Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Hansard source

I agree. Strict liability offences should only be used in particular circumstances throughout legislation. They are used in circumstances where there is a public interest ensuring that the regulatory schemes are observed and it can be reasonably expected that the person was aware of their duties and obligations.

The inclusion of the strict liability offences and the maximum of 100 penalty units is justified in the particular context of the regulatory scheme for therapeutic goods, given the potentially significant consequences for public health and safety in the event of noncompliance. For instance, a failure to provide information or documents could delay the investigation of a contravention of the act with patients suffering harm before the contravention is identified, and the provision of false and misleading information could lead TGA to conclude that a therapeutic good is safe for use by patients when it may not be.

It is an exception to the offence if a person has a reasonable excuse, such as being unable to answer for a reason such as being in hospital and unable to reply for not complying. In your second reading address, you raised comments about an automatic fine of $27,000. It's important to note that the penalty of 100 penalty units is a maximum penalty for natural persons and that the amount of any penalty would be for a court to determine in accordance with sentencing principles.