Understanding the changes to MDMA and psilocybin access

You may have heard that psychiatrists will soon be able to prescribe the psychedelic medicines, MDMA and psilocybin, to certain patients.

There is emerging evidence that these medicines may help people with specific mental health conditions that other medicines and therapies can’t treat.

For this reason, the TGA will permit medicines containing MDMA and psilocybin to be prescribed by authorised psychiatrists for people with certain mental health conditions from 1 July 2023.

Under the changes, MDMA can only be prescribed to treat post-traumatic stress disorder. And psilocybin can only be prescribed to treat depression that is resistant to other treatments. There are no other approved uses for these two medicines.

It's understandable some people are concerned the changes will make it easy to get access to these medicines. They are concerned that there are not appropriate controls in place to protect patient safety. Or that the changes may lead to substance abuse problems in the community.

To help prevent this and keep patients safe, we have put strict rules in place. These rules determine who can prescribe the medicines, and the settings in which they can be taken.

Only certain psychiatrists, registered under Australian law, will be able to prescribe them.

These psychiatrists will also need permission from a human research ethics committee. These committees will ensure the treatment protocol is right for the patient and the required safety measures are in place.

The psychiatrists also need authorisation from the TGA before they can prescribe the medicines.

If approved, psychiatrists must supervise their patients when they take the medicine. This will be in a hospital, clinic or another health setting. Patients won’t be able to use the medicine without the supervision of their psychiatrist. This means they also won't be able to take the medicine with them or access it outside the health facility.

The restrictions to strictly access in a controlled medical setting means the risk of diversion or illegal use in the community is extremely low.

While research on psychedelic medicines is not conclusive, there are promising signs. Australians with treatment-resistant mental health conditions can now access the treatment through their psychiatrist, an important opportunity that may improve their health.

When the changes take place on 1 July, we will closely monitor them. We will work to ensure the possible benefits of the treatments will outweigh any risks. We will also analyse any reported side effects and take action if needed.

Read more about the changes to psilocybin and MDMA.