by Sarah Lee Gossett Parrish, Cannabis Lawyer
In the wake of passing the MORE Act, which I wrote about in my December 2020 column, two other Acts related to marijuana were passed by Congress at the end of 2020. The U.S. House of Representatives approved the Medical Marijuana Research Act (“MMRA”) on December 9, 2020. MMRA is bipartisan legislation introduced by U.S. Representatives Earl Blumenauer (D-OR) and Andy Harris (R-MD) that addresses the burdensome impediments to legitimate medical research. Subsequently, on December 15, 2020, the U.S. Senate approved its own bipartisan bill, the Cannabidiol and Marihuana Research Expansion Act (CMREA). The CMREA also promotes cannabis studies and addresses current impediments.
A 2017 report by the National Academies of Sciences, Engineering, and Medicine found that “research on the health effects of cannabis and cannabinoids has been limited in the United States, leaving patients, health care professionals, and policy makers without the evidence they need to make sound decisions regarding the use of cannabis and cannabinoids.” Thus, passage by the House and Senate of MMRA and CMREA is good news moving into 2021. It appears that Congress finally recognizes the value of cannabis research, and plans to encourage studies by removing antiquated federal roadblocks. The caveat is that, in order for federal legislation to become law, it must be passed by the House and the Senate, and signed by the President. Hopefully, Congress will reach an agreement on a unified version of these two bills during the early months of 2021.
Barriers to Cannabis Research
Federal law severely limits studies concerning health benefits of cannabis. There is a burdensome registration procedure, protocol reviews are redundant in many instances, security requirements are onerous and unnecessary, especially given that approximately ninety-nine percent of Americans now live in a state where marijuana is legal in some form, and there is just a complete lack of significant research. Limitations also apply to where marijuana for research can be obtained and unfortunately, the quality of that marijuana has been poor—a recognized fact now—which has inevitably hampered accurate results of any significant research studies concerning its health benefits
Source Limitations for Marijuana Used in Research Since “marihuana” remains a Schedule I substance under the federal 1970 Controlled Substances Act (“CSA”), the Drug Enforcement Administration (“DEA”) regulates its cultivation for research purposes. The DEA controls registration requirements and establishes annual aggregate production quotas under the authority of the CSA. Unbelievably, the DEA has issued only one registration for research marijuana cultivation—to the University of Mississippi. Thus, only the University of Mississippi has been authorized to grow marijuana for use in research studies. Every few years, the University designates the land where marijuana crops are grown based on current and expected demand. Then, the marijuana is grown, harvested, stored, and made available in bulk or as particular elements of the plant, for use in research. The subpar quality of the University-grown marijuana renders it almost useless in conducting serious studies that might yield reliable, usable data leading researchers to significant conclusions about marijuana’s health benefits.
Additionally, studies have shown that this marijuana has lower levels of THC and CBD as compared to commercial grade cannabis products and is, in fact, genetically closer to hemp than the marijuana varieties sold at dispensaries in states where marijuana is legal. Given that marijuana and hemp are genetically distinct, reliance upon the low-grade marijuana cultivated at the University of Mississippi for research about its health benefits is problematic. Participants in studies who consume the varieties cultivated at the University may experience vastly different effects than patients and adult-use consumers that obtain their marijuana product from dispensaries, yielding unreliable results and faulty conclusions. However, efforts by the DEA to expand the number of federally authorized marijuana cultivators for research purposes are underway, and passage of the above pieces of legislation will likely ensure that higher quality marijuana becomes available for research purposes.
Medical Marijuana Research Act
The MMRA achieves four main goals. It addresses the poor quality and inadequate supply of medical-grade marijuana available for use in research; provides a clear path for researchers to study cannabis products used by patients and adult-use consumers pursuant to state-legal programs; streamlines the unduly burdensome, redundant process that researchers must navigate before obtaining a license to conduct marijuana research while guarding against misuse and abuse; and requires that the Secretary of the U.S. Department of Health and Human Services provide a report on the status and results of new research concerning the health benefits of marijuana.
The full text of the MMRA can be found here.
Cannabidiol and Marihuana Research Expansion Act
The CMREA, passed by the Senate, is primarily intended to streamline the application process for researchers to study marijuana and to encourage the Food and Drug Administration to develop cannabis-derived medicines. The congressional summary of the Act states that it allows “accredited medical and osteopathic schools, practitioners, research institutions, and manufacturers with a Schedule I registration” to cultivate their own cannabis for research purposes. This provision would insulate researchers from the requirement of using the poor quality marijuana cultivated at the University of Mississippi.
The Act also specifies that physicians can discuss the risks and benefits of marijuana with patients, and, in similarity to the required report under the MMRA, requires the U.S. Department of Health and Human Services to submit a report concerning the potential health benefits of marijuana and addressing barriers to cannabis research and how best to overcome those barriers. The CMREA has been endorsed by mainstream medical organizations, including the American Academy of Pediatrics, the American Medical Association, the American Psychological Association and the American Society of Addiction Medicine.
The full text of the CMREA can be found here.
Differences in MMRA and CMREA
One major difference in the MMRA and the CMREA is that the House bill (MMRA) allows scientists to obtain marijuana from dispensaries in legal states for research purposes, whereas the CMREA allows them to cultivate their own marijuana for such purposes. Both provisions are clearly designed to circumvent current federal requirements that marijuana used for research purposes must be cultivated at the University of Mississippi. Another difference in the two pieces of legislation is the provision in the CMREA protecting physicians from penalties under the CSA, to allow discussion of risks and benefits of marijuana products with patients.
Will we see more federally-approved marijuana research projects in 2021?
Information contained herein provides general information related to the law and does not provide legal advice. It is recommended that readers consult their personal lawyer if they want legal advice. No attorney-client or confidential relationship exists or is formed between you and Ms. Parrish as a result of this article.