Tag Archives: legal

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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.

Supreme Court Denies Challenge to Colorado’s Cannabis Laws: Industry Outlooks

By Aaron G. Biros
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The Supreme Court shut down a lawsuit on Monday brought by two states against Colorado for its recreational cannabis laws. Nebraska and Oklahoma brought the case to the Supreme Court, claiming that the recreational cannabis industry in Colorado is responsible for the illegal exportation of cannabis outside of Colorado. “Colorado has facilitated purchase of marijuana by residents of neighboring states by issuing licenses to an unusually high number of marijuana retailers perched on Colorado’s borders,” the two states told the court in a supplemental brief.

In that brief, the two states argue that Colorado’s cannabis industry led to more cannabis illegally crossing state lines. They argue because of that influx of cannabis, they spend more on law enforcement and state resources, which is a detriment to their citizens. The Supreme Court did not provide an explanation for why they refused to hear the case.

Many view this as a big win for the legal cannabis industry. “The Supreme Court has protected the will of the people today and I believe the court has demonstrated that it understands legal cannabis is a fundamental right,” says Andy Williams, president of Medicine Man, the largest cannabis dispensary in Denver.

Still others see this simply as business as usual. “While I’m pleased to see the Court reject the challenge to Colorado’s cannabis law, this decision isn’t really a win for cannabis advocates- it only maintains the status quo,” says Aaron Herzberg, partner and general counsel at CalCann Holdings, a medical cannabis holding company specializing in real estate and licensing. “We are struggling with diversion in California, so hopefully states will continue to be on track to create a more regulated and taxed environment where cannabis can be manufactured and sold through channels where it is safe and tested,” continues Herzberg.

Adam Koh, chief cultivation officer at Comprehensive Cannabis Consulting (3C), warns that the Court’s denial to hear the case is not necessarily an affirmation of state’s cannabis programs. “It is evident that some diversion is taking place, which of course is against the provisions of the Cole Memorandum,” says Koh. “In order to avoid being implicated in such activities, legally licensed cannabis businesses in Colorado should not take the SCOTUS decision as a signal to relax, but should instead work to make sure that inventory control and record-keeping protocols are in place and even exceed the standards required in state regulations.”

The fact alone that Nebraska and Oklahoma even brought the case to the Supreme Court means that diversion is a major issue facing the cannabis industry. “Only by going above and beyond in terms of compliance will this controversial industry make itself credible in the eyes of its detractors,” says Koh. Some cannabis industry leaders take it upon themselves to help guide rule makers in crafting standards.

Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), believes the Cole Memo is currently the best guidance for states and business owners to follow by the federal government in regards to cannabis. “Gaping holes in cannabis regulations are glaringly identified via the pesticide issues and recalls recently,” says Engelking. “These issues showcase each state being in violation of the Cole Memo’s expectation that they will implement strong and effective regulatory and enforcement systems that address the threat to public safety, public health, and other law enforcement interests.”

The Supreme Court’s denial of the two states’ challenge to Colorado’s cannabis legislation suggests the federal government’s intentional avoidance of involvement in current state cannabis issues. The government’s inaction does not, however, indicate their support.

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Health Care Industry Cannot Ignore Cannabis Any Longer

By Robert T. Hoban, Esq.
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Twenty-four U.S. states now have some form of medical marijuana legalization on the books. These states allow patients with a variety of qualifying conditions to possess and cultivate cannabis lawfully as a treatment for such medical conditions. The number of states allowing medical cannabis is set to increase dramatically, as various additional state legislatures have bills or ballot measures pending on this topic. You can read more about this topic here.

The federal government surprisingly already has their hands in medical marijuana. The federal government sends free, pre-rolled cannabis cigarettes to a special, albeit dwindling, group of patients on a regular basis and they have been doing so since 1976. This is a product of the 1976 federal Investigational New Drug Program (Compassionate Access I.N.D.), which still operates, but was closed in 1992 to any new patients. 

The U.S. Government holds a federal patent for therapeutic cannabinoid use (US6630507 B1). The patent, “Cannabinoids as antioxidants and neuroprotectants,” (LINK) covers a method of treating diseases by applying a therapeutically effective amount of cannabinoids derived from marijuana. In addition, the White House website provides links to government-funded research projects involving medical marijuana. Presently, the links show 219 completed projects and 95 projects in progress.

On June 23, 2015, the American Medical Association adopted the formal position that marijuana is a form of medicine. Reliable scientific studies address the medical efficacy of the use of medical cannabis for an increasing number of conditions. Medical cannabis is here to stay and the health care industry needs to pay close attention.

 Simply put, the health care industry has been resistant to beginning the study of medical marijuana. This does not bode well for health care systems that will see more patients utilizing various forms of medical cannabis. Moreover, this is not a sustainable health care business model. With an increased focus on alternative forms of medicine and treatment both by practitioners and health care insurance providers, it is imperative that the health care industry studies the facts.

The New Mexico Workers’ Compensation Administration began requiring employers and insurers to reimburse injured workers for medical marijuana when the state’s health care provider fee schedule took effect January 1, 2016. Workers compensation claimants can be reimbursed up to $12.02 per gram of marijuana for up to 226.8 grams of marijuana per year, according to the fee schedule. Such reimbursements were ordered after the New Mexico Court of Appeals had ruled three times since May, 2014 that medical marijuana should be classified as reasonable and necessary medical care for injured workers.

The same momentum is impacting Latin America. Brazil’s governmental health care agency, ANVISA, recently removed a component of cannabis, cannabidiol (CBD), from the list of banned substances, meaning the marijuana molecule can now be prescribed by physicians for treating seizures, multiple sclerosis, schizophrenia and other ailments. As such, ANVISA has approved the importation of CBD from the United States.

More and more research studies are published every year. In the National Center for Biotechnology Information database of biomedical literature, 4,516 medical abstracts reference both cannabis and cannabinoids. Still the vast majority of medical schools do not educate students about the human endocannabinoid system.

Denis Petro, a neurologist and pharmacologist, researches cannabis as a treatment for multiple sclerosis. He founded Patients Out of Time, a non-profit organization dedicated to research and education on the endocannabinoid system. “At present, conventional treatments for spasticity are unsatisfactory,” Dr. Petro wrote, in an article, Indications for Therapeutic Use of Cannabis. “Based on scientific evidence, cannabis is a safe and effective alternative when compared to conventional treatments.”

Physicians in Colorado can recommend marijuana and the Colorado Constitution legally protects them (Article XVII, Section 14). The Colorado Constitution gives physicians immunity for advising a patient about the risks and benefits of medical marijuana for a debilitating medical condition, and for recommending medical marijuana to a patient.

Moreover, physicians have a duty to care for their patients, and that includes considering medical marijuana if it would help that patient. Consequently, by understanding the health benefits and the particularized sources of liability, physicians can lend clarity to the medical marijuana industry.

While medical marijuana policy changes may lead to uncertainty, most questions about the marijuana industry, including the risks and its related legality, have answers. The problem is that health care providers and insurance companies do not know where to turn for this information.

I delivered a number of presentations concerning this topic to various provider and insurance-related entities across the country serving our health care system. It is evident that many of these health care related entities can move forward with a better understanding of the risk implications and devise better informed strategies to incorporate medical cannabis into their operational plans, whether for now or in the near future.

An understanding of the researched health benefits of medical marijuana is increasingly necessary for physicians and other members of our health care system. A conservative approach is certainly advisable, but it is more than just a good thing to learn about; it is a necessity in this day and age to remain relevant and informed. This needs to happen now. And the providers that take appropriate steps soon will be better positioned to deal with these issues as they become increasingly prevalent.

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Why are Business Professionals Hesitant to Enter the Cannabis Industry?

By Tyler Dautrich
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I recently had a discussion with a colleague of mine on how the cannabis industry lacks business sophistication. There are not many MBA level, or proven business professionals, that have made a living and name for themselves in another industry, entering the cannabis space. At first glance, you would think there should be, primarily because they can leverage their previous expertise and success into a new, multi-billion dollar space. Instead, those professionals are watching from afar and eying a move to enter the industry five to ten years down the line.

It just so happens that the individual I was speaking to is in the situation described above, so I asked why? Why not leverage your success and make a name for yourself in this industry where there is clearly an opportunity? This individual is coming from a legal background so this piece will focus on that area primarily. However, the story is the same for many others that come from different professional backgrounds.

They informed me that entering the cannabis industry could risk them potentially losing their license to practice law. They practice law in a state that does not have any form of cannabis legalization. So even if this person wanted to actively pursue working in the cannabis industry (where legal), they run the risk of potentially losing their license and not being able to practice law again. This creates a difficult decision for someone considering an emerging industry that still has an uncertain future.

Beyond putting professional careers and relationships in jeopardy, the cannabis stigma affects personal lives. It amazes me that there is still an extremely negative stigma that surrounds this industry. No matter the level of professionalism the industry demonstrates, many still think working with cannabis could be considered unprofessional.

I know from first hand experience in talking with a handful of professionals that are working in the industry, they do not tell everyone what their job is. Or they use their job title from their other current, or previous, job outside of the industry. They do not want certain individuals to know they are in the industry because they know it will damage their current reputation in certain groups.

This is one of the recurring issues with startups not only going through Greenhouse Ventures accelerator program, but throughout the industry. Many lack that level of business sophistication to have the know-how and ability to scale and grow their startup. Yes, they are the founding team and they have the idea and the vision, but they are not the team that investors put their faith and capital in.

My question is, what needs to happen to start attracting these business professionals into the cannabis space? We have already seen a few of the more risk averse professionals jump ship, but a majority are still hiding in the shadows or watching from the sidelines.

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Time to Litigate: The Defense That Helps the Client but Hurts the Industry

By David C. Kotler, Esq.
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From time to time, lawyers that service the cannabis industry find themselves representing a client with a litigation matter. By anecdotal evidence, it appears that there is an up-tick in cannabis related litigation over the past year and a half, mostly in circumstances where respective promises made have not been lived up to or those who have invested money are seeking its return. Perhaps a partnership formed within the last few years is simply becoming unraveled.

In the world of litigation, we see defenses, or what are known as affirmative defenses, may be filed in response to a particular lawsuit or claim. One such affirmative defense often utilized in litigation is that a particular contract or agreement may be void based on illegality or void as against public policy.

In fact, this particular grounds for dismissal was at issue in a case in Maricopa County, Arizona wherein a judge in April of 2011 dismissed a lawsuit seeking enforcement of a loan agreement where two Arizona business people loaned $250,000.00 each to a Colorado-based medical marijuana dispensary. The agreement in that case specifically stated that the loan was for “a retail medical marijuana sales and growth center.” Colorado had the foresight in 2013 to legislate against this type of defense when their general assembly passed a law indicating “a contract is not void or voidable as against public policy if it pertains to lawful activities authorized by” Colorado’s constitutional and statutory cannabis law.

The issue becomes germane in emerging states wherein the legislatures and courts have not been dealing with cannabis related matters for any length of time. This is particularly true and ripe for problems in states such as Illinois and Massachusetts that have recently moved forward with cannabis programs and experienced an influx of out of state consultants and companies looking to partner with and work with local residents for licensure purposes. In Florida alone, there have been at least three lawsuits in the past year dealing with cannabis related civil disputes.

To my knowledge, none of those disputes were defended upon, nor did the court address, the legality of the underlying subject matter. However, the question arises whether the lawyer’s obligation to their client necessitates raising this as a defense, for instance, to an action for non-payment of a promissory note for a loan to fund cannabis related business. If the lawyer practices and seeks clients in the industry and hopes to move the industry forward in a positive manner, is it incumbent upon the lawyer to assist the client by making the best legal argument or protect the industry and greater good? As an aside, the answer is to zealously represent the client. Potentially, an adverse ruling in a particular jurisdiction could ultimately affect enforceability of cannabis related agreements in that jurisdiction. It is possible that having a court ruling, even if it is a trial level court within the jurisdiction, at least provides some precedent and a basis for the industry moving forward in that particular jurisdiction. If the ruling is unfavorable like the Arizona precedent mentioned earlier, perhaps planning for jurisdiction and venue to be in more favorable environs is key to document drafting on the front end. For investors, knowing the enforceability of their agreements in a particular jurisdiction could mean the difference between investing in a venture in a particular state or not.

Ultimately, I believe that as advocates, we must do whatever is in our power to protect the client even if it means testing the legal bounds by making an argument that at first blush may hurt the industry. However, having courts develop precedent by which the industry can govern itself in business dealings is important and takes away uncertainty, which in turn allows for good decision-making on the front end. Hopefully, in the near future this will be moot as the federal government moves forward to take actions that provide more certainty and uniformity in dealings within the cannabis space.

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.