Oregon Health Authority begins issuing Oregon’s 1st psilocybin licenses

In 2020, Oregon became the first state in the nation to allow the supervised use of psilocybin. Voters approved a measure that directed the Oregon Health Authority to develop a program of rules and regulations around the hallucinogen’s use.

Two and a half years later, the state is now accepting license applications for psilocybin facilitators, service centers, manufacturers and laboratories. The rollout has been rocky at times, with a major trainer for the program going bankrupt and several counties and municipalities opting out of the program. But the state’s first facilitators have graduated from training, and the first manufacturing licenses have now been issued.

We get an update on the rollout from Angie Allbee, manager of the psilocybin services section at OHA.

Correction: The caption on a photo of Rose City Laboratories has been updated to reflect that, while the Portland lab is the first in Oregon to apply for a psilocybin testing license, the license has not yet been issued. OPB regrets the error.

Note: The following transcript was created by a computer and edited by a volunteer.

Miller: This is Think Out Loud on OPB. I’m Dave Miller. In 2020, Oregon became the first state in the nation to allow the supervised use of psilocybin. Voters approved a measure that directed the Oregon Health Authority to develop the rules for the hallucinogen’s use. 2.5 years later, the state is now accepting license applications for psilocybin facilitators, service centers, manufacturers and laboratories. The rollout has been rocky at times with a major trainer for the program going bankrupt and several counties and municipalities opting out of the program. But the state’s first facilitators have graduated from training and the first manufacturing licenses have now been issued. Angie Allbee joins us now to talk about this. She is the manager of the psilocybin services section at the Oregon Health Authority. Welcome to the show.

Angie Allbee: Thank you so much. Happy to be here.

Miller: It’s great to have you on. The basics of the system that Oregon voters approved in 2020 are really different from the recreational sale of cannabis that voters said ‘Yes’ to back in 2014. Can you just remind us of this? Can you give us the high level view of how this is going to work?

Allbee: Absolutely. So first of all, it’s important to recognize that this model is not a dispensary model so people will not be able to go purchase the products in a dispensary type environments and take products off-site with them. This is really centered on clients accessing services. And so there are three components to psilocybin services which include a preparation session, an administration session where psilocybin is consumed at a licensed service center and then follow up integration session.

Under this measure people who are 21 years of age or older can access psilocybin services, but they first have to complete that preparation session with a licensed facilitator and ensure that the licensed facilitator believes that they can serve them and make sure that clients understand all of the informed consent and client bill of rights and the safety and support planning and all of the provisions around this model and make that determination if they want to take the next step.

So it is a highly regulated model. There are over 90 pages of rules and I’m happy to answer any questions about those. But it is very different from the cannabis model.

Miller: I mentioned the different licenses, just naming the entities or people who have to get them. But just to review them with a little bit more detail, the manufacturers are going to be the ones who are growing and processing the mushrooms. The laboratories are going to be testing them. The service centers are the places where the psilocybin are going to be consumed and the facilitators are the people who are going to be with clients before they take the psilocybin, during and then potentially after. And all of those people or places have to be licensed and all that is now under way. What’s proven to be the most challenging aspect of setting up this all-new system?

Allbee: I think there are two parts to that response. There are the external factors that are outside of our control. That could include things like making sure that the public has information that’s accurate. And of course, we’re doing our best to provide information on our website and provide information and meetings and presentations. But really to ensure that there’s accurate information when it comes to conversations around this work. Public perception is another piece that is outside of our control.

Internally, we’ve had a number of challenges. We are a part of the Oregon Health Authority Public Health Division and we are building a brand new section. And we have done a really good job within the timeline,in the development period. But, you know, our Public Health Division has just recovered from or is recovering from COVID response and that infrastructure has been challenged.

So bringing to life a new section has been definitely a challenge, getting all of our team members hired and on-boarded and then just setting up the infrastructure to support this work. It’s been a wonderful experience and, as you know, we’ve already started issuing licenses. I think that there’s a learning process along the way. There are certain things that you can anticipate that might be challenges and then others that come up and you overcome them as you go. We’ve got a fabulous team and we’ve been able to be pretty resilient around all of those spaces.

Miller: How are you thinking about the sequencing of licensing so that this whole network can work? I mean, for example, I’m thinking about licensing manufacturers first so they can actually get products to the labs for testing, who could then get them to the service centers. Or the possibility of having facilitators go through the thousands of dollars of the training and getting a license, but then not having a place to work yet because service centers haven’t been licensed. How do you think about that?

Allbee: We’ve thought about this in a number of ways. First, we always have to look at what we have the statutory authority to do or not to do. We are unable to limit licenses under the Oregon Psilocybin and Services Act. And so if people who apply, individuals or entities that apply, meet the criteria established in statute and rule, then we are required to issue a license. So we’re unable to really shape the way licenses are issued or come in. However, we’ve been very intentional about this. Beginning back in early 2022, we worked really closely with the Oregon Psilocybin Advisory Board to expedite recommendations to OHA so that we could do an initial rulemaking process that specifically looked at training program rules and those rules associated with product testing. And the reason for that is that, as you just mentioned, in order to qualify for a facilitator license, an individual would have to complete a Psilocybin Facilitator Training Program that had approval from OHA.

Those rules were all adopted in the spring and similarly, all testing labs have to be accredited by the Oregon Environmental Laboratory Accreditation Program. So we wanted to make sure that those processes could begin and that wouldn’t hold up the opportunity for folks to apply for licenses. Soon after that January 2, 2023 date. And so we feel like that’s actually come around pretty well. I’m happy to review some of our licensing stats, but at this point in time, we’re getting close to licensing all four license types. And as you know, we’ve issued two licenses for manufacturers with many more to process. So, although it obviously has been a little bit slower coming along and there are lots of considerations for those folks that want to start up a small business and be licensed under this framework, we’ve tried to provide a lot of information and resources and materials to help make people successful.

Miller: What’s the likely schedule right now for when someone can walk into a service center and be supervised as they take psilocybin?

Allbee: Yes, that is the question of the year. What I can say is that we do expect to issue all four license types, which is a requirement of service center doors opening. You have to have products obviously cultivated or processed by manufacturers. You have to have those products tested by laboratories. And you have to have license facilitators in order to provide the three components of assignment services that I mentioned earlier, the preparation administration and integration sessions.

So we expect to have all four license types issued to those folks in the coming months. It might take a little bit of time for service centers to establish their business relationships and hire their employees or contract with employees such as licensed facilitators and hire other workers to work in those locations. But we definitely expect that service center doors will open in 2023 and hopefully sometime in the fall. That’s a reality for us, late summer, early fall. It’s just really difficult because once we issue the license, there may be other considerations for that business before they can really open their doors.

Miller: But say six to eight months is your hope right now?

Allbee: That is an estimation. Yes.

Miller: What about cost? I know you don’t control this. But I imagine it’s something that people in your office are thinking about. What’s your best guess right now for how much this experience is going to cost?

Allbee: That’s really difficult to even provide a range at this point in time. But what I can say is that this is something we think about all the time. Access to services are very important for those that want to participate. So we’re constantly looking at how we create affordability, access, equity, consideration. Part of our rule making and the rules we adopted at the end of last year included a recommendation from the Oregon Psilocybin Advisory Board and Equity Subcommittee. And that’s to require social equity plans for each licensee.

So those licenses have to demonstrate the ways that they will work towards social equity. And then upon renewal, they will have to demonstrate how they’re reaching those goals that they’ve set. What this means is many people that expect to have service center licenses are looking at ways to create social equity considerations, whether that is a sliding scale for low income Oregonians or serving specific communities or populations.

At this point in time, because we don’t have those folks licensed, it’s hard to say and to provide a range. Again, we don’t set or regulate the cost of products or services. And so it would be very preliminary. We do know that there’s going to be a range and it depends on the dosage of product that a client will consume. Obviously, the lower the dose, the lower the minimal duration of time that they have to stay at a licensed service center. All of that is linked to dosage and can be found in our administrative rules.

Another factor is whether or not they decide to access an administration session, one-on- one with a licensed facilitator or they do a group administration session. That could reduce the cost as well. So there are considerations that we’ve been thinking about that we built into our administrative rules to help alleviate some of those concerns with cost. But we could see quite a difference in range for those folks that are coming into maybe a more urban setting, group administration session, lower dose administration session. It could cost significantly less than those that are coming in for a one-on-one standard dosage session. And I think that when you think about those services, that’s part of the costs that are built into all of these models.

Miller: Another cost that’s built into the model, as I understand it, are the fees that people in every part of the licensure have to pay. Most of them are annual fees and some of them, pretty sizable. And my understanding is this is built into the rulemaking because voters said, when they approved it, that this is going to be eventually, but not yet but eventually, a self-sustaining financial model. Does that cut against the equity goals that are also a part of what voters approved?

Allbee: So to begin, this was actually established in the statutory language of Measure 109. So what voters approved included a fee-based structure. So it was not addressed in rulemaking. That was actually created in the Oregon Psilocybin Services Act. So what that means is that the Oregon Psilocybin Services Section will be transitioning from the general funds that were allocated by the legislature for our development period in the 2021-23 biennium and transition to other funds. We are required to be self-sustaining as we move forward and we transition to those other funds. So we’re, obviously, looking closely at ways to create more equitable licensing fees. We know that it’s so important to have representation from diverse, lived, and professional experiences in our regulated community. We know that it’s really important to provide culturally responsive psilocybin services to people around the state. So we’ve really thought about that a lot.

As we’ve moved forward and looked at even our fee reductions, we’ve provided some reduced-fee opportunities for low income Oregonians, veterans, or nonprofit organizations. At the end of the day, because we have to have all of our budget covered by the cost of fees, it does strain us because at the end of the day, it is an equation. We’ve been really intentional though about the ways that we’re looking at our budget, the way that we look at our cost, and ensuring that we’re hiring the amount of team members that we need to do the work and also making sure that we’re thinking about all of the considerations and ways that we can reduce our cost as much as possible while looking at the equitable licensing fee issue. We know that that will trickle down to clients eventually.

Miller: What’s your assumption for what the black market for both psilocybin and even maybe the supervised use of psilocybin, something that’s been happening with whether it’s psilocybin or peyote or ayahuasca. Obviously, people have been doing this with, say, traveling medicine people for, for decades. Now. What’s your assumption for how much that’s going to continue in the black market once this legal system is up and running?

Allbee: There’s a couple of acknowledgements to make in the beginning as I answer this one. We know that for thousands of years, Indigenous and some Tribal communities have used psilocybin for ceremonial healing, spiritual and other purposes. And it’s really important that we are aware and mindful that that practice may still exist culturally for many people. So we want to honor that history and also ensure that we’re not causing harm to those cultural roots.

At the same time, any activity that takes place outside of this regulated model is subject to criminal penalties and is a matter for law enforcement. So, when we receive concerns, those are not concerns that we can act on, unless it’s a licensee that we’ve issued a license to and that we’re regulating. The unregulated space has had many iterations over the decades and throughout history, based on what’s happening at that time. We know that psilocybin grows naturally all over the world and over 200 species of psilocybin-producing mushrooms can be found.

So, I could not predict what will happen in that space. But as part of the Oregon Health Authority, it is part of our commitment to ensuring that we’re respecting equity and that we are reducing harm and being trauma informed as part of healing and wellness. It’s just really important for us to get information to anyone that’s interested in stepping into this space, helping to support them so that they can understand how to be in compliance with statute and rule, to not cause harm to the practice that’s existed for thousands of years, and really try to gain any insight, feedback, wisdom from people that have practiced in that space or whose ancestors have practiced in that space, just so we can be aware of different spaces that have sensitivities.

It’s really difficult to say, but as we evolve this work and continue working with partners and members of the public, we hope to build a deeper understanding of the ways that we can make it easier for people to step into this regulated model and also understand that it’s not a one size fits all, especially for those spiritual or ceremonial practices.

Miller: You mentioned that more than 200 species of mushrooms have been found to contain psilocybin. But as folks may have heard, only one of those species has been allowed for Oregon’s supervised use right now, the Cubensis variety. And you’ve explained that this is because of the amount of existing research into this one particular variety. But could that change in the future? Could other species be added to the approved list?

Allbee: Absolutely. So we wanted to begin with all of the hard work and that came in the recommendation from the Oregon Psilocybin Advisory Board. And there’s some deep mycological knowledge there. So we wanted to honor that and start building this framework simply knowing that we could make changes and evolve this work as more information comes to light. Because this is not a product-centered model, it’s a model that centers on clients accessing psilocybin services, we really have centered on client safety, access, and equity rather than on products. And so we wanted to start pretty simply.

As we move forward, the Oregon Psilocybin Advisory Board may make additional recommendations to add species to that list of acceptable species in our rules. We would go through a rule making process and work with members of the public and our rules advisory committees, to obviously hear feedback from everyone and before we adopted final rules just to give a little bit of clarity to that process. In 2023 we expect, later this year, to open rules just for any minor technical fixes or adjustments that we need to make or any work we’re directed to do that changes our statute, by the legislature when they conclude legislative session. In 2024 however, we expect the Board to make maybe some bigger policy recommendations for changes. And so we expect that 2024 will be a big year for rulemaking. And we’re looking forward to hearing from members of the public and partners and really pulling together some robust rules advisory committees, based on whatever recommendations we receive.

Miller: Psilocybin remains a schedule one drug as far as the federal government is concerned. Have you heard anything or have you reached out to the DEA or the US Department of Justice as you’ve been setting up the state’s system?

Allbee: Part of the statutory direction in the Oregon Psilocybin Services Act requires that the Board attempt to meet with the US Attorney for Oregon. So we pulled together and drafted a letter, the Board weighed in on what that letter said and we sent it to the US Attorney for Oregon, just reaching out and offering an opportunity to meet with board leadership and with some of us from OHA and we did receive a response. [It said] ‘thank you, we’re aware of what you’re doing and we’ll let you know if we have any questions.’ So I think at this time, there’s so much movement in the psychedelic space nationwide and I think that we’ll always provide information and answer any questions from federal partners. But at this point in time, we haven’t heard anything further.

Miller: Do you feel that it is a professional necessity or benefit for you to do a supervised session yourself to better understand the world that you are a part of regulating?

Allbee: I think it’s important to remember that I work for the Oregon Health Authority, a state agency and government. So, rather than responding to that personally, I’ll say that our team has considerable lived and professional experience that’s brought together and has been really shaping our work. And I think that we would never really speak openly about any experiences we may have had or will have. It would be a very contentious space to require any team members to access the assignment services once this model is up and running. But it wouldn’t prohibit anyone from accessing services. So I think I’ll leave it there for now.

What I can say is that our team has a really deep knowledge base. And all of our lived professional experiences have really contributed to considerations around client safety and the client experience and access and equity. We’ll continue being very intentional as we evolve this work and continue building it out.

Miller: Angie Allbee, thanks very much for your time.

Allbee: Thank you so much. It’s great talking with you today.

Miller: Angie Allbee is the manager for the psilocybin services section at the Oregon Health Authority.

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