National Health Amendment (Passive Immunological Products)

Current status

This bill became law on Apr 8th, 2026.

Policy area

Health, care & disability

What does this bill do?

The Act broadens the National Health Act definition of vaccine so it covers a preparation, including a vaccine or immunising agent, that protects people through active or passive immunityProtection given by ready-made immune agents, rather than by prompting the person's own immune system to produce the protection itself. against disease.

Why was it introduced?

The bill was introduced because the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost. could only designate products that fitted the old National Health Act definition of vaccine. The government said that definition covered active immunisationProtection that comes from the body making its own immune response after vaccination or infection. but excluded passive immunological products, including emerging therapies such as immunising monoclonal antibodies, creating a barrier to national listing and free access for eligible people.

Broader context

This was a narrow health-program eligibility bill. Its immediate context was the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost. definition of vaccine, which official materials said did not cover passive immunological products. Debate focused on RSV prevention, inconsistent access across states and territories, and whether extra testing rules should be added before the bill passed unchanged.

Key criticism

No speaker in the collected debate opposed the bill's core purpose of allowing passive immunological products to be considered for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost.. Criticism focused on related issues: inconsistent vaccine access across states and territories, broader delays or cost barriers in health technology funding, and Senator Roberts' proposal to require inert saline placebo testing before designation.

Who supported it?

Rebecca White MP introduced this bill. It passed with support from Labor, Greens, some crossbench members; opposed by One Nation, UAP.

Introduced in House 05 Feb 2026
Passed House 12 Feb 2026
Passed Senate 01 Apr 2026 Aye 39 No 5
Became law 08 Apr 2026

Did it become law?

Yes

Became law 08 Apr 2026

Final passage

Recorded final vote

1 counted final-passage vote was recorded.

Passage speed

62 days

From introduction to the latest recorded parliamentary step

Official record

View on APH

Parliament of Australia bill page

What does this bill do?

  1. The Act broadens the National Health Act definition of vaccine so it covers a preparation, including a vaccine or immunising agent, that protects people through active or passive immunityProtection given by ready-made immune agents, rather than by prompting the person's own immune system to produce the protection itself. against disease.

  2. Passive immunological products that do not trigger the body to make its own immune response can now be considered for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost., if they meet the usual listing requirements.

  3. The change does not itself list a product on the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost.; it removes the definition barrier so products can go through the existing assessment and designation process.

  4. The government pointed to Beyfortus, an immunising monoclonal antibodyA laboratory-made antibody that can give targeted immune protection or treatment, including some products used to protect against infection. for respiratory syncytial virus, as an example of a product the Pharmaceutical Benefits Advisory CommitteeThe Pharmaceutical Benefits Advisory Committee, which assesses medicines and vaccines before government subsidy or program listing decisions. could not recommend for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost. until the definition changed.

  5. The explanatory memorandum says the bill has no Commonwealth financial impact, and the Act commenced on 9 April 2026, the day after Royal Assent.

Show source excerpts
  1. vaccine means a preparation, including a vaccine or immunising agent, that confers protection to persons through active or passive immunity against disease.
    National Health Amendment (Passive Immunological Products) Act 2026 final Act text
  2. Immunisation products that do not elicit an immune response and provide protection through passive immunological means are unable to be listed on the NIP. The Bill will broaden the definition of vaccine in the Act to enable new and emerging technologies to be listed on the NIP.
    National Health Amendment (Passive Immunological Products) explanatory memorandum
  3. Importantly, the bill does not automatically list any product. It simply allows products to enter the existing evaluation process.
    House Hansard, Melissa Price second reading speech
  4. One example is Beyfortus, which protects children and babies from respiratory syncytial virus... The Pharmaceutical Benefits Advisory Committee has deferred a positive recommendation for Beyfortus because they are unable to recommend this product for inclusion under the NIP until the definition of a vaccine under the act is amended.
    House Hansard, minister's second reading speech
  5. There are no financial impacts for the Commonwealth in relation to this Bill. Clause 2 - Commencement This clause provides that the Act will commence the day after the Act receives Royal Assent.
    Explanatory memorandum and final Act metadata

Broader context for this bill

This was a narrow health-program eligibility bill. Its immediate context was the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost. definition of vaccine, which official materials said did not cover passive immunological products. Debate focused on RSV prevention, inconsistent access across states and territories, and whether extra testing rules should be added before the bill passed unchanged.

  1. Before 2026

    Vaccine definition excludes passive products

    The explanatory memorandum says the existing National Health Act definition supported active immunisationProtection that comes from the body making its own immune response after vaccination or infection. and left no scope to designate a product that did not meet that definition for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost..

    Explanatory memorandum ↗
  2. 2025

    Beyfortus highlights the listing barrier

    The minister's second reading speech said Beyfortus protects children and babies from RSV, but PBACThe Pharmaceutical Benefits Advisory Committee, which assesses medicines and vaccines before government subsidy or program listing decisions. had deferred a positive recommendation because it could not recommend the product for National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost. inclusion until the vaccine definition was amended.

    House Hansard, minister's second reading speech ↗
  3. June 2025

    National strategy backs access and innovation

    The minister said the National Immunisation Strategy for Australia 2025-2030 had been released in June 2025 and included priority areas on improving access to immunisation and harnessing new therapies.

    House Hansard, minister's second reading speech ↗
  4. 05 Feb 2026

    Government introduces passive-immunity bill

    The bill was introduced in the House of Representatives to broaden the National Health Act definition of vaccine so passive immunological products could be considered for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost..

    APH bill progress and minister's second reading speech ↗
  5. 11 Feb 2026

    House rejects broader access statement

    Monique Ryan moved a second-reading statement noting inconsistent vaccine funding and calling for national work with states and territories on access to immunisation products. The government opposed it and the question was negatived.

    House Hansard, Monique Ryan and Rebecca White speeches ↗
  6. 01 Apr 2026

    Senate rejects testing amendment and passes bill

    The Senate defeated Senator Malcolm Roberts' amendment on inert saline placebo testing by 5 votes to 43, then passed the remaining stages of the bill by 39 votes to 5.

    Senate Hansard divisions ↗

How did it move through Parliament?

House Senate
Introduced 05 Feb 2026

The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.

Introduced and read a first time

Second reading opened 05 Feb 2026

A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.

Second reading moved

Second reading debate 10 Feb 2026

The bill reached this recorded parliamentary step.

Sent to Federation Chamber for debate 10 Feb 2026

The bill reached this recorded parliamentary step.

Referred to Federation Chamber

Second reading debate 11 Feb 2026

The bill reached this recorded parliamentary step.

House second reading agreed 11 Feb 2026

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

Returned from Federation Chamber 12 Feb 2026

The bill reached this recorded parliamentary step.

Reported from Federation Chamber

House third reading agreed 12 Feb 2026

The chamber agreed to the bill at third reading, which completed passage through that chamber.

Third reading agreed to

Introduced 03 Mar 2026

The bill was formally presented to the chamber and read a first time, which starts its parliamentary journey.

Introduced and read a first time

Second reading opened 03 Mar 2026

A minister or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.

Second reading moved

Senate second reading agreed 01 Apr 2026

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

Senate third reading agreed Aye 39 No 5 01 Apr 2026

Recorded vote: 39 to 5.

The chamber agreed to the bill at third reading, which completed passage through that chamber.

Third reading agreed to

Passed both houses 01 Apr 2026

Both houses passed the bill in the same form, completing parliamentary passage.

Finally passed both Houses

Assent 08 Apr 2026

The Governor-General gave Royal Assent, turning the bill into an Act.

The main case against this bill

No speaker in the collected debate opposed the bill's core purpose of allowing passive immunological products to be considered for the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost.. Criticism focused on related issues: inconsistent vaccine access across states and territories, broader delays or cost barriers in health technology funding, and Senator Roberts' proposal to require inert saline placebo testing before designation.

The bill passed with broad support, but two proposed amendments sought to attach wider access or testing positions to the debate.

Inconsistent vaccine access

Monique Ryan supported the bill but argued that vaccine funding and administration rules differed between jurisdictions, leaving some families facing out-of-pocket costs or postcode-based access gaps.

Raised by Monique Ryan (independent) Source ↗

Broader health funding delays

Melissa Price supported the bill while criticising the government over broader delays in medicine listings, health technology assessment reform and pressure on hospitals.

Raised by Melissa Price (Liberal Party) Source ↗

Extra testing condition

Senator Malcolm Roberts moved an amendment that would have required a vaccine to be tested against an inert saline placebo to the named ICH E6(R3) standard before it could be specified under section 9B(7).

Raised by Malcolm Roberts (One Nation) Source ↗

Recorded votes

How the bill itself passed

The chamber-passage votes come first. Expand a vote to see the party breakdown.

Passed

House passed the bill

House agreed to the bill's third reading on the voices, so there is no list of individual Aye and No votes for final passage in that chamber.

12 Feb 2026

Passed on the voices

In a voice vote, members call out Aye or No and the presiding officer judges which side has it. Individual names are only recorded if a formal division is called.

Carried

Senate passed the bill

Aye 39 No 5

Passed 39 to 5. Support came from Labor, Greens, and minor parties and independents. Opposition came from One Nation and UAP. One cross-floor vote was recorded: Alex Antic (Liberal Party) voted no. Liberal Party had split recorded votes.

01 Apr 2026

Party Recorded votes Aye / No
Labor 25 / 0
Greens 10 / 0
Liberal Party 2 / 1
One Nation 0 / 3
Independent 2 / 0
UAP 0 / 1

Amendments at a glance

Recorded amendment and procedural votes grouped by chamber. Expand a vote to see the party breakdown.

Senate

Defeated

Require saline placebo vaccine testing

Aye 5 No 43

Moved by Malcolm Roberts (One Nation). Defeated 5 to 43. Support came from One Nation and UAP. Opposition came from Labor, Greens, and minor parties and independents. One cross-floor vote was recorded: Alex Antic (Liberal Party) voted aye. Liberal Party had split recorded votes.

01 Apr 2026

The amendment was defeated 5 to 43, so the bill proceeded without the extra testing condition.

Party Recorded votes Aye / No
Labor 0 / 23
Greens 0 / 10
Liberal Party 1 / 8
One Nation 3 / 0
Independent 0 / 2
UAP 1 / 0

This list includes amendment votes, procedural votes and votes on the bill itself.

Who spoke, and what they said

Start here — lead voices

Sponsor speech Supports

Rebecca White

Australian Labor Party • MP 05 Feb 2026

White introduced the bill for the government, saying it would let passive immunological products such as immunising monoclonal antibodies be listed on the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost..

Read in Hansard ↗
Lead supporting voice Supports

Melissa Price

Liberal Party • MP 10 Feb 2026

Price said the opposition supported the technical reform because it could improve national access to RSV immunisation products, while criticising the government over broader health-system delays and hospital pressure.

Read in Hansard ↗
Lead non-major voice Mixed

Monique Ryan

Independent • MP 11 Feb 2026

Ryan supported broadening the vaccine definition but moved a second-reading statement calling for more nationally consistent and affordable access to immunisation products.

Read in Hansard ↗
Lead voice Supports

Anthony Chisholm

Australian Labor Party • Senator 03 Mar 2026

Chisholm introduced the bill in the Senate through an incorporated speech, repeating the government's case that the definition change would let emerging therapies be listed on the National Immunisation ProgramThe national program through which eligible people in Australia can receive listed vaccines and immunisation products at no cost..

Read in Hansard ↗

All speeches by bloc

Labor

2 speakers · 3 contributions · 2 support

Coalition

1 speaker · 1 support

Minor parties and independents

1 speaker · 1 mixed

Full record

Full chat