Written by Principal, Jennifer Tutty

This week, the Therapeutic Goods Administration (TGA) announced that, as of 1 July 2023, approved psychiatrists will be able to prescribe psychedelic drugs for medical purposes. More specifically, they will be able to prescribe  MDMA (3,4-methylenedioxy-methamphetamine) for the treatment of PTSD and psilocybin for the treatment of treatment-resistant depression.

In its press release, the TGA says that this decision “acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting.”

According to Forbes Magazine, Australia is the first country to approve the provision of MDMA and psilocybin to members of the public who have the above mental health conditions.

So, what has changed?

For uses in the above circumstances, (namely MDMA (3,4-methylenedioxy-methamphetamine) use for the treatment of PTSD and psilocybin use for the treatment of treatment resistant depression), these substances will now be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standards.

For all other uses they will remain in Schedule 9 (Prohibited Substances), which for the most part restricts their use to controlled clinical trials.

Currently, the TGA has not been able to test and declare any MDMA and psilocybin products safe for use in Australia. However, the TGA states that the changes to the Poisons Standards will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for the specific medical uses outlined.

Before a psychiatrist will be able to prescribe the drugs to their patients, they will firstly need to be approved by a human research ethics committee, and then by the TGA under the Authorised Prescriber Scheme.

What will drug manufacturers be looking to do next?

In addition to obtaining the necessary approvals and consents  from the TGA, manufacturers of MDMA and psilocybin products wishing to enter the Australian market will need to consider protecting their brand assets. In other words, like any new brand or business, they’ll be needing to think about trade marks. 

From our review of the Australian trade mark register, it appears that potential providers of MDMA and psilocybin products in Australia have are already started to take these steps.

As of the date of this article, there are currently 4 trade marks registered specifically for MDMA and psilocybin. Additionally, there are 4 trade marks pending for MDMA and 5 for psilocybin. Brand names include Forensic Pathways, Vivid Mind Sciences, Reset Mind Sciences, Psychbio and Shroom Science.

What classes of goods and services should providers of MDMA and psilocybin products (and other health and wellness brands) register their trade marks in?

Trade Marks can be registered in 45 classes of goods and services in Australia. 

Manufacturers of MDMA and psilocybin products (as well as most health and wellness brands) should be looking to register in the following classes:

– Class 5: To cover the products themselves. Broadly class 5 covers pharmaceutical, veterinary and sanitary preparations, dietary supplements, disinfectants, vermin destroyers, fungicides and herbicides.

– Class 42: To cover research services. Broadly class 42 covers scientific and technological services and research and design relating thereto, industrial analysis, industrial research and industrial design services, quality control and authentication services, design and development of computer hardware and software.

– Class 45: To cover health and wellness consultancy services and the provision of health and wellness services. Broadly class 45 covers medical services, veterinary services, hygienic and beauty care for human beings or animals, agriculture, aquaculture, horticulture and forestry services.

– Don’t forget to also register in class 25 for clothing if you want to sell branded t-shirts (we have a feeling these might be popular in years to come!).

The above list is not exhaustive.

We recommend seeking legal advice on what classes to choose before applying to protect your health or wellness brand.

Written by Principal, Jennifer Tutty

Published 8 February 2023

Further Information

If you’re a health or wellness brand, and looking for compliance or IP advice, please contact us through our online form or via email at hello@studiolegal.com.au.

Photo by danilo.alvesd on Unsplash

DISCLAIMER

The information in this article is of a general nature. It does not constitute formal legal advice and should not be relied on as such. Please see the full disclaimer in our website terms. Please contact Studio Legal if you are seeking advice about a specific legal matter.