Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, June 2022

Closed 27 May 2022

Opened 29 Apr 2022

Feedback updated 27 Oct 2022

We asked

From 29 April 2022 to 27 May 2022, we sought submissions from the public on scheduling proposals referred to the June 2022 meetings of the Advisory Committees on Medicines and Chemicals Scheduling. Respondents were given the choice to indicate their support or opposition to the proposed amendments using survey buttons, with or without a written response.

You said

We received 6,766 responses, including 2,457 with written submissions, the majority of which commented exclusively on the proposals relating to MDMA and psilocybine. A tally of the survey responses supporting, partially supporting, or opposing each of the proposed amendments to the Poisons Standard can be found on the Published public submissions page

In the written submissions, the main points in support for the proposed amendments for MDMA and psilocybine were: restricted use of the substances for treatment-resistant mental illnesses have been approved abroad; the abuse potential of the substances when prescribed and used within an appropriate medical setting and supplied by trained professionals is low; and there is potential for significant benefits of the medicinal use of the substances to treat chronic treatment-resistant mental illnesses for which patients are urgently seeking new treatment options.  

The main points in opposition were: insufficient new evidence has been provided of the therapeutic value of the substances to that already previously considered by the Advisory Committee on Medicines Scheduling and the decision-maker; and although there are some phase 3 clinical trials underway, more evidence from such trials is required regarding safety, efficacy and potential for abuse and misuse before it can be considered again for down-scheduling.  

We did

The Delegate considered all submissions prior to making an interim decision on these proposals. The interim decisions on the proposed amendments to the Poisons Standard were published on 21 October 2022.

Due to the high volume of submissions for this consultation, we are releasing the written components of the public submissions in stages. All written responses about the MDMA and psilocybine proposals that were in PDF format, or were submitted as free text through the consultation portal form on behalf of organisations, have been published (if the respondent gave permission). All remaining written components will be published at a later date.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

Scheduling amendments referred to expert advisory committee

This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2022 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

The closing date for this consultation is close of business 27 May 2022. All submissions received by the deadline will be considered by the delegate before they make an interim decision.

The proposals under consultation are detailed in the public notice of April 2022.

Substances for which public comment is sought

  • Item 1.1 - Cetirizine
  • Item 1.2 - Budesonide
  • Item 1.3 - MDMA
  • Item 1.4 - Psilocybine
  • Item 1.5 - Apronal (allylisopropylacetylurea)
  • Item 2.1 - Helional
  • Item 2.2 - Hydroxypinacolone retinoate
  • Item 2.3 - MDMA and MDA
  • Item 3.1 - Dichloromethane (methylene chloride)
  • Item 3.2 - Ipflufenoquin

What happens next

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission information (see Privacy and your Personal information).

Public submissions are an important part of the process for amending the Poison Standard, and are published on the TGA website using the consultation hub.  Submissions by the public may not reflect the views of the Department of Health or TGA.  Published submissions should not be taken as being endorsed by the Department or TGA.

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments are anticipated to be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment in September 2022.

Audiences

  • General public

Interests

  • Legislation