The Therapeutic Goods Administration (TGA) announced on Friday that from July 1, 2023 the medical use of MDMA and Psilocybin will be rescheduled from Schedule 9 (prohibited substances) to Schedule 8 (controlled medicines).
Authorised psychiatrists will be able to prescribe these substances for those with treatment-resistant depression or PTSD. All other uses of the substances will remain in Schedule 9.
It’s great news for people with acute mental illness and those who have been campaigning for the schedule change for years.
The Chairman of Mind Medicine Australia, Peter Hunt, said on Friday he was “delighted with the decision, which will be welcomed by so many suffering Australians.”
“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,” Hunt said.
But if you’re hoping to get a prescription, you may have to wait a while.
MDMA and Psilocybin are unregistered substances in Australia, so although medical use under some circumstances will soon be legal, access to them will be highly restricted.
Before treatment is permitted for a patient, their psychiatrist must become an Authorised Prescriber.
To do so, they must obtain endorsement from a Human Research Ethics Committee or a specialist College, as well as the TGA. They have to prove they have sufficient processes and expertise to ensure the drug can be used safely and effectively as a mental health treatment.
The TGA said: “the onus and opportunity [will be] with a prospective prescriber of the Substances to devise and provide evidence of a suitable treatment protocol to the HREC and authorising TGA officer.”
This means even if your regular psychiatrist really wants to give you a script, it’s not as simple as that.
Rhys Cohen, a medical cannabis industry expert and an advisory board member of the University of Sydney’s Lambert Initiative, predicts accessibility to medical MDMA and Psilocybin will be similar to the early years of legalised medical cannabis in Australia.
Cohen said after it was downgraded from a Schedule 9 to 8 substance in 2016, it was common for patients and prescribers to be waiting weeks or months for an official decision on whether they could access medical cannabis.
“It took several years for the friction to be reduced [and] I can imagine similar issues emerging with psychedelics,” Cohen told VICE.
“In terms of accessibility, I think it will still be quite challenging for psychiatrists to get Authorised Prescriber status for these drugs.”
Cohen said the authorised prescriber scheme allowed for additional safeguards and oversight on the use of these substances because they were newer and less-studied than many other pharmaceuticals.
“Considering how new this field is I think it’s more likely there will be quite a long, considered dialogue between psychiatrists and the relevant agencies about negotiating the terms under which access may be permitted,” he said.
Since medical cannabis was legalised access has become much easier in recent years thanks to lobbying and advocacy of patient groups. But Cohen said the same may not happen with MDMA and Psilocybin because of community — and political positions and perceptions of the drugs. It’s safe to assume the average Australian is more cautious of psychedelics because far fewer people have used them compared to weed.
Cohen also said it will be hard to balance different perspectives on the medical use of these substances due to the nature of the illnesses they’ll treat. Consuming cannabis for pain relief for a cancer patient, for example, is much simpler for both patients and the community to understand, compared to psychedelics for mental illness.
“We’re talking about some of the most acutely unwell members of the community, with profound psychiatric conditions, who have often exhausted all other therapeutic options, so I can definitely understand why people have such strong interest for this change and there’ll be some heightened emotions during this debate,” Cohen said.
The rescheduling of MDMA and Psilocybin is still tremendously good news, he said, it just might be a while before we start to see the effects of this reform.
“The Australian Government has taken a really positive step in the right direction and instead of us having to wait ages for regulators to make up their own mind about … they’ve thrown it over to the psychiatric professions … which is quite pragmatic, but this is just the beginning of the process.”