Five of six subcommittees, plus the full NMAB met in July. Updates from each subcommittee that met, as well as the Natural Medicine Advisory Board, are shared below.
Emergency Response, Safety, and Ethics made significant headway this month. Dr. Bradley Connor presented a first draft Natural Medicine Facilitator Ethical Code. In addition to typical ethical considerations, the 11-page document contains unique considerations for natural medicine including the use of supportive touch and conflicting ethical codes when a facilitator holds another professional license.
The subcommittee also revisited a list of Oregon Health Authority regulations for Psilocybin Service Centers, which the subcommittee has been working through as a starting point for many of the nuts-and-bolts safety requirements of healing centers. Questions around security, alarm systems, and video recordings raised concerns about inflating costs and overburdening licensees. Here the question of whether multiple facilitators or video recordings will be required was raised. While that question is not expressly put to any one subcommittee, it is becoming clear that the answer will bear on many recommendations throughout the NMAB. The security-related questions were ultimately tabled until the subcommittee receives and reviews the Marijuana Enforcement Division’s equivalent requirements.
Several additional topics were tabled under the assumption that they will be effectively regulated by the ethical code. Those topics include preparation sessions, facilitator conduct, reporting misconduct, record keeping, and documentation requirements.
The subcommittee did land on two recommendations. First, if an interpreter will be needed for administration, the interpreter must also attend a preparation session to ensure the accuracy of informed consent. Second, any unused natural medicine must be returned to a facilitator following an administration session.
Next Meeting: August 9th, 2023, 1pm MST
Products, Research and Data committed to some of the first concrete recommendations to come out of a subcommittee, with a set of recommendations each for cultivation and production.
Regarding cultivation, the subcommittee will recommend the following:
- Psilocybe cubensis (and sub-strains) as the only cultivar in the regulated market.
- Synthesis, defined as the process of combining two or more components to produce a new substance, will not be permitted.
- 3rd-party testing will be required. In-house testing will be permitted but not required.
- Additives will be permitted that do not increase the harm or intoxicating effect of psilocybin, such as inactive ingredients from the FDA’s inactive ingredients list or soil additives that encourage cultivation but do not change the effects of the mushrooms.
Regarding production, the subcommittee will recommend the following:
- During production, adulterants as defined in OHA regulations, will not be allowed.1
- Additives which do not increase the harm or intoxicating effects, such as ingredients from the FDA’s inactive ingredients list, will be permitted during production.
- 3rd-party testing will be required. In-house testing will be permitted but not required.
In the next meeting, the subcommittee will consider adopting some or all of the USDA’s best practices for the cultivation of food mushrooms as best practices for the cultivation of psilocybin mushrooms.
Next Meeting: August 16th, 2023, 1pm MST
Indigenous and Religious Use and Outreach experienced a significant shift in the overall disposition of the subcommittee. Having previously been focused on defining Indigenous, Religious, and Spiritual use, the group has shifted its attention to the question of how to compensate traditional practitioners within the bounds of the law. The bill implementing the Natural Medicine Health Act contains explicit protection allowing an individual to perform a “bona fide religious, culturally traditional, or spiritual ceremony” but places some limitations on that protection.
First, the individual must inform anyone participating in the ceremony that they are not a licensed facilitator. Second, the ceremony cannot be “associated with business, commercial, or for-profit activity.” Subcommittee members have taken issue with these limitations. Chair Pinkola-Estés has lamented the requirement that a person define themselves by something they are not. Another sticking point for the subcommittee is how the language appears to require a traditional healer with many years of experience to be forced through the regulated training framework. The subcommittee finds this prospect disrespectful and likely to result in many legacy practitioners remaining underground.
Fortunately, the subcommittee has no shortage of allies in their new mission. A representative from the Attorney General’s office has offered the interpretation that cost-of-services compensation may be appropriate and that it is within the scope of the subcommittee and the NMAB to recommend where the line of “for-profit activity” lies. The subcommittee has also taken their case to the other NMAB subcommittees and found broad support. Qualifications, Licensing, and Training has taken up the task of finding a mechanism of equivalency to allow legacy and Indigenous practitioners to be licensed under the regulated framework.
Of course, there are more questions to be answered. What precisely qualifies as a “bona fide religious, culturally traditional, or spiritual ceremony”? How will regulators prevent bad actors from claiming the protections offered by the carveout? Will asking legacy healers to justify their lived experience to government agencies be seen as disrespectful, or legally risky? It may not be crystal clear, but it seems that the prospect of compensating Indigenous healers has a path forward.
Next Meeting: August 11th, 2023, 1pm MST
Qualifications, Licensing, and Training also saw a significant departure from their previous trajectory of tying facilitator licensing levels to formal education levels. After considering several alternative licensing models the subcommittee is moving forward with a single facilitator license and training. In this model, all facilitators would complete a standardized natural medicine curriculum. Licensed facilitators would then fall into one of two buckets. The first would be single licensure, consisting of individuals holding a natural medicine facilitator license only. The second bucket would be multiple-licensure and broadly consist of anyone holding a facilitation license plus one or more other licenses such as psychotherapy or medicine. The outer bounds of a particular facilitator’s scope of practice would be set by the limits of their licenses together and facilitators would be responsible for practicing within the bounds of their competency, established by their training. The subcommittee identified several advantages of this model, among them reducing the administrative burden on DORA (and thus reducing costs), allowing facilitators to build their own scope of practice through multiple licenses, and the potential of collaboration with other licensed professionals.
This meeting also opened a discussion on the question of licensing for Indigenous and legacy healers. With assurance from the Attorney General’s office that the NMAB has statutory authority to recommend a waiver process, the subcommittee will consider a mechanism that grants the same facilitator license through experience equivalency.
Dr. Bradly Cooper also presented his draft Natural Medicine Facilitator Ethical Code in this subcommittee. Concerns were raised around the code prohibiting facilitators from consuming natural medicine and an assumed requirement of two facilitators or video recordings. Some members expressed that a facilitator consuming small amounts of natural medicine while facilitating is a long and accepted practice in the traditional use of natural medicine. Increased costs and spiritual beliefs around recording the healing process came up as problems with that assumption. Arguments for a multiple-facilitator or recording requirement are for the protection of participants and facilitators if misconduct is alleged. Discussion on these topics remains open and ongoing.
Next Meeting: August 17th, 2023, 1pm MST
Harm Reduction and Public Safety did not meet during the July cycle of the NMAB and has not scheduled their next meeting
Public Health & Health Equity welcomed two non-voting participants into their ranks this month. Melissa Palmer is a social worker and palliative care specialist. Dr. Gillian Jones is an army-trained neurologist with experience in the cannabis industry and cooperative business models.
Dr. Tina Gonzales opened a discussion on collaborating with the larger equity ecosystem in Colorado by working with the Colorado Equity Alliance. The alliance is a collective of state agencies and community organizations dedicated to ensuring state-funded efforts create equitable systems. The subcommittee also reviewed a document by Chair Billy Wynne compiling ideas the subcommittee had generated. NMAB member Lundy presented a revised list of initiatives including social equity licenses; mentorship, loan, and grant programs; free, state-run facilitator training; and data collection programs to encourage insurance industry participation in the natural medicine market. This served as a jumping-off point for broader discussion with Department of Revenue representatives around equity initiatives in the cannabis industry. DOR representatives cautioned the group against front-loading the costs of programs which could drive up licensing costs and instead encouraged them to consider programs that can be implemented incrementally. Additionally, DOR and the Marijuana Enforcement Division urged subcommittee members to think long-term about required disclosures and eligibility restrictions for criminal histories as well as early data collection to drive sound decision-making. In the bigger picture, the subcommittee seems to be thinking critically about the difference between increasing equity for individuals and businesses.
Next steps for the subcommittee will be to hear from individuals representing Health First Colorado, the Colorado Equity Alliance, insurers, and traditional practitioners.
Next Meeting: August 10th, 2023, 1pm MST
Finally, the Natural Medicine Advisory Board held its fourth full meeting, albeit minus a few members. Acting Chair Dr. Joshua Goodwin informed the board and the public that work is proceeding in subcommittees with most having added non-voting participants. DORA program director Sam Bahrami announced the department would be posting open roles for natural medicine support staff in the coming weeks.
The Department of Regulatory Agencies provided the NMAB and the public an overview of their rulemaking process including a tentative timeline. The official process includes four steps beginning with the posting of a Notice of Proposed Rulemaking. Following the notice, there will be stakeholder engagement through written comments and meetings, culminating in final hearings. After the final hearing, the Attorney General reviews the rule and it is enacted. DORA intends to begin drafting rules based on NMAB recommendations in early 2024, with first public Notices of Proposed Rulemaking posted in spring-summer and final hearings taking place by early fall 2024.
Representatives from the Department of Revenue also gave a presentation on their rulemaking process but did not publicly discuss a timeline, despite having provided one to NMAB members prior to the meeting. The department will be forming rulemaking working groups in late 2023, with questions and subjects that build on the work of the NMAB.
Subcommittee members gave updates on work accomplished since the previous meeting of the NMAB. A representative of the Indigenous and Religious Use and Outreach subcommittee expressed the subcommittee’s position that Indigenous must be permitted to operate within the for-profit framework, with an equivalency mechanism for non-western education and experience. The Qualifications, Licensing, and Training update centered on the adoption of the single/multiple licensure model, indicating an intention to finalize that model in time for the August meeting of the NMAB.
Finally, the NMAB discussed dissolving the Harm Reduction and Public Safety subcommittee to avoid duplication of work. The board agreed that the questions directed to Harm Reduction and Public Safety could be effectively addressed in other subcommittees. The only downside identified was a loss of meeting time with which to move work forward. A solution of increasing meeting cadences satisfied this concern. With only nine of the 11 members required to amend the NMAB bylaws—and required for the dissolution of a subcommittee— no official action was taken. The board intends to vote on officially dissolving the Harm Rection and Public Safety subcommittee in August. Until then, other subcommittees will begin addressing those questions related to their subject areas.
Next Meeting: August 18th, 2023, 1pm MST
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- “Adulterant” means chemicals, drugs, plants or substances that alter the potency, intoxicating effect, duration of effect, toxicity or potential for excessive use when added to psilocybin products. Adulterant does not include naturally occurring substances contained in food items such as, but not limited to chocolate. OAR § 333-333-1010.