Psilocybin Regulation: GSJ & Co's Position Regarding Proposed Changes to the Special Access Program

On February 10, 2021, G.S. Jameson & Company submitted comments to Health Canada’s public consultation on proposed changes to the regulatory framework governing the Special Access Program (SAP). The SAP permits access to drugs that have not yet been approved for sale in Canada for patients with serious or life-threatening conditions. If approved, the proposed changes would allow access to “restricted drugs”, including psilocybin, through the SAP. While GSJ & Co supports a move towards more progressive regulation of psychedelics for medical treatment, we question whether the SAP is the most appropriate framework to regulate these important therapeutic options.

Our full letter can be found below.

FULL TEXT:

On behalf of my law firm, I am pleased to have the opportunity to comment on Health Canada’s intention to reverse regulatory changes made to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations in 2013, which prohibited access to restricted drugs for Canadians experiencing certain medical emergencies through the Special Access Program (“SAP”) and added unauthorized products containing cocaine to the definition of restricted drug.

G. S. Jameson & Company acts primarily for food value chain and life sciences stakeholders to assist with their regulatory and commercial needs. Over the last several years, our work has broadened to include clients that operate in the evolving psychedelic space working with substances governed under both or either the Controlled Drugs and Substances Act, SC 1996, c 19 (“CDSA”) and the Food and Drugs Act, RSC 1985, c F-27 (“FDA”) and as such we are engaged in a wide variety of roles relating to the regulatory and commercial needs of industry stakeholders.

Our comments in response to this consultation are based on our experience working with clients operating in the psychedelic sector and are not advocating on behalf of any particular client or group of clients. We thank you for the opportunity to provide comment and to contribute. We look forward to Health Canada’s evolving approach to controlled drugs and substances as accepted bodies of scientific and medical research grow and as Canada’s key trading partners are exploring a more permissive approach to the research, production, and use of controlled substances.

In responding to the proposed regulatory reversion, it is important to ask whether the prior use of the SAP actually benefited Canadians with health conditions that merited an application to the SAP for the use of psychedelics. We believe it would be incorrect to describe the SAP prior to the 2013 reforms as a process that enabled Canadians with medical needs to access psychedelic substances. So, we wonder if this regulatory change is progressive, or if it is a return to the bad old days of the SAP.

We support removing the prohibition on access to restricted drugs through the Special Access Program as a way to reduce the effect of the politics of the day on the decision-making process. Equalizing the treatment of psychedelics with other non-restricted drugs moves Canada in the right direction by helping to destigmatize the use of psychedelics for patients for which psychedelic treatment is an appropriate option; there can be an established pathway where currently there is none, other than seeking a Ministerial exemption. While acknowledging that the SAP is also currently subject to Ministerial discretion, we applaud the government’s intention to make psychedelics more widely available through a concrete framework other than Ministerial exemptions under s. 56.

However, we do not agree that the SAP as it currently exists is the appropriate framework in which to approve the treatment of psychedelics. For one, critics have described the SAP process as flawed because it “professes to make evidence-based decisions in situations where evidenced-based decision-making is impossible”, resulting in opaque, value-laden decisions.[1] Emerging evidence for the use of psychedelics treatment in a variety of conditions is strong, but it is still just that—emerging. What is the threshold of evidence required for psychedelics access to be approved for the SAP program? Will a handful of studies from prestigious American universities suffice?

Similarly, others have looked to the function of the program – responding to medical emergencies – as being unsuitable for the far-reaching situations that the program is asked to assess.[2] When does a condition that is potentially treatable through the use of psychedelics become a medical emergency? At what point is treatment resistant depression, PTSD, anxiety or mood disorders sufficiently urgent to be deemed an emergency? The clinical use of MDMA or psilocybin is unlikely to respond to the same emergencies that anti-malarial drugs or HIV medications can so easily demonstrate.

In addition, the SAP program is fundamentally designed for drugs that are not available in Canada and thus generally not manufactured in Canada. This makes sense for non-psychedelic drugs. SAP-approved drugs are often granted to patients prior to the drug being approved by Health Canada, thus creating the need to import the drug from a foreign market or a designated foreign manufacturer. For naturally occurring drugs such as psilocybin, for which production is not monopolized by one manufacturer, how will Health Canada make decisions about which manufacturer to authorize a letter? Will Health Canada be guiding and supporting the Canadian psychedelic industry through similarly formalized pathways that aren’t centred around ministerial discretion? Will manufacturers of psychedelics be assessed against industry standards? Will certain methods of production be valued over another (e.g. synthesized vs. natural cultivation)?

The Canadian psychedelic industry has quickly become among the global leaders in resources, process, technology and science. Canada could have a robust psychedelics cultivation industry if we had the right regulatory environment for it. We worry that the design of the SAP to access foreign drugs will be disproportionately impactful on domestic producers of psychedelics. If we’re opening up this pathway for the use of psychedelics by Canadians, then shouldn’t we ensure a manner to manufacture psychedelics within the safety of Health Canada’s drug manufacturing framework?

As Canada continues to open up the market for psychedelics treatment, the potential for safe, efficacious psychedelics production by Canadian manufacturers is significant. Health Canada should ensure that decisions made under the SAP program prioritize Canadian businesses in the procurement of psychedelics and support these businesses to ensure high industry standards. As Canada continues to take steps towards increasing accessing to psychedelics for those in need, Canada has a unique opportunity to design a robust regulatory framework for the cultivation of quality psychedelics from the ground up. 

[1] Christie, Timothy K.S., Harris, Marianne, Montaner, Julio S.G. “Special Access Denied: A Case Study of Health Canada’s Special Access Program.” Healthcare Policy Vol. 2, No. 2, 2006.

[2] Houston, Adam R., Blais, Catherine-Marie, Houston, Stan, Ward, Brian J. “Reforming Canada’s Special Access Programme (SAP) to improve access to off-patent essential medicines “ Official Journal of the Association of Medical Microbiology and Infectious Disease Canada Vol. 3, No. 2, 2018.

India Annamanthadoo