In February this year, Australia’s Therapeutic Goods Administration (TGA) announced it would allow medicines containing MDMA or psilocybin to be prescribed by authorised psychiatrists from 1st July. With the substances now formally reclassified, Australia has become the first country in the world to legalise psychedelics for mental health conditions.
The reclassification of the two substances places them on the list of approved medicines by the TGA, allowing them to be prescribed for certain treatment-resistant mental health conditions. For example, MDMA may be prescribed for PTSD and psilocybin may be prescribed for depression.
The decision to permit psychedelic therapy as a treatment option was made in view of the current lack of treatment options for those suffering with treatment-resistant PTSD and depression. The TGA have stated that these two indications possess the largest amount of evidence to suggest significant benefits to patients.
However, undergoing treatment isn’t going to be as easy as tripping in your therapist’s office.
Rules for both patients and practitioners appear to be strict. If a GP feels that psychedelic-therapy might be appropriate then they will refer the patient on to an authorised prescriber. As well as this, psychiatrists must also provide a clinical justification as to why psychedelic therapy is an appropriate treatment for the patient group.
To prescribe the substances, psychiatrists require approval from a human research ethics committee as well as the TGA themselves. They must also provide a proposed treatment protocol, including dosing information and the number of therapy sessions.
There is to be no dispensing for home use. Once psychiatrists gain approval they will need to supervise their patient in a clinical setting.
The strict regulations around the dispensing of medication will likely make it incredibly challenging to access, much like the UK’s medical cannabis system.
Barriers to psychedelic therapy in Australia
Whilst many have welcomed the progressive move, the introduction of psychedelic therapy in Australia has been criticised for being prohibitively costly. Estimates for the price of therapy vary between AUD $10,000 and AUD $35,000 (£5,200-£19,000). Whatever the exact figure, the high cost of therapy is likely to act as a barrier to access for the most vulnerable (which are likely to be the patients that need it treatment the most). Researchers have warned that if the therapy is not eventually available at an accessible price many patients may turn to self-administration.
There is also concern amongst some that the plans have been rushed. The TGA are yet to approve any products that contain MDMA or psilocybin, meaning that psychiatrists have to source and supply the unapproved medicines themselves. Given the novelty of psychedelic medicines for many psychiatrists, being able to understand the system will likely be a significant blocker to expanding access. The roll out of the plans feel eerily similar to the legalisation of medical cannabis in the UK in 2018, with the same lack of infrastructure available at the time of legalisation, which in turn creates roadblocks and teething problems down the line.
Clinics have also warned that it may be a while before the service is fully up and running for Australians to access. Speaking to The Guardian, Scott Kelly, co-founder of GoodMind Therapeutics, said there was a disparity between the demand for the service, and the clinicians that are appropriately trained to facilitate it – therefore, it could be up to 12 months before psychedelic therapy gets fully underway in Australia. Interest and demand from patients might be there, but there must be clinical buy-in and confidence to be able to prescribe these medicines in the first place.
The feeling among the wider psychedelics industry with regards to the move is one of careful scepticism. Whilst there’s no denying that patients are in desperate need of therapeutic psychedelic services, the TGA has left clinics and clinicians with much to do in terms of establishing protocols, training and acquiring approval for products.
Professor Chris Langmead speaking at PSYCH Symposium
Speaking at PSYCH Symposium, Professor Chris Langmead, Deputy Director of the Neuromedicines Discovery Centre at Monash University, said:
“It’s fair to say the decision that was made in February was somewhat unexpected.”
“What they [the TGA] have left the sector with is a number of problems and issues to tackle. […] We’re still grappling with the protocols and that’s before we even think about reimbursement.”
Australia’s developments are certainly one to watch for the remainder of 2023. However, it seems there is a need to be cautious about our optimism around how access to these treatments is actually rolled out.
This piece was written by Volteface Content and Media Officer Megan Townsend. She is particularly interested in the reform of drug legislation, subcultural drug use and harm reduction initiatives. She also has an MA in Criminology from Birmingham City University. Tweets @megant2799.