PAREA makes a submission to the EC consultations Stakeholders' Targeted Consultation on EU4Health: future priorities, orientation and needs’. The consultation results will be used in the consultation report and will also feed into the EU4Health stakeholders’ conference on 9 June 2023.

PAREA’s Tadeusz Hawrot discusses the organisation’s recent meeting with the European Commission’s Health Directorate (DG SANTE), and the need to begin work on equitable access to psychedelic therapies in Europe in the Psychedelic Health article: Building for the future: Preparing for equitable access to psychedelic medicines in the EU.

PAREA Chair Prof. David Nutt writes in Open Access Government “Why Europe needs to catch up with psychedelic research”. See page pages 1, 2 and the full issue here.

In early April, PAREA met with Stefan Schreck, Advisor for Stakeholder Relations at the European Commission DG SANTE (health directorate). Among discussed topics, PAREA emphasized a need for the EU Member States to proactively prepare for the roll-out of psychedelic medicines in order to build the necessary expertise and infrastructure for the highest quality, safe, affordable, and equitable access to psychedelic medicines.

One of the most influential psychedelic therapies media Lucid News profiled PAREA’s work in its recent article: The EU is Inching Closer to a Psychedelic Renaissance. The article covers topics like the beginnings of PAREA and the mental health political landscape in Europe. Read the full story here.

The involvement of the next generation of therapists will be crucial to expanding access to psychedelic medicine in the near future. Against this backdrop, PAREA Founder had an opportunity to sit on the panel "Psychedelic Interventions: When can psychedelic treatments be useful in a clinical context?” that took place during the 37th Congress of the European Federation of Psychology Students' Associations (March 27th – April 2nd 2023).

PAREA saw a reply from the European Monitoring Centre for Drugs and Drug Addiction to the letter sent by a cross-party group of MEPs. The letter observed that some substances listed in the UN conventions have authorization for medical use. It is possible that the WHO-ECDD will consider re-evaluating these substances as the scientific evidence base changes in relation to their possible therapeutic value.

See the MEPs letter here and the EMCDDA reply here.

PAREA Chair Prof. David Nutt provided a keynote lecture and PAREA Founder Tadeusz Hawrot brought the meeting to a close, presenting on the patient perspective at the European College of Neuropsychopharmacology meeting: New Frontiers Meeting on psychedelics which took place in Nice on 19-20 March.

In response to a letter from a group of cross-party MEPs calling for the EU to act fast on psychedelics, the EMA wrote that there are currently 16 clinical trials with psychedelic compounds in the EU and EMA will be holding a multi-stakeholder workshop on the topic towards the end of 2023.

Read the MEP’s letter to EMA here, the EMA reply here and the associated POLITICO article here.

PAREA was invited to the EMCDDA’s technical meeting in early MArch 2023. This is one of the many recent signs that the European Union followed PAREA’s call to prioritise this area/to reflect on how we can prepare for the adoption of psychedelic therapies.

The more inter-agency collaboration that we can foster the better.

In line with the European Commission’s effort towards Better Regulation, stakeholders were able to share their views on the performance of Horizon 2020 and Horizon Europe, as well as shaping the strategic orientations for the Horizon Europe Strategic Plan 2025-2027.

PAREA submitted a response to this consultation, read our response here->

The European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) need to play a more active role in psychedelics, say MEPs.

We are very pleased with this initiative from a cross-party group of MEPs who appreciate the important role that psychedelic-assisted therapies will likely play in addressing the pandemic levels of mental health and substance use disorders that we witness in Europe.

PAREA would like to welcome:

The Polish Psychedelic Society

The Conservative Drug Policy Reform Group

The French Psychedelic Society

Sociedade Portuguesa de Aplicação Clínica de Enteógenos (SPACE)

As we continue to grow, PAREA is committed to working collaboratively with all of our supporters to expand access to psychedelic-assisted psychotherapy.

PAREA applauds the new EU mental health initiative and, in particular, its objectives of support and improving access to treatment and care of mental health problems, focusing on evidence-based innovative, promising and personalised approaches and interventions, effective treatments and high-quality care.

A recent PAREA editorial written by Professor David Nutt highlights that despite Europe once leading the psychedelic research field, we are now lagging behind the Americas and Australia in turning this science into clinical practice.

Read how the US, Canada and Australia are outpacing Europe.

Representatives from the European Medicines Agency, national experts from the European medicines regulatory network, and the European College of Neuropsychopharmacology co-authored a joint commentary in the Lancet: "The Therapeutic Potential of Psychedelics: The European Regulatory Perspective".

Starting on July 1st, MDMA and psilocybin will be rescheduled and legalized in Australia for the treatment of PTSD and treatment resistant depression respectively, making Australia the first country in the world to officially recognize and regulate the medical use of these psychedelic drugs. The announcement was made on February 3rd by the Australian government’s Therapeutic Goods Administration.

Small Pharma announced the results of its Phase 2a clinical trial, treating moderate to severe Major Depressive Disorder (MDD) with DMT-assisted therapy.

The trial carries special significance, as it is the first-ever clinical trial attempting to treat a mental health disorder with DMT, the shorter-acting chemical cousin to psilocybin.

The second Phase 3, philanthropy-funded, clinical trial of MDMA-assisted therapy for posttraumatic stress disorder (PTSD) was published confirming prior positive results from the first Phase 3 trial. No serious adverse events were observed among the participants. The full data, expected to be published in a peer-reviewed journal later this year, will support a new drug application to be filed with the U.S. Food and Drug Administration10 .

As the Biden administration establishes a federal task force to address the roll out of psychedelic medicines in the US over the next 5 years.

Europe needs to implement a similar initiative to ensure that it does not fall behind on an international level.