Health Canada considers amending Special Access Program

by Jan 30, 2021

Health Canada may revise the Special Access Program to allow patients with a serious or life-threatening condition to request access to psychedelic therapy

Health Canada has decided to revise the terms of the Special Access Program (SAP) to allow patients with a serious or life-threatening condition to request access to MDMA and psilocybin assisted therapy. MAPS Canada supports this initiative and will be sending a letter to support the initiative.

The effectiveness of pharmaceutical therapies, regardless of their arbitrary listing as scheduled compounds, should be paramount when suffering Canadians remain in need.

Health Canada’s Special Access Program

When Canadian healthcare options fail, the occurrence of which would be absurd to refute, Canadians should have few limitations in their search for relief, healing, and peace.

While this justification remains adequate, it remains even more unbelievable that Canadians can be prosecuted for cultivating and consuming a mushroom – many species of which grow plentifully in the glorious forests and plains of Canada.

It continues to befuddle the conscious that a Canadian, dying of cancer, cannot collect wild, indigenous flora and bring them to a healer for the purpose of attaining peace of mind in their remaining time in our great land.

It saddens the spirit that a Canadian veteran, burdened with experiences that no human should suffer, must shun a fungus to treat their PTSD for fear of federal punishment.

By excluding scheduled compounds from the SAP program, important research is slowed and Canadians suffer – those most in need of innovative and novel treatments.

The deadline to send your input to Health Canada is February 10, 2021. You can read the full proposal here.

You can contact Health Canada directly on the matter at hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca

Letter from MAPS Canada

We are pleased, on behalf of the Multidisciplinary Association for Psychedelic Studies (MAPS) Canada, to congratulate Health Canada on their decision to consider removing the language prohibiting access to psychedelic medicines listed in the schedule to Part J of the Food and Drug Regulations.

MAPS Canada is a registered non-profit organization based in Vancouver, British Columbia. Our organization is committed to conducting and publishing scientific research and education supporting the beneficial uses of psychedelic medicines, which have already yielded promising results in the treatment of post-traumatic stress disorder (PTSD), end-of-life anxiety, major depressive disorder, and addictions.

Up to one third of Canadians will experience mental illness in their lifetime (Government of Canada, 2017), and studies show that many people live with mental illnesses that do not respond to conventional treatments (Rizvi et al., 2014). Beyond the unacceptable personal hardship imposed by mental illness, its economic burden to Canada, being a leading cause of disability and reducing a person’s life span by up to twenty years, is approximately $51 billion per year in costs including health care and lost productivity (CAMH, 2020).

While our government at all levels has taken the immediate and necessary precautions to prevent the spread of the coronavirus disease outbreak (COVID-19) in our communities, the pandemic is exacerbating the existing mental health crisis in Canada. For example, two recent surveys (Mental Health Research Canada, 2020, and Angus Reid Institute, 2020) indicate that the majority of Canadians reported worsening mental health since the pandemic began, with many feeling worried and anxious.

There is currently much interest and renewed clinical research into the potential therapeutic benefits of several psychedelic drugs, and emerging evidence suggests that psychedelic-assisted therapy holds the potential to radically change how chronic mental health issues are viewed and treated. For instance, the Food and Drug Administration in the United States of America has granted “breakthrough therapy” status for psilocybin and 3,4-methyl​enedioxy​methamphetamine (MDMA) therapy.

MAPS Canada is supporting clinical trials for MDMA-assisted therapy for PTSD in the context of MAPS USA, which is obtaining promising results indicating that MDMA may be more effective than conventional treatment methods (Jerome et al., 2020, and Mithoefer et al., 2018).

However, there are still significant barriers to access for Canadians who need these therapies now. To this end, we strongly support the proposed changes to the regulatory scheme which, as it stands, prevents access to life-changing psychedelic medicines. Specifically we support Health Canada’s proposal to repeal subsections C.08.010 (3) and C.08.011.1 (2) in Part C of the FDR and therefore allow restricted substances to be available through the Special Access Program.

Finally, you will find attached a list of people who support this letter, which includes concerned Canadian citizens, health professionals and advocates from across the country. In closing, given the current circumstances and emerging evidence, we are confident that the proposed regulatory amendments will contribute to the betterment of Canadians’ health.

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