Time for an Oregon psilocybin licensing discussion update.
Ballot Measure 109 gave the Oregon Health Authority (“OHA”) two years to create regulations for the manufacturing, testing, sale, and supervised administration of psilocybin. This two-year development phase started on January 1, 2021, and on March 18 Governor Kate Brown appointed members to the Oregon Psilocybin Advisory Board (“Board”). The Board had its first meeting on March 31, 2021.
The Board consists of five subcommittees covering various aspects of the emerging psilocybin industry including research, health equity, manufacturing, training, and licensing. Our own Mason Marks chairs the Licensing Subcommittee.
Our last licensing update was back on July 28. In this post we will explain what the Licensing Subcommittee covered in its meeting last month, on December 2. Next week, we will publish a post on what the Licensing Subcommittee covers this week, when it meets again at 4pm PST on January 6 (see agenda here).
Licensing Subcommittee Update
The Licensing Subcommittee meets every month to develop licensing requirements for psilocybin businesses and professionals. So far, it has developed recommendations regarding informed consent documents, professional codes of conduct, and licensing requirements for psilocybin facilitators.
Additionally, Board members have discussed requirements for group facilitation sessions, service center advertising, and service centers safety measures. Once the Licensing Subcommittee decides on a relevant issue, it offers a recommendation the entire Board. The Board will propose regulations to the OHA by June 2022.
Psilocybin storage, outdoor sessions, security at service centers, social equity, and service center personnel are among the complex issues discussed we’ve discussed so far. The Licensing Subcommittee has already made several recommendations to the Board on these matters. For instance, the Subcommittee recommended extra trained personnel both on-call and in the service center during psilocybin sessions. The Subcommittee plans to complete its recommendations by March 2022.
Recommendations at the Last Licensing Subcommittee Meeting
During the Licensing Subcommittee’s December 2 meeting, members discussed locations for licensed entities, facilitator conduct during administration sessions, and advertising.
Co-location of licensed facilities with unlicensed businesses and organizations
The Licensing Subcommittee began by discussing psilocybin service center locations, and how to enable equity. For instance, someone should not be excluded from providing psilocybin services merely because they lack access to a professional office building in a corporate campus. A service center could meet all comfort, safety and privacy requirements in a non-professional setting. This could be analogous to a therapist with an in-home practice.
That said, Measure 109 prohibits a service center from operating within a primary residence. Because ambiguity exists in that purported stricture, the Licensing Subcommittee postponed a vote on this matter to further discuss this ambiguity.
It’s important to note that a variety of locations could be desirable to site a licensed service center. For example, a psilocybin service center located adjacent to a healthcare facility can satisfy all client comfort, safety, and privacy requirements. A service center adjacent to a restaurant is another possible option– so long as requirements are met. Thus, the Licensing Subcommittee voted to recommend allowing business and organizational co-locations.
Finally, the Subcommittee decided the type of structure for service centers should not be limited to commercial buildings and office parks. There is no reason to prohibit variation as to structure. Such a prohibition would discourage diversity in applicants. Thus, the Subcommittee will recommend the OHA not prohibit manufactured structures, non-commercial buildings, outdoor spaces, or other non-conventional spaces from service center eligibility.
Facilitator Conduct During Administration Sessions
i. Facilitator leaving the room
When a client has completed all preliminary matters–including meeting with the facilitator and signing the informed consent form–a client can begin the “administration session.” This is when the facilitator gives the client psilocybin. Due to vulnerability during these sessions, it is important for facilitators to monitor clients and ensure their safety. But what if an administration lasts five to eight hours? A facilitator should be allowed to use the restroom and eat a meal during such long periods of time.
The Subcommittee will recommend allowing facilitators to leave the room while clients are experiencing altered states of consciousness. This would be allowed for limited reasons, such as short restroom and meal breaks on premises. To temporarily leave the room, the facilitator would be required to ensure the client is safe and comfortable. Another employee must monitor the client during this time. To help service centers avoid the expenses of hiring twice the number of facilitators, the Subcommittee decided the stand-in employee need not be another facilitator; another employee present on the premises would suffice.
ii. Contact
During an administration session, a client in an altered state may be comforted by a supportive touch, such as place a hand on their shoulder. While facilitators should be allowed to use this technique, contact with a client should be highly restricted. Thus, the Subcommittee will recommend that facilitators may use supportive touch, but only if the client gave informed consent prior the administrative session. Further, sexual, or romantic touch should be strictly prohibited, and grounds for license revocation. Subcommittee members agreed client safety during altered states of consciousness must be taken very seriously.
iii. Duration
A growing practice among psilocybin users is called “microdosing,” which involves consuming low levels of psilocybin and thus avoiding dramatic alterations in consciousness. There are many reasons a client may choose to microdose at a service center. These may include cost, or reluctance to enter a hallucinogenic state. The Subcommittee thus discussed how microdosing would affect the duration of administration sessions, and how a facilitator would determine when the session has ended.
When a client consumes higher doses of psilocybin, the client may experience an altered state of consciousness for eight hours, whereas a microdose may not noticeably affect them at all. Thus, the Subcommittee will recommend criteria for ending an administration session, rather than a maximum/minimum amount of time. These criteria include several factors such as: dose, client goals, transportation plans, and the effect of the dose on physical abilities and cognitive functions. Based on such criteria, a facilitator will use their professional judgement to determine when a session should end.
iv. Letting the client leave
There may be occasions when a client desires to leave the service center before an administration session has ended. A client may even demand to leave during the peak of a hallucinogenic state. While it may be dangerous for a client to leave the service center by themselves, it is likely more dangerous to restrain or otherwise keep the client there. Facilitators should strive for client safety, but a client should ultimately have the freedom to leave.
The Subcommittee will thus recommend facilitators must (1) inform the client they are leaving against the advice of the facilitator, (2) make a record of how and when the client is leaving, (3) ask the client to sign a form acknowledging that they are leaving, and (4) take steps to ensure they have safe transportation. These steps will be discussed with the client during the informed consent meeting prior to the administration session.
Advertising
Advertising psilocybin products and services is important to allow information to reach possible clients who may not know of them. The Subcommittee previously recommended to allow advertising so long as the advertisements do not contain false or misleading information, medical claims, or imagery that targets minors and other ineligible individuals.
It is important to note that advertising is a large topic. Advertising is a form of “speech” and restrictions are subject to Constitutional and jurisprudential safeguards. In all, the Subcommittee will make the following recommendations:
- Advertising shall be defined as commercial communications distributed through print, television, radio, internet, including but not limited to, websites and social media, signage, and other media that is accessible to the public outside of psilocybin service centers, manufacturing facilities, and laboratories. The terms “signage” and “other media” include employees holding signs on sidewalks, and even the wacky wavy inflatable arm tube men frequently use on car lots. The Subcommittee noted an large inflatable mushroom may be considered targeting minors.
- Advertising must not violate or promote breach of the facilitator’s code of conduct.
- Advertising may include the safety, risks, or effects of psilocybin products. There may be different method so administration, such as sublingual strips, that require advertising to inform potential clients.
- Advertising must not assert psilocybin products or service are safe because they are regulated by the Oregon Health Authority.
- Advertising may target individuals outside of Oregon.
- Advertising may not be based on Bluetooth beacons, radio frequency identification, and other location-based technology.
- Advertising may not be based on web tracking technologies or third-party internet cookies. However, a service center may use cookies for its own website so long as the information is not sold to third-party advertisers.
Future Meetings
These decisions are mere recommendations from the Licensing Subcommittee to the Board. They are subject to change. The Board will submit its own regulation recommendations to the OHA in June 2022.
Over the next several months the Licensing Subcommittee will be finalizing its recommendations for general licensing regulations. Members of the public are welcome to watch the meetings via Zoom and may give comments at the end of each meeting. The next Licensing Subcommittee meeting will be held on January 6 at 4:00 pm PST.
