Dear Ms Gillard,

I wish to bring to your  attention the current restrictions on the importation of
Mifepristone (RU486) into Australia. Mifepristone is a medication that blocks the
action of the hormone progesterone and causes an abortion as without progesterone,
a pregnancy cannot be sustained. Mifepristone has been proven safe and acceptable
for use by women and is been used for medical terminations in countries such as France,
China, United Kingdom, Sweden and in News Zealand. 

In 1996, an amendment to the Therapeutic Goods Act was passed that requires specific
approval to import Mifepristone must be obtained by the Federal Minister for Health.
This is an unusual requirement, as common method for approval of the importation and
distribution of therapeutic drugs into Australia is through the rigorous scientific and
evidence based assessment conducted by the Therapeutic Goods Administration (TGA). In the
case of mifepristone, a drug that is to be proven safe and effective, the additional
requirement of a Ministerial sanction is unnecessary.

Moreover, the requirement of ministerial approval continues to discourage pharmaceutical
companies and organisations from applying to distribute Mifepristone in Australia.  As the
TGA application process works on a cost recovery basis, the expense involved for the
sponsoring company can be very great.  Companies are unwilling to undertake this expense
for Mifepristone, when the Minister may overturn the approval by the TGA.  There are no
guidelines for Ministerial approval or rejection.

The current state of the approval process could be seen as lacking equity as the Minister
for Health could reject the application based on personal views alone. As well, it is
unreasonable to deny Australian women the safe reproductive health care choice of
Mifepristone when surgical termination of pregnancy is already available in this country. 

If the ALP is elected to Federal Government at the coming election, it should repeal this
inequitable amendment, or provide a commitment not to block an application to import and
distribute Mifepristone that has been approved by the TGA.
 
Yours sincerely,