The Medical Potential of Psychedelics: A View from the European Union

After the U.S., the European Union (EU) is the biggest medicines (single) market, accounting for a quarter of global pharmaceutical sales. Every year, the EU spends €200 billion on innovative drugs and attracts 31% of total R&D investment in pharmaceuticals. The EU is also a leading global regulator and its Horizon Europe R&D programme – with a budget of nearly €100 billion – is seen as “the best internationally cooperative endeavor anywhere in the world.”

And yet, Europe is only now waking up to the medical potential of psychedelics. While the research is flourishing, the policy and regulatory landscapes are lagging. To accelerate and streamline progress, a new partnership emerged in 2022 – Psychedelic Access and Research European Alliance (PAREA).

PAREA is a wide coalition of actors who ought to be involved early on in rolling out psychedelic treatments at the EU level. Its members include EU patient advocacy groups, professional organizations (e.g., the European Psychiatric Association), leading psychedelic foundations as well as industry players. This unique and diverse membership base gives PAREA the expertise and legitimacy needed to drive systemic change at the highest levels.

Setting up this collaboration couldn’t be timelier. There are significant policy opportunities in the EU regulatory pipeline within which psychedelic treatments might be spotlighted.

For one, the EU is conducting a major revision of its pharma strategy. It aims to rebalance stimulating innovation on the one hand and enhancing affordability of medicines and the sustainability of health systems on the other hand. Psychedelic drug developers should watch this space closely in 2023, given that changes to market incentives – such as the length of market exclusivity – are likely. One thing is certain, the impacts of this revision will be felt for decades; and not only in Europe, as the legislation is likely to spill over into other parts of the world via free trade agreements.

Connected to the pharma strategy revision is ongoing work on improving the conduct of clinical trials in Europe with measures such as supporting large clinical trials in multiple European countries and better provision of scientific and regulatory advice to help sponsors in navigating a complex EU environment.

A significant opportunity for psychedelic science will come in the shape of a European partnership on Brain Health (at this stage, no details are available publicly). Running between 2025-2027, it will be a major collaboration between EU Member States, aiming to collectively raise €200 million via global outreach and industry involvement.

PAREA is also encouraged by a supportive stance to psychedelics from the European Medicines Agency (EMA). The Agency is already supporting several psychedelics drug developers and plans two significant activities in 2023: i) an update of its depression guidelines which will include psychedelics and ii) publishing a paper on academic and regulatory challenges in PAT, to support their development. EMA is already clear that one of the critical issues to address will be the standardisation of therapy. The EU drugs agency, the European Monitoring Centre for Drugs and Drug Addiction, is also supportive and is developing an umbrella review of psychedelics to be published in the coming months.