We propose an alternative approach: regulating psychedelics as tools—evaluated not for what they treat, but for their ability to safely and reliably induce states that support or enhance another intervention.

This approach may be key to fulfilling the promise of psychedelic therapy at scale. /5

Existing regulatory frameworks are poorly suited to evaluate drug–psychotherapy hybrids, and current incentives push developers to minimise psychotherapy, mislabel it as “support,” and treat it as a liability. But evidence and frontline experience suggests therapy is key to safety and efficacy. /4

This reframing lets drug regulators focus on drug-specific effects, allowing psychotherapy to be governed by appropriate clinical bodies. It removes pressure to downplay or disguise psychotherapy to fit existing drug frameworks, a notable trend in the field that could undermine clinical outcomes. /3

Psychedelic therapy blends drug and psychotherapy, yet regulation treats the drug as the treatment. In this paper we propose a shift: regulate psychedelics not as treatments, but as tools that enable psychotherapy — like anesthetics enable surgery. /2