Australia's Potential Rescheduling of MDMA & Psilocybin Could Effect...Everything

Sep 04, 2020

Mind Medicine Australia Submits Application for MDMA and Psilocybin Rescheduling

In the same week that COMPASS announced IPO plans and Esketamine was again rejected by England’s National Health Services because of the price tag it is only fitting that Mind Medicine Australia is petitioning the Australian Therapeutic Goods Administration (TGA) to circumvent the traditional drug development process and reschedule MDMA and Psilocybin so that physicians can legally prescribe them in clinical practice.

“Mind Medicine Australia has submitted Australia’s first applications to Australia’s Therapeutic Goods Administration (TGA) to reschedule psilocybin and MDMA so that they can be more easily used as clinical therapies for the treatment of mental illnesses…
The rescheduling will enable psychiatrists and specialist addiction physicians to more easily access these medicines to augment therapy for patients suffering from key mental illnesses such as depression, PTSD and for the depression and anxiety…
It will also relieve a significant part of the regulatory burden associated with undertaking trials with these medicines in Australia.”

The proposal is seeking to reclassify MDMA and Psilocybin from Schedule 9 to Schedule 8.

Schedule 8 substances include opioids, benzodiazepines, and other drugs prone to abuse but used in medicine and require protective protocols for their administration, whereas Schedule 9 substances are strictly prohibited.

If Mind Medicine’s application is successful, Australia will become the first country in the world to reschedule these substances for therapeutic use.

Snowball Effect?

A few weeks ago, we saw groups advocate for the rescheduling of psilocybin in Britain to allow scientific research to be less bureaucratically encumbered.

Decriminalize Nature Canada has succeeded in having their petition read in parliament.

Congress will be voting on federal marijuana legalization in the US.

Health Canada approved four palliative patients exemption to use psilocybin for end of life anxiety.

And now we have an Australian measure that goes even further and, if passed, would allow the use of MDMA and Psilocybin in medical practice “as part of psychotherapy under the authorization of a treating psychiatrist or specialist addiction physician in a medically controlled environment.”

Is this an inflection point in drug policy? Will we see more countries consider similar medical rescheduling?

Extraordinary Times Calls for Extraordinary Measures

Mind Medicine’s application is arguing that the research to date is sufficient to show the safety and efficacy of MDMA and psilocybin, and the growing burden of the mental health crisis, citing covid and recnt brush fires, is enough to circumvent the traditional route of drug development and approval.

The application to the Australian TGA points to the FDA’s designation of MDMA and Psilocybin as Breakthrough Therapy, Health Canada’s recent exemption, the progress of MAPS, Usona, and COMPASS and leans on Usona’s Expanded Access, which I didn’t know about, as a precedent for this approach.

“The FDA has approved an “Expanded Access” or “Compassionate Use” scheme using psilocybin to treat both treatment-resistant depression and major-depressive disorder in patients who have exhausted all other options. A treating physician must obtain approval from the internally created Institutional Review Board of Usona Institute (a not for profit organisation in the US) along with approval from the FDA under its Expanded Access Scheme to receive these medicinesfrom Usona.”

What Does This Mean?

We won’t know the TGA’s decision until April 22, 2021, and we don’t have the details of how the regulation of manufacturing, shipping, storage, physician credentialing, therapist training, and other matters of rolling out of such a program.

For example, Oregon’s Psilocybin Services Initiative (PSI) is somewhat equivalent, and the first order of business is to establish a working group to iron out details which are to be completed by 12/31/22 and allow licenses applications by 1/2/2023.

Considering the lack of pharmaceutical infrastructure (manufacturing, labeling, packaging, marketing, etc.) that is usually built by the company that has brought a drug through the drug development process and the lack of clinical and regulatory infrastructure for psychedelic medicine, I would expect that if the TGA approves this application the first order of business is the assembly of a ‘working group’ to figure out all of these details.

Gradually, then all of a sudden

Here are questions that I can think of as it relates to such policy changes

This flavor of medical legalization only seems to be building momentum. Should we expect to see other local and national efforts? Medical Tourism is a booming industry, and I would think:
1. countries that have traditional ties to plant medicine (Brasil, Peru, etc.) will see psychedelic medicine/tourism as an economic opportunity and create a formalized infrastructure around it
2. countries that have exacerbated mental health crises might be willing to give psychedelic based therapies a “pass” considering the unique qualities and potential economic incentives

If we see an increase in the number of such efforts to rethink psychedelics, what kind of companies would be most likely to benefit?

How does such a measure affect patents and intellectual property rights? The idea of patents is to reward those who go through the gauntlet of drug development. In the absence of such requirements, patents must become less valuable, no?
How might companies that have committed to clinical development projects react if this measure is approved?
Do federal measures to reschedule for medical use increase or decrease existential risk to the movement?

No doubt, we’ll be watching this closely.

The Trip Report by Beckley Waves

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