Select campus:UKDubai
University of Birmingham
Menu

Psychedelics: Law, Ethics, and Society

Where altered states meet regulatory realities

PsychLES is a research programme that looks at how law, regulation, and policy affect the use of psychedelic therapies. It brings together experts from different fields to find out where legal research is most needed and how it can help shape future decisions and practices.

Following decades of prohibition, there has been a resurgence of interest in the therapeutic use of psychedelics - such as psilocybin, LSD, and MDMA – to treat a range of mental health conditions. Clinical research has shown that these substances may offer useful treatment options for conditions like treatment-resistant depression and post-traumatic stress disorder (PTSD), especially where existing therapies have not worked well. Trials using psilocybin, for instance, have reported reductions in depressive symptoms, while MDMA-assisted therapy for PTSD has shown promising results in reducing how often and how strongly traumatic episodes occur.

Despite this renewed clinical interest, psychedelics remain highly debated and are legally restricted in the UK and many other countries. They are Schedule I substances, meaning that they are viewed as having little to no therapeutic value and a high risk of harm. Strict licensing rules and tight legal controls, amongst other things, not only create barriers regarding (legal) therapeutic access but also to the generation of the kind of evidence required by regulators to approve these substances as medicines.

Nonetheless, change is underway. In 2023, Australia became the first country to reclassify psilocybin and MDMA for approved medical use under specific conditions. Elsewhere, countries are trying different legal approaches — from Canada’s limited exemptions for medical use, to decriminalisation initiatives in parts of the United States, to pilot schemes and advisory reviews across Europe. However, despite this, in 2024, the US Food and Drug Administration (FDA) rejected an application to approve MDMA-assisted therapy for PTSD, raising concerns about trial methods, possible bias, and long-term safety. This high-profile refusal highlights the complexities with integrating novel (and indeed contested) treatments into regulatory frameworks built around more conventional models of evidence and risk assessment.

PsychLES explores legal, regulatory, and policy aspects of this changing field, aiming to identify where (socio-)legal research is most needed, and how it can help shape policy and practice.

Mapping the legal, ethical, and social challenges

This exploratory strand of work begins to look at some of the main legal, ethical, and social dynamics surrounding the use of psychedelics in treatment. It explores barriers and opportunities emerging across policy, media, and clinical contexts, and is helping to lay the groundwork for future research.

Psychedelics and regulatory decision-making

This strand of work draws on scoping reviews, as well as interviews and roundtables with policymakers, industry experts, patients, researchers, and campaigners. Our aim is to better understand the legal and practical challenges involved in regulating psychedelic-based therapies. This work is intended to inform future socio-legal and policy-focused research directions by identifying key areas of regulatory uncertainty and ambiguity and exploring how these might be addressed.

Psilocybin, palliative care, and end-of-life

Along with colleagues at the University of Manchester, the PsychLES team is looking at the potential role of psilocybin in end-of-life care, particularly in light of the proposed Assisted Dying Bill 2025. We are considering the legal and regulatory barriers to integrating psilocybin-assisted therapy into palliative care pathways, including the complexities of amending existing drug legislation and the ethical challenges of using experimental treatments in this context.

Birmingham Network for Phenomenology and Mental Health

Members of the PsychLES team are part of the Birmingham Network for Phenomenology and Mental Health, a collaborative forum exploring the role of phenomenology in mental healthcare research and practice. Its emphasis on lived experience, embodiment, and meaning-making offers valuable perspectives for understanding and evaluating psychedelic-assisted therapies.

Research team

Professor Muireann Quigley

Professor of Law, Medicine, and Technology, University of Birmingham

Professor Quigley leads the PsychLES programme. Her research explores how law and policy respond to biomedical innovation, with a focus on concepts of personhood, regulation, and the governance of emerging health technologies. She brings extensive experience in normative analysis and interdisciplinary collaboration to this work on psychedelic medicine.

Dr Matt Hayler

Associate Professor in English Literature, University of Birmingham

Dr Hayler’s research focuses on digital culture, posthumanism, and the philosophy of technology. Within PsychLES, he contributes to the exploration of how psychedelic experiences challenge dominant epistemological and evidentiary frameworks, and how novel therapies reshape narratives of mind, body, and treatment.

Dr Louise Hatherall

Research Fellow, Birmingham Law School

Dr Hatherall is a socio-legal scholar specialising in the regulation of medical technologies. Her work on PsychLES draws on experience from interdisciplinary projects such as Everyday Cyborgs 2.0 and involves empirical research on regulatory decision-making, including interviews and roundtables with key stakeholders.

Dr Alana Farrell

Assistant Professor, Birmingham Law School

Dr Farrell’s work focuses on the legal and ethical regulation of healthcare, particularly in relation to reproductive rights and gender-based healthcare. Her interest in evidence, legitimacy, and global health governance supports the broader aims of PsychLES in examining how regulatory systems accommodate or resist novel therapies.

Dr Laura Downey

Research Fellow, Birmingham Law School

Dr Downey’s work focuses on understanding the interaction between law and regulation and the broader sociotechnical environment, with a focus on how sociotechnical change shapes legal and policy debates. Within PsychLES, she is exploring the potential role of psilocybin in palliative settings, including in the context of debates surrounding the Assisted Dying Bill.

Publications and outputs

Contact

We welcome interest from researchers, clinicians, policymakers, and others working in this evolving field, and invite collaboration across disciplines.

To find out more, please contact: psychles@contacts.bham.ac.uk

Follow us on Bluesky: @psychles.bsky.social