What is the Special Access Programme?
On January 5th 2022, Health Canada amended the Food and Drug Regulations and the Narcotic Control Regulations to allow previously excluded ‘psychedelic’ drugs such as Psilocybin to be included on the ‘Special Access Programme’ (SAP).
The SAP allows healthcare practitioners to request limited access to drugs that are not authorized for sale in Canada, for their patients. This is requested on a patient-by-patient basis examining the individual needs of that patient to determine whether said patient could benefit from a drug that is not yet legally available in Canada.
Who is eligible to access drugs through the SAP?
The SAP is intended for patients that:
- Have a serious or life-threatening condition
- Have not responded to conventional treatments
Have no suitable treatment options for their condition.
Why is this important?
‘Compassionate Access’ schemes exist in different jurisdictions all over the world. However, this programme is somewhat unique, as it allows any health care professional that has prescribing privileges in their province to file an application for a patient to receive psilocybin.
It is important to note that the SAP is only operational in Canada. The UK has a programme which is meant to be equivalent to the SAP called the ‘Early Access to Medicines’ Scheme. However, a psychedelic substance has never been prescribed through this scheme and it is unlikely that one ever will.
What is ‘Project Solace’ to patients?
TheraPsil has been supporting patients to access psilocybin through Health Canada’s ‘Section 56 exemption’ law. Section 56 exemptions are granted by the Minister of Health, who has the discretionary power to provide an individual with an exemption to possess a specified quantity of a controlled substance. The Minister of Health can also use this power to permit a therapist to administer a controlled substance to human subjects or animals for the purpose of research. In essence, this removes criminal sanctions for people wanting to possess or administer psilocybin. However, the aforementioned psilocybin still needs to be accessed illegally, as there is no exemption that can apply to a medical psilocybin product. Therefore, patients are still forced to access these drugs through the ‘black market’. Health Canada have created the SAP pathway for Canadians to access psilocybin-based medical products through professional and trusted manufacturers, rather than through the illicit market.
Project Solace is TheraPsil’s response to the change in the regulations on January 5th 2022, and is based on the framework of Drug’s Science’s observational medical cannabis study Project Twenty21.
TheraPsil’s mission has always been to support patients to access psilocybin-assisted therapy for those in medical need. TheraPsil believe that psychotherapy is vitally important to psilocybin’s potential to heal some of the hardest to treat conditions. To ensure the highest chance of success, Project Solace will pair patients with a local ‘Psilocybin-treatment team’. This treatment team will be trained to deliver the safest and highest quality psilocybin-assisted psychotherapy that’s available in the world right now.
To find out how you can access psilocybin-assisted psychotherapy through Project Solace – Click here.
Patients are already being granted access to psilocybin through the SAP programme from a small number of professional psilocybin manufacturers, ensuring that patients are dispensed high-quality medical-grade psilocybin products that are pure and precisely measured.
What is ‘Project Solace’ to Healthcare Practitioners?
The SAP puts a lot of responsibility on a Healthcare Practitioner to be well informed about psilocybin before prescribing it through the SAP. A Healthcare Practitioner is required to provide data about “use, safety and efficacy,” of psilocybin. Most Healthcare Practitioners will not be aware of the recent research regarding psilocybin as a treatment for conditions such as:
- End-of-life Distress (eg from a palliative diagnosis)
- Posttraumatic stress disorder (PTSD)
- Chronic Pain (eg cluster headaches)
TheraPsil is supporting Healthcare Practitioners to prescribe psilocybin for patients by providing template SAP applications for these four indications and will be looking to expand to other indications in late 2022.
In addition to this, Healthcare Practitioners are also expected to have an understanding of psilocybin-based medical products that have been granted SAP approval. TheraPsil will support Healthcare Practitioners by providing them with a product formulary and detailed medical product information leaflets for each medical-psilocybin product.
To find out how you can prescribe psilocybin for your patients through Project Solace – Click here.