EMA multistakeholder workshop on psychedelics - Workshop report

The European Medicines Agency has just released the extensive meeting report from EMA April's multi-stakeholder workshop on psychedelics: https://lnkd.in/ddrTvpR2
PAREA contributed to its development.

The EMA has significantly increased its focus on psychedelic therapies recently, resulting in several publications where EMA experts discuss the opportunities and challenges in the field. This report is the most comprehensive and wide-encompassing state of play so far. The EMA has done an excellent job synthesizing the workshop discussions into a well-structured summary around several key themes:

- Regulatory perspectives and developments
- Methodological challenges
- Safety considerations
- Considerations and challenges for implementation, including EU-specific issues like Health Technology Assessment, funding opportunities, and compassionate use programs in Europe.

PAREA’s input into the April discussions is mentioned throughout the document, and our reflections are extensively quoted in discussions on legal classification. We highlighted an asymmetry in the drug scheduling system, where minimal anecdotal evidence can classify a substance as Schedule I, but extensive phase III clinical trial data is required to reconsider its classification. The current scheduling adversely affects progress towards equitable access to psychedelic therapies. The report adds that PAREA believes there is enough evidence to initiate a discussion on the rescheduling of psychedelics, a process that falls under the purview of the UN Commission on Narcotic Drugs.

The report mentions PAREA's recommendation to create a pan-European multidisciplinary advisory body to offer a comprehensive framework for addressing mental health innovation in the EU. This body could recommend care models for psychedelics, training and licensing standards, ethical guidelines, and safety standards.