PSYCH spoke with Angela Allbee, Oregon Psilocybin Services Section Manager at Oregon Health Authority, for The Psychedelics as Medicine Report: Fourth Edition.
Oregon Psilocybin Services
Measure 109 (M109), the Oregon Psilocybin Services Act, creates a licensing and regulatory framework for the production of psilocybin products and the provision of psilocybin services. The Oregon Psilocybin Services (OPS) section is a new section housed within the Oregon Health Authority Public Health Division’s Center for Health Protection. OPS will begin accepting applications for licences on 2 January 2023.
M109 does not create a dispensary model like recreational cannabis in Oregon. People will not be able to purchase psilocybin and take products off-site with them for consumption.
Instead, a client 21 years of age or older may access psilocybin services. While no prescription or referral is necessary, a client will be required to complete a preparation session with a licensed facilitator before participating in an administration session. The client will only access psilocybin at a licensed service centre during an administration session in the presence of a licensed facilitator. An optional integration session will be offered to a client after the administration session.
The preparation session very much centres on client intake and informed consent process. This includes understanding the potential risks or potential benefits associated with psilocybin services and supporting a client in deciding whether psilocybin services are right for them. A requirement to review the client bill of rights is part of supporting a client. Finally, the preparation session is also a time to ensure that the licensed facilitator and the client are a good match to move forward together.
There is a lot of safety and support planning that must be done before a client enters an administration session. The client could experience shifts in their life, so it is important to make sure clients are fully supported through the process.
In the regulations there will be a specific dosage of product which will require minimal duration of time at a licensed service centre. Oregon Psilocybin Services is going through the rulemaking process now, which covers these and many other regulations. OPS will adopt final rules by 31 December.
The third part of psilocybin services is an optional integration session. An integration session is an opportunity for a client to have an additional follow-up session with a licensed facilitator, where they could be referred to peer support networks or other community resources that may help provide additional support. This is an important time for a client to determine next steps for either continuing with additional sessions or take time to process.
It is really important to understand that Measure 109 requires the Oregon Health Authority to prevent diversion of psilocybin products into the unregulated space and prevent interstate commerce to ensure public health and safety. Production limits must be set for manufacturing and processing of psilocybin products, which further illustrates that M109 is centred on a client accessing psilocybin services rather than creating a consumer market for products.
Another important point is that only indoor cultivation is allowed. While we know that there are over 200 species of psilocybin-producing mushrooms that grow naturally around the world and here in the Pacific Northwest, we are beginning with one species at the recommendation of the Oregon Psilocybin Advisory Board – psilocybe cubensis. There was more information available to the advisory board about psilocybe cubensis and its safety and reliability at the time of making recommendations to OPS.
Oregon Psilocybin Services will continue to evaluate the inclusion of new species as new research and information comes to light.
Indigenous communities around the world have worked with psilocybin for centuries. The Oregon Psilocybin Advisory Board and OPS have acknowledged that balancing cultural wisdom and anthropological information with scientific research is really important.
With that acknowledgement, we know that more discussion related to psilocybin products and services will be part of evolving this work into the future. In current regulations, whole dried fungi will be allowed, as well as extracts, edible psilocybin products, and also ground homogenized products.
licensed manufacturers will have their products tested by licensed testing labs for species identification and potency based on rules already adopted earlier this year. OPS will also be able to request additional tests if needed.
After the manufacturer has had their products tested, they will sell them to licensed service centres where products will be stored and subsequently sold to clients during administration sessions.
OPS did not want to overly burden licensees based on the understanding that they are stepping into this work to serve Oregonians, so we are focusing on what is essential for public health and safety for rulemaking.
The roll-out of regulated psilocybin
OPS will issue four types of licences- licensed manufacturers to cultivate and process psilocybin products, testing labs to test products, service centres where products can be consumed by clients during administration sessions, and facilitators who will be present to support clients in a non-directive approach throughout the preparation, administration, and integration sessions.
All four licence types are really important to the process moving forward in 2023. OPS has tried to expedite rules so that students can be trained and apply for facilitator licences in January, and testing labs can become accredited in time to apply for licences in January.
Under M109, local governments may adopt ordinances to prohibit manufacturers and service centres from being licensed in their jurisdictions. While many cities and counties have adopted ordinances, those ordinances have to be referred to voters at the next general statewide election. With this in mind, many licensees will have to wait until after the election to see if prohibitions will exist in their cities and/or counties.
Building a business, especially around a Schedule One substance, is very difficult. Funding to support business owners is limited, which creates an access issue for those who want to be licensed under M109. In addition, the fee-based structure of the measure means that the costs of licences must cover the cost of the OPS section’s work. This is another concerning access issue for licensees.
OPS will be ready to accept applications on 2 January 2023. We have been working to develop a really great licensee application system that we call TLC (Training Program, Licensing, and Compliance System).
We hope that by the second quarter of 2023 we will see service centres opening their doors. It depends on many factors, which we will continue to keep you updated on as we move forward. Until then, please stay tuned by signing up for updates on our website.
Angela E. Allbee MPA (She/Her)
Manager, Oregon Psilocybin Services Section
Oregon Health Authority
Public Health Division