Background Information

A summary of MMA’s applications can be found on the TGA website here.

As you will see our applications are to move the medical use of these substances as part of psychotherapy on a restrictive basis from Schedule 9 (Prohibitive Substances) to Schedule 8 (Controlled Medicines) of the Poisons Standard.  All other uses of these substances will remain in Schedule 9.

We are proposing that the medical use of psilocybin and MDMA as part of psychotherapy will only become Schedule 8 medicines in the following restricted circumstances.

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 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.

All other uses of psilocybin and MDMA will remain in Schedule 9.

The full applications lodged by MMA, as well as an explanatory memorandum that has been prepared to provide context to the rescheduling process can be viewed using the buttons below.

Frequently Asked Questions

"To my mind, the clinical evidence is clear...every day that this takes is a day that we lose people, and that's not acceptable..."

Dr Tra-ill Dowie, dual PhD holder and co-founder of the Mind Medicine Institute speaks of the injustice of denying those in need treatments that can alleviate their suffering.

The Majority of Australians ALREADY Support the Regulation of Psychedelic-Assisted Therapy... But The Regulators Don't Know Where You Stand. Show Them That It is Politically Safe to Listen to the Science By Making A Submission. 

If you would like to see the full poll results, click here.

Trigger Warning: some viewers may find these stories and the cost of inaction distressing

"There are people out there hurting and hurting badly, because we are not enabling them to get the treatments they deserve..."

Admiral Chris Barrie, former head of the Australia Defence Force and chairman of Fearless.org.au speaks of the injustice of denying those in need treatments that can alleviate their suffering.

Follow These Simple Instructions to Make a Submission

How to Lodge a Submission

Go to the TGA's consultation hub: https://consultations.tga.gov.au/tga/proposed_admendments_june-2022/

1. Once on the hub page follow the link “SUBMIT YOUR RESPONSE HERE”

2. Continue through the navigation using Continue. You can save a draft and return to your submission at any time using the "Save and come back later button".

3. You will first be asked to enter your details, then select which category you belong to from consumer/patient, registered healthcare professional, professional researcher or none of the above.

4. Then specify which medicine your submission is in relation to and your position of support before uploading your submission on to the portal. Please see screenshot of this page below (where an individual has selected “Fully Support” to the proposed amendments to the Poisons Standard).

In making a submission you have two choices:

1. To simply complete Part A as described above.

2. To also Complete Part B which involves providing a supporting document to explain your views.

Please note that completing both Part A and Part B is much more valuable  and will be regarded more highly than simply completing Part A.  We encourage you to complete both parts.

Upload or write your response and select “Continue”.

Completing Part B

To provide a supporting statement, select either "PDF upload" or "write response here" on the screen below.

Select which medicines your supporting statement is related to.

For the final step, you will be asked if you would like to make your submission public, unnamed or private and select “Continue”. Your submission will be much more powerful if you are prepared to be named.

Some Guidance in Completing Part B

In stating your reasons in your supporting letter it is critical that you provide reasons under one or more of the headings in Section 52E of the Therapeutic Goods Act.  This is because the Committee and the Delegate have a legislative obligation to consider these matters when they make their decisions.

Section 52E provides that;

In exercising a power under subsection 52D(2), the Secretary must take the following matters into account (where relevant):

                     (a)  the risks and benefits of the use of a substance;

                     (b)  the purposes for which a substance is to be used and the extent of use of a substance;

                     (c)  the toxicity of a substance;

                     (d)  the dosage, formulation, labelling, packaging and presentation of a substance;

                     (e)  the potential for abuse of a substance;

                      (f)  any other matters that the Secretary considers necessary to protect public health.

In addition to exercising power under Section 52E the Secretary must also comply with the guidelines of the Australian Health Ministers' Advisory Council.  These guidelines provide that to reschedule a substance to Schedule 8 of the Poisons Standard the substance must have, among other things, an established therapeutic value.

The difference between Schedule 8 (which we have applied for) and Schedule 9 (where MDMA and psilocybin are curently scheduled) is explained here.

In completing your supporting letter to the TGA to be attached in Part B of the TGA’s online forms you may want to comment on any of the following;

1. Your experience of mental illness either as a clinician, a patient or someone who has a family member or friend who suffers from mental illness.
2. The fact that current treatments don’t work, work inadequately and/or can have nasty side effects for many people. There is therefore a desperate need for treatment innovation.
3. The benefits of MDMA or psilocybin assisted psychotherapy (depending on the substance you are commenting on) in terms of safety, minimal side effects and high remission rates as evidenced from overseas trials.
4. The fact that these therapies are curative rather than palliative.
5. The fact that there is strong evidence for safety and efficacy and therefore the requirement of established therapeutic value has clearly been met.
6. The fact that the current position of these substances in Schedule 1 of the UN Convention on Psychotropic Substances should NOT inhibit rescheduling because there are a number of examples of previous reschedulings by the TGA where the substance has been in Schedule 1 of this Convention and there are a number of overseas countries that are making MDMA and psilocybin available as part of psychotherapy under Expanded Access Schemes. In addition there is a specific exemption for limited medical use in this UN Convention which would support the rescheduling and there are other UN Conventions to which Australia is a signatory which would also support access for medical use (eg the UN Convention on Economic, Social and Cultural Rights which provides in Article 12 that people have rights to “the enjoyment of the highest standards of psysical and mental health”).
7. That the benefits of downscheduling clearly outweigh the risks because the benefit is giving people with treatment resistant depression, post traumatic stress disorder or substance abuse the chance to receive a treatment which can be curative, has shown high remission rates in overseas trials and where the risks can be properly managed. This is because:

• There is now lots of evidence to show that these treatments can be used safely in medically controlled environments;
• Risks that the substances could be diverted into the recreational area are minimal because of existing Schedule 8 controls (these same controls are applied to much more dangerous and addictive medicines such as morphine and medical cocaine) and the fact that under the proposed rescheduling the substances will only be able to used in medically controlled environments and the patient will never be able to take them home;
• Our medical system is used to managing translation risk as medical interventions are moved from trial environments into clinical practice. In addition, under the proposed rescheduling three psychiatrists will be involved in the patient’s diagnosis and treatment plan and in the appropriateness of that diagnosis to these treatments, and two trained therapists will be with the patient at all times during each session with the medicine. Finally Australia now has a World leading course to train clinicians in the administration of these therapies;
• Given the limited basis of the proposed rescheduling there is no basis for interfering with the psychiatrist patient relationship, where the patient has given fully informed consent.

Please note that there is detailed information to support each of these statements in our rescheduling applications which can be found here - https://mindmedicineaustralia.org.au/tga/.

Remember: to be valid your submissions must be lodged online with the TGA on or before Friday 27^th May 2022.  It's very important that you put your submission in your own words.

Copying your Submission to Your State or Territory Minister of Health and Minister of Mental Health and Your Local Federal and State MPs

This is important because each of these individuals are there to look after your interests.  Its critical to let them know why rescheduling on the basis that we are proposing is important to you.

• You can find the name and email address of you local State MP here.
• You can find the name and address of your Federal MP here.
• To email the Federal and State Ministers of Health, you can use the links below.
• Each one will open an email template addressed to the stated minister. All you need to do is paste your written submission into the appropriate spot and add your name. If you would like to make changes to the template please feel free to.

Federal Health Minister: Greg Hunt

Federal Mental Health Minister: David Coleman

ACT Health Minister: Rachel Stephen-Smith

ACT Mental Health Minister: Emma Davidson

NSW Health Minister: Brad Hazzard

NSW Mental Health Minister: Bronnie Taylor

NT Health Minister: Natasha Fyles

QLD Health Minister: Yvette D'Ath

SA Health Minister: Chris Picton

TAS Health + Mental Health Minister: Jeremy Rockliff

VIC Health Minister: Martin Foley

VIC Mental Health Minister: James Merlino

WA Health + Mental Health Minister: Amber-Jade Sanderson

Once you've made your submission, please share this guide widely

The more submissions the TGA receives, the stronger the signal we can send them that a lot of Australians care deeply about this issue, and it's one they must seriously consider.

Please share this page with anyone you feel may make a submission to support the rescheduling of MDMA and psilocybin.

Click here to view a couple of email templates that you can use to share this guide with your friends, family, colleagues and patients.

Everyone on the team at Mind Medicine Australia would like to thank you for supporting these applications and for being a part of this historic moment in Australia.