ops m109 summary final draft 8.11 - read-only

PUBLIC HEALTH DIVISIONOregon Psilocybin Services

Oregon Psilocybin Advisory Board Monthly MeetingSummary of Measure 109

August 25, 2021

Jesse Sweet, Policy AnalystOregon Psilocybin Services

August 25, 2021

What does Measure 109 do?

M109 creates a license and regulatory framework for production of psilocybin and facilitation of psilocybin services for adults 21 years of age and older.

• M109 does not create a consumer market for psilocybin.

• M109 does not allow for export or import of psilocybin.

• M109 does not allows licensees to interact with unregulated markets.


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What doesn’t Measure 109 do?

License Types

• Manufacturer: Cultivates fungi containing psylocibin and produces psylocibin products

• Service Center: Provides psilocybin products to clients during administration session

• Facilitator: Facilitates client preparation, administration and integration sessions.

• Lab: Tests psilocybin products

PUBLIC HEALTH DIVISION Oregon Psilocybin Services

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OPAB shall make recommendations to Oregon Health Authority on…

• Administration of the measure

• Available research

• Requirements and guidelines for providing services to clients

• Public health and safety standards

• Code of professional conduct for facilitators

• Education and training for facilitators

• Facilitator examinations

• Public health and safety standards for administration sessions


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Oregon Health Authority Shall…

• Examine and publish available research

• Adopt rules to implement the measure, including rules necessary to protect public health and safety

• Issue licenses

• Ensure licensee compliance

• Administer the provisions of the measure


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Timeline

• Development Period: January 1, 2021 to December 31, 2022

• July 31, 2021: OHA published Rapid Evidence Review

• June 30, 2022: OPAB shall submit findings and recommendations– Some findings and recommendations may be requested as early as

2021

• December 31, 2022: OHA shall adopt rules necessary for implementation– Some rulemaking may begin as early as 2021.

• January 2, 2023: OHA shall begin receiving license applications


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Specific Recommendations

• OPAB shall make recommendations:

– on the requirements, specifications and guidelines for providing psilocybin services to a client;

– on public health and safety standards and practices for each type of license;

– on the formulation of a code of professional conduct for facilitators;

– on the education and training that facilitators must complete;

– on the examinations that psilocybin service facilitators must pass;

– on public health and safety standards and practices for holding and completing an administration session.


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Other OPAB Duties

• Develop a long-term strategic plan for ensuring that psilocybin services will become and remain a safe, accessible and affordable therapeutic option.

• Monitor and study federal laws, regulations and policies regarding psilocybin.

• Attempt to meet with the United States Attorney’s Office for the District of Oregon to discuss Measure 109 and potential federal enforcement policies regarding psilocybin in Oregon.


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Common Denial Criteria for All License Types

• Has not completed required training, education or exam

• Has made false statements to the authority

• Conviction history (exception for psilocybin and cannabis offenses)

• Is not legitimate owner of business

• Poor record of compliance with Measure 109


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Manufacturer License Requirements

• Greater than 50% of ownership group are Oregon residents

• An individual may not hold an interest in multiple manufacturers

• Must demonstrate that property owner has consented to production of psilocybin

• Cannot cultivate outdoors

• Premises must have defined boundaries

• Cannot exceed production quantities established by rule


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Service Center Requirements

• Greater than 50% of ownership group are Oregon residents

• An individual may not hold an interest in more than five service centers

• Cannot be located within 1000 feet of a school

• Must have defined boundaries

• Transfers psylocibin products to client for use during administration session

• Only license authorized to transfer psylocibin products to clients


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Facilitator License Requirements

• Held by individual. Facilitators can be associated with specific Service Centers, but it is not required.

• Must have been Oregon resident for two years (Expires January 2025)

• Must complete education and training approved by OHA

• Must pass exam approved or administered by OHA

• Cannot transfer psilocybin products to clients


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Laboratory License Requirements

• All psylocibin products must be tested by a licensed laboratory prior to transfer to Service Center.

• Labs must be accredited by ORELAP prior to licensure

• Testing results are entered into tracking system


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Worker Permits

• Most employees working for a licensee will be required to hold a permit issued by OHA

• This permit is separate from the Facilitator license

• OHA will adopt rules regarding term, fees and qualification

• OHA may adopt rules requiring an educational course


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Client Information Form

• Must be completed prior to Administration Session

• Must be reviewed by Service Center and Facilitator

• Identifies client risk factors and contraindications

• Contains health and safety warnings and disclosures


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Administration Session

• Must be held at Service Center and conducted by Facilitator

• Only place that clients may receive and consume psilocybin products

• Group sessions may be allowed, depending on recommendations and final rules

• OPAB to recommend public health and safety standards; OHA to adopt rules


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License Fees

• OHA shall adopt rules designating application, license and renewal fees for all license types

• Fees must be reasonably calculated not to exceed the cost of administration

• Oregon Psilocybin Services will be a fee-based program and fees must cover the costs associated with the agency’s work.


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Taxes

• Service Centers collect a 15% tax on the sale of psylocibin products– Services are not taxed

• Tax is payable to Oregon Department of Revenue– Local governments may not impose taxes or fees

• Tax revenues help fund administrative costs for Department of Revenue and Oregon Psilocybin Services.


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Tracking

• System required to track manufacturing, sale and transfer of psilocybin products

• Tracking system is designed to:– Prevent diversion

– Prevent tampering

– Ensure accurate accounting

– Ensure accurate reporting of lab testing results

• OHA shall:– Develop and maintain tracking system, or

– Contract with OLCC to use cannabis tracking system (Metrc)


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Local Government Opt-Out

• Local governments (cities and counties) may adopt ordinances that prohibit Manufacturers and Service Centers

• OHA may not issue licenses if the local government has adopted such an ordinance

• Ordinances must be referred to voters at the next general election


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Local Government Time Place and Manner Regulations

• Local governments may adopt reasonable regulations on hours, location and operation of licenses

• For example, a city may adopt a regulation that requires Service Centers to be located at least 1000 feet apart from one another

• Local taxes and fees are prohibited


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Land Use Compatibility Statements (LUCS)

• Applicants for Service Center and Manufacturer licenses are required to request a LUCS from their local government before submitting a license application.

• OHA may not issue a license if the proposed land use is prohibited.


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Questions….


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ops m109 summary final draft 8.11 - read-only

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