The Psychedelic Access and European Alliance (PAREA) has launched an appeal to European Union institutions and Member States for psychedelic-assisted therapies in Europe.
The appeal was launched at a meeting in the European Parliament on 6 December, entitled “Psychedelic-assisted therapies in the treatment of brain disorders”.
Over 400 people registered for the event including EU and government officials, which PAREA says is a clear sign that Europeans have started looking for “evidence-based education on psychedelic medicines”.
The meeting explored psychedelic-assisted therapies for the treatment of mental health conditions, substance use disorders and neurological conditions.
Expert members of PAREA in the field of psychedelic science made presentations on the current state of psychedelic research, including Tadeusz Hawrot, Founder and Policy Lead at PAREA; David Nutt, Professor of Neuropsychopharmacology Imperial College London; Anton Gomez-Escolar, MPH, MIR, MSc; and, Professor Dr Jan Ramaekers, Faculty of Psychology and Neuroscience, Maastricht University, The Netherlands.
PAREA has stated the launch of its appeal aims to further shape discussions on the responsible and safe roll-out of psychedelic treatments in the future.
Hawrot, told Psychedelic Health: “PAREA has been working hard in 2022 to raise awareness among the EU policymakers about the recent scientific and regulatory progress in the area of psychedelic science. This has now culminated in our first meeting organised in the European Parliament.
“We feel we are now ready to start moving from education to proposing concrete actions. To this end, at the event, we launched our appeal to European policymakers presenting our policy recommendations that can facilitate safe, responsible and equitable rollout of psychedelic-assisted therapies.”
Innovating mental healthcare in Europe
There are currently around 100 million people living in Europe with a mental health condition, including addictions such as alcohol use disorder (AUD).
With psychedelic therapies showing promise as potentially efficacious treatments for such conditions, more research will be needed into these compounds, along with discussions on how psychedelic-assisted therapies could be rolled out across European healthcare systems.
In its appeal, PAREA stated: “By and large, no new pharmaceutical treatments have emerged out of the pharmaceutical industry. We urgently need more innovation in these areas and psychedelic-assisted therapies (PATs) are emerging as a potent new class of treatments for mental, neurological and substance use disorders, as indicated by the rapidly growing, rigorous, and compelling body of research.
“In conjunction with proper psychosocial support, they hold the potential to provide safe, rapid-acting, and robust clinical improvements with durable effects.”
PAREA highlights that the US expects psychedelic therapies with MDMA and psilocybin to be approved by the FDA by 2025 and that the EU may follow these developments.
To do this, PAREA recommends the development of infrastructure that could facilitate high quality, safe, affordable, and equitable access to psychedelic-assisted therapies, including the establishment of standards of practice, training of specialised therapists, credentialing and licensing, safe and ethical use monitoring and more.
However, PAREA states that EU regulators are not currently equipped to evaluate the combination of a drug and therapy: “…traditionally they have been assessing the safety and efficacy of medications alone. Therefore, a close collaboration with the regulatory agencies is needed to overcome this barrier.”
Hawrot commented: “We believe that the best way forward is by establishing a European expert forum led by EU institutions and engaging a wide range of stakeholders spanning European governments, payers and health technology assessment bodies, patient organizations, scientists, doctors, psychedelic organizations active in research and education, relevant community-based services as well as industry voices.
“Together, we can start establishing European guidelines that the governments could choose to follow as they put in place frameworks and structures to accommodate the medical use of psychedelics.”
To find out more about the meeting please visit the PAREA website at: parea.eu
