Politics v women’s health: RU486 and the TGA saga

A much wider group of Australian women will be able to choose a medical rather than surgical procedure. spaceodissey/Flickr

The Therapeutic Goods Administration (TGA) finally included the abortifacient Mifepristone (also referred to as RU486) on the Australia Register of Therapeutic Goods (ARTG) in August 2012 – after nearly two decades of political opposition and obstruction from anti-choice groups and their parliamentary representatives.

Marie Stopes International Australia (MSI), a sexual and reproductive health agency applied to have the drug registered, triggering the first TGA assessment of the drug’s quality. Research in other countries has found that Mifepristone combined with misoprostol (which is already on the ARTG for other uses) is a safe and effective drug.

Access to this drug will enable more Australian women to choose to have an early medical abortion without surgical intervention and at home – if it is appropriate. Both methods are associated with some risks and adverse effects.

An unfortunate history

Mifepristone was first developed and marketed by the French pharmaceutical company Roussel Uclaf in the 1980s.

In the 1990s, a group of Australian researchers took part in a World Health Organization (WHO) project trialling regimens for medical abortions. In a related survey, they found that a number of women were satisfied with new medical method and concluded that it gave them more control and autonomy. But once information about this research became available to the Australian public, Mifepristone became the subject of heated debate.

This led to the anti-choice former Tasmanian senator Brian Harradine successfully moving an amendment to the Therapeutic Goods Act 1989 (Cwlth) in 1996, giving then-minister for health and ageing, Tony Abbott, the power to reject applications to import and market abortifacient drugs, such as Mifepristone.

Ten years later, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for the approval of RU486) Act 2006 (Cwlth) was passed after a cross-party vote. The legislation removed the ministerial approval requirement. And since 2006, the TGA has granted 187 doctors permission to prescribe Mifepristone under the Authorised Prescribers’ Scheme. But access has been extremely limited because it was not a registered medicine with the TGA.

Risky pathways

Mifepristone is available in many countries and plays an important role in women’s health internationally. It’s widely used in countries such as China, New Zealand, the United States, Canada, the United Kingdom, Vietnam and most Western European countries. In some places, it’s available over the counter.

As result of the de facto ban in Australia some women have taken the risky path of obtaining the medication via the internet or from contacts overseas. In the first Queensland case where a woman was charged with procuring her own abortion, the police found blister packs that had contained Mifepristone and misoprostol in the accused woman’s home. There was evidence that her partner’s sister had sent the tablets from Russia through the regular postal system.

It’s not possible to gauge the extent of the “blackmarket” traffic of these drugs, but it’s reminiscent of the days when unwillingly pregnant women sought assistance from backyard abortionists.

The new scheme will not be implemented until 2013 when there are adequate supplies of Mifepristone available. Marie Stopes is planning to provide training programs online or directly to health professionals and prescribing practitioners. Practitioners with a fellowship of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) or a diploma of the RANZCOG can register without training. Pharmacists will also be required to complete the training.

A last step

Once this scheme is implemented, a much wider group of women, including those living in regional and remote areas, will be able to choose a medical alternative to a surgical procedure. But this choice will be less feasible if medical terminations are not subsided by the government in the same way surgical terminations are.

The cost of Mifepristone is a commercial decision of Marie Stopes International. In order to be included in the Pharmaceutical Benefits Scheme (PBS), Marie Stopes is required to make an application to the Pharmaceutical Benefits Advisory Committee (PBAC) requesting the committee submit a positive recommendation to the minister for health and ageing. The minister will decide whether Mifepristone should be listed on the PBS and press reports suggest Minister Tanya Pilbersek would be supportive.

Now that abortion has been de-criminalised in Victoria, there are no legal concerns about doctors prescribing Mifepristone or women taking the drug. And since the Queensland District Court ruled that Mifepristone was not a noxious substance in the case discussed above, it’s unlikely that courts in other states would decide that prescribing or taking Mifepristone is a criminal offence

The leader of the Opposition, Tony Abbott, has chosen not to comment on these recent developments.