Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (March 2023)

Summary

The Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (the Amendment Act) was passed by both Houses of Parliament on 9 March 2023 and received Royal Assent on 21 March 2023. The main measures introduced by the Amendment Act include:

• Establishing a framework for the mandatory reporting of medical device adverse events by healthcare facilities (principally public and private hospitals) in specified circumstances (e.g. where the use of a reportable device in a hospital has resulted in a person’s death or serious health deterioration), to enhance patient safety and improve the safe use of devices.
  • The requirement to report will not apply where an event has already been reported to a state or territory health department or the Australian Commission on Safety and Quality in Health Care, to reduce regulatory burden.
  • Reportable devices will be prescribed in regulations, following further consultation.
• Introducing a new, reduced burden, pathway for the inclusion of export-only biologicals in the Register, similar to existing pathways for export only medicines and medical devices, to support innovation and investment in these products.
• Strengthening post-market monitoring and compliance, including by enabling the Secretary to require any person to provide information or documents relevant to a contravention or possible contravention of the Therapeutic Goods Act 1989 (the Act) (e.g. financial records relating to a contravention held by a bank or financial institution), and allowing goods seized by an authorised person to be retained for 120 days, rather than 90 days, to better allow for testing and consideration of test results as part of court or regulatory action.
• Reducing regulatory burden by allowing the Secretary, on the Secretary’s own initiative, to extend the period for a person to pay the amount stated in an infringement notice, to avoid a new notice having to be issued and supporting the early resolution of contraventions, and permitting therapeutic goods advertising directed exclusively to specified kinds of health professionals and purchasing officers to be made without having to comply with the advertising requirements in the Act.
• Supporting medicines shortages and patient safety by:
  • Clarifying that sponsors of reportable medicines in shortage must provide updates about changes to the period of the shortage and when a shortage has been resolved, to assist patients and health practitioners to make informed treatment decisions.
  • Enabling the Secretary to approve the importation and supply of an unapproved medicine that could act as a substitute for a medicine that has been cancelled from the Register.
  • Enabling the Secretary to withdraw approval for the use of a restricted representation if new information becomes available about the medicine’s efficacy.
• Making a small number of other amendments including clarifying requirements relating to the release of therapeutic goods information under section 61 of the Act.

Commencement

The mandatory reporting measure will commence by proclamation but, If not commenced within 24 months of Royal Assent, will commence the day after that period, ie 21 March 2025. The export only biologicals measure commenced on 21 June 2023. All other measures commenced 22 March 2023.

More information

More information in relation to the Amendment Act is available at Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 – Parliament of Australia (aph.gov.au).