The Therapeutic Goods Amendment Bill 2025 makes a minor technical change to the Therapeutic Goods Act 1989 by updating subsection 63(4) so that regulations can incorporate, by reference, matters contained not only in instruments but also in other writing.
This amendment aligns the Act with the Legislation Act 2003 and similar provisions elsewhere in the Therapeutic Goods Act, reducing ambiguity in how external standards are adopted.
The Bill amends the Therapeutic Goods Act 1989 (the Act) to replace subsection 63(4). Under the existing provision, regulations made under the Act may apply, adopt or incorporate, with or without modification, any matter contained in an instrument in force at the time or as in force from time to time, but do not expressly refer to ‘other writing’. Item 1 of Schedule 1 substitutes subsection 63(4) to add a reference to ‘other writing’, allowing regulations to apply, adopt or incorporate matters from instruments or other writing as in force or existing from time to time. This change brings subsection 63(4) into alignment with subsection 10(4) of the Act and subsection 14(2) of the Legislation Act 2003.
The amendment is purely technical, carries no financial implications, and will commence the day after Royal Assent. By clarifying the scope of the regulation-making power, it helps ensure Australia’s therapeutic goods framework remains aligned with key overseas benchmarks, reducing the risk of delays in availability of new products for Australian patients.
The amendment is a straightforward, technical correction that resolves an unintended gap in the current drafting of subsection 63(4), supplying clarity and legal certainty without altering the substantive scope of the regulation-making power [Judgment].
By expressly permitting incorporation of “other writing” as well as instruments, the Bill ensures that Australia’s therapeutic goods regulations can reference up-to-date technical standards and scientific benchmarks—many of which exist in non-instrument form—in order to keep pace with developments in major jurisdictions such as the EU and the US. This alignment reduces the risk that sponsors will delay importation or introduction of new medicines and devices, thereby promoting timely patient access to innovations and improving public health outcomes [Judgment].
Furthermore, because the change is fully consistent with existing consultation, disallowance and impact-analysis requirements under the Legislation Act 2003, it imposes no new costs or procedural burdens on stakeholders or government agencies.
While the amendment is pitched as technical, extending the power to incorporate “other writing” by reference risks reducing parliamentary and public oversight over which external materials become part of the regulatory framework. Unlike instruments gazetted by government, “other writing” may include privately produced standards or scientific benchmarks that are not routinely tabled in Parliament or freely accessible to all stakeholders [Judgment].
Parliamentary scrutiny and disallowance procedures depend on clear, transparent identification of the source materials being adopted. Broad references to “other writing” could lead to reliance on obscure or subscription-only documents, undermining democratic accountability and informed debate over the content of Australia’s therapeutic goods regulations.
2025-07-22
House of Representatives
Before House of Representatives
Unspecified
Prime Minister
Healthcare, Science / Technology, Consumer Protection