Rebecca White (Lyons, Australian Labor Party, Assistant Minister for Women) | Hansard source

I move:

That this bill be now read a second time.

Today, I introduce the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026.

This bill amends the Therapeutic Goods Act 1989 (the Therapeutic Goods Act) to implement several important public health measures, including in relation to the management of medicines shortages and discontinuations.

Medicines are essential for the health and wellbeing of Australians. This means that shortages and discontinuations of medicines can cause significant impacts for Australian patients, and the health practitioners and systems that support them.

Interruptions to the supply and availability of medicines in Australia can occur for various reasons, and unfortunately some supply disruptions can be unavoidable. Medicine supply chains are complex global systems and there are numerous points in the supply chain where problems can cause a medicine supply disruption, each requiring a different response.

Although many improvements have been made since the introduction of the mandatory medicines shortages and discontinuations reporting scheme, the Australian government is continuing to make improvements to the way that supply disruptions are monitored and managed to further reduce impacts.

The government has undertaken extensive consultation over the past two years to better understand the most pressing challenges and barriers experienced by individuals and businesses in Australia relating to medicines shortages and discontinuations.

This bill introduces legislative changes designed to address key challenges raised by stakeholders across the medicines supply chain in their consultation feedback.

These legislative changes will strengthen key aspects of the mandatory reporting scheme under the Therapeutic Goods Act, to enable Australia to be better prepared for shortages and discontinuations of critically important medicines.

Specifically, this bill includes amendments to require sponsors to notify the Secretary of the Department of Health, Disability and Ageing of any decision to permanently discontinue the supply of reportable medicines in Australia at least 12 months in advance.

This will provide more time for health practitioners and patients to make plans for ongoing treatment, where needed. The existing clause'or as soon as practicable after the decision is made' will be maintained, acknowledging that unforeseen circumstances can impact a sponsor's ability to report a discontinuation 12 months in advance.

Further, sponsors who give such notice will be required to update the secretary if there is a change in the initial approach, including if the supply is no longer proposed to be discontinued, or if the discontinuation is to occur at a different time than previously notified.

The bill also enables the secretary to require all sponsors of approved medicines to provide, upon request, information about the availability, and any shortage or discontinuation, of their products in Australia.

Currently, this information can only be requested about a subset of approved medicines that are designated as reportable medicines. The bill will enable this information to be requested regarding any approved medicine, not just reportable medicines. This is important, as shortages of any approved medicine can have a significant impact on the health and wellbeing of people in Australia.

In addition to the medicines shortages and discontinuations measures, the bill makes several other important amendments to the Therapeutic Goods Act.

The bill enables the secretary to determine common biologicals groups so that similar biologicals can share a single entry in the Australian Register of Therapeutic Goods (the register).

Currently, a sponsor must navigate duplicative processes. This includes maintaining separate entries in the register for biologicals that are essentially the same but have minor differences—such as minor formulation changes or extensions of indications. They must bear the cost of maintaining multiple listings for essentially the same product. They may also be required to cancel existing entries when a new product with only a minor change in indication or intended use is approved, resulting in avoidable cost, delay, and administrative burden.

This amendment will allow sponsors to combine their entries in the register, avoiding duplication and reducing costs and regulatory burden for industry.

Additionally, the bill makes a technical amendment to confer clear legal powers on authorised persons to enter, search and inspect clinical trial sites. Such inspections will ensure that unapproved therapeutic goods supplied and used in clinical trials are in accordance with the applicable exemption and approval schemes, and will safeguard the rights, safety and wellbeing of clinical trial participants.

This will be implemented by moving existing powers from delegated legislation to primary legislation to ensure that the legislation operates as intended.

The bill also enables the instrument made under section 30EJ of the Therapeutic Goods Act, known as the Medicines Watch List, to incorporate other documents as in force from time to time.

This instrument lists certain medicines for which a shortage or discontinuation in Australia would be of critical impact. This amendment will ensure that the list of critically important medicines specified in the instrument remains as current as possible at all times, for the purposes of mandatory reporting requirements and timeframes.

The bill includes other minor consequential and technical amendments to the Therapeutic Goods Act, including to improve consistency, remove outdated provisions and correct errors.

The bill is complemented by the Therapeutic Goods (Charges) Amendment Bill 2026 which makes associated amendments to the Therapeutic Goods (Charges) Act 1989 to allow the prescribing of annual charges for the inclusion of grouped biologicals in the register. This will ensure that the common biologicals groups measure in this bill is able to operate as intended.

Debate adjourned.

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