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.

In this episode, leading experts Tadeusz Hawrot; and Ellen James, Director of Research and Development, Small Pharma, discuss new research into psychedelic-assisted therapies and how the views surrounding psychedelics within the medical field are evolving.

In December, PAREA had a second meeting with EMA Chief Medical Officer. The Agency plans two significant activities in 2023:

i) an update of its depression guidelines which will include psychedelics

ii) publishing a paper on academic and regulatory challenges in PAT, to support their development.

EMA acknowledges that regulating psychotherapy is a challenge and one of the critical issues to address will be the standardisation of therapy. The more heterogenous the PAT delivery will be across European countries, the more concerned the regulators might be.

On 6th December, we organized our first policy meeting in the European Parliament, looking at the basic ingredients of psychedelic novel treatments captured in the event’s title: “Psychedelic-assisted therapies in the treatment of brain disorders”.

Over 400 people registered for online and in-person attendance, including many EU and government officials. This is a clear sign that Europeans start looking for evidence-based education on psychedelic medicines.

Today, PAREA sent out a communiqué on several significant developments in the area of psychedelic science, policy and regulation that took place in the week of 14 November. You can access this by clicking on this post.