Will Alberta’s new regulatory framework for the delivery of psychedelic therapies pave the way for their integration into the healthcare system, or will it create a barrier to access for patients?
Alberta will be regulating the delivery of psychedelic-assisted therapies to ensure the safety of patients.
The bill proposes that, with certain exceptions, clinics offering psychedelic-assisted treatment must be licensed and have the medical oversight of a psychiatrist, and patients undergoing psychedelic drug treatment must be monitored by qualified health professionals.
The change will only apply to licensed medicines which, in Canada, is currently only ketamine, with substances such as MDMA and psilocybin being delivered as unlicensed medicines under Canada’s Special Access Programme.
Limiting patient access?
The development in Alberta has been largely welcomed, but Project Delivery Manager at non-profit TheraPsil, a coalition of professionals dedicated to providing access to psilocybin therapy for patients in Canada with a palliative diagnosis, James Bunn, highlights that reservations remain regarding the lack of patient consultation over the process and the challenges that some of the changes may create for patients.
“This development is about laying the groundwork for the method in which psychedelic-assisted psychotherapy is going to be delivered going forward as drugs become regulated in Alberta,” says Bunn.
“There are two things that people within this industry think are terrible about this change.
“The first being the need for a psychiatrist throughout this process. Lots of people believe that to deliver this sort of therapy, you don’t really need a psychiatrist to be present and if anything, they know less than the psychotherapists. It’s just a different kind of modality.”
Bunn highlights that the requirement to have a therapist present during the delivery of the care will only rack up prices for patients. In the short term, with the changes currently only applying to ketamine, this would pose a barrier to patient access to ketamine therapy in Alberta.
In the long term, this could have an impact on patient access to psychedelic therapies in Alberta as regulation around therapies such as MDMA and psilocybin evolve.
“It does mean that those in Alberta will have to have a psychiatrist on board throughout the process, which is inevitably going to rack the prices up and price some people out. Whereas actually, you could do it with a registered nurse that’s gone through psychedelic-assisted psychotherapy training.
“And although the regulation states you need a psychiatrist there, they don’t say that psychiatrist needs to be trained to deliver this type of therapy.
“However, I also understand that in order for government agencies and regulators to feel comfortable with this in the first place, you need to take the most conservative approach.”
For feedback on the framework, the government did not consult with patients or patient bodies, notes Bunn.
“The other thing that I think the psychedelic industry will lament by this decision is the consultation process that happened to come to these decisions. This one does seem to have happened a lot behind closed doors.
“The consultation should really take into account patient views on the matter. It does feel like a lost opportunity to get consulted those that do the therapist training in Canada and do the clinical trials which are approved. I wish they had opened this out to asking for patient views on this and also those that facilitate patient access.”
Change is coming
Bunn emphasises that, while there may be issues that need ironing out, the development is a win for psychedelic-assisted therapies – with the move symbolising a coming change.
“This is a symbolic move of the Canadian province,” said Bunn. “It is saying – let’s take a chance on regulating psychedelic therapy. Firstly, this indicates that Alberta’s government is aware that change is coming – that something is going to happen soon and that there is a need to do this.
“Otherwise, they would have just said that these are the rules for regulating ketamine, but they said these are the rules for regulating psychedelic therapy. I think that’s a really huge win.
“I’m really pleased that this is moving forward. It’s a great sign – Canada is showing really good promise of progressive policies.”
Bunn says the best way for progression to happen now would be federalised regulation on psychedelic-assisted therapies, rather than on a state-by-state basis.
“Advocacy groups need to be involved, whether that’s charities or non-profits that have been operating in the space for years,” says Bunn. “Key academics need to be involved as well as those that have been delivering them as a clinical investigator for a clinical trial of some kind.
“A process of how prescriptions are delivered to patients needs to be worked out, and whether it’s included on local insurance, for example. I would like at least to see a want from the government to get as many views on this as possible because there are a lot of people that would love to talk about this.
“Overall, this is a great win. It’s just a hard one to swallow sometimes.”
