Psilocybin is one of several psychedelic compounds that have shown remarkable promise for the
treatment of a range of mental health conditions, including treatment resistant depression,
post-traumatic stress disorder, anxiety, anorexia, end-life-trauma
and substance abuse disorder. Designated a break-through therapy by the U.S. Food and Drug
Administration, psilocybin is currently being studied in phase three clinical trials to
establish its safety and efficacy for therapeutic
use. However, the current status of psilocybin as a Schedule I drug under the 1971 UN Convention
on Psychotropic Drugs adds significantly to the costs, complexity and duration of research and
will ultimately delay the availability
of treatments for patients in most countries around the world.
In most jurisdictions,
the legal control of psilocybin and other psychedelics results from the 1971 Convention on
Psychotropic Substances.
The 1971 Convention contains four Schedules of controlled substances, ranging from Schedule I,
the most restrictive, to Schedule IV, the least restrictive. Schedule I includes psychedelics
drugs such as psilocybin, MDMA, mescaline
and LSD, whereas Schedules II through IV are mainly composed of licitly manufactured
pharmaceuticals. The evidentiary basis for including various psychedelics compounds in Schedule
I are unclear but appear to have been based largely
on political considerations and a mistaken presumption that these drugs offered no medical
benefit and posed a high risk of abuse and dependence.
These scheduling decisions and
implementing legislation such as the U.S.
Psychotropic Substances Act, the UK Misuse of Drugs Act and the Canadian Controlled Drugs and
Substances Act make conducting research on these drugs, either basic or clinical, both costly
and difficult. State Parties to the 1971
Convention, of which there are 175, are obligated to implement the Convention’s Article 7
Special provisions regarding substances in Schedule I. These provisions provide for a level of
regulatory control and supervision that is
drastically more onerous than for those drugs under Schedules II through IV. As a result,
researchers wishing to study psilocybin face numerous regulatory hurdles which create
significant burdens in terms of expense and the length
of time required to carry out research and secure approvals for treatments.
While a small number of regulatory bodies, including the U.S. FDA and Canadian
Department of Health have taken positive steps in recognizing the therapeutic potential of
psilocybin, these are unlikely to have any impact
on regulatory regimes that hinder research and the availability of therapies around the rest of
the world.
Rescheduling procedures under the 1971 Convention offer a potentially
game-changing opportunity to advance further
research and accelerate the approval of treatments for patients by providing signatory
governments with the legal flexibility and evidentiary basis adopt changes in regulatory
controls for scientific and medical use.
Around the world, hundreds of millions of individuals struggle daily mental illness and
substance use disorder, a situation that have been massively exacerbated as a result of the
COVID-19 pandemic. According to the World Health Organization (WHO), mental
health conditions are the leading cause of disability-adjusted life years lost and account for
37% of healthy life years lost from non-communicable diseases.
Despite the massive scope of this problem few effective treatments are available for
patients. According to the WHO’s Office for Disease Prevention and Promotion, the public health
need for new medicinal treatments to
support those with mental health problems is vast. This is particularly the case in many
low-and-middle-income countries where governments struggle to provide even basic medical
services.
Current standard of care treatments such as SRRIs often prove ineffective for most
patients, while for others the benefits of these drugs, which may have to be taken daily for
months and even years, are often accompanied
by significant adverse side-effects. With few medications under development there exists a
desperate need for new and alternative treatments.
Scheduling decisions in terms of adding substances or changing the scope of control are governed
by scheduling procedures under the 1971 Convention on Psychotropic Drugs and fall under the
purview of the UN Commission on Narcotic Drugs (CND). Formal scheduling
reviews may be initiated either by the World Health Organization (WHO) or by notification by any
State Party to the treaty. As part of this process, the WHO’s Expert Committee on Drug
Dependence (ECDD), which is composed of independent
experts in the field of drugs and medicines, is tasked with making scheduling recommendations
based a medical and scientific review of therapeutic potential and abuse liability of the
compound in question.
Guided by the provisions of the 1971 Convention, its preambles and the WHO’s Guidance
for the WHO Review of Psychoactive Substances for International Control, the ECDD has adopted
the following criteria for its scheduling
recommendations:[1]
According to guidance adopted by the WHO Executive Board in 2010, recommendations for
inclusion in Schedule I should be made only when the above criteria are fully met with respect
to both therapeutic usefulness and the
risk to public health.[2] Given today’s scientific understanding of psilocybin’s high potential
therapeutic value and low risk of abuse liability profile a change to its current status as a
Schedule I drug is long overdue.
Encouragingly, recent precedent exists for the review and rescheduling of drugs under
the UN drug treaties. On December 4, 2020, the CND voted to accept a WHO recommendation to
remove cannabis and cannabis resin from Schedule
IV (the most restrictive) of the 1961 Single Convention on Narcotic Drugs. The WHO’s
recommendation was based on an ECDD review which stated in part that:
“The evidence presented to the Committee did not indicate that cannabis plant and
cannabis resin were particularly liable to produce ill-effects similar to the effects of the
other substances in Schedule IV of the 1961
Single Convention on Narcotic Drugs. In addition, preparations of cannabis have shown therapeutic potential for treatment of pain and other medical
conditions such as epilepsy and spasticity associated
with multiple sclerosis. In line with the above, cannabis and cannabis resin should be scheduled
at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development
of cannabis-related preparations for medical use [emphasis added].” [3]
As
part of our efforts to ensure equity of access to psilocybin-assisted therapy as a global public
good, ITPRI is engaging, educating and
mobilizing a broad range of officials and other stakeholders operating within the Geneva based
ecosystem of Member State Permanent Mission, UN Institutions and NGOs that will be critical to
achieving a review and change in scheduling.
We invite you to join us.
[1] WHO Expert Committee on Drug Dependence. Seventeenth report. Geneva, World Health
Organization, 1970 (WHO Technical Report Series, No. 437).
http://apps.who.int/iris/bitstream/handle/10665/40766/WHO_TRS_437.pdf?sequence=1
[2] Guidance on the WHO review of psychoactive substances for international control, WHO 2010.
https://www.who.int/medicines/areas/quality_safety/GLS_WHORev_PsychoactSubst_IntC_2010.pdf
[3] Annex 1- Extract from the Report of the 41st Expert Committee on Drug Dependence:
Cannabis and cannabis-related substances.
https://www.who.int/medicines/access/controlled-substances/Annex_1_41_ECDD_recommendations_cannabis_22Jan19.pdf?ua=1
Psilocybin, a classical psychedelic, is a chemical produced by more than 100 species of
mushrooms of various potency worldwide. Used by different cultures throughout history in
religious and other ceremonies, it was first isolated by Swiss chemist Albert
Hofmann in 1957 and synthesized the following year.
With similar properties to lysergic acid diethylamide (LSD) and mescaline but a
somewhat different chemical structure, psilocybin works by stimulating some types of
5-hydroxytryptamine receptors (serotonin receptors),
including in thalamus and cerebral cortex, the parts of the brain responsible for sensory input,
mood, cognition and perception. Resulting in often intense mood and perceptual changes in space
and time, including sensory alterations
commonly referred to as hallucinations, psilocybin can occasion mystical type experiences
associated with lasting and positive changes in mood, outlook and behaviour.
Following
ingestion, psilocybin is converted by the
liver into psilocyn. The hallucinogenic effects of psilocybin usually occur within 30 minutes to
an hour of ingestion and typically last between 4 and 6 hours. As with other psychedelics
compounds, the effects of psilocybin are
likely to be impacted by the quantity consumed, past experiences, the environment in which it is
taken and expectations as to the nature of the experience.
While psilocybin may
occasion unpleasant or distressing effects,
particularly if taken in high doses in uncontrolled settings, these experiences are shown to be
relatively rare. Generally experienced by health adults without significant and lasting adverse
effects, psilocybin should, however,
be avoided by certain individuals, including those with a family history of or disposition to
psychotic disorders as well as those with untreated hypertension or other cardiovascular issues.
First studied in the 1950s and 1960s, psilocybin and other psychedelic compounds showed
early therapeutic promise but changes in regulatory controls, including those resulting from the
1971 Convention on Psychotropic Drugs,
brought research efforts to a halt. Following a decades long hiatus, research was allowed to
resume in the early 2000s under strict regulatory controls. Since then, research efforts have
accelerated with leading academics institutions
such John’s Hopkins, Imperial College London, University of Zurich, NYU and others conducting
multiple early stage clinical studies.
Research conducted to date has shown potentially game-changing promise for the treatment of
a range of mental health conditions, including major depressive disorder, treatment resistant
depression, anxiety disorder, post-traumatic
stress disorder, anorexia, substance abuse and cancer-related and other end-of life
psychological distress.
A 2016 study conducted by Robin Carhart-Harris and colleagues
at Imperial College London found that two psilocybin
therapy sessions coupled with pre and post psychological support appeared to “markedly reduce”
depressive symptoms in twelve patients suffering from unipolar treatment resistant depression.
In John Hopkins study published in JAMA Psychiatry in 2020, a group of 24 patients
suffering from major depression was given two doses of psilocybin and psychotherapy support.
Researchers reported “rapid and large reductions
in depressive symptoms, with most participants showing improvement and half of study
participants achieving remission through the four-week follow-up.” According to researcher Alan
Davis, “The magnitude of the effect we saw was
about four times larger than what clinical trials have shown for traditional antidepressants on
the market.” According to the study, the result suggest that psilocybin may be effective in a
much wider population of patients who
suffer from major depression than previously believed.
Designated a break-through
therapy by the U.S. Food and Drug Administration, psilocybin is currently being studied in phase
three clinical trials to establish its
safety and efficacy for therapeutic use with patients suffering from treatment resistant
depression.
Despite the promising results of research to date, more data from large
scale clinical trials in needed to establish
safety and efficacy and secure regulatory approvals for a range of potential treatments. Without
a rescheduling of psilocybin under the 1971 Convention and within domestic regulatory regimes,
this process will remain unnecessarily
complex, costly and will ultimately delay the availability of treatments for patients.
*The information on this site should not be used to make decisions about medical treatments. Please conduct your own research and due diligence before making any major health changes.
Give today to support ITPRI’s mission to promote and secure a rescheduling of psilocybin under the 1971 Convention on Psychotropic Substances.
Our work would not be possible without the financial support of our funders and donors as well as the critical contribution made by our partners and collaborators.
Please help spread the word by sharing via your social media networks.
The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) was established in 2021
as a civil society, not-for-profit association under Articles 60 et seq. of the Swiss Civil
Code.
ITPRI’s mission is to promote and secure a rescheduling of psilocybin under the 1971 UN
Convention on Psychotropic Substances in order to accelerate research and foster the
availability of psilocybin-assisted therapies
for those suffering from mental illness and addiction.
Rescheduling procedures under the 1971 Convention offer a potentially game-changing
opportunity to advance further research and accelerate the approval of treatments for patients
by providing signatory governments with
the legal flexibility to adopt changes to domestic regulatory controls that currently limit
psilocybin’s scientific and medical use.
Driven by concerns regarding equity of access and a belief that the benefits of
psilocybin-assisted therapies represent a global public good, ITPRI was founded to ensure that
patients everywhere can gain access to these
potentially life-changing therapeutics.
Please note that the content described in this website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please conduct your own research and due diligence and speak with a medical professional before making any major health changes.
PRESS RELEASES
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12 . 3 , 2021
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The protection of your personal data is of vital importance to the International Therapeutic
Psilocybin Rescheduling Initiative. Below, you will all the necessary information regarding our
Privacy Policy in relation to the personal data we collect and
how we use it, including:
• Who is responsible for the collection and processing of your data (data controllers).
• The purposes for which we collect the data.
• The approval process for its
processing.
• The length of time for which
date is stored.
• The third parties that your data may be share with.
• Your rights in
relation to the data we collect.
International Therapeutic Psilocybin Rescheduling Initiative (ITPRI)
Frohbergstrasse 36B
8832 Wollerau
Canton Schwyz
Switzerland
info@reschedulepsilocybin.org
+41 (79) 434 25 78
The operational data protection officer of the International Therapeutic
Psilocybin Rescheduling Initiative is reachable under the aforementioned address, email and
phone number.
Personal data refers to any information or data that could identify a
person directly or indirectly. Personal data includes but is not limited to information such as
email addresses, postcodes, contact telephone numbers, username(s),
credit and debit card number or other data used to make contributions to support our activities.
It may also include unique numerical identifiers such as your computer’s IP address and
information obtained through the use of cookies.
This privacy policy covers all the personal data collected and used by ITPRI.
The user
(you) hereby guarantees that the personal data provided is true and accurate and undertakes to
notify ITPRI of any change or modification
to the data provided. Any loss or damage caused by ITPRI’s website, the party or parties
responsible for data processing or any third party due to the communication of erroneous,
inaccurate or incomplete data in the registry forms
will be exclusive responsibility of the user.
We may collect or receive your data through
our website or forms, amongst other means. In some cases, you provide us will your personal data
directly (for example, when you subscribe
to our mailing list or when you contact us) and in other cases we collect the data ourselves
(for example, using cookies to understand how visitors use our website).
• PURPOSES, APPROVAL AND
CONSERVATION of the data to be processed, sent through:
– Purpose: To provide you with a medium to contact us and for us to answer
your requests for information, as well as to send you notices and information on our products,
services and activities, including by computerised means,
including but not limited to email, SMS and WhatsApp, if the privacy policy acceptance checkbox
is checked.
– Legitimate interests: Your consent upon requesting information through
our contact form and or upon checking
the checkbox for acceptance of the newsletter subscription.
– Conservation: Once your
request is resolved through our form or answered by email, if a new treatment was not generated,
and in the case of having accepted
the receipt of marketing notices, until you request to be unsubscribed from these.
– Purpose: The sending of our marketing bulletin and informational notices
and advertisements regarding our products or services that might fit your interests, including
by computerised means, including but not limited to email,
SMS and WhatsApp.
– Legitimate interests: Your consent upon signing up for our
marketing notices and/or newsletters.
– Conservation: Until the interested party
revokes the consent and requests to be unsubscribed
from the service.
– Purpose: For the correct management of the business relationship with
you, which includes: the management of your orders, sending to the address you indicated,
answering your questions regarding your orders and interacting with
you, processing and follow-up of your order or administering the payment of your order, as well
as for the sending of our marketing bulletin and informational notices on our products and
services, including by computerised
means.
– Legitimate interests: Your express consent. Acceptance of the Terms and
Conditions.
– Conservation: Until the data’s deletion is requested.
The
payment information (credit card number / PayPal
information / bank account details) is not collected by us, but directly by the payment service
providers.
– Purpose: To respond to your requests for information, see to your
requests and answer your queries or issues. In the event your CV is received, your personal data
and professional CV information may be added to our databases
in order to participate in our present and future recruiting activities.
– Legitimate
interests: The user’s consent upon requesting information through the email address or when
sending us information and CV in order
to participate in our recruiting activities.
– Conservation: Once your request is
answered by email, if no new treatment was generated. In the case of receiving your CV, your
data may be stored for a maximum of one
year for future recruitment activities.
It is possible that we retain some personal
data in order to comply with our legal or regulatory obligations, as well as to administer our
rights (for example, in order to file
claims with courts) or for statistical or historic purposes.
When we no longer need to
use your personal data, it will be deleted from our systems and records and will be anonymized.
The provision of personal data requires a minimum age of 14 years old or,
where applicable, having sufficient legal capacity to sign up.
The personal data requested are necessary in order to manage your requests and/or
provide you with the services that you may contract, for which, if you do not provide it to us,
we will not be able to correctly attend
to you or render you the service you have requested.
In all cases, we reserve the right
to decide whether your personal data, as well as other information, will be entered into our
databases.
We sign contracts with trusted third parties so these can carry out a
variety of business operations on our behalf. We only provide them with the information they
need to execute the service, and we demand that they do not use
your personal data for any other purpose whatsoever. We always make our best efforts to
guarantee that all the third parties with which we work maintain the security of your personal
data.
Likewise, the Personal Data
we collect may be sent to:
– Payment service providers and credit reference agencies
for the purpose of verifying your details when this is a condition to sign a contract with you.
– Third parties that help
us provide IT services, such as providers of platforms, storage solutions, maintenance and
support for our databases, as well as support for our software and applications that could
contain data on you.
– Advertising,
marketing and digital media agencies in order to help us offer ads, marketing and campaigns, to
analyse their effectiveness and to manager your contact and your questions.
– Third
parties that help us provide digital
and e-commerce services such as CRM, web analytics and search engines, amongst others.
– Service providers located outside the European Economic Area such as Google, LLC may access
your personal data. These service
providers are under a Privacy Shield and are therefore obliged to protect your personal data
pursuant to a series of protection and safeguarding standards as defined by the European Union.
Any person may withdraw their consent at any time, when this was granted
for the processing of their data. Under no circumstances does the withdrawal of this consent
condition the execution of the subscription contract or the relations
generated prior to the withdrawal of consent.
He or she may likewise exercise the
following rights:
• Request access to their personal data or its correction when this
is inaccurate.
• Request its deletion when, amongst other reasons, the data is no longer necessary for
the purposes for which it was collected.
• Request the limitation of its processing in
certain circumstances.
• Request the opposition to the processing of their data due to reasons related to
their particular situation.
• Request the portability of the data in the cases established
by the regulations.
• Other rights recognised in the applicable regulations.
Where and how to request
your right of consent withdrawal: Through a written letter sent to ITPRI at its mailing address
or email address (indicated in
Point 1), stating the reference “Personal Data”, specifying the right wished to be exercised and
with respect to which personal data.
For the purpose of safeguarding the security of your personal data, we inform you that we have adopted all the technical and organizational measures necessary in order to guarantee the security of the personal data provided from its alteration, loss or unauthorised processing or access.
For us to be able to keep your personal data updated, it is important that
we always inform you when there has been any modification whatsoever to this data, otherwise we
will not be responsible for its veracity.
We will not be held responsible for the Privacy Policy with respect to personal data
provided to third parties by means of links available on our webpage.
If you have any issue or query regarding the manner in which we process and
use your personal data or wish to execute any of the rights described above, please contact info@reschedulepsilocybin.org.
This website uses cookies and data analysis software to track users’
behavior. Users of the site must explicitly accept the use of cookies to navigate the site.
If you leave a comment on our site you may opt-in to
saving your name, email address and website in cookies. These are for your convenience so that
you do not have to fill in your details again when you leave another comment. These cookies will
last for one year.
Google Analytics is a web analytics service. Web analysis is the gathering, collection
and analysis of data about the behavior of visitors to websites. Among other things, a web
analysis service collects data on
which website a data subject has come to a website from (so-called referrers), which subpages of
the website were accessed or how often and for which period of time a subpage was viewed. A web
analysis is mainly used to
optimize a website and for the cost-benefit analysis of Internet advertising.
The
operator of the Google Analytics component is Google Inc., 1600 Amphitheatre Pkwy, Mountain
View, CA 94043-1351, USA.
Google Analytics uses cookies. The information generated by the cookie about your use
of this website is usually transmitted to a Google server in the USA and stored there. Google
might transfer the personal information
collected via this technical procedure to third parties.
As IP anonymization is
activated on our website, your IP address will be shortened by Google within Member States of
the European Union or other states in
agreement with the European Economic Area. Only in exceptional cases, the full IP address is
sent to and shortened by a Google server in the USA. On behalf of the operator of the website,
Google will use this information
to evaluate your use of the website, compile reports on website activity and to provide further
services related to website and internet use to us. The IP address transferred through your
browser to Google Analytics will
not be combined with other data held by Google.
In addition, this website uses the
Analytics feature UserID to track interaction data. This User ID will be additionally anonymized
and encrypted and will not be
linked with other data.
You can prevent the storage of cookies by a corresponding
setting of your browser software; however, please note that if you do this, you may not be able
to use all the features of this
website to the fullest extent possible.
In addition, you may prevent the collection of
the data generated by the cookie and related to your use of the website (including your IP
address) by Google as well as the
processing of this data by Google by downloading and installing the browser plug-in available
under the following link:
https://tools.google.com/dlpage/gaoptout?hl=en
This browser add-on informs Google Analytics via JavaScript that no data and information
about website visits
may be transmitted to Google Analytics.
In addition, a cookie already set by Google
Analytics can be deleted at any time via the Internet browser or other software programs.
Further information and Google‘s applicable privacy regulations can be found at https://policies.google.com/privacy?hl=en
and
The following link provides a further
explanation of Google Analytics https://marketingplatform.google.com/about/.
Our website also uses Google Analytics
performance reports relating to demographics and interests and reports on Google Display Network
impressions. You can disable Google Analytics for display advertising and customize the ads on
the Google Display Network
by visiting the ad settings at this link: https://adssettings.google.com.
Please
note that the content described in this website is not intended to be a substitute for
professional medical advice, diagnosis, or treatment. Please conduct your own research and due
diligence and speak with a medical professional before making any major health changes.
info@reschedulepsilocybin.org
+41 (79) 434 25 78
Frohburgstrasse 36B 8832 Wollerau, Switzerland