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Therapeutic Goods Amendment (Repeal of Ministerial
responsibility for approval of RU486) Bill 2005
EXPLANATORY MEMORANDUM
A Bill for an Act to repeal Ministerial approval and to leave approval with
the Therapeutic Goods Administration over access to RU486, and for related
purposes.
The purpose of this bill is to remove responsibility for approval for RU486
from the Minister for Health and Ageing and to provide responsibility for
approval of RU486 to the Therapeutic Goods Administration.
In 1996 amendments to the Therapeutic Goods Act were passed that placed
medications such as RU486 in a special group of drugs known as 'restricted
goods'.
According to the 1996 amendments restricted goods cannot be evaluated,
registered, listed or imported without the written approval of the Minister
for Health and Ageing.
In addition, any such written approval must be laid before each House of
the Parliament by the Minister within 5 sitting days of being given.
RU486 is the only medicine that is subject to the restricted goods
condition.
Medicines used for any purpose other than abortion are evaluated and
regulated by the Therapeutic Goods Administration (TGA) alone and do not
require additional approval from the Minister for Health and Ageing.
The TGA is specifically charged with identifying, assessing and evaluating
the risks posed by therapeutic goods that come into Australia, applying any
measures necessary for treating the risks posed, and monitoring and
reviewing the risks over time.
The TGA is regarded by the government as being qualified to manage the
risks associated with any therapeutic good that is used (or proposed for
use) in Australia. It is therefore reasonable to assume that it is also
qualified to manage the risks associated with medications such as RU486.
Removal of the restricted goods provisions in the Act would mean that RU486
could be evaluated within the same framework as applies to all other
medicines. It is reasonable to assume that this may provide potential
sponsors of the drug with greater confidence that an application for
approval would be worth pursuing-in that the determining factor in the
process would be an evidence-based evaluation by the TGA of the merits and
risk profile of the drug.
The amendments to the Therapeutic Goods Act 1989 in this Bill will bring
the approval process for medications such as RU486 into line with the
evidence-based assessment used for all other medicines in Australia.