highly regulated industry, cannabis companies could be investigated at any time. Regulatory authorities may, at the very least, request proof that they are compliant with state restrictions. Cannabis enterprises will only be able to quickly and easily provide that proof if they have immediate access to accurate historical data. With that information, they can generate the necessary reports at a moment’s notice and maintain a reliable audit trail.

Cultivation is where the tracking process begins.

Historical data is also useful for both growers looking to evaluate why certain plants are more successful than others and for sellers looking to improve their customer experience. By tracking everything from mother plants to clones, growers can build a strong genetics profile and gain a powerful competitive edge. Historical data also aids sellers, who can use it to enhance their digital storefronts and keep track of customer information, shopping history and other details that could improve the e-commerce experience.

In addition to customer details, sellers must also keep track of patient information when selling in a medical-only environment. Prescriptions need to be carefully managed to ensure that patients only receive products that they have been approved to purchase and use.

Utilize process control to foster scalable and repeatable processes

Process control is another vital component that every cannabis grower, manufacturer, processor and distributor must possess. They need scalable and repeatable processes to prevent steps from being bypassed, ensuring that every finished product matches the same high-quality standards. If there are no stopgaps in place, steps could be missed if employees are rushing to meet a deadline or simply think that a particular test or check isn’t needed. Those kinds of mistakes can be hugely detrimental to any cannabis company and may waste product, diminish profits and turn off customers.

PlantTag
A plant tagged with a barcode and date for tracking

Similarly, visibility and control over inventory is a top priority for any business, but it reigns supreme in the cannabis space. Managers should always, at all times, know where the product is as it moves throughout the warehouse, or risk costs and waste. By directly tying scanners and barcodes to the right technology, organizations can ensure that all product is accounted for and easily located using real-time data.

Build a foundation for scalability 

Cannabis businesses don’t have the time to manually keep track of these aspects, and it wouldn’t even be possible as they grow and expand their operations. As they evolve, so too will the list of software requirements that are needed to operate smoothly, reliably and efficiently.

Cannabis processors have traditionally invested in seed-to-sale technology, relying on barcodes to track products throughout their lifecycle. While it is critical for cannabis enterprises to keep a strong level of control over lot tracking, this type of software is very limited. Cannabis firms would therefore be better served by an ERP solution with a single data source that provides centralized, real-time access to vital business information.

ERP technology can also help cannabis businesses better manage their production schedule, material requirements planning, accounting, purchasing, inventory management and document generation. The key, however, is to choose the right technology, avoiding ERP solutions that rely on customizations and bolt-ons, which will impede an organization’s ability to scale. Cannabis businesses should instead use technology that makes all of its features, enhancements and extensibility available to all customers, ensuring that every user has access to the same benefits.

Cannabis Registry Reality Check: Privacy Must be Paramount

By Shadrach White
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The task of preserving privacy for any records platform, especially a cannabis registry, cannot simply be relegated to ones and zeros lurking in some forgotten codebase. This past year taught us many lessons, especially related to the trauma unleashed by vulnerabilities in government domains. We learned time and again that a registrant’s privacy must be the first order of business for the architects of registries.

But the first order of business isn’t the last order of business. That intention and effort to secure privacy must then be communicated and reinforced through real-world reality checks.

Lapses in data security and rising distrust for government institutions block the efficacy of well-intentioned and vital registries. Those states launching new registries in 2021 are at a precarious crossroads as public trust erodes.

As I write this, we’ve just learned illicit operators hacked a third-party service provider for the Washington State Auditor’s office. The attack compromised the personal data of 1.4 million users seeking unemployment benefits. Security hacks are a cautionary tale, whose impact is felt too often.

But many in the government sector are staring at a once-in-a-generation challenge to launch new registries – those related to cannabis – with privacy top-of-mind from the initial Request For Bid.“The question isn’t when these privacy-first registries will be implemented, it’s a question of whether they’ll be implemented proactively ahead of hacks or after the damage is done.”

Here’s how:

Table Stakes for New Cannabis Registries

These suggestions are just the beginning, and I see them as the minimum buy-in to begin the architecture of a new cannabis registry. They include:

  • End-to-end data encryption while in transit and within the system while the data is at rest.
  • A solution that is a cloud-native web application which is managed as a service for maximum uptime and strong security posture.
  • Registries should also leverage algorithms and machine learning to ensure accurate data entry by analyzing incorrect or duplicate data before it is saved within the system.

Beyond HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) requires privacy and security measures to protect Personal Health Information (PHI). Debate exists on whether compliance is a requirement for all entities transacting in the medicinal cannabis space. While some state registries are exempt from HIPAA, others choose to provide HIPAA compliance not just for the optics, but the known benefit to users’ privacy and confidence. New cannabis registries should commit to HIPAA-compliance to set a trusted new privacy standard for medical patient credentials and legal authorization for the use of cannabis for medical purposes.

That’s just the start. Registries should also ensure SOC2 Type II certification, which safeguards security, site availability, confidentiality and privacy through independent third-party auditors.

Connect with Confidence

Registries function as a hub of information in an often-confusing cannabis space. The California Bureau of Cannabis Control displays more than 25 links wired into its top navigation bar alone. Each link sends the curious to new resources. Registries must establish themselves as credible resources, especially when directing users to third-party sites.

One example is for cannabis registries to provide secure access to healthcare professionals who are verified by the Drug Enforcement Agency (DEA). These healthcare professionals are licensed to distribute controlled substances including cannabis. Each third-party link should offer the same high-level of scrutiny to enshrine confidence and credibility in the registry.

Next-Generation ID Cards

A cannabis registry card should not just be a document, but a toolset that attests to the identity and the authority of the carrier represented. An illicit counterfeiting market seeks to exploit registry card vulnerabilities. Next generation ID cards present the best defense against counterfeiting and illegal use with robust security measures. That starts with assuring that any credential is mobile ID compatible with iOS Wallet and GooglePay for mobile identification.

ID cards should also include:

The automated modification of the document bearer’s photograph to ICAO (International Civil Aviation Organization) standards. This critical modification makes the photograph easier to use for ID verification; it also facilitates the detection of photograph substitution.

A two-dimensional barcode compiles information contained in a one-dimensional barcode. It also delivers confirmation of other data shown on the card or in the system such as license authorization and limitations. Adding additional material to the physical document such as holograms, UV image, micro-printing or laser perforations offers another level of protection against illicit use or counterfeiting.

While cannabis registries are the beginning, they’re not the end. Driving efficacy for government registries needed for COVID19 track-and-tracing, cannabis plant track-and-tracing and vaccine distribution require the same attention to privacy, security and ultimate useability. A sea change is required – not just for the sake of those who use the registries but also for those who must implement, deploy and maintain those registries. The question isn’t when these privacy-first registries will be implemented, it’s a question of whether they’ll be implemented proactively ahead of hacks or after the damage is done. I believe the government sector leaders exploring new cannabis registries offer the wisdom and foresight to choose the proactive approach.

New Book On Cannabis Describes A Global Market In Transition

By Marguerite Arnold
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Editor’s Note: This piece is an excerpt from Marguerite Arnold’s Green II: Spreading Like Kudzu. Click here to buy the book.


THC as of February of 2019, certainly in the recreational sense, was not much seen in either Switzerland or much of Europe. Even in Holland, the coffee shops were getting more regulated along with the supply chain for them. In Spain, the cannabis clubs thrived in a grey area. But outside of these two very narrow exceptions, the biggest, most valuable part of the cannabis market (medical and THC) was just as fraught with similar kinds of issues. And those were occurring not in Spain, Holland or even Switzerland, but just across the border, in Germany.

In fact, the real news on the industry side in Europe, as it had been for the past few years, was not the consumer CBD market, however intriguing and potentially valuable it was in the foreseeable future, but the medical, and “other” cannabinoid universe that included THC. And the real triggering event for the beginning of the European march towards reform was certainly influenced by what happened both in the United States and Canada as much as Israel. Where it landed first and most definitively was not Holland, circa 2014, or even Switzerland or Spain soon thereafter, but rather Deutschland.

Green II: Spreading Like Kudzu

The Canadian market without a doubt, also created an impetus for European reform to begin to roll right as German legislators changed the laws about medical cannabis in 2017. But even this was a cannabis industry looking to foreign markets that they presumably knew were developing (if not had a direct hand in doing so, including in Berlin, come tender-writing time).

Divorced from inside knowledge about moving international affairs, why did Germany – certainly as opposed to its certainly more “liberal” DACH trading partner Switzerland- suddenly turn up in the summer of 2016 as the “next” hot thing for Canadian cannabis companies?

The answer is in part political, certainly economic, and absolutely strategic.

Germany is in the EU, unlike Switzerland, and is a G7 country.6  It also was, by 2016, certainly much closer to legalizing federally authorized and insurer-reimbursed medical use cannabis. This was because sick patients had by this time successfully sued the government for access (including home grow). And the government, citing concerns about the black market and unregulated cannabis production (see Canada) wanted another option.

Not to mention was a market, certainly in 2016, helped with a little CETA inspired “juice.”

The international trade treaty between Canada and the EU (if not the other big treaty, the pharmaceutically focused Mutual Recognition Agreement (MRA) with the U.S.) has been in the back of the room throughout the entire cannabis discussion during the expansion of the Canadian industry across Europe.  It is still unclear at this writing if the juxtaposition of CETA and the start of the Canadian cannabis trade had anything to do with lengthening the process of the German cultivation bid – but given how political the plant had also become, this was at this point more than a reasonable assumption to make.

As a result so far at least, since the beginning of the real German cannabis market in 2016 (namely the beginning of an import market from not just Holland but Canada) and Europe beyond that, Canadian companies have played an outsize role (starting with bankrolling operations in the first place). The growth of the Canadian market as well as developments within it absolutely spawned if not sparked the change if not beginning of the changeover within Europe by starting, of all places, with Germany.

Marguerite Arnold, CIJ contributor and author of Green II: Spreading Like Kudzu

But again, why Germany? And why the coalescence of the industry as well as other Euro hot spots outside its borders since then?

There are several explanations for this.

One is absolutely timing and strategic positioning.

Germany had, since 2015, begun the slow process of dealing with the medical cannabis issue on a federal basis, informed if not greatly influenced not only by what was happening in events abroad in Canada and the U.S. but also Israel. At home, there was also pressure to begin to address the issue. Albeit highly uncomfortably and at least in the eyes of the majority of centrist legislators, as far at a distance as possible.

Namely, patient lawsuits against insurers began to turn in favor of patients. Technically, between the turn of the century and 2016, patients could buy cannabis in pharmacies with a doctor’s prescription in Germany. But it was hugely expensive and beyond that a cumbersome process. Only 800 patients in fact, by 2017 had both managed to find doctors willing to prescribe the drug and could afford the €1,500  (about $1,700) a month to pay for it.

Everyone else, despite nobody’s willingness to admit it, found their supplies in the grey (non-profit patient collective) or black (street and largely criminally connected) market.

Günther Weiglein, a patient from Wurzburg, a small town in Bavaria, changed all of that.

In 2015, he won his court case against his insurer, claiming that even though he qualified as a patient, he could not afford the cannabis for sale in pharmacies. With that, he and a few patients temporarily won the right to grow their own (with permission).

Weiglein is the epitome of the German “everyman.” Blond, stocky and in his fifties, he has suffered chronic pain since a devastating motorcycle crash more than two decades ago. He has also taken to the cannabis cause with a dedication and singularity of purpose that sets him apart even from most other patient activists (in Germany or elsewhere). He is fiercely independent. And not afraid of expressing his desire for a “freedom” that has not yet come.

However, in 2015, there seemed to be several intriguing possibilities.

Indeed, at the time, it seemed possible, in fact, that Germany seemed poised to tilt in the direction of Canada – namely that patient home grow would be enshrined as a kind of constitutional right.

However, it did not turn out that way. Desperate to stem the pan European black market, which is far more directly connected to terrorism of the religious extremist and Mafia kind in these waters and to avoid a situation where Berlin became the next Amsterdam, the German parliament decided on a strange compromise.

On one level, it seems so predictably orderly and German. If cannabis is a medicine, then Germans should be able to access the same through national health insurance.

In fact, however, the process has been one that is tortured and has been ever since, not to mention compounded the difficulties of just about everyone connected to the market. From patients to producers.

“In practice it has so far not evolved quite so smoothly.”Here is why. The government decided that, as of passage of a new law which took effect in March 2017, the German government would regulate the industry via BfArM, the German equivalent of the American Food and Drug Administration (FDA), and issue formal federal cultivation licenses.

This makes sense from a regulatory perspective too. Cannabis can be used as a medical drug. Even if its definition as a “narcotic” – even on the medical side – leaves a lot to be desired.

This is especially true on the CBD part of the equation. It is even more particularly relevant for those who use THC regularly for not only chronic pain, but as an anti-convulsive or anti-inflammatory agent.

However unlike Canada, the German federal government also chose to revoke patient grow rights while mandating that insurers cover the cost of the drug if prescribed by a doctor. In practice also spawning a specialty distributor market that is still forming.

All very nice in theory. In this abstract world, these rules make sense for a pharmacized plant if not drug beyond that. This is the route all other medicines in Germany take to get into the market if not prescribed in the first place.

In practice it has so far not evolved quite so smoothly. Indeed, while understandable for many reasons from stemming the black market to setting standards, this rapid switch from patient or collective grown cannabis to requiring patients to interact with both a doctor and a pharmacy (beyond the insurer) with no other alternative also creates its own serious problems. For everyone along the supply chain. But most seriously and problematically for both patients and doctors.


Support Marguerite Arnold’s work by buying your copy of Green II: Spreading Like Kudzu from us! 

How GW Pharma Won CBD

By Cathleen Rocco
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As of this writing, the United States Food and Drug Administration (FDA) has approved GW Pharma’s CBD drug Epidiolex for treating profound refractory pediatric epilepsy syndromes (Dravet syndrome and Lennox Gastaut syndrome) as well as for treating seizures associated with tuberous sclerosis complex (TSC) in patients one year of age or older. The product is a very simple, orally-administered formulation comprised of 100mg/ml cannabidiol (CBD), dehydrated alcohol, sesame seed oil, strawberry flavor and sucralose – basically, an alcohol-based solution with sesame seed oil to help solubilize the CBD oil, flavoring and sweetener.

GW logo-2On April 6th, 2020 GW Pharma performed a regulatory miracle when they succeeded in convincing the Drug Enforcement Administration (DEA) to deschedule Epidiolex (i.e., remove it from the Schedule 1 and Schedule 5 lists of substances that the agency regulates due to concerns regarding safety, potential for abuse or both) for all indications – including indications for which it has not yet been approved by the FDA.1 The benefit to GW of having their product descheduled is incalculable. This status change removed potential barriers to insurance reimbursement and made the need to set up and administer an expensive REMS2 drug safety program less likely. In part because of this regulatory coup d’état, the drug recently posted yearly earnings of nearly $300 million.

It is important to note that the DEA descheduled the Epidiolex formulation and not cannabis-derived CBD itself. Thus, GW Pharma is now in the enviable position of being the only company that can legally sell cannabis-derived CBD. More importantly, because the DEA descheduled the formulation and not the active ingredient, other companies who wish to market cannabis-derived CBD pharmaceutical formulations will have to repeat whatever it is that GW did to get Epidiolex descheduled.3 The DEA effectively gave the company a huge head start with respect to competitors who are developing other cannabis-derived CBD formulations that would compete with Epidiolex. That advantage will remain in place unless and until cannabis-derived CBD itself is descheduled or cannabis is legalized at the federal level.

GW Pharma’s CBD drug Epidiolex, which is FDA-approved to treat profound refractory pediatric epilepsy syndromes

GW Pharma’s attorneys demonstrated considerable virtuosity in devising this approach. However, there is another aspect of the GW Pharma story – one that could have profound implications for the exploding CBD consumer packaged goods (CPG) industry. The Federal Food, Drug, and Cosmetics Act4 (FFDCA) prohibits the introduction into interstate commerce of any food to which has been added an approved drug or a drug for which substantial clinical investigations have been instituted and made public.5 Because CBD was and is still the subject of clinical trials run by GW Pharma and others, even hemp-derived CBD is currently illegal to use as a food additive or dietary supplement under the FDCA

The FDA has recently re-started the public commentary stage of a long process that will hopefully result in the creation of a regulatory pathway for CBD to be used as a food additive – something that would seemingly be a straightforward matter given the copious amounts of safety data being generated from all of GW Pharma’s clinical trials. However, as long as the FDA continues to drag its feet in providing a regulatory pathway for CBD CPG products, CBD, regardless of its source, will remain illegal to use as a food additive or supplement under either the CSA or the FFDCA despite the existence of safety data obtained through the Epidiolex clinical trials. If, as many people in the industry anticipate, the agency decides to begin enforcement action, this could have a hugely negative impact on the industry.

In addition to the potentially disastrous effect that federal law could have on an important new industry, the federal regulatory scheme introduces unnecessary regulatory complexity and cost by imposing two different regulatory schemes depending on the source of the CBD. CBD derived from hemp is chemically identical to CBD derived from cannabis. Despite that identity, the 2018 Farm Bill nonsensically exempts only hemp-derived CBD from the Controlled Substances Act. If a regulatory pathway is created for hemp-derived CBD, but the DEA insists on maintaining cannabis-derived CBD as a schedule 1 substance, then the same molecule will be subject to two different regulatory schemes. This scenario would require tracking and certifying CBD sources and thereby impose regulatory and economic burdens that are entirely unnecessary from a public health point of view.

FDAlogoAn alternative, economically disastrous scenario: given the pharmaceutical industry’s formidable lobbying power, it is entirely possible that the FDA could decide to limit the use of CBD exclusively in prescription drug formulations. This could kill the entire US hemp CBD CPG industry, currently estimated to reach $22 billion by 2022.6

Overall, the current state of affairs is unfair, expensive, uncertain and entirely unworkable over the long term. The CSA must be amended, ideally to deschedule both hemp and cannabis entirely, but at least in the short term, to deschedule CBD and preferably all non-THC cannabinoids regardless of their source. Further, the FDA must provide a regulatory pathway to allow the use of low doses of cannabinoids shown to be safe, either by existing clinical trial data or future testing pursuant to the NDIN submission process.

A 2019 Gallup poll found that 14% of Americans – 1 in 7 – use CBD products.7 The demand is there, the industry is thriving, and adequate safety data exists to justify a regulatory system that allows low-dose over the counter CBD products provided those products are produced using Current Good Manufacturing Practices (CGMPs) for food and dietary supplement manufacturing prescribed by the FDA and that such products undergo regular testing that demonstrates they are safe, unadulterated and accurately labeled. It is time for the industry to collectively fund a New Dietary Ingredient Notification (NDIN) submission that would provide safety data sufficiently compelling to force the FDA to either recognize CBD and other non-THC cannabinoids as being GRAS substances regardless of their source, or in the alternative create a regulatory path for CPG products containing low-doses of CBD and other non-THC cannabinoids.

Editor’s Note: The opinions expressed in this publication are those of its author. They do not purport to reflect the opinions or views of the Cannabis Industry Journal, its editorial staff or its employees.


References

  1. Clincialtrials.gov lists 256 different clinical trials in which Epidiolex has been, is being or will be tested for a wide variety of other indications, including but not limited to opioid use disorder, several types of prostate cancer, alcohol use disorder, musculoskeletal pain, and a host of others.
  2. REMS – risk evaluation and mitigation strategy – are drug safety programs that the FDA requires in cases where mediations pose serious safety concerns with respect to potential abuse and other adverse effects.
  3. Exactly what they did isn’t clear, and won’t be for a long while given the snail’s pace at which FOIA requests are filled.
  4. Title 21 United States Code Chapter 9
  5. Title 21 United States Cod Chapter 9, Sections 331(ll), 342(a)(1) and Section 342(d)(f)(1)
  6. “Exclusive: New Report Predicts CBD Market Will Hit $22 Billion by 2022” Rolling Stone Magazine, September 11, 2018, citing cannabis industry analysis from the Brightfield Group.
  7. Gallup poll on American CBD product usage

Do Varying Cannabis Laws Adequately Serve Patients, Businesses or Government?

By Jason Warnock
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Cannabis laws are changing at a rapid pace across all 50 states and around the world. Currently, Cannabis is legal in 11 states for adults over the age of 21, and legal for medical use in 33 states.

Across the nation, many states have been struggling to enact a viable medical and potential adult use cannabis system since Initiative 59 and the “Legalization of Marijuana for Medical Treatment Initiative of 1998.”

Unfortunately, the program has been continuously impacted by the federal government’s presence, first with the passage of the Barr Amendment by Congress overturning the early legalization progress and continuing to delay the onset of the first medical sale at a dispensary until 2013. The federal government continues to exert influence and control over the program expansion including adding Congressional riders on every proposed update including the latest “Safe Cannabis Sales Act of 2019.”

In Washington DC for example, 18 organizations including the National Cannabis Industry Association (NCIA), the ACLU and Law Enforcement Action Partnership petitioned the US House and Senate Financial Services Subcommittees to remove the rider given that “[the] Current law has interfered with the District’s efforts to regulate marijuana, which has impacted public safety. Without the ability to regulate marijuana sales, the grey market for marijuana flourishes despite the need and want of the District leadership and residents alike to establish a regulatory model.”

States with limited availability of medical cannabis, possession laws or with the ability to legally gift up to one ounce and the constant pressure by the federal government, the grey market has expanded with public safety and the safety of these pop-up businesses put at risk. The current state health and safety laws require a seed-to-sale tracking system and testing at independent labs for all medical cannabis, however the grey market consumers are afforded no such protection. The District of Columbia is unique in the US cannabis landscape as it grapples with the local government trying to provide clarity, safety and equity to a medical and adult use community, but it is hampered by what it can and cannot control through federal influence.

As the United States continues to recover from the effects of the COVID-19 pandemic, control and use of tax revenue will move to center stage in all these communities and the cannabis tax revenue will return to focus.

Cannabis tax revenue has shown a massive disparity between projection and reality. In 2018, California projected upwards of one billion dollars in cannabis tax revenue, but in reality was only able to recover a third of that amount. California in response continues to increase the excise tax and even proposed changes to taxes dependent on the amount of THC, creating new pressure on producers, in-part pushing some back into the grey market.

During the pandemic, Colorado enacted emergency rules to extend cannabis sales online. Allowing customers to pay for cannabis via the web and then pick up their purchases at the store. In a testament to what is considered a “critical businesses” the cannabis industry is given opportunity to expand during the pandemic, but still hampered by severely limited access to standard e-commerce options as credit card merchants still remain concerned that cannabis sales are illegal under US federal law. Alaska, Massachusetts, Michigan, Illinois and Oregon also allowed online sales and curbside pick-up, but remain limited in sales as federal banking and access to credit is limited as the Secure and Fair Enforcement (SAFE) Banking Act remains in limbo.

Overarching technologies such as DNA tracking that provide a clear indicator that the cannabis is produced and tested from legal sources, can be proven safe and protects local legal businesses’ products against out of market cannabis would provide such clarity.

As the country moves forward from the COVID-19 health crisis, all legal and safe ways to rapidly restart the economy will be needed, the cannabis economy will be no exception. We should be looking to this emerging market right now to help safely drive revenue and taxes into our states.

Soapbox

A Response to Governor Wolf’s Call for the Legalization of Recreational Cannabis

By Chris Visco
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As a medical cannabis professional, I, like most industry leaders, have been left out of the conversation around the Governor’s call to legalize recreational cannabis. Much like flying a plane without the advice of the pilot, those of us who are rooted in this space should be given a seat in the cockpit if we’re headed in this direction.

While Governor Wolf has called for legalization, which is absolutely necessary, those who understand where legislation has gone wrong and what works well – including business owners and most importantly, patients – have been largely left out of the conversation.

I meet regularly with legislators and unlike many, I speak and listen to both sides. I applaud the call for legalization by Governor Wolf, however, I question his true intentions. Is this political posturing to make Republicans look out of touch? Any political strategist would say that if you actually want something done, you must work with the opposition. Like many issues today, change can only be created once we come together. This is no different.

Few people understand that cannabis was used as medicine for thousands of years and legal in the U.S. until 1969. In 1971, Nixon told us that cannabis was “bad” and drug abuse was public enemy number one, so Americans listened. Nixon then goes on to break American law, be impeached, resigns, and yet, Americans continue to follow his lead, vilifying cannabis users, 46 years later. As a society, we are taught to conform to what we are told by elected officials and community leaders as truth.

PA Governor Tom Wolf
Image: Flickr

Act 16 legalized cannabis – a term illegal to use by someone like me, who has been mandated by The Commonwealth of Pennsylvania, to use ONLY the racist term “marijuana” – but in a way that shames users. The system fails our patients at every turn leaving business owners hostage to an unmanageable “seed to sale” platform, leaving many patients without access to their medicine. Low income patients have been left out of our program by high prices and have not received any of the subsidies they were promised, even though the program has produced hundreds of millions of dollars.

Pennsylvania law strictly prohibits anyone charged with the use of cannabis to work in the industry. You cannot own a cannabis business or work for a cannabis company if you have been arrested for possessing a $10 joint. Yet, my customers skip to their cars with hundreds of dollars of weed in their bags and go about their day. Meanwhile, a 19-year-old black kid’s life just ended after he was pulled over, driving while black and the officer finds a joint. He can never receive financial aid for college or get a job because he has “a record.” The reality is, the black teen’s life will most definitely come to an end because of a joint while others can smoke walking down Broad Street and no one blinks.

Pennsylvanians want legal cannabis. It has a consistent history of reducing opioid deaths, state by state, by 25%. How many lives would be saved if we allowed those who cannot afford legal cannabis but fear prosecution for illegal use, to grow their own?

I have no judgement against those who have been conditioned to believe cannabis is an “illicit drug” because this is how we’ve been programmed. Cannabis has healed but has killed no one. We must educate our legislators before we vilify them. There are more Republicans quietly for legalization than against, but they need information, not shaming.

Legalization of cannabis is necessary to preserve our health and welfare, because we’ve become a society addicted to chemically derived pharmaceutical drugs designed to cause dependence. Cannabis is not physically addicting. It can prevent and eliminate seizures, shrink and even kill cancer tumors, settle the nervous system from diseases like Parkinson’s and MS and help those with anxiety, depression and PTSD. Legalize cannabis and clean up our homelessness, allow people of color to profit from an industry which has capitalized on them, allow low income people and all people to grow their own medicine, and reduce the violence in our streets caused by prohibition.

Pennsylvania needs a legalization law that includes real, hard-working Americans. I am one of the few, born and bred small business cannabis owners in Pennsylvania and I want opportunity for my neighbors and fellow Pennsylvanians in this space. We need legalization to save our communities, but we need two separate application processes – one that is directed toward those disproportionately impacted by the war on drugs which should be crafted to protect applicants who cannot afford thousands of dollars of application fees and the uncertainty of losing hundreds of thousands of dollars via legislative delays. The system is broken. There must be two points of entry.

Pennsylvania Republicans will legalize cannabis. Pennsylvania Democrats will not. Democrats hold no power or authority in our Republican controlled state, and they have shown no attempt to educate. Cannabis legalization is necessary to save the state, but money should not be the reason. Pennsylvanians deserve the education to understand what they do not understand.

Instead, lets legalize and allow 50% of the licenses to be awarded to social equity applicants (those disproportionately affected by the war on drugs) with a bill that is written in the best interest of the social equity applicant and the consumer. The other 50% of the applications should be open to current license holders (who should be grandfathered in with a high price license acceptance fee) and small business owners from Pennsylvania. (It is federally illegal to require residency requirements).

We must not eliminate the Multi State Operators (MSOs) because a free market depends on expertise and stability – and whether anyone wants to hear it or not, being disadvantaged is not enough to be a successful businessperson. We need a balance, but more importantly, as with our nation in crisis, we need to come together.

We CAN 

  • Provide affordable, non-addictive medicine to patients.
  • Allow people to grow their own cannabis.
  • Create BILLIONS in tax revenue nationally by taxing adult use cannabis.
  • Demand social equity reform where anyone can profit from the plant.
  • Free Americans from prisons and parole and expunge records.

All of this is a cry for peace. As a wise person once said, “Drunk men in a bar start a fight, high men start a band.”  Spread peace not hate. Thousands die from excessive alcohol consumption every year, but legalization of cannabis does not increase usage. No one has ever died from cannabis. Tell me again why we shouldn’t legalize? Those who believe we should not might as well push for alcohol prohibition again – it has no medicinal properties and kills.

Hopes and dreams will not help our humanitarian crisis – but action and education just might…

german flag

Shakeups In The German Cannabis Market

By Marguerite Arnold
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german flag

As Germany begins to enter a summer where life seems ever more normal, there are fairly major shakeups underway in the German cannabis market. These are structural but will have a profound impact on the entire market going forward.

A Mass Of Distribution Licenses
It is an interesting metric to understand that before 2015, there were no specialty cannabis importer/distributors in Germany. As of July 2020, there are rumors that this number has now shot to close to 80 (either licensed or in the process to become licensed). That is a huge number. So was the last amazing number (40) as of the beginning of this year. Just the previous estimate would mean, literally, 1 specialty cannabis distributor for every 2 million Germans. That obviously is not sustainable. What it does indicate is the huge surge of interest in medical cannabis not to mention acceptance, as well as the amount of money actually now beginning to slosh around in the domestic market.

And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.How many of these distributors will survive is another question, particularly in an environment where the government is looking for just one to fulfil the needs of all of Germany’s pharmacies from what is grown domestically. This does not of course mean the end of specialty distribution. Indeed, far from it. There is not enough cannabis entering the market, presumably this fall, that is grown here to even come close to meeting demand.

No surprises here. This has been one of the enduring criticisms of the entire process, if not the bid itself since 2017.

However, one thing this does mean is that distribution fees, like pharmacy fees for processing the plant before them, are finally hitting a price adjustment phase.

This is also going to be good not only for patients, but also health insurers.

For all the standardization of the industry, including fees and mark-ups, one of the strangest things about the German cannabis market is how widely cannabis prices can differ even between pharmacies. This is as true of flower as it is of dronabinol.

The Wholesale Price Of Medical Cannabis Is Dropping
Again, no surprise here, the government will end up buying more cannabis than contracted for under the original bid. This was actually anticipated in the language of the contract that currently exists between the government and the three bid winners. Namely, an automatic 50% reduction in price is mandated for any cannabis sold beyond the 120% agreed upon qualities.

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Photo: Ian McWilliams, Flickr

The growers domestically, in other words, who won the bid will be under a severe price restriction. This may have been the ultimate strategy of the government to begin with (namely to attract foreign capital and expertise but then begin to reign in the sky-high prices of medical cannabis so far.)

This means that the price of €2.30 a gram will undoubtedly fall. Where it will float is anyone’s guess, but right now it appears on course to hit about €1.87. Or about the same price that other governments across Europe (notably Italy) had previously negotiated with the big Canadian cannabis companies (notably on this one, Aurora’s military contract in Italy).

Implications For The Import Market
With domestic producers under the gun, this also means that all imports will begin to feel the price squeeze too. And that will also have a significant impact on point of sale cannabis prices.

And that spells good news for both patients and insurers. The rest of the industry, however, will be under further pressure to reduce cultivation and operation costs to meet the challenge.

Will Australia’s Cannabis Program Follow Canada’s Lead?

By Marguerite Arnold
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The news is intriguing in a world overwhelmed with pandemic news. THC Global, a Canadian-Aussie company now raising money and signing global deals, has just bought a “clinic network” of 30 prescribing physicians that will be able to supply up to 6,000 Australian patients this year.

In doing so, this entity is clearly beginning to establish a pattern of expansion in a new medical market not seen so far outside of Canada. Namely being able to obtain the all-important prescription for one’s brand at the doctor or prescriber’s office which is affiliated with a certain producer. Pharmacies and dispensaries downstream have no discretion for any other product to sell if the brand is written right on the prescription itself.

And this marks a new step in an industry frustrated with the high prices and high levels of red tape in other international environments where more widespread medical cannabis reform has come.

The Situation in Germany
Germany represents, so far at least, the destination market of choice for Canadian cannabis firms (for the last several years at least). This is for several very sound business reasons (at least in theory).

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Photo: Ian McWilliams, Flickr

The German medical market is the largest in Europe. Health reforms which swept the country at the time of reunification also created a system that is in its own way a hybrid of the more European (and British) NHS and American healthcare. Namely, 90% of the German population is on the system, but it is tied to employment and income. Freelancers, even of the German kind, must use private healthcare as must all non-passport foreigners. If you make over a certain amount of money (about $65,000), you must also pay for private healthcare. As the cannabis revolution rolls forward, many cannabis patients are caught in changing rules and a great reluctance by public health insurers to allow fast entry of any new drug, including this one. This is based on “science” but also cost.

Bottom line? Yes, the market is lucrative and growing, and yes, cannabis is covered under public health insurance, but the ability of any producers to be able to maintain a reliable, steady market of “prescribers” is highly limited. Furthermore, unlike anywhere else in the world, pharmacists play an outsized role in the process – namely because there are no chains (more than four brick and mortar outlets are verboten). Prices and availability vary widely across the country.

There are also no “online” drug stores where patients can send prescriptions in the sense that this vertical has developed in other countries.

Hospital dispensation is, for all the obvious reasons, highly expensive and generally prohibitive for the long term, if not serving much larger numbers of patients.

The Problem in the UK
Like Germany, the UK decided to launch medical “cannabis” – or at least cannabinoid-related drugs under the purview of the NHS, but there are several issues with this.

Epidiolex-GWThe problems start with the fact that the system remains a monopoly for one British company, GW Pharmaceuticals. The medication produced by them, including Sativex and Epidiolex is expensive and does not work for many patients that it is produced “on label” for (such as MS or childhood epilepsy).

And then of course, the largest group of cannabis patients anywhere (chronic pain) have been explicitly excluded from the list of conditions cannabis can be prescribed for under public health guidelines in the UK. This, like Germany, has created a highly expensive system where those patients who obtain the drug on a regular (and legal basis) have to have both private healthcare and obtain help through private clinics. While there are several chain clinics now forming in the UK, this is not the same thing as “buying” patients in the thousands – the model seen in Canada from the beginning of 2014.

The market has a lot of potential, in other words, but like Germany, via very different paths to market than seen in Canada, in particular.

Why Is Canada Different?
The development of the medical market came through federal change in the law around the turn of the century. Namely, after patients won the right to grow for themselves, via Supreme Court legal challenge, patient collectives gradually formed to grow and sell cannabis that was more “professionally” cultivated. This, in turn, became the right of private companies and indeed household names in the Canadian market saw buying patient pools as their path to financing on the equity markets as of 2014.

This is not widely popular within the industry. Indeed, the last legal challenge mounted by the industry to ban non-profit patient collectives fell apart in 2016 – the year that the larger Canadian companies began to look abroad to Europe.

It is also undoubtedly why, beyond the red tape they face in Germany and the UK if not across Europe, Canadian firms are looking to hybridize a model which worked well for them at least in the early days of capitalization of the private industry. And maybe Australia will be “it.” Stay tuned.

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Access to Cannabis Is About to Get Easier in UK

By Marguerite Arnold
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As of March 2, right before the UN punted on reclassification of cannabis at the international level for another nine months, the UK government eased import restrictions for people in search of the drug.

Specifically, licensed wholesalers will now be able to import larger quantities of cannabis-based products and hold supplies for future use by patients with prescriptions.

Previous restrictions meant that patients had to wait for weeks or months to obtain the still highly expensive drugs (an import license from Canada can take 8 weeks).

Essentially, while welcome, this also means that every single potential cannabis patient who does not suffer from epilepsy or MS must import, via private means, a drug that is still unbelievably expensive. Those with the means are subjected to high prices and bureaucratic complications (like a regular thirty-day review of the prescription).

Cynical Cannabis Moves

While those who can afford to pay approximately $1,000 a month now have options, this is not exactly cannabis reform that is inclusive. Indeed, the entire conversation appears to be about making sure that private companies make profits rather than scientific advancement.

While the government is planning to engage with patients and to participate in trials to figure out how the NHS can utilize the drug, this is little help for sick patients now. Particularly in the middle of a global pandemic and almost as surely, global recession.

Soundbites by government ministers are also putting a cheery face on a situation that is dire, not just because of access but because of cost.

Per British Health and Social Care Secretary Matt Hancock, “We still have a long way to go. We need more research into the quality and safety of these medicines, and to do all we can to cut down the costs and remove barriers so that, when appropriate, patients can access it, including on the NHS.”

How long that might be, however, is anyone’s guess. This discussion has now stuttered on for the last several years domestically.

Why all the Delay?

As recent events, including not only Brexit and cannabis reform, but indeed the now global pandemic have proven, healthcare systems globally are not up to the kinds of threats now thrown in their direction. Designed mostly after WWII, with a far different tax and economic base to support them, as well as far different demographics, most are also clearly not up to the rigors of the 21st century.

It is not just the supply chains for cannabis or even pharmaceuticals that are in the mix of course. Food security in the UK is now also, according to one international expert, Tim Lang, World Health Organization advisor, “in serious trouble.”

The Covid-19 pandemic, in other words, caught the world with its pants down, despite numerous warnings and even models predicting almost exactly this situation as recently as last year. Just like the AIDS crisis. This time, however, there are options available.

The question is, will governments and international organizations rise to the challenge to meet them?

A New World Drug Order

The British, while behind the Germans, are unfortunately, delaying a decision which has been already extended for too long. Relaxing drug import rules are one thing. But recommendations about the uses of the drug are still very narrow in the UK (even more stringent than in Germany).

Beyond that, overall food and drug security (supply chain) issues are in the room and for drugs far from cannabis. As many have begun to point out, cannabis is now prescribed for patients (and in many countries) and these patients are the most vulnerable to a virus like Covid-19. They are vulnerable not just because their immune systems are weak, but frequently because they are also economically exposed.

As the world battles another retrovirus pandemic, perhaps it is time that the lessons of the past be learned by those with the power to make decisions that will ultimately affect billions of people globally.

Doctors & Researchers Push Medical Efficacy Forward at 10th IACM

By Marguerite Arnold
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It is easy to forget as one steps inside this world-class medical conference (held this year in Berlin), that cannabis is disputed as medicine anywhere in the world.

Inside a packed conference hall in an upscale hotel in East Berlin, international researchers presented evidence that when taken as a drug, this simple plant can make a world of difference to patients suffering from a range of illnesses.

There were also doctors who talked about prescribing this as medicine (even to children), with dramatic and affirming results (if not heart-warming pictures).

In sum, as always, the IACM is the best place to find facts if not evidence galore to convince even the most hard-boiled egghead that this drug works – and across a broad range of so far “other” drug-resistant medical conditions.

As a participant in the IACM said after the opening remarks on the very first morning, it is so easy to ask the question – “Why are doctors still so afraid of if not resistant to this drug?”

Medical efficacy is no longer an unanswered question…

For those seeking affirmation and evidence, this year’s IACM did not disappoint. There were presentations on the drug’s impact on neurological, oncological and inflammatory conditions that while not all new, are increasingly impactful in an aging planet.

A full house of attendees for the patients panel

But that is not all that was discussed. The broader implications of adding cannabis into skincare, diets and medicine chests were also presented – from cannabis’ impact on lowering obesity and positively affecting acne to impacting the opioid epidemic.

Also intriguing this year was a far-reaching study on how polluted the CBD supply chain is in Europe, even for non-medical and nutraceutical products. Not to mention a socio-political plea for legalization of personal use in South Africa.

And that was just the presentations from the stage and in the poster hall.

The conversations swirling around were just as interesting. Because of course, nobody at this three-day gathering, for all the normalization on display, did forget that this gathering of doctors, scientists, cannabis companies and patients is still an anomaly.

The fact is that there are still too few doctors prescribing. And too few trials. And too many fights over efficacy still in the room.

As Alice O’Leary Randall (wife and former partner in activism with her late husband, Professor Randall who initiated the medical efficacy fight in the U.S. in 1975 over glaucoma) said to Cannabis Industry Journal, “It is hard to believe that we are still fighting the same fights all over again.”

Another “AIDS” Crisis?

There is a more dramatic sense of urgency at the IACM than other conferences that focus just on the “business.” In part, this is because the conference is made up of not only doctors and researchers who fight to prescribe the drug or get trials funded, but also patients on the front lines in a country where the drug is supposed to be covered by health insurance.

Dr. Franjo Grotenhermen (seen on the table) and others during a panel discussion

The patient panel, as a result, was an international face of accusation: To national authorities who still refuse to mandate cannabinoid care – across Europe and beyond. To medical establishments who are not demanding cannabinoid treatment be made mandatory in hospitals and emergency rooms in every country in the EU and beyond. To individual doctors who refuse to come to such conferences, where, if they wanted to, could learn how to begin prescribing the “next penicillin.” To payers and insurers who are still too slow to pick up the message if not the tab.

Indeed, one of the best panels of the conference was a gaggle of doctors, led by Grotenhermen, who discussed the particulars of approaching a new drug – for the very first patient and first time.

Act Up, Speak Out, Silence Equals Death

As the conference wrapped up with its awards dinner, there was of course, a sense of needing to go home with not wanting this to end. For those in the thick of this multi-generational fight, there of course were words of encouragement to colleagues from the industry, internationally. But there was also a new sense of needing to up the pace, if not create faster change.

The battles are far from over – in fact, they are just beginning in many places. As one questioner said of a panel about halfway through the conference – “We need to pick up the fight the same way the AIDS community did on this drug.”

That remark perhaps means less today than it did 20 to 30 years ago when an embattled LGBTQ subculture was the organized point of the spear that fought the early state legalization battles as pioneers for a cause that sought equality as much as it sought a cure.

The plea did not fall on deaf ears.

In the midst of studies, statistics and scientific evidence, in other words, there was a new sense of a need for a renewed fight – and from the medical and scientific community as well as patients.