Division Description Changes — Bills — Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022; Second Reading — 9th Mar 2023

Change	Division
senate vote 2023-03-09#3 Edited by mackay staff on 2023-03-17 11:06:56	Title Bills — Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022; Second Reading Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 - Second Reading - Agree with bill's main idea Description ~~<p class="speaker">Deborah O'Neill</p>~~ ~~<p>The question is that the bill be read a second time.</p>~~ The majority voted in favour of a [motion](https://www.openaustralia.org.au/senate/?gid=2023-03-09.12.1) to agree with the bill's main idea. In other words, they voted to read it for a [second time](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/). They can now discuss it in greater detail. ### What is the bill's main idea? According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2223a/23bd046): > The Bill proposes amendments to the Therapeutic Goods Act 1989 (the Act) that include: > > * imposing a new reporting requirement on CEOs of healthcare facilities for adverse events involving medical devices > * establishing a new ‘export only’ pathway for biologicals > * expanding the Therapeutic Goods Administration’s information gathering powers > * enabling the withdrawal of restricted advertising approval for therapeutic goods if concerns arise following the release of new efficacy information > * expanding the list of exempt persons who may receive direct therapeutic goods advertising and for whom the Act’s advertising requirements do not apply > * expanding existing powers to enable the importation or supply of (unapproved) substitutable medicines in the event of a medicine shortage where no appropriate alternative is available in the Australian Register of Therapeutic Goods and it is in the interests of public health. > > Several of these amendments build on ongoing therapeutic goods reforms and are in response to stakeholder feedback. ~~<p></p>~~ ~~<p></p>~~

~~Deborah O'Neill~~
~~The question is that the bill be read a second time.~~
The majority voted in favour of a [motion](https://www.openaustralia.org.au/senate/?gid=2023-03-09.12.1) to agree with the bill's main idea. In other words, they voted to read it for a [second time](https://peo.gov.au/understand-our-parliament/how-parliament-works/bills-and-laws/making-a-law-in-the-australian-parliament/). They can now discuss it in greater detail.
### What is the bill's main idea?
According to the [bills digest](https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2223a/23bd046):
> *The Bill proposes amendments to the Therapeutic Goods Act 1989 (the Act) that include:*
>
> * *imposing a new reporting requirement on CEOs of healthcare facilities for adverse events involving medical devices*
> * *establishing a new ‘export only’ pathway for biologicals*
> * *expanding the Therapeutic Goods Administration’s information gathering powers*
> * *enabling the withdrawal of restricted advertising approval for therapeutic goods if concerns arise following the release of new efficacy information*
> * *expanding the list of exempt persons who may receive direct therapeutic goods advertising and for whom the Act’s advertising requirements do not apply*
> * *expanding existing powers to enable the importation or supply of (unapproved) substitutable medicines in the event of a medicine shortage where no appropriate alternative is available in the Australian Register of Therapeutic Goods and it is in the interests of public health.*
>
> *Several of these amendments build on ongoing therapeutic goods reforms and are in response to stakeholder feedback.*
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