Is Psychedelic Assisted Psychotherapy (PAP) legal?

Is Psychedelic Assisted Psychotherapy (PAP) legal? 

Psychedelic Assisted Psychotherapy (PAP) has been stuck behind a regulatory roadblock for quite some time now; it is not formally acknowledged by the scientific community because of the illegal status currently ascribed to most psychedelic substances.

Be that as it may, Australia’s Therapeutic Goods Administration (TGA) has recently been assessing a proposed amendment to the Poisons Standard which, if successful, will allow greater freedoms for clinicians looking to prescribe two of the so-called psychedelic drugs methylenedioxy-phenylethylamine (MDMA) and psilocybin (commonly known as “magic mushrooms”) for their patients.

What is Psychedelic Assisted Psychotherapy (PAP)?

PAP is a form of treatment that blends a traditional session of psychotherapy with the ingestion of a classical psychedelic such as psilocybin or MDMA. Lysergic acid diethylamide (LSD) has also been researched for therapeutic use in psychiatry.

The amount of research into these compounds grows more voluminous by the day, however, the general consensus amongst medical professionals is that psychedelics have potential for a wide range of therapeutic benefits and are likely to reach the market once further success occurs in future clinical trials.

The Australian Medical Association (AMA) have commented that, “Even though the treatment of certain medical conditions with MDMA and psilocybin is an emerging field, research has reported positive outcomes with minimal risk to the patient.”

‘While MDMA and psilocybin have been considered “breakthrough therapies” in the US, transition to a prescription medicine is still subject to Phase 3 trials. This shows that these therapies are not ready for use outside of clinical trials.’

What does the TGA say about Psychedelic Assisted Psychotherapy (PAP)? 

Historically, most PAP substances have been placed in Schedule 9. This categorisation infers that, from a regulatory perspective, there is no legitimate medical use for these particular materials.

The TGA has, to date, identified a lack of evidence-based clinical benefit from PAP drugs.

However, as for the two psychedelic compounds undergoing re-evaluation (psilocybin and MDMA), the TGA has deferred its down-scheduling decision, pending an independent expert review into the “therapeutic value, risks and benefits to public health outcomes for these substances.’

Down-scheduling from Schedule 9 (prohibited drug) to Schedule 8 (controlled drug) means an endorsement by the TGA of the controlled use of psilocybin and MDMA.

The independent expert panel will report findings on the “evidence of therapeutic value, benefits and risks of MDMA and psilocybin for the treatment of mental health conditions, including the size of effect, the quality of evidence and the applicability of the evidence to real-world use in Australia, currently and into the future”.

The review excludes pre-clinical trials (i.e. experimental pharmacology studies in test tube or animal models).

The panel’s report will be publicly available on the TGA website on 30 September, which will then be considered by the TGA’s decision making “Delegate” and the “Advisory Committee for Medicines Scheduling”.

How do you access psychedelic drugs legally in Australia?

PAP drugs like psilocybin, LSD and MDMA that sit in Schedule 9 can’t legally be supplied to the general public in any way. The only mechanisms for getting legal access to psychedelic drugs is through some form of research – whether that’s analytical, chemistry research or as part of a clinical trial.

It is important to have these regulatory frameworks in place because, without them, there comes the potential for substance abuse and, especially in the case of psychedelics, unpredictable reactions can occur, especially when there are underlying psychological conditions.

What does it mean if psychedelic drugs are “down-scheduled” by the TGA?

If these psychedelic drug items are down scheduled from Schedule 9 to Schedule 8, as happened with cannabis several years ago, it would be considered an acknowledgement by TGA that there may be a legitimate medical use for these substances such as in Psychedelic Assisted Psychotherapy (PAP).

Former Senior Evaluator at the TGA, Dr. Tony Whittaker said that even if access to particular psychedelic substances were expanded by this process, there would still be ‘a risk of abuse that has to be controlled quite tightly.’

Opioid painkillers, for example, belong in Schedule 8 because of the significant risk of dependency that they are associated with. PAP, as well, will likely end up in this category because of their potential for diversion and abuse, as well as the existential ramifications that comes with the psychedelic experience.

Essentially, keeping a substance in this category tries to ringfence the risk that they could be used inappropriately.

How would the TGA down-scheduling take effect for psychedelic drugs psilocybin and MDMA?

If psilocybin or MDMA were to be down-scheduled to Schedule 8, there would be potential for controlled supply of those products for patients.

To start a down-scheduling process, someone has to apply for this down-scheduling to happen. And that’s usually either someone from the industry, a doctor, or even a private individual. It also can be the TGA or the health department itself, which is what happened with cannabidiol, or CBD. But, at the end of the day, someone has to fill in the paperwork and put in the data package that would be needed to substantiate the proposal.

The “Advisory Committee for Medicines Scheduling” then review that information, meet to discuss it, and hand their findings over to the TGA “Delegate”. According to Dr. Whittaker, ‘The Delegate is the ultimate decision maker; taking into account the committee’s findings as well as any public submissions.’ After this process, the Delegate then renders an interim decision and opens up the proposal for further comments. Submissions can be from the general public, doctors, or any other interested party.

Where does the regulator stand on psychedelic drugs now?

The TGA’s interim decision for MDMA and psilocybin to remain in Schedule 9 is where we currently reside for psychedelic drugs, but in a show of their willingness to consider the medical possibilities, an independent expert panel has been established to review the “therapeutic value, risks and benefits to public health outcomes for these substances’ by September 30.

If the TGA were to down-schedule from Schedule 9 (prohibited drug) to Schedule 8 (controlled drug) it would be an endorsement by the TGA of the controlled use of psilocybin and MDMA.

We, the public, will be able to view the report on the TGA website on 30 September, but the final decision rests with the TGA’s decision making “Delegate” and the “Advisory Committee for Medicines Scheduling” to greenlight a move to Schedule 8.

Given the present body of evidence surrounding MDMA and psilocybin, the AMA currently remains opposed to the down-scheduling of these substances, but it will be very interesting to see the report’s findings.

Importance of research and evidence to make PAP psychedelic drugs legal

To give context, Dr. Whittaker said that this interim decision provides an opportunity for the TGA to gather more evidence before coming to a final decision, which is currently delayed pending a further independent review.

The AMA has commented that ‘more high-quality research using larger scale studies are needed before it can be used more widely by medical practitioners.’

‘High quality studies would determine the safety and efficacy of using these psychedelic drugs for mental illness.’

This is especially relevant given the fact that, ‘currently, long-term side effects of psychedelics are not known.’

The organisation also added that: ‘The AMA appreciates the barriers to research as raised by the applicant. However, these barriers should be addressed outside of the Poisons Standard Framework. The AMA believes that the need to reduce research barriers does not warrant making psilocybin and MDMA more readily available to practising medical practitioners as it would through down-scheduling. For example, a review of the barriers to MDMA and psilocybin through the Special Access Scheme or the Authorised Prescriber Scheme might be more appropriate.

Just as with low-dose CBD being down-scheduled in late 2020, we are now looking to the TGA to reach a final decision on down-scheduling certain psychedelics for PAP.

How is the down-scheduling process for psychedelics documented?

There will be internal documents at the TGA: there’ll be the information provided by whoever put the application in, there’ll be the public submissions, there’ll also presumably be evidence from the public literature, and, when the committee meets, there’ll be minutes and recommendations from those meetings.

Those documents aren’t all in the public domain, but are documented. Summary details of the committee’s discussion, the review by the Delegate, their initial decision and the reason for it and summarised on the TGA website.  Similarly, when a final down-scheduling decision is reached, details of that decision and a summary of the considerations will also be available.

What are the key drivers in the decision making process to down-schedule psychedelics?

The key driver in TGA decisions to down-schedule psychedelic drugs and thus allow greater medical use, is weighing between risks and benefits. If they choose to down-schedule something from Schedule 9 to Schedule 8, whatever risks are posed must be outweighed by the potential benefits that psychedelic drugs psilocybin and MDMA would bring.

In the case of Psychedelic Assisted Psychotherapy (PAP), the potential benefits would be that society may have access to a new avenue of treatment for mental health conditions that can be serious and chronically untreatable through conventional therapies. Down-scheduling would help promote medical and clinical research into PAP through increased public consensus.

The side effect profile may be unacceptable relative to the clinical benefit and may expose patients to an unacceptable risk.  In addition, drugs proposed for use in PAP (such as MDMA and psilocybin) have significant abuse potential and risk of diversion that would need to be managed if supply was to be permitted.

The important thing to consider is where to draw that line.

What are the risks of PAP psychedelic down-scheduling being significantly delayed?

If things go through super smoothly for psychedelic PAP drugs, the down-scheduling process could take around a year, but because of this extra round of investigation, it might take longer. If, with this proposal for psychedelics, the TGA ultimately chooses not to down-schedule these products, it may take quite some time for another proposal to come through.

The AMA has said that it will ‘support best practice advice for medications that are evidence-based from high quality studies specific to the health condition being treated.’

So, down-scheduling of PAP psychedelic drugs will occur if this criteria is met. If the criteria is not met, the process would take at least a year from whenever a new proposal is made.  Simply put, further clinical evidence through trials into the benefits vs the risks would need to be obtained to support any down-scheduling resubmission. 

Once PAP is down-scheduled, through what process will Psychedelic-Assisted Psychotherapy be made available to the public?

For the foreseeable future, if MDMA and psilocybin were to get down-scheduled to Schedule 8, access could be controlled  similar to medicinal cannabis – with availability through the Special Access Scheme (SAS) or the Authorised Prescriber Scheme (AP). This would not be without its own obstacles, however, as any supply through the SAS and AP pathways requires a company prepared to supply to product, and a process in place to control distribution and security. Additionally, TGA approval for each patient would likely be required if the supply was under SAS.

Will psychedelics be available over the counter?

It is unlikely that psychedelic substances would ever be made readily available over the counter because the conditions to be treated and the nature of the possible side effects following ingestion of these substances would require close medical oversight.