A European citizens’ initiative aimed at promoting psychedelic-assisted treatments for mental health disorders has been registered by the European Commission.
The initiative, dubbed “PsychedeliCare,” was registered on Sept. 11, according to the European Commission’s official website, in a bid to establish a transnational legal framework around psychedelic therapy in the union.
“The PsychedeliCare Initiative will be an amazing participatory democracy tool to put pressure on the EU to finally take action on the medical use of psychedelics,” Théo Giubilei, founder and organizer of the initiative, said on the group’s website.
The initiative proposes several objectives, including supporting “the establishment of an expert consensus on standards of psychedelic care, with psychological support, therapist training, ethical guidelines and safety measures.”
It also aims to boost “EU-funded research into the therapeutic applications of psychedelics to strengthen the evidence of their safety and efficacy,” and adopt “common positions within UN fora to advocate for pragmatic, progressive transnational regulations concerning psychedelic compounds.”
Organizers cited data from the Organisation for Economic Co-operation and Development (OECD) estimating the economic impact of mental illnesses at 4.2% of the EU’s annual GDP, or about 600 billion euros ($665 billion) per year. The group argues that up to 50% of patients do not respond to currently available psychiatric treatments.
“The EU has approved only one new psychiatric treatment in the last three years, in stark contrast to the 68 approvals in oncology,” the organizers said.
To succeed, the initiative must collect 1 million signatures within a year and meet minimum thresholds in at least seven EU member states.
“We call on the Commission to recognize the unique specificities of psychedelic therapies and their potential to meet high unmet needs for mental health conditions and substance use disorders,” the organizers said on the EU’s official initiative page.
The group noted that the U.S. Food and Drug Administration has already granted several breakthrough therapy designations for MDMA, psilocybin and LSD treatments.
Canada also allowed psychedelic-assisted therapy for end-of-life anxiety in 2022, while Australia recently authorized prescriptions of MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression.
The news follows the European Medicines Agency’s call earlier this year for psychedelic drug developers to target the EU market. The proposal also calls for the creation of a European hub for mental health R&D and the implementation of incentives to spur innovation in the field.
The PsychedeliCare organizers now have six months to start collecting signatures.
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