Title Therapeutic Goods (Charges) Amendment Bill 2017
Database Explanatory Memoranda
Date 16-04-2018 03:36 PM
Source House of Reps
System Id legislation/ems/r5978_ems_179ca3c5-6444-4f9b-9d25-8b7cc7dd4eb4

Therapeutic Goods (Charges) Amendment Bill 2017




































This addendum responds to concerns raised by the Senate Standing Committee for the Scrutiny of Bills in Scrutiny Digest No. 12 of 2017, dated 18 October 2017.        



(Circulated by authority of the Minister for Health and Minister for Sport,
the Honourable Greg Hunt MP)


Item 5


At the end of item 5 – add:


The Australian Government Charging Framework requires cost recovery levies to be imposed as annual charges when a good, service or regulation is provided to a group of individuals or organisations rather than to a specific individual or organisation. Unlike general taxation, such levies are earmarked to fund activities provided to the group that pays the levy.


The annual charges relating to conformity assessment body determinations will be calculated after taking into account the total expected cost of the monitoring and compliance framework for conformity assessment bodies and will be set in accordance with the Australian Government Cost Recovery Guidelines.


Setting the amount, or the method for calculating the amount, of annual charges in the regulations, rather than the principal legislation, is designed to provide the appropriate level of flexibility to:

·                impose different amounts of charges, or have different methods of calculation, depending on the scope of conformity assessment body determinations (that is, whether a determination is of general application or is limited to specified medical devices and/or specified conformity assessment procedures); and

·                set the amount of annual charge, or its method of calculation, to accurately reflect the cost of regulation as the scheme evolves, and to adjust the amount over time to avoid over or under recovery.


Before prescribing the amount of annual charges in respect of conformity assessment body determinations, the Department of Health (through the Therapeutic Goods Administration (TGA)) will undertake detailed consultation with stakeholders, including medical device industry peak bodies through the TGA’s Regulatory and Technical Consultative Forum (RegTech). A Cost Recovery Implementation Statement will be prepared and published on the TGA’s website which will further facilitate transparency and accountability.


This approach, then, will prevent the need to amend primary legislation whenever there are changes to cost recovery arrangements, and is also consistent with the approach taken in relation to existing annual charges imposed on the registration, listing and inclusion of goods in the Australian Register of Therapeutic Goods, and the licensing of manufacturers of therapeutic goods.


The Bill does not include a maximum amount of charge because any such limit prescribed would be arbitrary and would need to be substantially in excess of the amount proposed to be charged, which would likely result in confusion of, and criticism by, stakeholders.


As legislative instruments, the regulations will be subject to the requirements of the Legislation Act 2003, including requirements in relation to consultation and parliamentary scrutiny. In particular, the regulations will be tabled in Parliament and are disallowable by either House, which will assist in ensuring that charges are not excessive. They will also be subject to scrutiny by the Senate Standing Committee on Regulations and Ordinances.