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.

Our Founder Tadeusz Hawrot speaks about the “Future of Psychedelic Medicine in the EU”, alongside Cyrus Engerer, MEP for Malta and Mikuláš Peksa, MEP for Czechia, with Steph Price moderating the PSYCH Symposium on 6th July in London, at the British Museum.

Open Access Government publishes an article by Tadeusz Hawrot, Founder of PAREA, on the potential of psychedelic therapies in transforming EU's mental health care approach. A timely piece on the underserved area of psychedelic therapies. Read the full article here.

The BBC covers a historic moment in medicine. Starting today, Australia is the first country to classify psychedelics as medicines at a national level. Additionally, the Royal Australian and New Zealand College of Psychiatrists has just issued a relevant memorandum on the therapeutic use of these substances. PAREA founder, Tadeusz Hawrot, speaks with Polish television TVP World about concerns & progressions moving forward.

Our latest news release is out, covering key relevant advancements in the field of psychedelics. For the 1st time the UN and EMCDDA included chapters on psychedelics in their reports. The FDA in the US issued its guidelines. Nature paper explores the potential of psychedelics in brain development.

In lead-up to the PSYCH Symposium, July 6th at the British Museum, Psychedelic Health interviews panel members Tadeusz Hawrot, founder of PAREA, and MEP for Czechia, Mikuláš Peksa about their thoughts on the future of Psychedelic Medicine in the European Union. Read about their thoughts, including parallels between psychedelics and stroke care in the interview here.

The largest gathering of its kind, MAPS Psychedelic Science took place in Denver, Colorado bringing 11,000 attendees together with experts and innnovators to converge and share. PAREA founder, Tadeusz Hawrot, spoke during the policy session "From research to regulatory changes: Australia, the EU, and beyond" on Thursday.

Voices from the front lines, founder of PsyPAN, Psychedelic Participant Action Network, Ian Rollier is interviewed by EURACTIVE on the transformative process of the innovative mental health treatments, therapeutic value and the effects of psilocybin on depression.

In solidarity, the EU Commission moves to support its citizens and their mental health and has released a comprehensive outline featuring 20 initiatives aimed at destigmatizing mental health issues and guaranteeing universal care access. €1.23 billion has been designated for this initiative. The new measures aim to improve prevention, treatment and care, plus social reintegration after recovery, truly making mental health a priority.

PAREA's latest EU Insights edition delves into the crucial intersection of EU policy and psychedelic science, particularly focusing on the recent transformation of EU pharma legislation. This update also introduces our new feature - a curated selection of the top psychedelic science developments. Support our mission to enjoy exclusive benefits and contribute to this ground-breaking field.