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.

PAREA is excited to announce the release of its manifesto for the EU Parliament elections in 2024, focusing on transforming mental health care through psychedelic therapies. As Europe grapples with a rising mental health crisis, it offers a forward-thinking approach, advocating for the EU to prioritize mental health and explore innovative treatments. The manifesto also proposes the creation of an EU inter-institutional task force to establish guidelines for the safe and equitable use of psychedelic therapies.

Read Our Manifesto

PAREA is an Association Partner for The Neuro Summit along with the Human Brain Project, the Brain Capital Alliance and more. The Summit, in Lisbon from the 11th to the 13th of October, brings global visionaries in brain health, neuro and mental health-centric digital health, medtech, deeptech, data, and artificial intelligence to chart the course for our collective brain well-being and prowess in the contemporary economy.

Find all the summit details here.

The European Parliament Health Subcommittee (SANT) is developing a mental health report, led by MEP Sara Cerdas, who is also involved in the MEP Action Group for the Medical Use of Psychedelics. During a recent SANT meeting, discussions were held on amendments to the report. PAREA, advocating for the inclusion of psychedelic medicines, is pleased to note a recent amendment recommending further exploration of innovative treatment options, specifically the use of psychedelic-assisted therapies for mental health conditions. The report is set to be adopted later this year.

The European Medicines Agency has released a draft guideline on clinical investigation of medicinal products for depression, marking its third revision since 2002. Notably, the draft includes a dedicated chapter on psychedelics, recognizing their unique development needs for treating depression. The guideline also acknowledges the challenges of standardization, training, monitoring, and safety in psychedelic-assisted psychotherapy.

Read the full draft here.

The American Journal of Endocannabinoid Medicine interviewed PAREA Founder, Tadeusz Hawrot, during the MIND Foundation INSIGHT 2023 conference about the work of PAREA and the wider EU landscape.

Read the full interview here.

Our September edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: PAREA’s call to establish a Psychedelics Advisory board, the first time psychedelics are mentioned in official EU documents, and more. Read the full EU Insights here.

Psychedelic Health featured PAREA’s call for a European advisory body on psychedelics in a recent policy briefing to the European Medicines Agency (EMA), aligning with the EMA's 2023 workshop on the topic. This development responds to a letter from cross-party MEPs, including Alex Agius Saliba, Robert Biedroń, and Sara Cerdas, urging swift EU action on psychedelics. Tadeusz Hawrot, Founder and Director of PAREA, emphasizes the need for a multidisciplinary advisory body to establish standards and facilitate regulatory approval for psychedelic therapies.

Read the full article here.

PAREA is proud to stand alongside other cosignatories in endorsing this crucial declaration with EU 4 Health, a unified coalition of civil society entities. The joint statement calls for the implementation of sustainable funding mechanisms and the establishment of more transparent actions by the European Union. These measures are essential in ensuring that civil society organizations have equitable access to funding, facilitating their continued contribution to the policy discourse.

Read the full statement here.

At the forefront of psychedelic research, this year's INSIGHT conference featured the founder of PAREA, Tadeusz, Hawrot, sharing policy, economic and ethical insights at a panel on Patients or Patents with philanthropists and other fiscal experts. Discussions and workshops at the event spanned psychedelic neuroscience, non-clinical uses, mindfulness in business, and integration of indigenous wisdom traditions.

See the full conference details here.

We're excited to announce the launch of our comprehensive position statement "Leveraging the EU Pharmaceutical

Package; A Life Cycle Approach to Address High Unmet Needs and Foster Mental Health Innovation by Incentivizing Psychedelic Novel Medicines." This document, while rooted in the EU Pharmaceutical Package, broadens the scope to encompass the full lifecycle of medicines, including critical aspects like access.

READ POSITION STATEMENT

Exciting new podcast episode of Drug Science, hosted by Professor David Nutt, catches up with PAREA founder Tadeusz Hawrot and Frédéric Destrebecq, Executive Director of the European Brain Council (EBC) about the latest developments in research and clinical development with psychedelics in Europe.

Our July edition of PAREA EU Insights is out! Stay updated on the latest EU policy news. Highlights including: New EU Mental Health Strategy with €1.23B for 20 flagship initiatives. Training 2K professionals for psychedelic therapy and a special Feature: EU HTA. Read the full EU Insights here.

Psychedelic therapies are officially recognized in an EU document for the 1st time. The European Economic and Social Committee recommends further research and funding to investigate their potential in treating severe depression, PTSD, and alcohol use disorder. Read all the details in our news flash.