Understanding the TGA Framework for Psychedelic-Assisted Therapy Queensland
The 2023 rescheduling marked a pivotal shift in the TGA framework for novel treatments. As Psychedelic-Assisted Therapy becomes a regulated clinical option, the mental health landscape has matured, particularly for those accessing Psychedelic-Assisted Therapy in Queensland.
We have seen a shift in how these treatments are accessed, where they can be delivered, and we have seen new funding options come online. As this field continues to expand and develop a clinical workforce to hold this container, it is a significant development in clinical options for patients and mental health professionals in Australia.
For patients searching for Psychedelic-Assisted Therapy in QLD, it is important to understand that these treatments are currently classified under a highly regulated “Authorised Prescriber” pathway.
At our Gold Coast-based clinic, we prioritize clinical safety and adherence to the Royal Australian and New Zealand College of Psychiatrists (RANZCP) guidelines. We focus on evidence-based interventions for conditions that have not responded to traditional therapies.
What is the Authorised Prescriber Scheme (APS)
The Authorised Prescriber Scheme allows medical practitioners to apply to prescribe unapproved therapeutic goods. The application process requires Doctors to complete a Human Research and Ethics Committee (HREC) application, followed by review and approval from the Therapeutic Goods Administration (TGA). In Australia, the TGA currently restrict Authorised Prescriber status for these specific protocols to Fellowship-trained psychiatrists who have undergone the HREC and TGA approval process for MDMA and Psilocybin. Becoming an Authorised Prescriber for Psychiatrists.
The 2023 Rescheduling of MDMA and Psilocybin: What it Means for Patients
The TGA’s landmark decision to reschedule MDMA and psilocybin marks a significant shift in Australian mental health care. For those seeking Psychedelic-Assisted Therapy in Queensland, this means that patients who meet specific clinical requirements can now access these treatments within a highly controlled medical and psychological framework. Currently, the TGA has approved the use of these substances only for two specific conditions:
* MDMA: For the treatment of Post-Traumatic Stress Disorder (PTSD).
* Psilocybin: For the treatment of Treatment-Resistant Depression (TRD).
Accessing Treatment on the Gold Coast, unlike standard medications, these are not “take-home” prescriptions. Patients do not receive a script to pick up from a local pharmacy. Instead, access is strictly limited to clinical settings under the Authorised Prescriber Scheme.
At our clinic, we follow a multidisciplinary model. This medicine is prescribed by an Authorised Prescriber Psychiatrist, which is then supported by “wrap-around” psychological care. This approach ensures that the pharmacological intervention is paired with a robust clinical psychology framework to support long-term patient outcomes.
Who is Eligible for Novel Clinical Protocols?
In line with current Australian regulations, specific substances, often referred to in research as Psychedelic-Assisted Therapy, are only accessible for two specific conditions:
* Treatment-Resistant Depression (TRD): Defined as persisting depression that has not responded to treatment as usual including two types of antidepressants and psychotherapy such as Cognitive Behavioural Therapy (CBT).
* Post-Traumatic Stress Disorder (PTSD): Defined as chronic and enduring, and often complex-PTSD where traditional trauma-therapy and standard medications, at least two anti-anxiety or anti-depressants, have been unsuccessful.
The ‘treatment-resistant‘ label matters, for patient to qualify for these novel treatment protocols in Queensland, and to meet the TGA criteria for referral, patients have to demonstrate they have not found sufficient relief from traditional first-line treatment interventions including traditional talk therapy. These novel treatments are deemed adjunct treatments for treatment-resistant conditions.
Taking the First Step - Clinical Assessment on the Gold Coast
Navigating novel mental health treatments requires a thorough, evidence-based approach. If you or a loved one are managing Treatment-Resistant Depression or PTSD and would like to explore our multidisciplinary framework, the first step is a referral from your GP or Psychiatrist to undergo formal clinical assessment comprised of two stages.
Our Gold Coast team, led by our Clinical Psychologist in collaboration with Authorised Prescriber Consultant Psychiatrists, providing comprehensive screenings to determine suitability for our intensive support programs. We work closely with your GP to ensure a coordinated path of care.
Contact our Administration Team below for further information or call our Gold Coast clinic directly at (07) 5616 2119 to discuss the referral process.
Shai Hipperson
Shai Hipperson is a Clinical Psychologist based on the Gold Coast with a focus on PTSD, Trauma, Adverse Childhood Experiences, Complex PTSD, and integration of altered states. As the founder of Conscious Mind Centre’s novel treatment program, Shai Hipperson and clinical team have developed a ground-up clinical framework that integrates evidence-based psychotherapy with TGA-regulated protocols. Our program is a multidisciplinary collaboration, utilising a Consultant Psychiatrist for medical assessment and prescribing via the Authorised Prescriber Scheme.
Regulatory & Medical Disclaimer:
This article is provided for educational and research purposes only and does not constitute medical advice or the promotion of any specific therapeutic good. In Australia, the use of certain substances in a clinical setting, often referred to as Psychedelic-Assisted Therapy, is strictly regulated by the Therapeutic Goods Administration (TGA) under the Authorised Prescriber Scheme. These treatments are not included on the Australian Register of Therapeutic Goods (ARTG) and are only accessible for specific conditions such as Treatment-Resistant Depression (TRD) and PTSD under psychiatric supervision. Access is subject to a rigorous clinical assessment and TGA approval. Always consult a qualified medical professional before making decisions regarding your mental health.
