Oregon PSI 2020 initiative summary

Published: March 2019

Background:

The Psilocybin Service Initiative of Oregon (informally "PSI 2020") is a ballot initiative intending to legalize psilocybin therapy in Oregon. The initiative is currently collecting signatures to qualify for the 2020 ballot.

Here's the PSI 2020 campaign website. Here's the initiative's ballotpedia page.

Our purpose here is to summarize the full text of the initiative, and to offer light commentary on each section of the text.

The motivation for this report is exploratory – we're continuing to learn about the PSI 2020 initiative. We hope this report will contribute to our understanding as well as that of other interested stakeholders.

With that in mind, the below should be considered as preliminary exploration, not solid judgment.

Also, a necessary disclaimer: we aren't lawyers. We are reading & interpreting the PSI 2020 initiative text as lay people trying to understand the implications of a legal document. Very likely we have made oversights & other errors due to our lack of legal background.

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How it works:

The basic intent of the PSI 2020 initiative is to introduce a change in Oregon law such that administering & receiving psilocybin therapy becomes legal under state law. A host of concomitant behaviors (e.g. growing mushrooms) would become legal as well, in limited contexts.

To accomplish this, the initiative introduces a framework for how psilocybin would be legally produced, processed, distributed, and administered in Oregon. It introduces a taxonomy of legal psilocybin business roles, and a process for becoming licensed in each role. It also empowers the Oregon Health Authority (OHA) to license & regulate the new industry, and creates an advisory board to help guide the OHA in this new mandate.

Notably, the PSI 2020 initiative changes the law such that psilocybin therapy would be available to most citizens, not just people with a medical diagnosis. As the PSI 2020 website says:

The measure doesn’t limit services just to individuals with medical or psychiatric conditions. We did that because, according to the research, psilocybin services are safe and enhance a general sense of well-being, openness, creativity, and spiritual connectedness. Why would we limit access to these services?

The initiative text does not discuss how the change in state law would interact with federal law, under which psilocybin remains a Schedule I substance (a). The initiative does task the advisory board with "monitor[ing] and study[ing] federal laws, regulations, and polices related to psilocybin."

It's unclear how this will be operationalized in practice – how the state-level regulatory framework would interact with federal law remains one of our biggest open questions about the PSI 2020 initiative.

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Our biggest open questions:

• How will the PSI 2020 initiative interact with federal law, under which psilocybin remains a Schedule I substance?
• How will the PSI 2020 initiative affect the FDA rescheduling process for psilocybin, which is currently underway, being shepherded by Compass Pathways?
• The PSI 2020 initiative relies on an empowered Oregon Health Authority (OHA) to specify & implement much of the law change. What is the present stance of the OHA to psilocybin, and to the PSI 2020 initiative specifically?

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Section-by-section:

Full text here.

Section 1: Definitions.

• Summary: Defines the terms that will be used in the act; introduces a taxonomy of roles for legal psilocybin business, as well as the four-step process clients will undergo to receive psilocybin therapy.
  • There are five psilocybin business roles defined, each licensed separately:
    • Psilocybin producer – grows mushrooms or synthesized psilocybin
    • Psilocybin processor – converts raw mushrooms into "psilocybin products"
    • Psilocybin products center – receives & distributes "psilocybin products"
    • Psilocybin services center – where psilocybin sessions are administered (sessions consist of a preparation session, a psilocybin session where the drug is taken, and an integration session)
    • Facilitator – administers the psilocybin session
  • The four-step process for receiving psilocybin:
    1. Preliminary screening with a "qualified medical practitioner" (a physician or nurse practitioner)
    2. Preparation session with a licensed facilitator
    3. Psilocybin session with a licensed facilitator
    4. Integration session with a licensed facilitator
       
       
• Our comment: To become a "qualified client," one must be screened by a doctor or nurse practitioner, so the protocol isn't totally divorced from the medical system. Interestingly, it doesn't look like psychologists are able to do the screening.
  
  

Section 2: Oregon Psilocybin Services Program – Establishment of program.

• Summary: Tells the Oregon Health Authority (OHA) to establish the Psilocybin Services Program, start issuing the various kinds of psilocybin licenses, and authorize licensed businesses to administer psilocybin services to qualified clients (i.e. clients who passed preliminary screening).
  
  
• Our comment: Straightforward enough.
  
  

Section 3: General Powers and Duties – Duties; rules.

• Summary: Empowers the OHA to "adopt, amend, or repeal" rules as necessary to implement to the Psilocybin Services Program. Also empowers the OHA to specify "minimum criteria" for becoming a qualified client, and for being a psilocybin services center.
  
  
• Our comment: This section introduces a pattern of having the OHA set the specific rules & requirements for many aspects of the new framework. Given this strategy, it seems like much of the on-the-ground change, in the world where PSI 2020 passes, would hinge on the stance of the OHA.
  
  

Section 4: Qualified Clients – Eligibility; fees; rules.

• Summary: People can't use psilocybin services until they've passed a screening session that establishes them as a "qualified client." Qualified client status expires one year after the screening session, people have to be re-qualified each year (by doing another preliminary screening session).
  
  
• Our comment: Having people have to renew their "qualified client" status each year seems strangely high friction; not sure what the intent of structuring it that way is.
  
  

Section 5: Application Process and Licensing – Application process for all licenses; rules.

• Summary: OHA will determine the process for applying for licenses; people who want licenses will follow this process. People can hold licenses for multiple locations, and for multiple roles in the process (e.g. could hold both a "psilocybin producer" and a "psilocybin processor" license).
  
  
• Our comment: Straightforward. It's unclear how onerous the application process will be, because OHA will set the process.
  
  

Section 6: Application Process and Licensing – Grounds for refusing a license.

• Summary: Delineates the reasons for which OHA can refuse or revoke a license, which include lying, using psilocybin without a license, not having a good record of compliance with the act, not being of "good repute and moral character."
  
  
• Our comment: Some of the reasons for refusing to license seem pretty underspecified (e.g. what is a "good" record of compliance, in this context? e.g. who determines who is of good moral character?). You could imagine an antagonistic OHA using these criteria as grounds for refusing to license most people. Also, this may set up a narrow target for who can become a facilitator – someone has to (1) not lie, (2) not admit to have used psilocybin without a license, and (3) have sufficient experience with psilocybin to qualify for a facilitator's license. (This point is speculative, and could be ameliorated by the training program introduced later in the act, depending on how that is specified.)
  
  

Section 7: Application Process and Licensing – Authority to require fingerprints of applicants and other individuals.

• Summary: OHA may require fingerprints from license applicants and essentially everyone who holds a stake in the psilocybin businesses.
  
  
• Our comment: It's interesting to speculate about how this interacts with psilocybin remaining illegal at the federal level. Would this be a big hurdle for potential investors, given that their records & fingerprints would be held by the State of Oregon (and could be subpoenaed by the Feds, see section 24)?
  
  

Section 8: Licensees In General – Lawful production, delivery, and possession of psilocybin products for regulated psilocybin services.

• Summary: Makes explicit that licensees may produce, deliver, administer, and possess psilocybin (subject to the parameters of the act), and that this is not a criminal or civil offense.
  
  

Section 9: License to Produce Psilocybin – Production license; fees; rules.

• Summary: The license to produce psilocybin is regulated by OHA. Licensees must follow the OHA process, and only deliver their product to licensed psilocybin processors, product centers, and/or service centers. Licensees must follow OHA rules, and OHA must institute the following rules:
  • Annual renewal of the license
  • Collect fees for processing licenses (only enough to cover OHA's costs of administering the act)
  • Establish specs for storing, securing, and delivering psilocybin
  • Establish maximum amount of psilocybin that can be produced at a single site
  • Establish procedures for safety & potency testing
    
    
• Our comment: OHA is given wide latitude to set the rules around licenses. It seems that OHA could establish other rules outside the ones it is required to set, uncertain how much the program could be shaped by other rules the OHA creates. The fee structure in particular could be quite onerous, as governments can charge a lot of money just to cover their administrative costs. Also, would be interesting if the OHA ended up using a phenomenological method of testing psilocybin potency.
  
  

Section 10: License to Produce Psilocybin – Duty to submit production and delivery data to OHA.

• Summary: Producer licensees must submit to OHA info on the amount produced and delivered. They also must keep records of this for at least two years. The OHA may request additional info from licensees.
  
  

Section 11: License to Process Psilocybin – Processor license; fees; rules.

• Summary: Basically the same structure & content as Section 9, but for psilocybin processors.
  
  

Section 12: License to Process Psilocybin – Duty to submit production and delivery data to OHA.

• Summary: Basically the same structure & content as Section 10, but for psilocybin processors.
  
  

Section 13: License to Operate Psilocybin Products Center – Operator license; fees; rules.

• Summary: Basically the same structure & content as Section 9, but for psilocybin products centers.
  
  

Section 14: License to Operate Psilocybin Products Center – Duty to submit data to OHA.

• Summary: Basically the same structure & content as Section 10, but for psilocybin products centers.
  
  

Section 15: License to Operate Psilocybin Services Center – Operator license; fees; rules.

• Summary: Basically the same structure & content as Section 9, but for psilocybin services centers. The OHA will establish a process for filing & resolving complaints against centers. Also, the OHA will impose "any other standards" on the operation of these centers to ensure public health & safety.
  
  
• Our comment: "Any other standards" gives the OHA a broad remit to protect public health & safety. We could imagine this clause being used to curtail center operations, if an antagonistic OHA had a narrow understanding of "public health."
  
  

Section 16: License to Operate Psilocybin Services Center – Duty to submit data to OHA.

• Summary: Basically the same structure & content as Section 10, but for psilocybin services centers.
  
  

Section 17: License to Facilitate Psilocybin Services – Lawful administration of psilocybin products at psilocybin services centers.

• Summary: Affirms that it is now legal (under Oregon state law) to administer psilocybin at psilocybin services centers, under the protocol being established by the act.
  
  

Section 18: License to Facilitate Psilocybin Services – Facilitator license; fees; rules.

• Summary: Basically the same structure & content as Section 9, but for psilocybin services centers. Facilitators will have to create a training course before being licensed. Facilitators will carry their license with them "at all times" when administering psilocybin services.
  
  
• Our comment: Perhaps carrying the license while administering therapy is a safeguard against DEA raids etc.
  
  

Section 19: Powers and Duties of the OHA with Respect to Licenses – Authority to inspect.

• Summary: OHA can inspect licensed premises.
  
  
• Our comment: Not specified whether inspections have to be scheduled or can be surprise visits. Presumably that's left to the OHA's discretion.
  
  

Section 20: Powers and Duties of the OHA with Respect to Licenses – Authority to limit quantity of psilocybin products delivered and issuance of licenses.

• Summary: OHA may seize & dispose of psilocybin to ensure compliance with the act. If OHA determines that there's excess supply of psilocybin services, it may temporarily suspend the issuance & renewal of licenses.
  
  
• Our comment: Unclear how OHA would make the determination that there's excess supply... what base rate would they use? Also, "temporarily" could be a long time, as it's not specified (and so presumably set at OHA's discretion).
  
  

Section 21: Powers and Duties of the OHA with Respect to Licenses – Minimum standards and guidelines.

• Summary: OHA will establish minimum standards & guidelines for licensed operators. These must include:
  • A protocol for how facilitators administer psilocybin to clients
  • A two-week waiting period between psilocybin sessions for each client
  • All facilitators must complete a training course
  • OHA to determine the maximum time allowed between each phase of the psilocybin service (preparation, psilocybin delivery, and integration)
    
    
• Our comment: A little surprising that the act doesn't spec out the protocol for administering psilocybin. Seems like it's banking on the OHA conferring sensibly with the Advisory Board to arrive at a sensible protocol for this (or relying on in-house expertise, but that seems much less likely).
  
  

Section 22: Powers and Duties of the OHA with Respect to Licenses – Code of ethics and professional conduct.

• Summary: Working with the Advisory Board, OHA will adopt a code of ethics that specifies permissible & prohibited activities for facilitators. This code will be reviewed annually.

Section 23: Powers and Duties of the OHA with Respect to Licenses – Psilocybin services training course curriculum.

• Summary: OHA will accredit training courses and training course providers for all licensees (producers, processors, products centers, services centers, and facilitators).
  
  
• Our comment: A little unclear how OHA will determine which courses to accredit. Perhaps they will lean heavily on the Advisory Board for sourcing this. Will the highest-caliber underground teachers surface for this, given that there is still federal legal risk? (Probably yes, at least to some extent. It's protected under First Amendment, and CIIS hasn't seem to have had a problem with this for their psychedelic certificate.)
  
  

Section 24: Database and Confidentiality of Information – Duty to establish and maintain system for tracking, production, processing and delivery of psilocybin products.

• Summary: OHA will create a database that holds the names & addresses of licensees.
  
  

Section 25: Database and Confidentiality of Information – Use of this database to verify information.

• Summary: OHA will use this database to determine who holds a license. The data is confidential.
  
  

Section 26: Database and Confidentiality of Information – Confidentiality of information.

• Summary: Affirms that this data is confidential.
  
  

Section 27: Authorized Employees and Other Personnel - Permit required to perform work for or on behalf of psilocybin licensees.

• Summary: Employees of psilocybin businesses have to obtain a permit to work there (and to access the OHA database to validate that employees of other businesses in the supply chain are properly licensed). OHA will establish the qualifications for acquiring this permit.
  
  

Section 28: Psilocybin Control & Regulation Fund.

• Summary: The State Treasury will establish this Fund (separate from the General Fund). Fees from OHA licensing & permits pay into it; funds are "continuously appropriated" out of it to cover OHA's added costs of administering the psilocybin licensing & regulation.
  
  
• Our comment: A vehicle for paying for the new psilocybin framework. Looks like it's set up to be revenue-neutral, and OHA has a lot of discretion as to what fees it collects. Aside: where is taxation discussed in the act?
  
  

Section 29: Advisory Board on Psilocybin Services.

• Summary: Establishes the Advisory Board, to be composed of 11 voting members appointed by the Director of the OHA, including (if possible):
  • Someone who has done scientific research with psychedelic drugs
  • A naturopathic physician
  • Someone who has used psychedelic drugs in clinical therapy
  • An ethnobotanist
  • A mycologist
  • A licensed psychotherapist
  • Someone with knowledge of psychedelic psychopharmacology
    
    
• Our comment: Not sure why the composition of the Advisory Board is so specific, whereas so much else is left up to the OHA. Perhaps they're planning on the Board really helping out the OHA with decisions, but it looks like the Board doesn't have any codified power to make decisions (e.g. an antagonistic OHA could just ignore Board recommendations, right?). Comparison point: the DEA has a history of ignoring well-supported advice on drug policy.
  
  

Section 30: Advisory Board on Psilocybin Services – Duties of the board.

• Summary: Essentially the Advisory Board exists to advise the OHA Director on decisions about setting up the psilocybin regulatory & licensing framework. A few specific advice-cases are outlined.
  
  

Sections 31 & 32: City and County Government.

• Summary: City and county governments in Oregon are preempted from setting their own psilocybin policy (in Section 31), though are allowed to introduce "reasonable regulations" for some things (in Section 32).
  
  
• Our comment: "Reasonable regulations" seems pretty loose. Presumably, any set of regulations that's supported by a city's populace will be seem reasonable to them, so perhaps this could be used by activist cities & counties to avoid rolling out psilocybin services in their jurisdictions.
  
  

Sections 33 to 36: Prohibited Conducted.

• Summary: These sections delineate what psilocybin activities would become illegal under the act. (Recall that only a limited set of activities, specified above, would become legal.)
  
  
• Our comment: We haven't read these sections closely yet.
  
  

Section 37: Protection from Criminal Liability – Criminal exemption.

• Summary: Affirms that licensees are exempt from Oregon's drug laws so long as they're complying with the parameters of the act.
  
  

Sections 38 to 41: Conforming Amendments.

• Summary: Amends other parts of Oregon law to align with the new act.
  
  
• Our comment: We haven't read these sections closely yet.
  
  

Sections 42 & 43: Dates.

• Summary: Gives the OHA until December 31, 2021 to implement the Oregon Psilocybin Services Program.

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~fin~