Bills – Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 – In Committee, 9 March 2023

Senator BABET (Victoria—United Australia Party Whip) (11:13): by leave—I move amendments (1) and (2) on sheet 1849 together:

(1) Schedule 9, item 5, page 27 (lines 30 and 31), omit the item, substitute:

5 Subsection 19A(11)

Repeal the subsection, substitute:

(11) An approval under subsection (1), (1A), (2), (2A) or (2B) is a legislative instrument.

(2) Schedule 9, page 27 (after line 31), after item 5, insert:

5A At the end of section 19A


(12) If the Secretary intends to grant an approval under this section, then prior to granting the approval, the Secretary must:

(a) give a notice (a ministerial notice) to the Minister in accordance with the requirements in subsection (13); and

(b) receive the agreement of the Minister.

(13) The ministerial notice must:

(a) be in writing; and

(b) include:

(i) the reasons for granting the approval; and

(ii) the conditions (if any) that are to be specified in the notice of approval; and

(iii) the period to be specified in the notice of approval; and

(c) seek the agreement of the Minister to the approval; and

(d) request that the Minister agree to, or object to, the approval before the end of 14 days beginning on the day the ministerial notice is given to the Minister.

(14) If the Minister does not agree to, or object to, the approval within 14 days, then at the end of that period the Minister is taken to have agreed to the notice of approval.

My intent in proposing these two amendments is as follows. Amendment (1) amends subsection 19A(11) of the TGA Act 1989 to provide that approvals made by the secretary are legislative instruments and will therefore be subject to disallowance under section 42 of the Legislation Act 2003. Quite simply, we’re seeking to ensure proper oversight and political accountability for decisions made by the secretary as a result of proposed amendments. I believe that in the bill as it is written right now there appears to be a lack of accountability and too much power placed in one person’s hand.

Amendment (2) is designed to serve two functions. It will ensure that there is ministerial oversight and that, before giving notice of approval, the secretary must first give notice to the minister and seek their agreement. We have proposed that the minister be asked to provide their agreement or objection within 14 days, or otherwise it is considered to have been given.

Progress reported.