Mental health is critically important to everyone, everywhere. Yet, it stands out as an area with some of the most glaring unmet needs. Psychedelic therapies have the potential to address critical gaps in treatment for various mental health conditions in Europe. However, before reaching patients, they must first gain approval from the European Medicines Agency (EMA), followed by integration into national healthcare systems for accessibility and reimbursement.

PAREA has issued a commentary in response to a recent high-level expert report commissioned by the European Commission, which outlines strategic recommendations for the future of the EU’s R&I Framework Programme. The report underscores the need for increased funding and prioritization of critical societal challenges like mental health, which is increasingly affecting Europeans but remains underfunded and under-researched.

In September, PAREA engaged with key European institutions to build political support for mental health and psychedelic therapies. Following the recent EU elections, we see fresh opportunities to re-engage with the European Parliament, Commission, and Council. 

The PsychedeliCare European Citizens’ Initiative has been officially registered by the European Commission.

The European Citizens' Initiative is a mechanism that allows EU citizens to propose new legislation by gathering one million signatures from at least seven EU Member States, prompting the European Commission to consider and potentially act on the initiative.

On 17 and 18 August, PAREA's Founder attended the Hopkins-Oxford Psychedelic Ethics (HOPE) Summit in Washington, D.C.. Tadeusz spoke about PAREA’s work and the newly funded EU project on psychedelic therapies, PsyPal...

A recent study published in Nature Scientific Reports offers insights into the attitudes of European psychiatrists toward “psychedelic-assisted psychotherapy”. The study surveyed psychiatrists across 33 European countries, revealing that while there is a general openness to the potential of psychedelics in treatment, concerns remain about their associated risks...

The scale of human suffering caused by the war in Ukraine and the degree of unmet mental health needs create a sense of urgency and call for increased collaboration...

I co-authored an extensive position statement by Drug Science, PAREA, and Mind Medicine Australia published today. We are addressing key concerns discussed at the FDA Advisory Committee. Read the full position statement.

The European Union Drugs Agency (EUDA) has just released a FAQ document on the therapeutic use of psychedelic substances to enhance understanding of key developments, address policymakers' concerns, and provide insights into ongoing research. The document covers the therapeutic use and clinical research of psychedelics, as well as the prevalence and patterns of their use in Europe and the presence of unlicensed and illegal practices...

Today, we are welcoming a new PAREA Community Supporter: Foundation for Therapeutic Advancement and Innovation with Psychedelics SA TAIP. TAIP is an Estonian organisation that advances science-based approaches to using psychedelics in contemporary therapeutic practices. ...

In April, the European Medicines Agency organized a workshop on psychedelic therapies to discuss the specific challenges of their research and application. The aim was to explore how the EU regulatory framework can support their development and marketing authorization...

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.

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…

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.

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.