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Oregon is on the verge of deciding rules and regulations for legalizing medicinal psilocybin.

The state’s voters approved legalization in November 2020 through Measure 109, with an operational program to be scheduled by early 2023, a move which instantly brought a huge international spotlight on the state.

Since 2019, other cities and states have looked to decriminalization of psilocybin and other psychedelics rather than full legalization, within a still-evolving patchwork of rules. The plan for most of the rules is to eventually have medical legalization. But those states are now looking at Oregon for a business model to emulate or improve.

Starting in January 2023, Oregon will become the first state to set up a legal psilocybin program, with licensed growers, clinical settings for distribution and use, and facilitators.

Even Canada has taken an interest in how the Oregon model is being developed. In a tweet in August, the Canadian Minister of Mental Health and Addictions, Carolyn Bennett, reported that she met with members of the Oregon psilocybin program, including Go. Kate Brown, in what was termed a surprise move to develop more background on psilocybin legalization.

“The Oregon Psilocybin Advisory Board (OPAB) gave us a presentation on the state’s framework for psilocybin services from manufacturing and delivery to purchase and consumption services as a result of Ballot Measure 109 that passed in Nov 2020,” she tweeted.

Canada has its own issues with psilocybin. Eight Canadians filed a lawsuit in late July against the government and the minister of health regarding patient access to psilocybin and psilocybin therapy.

The Oregon advisory board recommended draft administrative rules in mid-September. Those rules will be further refined after the Rules Advisory Committee meetings in September and the public comment period in November. The Oregon Psilocybin Services (OPS), a new section within the Oregon Health Authority Public Health Division’s Center for Health Protection that was created to implement Measure 109, will finalize and adopt rules by Dec. 30, 2022.

Only the sale of natural psilocybin or psilocin will be allowed – specifically psilocybe cubensis, one of the 10 most common psychoactive mushrooms. The variety, also called magic mushrooms, contains 10-12 milligrams of psilocybin per gram of dried mushrooms. The effective oral doses range is 6-20 milligrams. Oregon has proposed selling packages containing a single 25 milligram dose.

But as this rulemaking is happening, there continue to be snags along the way. According to a report by Oregon Public Broadcasting, large portions of Oregon may lose access to psilocybin treatment before a single center opens. That’s because Measure 109 gives local governments the option to send the issue back to voters, either for a total ban or a two-year moratorium.

As of late August, more than 40 cities and counties are expected to put the issue before voters in the general election in November, with most of them considering complete bans. If passed, the measures would create expansive tracts in eastern, central and southern Oregon where people would not be able to access psilocybin.

Advocates say fear is fueling the efforts against psilocybin, driven in part by widespread misconceptions about the drug and what access will look like when Measure 109 takes effect in January.

Many mistakenly believe that psilocybin will be recreationally available like cannabis. That use is not allowed under the terms of the measure, but it appears to be a valid concern because of a subtext in neighboring Washington’s decriminalization rules. Washington’s legislation, which takes the form of a ballot initiative to be voted on in November, allows anyone over 21 to purchase a microdose of psilocybin after a brief preparation session with a facilitator. They can then take it with them for consumption at their leisure rather than sitting in a pseudo-clinical setting being monitored before and after the psilocybin dose has worn off.

In addition, under the Oregon program, facilitators don’t need to be college graduates or taken any medicine-related college courses, according to the OPS. This calls into question for some whether this is actually a medical program at all.

Other issues revolve around type and depth of facilitator training to be offered by the state and the physical and psychological safety of people being treated during their psilocybin session.

Details of the Draft Proposal

Exactly when anyone can go to a facility and get psilocybin treatment is still a moving target. OPS will begin accepting applications for licensing psilocybin products, testing labs, service centers and facilitators on Jan. 2, 2023.

“It will take some time for all four license types to become licensed and set up operations,” the OPS website stated in its Q&A section. Mason Marks, a former member of OPAB, told Oregon Public Broadcasting that estimates for actual operations to be up and running are mid- to late-2023.

The OPS team is developing an online training program, licensing and compliance system to allow for a streamlined online application process, although paper applications will also be available. License fees will be determined through the state agency budget process and adopted in final rules by the end of December.

As set out in the current draft of rules from September, a service center, manufacturer or laboratory applicant must pay a $500 nonrefundable fee. If the application is approved, the proposed annual license fees are:

• $10,000 for a laboratory, manufacturer or service center
• $2,000 for a facilitator

The patient costs for a single psilocybin session are still being worked out, but might be $1,000 or more.

The financial impact to the state to establish the program under Measure 109 is estimated to be $5.4 million through November 2022. Once the program is established, ongoing costs are expected to be $3.1 million annually.

Opposition to Oregon’s Proposed Program

Oregon’s program has its proponents, beginning with nearly 1.3 million people in the state who voted in favor of Measure 109. But the Oregon medical community is still pushing back, with no clear response from the state – and that is a clear sign to other cities and states that finding a working, reliable and tested business model for a similar medical-but-not-medical psilocybin program could be fraught with discord.

For example, one recent study authored by researchers at Oregon Health and Science University warned about the outcome of mixing psychedelics with other widely used psychiatric medicines.

Another doctor was more direct in a statement before the measure passed. Dr. Nicole Cirino, president of the Oregon Psychiatric Physicians Association (OPPA), noted: “No chemical or medical treatment we use would ever be used to treat all the psychiatric conditions like they’re claiming. The disparity between the amount of data we have and the widespread publicity about the safety and effectiveness of this substance is what makes it unsafe.”

Cirino added that Measure 109 “would set up Oregonians as really the guinea pigs to be receiving psilocybin treatment for psychological conditions with high rates of morbidity and mortality if treated quickly or left untreated.”

The OPPA issued their own opposition statement before Measure 109 was approved by voters: “Given our limited understanding of psilocybin’s effects on patients and how it may interact with other medications, it is dangerous to allow practitioners – especially those with no medical training – to dispense a controlled substance.”

Oregon’s Psilocybin Legalization Plan Under Scrutiny on Green Market Report.