Targeted consultation - AP scheme for psychedelics

Recommendation 1: Psychiatrist experience

The psychiatrist must provide evidence of experience in psychedelic-assisted psychotherapy through involvement in clinical trials.

OR

The psychiatrist must provide evidence that they have received supervision in psychedelic-assisted psychotherapy from an experienced Authorised Prescriber.

Psychiatrists should refer to appropriate guidance from the Royal Australian and Mew Zealand College of Psychiatrists (RANZCP) regarding specific supervision and supervisor experience criteria. 

Why the recommendation was made:

Considering that psychedelic-assisted therapy involves the administration of unapproved therapeutic goods, the TGA requires all AP psychiatrists to demonstrate expertise in the product and the condition treated through this scheme.

Consultation feedback supported two pathways:

• Prior clinical trial experience in psychedelic-assisted psychotherapy, or
• Competency developed in psychedelic-assisted psychotherapy through supervision from an experienced Authorised Prescriber.

Stakeholders noted that few psychiatrists have participated in clinical trials, so requiring trial experience alone could restrict access. They also noted a need for clearly defined supervision criteria, training, and continuing professional development (CPD), which fall outside the TGA’s regulatory scope.

Psychiatrists should refer to the RANZCP’s Psychedelic training framework for psychiatrists which outlines expectations for knowledge, supervised practice and competency assessment in psychedelic‑assisted therapy, to support psychiatrists seeking authorisation to prescribe MDMA or psilocybine.

How the recommendations will affect practice:

These recommendations clarify the expectations for psychiatrists seeking AP status for MDMA and psilocybine, by requiring demonstration of expertise in both the therapeutic use of the product and the condition being treated.

The recommendations are expected to support safe and consistent clinical practice while maintaining patient access. Psychiatrists are encouraged to engage with professional guidance on psychedelic therapies to inform competency development, supervision, and ongoing professional development.

Overall, the approach maintains safeguards around the use of unapproved psychedelic therapies while enabling a broader cohort of suitably trained psychiatrists to participate in the AP scheme.

Recommendation 2: Therapy Dyad

The psychedelic‑assisted psychotherapy dyad must include at least ONE therapist who holds the following registration with one of the following National Boards:

• Psychology Board with endorsement as a clinical psychologist
• Medical Board with general registration
• Nursing and Midwifery Board with mental health experience
• Occupational Therapy Board

AND

• where the practitioner’s scope of practice includes psychedelic-assisted psychotherapy.

That health practitioner must demonstrate appropriate skills, training and competence relevant to psychedelic‑assisted psychotherapy, as determined by the AP psychiatrist and subject to HREC oversight.

The AP psychiatrist is responsible for determining the qualifications and experience of any ADDITIONAL practitioners.

Why the recommendation was made:

Consultation feedback supported broadening the range of therapists able to be involved in psychedelic‑assisted therapy to improve access, particularly in rural and regional areas, address workforce shortages, and to better support culturally appropriate care. Stakeholders emphasised that professions involved with psychotherapy bring highly relevant, specialised skills, and that practical experience and competency should be prioritised over professional discipline alone.

However, it was also recognised that mechanisms for assessing therapist qualifications and competence are limited. Human Research Ethics Committees (HRECs) advised that this function is outside their remit, and there was general agreement that responsibility for determining suitability should rest with the AP psychiatrist.

Given the vulnerability of the patient population and the emerging evidence base for these therapies, the TGA determined that clinical governance and oversight are necessary to ensure patient safety. While practitioners from self‑regulated professions (such as psychotherapists, counsellors and social workers) may contribute to therapy delivery, they are not subject to the same statutory regulatory framework as practitioners registered under the National Law. This framework provides enforceable standards for education, conduct, continuing professional development and indemnity, as well as formal regulatory powers.

Feedback from Ahpra and National Boards supported involving a broader range of registered health practitioners but consistently highlighted the need for appropriate training and competence. Noting that no National Board currently specifies a dedicated pathway for psychedelic‑assisted therapy, and that patients are likely to have complex and severe conditions, the TGA considers that oversight by at least one practitioner registered with a National Board remains essential.

The recommendation therefore balances the need to expand the available workforce and improve access, with the requirement to maintain consistent standards of safety, accountability and clinical oversight.

How the recommendations will affect practice:

These recommendations introduce a structured but flexible approach to staffing psychedelic‑assisted psychotherapy teams.

In practice, the AP psychiatrist:

• has increased responsibility for determining the suitability, qualifications, and competence of all therapists involved in care. This includes assessing both the National Board‑registered practitioner and any additional practitioners, such as psychotherapists, counsellors, social workers, or Aboriginal and Torres Strait Islander health workers.
• must ensure that all members of the therapy team are appropriately trained and capable of delivering safe and effective care, with these decisions subject to oversight through the HREC process.

Recommendation 3: Authorised Prescriber oversight

The AP psychiatrist is responsible for conducting patient screening and ongoing informed consent.

The AP psychiatrist must be present in-person during the administration of the psychedelic (this does not need to be the full dosing day). This ensures the AP psychiatrist can manage any immediate issues and adverse events that may occur.

Why the recommendation was made:

Prior to the consultation, there was a lack of clarity regarding the level of AP psychiatrist oversight, including on-site physical presence and requirements for screening and consent.

Stakeholder feedback strongly supported the requirement for the AP psychiatrist to be physically present on-site during the administration of the psychedelic medicine, justifying the experimental nature of this treatment and the need to manage potential adverse events in real-time.

Stakeholders raised concerns that requiring in‑person screening and consent, would be burdensome and limit access—particularly in rural and regional areas where psychiatrist availability is limited. Whilst virtual screening and consent may not adequately meet safety expectations for this patient cohort, some stakeholders proposed more flexible arrangements, such as an “on call” availability to reduce logistical and cost barriers.

The recommendation was for real-time screening and consent at this time, with any concerns relating to screening and monitoring to be referred to Ahpra, noting the vulnerability of patients and limited safety data for psychedelic-assisted psychotherapy.

This recommendation aligns with state and territory regulatory frameworks for Schedule 8 psychedelic medicines (MDMA and psilocybine), which require that these medicines are not provided to patients for unsupervised use and are administered only within controlled clinical settings under the direct supervision and oversight of the AP psychiatrist.

This approach therefore prioritises direct oversight at the highest risk stage (administration), while allowing some flexibility in other aspects of care, consistent with clinical guidelines and evolving practice.

How the recommendations will affect practice:

These recommendations clarify the level of AP psychiatrist oversight required across the treatment pathway.

In practice, the AP psychiatrist will:

• be expected to take a direct and clearly defined role at critical points in care, particularly in patient screening, informed consent, and medicine administration
• be required to conduct patient screening and informed consent discussions in real time, ensuring that patients are appropriately assessed and fully informed prior to treatment
• be physically present on-site at the time of psychedelic administration, enabling immediate clinical oversight and management of adverse events.

Continuous on-site presence of the AP psychiatrist is not required, and this approach preserves a degree of flexibility to support service accessibility.

Overall, the recommendations maintain strong patient safety and regulatory compliance by ensuring direct AP psychiatrist involvement at higher-risk stages of treatment, while balancing the need for practical and scalable service delivery.

Recommendation 4: Appropriate site location

AP psychiatrists must provide details of the treatment site to demonstrate it is a suitable medically supervised environment.

The AP psychiatrist is responsible for ensuring the site meets the following requirements:

• Equipment and trained staff for clinical care, monitoring, medical/behavioural emergencies and emergency resuscitation.
• Secure storage and record keeping for Schedule 8 medicines as per jurisdictional regulations.
• Ability to address treatment-emergent adverse events, with immediate access to rescue medications.
• Located near (within 15 minutes of) an accredited healthcare facility with an emergency department.
• Clear documentation of treatment plans, consent, and adverse events.
• Adheres to all state/territory requirements.

Why the recommendation was made:

Prior to consultation, there was a lack of clarity regarding what constituted an appropriate site location, and whether sites other than day hospitals or inpatient settings could be deemed acceptable.

Stakeholder feedback strongly supported allowing treatment in settings beyond traditional hospital environments, noting that less overtly clinical, more therapeutic settings can improve patient comfort and outcomes. Such environments were also considered more culturally appropriate for First Nations people and more accessible for patients in rural and regional areas.

While formal accreditation, such as the National Safety and Quality Health Service Standards (NSQHS), were recognised as providing a high level of assurance, stakeholders raised significant concerns about its practicality. In particular, the costs, administrative burden, and indemnity risks associated with accreditation were seen as prohibitive for many providers, especially small, regional, and community‑based clinics. There were concerns that mandating accreditation could limit service availability, favour large metropolitan providers, and reduce patient choice.

It was also noted that accreditation is not universally required for comparable outpatient mental health services, and that there is limited evidence of systemic safety issues that would justify such a requirement at this stage. Additionally, stakeholder feedback emphasised the importance of “set and setting” in influencing therapeutic outcomes, further supporting flexibility in site selection.

At the same time, the TGA recognised that HRECs are not responsible for assessing site suitability and that minimum safeguards are necessary given the emerging evidence base and patient vulnerability. As a result, the recommendation maintains expectations on the AP psychiatrist for treatment to occur in medically supervised settings with appropriate emergency protocols and compliant handling of Schedule 8 medicines.

This recommendation seeks to enable broader patient access while ensuring patient safety, governance, and regulatory requirements are maintained.

How the recommendations will affect practice:

These recommendations introduce clear, minimum requirements for treatment site suitability while allowing flexibility in the type of setting used for psychedelic‑assisted therapy.

In practice, the AP psychiatrist will:

• be responsible for selecting and maintaining treatment environments that meet defined safety, clinical governance, and regulatory standards,
• need to ensure that their chosen sites are medically supervised and equipped to manage both routine care and potential emergencies,
• need to ensure availability of appropriately trained staff, resuscitation capabilities, access to rescue medications, and robust systems for monitoring and responding to adverse events,
• be responsible for compliance with Schedule 8 medicine storage, handling, and record‑keeping requirements
• remain responsible for ensuring compliance with all applicable state and territory laws, conditions and approval processes, for psychedelic medicines which may change over time.

Further information

For further information on the recommendations, contact the Authorised Prescribers team Authorised.Prescribers@health.gov.au.