Accessing MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin as a psychiatrist

The TGA administers the Therapeutic Goods Act 1989 (TG Act), which establishes the Australian regulatory framework for all therapeutic goods, including medicines.

Generally, medicines used in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG). For a prescription medicine to be registered in the ARTG, a sponsor of the product (usually a pharmaceutical company) is required to submit a dossier of evidence on the clinical efficacy, safety and manufacturing quality for evaluation by the TGA. However, the Australian Government has no power to compel a sponsor to make a submission to the TGA for registration in the ARTG.

Under the provisions of the TG Act, the TGA administers a number of mechanisms to enable access to therapeutic goods which are not registered on the ARTG, referred to as ‘unapproved’ therapeutic goods.

These mechanisms include the Special Access Scheme (SAS), the Authorised Prescriber (AP) scheme and access through clinical trials. Importantly, unapproved therapeutic goods accessed through these pathways have not been evaluated by the TGA for safety, quality and efficacy.

Scheduling is a national classification system that determines how medicines and chemicals are made available to the public. Medicines and chemicals are classified into ‘schedules’ in the Poisons Standard according to the risk of harm and the level of access control required to protect public health and safety.

Psilocybin and MDMA are included in Schedule 9 (Prohibited Substances) of the Poisons Standard, which because of interaction with state and territory regulation has largely restricted the lawful supply of goods containing these active ingredients to clinical trial settings only.

Effective from 1 July 2023, the TGA made the decision to down schedule psilocybin and MDMA to Schedule 8 in the Poisons Standard when used under certain conditions.

From 1 July 2023, the amendments mean that:

• Through rescheduling from Schedule 9 to Schedule 8 (“controlled drugs”) of psilocybin for the treatment of treatment-resistant depression, and MDMA for the treatment of post-traumatic stress disorder, restrictions by state and territory governments (including in some cases absolute prohibitions) on use of these substances outside clinical trials do not apply;
• However, access to these substances is restricted through new entries in Appendix D of the Poisons Standard, only permitting access to the substances under Schedule 8 as follows:
  • authorisation to prescribe the substances for the above conditions will be restricted to registered psychiatrists who have obtained approval from a Human Research Ethics Committee (HREC), and have also been authorised by the TGA to be an Authorised Prescriber under the Authorised Prescriber (AP) scheme.
  • possession of the substances without authority will be illegal (for example, possession other than in accordance with a legal prescription). Note, however that it is not anticipated at this time that approval would be granted for protocols which enable the patient to be dispensed medicines containing these substances to take home.
• Access restrictions remain in place for all indications for psilocybin and MDMA other than treatment-resistant depression and post-traumatic stress disorder respectively. For other indications these will remain as prohibited substances and remain in Schedule 9 of the Poisons Standard, limiting their use to medical and scientific research, such as clinical trials.

For further information visit Re-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answers.

Under the AP scheme, the TGA is able to grant a medical practitioner authority to prescribe a specified unapproved therapeutic product for particular indications to a class of patients in their immediate care.

To become an AP for MDMA or psilocybin, a psychiatrist must obtain approval from a HREC to prescribe the product. As part of their assessment the HREC is required to assess the suitability of the psychiatrist’s clinical treatment protocol.

Both the HREC approval and clinical treatment protocol are required to be presented to the TGA as part of the AP application process.

Once a medical practitioner becomes an Authorised Prescriber, they are not required to notify the TGA each time they prescribe the unapproved product, but they must report to the TGA the number of patients treated with the unapproved product twice yearly.

There is no application fee.

For further information visit the Authorised Prescriber Scheme.

The changes to the scheduling of psilocybin and MDMA limit the prescribing of these substances to psychiatrists who are registered with the Australian Health Practitioner Regulation Agency (AHPRA) with a specialist registration in psychiatry and completed a Fellowship with the Royal Australian and New Zealand College of Psychiatrists (RANZCP).

To prescribe MDMA and psilocybin psychiatrists must:

• have obtained approval for purposes of the Authorised Prescriber Scheme to use the substance for treating the conditions from a HREC that is registered with the National Health and Medical Research Council (NHMRC), and subsequently
• have sought and obtained authorisation by the TGA under the Authorised Prescriber Scheme (the AP scheme) to prescribe these substances for patients under their care.

A list of registered HRECs is available on the NHMRC website.

TGA will only consider applications under the Authorised Prescriber Scheme for prescription of psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder respectively. Psychiatrists should also consider and discuss with their patients the suitability of medical treatment options that are TGA approved (i.e. included on the Australian Register of Therapeutic Goods) before seeking to prescribe psilocybin or MDMA to them under the Authorised Prescriber scheme. The Special Access Scheme is not open to prescriptions of medicines containing these substances.

Part 1: Develop a clinical treatment protocol

Psychiatrists are required to provide a clinical protocol as part of their HREC application and their AP application to the TGA.

The TGA administers access of MDMA and psilocybin containing products through the AP scheme however is not involved in clinical practice.

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has established a RANZCP Psychedelic-Assisted Therapy Steering Group to assist psychiatrists and members of the public with clinical guidance including a detailed Clinical Memorandum. It is recommended advice by the RANZCP is followed in developing clinical protocols. Information is available on the RANZCP Psychedelics hub.

The TGA would expect that that treatment of post-traumatic stress disorder with MDMA and treatment-resistant depression with products containing psilocybin is part of a treatment protocol involving assessment and on-going psycho-therapeutic management by the psychiatrist before and after administration of appropriately supervised dosing of the patient in an appropriate setting (such as a day hospital or an inpatient setting). It is important to specify that patients will not have access to MDMA or psilocybin other than at the time of the supervised dosing.

The TGA expects that the HREC reviewing the treatment protocols would consider the training and experience of all staff involved in the treatment. It is likely that a minimum standard of training of others involved in patient oversight would be that of clinical psychologists who hold general registration with the Psychology Board of Australia and an endorsement in the area of practice of clinical psychology or equivalent. The protocol should include details of the informed consent obtained, including consideration of the risks associated with these treatments.

These aspects of the treatment protocol are likely to be very similar to the protocols that have recently been used in Australia and internationally in clinical trials of these substances.

Regarding trialled dosages and formulations, more information can be found within the following publications:

• The published study titled Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression, published in the New England Journal of Medicine on 3 November 2022
• The Independent expert panel report titled An evaluation of the therapeutic value, benefits and risks of methylenedioxymethamphetamine (MDMA) and psilocybin for the treatment of mental, behavioural or developmental disorders.

Part 2: Submit an application to a HREC and receive approval

To prescribe psilocybin and MDMA psychiatrists must have obtained approval to use the substances for treating these conditions from a HREC that is registered with the National Health and Medical Research Council (NHMRC).

A list of registered ethics committees is available on the NHMRC website.

The TGA does not provide a set template for HREC applications. The medical practitioner's application for HREC approval must be made in writing and provide sufficient evidence to justify the use of the unapproved product. An application for HREC approval must contain details of the:

• medical practitioner applying for Authorised Prescriber status
  • The application should provide evidence that the psychiatrist has the qualifications and experience necessary to appropriately manage the medical condition and use of the product.
• the 'unapproved' product details
  • The application should contain evidence of the unapproved product’s suitability for the intended indication that supports the clinical justification provided. The application should include details of the unapproved product, including active ingredient, strength, dosage form and sponsor/manufacturer details. It is best practice that the proposed treatment utilises pharmaceutical grade products that have been manufactured in accordance with Good Manufacturing Practice. Therefore neither “street” (illicit) psilocybin or MDMA nor mushrooms or their extracts known to contain psilocybin would be permitted for use.

A number of North American and European companies manufacture pharmaceutical grade psilocybin and/or MDMA. Details of product sources can be obtained from the ClinicalTrials.gov website and from recent publications of the results of clinical trials in the referred medical literature.

The application should also include information regarding the use of the product (dosage regimen and clinical protocol) and the proposed monitoring protocol.

Psychiatrists are also required to provide information detailing the product’s efficacy and expected benefits and any expected adverse effects, including known risks and safety issues. It is expected that psychiatrists will be able to provide appropriate sources of evidence to support the use of the unapproved product.

• clinical justification for the use of the good
  • The clinical justification for use of an unapproved product should provide sufficient evidence to demonstrate that its use is appropriate, considering the availability of any approved goods that may be suitable alternatives.

The HREC will also determine the information required from the applicant about the clinical protocol for use of psilocybin and MDMA. However, it is anticipated that in order to receive both HREC and Authorised Prescriber approvals, issues of patient selection and exclusion, the setting for administration of the medicine and how it will be controlled and how the use of the substance will be combined with psychotherapy as part of psychedelic assisted psychotherapy will need to be provided and considered to contain appropriate safeguards. It will be particularly important to ensure that the treatment does not cause unintended harm.

Detailed information on applying for HREC approval is available on our website at Authorised Prescriber Scheme Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors.

Part 3: Complete an Authorised Prescriber application

Following approval from a HREC, an application to become an Authorised Prescriber through the standard pathway must be submitted to the TGA.

Applications to the TGA must be submitted using the SAS and AP Online System. Please note, both the clinical treatment protocol and HREC approval are required to be uploaded as part of the application.

A delegate of the Secretary of the Department of Health and Aged Care who is registered as a medical practitioner with AHPRA will review Authorised Prescriber applications for MDMA and psilocybin.

In reviewing the application, the TGA delegate will ensure they are satisfied regarding matters including the applicant prescriber’s clinical justification for their treatment regimen, governance over the treatment process, and the use of suitable measures to protect patients, such as records of informed consent. The TGA delegate will also expect that psychiatrists will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access a psilocybin or MDMA-containing product for their patient.

All Authorised Prescriber approvals are subject to general conditions. The TGA may also apply specific conditions on a case-by-case basis. Authorised Prescribers must meet these conditions to retain authorisation. The approving HREC may also apply conditions to the approval.

Once approved, the Authorised Prescriber may prescribe the unapproved good to a patient under their direct care.

Failure to comply with conditions of authorisation may result in the revocation of the Authorised Prescriber's status.

The implementation of the Poisons Standard, as it affects access to and supply of medicines and poisons, is given legal effect through relevant State and Territory drugs, poisons and controlled substances legislation.

Psychiatrists must prescribe the goods in accordance with the legislative requirements relevant to their State or Territory.

State and Territory Health Departments should be contacted regarding advice on the interpretation of the Poisons Standard and/or the legal requirements for the supply and prescribing of MDMA and psilocybin containing products prior to submission of an application under the Authorised Prescriber scheme.

The personal information of the medical practitioner and the outcome of the application, including the TGA decision letter may be disclosed to state and territory authorities with responsibility for therapeutic goods or health practitioner registration.

Six monthly reporting

It is a condition of the Authorised Prescriber scheme that medical practitioners provide supply reports on the number of patients treated for each of their Authorised Prescriber approvals for the periods 1 January to 30 June and 1 July to 31 December each year.

Reports must be sent to the TGA within one month of the reporting period ending.

There are two categories to report:

• Number of new patients commenced on treatment
• Number of total patients treated during this period.

To submit your authorised prescriber six monthly reports, go to the SAS and AP Online System.

If no patients have been treated in the relevant period, this must also be reported. The online system will not allow you to submit your report if any of the fields are left blank. If you have not prescribed for any patients using your approval during the reporting period, you must enter zero for new and total patients in order for the report to be submitted.

Information on using the online portal system to submit six monthly reports is found in the Authorised Prescriber online system.

Reporting adverse events and product defects

MDMA and psilocybin have not been evaluated for safety, quality and efficacy and could pose unknown risks. Authorised Prescribers are responsible for reporting adverse events or defects arising from the use of unapproved therapeutic goods accessed under the AP scheme.

There are various ways to report adverse events and product defects, which can be found on the TGA website at Reporting adverse events.

Authorised Prescribers will be able to either import MDMA or psilocybin directly or obtain them from an Australian manufacturer or an importer.

See the Office of Drug Control’s website, Access to MDMA or Psilocybin for requirements relating to importing MDMA and psilocybin for use by an Authorised Prescriber.

Read more about how to supply, manufacture or import MDMA or psilocybin (sponsors and manufacturers).

Ensuring legal supply

An Authorised Prescriber is only allowed to supply the product directly to specified patients under their immediate care and not to other practitioners to prescribe and administer the product. The use of the product under an authorisation must be in line with the conditions specified in the authorisation at all times.

Authorised Prescribers must also ensure that they comply with State and Territory Health Department regulations and requirements concerning supplying and holding stock of Schedule 8 products. Where necessary, this could include arranging for a pharmacy to hold the product securely on the prescriber’s behalf until it is dispensed to the Authorised Prescriber for administration to the patient.

Safety considerations

The TGA cannot provide an assurance regarding the quality, safety or efficacy of an unapproved product. All parties involved in the supply of unapproved products must recognise that the practice may carry medico-legal risk, and, in the case of a company, there may be implications for the company's indemnity.

In prescribing the unapproved product containing MDMA or psilocybin for a patient, psychiatrists are responsible for considering the benefits and risks for the patient. Authorised Prescribers should remain informed of changes to the benefits and risks as they arise.

Cost

As unapproved medicines, MDMA and psilocybin containing products are not eligible for listing on the Pharmaceutical Benefits Scheme (PBS). Treatment costs must be met by the patient or a third party.

All advertising of therapeutic goods in Australia is subject to the requirements of the TG Act and the Therapeutic Goods Advertising Code (the Code).

Both prescription medicines and all unapproved therapeutic goods, including those containing MDMA and psilocybin, are prohibited from being advertised to the public. Authorised Prescribers must not promote, either expressly or impliedly, the use or supply of MDMA or psilocybin in any content available to members of the public. This means that it is illegal for prescribers or healthcare facilities to indicate that they can prescribe and/or supply MDMA and/or psilocybin. Substantial penalties apply.

MDMA and psilocybin may be advertised exclusively to health professionals, including psychiatrists and pharmacists. The TGA has published guidance on advertising exclusively to health professionals.

Information shared between a health practitioner and their patient during consultation or treatment is not subject to the advertising rules for therapeutic goods, including the prohibition on advertising prescription medicines.

In addition, presenting factual and balanced information about MDMA and psilocybin (e.g. in scientific papers or at medical conferences) is also unlikely to be considered advertising, depending on the context in which the information is presented. However, if a reasonable consumer or member of the public is likely to interpret the content as promotional, then the advertising rules will apply.

Refer to the Regulation of therapeutic advertising in Australia for further information.

As mentioned above, access restrictions remain in place for all indications for psilocybin and MDMA other than treatment-resistant depression and post-traumatic stress disorder respectively. For other indications these will remain as prohibited substances and remain in Schedule 9 of the Poisons Standard, limiting their use to medical and scientific research, such as clinical trials.

The TGA regulates the use of unapproved therapeutic goods supplied in clinical trials in Australia via the CTN scheme. This pathway provides for the lawful importation into and/or supply in Australia of unapproved therapeutic goods, solely for this purpose.

The TGA receives a notification, and the overseeing Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol. The HREC is also responsible for monitoring the conduct of the trial.

Information about how TGA regulates clinical trials is on our website at Clinical trials.