PsychedelicsEUROPE
PE
PsychedelicsEUROPE (PE) is an innovative mental health association with a global reach that brings together leading research centers, NGOs and private companies.
ID: 302850543434-74
Lobbying Activity
Meeting with Tomáš Zdechovský (Member of the European Parliament)
28 Nov 2023 · High-Level roundtable on Psychedelic-Assisted Therapy in Ukraine
Meeting with Cyrus Engerer (Member of the European Parliament)
7 Nov 2023 · Psychedelics in ongoing pharmaceutical package
Response to A comprehensive approach to mental health
15 Feb 2023
There is a growing body of evidence supporting the therapeutical potential of the medicinal use of psychedelics, especially when it comes to serious mental health conditions, such as treatment resistant depression or post-trauma conditions (reference 1). Beyond these, psychedelic assisted therapies (PAT) may also help patients with anxiety, prevent self-destructive behaviour and may soon become standard in palliative care (reference 2). Additionally, promising results have been found also in addictions treatment for substance use disorder, including tobacco and alcohol, obsessive compulsive disorders, and studies are underway in areas such as anorexia nervosa, cluster headache, pain management, and some neurodegenerative diseases. Single doses of psychedelics taken during PAT are fast acting and produce long-lasting effects, bringing a wide range of benefits to patients, especially those who may remain resistant to standard psychiatric treatment. Without having addictive properties, psychedelics are also promising in terms of cost effectivity. This might be additional positive feature in the post-covid reality where mental health diagnoses are on the rise, creating thus further pressure on the healthcare budgets of the EU Member States. The European Commission should include the following elements to the upcoming comprehensive mental health strategy: 1. Supporting the medicinal use of psychedelics in the EU Across the globe, significant regulatory changes have been implemented in connection to the medicinal use of psychedelics. In the United States, a successful second Phase 3 study of MDMA-assisted therapy for PTSD was announced in January 2023 (reference 3) and it is expected that the FDA will approve MDMA-assisted therapies by the end of 2024. Simultaneously in Australia, the Therapeutic Goods Administration declared the reclassification of psilocybin and MDMA from prohibited substances to controlled medicines as of July 2023 (reference 4). This will allow authorised psychiatrists to prescribe these substances to patients suffering from treatment resistant depression or PTSD. Similar course of actions can be seen also in Canada or Israel. The EU should pay close attention to these developments and reflect the most recent scientific findings as well as the potential for novel approaches in the upcoming mental health strategy. 2. Mainstreaming PAT the EU initiatives PAT should become an integral part of the already existing EU initiatives in the field of healthcare, such as the Pharmaceutical Strategy for Europe or the Europes Beating Cancer Plan. Furthermore, the planned revision of the EMAs guidelines on depression is a good opportunity to incorporate PAT as a solution in the toolbox. This possibility has been already mentioned at the high-level conference Resilient Mental Health that took place under the auspices of the Czech Presidency of the Council of the EU in November 2022. 3. Financial allocation for research Finally, the European Commission should stimulate new opportunities for research on the novel approaches to mental health and medical use of psychedelics. Given the raising numbers of mental health disorders in Europe, it is an imperative that more funding opportunities are dedicated to the innovative solutions in mental health, including the medicinal use of psychedelics. Specific funding opportunities should be also dedicated withing the scope of the ongoing EU programmes, such as the EU4Health or Horizon Europe. References: 1. MDMA-assisted therapy for severe PTSD, https://doi.org/10.1038/s41591-021-01336-3 (attached) 2. A Meta-Analysis of Placebo-Controlled Trials of PAT, 2020 https://doi.org/10.1080/02791072.2020.1769878 (attached) 3. January 3, 2023 https://maps.org/2023/01/05/prior-positive-results-confirmed/ 4. February 3, 2023 https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists
Read full response