By Dave Kopilak
In November 2020, Oregon voters passed the Oregon Psilocybin Services Act (the “Act”), of which I was the primary drafter. This piece of legislation legalizes and regulates the manufacturing of psilocybin products and the provision of psilocybin services under Oregon law. The manufacture, sale, and use of psilocybin products under the Act will continue to be illegal under federal law.
The Oregon Health Authority (OHA) is the state agency that will regulate the program. The Act provides for a two-year program development period that began on January 1, 2021 and that will end on December 31, 2022. The OHA is currently engaged in the rulemaking process and will adopt final rules by no later than December 31, 2022. The OHA will begin receiving license applications on January 2, 2023, and the first licensed businesses likely will begin operating in the first half of 2023.
Under the Act, a “client” will be able to purchase, consume, and experience the effects of a psilocybin product only at a “service center” and only under the supervision of a “facilitator.” Clients will not be able to purchase psilocybin products and take them home with them.
The term “psilocybin services” means the services that a facilitator will provide to a client before, during, and after the client’s consumption of a psilocybin product, including: (1) a “preparation session,” which is a meeting between a client and a facilitator that must take place before the client consumes a psilocybin product; (2) an “administration session,” which is the session where the client consumes and experiences the effects of the product; and (3) an optional “integration session,” which is a follow-up meeting between a client and a facilitator that may occur after the completion of the administration session.
The requirements, specifications, and guidelines for each of the three sessions are still being considered by the OHA.
The Act delegates the issue of dosing to the OHA. The Act does not provide for any minimum or maximum dosage requirements, although it does require the OHA to establish a maximum dosage permitted in a single serving. The OHA can, but is not required to, set a minimum dosage.
Consequently, microdosing (however one defines it) is certainly possible under the Act, unless the OHA sets some minimum dosage requirement that would be higher than the generally understood definition of a microdose. Nobody expects the OHA to do this, and so we probably can assume that microdosing will be legally permissible.
But will it be commercially practical for anyone? Even if microdosing is permissible, would it ever make sense for a client to travel to a service center, consume a microdose portion of a psilocybin product on site under the supervision of a facilitator, complete the administration session, and then leave? This sounds like an awful lot of trouble and expense to consume a single microdose.
There are numerous rules that the OHA could adopt that could make microdosing a commercially viable proposition. Naturally, the OHA could do the opposite and make microdosing under the Act completely impractical.
The blueprint for maximum commercial viability would allow for substantial discretion between facilitators and clients and would look like something like this:
- Preparation sessions:
- No unduly burdensome requirements to complete
- Online sessions permitted
- No minimum period of time between a preparation session and an administration session
- No requirement that there be a preparation session before every microdose administration session, or if required, allow for an abbreviated “verification that things are going well” preparation session
- Administration sessions:
- No unduly burdensome requirements to complete
- No minimum length of time before an administration session can be considered complete
- No restrictions on the number of administration sessions that a client could participate in during a given time period
- Group sessions permitted, with a relatively high client-to-facilitator ratio
With such rules, one can envision a streamlined system where a number of clients arrive at a service center at regularly scheduled intervals under the supervision of a single facilitator, participate in a relatively short administration session, and then leave.
Whether something like this could happen, however, is completely up to the OHA. It is a pure policy decision on their part.
Significantly though, the OHA has emphasized repeatedly that their two most significant concerns under the Act are: (1) equity, accessibility, and affordability for clients; and (2) safety. Permitting microdosing would appear to be a “Yes” with respect to the first concern. And so it may end up depending on whether the OHA believes that microdosing at regular intervals is a safe thing for clients and the general public.
Dave Kopilak is an attorney at Emerge Law Group in Portland, Oregon. He was the primary drafter of the Oregon Psilocybin Services Act.