Tag Archives: medical cannabis

Canadian Cannabis Recalls Raise Questions About Choices in Testing Methods

By Aaron G. Biros
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Cannabis sold between August and December of 2016 is being voluntarily recalled by Organigram, a Canadian cannabis producer, due to the detection of unapproved pesticides, according to a press release. Organigram is a licensed medical cannabis producer in Canada, which received an organic certification back in 2014 by ECOCERT, a third-party organic certification organization based in France.

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Organigram and Health Canada deemed it a Type III recall, meaning “a situation in which the use of, or exposure to, dried marijuana, fresh marijuana or cannabis oil, marijuana plants or seeds is not likely to cause any adverse health consequences,” according to that press release. They don’t know how the products were contaminated as routine use of pesticides is barred under their organic certification. Organigram is cooperating with Health Canada to conduct a full investigation to determine how the cannabis was contaminated.

About a month before Organigram’s recall, Mettrum Health Corp., a Toronto-based licensed medical cannabis producer, voluntarily recalled medical cannabis products that might have contained trace levels of pyrethrin, an insecticide not approved for use on cannabis, but generally regarded as safe with a low toxicity. That press release only mentions the detection of pyrethrin and downplays the health effects. “While the ingredient is not harmful and there is no negative effect on product quality and safety, we are doing everything possible to ensure client satisfaction and confidence is upheld,” says Michael Haines, director and chief executive officer of Mettrum Health Corp.

Pesticide Use was a major issue of 2016 Photo: Michelle Tribe, Flickr
Photo: Michelle Tribe, Flickr

Reporting in an article last week, The Globe and Mail discovered that Mettrum’s recall included lots where they detected trace levels of Myclobutanil, a hazardous and illegal pesticide that is banned in a number of states as well. Myclobutanil has been discovered as the culprit in a slew of pesticide-related recalls in Colorado and Washington.

But Mettrum’s updated press release doesn’t include any mention of Myclobutanil. Health Canada also didn’t make any public disclosures addressing the detection of Myclobutanil. The Globe and Mail only found out that the recall included the banned pesticide after asking a Mettrum employee.

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Tegan Adams, business development manager at Eurofins-Experchem

Tegan Adams, business development manager at Eurofins-Experchem Laboratories, Inc., a Toronto-based GMP testing lab, indicated that while the regulations are clear in their statement on zero tolerance for pesticides- reasons for inconsistent testing results are in part related to variations in rigor of testing methods available to monitor for pesticides in cannabis. “Licensed producers do not have to release routine test results to the public,” says Adams. “There is a group of us, inclusive of representatives from licensed producers (LPs), working on proposing a new federal cannabis accreditation standard that would make testing results, grading quality, DNA and a few other things public for each cannabis batch legally released to the public to be accredited. Making information like this public would help remove a lot of consumer scrutiny on LPs, as it currently exists in the marketplace. Most of them care so much about their products and patients, they work very hard to create safe quality products”

According to Adams, routine pesticide testing typically scans for roughly 100 pesticides. She says a more rigorous test could scan for 500-700 different pesticides, a more accurate representation of what’s on the market. Adams says the regulations have zero tolerance for any detection of pesticides, not necessarily an action level for what is a safe amount to be present.

Toronto Photo: Paul Bica, Flickr
Toronto
Photo: Paul Bica, Flickr

More research is needed on the smoking and inhalation aspects of pesticide products to say what is safe and what is not. “There are different methods available to test for pesticides, and SOPs to follow to avoid their application,” says Adams. “But if a licensed producer chose a testing method that doesn’t for some reason cover a pesticide they are later found to have on their product, that could present the need for a recall if Health Canada or another entity were to somehow to detect it using a different method.”

Health Canada determined both of those recalls to be Type III recalls. Both companies said they are cooperating fully with the regulatory body. By embracing the proposed new cannabis testing accreditation standard, Health Canada could remedy the testing methodology discrepancies and require a greater level of transparency.

PA Cannabis Banking Committee Announces Formation

By Aaron G. Biros
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The Hoban Law Group announced today the formation of a committee to address banking access issues for the Pennsylvania cannabis market. Steve Schain, Esq., nationally recognized consumer finance litigation, banking law and cannabis law expert practicing with national cannabis law firm Hoban Law Group, is the committee’s spokesman and chair.

Steve Schain, Esq. practicing at Hoban law Group and chairperson of the committee.
Steve Schain, Esq. chair and spokesperson of the committee.

Limited access to banking is an ongoing issue plaguing cannabis businesses due to its federally illegal status. According to Steve Schain, cannabis businesses across the country are forced to pay their vendors, utility bills, payroll, taxes and insurance in cash. “At any time, a dispensary or cultivation operation could have up to $200,000 in cash on site- not having a place to bank opens opportunities for criminal activity,” says Schain. It also presents operational issues for business owners like record keeping or even personal bank accounts getting shut down.

“All of those issues could mean less jobs, less economic activity and less tax revenue for the state,” says Schain. “Fully compliant operations should not have to deal with this.”

Schain formed the committee for a number of reasons, including “Setting the table and starting a dialogue. We want this to be scalable. In the past, the great flaws in banking efforts for cannabis were a lack of cohesion and operating credibility- we hope to approach it from a multi-disciplinary angle and change that,” says Schain.

State Senator Daylin Leach introduced the bill
State Senator Daylin Leach

The committee’s members include three PA politicians: Daylin Leach, State Senator of the 17th District, who introduced the bill that legalized medical cannabis in Pennsylvania, Derek Green, Philadelphia City Councilman and Mary Jo Daley, Representative of the 148th District. Tom Fleming, former assistant director of the Office of Compliance at the Treasury Department’s Financial Crimes Enforcement Network, is also a member of the committee.

A number of committee members are actively involved in the legal cannabis industry and cannabis banking initiatives. Sundie Seefried, a member of the committee, is the chief executive officer of Partner Colorado Credit Union, which is

Lindy Snider, advisor at Greenhouse Ventures and KIND Financial
Lindy Snider, advisor at Greenhouse Ventures and KIND Financial

currently handling over half of Colorado’s estimated billion-dollar cannabis banking market, according to Schain. Lindy Snider, founder and chief executive officer of LindiSkin, advisory board member of KIND Financial and Greenhouse Ventures, is also listed as a member of the committee.

“According to the treasury department, only 301 financial institutions have reported banking cannabis cash,” says Schain. “Few federally chartered banks or credit unions will work with cannabis businesses, but two states-Washington and Maine- have banking regulators sensitive to cannabis banking and we have found 36 banks and credit unions providing financial services to cannabis enterprises.”

The goal with forming this committee is to change that and create an environment where banking for cannabis businesses is much easier. “We plan on drafting a white paper with best practices on compliant and profitable banking on behalf of cannabis-related businesses and financial institutions,” says Schain.

Working from a banker’s perspective is the key here, says Schain. They want to create a working, compliant and profitable system for banks to do business with cannabis cash. One of the problems in the meantime is the high-risk nature of dealing with cannabis companies, leading to an inability to get insurance on those accounts. In the eyes of the federal government currently, conducting cannabis-related transactions may be deemed money laundering and highly illegal. “The real issue is with the federal government and I strongly suspect this is not an issue at the top of the Trump White House agenda.”

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Quality From Canada

The Devil is in the Detail – Changes to Canada’s Cannabis Regs to Encourage Patient Independence and Business Competition

By Tegan Adams, Elfi Daniel-Ivad MSc
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Canada’s new ACMPR was launched late last month on August 24th. The key change that most notice is that Canadians may now again grow their own cannabis at home for medical purposes. In addition, more strict guidelines for product testing and labeling requirements for Licensed Producers (LPs) were released.health-canada-logo

Short term pain for long term gain. While the combination of allowing patients to grow at home and more strict regulations for LPs may at first seem like a business disadvantage; overtime LPs will be thankful for the combination switch. Health Canada’s new requirements encourage a leveling of the playing field globally between LPs and large scale product manufacturers of pharmaceuticals, therapeutics and natural health products. The steps Health Canada is taking to regulate our producers, is exactly what they need to get ready for mass production that will be necessary for recreational markets, scheduled for release in Spring 2017.

Picture rows of Tylenol bottles on the shelf at your favorite pharmacy. Now picture rows of cannabis bottles on the shelf beside them. This is what medical cannabis will look like in Canada perhaps as early as 2018, if not sooner. With just under forty LPs on the map and a projected sales volume of modest billions, Canada’s LPs’ eyes are widening with dollar signs as they lube up their oil production and more to see what shelves in Canada will hold.

Curious to know more? Our regulatory department manager Elfi Daniel-Ivad is an expert in regulatory change. She has worked on close to 150 submissions for cannabis licensees in Canada and beyond. Here are a few key changes from her department’s overview to better understand.

MMPR ACMPR (Updated)
No personal production or designated production available to patients (aside from that grandfathered in by MMAR). Personal production and designated production available. Patients may grow 5 indoor plants OR 2 outdoor plants at any given time per gram prescribed to them.
Licensed Producers were not required to label THC or CBD amounts in dried cannabis, though most producers did for sales and educational purposes. Oils had to be labeled with THC and CBD amounts. Licensed Producers must label their percent THC and CBD for dried and fresh cannabis products.
For the labelling of oils, the total quantity of THC, CBD and oil in a container had to be shown. Restrictions on THC allowed no more than 10mg/mL THC per capsule and no more than 30mg/mL THC per mL oil to be distributed. In addition, oil labels must now include information on “carrier” oil and allergen information. Containers must be labelled with number of capsules, the net weight and volume of each capsule. .
No reference to validation of analytical testing methods. Analytical testing must be completed using validated testing methods; confirming reliability and consistency in results for   contaminants, disintegration, residues and THC, THC-A, CBD and CBD-A
Accredited labs can only test products as received from Licensed Producers. In addition to Licensed Producers, patients growing their own or having a designated grower growing for them may also test their products at an accredited lab.

In addition to these changes, it is important to note that if an individual or company has an MMPR proposal already submitted they can now revise it to include oil production (previously, it was first dried bud only). If a company submits a new ACMPR proposal, they can include oil production on their application right away. Interested in submitting your own application? Or need help with one in the USA? Our regulatory department would be happy to answer any questions you might have about the process.

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Documentation & Compliance: A Q&A with Michael Shea, ConformanceWare

By Aaron G. Biros
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Cannabis safety throughout the supply chain requires active documentation tools for business owners to keep up with standards and regulations on the local and state level. Michael Shea, founder and president of AccessQMS and chief executive officer of Upshot’s ConformanceWare, provides consulting support across multiple industries with independent referral services to compliance professionals. With quality, safety and efficiency at top of mind, ConformanceWare’s design team developed the Medical Cannabis Series (MC Series™) to help cannabis business owners make the task of compliance easier. The documentation tools in the program are individually tailored to address needs in cultivation, processing, analyzing and dispensing.MC series

The MC Series-Analyze Edition is currently in use at Canalysis Laboratories and NV Cann Labs, both operating in Nevada. According to Tara Lynn, chief executive officer at NV Cann Labs, the product helps them meet all of their documentation needs. “I appreciate all of the development using the MC Series- Analyze Edition and look forward to developing even more of a relationship through the years to come,” says Lynn. We sit down with Michael Shea to learn more about his product and how cannabis business owners can stay on top of regulatory compliance.

CannabisIndustryJournal: How will the MC Series help cannabis laboratories, cultivators, processors and dispensaries navigate regulatory compliance?

Michael Shea: To open a sustainable business involving cannabis goes beyond submitting applications, paying fees and focusing on profit alone. As laws adjust and tighter controls are put in place, more and more business owners are realizing what preserves and sustains their business is, in fact, compliance.

True sustainability is driven by forward thinking that values documenting and following best practices to ensure quality, safety and efficiency. Ambiguity concerning where to turn or how to correctly produce this documentation not only poses a difficult dilemma, it can put one’s investment at risk as well.mcserieslaptop

Finding a remedy for the situation begins with an expansion of perspective. Businesses will benefit most by actively working toward compliance from the onset. This approach eliminates having to face non-compliance and the enforcement that goes along with it.

MC Series™ is designed for this purpose and will greatly help businesses precisely document how their method of operation demonstrates full compliance with applicable laws and standards. Each MC Series™ edition is developed using Microsoft Word and Excel, which is then customized to mirror each organization’s processes, procedures and instructions.

Being user friendly, we have built in numerous hyperlinks for navigating and managing files and documents so that the documentation behaves like a website. This enables each user to access, edit, save and retrieve information instantly.

CIJ: How does your product utilize CMC’s, FDA, ISO, FOCUS, AHPA and EPA standards to help business owners?  

Michael: Businesses handling cannabis are subject to strict regulations and are expected to show full compliance with regulatory protocols. Setting up your business correctly means playing by the rules and operating with the proper documentation and structural foundation.mcserieslaptop2

By applying established best practices from the start, business owners will be able to minimize risk for investors, tighten efficiencies and quickly adapt to regulatory changes with minor adjustments. This serves two primary functions: Business owners will now have the protection they need and the means to promote their brand as a world-class operation.

Because laws surrounding cannabis are in such a state of flux and revision, what is most valuable to know is what technical documents lawmakers select for the purpose of writing regulations. Putting this knowledge to work, the MC series uses a variety of guidance documents designated by regulatory and standards bodies for best establishing compliance.

Developed with regulations in mind, each series edition accurately defines the scope of applicability required for your business model. Whether you’re a grower, processor, cannabis testing service or dispensary the MC series has a solution. It significantly helps business owners to achieve compliance by providing the required documentation with an operations framework.

MC series merges regulatory best practices with internationally accepted standards to deliver a complete solution with a very quick turnaround time. Designed to ensure public safety and protect human health, the MC series provides a much-needed tool that bridges the gap between compliance and profitability.

CIJ: How might you be ahead of the curve in looking toward a rescheduling or a schedule 2 cannabis framework?

Michael: Being ahead of the curve simply translates to knowing the regulatory landscape and what’s involved moving forward. When the goal is to legalize cannabis for its great many uses and benefits, public health and safety must come first. Now is the time for business owners to get serious and effectively address the process of legitimizing it.

As with anything available for consumption, standardization is the method and regulators have a long established process for putting controls in place to ensure the health and safety of consumers. We have a lot of experience in this area, and our MC Series™ is an exceptionally useful tool for people who don’t. It is our way of contributing to assisting and accelerating the process.

Essentially, we are saying to business owners, operate your business as if cannabis is already legal. Managing your operations in compliance to existing regulatory best practices will speak volumes to lawmakers. You will be effectively demonstrating to Federal and State governments that you understand the importance of regulations to ensure public health and safety and are making compliance top priority.

This will make your business fluid in relation to regulatory changes and prepare you for Schedule II and beyond.

CIJ: Why should business owners be proactive in navigating regulatory compliance with a documentation management system?

Michael: With so many regulations targeting the cannabis industry, it is hard to keep track of and adjust accordingly. Many business owners are getting excited about being involved and making a difference. Amidst all this enthusiasm, the importance of best practices is often times overlooked and prioritized for when business is good and finances improve.

At this point, business owners can no longer afford to position best practices for future use.

For businesses handling cannabis, taking a future stance will always increase risk.. This leaves you legally exposed to unforeseen costs and complications. More importantly, it will exponentially increase the potential for watching your investment, hard work and business be out paced by the competition, or even worse, closed down permanently.mcseriesipad

Alternatively, being proactive will yield different results. Great benefits will come by adopting and following best practices to operate your business. In doing so, you now have an effective method to ensure quality, health and safety, environmental stewardship and sustainability. As a rapidly growing industry, these areas of discipline are absolutely critical for cannabis to reach its full potential and be fully accepted.

In many industries, legitimate and successful companies see best practices as simply part of doing business. Many see it as a tool that provides a useful roadmap for continually improving their operations and strengthening their position in the market.

When the legal obligations have been taken care of, success becomes a matter of setting realistic goals, planning well and delivering with impeccable timing. Operational performance can now be measured and improved for unhindered growth. Everyone involved or tied to your business is now on the same page and in areas of supervision, micromanagement is replaced with a documented system. Documentation should clearly define everyone’s roles and responsibilities, so that when errors occur, there are corrective action procedures available to fix them.


Editor’s note: For more information you may reach out directly to Michael Shea at 313-303-6763 or info@conformanceware.com

Philly Tech Week Hosts Conference on Cannabis Investment and Medtech

By Aaron G. Biros
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Philly Tech Week held its first cannabis industry conference this past weekend, hosted by Greenhouse Ventures, a cannabis startup accelerator based in the Northeast. The Innovation in the Cannabis Industry conference brought leaders in cannabis technology, investing and medical research to discuss the changing landscape of the cannabis marketplace in the Northeast.

Tyler Dautrich, co-founder of Greenhouse ventures, welcomes a sold-out crowd.
Tyler Dautrich, co-founder of Greenhouse ventures, welcomes attendees; the event sold out.

Kicking off the event, Tyler Dautrich, co-founder of Greenhouse Ventures, welcomed attendees to the first ever Philadelphia cannabis conference. The initial panel of the day reviewed investment trends and included Scott Greiper, president & founding partner of Viridian Capital Advisors, Marc J. Ross, Esq., founding partner of Sichenzia Ross Friedman Ference LLP, Jim Fitzpatrick, advisory board member at Kodiak Capital Group and John Kagia, director of industry analytics at New Frontier Data Analytics. The panel, moderated by Kevin Provost, co-founder of Greenhouse Ventures, examined various financial trends in the marketplace, roadblocks to raising capital for startups and emerging markets.

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The Investment Trends Panel from left to right: Scott Greiper of Viridian Capital, Jim Fitzpatrick of Kodiak Capital, Marc Ross, Esq., John Kagia of New Frontier and moderated by Kevin Provost.

John Kagia of New Frontier provided useful tools in comparing cultivation models as well as industry projections. “It [the legal cannabis market] has largely been dominated by the West Coast,” said Kagia. “The East Coast is very well poised for success.” Scott Greiper, president of Viridian Capital, discussed his top performing markets. “Biotech is definitely the top performing category and a close second is cultivation and retail –production and sale is at the root of every industry,” said Greiper. “At its core, cannabis is an agricultural commodity.” He went on to list infused products as the third top performing market, noting that edibles account for over half of retail sales.

Future Business Outlook Panel from left to right: Steven Schain of Schain Law Firm, Leslie Bocksor of Electrum Partners and Matt Karnes of Greenwave Advisors.
Future Business Outlook Panel from left to right: Steven Schain of Schain Law Firm, Leslie Bocksor of Electrum Partners and Matt Karnes of Greenwave Advisors.

In looking at emerging markets, Leslie Bocksor, president and founder of Electrum Partners, echoed Scott Greiper’s advice for new businesses to stay grounded in the numbers and operations. “Stay focused on solid, tangible data,” Bocksor said. The two also shared a similar view in opportunities in hemp. “Hemp is a very underserved niche and there are ample opportunities for new businesses,” said Bocksor.

State Senator Daylin Leach (D- Montgomery/Delaware), co-sponsor of the bill for Pennsylvania’s medical cannabis legalization, delivered the keynote address. He lauded the bill, mentioning that patient advocates were instrumental in swaying the legislature. “This is the most important piece of legislation for PA in thirty years,” said Leach. “I have always believed in moving this bill forward and very recently, we passed it with a huge bipartisan majority.” Attendees gave Senator Leach a standing ovation in response to his positive outlook on Pennsylvania’s future with cannabis. “This will be a huge new industry and medical technology is vital to moving it forward.”

State Senator Daylin leach was welcomed with a standing ovation.
State Senator Daylin Leach was welcomed with a standing ovation.

In the afternoon, a panel on medical technology discussed the need for more comprehensive diagnostic tools and crowd-sourced data for treatment with cannabis. David Goldstein, chief executive officer and founder of PotBotics, expressed concerns over bringing consistency to patients. “We need to understand how cannabinoids are affecting patients,” said Goldstein. “We want patients to feel confident in their medication.”

David Goldstein (center) sat on a panel discussing med-tech and how it can help the cannabis industry.
David Goldstein (center) sat on a panel discussing med-tech and how it can help the cannabis industry.

The conference closed with a panel of physicians discussing their clinical experience with recommending cannabis and the gaps in medical research. Among them, Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, discussed some of his experience in recommending cannabis in treating neuropathic pain. The closing panel emphasized the need to educate more physicians and some of the obstacles to physicians recommending cannabis. The conference highlighted the Northeast as a quickly emerging cannabis market ripe with business opportunity.

Pennsylvania to Legalize Medical Cannabis

By Aaron G. Biros
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HARRISBURG, PAOn Wednesday, the Pennsylvania Legislature approved a bill to legalize medical cannabis. Pennsylvania will be the 24th state to legalize cannabis in the United States. The House voted 149-46, passing bill SB3 and sending it to Governor Tom Wolf, who signed the bill into law on Sunday.

The bill, with a list of seventeen qualifying conditions, will allow for certifying physicians by the Pennsylvania Department of Health and licensing growers and dispensaries. The bill also requires standards for traceability in regulatory oversight, establishing criminal penalties for diversion or falsification of identification cards issued to caregivers and patients.

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House Majority Leader Rep. Dave Reed

House Majority Leader, Rep. Dave Reed (R-Indiana), believes the bill allows for robust regulatory oversight. “[…] I am confident Senate Bill 3 provides all the necessary protections to prevent the abuse of medical cannabis, including its unavailability in leaf form,” says Reed. “This new health care program will be closely monitored and if there are found to be weaknesses in the law down the road, we can certainly make any necessary revisions.”

The measure’s prohibiting the distribution of cannabis in dry flower form follows New York’s policy of only allowing patients to use it in forms other than smoking, such as vaporizing or consuming orally in capsules.

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Tom Santanna, director of government relations at the Pennsylvania Medical Cannabis Society, is confident the PA Department of Health is the right organization to regulate medical cannabis. “An important part of the regulatory process includes providing for the safety of cannabis via laboratory testing, and it is our feeling that the PA Department of Health is the correct agency for that task,” says Santanna. “The legislation gives the Department of Health the authority to create standards for safety and it is our goal as an organization to work with them to make sure the proper safeguards are in place.”

State Senator Daylin Leach introduced the bill
State Senator Daylin Leach introduced the bill.

The passing of this legislation will undoubtedly encourage more doctors to consider recommending cannabis as a treatment option in Pennsylvania. Dr. David Casarett, professor of medicine at the Perelman School of Medicine, University of Pennsylvania, believes this could help a number of his patients. “When it becomes legal in Pennsylvania, I will certainly discuss it as an option for some of my patients,” says Casarett. “If it is legal, then at least I will know my patients are getting it from a safe and reliable source, without supporting the illegal drug trade and organized crime.”

State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and has introduced medical cannabis legislation in every session since 2009. Steve Hoenstine, spokesperson for State Senator Leach, believes the measure will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Hoenstine. “The seed-to-sale tracking system and the bill’s other protections do just that.” State Senator Leach will deliver the keynote speech at the Innovation in the Cannabis Industry; Technology, Medical & Investment Conference in Philadelphia on April 30.

It is expected to take up to two years to begin the implementation of regulations and allow retailers to open their doors to patients.

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Soapbox

Bridging the Gap: Doctors, Education and Compliance

By Aaron G. Biros
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Doctors are still very hesitant to recommend cannabis in medical treatment of their patients. A key aspect missing from the medical cannabis industry is participation from physicians and the medical community. Cannabis’ Schedule I drug status blocks medical research and leaves a stigma in the medical community. Doctors are concerned with the implications of recommending cannabis, the possibility of losing their license to practice and most lack any formal education in prescribing cannabis. The DEA’s recent announcement to consider rescheduling cannabis this year could dramatically impact doctor’s willingness to work with the drug.

The DEA’s plan to release a decision on the matter represents a major shift in attitude toward treating patients with medical cannabis. This could very possibly culminate in the rescheduling of cannabis, which would allow for more medical research, including clinical trials. Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, believes the bigger obstacles for doctors prescribing cannabis include the stigma associated with it, legal concerns and physicians’ lack of education. Dr. Gottlieb has practices in both New York and New Jersey where he recommends patients cannabis. He believes there should be some type of recourse to help physicians circumvent legal issues. “Some of the bigger legal concerns regarding cannabis surround complying with state regulations,” says Gottlieb. “That sort of compliance includes confirming the diagnosis of the patient with thorough documentation, making sure it is an approved condition to treat with cannabis, documenting continued treatment of the illness and clearing the patient of any contraindications.”

Dr. Gottlieb believes it should be a collaborative effort on behalf of states, dispensaries and patients working to help educate doctors on the legal concerns surrounding the recommendation of cannabis. “Physicians are not taught anything in medical school about dosing or the medical effects of cannabis,” says Gottlieb. “With more education we can get rid of the stigma and get physicians aware of the potential benefits for their patients and the ability to control dosage in medication.”

Currently, there is very little communication between doctors and dispensaries in New York. A collaborative effort to educate all stakeholders involved could help get more doctors involved and streamline the entire process. “Doctors want patients to feel comfortable and know what to expect in receiving treatment with cannabis,” continues Gottlieb. “Which will come with a more transparent system, involving patients, doctors and dispensaries in a conversation about education.”

Pointing to the success of doctors actively recommending cannabis could also facilitate doctor participation. “The number one reason why I recommend cannabis is that I have a number of patients that use it to successfully treat their conditions and completely eliminate their opioid regiment,” says Gottlieb. That kind of success in a treatment should grab the attention of physicians as what could possibly be best for their patients. With more education and research, doctors will gradually feel more comfortable recommending cannabis to their patients.

Marijuana Matters

The Legal State of Cannabis in Florida

By David C. Kotler, Esq.
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It is now December of 2015 and we are one year removed from the loss at the polls of an amendment that would allow for full spectrum medical cannabis in Florida. The defeat of Amendment 2 allowed for the implementation of the Compassionate Medical Cannabis Act of 2014, albeit a rather rocky implementation, thus legalizing low THC, high CBD cannabis strains. I participated in many of the public meetings which took place and watched the different draft regulations set forth by the Florida Department of Health be debated, commented on and ultimately revised. The process underwent legal challenges and as of the publication of this, applications for five license holders were awarded.

As many might be aware, the Compassionate Medical Cannabis Act applicants were required to be nurseries continuously operating for over 30 years with a plant registration of 400, 000 plants as of the time of application. There were other relevant requirements, but the two foregoing were the most restrictive and narrowed the market of potential applicants.

Following in line with legislative means to put cannabis in the hands of a few large, Florida-centric entities, a Bill recently passed the Senate in Florida allowing for the expansion of the use of cannabis with higher THC content for patients with debilitating diseases under Florida Statute 499.0295. Presumably, the five licensees would then be authorized to expand their crop to include THC based plants and provide those to qualifying patients.

My fear all along has been that Florida would abandon the possibility of having a robust economic, yet patient-centric model not dissimilar to Colorado, Washington or Oregon, but more akin to what one might see in New York or what was narrowly avoided in Ohio. In fact, I have considered the possibility that should the new Amendment supported by United for Care passed, since that Amendment allowed for the Department of Health to promulgate the rules and regulations, that the Department could, assuming the five licensees are operational, merely give responsibility to the five licensees, allowing them to expand.

Alas, I believe, and I am happy to admit it, I may be wrong. In Florida, constitutional amendments require a review by the Office of Economic and Demographic Research. It is the focus of this body to analyze and report the economic impact that a particular amendment might have upon passage and effectuation. Data from numerous sources are reviewed and integrated into the Committee’s opinion. Of note, during my review of the October Economic Estimating Conference Meeting and Reports was the position taken by the Department of Health. Specifically, the Department of Health did not indicate that it could implement a system by merely expanding or working off of the framework it has for the Compassionate Medical Cannabis Act. Instead, the Department took the approach that a new set of regulations and guidelines, as well as departmental operations, would need to be implemented. In fact, it would need to be implemented to comply with the MMTC system authorized by the amendment. Whether one believes in the vertical model or one which licenses similar to Maryland and a few other states, the important point is that the Department of Health seemingly recognizes that a more robust model will have to be implemented.

So what does all this mean for patients and potential businesses in Florida? In regard to patients, I wish I could say that the potential for treatment through cannabis is foreseeable in the short term. However, I am not convinced of this. I do believe that the selections and process for which applications were selected under the Compassionate Medical Cannabis Act will be challenged, thus resulting in more delays. With regard to the Amendment and implementation should it pass, it will not be until the middle of 2017, approximately one and one-half years away. Should businesses begin preparations in Florida currently? In my honest opinion I believe it is hard to say. In the summer of 2014, I spent a lot of time counseling individuals and businesses on planning for the legalization of medical cannabis in Florida. Some clients were more aggressive than others and ultimately spent time and money, perhaps unnecessarily. On the flip side, I participated in the application process in Maryland and am of the belief that individuals who made application for Maryland cultivation licenses benefitted from an early start and preliminary planning.

I know a number of successful cultivators in legal states who moved on Maryland as a last minute decision once recognizing that although scored as part of an application, residency or lack thereof was not a bar to licensure. I am therefore of the opinion that certain preparation in advance is advantageous and allows alteration of the plan and adaptation at a later stage without wasting resources to accomplish much of the work that is capable of being accomplished in advance. I do believe there are a good deal of uncertainties, depending on how things move forward, as to what our model will look like and if that model will get into place, depending on the rollout of the Compassionate Medical Cannabis licenses as well as the possibility of some of the legislative initiatives catching wildfire, much as the Compassionate Medical Cannabis Act of 2014 did at the very end.