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.

MAPS PBC has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy in treating post-traumatic stress disorder (PTSD). This marks the first instance of a psychedelic-assisted therapy being considered for FDA approval, potentially introducing a novel treatment option for adults with PTSD.

Read the full news release here.

We are pleased to announce our newest Community Supporter: HoloMind - Instytut Terapii Psychodelicznej. Recently launched in Poland, the organization is dedicated to educating about the therapeutic use of psychedelics and advocating for psychedelic treatments in PL. Welcome aboard, HoloMind!

In today's POLITICO Europe Morning Health Care, psychedelics are "driving the day", reflecting the latest updates on efforts across several EU countries to facilitate access to psychedelics as medicines.

Psychedelics Today webinar featured PAREA founder. Tadeusz explores psychedelic breakthroughs and their impact on Europe's mental health. Watch the full webinar here.

Led by the Spanish Presidency, the Council of the EU recently adopted conclusions on mental health, stressing its individual, social, and economic importance. These conclusions urge member states to create cross-sectoral action plans, ensuring timely access to mental health care and establishing an interdisciplinary mental health workforce.

Videos from the MAPS Psychedelic Science Denver conference are now publicly available. PAREA founder, Tadeusz talk starting at the 14-minute mark. The session was moderated by Zara Snapp with esteemed co-panelists Veronica Magar DrPH, MPH, MA, Dr. Larissa J. Maier, and Dr. Prash P. Watch the full video here.

Psychedelics are being recognized among the most promising innovations in the field of brain science at the the European Brain Council - a founding member of PAREA - Brain Innovation Days.

More on Psychedelics and Brain Innovation Days here.

Frédéric Destrebecq, PAREA Vice-Chair, recently presented at a Brussels meeting of the COST Association, focusing on "Advancing Mental Health Research in Europe." PAREA was featured alongside esteemed organizations like the Researcher Mental Health Observatory and European Organization for Rare Diseases. Established in 1979, COST bridges science, policymakers, and society in Europe. Read more details here.

Amidst the EU's critical discussions on pharmaceutical legislation, PAREA has launched a policy paper during the MEP Action Group for the Medical Use of Psychedelics meeting "Innovating Mental Health in the EU Pharma Legislation: Regulatory Pathways for Psychedelic Therapies." You can access the meeting recording and the paper here.

The Psychedelic Society is a not-for-profit, UK-based organization, focusing on cultivating the psychedelic community and delivering education about the safe and responsible use of psychedelics.

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. Find out more and register for an in-person/online participation here: https://tinyurl.com/EU-Par

PAREA met with the EMA CMO Steffen Thirstrup to discuss the EMA upcoming mutli-stakeholder workshop on psychedelics therapies addressing unmet medical needs in Europe. The workshop will take place in April 2024.

PAREA facilitated a session on psychedelic therapies that took place during the 13th Congress of the European Pain Federation EFIC, held in Budapest, Hungary. Deirdre Ryan, Vice-Chair of PAREA was instrumental in creating this opportunity. James Close from the Imperial College London spoke at the session about his research on psychedelics in the realm of pain management.