Bills Digest no. 82 2009–10
Therapeutic Goods (Charges) Amendment Bill
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
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introduced: 25 November
House: House of Representatives
Portfolio: Health and Ageing
Formal provisions: on Royal Assent
Schedule 1: on a day
to be fixed by Proclamation
relevant links to the Bill, Explanatory Memorandum and second
reading speech can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
The Therapeutic Goods (Charges)
Amendment Bill 2009 (the Bill) proposes to amend the
Therapeutic Goods (Charges) Act 1989 (the Charges Act) in
- the imposition of annual charges for the continued inclusion of
biologicals in the Register, and
- the impact of suspension of therapeutic goods or biological on
the imposition of charges.
The Bill complements the Therapeutic
Goods Administration (2009 Measures No. 3) Bill 2009 (the TGA
No. 3 Bill). In addition, the Therapeutic Goods Act 1989
(the TGA Act) is incorporated and is to be read as one with the
For background information, including the policy commitment
behind both Bills, please refer to the Bills Digest for the TGA No.
As at 30 November 2009 the last day of sitting for Parliament in
2009, the Bill had not yet been referred to a parliamentary
committee for review.
According to the Government, these proposed amendments would not
impact financially on the Commonwealth as the Therapeutic Goods
Administration operates on a cost recovery basis. Although it would be expected that
these proposed amendments would have some financial impact on
industry (which presumably would be passed on to consumers), to
date, there appears to have been no publicly available comment from
the pharmaceutical industry. Arguably, any kind of change would
result in some sort of financial impact but, at this stage, it
remains obscure just what that impact would be.
Item 1 proposes to insert new
subsections 3(1A) and (1B) into the
Charges Act. These new subsections would mean that despite
suspension of a therapeutic good or biological from the Australian
Register of Therapeutic Goods (the Register), the therapeutic good
or biological would be taken as being included in the Register for
the purposes of the Charges Act.
It is stated in the Explanatory Memorandum that:
This is to ensure that annual charges remain payable in respect
of therapeutic goods that are suspended from the Register. This is
necessary because suspension is temporary (not more than six
months, unless it is extended) and does not result in a reduction
to the usual regulatory work required to be undertaken by the
Therapeutic Goods Administration (TGA) in relation to the
This is consistent with the approach already taken regarding
medical devices under subsection 3(2) of the Charges Act.
Item 3 proposes to insert new
subsection 4(1AA) into the Charges Act. This means that an
annual charge of a prescribed amount would be payable for the
inclusion of a biological in the Register under Part 3-2A of the
TGA Act, effective at any time during the financial year.
Subsection 6AAE of the TGA Act provides that where a State law
- the function of including therapeutic goods in the Register,
- the power to include goods in the Register,
on a Commonwealth officer or authority, that officer or
authority may include the goods in the Register according to the
corresponding State law.
Item 4 proposes to insert new
subsection 4(4A) into the Charges Act. This means that if
a biological is included in the Register in the exercise of a
function conferred on the Secretary by a corresponding State law,
annual charges would apply to that biological as if it had been
included in the Register under Part 3 2A of the TGA Act.
This approach is consistent with that taken regarding both
listed and registered therapeutic goods, as well as medical
These proposed amendments are consequential to and would
complement the amendments proposed in the TGA No. 3 Bill. These
amendments would also ensure consistency with the approach taken
towards all therapeutic goods (including biologicals) and medical
devices that are suspended under the Charges Act.
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21 January 2010
Bills Digest Service
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