The Government Is Allowing MDMA and Psilocybin to Be Prescribed for Mental Health

mdma tga psychedelics approved

You’ve heard the news: on July 1, Australians will be legally allowed to take MDMA and magic mushrooms.

So, the question on everyone’s mind is: When do I get my free drugs and how long before Australia turns into a non-stop freak-fest hippy love-in? The 60s are back, baby!

Before you start thinking all the rules have gone out the window, there are quite a few caveats here.

The drugs have been re-classified by the Therapeutic Goods Administration, following a lengthy medical consultation for two very specific uses only. These drugs have only been made slightly less illegal than they otherwise are.

Both MDMA and psilocybin, the active chemical in magic mushrooms, will be able to be prescribed for the treatment of specific mental health conditions under the observation of licenced medical practitioners.

In limited clinical data, both drugs have been shown to have remarkable abilities to treat post-traumatic stress disorder and treatment-resistant depression, two debilitating conditions for which there are few alternatives for help.

The decision by Australia’s medicines regulatory body makes our country the first in the world to provide legal access to these drugs for medical use.

But it’s not going to be a psychedelic free for all and there are concerns over exactly how these drugs will be accessed and who will be able to get them.

Here’s what you need to know about what how this whole thing is going to work.

What Have the TGA Said About MDMA and Psilocybin?

In February, the Therapeutic Goods Administration (TGA) announced that they would reclassify MDMA and psilocybin. On July 1, these drugs will move from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Drugs).

This legal change will “permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression,” the TGA said in a statement at the time.

“These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients,” they added. This means recreational use and possession of the drugs are still 100% illegal.

The TGA has said that they made this decision, which overrides a previous decision not to allow the drugs to be re-classified, owing to the “current lack of options for patients with specific treatment-resistant mental illnesses”.

“It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting”.

How Will MDMA and Psilocybin Therapy Work in Australia?

Only highly qualified people with specific justifications and approvals will be allowed to give people suffering from severe mental health conditions, for which other treatments have failed, doses of either MDMA or psilocybin in highly controlled settings.

MDMA has been shown in some clinical trials to be highly effective in treating post-traumatic stress disorder when used in combination with psychotherapy. Psilocybin has also been shown, separately, to be able to significantly reduce the symptoms of major depression. Therefore, each drug will only be able to be prescribed for those specific conditions and, likely, in conjunction with a course of psychotherapy.

Because people under the influence of these drugs are in altered states of consciousness, serious ethical considerations must be made about who can oversee treatment.

The only people who will be able to prescribe this treatment will be registered psychiatrists who have the support of a registered human research ethics committee. Once they have that, they will also need individual approval by the TGA as an authorised prescriber of these medications. In addition, they’re going to need importation and possession permits and licences, which may or may not be granted, depending on the state or territory they reside in.

The TGA will need to see evidence that these people have undertaken “practitioner training” and have “evidence-based treatment protocols” in place. This is tricky given that, this being a world-first, there are no training courses or treatment protocols to follow outside of best-guess options based on clinical trial practices.

It’s also unclear exactly who will be giving the therapy since it’s a psychiatrist’s job to prescribe medications for mental health conditions and a psychologist’s job to deliver therapy. Will authorised prescribers be giving the green light for other people to take over with the actual delivery of these treatments? The TGA says details are still forthcoming on specifics.

So, When Do We Get Our Drugs?

Depression and PTSD are some of the most widely experienced mental health conditions in the world. Last year, 4.7% of Australians experienced a “depressive episode,” while 5.7% experienced PTSD, according to the Australian Bureau of Statistics.

For people with depression, an estimated 30% of those conditions are thought to be treatment resistant. That is, people whose depression does not improve with treatments like therapy or anti-depressant medications.

The TGA has stated that people seeking MDMA or psilocybin treatment for PTSD and depression will have to have a demonstrated history of other treatment options that have failed to improve their condition.

In theory, this will make some 400,000 people in Australia eligible for treatment with psilocybin, although the reality is likely to be far fewer, given that a “depressive episode” does not equal major depression for which treatment would be given.

Still, there are likely to now be thousands of people and their families seeking treatment using these novel drugs. Dealing with the sheer quanitity of the demand here is going to be tricky. Psychiatrists are notoriously difficult to book an appointment with and cost a lot of money. Not to mention that anyone who wants to become an “authorised prescriber” of these medications will have a lot of initial hurdles to jump through.

Some commentators estimate that access will not be up and running until the end of this year, while others suggest psychedelic therapy may follow a similar path to medicinal cannabis. Cannabis was legalised for medicinal use in 2016 but it wasn’t until 2018 when prescriptions begun to trickle through, and not until 2020 were systems really in place to manage demand. Because of this, the more sceptical crowd suggest MDMA and psilocybin may not become readily available in a consumer sense for several years.

Australian advocacy group, Psychedelic Research in Science and Medicine (PRISM), have stated that the expectations of people seeking access to these drugs should be tempered.

“To date, there is a very small cohort of appropriately qualified and experienced therapists and practitioners of psychedelic-assisted psychotherapy. This situation will take some considerable time to be addressed,” they wrote in a statement.

This assessment is supported by the Australian Psychedelics Society, which has said that “for the next few years at least, very few psychiatrists will have gone through the process.”

“Wait times could be much longer than for the average psychiatrist, though we would expect prescribers to prioritise patients with the greatest need,” they have written.

How Much Will Psychedelic Therapy Cost?

One of the biggest hurdles with any mental health treatment is cost. Psychiatrists are at the top of the mental health care professional tree and visits to them are frequently not covered, or are only partially covered, under Medicare. This means people can shell out anywhere from $200 to $600 per visit, often for just an hour of their time.

Therapy models for treatment with MDMA or psilocybin often include a number of therapy sessions before and after a number of treatment sessions with the drugs themselves. The drug-assisted sessions typically last around eight hours, meaning patients could end up spending thousands for a course of treatment.

Professor Chris Langmead of the Monash Institute of Pharmaceutical Sciences has estimated that the true cost of psychedelic therapy could be in the $25,000 to $35,000 range.

Speaking to The Latch, Professor Ian Hickie, Co-Director of Health and Policy at The University of Sydney’s Brain and Mind Centre and a Senior Principal Research Fellow at the National Health and Medical Research Council, has said he is concerned about these prosepective costs.

“There’s a whole expensive therapeutic environment required. Doctor time’s, therapist’s time, regulation, supply, appropriate settings, hospitals. There are all sorts of things to be paid for,” Hickie told The Latch.

“I think what you’ll see in the first instance is a very small number of clinics or services that are willing to go down that path”.

Unless these treatments are subsisded in some way, or an alternaitve provider model is worked out, they would be reserved only for the extremely wealthy.

Hickie notes that a number of alternative financial models are on the table, including total out-of-pocket costs to patients. But there is also the suggestion that charities or commercial interests will cover some of the costs.

Psychedelics have, for a while now, been a concept that venture capitalists are convinced could be one of the most lucrative on the planet if the right model for delivery can be found. Australia, as a global first-mover, will be watched very closely by key financial players looking to see what sticks and what doesn’t.

“There’s been a lot of political lobbying. There’s been a lot of commercial interest in this,” Hickie said.

In summary, the new changes are a tentative but significant step towards a planet in which access to medication that has life-saving potential is accessible. However, there are many, many more steps to be taken until the 60s hippy free-love sessions can begin.

Additional reporting by Ruby Feneley.

Related: MDMA and Psilocybin Will Soon Be Mental Health Meds in Australia

Related: Professor David Nutt Explains Exactly How Psychedelic Therapy Works

Read more stories from The Latch and subscribe to our email newsletter.