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

A European consortium of 19 partners has been awarded over €6,5 million by the European Union to study psilocybin to treat psychological distress in people with progressive incurable illnesses requiring palliative care. This is the first time the EU his funding a multisite clinical study into psychedelic-assisted therapy. PAREA efforts have been instrumental in initiating this project, and we will play an important role in its implementation.

Alongside organizations like the European Brain Council, PAREA is pleased to be a partner of the Bio-Neuroscience Summit, a premier event for global leaders in CNS neuroscience drug R&D. As such, our members and network can enjoy a special 20% discount by using the code PAR23.

The Bio-Neuroscience Summit, 14-15 February in Amsterdam, is an initiative by our partners, Broadreach Global, and the event’s hosts, Amsterdam Neuroscience.

The EU is currently revising its pharmaceutical legislation, the first revision in 20 years. This presents a significant opportunity to focus on mental health innovation and realign our healthcare innovation priorities to more effectively address the unmet needs in mental health care.

For further insights, read PAREA’s Founder article “Closing the innovation gap: Advancing psychedelic therapy and medicines in EU mental health care,” published in Open Access Government

A recent talk by PAREA's Founder was elaborated in Blossom by Floris Wolswijk. It highlights the challenges on the road to widespread access to novel treatments that spam across several layers: global level; authorisation; market placement; pricing & reimbursement; distribution & supply; and cost.

Our September edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: the launch of PAREA third policy paper this year, centred on the critical topic of unmet medical needs.

Read the full EU Insights here.