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Legalizing Therapeutic Access To Psilocybin

November 27, 2020 9:14 am
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Legalizing Therapeutic Access To Psilocybin

This article was originally published on Hoban Law Group, and appears here with permission.

Written by: Noah Potter

Oregon Measure 109 presents voters with the opportunity to pass a statute that will create a regulatory system for psilocybin-assisted therapy based on a clinic model with the licensure of manufacturers, clinic operators, treatment providers, and testing laboratories. The statute makes possible a market with low barriers to entry, so, depending on how restrictive the regulations are, there could be a relatively large number of licensees who will be prepared to handle a high volume of patients. The measure keeps all control at the state level and limits the ability of local governments to regulate but still grants authority to pass regulations governing the operation of licensees. The measure explicitly does nothing to end psilocybin prohibition outside the licensed system. Still, there will be some protections to individual consumers of psilocybin if Measure 110, a general drug decriminalization bill, also passes. Measure 109 gives extensive discretion to the Oregon Health Authority over almost all aspects of the market, so if the measure passes, the question critical to the success or failure of the system will be whether the regulations are appropriate for psilocybin.

Psilocybin Proposed System Looks Like Medical Cannabis System

The proposed system looks very much like a state-level medical cannabis system. M109 provides for four different license classes: psilocybin product manufacturers, psilocybin service center operators, psilocybin service facilitators, and testing laboratories, with the service centers playing the role of the clinics at which all consumption of psilocybin must take place and the facilitators taking the role of the medical supervisors of psilocybin therapy.

It is clear from the language that licensees can be for-profit businesses. There is no explicit language that permits or prohibits nonprofit corporations or unincorporated associations. It doesn’t appear that governmental agencies can be licensed. It appears that a licensee must be a single-purpose entity; in other words, it seems that an existing business cannot acquire a license. There are generally very few explicit requirements for licensees: residency requirements, age minimums, and relatively few disqualifications. There are certain restrictions on holding multiple licensees: an individual cannot have a financial interest in more than one psilocybin product manufacturer or more than five psilocybin service center operators. However, a person can hold multiple service center operator licenses. A person may hold both a manufacturer license and a service center operator license, whether at the same or different locations.

Psilocybin Clinic Model Differs From Medical Cannabis System

This clinic model differs from a medical cannabis system in that there is nothing like dispensary access in which a patient buys “psilocybin products” (which includes the mushrooms themselves and mixtures containing psilocybin and psilocin) and takes them home. In essence, it creates a model of access to a psychedelic “medical procedure” that takes place in a facility licensed by the state. On the other hand, the measure creates very few barriers to entry: for example, the sections governing licensees do not require medical training or higher education degrees. Instead, the measure grants extremely broad power to the OHA to create requirements for licensure. OHA also has extremely broad to create standards for “psilocybin services,” the term that describes the treatment itself. Psilocybin services include the mandatory preparation session, the “administration session” at a service center in which a patient receives psilocybin, and the “integration session” afterward in which the patient reviews the experience with a facilitator.

The degree of discretion granted to the OHA is likely based on the recognition that there is no model yet for a fully-formed legal system for psilocybin-assisted therapy, and the health department will be building it from the ground up. The measure requires the creation of the Oregon Psilocybin Advisory Board, consisting of members of the state health care agencies and other categories of persons appointed by the governor, to provide guidance to the OHA is promulgating regulations.

Psychedelic Policy Reform

There will be a long lead time before the system will be operational. The measure creates a two-year development period from January 1, 2021, to December 31, 2022, in which no licenses will be issued. The Advisory Board’s recommendations are not due until June 30, 2021, and the OHA will not begin receiving license applications until January 2, 2023.

The measure contains a broad “preemption” clause that prevents local governments from passing laws other than as authorized by the state. Although local governments will have no power to issue licenses, the language in the measure seems to give local governments to regulate the manner in which licensees operate. In addition, cities and counties can opt-out of the system: local residents can vote to prohibit psilocybin product manufacturers and psilocybin service center operators in their jurisdictions.

M109 Has Impressive List Of Supporters

M109 has attracted an impressive list of supporters, including the Oregon Democratic Party, the Oregon American Federation of State, County and Municipal Employees, several county-level Democratic clubs, elected officials including U.S. Representative Earl Blumenauer and six state legislators, numerous candidates for elected office, cannabis industry organizations, and progressive advocacy groups. The opposition includes mental health organizations, including the American Psychiatric Association, Oregon Medical Association, Oregon Psychiatric Physicians Association Organizations, the American Academy of Child and Adolescent Psychiatry, and the Oregon Council of Child and Adolescent Psychiatry, but not police or prosecutor organizations or substance abuse prevention and treatment providers.

However, there is a noteworthy source of opposition: the Decriminalize Nature movement that has succeeded in convincing several local governments around the country to adopt decriminalization ordinances and is operating in dozens of other cities. Decriminalize Nature seeks to eliminate penalties for non-commercial activity around naturally-occurring psychedelics and has expressed opposition to this licensure system that retains penalties for anyone outside its scope.

It is difficult to overstate the importance of M109 for psychedelic policy reform. Due to the degree of discretion that Measure 109 will give to the OHA, the system’s success will depend on whether that agency is open to being educated by people who have prior experience and direct knowledge of psilocybin. It is to be hoped that the governor will wisely appoint to the Advisory Board people who understand psychedelics—people from the legacy market, harm reduction providers, integration therapists, medical researchers, and patient advocates.

Read the original Article on Hoban Law Group.

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