BUREAUCRATIC restrictions on medical abortions are hurting Australian women and it is long past time they were lifted, says a leading women’s health expert and advocate.

Mifepristone, known commonly as RU486, is the drug used to initiate the medical abortion process. It is currently listed by the Therapeutic Goods Administration (TGA) as a special drug. “As such, the doctors who can prescribe it must register with MS Health (the company that sponsors the drug in Australia) and complete a 2–3‐hour online education program or be either Fellows of the Royal Australian College of Obstetricians and Gynaecologists (RANZCOG) or have an advanced diploma from RANZCOG.

An additional hurdle is that mifepristone can only be dispensed by registered pharmacies.

Professor Caroline de Costa AM, chair of Obstetrics and Gynaecology at James Cook University in Cairns, says these hurdles are off-putting for both doctors and pharmacies, with the end result that Australian women may not know about, nor have access to, medical abortion.

“A doctor can start to feel like, ‘well, I don’t have to do this for any other drug I want to prescribe, so this must mean [mifepristone] is difficult and contentious, and I’m not sure I want to put myself through this’,” Professor de Costa says in an exclusive InSight+ podcast.

“These are great challenges that face a doctor, particularly a single doctor in a small town, for example.”

According to Professor de Costa, 1500 GPs nationally have gone through the process to become an authorised prescriber of mifepristone.

“But there are 35 000 who haven’t,” she says.

“This is a drug that should be very suitable for GPs. Being able to provide an early medical abortion for a woman who has been your patient for some time, whom you know and who has made an [informed] decision, who wants to carry out the procedure at home – that should be part of general practice.

“That should be part of the kind of general practice and holistic women’s reproductive health care that we provide in other ways.

“But at the moment, women are being deprived of this possible process.”

Professor de Costa is lead author of a Perspective published by the MJA which details the history of mifepristone in Australia and the consequences of the restrictions on its use.

Senator Brian Harradine made mifepristone completely unavailable to Australian women from 1996 to 2006 via an agreement between himself and then-Prime Minister John Howard. Howard supported the “Harradine Amendment” to ban the import or use of mifepristone in Australia in exchange for Harradine supporting the partial privatisation of Telstra.

“It had nothing to do with women’s health or women’s needs but it succeeded,” Professor de Costa says.

“It meant that not only was mifepristone not available, it also meant women in Australia didn’t know about medical abortion at all.

“Women in many places overseas were learning and had already learned about it by 1996. It was available widely in Europe. It was available by the year 2000 in the United States and in a number of other places, such as Russia and in some north-African countries. But not to Australian women.”

In late 2005 and into 2006, women in Parliament, such as Victorian Senator Lyn Allison and Queensland Senator Claire Moore, as well as medical advocates, including Professor de Costa, and other women fighting for abortion reform, ran a strong campaign. In February 2006, legislation overturning the Harradine Amendment was passed by both Houses.

“However, because it had acquired such notoriety in Australia, there was no drug company prepared to go to the TGA and make an application to import and market it, so that was a problem,” says Professor de Costa.

So, how did an Australian woman, in 2006, access a medical abortion?

Professor de Costa and her colleague, Cairns gynaecologist Dr Michael Carrette, found a loophole that still exists today in the TGA regulations.

“Doctors in private practice can apply to the TGA to import drugs,” she says. “It had nothing specifically to do with abortion, and it is meant for drugs that are available overseas and are known to be safe and effective but are not available in Australia.

“If you want to bring them in and use them in your own private practice this is permitted. It just requires a very large amount of paperwork.

“So, Michael and I decided that we would do this.

“We did not expect to get approval from the TGA, but by going public and saying we are going to apply, we thought it would help the campaign.”

They were “pleasantly surprised when, 6 months later, the TGA approved their application.

“We were able to import it from New Zealand colleagues who had already imported it from France,” says Professor de Costa.

“We began to use it in June of 2006 here in Cairns, but in a very limited way because we were still restricted by Queensland law.”

At the same time, French physician and pharmaceutical manufacturer André Ulmann, in partnership with Marie Stopes International Australia, was applying to the TGA to bring mifepristone to Australia.

In 2012, the TGA approved his application, and MS Health — a separate entity from Marie Stopes International Australia — became the drug’s distributor, because even then no Australian-based pharmaceutical company was prepared to take it on. But to this day, mifepristone is subject to the special drug status described earlier.

“Abortion is still stigmatised,” says Professor de Costa.

“It’s stigmatised in society generally, but also in the medical profession. It occupies a gray area whereas it should be part of mainstream medical care.

“There have been some encouraging events in the past few months – the passage of the Queensland abortion law reform legislation in October 2018 was amazing and very welcome; the recent announcement from Tanya Plibersek that Labor, if elected, would tie federal funding for health in the public sector to the provision of abortion services.

“That is saying clearly that we are normalising this and this is where we want abortion provision to be – within the public sector so that women can access it.”

In the conclusion to their MJA article, Professor de Costa and her colleagues wrote:

“It is time for mifepristone to be relieved of its special status and made available universally for prescription by registered medical practitioners who wish to do so and be likewise supplied by all pharmacies. Medical abortion is now available to women in many parts of Australia, but not all. 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.”


Poll

There is no room for April Fool's jokes in medicine
  • Strongly agree: bah humbug (27%, 23 Votes)
  • Is it 1 April already? (26%, 22 Votes)
  • Strongly disagree: every day is Funny Doctor Day (19%, 16 Votes)
  • Agree: who's got time? (15%, 13 Votes)
  • Disagree: I've got my clown nose on (13%, 11 Votes)

Total Voters: 85

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16 thoughts on “Lifting the lid on mifepristone and medical abortion

  1. Dr Roger McMaster-Fay says:

    OK but what about sex education in schools? and the prevent unwanted pregnancies before they even start. Why doesn’t the massive health bureaucracy in this country wake up to its impressionability to properly educate young Australians?

  2. Anonymous says:

    A timely article. Thankyou Caroline.
    It is not only senators who block access to this medication. Very senior medical people are also implicated.
    There has been a public tertiary hospital whose administration – that is, some of its executive, which included medical people ( and not its pharmacy/ drug utilisation committee), that blocked MS2step from being in the hospital pharmacy and from being used in the family planning/ contraception service. This was well after mifepristone had been PBS listed. ( We risked our jobs and did provide MTOPs anyway – using external pharmacies instead).
    The senior executive claimed it was not for religious reasons, but the decision to block access/provision in the public hospital was clearly meant to lead to reduced services and for the clinical service to provide less that best practice care, and to not offer evidence based options in this field of womens health.
    A change in executive staff members at the hospital resulted in a prompt correction of these anti-best practice and anti-womens’ health practices and medical TOPs are now offered with the medications provided within the hospital.

  3. Kah-Lim Tay says:

    No matter what, unplanned pregnancies are one of those life events that WILL continue to happen to our women . . . . .Mifepristone and early abortion WILL make surgical abortion a thing of the past.

  4. Randal Williams says:

    I don’t see any problem with doctors getting special training to prescribe this drug; when you look it up it has an impressive list of adverse effects , drug interactions and occasional serious allergy. Taking a couple of hours to learn about all this and to manage the medical abortion process would be time well spent in my view.

  5. Dr Michael Pearcy says:

    Speaking for myself I would not prescribe it, because you are taking a human life in the process. Just because it is now legal doesn’t make it right. You can detect a fetal heart beat from 6-7 wks onward, & many medical abortions are done at this stage or later.

  6. Steve sonneveld says:

    Agree will Randall Williams. Knowledge and training worthwhile. Why not do training at racgp conference

  7. Paul Hyland says:

    Mifepristone misoprostol combination costs over $312 but mfepristone in China costs about $5. We urgently need a generic drug to reduce the burden on the Australian taxpayer.

  8. Anonymous says:

    Abortion is stigmatised because many equate it to murder. This article is partisan opinion, and is condescending to those of us who equate conception to the commencement of human life.

  9. Ray Hyslop says:

    For almost three decades Australian women have been denied the same access to RU486 as any PBS listed drug. Caroline is to be heartily congratulated for her ceaseless campaigning over this time.
    Much more can be done in sexually educating our teenagers but human nature being what it is pregnancies will still occur.
    Over the years of preforming terminations in a Public Hospital I worked on the principle that all children should come into this world wanted and loved. Too often they are the result of the inability of people to keep their pants on or as a means of obtaining more taxpayer financial support resulting in many of society’s social problems

  10. Anonymous says:

    The authors say it’s safe, and want it available “in particular to Indigenous women” who often live remote from doctors and pharmacies. Why not, like paracetamol which has caused many deaths, simply make it available at Coles and Woolies?

  11. Dr John Obeid says:

    “It is time to make mifepristone and early medical abortion accessible to all Australian women.” – Yes of course! That’s just what we need – abort ourselves out of existence, steal taxpayers hard earned money, spend it on killing babies in utero, devalue human life even further and undermine all the basic principles that built Western Civilisation in the first place. Good job, keep it up Professor De Costa.

  12. Marcus Aylward says:

    It was a Clinton I think who said that abortion should be “legal, safe and rare”.
    Comments 5 and 8 confirm that there are many who view abortion as more than just another medical procedure dealing with an unwanted scrap of tissue, and it would be unwise to be so dismissive of the philosophical underpinnings of this view.
    Ray Hyslop (#9) says that: “Over the years of preforming terminations in a Public Hospital I worked on the principle that all children should come into this world wanted and loved”. If women were more prepared to give unwanted children up for adoption, this would certainly be the case, and if Ray has a clear interest in the well-being of the child as he shows, then for the child being born is surely more beneficial than not being born.
    The psychological trauma of giving up a child is not necessarily more than the similar trauma of an abortion (surgical or medical). Adoption within Australia has essentially been terminated out of existence.

  13. Anonymous says:

    Unwanted pregnancies can occur at any age for women and men. Education around abstinence does not work. Education in safe sex practices and consent are somewhat effective.
    Ultimately, women have the right to determine what happens to their body. Denying women a safe and non-surgical option is reinforcing toxic attitudes.
    If a health professional does not recognise the agency that their patient holds, one wonders why?

  14. James Acton says:

    The egregiously ignorant moralistic comments all with a hint of misogyny on this post highlight medical practitioners are no different to everyone else, and most certainly should not be held in the high regard they imagine they deserve.

    Accidents happen, women should not be blamed, nor shamed, and must hold bodily autonomy.

  15. Anonymous says:

    babies and children are not the sole property or responsibility of the mother. Fathers are important too. While we give the rights to the mother, the responsibilities, especially financial lie with the father. “toxic attitudes” is a phrase used by people who deride others opinions as different to their own, nothing more. If we want to address suicide, we must 1. appreciate the roles males have in fatherhood, and 2. Stop derision of men with phrases like “toxic attitudes”. Male suicide is an ignored epidemic, and with attitudes like these, its no wonder its growing.

  16. Ray Hyslop says:

    Marcus Aylward (#12)is to be commended for bringing up adoption as an alternative to termination. Until the Whitlam government brought in the well intentioned financial support for MARRIED women who had been deserted by their HUSBANDS, adoption was a safe solution for unwanted pregnancies. Adoption virtually disappeared from the scene when social workers informed unmarried pregnant girls that they had cracked the ” jackpot” and there were all forms of benefits to be had by keeping the child and that having many more was an alternative way of life. The death knell of adoption occurred when there was the “forced adoption hysteria” and the NSW government apology. Sadly, labouring unmarried women were not cared for in the way they should have been by some judgmental midwives. For my first ten years in Liverpool we always had babies in the nursery awaiting adoption by grateful infertile couples. Was this such a bad alternative to what we have now? Women with five or more children from three or more “partners”, often the victims of domestic violence and with no satisfactory male role model to guide the growing family.

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