Is This a Backdoor for Big Pharma?

In the July sitting, the Albanese Government introduced the Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025. Most of the bill was a tidy-up of poorly drafted health legislation from the previous parliament.

However, one section was slipped in — a new power allowing the Therapeutic Goods Administration (TGA) to declare a drug shortage based merely on the suspicion of a future shortage. This would then enable the approval of drugs that haven’t been properly tested or assessed.

The TGA already has a similar power with a higher threshold for approval. This new legislation appears to be nothing but a pretense to give the TGA sweeping authority to bypass safety testing and scrutiny for new drugs. Even under the current “higher bar,” Section 19(1) has been used to approve 135 current drugs and 600 expired or lapsed ones — a total of 735 approvals of new drugs - or versions of drugs in two years.

I asked the Minister to provide an example of how Australians might be disadvantaged without these new powers. The Minister couldn’t answer. So I must ask — who actually wrote this? It clearly wasn’t the Government.

One Nation will repeal Section 19(1) and ensure that every new drug is subject to proper safety testing and full regulatory oversight.

Watch the video and see for yourself how clueless this Government is.

Transcript: https://www.malcolmrobertsqld.com.au/is-this-a-backdoor-for-big-pharma/