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Therapeutic Goods Amendment (2022 Measures No. 1)

Current status

This bill became law on Mar 21st, 2023.

Policy area

Health, care & disability

What does this bill do?

Hospital leaders must report harmful incidents involving prescribed medical devices, so regulators can spot device safety problems earlier.

Why was it introduced?

Gaps in device incident reporting, medicine shortage powers, and information-gathering rules left safety problems harder to detect and critical warnings open to delay. The bill requires hospitals to report device harmA harmful incident or safety problem involving a medical device, such as an implant causing injury; the bill introduces stronger reporting of these events., lets Australia use overseas substitute medicines, expands document powers, and allows faster release of urgent safety information.

Broader context

Australia already regulated therapeutic goods, but gaps remained in post-market monitoringMonitoring a product after it is already being used by patients, so regulators can spot safety problems that were not obvious at approval time. of medical devices, medicine supply safeguards and regulators’ ability to quickly obtain and publish urgent safety information. After the 2017 Senate inquiryA 2017 Senate inquiry into harmful mesh implants that helped drive the bill's device reporting changes. into transvaginal mesh implants highlighted the need for earlier detection of device harmA harmful incident or safety problem involving a medical device, such as an implant causing injury; the bill introduces stronger reporting of these events., this bill was introduced in December 2022 to tighten reporting and enforcement powers, passed Parliament in March 2023 and became law later that month.

Key criticism

The main criticism was that the bill gave the Therapeutic Goods AdministrationAustralia's regulator for medicines, medical devices and related products; on this page, it is the agency given more reporting, disclosure and information-gathering powers. and the secretaryThe senior department official who is given several of the bill's new powers, including information requests and medicine shortage approvals. broader powers while cutting back procedural safeguards, especially by limiting merits reviewA process where a decision is reconsidered on the facts and law by a reviewer, not just checked for legal error; critics say the bill narrows this safeguard. and allowing some safety information to be published without a natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. hearing. Those concerns were raised most clearly by Coalition speakers seeking amendments, while stronger outright opposition came from One Nation and the Greens mainly argued the device-reporting reforms did not go far enough.

Who supported it?

Ged Kearney MP introduced this bill. In the recorded Senate second-reading vote, support came from Labor, Greens, Liberal Party, Jacqui Lambie Network, some crossbench members; opposition came from One Nation, UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions..

Introduced in House 01 Dec 2022
Passed House 08 Feb 2023
Passed Senate 09 Mar 2023
Became law 21 Mar 2023

Did it become law?

Yes

Became law 21 Mar 2023

Final passage

No counted final vote

1 recorded vote on the bill was found earlier in passage, but the final chamber agreement was not a counted division.

Passage speed

110 days

From introduction to the latest recorded parliamentary step

Official record

View on APH

Parliament of Australia bill page

Meaning

What does this bill do?

  1. Hospital leaders must report harmful incidents involving prescribed medical devices, so regulators can spot device safety problems earlier.

  2. Companies can apply to list biological products made only for export, creating a clearer approval pathway for Australian export-focused biotech products.

  3. Australia can approve overseas prescription medicines as substitutes when a medicine once approved here is no longer available, helping manage shortages.

  4. People and businesses can be required to hand over information or documents about possible breaches of therapeutic goods law, even if they are third parties.

  5. Health authorities can release important therapeutic goods safety information without waiting for a natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. hearing, so warnings can reach the public faster.

Show source excerpts
  1. (1) The chief executive officer (however described) of a healthcare facility must give a report to the Secretary if subsection (2), (3) or (4) applies to the healthcare facility in relation to a reportable medical device and a person.
    Therapeutic Goods Amendment (2022 Measures No. 1) as-passed bill text
  2. (1) A person may make an application to the Secretary to include an export only biological in the Register.
    Therapeutic Goods Amendment (2022 Measures No. 1) as-passed bill text
  3. (2A) The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods (the subject goods) if the Secretary is satisfied:
    Therapeutic Goods Amendment (2022 Measures No. 1) as-passed bill text
  4. (1) The Secretary may, by written notice given to a person, require the person to give to the Secretary any information, or produce to the Secretary any documents, specified in the notice that are relevant to a contravention, or possible contravention, of a provision of this Act or the regulations.
    Therapeutic Goods Amendment (2022 Measures No. 1) as-passed bill text
  5. clarify that the Secretary is not obliged to observe the requirements of the natural justice hearing rule when releasing therapeutic goods information, to ensure that critical information about the safety of therapeutic goods is able to be released without delay;
    Therapeutic Goods Amendment (2022 Measures No. 1) explanatory memorandum

Context

Broader context for this bill

Australia already regulated therapeutic goods, but gaps remained in post-market monitoringMonitoring a product after it is already being used by patients, so regulators can spot safety problems that were not obvious at approval time. of medical devices, medicine supply safeguards and regulators’ ability to quickly obtain and publish urgent safety information. After the 2017 Senate inquiryA 2017 Senate inquiry into harmful mesh implants that helped drive the bill's device reporting changes. into transvaginal mesh implants highlighted the need for earlier detection of device harmA harmful incident or safety problem involving a medical device, such as an implant causing injury; the bill introduces stronger reporting of these events., this bill was introduced in December 2022 to tighten reporting and enforcement powers, passed Parliament in March 2023 and became law later that month.

  1. 2017

    Senate inquiry examines transvaginal mesh implants

    The inquiry highlighted widespread complications from transvaginal mesh and pushed for stronger post-market monitoringMonitoring a product after it is already being used by patients, so regulators can spot safety problems that were not obvious at approval time., including better adverse-event reporting for medical devices.

    Hansard ↗
  2. 01 Dec 2022

    Government introduces changes to tighten therapeutic goods oversight

    The bill was introduced with measures to require hospital reporting of device harmA harmful incident or safety problem involving a medical device, such as an implant causing injury; the bill introduces stronger reporting of these events., manage unavailable prescription medicines through overseas substitutes, expand document powers and speed urgent safety disclosures.

    Hansard ↗
  3. 08 Feb 2023

    House passes the bill

    House passage showed bipartisan support for updating therapeutic goods regulation after debate centred on patient safety and medicine access.

    Parliamentary timeline ↗
  4. 09 Mar 2023

    Parliament passes the bill

    Both houses agreed on the final text, clearing the way for the new reporting, substitution and information-gathering powers to become law.

    Parliamentary timeline ↗
  5. 21 Mar 2023

    Royal Assent makes the changes law

    Royal Assent turned the bill into an ActThe main law the bill amends; it sets the rules for approving, monitoring and enforcing therapeutic goods in Australia., completing the legal step needed to implement the strengthened safety and compliance measures.

    Parliamentary timeline ↗

Legislative route

How did it move through Parliament?

House Senate
Introduced 01 Dec 2022

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 01 Dec 2022

A ministerThe minister responsible for the portfolio; the bill and amendments refer to this office in relation to oversight and delegation. or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.

Second reading moved

Second reading debate 07 Feb 2023

The bill reached this recorded parliamentary step.

Sent to Federation Chamber for debate 07 Feb 2023

The bill reached this recorded parliamentary step.

Referred to Federation Chamber

Second reading debate 08 Feb 2023

The bill reached this recorded parliamentary step.

House second reading agreed 08 Feb 2023

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 08 Feb 2023

The bill reached this recorded parliamentary step.

Reported from Federation Chamber

House third reading agreed 08 Feb 2023

The chamber agreed to the bill at third reading, which completed passage through that chamber. Later message exchanges with the other chamber were still recorded afterwards.

Third reading agreed to

Introduced 09 Feb 2023

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 09 Feb 2023

A ministerThe minister responsible for the portfolio; the bill and amendments refer to this office in relation to oversight and delegation. or sponsoring member moved the second reading, opening the main debate on the bill's purpose and principles.

Second reading moved

Second reading debate 07 Mar 2023

The bill reached this recorded parliamentary step.

Second reading debate 08 Mar 2023

The bill reached this recorded parliamentary step.

Second reading debate 09 Mar 2023

The bill reached this recorded parliamentary step.

Senate second reading agreed Aye 35 No 3 09 Mar 2023

Recorded vote: 35 to 3.

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 agreed to amendment packages 09 Mar 2023

The chamber considered amendments before the bill moved to the next stage.

Committee of the Whole debate

Senate third reading agreed 09 Mar 2023

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

Third reading agreed to

Message from Senate reported 09 Mar 2023

The bill reached this recorded parliamentary step.

House agreed to Senate amendments on rule-making limits 09 Mar 2023

The House dealt with Senate amendments or requests so both chambers could settle the bill in the same form. The main amendments were: Observed text changed from "(13) The SecretaryThe senior department official who is given several of the bill's new powers, including information requests and medicine shortage approvals. is not required to observe any requirements of the natural justice hearing ruleA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. in relation to relea…" to "(13) The SecretaryThe senior department official who is given several of the bill's new powers, including information requests and medicine shortage approvals. is not required to observe any requirements of the natural justice hearing ruleA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. in relation to: (a)…".

Consideration of Senate message

Passed both houses 09 Mar 2023

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

Finally passed both Houses

Assent 21 Mar 2023

The Governor-General gave Royal Assent, turning the bill into an ActThe main law the bill amends; it sets the rules for approving, monitoring and enforcing therapeutic goods in Australia..

Key criticism

The main case against this bill

The main criticism was that the bill gave the Therapeutic Goods AdministrationAustralia's regulator for medicines, medical devices and related products; on this page, it is the agency given more reporting, disclosure and information-gathering powers. and the secretaryThe senior department official who is given several of the bill's new powers, including information requests and medicine shortage approvals. broader powers while cutting back procedural safeguards, especially by limiting merits reviewA process where a decision is reconsidered on the facts and law by a reviewer, not just checked for legal error; critics say the bill narrows this safeguard. and allowing some safety information to be published without a natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. hearing. Those concerns were raised most clearly by Coalition speakers seeking amendments, while stronger outright opposition came from One Nation and the Greens mainly argued the device-reporting reforms did not go far enough.

Most criticism was targeted at safeguards and scope, not the bill’s core safety aims.

Weaker review and procedural fairness safeguards

Critics argued the bill removed or narrowed important checks on executive decisions, especially by reducing merits reviewA process where a decision is reconsidered on the facts and law by a reviewer, not just checked for legal error; critics say the bill narrows this safeguard. and letting some information be released before affected parties had a chance to respond. They warned this could weaken procedural fairness even where the policy goal of faster safety action was accepted.

Raised by Coalition speakers including Julian Leeser, Melissa McIntosh and Anne Ruston, with stronger opposition from Pauline Hanson and Malcolm Roberts Source ↗

Publication power seen as too broad

A key reservation was that schedule 10 let the TGAAustralia's regulator for medicines, medical devices and related products; on this page, it is the agency given more reporting, disclosure and information-gathering powers. publish information too broadly and without ordinary natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. steps. Critics wanted the power confined to genuine safety matters so it could not be used more widely than necessary.

Raised by Anne Ruston and Coalition senators seeking to limit the scope of the publication power Source ↗

Medical device reporting reforms seen as too weak

Some critics said the bill did not fully implement the mesh inquiryA 2017 Senate inquiry into harmful mesh implants that helped drive the bill's device reporting changes.’s recommended mandatory reporting scheme because it focused on hospitals rather than making reporting compulsory for medical practitioners more broadly. Their concern was that serious device harms could still be missed or reported too slowly.

Raised by The Greens, especially Jordon Steele-John Source ↗

Further sources

parlinfo.aph.gov.au ↗ openaustralia.org.au ↗

Votes

Recorded votes

How the bill itself passed

The bill passed both chambers on the voices. The counted divisions below were about amendments or procedure, not final passage.

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.

08 Feb 2023

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.

Passed

Senate passed the bill

Senate 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.

09 Mar 2023

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 cleared second reading

Aye 35 No 3

Passed 35 to 3. Support came from Labor, Greens, Liberal Party, Jacqui Lambie Network, and minor parties and independents. Opposition came from One Nation and UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions..

09 Mar 2023

Party Recorded votes Aye / No
Labor 16 / 0
Greens 11 / 0
Liberal Party 5 / 0
Jacqui Lambie Network 2 / 0
One Nation 0 / 2
Independent 1 / 0
UAP 0 / 1

Amendments at a glance

Amendments grouped by chamber. These cards include amendment outcomes recorded without a counted division.

House

Carried

House accepted all Senate amendments

The House agreed to the amendments made by the Senate, so the bill could pass both chambers in the same form.

Carried on voices

The chamber decided this amendment without a counted division, so there is no list of individual Aye and No votes.

Hansard record ↗

Senate

Defeated

Call for mandatory device reporting

Aye 14 No 25

Defeated 14 to 25. Support came from Greens, Jacqui Lambie Network, One Nation, UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions., and minor parties and independents. Opposition came from Labor, Liberal Party, and Nationals.

08 Mar 2023

If carried, it would have attached the Senate’s support to a broader reporting approach, reflecting Greens criticism that the bill did not go far enough on patient safety.

Party Recorded votes Aye / No
Labor 0 / 19
Greens 9 / 0
Liberal Party 0 / 4
Jacqui Lambie Network 2 / 0
Nationals 0 / 2
Independent 1 / 0
One Nation 1 / 0
UAP 1 / 0
Defeated

Call for equal blood donation rules

Aye 15 No 23

Defeated 15 to 23. Support came from Greens, Jacqui Lambie Network, and minor parties and independents. Opposition came from Labor, Liberal Party, Nationals, and One Nation.

09 Mar 2023

The amendment was a statement of principle urging an individual risk-assessment approach instead of the existing population-based assessment and three-month deferral rule.

Party Recorded votes Aye / No
Labor 0 / 17
Greens 11 / 0
Liberal Party 0 / 4
Independent 2 / 0
Jacqui Lambie Network 2 / 0
Nationals 0 / 1
One Nation 0 / 1
Defeated

Back minister oversight for substitutes

Aye 2 No 36

Defeated 2 to 36. Support came from One Nation and UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions.. Opposition came from Labor, Greens, Liberal Party, Jacqui Lambie Network, and minor parties and independents.

09 Mar 2023

The amendment would have added political oversight to the medicine-substitution power rather than leaving the approval solely with the department.

Party Recorded votes Aye / No
Labor 0 / 17
Greens 0 / 11
Liberal Party 0 / 4
Jacqui Lambie Network 0 / 2
Independent 0 / 1
Nationals 0 / 1
One Nation 1 / 0
UAP 1 / 0
Defeated

Expand medical device reporting

Aye 16 No 22

Defeated 16 to 22. Support came from Greens, Jacqui Lambie Network, One Nation, UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions., and minor parties and independents. Opposition came from Labor and Liberal Party.

09 Mar 2023

These amendments would have pushed the bill toward a stronger mandatory reporting frameworkA rule that requires certain facilities or people to report specific safety incidents, rather than leaving reporting voluntary. and related reporting-system reforms for medical device safety.

Party Recorded votes Aye / No
Labor 0 / 18
Greens 11 / 0
Liberal Party 0 / 4
Jacqui Lambie Network 2 / 0
Independent 1 / 0
One Nation 1 / 0
UAP 1 / 0
Defeated

Reject minister sign-off on substitutes

Aye 2 No 35

Defeated 2 to 35. Support came from One Nation and UAPThe minor party whose amendment would have required ministerial approval before certain substitutable medicine decisions.. Opposition came from Labor, Greens, Liberal Party, and minor parties and independents.

09 Mar 2023

Defeat of the amendments left the bill without the extra ministerial veto or sign-off mechanism over those approvals.

Party Recorded votes Aye / No
Labor 0 / 18
Greens 0 / 11
Liberal Party 0 / 4
Independent 0 / 2
One Nation 1 / 0
UAP 1 / 0
Carried

Government safety-information amendments added

The Senate added government amendments about when the SecretaryThe senior department official who is given several of the bill's new powers, including information requests and medicine shortage approvals. can release therapeutic goods information without observing the natural justice hearing ruleA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases..

Carried on voices

The chamber decided this amendment without a counted division, so there is no list of individual Aye and No votes.

Hansard record ↗

Carried

Government [sheet UD159] agreed

These amendments balance the provision of natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases. in relation to the release of information with the need to ensure the timely release of health and safety information to the public.

Carried on voices

The chamber decided this amendment without a counted division, so there is no list of individual Aye and No votes.

Hansard record ↗

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

The parliamentary record also shows 3 Government amendments agreed without a counted division.

Parliamentary debate

Who spoke, and what they said

Start here — lead voices

Sponsor speech Supports

Ged Kearney

Australian Labor Party • MP 01 Dec 2022

Ged Kearney supports the bill and says it strengthens therapeutic goods regulation, helps manage medicine shortages, and improves safety monitoring and compliance.

Read in Hansard ↗
Lead opposing voice Opposes

Malcolm Roberts

Pauline Hanson's One Nation Party • Senator 08 Mar 2023

Roberts opposes the bill and urges senators to vote it down, arguing that it strips common law rights, expands bureaucratic power, and weakens safeguards around medicine approvals.

Read in Hansard ↗
Lead supporting voice Supports

Anne Ruston

Liberal Party • Senator 07 Mar 2023

Ruston says the coalition will support the bill because it improves access to medicines and strengthens therapeutic goods safety, but she wants schedule 10 amended so the TGAAustralia's regulator for medicines, medical devices and related products; on this page, it is the agency given more reporting, disclosure and information-gathering powers. publication power is limited to safety issues and does not override natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases..

Read in Hansard ↗
Lead non-major voice Mixed

Ralph Babet

United Australia Party • Senator 08 Mar 2023

Babet says he supports some parts of the bill, including measures dealing with medicine shortages, but raises serious concerns about scrutiny, delegated powers and the removal of review rights.

Read in Hansard ↗

All speeches by bloc

Labor

4 speakers · 5 contributions · 4 support

  1. Gordon Reid Gordon Reid supports the bill, saying it strengthens patient safety, improves monitoring of adverse events, reduces unnecessary regulatory burden, and helps patients get therapeutic goods faster.
    “In closing, I'll say that all the changes in this bill are vital in supporting improvements to the safety of the patient; reduce ongoing regulatory burdens; support timely access to therapeutic goods; and enhance compliance and enforcement activities. It's good for patient safety, and it's good for the therapeutic alliance.”

    Australian Labor Party • MP • 08 Feb 2023

    Read the full speech in Hansard ↗
  2. Mike Freelander Freelander supports the bill and says it will modernise the therapeutic goods system by improving adverse-event reporting, speeding up responses to safety problems, and making it easier to manage shortages and alternatives.
    “I've no hesitation in standing here today to support this bill. Under the amendments to the TGA Act via the therapeutic goods amendment bill, issues with devices and some pharmaceuticals that we use in health care are identified to enable complications and problems that may occur in their use to be notified in a systematic way, and to enable the TGA to recommend the withdrawal of approval or special restrictions on use of certain devices.”

    Australian Labor Party • MP • 08 Feb 2023

    Read the full speech in Hansard ↗
  3. Ged Kearney ★ 2 contributions Ged Kearney supports the bill and says it strengthens therapeutic goods regulation, helps manage medicine shortages, and improves safety monitoring and compliance.

    Hansard records 2 separate contributions by Ged Kearney, including an amendment-moving contribution. They are grouped here so the speaker is listed once.

    Moved amendment Australian Labor Party • MP • 01 Dec 2022

    Ged Kearney supports the bill and says it strengthens therapeutic goods regulation, helps manage medicine shortages, and improves safety monitoring and compliance. She presents it as a practical package to protect patients and keep critical medicines available.

    “This bill amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest-quality health care for the Australian public by ensuring the continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance.”
    Read this contribution in Hansard ↗

    Second reading speech Australian Labor Party • MP • 08 Feb 2023

    Kearney supports the bill, saying it will improve access to critical medicines and strengthen the monitoring, compliance and advertising rules for therapeutic goods. She highlights the new hospital reporting scheme for adverse events and the measures to address medicine shortages as the main reasons for backing it.

    “The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest quality health care for the Australian public by ensuring continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance.”
    Read this contribution in Hansard ↗
  4. Murray Watt Watt supports the bill because it improves access to critical medicines and strengthens safety monitoring and compliance for therapeutic goods.
    “The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest quality health care for the Australian public by ensuring the continued access to critical prescription medicines, and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance.”

    Australian Labor Party • Senator • 08 Mar 2023

    Read the full speech in Hansard ↗

Coalition

4 speakers · 4 support

  1. Anne Ruston ★ Ruston says the coalition will support the bill because it improves access to medicines and strengthens therapeutic goods safety, but she wants schedule 10 amended so the TGAAustralia's regulator for medicines, medical devices and related products; on this page, it is the agency given more reporting, disclosure and information-gathering powers. publication power is limited to safety issues and does not override natural justiceA fairness rule that usually gives affected people a chance to respond before a decision is made; the bill limits this in some urgent information-release cases..
    “For these reasons we are keen for the government to amend this particular bill and to make changes to schedule 10 to only relate to the release of information on issues that relate to safety. On behalf of the coalition, I am more than happy to say that we will be happy to support this bill, although obviously we're very keen to make sure that the amendment to schedule 10 is moved.”

    Liberal Party • Senator • 07 Mar 2023

    Read the full speech in Hansard ↗
  2. Melissa McIntosh McIntosh says the coalition supports the bill because it strengthens the safe use of therapeutic goods, improves monitoring and compliance, and may help patients affected by mesh implant harms.
    “In conclusion, the coalition supports the bill as it will assist Australian patients and people who have gone through extraordinary pain, particularly through mesh implants, to ensure a more compliant-safe and accessible medicine market.”

    Liberal Party • MP • 08 Feb 2023

    Read the full speech in Hansard ↗
  3. Julian Leeser Leeser says the coalition will support the bill because it improves the safety and supply of therapeutic goods, but he criticises the removal of merits reviewA process where a decision is reconsidered on the facts and law by a reviewer, not just checked for legal error; critics say the bill narrows this safeguard. rights and argues the government must do more to address cost-of-living pressures that affect access to medicines.
    “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.”

    Liberal Party • MP • 07 Feb 2023

    Read the full speech in Hansard ↗
  4. Russell Broadbent Broadbent supports the bill because he says it is crucial to prevent the kind of harm caused by mesh implants from happening again.
    “on indulgence—This legislation is really important because the mesh implants cause untold harm and damage to thousands of women across Australia. This legislation goes right to the heart of many people in this nation that are dealing with issues that are ongoing; they don't end. The legislation being brought forward by the government today is crucially important so that the tragedy that happened with these mesh implants will never happen again—ever, ever again. Thank you for the opportunity to make that contribution.”

    Liberal Party • MP • 01 Dec 2022

    Read the full speech in Hansard ↗

Greens

1 speaker · 2 contributions · 1 mixed

  1. Jordon Steele-John 2 contributions Steele-John supports the bill and says it should be used to actThe main law the bill amends; it sets the rules for approving, monitoring and enforcing therapeutic goods in Australia. on the committee’s findings, especially by fixing barriers to blood donation equality and improving access to affordable medicinal cannabis.

    Hansard records 2 separate contributions by Jordon Steele-John on this bill. They are grouped here so the speaker is listed once.

    Second reading speech Australian Greens • Senator • 07 Mar 2023

    Steele-John says the Greens will support the bill as a response to the transvaginal mesh inquiryA 2017 Senate inquiry into harmful mesh implants that helped drive the bill's device reporting changes., but they think the government has put forward a weak half measure instead of the full mandatory reporting frameworkA rule that requires certain facilities or people to report specific safety incidents, rather than leaving reporting voluntary. the inquiry recommended. He says the Greens will move an amendment to make reporting compulsory for medical practitioners.

    “Now, the decision that will come before this Senate tomorrow will be whether we answer those calls with action—actually implementing the recommendations of the inquiry. So many gave their time and energy to generate those recommendations for a full mandatory reporting framework, not the half-baked half measure the government is putting forward this evening in the form of its definition of what healthcare facilities should or should not have to report. Let me state this clearly: the report really did not mince its words. All medical practitioners, as defined in the act, 'should report'. They should report to keep people safe. The Greens will be putting forward an amendment tomorrow to give effect to that recommendation.”
    Read this contribution in Hansard ↗

    Second reading speech Australian Greens • Senator • 08 Mar 2023

    Steele-John supports the bill and says it should be used to actThe main law the bill amends; it sets the rules for approving, monitoring and enforcing therapeutic goods in Australia. on the committee’s findings, especially by fixing barriers to blood donation equality and improving access to affordable medicinal cannabis. His case is that the legislation should go further to remove discrimination and deliver the reforms patients and donors need.

    “The Greens encourage the Senate to work in line with the community need, the clear evidence provided to this place, and to support this amendment.”
    Read this contribution in Hansard ↗

One Nation

2 speakers · 2 oppose

  1. Malcolm Roberts ★ Roberts opposes the bill and urges senators to vote it down, arguing that it strips common law rights, expands bureaucratic power, and weakens safeguards around medicine approvals.
    “The ALP have learned nothing from history, or they have deliberately ignored history. These four criticisms alone from the Senate Scrutiny of Bills Committee are all valid. The Soviet-style government should have addressed all before the bill came to the Senate. I urge all senators to vote this bill down and resist the attack on common law rights and restore principles of law that everyday Australians have held since Western settlement of our beautiful country.”

    Pauline Hanson's One Nation Party • Senator • 08 Mar 2023

    Read the full speech in Hansard ↗
  2. Pauline Hanson Pauline Hanson says One Nation will oppose the bill because she believes it attacks the presumption of innocence and procedural fairness, and gives officials too much power over therapeutic goods and medicine imports.
    “I rise to speak on the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. One Nation will not support this legislation. This bill is so flawed. It needs to be reviewed by a committee, but Labor, of course, is following its new procedure and ramming through legislation without giving this Senate the opportunity to review and improve it. Mark Butler should hang his head in shame.”

    Pauline Hanson's One Nation Party • Senator • 08 Mar 2023

    Read the full speech in Hansard ↗

Minor parties and independents

1 speaker · 1 mixed

  1. Ralph Babet ★ Babet says he supports some parts of the bill, including measures dealing with medicine shortages, but raises serious concerns about scrutiny, delegated powers and the removal of review rights.
    “I support various aspects of this bill, including the introduction of a mandatory medical device adverse event reporting scheme for hospitals and other healthcare facilities.”

    United Australia Party • Senator • 08 Mar 2023

    Read the full speech in Hansard ↗

Record

Full record

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