Authorised Prescriber scheme for psychedelics targeted consultation meeting statement

The Therapeutic Goods Administration (TGA) convened a stakeholder meeting to discuss proposed changes to the Authorised Prescriber application process for psychiatrists seeking access to psychedelic medicines. The discussion focused on clarifying competency requirements, therapy team composition, prescriber oversight, and treatment site standards.

On 1 July 2023, the Poisons Standard was amended to allow access to MDMA for the treatment of post-traumatic stress disorder and psilocybine for treatment-resistant depression by psychiatrists who are specifically authorised under the Authorised Prescriber (AP) scheme. Since this time, several procedural and practical challenges have emerged for AP applicants, Human Research Ethics Committees (HRECs), and the TGA.

To address these concerns and support the continued safe use of psychedelic-assisted psychotherapy (PAT or PAP), a review of the application process is underway.

A targeted consultation invited comment from 83 stakeholders, including AP psychiatrists, peak professional bodies, HRECs and state and territory medicines and poisons units.

The consultation outcomes and recommendations were discussed further in a roundtable meeting with stakeholders. Insights from the discussion will guide refinements to the recommendations.

A summary of the discussion is outlined below:

• Recommendation 1 - psychiatrist experience: stakeholders discussed whether psychiatrist applicants must have demonstrated experience in psychedelic-assisted psychotherapy clinical trials OR have complied with specific supervision, training and peer support criteria to demonstrate competence. The relevant body or organisation to determine specific criteria was also discussed.
• Recommendation 2 - therapy dyad: stakeholders discussed if therapists should be registered with a National Board, including whether more flexibility is required to include other qualified practitioners (such as psychotherapists, counsellors, social workers) and to ensure cultural safety.
• Recommendation 3 - Authorised Prescriber oversight: stakeholders discussed whether the Authorised Prescriber psychiatrist should be physically present for screening, consent, and medicine administration. This also included considerations around flexibility in rural settings.
• Recommendation 4 - appropriate site location: stakeholders discussed safeguards for appropriate site locations. Jurisdictional site requirements were clarified. The discussion emphasised balancing full accreditation of sites with accessibility, cost and cultural safety.