LEGISLATIVE WRAP UP – Summer 2024

The first half of 2024 has been riveting for a few reasons. By now, Oregon’s regulated access program has been in effect for eighteen months, with thousands of people having received psilocybin services; a rulemaking process is well underway in Colorado while the state simultaneously adjusts to decriminalization of multiple sacred plants; and technical lessons learned from past policy efforts – successful or not – are beginning to be implemented in new proposals across the country. 

While many watch the rollercoaster leading up to FDA’s decision about Lykos’ application seeking approval of MDMA-assisted therapy, advancements quietly continue in the background – state-regulated psychedelic programs are being designed and implemented, and novel approaches to decriminalization, community use, and therapeutic access continue to emerge.

We applaud the continued forward momentum of this spring psychedelic legislative season, and are proud to have provided advisory input or testimony for bills, committees, proposals, and task forces across the country in states including Connecticut, Minnesota, and Hawaii. We’ve also been excited to see interest from and engage with formal bodies around the world, from Mexico to Chile to Ukraine to the United Arab Emirates. These political and public health efforts are being proposed and considered by a variety of organizations with diverse strategic approaches, social goals, and community relationships.  We applaud the commitment of these small groups of engaged citizens that drive these advancements.

Here we’ll share some state-focused trends and case studies to offer some of our own thinking about how different policy approaches fit within the larger United States ecosystem. Here we’ll comment on a voter initiative in Massachusetts, a fresh proposal in New York, a sleeper development out of Utah, and an open-sourced voter initiative in Washington. 

Notable Bills:

MASSACHUSETTS

Our colleagues at New Approach have drafted and introduced House Bill 4255 in Massachusetts, which would create regulated access to “natural psychedelic substances” including psilocybin, DMT, ibogaine, and mescaline excluding peyote) for adults 21 and older, while also decriminalizing limited personal adult use. The legislature has taken no action on the measure, so the campaign is currently collecting a second round of ~13,000 valid signatures to qualify for the November ballot.

This bill’s regulated framework would issue licenses for psychedelic therapy centers, facilitators, cultivation, processing, sales, and testing. Licensed natural psychedelic substance facilitators would administer the regulated substances at licensed psychedelic therapy centers (not unlike Oregon, which also licenses locations for use). Group use is explicitly permitted by this bill, and preparation and integration sessions are also included in the regulated scheme. Notably this bill, like some others that have been introduced in the last few years, would exclude synthetics or synthetic analogs of any of these substances. 

The regulated program would establish a state-appointed commission to oversee the program. Notably, this bill imposes a 15% state excise tax upon the sale of natural psychedelic substances to anyone other than a natural psychedelic substance licensee, presumably to incentivize participation in the regulated program, one question we know that has come up in the state of Colorado as it also navigates the creation and maintenance of parallel regulated and decriminalized schemes. 

We’re glad to see that in addition to this regulated program, this bill would also allow adults 21 and older to cultivate these substances in a 12’ by 12’ area at their home, and also use these substances at their home. In addition to whatever they might grow at their home, adults may possess threshold “personal use” amounts: 1g psilocybin, 1g psilocyn, 1g DMT, 18g mescaline, 30g ibogaine – and to give away up to that personal amount to another adult that is 21 and older.

The issue of local control came up in Oregon, and we anticipate it with this bill too – under HB4255, cities and towns may adopt or enact ordinances or by-laws that reasonably restrict facilities, and impose lesser criminal or civil penalties related to the substances if they wish.

NEW YORK

New York Assembly Bill A10375, introduced on May 21, 2024 and backed by New Yorkers for Mental Health Alternatives (NYMHA), proposes the legalization of psilocybin. Like other bills introduced across the country, the bill aims to establish a state-regulated framework for the safe and controlled use of psilocybin-containing mushrooms by adults, primarily for therapeutic purposes; however unlike most other state-regulated approaches, this bill proposes a personal use permit that individuals have to acquire by completing an educational process. 

Under this policy, adults 18 and older would be able to acquire a permit that would allow them to legally personally use psilocybin, contingent on completing a health screening and an educational course (not to exceed five hours). The permit holder may then either purchase up to two ounces of dried fungi from a licensed cultivator, cultivate mushrooms themselves, or receive them as a non-commercial gift from another permit holder. The bill establishes an additional certification process for support service providers, who may offer risk reduction and support services to people who hold permits, but does not extend licensure authority to those service providers to provide therapy, coaching, or treatment in connection to the use of psilocybin. This policy thoughtfully sets some parameters for cost, timing, and curriculum for the educational course for personal use permit holders, as well as the training program for support service providers, and attempts to explicitly delineate different kinds of services to enhance consumer protection. 

The New York Department of Health would oversee this entire program, including the issuance of permits, regulation of cultivation, and evaluation of the program’s effectiveness. Certain rulemaking authority is granted to the department, including whether to promulgate rules for a dispensary model. If passed, the department would be required to report every two years to the governor and legislature on the status and impact of the regulated psilocybin program, including health and experience data from permit holders (in other words – some data would have to be collected to report outcomes). An advisory board within the department would provide ongoing advice to the department regarding adaptations to the program, and recommendations based on the latest research.

A10375 would pass an income tax on support service providers receiving remuneration for their services, as well as on the psilocybin-containing mushrooms that cultivators may sell. These fees will support costs the department may incur for administering the program, as well to further public education. Given the difficulty in securing state funds for educational or harm reduction programs thus far, we’re cautiously optimistic that prioritizing the funding of educational programs will result in better public health outcomes across the board, whether or not someone chooses to work within the regulated system. Whether or not that tax is sufficient to float the program as a whole remains to be seen. 

UTAH

Passed by the state legislature,  SB 0266 creates a pilot program for hospitals to administer psilocybin and MDMA as an alternative treatment option for adults 18 and older. This bill was signed for filing on 03/21/2024. 

What makes Utah’s legislation unique – and perhaps limited in its likelihood of implementation –  is that it effectively positions one hospital group (Intermountain Health) and one university (University of Utah) to conduct these treatments. Significant elements of a prospective program, like facilitator training and product sourcing, are not directly mentioned by this bill. However, the bill uses language that isn’t totally clear, but may imply that it could source either substance from a source other than an FDA-approved – or even FDA-regulated – one: “any form of psilocybin or methylenedioxymethamphetamine that is in federal Food and Drug Administration Phase 3 testing for an investigational drug.” Notably, this bill also allows access for adults 18 or older (instead of 21 and older like some other bills).

WASHINGTON

Responsible Entheogen Access & Community Healing Coalition (REACH) Washington,  an advocacy organization made up of drug policy activists, community leaders, and experts in the field, came together to draft a collaborative voter initiative, The Natural Psychedelics and Supportive Services Act, aiming for the 2025 legislative season. Like some other bills and initiatives we’ve supported, it specifically decriminalizes the noncommercial cultivation and distribution, making it lawful for adults 21+ to possess, use, cultivate, prepare, gift, or transfer certain entheogenic plants without compensation.

The entheogenic substances decriminalized by REACH’s initiative include the following substances, in any form: psilocybin, psilocin, DMT, 5-MeO-DMT, and mescaline (excluding peyote cactus). Notably, the decriminalization only applies to these substances if they are derived from a plant or fungal source, and do not include versions of these substances that are created by means of chemical synthesis, or that are obtained from animal sources.

This initiative also provides for compensated supportive services in which a facilitator administers and a participant consumes entheogenic plants. These services are limited, and do not extend to consumption in a “public place,” meaning that this protection might preclude use by individuals in parks, beaches, festivals, etc. This could practically limit (or at least limit some risks related to) non-facilitated personal use, or facilitated 1-on-1 or group experiences by restricting location less than states like Oregon that require licensed locations, but more than what might otherwise be interpreted by skeptical voters as a free-for-all. 

This bill includes the most comprehensive and proactive guidelines for ethical provision of supportive services we’ve seen so far, including the establishment of an Entheogenic Community Resources Advisory Council to develop non-binding guidance for support service providers. This novel approach, which stands out as a community organization-appointed oversight committee rather than something with state-designated authority, attempts to thread a complex needle of oversight and accountability.

In Conclusion:

In closing, we’d like to comment on a few themes and points that emerge across these bills and others in the field. 

First, we recognize the challenge of decriminalizing anything at all –  it hasn’t yet happened through a state legislature for anything besides cannabis – and recognize the particular difficulties of specifically decriminalizing synthetic substances. Because lab manufacture – an inherently risky activity that is necessary for some extraction or synthesis processes – can be challenging to regulate, a higher-touch scheme might be necessary.  However, for both regulatory and ecological reasons, we support the inclusion of synthetic substances in decriminalization or regulated access schemes, and look forward to continuing to support education about how the stigma against synthetic substances in fact undermines rational approaches to public safety and ironically increases risk. Of course, this needs to be balanced with cultural and economic considerations that may take more time to reveal themselves but are equally important. 

While we acknowledge and applaud the significant progress demonstrated in states like Oregon and Colorado, we also recognize that tightly regulated state systems – or pharmaceutical medical use, for that matter – may not capture the myriad ways people engage with psychedelic substances. Given that reality, we appreciate how the new wave of psychedelic legislation proposals are considering a variety of approaches to better capture that range, including how to incorporate decriminalization for personal use, explore options for non-commercial sharing among friends or community, and create safety guardrails like education or crisis response training for the many people who don’t yet – or may simply not want to – fit into a box. 

As important as the substance of the proposals themselves are the ways people organize to advocate for change and to navigate the complex multi-stakeholder ecosystem we are all working within. We specifically named the organizations and not the sponsors of the aforementioned bills in part to bring attention to the fact that while political progress is encouraging, we are encouraged to see politicians across the US pay more attention to this issue and take it more seriously, it continues to be small groups of committed people from across multiple spectrums that make these advancements possible.

We continue to be proud to work alongside such committed advocates as more people learn about this important work. Things are moving fast out there, and we’re not sure exactly where we’re going – but we are sure that wherever it is, it will be better if we figure it out together.

2024 Legislative Notes:

Psychedelic Bills that Passed First Committee
  • AK – HB 228/SB 166 – task force – awaiting transmittal to governor (05/10/2024)
  • AZ – HB2015 – psilocybin research – voted to pass (01/22/2024)
  • AZ – SB 1570 – psilocybin services; regulation & licensure, and creates advisory board – passed HHS committee 03/11/2024
  • AZ – HB 2274/SB 1677 – covers MDMA treatment for firefighters & peace officers – voted to pass (04/10/2024)
  • CA – AB 941 – to convene a workgroup to establish framework for PAT by Jan. 2026 – referred to committee on health (05/01/2024)
  • CA – SB 1012 – Psychedelic Facilitators Act – placed on suspense file 05/13/2024
  • HI – HB 2630 – advisory council to review MDMA/psilocybin treatments – crossed over (02/16/2024)
  • MD – HB548 – task force on responsible use of natural psychedelic substances to report findings by July 2025 – passed (04/4/2024)
  • ME – LD 1914 – provides a regulatory framework for providing psilocybin products to adults 21+  – passed (04/3/2024)
  • MO – HB 1830 – outlines conditions under which a person, specifically a veteran, may acquire, use, produce, transfer or administer psilocybin for therapeutic use – voted to pass (04/15/2024)
  • NH – B 1692 – qualifying caregiver working through non-profit entities to administer to qualifying patients psilocybin, LSD, or mescaline –  refer for interim study (02/15/2024)
  • NM – SM 12 – study psilocybin for therapeutic treatments & establish a regulated program – passed (02/14/2024)
  • WA – SB 5263 – establishes work group to provide recommendations for the provision of psilocybin therapeutic services – partially passed 05/09/2023 (sections 1, 2, 3, 4, 5, 7, 10, 11, and 13 were vetoed by the governor)
Bills Introduced in 2024 that include MDMA
  • Arizona – AZ HB2274/SB 1677
    • The bill proposes the amendment of AZ’s workers compensation laws to provide coverage for firefighters and peace officers diagnosed with PTSD; coverage includes MDMA-assisted therapy. The bill lays out regulations for certification and licensing of the healthcare providers authorized to prescribe this treatment. To take effect upon FDA approval.
    • Last action: Senate minority caucus recommends “Do Pass”, 04/10/2024
  • CA – CA SB 1012 – The Regulated Psychedelic Facilitators Act and the Regulated Psychedelic-Assisted Therapy Act
    • Last action: Placed on suspense file 05/13/2024
  • Hawaii – SB 1531 – Relates to Mental Health
    • Requires the Director of Health to establish a Temporary Breakthrough Designation Advisory Council within 3 months of certain breakthrough therapy designation approvals by the US FDA
    • Last action: Dead as of 05/03/2024
  • Massachusetts
    • HB 3574 – An Act Concerning the Use of a Prescription Medicine that contains MDMA
      • Any person or entity registered to prescribe, manufacture, distribute, dispense, or provide services related to MDMA shall not charge more than $5k per MDMA treatment service unit. To take effect upon FDA approval.
      • Last action: Public Health committee hearing 06/06/2023
    • S 1439 – An Act to Conduct a Public Health study of Synthetic Drugs in the Commonwealth
      • Dept of Public Health to conduct a comprehensive study on synthetic drugs, as well as their use, effects, prevalence, and health implications (includes MDMA and synthetic psychedelics).
      • Last action: Accompanied a study order, 02/15/2024
  • Minnesota – HF 1884/SF 1954 – Psychedelic medicine task force established, and report required
    • Last action: In committee 02/16/2023
  • North Carolina – H727 – Breakthrough Therapies Research/Advisory Act
    • Establishes a grant pilot program and advisory board for breakthrough therapies (drugs granted expedited approval by the FDA); eligible projects are those focused on the use of MDMA and psilocybin for the treatment of PTSD and anxiety disorder respectively.
    • Last action: re-ref com on appropriations, 05/15/2023
  • New York
    • SB 3520 – Relates to medical use of psilocybin; establishes a psilocybin therapy grant program; makes an appropriation therefor.
    • Last action: in first committee, 03/07/2023
  • South Carolina – S 0277 – Sentencing Reform
    • Increased criminalized threshold amount of MDMA from fifteen tablets/capsules to four grams.
    • Last action: Dead as of 02/09/2023