Should There be More Sources of Medical Marijuana For Federally-Funded Research? (H.R. 5634)
Do you support or oppose this bill?
What is H.R. 5634?
(Updated December 3, 2018)
This bill -- known as the Medical Cannabis Research Act of 2018 -- would increase the number of cannabis manufacturers allowed to grow the substance for legitimate research purposes; authorize healthcare providers at the Dept. of Veterans Affairs (VA) to provide recommendations to veterans regarding participating in federally-approved cannabis clinical trials; and create a “safe harbor” for VA researchers and VA-funded institutions studying medical cannabis and the patients in federally-approved medical cannabis clinical trials. It would not interfere with or change federal or state laws or law enforcement, or make any changes to cannabis’ legal status.
Starting in 2019, the Attorney General (AG) would be required to increase the number of manufacturers allowed to manufacture cannabis for legitimate research purposes from its current number of one to at least three.
Manufacturers authorized by the AG would be required to:
Comply with all applicable requirements of this legislation;
Limit the transfer and sale of any cannabis they manufacture under this legislation to researchers registered to conduct research with Schedule I controlled substances, preclinical research, and clinical investigations;
Transfer or sell any cannabis manufactured pursuant to this bill only with the prior, written consent of the AG;
Complete an application and review process for the bulk manufacture of schedule I controlled substances;
Have a process for storing and handling schedule I controlled substances that includes inventory control and security monitoring;
Be able to provide at least 10 unique plant cultivars to ensure plant diversity and scale up to produce bulk plant material on an uninterrupted basis to meet forecasted demand;
Hold a license to manufacture cannabis in each state in which they conduct operations;
Complete criminal background checks for all personnel involved in their operations, in order to confirm that they have no convictions for felonies or drug-related misdemeanors;
Have a letter of reference from state health and law enforcement authorities in whose jurisdictions they operate, affirming their good standing; and
Have the ability to test for and isolate at least 12 cannabinoids for the purposes of producing specific products for specific studies by compounding pharmacists or others, labeling, and chemical consistency
The AG would be responsible for conducting annual assessments to determine whether there’s an adequate and uninterrupted supply for cannabis for legitimate research purposes.
This legislation would also explicitly allow healthcare providers at the VA to: 1) provide information to veterans regarding participation in federally-approved cannabis clinical trials, and 2) to complete forms relating to veterans’ participation in federally-approved cannabis clinical trials.
It’d also allow healthcare providers and other VA employees to accept information regarding federally-approved cannabis clinical trials provided by individuals who are not VA employees, as long as they are researchers registered under the Controlled Substances Act to conduct research with schedule I controlled substances. Finally, this legislation would allow the VA to conduct medical cannabis research for the VA employees conducting the research are researchers registered under the Controlled Substances Act to conduct research with schedule I controlled substances.
Argument in favor
Medical cannabis has many potential applications. Federally-funded researchers should have access to high-quality product with which to conduct research, and veterans should be able to be advised on, and participate in, federally-approved trials.
Argument opposed
Banning people with criminal records from working at cultivators and requiring cultivators to have letters of good standing from local law enforcement agencies may make it harder for cultivators to run their businesses.
Impact
Medical cannabis research; VA health care providers; VA hospitals; Department of Veterans Affairs; and the Attorney General.
Cost of H.R. 5634
A CBO cost estimate for this bill is unavailable.
Additional Info
In-Depth: Rep. Matt Gaetz (R-FL) introduced this bill to allow researchers to study the potential cures medical cannabis may unlock:
“This bipartisan cannabis reform legislation will improve the quality of scientific research on cannabis, while protecting research institutions nationwide. I fully believe that this bill has a chance to pass this Congress and be signed into law by the President, who expressed his support for medical cannabis during his campaign. It is monumental for the House Judiciary Committee to consider cannabis-related legislation. They have not tackled legislation on this topic since 1978, before I was born. I have been assured that the committee will take up my legislation, however; the Medical Cannabis Research Act was cosponsored by Judiciary Chairman Bob Goodlatte, and his office was instrumental in helping to draft the final legislation. He has been invaluable in making this legislation a reality, and I thank him for his help.
Cannabis has always faced a Catch-22 in Congress: we can’t change cannabis laws without doing research, but we can’t do more research without changing the law. Our bill finally breaks that logjam. This legislation will make a tremendous difference to researchers nationwide, who may finally be able to develop cures for illnesses that affect many of America’s most vulnerable populations. I thank my colleagues for their support, and look forward to passing sweeping cannabis reform legislation this Congress.”
Some drug policy reform advocates, who otherwise strongly support expanding medical marijuana research, have expressed concerns with some of this bill’s provisions. Namely, they don’t like that it bars people with felony or drug-related misdemeanor convictions from being affiliated with research cultivation operations, or that it requires research cultivation operations to have letters of good standing from local law enforcement agencies, many of which have historically opposed cannabis reform. Michael Collins, interim director of the Drug Policy Alliance’s Office of National Affairs, says:
“Precedent is the biggest concern. If the committee is already on the record saying we ban people from participating in this sector of this industry, that's going to possibly win the day going forward. While the bill’s consideration represents progress, it’s a drop in the ocean given what we need to do to end federal prohibition and repair the harms of the drug war… [and the restrictive provisions are] egregious, unnecessary, and representative of an outdated approach to public policy.”
In response to these concerns, Rep. Gaetz says that he doesn’t necessarily disagree, saying, “I would go a lot further. If I was king for a day, marijuana doctrine would look different from this bill.” But he argues that the concessions in the bill were needed to get other GOP lawmakers on board:
"For many of my Republican colleagues, the most difficult marijuana reform vote to take is the first one. I'm trying to create the most comfortable setting for marijuana skeptics to do something right by their constituents, and that process can yield imperfect legislation that is directionally correct."
However, Collins contends that removing the restrictions in this bill wouldn’t harm its chance at passage, and argues that the restrictions may actually make passage less likely because criminal justice reform advocates who otherwise wouldn’t care about a marijuana research bill are now concerned:
“The provisions are overly cautious and unnecessary given what the committee has voted on in the past (namely, broader criminal justice reform aimed at giving people second chances after serving prison terms)... [the Drug Policy Alliance] would like to get behind this bill, but with these provisions it's going to be very difficult.”
NORML, a nonprofit public-interest advocacy group advocating for marijuana reform, calls this legislation a step in the right direction to lay the foundation for future medical cannabis research in spite of its overly-restrictive permitting process. NORML Political Director Justin Stekal says:
“The Medical Cannabis Research Act would, in theory, dramatically expand access to medical grade cannabis for researchers for scientific purposes. While the bill is imperfect as it would rely on known prohibitionist Attorney General Jeff Sessions to oversee an overly restrictive permitting process, its passage would be a step in the right direction to lay the foundation for future research into marijuana’s most beneficial properties.”
Attorney General Jeff Sessions said at a Senate hearing in 2017 that adding additional cannabis cultivators would be “healthy,” and testified at a hearing in spring 2018 that a dozen applications for additional cultivators’ licensing would be acted upon “soon.” However, nothing has been announced as of September 2018.
The Dept. of Justice’s Office of Legal Counsel has recently concluded that this bill’s plan to license more growers violates U.N. drug treaties. However, the Obama administration’s State Department said in 2016 that allowing additional cultivators wouldn’t violate international agreements.
This bill will go before the House Judiciary Committee for a vote on Thursday. It has the support of 40 cosponsors, including 19 Republicans and 21 Democrats. Most notably, House Judiciary Chairman Bob Goodlatte (R-VA), who has historically opposed marijuana reform, is an original cosponsor of this bill. Rep. Goodlatte’s support has been key to this bill’s advancement.
Of Note: Currently, all federally-approved studies of medical cannabis receive their product from one subpar source. This leads to product that is weak and often moldy, potentially causing illness. In addition to being poor quality, federally-grown cannabis is also scarce. In the closing months of the Obama administration, the Drug Enforcement Administration (DEA) moved to create a process to license additional cannabis cultivators, but the Trump administration’s DEA has since blocked DEA from acting on the proposals, leaving applications from over two dozen entities unread. AG Sessions has stated that action on these applications is coming “soon,” but DOJ has made no other statements on these applications.
Some federally-funded institutions, such as universities, are interested in researching medical cannabis, but can’t do so, as it would jeopardize their federal funding.
Media:
Summary by Lorelei Yang
(Photo Credit:iStockphoto.com / LPETTET)
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