Tag Archives: medical

Health Canada Issues Voluntary Cannabis Recall Guide

By Marguerite Arnold
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Last month, Health Canada published a Voluntary Recall Guide to help producers not only stay in compliance but run their operations better. While it will certainly prove to be a critically useful guide for Canadian LPs who are now subject to domestic regulations, it is also a highly useful document for others. Namely, newly legalizing U.S. states and even European countries now looking for guidance on how to shape, structure and regulate their own burgeoning domestic cultivation markets either underway now or about to start.

What Is Of Particular Interest?

While it may sound like a no-brainer, the guide lays out, albeit in very broad strokes, the kinds of procedures all licensed producers should be implementing anyway to efficiently run a compliant business.

It could be considered, on one level, a critical start-up business guide for those still looking for guidance in Canada (as well as elsewhere). Domestically, the document is clearly a handy template, if not something to create checklists from, in setting up a vital and at this point, mandatory part of a compliant cultivation facility in Canada.

The guide also covers not only domestically distributed product but that bound for export.

One of the more intriguing aspects of the guide is also how low tech it is. For example, the guide suggests that a license holder responsible for recall notices, plan on quick response methods that include everything from a self-addressed postcard to an email acknowledgement link.

That said, recalls must be reported to the government exclusively via an email address (no mail drop is listed). And suggestions about media outlets to which to submit recall notices are noticeably digitally heavy. Websites and social media platforms are suggested as the first two options of posting a recall. Posters at retailers is listed dead last.

What is also notable, not to mention commendable, is the inclusion of how to include supply chain partners in recall notices, as well as the mandate to do it in the first place.

Also Of Note

Also excellent is the attempt to begin to set a checklist and process about evaluating both the process of the recall itself and further identification of future best practices.Health Canada also expects companies to show proof of follow up efforts to reach non-responders all along the supply chain.

For example, the report suggests that LPs obtain not only feedback from both their supply chain and consumers involved, but elicit information on how such entities and individuals received the information in the first place. Further, the volume of responses (especially from end consumers) or lack thereof should be examined specifically to understand how effective the outreach effort actually was in reaching its target audience.

This is especially important because Health Canada also expects companies to show proof of follow up efforts to reach non-responders all along the supply chain.

Regulatory Reporting Guidelines

One of the reasons that this guide is so useful is that Health Canada also expects to receive full written reports touching upon all of the issues it lays out within 30 days of the recall announcement itself.

In turn, this is also a clear attempt to begin to start to document quality controls and attempts to correct the same quickly in an industry still plagued by product quality issues, particularly at home, but with an eye to overseas markets.

As such, it will also prove invaluable to other entities, far beyond Canadian LPs involved in the process this document lays out. Namely, it is a good comprehensive, but easy to follow and generally applicable guide for new states (in the case of the US) if not national governments in Europe and beyond who are now starting to look at regulating their own burgeoning industries from the ground up.

steep-hill-labs-logo

Steep Hill Expands To New Jersey

By Aaron G. Biros
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steep-hill-labs-logo

steep-hill-labs-logoAccording to a press release published today, Steep Hill has signed a licensing agreement with Green Analytics East to open a new laboratory, Steep Hill New Jersey. “We are pleased to announce a licensee partnership with Green Analytics East to bring Steep Hill to New Jersey,” says Jeffrey Monat, chairman of the Steep Hill board of directors. “Since 2008, Steep Hill has developed and now employs cutting edge cannabis testing practices, providing analysis to ensure safe medicine and products. With Green Analytics East as our trusted partner, New Jersey patients and consumers can be confident that all Steep Hill-tested products will fully comply with public safety and regulatory standards.”

They haven’t obtained the local permits yet, but the press release states they expect to be open for business in the third quarter of 2019. Steep Hill began their cannabis laboratory testing business in California. Since their start in 2008, the company has grown rapidly, developing programs for regulatory compliance testing in medical and recreational cannabis markets. They have also ventured into research and development testing, licensing, genetics and remote testing.

The company has a history of expanding into new markets via licensing partnerships, including states such as Washington D.C., Pennsylvania, Maryland, OregonHawaii, among others. As recently as May of last year, Steep Hill announced they will expand their international footprint as well, including opening locations in countries like Mexico, Germany, Spain, France, Italy, Switzerland and the United Kingdom, all through their Canadian branch.

New Jersey Governor Phil Murphy
New Jersey Governor Phil Murphy

The news of Steep Hill moving into the New Jersey market comes at a time when Governor Phil Murphy and lawmakers in the state are in the midst of planning adult use legalization. According to Shannon Hoffman, director of operations of Steep Hill New Jersey, they are hoping lawmakers reach a decision soon. “We are excited to bring our focus of service, accuracy, and scientific knowledge and expertise to the New Jersey market,” says Hoffman. “We look forward to serving the licensed producers, the patient community, and hopefully soon, the adult use consumer.”

How To Choose The Right Cannabis Consultant For Your Company

By Martha Ostergar
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The cannabis industry is growing fast as more states implement legislation to legalize cannabis in different ways. If you’re trying to break in or keep your place in this new market, it can be difficult to understand and comply with ever-changing government regulations as you try and scale your business.

Cannabis businesses need to comply with a range of new local, state and federal regulations related to cannabis specifically, in addition to regulations already in place for the pharmaceutical and food industries to ensure their products are safe for public consumption. On top of that, there are the complexities of managing a supply chain, including growing, warehousing, transportation, food safety requirements, product labeling, business plans, marketing, selling and any other necessities that come with running a businesses.

This is a lot of new information when you’re vying for your place in the cannabis industry. That’s why some businesses are turning to consultants to help. Consultancy is a great and time-tested way to grow your businesses and keep a competitive edge. But just like every other industry, when you choose a consultant, there are specific things to look for and avoid.each party will have work to do in order to communicate clearly, define responsibilities and execute on a plan.

Understand the Role of Consultants

The expertise of  cannabis consultants can vary widely. Usually there’s no “one stop shop” for everything you need to run your business, meaning consultants often specialize in a specific area. Consultant expertise includes specialties such as cultivation, manufacturing, food safety, dispensary, transportation, legal, accountants, human resources and more, all within different regulatory compliance wrappers.

It’s important to remember that consultants are usually not responsible for setting goals for you, but the right consultant can help you refine, meet and even exceed your goals. However, each party will have work to do in order to communicate clearly, define responsibilities and execute on a plan.

Focus on Your Specific Needs

Identifying your specific needs and understanding what success looks like for you is a critical step to take before contacting any consultant. This prep work helps you identify what kind of consulting you actually need and what you’re willing to spend to get it. Some consultants can help you tackle more than one area, but most will specialize. In fact, choosing several specialized consultants (if you have many needs), may feel like it costs more up front, but it will likely save you frustration, headaches and money in the long run. Additionally, if a consultant claims they can do everything in several areas of expertise, they may be overpromising on what they can actually deliver to you as a customer.

Ask the Right Questions

When vetting a consultant, it’s your job to ask probing questions. Don’t hold back and don’t be put off by vague answers. If a consultancy avoids questions or can’t give clear answers, they may be overpromising or being less than honest about their skillset. Here are some general areas of discussion to help you get started when interviewing consultants:

Consultants can help you get through unfamiliar territory or help you to manage your team’s workload.
  • The consultant’s relevant experience.
  • Past or current client references.
  • Detailed discussion of your specific needs as a business.
  • How much time can the consultant dedicate to you as a client.
  • Detailed outline of the consultation plan, including a clear timeline.
  • Responsibilities of each party, deliverables and what success looks like for customer sign off.
  • Certifications and credentials if relevant to your consultation needs (e.g. legal, accounting, regulatory).
  • What is and is not included with their quoted fee, and what you may be charged for as an “add on” to your contract.
  • Any possible conflicts of interest, including how consultants separate work for clients who are competitors.

Avoid Red Flags

As with any burgeoning market, there will be consultants who get into the cannabis space that are more interested in making money than helping you as an individual client as businesses work to legitimize the industry as a whole. Doing your research and asking for referrals helps, but there are also red flags to look for. Some of these red flags may pop up due to inexperience and some may be a sign of bad actors in the consultant market.

  • Asking for equity as payment.
  • Refusing to provide references.
  • Avoiding questions or giving unclear answers.
  • Unwilling to track time and itemize costs on bills.
  • Overpromising AKA “this sounds too good to be true.”
  • Dominating the process instead of treating you like a partner.

Build a Strong Relationship

To get the most out of a consultancy experience, it’s important for both parties to work at building a strong business relationship. You know you’re hitting the sweet spot in business relationships when you have well-oiled communication and feedback loops, including honesty around expectations and frustrations from both parties. A great consultant wants feedback so they can improve their process, therefore they will actively listen to and address your concerns. Additionally, it’s important for you as a client to also be open to feedback and ready to make changes to your process to get the best return on your investment.

Legalization & Regulation Recap: This Week’s News

By Aaron G. Biros
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Across the country, a handful of states are expected to move forward with a number of bills making their way each state’s legislature. Here is a quick recap on some of the more newsworthy bills from this week.

Arizona

When Arizona legalized medical cannabis use, there was no provision in the legislation that required laboratory testing to insure the safety of cannabis products. To this day, Arizona is one of the few states left that has legalized medical cannabis, but does not require lab testing. A bill, SB 1494, that just passed through the state’s Senate could very well change that. According to azmarijuana.com, the bill passed unanimously through the Arizona Senate and would require the Arizona Department of Health Services (ADHS) to implement regulations for laboratories to test for contaminates like pesticides.

They need at least 75% of the House to vote in favor in order for it to pass. If that happens, testing could be required as soon as June 1, 2020.

New Hampshire

In the Northeast, New Hampshire and Vermont have bills related to cannabis making their way through the state legislatures. A committee in the New Hampshire House of Representatives just backed a bill to legalize recreational cannabis.

The House Criminal Justice and Public Safety Committee voted 10-9 to recommend HB 481, which would legalize recreational cannabis, including growing up to 12 plants, imposing a tax of $30 per ounce on cannabis sold through retail. It would also set up a regulatory agency in charge of licensing and regulating the industry.

New Jersey Governor Phil Murphy
New Jersey Governor Phil Murphy

New Jersey

Governor Phil Murphy met with lawmakers earlier this week to discuss the legalization of recreational cannabis. According to CBS New York, the Governor reached a deal with Senate President Steve Sweeney, Assembly Speaker Craig Coughlin, Sen. Nicholas Scutari and Assemblywoman Annette Quijano to introduce a bill that he would sign into law.

The deal would legalize and regulate recreational cannabis, expunge previous cannabis-related convictions, levy a $42 tax per ounce of cannabis sold, along with setting up a commission to issue licenses and regulate the market. When Governor Murphy ran for office, his campaign included a pledge to legalize recreational cannabis, A previous attempt to get a bill through the legislature failed to get enough votes last year.

Vermont

Back in February, the Vermont Senate passed a bill to regulate and tax recreational cannabis with a veto-proof majority. SB 54 is now in committee review in the House, where it is expected to see more hurdles, according to Burlington Free Press.

Another bill was introduced in the Vermont Senate, SB 117,which would reportedly open up more access to the medical cannabis program, including increasing possession limits, allowing patients to grow more plants at a time and set up a lab testing program as well.

Wyoming

Last week, Governor Mark Gordon signed a bill into law that legalizes and regulates the cultivation and sales of hemp-derived CBD. The state is now working with the WY Department of Agriculture to submit plans to the federal government for regulating the industry.

Marguerite Arnold

Countries Take Lessons From Others On Legalizing Cannabis

By Marguerite Arnold
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Marguerite Arnold

As the German bid fiasco proves, and in spades, there is no easy transition out of prohibition. As of this April, it will be two years since the German Cannabis Agency issued its first cultivation bid. Since then, the first attempt went down in legal flames (in court) and the agency in charge, BfArM took an embarrassing hit for committing a “technical fault.” As of April, the second issuance gets its day in court. And then presumably, hopefully, cultivation can start to get going.

However, the German cultivation bid is far from the only time that government officials and regulators have created canna Frankensteins. In every legalizing market so far, in fact, from Colorado’s recreational start in 2014 to Canada, lawsuits, flubs and mistakes have been the order of the day.

There is a growing debate in Europe over how the cannabis industry should be allowed to flourish.States throughout the US continue to model their legalization frameworks off of states that have already done so. No wonder, then that as legalization rolls on, other countries are beginning to study the early movers- for tips on what to do and what to avoid.

New Zealand Takes A Look At Portugal

New Zealand is widely expected to become either the “next” country (or the one after that) to fully legalize recreational cannabis. Further it plans to do so during a national election (presumably ahead of the U.S. but that will be interesting to watch). New Zealand has jumped the gun already and put it on the electoral agenda.

That leaves the Kiwis with at least another 18 months to consider how they might pull it off. Don’t forget, it took the Canadians that long, with one failed initiation date last summer that was pushed to the fall. And that was with a medical market that was already three years old.

As of this month at least, New Zealanders are looking at several options, Portugal being one of them. Portugal gained distinction by decriminalizing all drugs at the turn of the century and has not looked back.

The country has seen a steady decline in all the bad stuff associated with the black market. Overdoses, drug crime, teen use and HIV infections have all dropped dramatically.

That said, for all Portugal’s forward motion, nobody else, yet, has quite followed suit.

Decriminalization, it should be pointed out, is also only one of the many issues facing a national change in policy. As Canada knows well.

Luxembourg Takes A Look At Canada

The Greens in Luxembourg certainly made news last year when they announced that recreational cannabis legalization was on their five-year legislative plan. In a tip to both U.S. and Canadian discussions about how legalization can increase tax revenues, Luxembourgers are also clearly looking at how to follow suit.

Auroraaurora logo cannabis so far has the only distribution agreement inked with the country to provide medical supplies, but it is unknown at this point whether Luxembourg will be content to merely import or grow its own.

One of the biggest problems Europeans will encounter immediately in looking at the Canadian transition to recreational use is that the government literally had to mandate an additional five-year period for medical use after the beginning of the recreational market. So far, at least, Luxembourgians appear to want to do this the other way around. They have already created a multi year test and study program for medical uses of the drug.

A Big Difference In Approaches

There is a growing debate in Europe over how the cannabis industry should be allowed to flourish. On one end of the discussion who see no issues with the North American model of public companies, in particular, having the greatest influence over the shape of the industry. But this is not the only discussion in the room at this point, particularly given the huge head start the Canadian public companies now have in the rest of the world.

In places like Spain and Thailand, for example, politicians are also starting to bring other models to the fore- including protectionist policies around domestic cannabis production.

Regardless, compare and contrast is a trend that is still in its infancy as the market leaders struggle with the implications of half-baked policies and those who follow seek to emulate the successes but avoid the mistakes.

2nd Annual Cannabis Labs Virtual Conference Announced

By Cannabis Industry Journal Staff
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The 2ndAnnual Cannabis Labs Virtual Conference is set to take place on Tuesday, April 2, 2019, starting at 12:00 Noon and concluding at 4:00 PM EDT. This complimentary series of webinars will take a deep dive into a variety of subjects related to cannabis testing and the laboratory industry.

The virtual event will help attendees better understand some of the more technical aspects of starting and operating a laboratory. Topics discussed will include pesticide testing, cannabinoid and terpene testing, the new ISO 17025:2017 accreditation and a lesson in starting a laboratory in a new market.

Attendees registering for this complimentary series of webinars will get access to four veterans of the cannabis lab testing industry, who are available for Q&A after each presentation. In addition to getting the opportunity to chat with these subject matter experts on April 2, a recording of the presentations will be made available to all who register.

Charles Deibel, President & CEO – Deibel Labs, Inc.

Here is a snapshot of the agenda:

Pesticide Testing: Methods, Strategies & Sampling
Charles Deibel, President & CEO – Deibel Labs, Inc.

Pesticides represent the number one area for batch failures in the US cannabis market. These are concerns not only for consumers, but are a very big concern for cultivators and manufacturers of cannabis products. remediation of the pesticides, once they are in the product are not always feasible From the lab level, they are also the hardest test to run in the laboratory, even one equipped with state-of-the-art equipment. The best instruments on the market are very expensive and there are no standardized methods, meaning lab to lab variability has happened.

  • What are the pesticides in cannabis and are there any that are the “main concerns” or ones that stand out as particularly damaging?
  • What is a basic breakdown of the testing and methods used for pesticide testing?
  • What are the best strategies for the sampling of cannabis products?

    Chris Martinez
    Chris Martinez, Co-Founder & President, EVIO Labs FL

Building a Lab in an Emerging Market
Chris Martinez, Co-Founder & President, EVIO Labs FL

  • Will present a discussion of the genesis of EVIO Labs Florida, how to start a lab in a new market
  • Challenges in how we navigated changing regulations in a state with newly legalized cannabis
  • Expanding a lab to a second location – logistics, hiring, training, consistency.

Cannabinoid & Terpene Testing: Methods, Strategies & Standardization

Dr. Cindy Orser, Chief Science Officer, Digipath Labs

  • Appreciation of “measurement uncertainty” in cannabis testing

    Dr. Cindy Orser, Chief Science Officer, Digipath Labs
  • Standardization of testing methods is a high priority
  • Terpenes are the distinguishing chemicals in cannabis sensory perception and chemotaxonomy

Benefits of Accreditation to the ISO 17025:2017 Standard
Jane Weitzel, Independent Consultant

  • The ISO/IEC 17025:2017 standard is now being used to accredit cannabis testing laboratories. From this presentation you will learn the key new aspects of the standard. This includes risk-based thinking. Many aspects of this risk approach require the use of measurement uncertainty. This means the measurement uncertainty must be adequately evaluated. You will be introduced to evaluating and using measurement uncertainty.
  • The 2017 standard emphasizes conflict of interest and impartiality. Procedures and practices to achieve impartiality will be shown. This reduces the risk of potentially damaging leaks of information or the risk of people not working to the best interests of the laboratory and its clients.

    Jane Weitzel, Independent Consultant
  • The 2017 standard is a valuable and useful business tool that can save the laboratory resources, effort and money. Are you doing too much testing? Are you doing too little testing? When you evaluate the measurement uncertainty you can use it to learn the steps in your test method that need enhancement to reduce the risk of making mistakes. You can also use the measurement uncertainty to focus on the significant steps and stop wasting time on steps and activities that are insignificant.
  • These benefits of laboratory accreditation will be demonstrated with examples from the cannabis industry.

To learn more about this complimentary series of webinars, click here to look at the agenda and register.

european union states

European Moves Signal Green Spring For Cannabis

By Marguerite Arnold
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european union states

It is hard to believe that two years have passed since the German government changed the law to mandate insurance coverage of cannabis by public health insurers. It is not so much the passing of time, but what has and what has not happened here on the ground during this stretch.

This is borne out by a quick overview of regional developments just in the last few weeks on the ground across the European Union.

Germany

The country that is still given credit for kicking off the whole medical cannabis enchilada discussion on a formal, federal level in Europe, still has not issued its first domestic cannabis cultivation tender. It will be two years this April since the initiative was first announced. Since then, several lawsuits have derailed the process, BfArM, the federal agency in charge of the tender, has admitted to a “technical fault,” and, presumably after the next round in court, the agency might be able to get on with business. The next date of note is April 10 (when the lawsuit will be heard in Dusseldorf).

german flag
Photo: Ian McWilliams, Flickr

Hopefully, this also means that the domestic cultivation of cannabis will finally begin (according to the agency) by, at latest, the fourth quarter of 2020. In the meantime, look for the awarding of bid finalists (or in the worst case, one more bid issuance after April) this year.

In the meantime, and even according to BfArM’s press statements, the import industry will fill in the gaps- meaning that by the time cultivation actually gets under way for real here, it will already be swamped, in terms of volume, by imports.

Where those imports will come from is another discussion. Right now, the only two countries with import rights for cannabis into Deutschland are Holland and Canada. Expect that to change this year, with Israel, Portugal, Spain and potentially even Greece all being very likely contenders.

Switzerland

Significantly, this tiny, non-EU but Schengen state is considering a pilot to study recreational cannabis. Namely, 5,000 recreational users could soon be recruited to help the government set the rules for a fully recreational market, presumably sometime in the near future.

Switzerland has led the discussion in the region on several fronts- notably setting the pace on CBD sales and continuing to air debates about how profitable the fully recreational industry will be for the public purse.

Bern, the capital of Switzerland
Photo: martin_vmorris

It is all very intriguing, particularly to neighbouring DACH state, Germany, but don’t expect the Swiss to do anything too outrageous on the legalization front- namely step too far out in front of either the UN or the European Parliament. Or anger their other DACH trade partner, Austria, who has taken the extreme polar opposite approach to all things CBD.

So to the extent that the Swiss have very much led the charge on the CBD front, such policies have not and will certainly not be copied across Europe (and has not been so far) any time soon. See the controversies over “novel foods” popping up not only in Austria, but Spain too.

Regardless, like Luxembourg, the Swiss are eyeing this new industry and proceeding cautiously in line with larger, international regulations that so far have led the pack on tweaking, testing and presumably changing in the next couple of years.

There are at least 200,000 people who currently use the fully leaded THC version of the drug illegally. Those who would qualify for the pilot study (only one of several proposed as the country considers the impact of cannabinoids from all angles) would have to be adults who already use the drug.

Stay tuned. This will certainly be one interesting trial.

Belgium

Belgium has also just announced the formation of its own “Cannabis Agency.” The new agency will, just as in Germany, oversee the development of the industry domestically- namely issuing licenses for production and import and overseeing quality.

Does this mean a Belgian cultivation bid is on the horizon? Could be. Although so far, no country except Greece has engaged in any large-scale cultivation effort commissioned by the government. And no country except Germany has so far issued a public tender. Even Italy proceeded with a unique hybrid last year when the military essentially turned over the domestic production it controlled over to Aurora.

This too is also likely to be an interesting space over the next few years.

A Belgian tender, right along with a Polish one (also expected after BfArM successfully executes at least one) may well be in the offing this year. This may also put additional heat on the German agency to bite the bullet and issue cultivation licenses by the end of 2019 no matter what happens in Dusseldorf in April.

Helix TCS Expands Internationally

By Aaron G. Biros
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According to a press release, Helix TCS and its subsidiary, BiotrackTHC, are expanding internationally at a rapid pace. The seed-to-sale traceability software solution now has customers in the United Kingdom, Canada, Colombia, Jamaica, Australia and New Zealand, in addition to the United States.

At home, they just successfully deployed North Dakota’s government cannabis traceability program. That program is one of nine government contracts the company has currently, where their seed-to-sale software is mandated for the state’s entire cannabis supply chain for compliance and regulatory oversight.

In addition to their international expansion and successful domestic government contracts, Helix TCS announced an exciting new addition to their leadership team. The company added former President of Mexico, Mr. Vicente Fox Quesada, to its Board of Directors, according to a press release. “A new industry is being borne, with high ethical standards, attracting massive investment in medical and health products, bringing economic growth and jobs to communities and nations,” says Fox. “I am proud to be part of it.”

According to Zachary Venegas, executive chairman and CEO of Helix TCS, Inc., Vicente Fox will help serve as a strategic advisor for their continued expansion abroad. “”We are honored to welcome former President Fox to our Board of Directors and to benefit from his strategic vision and global network,” says Venegas. “His addition is a significant multiplier in our further expansion into key production markets that we expect to become dominant cannabis export hubs that will require our full suite of services.”

According to Venegas, they are prepared to meet the needs of a globalizing cannabis economy. “As international markets develop and more countries create a legal cannabis industry, our technology and service solutions will continue to reach new markets quickly to meet the needs of businesses and regulators in any regulatory environment,” says Venegas. “We are very excited to see the progress of legal cannabis on the global stage and we look forward to continuing to play a vital role in enabling a transparent and secure supply chain.”

german flag

Where Is The German Cultivation Bid?

By Marguerite Arnold
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german flag

For those following the German cultivation bid drama, there appears to be a real light at the end of a now two year tunnel– driven by a domestic demand that essentially requires that there be no more delays.

Then again, given developments so far, who knows really what will happen in April. It could be a whole new “fresh start” for a much-beleaguered process or it could just go down as yet another “train” on the basis of a “technical fault.”

One thing is for sure: BfArM again appears to be cautiously optimistic. Yet they have been there before, too. Yes, there is a rising patient count. But there are also now many other import options and cheaper prices coming into the EU. As a result, there is still the likelihood, however implausible, that the German government will want to kick this can a bit further down the road.

German Parliament Building

What is the newest development? In late January, BfArM, the German equivalent to the FDA and the agency in charge of oversight and regulation of all medicines and medical devices, issued a press release about the status of the cannabis cultivation bid they are tasked with overseeing.

If things are not taken off track by the next still pending lawsuit (due to be heard by the high court in Dusseldorf on 10 April of this year), the agency will award the bid. Not before, as the press release also states categorically.

The Highlights

There is no award date yet of course. However, if the court case is decided in favour of BfArM this time (namely defending their exclusion of a bidder even though the deadline was delayed again for seven weeks last fall), there is reason to believe the public airing of that final list of license holders will be released soon after. That means the bid decision could come as soon as the next day and certainly by the end of April.

There were over 200 questions asked of the agency this time by around 79 bidders who submitted a total of 817 bids for a total of 13 cultivation lots. No more than five lots can go to any one bidder or consortium.

The amount to be cultivated under this first bid is 10,400 kg over four years (up from the first amount). Even this is expected to be too low to meet a clear and increasing domestic demand. That said, there is clear expectation that the remainder between what is cultivated domestically and consumed will be taken up by imports (although from where was not explicitly discussed).

The agency also stressed that they are responsible only for the administration of the tender itself. They will not receive, store or redistribute the cannabis or cannabis products. Further, BfArM also stressed that they are not responsible for the regulation of the final retail price at pharmacies.

Finally, the target date for the delivery of the first crops is a conservative estimate which says two things. One, BfArM are not tipping their hand in favour of Wayland (who at present has the largest licensed GMP facility in the country), and second, they are leaving themselves and bid respondents a little more wiggle room. Just in case. For whatever reason.

As the bid states, successful respondents do not need to have suitable real estate under contract until the finalists are announced, but if they are awarded the bid, they will have to not only move fast to secure a facility, but also set up a grow facility that can be certified in the next interim period.

By way of contrast, Wayland announced its purchase of the Ebersbach facility in the summer of 2017. They have just received, 18 months later, their GMP certification. Anyone starting from scratch, in other words, would have to move at least as fast as Wayland has. If not a bit faster, considering that Wayland is already up and running, and at this point certified.

Between The Lines

The entire cannabis legalization discussion has been caught up in the cultivation bid since the beginning. Patients in fact, lost their temporary right to grow if they could not afford the expensive cannabis being sold in pharmacies before 2017. After the law changed, only licensed and regulated operators were allowed to distribute the imported variety and then only from Holland and Canada.

Since then, the first cultivation bid went down in a legal challenge, the price of cannabis at the retail end has effectively increased at least 1,000 euros a month and there are as many as 80,000 German patients taking some kind of cannabinoid, mostly for chronic pain.

It is insurers, in other words, at least as much and now more than patients who are now on the sharp and expensive end of the stick.

Then again, until the actual announcement from the Dusseldorf high court if not BfArM itself, expect late breaking developments and drama until the very end.However, the interim frustrating period auf Deutschland plus the continuing needle of political reform just about everywhere (certainly in Europe) has changed the scenery dramatically in just two years. There are cultivation operations in Spain and Portugal with crops ready to be exported to the German consumer. Eastern Europe and Italy are also cultivating. Greece is preparing to. And Israel finally allowed its producers to jump into the medical game globally.

Prices will inevitably come down. The German government and insurance industry beyond that are two powerful drivers to insure the same. And a big part in bringing that price down is setting a bid reference price to begin with.

The situation, in other words, is being staged to move into the next “four-year plan” where Germany begins to understand how widely effective cannabinoids can be, for what conditions and what kind of delivery mechanisms work best for different patients.

It also aligns the country’s medical program perfectly with Luxembourg’s own four-year medical trial and now stated timeline of ensuring there is recreational reform by 2022.

All of which, in other words, also spells victory and potentially the end game to the first part of the German medical cannabis cultivation question and a larger first step for the EU beyond that to finally end medical cannabis prohibition.

Then again, until the actual announcement from the Dusseldorf high court if not BfArM itself, expect late breaking developments and drama until the very end.

Stay tuned.

Cannabusiness Sustainability

2nd Annual Cannabis Labs Virtual Conference

CannabisIndustryJournal.com is proud to present the 2nd Annual Cannabis Labs Virtual Conference. This complimentary collection of webinar presentations will help attendees better understand some of the more technical aspects of starting and operating a laboratory. We will take a deep dive into pesticide testing, cannabinoid and terpene testing, the new ISO 17025:2017 accreditation and a lesson in starting a laboratory in a new market.

Attendees registering for this complimentary series of webinars will get access to four veterans of the cannabis lab testing industry, who are available for Q&A after each presentation. In addition to getting the opportunity to chat with these subject matter experts on April 2nd, a recording of the presentations will be made available to all who register.

Practical and educational information from experts in the cannabis lab testing industry, all on the same day and all from the comfort of your office, lab or home. Want real inside knowledge on the cannabis testing industry? Sign up today!