Julian Leeser (Berowra, Liberal Party, Shadow Minister for Indigenous Australians) Share this | Link to 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 that seek to ensure continued access to critical prescription medicines, as well as to support the safe use of therapeutic goods by strengthening the post-market monitoring and compliance of therapeutic goods.

Following an investigation of medical devices that were developed in the late 1990s and later had reported widespread complications, a 2017 Senate inquiry emphasised the need for improvements in safeguarding patient safety through post-market monitoring to ensure the early detection of adverse events relating to medical devices. Recommendation 1 of the inquiry noted that adverse-event reporting plays a vital role in post-market surveillance and proposed a mandatory reporting scheme for health practitioners. As such, this bill will introduce a framework for mandatory reporting of adverse-event information by hospitals, supporting improved monitoring, earlier detection and timely action to prevent adverse events and safeguard patients from harm. It will support the safe use of therapeutic goods by strengthening post-market monitoring and compliance activities, reduce regulatory burden, and make a number of amendments to improve requirements, codify current practices and remove redundant provisions.

Although the coalition supports the necessary intention of this bill to strengthen the safe use of therapeutic goods, we do have some concerns with the removal of merits review rights for decisions made by the secretary to require the provision of information and documents. We will keep a close eye on how this process rolls out, and we will hold the government to account if these new powers stray from the policy intent of this amendment.

The bill will also introduce a dedicated marketing approval pathway for export-only biologicals and support activities to relieve medicine shortages by enabling the Secretary of the Department of Health and Aged Care to approve the importation or supply of overseas prescription medicines that are substitutes for medicines which have been previously approved in Australia. The coalition supports the intention of the government to ensure continued access to potentially life-saving or life-improving medicines for Australian patients, but more must be done to safeguard access to critical health care for Australian households currently facing significant cost-of-living pressures.

Recent reporting has shown that the out-of-pocket costs for GP consults have risen to $60 for some families and the cost to fill a script could be $55, at the same time that energy bills and mortgage payments are skyrocketing. If the government are serious about ensuring continued access to critical medicines for all Australians, they must take action to relieve the cost-of-living pressures for Australian families, who are struggling to afford the cost of consults and scripts, so that they can continue to afford the medicines they rely on. Action to ensure continued access to critical health care must include a plan to relieve these significant cost-of-living pressures, which are only continuing to rise under the Albanese Labor government.

Debate adjourned.

Leave granted for second reading debate to resume at a later hour this day.