Psychedelics Law Blog, Author at Harris Sliwoski LLP Tough Markets, Bold Lawyers Tue, 26 Dec 2023 16:19:25 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://harris-sliwoski.com/wp-content/uploads/cropped-Harris-Sliwoski-Logo-FinalIcon-White-1-32x32.png Psychedelics Law Blog, Author at Harris Sliwoski LLP 32 32 Four Harris Sliwoski Attorneys Named as Global Top 200 Psychedelic Lawyers https://harris-sliwoski.com/psychlawblog/five-harris-bricken-attorneys-named-as-global-top-200-psychedelic-lawyers/ Mon, 09 Jan 2023 15:00:33 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=129270 We are pleased to announce that four (!) Harris Sliwoski attorneys have all been recognized as Global Top 200 Psychedelic Lawyers and Policy & Regulatory Experts for 2023 by the Cannabis Law Report. The Cannabis Law Report compiles a directory of lawyers that it considers to be the best legal minds, whether they come from

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We are pleased to announce that four (!) Harris Sliwoski attorneys have all been recognized as Global Top 200 Psychedelic Lawyers and Policy & Regulatory Experts for 2023 by the Cannabis Law Report.

The Cannabis Law Report compiles a directory of lawyers that it considers to be the best legal minds, whether they come from a policy, corporate, regulatory, or criminal background. The directory also includes individuals at medical psychedelic companies with legal and policy skill sets, as well as individuals from universities, the media and other backgrounds.

The following Harris Sliwoski attorneys were recognized this year: Jonathan BenchEthan Minkin, Vince Sliwoski, and Griffen Thorne. Harris Sliwoski was also named a leading firm in the psychedelic law space, and for good reason: we have been writing about and working in psychedelics since 2018.

Today, our clients range from small businesses and investors (many in the Oregon Measure 109 ecosystem), to widely held research and drug development companies. We have also consulted with state and local governments on legislation along the decriminalization and legalization continuum. Our services in the psychedelics sector include:

  • Entity formation, administration, and governance
  • Finance and investment
  • Intellectual property protection and registration (including patents)
  • Technology related agreements
  • Regulatory compliance advice and counsel
  • Legal opinion work
  • Contracts
  • Regulatory compliance
  • Litigation

Congratulations to our team members! Learn more about our psychedelics practice here, and stay up-to-date on emerging industry news by subscribing to our Psychedelics Law Blog.

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January 12 – Legal and Regulatory Landscape for Psychedelics https://harris-sliwoski.com/psychlawblog/january-12-legal-and-regulatory-landscape-for-psychedelics/ Thu, 05 Jan 2023 21:30:59 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=129229 Register Here Harris Sliwoski attorneys, Paul Coble, Griffen Thorne, and Vincent Sliwoski, will be presenting on the “Legal and Regulatory Landscape for Psychedelics” in the following CLE webinar on January 12th, 2023, hosted by The Seminar Group. “This program will provide an overview of emerging drug therapies, including psilocybin, ketamine infusion clinics, MDMA and other

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Register Here

Harris Sliwoski attorneys, Paul Coble, Griffen Thorne, and Vincent Sliwoski, will be presenting on the “Legal and Regulatory Landscape for Psychedelics” in the following CLE webinar on January 12th, 2023, hosted by The Seminar Group.

“This program will provide an overview of emerging drug therapies, including psilocybin, ketamine infusion clinics, MDMA and other psychedelic substances. Our panel of experts will address the results of recent elections and other developments related to psychedelic drugs and new drug therapies. We will look at the process and results for Measure 109 (psilocybin licensing) and Measure 110 (controlled substance decriminalization) in Oregon, as well as future efforts to decriminalize, protect and regulate psychedelic drug use.

As the legal and regulatory frameworks of these industries begin to solidify, new opportunities are emerging for the commercialization and research of new drug therapies and alternative medicine. If you have an interest in the law of psychedelics, you don’t want to miss this review of the rapidly evolving laws and regulations in the industry.”


Griffen Thorne

Program Chair

Federal Regulation and State Law Roundup

  • Status of psilocybin and other psychedelics under federal law
  • Lessons learned from federal cannabis laws, including taxation, banking, real estate, intellectual property, and federal illegality issues

Vincent Sliwoski

Kickoff of Oregon Measure 109

  • How we got here – M 109 overview
  • Adopted final OHA rules highlights
  • Local jurisdiction opt-in and opt-out results, and any pending local issues
  • Business and legal challenges for licensed psilocybin businesses
  • Possibility of legislative session changes to the OHA program
  • Timeline forecasts for OHA license grants

Paul Coble

Protecting Intellectual Property

  • Patents, copyrights, trademarks, and trade secrets in the psychedelics industry
  • IP litigation and how to avoid it
  • IP valuation and due diligence

 

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Happy Thanksgiving from the Psychedelics Law Blog https://harris-sliwoski.com/psychlawblog/happy-thanksgiving-from-the-psychedelics-law-blog/ Thu, 24 Nov 2022 15:00:20 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=128668 The post Happy Thanksgiving from the Psychedelics Law Blog appeared first on Harris Sliwoski LLP.

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Washington Psilocybin Update https://harris-sliwoski.com/psychlawblog/washington-psilocybin-update/ Fri, 23 Sep 2022 14:00:49 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=124208 In March of this year, the Washington State Legislature passed Senate Bill 5693. Section 211, subpart 99 of this bill directs the Washington State Health Care Authority (HCA) to create a psilocybin work group to assess the feasibility of bills like Senate Bill 5660 (see our initial take on that one here). In particular, the

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In March of this year, the Washington State Legislature passed Senate Bill 5693. Section 211, subpart 99 of this bill directs the Washington State Health Care Authority (HCA) to create a psilocybin work group to assess the feasibility of bills like Senate Bill 5660 (see our initial take on that one here). In particular, the work group will investigate whether state sanctioned psilocybin services are appropriate for Washington. Further, the work group will assess Measure 109, Washington cannabis regulations, and potential psilocybin regulations in Washington.

The work group must deliver a preliminary report to the Washington State Governor and Legislature by December 1, 2022 and a final report by December 1, 2023. The work group scheduled five meetings: June 2022, August 2022, October 2022, March 2023, and May 2023. In this post we will discuss the work group’s first two meetings.

Meeting 1: June 30, 2022

The work group began its first meeting by clarifying its scope. It operates under the HCA, which is the Washington state agency for Medicaid and public employee benefits. The HCA does not have licensing functions, and since psilocybin is a Schedule I substance under the Federal Controlled Substances Act, Medicaid cannot currently pay for psilocybin. So, while the work group will provide insights into licensure and regulation in Washington, the HCA would not solely regulate psilocybin services.

Next, the work group discussed Measure 109 and Oregon’s psilocybin regulations. Although Measure 109 establishes a regulatory framework for psilocybin consumption, it does not allow retail sales or off-site consumption. Oregon must track all psilocybin products, and psilocybin is limited to adults over 21 years of age. The Oregon Psilocybin Advisory Board (OPAB) made regulation recommendations in June 2022, the Oregon Health Authority (OHA) will adopt regulations in December 2022, and will begin accepting psilocybin service applications from businesses in January 2023.

The work group then discussed Oregon psilocybin administrative rules. OPAB has five subcommittees that made recommendations for rules in five areas: equity, training, research, products, and licensing. OPAB recommended rules for four types of licenses: Manufacturer, Testing Lab, Facilitator, and Service Center. OPAB recommended specific rules for each type of license. For example, a manufacturer must obtain consent from the property owner to produce psilocybin, and a facilitator must complete an OHA approved training program before applying for licensure.

OPAB also recommended rules for each session of psilocybin services: preparation, administration, and integration. For instance, a client must give informed consent during the preparation session in order to move on to the administration session. Additionally, OPAB recommended rules for tracking psilocybin and psilocybin products as mandated by Measure 109.

The meeting ended with a discussion about the results of a work group survey, where members expressed their opinions on psilocybin-related issues. The survey showed members want to duplicate aspects of Measure 109 for Washington, such as the two-year development period, promote access for end-of-life care, and decriminalize psilocybin. In contrast, members wanted to avoid restrictions in Measure 109 by allowing at-home administration, and enabling micro-dosing outside of service centers. Additionally, most members agree that safety is their top priority for a Washington psilocybin program. For more results of the survey, review the presentation slides here.

Psilocybin Map

View the US Map of Psilocybin Legality by State

 

Meeting 2: August 4, 2022

During its second meeting the workgroup heard a presentation by Jim Morgan, the CFO of the Washington Liquor and Cannabis board (LCB). Morgan focused on the methods of tracking cannabis and cannabis products in Washington state, providing examples of how Washington could track psilocybin products. The Washington cannabis industry has five types of licenses: Grower, Processor, Retailer, Transportation, and Research. All of which require cannabis tracking.

The big lesson learned from the Washington cannabis industry was to have specific tracking systems already in place. LCB had no tracking systems specific to cannabis, which made tracking complex and difficult. At first, LCB tried tracking cannabis with a system for tracking pharmaceuticals. After three years, LCB had to switch to another system to improve tracking. However, this second system was even more problematic than the first. Finally, on June 30, 2022 LCB phased out that system and implemented their current system. The current system more effective than the first two, because it is specifically tailored to Washington cannabis rules and statutes.

The work group then heard from Duncan Stuard of the Center for Evidence-based policy. Stuart gave an overview of the national landscape of psilocybin laws. Twenty-one states have introduced bills and ballot initiatives related to psilocybin. However, not all states are following the Oregon model for psilocybin access. Some state laws require medical diagnosis, some allow use for wellbeing, and others allow individuals to possess and use psilocybin themselves. Overall, eight bills passed, five are in committees, and three were pushed to the next session. We will discuss these bills further in a future post.

The second meeting ended with another survey of the members’ opinions. Again, members expressed support for microdosing, with nine out of thirteen members strongly supporting it. Members also supported a “wellness” model over a “clinical” model to broaden access to psilocybin services. Eight out of thirteen members felt psilocybin services should be covered by both private insurance and state funding. The work group also revisited opinions on Oregon’s model, with members showing the most support for decriminalizing psilocybin and requiring only a high-school diploma for facilitators.

Outlook

While Washington has not passed legislation allowing psilocybin services, initiating this work group shows the legislature is considering it. Outside of Washington and Oregon, states across the nation are moving toward less restrictions for psilocybin as a consumable substance. Though, the federal government shows no signs of removing psilocybin from the CSA. Like cannabis, psilocybin-friendly states will be in conflict with the federal government. It is unclear if the federal government will maintain its “hands-off” approach for both cannabis and psilocybin.

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Troy Sims is an associate attorney at Piskel Yahne Kovarik, PLLC in Spokane, WA. He focuses on business law, commercial litigation, real estate law and construction law. You may contact him at tsims@pyklawyers.com, or connect with him on LinkedIn.

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Oregon Psilocybin Culture and Anthropology: Research Subcommittee Meeting Notes https://harris-sliwoski.com/psychlawblog/oregon-psilocybin-culture-and-anthropology-research-subcommittee-meeting-notes/ Tue, 19 Jul 2022 14:00:36 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=118697 Since January 1, 2021, the Oregon Health Authority (OHA) has engaged in a two-year development phase, creating regulations based on Ballot Measure 109. There are five subcommittees covering different aspects of the emerging psilocybin industry including research, health equity, manufacturing, training, and licensing. In this post, we will cover the most recent Research Subcommittee meeting

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Since January 1, 2021, the Oregon Health Authority (OHA) has engaged in a two-year development phase, creating regulations based on Ballot Measure 109. There are five subcommittees covering different aspects of the emerging psilocybin industry including research, health equity, manufacturing, training, and licensing.

In this post, we will cover the most recent Research Subcommittee meeting on July 23, 2022. The Subcommittee discussed the Cultural and Anthropological Review of Resources (Review), and whether to recommend it to the Oregon Psilocybin Advisory Board (OPAB). Unfortunately, there was not a quorum in attendance at this meeting, thus the Subcommittee was not able to vote to recommend the Review at this time.

Psilocybin culture and anthropology research

The Review is a work product of Research Subcommittee meetings over the past year. It summarizes the salient talking points and work of guest speakers who attended these meetings.

While expertise and research varied among the speakers, all of their presentations to the Subcommittee focused on cultural and anthropological aspects of psilocybin use. All presentation recordings and supporting documents are available on the Research Subcommittee website by clicking the corresponding meeting dates.

Dr. Del Potter

Dr. Potter is a medical anthropologist who spoke to the Subcommittee on August 26, 2021.

He stressed the OHA and OPAB must mindfully engage with indigenous groups in Oregon, which is essential for psilocybin services in Oregon. He said OHA has a responsibility to communicate with indigenous groups during the rulemaking process to benefit these communities. This opens the door for different models for psilocybin services. The Research Subcommittee reiterated the importance of being open to different models.

It is important to note that OPAB recently reviewed a different model framework for entheogenic practitioners. This topic was very controversial, and you can read our post on it here.

Dr. Potter explained there is a lack of research on indigenous psilocybin use in Oregon, despite the historical importance of psilocybin in these communities. More research will help reconcile traditional psilocybin use with modern western framework of Measure 109.

Dr. Bia Labate

Dr. Labate is a social anthropologist who spoke to the Subcommittee on October 28, 2021.

She stressed how projecting indigenous speakers is essential to understanding psilocybin use; not all indigenous communities use psilocybin. Further, speakers representing women, black communities, LQBTQ+, an people from other countries is essential for community healing. She focused on social justice and equity, and emphasized how indigenous cultures use psychedelics to heal the community through the individual, not merely the individual.

She said Social justice must also be brought with compassion, humor, and fun.

Dr. Paula Noel Macfie

Dr. Macfie is an Indigenous Science researcher who spoke to the Subcommittee on November 18, 2021.

While all of these speakers posited the importance of “bridging” research gaps, Dr. Macfie emphasized the “bicultural research model,” which bridges Western and indigenous science. She stressed that OHA should avoid limiting the psilocybin industry to an exclusive Western scientific paradigm. The narrow Western models misses out on valuable indigenous knowledge, from which the entire community may benefit.

She provided resources for her presentation, including a paper on the psychedelic renaissance, a list of related terms, a summary of indigenous science criteria, a list of indigenous social rules and protocols, measures of the indigenous mind, and a list of resources.

Dr. Monnica Williams

Dr. Williams is a licensed clinical psychologist who spoke to the Subcommittee on February 24, 2022. A reader-friendly version of her presentation is available here.

She focused on diversity, pointing out the eight major categories: culture, race/ethnicity, gender, sexual orientation, social/economic classification, age, disability, and religion. She explained how racism causes negative mental health outcomes, known as “racial trauma.” The War on Drugs has been an ongoing source of racial trauma and causes people of color and low-income communities to distrust medical research.

The psilocybin industry can be an antidote to racial trauma by incorporating culturally informed care. Adequately representing people of color in psychedelic research is not only wanting, but essential for the psilocybin industry.

Dr. Benjamin Feinberg

Dr. Feinberg is an anthropology professor at Warren Wilson College, and spoke to the Subcommittee on March 31, 2022.

He discussed cultures in the Sierra Mazateca region who use psilocybin. The Western world tries to dominate these cultural uses by imposing a perceived “sophisticated” method. Yet, he maintains, respect and reciprocity is the path to a deeper understanding of psilocybin.

The Sierra Mazateca people who use psilocybin have different definitions of language and healing, which leads to psilocybin practices much different than the Western world. For instance, rain can be a way ancestors speak them, and healing can involve locating a lost soul.

He explained Oregon psilocybin services should not dominate, or forcibly alter, such practices by imposing a strictly Western model.

Outlook and OPAB public listening sessions

If the Research Subcommittee eventually votes to recommend this document to OPAB, it is unclear how OPAB will use the information. As discussed in another post, OPAB already reviewed and rejected a framework for entheogenic practitioners. While indigenous practices are not exclusively entheogenic, OPAB may be similarly reluctant to recommend indigenous-related rules to OHA. You can read more about the entheogenic framework here.

On another note, from July 13 through 15 OHA will hold Oregon Psilocybin Services listening sessions. This is an opportunity for members of the public to speak directly to OHA about the developing psilocybin industry in Oregon. Zoom links are available on the Public Listening Sessions webpage.

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Oregon Psilocybin Advisory Board: June 22, 2022 Meeting https://harris-sliwoski.com/psychlawblog/oregon-psilocybin-advisory-board-june-22-2022-meeting/ Wed, 13 Jul 2022 14:00:02 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=117847 The Oregon Psilocybin Advisory Board (OPAB) was established by Measure 109 and is responsible for making recommendations to the Oregon Health Authority (OHA) for psilocybin services in Oregon. OPAB has met monthly since March of 2021, and the last monthly meeting was set for June 22, 2022. After that, OPAB will meet every two months. In a

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The Oregon Psilocybin Advisory Board (OPAB) was established by Measure 109 and is responsible for making recommendations to the Oregon Health Authority (OHA) for psilocybin services in Oregon.

OPAB has met monthly since March of 2021, and the last monthly meeting was set for June 22, 2022. After that, OPAB will meet every two months. In a typical meeting, board members vote on what recommendations OPAB will make to OHA.

In the June 22 meeting, OPAB discussed the psilocybin client information form, the informed consent document, risk assessment and safety planning, psilocybin amounts for products and dosage, product handling, integration sessions and facilitator licensure. OPAB voted on recommendations under these topics for OHA’s consideration.

Informed consent document

Informed consent is an agreement with sufficient knowledge of relevant facts, and is often required for legal services, scientific research and medical treatment. For example, a medical patient must agree to undergo surgery before the procedure can begin. After the patient hears all of the information relevant to the surgery (the risks, benefits, and alternatives), the patient can then give informed consent to the healthcare provider.

Under OHA rules, psilocybin facilitators will be required to obtain informed consent from clients prior to an administration session. The Licensing Subcommittee voted to recommend this informed consent document to OPAB in November, 2021.

At the June 22 meeting, board members generally agreed on the document, but voiced concern that “trying to leave a service center before it is safe” is not listed as a side effect of psilocybin, and suggested adding an “agreement to not leave until cleared by the facilitator” to the document. Other members explained the content in the document is exhaustive, and the format should actually be simplified to ensure no lines are missed.

After some debate, OPAB voted to recommend this document to OHA.

Client information form

The “client information form” will be a tool for facilitators to adequately assess prospective clients. Facilitators are responsible for screening prospective clients and rejecting anyone who may be harmed by psilocybin services. The client information form will guide facilitators in gathering necessary information to make these determinations. OPAB discussed a list of required content for this form.

The list of content includes mental and medical history such as suicidal ideations, trauma, substance use, and current medications. It also explores the prospective client’s social support and living situation, as well as the person’s mobility concerns and possible language needs. The full list of content is available here on page 8.

Board members noted much of this information is medical in nature and HIPAA will apply some, but not all, of the content. Members felt the form is most appropriate as a set of “yes or no” questions, guiding the facilitator in a discussion while keeping the form simple. OPAB voted to approve the client information form, so long as it is reformulated as a “yes or no format.”

Risk assessment framework and safety planning framework

These frameworks work in tandem, and OPAB explained one is meant to help facilitators know what information to solicit from clients, while the other would indicate what to do with that information.

First, the risk assessment framework is meant to further guide a facilitator in deciding whether psilocybin is safe for a prospective client. The facilitator will either find a person eligible for psilocybin services at that time, or not eligible now but may be re-screened at a later date.

The framework requires a facilitator to find a person “ineligible” if psilocybin services are likely to cause harm to the person or others. For instance, an active psychosis, pregnancy, or unsafe living situation all make a person ineligible. Further, if a person cannot provide informed consent due to impaired decision-making capacity, or is using contraindicated medications, the person is ineligible. Contraindicated medications are those which interact negatively with psilocybin; OPAB noted that more research is needed for an exhaustive list of these medications.

Other information, such as alcohol use and childhood trauma, requires further screening to determine if a person is ineligible. You can view the full list here on pages 9 and 10.

OPAB then discussed the safety planning framework, i.e., what to do with the risk assessment information. All eligible clients will receive a safety plan for their unique needs. Facilitators and clients will discuss physiological “warning signs” of distress, like a racing heart. They will then make a plan to resolve the distress using coping strategies, useful distractions like music (you can read a related post on music here), supportive people to contact, and ways to avoid self-harm.

OPAB voted to recommend both frameworks to the OHA, so long as facilitators stay within their scope of practice.

Amount of psilocybin in products and dosage

Before manufacturers can know how much psilocybin to put in products, they will need a standard way to measure it. The Products Subcommittee recommended psilocybin be measured in milligrams. While a standard measurement provides consistency, some board members noted such standardization may be limiting because it is culturally colonial. For instance, some may traditionally measure psilocybin in terms of stems or caps rather than grams.

Nonetheless, OPAB voted to recommend “milligrams” as the measurement standard.

Similarly, before a facilitator knows how much psilocybin a client should have, they need a standard dose. The Products Subcommittee recommended 10 mg doses for extracts and .5 grams for fruiting body and mycelium products. The Research Subcommittee, on the other hand, recommended 25mg doses. The Licensing Subcommittee did not specify a standard dose, but recommended administration sessions should not have a minimum or maximum dose or duration.

OPAB voted to forward the Research Subcommittee and Licensing Subcommittee recommendations to the OHA.

OPAB also discussed microdosing, or sub-hallucinogenic products. Ultimately, the OPAB endorsed the licensing subcommittee’s recommendation that there be no minimum nor maximum dose and that facilitators end administration sessions when appropriate based on the dose, their professional judgment, and how the dose has affected the client. The board decided not to recommend distinguishing between psilocybin products designed for macrodosing versus macrodosing.

Product handling

Mixing psilocybin products with other substances, like alcohol, may cause unpredictable or negative results for the client. Further, if a product is mishandled it could become ineffective or contaminated and should only be handled by those trained to do so. Thus, the Training Subcommittee recommended a rule prohibited facilitators from preparing, handling, or administering the products unless the facilitator is also the service center operator.

Similarly, the Equity Subcommittee recommended rules prohibiting clients or facilitators mixing psilocybin products with homemade food products, alcohol, and prescribed or over-the-counter drugs. However, this does not prohibit all mixing; for instance, clients will be able to mix psilocybin with tea such as tea.

OPAB voted to recommend all of the above measures to the OHA.

Integration sessions

An integration session is a meeting between a client and facilitator to discuss the client’s administration session experience. While most integration sessions will be simple reflection or life coaching, a client’s administration session could unveil repressed memories or cause a vulnerable emotional event. That client may want to discuss childhood trauma or other topics commonly reserved for licensed therapists and psychologists. If a facilitator is not also licensed to provide such services, the facilitator should avoid acting as a mental health therapist, psychologist, counselor, etc.

Thus, the Training Subcommittee recommended facilitators only act within their “scope of practice” according to the required training, and avoid any activities reserved for therapists and psychologists (unless they are licensed as such). If the client wants to discuss topics outside the scope of practice, the facilitator may refer the client to supportive services and other resources.

Next meeting

OPAB will meet again on August 4, 2022. You can attend the meeting via Zoom here.

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Legal Memorandum on Entheogenic Framework https://harris-sliwoski.com/psychlawblog/legal-memorandum-on-entheogenic-framework/ Fri, 01 Jul 2022 14:00:01 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=117450 On May 26, 2022, the Oregon Health Authority (OHA) announced it received a legal memorandum from the Oregon Department of Justice (ODOJ). The legal memorandum (memo) addresses the Oregon Psilocybin Services Program and discussed the Entheogenic Framework. The Entheogenic Framework is a document created by Jon Dennis, an attorney in Oregon. It is a set

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On May 26, 2022, the Oregon Health Authority (OHA) announced it received a legal memorandum from the Oregon Department of Justice (ODOJ). The legal memorandum (memo) addresses the Oregon Psilocybin Services Program and discussed the Entheogenic Framework.

The Entheogenic Framework is a document created by Jon Dennis, an attorney in Oregon. It is a set of measures to reconcile Measure 109, a secular law, with the spiritual and religious traditions of psilocybin. An “entheogenic practitioner” is a person who works with substances in a spiritual or sacred context. The Entheogenic Framework carves out privileges and duties for entheogenic practitioners in the psilocybin industry. The Licensing Subcommittee recommended this document to the Oregon Psilocybin Advisory Board (OPAB), which we covered in a previous post.

At its meeting on May 25, OPAB reviewed the document voted against it. The document was controversial, and board members continue to argue over its applicability. Further, members of the public have voiced their support for the document. Yet, according to the ODOJ the document as written is not legally viable.

What the Memo Says on the Entheogenic Framework

The ODOJ’s memo was a response to several legal questions raised by OHA. It begins by giving short answers to these legal questions, saying OHA cannot exempt entheogenic practitioners from licensure, rules, and OHA’s legal duty to regulate all licensees. We note that the Entheogenic Framework does not mention “exemptions,” nor does it call for entheogenic practitioners to be unregulated. The memo, however, argues the rules in the Entheogenic Framework are less restrictive.

Duties and Privileges

The memo briefly mentions the duties that would be imposed on entheogenic practitioners, stating they would be required to participate in, or donate to, a reciprocal exchange program and report this activity to OHA annually. Further, the Entheogenic Framework limits possible clients. In other words, clients seeking services from entheogenic practitioners would have to be formally affiliated with an entheogenic service center and sign an attestation that they are exploring their religion or spirituality. For a comprehensive review of the duties imposed, read the Entheogenic Framework.

The memo then moves on to the “privileges” in the document, explaining how entheogenic practitioners would not be restricted in dosage amounts or number of administration sessions. Further, they could store, handle and discard psilocybin products based on their beliefs, so long as they are safe, and would not be restricted to one species of psilocybin nor restricted in growing techniques. They could offer fresh mushrooms, would not be required to test products upon OHA request, and could allow clients to lead ceremonies.

Each privilege listed in the memo has a caveat explaining OHA is likely to promulgate rules directly contrary to these privileges.

The Main Conflict: Less Restrictive Rules

The crux of the conflict is Question #3 in the memo:

Can OHA adopt rules with different or less restrictive standards for entheogenic practitioner licensees?

While the question raises two ideas, different rules for entheogenic practitioners and less restrictive rules for entheogenic practitioners, the memo addresses them synonymously.

The memo states that the privileges listed in the Entheogenic Framework are clearly intended to benefit religious practitioners, even though it avoids using the term “religious” to avoid legal scrutiny. The memo states the privileges would provide a more relaxed regulation to religious practitioners, which would not be available to someone with secular beliefs. It further states any clients seeking services from entheogenic practitioners are also limited to those exploring religion or spirituality. The memo explains that benefiting religious practitioners and limiting clients violates OHA’s anti-discrimination rules.

Turning to the Oregon Constitution, the memo states the framework runs afoul of Constitutional protections because “it is impermissible for a statute to draw a distinction between churches a nonchurch religious organizations.” See Newport Church of the Nazarene v. Hensley, 335 Or 1, 10, 56 P3d 386 (2002). This violation, the memo states, arises because the Entheogenic Framework is reserved for religious practitioners and would not extend to practitioners using psilocybin for general wellness or mental health treatment. The memo further states the Entheogenic Framework likely violates the Establishment Clause because it does not have a secular purpose. See Eugene Sand & Gravel v. City of Eugene, 276 Or 1007 (1976).

Finally, the memo addresses the Religious Freedom Restoration Act (RFRA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA). The memo states these federal acts would not compel OHA to treat entheogenic organizations differently than other organizations.

Outlook for the Entheogenic Framework

The memo essentially states the framework is not legally viable for the OHA to incorporate, due primarily to OHA’s anti-discrimination rules as well as Oregon’s Constitution. However, this opinion is based on the Entheogenic Framework as written.

The memo’s disagreement with the current Entheogenic Framework stems from the privileges in the Entheogenic Framework and concludes these are less restrictive rules, which benefit religious practitioners and discriminate against secular practitioners. The duties imposed by the Entheogenic Framework are apparently irrelevant to this analysis.

Further, there is a discrepancy of language between the memo and the Entheogenic Framework. The memo’s apparent basis for its opinion is the Entheogenic Framework intends to benefit “religious” practitioners. Yet, the Entheogenic Framework notedly uses the term “entheogenic” to include “non-religious spiritual communities.” Throughout the memo, “religious” and “spiritual” were used synonymously, drawing no attention to “non-religious spiritual organizations,” likely because it was only mentioned in the framework in a footnote.

A new draft of the Entheogenic Framework could highlight, or expand on, the duties imposed on entheogenic practitioners. It could also propose different rules for entheogenic practitioners, rewriting rules that appear less restrictive. While this would cure the defects discussed in the memo, it is unclear whether these changes would impact the opinion of ODOJ.

Ramifications for the Psilocybin Industry

Currently, there are no OHA rules addressing entheogenic practitioners in the psilocybin industry, and it is unclear whether the ODOJ will change its opinion upon a new draft of the Entheogenic Framework. Yet, the OHA could prompt the ODOJ to differentiate between different and less restrictive rules. OHA could also reach out to more legal experts and academics for ways to include entheogenic practitioners in the psilocybin industry. It should also assess the public’s stance on the matter and evaluate the support for entheogenic practitioners in Oregon.

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Oregon Psilocybin Advisory Board Update: May 25, 2022 Meeting https://harris-sliwoski.com/psychlawblog/oregon-psilocybin-advisory-board-update-may-25-2022-meeting/ Wed, 08 Jun 2022 14:00:47 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=115545 The Oregon Psilocybin Advisory Board (OPAB) was established by Measure 109 and is responsible for making recommendations to the Oregon Health Authority (OHA) for psilocybin services in Oregon. OPAB has met monthly since March of 2021, and the last monthly meeting is set for June 22, 2022. After that, OPAB will meet every two months.

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The Oregon Psilocybin Advisory Board (OPAB) was established by Measure 109 and is responsible for making recommendations to the Oregon Health Authority (OHA) for psilocybin services in Oregon. OPAB has met monthly since March of 2021, and the last monthly meeting is set for June 22, 2022. After that, OPAB will meet every two months. In a typical meeting, board members vote on what recommendations OPAB will make to OHA.

At last meeting on May 25, 2022, OPAB discussed the proposed Entheogenic Framework, group administration sessions, facilitator duties, facilitator code of conduct, the client bill of rights, and  client transportation. Most of the subjects were put to a vote, while others require more discussion.

Additionally, OPAB announced the OHA has adopted the first set of rules for the psilocybin industry, available here.

Entheogenic Framework

As discussed in a previous post, the Entheogenic Framework is a document proposed by Jon Dennis, an Oregon lawyer. The document proposes a framework for entheogenic practitioners to legally engage in the psilocybin industry while respecting religious and spiritual customs. Visit the above mentioned post for further discussion on entheogenic practitioners.

This document was controversial during the OPAB meeting. Some members asked who drafted the document, and called into question the motives of the drafter. Others called into question the connection the document has to Measure 109, claimed it is too complex, or claimed it was a last-minute add-on.

Still, other members stated the document had been reviewed by two different subcommittees months ago. Further, the document need not be accepted in totality, but rather OPAB could vote to accept it in part. The religious/entheogenic aspect of the document need not be its anchor; rather, it could be a “community-based” or “non-profit” based framework. This could simply be an alternative pathway to licensure.

Board members stated there has been constant public support for this framework. Indeed, during the comment period of the meeting members of the public voiced their support for the document. However, a board member pointed out there is no evidence that the majority of the public supports it, rather than a few vocal people who attend the meetings.

OPAB spent 25% of their public discussion time on this topic, but ultimately voted against it. The vote is consistent with the Oregon Department of Justice’s recently published view on the legal quagmire of OHA adopting any lesser standard of licensure or OHA regulation. Further, at the end of the meeting OPAB voted on an alternative, community-based approach. This, too, did not pass.

Group administration sessions

Service centers may offer group sessions, where clients can consume psilocybin along with other clients. This option not only gives people an opportunity to experience psilocybin with loved ones, but also offers a cost-effective solution to low-income clients who cannot afford a one-on-one session. How many facilitators should be required in these groups? Ultimately, OPAB considered the interests of client safety and affordability.

In a setting with a large group of people, if multiple clients begin to have negative experiences, one facilitator may not be enough to help everyone. In August 2021, the licensing subcommittee recommended a three-to-one ratio to OPAB, meaning three clients for every one facilitator. OPAB thus voted to accept the three-to-one ratio as a recommendation to OHA.

OPAB also discussed “sub-perceptual doses,” also known as “microdoses,” and whether the ratio can change based on the decreased risk of small doses. This topic was also controversial, consistent with concept of microdosing more generally under Measure 109. OPAB decided not to recommend a ratio based on sub-perceptual doses. Members stated each person is different, and doses are too personal to ensure it will be sub-perceptual for each person.

Facilitator Duties

Fiduciary duties, generally, are responsibilities one has to act for the benefit of another. For example, a lawyer owes fiduciary duties to a client, a doctor owes fiduciary duties to a patient, and a corporate director owes them to the corporation. Here, OPAB considered the fiduciary duties a facilitator will owe to a psilocybin client.

Last September, the licensing subcommittee recommended fiduciary duties outlined in this document. The three primary fiduciary duties are loyalty, care, and confidentiality, which are common fiduciary duties for lawyers, doctors, corporate directors, and other professions. OPAB voted to accept these duties for facilitators, and will recommend them to OHA.

Facilitator code of conduct

In January 2022, the licensing subcommittee recommended this code of conduct. It includes the fiduciary duties mentioned above, as well as competence, record keeping, advertising and more. Some of these concepts are influenced by other ethical codes, like the code used by MAPS.

There was some discussion over the non-directive requirement during a preparation session. A “non-directive” approach means a facilitator will assist a client in their experience, but will not instruct or actively guide a client. Members were concerned this could not occur during a preparation session, because a facilitator will need to instruct clients to prepare them for the administration session. However, Measure 109 requires facilitators to be non-directive, and this is required to avoid facilitators acting as psychiatrists.

OPAB voted to accept the Facilitator Code of Conduct.

Client bill of rights

This topic was also controversial during the meeting. OPAB discussed the proposed bill of rights, available here, as well as an updated version available here. (See page 27).

Members were concerned about the right to refuse psilocybin services once they have begun. Clients may be distressed or in a state of paranoia during an administration session, and refuse to continue services. However, OPAB noted clients do not have the legal capacity to withdraw consent during an administration session. Thus, clients have the right to refuse services at any time, other than during an administration session.

Most of the discussion on this topic focused on the clients leaving the service center. After a client ingests psilocybin, facilitators must advise the clients to wait to leave the service center until the facilitator deems them “safe” to leave. Further, the client must have transportation arranged to ensure the client does not drive after the administration session. Members expressed concern over keeping clients at a service center, and whether that involves physically restraining them, calling emergency services, or other unwanted measures.

Members noted a difference between refusing services and leaving the service center. Indeed, a client may refuse further services, and wait in the lobby until they are deemed safe to leave. Members compared this to the medical context, where patients must sign a sheet acknowledging they are leaving even though staff has not deemed them safe to leave.

Other than some minor changes to the language, OPAB voted to accept the client bill of rights and will recommend them to OHA.

Client transportation

Both the licensing subcommittee and training subcommittee recommended that clients be required to have a transportation plan. Clients are expected to have another person pick them up from the service center so the client does not operate a motor vehicle. While a client could leave an administration session before it has concluded, facilitators should not advise the client to do so.

OPAB continued its discussion of clients leaving the service center before they are deemed safe to leave. Members agreed that facilitators are not expected to physically restrain clients trying to leave prematurely, and clarified facilitators are merely not allowed to advise clients they may leave before it is safe.

OPAB voted to approve this recommendation.

Next meeting

OPAB will meet again on June 22, 2022. Per Measure 109, OPAB must submit its recommendations to OHA by June 30, 2022. Thus, the next meeting will be the last meeting in the recommendation period. You can attend the meeting via Zoom here.

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Music and Psilocybin Service Centers https://harris-sliwoski.com/psychlawblog/music-and-psilocybin-service-centers/ Thu, 02 Jun 2022 14:00:16 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=115095 Oregon psilocybin service centers will be open for business after the Oregon Health Authority (OHA) finalizes regulations and issues licenses early next year. Psilocybin services will be heavily regulated, and business owners are encouraged to pay close attention to OHA rules. But unexpected issues may arise that are unrelated to OHA. For instance, the legal

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Oregon psilocybin service centers will be open for business after the Oregon Health Authority (OHA) finalizes regulations and issues licenses early next year. Psilocybin services will be heavily regulated, and business owners are encouraged to pay close attention to OHA rules. But unexpected issues may arise that are unrelated to OHA. For instance, the legal issues involved in playing music for psilocybin service clients.

Music is to psilocybin as chocolate is to coffee

A business owner may open a psilocybin service center without ever contemplating “music” as a feature of its services. While music is not necessary for a service center to operate, it may behoove business owners to offer music to psilocybin clients. Indeed, music can enhance a client’s psilocybin experience.

Music has been a component of psychedelic studies since the 1960s. One study from 2018 analyzed the impact music has on a person’s psychedelic experience. Participants in the study consumed psilocybin, listened to a curated playlist of music, and reported their experiences with the music. In general, the music acted as a guide for participants, leading them to different psychological places. The study found that music plays a central role in psychedelic experiences, and the right music creates positive experiences for individuals.

The scientific community is developing playlists specifically aimed at enhancing the positive effects of psychedelics. Indeed, Johns Hopkins University has developed a playlist to cultivate an elevated experience for people who ingest psilocybin. The playlist is meticulously curated, and even correlates to different segments of the session; i.e., when the participant arrives, ingests psilocybin, ascends, peaks, then returns to ordinary consciousness.

The legal issues of music in a psilocybin service center

Unfortunately, a psilocybin service center cannot merely play music for its clients. These service centers are businesses and operate under the same rules as bars and restaurants. The songs belong to the musical artists who created them (or perhaps a third party, if the artists has sold off any of the rights), and copyright law requires businesses to obtain a license and pay royalties for each song before playing it for their customers. This prevents businesses from using music to draw customers, and thus profit from the music, without compensating the creators.

When a restaurant wants to play music for customers, it can work with a performing rights organization (PRO). These organizations can give licenses for millions of songs, charging businesses an annual fee. Under Oregon law, these organizations are known as “performing rights societies” and must adhere to Chapter 647 of the Oregon Revised Statutes. For example, PROs must provide lists of available music and payment rates before they can contract with businesses, and they must submit a copy of their contract forms to the Secretary of State.

Can a psilocybin service center just pay for a streaming service?

There are several considerations for a business using music, but a prominent concern for business owners is the cost of licensing. One frugal option is paying for a business streaming service such as Pandora for Business, which costs $26.95 per month. However, there are limitations to this option. These streaming services only give licenses for background music, and the service contract is violated if the business uses music for activities like dancing.

In the Pandora for Business Terms of Service, the contract provides that the copyright licenses:

“do not cover any music used by You in the following ways: (a) music used by a DJ or VJ or to displace a live orchestra; (b) music used in areas of a Service location where an admission fee or cover charge is charged; (c) music used to accompany dancing (including ballrooms, discotheques and dance studios), bowling, skating or instructed health club classes; or (d) music included in commercial television programming or digital signage.”

(Our emphasis.)

While “psilocybin services” are not contemplated by these streaming contracts, it is clear the intention of the license is for “background” music. If music is used for a type of activity which draws customers, like dancing at a dance club, low-cost streaming is not an option.

Outlook

Music is a prominent asset in psychedelic culture, and will be a sought-after feature of psilocybin administration sessions. Psilocybin service centers will be subject to the same copyright laws as bars and restaurants, and they have similar options for playing music. Service centers could argue the music they play for clients is mere “background” music and under current Terms of Service that argument may hold water. That is, until streaming services will likely alter the language in their contracts.

Considering music is viewed as a central component of a psilocybin experience, psilocybin service centers will profit from using music for clients. PROs will likely seek royalties from these businesses for the copyrighted songs they play. Business owners should look carefully at options for music for their clients, and ensure they are not violating copyright law or contract terms.

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Psilocybin, Synesthesia and Informed Consent https://harris-sliwoski.com/psychlawblog/psilocybin-synesthesia-and-informed-consent/ Wed, 18 May 2022 14:00:57 +0000 https://harris-sliwoski.com/?post_type=psychlawblog&p=113354 Psilocybin, synesthesia and informed consent. What a mashup! When a person can hear the color “blue,” or taste the word “apple,” can that person legally give consent? What if a client requests a facilitator to give a reassuring touch during an administration session, but later sues the facilitator for unwanted physical contact? Oregon is in

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Psilocybin, synesthesia and informed consent. What a mashup!

When a person can hear the color “blue,” or taste the word “apple,” can that person legally give consent? What if a client requests a facilitator to give a reassuring touch during an administration session, but later sues the facilitator for unwanted physical contact?

Oregon is in the process of developing regulations for the psilocybin services industry, and one concept still in development is informed consent. Last fall, the Licensing Subcommittee produced a draft of an informed consent form available here. To provide psilocybin services to a client, the client must give the facilitator informed consent. The client will review and sign an informed consent form prior to the administration session, which is when the client consumes psilocybin.

But what if a client changes their mind during the administration session?

What is informed consent?

Informed consent is an agreement with sufficient knowledge of relevant facts, and is often required for legal services, scientific research and medical treatment. For example, a medical patient must agree to undergo surgery before the procedure can begin. After the patient hears all of the information relevant to the surgery (the risks, benefits, and alternatives), the patient can then give informed consent to the healthcare provider.

One problem that occasionally arises is alcohol intoxication. Informed consent is not legally sufficient if a person lacks the capacity to make an informed decision. While intoxication alone does not diminish capacity, if a person is too intoxicated to understand the risks of a surgery, they cannot legally agree to it. Similarly, if a person agrees to participate in a scientific study, but is too intoxicated to understand what the study entails, that data cannot be used in the study.

Alcohol intoxication impairs cognitive functions, which diminishes capacity to make decisions and thus can bar informed consent. But what about a non-ordinary state of consciousness induced by psilocybin?

Psilocybin and consciousness

A facilitator must obtain informed consent prior to the administration session, but things may change after the session begins. What if a client does not consent to physical contact before consuming psilocybin, but suddenly requests a reassuring touch during the administration session? Does a non-ordinary state of consciousness diminish the client’s capacity? Will a facilitator have to determine capacity during the administration session, similar to emergency responders on the scene?

In the brain, psilocybin affects the claustrum, a collection of neurons and glial cells that connects different parts of the brain. This chemical interaction temporarily alters a person’s consciousness, and people commonly experience a heightened sense of connectivity, complex imagery, and sensory alterations. Further, studies show significant doses of psilocybin induce synesthesia.

Synesthesia is a heightened perception of one’s surroundings, involving connected physical sensations, images, and thoughts. A person experiencing synesthesia can hear a Beatles’ song and see a fractal image appear in the visual field or taste warm soup when they hear the word “home.” Various theories are still developing to explain this and other effects of psychedelics.

Alcohol interferes with a person’s balance, memory, speech, and judgment. Intoxication from alcohol and a non-ordinary state of consciousness from psilocybin are clearly two different cognitive states. But will the law treat both states the same for informed consent purposes?

Outlook

Current research is still analyzing whether psilocybin heightens consciousness entirely, or merely enhances some cognitive activity while dampening others. Nevertheless, informed consent is an increasingly important topic for ethics in psychedelic therapy. In fact, the Multidisciplinary Association for Psychedelic Studies (MAPS) allows for informed consent during a non-ordinary state of consciousness, per their code of ethics.

Psilocybin service businesses could adopt similar policies for informed consent. But until there is more research on the decision-making capabilities of someone who ingests psilocybin, it is unclear whether a court of law would find that person to have legal capacity for consent.

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