Australia the first country to officially recognise illegal drugs as medicines

Pharma News: From 1 July 2023, Australia will be first country in the world to allow the prescription of illegal drugs for the treatment of certain mental health conditions.

The Therapeutic Goods Administration (TGA) will permit the prescribing of MDMA (3,4-methylenedioxy-methamphetamine) by approved psychiatrists for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression.

Dr Stephen Bright, Senior Lecturer of Addiction within the School of Medical & Health Sciences at Edith Cowan University, said “Recognising that illegal drugs like MDMA and psilocybin have medical utility is an important step in drug policy reform. However, the safe provision of these treatments requires extensive training which is why they have been limited to clinical research in Australia to date.

“To ensure that people accessing these treatments are not harmed, it will be important that the TGA provides a clear expectation regarding the minimum training standards required for psychiatrists who the TGA approves to prescribe these drugs.”

To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients. 

Professor Susan Rossell, cognitive neuropsychologist and Professorial Research Fellow at Swinburne’s Centre for Mental Health is the lead researcher on Australia’s biggest research trial examining ‘psilocybin’ for treatment-resistant depression.

She said “I have a significant degree of caution about this decision because these treatments are not well established at all for a sufficient level of broad-scale implementation. Substantial further research needs to be done.

“First, to confirm efficacy to international standards for all psychotropic medications and to understand which conditions are best treated and which formulations will best serve the patients and minimise risks. We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study.”

Dr David Caldicott, Emergency Consultant and Senior Clinical Lecturer in Medicine at the Australian National University (ANU), commented “The approval of MDMA and psilocybin represents an inevitable outcome for a process that in different political circumstances, might have occurred at least 5 years ago. The data that supports this move has been in play for some time, and it is perhaps a reflection of a change in the policy ecosystem that has seen changes being introduced at this late stage, rather than when the evidence to support the move originally became available.

“MDMA was being used as medication in 1985, when it was banned by executive order of the President of the USA, and against the advice of medical professionals and administrative agencies. In the last decade, with advances in functional neuroimaging, it has become abundantly clear that a controlled supply of known doses of both MDMA and psilocybin can have dramatic effects on conditions often considered refractory to contemporary treatment.”

He added “Perhaps most excitingly, many of the treatments that are emerging with these previously banned products require only a brief exposure to facilitate therapy, and not the life-long prescription of drugs that do little more than dull the edge of psychological trauma.”

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials. 

The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

Peter Hunt AM, Chairman of Mind Medicine Australia, said medical grade psilocybin had been imported from Canada and MDMA is also on its way.

There are currently no approved products that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses. 

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