Thursday, 9 March 2023
Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022; Consideration of Senate Message
Ged Kearney (Cooper, Australian Labor Party, Assistant Minister for Health and Aged Care) Share this | Link to this | Hansard source
That the amendments be agreed to.
The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022, or the bill, amends the Therapeutic Goods Act 1989, or the act. The measures in the bill are intended to improve patient safety, support timely access to therapeutic goods, reduce regulatory burden and strengthen post-market compliance and enforcement activities.
The bill, as originally introduced into the House, included a measure to clarify that the natural justice hearing rule is not required to observed in relation to the release of therapeutic goods information. This is because an obligation to observe the natural justice hearing rule prior to releasing information could directly prevent or delay the release of health and safety information to the public or relevant stakeholders. Delaying the release of this information could risk the health and safety of patients, frontline healthcare workers and the public.
The government amendment to this measure will limit the exclusion of the natural justice hearing rule in relation to the release of information to the public, under section 61(5C) of the act, to the release of information that is in the interests of public health or safety, or where the information relates to the safety of one or more therapeutic goods. These amendments balance the provision of the natural justice rule with the need to ensure the timely release of health and safety information to the public.
If the bill were to specify that the natural justice hearing rule is only required in relation to the release of critical or urgent safety information, this would present a risk to the safety of Australian patients, health professionals and the public as some safety information may not be available to them in a timely manner. The release of safety information is necessary to prevent harm and even potentially death. In some instances, TGA safety information is combined with information from other sources—for example, state and territory health departments—in order to recognise that the information concerns health or safety issues.
Overall, the release of therapeutic goods information under the act is a critical element of Australia's regulatory framework for therapeutic goods, as its use underpins community and healthcare industry awareness of the safe use of therapeutic goods, compliance and enforcement activities and cooperation with international regulators to bring new treatments to Australia as quickly as possible.
I thank the Senate for their support of this amendment and I commend the amendment to the House.
Question agreed to.