Market approval and the right to health: a human rights perspective on MDMA-assisted therapy
Christoph Bublitz
JME Practical Bioethics April 1, 2026 DOI: 10.1136/jmepb-2025-000039 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Randomized Double-blind Peer reviewed |
|---|---|
| Intervention | MDMA-assisted therapy |
| Topics | MDMA |
| Key points | Argues that typical ethical arguments for rejecting MDMA-assisted therapy insufficiently consider the costs to patients who would have benefited, and that a human rights-based approach may support expanded unlicensed use programs and reconsideration of double-blind trial requirements for psychedelics. |
Abstract
The application for MDMA-assisted therapy (MDMA-AT) and its rejection by the FDA in 2024 prompted a debate about ethical aspects in drug regulation. This paper examines central issues raised in that debate through the lens of human rights, especially the right to health. It argues that drug approval decisions must take into account the multipolar constellation of and dependencies between patients, regulators, pharmaceutical sponsors and members of the public whose health interests may be affected. With an eye on future applications of psychedelics expected soon, the paper analyses key ethical arguments brought forward for rejecting the MDMA-AT application. While acknowledging the importance of the ethical concerns raised, the analysis suggests that typical arguments for rejection insufficiently considered the costs imposed on patients who would have benefitted from the therapy. These ethical arguments, taken by themselves, are insufficient to justify the rejection. The paper further situates market authorisation within broader considerations of access to medicines and argues that, under certain empirical conditions, a human rights-based approach supports expansions of unlicensed use programmes. Finally, it examines the ethical implications of evidentiary standards for market approval in light of the problem of functional unblinding in psychedelic trials, suggesting that double-blind randomised controlled trial requirements warrant reconsideration should they prove practically infeasible.
Comparable studies
Other theoretical and historical papers on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Differences Between the Mechanism of Action of MDMA, MBDB, and the Classic Hallucinogens. Identification of a New Therapeutic Class: Entactogens | 1986 | Theoretical or philosophical paper | |
| The Background and Chemistry of MDMA | 1986 | Historical analysis | |
| The origin of MDMA (ecstasy) revisited: the true story reconstructed from the original documents* Original documents in Merck's historical archive in Darmstadt, Germany, years 1900–1960 | 2006 | Historical analysis | |
| Distinct neural mechanisms for the prosocial and rewarding properties of MDMA | 2019 | Theoretical or philosophical paper | |
| How could MDMA (ecstasy) help anxiety disorders? A neurobiological rationale | 2009 | Theoretical or philosophical paper |
Citations in the library
Cites 32
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Classic psychedelics: An integrative review of epidemiology, therapeutics, mystical experience, and brain network function. Pharmacology & Therapeutics May 1, 2019
- Blinding and expectancy confounds in psychedelic randomized controlled trials Expert Review of Clinical Pharmacology May 26, 2021
- Studying Harms Is Key to Improving Psychedelic-Assisted Therapy—Participants Call for Changes to Research Landscape JAMA Psychiatry March 29, 2023
- History repeating: guidelines to address common problems in psychedelic science Therapeutic Advances in Psychopharmacology 2023
and 27 more in the library