RU486: time to lift restrictions on medical abortion

Cate Swannell
Med J Aust
Published online: 24 March 2019

STRINGENT rules in Australia are an obstacle to medical abortion across the country, but the time has come to lift restrictions to enable equitable access for all Australian women, according to the authors of a Perspective published today by the Medical Journal of Australia.

The gold standard for medical abortion involves the administration of mifepristone (popularly known as RU486) and misoprostol for both early medical abortion (up to 9 weeks’ gestation) and later medical abortion in hospital.

Professor Caroline de Costa, professor of Obstetrics and Gynaecology at James Cook University in Cairns, and colleagues wrote that availability of mifepristone was blocked from 1996 to 2006 when Senator Brian Harradine’s amendment to the Therapeutic Goods Act of 1989 was supported by then Prime Minister John Howard in exchange for Harradine’s support for the privatisation of Telstra.

“This amendment meant that, for 10 years, Australian women were not only unable to access the drug but they also knew very little about its increasingly wide and safe use overseas,” wrote de Costa and colleagues.

The Harradine amendment was overturned in 2006, but the controversy surrounding the drug in Australia deterred all pharmaceutical companies from manufacturing or promoting mifepristone here. Doctors in private practice could import it via the Authorised Prescriber legislation, and by 2012 more than 80 doctors were doing so.

“The approval for the drug [by the Therapeutic Goods Administration] was finally granted in 2012; however, its registration was accompanied by an onerous risk management plan that placed conditions and restrictions on how the drug would be prescribed and dispensed for medical abortion,” wrote de Costa and colleagues.

“There may have been some justification for all these requirements in 2012, when the drug was (fairly) new in Australian practice. It has now been licensed for more than 6 years and over 100 000 medical abortions have been performed using it.

“There is no good reason why mifepristone, which has minimal side effects and is supplied uniquely as a single tablet, needs to remain indefinitely as a special drug — a status that contributes to the stigmatisation of abortion itself and of the many women who make the decision to terminate a pregnancy.

“The procedure of medical abortion can be easily managed by any medical practitioner, including in rural practice, who routinely cares for women presenting with spontaneous miscarriage. No extra procedural skills are required, provided the practitioner can refer those women needing surgical evacuation of incomplete abortion to an appropriate hospital.

“Medical abortion is now available to women in many parts of Australia, but not all,” they concluded. “Despite the introduction of telemedicine abortion services, these are not available to all women, especially in rural and remote areas, and in particular to Indigenous women, who often present later and have to travel further to access abortion care.

“It is time to make mifepristone and early medical abortion accessible to all Australian women.”

  • Cate Swannell



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