PAREA is proud to be a supporter of this important initiative by one of our Founding Members.

The recent rejection of MDMA-assisted therapy for PTSD by the FDA Psychopharmacologic Drugs Advisory Committee (AdCom) was surprising to many working in the field of mental illness where MDMA-assisted treatment was seen as a vital innovation for PTSD. The panel voted 9-2 against the evidence showing real clinical efficacy and 10-1 that MDMA -assisted therapy had a negative benefit-risk ratio. These votes were surprising given the overwhelming clinical data in leading peer reviewed journals of highly significant clinical effects in two large phase 3 trials.

In May, PAREA submitted feedback to two European consultations focusing on mental health: the Horizon Europe work programme Cluster 1, addressing diseases and reducing disease burden, and the EU survey "Transforming Health and Care Systems."

Join our Founder and other co-organisers of Paths for the May 16th, 2024 Q&A session: OPEN Foundation, Norrsken Mind, Psychedelic Alpha, and Blossom will discuss online why access to psychedelic treatments is a pressing issue now. This is a unique opportunity to ask questions, share insights, and prepare for the groundbreaking discussions at the summit.

The EU4Health Civil Society Alliance, including PAREA as a member, has raised concerns regarding the reduction in the total budget allocated for the EU4Health Programme during the midterm review of the EU Multi-annual Financial Framework (MFF). A strong and consistent budget is crucial for strengthening healthcare systems and addressing future health threats.

The Paths summit is a dynamic, one-day gathering that will bring together key stakeholders from government, industry, non-profits, patient organizations, and regulatory bodies, including the European Medicines Agency. Together, we'll explore the specific opportunities and challenges that shape the development, approval, and integration of psychedelic medicines within the mainstream European healthcare system. Discussions will include critical areas such as EU requirements for clinical trial designs as well as pricing and reimbursement assessments.

The PsyPal launch event recording is now available here: https://lnkd.in/dWu-Zw9F We are also very pleased that @Science|Business, an influential EU network/publisher representing industry, research and policy, has published a comprehensive article on our launch: EU launches landmark €6.5M study on use of psychedelics to treat mental disorders

The EU-funded PsyPal project which PAREA is involved in, was launched on 9th April in the European Parliament. The event was held under the auspices of the MEP Interest Group on Brain Health and Neurological Conditions and the MEP Action Group for the Medical Use of Psychedelics.

Today, the PAREA Community Supporters network is joined by the Fundación inawe , a non-profit organization dedicated to advancing mental health innovation by fostering the integration of psychedelic-assisted therapies in Spain. Find out more at https://inawe.life/

Welcome to PAREA, inawe!

Welcome to this edition of our newsletter, which is brimming with updates and opportunities for our community. Firstly, our EU Elections Campaign 2024 is in full swing, and you can join us in advocating for mental health innovation and the potential of psychedelic therapies. Your voice is important and together, we can make a significant impact…

We're proud to announce the release of PAREA's Annual Report for 2023. This document highlights our achievements, challenges, and the strides we've made in the past year. It's a testament to the hard work and dedication of our community, and we hope it inspires you as much as it does us. Read more & download the full report.

In a recent interview published by the European College of Neuropsychopharmacology (ECNP), the Chief Medical Officer of the European Medicines Agency, Dr. Steffen Thirstrup, shared insights on the evolving perspective towards psychedelics in medical treatment. Read our summary and access the original article.

PAREA launches EU Elections 2024 campaign

The PAREA Steering Committee has unanimously decided to extend the term of our Chairs.

MEP Action Group Co-Chairs, Sara Cerdas and Tilly Metz, Honored Among Top Influential Figures in Health Policy

There's no more fitting way to begin this newsletter than by honouring the late Dr. Roland Griffiths, Ph.D., who passed away earlier this week. A distinguished psychopharmacologist at Johns Hopkins University, Dr. Griffiths is widely credited with revitalizing medical research on psilocybin. He notably led his first clinical trial on the substance back in 1999. While he may not be here to witness the full impact of his groundbreaking work, the significance of his contributions will undoubtedly continue to resonate long after his passing. Read More

This paper, co-authored by European psychedelicresearchers as well as European Medicines Agency representatives was recently published. It outlines key knowledge gaps “that may be imperative for a successful implementation of psychedelic drugs as medicines”. It provides a summary of topics discussed at the European College of Neuropsychopharmacology at the New Frontiers Meeting in Nice and paves the way for the upcoming EMA workshop on psychedelics.

Lykos Therapeutics (formerly MAPS PBC) announced that the U.S. FDA has accepted its new drug application for MDMA used in combination with psychological intervention, including psychotherapy for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review, with a decision expected by mid-August 2024.

We warmly welcome two new PAREA Community Partners: Institute of Psychedelic Therapy and Spanish Society of Psychedelic Medicine - SEMPsi.

The European Commission answers to the parliamentary inquiry from the MEP Action Group

In December, members of the MEP Action Group for the Medical Use of Psychedelics posed several Parliamentary questions to the European Commission, seeking clarity on the prioritization of novel mental health treatments in the EU R&I area.

Health Commissioner Ms Kyriakides has now responded, offering insights that, while not directly addressing each query, provide valuable information and policy guidance: https://www.europarl.europa.eu/doceo/document/P-9-2023-003603_EN.html