Ged Kearney (Cooper, Australian Labor Party, Assistant Minister for Health and Aged Care) Share this | Hansard source

I thank the member for Robertson and the member for Macarthur for their contributions to this debate. It's really wonderful to have such knowledgeable, hands-on doctors in this government who understand—along with you, Madam Deputy Speaker Ananda-Rajah—the arguments as to why this bill is very important. There were real, firsthand examples of how it's going to make a difference to people's lives. Of course, I'd like to acknowledge the member for Lindsay as well, who is clearly across the subject and also knew just how this measure is going to improve health care in Australia for Australians. I'd also like to acknowledge the member for Monash, who, when I introduced this bill, made a very passionate plea for its support with respect to members of his constituents who had been impacted by the vaginal mesh disaster. So thank you to all of those members for their support.

The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest quality health care for the Australian public by ensuring continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance. In particular, the bill supports the implementation of a scheme for the mandatory reporting by hospitals of adverse events associated with medical devices. This measure would support the improved monitoring of safety concerns associated with medical devices through access to information held by hospitals that identifies serious adverse events, and earlier detection of safety signals that may raise concerns about particular devices.

The bill encourages innovation and investment in biologicals in Australia by introducing a new, dedicated pathway for marketing approvals of biologicals that are for export only. The bill addresses and alleviates the effects of medicine shortages by amending the act to allow the Secretary of the Department of Health and Aged Care to approve the importation or supply of an unapproved medicine that could act as a substitute for medicine that was previously approved in Australia. This measure is designed to ensure the continued supply of critical prescription medicines in Australia.

The bill supports the safe use of therapeutic goods by strengthening monitoring and compliance activities through a number of measures, including stronger information-gathering powers, extending the time frame for retaining seized goods and allowing the due date for an infringement notice to be extended once the due date has passed. The bill expands the persons to whom therapeutic goods advertising may be directed to include certain health professionals, persons purchasing therapeutic goods on behalf of registered charities or governments, and purchasing officers or practice managers of a healthcare practice. The bill also provides a mechanism for the approval of a restricted representation to be withdrawn where additional information about the efficacy of therapeutic goods becomes available, ensuring that advertising only contains correct and accurate information and reducing the risk of unsafe use by consumers. I thank everyone for their contributions to the debate on this bill.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that this bill be reported to the House without amendment.

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