The Global Top 200 Psychedelic Lawyers

Policy & Regulation Experts 4th edition 2025

For the past four years we have been publishing a daily column at our website Cannabis Law Report highlighting the latest in regulatory news and information for the world of psychedelics as an increasing number of cities and states in North America take a more enlightened view towards the medical and personal use of psychedelics.

2024 for psychedelics law and regulation was, the not unexpected, take few steps forward and then take a few back.

The rise, though,  in submitted bills, ballots, litigation and discussion mean that if the reality of psychedelics regulation is still some way in the dim distant future the knowledge that accompanies these developments has jumped by leaps and bounds over the last 12 months.

Major Developments In Psychedelics in 2024

Colorado

Colorado has emerged, alongside Oregon, as a pioneer in psychedelic legislation and regulation, following the passage of Proposition 122, also known as the Natural Medicine Health Act, in November 2022.

This groundbreaking law has set the stage for a regulated psychedelic therapy industry in the state, with significant developments unfolding throughout 2024.

Legalisation and Decriminalisation

The Natural Medicine Health Act decriminalised the cultivation and personal use of certain psychedelics for adults over 21.

Specifically, the law removed criminal penalties for growing, processing, storing, using, transporting, obtaining, sharing, and ingesting psilocybin, DMT, ibogaine, and mescaline (excluding peyote).

This marked a significant shift in Colorado’s approach to these substances, placing the state at the forefront of psychedelic reform in the United States.

Regulatory Framework

Healing Centres and Facilitators

A key component of Colorado’s psychedelic legislation is the establishment of “healing centres” where people can legally consume psilocybin under supervision. The state is expected to begin licensing these centres in the coming months, with operations likely to commence by the end of 2024.

The Colorado Department of Regulatory Agencies (DORA) has issued draft rules for licensing facilitators who will administer natural psychedelics for therapeutic purposes. These preliminary requirements include:

• Being 21 years of age or older
• Proof of basic life-support training (e.g., CPR)
• Completion of 190 hours of training programs in natural medicine
• Alternative pathways for individuals with prior experience in natural medicine

Oversight and Regulation

The Natural Medicine Division, a state entity operating under DORA and the Department of Revenue, will oversee healing centres, cultivation facilities, manufacturers, and testing facilities. This division is responsible for supervising the emerging psychedelic therapy industry in Colorado.

Local Zoning and Restrictions

While cities cannot prohibit healing centres entirely, they can impose modest restrictions on their operation 1. For example, Boulder has proposed zoning rules that would:

• Prohibit centres within 1,000 feet of residential areas
• Classify healing centres as medical offices, permitted in business, downtown, and mixed-use zones
• Restrict cultivation facilities to industrial areas of the city

While psilocybin is at the forefront of Colorado’s psychedelic program, the law also provides for potential expansion:

• Psilocybin treatments are expected to be available at licensed healing centres by the end of 2024
• Rules to approve and regulate DMT, ibogaine, and mescaline may come into effect after June 1, 2026

Business Opportunities and Compliance

The legislation has opened up several business opportunities in the psychedelic sector, including:

• Operating healing centres for psychedelic treatments
• Cultivating natural psychedelics for use in healing centres
• Manufacturing products for use in healing centres
• Operating testing facilities for psychedelic products

However we do highlight that businesses must navigate a complex regulatory environment. Compliance with state regulations is crucial, and businesses are advised to seek legal counsel experienced in this emerging industry.

Limitations and Safeguards

Despite the progressive nature of Colorado’s psychedelic legislation, there are important limitations and safeguards in place:

• Retail sales of psilocybin are not allowed
• Psychedelic therapy will not be offered to individuals under the age of 21
• Licensed healthcare and counselling facilities may not administer psychedelics while anyone under 21 is on the premises
• Labeling must be clear, free of manipulative branding, and indicate dosage, harvest date, and strain type

2024 Legislative Developments

In April 2024, a new bill (Senate Bill 24-198) was introduced to further refine the regulatory framework. This bill proposes to:

• Authorise the approval of facilitator education and training programs
• Update rules related to laboratory testing and certification of natural medicine products
• Limit individuals to financial interests in no more than five natural medicine business licenses
• Clarify authorised transfers and distributions between licensed entities

Conclusion

Colorado’s psychedelic legislation and regulatory rules in 2024 represent a bold step towards integrating psychedelic therapies into mainstream healthcare.

As the state navigates this uncharted territory, it is balancing the potential therapeutic benefits of these substances with the need for careful regulation and public safety measures. The coming months and years will be crucial in shaping the future of psychedelic therapy in Colorado and potentially influencing similar initiatives across the United States.

Oregon

Oregon’s pioneering approach to psychedelic regulation continued to evolve in 2024, with significant developments in the state’s psilocybin services program and broader drug policy landscape.

Here’s a quick summary of the key updates

Psilocybin Services Program

Growth and Expansion

2024 marked the first full year of Oregon’s regulated psilocybin services program.

By the end of the year, approximately 8,000 clients had undergone psilocybin sessions, surpassing the number of participants in all previous clinical trials combined.

This substantial increase in access provided a wealth of data for researchers and policymakers to evaluate the program’s impact.

Service Centres and Facilitators

The number of licensed psilocybin service centres grew to 31, primarily concentrated along Interstate 5.

Concurrently, 356 psilocybin facilitators received state licensure, indicating a robust workforce to meet the growing demand for these services .

Research Initiatives

To address concerns about the lack of evidence cited by some jurisdictions that banned psilocybin services, the Open Psychedelic Evaluation Nexus at Oregon Health & Science University launched a comprehensive study. This research aims to follow clients for up to a year post-therapy, with preliminary results expected in early 2025.

Legislative and Regulatory Updates

Psilocybin Program Improvement Bill

Advocates proposed a “Psilocybin Program Improvement Bill” for the 2025 legislative session.

Key provisions include:

1. Legal protections for licensed healthcare providers discussing psilocybin services with clients
2. A “dual licensure” provision allowing healthcare providers who are also licensed psilocybin facilitators to participate in both preparation and integration sessions

Rule Changes

The Oregon Health Authority adopted new rules for the psilocybin services program, set to take effect on January 1, 2025. These changes aim to refine the program but may increase operational costs for licensees.

. Notable updates include:

1. Clarification on training program requirements, emphasising the need for Higher Education Coordinating Commission licensing or exemption
2. Redefinition of “nondirective facilitation” to ensure client autonomy in decision-making while allowing facilitators to provide resources and safety support
3. Revised adverse event reporting requirements, focusing on incidents requiring medical intervention

Data Reporting and Client Records

New regulations implemented stricter requirements for data reporting and maintaining client records, aiming to improve program oversight and facilitate research.

Challenges and Controversies

Oregon’s Drug Policy Recriminalization Impact On Psychedelics

In response to concerns about public drug use and overdoses, Oregon passed House Bill 4002, which recriminalized personal possession and use of various substances, including psilocybin.

This legislation marked a significant shift from the state’s previous decriminalization efforts.

Impact on Psychedelic Access

While the bill does not affect the regulated psilocybin services program (Measure 109), it effectively eliminates the decriminalized status of personal psilocybin use outside of licensed facilities. This change has raised concerns among advocates for more accessible and diverse psychedelic experiences.

Local Bans

Despite the state-level program, many local jurisdictions in Oregon voted to ban psilocybin services in their areas.

In the November 2024 election, voters in 16 out of 17 jurisdictions approved such bans, highlighting ongoing resistance to psychedelic services in some communities.

Emerging Trends and Proposals

Microdosing Advocacy

The Microdosing Collective, founded in 2023, led efforts to establish a legal framework for microdosing psychedelics as wellness supplements. Their proposals for 2024 rule changes included:

1. Flexible session duration requirements, with shorter minimum observation periods for initial sessions and no mandatory minimum for subsequent sessions
2. Revised transportation guidelines to remove barriers for clients using microdosing protocols

Federal-State Dynamics

While Oregon has taken the lead in psychedelic regulation, the federal status of these substances remains unchanged. The State explicitly states that their laws do not exempt individuals from federal law or enforcement.

The federal government’s response to these state-level initiatives remains a subject of interest and potential concern for stakeholders in the psychedelic space.

Looking Ahead

As Oregon’s psilocybin services program matures, several key areas will shape its future:

1. Research Outcomes: The results of ongoing studies, particularly those from the Open Psychedelic Evaluation Nexus, will likely influence future policy decisions and public perception
2. Legislative Refinements: The proposed Psilocybin Program Improvement Bill and other potential legislative changes will continue to shape the regulatory landscape
3. Access and Affordability: Balancing regulated access with affordability remains a challenge, as current session costs ranging anything from $1,000 to $3,000
4. Local Implementation: The success of the program in jurisdictions that have not banned services will be crucial for potential expansion to other areas
5. Integration with Healthcare: The proposed dual licensure provision could pave the way for better integration of psilocybin services with traditional healthcare

Oregon’s pioneering efforts in psychedelic regulation continue to provide valuable insights for other states considering similar measures.

As the program evolves, it will likely face ongoing challenges in balancing public health concerns, therapeutic potential, and diverse perspectives on psychedelic use. The coming years will be critical in determining the long-term viability and impact of this groundbreaking approach to psychedelic regulation.

Here is a list of cities, counties, and states in the USA where psychedelics have been decriminalised as of late 2024

States

• Oregon: Decriminalised small amounts of all psychedelics for personal use
• Colorado: Decriminalised possession and use of small amounts of natural psychedelic substances for those 21 and over

Cities and Counties

California

• Arcata
• Berkeley
• Eureka
• Oakland
• San Francisco
• Santa Cruz

Colorado

• Denver

District of Columbia

• Washington D.C.

Maine

• Portland

Massachusetts

• Cambridge
• Easthampton
• Medford
• Northampton
• Salem
• Somerville

Michigan

• Ann Arbor
• Detroit
• Ferndale
• Hazel Park
• Washtenaw County

Minnesota

• Minneapolis

Washington

• Olympia
• Port Townsend
• Seattle

It’s important to note that while these locations have decriminalised psychedelics, psychedelic compounds remain illegal under US federal law.

Decriminalisation typically means that law enforcement has deprioritised enforcement of prohibition, but the substances are still technically illegal.

The specific substances decriminalised and the extent of decriminalisation may vary by location.

The Lykos Hearings

If there was one event in 2024 that determined the speed at which psychedelics would be approved, legalised and regulated in the US it was Lykos presenting their MDMA-assisted therapy for post-traumatic stress disorder (PTSD) to the FDA in June. All industry watchers will be aware of the FDA’s decision.

Here’s a short summary that outlines the what, why and wherefores.

Lykos Therapeutics quest to bring a novel MDMA-assisted therapy for post-traumatic stress disorder (PTSD) to market involved several key events and decisions by the U.S. Food and Drug Administration (FDA) throughout 2024.

FDA Advisory Committee Meeting

On June 4, 2024, the FDA’s Psychopharmacologic Drugs Advisory Committee convened to evaluate Lykos’ MDMA-assisted therapy for PTSD.

The committee voted overwhelmingly against recommending the treatment, with a 10-1 decision.

This vote was based on several FDA concerns:

1. Functional Unblinding: Committee members were worried about potential selection bias and functional unblinding in the clinical trials. Participants could often tell whether they had received the active drug or a placebo, which could have influenced the results.
2. Safety Concerns: The FDA staff questioned the strength of Lykos’ data and raised concerns about potential risks to cardiovascular and liver health. They also noted a lack of sufficient data collection on adverse events associated with MDMA abuse.
3. Efficacy and Durability: There were concerns about the sufficiency of clinical data to demonstrate the treatment’s effectiveness and long-term benefits.
4. Therapist Misconduct: A 2015 phase 2 trial incident involving therapist misconduct was brought up, raising questions about ethical practices and participant safety.

Lykos’ Responded thus

Following the advisory committee meeting, Lykos released a statement addressing the concerns raised.

1. They acknowledged the challenge of blinding in psychiatric treatments with psychoactive effects but emphasised that the trial design was extensively discussed with the FDA during the 2017 Special Protocol Assessment process.
2. Lykos pledged to work further with the FDA to evaluate existing data or collect new data to address potential cardiovascular and hepatotoxicity risks.
3. Regarding the therapist misconduct incident, Lykos assured that they had reported the violation to relevant authorities and implemented new policies to prevent similar occurrences.
4. The company expressed confidence in their data, stating that it provided sufficient evidence of efficacy and durability in line with FDA guidance.

FDA Decision

On August 9, 2024, the FDA issued a Complete Response Letter (CRL) for Lykos’ New Drug Application (NDA) for midomafetamine capsules.

The key points of the FDA’s decision were as follows:

1. Rejection: The FDA determined that the NDA could not be approved based on the data submitted.
2. Additional Study Required: The agency requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of the treatment.
3. Echoed Concerns: The issues expressed in the CRL mirrored those raised during the FDA Advisory Committee meeting.

Lykos’ Next Steps

Following the FDA’s decision, Lykos outlined its plans to move forward:

1. Reconsideration Request: The company planned to request a meeting with the FDA to ask for reconsideration of the decision and to discuss the agency’s recommendations for a new submission.
2. Data Utilisation: Lykos claimed it could answer many of the FDA’s outstanding questions with existing data.
3. Regulatory Pathways: The company stated its intention to pursue all available regulatory pathways to bring the treatment to market expeditiously.

Recent Developments

On October 21, 2024, Lykos announced a “productive” meeting with the FDA:

1. New Leadership: The meeting was led by new interim CEO Michael Mullette and new Chief Medical Officer David Hough.
2. Path Forward: The company reported that the meeting resulted in a path forward, including an additional Phase III trial and a potential third-party review of prior Phase III data.

Broader Context

This case highlights several important aspects of drug development and approval:

1. Novel Treatments: The challenges of evaluating and approving novel treatments, especially those involving psychoactive substances, are evident in this process.
2. Blinding Challenges: The difficulty of maintaining proper blinding in trials involving psychoactive substances is a significant hurdle for researchers and regulators.
3. Safety Concerns: The FDA’s focus on comprehensive safety data, including long-term effects and abuse potential, is clear.
4. Stakeholder Involvement: The process involved various stakeholders, including patients (particularly veterans), lawmakers, and advocacy groups, demonstrating the complex landscape of drug approval.
5. Regulatory Flexibility: The FDA’s willingness to meet with Lykos after the initial rejection shows some flexibility in the regulatory process.

Conclusion

The outcome of this case may set important precedents for future psychedelic therapy approvals and highlights the complex balance between innovation, safety, and regulatory rigour in addressing critical mental health needs like PTSD.

The Failure of the Massachusetts Ballot November 2024

The November 2024 election saw a notable setback for the psychedelic legalisation movement with Massachusetts voters rejecting a ballot measure that would have legalised certain natural psychedelic substances.

The Massachusetts Ballot Initiative

Question 4 in Massachusetts proposed a two-pronged approach to legalising psychedelics:

1. It would have authorised a system of psychedelic therapy centres where clients could purchase and use substances like psilocybin, DMT, ibogaine, and mescaline under supervision.
2. It would have allowed residents to grow, share, and use these plants at home, provided they did not advertise or sell them.

The measure was defeated with 57% voting against and 43% in favour, based on 73% of ballots counted.

This outcome prevents the question from appearing on the ballot again until at least 2028, as state law prohibits the same question from being presented in consecutive election cycles.

Reasons for Failure

1. Concerns about home cultivation: The Yes on 4 campaign acknowledged that worries about the home grow provisions likely influenced the result.
2. Health risks: Opponents warned about potential unintended health consequences, especially for unsupervised home use.
3. Cost barriers: Critics argued that the high cost of treatment at regulated psychedelic therapy centres would limit access.
4. Conservative shift: The 2024 election saw a general trend towards conservatism, which may have influenced voters’ decisions on drug policy.

Possible Implications and Future Outlook

The failure of the Massachusetts ballot initiative represents a significant setback for psychedelic reform advocates . It leaves Oregon and Colorado as the only states with legalised psychedelic programs at the state level.

The Yes on 4 campaign have expressed their intention to continue advocating for access to psychedelic therapies and to work with legislators in the upcoming session.

However, the ballot measure’s failure may impact the momentum of similar initiatives in other states. It demonstrates that even in traditionally progressive states like Massachusetts, there is still significant resistance to psychedelic legalisation.

Legislative Efforts

Prior to the ballot initiative, several legislative efforts to decriminalise psychedelic plants in Massachusetts gained little traction. Bills introduced by both Republican and Democratic lawmakers were sent to dead-end study orders.

The failure of the ballot measure suggests that these legislative efforts are unlikely to progress significantly in the near future.

In conclusion, the rejection of the psychedelic legalisation measure in Massachusetts marks a significant moment in the ongoing debate over drug policy reform in the United States.

While advocates for psychedelic therapies continue to point to potential benefits for mental health treatment, the 2024 election results indicate that many voters remain cautious about broadening access to psychedelics.

In 2025, a limited number of regulatory developments are expected to further shape, if rather slowly, the global landscape of psychedelics.

1. The Drug Enforcement Administration (DEA) in the US will increase the production quota for DMT to 20,000 grams.
2. 2025, supporting research and development of FDA-approved psychedelic drugs.
3. Australia is implementing a new framework for regulating medicinal use of psychedelic substances like MDMA and psilocybin, potentially leading to broader access in 2025.
4. Canada’s Special Access Program (SAP) may continue to provide limited access to certain psychedelics for serious.
5. medical conditions, though it remains restricted.

While these developments signal a growing acceptance of psychedelics in therapeutic contexts, it’s important to note that most psychedelic substances remain illegal at the federal level in many countries, including the United States.

The regulatory landscape continues to evolve, with a focus on balancing potential therapeutic benefits with safety concerns and existing drug control treaties.

Who Are The Powerhouse Law Firms Practicing in the field?

Canada

• Aird Berlis

UK

• Mackrell

USA

• Husch Blackwell
• Emerge Law
• Antithesis
• Vicente Sederberg
• Perkins Coie
• Calyx – Intellectual Property Experts
• Harris Sliwoski
• Gleam
• Law Offices of Omar Figueroa.
• Zuber Lawler

Although we don’t really subscribe to the star lawyer narrative a special mention must go to Matt Zorn in 2024 whose sleep patterns must be severely in flux after a year which included the following.

• Zorn was involved in a case against the DEA regarding access to psilocybin-assisted therapy under federal Right to Try laws.
• He participated in a lawsuit alleging the DEA’s “abuse and unlawful diversion of legitimate Freedom of Information Act requests”
• Zorn contributed to a successful challenge against the DEA’s plan to schedule five tryptamines
• He was part of the legal team in the Iowaska Church of Healing v. Werfel case, which dealt with religious use of Ayahuasca and tax-exempt status.

Solo Practitioners

Psychedelic law is also a field full of strong solo practitioners specialising in a wide range of practice areas from IP, to entheogen-based religious institutions and M&A, healthcare, just to name a few.

In Europe not much has really changed over the past 12 months and once again we would give a mention to Elliott Rolfe @ Mackrell Solicitors in the UK and in Portugal Joao Taborda da Gama at Gama Gloria.

Unfortunately, just as we noted last year , Australia & NZ are distinctly lacking in lawyers with a skill base or desire to understand the topic and yet again we can’t make any relevant recommendations.

Solo Practitioners We Recommend

Allison Hoots
Paula Amy Hewitt
George Lake
Rod Kight
Courtney Moran
Andrew De Reese
Robert T Rush
Sean McAllister

Don’t Forget That This Directory Also Recommends Experts Who Can Advise On Policy & Provide Expert Witness Testimony, advise on litigation etc.

If you have any questions about experts in specific fields do get in touch and we are only too happy to try and point you in the right direction.

Although we have some MAPS employees fellows listed in the directory they aren’t your only source for great information, there are plenty of other great and relevant bodies and organisations.

Questions to [email protected]

The USA based  Psychedelic Bar Association continues to build its membership and they’ve just started publishing a blog with articles relating to psychedelics and the law.

Media

We recommend:

Psychedelic Alpha (UK) for Business & Markets.
DoubleBlind for everything else.

We hope you find this our 4th edition of The Global Top 200 Psychedelic Lawyers, Policy & Regulation Experts a worthwhile read and resource tool.

Please do get in touch with us with any questions, comments or thoughts for the next edition.

Sean Hocking – Editor
The Global Top 200 Psychedelic Lawyers, Policy & Regulation Experts 2025

Contact Sean Hocking