Sharman Stone (Murray, Liberal Party, Minister for Workforce Participation) Share this | Hansard source

I rise to very strongly support the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Since the Harradine amendment of 1996, no pharmaceutical company has applied for approval for the trialling, supply or distribution of the now restricted RU486. Clearly, after 1996, pharmaceutical companies anticipated that a very costly application for consideration of the safety and efficacy of RU486 would simply not succeed. Consequently, since 1996, Australian doctors have not had the option of recommending a medical rather than a surgical abortion for their patients. So, despite pregnancy terminations being lawful in all states and territories, medical terminations are effectively banned. This surprises the international medical fraternity, who are used to Australia being a world leader or early adopter of best medical practice.

I argue that it is totally unacceptable to have, effectively, a ban on medical abortions in a developed country like ours, where doctors and their patients should expect to have access to the safest medical procedures for a lawful procedure. It is 10 years now since the 1996 Harradine amendments. It is now imperative that we remove the roadblocks that are dissuading pharmaceutical companies from applying to have RU486 evaluated properly.

RU486 has, in those 10 years, become well established as a very safe, non-surgical option for women requiring an abortion. As many other speakers have said, in over 30 countries including France, where the drug was developed, New Zealand, the UK, the USA, Israel, China, Sweden—in all of those countries—the women can expect, when they go to their doctor, to have an alternative to surgical abortions if that is what best suits their condition.

Medical research carried out in these countries and more than one million episodes of the drug’s use have found that the drug avoids surgical and anaesthetic risks and is as safe as surgical abortions, which are very safe indeed. However, unlike surgical procedures, this drug can be used from the earliest stages of pregnancy, and usually that is the preferred process if an abortion is needed—as early as possible. As well, in no country has the use of RU486 led to an increase in the number of abortions performed.

It is important to note that the drug RU486, or mifepristone, is not an over-the-counter product. This is not like the so-called morning-after pill, which has a different but still very important function. RU486 can only be prescribed and its use supervised by a doctor. Protocols for the drug’s use requiring close medical supervision have been mandated in all countries where it is used. You would not expect any doctor, rural or urban based, who was not intending to closely supervise this drug’s use to prescribe it.

The World Health Organisation has now designated RU486 as an essential drug for developing countries. The Royal College of Obstetricians and Gynaecologists in the United Kingdom recommends non-surgical in preference to surgical abortions for women with pregnancies of 49 days or less. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, our most eminent body of specialists; the National Association of Specialist Obstetricians and Gynaecologists; the Australian College of Rural and Remote Medicine; the Australian Medical Association; and the Public Health Association of Australia are all amongst those who ask that RU486 be allowed to go through for evaluation by the TGA, the eminent and evidence based specialist body that assesses all drugs in Australia. And of course they hope that, after that process, there will be an approval for this drug so that they can prescribe it where it is the best option for their patients. RU486 now has at least a 10-year history in its use internationally, and its history is of a safe and effective, non-surgical option for doctors to prescribe—not that those of us in this House who support the bill are trying to call the safety of this drug; we say that it should go to the TGA for its expert assessment.

The further major development since 1996 is that, while the Australian government supports the concept that comprehensive, affordable and confidential reproductive health services should be reasonably available to all Australians, the 1996 Harradine amendment has effectively banned RU486. This has meant that rural women terminating a pregnancy often have a much more traumatic, costly and delayed abortion because surgical procedures are too often no longer locally available to them. In fact, rural communities’ access to any reproductive health related medical procedures—for example, the implantation or removal of a contraceptive under the skin, the insertion of an IUD, a vasectomy or indeed a pregnancy termination—is today far less likely to be available in a rural medical clinic or country hospital than in a capital city.

It is a different world beyond the tram tracks, and I am not just talking about the smallest country towns, where access to medical procedures is limited or nonexistent. For example, none of the doctors, specialist gynaecologists or obstetricians in the city of Bendigo, which has a population of over 100,000, will carry out a surgical pregnancy termination. I am told that no terminations are carried out in my electorate, which includes two rural cities and 50 towns. Rural doctors who recommend or support a pregnancy termination direct their patients to find an abortion clinic in a capital city. That could be a seven-hour drive away. It is a serious issue for a person who is experiencing the trauma of having to think about an abortion to be told they must find their own way to an abortion clinic in the city. They are warned by the doctors or the nurses in their rural clinic that there will probably be protestors waiting to photograph them as they enter the city clinic and they will be abused by the placard-carrying protestors who are rostered on, typically day and night, outside these abortion clinics in the capital cities.

The patient will need private or public transport to the clinic and an overnight stay. Many country women I know have simply slept in a car; they could not afford the accommodation. A rural teenager with little support or a low-income woman or someone from a minority culture who is urgently in need of anonymity find it very hard to make the complex, costly arrangements of finding their way to a city abortion clinic, which typically delays the timing of their terminations by many weeks, causing additional trauma and distress.

Some rural doctors tell me that they do not carry out surgical abortions because of their own faith. I respect a doctor’s right to decide not to carry out an abortion and would expect they would refer their patients to others. However, the majority of doctors do not carry out surgical abortions in rural areas because they no longer perform any surgical procedures of any description. There is a whole range of reasons for that, including their insurance policies, their own experience and their access to hospitals that support their procedures. These doctors believe that the ability to prescribe a drug such as RU486 for their patients is a very important medical option for them. They talk about being better able to guarantee their patients’ anonymity and about it being a safe, more manageable and affordable outcome for their rural women patients. They know the difficulties and the stresses of having to find your way to a city clinic.

These country doctors would prescribe and supervise the drug’s use, of course. Should an emergency arise, their patients would have the same hospital emergency access as any other patient. Rural doctor organisations and specialists have made these same points over and over again, in particular in their submissions to the Senate inquiry into this matter. Doctors in at least three regional women’s health clinics—in Albury, Mildura and Cairns—have now applied to be individual authorised prescribers of RU486. One of these applications has already been in the system for three months. This gynaecologist applicant was told she would have an outcome in several weeks; it has already been three months. Obviously these rural gynaecologists, obstetricians and GPs are saying, ‘Please, can we remedy this current ban on medical abortions in Australia.’ Their patients deserve better.

Like most Australians, I am concerned that too many women—especially teenagers—find themselves in the traumatic situation of needing to terminate a pregnancy. We urgently need to address all of the factors that lead to an unwanted pregnancy, but that in no way negates the need to assist women who are in need right now and have a right to the best possible medical care. On the basis of the impact on rural women alone, I believe we need to repeal the amendment that has effectively blocked access to RU486 in Australia for the last 10 years. Of course, there were no references to rural population consequences during the 1996 debate. Perhaps they were not foreshadowed. Instead, several other arguments were advanced by those supporting Senator Harradine. The first argument was that the drug RU486 had unique characteristics, being an abortifacient. It was then claimed that, because of its special properties, decisions about access to this drug—or even whether it should be trialled—should be made by the minister of the day and not by the expert and independent TGA, which makes such decisions on all other drugs in Australia. Of course, the TGA consults the Australian Drug Evaluation Committee, another panel of experts.

This argument was and continues to be quite spurious. The fact is that the termination of a woman’s pregnancy by properly qualified medical practitioners is legal in all Australian states and territories, according to each jurisdiction’s psycho-social and medical criteria. It is therefore quite inappropriate for anyone to suggest that we should be re-debating the social policy which delivered lawful abortions to all Australian states and territories 30 or so years ago. This issue is, instead, about who is best equipped to assess the safest and best drug alternatives for a lawful medical situation. Quite obviously I believe the task of drug evaluation is best entrusted to the TGA.

The second argument in the 1996 debate was that the drug was so unsafe, as well as being an abortifacient, that its introduction to Australia required extra scrutiny and transparency. Thus supporters of Senator Harradine contended that the new process for evaluation of RU486 would become more effective, transparent and accountable. It became ‘restricted’ and the minister’s unilateral discretion replaced the expert, evidence based TGA process.

The Harradine amendments did not provide any extra levels of efficacy, scrutiny or transparency; in fact, the opposite is the case. The Harradine 1996 TGA Act amendment does not require the minister to notify the parliament or to justify why he might deny a request for a trial, evaluation or monitoring by the TGA. No guidance is given as to the criteria the minister should use or may use in coming to his or her decision on the request. There is therefore no added layer of evidence based scrutiny at all as a result of the Harradine amendment. The opposite effect has been realised and the message has gone out to pharmaceutical companies, ‘Do not bother further with this drug in Australia.’

I will comment on the two amendments submitted or foreshadowed by the honourable members for Bowman and Lindsay respectively. These amendments do not add extra levels of scrutiny to the evaluation of any abortifacient drugs, although that appears to be the stated intention of these amendments. Instead their amendments would either have the minister of the day continuing to make a unilateral decision or place the drug before the parliament for a disallowable period. If only one member brought on a debate to have the drug considered, we would have a re-debate of this issue just as we are doing today.

In these new debates, which would happen again and again—we have to anticipate at least three new debates because we have three applications already before the TGA—we would see the arguments re-run, as we are seeing today, in both the Senate and the House of Representatives. Again, much of the debate would be focused on an anti-abortion stance. This is irrelevant to the issue addressed in the main bill that we are debating today.

Abortion is lawful in Australia. Its legality was settled 30 years ago. We are not redebating that issue. Therefore, I strongly reject the Kelly and Laming amendments. They are simply perpetuating the status quo, which effectively produces a ban on RU486. I therefore strongly support the bill as already tabled. I wish very much to remove the minister’s unilateral discretion and have any applications for the consideration of the use of RU486 or any other abortifacient put before the scrutiny of the TGA.

Let me finally say why I think it is very objectionable that the TGA should be described as faceless men or petty bureaucrats. The TGA has been established to scientifically evaluate and monitor all legal drug access and use in Australia. It is a World Health Organisation collaborating centre, a designation which can only be achieved after consideration of the scientific and technical standing of the institution at the national and international levels, with particular reference to its recent records of achievement and its ongoing activities. The World Health Organisation has assessed the TGA and said it is of international standing and should therefore be a collaborating centre. The TGA, like Biosecurity Australia, is an internationally respected body capable of expert, independent, evidence based evaluation.

I repeat that there is a great deal of distress and trauma in the Australian society as a result of the current outcomes of the Harradine amendments of 1996. We are a developed country. Our Australian women deserve better than what they are able to access today. I am hoping very much that this bill will be supported by all of those in this House, because quite frankly our Australian women deserve better.

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