Murray Watt (Queensland, Australian Labor Party, Minister for Agriculture, Fisheries and Forestry) Share this | Hansard source

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 the 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 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 approval of biologicals that are for export only. The bill addresses and alleviates the effects of medicines 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 for Australians.

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The bill also provides a mechanism for the approval of a restricted representation to be withdrawn where additional information about the efficacy of therapeutic goods becomes available, ensuring that advertising only corrects correct and accurate information and reducing the risk of unsafe use by consumers. I thank senators for their contributions to debate on this bill.