Oregon Psilocybin Services Publishes Final Psychedelic Rules: A Detailed Analysis

Microdosing, new exclusion criteria, client data rights, no friends & family (unless they consume psilocybin), high annual fees (except for training programs), revised duty to contact police, and more

Oregon’s official state animal, the beaver, drafts final psilocybin rules.

This article is a living document that may be amended after further analysis of Oregon’s final rules. It was last updated on December 29, 2022.

Yesterday, the Oregon Health Authority (OHA) became the first state agency to publish comprehensive rules for a regulated psychedelic industry. The rules mark the end of a two-year implementation period for Measure 109, the Oregon Psilocybin Services Act, which voters approved on November 3, 2020.

After listening to public comments on its November draft rules, the OHA updated many sections while leaving other rules unchanged. I’ll provide a detailed analysis of what’s new. But first a little background.

By passing Measure 109, Oregon created the first regulated framework for the supported (and non-medical) adult use of a psychedelic substance, in this case psilocybin. The successful ballot initiative required the OHA to draft rules for Oregon’s psilocybin industry and tasked the governor with assembling an advisory board to make recommendations to the OHA. The advisory board’s final recommendations were due in June, and the OHA’s finals rules were required by December 31st. However, the agency fast-tracked rules for psychedelic facilitator training programs to promote the availability of facilitators, professionals the OHA will license to administer psilocybin.

After the advisory board published its final recommendations in June, the OHA published draft rules for other facets of the industry in September and November before releasing final rules on December 27.

What’s new in the final rules?

There are many new additions in the OHA’s final rule set. I’ll describe some of the most controversial issues raised during the November public comment sessions and how the OHA addressed or overlooked them in its final rules. Readers can access recordings of the comment session sessions held on November 15th, 16th, and 17th.

Many organizations and individuals also submitted written comments. The OHA does not publish them, however, some groups have made their comments available online. They include the Oregon Psilocybin Services Collaborative Community (OPSCC) and the Healing Advocacy Fund. You can read my personal comments to the OHA at this link. I also contributed to the OPSCC recommendations, most of which I fully support. The OPSCC received an unexpected acknowledgement in an OHA report that explains the agency’s reasoning behind certain rules, which include the following:

Rules that Accomodate Psilocybin Microdosing

Some said it couldn’t be done. Others said it shouldn’t be done. But the OHA has implemented rules that support a limited form of psilocybin microdosing. This practice involves consuming doses that are one-twentieth to one-tenth the size of a standard dose. Microdoses are typically subperceptual, which means they do not produce the profound sensory and cognitive changes associated with standard doses.

The advisory board intensely debated microdosing over the past two years. Former board chair and Measure 109 co-drafter Tom Eckert told the board that microdosing was “not in the spirit of Measure 109.” However, attorney and fellow co-drafter Dave Kopilak disagreed. In an article for Bill of Health, the blog of the Petrie-Flom Center at Harvard Law School, Kopilak wrote: “microdosing (however one defines it) is certainly possible under the Act [Measure 109], 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.”

The OHA’s psilocybin advisory board agreed. It recommended that the agency allow administration sessions of variable duration, depending on the dose of psilocybin consumed, to accommodate microdosing clients. Some board members feared this approach would encourage the proliferation of “microdosing cafes,” where clients consume microdoses of psilocybin and leave a service center shortly therafter. Some even argued for implementing a minimum psilocybin dose to prohibit the practice altogether. Others felt it was important to accommodate microdosing becasue the shortened adminsitration sessions might help reduce costs and increase equitable access to psilocybin services. Moreover, including microdosing within Oregon’s program allows clients to consume microdoses that are safely produced (as opposed to those obtained illicitly) under the guidance of trained facilitators.

Despite enthusiasm for microdosing, and given concerns expressed by some advisory board members, many were suprised that the OHA’s draft rules were relatively microdosing-friendly (at least they did not prohibit the practice). Those rules allowed clients consuming 5 mg or fewer of psilocybin to leave service centers after a minimm of sixty minutes. In response, public commenters urged the OHA to create a lower tier for doses of 2.5 mg or fewer, which would allow clients to leave administration sessions after less than an hour, perhaps even immediately.

The OHA listened to and addressed these concerns. Its final rules created a lower tier that allows clients who consume 2.5 mg of psilocybin or fewer to leave service centers after as little as thirty minutes if they have previously completed an initial administration session lasting at least one hour. The initial session will help facilitators assess each client’s response and find the optimal subperceptual dose.

Two Additional Disqualifying Criteria

The final rules add two new disqualifying criteria to Oregon’s psilocybin program. Individuals with a history of active psychosis or current thoughts of harming themselves or others will be excluded from receiving services. The OHA added questions regarding these criteria to the intake form that all psilocybin clients must complete.

This form was heavily debated by the advisory board. Some board members wanted a comprehensive medical screening form that asked detailed questions about clients’ physical and mental health. Former advisory board chair Tom Eckert advocated for a software program to algorithmically screen clients. Others suggested a pared down approach with minimal questions focused only on the most important contraindications.

The OHA’s November draft rules followed a middle path. They contained only one absolute contraindication to receiving psilocybin: having taken the prescription drug lithium in the past thirty days. Other circumstances, such as being treated for medical or mental health conditions, required facilitators to urge clients to consult a healthcare provider before consuming psilocybin but did not disqualify those clients. OHA’s final December rules retain lithium consumption as an absolute contraindication while adding active psychosis and thoughts of harming oneself or others to the list of exclusion criteria. Though likely well intentioned, these additions lack nuance and could unnecessarily prevent people from accessing psilocybin services.

The OHA does not define active psychosis, but the term likely refers to the second stage of schizophrenia, which may involve hallucinations, delusions, and other psychological symptoms. However, some potential psilocybin clients may have experienced psychotic symptoms that were not associated with schizophrenia. For instance, psychosis can be caused by injury, illness, and drug use. Because clients might not understand the differences between “active psychosis” associated with schizophrenia and psychosis due to other causes, they may indicate that they have a history of active psychosis and be screened out of the program unnecessarily.

It would have been helpful if the OHA had defined active psychosis or included additional detail regarding this rule. Facilitator training programs might have to pick up the slack by providing the nuance the OHA’s rules lack.

The second new exclusion criterion involving thoughts of harm to self and others may be more problematic. It is vague, overbroad, and potentially discriminatory against people with disabilities who pose no risk of harm to facilitators, themselves, or others. Many people experience thoughts of harming themselves or others without posing an actual danger. For instance, people who are severely depressed may have recurrent thoughts of suicide without having the intent to act on them. Similarly, people with obsessive compulsive disorder (OCD) may have recurrent thoughts of harming themselves or others without any risk of actually carrying them out (which is informally referred to as Harm OCD). For these reasons, therapists and psychiatrists often ask patients whether they have a plan to act upon their thoughts, which helps distinguish thoughts that warrant immediate attention from those that can simply be monitored. It would have been helpful if the OHA had included additional questions on its client intake form to differentiate these circumstances.

The form could have asked clients, “do you have a plan or the intention to act on those thoughts” and “are those thoughts associated with a medical condition such as obsessive-compulsive disorder?” Without these questions, individuals who should not be excluded from psilocybin services may be inappropriately screened out. Instead of unequivocally disqualifying them, the OHA could have urged or required them to seek a medical opinion before proceeding.

Oregon attorney Jon Dennis has pointed out that overbroad exclusion criteria may incentivize clients to omit information when completing intake forms. To avoid being excluded from the psilocybin program, clients may elect not to disclose their history of psychosis or thoughts of harming themselves or others, which is as easy as checking “no” on two boxes of the client intake form. This incentive structure may have the paradoxical effect of making Oregon’s psilocybin program less safe. If clients don’t disclose past medical conditions, facilitators will be unaware, and the bad outcomes the OHA seeks to prevent may become more likely. Instead, the OHA should incentivize clients to be honest by replacing absolute contraindications with requirements for additional follow-up questions or medical evaluation.

Some stakeholders signed a letter drafted by the Healing Advocacy Fund, which urged the OHA to add a long list of medical questions to the client intake form. However, the OHA declined to include them, stating, “psilocybin facilitators are not clinicians and may not practice under other license types while providing psilocybin services. The additional questions were not included because they are not appropriate in the context of non-directive facilitation of psilocybin services.”

Family and friends prohibited from attending administration sessions

During November’s public listening sessions, several commentators expressed concern that clients were prohibited from inviting friends and family members to attend psilocybin administration sessions. Some felt bringing a loved one into a session might alleviate anxiety, particularly because psilocybin experiences can be emotional and clients will often be unfamiliar with their facilitators. However, at least one commenter expressed concerns that friends or family members might have unexpected reactions to seeing clients undergo a psychedelic experience, presumably putting facilitators in unsafe or awkward conditions. The OHA expressed similar concerns regarding a request to allow animals in administration sessions.

There are certain medical procedures, such as surgeries, where friends and family are unwelcome. However, most healthcare providers would allow others in the room during minor procedures and other medical appointments. One can imagine that having at trusted person in the room could decrease the anxiety of some psilocybin clients and potentially reduce the likelihood of adverse outcomes. Safety concerns could be addressed by recording psilocybin sessions, which is allowed under the final rules.

It seems odd that under those rules, friends or loved ones could attend a group psilocybin session, where all participatns are under the influence of the substance. However, if clients invite a sober friend or family member to provide support during a solo administration session, those guests would be prohibited from attending. These rules send the message that friends and family are welcome only if they too consume psilocybin.

Enhanced Data Protection in the Client Bill of Rights

I previously described the privacy risks associated with collecting data from psilocybin clients in state regulated programs. Though Measure 109 includes robust protections for client confidentiality, some stakeholders urged the OHA to require clients to agree to share data as a condition of receiving psilocybin. The agency’s September and November draft rules appeared tailored to achieve this end. For instance, the OHA’s draft client bill of rights removed data protections recommended by its advisory board. These safeguards included client rights to control how their data is collected and used and a right to decline to share data with third parties.

The OHA replaced those rights with a right “to refuse to release any personal information to third parties” (italics added). This change appeared to allow clients to decline to share information that could reasonably be used to identify them while preventing them from refusing to release de-identified data, from which certain personal identifiers have been removed. Despite the removal of certain personal identifiers, de-identified data poses significant risks to clients, including the risk of being re-identified or subjected to legal penalties.

Many commenters expressed concern over the OHA’s changes and urged the agency to clarify that clients can decline to share any information with third parties, whether that information is personally identifiable or de-identified. Fortunately, in its final version of the client bill of rights, the OHA deleted the limitation to personal information and reintroduced the right “to refuse to release any information to third parties” (italics added), restoring clients’ ability to control how their information is processed and used, as required by Measure 109’s client confidentiality provisions.

Clients Can Decline to Share De-identified Data

To accompany the revised data protections in the final client bill of rights, the OHA amended the informed consent document that all clients must sign. Previous versions required clients to agree to share de-identified data with third parties outside service centers “for research or other purposes,” which was incredibly broad and vague, in addition to being coercive.

Notably, the final informed consent document requires service centers to inform clients if they plan to share their de-identified data with third parties. The required disclosure must describe who will receive the de-identified data and how it will be used. Most importantly, service centers must allow clients to opt-out of sharing de-identified data with third parties.

During public comments, some stakeholders urged the OHA to require clients to unambiguously opt-in to sharing de-identified data (as opposed to opting-out). That would have placed the burden on service centers and data collectors to obtain client consent. Instead, the agency chose an opt-out format, where the expectation is that de-identified data may be collected from clients unless they take active steps to prevent it. Though the OHA’s choice is not ideal, when combined with the revised client bill of rights, which gives clients the right to decline to share any information with third parties (de-identified or otherwise), the updated informed consent document is a substantial improvement over the OHA’s draft rules.

No Scaled License Fees

When the OHA released its draft September and November rules, many were shocked by the high license fees. Starting January 2, the agency will accept license applications for aspiring psilocybin manufacturers, testing labs, service centers, and facilitators. Manufacturers, labs, and service centers will pay annual license fees of $10,000 (nonprofit organizations receive a 50% fee reduction) and facilitators will pay $2,000 (veterans and low-income individuals receive a 50% fee waiver). When compared to the license fees paid by other Oregon professionals, these fees seem exorbitant. For instance, physicians pay annual fees of approximately $500 to maintain their licenses to practice medicine.

Some public commenters asked the OHA to reduce license fees across the board or increase them for some license types, such as service centers, while reducing them for others. Some suggested a scaled license fee program where fees increase based on either a licensee’s volume of business or its gross annual revenue. Commenters felt this approach would reduce the burdens on small businesses and independent facilitators. Colorado’s Natural Medicine Health Act (Proposition 122) includes this kind of escalating fee structure. However, the OHA declined to adopt it, stating it was “not feasible due to the work required to identify appropriate tiers and evaluate license applications and supporting documentation to determine which tier is appropriate.” The agency claims that work would require “additional budget resources, which would result in higher license fees overall.”

Facilitator Training Programs Pay No Annual Fees

Of all the businesses involved in Oregon’s psilocybin industry, facilitator training programs are the only ones that pay no annual fees. Instead, they pay a one-time $500 application fee and a $500 renewal fee every five years. Some find this arrangement concerning because Oregon’s psilocybin services program is asking the state for an additional $6.6 million to sustain the program from July 2023 to June 2024.

Training programs may be more profitable than other psilocybin-related businesses because they have lower overhead and are not subject to Section 280E of the Internal Revenue Code, which prevents other psilocybin companies from deducting business expenses. Collecting annual fees from training programs could have helped fund the program and offset the OHA’s impending budget shortfall. Moreover, some object to the fact that Measure 109, which was drafted and implemented largely by individuals who founded facilitator training programs, exempts training programs from paying annual fees.

Though imposing annual fees on training programs is within the OHA’s power, the agency declined to impose them in its final rules, stating “[f]ees for training program curriculum approval were adopted in May of 2022,” and the request to implement them was “outside the scope of the current rule making.” Moreover, the agency said its “authority for training programs is limited to approving curriculum rather than general authority to regulate training program operations.” However, if the OHA has the power to set application and renewal fees, it could also assess annual fees (its final rules were not due until December 31, 2022). Nevertheless, Measure 109 includes limits on how those fees might be used, and legislative action could be necessary to change that. Consequently, for the foreseeable future, training programs are unlikely to fund the program’s general operation despite being the only psilocybin-related entities currently in operation.

Amended Facilitator Duty to Contact Emergency Services

In response to public comments, the OHA amended facilitators’ duty to contact emergency services. The September and November draft rules required facilitators to immediately contact emergency services whenever conditions at a service center endangered a client’s safety (or that of any other person on the premises). Commenters expressed concern that this rule encouraged facilitators to contact police regardless of the magnitude of the risk. For instance, conditions that could easily be remedied, such as leaking faucets or dislodged floor tiles (which could pose a risk of slipping or tripping) would more appropriately be addressed by plumbers and flooring contractors than by emergency services.

Requiring facilitators to contact law enforcement or other emergency services could lead to tense and dangerous confrontations between police and clients, while clients are under the influence of psilocybin. Fortunately, under the final rules, facilitators and service centers are first required to make reasonable efforts to resolve any conditions on the licensed premises that endangers the safety of any person present.

Amended Intoxicant Definition

During OHA’s listening sessions, some stakeholders expressed concerns regarding the agency’s general prohibition on intoxicants. Specifically, the draft rules prohibited facilitators from consuming intoxicating substances while providing psilocybin services to clients. However, the OHA’s definition of intoxicants was so broad and vague that it prohibited facilitators from consuming caffeine, nicotine, and certain prescription medications. For instance, facilitators who take antianxiety medication could be prevented from performing their duties while under the influence of those substances. The OHA’s rules also prohibited other licensees and their representatives, such as manufacturer and service center staff, from working while under the influence of intoxicants, broadly defined.

Commenters urged the OHA to amend the intoxicant rules to allow employees in the psilocybin industry to utilize caffeine, nicotine, and other substances legally prescribed or recommended by healthcare providers who, in their professional opinion, believe those substances will not impair the employee’s ability to competently perform their duties. In response, the OHA amended the definition of intoxicants only to exclude nicotine and caffeine. The agency overlooked the concern regarding licensees’ ability to use legally prescribed substances. Instead, in its explanation for this rule, the agency focused solely on potential interactions between psilocybin and other intoxicants, which would pose no risk to facilitators and other employees (because they are prohibited from consuming psilocybin while on duty). These rules could prevent people with disabilities from working in Oregon’s psilocybin industry and should be re-evaluated. The question is whether people should be barred from employment in the psilocybin industry because they take Xanax, Adderall, or cannabis to treat medical conditions. Perhaps in some cases, they should. However, like other rules, such as the amended client exclusion criteria, the OHA’s rules regarding intoxicants lack necessary nuance.

Conclusions

This article presented only a glimpse at Oregon’s final psilocybin rules. I will update this document as I continue to analyze the updates. Please leave comments below and subscribe to Psychedelic Week for additional free posts.

*The views expressed on Psychedelic Week do not represent the views of POPLAR at the Petrie-Flom Center at Harvard Law School or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these programs and institutions.

Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at the Florida State University College of Law. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches constitutional law, administrative law, drug law, and psychedelic law, . Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.