It might seem that changes to pharmaceutical regulations move at a glacial speed but, be assured, that they do move and they are happening.

Back in August 2020 (you remember that year – you made a LOT of sourdough), Australia’s Therapeutic Goods Administration (the TGA) announced a consultation regarding amendments to the Poisons Standard.

Amongst a number of proposals were those to amend psilocybin and MDMA from Schedule 9 to Schedule 8 for use in the treatment of medical conditions:

“In preparation for oral use as part of psychotherapy under the authorisation of a treating psychiatrist or specialist addiction physician in a medically controlled environment.”

What is the Poisons Standard?

The Poisons Standard (AKA The Standard for the Uniform Scheduling of Medicines and Poisons, SUSMP) is a legislative instrument which records the classification (schedules) of medicines and chemicals such that there can be a consistent approach to the management of materials that present similar risks.

Schedules are determined based on the toxicity, purpose of use, potential for abuse, safety and need of a substance. The Poisons Standard includes ten schedules, listed according to the degree of control over accessibility that is recommended.

Schedule 1	Intentionally blank
Schedule 2	Pharmacy medicines
Schedule 3	Pharmacist only medicine
Schedule 4	Prescription only medicine
Schedule 5	Caution
Schedule 6	Poison
Schedule 7	Dangerous drug
Schedule 8	Controlled drug
Schedule 9	Prohibited substance
Schedule 10	Danger to health

TGA Poison Standard: Psilocybin and MDMA

In the context of this blog, we are mainly concerned with:

Schedule 8: Medicines for therapeutic use but which pose a risk to health, have a high potential for abuse and addiction, and require authorisation for their possession.
Schedule 9: These substances may only be used for research purposes, and their manufacture or distribution is strictly prohibited except with a permit.

Both Psilocybin and MDMA have thus far remained listed in Schedule 9, limiting their use to research only.

Psilocybin is a hallucinogenic compound of the alkaloid class, found in more than 200 species of mushroom
MDMA (3,4-Methylenedioxymethamphetamine) AKA ecstasy; a potent empathogen–entactogen with stimulant properties primarily used for recreational purposes. The desired effects include altered sensations, increased energy, empathy, and pleasure. (wiki)

Psilocybin and MDMA - TGA poison schedule and use of Psilocybin and MDMA in medical treatments

Psychedelics and hallucinogens such as these have a long history in human culture dating back to the Egyptians.

Despite some early investigations in the 1950s and 1960s into the therapeutic benefit of these substances, research came to an abrupt halt when Richard Nixon announced his “war on drugs.”

It wasn’t until the 1990s that this research field was reinvigorated.

Hallucinogens: Hallucinogens are a type of psychoactive drugs; these may be categorised as psychedelics, dissociatives, or deliriants and can produce altered states of consciousness characterised by major alterations in thought, mood, and perception as well as other changes.
Psychedelics: The primary effect of psychedelics is to trigger non-ordinary mental states and/or an apparent expansion of consciousness, causing effects on the mind, such as feelings of deep understanding or unusually strong experiences of colour, sound, taste, and touch

How are psychedelics used in the treatment of medical conditions?

The release of psilocybin and MDMA into Schedule 8 will permit authorised psychiatrists to prescribe these drugs to their patients.

The TGA has been at pains to iterate that it is not their role to mandate clinical procedure, but during the consultation process, they reviewed a number of clinical trials which supported the use of psychedelics in conjunction with talk therapy to support the patient before, during and after ingestion of the medicine.

It is believed that the therapeutic effect is a result of the interaction between the drug and the mindset of the patient (together often referred to as ‘set’), the external conditions (often referred to as ‘setting’), and the therapist(s). Garcia-Romeu A et al, Int Rev Psychiatry, 2018

There have been a raft of studies demonstrating profound and lasting positive changes for patients:

If you want some further information about the data that has supported the TGA’s move, take a look at this report.

TGA-approval-of-Psilocybin-and-MDMA-depression

So how is the industry currently positioned?

Now that you’re all caught up, let’s get back to the regulatory changes.

There were some bumps in the road when the TGA initially rejected the proposal in December 2021. Whilst there was bitter disappointment in the industry, it’s understood that due process is required to ensure the future safety of all those who go on to take such medicines.

The proposed Poisons Standard entry was amended to additionally:

Identify the use of psilocybin for treatment-resistant depression, and MDMA for PTSD, only,
Require that prescribing pharmacists are state/territory registered,
Require that clinical trial use is approved by the Secretary.

Notably, the mandates for treatment in a “medically controlled environment” and to manufacture, import, and supply in accordance with the Narcotic Drugs, and Therapeutics Goods Acts have been removed.

However, during a webinar held in March 2023, the TGA was keen to reiterate that:

They do not regulate clinical protocol and that this is the role of professional clinical organisations
“GMP manufacture [is] strongly preferred”

On 03 February 2023, the TGA announced its final decision to accept the rescheduling of both substances and to permit:

“prescribing of MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression (TRD) by [authorised] psychiatrists.”

This is massive! This places Australia as the first country to take that step that bridges the divide between clinical research and actual clinical treatment with these psychedelic compounds by recognising psilocybin and MDMA as medicines (as from a few international compassionate use schemes).

From 01 July 2023, authorised psychiatrists will have another therapeutic treatment at their disposal for specific patient populations for whom other treatments have been ineffective.

Aside from the access for patients, this change also offers the Australian pharmaceutical industry a great opportunity to lead the international market regarding the production and manufacture of psychedelic therapeutic products.

How does the industry move forward from regulatory permission to market supply?

Much of the regulatory rhetoric has been centred around the end-users regards prescribing, psychiatrists, and patient access. But making regulatory changes that permit the prescription of new medicines is worthless if there are no products available to fulfil that market need, as we’ve seen with the rescheduling of cannabidiol from Schedule 4 (prescription only) to Schedule 3 (pharmacist only).

Supply to market inevitably needs to be supported by a suitable regulatory framework that permits:

The TGA has confirmed that it will soon announce guidance to support domestic manufacture. It may be a framework similar to that for medicinal cannabis. This should allow manufacture/importation via licences and permitting to supply Authorised Prescribers with unapproved medicines (i.e. not listed on the ARTG).

If you decide that you’d like to be part of this exciting new development, PharmOut out will be available to help you navigate the path to licenced distribution; from facility design that meets security, process flow and cleanliness needs, to regulatory support identifying the information and documentation you need to raise and provide for a successful licence application. When you’re ready to take that first step, we’d be happy to talk through your plans with you.

And what about the future?

It’s worth noting that, although the TGA has specified the use of psilocybin and MDMS specifically for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression (TRD), clinical studies are currently investigating their potential use in many other treatment areas.

With trials currently underway to assess the impact of these compounds on conditions such as obsessive-compulsive disorder, substance dependence, anxiety, anorexia, body dysmorphic disorder, Alzheimer’s, phantom limb pain, and autism, it seems we have a way to go before we will understand the full impact that psilocybin, MDMA et al could have on mental health in our communities.