Key Points
- From 1 July, MDMA and Psilocybin have been reclassified as medicine for some complex mental health conditions.
- They have been rescheduled from 'prohibited' to 'controlled' substances but only for strict medicinal use.
- People with post-traumatic stress disorder and depression can access them through authorised psychiatrists.
Australia has become the first country in the world to recognise two different psychedelic substances as medication.
From today, 3,4-methylenedioxy-methamphetamine - better known as MDMA - and psilocybin - the active ingredient in 'magic mushrooms' - can legally be used for specific mental health conditions.
The drugs, best known for recreational and illegal use, can only be accessed under strict conditions.
So how can these substances be used for medical treatment, and who can access them?
Are MDMA and psilocybin legal in Australia?
As of 1 July, the Therapeutic Goods Administration (TGA) has moved MDMA and psilocybin from Schedule 9 (prohibited substances) to Schedule 8 (controlled substances) in limited circumstances for medical use.
They must be prescribed by a psychiatrist with pre-approval via the TGA's Authorised Prescriber scheme and remain prohibited substances in all other circumstances.
Psilocybin is accessible to people with treatment-resistant depression, while MDMA can be accessed for treatment-resistant post-traumatic stress disorder (PTSD).
The substances can also now be used in clinical trials for investigating these conditions.
They must be accessed in supervised clinical settings and cannot be dispensed for home use.
Are psychedelics effective in medical treatment?
, psychotherapy involving psilocybin and MDMA has been shown to be "potentially beneficial" in the treatment of PTSD and depression.
Psilocybin and MDMA are relatively safe when used in a medically controlled setting under the supervision of appropriately trained healthcare professionals and in the dosages that have been studied in clinical trials, the TGA says.
Mike Musker is an enterprise fellow in the mental health and suicide prevention research and education group at the University of South Australia and a member of the medical advisory board at a clinic offering psychedelic-assisted therapy.
He said psychedelics can provide a profound change in mood, mental experience, feelings of connection and consciousness.
"I think it's a game changer for psychiatry," he said.
"It's one of the biggest evolutions in psychiatry in the last 70 years."
Depression and PTSD account for almost half of all mental health conditions in Australia, Dr Musker said.
"Access to psilocybin and MDMA in Australia has been long-awaited for both research and treatment," he said.
"There are many people in the community experiencing PTSD and depression, particularly army veterans and people who have worked in emergency services, where standard psychiatric drugs have not worked and offer no relief."
Are psychedelics legal in other countries?
While Australia is the first country to classify psychedelics as medicine, a number of countries have other methods of regulated access.
Daniel Perkins, co-executive director of the Psychae Institute and senior research fellow in the School of Population and Global Health at the University of Melbourne, said Australia's classification was one of the more strict schemes.
"Australia is the first country in the world that has actually rescheduled psilocybin and MDMA to make them available for clinical treatments," he said.
"In this world context, we can see Australia is in this group of leading jurisdictions, but our approach is pretty narrow and highly regulated compared to some of these other countries," Dr Perkins said.
He said countries including Switzerland, Canada, Israel, New Zealand and the United States have pathways including exceptional permits and special access programs to access psychedelics.
A number of states in the US are introducing regulated access to psilocybin this year, where people aged over 21 who meet certain criteria can access the treatment through facilitators.
What are the risks of psychedelics?
The TGA has acknowledged patients may be vulnerable during psychedelic-assisted psychotherapy, with both substances having potential side effects.
According to the TGA, adverse effects of psilocybin can include a temporary increase in blood pressure and a raised heart rate and some risk of psychosis in predisposed individuals.
Adverse effects of MDMA include high blood pressure and pulse rate, faintness and panic attacks, and in some rare cases, it can cause loss of consciousness and trigger seizures.
Other side effects include involuntary jaw clenching, decreased appetite, detachment from one's own mind or body, disorganised thoughts, restless legs, nausea, fever, headache, sweating and muscle/joint stiffness.
The TGA says these side effects are "unlikely" at low doses and in the appropriate settings with direct medical supervision.
Professor Susan Rossell is a cognitive neuropsychologist and professorial research fellow at Swinburne's Centre for Mental Health and has expressed concern about the TGA's decision.
"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."
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