Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Clarifying eligibility for origin claims in the Complementary Medicines Sector

24th January 2020

Non-compliance with COAG’s best practice regulation requirements – Legislative and Governance Forum on Consumer Affairs (CAF)

On 12 December 2019, the Legislative and Governance Forum on Consumer Affairs (CAF) agreed interim and on-going measures to allow complementary medicines which meet certain Australian manufacturing eligibility requirements to make an Australian origin claim, and to have access to the Australian Made, Australian Grown (AMAG) logo. Further details can be found in the announcement.

Prior to CAF agreement, the local complementary medicine sector claimed there was a tension between regulation of certain complementary medicines manufactured in Australia by the Therapeutic Goods Administration, and also their regulation under the Australian Consumer Law, which imposed stringent eligibility requirements for making origin claims and permitting access to the AMAG logo.

In response to sector concerns, the Department of Industry, Innovation and Science (the Department) prepared a COAG Regulation Impact Statement (RIS) to analyse and test options which balanced product safety and quality assurance against consumer perceptions and protections. Those options included:

  • maintenance of the status quo,
  • self-regulation by industry, and
  • changing the Australian Consumer Law (ACL) by creating examples of processes in the manufacture of complementary medicines which would meet the ACL’s substantial transformation test.

A COAG decision RIS prepared by the Department, based on extensive stakeholder consultation, found no reliable evidence of any problem nor any case for government action, indicating maintenance of the status quo was the best option.

The Office of Best Practice Regulation (OBPR) assessed the decision RIS as compliant with COAG Best Practice Regulation requirements. However, the OBPR notes the subsequent decision taken by the CAF is inconsistent with COAG Principles of Best Practice Regulation in regard to establishing a case for action, and government action being effective and proportionate to the issue being addressed.

Please note: any accessibility queries should be directed to the Department.

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