Abortion pill RU486 approved by TGA

30 Aug 2012, 6:36 pm   -   Source: AAP
(AAP)

(AAP)

All GPs who have completed a training program will be able to prescribe the abortion pill RU486 from later this year.

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The controversial abortion pill RU486 will be widely available in Australia from later this year after the national drug regulator approved its registration.

The drug has been available here since 2006 but only under tight controls.

Doctors had to apply the Therapeutic Goods Administration (TGA) for permission to import the drug from overseas because it wasn't registered. Fewer than 200 GPs have done so.

But now all doctors who've completed a training program conducted by the product's sponsor, sexual health group Marie Stopes, will be able to prescribe the pill.

It can then be purchased from nominated pharmacies.

Federal Health Minister Tanya Plibersek on Thursday welcomed the listing of RU486 and a drug used in conjunction with it called misoprostol.

"The TGA is an independent body and the Australian government has not intervened in the listing process," Ms Plibersek said in a statement.

"(But) 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."

RU486 has been approved for women who are up to seven weeks pregnant.

The medicines regulator says it's been assessed for "efficacy, safety and quality".

"The associated types of risks and complications are similar for both medical and surgical termination of pregnancy," the TGA said.

Packs will contain a highlighted warning that women must visit their GP for a check-up 14 to 21 days after taking RU486.

There's a failure rate of two to seven per cent, slightly higher than for surgical terminations. In Australia there's been one reported RU486-related death in 2010.

The online or face-to-face training program for doctors will include information on counselling, the need for patient consent and details of risks and adverse events.

Marie Stopes expects to commence selling the drug later this year after finalising supply and approved packaging and labelling. The group will consider applying to have the drug listed on the pharmaceutical benefits scheme (PBS) "in due course".

Without a government subsidy, Greens senator Lee Rhiannon believes RU486 could cost up to $500.

"It is important we work to bring the price down so it becomes more accessible," Senator Rhiannon told reporters in Sydney.

The use of the abortion pill has been hotly contested in Australia even though it was first approved in France and China in 1988.

In February 2006 parliament - following a passionate conscience vote - stripped then health minister Tony Abbott of the right to veto the drug and handed regulatory control to the TGA.

Mr Abbott's office on Thursday referred media inquiries to opposition health spokesman Peter Dutton.

His spokesman would only say registration was "a matter for the TGA".

The Australian Christian Lobby condemned Thursday's announcement saying in a statement: "Women facing unsupported pregnancy should be offered real choices by our society, not a dangerous chemical to poison their unborn child."

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