Insights / August 1st, 2023

Medicinal Mdma and Psilocybin: How Not to Trip on Australia’s New Legal Framework

On 1 July 2023, the Therapeutic Goods Administration (“TGA”) downgraded both MDMA and psilocybin from ‘Prohibited Substances’ (Schedule 9 of the Poisons Standard) to ‘Controlled Drugs’ (Schedule 8 of the Poisons Standard) for the treatment of certain conditions. As a result, as of 1 July 2023, Australian psychiatrists can prescribe MDMA and psilocybin to treat post-traumatic stress disorder (“PTSD”) and treatment-resistant depression (“TRD”), respectively. Whilst the two drugs have been legalised for similar uses in other countries, Australia is the first to regulate them as medicines – cementing our position as a world leader in this space.

MDMA (3,4-methylenedioxy-methamphetamine), the main ingredient in ‘ecstasy’, is a substance that stimulates the body’s central nervous system, causing the release of large quantities of dopamine. This can cause the user to experience a range of both positive and negative symptoms, including a euphoric rush, floating sensations and hallucinations.

Psilocybin, the main ingredient in ‘magic mushrooms’, is a psychedelic that activates the serotonin receptors in the brain. Like MDMA, psilocybin can have a range of different effects, including euphoria, hallucinations and changes in thought.

The legalisation of these two drugs represents a significant step forward for those in the medical and pharmaceutical industries who have been endorsing their benefits for some time. That being said, due to their potency and risk profile, the use of MDMA and psilocybin will undoubtedly remain very heavily regulated for the foreseeable future. Therefore, those who wish to become involved in the prescription, supply and/or importation of these drugs must ensure that they have a comprehensive understanding of the relevant legal requirements.

To assist, we have prepared summaries of the requirements that apply to psychiatrists, pharmacists and importers who wish to become involved in this space. We will be publishing these summaries as a series of insights that, together, seek to guide these industry participants through the process of getting authorised and ensuring ongoing compliance. In this insights, we focus on psychiatrists – specifically, the first four regulatory hurdles that they must leap in order to deal with these two drugs.

Psychiatrists – Getting Authorised

Psychiatrists play a key role in the new regulatory regime, being the only industry participants who are able to prescribe MDMA and psilocybin to patients. Given the importance of this role and the power that they wield, there are a number of requirements that psychiatrists must satisfy before they are allowed to prescribe.

These requirements are:

  1. Psychiatrists must be registered with the Australian Health Practitioner Regulation Agency (“AHPRA”) as a specialist psychiatrist.

  2. Psychiatrists must have completed a Fellowship with the Royal Australian and New Zealand College of Psychiatrists.

  3. Psychiatrists must apply for, and receive, the approval of a Human Research Ethics Committee (“HREC”) that is registered with the National Health and Medical Research Council.

    Whilst there is no prescribed form for this application, the TGA has provided that an application should explain and justify why the psychiatrist should be able to prescribe the relevant drug(s), and should include:

    • ‎‎‎‎details about the psychiatrist (e.g. their qualifications and experience);

    •‎ details about the drug(s) (e.g. strength, dosage form and manufacturer); and

    •‎ a clinical justification for the use of the drug(s).

  4. After receiving HREC approval, psychiatrists must apply for authorisation under the Authorised Prescriber (“AP”) Scheme by lodging an application with the TGA. Once the TGA has approved their application, the psychiatrist can begin to prescribe the drug(s) to patients.

Note that, depending on the state or territory in which a psychiatrist is practising, there may be other, state-specific requirements that also apply.

If you need any assistance navigating the above requirements, please get in touch with Cowell Clarke’s MedTech team by contacting either Anna Young or Zac Mizgalski.

Don’t forget to keep an eye out for our next insights, in which we will consider how importers and pharmacies can be authorised to import and supply MDMA and psilocybin. If you would like to receive all of our updates on MDMA, psilocybin, medicinal cannabis and other interesting developments in the MedTech sphere, you can subscribe to our MedTech mailing list by clicking here.

This publication has been prepared for general guidance on matters of interest only and does not constitute professional legal advice. You should not act upon the information contained in this publication without obtaining specific professional legal advice. No representation or warranty (express or implied) is given as to the accuracy or completeness of the information contained in this publication and to the extent permitted by law, Cowell Clarke does not accept or assume any liability, responsibility or duty of care for any consequences of you or anyone else acting or refraining to act in relation on the information contained in this publication or for any decision based on it.