The so-called abortion drug RU486 will be widely available to Australian women after the Therapeutic Goods Administration approved an application to import the drug by a company set up by the reproductive health group Marie Stopes International.
A ministerial veto over the drug was lifted by Parliament in 2006 but the drug has had only very limited availability because just a handful of individual general practitioners were granted permission to import and prescribe the drug.
"In line with its global objective of ensuring choice and access to sexual and reproductive health services for women Marie Stopes International has established a not-for-profit health subsidiary, MS Health, to market and distribute reproductive health products," a spokeswoman for Marie Stopes International said.
"MS Health will be marketing and distributing mifepristone and misoprostol in Australia for medical termination of early pregnancy."
The decision by the TGA to register MS Health – made early this morning – means women will be able to access the drug much more easily than before.
Health Minister Tanya Plibersek welcomed the listing of the two medicines, but said the Therapeutic Goods Administration was an independent body and the Gillard Government had not intervened in the listing process.
‘‘RU486 is on the World Health Organisation list of essential medicines but until today has not been registered for use in Australia. The use of these medicines has also been endorsed by the Royal College of Obstetricians and Gynaecologists,’’ Ms Plibersek said in a statement.
‘‘For more than two decades tens of millions of women throughout the world have used RU486. This listing means Australian women will have the same options as women in over 46 countries including the UK, USA, New Zealand and in Europe.''
The drug's previous limited availability was largely due to a lack of interest by major pharmaceutical companies to import the drug for sale in Australia.
Even though the drug had been approved as safe for use it was not seen as something that would sell sufficient numbers to warrant the time and money a drug company would spend importing it into Australia.
Marie Stopes International set up a private pharmaceutical company – MS Health – and made an application to the TGA to import the drug.
"Mifepristone and misoprostol are prescription medications and will only be available on prescription from qualified general practitioners," a spokeswoman for Marie Stopes International said.
"The prescribing doctor must ensure that consent and treatment of the patient is in accordance with the appropriate state or territory legislation."
Marie Stopes is now considering whether to apply to the Pharmaceutical Benefits Advisory Committee to have mifepristone and misoprostol listed on the Pharmaceutical Benefits Scheme.
"Affordable and accessible choices in sexual and reproductive healthcare for all women is central to Marie Stopes International's global objectives," the spokeswoman said.
"Registration is a significant step towards greater equity of choice and access in pregnancy termination and we will be considering the option of a PBS application in due course."