Saatja: <
[email protected]>
Saadetud: 12.12.2022 13:04
Adressaat: Tadeusz - PAREA <
[email protected]>
Teema: Calling for the EU task for on psychedelic-assisted therapies
Dear representatives of the EU Health Ministries,
On 6th December, organized its first policy meeting in the European
Parliament looking at the basic ingredients of psychedelic novel
treatments captured in the events 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.
The meeting recording and slides are now available , including the
testimonial from the clinical trial participant of the MDMA-assisted
therapy for PTSD. We also invite you to watch a powerful testimonial from
the PAREA launch featuring a person undergoing psychedelic-assisted
therapy (PAT) for alcohol use disorder - see .
At the event, PAREA launched An appeal to the EU institutions and Member
States (attached). The US Administration expects that PATs with MDMA and
psilocybin - for depression and PTSD - will be approved by FDA in
2024/2025. Soon after, the EU approvals may follow, and millions of
Europeans affected by mental health conditions and addictions may be
eligible to undergo PAT. This is an unparalleled opportunity which also
calls for bold but thoughtful measures to prepare for responsible and
safe roll-out of those treatments. To address these opportunities and
challenges proactively, the Biden administration is establishing an inter-
agency Federal task force. We need to formulate a similar initiative in
Europe to foster a close collaboration across a wide range of stakeholders.
We believe that the best vehicle to drive this work will be to
i) Form a sub-group within the Commission Expert group on Public
Health (which recently replaced the Steering Group on Health Promotion,
Disease Prevention and Management on NCDs)
ii) Or create a stand-alone PAT Expert Forum, similar to the one
recommended in the official conclusions adopted at the recent EPSCO
meeting to tackle vaccine hesitancy.
We must act now we owe it to more than half of EU citizens affected by
brain disorders who are often in desperate need for better treatments.
We remain at your disposal to discuss this further and offer our
expertise to help prepare the EU for these novel treatments.
With best wishes,
Tadeusz Hawrot
Tadeusz Hawrot
Founder and Executive Director
Psychedelic Access and Research European Alliance
(+351) 920 39 19 29
APPEAL TO THE EUROPEAN UNION
INSTITUTIONS AND MEMBER STATES
Psychedelic-Assisted Therapies in Europe
Mental healthcare is in crisis, and we don’t have the tools to truly help millions of Europeans in need. In the EU,
a shocking number of over 100 million people are affected by mental health conditions, including alcohol
use disorder. 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.
While no treatment is without risks, as a rule psychedelic compounds are non-toxic and non-habit forming,
and research shows that PAT is physiologically and psychologically safe when delivered in controlled and
supportive settings.
Unlike current treatments that mostly address symptoms, psychedelic therapies help to confront the root
causes of mental health problems or addictions. In doing so, they demonstrate a unique ability to restore a
sense of purpose and connection. This, coupled with increased neuroplasticity, provides a deep foundation
for those affected by mental illnesses to embark on a healing process. A crucial aspect of PAT is that
improvements are often seen across the board: e.g., someone treated for PTSD may also drink less, have a
healthier relationship with food, and feel less depressed.
The US Administration expects that psychedelic therapies with MDMA and psilocybin will be approved
by FDA in 2024/2025. Soon after, the EU may follow, and millions of Europeans may be eligible to
undergo PAT. This is an unparalleled opportunity which also calls for bold but thoughtful measures. We need
[email protected] parea.eu
to develop the infrastructure for the highest quality safe, affordable, and equitable access to PATs so that
they can benefit the greatest number of people. This will include establishing good standards of practice,
training of specialised therapists, credentialing and licencing, safe and ethical use monitoring (including
setting up safety and ethical violation reporting systems to hold session facilitators accountable), evidence-
based protocols to support people with challenging experiences, engagement of communities and peer-
support networks, and developing ethical guidelines and data standards. These models will benefit from
practices already developed by experienced professional boards and will be further informed by a critical
assessment of the pertinent peer-reviewed evidence.
Importantly, regulators are not 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.
To address these opportunities and challenges proactively and in a timely manner, the Biden
administration is establishing an inter-agency Federal task force. We urgently need to formulate a
similar initiative in Europe to address numerous policy and regulatory considerations related to the
future roll-out of psychedelic treatments. This could take the form of an EU-led Joint-Action, EU4Health
project, EMA pilot, a horizon-scanning activity as part of the Oslo Medicine Initiative or be part of the HTA
Regulation and its work to identify emerging health technologies. Indeed, the EU institutions and WHO
Europe are perfectly placed to develop and lead such efforts and the chances of succeeding will depend
heavily on proactive measures from the EU Institutions and Member States in advance of potential EMA
approval of PATs.
A broad range of stakeholders needs to be strongly involved from the outset of the process. This collective
effort will help to lay strong and safe foundations for the rollout of the PATs by establishing European
guidelines that the EU Member States could choose to follow as they put in place frameworks and
structures to accommodate the medical use of psychedelics.
Such central coordination would create an effective and efficient mechanism to advance the field, as
opposed to having individual EU countries setting up their own work groups, or literature reviews exploring
the efficacy and regulation of psychedelic novel therapies. This collaboration could also work on developing
independent economic analyses to determine healthcare and broader social cost savings to inform HTA
bodies and payers.
Importantly, given the foreseeable bottleneck of qualified, trained providers based on a likely high
demand, PAREA believes that a phased roll out will need to be considered, balancing a need for
widespread access with safety, monitoring and supervision.
Science is revealing that psychedelic substances can be powerful tools with considerable potential for
alleviating human suffering. Though studies show that psychedelics are mostly safe and well-tolerated
when used in appropriate settings, these medicines do nevertheless come with a potential for serious
risks, as their safety and efficacy are dependent upon their integration within a therapeutic framework,
as well as thorough preparation, support and integration and aftercare in specialised healthcare settings.
Through cooperative and EU-led stakeholder engagement, a short window of opportunity opens for
the creation of a therapeutic framework that can facilitate safe, ethical, accessible and equitable
access to psychedelic-assisted therapies.
We must act now – we owe it to more than half of EU citizens affected by brain disorders who are often in
desperate need for better treatments.
[email protected] parea.eu