This bill is currently before Parliament.
Health, care & disability
Medicine sponsors must tell the SecretaryThe Secretary of the Department of Health, Disability and Ageing, who receives notices and can require sponsors to provide supply information. at least 12 months before permanently stopping a reportable medicineA medicine whose shortage or permanent discontinuation must be reported, including prescription medicines, controlled drugs and certain other critical medicines., or as soon as practicable when that is not possible.
Medicine shortages left patients and health practitioners without timely information, while some essential medicines fell outside mandatory reporting and the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. had limited power to obtain supply details. The bill requires earlier, updated discontinuation notices, expands supply-information powers, streamlines similar biologicalsA group of sufficiently similar biological medicines that can share one Register entry under the bill. and strengthens clinical-trial inspections.
Australia already had mandatory shortage reporting and supplier stockholding rules, but the 2023 amoxicillin and Hysone shortages showed patients and clinicians still lacked reliable supply information, while some essential medicines remained outside the reporting scheme. After TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. consultations in 2024 and 2025, and renewed supply pressure when the Middle East war forced companies to reroute critical medicines in 2026, the bill was introduced to require earlier and updated discontinuation notices, widen the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods.’s information powers, streamline similar biologicalsA group of sufficiently similar biological medicines that can share one Register entry under the bill. and strengthen clinical-trial inspections.
No MP or party has spoken against the bill, but the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods.'s own consultation recorded industry concerns: that sponsors may not always be able to give 12 months' notice of a discontinuation driven by unforeseen commercial factors, and that publishing discontinuation plans earlier could prompt stockpiling. The explanatory memorandum says the bill keeps the 'as soon as practicable' fallback and gives the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. flexibility over publication timing to address both.
Rebecca White MP introduced this bill. Supportive speeches so far have come from Labor.
Did it become law?
Not yet
Final passage
No final vote yet
The bill has not yet completed passage through Parliament.
Days since introduction
36 days
Updated 07 Aug 2026.
Meaning
Medicine sponsors must tell the SecretaryThe Secretary of the Department of Health, Disability and Ageing, who receives notices and can require sponsors to provide supply information. at least 12 months before permanently stopping a reportable medicineA medicine whose shortage or permanent discontinuation must be reported, including prescription medicines, controlled drugs and certain other critical medicines., or as soon as practicable when that is not possible.
Sponsors must quickly report changes to planned discontinuations, with critical-impact changes due within 2 working days and other changes within 10 working days; breaches can attract civil penalties.
The SecretaryThe Secretary of the Department of Health, Disability and Ageing, who receives notices and can require sponsors to provide supply information. can require all medicine sponsors to provide information about product availability, shortages and discontinuations, including medicines outside mandatory reporting.
Similar biologicalA therapeutic product made from or involving biological material, which is regulated differently from ordinary chemical medicines. medicines can share one Australian RegisterThe official register of therapeutic products approved for lawful supply in Australia. entry, reducing duplicate paperwork and annual charges for industry.
Australia’s critical-medicine listThe official list of medicines for which an Australian shortage would have a critical impact. can stay current, while authorised inspectors can enter clinical trial sites to check compliance and participant safety, subject to legal safeguards.
To address these issues, this item replaces paragraphs 30EG(1)(a) and (b) of the Therapeutic Goods Act with new paragraphs 30EG(1)(a) and (b), which require the sponsors of all reportable medicines to notify the Secretary of any discontinuation decision (regardless of whether it is likely to be of critical impact) at least 12 months before the discontinuation is proposed to occur. If the sponsor is unable to comply with that timeframe (for example, because of unforeseen commercial or manufacturing factors such as lack of ingredient availability, unplanned global discontinuations, or price reductions where notice is given within the reporting timeframe), the discontinuation decision must be notified as soon as practicable after the decision is made.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum
a change to the date on which the discontinuation is to occur, where the discontinuation is likely to be of critical impact (as defined in new subsections 30EGA(4) and (5) discussed below), must be notified as soon as possible but no later than 2 working days after the first day the sponsor knows, or ought reasonably to have known, of the change;Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum
These items make amendments to section 31 of the Therapeutic Goods Act to enable the Secretary to require all sponsors in relation to whom therapeutic goods that are medicines are registered or listed in the Register to provide information or documents on request relating to the availability, and any shortage or discontinuation, of their products in Australia.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum
New subsections 32DB(2A), 32DCB(2A) and 32DF(2A) of the Therapeutic Goods Act provide that, if the Secretary includes a biological in the Register and the biological is within a common biologicals group and one or more other biologicals within the common biologicals group are included in the Register in relation to a sponsor, then the Secretary may group the biologicals that are within the same common biologicals group in a single entry in the Register. If biologicals are grouped, the Secretary must assign a unique number to the group, which may be any combination of numbers, letters and symbols.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum
This item therefore amends section 30EJ of the Therapeutic Goods Act to include a contrary intention to subsection 14(2) of the Legislation Act, to enable the Medicines Watch List to incorporate other documents, such as the NIP Schedule or other documents that list medicines deemed essential to healthcare in Australia, as in force from time to time. The purpose of this amendment is to help ensure that the Medicines Watch List, and the list of critically important medicines determined under it, remains as current as possible at any given time.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum
Context
Australia already had mandatory shortage reporting and supplier stockholding rules, but the 2023 amoxicillin and Hysone shortages showed patients and clinicians still lacked reliable supply information, while some essential medicines remained outside the reporting scheme. After TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. consultations in 2024 and 2025, and renewed supply pressure when the Middle East war forced companies to reroute critical medicines in 2026, the bill was introduced to require earlier and updated discontinuation notices, widen the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods.’s information powers, streamline similar biologicalsA group of sufficiently similar biological medicines that can share one Register entry under the bill. and strengthen clinical-trial inspections.
Amoxicillin shortage prompts warning of risks to patients
The Australian Medical Association called for a national medicines plan as pharmacies struggled to obtain amoxicillin and other antibiotics amid rising streptococcus A cases.
ABC News ↗Hysone shortage exposes gaps despite stockholding rules
Patients reported difficulty finding essential medicines, while pharmacists and advocates said supplier stockholding requirements had not resolved shortages on the ground.
ABC News ↗TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. research identifies reporting gaps
Consultation and market research involving 221 responses and 800 surveyed consumers, pharmacists and prescribers found a need for earlier notices and information about essential medicines outside mandatory reporting.
Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum ↗Further consultations shape the proposed reforms
The TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. tested 12-month discontinuation notices, wider supply-information powers, mandatory notice updates and grouped biologicalA therapeutic product made from or involving biological material, which is regulated differently from ordinary chemical medicines. registrations, with most participants supporting the proposals.
Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum ↗Middle East war disrupts medicine routes
Pharmaceutical companies rerouted critical medicines to maintain Australian supplies after the war closed transport routes and increased pressure on global supply chains.
ABC News ↗Rebecca White MP introduces the bill
The bill proposed earlier and updated discontinuation reporting, broader TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. supply-information powers, grouped biologicalA therapeutic product made from or involving biological material, which is regulated differently from ordinary chemical medicines. registrations and clearer clinical-trial inspection powers.
Australian Parliament House ↗Legislative route
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
Introduced and read a first time
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Second reading moved
Referred to Committee (02/07/2026): Senate Community Affairs Legislation Committee; Report due 01/09/2026
Report due 01 Sep 2026
APH bill page notesKey criticism
No MP or party has spoken against the bill, but the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods.'s own consultation recorded industry concerns: that sponsors may not always be able to give 12 months' notice of a discontinuation driven by unforeseen commercial factors, and that publishing discontinuation plans earlier could prompt stockpiling. The explanatory memorandum says the bill keeps the 'as soon as practicable' fallback and gives the TGAThe Australian regulator that monitors medicine supply and oversees the safety, quality and availability of therapeutic goods. flexibility over publication timing to address both.
Most of the 39 consultation submissions supported the changes, and the parliamentary record is preliminary — the Senate committee's report is not due until 1 September 2026.
Further sources
Votes
No recorded votes have been found yet for this bill.
Parliamentary debate
Start here — lead voices
White supports the bill because it strengthens reporting and oversight of medicine shortages and discontinuations, giving patients and health practitioners more time to plan while also reducing regulatory duplication and improving clinical trial safeguards.
Read in Hansard ↗All speeches by bloc
1 speaker · 1 support
“These legislative changes will strengthen key aspects of the mandatory reporting scheme under the Therapeutic Goods Act, to enable Australia to be better prepared for shortages and discontinuations of critically important medicines.”Read the full speech in Hansard ↗
Record
House · Introduced and read a first time
Introduced
The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.
House · Second reading moved
Second reading opened
A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.
Senate Community Affairs Legislation Committee
Report due 01 Sep 2026
Referred to Committee (2 July 2026): Senate Community Affairs Legislation Committee; Report due 1 Sept 2026
APH bill page notes