Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Hansard source

I acknowledge Senator Ruston's contribution, but if I could just speak quickly to the government amendments that are before the chamber. The bill included a measure to clarify that the natural justice hearing rules are not required to be observed in relation to the release of therapeutic goods information. 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—for example, state and territory health departments—which could risk the health and safety of patients, frontline healthcare workers and the public. The government amendments mean 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 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 good.

These amendments balance the provision of natural justice in relation to the release of information with the need to ensure the timely release of health and safety information to the public. If the amendments to this measure were to go further and only exclude the natural justice hearing rule 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. The release of this information is necessary to prevent harm and even potentially death and would not be able to be released if it did not meet this threshold or if its release was delayed through courts. In some instances, TGA safety information would need to be 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 it 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.