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Australia reschedules psilocybin and MDMA

The decision “sets a new global standard for treatment with molecules like MDMA and Psilocybin”. 

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A brief history of psychedelics

In a groundbreaking development, Australia is to reclassify psilocybin and MDMA to enable prescribing by authorised psychiatrists. 

Under the new classification, the substances will change from Schedule 9 which is prohibited substances, to Schedule 8, which is controlled drugs, of the Poisons Standard. The change will take effect from 1 July, 2023. 

Under the new classification, Australia’s Therapeutic Goods Administration (TGA) will permit prescribing of MDMA for post-traumatic stress disorder (PTSD), and will permit prescribing of psilocybin for treatment-resistant depression.

Acknowledging the current lack of options for patients with specific treatment-resistant mental illnesses, the TGA has stated that these two conditions are the only ones for which there is currently sufficient evidence for potential benefits in certain patients.

How will it work?

According to a statement from the TGA, prescribing will be limited to psychiatrists “given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established”. 

It has also confirmed that any psychiatrists that want to prescribe these therapies will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

Access to psychedelic therapies for Australians

The news has been welcomed by the industry in Australia, which has been pushing for a change in scheduling.

The decision was made following multiple applications to the TGA to reclassify the substances in the Poisons Standard, as well as public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

See also  Study to explore effects of LSD microdosing

Australian-based psychedelics company, Mind Medicine Australia, made a statement saying: “We are delighted with the decision which will be welcomed by so many suffering Australians. It specifically recognises the current lack of options for patients with specific treatment-resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials.

“We want to express our enormous gratitude to the tens of thousands of people who have made this breakthrough possible including the TGA, the Delegate, the members of the TGA’s Medicines Scheduling Advisory Committee and all of the psychiatrists, psychologists, other mental health professionals, world-leading experts and all of the people who put in submissions of support.

“The support that we have had throughout this process has been incredible and overwhelming.

“Finally, our hearts go out to all those Australians suffering from treatment-resistant depression and treatment-resistant post-traumatic stress disorder. 

“They will now have the opportunity of accessing this breakthrough treatment with their mental health professionals, which has shown such positive safety and efficacy results internationally.”

PharmAla Biotech Holdings CEO, Nick Kadysh, stated: “This is a critically important announcement by the TGA, allowing for the direct prescription and treatment of patients with PTSD and Treatment-Resistant Depression with Psychedelic molecules.

“As the registered supplier to three different Australian clinical trials using MDMA – more than any other Psychedelics API supplier – PharmAla is the only company which has both GMP MDMA and Psilocybin in inventory, and stands ready to ship these molecules to Australia.”

COO of PharmAla Biotech, Dr Shane Morris, added: “The TGA decision absolutely sets a new global standard for treatment with molecules like MDMA and Psilocybin.

See also  MEPs urge European regulators to move faster on psychedelics

“Allowing specially-licensed psychiatrists to prescribe these molecules directly to patients is an excellent approach, and will certainly help drive other countries to re-assess how they regulate these molecules to meet patients’ medical needs.”

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Now is the time for psychedelic access, says campaigner

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Now is the time for psychedelic access, says campaigner

Activists in Oakland recently filed a ballot put forward by Dave Hodges seeking to legalise safe and legal access to psychedelics for therapeutic uses. 

In the face of critics, Hodges has said now is the time for safe access to psychedelics.

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

Hodges has said: “Now is the time for safe, controlled medical access for patients in need. The way to solve the problem is not by continuing to ignore it.” 

Hodges’ solution is to create a structure for use that includes proper dosages and access to experts who can help users benefit from appropriate treatment.

The updated initiative language emphasises safety, and gives doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of conditions.

Research by the University of Michigan and Columbia University shows non-LSD hallucinogenic use on the rise and Hodges has stated that increase means that the initiative providing guidelines for use is needed more than ever. 

Hodges said he hopes Californians will read the initiative, share their thoughts about it over the holiday week and offer feedback via the initiative website, PW4CA.com, by 27 November, 2023, the deadline for modifications.

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

“Now is the time to provide medical and therapeutic access to psychedelics,” Hodges said. “The way to do this is through the initiative.”

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Transform Drugs releases groundbreaking book: How to regulate psychedelics

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Transform Drugs releases book: How to regulate psychedelics

UK charity Transform Drug Policy Foundation has published a new book ‘How to Regulate Psychedelics: A Practical Guide’ that sets out how psychedelics can be legalised and regulated for non-medical adult use.

While an increasing amount of research is pointing to the potentially beneficial effects of psychedelic treatment on mental health conditions, many people across the globe are using psychedelics outside of the clinical setting.

The book includes a set of proposals for post-prohibition policies, covering psychedelics including psilocybin, LSD, DMT and Mescaline. 

Previously, Transform’s guides on regulating stimulants and cannabis have been used to advise governments around the world on drug policy. This book seeks to inform the debates on psychedelic drug reforms taking place across the world.

Co-author and Public Affairs and Policy Manager at Transform Drug Policy Foundation, Ester Kincová, stated: “Despite psychedelic drugs being illegal, their non-medical use within society has been steadily increasing. 

“Punitive enforcement has not decreased use or eliminated supply, but it has made use more unsafe. 

“Legalising and regulating psychedelics is a pragmatic move to reduce harm. This is no longer a theoretical debate, states in the US are already recognising the need and  making moves to regulate for non-medical adult use.”

Scientific Chair of Drug Science, Professor David Nutt, added: “Once again Transform have come up with a well thought out and practical plan for the regulation of another group of currently illegal drugs – in this case psychedelics. 

“Their ideas would be both easy to implement and to engage with and will, if adopted, radically enhance the safe use of these remarkable agents.”

See also  DMT research receives $1.5 million donation

Proposals for regulation

The book includes a four-tiered regulation model “that attempts to manage the variety of psychedelic preparations and the different ways in which they are used”.

These include:

  • Private use, home cultivation, foraging and not-for-profit sharing.
  • Membership-based non-for-profit associations for plant-based products.
  • Licensed production and retail adaptable to different products and environments
  • Regulated commercial guided or supervised use

Additionally, a decriminalisation model is proposed which suggests that possession for personal use should no longer be an offence of any kind or be subject to any sanctions; Drugs for personal use should not be confiscated; cultivation of small amounts of plant-based drugs for personal use should be decriminalised, among other suggestions.

The book also includes topics such as embedding social justice, equity and human rights into policy design, how to think about psychedelics regulation, why regulate psychedelics and why now, and psychedelics and the UN drug treaties.

To read the book, please visit transformdrugs.org/.

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Policy

Oakland ballot seeks to legalise medical psychedelics

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Oakland ballot seeks to legalise medical psychedelics

Activists in Oakland have filed a ballot that seeks to legalise safe and legal access to psychedelics for therapeutic uses. 

The Psychedelic Wellness & Healing Initiative would enable the sale, possession and use of psychedelics for therapeutic purposes if passed. Psychedelics that would be allowed under the ballot include Psilocybin, MDMA, DMT, and Mescaline.

If passed, the initiative would give doctors and mental health specialists the right to recommend psychedelics to ease the debilitating symptoms of a range of problems, including obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), depression, anxiety, addiction, suicidality and traumatic brain injury (TBI), among others.

See also  Australia reschedules psilocybin and MDMA

Additionally, it would create a statewide framework for regulating the possession, use, cultivation and production of substances for medical and therapeutic use.

The initiative has been introduced by proponent and founder of the Oakland-based Church of Ambrosia, Dave Hodges, to the California Attorney General’s office for the 2024 ballot, and will need 546,651 valid signatures to qualify.

See also  CDPRG discusses the UK's Reschedule Psilocybin campaign

The filing follows California Governor Gavin Newsom’s recent veto of Senate Bill 58, the bill that sought to decriminalise the use of certain psychedelic drugs. 

Hodges emphasised that SB58 would have been a step forward, but that it had major flaws concerning its lack of provisions to ensure access, public safety and quality control. That veto, Hodges said, compelled him to move quickly on the initiative filing.

When the California Attorney General certifies the initiative for circulation, backers will have about four and a half months to gather the required signatures for ballot placement. 

Signature collecting will begin in early December.

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