Bills – Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 – Second Reading

Senator BABET (Victoria—United Australia Party Whip) (12:08): Obviously, I rise here today to speak in regard to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. 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. I acknowledge that the TGA has an important role to play in managing medicine shortages. They have an important responsibility to find suitable substitutes to ensure that Australians have access in a timely manner to the medications that we all require. The bill in part seeks to address critical shortages on life-saving medications—for example, I know that warfarin tablets are currently listed as being in critical short supply. This is, of course, a potentially life-saving drug for persons with cardiovascular conditions.

I’d also like to acknowledge Minister Butler’s office for responding to several questions that I had in relation to portions of this bill. However, I must raise some concerns relating to what appear to be extraordinary powers to be granted to the secretary in this bill without, I believe, sufficient ministerial oversight.

The amendments in this schedule are intended to address the gap in the range of measures available under the act to alleviate the effects of shortages—which is fair enough—by amending section 19A of the act to introduce a mechanism to enable the secretary to approve the importation or supply of an unapproved medicine that is principally similar to a medicine that has been cancelled or suspended from the register. Let’s just say, as an example—let’s just throw one out there—that the secretary wants to substitute a certain medication with, I don’t know, a novel technology. What would be the chances, for example, of indemnity being granted to said sponsor? Will there be any guarantees that to substitute is both safe and effective? What if there was to be a safety signal? What happens then? Would the data and rationale behind the decision be disclosed for the public to review? I think we all know where this could potentially go.

We know that there exists a presumption of commercial-in-confidence of information provided by pharmaceutical companies. We know that already. There must exist an obligation for transparency of data and agreements, because, as we all know, transparency builds trust. In our correspondence with the minister’s office and the TGA around section 19A, the TGA advised that before a section 19A approval is given the secretary must be satisfied that an approval is necessary and in the interests of public health and that the registered medicines could act as a substitute if the overseas registered goods are unavailable or in short supply. Now, ‘in the interests of public health’—we’ve all heard that before. I wonder what could happen there.

I can think of quite a few recent examples where measures were put in place in the interests of public health but arguably resulted in quite a bit of harm being done. Let’s go through them: mask mandates, school closures, lockdowns, vaccine mandates, border closures, curfews and interference with the doctor-patient relationship. There are quite a few. Many failed dictates have been put in place in the interests of public health.

I know this bill is not specifically linked to pandemic measures. I know that. But the overreaches are symptomatic of absolute power leading to poor decision-making and significant unintended consequences. I aim not to stand in the way of large portions of this bill which are necessary. But section 19A is one that needs more attention. I’ve touched on just a small portion of this bill, and there are many reasons that we should, in the public interest, debate the bill at length. I’ll be proposing amendments to this bill. One is proposing referral to the Community Affairs Legislation Committee and another is requesting ministerial responsibility for the decisions made by the secretary as a legislative instrument.

It is unacceptable that we should award great power to a bureaucrat who has no direct accountability to the Australian people. The Australian people can’t vote a secretary out at a general election. What I seek is greater transparency, accountability and disclosure of information so we don’t repeat the mistakes of the past. Power must be decentralised, decision-making must be transparent and, above all else, the Australian people should be well informed. That is why this bill needs proper scrutiny. For that reason I foreshadow that I’ll be moving a second reading amendment at the end of this debate.

Senator BABET (Victoria—United Australia Party Whip) (18:32): I move my amendment on sheet 1850:

At the end of the motion, add “and the bill be referred to the Community Affairs Legislation Committee for inquiry and report by 29 June 2023”.

The ACTING DEPUTY PRESIDENT: The question is that Senator Babet’s amendment on sheet 1850 be agreed to. A division having been called for, pursuant to standing order 57(3), the vote will be deferred till the next day of sitting.

Debate adjourned.

The ACTING DEPUTY PRESIDENT (Senator O’Neill) (10:20 09 March 2023): The question is that the second reading
amendment moved by Senator Babet be agreed to.
The Senate divided. [10:20]
(The Acting Deputy President—Senator O’Neill)

Majority ……………..34
Babet, R. (Teller) Roberts, M. I.
Allman-Payne, P. J. Ayres, T. Bilyk, C. L. Canavan, M. J. Chisholm, A. Cox, D. Faruqi, M. Gallagher, K. R. Green, N. L. Grogan, K. Hanson-Young, S. C. Henderson, S. M. Lambie, J. McAllister, J. R. McKim, N. J. O’Neill, D. M. Paterson, J. W. Payman, F. Pocock, B. Pocock, D. W. Polley, H. Pratt, L. C. Rice, J. E. Ruston, A. Scarr, P. M. (Teller) Sheldon, A. V. Shoebridge, D. Smith, M. F. Steele-John, J. A. Sterle, G. Tyrrell, T. M. Urquhart, A. E. Walsh, J. C. Waters, L. J. Whish-Wilson, P. S. White, L