These changes demonstrate efforts by the Australian Government to ensure the safety of therapeutic goods (medicines, biologicals, and medical devices) in the interest of consumers.

In brief

The Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (Cth) (TG Amendment Act) introduces a wide range of amendments to the Therapeutic Goods Act 1989 (Cth) (TG Act) in 12 schedules which commence at differing times. The changes aim to enhance and support the current regulatory framework by implementing changes, including changes to:

  • strengthen post-market monitoring and regulatory compliance of therapeutic goods;
  • reduce regulatory burden;
  • improve patient safety and the safe use of medical devices;
  • support innovation and investment in the Australian biologicals industry;
  • support activities to relieve medicine shortages;
  • support the existing regulatory scheme.

Many of the amendments commenced on 22 March 2023 and will have had immediate and ongoing impacts on sponsors, manufacturers, healthcare facilities and other key stakeholders involved in the supply and use of therapeutic goods in Australia.

We provide a summary of the key changes, commencement dates and their impact below.

  • Changes to strengthen post-marketing monitoring and compliance

    The TG Amendment Act aims to strengthen post-market monitoring and compliance with the therapeutic goods regulatory regimes by:

    • reducing the use of merits review pathways for regulatory notices which only require providing information or producing documents, the aim being to mitigate the risk of delay or frustration of post-market monitoring and investigations (schedule 3);
    • expanding information-gathering powers to permit obtaining information from any person (including third parties) relevant to a contravention or alleged contravention of the TG Act or related regulations (schedule 5). Those parties may include, for example, financial institutions;
    • increasing retention time for seized goods to support proper analysis and assessment of goods for legal or regulatory actions (schedule 6).

These changes commenced on 22 March 2023.

  • Changes to reduce regulatory burden

    Changes have been made to the TG Act to reduce the regulatory burden by:

    • empowering the Secretary of the Department of Health and Aged Care (Secretary) to extend the period for payment of an infringement notice without requiring an application from the notice recipient (schedule 4);
    • providing consistency and clarity on therapeutic goods advertising which is directed exclusively to certain classes of health professionals and individuals and the circumstances in which the advertising requirements of the TG Act and associated regulations do not apply (schedule 7).

Amendments to subsection 42AA of the TG Act have been made to reflect existing definitions of ‘health practitioners’ under the Health Practitioners Regulation National Law and to add two health professions to the list – oral health therapy and paramedicine – in order to exempt advertising to those professionals from the legislative requirements.[1] Further, therapeutic goods advertising directed exclusively at individuals who are:

  • purchasing therapeutic goods on behalf of a registered charity;
  • purchasing therapeutic goods on behalf of a government or government authority (including a foreign government or foreign government authority);
  • purchasing officers, or practice managers, for a person mentioned as a health professional in subsections 42AA(1)(a) and (aa) (other than pharmacists in retail pharmacies),[2]

are now included in the classes of persons to whom the legislative rules regarding the advertising of therapeutic goods do not apply.

These changes commenced on 22 March 2023.

  • Changes to improve patient safety and safe use of medical devices

    Significant changes have been made to improve patient safety and the safe use of medical devices by:

    • enabling the Secretary to withdraw approval for the use of a restricted representation in therapeutic goods advertisements if new information about the goods’ efficacy (rather than new information only about safety) becomes available (schedule 8);
    • clarifying that the Secretary is not required to apply the requirements of the natural justice hearing rule when releasing therapeutic goods information, to ensure that critical information about the safety of therapeutic goods is able to be released without delay (schedule 10). The practical effect of this is that the Secretary does not need to let the relevant party know of and provide them with a right to respond before publishing information that may adversely affect the rights of the party, such as a sponsor of the goods;

(the above changes commenced on 22 March 2023)

  • introducing mandatory reporting obligations relating to adverse events (and near misses) involving ‘reportable medical devices’ to a broader range of bodies including public hospitals, private hospitals (including day surgeries) and any other healthcare facility prescribed by regulations that may be made under the TG Act (schedule 1). Under this framework, mandatory reporting will be required by the Chief Executive Officer (however described) of a healthcare facility in certain circumstances.

The mandatory reporting requirements are scheduled to commence on 21 March 2025, unless an earlier commencement date is proclaimed. Additional information about what kinds of devices will be ‘reportable devices’ is yet to be provided and will be contained in amendments to the therapeutic goods regulations.

  • Changes to support innovation and investment in the Australian biologicals industry

    In schedule 2 of the TG Amendment Act, changes have been introduced to support innovation and investment in the Australian biologicals industry by introducing a new ‘export only’ biologicals pathway.[3]

    Currently, only biologicals included in the ARTG for use and supply in Australia can be exported to other countries. In Australia, there are dedicated approval pathways for ‘export only’ medicines and medical devices but there have not been similar pathways for biologicals.

    These changes will commence on 21 June 2023.

  • Changes to support activities to relieve medicine shortages

    Amendments have been made to support medicine shortage relief in Australia by:

    • introducing a new mechanism for the import and export of substitute medicines, upon satisfying certain criteria (including previous inclusion in or existing suspension from the ARTG) (schedule 9);
    • refining the reporting requirements relating to significant changes to a medicine shortage (schedule 11).

The first of these changes commenced on 22 March 2023, while the second will commence on 21 September 2023.

  • Changes to support the existing regulatory scheme

    In schedule 12 of the TG Amendment Act minor amendments to provisions of the TG Act have been made to support existing mechanisms which help regulate therapeutic goods in Australia. Amendments have been made to:

    • clarify that an order made under section 41BD(3) of the TG Act to declare particular products not to be a medical device (such as an appliance, software, implant, reagent, material or other article) is a legislative instrument. This ensures that the exercise of power is subject to consultation, more transparent regulation and consistency with other powers under the TG Act;[4]
    • clarify the responsibilities of sponsors of medical devices to have available, or be able to obtain (by way of written agreement with the manufacturer), information to substantiate compliance with the essential principles and conformity assessment procedures, within a new prescribed timeframe of 20 working days. Sponsors and manufacturers will need to review any existing procedures and written agreements to obtain such information within the legislative timeframe;[5]
    • clarify that an authority under the authorised prescriber scheme for biologicals may only be given to a medical practitioner of a class prescribed in the regulations and a medical practitioner who has obtained the approval of an ethics committee to supply the biological. This does not affect authorities given before the commencement of the Act;[6]
    • expand the individuals to whom the Minister may delegate powers and functions under section 57 of the TG Act. This will enable individuals other than the Secretary, such as the Deputy Secretary and a Medical Officer (Principal Medical Adviser) of the Department to make an instrument granting an exemption in the event of a public health emergency, or for the purpose of creating a preparedness to deal with a potential threat to public health. This allows more than one person to make an urgent exemption at short notice.[7]

These changes commenced on 22 March 2023.

Key takeaways

The regulation of therapeutic goods in Australia is complex and many of the changes discussed above have been introduced to address the needs of a rapidly evolving landscape. Most changes made under the TG Amendment Act commenced on 22 March 2023. However, the changes which are yet to commence include:

  • the dedicated pathway for export only biologicals (Schedule 2; start date: 21 June 2023);
  • new medicine shortages requirements (Schedule 11; start date: 21 September 2023);
  • mandatory reporting of adverse events involving medical devices (Schedule 1; start date: to be Proclaimed or if not fixed by Proclamation, 21 March 2025 (being, 24 months from the day the Act received Royal Assent)).

Impacted stakeholders including sponsors, manufacturers (existing or prospective) and healthcare facilities should be prepared for these changes and understand how these changes may impact them.

Read more from the Prescription - May 2023

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