The Oregon Health Authority acknowledges most recent draft of proposed psilocybin services rules will incur costs that "could ultimately be passed onto clients."
The Oregon Health Authority’s proposed rules for legal psilocybin services in the state “may have a negative impact on lower income individuals,” according to the regulatory body.
OHA released its latest revision to proposed rules on April 1. The revisions, which are still up for discussion, focus on the manufacture of psilocybin products, the testing of those those products, and training curriculums for aspiring licensed facilitators ahead of Oregon Psilocybin Services opening to the public and private business sector in early 2023.
“The rules will impact all psilocybin training programs, psilocybin manufacturers, psilocybin service centers, psilocybin
facilitators, psilocybin testing laboratories and clients in Oregon,” the OHA states on the second page of the 44-page notice of proposed rulemaking.
And those rules will cost all those parties involved money to adhere to regulations, and the cost of participating in this emerging industry will be, of course, passed down to the consumer.
“The rules may have a negative impact on lower income individuals because the scope and cost of required facilitator training could influence the cost of psilocybin services,” the OHA states in the document. “The [fungi] testing rules are likely to impact lower income clients more acutely because the cost of testing could be passed onto clients receiving psilocybin services.”
As Psychedelic Spotlight previously reported, the Oregon Psilocybin Services Advisory Board has decided on allowing just one species of fungi — Psilocybe cubensis; also known as Golden Teacher mushrooms — for cultivation, sale, and use. Prospective facilitators will be required to complete a 120-hour Core Training program—covering everything from integration and psilocybin pharmacology to “safety, ethics, and responsibilities” and “cultural equity in relation to psilocybin services”—and a minimum 40 hours of practicum training.
Although the OHA states “the overall fiscal and economic impact of the rules cannot be quantified at this time,” it acknowledges this first-ever regulatory framework will incur additional costs throughout the chain of production through delivery to clients.
“Less restrictive rules could carry a lower cost of compliance for manufacturers. However, this lower cost would be coupled with higher risks of negative outcomes for clients, including health and safety concerns, leading to fiscal and economic impact to individuals,” the documents states. “Additionally, an appropriately regulated market creates consumer confidence and encourages members of the public to access psilocybin services through the ORS chapter 475A model rather than purchasing from sources in the unregulated market.”
“If rules for training curriculum were less comprehensive, psilocybin facilitators could conceivably pay lower training costs,” authors state, adding: “The testing rules require psilocybin products to undergo certain tests before they may be sold. Licensed psilocybin manufacturers will pay costs to perform the required tests. A portion of these costs could ultimately be passed onto clients.”
This latest revision of rules also limits consumption or delivery method of the psychedelic compound strictly to oral ingestion. “The rules could also impact clients who prefer or require alternate delivery methods, such as topicals or suppositories,” the OHA admits. “Psilocybin products designed to be delivered to clients through any method other than orally, including but not limited to, transdermal patches, inhalers, nasal sprays, suppositories and injections, are prohibited.”
The OHA is accepting public comments on this proposed regularly framework through April 22, and a virtual public hearing will be held via Zoom on April 18 at 5 PM. The agency has until December 31 of this year to finalize the rules, paving the way for licensure in early 2023.