This bill is currently before Parliament.
Health, care & disability
Medicine companies must give at least 12 months’ notice before permanently stopping a medicine covered by mandatory reporting.
The government said global supply problems can interrupt essential medicines and harm patients. Its 2024 consultation received 221 responses, while related research surveyed 800 consumers, pharmacists and prescribers. A later consultation received 39 submissions, with most respondents supporting earlier reporting. The government said the changes would give patients and health workers more time to find other treatments and manage disruptions.
Australia already had mandatory reporting and TGA shortage monitoring, but medicine supply disruptions—including those highlighted during COVID-19—left patients, clinicians and hospitals without enough warning about shortages or permanent discontinuations, while some essential medicines fell outside mandatory reporting. After 2024–25 consultations identified these gaps, Rebecca White MP introduced the bill on 2 July 2026 to require earlier notices, expand information-gathering and strengthen oversight, and the House passed it on 12 August 2026.
Mrs McIntosh’s proposed amendment argued that the bill did not address the underlying causes of medicine shortages. It said Australia imports around 90 per cent of its medicines but represents barely two per cent of the global market. It also said more than 400 shortages were listed during 2025 and called for stronger local production and shortage-reduction targets. Dr M Ryan separately sought a national review of import dependence, limited local manufacturing and medicine stockpiles.
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
96 days
Updated 06 Oct 2026.
Meaning
Medicine companies must give at least 12 months’ notice before permanently stopping a medicine covered by mandatory reporting. If that is impossible, they must report as soon as practical.
Patients and health workers get faster updates when a planned medicine withdrawal changes. Critical changes must be reported within 2 working days, and others within 10.
Medicine companies risk penalties if they fail to report those changes. Maximum penalties are 100 penalty units for individuals and 1,000 for companies.
Patients using any approved medicine may benefit from earlier action on shortages. The health department can request supply information even when mandatory reporting does not cover that medicine.
Companies supplying similar biological products, which are medicines made from living cells or tissues, can place them in one government register entry. This reduces duplicate paperwork and costs.
Clinical trial participants receive clearer legal protection through site inspections. Authorised inspectors can enter trial sites and inspect experimental products, records and related materials.
Patients relying on critical medicines get a more current Medicines Watch ListThe government list of medicines considered critical during shortages., the government list that triggers faster shortage reporting. It can automatically follow updates to documents such as the national vaccine schedule.
2 Paragraphs 30EG(1)(a) and (b) Repeal the paragraphs, substitute: (a) at least 12 months before the discontinuation is proposed to occur; or (b) if the person is unable to comply with paragraph (a)—as soon as practicable after the decision is made.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
4 After section 30EG 30EGA Reporting changes to a discontinuation of supply of medicine Reporting changes to a discontinuation decision (1) A person who has notified a discontinuation decision in accordance with section 30EG must notify the Secretary of each change to the decision that is of a kind mentioned in subsection (2). (2) The following changes are covered by subsection (1): (a) a change to the date on which the discontinuation of the supply of the medicine is to occur; (b) if the change is made less than 12 months after the discontinuation decision is notified—a change to no lonTherapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
Civil penalty (8) A person contravenes this subsection if: (a) the person is subject to a requirement under subsection (1) or (3); and (b) the person contravenes the requirement. Maximum civil penalty: (a) for an individual—100 penalty units; and (b) for a body corporate—1,000 penalty units.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
6 Paragraph 31(1)(ja) Repeal the paragraph, substitute: (ja) if the goods are medicine registered in relation to the person: (i) the availability of the medicine in Australia; or (ii) whether or not there is a shortage of the medicine in Australia; or (iii) if there is a shortage of the medicine in Australia—the shortage; or (iv) whether the person has made a decision to permanently discontinue the supply of the medicine in Australia; or (v) if the person has made a decision to permanently discontinue the supply of the medicine in Australia—the decision; 7 After paragraph 31(2)(gc) (gTherapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
23 After subsection 32DB(2) (a) the Secretary includes the biological in the Register; and (b) the biological is within a common biologicals group; and (c) one or more other biologicals within the common biologicals group are included in the Register in relation to the person; the Secretary: (d) may group the biologicals that are within the same common biologicals group in a single entry in the Register; and (e) if biologicals are grouped under paragraph (d), must assign a unique number to the grouped biologicals. The number assigned may be any combination of numbers and either or both oTherapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
32 After paragraph 46A(4)(a) (aa) premises at which therapeutic goods for use solely for experimental purposes in humans are being used or stored, or documents or records relating to such use or storage are kept, and those goods are: (i) exempt under subsection 18(1), 32CA(2) or 41HA(1); or (ii) the subject of an approval under subsection 19(1), 32CK(1) or 41HB(1); andTherapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
34 At the end of section 30EJ (3) Despite subsection 14(2) of the Legislation Act 2003, a determination made for the purposes of subsection (1) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.Therapeutic Goods Amendment (Medicines Shortages and Other Measures) introduced text
Context
Australia already had mandatory reporting and TGA shortage monitoring, but medicine supply disruptions—including those highlighted during COVID-19—left patients, clinicians and hospitals without enough warning about shortages or permanent discontinuations, while some essential medicines fell outside mandatory reporting. After 2024–25 consultations identified these gaps, Rebecca White MP introduced the bill on 2 July 2026 to require earlier notices, expand information-gathering and strengthen oversight, and the House passed it on 12 August 2026.
ACCC authorises coordination during COVID-19 medicine shortages
The authorisation allowed distributors and pharmacy groups to coordinate with government agencies to maintain equitable access when COVID-19 shortages arose.
ACCC ↗TGA consultation records impacts of medicine shortages
The TGA received 221 consultation responses and surveyed 800 consumers, pharmacists and prescribers about the clinical, economic and lifestyle effects of shortages and discontinuations.
Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum ↗TGA consults on earlier discontinuationA permanent end to supplying a medicine in Australia. warnings and supply data
The TGA received 39 submissions on requiring 12 months’ notice of permanent discontinuations and allowing detailed supply information to be requested for any approved medicine.
Therapeutic Goods Amendment (Medicines Shortages and Other Measures) explanatory memorandum ↗Rebecca White MP introduces the bill
Rebecca White MP introduced the bill in the House of Representatives, proposing earlier discontinuationA permanent end to supplying a medicine in Australia. notices, stronger shortage information powers and other TGA measures.
Hansard ↗House passes the bill
The House agreed to the bill at third reading, completing its passage through the originating chamber.
Parliamentary timeline ↗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 notesThe bill reached this recorded parliamentary step.
The bill reached this recorded parliamentary step.
Referred to Federation Chamber
The bill reached this recorded parliamentary step.
Second reading debate
The bill reached this recorded parliamentary step.
The chamber agreed to the bill at second reading, meaning it accepted the bill in principle and allowed it to continue.
Second reading agreed to
The bill reached this recorded parliamentary step.
Reported from Federation Chamber
The chamber agreed to the bill at third reading, which completed passage through that chamber.
Third reading agreed to
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
Key criticism
Mrs McIntosh’s proposed amendment argued that the bill did not address the underlying causes of medicine shortages. It said Australia imports around 90 per cent of its medicines but represents barely two per cent of the global market. It also said more than 400 shortages were listed during 2025 and called for stronger local production and shortage-reduction targets. Dr M Ryan separately sought a national review of import dependence, limited local manufacturing and medicine stockpiles.
The government presented the bill as a targeted improvement to shortage monitoring and early warning. It said earlier information would give patients and health workers more time to plan, while retaining flexibility when companies cannot provide 12 months’ notice.
Further sources
Votes
No recorded votes have been found yet for this bill.
Parliamentary debate
Start here — lead voices
White supports the bill as a way to better protect patients from medicine supply disruptions by strengthening shortage and discontinuationA permanent end to supplying a medicine in Australia. reporting, while also reducing regulatory duplication and improving clinical trial oversight.
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.
House · Second reading debate
Second reading debate
The bill reached this recorded parliamentary step.
House · Referred to Federation Chamber
Referred to Federation Chamber
The bill reached this recorded parliamentary step.
House · Second reading debate
Second reading debate
The bill reached this recorded parliamentary step.
House · Second reading debate
Second reading debate
The bill reached this recorded parliamentary step.
House · Second reading agreed to
Second reading agreed
The chamber agreed to the bill at second reading, meaning it accepted the bill in principle and allowed it to continue.
House · Reported from Federation Chamber
Reported from Federation Chamber
The bill reached this recorded parliamentary step.
House · Third reading agreed to
Third reading agreed
The chamber agreed to the bill at third reading, which completed passage through that chamber.
Senate · 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.
Senate · 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