From July 1 this year, it will be legal in Australia to prescribe Psilocybine (the hallucinogenic chemical in ‘magic mushrooms’) and methylenedioxy-methamphetamine (better known as MDMA) after a landmark announcement by the Therapeutic Goods Administration (TGA) late this afternoon.
Psilocybine and MDMA have been used in trials in the US and other countries, and also in Australia, but pressure was mounting for the drugs to be reclassified in Australia to allow their prescribed use in treatments for illnesses such as depression and Post Traumatic Stress Disorder (PTSD).
This afternoon, the TGA announced that from July 1, Psilocybin and MDMA – which are both currently classified as Schedule 9 substances (meaning their use is prohibited) – will be reclassified as Schedule 8 drugs (controlled medicines), paving the way for them to be prescribed by suitably qualified psychiatrists.
That doesn’t mean it’s legal to go out and obtain mushrooms or MDMA – the drugs retain their Schedule 9 status outside a prescribed, therapeutic environment, making it illegal to use or possess them. Psilocybine can specifically be prescribed for treatment resistant depression, and MDMA can be prescribed for treatment of Post-Traumatic Stress Disorder.
The TGA noted that in deciding to reschedule MDMA and Psilocybine, it considered almost 10,000 public submissions across the two drugs (3,442 for Psilocybine and 6,505 for MDMA), along with other material including reports from an independent expert panel, input from the Royal Australian and New Zealand College of Psychiatrists’ (RANZCP)and a presentation to the TGA by Professor David Nutt, a renowned British neuropsychopharmacologist.
You can read the TGA’s full announcement here.
Chairman of Mind Medicine Australia, Peter Hunt AM said his organisation was delighted at the development, which would be welcomed by many Australians suffering from depression and PTSD.
“The decision specifically recognises the current lack of options for patients with specific treatment resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials,” Mr Hunt said.
“Whilst not yet a medicine registered on the Therapeutic Goods Register, this decision will enable appropriately screened patients with treatment resistant depression and treatment resistant post-traumatic stress disorder to access these medicinal therapies through authorised psychiatrists.”
Executive Director of Mind Medicine Australia, Tania de Jong AM said: “We want to express our enormous gratitude to the tens of thousands of people who have made this breakthrough possible including the TGA, the Delegate, the members of the TGA’s Medicines Scheduling Advisory Committee and all of the psychiatrists, psychologists, other mental health professionals, world leading experts and all of the people who put in submissions of support.
“The support that we have had throughout this process has been incredible and overwhelming. We were also delighted that the work of Professor David Nutt who presented to the TGA last November was specifically recognised by the Delegate in the Final Decision.”
A spokesperson for the TGA noted there are currently no approved products containing psilocybin or MDMA 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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