INVITATION

On behalf of the MEP Action Group for the Medical Use of Psychedelics, we warmly invite you to an event at the European Parliament, focusing on the potential of psychedelic therapies within the evolving EU pharma legislation context. This event marks the first meeting organized under the umbrella of the recently formed MEP Action Group. The key focus of the meeting will be on discussing the creation of a supportive regulatory environment to stimulate innovation in novel mental health treatments, particularly in the promising field of psychedelic therapies.

Event details:

• Date: 6th November 2023

• Time: 16:15 – 18:00

• Venue: European Parliament and online

Background information

The EU pharma package released by the European Commission earlier this year aims to address critical issues in the EU pharmaceutical sector, including equitable access to medicines and innovative solutions for unmet medical needs. The revision of the EU pharma package is currently discussed by the EU co-legislators, the European Parliament and the Council of the EU, with a hope to finalize respective positions before the European elections in June 2024.

The current momentum in EU mental health policy, coupled with the ongoing reform of pharmaceutical legislation, provides a unique opportunity to engage in discussions about psychedelic therapies, which are emerging as a potent new class of treatments for conditions like depression and alcohol use disorder. Used in conjunction with psychosocial support, they hold the potential to provide safe, rapid-acting, and robust clinical improvements with durable effects.

This year, Australia became the first country to officially regulate the medical use of psychedelics for the treatment of PTSD and depression. The first psychedelic therapy is most likely to be approved in the US in 2024.

There are 16 ongoing clinical trials with psychedelic compounds in the EU for a range of brain disorders as well as for alleviating existential distress in end-of-life care. In the coming years, it is expected that EU regulators will approve novel psychedelic treatments. In the meantime, there is a need to stimulate innovation in this area. This is in line with the recommendations included in the European Economic and Social Committee recent report: “Measures to Improve Mental Health" which reads: “The EESC recognizes the potential of these treatments and asks for devoted funding for promoting research, development and eventual commercialisation of them”. This is also supported by the Czech EU Presidency “Memorandum on Future EU Action in Mental Health” which calls for an “ecosystem that stimulates state-of-art research and introduction of novel therapies such as the medicinal use of psychedelics for the benefit of patients”.