Cannabis's federally illegal status makes it difficult to conduct licensed clinical research on the plant and products made from it, hampering medical and commercial advancements in cultivation, extraction and ingestion. Colorado legislators, tired of waiting for the feds, passed a bill in May 2017 that allows for state-approved research-and-development licenses for clinical studies on potency, chemical composition, agriculture and other areas.
HB 1367 created a licensing program within the Marijuana Enforcement Division that will issue research-and-development licenses for public and private studies by nonprofit and government organizations and commercial businesses. But even though the bill passed months ago, its statutory language is still being tweaked; the program won't start before 2018.
Governor John Hickenlooper didn't sign the bill before sending it to the Colorado Secretary of State's Office to become law. Explaining his lack of a signature, Hickenlooper called on the bill's sponsors to present clarifying legislation at the start of next year's legislative session, since the wording in late amendments had unintentionally limited the MED's power to enforce contamination and potency rules.
When that legislation is introduced in early January, sections on the proposed licensee program will be a little different from what was originally envisioned. As part of the MED's 2017 rule-making sessions, state officials, industry stakeholders and health professionals met on Thursday, September 14, to make some changes to how cannabis research will be approved and conducted in Colorado.
The four-hour discussion focused on issues ranging from how applications are reviewed to further defining what can and can't be researched. The need to include retail cannabis in the program was immediately brought up – and widely agreed upon – by stakeholders. Business owners, Colorado officials and health-care representatives, including the Colorado Psychiatric Society, believe it's important to include retail in studies. "Most of our patients, whether they have a medical card or not, are buying from the retail side," noted Karen Rice, a psychiatry specialist based in Boulder.
But despite that general agreement, retail cannabis cannot be added to the current program, because the original bill was drafted to include just medical marijuana, according to the Colorado Attorney General's Office, which says retail and medical products can't intermingle during studies.
As it stands, applicants must submit a project proposal to an institutional review board and then the MED for approval before obtaining a license – but several stakeholders, mostly businesses owners, would like to be able to receive approval before submitting a proposal if their facilities are ready for research. Business owners were also concerned with the length of review time, which was recommended at ninety days by the Colorado Department of Environmental Health during the meeting.
Medicine Man founder and CEO Andy Williams pushed for a quicker review process, pointing out that only Pennsylvania has a state program to license cannabis research. "Theirs isn't up and running yet," he noted. "Colorado has a chance to be out front here." Officials from the MED, CDPHE and the Department of Revenue preferred a more open-ended timeline, but recognized the need for further discussion on the process.
Teri Robnett, executive director of the Cannabis Patients Alliance, pointed out the need for a more robust reviewing process that involves two or three layers for studies involving consumers. "Study plants is one thing, but once you get humans involved, I think that requires more reviews," she said.
John Andrle, co-founder and co-owner of L'Eagle dispensary, also wanted reviews to follow studies approved by the U.S. Food and Drug Administration. "Every bit of evidence I've provided has been scoffed at as anecdotal," he explained. "I would cede to anything that makes what we do more concrete or 'real.'"
The current categories for research under the new law:
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- Chemical potency and composition levels
- Clinical investigations of marijuana-derived products
- Efficacy and safety of administering marijuana as part of medical treatment
- Genomic research
- Horticultural research
- Agricultural research
- Marijuana-affiliated products or systems
Cannabis activist and caregiver representative Jessica LeRoux takes issue with the lack of cannabis breeders in the stakeholder group, arguing that the true intention of the bill has been twisted to create a program benefiting the wealthier side of the cannabis industry. "This legislation wasn't written for marketing, it was written for research," she says. "Breeders should be able to study phenotypes at home. When you're excluding these licenses to million-dollar facilities, you're keeping out people that have been doing it for twenty years."
The MED will hold another stakeholder session on Friday, September 15, from 1:30 to 5 p.m., to further discuss logistics for research licensees, as well as product transportation and prohibited acts. The meeting will be at the Colorado Gaming Commission conference room, 17301 West Colfax Avenue in Golden. Any unresolved issues from the meetings on HB 1367 will be considered at catch-all sessions on Tuesday, September 19, and Friday, September 22, at the same location. The final day for consideration of public and written comment is Monday, October 16, during the final rule hearing.