Fuente: Prohibición Partners Lugar: General Report Contents
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Introduction →
Definitions And Scope →
Executive Summary →
Key Trends →

Market Value →
Legislation and Regulation →
Consumer Attitudes →
Healthcare Providers’ Attitudes →

Spotlight On Health →
Psychedelics – Timeline of Key Developments →
Countries to Watch →
Psychedelic Profiles →

Key Psychedelics Deep Dive →
Other Psychedelics of Note →
Psychedelics as Medicine: Potential Therapies →
Psychedelics and Technology →

Psychedelics Per Country →
Psychedelics and The Law →
Patents and Intellectual Property →
Therapy Practitioners →

Psychedelic Research →
Glossary →


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Key Takeaways



For more than 50 years, psychedelic substances have been subject to some of the most restrictive drug control laws in the world. These classifications effectively halted research into their therapeutic potential for decades. However, mounting clinical evidence demonstrating safety and efficacy—particularly in mental health treatment—has begun to drive meaningful legal and regulatory change.



Over the past two years, psychedelics have been decriminalised in multiple US cities, while several US states have introduced active legislation that either lowers enforcement priority or establishes regulated frameworks for therapeutic use. Oregon currently leads this shift, having created the first legal framework for state-licensed psilocybin-assisted therapy.



The War on Drugs and the Global Scheduling of Psychedelics (1971–1985)



In 2021, the United States marked the 50th anniversary of President Richard Nixon’s “war on drugs” speech, delivered against the backdrop of increasing recreational drug use within 1960s counterculture movements. This political moment directly influenced international drug policy.



In response, the United Nations introduced the Convention on Psychotropic Substances in 1971, placing a wide range of psychoactive compounds—including common tryptamines—under strict international control. These measures effectively abandoned most research into the therapeutic potential of psychedelic medicines.



MDMA was initially excluded from early scheduling, although its close analogue MDA was classified. Following anecdotal reports of MDMA’s effects in psychiatric settings, chemist Alexander Shulgin—who first synthesised MDMA in 1965—began exploring its clinical use in the late 1970s. In 1978, he described MDMA as producing an “easily controlled altered state of consciousness,” suggesting medical potential.



Despite this promise, the US Drug Enforcement Administration imposed an emergency ban on MDMA in 1985, adding it to the Controlled Substances Act alongside LSD and psilocybin. This decision effectively halted all patient-based research, although early findings would later underpin the modern resurgence of psychedelic medicine.



The Resurgence of Psychedelic Research (2000–2011)



At the turn of the century, researchers began re-examining MDMA’s potential role in treating mental health disorders. In 2000, the first modern clinical trial of MDMA-assisted psychotherapy launched in Spain. Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the trial aimed to investigate MDMA’s use in psychiatric treatment but was closed prematurely in 2002, with only four patients completing the protocol.



Despite limited data, MAPS continued to advocate for MDMA-assisted psychotherapy, particularly for treatment-resistant post-traumatic stress disorder (PTSD). This sustained effort led to a significant regulatory milestone in 2004, when the US Food and Drug Administration (FDA) approved two MAPS-sponsored clinical trials investigating MDMA-assisted psychotherapy for PTSD.



The results, published in 2011, demonstrated sustained therapeutic benefits with no evidence of subsequent drug abuse or neurocognitive decline among participants. This research validated both the safety and efficacy of MDMA-assisted therapy and laid the groundwork for renewed interest in psychedelic medicines more broadly.



From Clinical Evidence to Regulatory Momentum (2017–Present)



The regulatory reassessment of MDMA paved the way for renewed interest in other psychedelics, particularly psilocybin. An open-label study examining psilocybin-assisted therapy for smoking cessation demonstrated outcomes superior to existing treatments, drawing attention from regulators and drug developers alike.



In 2017, the FDA granted Breakthrough Therapy designation to MDMA-assisted psychotherapy for PTSD, recognising its potential advantage over available treatments. One year later, COMPASS Pathways received the same designation for its proprietary psilocybin formulation, COMP360, marking a pivotal shift in US drug policy.



These regulatory signals coincided with growing public support and a wave of state-level reform. In 2019, Denver and Oakland became the first US cities to decriminalise psychedelic substances, followed by Santa Cruz, Washington D.C., and Ann Arbor in 2020.



In November 2020, Oregon voters approved Measure 109—the Oregon Psilocybin Services Act—making Oregon the first US state to legalise and regulate psilocybin-assisted therapy. Under this framework, the Oregon Health Authority is responsible for licensing and oversight, with services expected to begin as early as January 2023. Oregon remains the only jurisdiction offering this state-level regulatory model for psychedelic therapy.



International Developments and the Path Ahead



Outside the US, Canada has emerged as a key jurisdiction exploring psychedelic-assisted therapy at a national level. Health Canada has granted multiple Section 56 exemptions allowing access to psilocybin in palliative care settings, reflecting a growing willingness to engage with psychedelic medicine through compassionate use pathways.



Globally, interest continues to expand. The United Kingdom has approved its first clinical trial involving DMT, while the Australian government has committed AU$15 million in funding to psychedelic research initiatives.



In 2021, MAPS published results from its FDA-approved phase IIIa clinical trial of MDMA-assisted psychotherapy for PTSD. In this randomised, placebo-controlled study, 67% of participants receiving MDMA no longer met diagnostic criteria for PTSD at the end of treatment, with minimal adverse effects. These results have positioned MDMA-assisted therapy for potential FDA approval in 2023.



Psychedelics, Policy, and Long-Term Legal Reform



Despite this progress, psychedelics remain far from full legalisation or widespread medical adoption. Early legislative efforts at the US federal level have faced resistance, including the rejection of an amendment proposed by Representative Alexandria Ocasio-Cortez to reduce barriers to federal psychedelic research funding.



Advocacy groups such as the Plant Medicine Coalition continue to push for reform, calling for up to US$100 million in federal funding to support psychedelic research. The trajectory of psychedelics increasingly mirrors that of cannabis, which followed a similar path from prohibition to gradual acceptance through state-level reform.



California approved medical cannabis in 1996; 25 years later, cannabis has become a multibillion-dollar industry across numerous US states. Psychedelics now appear to be at the beginning of a comparable, though distinct, regulatory journey—one driven by clinical evidence, cautious reform, and evolving public perception.








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The post Psychedelics and the Law: How Regulation Is Beginning to Change – PSYCH: The Psychedelics As Medicine Report 3rd Edition appeared first on Prohibition Partners.