Medical Cannabis Handbook
For Healthcare Professionals
Legal Landscape
OBJECTIVE
This introductory chapter is intended to enable medical professionals to better understand the legal terrain of medical cannabis. It provides clinicians with an overview from a legal perspective of relevant medical cannabis regulations and what clinicians may and may not do when discussing cannabis in the context of a patient visit.
INTRODUCTION
This chapter provides a legal framework for the topics that will be discussed throughout this handbook as well as future interactions and conversations with patients. Further chapters will dive deeper into many of the topics touched on in this legal overview including the history of medical cannabis use, an overview of prohibition, legalization and regulation, practical information for dosing, delivery and the clinical application of cannabis, and so much more. This section will provide up to date information regarding the current regulatory landscape of medical cannabis, and the application of those regulations in a medical and legal context.
FEDERAL LEGAL OVERVIEW
Cannabis, also commonly referred to as marijuana or hemp, is a genus of flowering plants in the family Cannabaceae that includes at least three species, Cannabis sativa L., Cannabis indica, and Cannabis ruderalis, as determined by plant phenotypes and secondary metabolite profiles (terpene profiles).1 In practice, cannabis nomenclature is often used interchangeably or seemingly arbitrarily. Legally, however, hemp and marijuana are distinguished by their respective concentrations of the cannabinoid delta-9 tetrahydrocannabinol (
This legislature removed Industrial Hemp from the Schedule I drug classification per section 10113 of the Farm Bill.4 With the declassification of Industrial Hemp, products that contain cannabidiol (
Since 1972, cannabis has been classified as a Schedule I drug under the U.S. Controlled Substances Act because the U.S. Drug Enforcement Agency considers it to have “no accepted medical use.”5 In stark contrast to this position, 33 of the 50 U.S. states and the District of Columbia have recognized the medical benefits of cannabis and have decriminalized its medical use.6 The approved list of conditions/diseases and the other laws/rules regarding the possession and cultivation of medical marijuana generally differ by state. In addition, 11 of the 50 U.S. states and the District of Columbia legalized recreational cannabis use for adults 21 years of age and over, with varying rules and regulations.
In 2014, President Obama publicly commented on the recreational legalization of cannabis in Colorado and Washington, stating that “it’s important for it to go forward because it’s important for society not to have a situation in which a large portion of people have at one time or another broken the law and only a select few get punished.” President Obama further remarked, “I don’t think it’s more dangerous than alcohol. In fact, it is less dangerous than alcohol in terms of its impact on the individual consumer.”7
In line with the president’s comments, the U.S. Attorney General Eric Holder announced that the federal government would allow states to create a regime that would regulate and implement the legalization of cannabis, including loosening banking restrictions for cannabis dispensaries and growers.8
The Cole Memo9 and the Financial Crimes Enforcement Network (
An October 2017 Gallup poll found an all-time high of 64 percent of Americans support full legalization. The same poll was also the first time Gallup recorded a majority of Republicans, 51 percent, favoring full legalization.11
Legal cannabis has become one of the fastest-growing industries in the United States, and state representatives have found that none of the problems predicted with legalization occurred. Sales jumped from $1.5 billion in 2013 (U.S.) to an estimated $10 billion (for North America) in 2017, according to Arcview Market Research. The industry now employs more than 150,000 Americans and has become more deeply entrenched in every quantifiable way.12
In addition to these recent developments, the U.S. government has set a precedent for patenting cannabis and cannabis-related inventions. For example, U.S. Pat. No. 6,630,50713 issued on October 7, 2003, and assigned to the United States of America, is directed to methods of treating diseases caused by oxidative stress by administering therapeutically effective amounts of a
In contrast, the Office of Trademarks at
OTHER PATENT AND TRADEMARK CONSIDERATION
Federal protection is not available for cannabis trademarks, except where it does not violate the Controlled Substances Act.17,18 Registration is refused because applicant does not have a bona fide intent to lawfully use the applied-for mark in commerce.19,20,21
Plant, design, and utility patents are available for cannabis inventions.
Copyright registrations are enforceable for cannabis creative works.
Despite the conflicting official positions within the federal government, many states have recognized that cannabis provides substantial benefits for medical and recreational uses. Cannabis is regularly used by a wide cross-section of society to treat a variety of maladies, conditions, and symptoms including, but not limited to, the following: nausea, glaucoma, lack of appetite, Crohn’s disease, epilepsy, post traumatic stress disorder, intractable pain, fever, obesity, asthma, urinary tract infections, coughing, anorexia associated with weight loss in
With the number of people depending on cannabis to treat a myriad of medical conditions, and the increase in tax revenue in the states that have decriminalized both medical and recreational cannabis, it is unlikely that a reversal in policy by the federal government will take immediate effect. There will be significant legal challenges and a call for a delisting of cannabis as a Schedule I controlled substance. At this time, the legal future of cannabis is uncertain.
FEDERAL LAW OUTLINE
This outline list provides an introductory overview of relevant federal cannabis regulations. Many sections included here may not be relevant to medical application but are important for patients to consider before deciding to use medical cannabis.
CONTROLLED SUBSTANCES Act (21 USCV 801, et seq.)
Marijuana is a Schedule I drug.22 Schedule I drugs are defined as:
The drug or other substance has a high potential for abuse.
The drug or other substance has no currently accepted medical use in treatment in the United States.
There is a lack of accepted safety for use of the drug or other substance under medical supervision.
Federal preemption23 of state laws is in “direct conflict” with the Controlled Substances Act.
OGDEN MEMO24
First guidance from the U.S. Department of Justice (
DOJ ) on medical marijuana enforcement.
COLE MEMO25
In an historic position change, the U.S. Justice Department’s Deputy Attorney General James Cole announced in 2014 that the federal government would not interfere with a state’s rights to manage and regulate marijuana based on eight conditions. This ruling is known as the Cole Memo and serves to remind individuals working in the legal marijuana industry that they remain under scrutiny.
It is important to note that under the current Attorney General, the future of the Cole Memo is unknown.
THE COLE MEMO states that the
DOJ is not waiving “immunity” or offering “a free pass” to marijuana providers; instead, the Justice Department promises that federal prosecutors will aggressively investigate/prosecute any cannabis business that interferes/obstructs any one of the following eight federal priorities:Distribution of marijuana to minors;
Revenue from the sale of marijuana from going to criminal enterprises, gangs, and cartels;
Diversion of marijuana from states where it is legal under state law in some form to other states;
State-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity;
Violence and the use of firearms in the cultivation and distribution of marijuana;
Drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use;
Growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and
Marijuana possession or use on federal property.
WILKINSON MEMO26
Extended Department of Justice enforcement priorities to tribal lands.
THE ROHRABACHER–FARR AMENDMENT27
(recently known as the Rohrabacher–Blumenauer Amendment)
Legislation first introduced by U.S. Representatives Maurice Hinchey, Dana Rohrabacher, and Sam Farr in 2003, prohibiting the Justice Department from spending funds to interfere with the implementation of state medical cannabis laws. The amendment does not change the legal status of cannabis, however, and must be renewed each fiscal year in order to remain in effect.
There is one unpublished case in California where the federal court extended the protection to recreational cannabis.28
Recreational marijuana is currently legal in 11 states plus Washington, D.C., and medical marijuana is legal in 33 states.29
TAXES
The Internal Revenue Service Section 280(e)—Calculation of taxable income:
May discount the cost of goods sold from gross revenues.30
May not discount ordinary business expenses.
No deduction or credit shall be allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances (within the meaning of Schedule I and II of the Controlled Substances Act) which is prohibited by federal law or the law of any state in which such trade or business is conducted.31
NO BANKRUPTCY PROTECTION FOR CANNABIS BUSINESSES32
10th Circuit Bankruptcy Appellate Panel held:
“Impossible for the Chapter 7 Trustee to administer the Arenases’ estate because selling and distributing the proceeds of the marijuana assets would constitute federal offenses.”
“If the Trustee abandoned the Assets, the debtors would retain their business after exposing the Trustee to grave risk, provide the creditors with little or no recovery, and receive a discharge, protected all the while from their creditors’ collection efforts by the automatic stay and then the discharge injunction. That is the epitome of prejudicial delay.”
Marijuana businesses are not eligible for Chapter 7, nor are they eligible for Chapter 13 bankruptcy protection.
Employment Law
Drug testing is still permitted because it is still a federal crime.
Employees can be fired for having
THC in their blood/urine, even if smoking has nothing to do with their job and had no effect on their job performance.Cannabis smokers are not a protected class; employers are free to discriminate.
Rightful termination may depend on whether the employment contract contains a provision with the requirement of following all federal laws, refraining from partaking illegal drugs, and so forth.33
ACCESS TO BANKING
The Financial Crimes Enforcement Network (
ADDITIONAL LEGAL CONSIDERATIONS FOR MEDICAL PROFESSIONALS
In addition to the federal legal overview, there are several other legal details medical professionals should consider when discussing cannabis with patients and caregivers. The Cole Memo provides guidelines for the regulation of medical cannabis at the state level and includes important guidelines regarding federal prosecution of cannabis businesses. The Conant v. Walters decision outlines how doctors can discuss and recommend cannabis for patients and is further detailed in this section. Affirmative defense is also an important topic of conversation.
CONANT V. WALTERS—HEALTHCARE PROVIDER RECOMMENDATIONS35
The 9th U.S. Circuit Court of Appeals ruled that doctors may discuss medical marijuana with their patients and may issue written recommendations for its use as part of a comprehensive treatment plan—Conant v. Walters, 309 F.3d 629 (2002). When this ruling was appealed again, the U.S. Supreme Court refused to hear the case, allowing the decision to stand.
After California and Arizona decriminalized medical marijuana in 1996, the Federal Department of Justice and Department of Health and Human Services sent a policy to federal, state, and local practitioner associations cautioning physicians who “intentionally provide their patients with oral or written statements in order to enable them to obtain controlled substances in violation of federal law risk revocation of their
DEA prescription authority.”In 2002, the 9th Circuit affirmed an order permanently enjoining the federal government from either:
Revoking a physician’s license to prescribe controlled substances, or
Conducting an investigation of a physician that might lead to such revocation, where the basis for the government action would be solely the physician’s “recommendation” of the use of medical marijuana, on First Amendment grounds.
After 2002, a provider may discuss the pros and cons of medical marijuana with his or her patient, and issue a written or oral recommendation to use marijuana within a bona fide provider– patient relationship without fear of legal reprisal.
And this is so, regardless of whether he or she anticipates that the patient will, in turn, use this recommendation to obtain marijuana in violation of federal law.
On the other hand, the physician may not actually prescribe or dispense marijuana to a patient or recommend it with the specific intent that the patient will use the recommendation like a prescription to obtain marijuana.
However, despite the First Amendment protections affirmed by the 9th Circuit, most healthcare providers are reluctant to recommend medical marijuana due to a claimed lack of scientific evidence or because the organization the provider works for has a policy against such recommendations.
AFFIRMATIVE DEFENSE
In states that have decriminalized medical cannabis, but not recreational cannabis, individuals possessing marijuana for a medical condition may have an “affirmative defense” for such possession. Each state’s specific rules are state specific, and the medical marijuana consultant should be familiar with the laws within their respective state. Generally, an affirmative defense to a criminal charge is a fact or set of facts other than those alleged by the prosecutor, which, if proven by the defendant, defeats or mitigates the legal consequences of the defendant’s otherwise unlawful conduct.
MEDICAL PROFESSIONALS
MAY:
Discuss, fully and candidly, the risks and benefits of medical marijuana with patients.
Recommend (or approve, endorse, suggest, or advise, etc.), in accordance with their medical judgment, marijuana for patient use.
Record in their patients’ charts discussions about and recommendations of medical marijuana.
Sign government forms or inform state or local officials that they have recommended medical marijuana for particular patients.
Testify in court or through written declaration about recommending medical marijuana for their patients.
Educate themselves about the medical benefits of marijuana, its various clinical applications, and different routes of ingestion.
MAY NOT:
Prescribe medical marijuana. This includes writing a recommendation on prescription forms.
Assist patients in obtaining marijuana.
Cultivate or possess marijuana for patient use.
Physically assist patients in using marijuana.
Recommend marijuana without a justifiable medical cause.
Early drafts of the Declaration of Independence were written on hemp paper.
REFERENCE LIST
- 1. Classification | USDA PLANTS. plants.usda.gov. 2017. Available at: https://plants.usda.gov/java/ClassificationServlet?source=display&classid=CASA3. Accessed October 31, 2017.
- 2U.S.C.. . Title 7. Sec. 5490 – Legitimacy of industrial hemp research. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 3U.S.C.. . Title 21. Chapter 13, Subchapter I. Sec. 802 – Definitions. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 4Agriculture Improvement Act of 2018, H.R.2, 115th Cong (2018)
- 5U.S.C.. . Title 21. Chapter 13, Subchapter I. Sec. 812 – Schedules of controlled substances. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 6. State Medical Marijuana Laws. www.ncsl.org. September 14, 2017. Available at: http://www.ncsl.org/research/health/state-medical-marijua-na-laws.aspx. Accessed October 31, 2017.
- 7Friedersdorf C. Obama on Pot Legalization: ‘It’s Important for It to Go Forward’. www.theatlantic.com. January 21, 2014. Available at: https://www.theatlantic.com/politics/archive/2014/01/obama-on-pot-legalization-its-important-for-it-to-go-forward/283201/. Accessed October 31, 2017.
- 8Sullum J. Eric Holder Promises To Reassure Banks About Taking Marijuana Money ‘Very Soon’. www.forbes.com. 2014. Available at: https://www.forbes.com/sites/jacobsullum/2014/01/24/eric-holder-promises-to-reassure-banks-about-taking-marijuana-money-very-soon/-3b5ce6307254. Accessed October 31, 2017.
- 9Cole, JM. Memorandum For All United States Attorneys: Guidance Regarding Marijuana Related Financial Crimes. Washington, D.C.: U.S. Department of Justice, Office of the Deputy Attorney General; February 14, 2014.
- 10FinCEN. Guidance FIN-2014-G001: BSA Expectations Regarding Marijuana-Related Businesses. Washington, D.C.: Department of the Treasury Financial Crimes Enforcement Network (FinCEN); February 14, 2014.
- 11. Record-High Support for Legalizing Marijuana Use in U.S. http://news.gallup.com/poll/221018/record-high-support-legalizing-marijuana.aspx-?g_source=Politics&g_medium=newsfeed&g_campaign=tiles. October 25, 2017.
- 12. Legal Marijuana Is The Fastest-Growing Industry In The U.S.: Report. https://www.huffingtonpost.com/2015/01/26/marijuana-industry-fast-est-growing_n_6540166.html December 6, 2017.
- 13. The United States of America As Represented By The Department of Health and Human Services. Cannabinoids as antioxidants and neuroprotectants. 1999. (US6630507 B1)
- 14U.S.C. . Title 15, Chapter 22, Subchapter I, Sec. 1051 Application for registration; verification, Washington, D.C.: U.S. Government Publishing Office; 2016.
- 15U.S.C.. . Title 15, Chapter 22, Subchapter III, Sec. 1127 – Construction and definitions; intent of chapter, Washington, D.C.: U.S. Government Publishing Office; 2016.
- 16In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016).
- 17U.S. Patent and Trademark Office. Trademark Manual Of Examining Procedure, Section 704.02 - Examining Attorney’s Search. Washington, D.C.: U.S. Government Publishing Office; 2017.
- 18U.S.C.. . Title 15. Chapter 22, Subchapter I. Sec. 1052 – Trademarks registrable on principal register; concurrent registration. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 19U.S.C.. . Title 15. Sec. 1051 & Sec. 1127 – U.S. Trademark Law. Washington, D.C.: U.S. Government Publishing Office; 2013.
- 20The John W. Carson Foundation V. Toilets.com, Inc., Opposition No. 91181092. 94 USPQ2d 1942, 1948 (TTAB 2010).
- 21U.S. Patent and Trademark Office. Trademark Manual Of Examining Procedure, Section 907 – Compliance with Other Statutes. Washington, D.C.: U.S. Government Publishing Office; 2017.
- 22U.S.C.. . Title 21. Chapter 13, Subchapter I. Sec. 812 – Schedules of controlled substances. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 23Constitution Of The United States Of America: Analysis And Interpretation. Article VI – Prior Debts, National Supremacy, and Oaths of Office. Washington, D.C.: U.S. Government Publishing Office; August 26, 2017.
- 24Ogden, DW. Memorandum For Selected United States Attorneys: Investigation and Prosecutions in States Authorizing the Medical Use of Marijuana. Washington, D.C.: U.S. Department of Justice, Office of the Deputy Attorney General; October 19, 2009.
- 25Cole, JM. Memorandum For All United States Attorneys: Guidance Regarding Marijuana Related Financial Crimes. Washington, D.C.: U.S. Department of Justice, Office of the Deputy Attorney General; February 14, 2014.
- 26Wilkinson, M. Memorandum: Policy Statement Regarding Marijuana Issues in Indian Country. Washington, D.C.: U.S. Department of Justice, Executive Office for United States Attorneys; October 28, 2014.
- 27H. Amdt. 748 to H.R. 1866. Washington, D.C.: 113th Congress; 2013-14.
- 28United States Of America V. Steve McIntosh. F. 3d 833, 1163, 1176 (9th Cir. 2016).
- 29Wikipedia. List of 2017 United States cannabis reform proposals. en.wikipedia.org. 2017. Available at: https://en.wikipedia.org/wiki/List_of_2017_United_States_cannabis_reform_proposals. Accessed October 31, 2017.
- 30McElroy Jr, WT. Memorandum No. 201503011: Taxpayers Trafficking in a Schedule I or Schedule II Controlled Substance – Capitalization of Inventoriable Costs. Washington, D.C.: U.S. Internal Revenue Service, Office of Chief Counsel; December 10, 2014.
- 31U.S.C.. . Title 26. Chapter 1, Subchapter B, Part IX. Sec. 280E – Expenditures in connection with the illegal sale of drugs. Washington, D.C.: U.S. Government Publishing Office; 2016.
- 32In Re Arenas V. United States Trustee. 535 B.R., 845 (10th Cir. 2015).
- 33Brandon Coats V. Dish Network, LLC. 350 P.3d 849 (Colo. 2015).
- 34FinCEN. Guidance FIN-2014-G001: BSA Expectations Regarding Marijuana-Related Businesses. Washington, D.C.: Department of the Treasury Financial Crimes Enforcement Network (FinCEN); February 14, 2014.
- 35John P. Walters, Et Al V. Dr. Marcus Conant, Et Al. F. 3d 309, 639 (9th Cir. 2003).
NOTES
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