Project Solace

The Special Access Program (sometimes referred to as the SAP) is Health Canada’s preferred pathway, outside of clinical trials, for patients in medical need to access legal psilocybin-assisted psychotherapy and psilocybin for medical purposes.

As of January 5th, 2022, Prescribers (MDs and Nurse Practitioners) can now request psilocybin products from Health Canada approved manufactures, on behalf of their patients with a life-threatening or serious illness through the SAP.

You can learn more about this pathway, here.

Through Project Solace, TheraPsil will support prescribing healthcare practitioners in Canada to feel confident and capable to request psilocybin-based medical products on behalf of their patients through Canada’s Special Access Program. As part of ensuring patient safety and treatment efficacy, TheraPsil will also identify and connect prescribing healthcare professionals with treatment therapy teams across Canada that will support patients in medical need through the facilitation of psilocybin-assisted psychotherapy.

Project solace will begin assisting patients in 5 primary regions and expand as additional treatment teams are onboarded.

TheraPsil will help prescribing healthcare professionals to request cGMP psilocybin from licensed dealers enrolled in Project Solace.

Patients who consent to participate in Project Solace will complete standard healthcare questions at various points in their psilocybin-therapy journey including during preparatory and integration sessions.

Several barriers prevent psilocybin to be widely utilized as a treatment for those in Canada. While the current subsection 56(1) exemptions have helped exemption holders to avoid a criminal conviction, it is not sustainable. Individuals with a section 56(1) exemption have been permitted to use and possess psilocybin for medical purposes, but they are still not legally able to access the drug from a reliable and safe source. In most cases, individuals who hold a subsection 56(1) exemption have unwillingly accessed psilocybin on the illicit market and therefore, they have had to break the law. Furthermore, because these products are not regulated, to date, there has been no real data collected regarding the safety and efficacy associated with psilocybin products obtained by patients in medical need.

In lieu of this, the Special Access Program (SAP) now begins to be the favoured route of access to psychedelic-based medical products in Canada. However, it still requires layers of bureaucracy and the support of a prescribing Healthcare Practitioner who is proficient in completing the necessary paperwork and willing to collaborate to form a treatment team.

For many patients, SAP is only a viable option when provided sufficient support throughout the process. TheraPsil sees an opportunity to work collaboratively with Licensed Producers and our network of trained treatment teams to ensure that patients are adequately supported in their quest to gain healing through psilocybin-assisted psychotherapy and in turn, that they are able to access a safe supply of GMP grade psilocybin. The efficacy of these medical products will then be documented through real-world data and observational research.

This data will be provided to regulatory bodies such as Health Canada, the Canadian Institutes of Health Research (CIHR), and the Royal College of Physicians and Surgeons of Canada, to facilitate decision-making surrounding the regulatory system for the future of medicalized psilocybin.

Interest in the burgeoning ‘psychedelic industry’ has blossomed over the past 10 years. Prior to 2012, you could count the amount of ‘psychedelic medicine providers’ on one hand. Now, this number has risen exponentially, as old and new pharma are realizing the viability of psychedelic based medical products (PBMPs).

Despite this, the 1971 UN Convention on Psychotropic Substances has placed significant barriers to bringing these medicines to market, requiring Licensed Producers (LPs) to spend inordinate amounts of money and time attempting to push psychedelics through various regulatory frameworks around the world. As a result, many of these pharmaceutical companies are spending tens of millions of dollars to have their products tested in cohorts of 100 people or less.

It is widely recognized that there is a need for additional research to support the use of medical psilocybin worldwide, as the rapid rise in the use of psilocybin has not yet been accompanied by conclusive evidence of its efficacy. Although randomized controlled trials (RCTs) are regarded as the gold standard of evidence, many individuals who are seeking psilocybin access for medical reasons are not suitable to be entered into the clinical trial process due to various barriers such as specific inclusion criteria, geographical restrictions, and time sensitivity. Additionally, RCT evidence for the effectiveness of PBMP for a wide range of conditions has been increasing rapidly. But little is known about the differences between PBMPs.

Thus, we propose a real-world registry to map out the benefits of psilocybin as a robust and compassionate treatment for those in medical need. The findings will make an important contribution to research, practitioners, and politicians. The results should then instigate changes in funding, prescription patterns, and legal frameworks, respectively.

In the Medical Cannabis space, there was a large shift post-2015, with large-scale databases being developed by Health Canada (2015), BFarm (2020) in Germany, and the Minnesota database (2020). For 2021, both the French and the UK governments have announced that they would begin their own national databases to collect data on the effectiveness of Cannabis-Based Medicinal Products (Pascual 2020) and in the charity sector, Drug Science (UK) has developed the largest European and Australian real-world database of medical cannabis products. These are now being relied upon to give longitudinal data of the pharmacovigilance of the safety and efficacy profiles of medical cannabis products.