RACS understands that the primary Bill amends the Therapeutic Goods Act 1989 to strengthen medicines shortage reporting, enable common biologicals groups, and give Therapeutic Goods Administration (TGA)-authorised officers enhanced powers over clinical trial sites.
RACS supports the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026 and the Therapeutic Goods (Charges) Amendment Bill 2026, recognising their potential to strengthen medicines shortage management, improve regulatory oversight, and reduce administrative duplication.
RACS emphasises that reliable access to medicines is essential for maintaining surgical services, patient safety, and timely access to care. Shortages or discontinuations of critical medicines, including anaesthetic agents, intravenous fluids, antibiotics, opioids and reversal agents, can delay procedures, reduce elective surgery capacity, and increase waiting times. These impacts are particularly significant in rural, regional and remote communities where surgical workforce shortages already exist.
To strengthen the proposed reforms, RACS recommends:
- A defined and enforceable notice period for the permanent discontinuation of reportable medicines wherever possible, ensuring health services have sufficient time to implement alternative treatment pathways and maintain continuity of care
- A formal notification mechanism between medicine sponsors, the Therapeutic Goods Administration (TGA), and specialist medical colleges to facilitate timely communication regarding critical medicine shortages and medicines listed on the Medicine Watch List
- Monitoring of the impacts of biologicals grouping reforms, ensuring any changes to sponsor charges do not lead to increased costs for surgeons, private hospitals or patients, and do not undermine the viability of private surgical practice.