If the Secretary of the Department of Health and Ageing relies on
false information to approve a request, there could potentially
be serious consequences for public health
and safety [AS THERE NOW IS].
Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013
Full Text → HERE
The Parliamentary Secretary replied
to the Scrutiny of Bills Committee as follows:
The information provided by a sponsor for the purposes of [a request for variation] can include complex and extensive scientific data about the goods, e.g., results of clinical trials, or the incidence of adverse reactions to prescription medicines. This information will be exclusively and confidentially within the knowledge of the sponsor. Moreover, it is up to the sponsor to demonstrate that the basis on which the product was approved for marketing in Australia (via inclusion on the Register)—i.e. that its quality, safety and efficacy/performance was acceptable—remains, and that, as such, it should continue to ‘be on the Register notwithstanding the proposed change.
[WATER FLUORIDATION SHOULD BE ON THE REGISTER]
Thus there is a particular level of dependence on the accuracy and comprehensiveness of the supporting information provided to support a section 9D request, especially in relation to higher risk goods like prescription medicines [ INCLUDING WATER FLUORIDATION ? ]. If the Secretary of the Department of Health and Ageing relies on false information to approve a request, there could potentially be serious consequences for public health and safety [AS THERE IS].
Where non-compliance with the requirement to provide accurate information that is not false or misleading is likely to cause harm or injury (as per proposed subsection 9G(2)), it is considered that non-compliance should attract a criminal sanction regardless of any mental element. By setting out a strong deterrence against providing false or misleading information, and by forming an integral part of the suite of sanctions proposed for such conduct, it is expected subsection 9G(2) will significantly enhance regulatory enforcement and help to protect the public from exposure to therapeutic goods that have been approved for continued supply on the basis of false or misleading information.
Proposed section 9G is consistent with the existing tiered criminal offences in the Act that apply in relation to the provision of false or misleading information (e.g. by applicants for the inclusion of products in the Register) , and with the current approach of tiered criminal offences in the Act which include in that structure an offence of strict liability along the same lines as proposed subsection 9G(2).….