How to Regulate Psychedelics

Regulating psychedelics demands a paradigm shift from prohibitionist fear to evidence-based, rights-centred policy. The Transform report underscores that,

effective regulation must prioritise harm reduction, equity, and flexibility,

Central to this vision is the principle that “the setting and intent of use are as critical as the substance itself.” Psychedelics’ effects are profoundly influenced by the environment: a clinical trial administering psilocybin for depression involves meticulous preparation and integration, while an ayahuasca ceremony relies on cultural expertise and communal support. Regulation must therefore tailor rules to these contexts. Oregon’s Psilocybin Services Act, which licenses facilitators and service centres, exemplifies this by prioritising safety without mandating a medical framework, allowing use for both therapy and personal growth.

The report also stresses “the need for iterative policymaking,” as psychedelic science and cultural attitudes evolve rapidly. For instance, MDMA’s pending FDA approval for PTSD will require new guidelines for therapist training and clinic oversight, while decriminalisation initiatives (e.g., in Washington, D.C. and Cambridge) demand parallel investments in public education to reduce stigma and prevent misuse. Flexibility is key: policies should adapt as research uncovers new applications or risks, such as microdosing trends or the rise of synthetic psychedelics.

Critically, regulation must address power imbalances. The report warns against “corporate capture,” where profit-driven entities monopolise access, pricing out marginalised communities. To prevent this, it proposes equity measures like subsidised therapy programs, community-based licensing, and reparative justice for those harmed by the drug war. Indigenous stewardship is non-negotiable: “Traditional use must be legally protected, not tokenised,” the report asserts, urging exemptions for ceremonial practices and co-design of policies with native leaders.

Ultimately, the goal is to balance autonomy and safety. As the report notes,

Adults have the right to explore their consciousness, but also the right to evidence-based guidance and harm reduction resources.

The Transform report argues that psychedelic regulation cannot succeed unless it actively dismantles the systemic inequities perpetuated by decades of prohibition. “The war on drugs was never about public health, it was a tool of social control,” the report asserts, citing how Black, Indigenous, and Latino communities have borne the brunt of punitive drug laws. For example, despite similar usage rates across races, Black Americans are 3.6 times more likely to be arrested for drug possession than white Americans (ACLU, 2020). Regulation must therefore prioritise reparative justice, including expunging past psychedelic convictions and reinvesting tax revenues from legal markets into communities devastated by the drug war.

Central to this vision is economic equity. The report warns that without safeguards, the psychedelics industry risks mirroring the failures of cannabis legalisation, where corporate giants dominate markets while those criminalised under prohibition are shut out. To prevent this, it proposes:

• Community licensing: Reserving a percentage of business licenses for individuals from disproportionately policed neighbourhoods.
• Non-profit models: Supporting cooperatives and Indigenous-led initiatives, such as the Uñaio Vakiva collective in Peru, which sustainably harvests ayahuasca while reinvesting profits into local education and healthcare.
• Price controls: Capping costs for therapies to ensure accessibility, paired with insurance coverage and sliding-scale payment options.

Sacred medicines like peyote are not commodities, they are living traditions,

The report also stresses participatory governance, urging governments to include impacted communities in policymaking. For instance, Oregon’s Psilocybin Advisory Board includes a designated seat for a traditional Indigenous practitioner, while Colorado’s Natural Medicine Advisory Board mandates representation from harm reduction and racial justice advocates. “Nothing about us, without us,” says Kassandra Frederique, Executive Director of the Drug Policy Alliance. “Communities targeted by the drug war must lead this movement, not be consulted as an afterthought.”

Finally, the report links psychedelic reform to broader struggles for human rights. Decriminalising personal use aligns with the right to cognitive liberty, the freedom to explore one’s consciousness, while medical access upholds the right to health. As the UN Special Rapporteur on the right to health has noted: “Criminalising drug use violates fundamental human rights by prioritising punishment over care.” Regulation, therefore, becomes an act of both repair and reimagining, a chance to build systems that heal, rather than harm.

The Transform report outlines a tiered regulatory framework designed to balance safety, access, and autonomy while prioritising public health and equity. These proposals reject the false binary of prohibition versus unregulated commercialisation, instead advocating for “pluralistic models that reflect the diversity of psychedelic use contexts.” Below are the core pillars of this approach:

1. Medical and Therapeutic Access

1. Decriminalisation and Personal Use

1. Licensed Adult Use in Supervised Settings

1. Home Cultivation and Community Sharing

1. Cultural and Religious Protections

1. Equity-Centred Market Design

As the report concludes: “Regulation is not a single policy but an ecosystem, one that must adapt to science, culture, and justice.” By centring these principles, policymakers can create frameworks that honour psychedelics’ complexity while repairing the harms of prohibition.

The international legal framework governing psychedelics, rooted in three United Nations drug control treaties (1961, 1971, 1988), poses a significant barrier to progressive regulation. These treaties, drafted during an era of prohibitionist fervour, classify most psychedelics as Schedule I substances, deemed to have “no medical value” and a “high risk of abuse.” This outdated designation, as the Transform report argues, “ignores decades of scientific evidence and perpetuates a harmful status quo.” For instance, psilocybin and MDMA, now recognised as breakthrough therapies for depression and PTSD, remain trapped under restrictive global laws that stifle research, limit access, and criminalise cultural practices.

The report highlights a glaring contradiction: “The UN’s scheduling system is based on political compromise, not empirical data.” Psychedelics’ Schedule I status, shared with heroin and cocaine, ignores their low potential for addiction or overdose. For example, a 2010 study in The Lancet ranked psilocybin as one of the least harmful recreational substances, yet international law treats it as a grave public health threat. This misclassification has dire consequences: researchers face bureaucratic hurdles to study Schedule I drugs, clinicians cannot prescribe them, and Indigenous communities risk prosecution for using ancestral medicines like ayahuasca or peyote. Despite these challenges, the Transform report outlines pathways for reform. Nations can leverage treaty flexibilities, such as:

• Rescheduling: Countries may petition the UN to reclassify substances based on new evidence. The 2019 reclassification of cannabis, following a WHO review, sets a precedent.
• Medical Exemptions: Article 7 of the 1971 Convention allows nations to permit medical and scientific use of controlled drugs. Canada’s Special Access Programme, which grants psilocybin access to terminally ill patients, exemplifies this approach.
• Cultural Protections: The 2007 UN Declaration on the Rights of Indigenous Peoples (UNDRIP) could supersede drug treaties, protecting ceremonial use. Ecuador, for instance, has constitutionally recognised Indigenous rights to traditional plant medicines.

Calls for Systemic Reform