Compassionate Access to Psilocybin report
Read our latest report on why patients experiencing 'Existential Distress' ought to be permitted access to psilocybin-assisted psychotherapy
By James Bunn Chief Executive Officer – Psilonautica
Psilocybin for existential distress
Psilocybin has shown promise as a treatment for existential distress, a condition marked by feelings of hopelessness, despair, and a lack of meaning or purpose in life following a terminal diagnosis. Recent studies have found that Psilocybin-Assisted Psychotherapy (PAP) can lead to significant improvements in mood, anxiety, and quality of life.
However, psilocybin remains illegal in many parts of the world, and access to this treatment is limited. As a result, some patients with existential distress may be left without effective treatment options. Legal access to psilocybin is almost exclusively limited to clinical trials participants, which comprise a relatively small population when compared to the number of individuals using psilocybin illicitly or in countries where its possession is de facto, or de jure decriminalised.
Despite the significant interest in the potential clinical applications of psilocybin, and its well-established safety profile, most jurisdictions worldwide have classified psilocybin under the most tightly controlled restrictions, hindering research efforts. While a few countries such as Australia, Canada, and Switzerland permit the prescription of psilocybin by medical practitioners, some jurisdictions offer schemes or programs that enable patients to access drugs that have not yet obtained all the necessary approvals to become a licensed medicine.
Compassionate Access
These initiatives are typically referred to as “compassionate access” schemes, although official names vary across jurisdictions. This report assesses the schemes available to individuals experiencing existential distress in the UK and abroad. Compassionate access schemes allow patients with serious medical conditions to access unapproved treatments in certain circumstances. These schemes may provide a way for patients with existential distress to receive psilocybin therapy. Such schemes would require careful oversight to ensure patient safety and to gather data on the effectiveness of psilocybin for this condition.
Accessibility in the UK
The UK’s Early Access to Medicines Scheme (EAMS) is inefficient at providing patient access, and PAP is not appropriate for this scheme due to several reasons outlined in this report.
Instead, the Canadian compassionate access model could be adopted in the UK to reduce the rigidity of EAMS and provide patients in dire need to access PAP.
UK clinicians are slowly accepting that PAP is a viable medical intervention. This was driven by large patient-led campaigns such as ‘Project Solace’ by the Canadian charity – TheraPsil. Qualitative interviews with patients who have received PAP indicate that compassionate access is essential for vulnerable patients who have exhausted other treatment options and are experiencing significant psychological distress.
Psilocybin is a very effective treatment for existential distress
Empirical evidence from several studies has demonstrated that psilocybin causes a sustained reduction in symptoms of existential distress, for up to four years, and that patients experienced ‘immediate, substantial and sustained clinical benefits’. Research also found that six months following the dose, approximately 80% of their patients continued to experience a significant reduction in their depression and anxiety symptoms, as well as improvements in hopelessness and demoralisation.
Current, approved treatment options for existential distress are confined to psychological therapies, including creative therapies, whose effects have been demonstrated to be modest in both controlled trials and in clinical palliative care settings. ‘Antidepressant’ Selective Serotonin Reuptake Inhibitors (SSRIs) are the most commonly used pharmacological treatment. However, a Cochrane review concluded that the use of these drugs did not result in a reduction in depressive symptomatology compared to placebo.
The UK government’s position needs to evolve
Since 2005, psilocybin has been a controlled ‘Class A’ substance in the UK and anyone possessing the drug can face up to seven years in prison. The Misuse of Drugs Regulations 2001 classify psilocybin as Schedule 1 (drugs with no currently accepted medical use).
On the subject of psilocybin’s possible rescheduling to schedule 2 (which covers drugs with therapeutic value, such as morphine) The Home Office stated in July 2023:
“We sympathise with patients suffering from distressing conditions and can understand the desire to seek the best possible treatment available…. We wrote again to the Advisory Council on the Misuse of Drugs this week to seek their views on removing licensing requirements for legitimate research with clinical trials approval.”
The authors of today’s report welcome the government’s willingness to review its position on psilocybin research and argue that similar flexibility should now be afforded to patient access.
The drug has already completed two out of three clinical trials
Psilocybin is accessible to patients in Canada, Switzerland and Australia — where it is legally prescribed for treatment-resistant depression. For a treatment to be similarly approved in the UK, it needs to complete three (out of four) phases of clinical testing. Phase 1 and 2 trials have already established it as a safe, effective therapy for existential distress. Phase 3 will determine whether the drug is more effective than one already approved, and this will take years to complete.
This report argues that terminal patients don’t have this time and they deserve compassionate, early access.
Compassionate access is not just possible, it has life-changing precedent
In England and Wales, the Early Access to Medicines Scheme (EAMS) is a regulatory framework that facilitates compassionate access to unlicensed medical products/ ‘promising innovative medicines’. It aims to ‘give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need’.
All of which is relevant to psilocybin.
EAMS is implemented through the Human Medicines Regulations 2012 (SI 2012/1916) which transposes the EU legislation into UK national laws. EAMS was established by the Medicines and Healthcare Products Regulatory Agency (MHRA) in April 2014 and allows clinicians to apply for an exemption from the standard rule that only licenced medicines can be prescribed, on behalf of specific patients. Examples include Remdesivir, the first antiviral treatment for Covid-19 and Atezolizumab, a lung cancer medication.
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Lead author, James Bunn states:
“These four points make a convincing case for compassionate access to psilocybin. It isn’t even a groundbreaking idea, as Swiss, Australian and Canadian patients are already doing it.
So as always, we encourage the UK government to follow the science. And we welcome their willingness to look again at laws that are stopping patients here from accessing a therapy that could really benefit them.
And the evidence is already in. Psilocybin has already proven to be very, very effective in helping this patient group with their distress. And the last thing these people need is to be criminalised, simply because the approval process for drugs is so slow.”
Find out more
Terminal patients and scientists are joining forces and call for the UK government to redraw its rules around psilocybin therapy.
To read these incredible patient stories please click the link below and if you would like to contribute to this work, please contact the lead author here.