Spencer Hawkswell | CEO, TheraPsil

Spencer Hawkswell is the CEO of TheraPsil, a coalition of healthcare professionals, patients and advocates dedicated to fighting for the rights of Canadians facing end-of-life or illness-related distress to have compassionate access to psilocybin-assisted therapy.
In our last interview with Spencer in December of 2020, we talked with him about his background, how he became interested in psychedelic-assisted therapy and became involved with TheraPsil. At that time, Section 56 Exemptions had only recently been offered to patients and practitioners. Now, with recent changes to the Special Access Program, we wanted to revisit with Spencer and find out what has changed since then.
You can read the previous interview here.
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Since we last spoke, TheraPsil has helped dozens of patients and practitioners gain Section 56 Exemptions to facilitate access to compassionate end-of-life psilocybin-assisted therapy and launched a training program for qualified Health Care Practitioners to offer psilocybin-assisted therapy.
Most recently, Canada appeared to loosen regulations and allow expanded compassionate access to these important programs through, not only Section 56 exemptions, but now the Special Access Program.

This SAP regulatory change hasn’t expanded access has it? What has happened since this new regulation change has been implemented? 

The Special Access Program is now one of three regulatory routes for patients to access psilocybin.

In the past, it was Section 56 exemptions or clinical trials and much of our programming, the work that TheraPsil has been doing, was supporting the patients who didn't have enough time or the resources to get into clinical trials, of which there are many people. So, we focused on advocating for compassionate access and we’re able to secure that through section 56 exemptions.

We think it's wrong for people in Canada to be denied access to a mushroom when the only alternative is medical assistance in dying or continuation of treatments that aren’t working. So we were, of course, excited to hear about the special access program being an alternative for patients to access psilocybin, but for the last year, we've had some concerns. Specifically, addressing the concern that the Special Access program still leaves the decision of whether or not a patient gets access to psilocybin in the hands of a bureaucrat, not at the discretion of a doctor.

What we're seeing today is that the Special Access Program, which is intended to be one of three routes, is now being treated like the only route. We're putting patients through the Special Access Program and supporting the patients with a doctor already by helping them with the paperwork — which is about two to six hours of paperwork per application. If you're working on a new diagnosis for which the SAP has not been used before, or new products, it can take up to two months. That's how long it's been taking us. So, unfortunately, for some patients and doctors, the Special Access Program is actually blocking access — It's more like the “Slow Access Program.”

It's unfortunate, because these are patients who have section 56 exemptions written already.  Section 56 exemptions are much less time and resource dependent. Doctors, patients, nurses or therapists can get one together in a matter of hours, in fact, less than an hour, and submitted to the government. Those exemptions, at one time, have been granted in as little as 24 hours.

These SAP approval requests, however, are taking a lot of time. It's very demanding on the doctors that they have liability insurance and that they know how to prescribe controlled substances. It’s now being treated as a prescribed substance, which is different from the Section 56 exemptions.

So, essentially, you have two resources: SAP approval and Section 56 exemptions. But for many patients and doctors, the SAP is too difficult. Section 56 needs to be an alternate route. What we're finding is that Health Canada is not treating it that way. They're actually denying patients on the basis that they haven't fully utilized SAP even though they've communicated very clearly that it's not possible.

For example, there is a patient who was waiting for two months to get access to psilocybin through section 56 and reaching out to the Minister of Health Canada. They responded that they were not going to grant the exemption until they had tried the SAP route. We communicated back to Health Canada that there are no doctors or resources available to this patient, nor do they have the time to wait for SAP access, they're going to pass away before that time comes. And unfortunately, Health Canada ignored that patient and it's too late for that patient now. 
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This is so unfortunate because it’s in contrast to past exemptions where patients — who were in severe distress and close to death — were getting access to psilocybin in as little as 24 hours through Section 56 exemptions. I think I can confidently say that the introduction of this SAP program has been disastrous for patients.

Does this new SAP regulation restrict how people can access psilocybin?

Absolutely. The main difference between SAP and section 56 is, when we're talking about SAP, we're talking about a doctor prescribing a drug. That doctor needs to then provide evidence showing why that drug is going to be effective in treating the patient's disorder.
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Luckily, we have evidence showing that psilocybin 99.99%, pure GMP, psilocybin is effective in treating end-of-life distress. So, that doctor is making a regulated, legal prescription.
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With a Section 56 exemption, it's not a prescription — it's just a doctor saying, “Can you please exempt my patient from the laws that would otherwise criminalize them from accessing their psilocybin?” And that's easy.
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It's almost like Health Canada has amnesia. Let's use history as an example and look back at what doctors have been doing with cannabis. Prescription cannabis was not the popular choice. It’s still not the popular choice for doctors, the popular choice are medical documents which support medical access to cannabis at the patients discretion. What we're seeing now is the exact same thing. The doctors don't know what psilocybin “the prescription drug” does. But everybody knows what psilocybin does — like mushrooms. We know they're safe; we know they're effective; we know they have no known overdose. Doctors are comfortable prescribing that, and unfortunately, this policy goes against what doctors and patients want, which is why, though it may help some, it leaves a lot of people in the dark.

Why is it important for exemptions to be allowed for training purposes?

It's interesting that the current government is going against past precedent. Minister Patty Hajdu, our previous health minister — a wonderful politician, health minister, and leader—granted these exemptions for health care practitioners and patients. 
Now, for some reason, minister Jean-Yves Duclos has declined to live up to that legacy and follow suit.
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We’re now in a situation where we're making this substance available to patients without allowing health care practitioners to train with it. If you don't train healthcare practitioners how to use these substances, if you don't let them know about the issues that come up, specifically regarding to sexual misconduct, over bonding, transference syndrome; these things become more possible and more likely.
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The training is very important. It's important for patient safety; it's important for health care practitioners safety. But, the minister seems to be blocking training, as well as access. We should be granting exemptions to health care practitioners at the same time as patients, or before patients, so that practitioners can train properly.
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Right now, we have approximately 160 healthcare practitioners looking for exemptions to complete their training and treat patients. About 90 to 100 of them have received letters of “intent to refuse” from the Minister of Health saying that clinical trials are a better route.
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And that's absurd. We know that clinical trials are the right route when you have a specific question to answer. What's the question we're asking? Is it better to provide therapy with training? Obviously, it is.
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In the US, they have a code of ethics for clinical trials. It's actually unethical to force someone to do clinical trials when there's no reasonable question. We are proclaiming that it is unreasonable to force us to ask if training helps with therapy. We hold that to be self-evident. It is a self evident statement that training makes therapy better.
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In many ways, it feels like, far more often, we're being sent on a wild goose chase and given excuses instead of genuine support. Which is unfortunate when what we need is compassion from the government and help for patients and healthcare practitioners.

Why are some health care practitioners allowed access and training, but others not? And how is that limiting patient access?

It's an issue of equality. It's a major issue of equality in Canada. Our government is actively discriminating against patients and health care practitioners. They're essentially saying that one patient is more important and deserves access, while another patient doesn't — that is completely unconstitutional.
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It's sad to see how little regard there is for our constitution these days. This is a matter of Canadian rights, specifically, Section 7 and Section 15 of the Canadian Charter of Rights and Freedoms. Charter 7 protects the rights to life, liberty and security of persons.
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In the past, with regards to cannabis, it was deemed absolutely against the charter and against a patient's rights to life, liberty and security of persons. To leave the decision of access up to the minister and to make them pursue illegal pathways was all deemed unconstitutional. As Canadians, we should be able to use common sense and say — shouldn't that apply to psilocybin also? Obviously. Yet, here we are fighting for just that.
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So, it is a disregard for what's been proven in the past. Then — right when you think that we're making progress — we encounter a new government that thinks it's okay to ignore palliative patients and doctors.
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The support we have is growing, and we've got a charter challenge brewing right now. We're actually launching fundraising this week on whether to do a judicial review, or a full charter challenge because, you know, it's going to cost about $100,000. It's not easy. And quite frankly, it's unfair to have to make non-profit groups, like us, and patients raise money to bring the government to court.
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We need an effective government who listens — that's what we need. We can't be taking them to court all the time. That charter equally applies to the patients who have this right to not be discriminated against and to have access to psilocybin and then it also applies to the healthcare practitioners. What's the difference between Dr. Masuda and  any other doctor? They should all have the ability to get psilocybin Section 56 exemptions to use for training purposes to better treat their patients, either through the SAP or Section 56— whatever works best for them and their patient?

Is this new regulation a step backwards in some ways?

Whenever you make policy, especially at the federal or provincial level, you always set a date and you usually have a team checking to see if that policy does what it purports to do. So if you have a policy or program that tries to reduce, say, the amount of drinking in schools, you want to make sure that that policy is actually making the problem better, not worse.

Interestingly, what we have found is that a lot of times, those policies can make things worse. And we don't exactly know why.
We need to understand huge systems and human behavior to create effective policy, because these initiatives don't always do what they purport to do. So, it's important to look at the policy pragmatically and say, “Is this working or is it hurting people?” and the second you find out that it’s hurting people, you should find out why, and probably stop it or make adjustments.
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The new policy itself, the SAP, in a perfect world, shouldn't hurt anybody. Theoretically, it should make access better. However, the way that it is being executed right now is with this assumption that it's SAP first, and then section 56. In that sense, it is quite literally blocking patient’s access.
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At a glance, the Special Access Program regulation change has nothing wrong with it, it should be positive. The way Health Canada is executing it right now though, I can tell you with confidence, is harming the patients that are trying to get access to psilocybin. It is slowing or even blocking their access. The policymakers in Ottawa, they may say it's better, but our experience here on the ground — with the couple hundred patients and health care practitioners we are supporting — I can tell you, it's making things worse for a lot of them.
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The SAP right now is set up in such a way that you need scientific, or clinical data that shows why a drug is suitable for your patient. We've got lots of research on psilocybin for end-of-life distress. However, if we're talking about psilocybin for cluster headaches, or substance use disorder, it's very possible that we do not have enough evidence for that, in which case, our patients are going to be denied access and Section 56 exemptions will be the only alternate route.
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The SAP program in itself is not perfect; it's not going to address all of the Canadians that need access to psilocybin in a timely manner. In the past, when Health Canada has told us that the best route is to go through clinical trials for patients, we calmly let them know that — yes — the patients who qualify for clinical trials have already been directed to clinical trials. We're supporting the people for whom clinical trials are not possible. Similarly, we're doing the same with patients for whom SAP is not possible. It's just unfortunate that that's falling on deaf ears and leading to patients not getting access.

What has Therapsil been doing to advocate for patients and change these rules to be more compassionate and consistent? 

I think that our strategy has always been incredibly clear to the Minister of Health and to the Canadian government — we want to work with them. We want to support patient’s rights. What we're facilitating is the actualization, or the realization, of Canadians Charter rights so that they can access psilocybin for medical and compassionate purposes.
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We have wanted to play ball and work with the government for the past two years, and we were very lenient when the new minister came into Power. Earlier this year, however, after a number of months for some patients, almost 365 days of waiting for just a response to their exemption request, and people are still waiting — people who are eligible for medical assistance and dying from their condition.
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Minister Jean-Yves Duclos is making patients wait a year for a response to an urgent need for access to psilocybin. It's completely unacceptable. At some point, we cannot continue to try to be diplomatic. And at some point, we have to move towards the court system—towards a legal challenge—and I'm very sad to say that, because that is the point where patients start dying before they're getting responses. But that’s where we are currently at and so it's unacceptable for us to allow that to happen. We've got to move towards the courts, and try and force a decision. We're confident, though, that this court challenge will win. We know what our rights are. We know what the charter says and we know what past decisions have been in regards to cannabis.
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It's a sad day in Canada, when our government is so irresponsible to the patients that they're supposed to serve, that they ignore their requests, and would rather things be pushed to the courts instead of having the courage to make a decision — even when the majority of Canadians support that decision. Maybe the bureaucracy is just too big. Maybe certain politicians' hearts aren’t big enough. I don't know what it is. But absolutely, we'll be taking it to court. 
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We're fundraising now. Because we can't have a repeat of what happened with cannabis. People can't be waiting 20 years for policymakers to slowly make their way and realize that this is a medical right. We have to get there sooner than last time.

What can individuals do to support Therapsil and to help pass meaningful legislation for compassionate access to psilocybin? 

The best thing that people can do is support our legal challenge, so that we can then support these Canadians who are being denied access to psilocybin against their Charter 7 Rights. It's unfortunate that it's come to that, but I know that that's a winning winning strategy, it's going to be successful.
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We do not have a lot of time — patients are suffering right now. So, we're trying to launch this as quickly as possible.
We're looking to fundraise $100,000, as soon as possible so that we can launch this charter challenge. We retained our legal team and the support of a number of patients and we’re ready to go. We hope that the Canadian public can help us accomplish this, by donating funds to support patients in a push towards new regulations.

Are there any other organizations, politicians, or healthcare practitioners who are helping you advocate for these changes? 

We are looking to work with as many Canadian organizations as possible. We don't have formal partnerships yet, but we are excited to be working with a few organizations: the Canadian Psychedelic Association, MAPS Canada, and the Heroic Hearts project in Canada. 
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I think working with universities will also be really important and, of course, politicians too. We've had extensive communications with Sheila Malcolmson, the BC Minister of Mental Health and Addictions. But we need to continue communicating with our national ministers, like Jean-Yves Duclos, our Minister of Health, and Dr. Carolyn Bennett, our Minister of Mental Health and Addictions.
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Recently, several MPs have all signed an open letter to Minister Jean-Yves Duclos seeking immediate response to these patients and health care practitioner exemptions and requesting progress on medical psilocybin regulations. Those MPs included: Dr. Marcus Polewski, Marcus Powlowski, MP of Thunder Bay - Rainy River, Ontario; Nathaniel Erskine-Smith, MP of Beaches-East York, Ontario; and Jenica Atwin, MP of Fredericton, New Brunswick. So we now have Canadian Members of Parliament who are supporting these patients and calling for regulatory change. 
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It's a major time right now and I'm hoping that we can bring this to Parliament and get changes made. You know, Canadians are on board. We've done polls and an overwhelming amount — a landslide majority — of Canadians support medical psilocybin regulations. It's just about how fast our institutions, like Health Canada, can respond. It’s not like this issue will go away. If they don't respond all we're going to see is more patients going underground, more unregulated stores like Zoomers dispensary opening up in downtown Vancouver.

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If you want to support Therapsil and their efforts you can donate to TheraPsil's legal challenge or, if you live in Canada, write your Member of Parliament advocating for compassionate access to psilocybin. ‍

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