By Sam Douglas

As many of you will know, Mind Medicine Australia (MMA) has submitted another application to the Therapeutic Goods Administration (TGA) to make changes to the scheduling of psilocybin and MDMA. They argue these changes (detailed below) will enable an improvement to patient access to these substances under the Special Access Scheme-B, and are encouraging people to make a submission to the TGA to support their application. 

The details of MMA’s proposal aren’t hard to find, but they’re worth looking at. Just to be clear, I’m not going to tell you whether you should support this or not, though I will say what I think the implications are and what I think some viable options for action are. (Spoilers: this will not instantly legalise possession of Psilocybe subaeruginosa mushrooms!) 

As we know, the overall mental health situation in Australia is not fantastic, and we do need better approaches to depression and PTSD (amongst many other things). Psychedelics are not a cure-all, not least because they don’t automatically change the social & economic structures that contribute to mental illness. But I do think research shows that they at least have the potential to make life better for some people, so long as we’re always mindful of the need for harm reduction. 

MMA’s previous application was rejected by the TGA. The reasons given were essentially that more research is needed and the risk is too high. Personally, I think the reasons for the rejection are somewhat bound up with politics and inherent conservatism of the TGA (not to mention that they see psychoactivity inherently as a side-effect). But it’s also worth remembering that phase 3 trials hadn’t yet been completed for psilocybin or MDMA at the time of the first application, so the TGA asking for more research into therapeutic use wasn’t totally unfounded. 

How best to win them over (or if it’s even possible) is a discussion for another day. But I will say that, in my opinion, we’d need to get politicians on-side first, then the TGA might follow - not the other way around. 

Current application

In response to TGA feedback, MMA has put forward a new, and even more modest & restrictive proposal. The core details of the current application have been summarised by MMA:

1. As an unregistered medicine, the treating psychiatrist will only be able to prescribe pharmaceutical grade psilocybin or pharmaceutical grade MDMA as a Schedule 8 controlled medicine if the psychiatrist first obtains approval from the TGA under its Special Access Scheme-B to use these substances as part of psychotherapy. To obtain such an approval, the psychiatrist will have to demonstrate to the TGA that the patient is treatment resistant and “at risk”.

2. The treating psychiatrist will need to have received specific training in the use of the proposed medicine- assisted psychotherapy.

3. The psychiatrist’s patient diagnosis and treatment plan will have to be confirmed by two other psychiatrists.

4. The Government of the State or Territory where the treatment is to occur will also need to approve the proposed treatment for the specified patient under its own Schedule 8 permit procedures.

If this proposal were to be adopted, psilocybin or MDMA-assisted therapy can only be an option if all of the following conditions are met: 

• The patient has had three psychiatrists confirm their diagnosis and that this is a suitable treatment plan;

• The treating psychiatrist has completed specific psychedelic-therapy training;

• The Special Access Scheme, Category B, application is approved and;

• The state or territory this is happening in approves the Schedule 8 procedures and removes any other legal barriers. 

To be very clear, the way this sort of change works is that Schedule 8 (S8) conditions are carved out, rather than  the substance being down-scheduled in a wholesale manner. I.e., if the conditions are met, the substance is S8. If not, it’s still S9. Our existing medicinal cannabis system is largely based on this. I.e.: some cannabis products are S8, S4, or S3 (for low-dose CBD products - not that any have made it to market yet). Any cannabis outside of these approved products and uses is still S9. As far as I know, the TGA has never moved something entirely from S9 to a lower schedule.

Potential issues with the proposed model

In my opinion, this proposal presents a number of barriers to treatment and potential complications. 

Who will diagnose & prescribe?

I assume MMA are confident they know of at least three psychiatrists (one to prescribe, two to verify) who will sign off on psychedelic-assisted therapy. But, at a glance, I would think this in itself would be a time-consuming and potentially expensive exercise for most people. Note that this will only be an option for psychiatrists, not general practitioners or clinical psychologists (and definitely not underground practitioners). It’s also going to be a while before many psychiatrists would consider this treatment. 

So, even if approved and even if everything else lines up, it’s going to be a very slow start. Let me spell it out for you: It isn’t uncommon for people to wait months to see one psychiatrist who almost certainly hasn’t done Mind Medicine Institute (MMI), MAPS, CIIS, or Johns Hopkins training in psychedelic-assisted therapy. I can only estimate, but if there were more than a dozen psychiatrists in Australia  who had done any specific training, I’d be very surprised. Waiting lists just to see them are likely to be exceptionally long, if you can even find out who they are.

Anyone who has dealt with mental health issues or knows someone who has, will be aware of the time and emotional effort that seeking treatment can sometimes entail. Some people need support to get the help they need from one psychiatrist or psychologist. Finding three psychiatrists while also experiencing severe treatment-resistant depression or PTSD is going to be too big an ask for many people in that situation.   

Cost to the patient

I also want to note the considerable potential cost of seeing multiple psychiatrists. If these services are not covered by Medicare or private health insurance (and other than maybe the initial consultations, they won’t be), patients would need to pay hundreds of dollars for every appointment with each of the three psychiatrists. Unless these practitioners decide to charge less, or some charity helps cover the costs, this is going to add up to a lot of money, very quickly. 

Training

The treating psychiatrist will have to have completed specific training in utilising psychedelics in therapy. At this time, the Mind Medicine Institute is the only organisation that I’m aware of that is offering in-person psychedelic training in Australia, via its Certificate in Psychedelic-Assisted Therapy (CPAT). MMI is a for-profit entity jointly owned by MMA and IKON HEALTH & HUMAN DEVELOPMENT CORPORATION PTY LTD, (the ownership of which appears to be split between MMI directors, Nigel Denning and Traill Dowie). As of earlier this year, MMI’s directors were Tania DeJong, Peter Hunt, Nigel Denning, and Traill Dowie. 

(Side note: Such arrangements are not unheard of in the nonprofit world, as they allow private investment in activities that generate funds to be used for their charitable purposes. I am making no comment here on whether this is a good or bad, just noting that it’s a legitimate and legal option for charities in Australia.)

I have raised the possibility that this could look like a conflict of interest for MMA in discussions with Tania and Peter. They responded that any appropriate training would meet this requirement, and that it’s not their fault that no one else in Australia has set up similar training thus far. 

What counts as good training and education for psychedelic-assisted therapy (How much training is necessary? What should students learn? Who should teach them?) is a contested area that warrants a much larger discussion, so I’ll put that to one side, for now. 

The fact remains though, that it is likely that many more people in Australia have completed the MMI CPAT than similar international training. It’s certainly plausible that the changes could generate increased interest from psychiatrists in this single local offering. 

Is this a conflict of interest though? In my opinion, it could consolidate the power of the MMA/MMI operations and leadership, as well as generate funds for MMA and profit for IKON HEALTH. Based on the official evidence of who owns what (from ASIC company extracts that I purchased), I can’t see any profit from increased MMI enrolments making its way back to MMA leadership via ownership of shares in IKON. Since both Tania and Peter have told me that they will gain no financial benefit from this, I’m assuming their directorships with MMI are unpaid, and that they do not (directly or otherwise) own shares in any company that is likely to profit from these changes. If there is a conflict of interest, I’ve seen no evidence that it’s financial in nature, and it would be defamatory of me to speculate where I have no good reason to. 

I think we should be concerned about the training of future psychedelic therapists being monopolised. But if psychedelics become part of an accepted mainstream therapy, it will be inevitable that universities will enter the market, and any qualifications would be subject to rigorous attention from bodies such as the Royal Australian and New Zealand College of Psychiatrists (RANZCP) and Tertiary Education Quality and Standards Agency (TEQSA) etc. There would also be a role for an independent professional association for those providing psychedelic assisted therapy in ensuring that any qualifications are fit for purpose in terms of content, outcomes, and professionalism. 

If MMI’s CPAT wants to compete against university programs, it will have to meet the same benchmarks and standards, and compete against the marketing budget & prestige of these institutions. In my opinion, in a competitive higher education market, they would be utterly outgunned (and out-spent) by even mid-tier institutions, let alone the ‘sandstone’ universities. So, I see this monopoly as an unfortunate but temporary problem. 

State Laws

I have also been concerned that even if these changes are approved by the TGA, it will still be an uphill battle to get the relevant state laws and regulations changed to enable these particular Schedule 8 approvals to be given. This will vary state by state, but it’s important to know that changing the scheduling is not necessarily the end of the story. MMA admits this, stating in the explanatory memorandum to the application that:

By moving the Scheduling of these substances as part of therapy into Schedule 8 of the Poisons Standard permit systems will become available in all States and Territories of Australia. This will lead to State and Territory Governments developing policies for granting approvals.

Such policies could take some time, especially in places where the Coalition or Labor are not forced to work with more progressive parties. 

What will change if this is approved?

It’s vital that people really understand what this proposal will or won’t change (and when the changes might occur) if the application is eventually successful.

No, this isn’t decriminalisation or legalisation 

In the short term, this will not have any impact on the criminalization of either substance. Just because you could theoretically get psilocybin therapy under the circumstances described above, it won’t mean you aren’t in deep trouble if the police catch you with a bag of fresh Psilocybe subaeruginosa or a handful of pills (that you hope have at least some MDMA in them).  What can be used as a therapy and what people can purchase or possess for their own purposes are governed by different laws, often at different levels of government. Nor would any of the changes apply to underground practitioners, guides, or facilitators. 

Just so we’re clear, here are some quick definitions of reform-relevant terms:

Decriminalisation: Possession of a psychoactive substance does not attract criminal charges, but cannot be legally purchased. 

Legalisation: Psychoactive substances can be legally acquired, though regulations will determine exactly how this occurs.

Safe supply: Safe supply refers to a legal and regulated supply of psychoactive substances that traditionally have been accessible only through the illicit drug market. 

Note that there can be variation within some of these terms. E.g.: Decriminalisation can just extend to possession and use, as it does in Portugal, or it can cover things like the ‘grow, gift, gather’ concept that Decriminalize Nature favours in the US. A more local example of this is for cannabis in the ACT, where limited home-growing is decriminalised. Legalisation can also vary. Who can you acquire psychedelics from, and what regulations might (or might not) apply to them? Is the legal access purely medical or does it allow ‘recreational’ use?

I would dispute the link between medical use of a substance, and broader legal reform, in Australia at least. Yes, in the US, medical cannabis has preceded recreational legalisation of cannabis in an increasing number of states. But the same has not happened here. 

Our medical cannabis regime is much more restrictive than existed in California, Oregon, or Colorado etc. before recreational legalisation. Our politicians and bureaucrats are smart enough to see what happened there, and, in my opinion, have done their best to ensure it never happens here. Medical use of something can contribute to legal reform, but it's not a foregone conclusion. If it were, we’d be talking about legalising ketamine or opiates. It’s also worth remembering that corporate interests may see decriminalisation and legalisation as a threat to their profits, rather than an opportunity.

So no, I do not think this application being approved is necessarily a step toward decriminalisation, legalisation, or safe supply. It could be an opportunity. But only if pro-reform activists are willing to put in the political work. Even then, I’ve watched many applications for rescheduling fail over the years, so I wonder where activists’ energy is best spent. 

MMA has always been very clear that they have chosen to not do the work of legal reform outside of clinical applications. So those of us who want to address the harms and injustice of prohibition, and fight for safe supply, will need to continue with our own efforts. (If you do want to do this sort of work, please reach out, I’d love to hear from you!)

No, you won’t instantly be able to get psychedelic-assisted therapy

People regularly contact the Australian Psychedelic Society who are desperate for relief from treatment-resistant mental health conditions. They think there is a chance that psychedelic-assisted therapy could help them. And they are right, in that it’s quite possible that psychedelics would help. But because of the legal situation, there’s basically nothing we can do for them. So, I know how important this is for people.

Even if these changes are approved by the TGA, it will be at least six to twelve months before they come into effect, and then even more time before any significant numbers of patients receive treatment. Yes, MMA likely has some psychiatrists on-board, and they will have patients they would like to treat. But between the time to implement regulatory changes (at both federal and state levels), relatively few prescribing psychiatrists, and a backlog of potential patients, it could be years before most people even start treatment. There will be a lot of moving parts to this. E.g., any training will likely need to be approved in some way by the Royal Australian and New Zealand College of Psychiatrists (RANZCP), a process which is likely to add even more time until services are available. Whatever else I can say about this proposal, I have to admit that, by itself, it does very little for patient access.  

So, if you are reading this, and feel like psilocybin or MDMA are the last hope for yourself or a loved one, I have some important advice for you: If the situation can’t wait at least two years, then please don’t pin all your hopes on this proposed scheduling change. Find another plan. For legal reasons, I can’t tell you what this plan should be, though I will point out that psychedelics are not as restricted everywhere as they are in Australia. After all, Tania and Peter were inspired to form MMA after the positive and healing psychedelic experiences they had overseas, and if it’s good enough for them…

How to support this? 

I’m not going to tell you what you should do. Whether or not to support this proposed change is a decision that only you can make. I do not think there is a 100% consensus in psychedelic communities in Australia and around the world. Some people think psychedelic science is not sufficiently explored, or that there isn’t enough training available for therapists. Some people oppose any commercialisation of psychedelics, feel that psychedelics should be kept entirely separate from capitalism, or assert that no one should make any money from either psychedelics or psychedelic-related services. Alternately, there are people who are pro-business, but feel that psychiatry ought not to be the gatekeeper of psychedelic therapy, or that psychedelics should be available from dispensary-style stores, but are incompatible with a medical model. I’m not offering critique or endorsement of any of these views, but think it important to not pretend there's ideological uniformity where there clearly isn't. 

I think one viable response to this is “yes, and…” where the “and” is a comprehensive statement that the way psilocybin and MDMA are currently treated under state and federal law is deeply unjust and actively harmful. If it's OK for people to receive psychedelic assisted therapy, then no one should ever face a criminal charge for picking some mushrooms. And I’ve argued that it's unethical to profit from psychedelics while not opposing from psychedelic prohibition. So, I would encourage people to not just check the box to express support for Part A, but also lodge a written response via Part B of the process. If you just check the box and don’t add anything, this sends the message that you entirely agree with MMA, and are not interested in anything other than incremental increases in therapeutic access. 

Would I exactly follow MMA’s guidance on what to talk about in Part B? Not entirely, in that I think we should talk about psychedelics outside of clinical settings, namely that prohibition is one of the key causes of risk of harm for both of these substances. Their idea about copying your response and sending it to politicians is a good one though. For maximum effect, include your state health minister, and maybe wait a while before emailing any federal MPs, so you know who’s actually in that portfolio.

On the other hand, you might feel that the potential changes are too small, the potential cost to patients too high, or that there’s too high a risk of gatekeeping by psychiatry or a single training organisation. If you don’t choose to support this application, for these or other reasons, I would encourage you to still support organisations whose values more closely align with your own, and take action to push for the changes you do want to see.

You don’t have long to make a submission regarding the current application - this closes on May 27. Whatever you decide, if you want to have your say, you can do so here: Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, June 2022.