Oregon has been working on rules that outline how to implement the psilocybin measure that passed in 2020. The Oregon Health Authority recently released one set of its final rules for the therapeutic use of psilocybin. And the agency began accepting applications this week for programs to train those who want to provide the service. Oregon is the first state to pass a law to provide the psychedelic in a supervised setting, but a handful of cities have decriminalized small amounts of the drug. Mason Marks was a member of the advisory board until a few months ago and also provides legal advice to businesses and cities around the country. He wrote the psilocybin ordinance Seattle city councilors passed last year. He joins us to give us an overview of the latest rules and update us on the timing of the rollout. He also explains how OHA’s approved rules differ from some of the recommendations of the advisory board — and why it matters.
The following transcript was created by a computer and edited by a volunteer:
Dave Miller: In November of 2020, voters made Oregon the first state in the country where the supervised use of psilocybin, a psychedelic mushroom, would be legal. Since then state officials and an advisory board have been working to implement Measure 109. The first set of finalized rules is now in effect. It covers testing of psilocybin products and how the training will work for people who want to facilitate these supervised sessions. The state is now accepting applications for training programs. Mason Marks joins us to talk about all of this. He is a former member of Oregon’s Psilocybin Advisory Board, an attorney with the Portland office of Harris Bricken and a senior fellow and project lead at the project on psychedelics Law and regulation at the Petrie-Flom Center at Harvard Law School. I want to start with the basics here. What exactly did Oregon voters say yes to back in November of 2020?
Mason Marks: Great question. Measure 109 was a ballot initiative approved by voters in November of 2020. It’s the first program of its kind in the country and really the world that will allow for the supported adult use of psilocybin. That means that psilocybin will be administered by people for any reason by facilitators who are trained and licensed by the state by the Oregon Health Authority. People can come to facilitators at a service center, that’s the licensed location where these services will be provided, and they can consume psilocybin for spiritual growth, for improved creativity, or for mental or physical wellness.
Miller: In other words, [for] the medical marijuana program, which once loomed large in Oregon and other states, most of which have since also added recreational programs so that they loom less large, you had to say “I have these particular medical issues for which I want a prescription.” It won’t be like that for getting access to [psilocybin] for supported adult use?
Marks: That’s correct. It’s important to distinguish what’s happening in Oregon from the psilocybin trials that are sanctioned by the Food and Drug Administration that are occurring in the United States and also around the world to look at using psilocybin to treat mental health conditions like anxiety and depression. That’s very different. In those situations, once psilocybin becomes FDA approved, it will be administered by licensed health care providers. Whereas in Oregon you don’t have to be a healthcare provider, a doctor or a nurse practitioner to become a psilocybin facilitator, you simply have to have a high school education and to have undergone the training that’s approved by the Oregon Health Authority (OHA).
Miller: We’re going to dig deeper into that training because that’s a big part of the first set of finalized rules that were put forward. But I want to first focus on the drug itself because there are some rules about testing and also the forms of the drug people will be able to take. So how will people be able to take psilocybin?
Marks: So that’s another great question. If we look at the cannabis industry in Oregon and throughout the country by comparison, people can consume cannabis in many different forms. It can be smoked, it can be consumed in edible form, they even have breath strips or tinctures you can put under your tongue. In Oregon, at least under the current set of rules that were recently released by the health authority, people will only be able to consume ingestible forms of psilocybin. So orally or enterally consumed psilocybin. Enterally means through the digestive tract.
Miller: A suppository?
Marks: That’s a different story. Suppositories are actually excluded by these current rules, which I think is unfortunate.
Miller: How else does it get into the digestive system?
Marks: It would have to pass through the intestines, so someone who has difficulty swallowing, for example, might have a tube inserted into their stomach or directly into their intestine. That person could potentially receive psilocybin through one of those tubes.
Miller: Why is this question of how a person could actually get the drug into their bloodstream, why is this an important one to you?
Marks: It’s a disability rights question because one of the populations that stands to benefit the most from psilocybin are people towards the end of life with serious medical conditions like cancer. Those are people that have been studied the most perhaps in clinical trials for example. And psilocybin has been shown to decrease anxiety and depression associated with nearing the end of life. It’s been very effective, sometimes for months. The problem with limiting the ways that people can receive psilocybin in Oregon is that you might be excluding some people who have muscle weakness [or] difficulty swallowing. There are people who might not be able to chew and swallow an edible form of psilocybin. They might not be able to swallow even a liquid form of psilocybin, and requiring them to have a tube into their stomach is a bit restrictive as well. From an access standpoint for those individuals with disabilities, it’s important to have a wide variety of options.
Miller: Am I right that the state made this decision to limit the ways the drug can be taken based on their reading of the wording that Oregon voters said yes to?
Marks: That’s right. In my reading of Measure 109, which is the law that governs this emerging industry, there’s nothing that limits the variety of products that you could have. But the OHA looked at the language they saw the word “consume” in the text of that law and they interpreted it in a strange way and said that “consume” can only mean “orally ingested.”
Miller: How will the facilitators actually get the psilocybin that they’re going to be giving to the people who are going to be ingesting or taking the drug. First of all, what are they called?
Marks: We call them clients. They’re referred to as clients in the statute. The psilocybin will be produced by licensed manufacturers. It’s one of the four license types that’s created by the law, the Oregon Psilocybin Act or Measure 109. Those four license types are manufacturing, testing, service centers, and facilitators. And so people who are licensed manufacturers will be able to produce naturally occurring psilocybin. The synthetic form is prohibited by the current rules. The product could either consist of a whole mushroom that’s dried and processed or psilocybin that’s extracted from that mushroom.
Miller: Will Oregonians have any choice over the strain or the dosage? I’m thinking about Oregonians who are at this point very used to recreational stores where there is just a huge variety that’s all legal and available. Will psilocybin be the same way, even if you have to go through a service center and a facilitator?
Marks: The dosage has not been weighed in on yet by the health authorities. The current set of rules that we have doesn’t address a minimum or maximum dose and that might be addressed in the next round of rules that we expect around September. But the current rules do limit the varieties of fungi that can be utilized in this program. They limit it to a single variety called psilocybe cubensis. There are over 100 other types of psilocybin producing fungi that could have been included in the program. You mentioned the cannabis industry in Oregon where people can purchase probably hundreds of different strains of cannabis. The reason that’s important is that we’ve learned from cannabis that people report that different strains provide different benefits. People with insomnia, for example, might benefit from a certain strain. People with a lack of an appetite might benefit from another. And the same is likely true with psilocybin producing fungi. If you look at the Netherlands for example, and the psilocybin industry there, people can walk into what’s called a Smart Shop in Amsterdam for example, and purchase a wide variety of different varieties of fungi and that they might have a menu that suggests different varieties for different benefits. However, people in Oregon, at least right now under the current rules, won’t be able to use other varieties aside from this psilocybe cubensis. That might be a problem because certain people might not react well to that variety, whereas they might have reacted better to another, such as psilocybe mexicana, which is a variety that’s used extensively by tribes in Oaxaca, Mexico, and around that region. Some people have voiced concerns that this narrow focus on a specific type may marginalize this more historical indigenous use of psilocybin.
Miller: So there are two issues here. One is the focus among the psilocybin producing fungi of just one particular genus and species. But obviously there are plenty of other naturally occurring psychedelic substances, let alone synthetic ones. Do you have a good understanding for why it is that the measure writers initially only focused on psilocybin as opposed to mescaline or that psychedelic frog thing or any number of other substances?
Marks: That’s a great point. Psilocybin was targeted because it is one of the best known psychedelic substances from a scientific perspective. It’s known to be very safe. It has a very low toxicity and it’s non addictive, so there’s very low potential for physical or psychological dependence. And so there’s a certain comfort level there with psilocybin. I think that is one reason why the current rules might be a bit too conservative. Because of that safety margin, it would be reasonable to include a wider variety. I think you need to realize that whatever you don’t include within the rules, what you don’t welcome into this program, people will be encouraged to utilize that without support in the illicit or underground market and that may be a safety or public health issue.
Miller: Is it fair to say that because we’re at the forefront as a state in putting forward these, these rules at the state level, there is so much uncharted territory that Oregon is taking a kind of conservative approach to see how how it goes and then there could be incremental changes as they go?
Marks: I think that’s true to some extent and I do want to emphasize this really is a very historic moment and something that everyone should be very proud of in Oregon. It really is a landmark achievement. I am a little bit hesitant to put off making adjustments into the future because as we’ve learned from other industries, it can be very difficult to go back and make changes. It’s important to try to get it as close to right the first time, although it’s impossible to make a perfect law the first time around. It’s important to get it as close to right as possible on the first try. Another important reason is that many other states are looking to Oregon and they will replicate what we do here. It will have a ripple effect across the country and potentially around the world. And so that really sort of sets the stage for what happens outside of Oregon as well.
Miller: Let’s turn to the other big part of this first set of finalized rules that the state has put out with a focus on facilitators. Can you remind us what these people are going to be doing?
Marks: Facilitators will be the people who are trained and licensed to administer psilocybin to clients and that will happen at a licensed service center. According to the law, in order to become a facilitator, you need to complete a training program that’s approved by the health authority. This current set of rules that we have contains the curriculum and fairly broad strokes that must be completed. It consists of a total of 160 hours of training, 120 hours of which is the core curriculum. It’s really what you would think of as traditional classroom education. And then there’s 40 hours of hands-on practicum training which ideally involves administering actual psilocybin to clients.
Miller: I was wondering about the chicken and egg aspect of that. If you have to go through this training to be certified by the state to be a licensed facilitator at a licensed service center, and part of that training requires perhaps 40 hours of practical training and actually administering psilocybin, how can you get that legally get that training in a way that the state would recognize?
Marks: That’s a great question. It’s a bit of a problem. This week, the health authority started accepting applications for training programs, so it’s really just right now that these training programs can start applying to even become approved by the state. But there are many that are already positioning themselves to get up and running very quickly. There has been some concern raised about that, I should note, because a lot of these companies come from outside Oregon, from the Netherlands as well, where psilocybin is not criminalized, and so there’s likely to be a heavy influence from companies outside the state that are setting up training programs and some of them have been involved with the rulemaking process even before measure 109 was passed by voters. So there will be programs in place to serve aspiring facilitators, [but] there is concern that the training will be very expensive. Some programs have even given prices in the $10-20,000 range. It’s a little unclear when we’ll actually start seeing our first class of fully trained facilitators. However, the health authority will not be able to even start accepting license applications from aspiring facilitators until at least January second of next year.
Miller: What was most important to you and other members of the advisory board when you were thinking about how facilitators would be trained? What were your guiding principles?
Marks: One really important feature to build into the training program is an appreciation for the long history of use of psilocybin by indigenous communities which have been using it for hundreds, really likely thousands of years. It’s important to gain an appreciation for psilocybin in its historical and cultural context and not just as a synthetic substance that is produced by drug companies and tested by the Food and Drug Administration. There’s a long history of use in a religious context, by devoted spiritual communities. And so building that into the program is very important.
Miller: Is that in the program?
Marks: I would say minimally, perhaps not as heavily as it as it should be or could be.
Miller: My understanding is that you and perhaps other members of the board also had issues about the extent to which these classes would have to all be done in person as opposed to various kinds of online modules. Obviously this is not for the practicum part but for the book-learning part. Why was that important to you?
Marks: Initially [it was recommended] that 120 hours of core training, the majority of it had to be completed in person. Coming out of the COVID pandemic we’ve learned a lot of people benefit from online education and working remotely. There are people who have irregular schedules or have childcare responsibilities. It’s important to have flexibility for those people so that the training programs are accessible. And I do credit the health authority for removing some of those restrictions on the latest set of the rules so that people can complete the core training online.
Miller: Can you describe the three components of the experience that these facilitators would be leading clients through at these licensed service centers? What are the three parts?
Marks: There are three stages: a preparation session, an administration session, and an integration session, which is optional under the program. During the preparation session, the facilitator explains the process to the client that’s likely when informed consent might be obtained from the client so that they understand what they’re getting themselves into. That’s very important because a psilocybin session can be a very emotionally intense experience, it can be frightening. It’s common for people to experience mild anxiety that usually subsides but they need to understand that, and that’s what the preparation session is for. The administration session is when psilocybin is actually consumed by the client. These sessions can last for five or six hours because the duration of effects of psilocybin is quite long. That’s really where the facilitator comes in. They’re not supposed to intervene too much in the experience, but they’re there to support the client, make sure they’re safe and comfortable throughout the experience. And then the optional integration session is an opportunity for clients to discuss with the facilitator what this experience meant to them. What happened? What did they see and feel during the administration session, and how can they use that to obtain the greatest benefit in their lives?
Miller: Do you have a sense for how much this might end up costing clients?
Marks: That is the big question. Because we have to realize that psilocybin will still be illegal at the federal level, it’s a Schedule 1 controlled substance, there are certain tax implications. These businesses will have a lot of tax liability because of a law called Section 2, ADE of the Internal Revenue Code. It’s unknown, but I’ve heard estimates that a single administration session could cost as much as $1,000 or more. Accessibility of these services is a real concern. They might be very expensive. It’s possible that they might cater to wealthier clients in the beginning.
Miller: If it’s $1,000 a session, I guess I would say it’s not just possible they would cater to wealthier clients, but almost exclusively. Especially if under Measure 110 Oregonians don’t really have too much concern about possessing small quantities of these mushrooms, right?
Marks: I think that’s right, and I think it’s a real puzzle how the cost can be brought down. People have made various proposals. There was a proposal, primarily an equity proposal that would likely have made these services more affordable, that was considered at the board meeting last month and unfortunately it was not approved by the board.
Miller: How do you think that Measure 110, which decriminalized personal amounts of all kinds of drugs including heroin and meth, and Measure 109 will interact with each other?
Marks: It’s difficult to say. I think there are definitely people who want a supportive, more structured experience where they have someone they can trust to be there for them because as I mentioned, a psilocybin session can be an uncomfortable or challenging experience for people. It’s a great idea to have a system that’s more structured and provides that support. I think of Measure 110 as more a form of partial decriminalization. There really are certain limits imposed by that law. I mentioned that people historically use psilocybin in a community setting in indigenous communities, for example. That’s really not permitted under Measure 110.
Miller: You mean because the facilitator of an ayahuasca session may have enough quantity of the drug that it would be more than is allowed for personal use for any particular session?
Marks: That’s exactly right.
Miller: You mentioned that what we’re looking at in Oregon is being looked at in other states and other countries. What is happening right now around the country or around the world in terms of psilocybin or other hallucinogenic law?
Marks: It’s really incredible to watch. Right now, there are 13 U.S. cities that have decriminalized psilocybin and other psychedelics like ayahuasca and ibogaine, for example. Denver was the first in 2019. And since, we’ve seen many more like Detroit, Michigan. Seattle, Washington was one of the more recent ones. We’ve also seen about 12 or so U.S. states that have proposed various types of legislation that are comparable to Measure 109 or Measure 110. So far Oregon is the only state that has successfully implemented a Measure 109 type system. Texas of all places actually passed a psilocybin research bill which is a little more conservative. There’s a lot happening across the country, not only in liberal states but also more conservative states. It’s really interesting to watch, but everyone is looking at Oregon as sort of the leader in this space.
Miller: Should Oregon look to other cities or other states as well? Are there aspects of laws being proposed in other places that you think provides a road map for Oregon?
Marks: Absolutely. Washington, for example, has a bill that came up for a vote at the last legislative session and was not approved, but it will be resubmitted. It makes some improvements on measure 109. One example is it allows for the home administration of psilocybin and that’s something that was explicitly prohibited In measure 109 in Oregon. I mentioned people toward the end of life who stand to benefit from psilocybin. Those people in many cases might not be physically able to travel to a service center and participate in these services in Oregon. That’s one way that other states are iterating on what’s happening in Oregon. And it’s important for the Oregon legislature and the health authority to pay attention and try to incorporate some of those changes into the system here. Colorado is another example that has some bills that are a bit more progressive and they include some other substances in addition to psilocybin. There’s a lot going on, and it’s important for regulators and legislators to be knowledgeable about that.
Miller: You mentioned that it’s not going to be until the beginning of 2023 before facilitators are licensed. What’s the likely overall timeline right now before Oregonians can pay their money, go to a service center, and have a supported psilocybin trip.
Marks: We don’t know for sure, but I would estimate that it won’t be until at least halfway through next year. I would say at least mid-to-late 2023.
Miller: It seems like where we are right now in the United States in terms of psilocybin is sort of comparable to where the regulation of cannabis was a few decades ago. Given that medical cannabis programs preceded recreational ones by a lot of time, what do you imagine the landscape for psilocybin or other psychedelic substances could look like in the United States 10 years from now?
Marks: In 10 years I’m certain that we will see FDA approved psilocybin so physicians and other health care providers will be able to prescribe psilocybin under certain conditions. That’s one strand of this story. I think we’ll also see other states successfully pass legislation like Measure 109 so other states will provide similar types of services. And I mentioned the bill in Colorado, where potentially other types of psychedelics will be available through this form of supported adult use. On the federal level I think things will be a little slower. There is discussion in various circles about potential bills to open up more funding for psychedelics. There’s a lot of interest at the Veterans Administration, for example, because these substances have proven beneficial to veterans with post-traumatic stress disorder (PTSD) and depression. We have a real suicide and substance-use epidemic in this country, and psychedelics appear to hold a lot of promise to potentially help address those issues. I think we’ll see more federal funding poured into research and a lot of activity at the state level, but substantial change on the federal level may be quite a bit slower.
Miller: And the possibility of big corporations getting involved?
Marks: Oh, that’s already happening. There is a risk of this becoming a landscape that’s dominated by large corporations that are patenting either variations of these substances or the means in which they can be administered. That is a bit of a concern because, as I’m sure you know, drug prices have skyrocketed. We’ve even seen some genetic therapies that can cost $1 million dollars or more. I obviously don’t expect psychedelics to cost that much, but we could see many people could be priced out of the market, and I think that would be a real problem.
Miller: Priced out of the official market, and if they want, right back to the black market.
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