Helen Polley (Tasmania, Australian Labor Party) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Before I proceed much further I want to acknowledge the thousands of submissions received from many individuals and organisations. They are submissions that clearly indicate that this piece of legislation and its potential ramifications lies close to the heart of many Australians—so much so that they felt strongly inclined to put pen to paper to voice their concerns. I also acknowledge that when legislation is presented in this chamber for debate an open mind is required, a mind that pushes personal beliefs aside and listens to the arguments both for and against. I can stand here with a clear conscience, knowing that I have given the legislation my best and fairest judgment. Sometimes one wonders, when legislation such as this is presented, why it has been rushed through, and I refer particularly to the limited time the Senate Community Affairs Legislation Committee had to study submissions, attend hearings and draw conclusions.

Let us get one thing very clear here: RU486 is not a simple drug like paracetamol. This drug will expel human life, and its consequences on the health of women are varied and dependent upon constant medical supervision. The question that springs to my mind is: why are we considering allowing the TGA to make a decision about a drug that kills? The TGA’s role is to assess therapeutic goods. A therapeutic good is a good that is to be taken for therapeutic use. Is RU486 for therapeutic use? It is clear that it is not.

The term ‘therapeutic’ should not be bandied about loosely. It refers specifically to goods that are given to remediate or prevent illness. They provide a cure and promote wellbeing. The following description of ‘therapeutic’ comes directly from the TGA’s website:

... “therapeutic use” means use in or in connection with: preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons ... influencing, inhibiting or modifying a physiological process ...

It may be argued that RU486 fits this category. However, RU486 does not have a positive health benefit for the women who use it. The description of ‘therapeutic’ continues:

... testing the susceptibility of persons ... to a disease or ailment; or influencing, controlling or preventing conception in persons; or testing for pregnancy in persons; or the replacement or modification of parts of the anatomy ...

These are a few of the definitions of therapeutic use, and RU486 does not fall into any of the categories that are used for defining the role of the TGA.

While the TGA regulates all drugs in Australia, its authority specifically only relates to the safety, efficacy and quality of a drug. It is expert at dealing with raw data. However, as an unelected body it is not appropriate for it to make decisions about goods that have a social or a moral dimension. In its regulatory role the TGA only has to consider drugs on a technical basis. It does not have to address the moral and ethical issues associated with RU486. Let us not kid ourselves here: no matter which way you analyse it, no matter what technical terms you apply, whether you call it a foetus or an embryo or, as I do, a baby, at the end of the day this drug is designed to terminate the life of a child—at what cost?

You may be thinking at this point that I am taking the moral high ground and that I am making judgements about pro-abortion or pro-choice. However, at this time I am focused upon the health of Australian women. RU486 requires constant or close medical supervision during its administration and for up to five days after it has been taken. The level of medical supervision is paramount to ensuring that the drug effectively terminates the pregnancy. However—as I have discovered through discussions with medical practitioners and through evidence given during our hearings—while in principle it is a simple process, the reality is that the foetus is not always expelled the way it is supposed to be. This drug has, in some instances, resulted in serious infections in the women who have used it, and the effects could include losing a fallopian tube, endometriosis, and—in some very extreme cases reported in the United States—death. It is as simple as that.

RU486 is not a medicine; it is a drug with potentially serious side effects. The definition of ‘medicine’, from the dictionary, is ‘an agent, such as a drug, used to treat disease or injury’. Pregnancy is not a disease, nor is it an injury. RU486 is designed to disrupt an entirely healthy pregnancy. RU486 is a drug with potentially serious side effects. By allowing the TGA the authority to decide its use we would be effectively allowing them to facilitate the violation of human rights rather than to limit such violations.

The competence of the TGA is restricted to assessing medicines on medical grounds. Leaving out the cruel human rights considerations raised by RU486, the faceless public servants of the TGA should not make the decision. RU486 is not comparable with any other drug that may be considered by the TGA. It is a drug that ends life and has the potential to harm another. Is that safe? Is that effective? Is that quality? This is not merely a medical matter and therefore the decision regarding the use of RU486 should not be left to the TGA. This is a unique drug, a drug that should be in a category all of its own, a drug that cannot be grouped with other drugs or even considered broadly in the same context as any other drug.

Many people have voiced their concerns about this bill, and I am sure I am not the only one who has received correspondence from concerned constituents. Let me read an extract from the submission from the Catholic Women’s League of Tasmania:

Induced abortion using RU486 has features not met in surgical abortion. The apparent simplicity when compared to a surgical abortion is likely to result in those close to the women regarding it as a relatively trivial event. The process has particular psychological risks. Abortions performed using RU486 can be very stressful because time elapses as the baby dies and is then expelled by the actions of prostaglandin misoprostol. The process is prolonged and painful. The expulsion is a traumatic experience. It can occur unexpectedly at home...at work or in a public place...and then...how to dispose of it?

Please let me reiterate that my comments here today are not about condemning those who are pro-choice or pro-abortion. Even with my conservative views I am the first to admit that there are times when a mother’s life needs to be saved and there are some circumstances when an abortion is in the woman’s best interests. My main concern is the health of women. Put the ideological views aside and let us make decisions that are in the best interests of the health of Australian women and our society.

Let us also make a decision based upon the medical services that are required for monitoring the women who use the RU486 pill. Bear in mind that many Australians do not have the privilege of living close to hospitals and medical practitioners. Obviously I am concerned for Tasmanian women and those who live in some of Australia’s remotest communities and/or are disadvantaged in some way. Picture a woman who lives in a rural community who has been offered RU486 and is requested to stay close to, or in regular contact with, her doctor. How practical is this for a woman who has other young children look after, who does not have transport and who is perhaps not used to regularly contacting her doctor? What happens when complications occur and the expulsion of the baby does not quite go to plan? Or alternatively, from the perspective of a busy medical practice, what happens if the doctor who prescribes the drug forgets to remain in contact with the patient? Doctors are only human and it is known to have happened in other circumstances affecting women. And patient workloads are getting increasingly heavier. Is it fair to lumber GPs with the increased responsibility of the close monitoring of a patient to ensure all goes to plan?

Given that scenario, this drug seems a bit hit and miss. There are too many variables, too many risks and not enough guarantees for the safety of women. Many rural and isolated women do not have ready access to emergency facilities and the time delay in getting the appropriate help could be very serious and even fatal. The supposed ‘benefits’ for rural women should be dismissed.

If you think I am dramatising the side effects of RU486, consider this: the US Food and Drug Administration have registered over 600 reported adverse reactions to RU486. Reporting adverse reactions is not mandatory and estimates are that only about 10 per cent are reported. Five women have died as a direct result of RU486 and the use of RU486 in America is now under review. The US Food and Drug Administration have now issued a warning regarding the serious side effects of the drug. Another factor that requires due consideration is that a surgical procedure will be required in up to 23 per cent of cases of women using RU486 to stop excessive bleeding and to totally complete the abortion. That is almost a quarter of all cases. A quarter of all cases will require a surgical procedure to abort a foetus regardless of the use of RU486 but with even more trauma for women.

Former Senator Brian Harradine presented a background paper to Hansard on 9 May 1996, and I will read a section of that which has particular relevance to the point I am making. He said:

Of critical concern are the short and long term ill-effects on women exposed to RU486. Women taking the drug are advised to live within about 40 kilometres of an abortion clinic. RU486 is promoted as a simple do-it-yourself, private, demedicalised abortion. Yet it requires three or four visits to a specialised medical centre, the taking of up to five hazardous drugs, vaginal ultrasound that all may result in serious complications.

As a mother and grandmother, I dread to think of the implications of allowing such a drug free rein within Australia. I dread to think that this chamber might very well be condemning our daughters to a horrible death or complications that may remove the opportunity for them to ever conceive again.

Former Senator Harradine concludes:

... people on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents raise major public health and public policy issues and should not be left in the hands of bureaucrats and science technologists. There should be ministerial responsibility subject to effective parliamentary scrutiny.

In my view, nothing has changed in the last decade. Further thought should be given to the reason this drug was brought into existence in the first place. Potentially its use as an armoury for the control of population growth attracted the necessary research, promotion and funding required. Developing countries were to be the target for the introduction of RU486. Ninety thousand abortions are performed each year in Australia and if this bill is passed that number has the potential to increase to levels we have never seen before or should wish to see. An increase in the number of abortions will also increase the load on our public hospitals and medical practitioners, and with our health system in the mess that it is in the extra load is definitely not needed.

I have presented a number of arguments which clearly are beyond the criteria of the TGA risk management approach. Will the TGA take the social issues into account? Will they determine the ramifications of increasing abortions in Australia due to the introduction of this drug? Will they make recommendations for increased funding to support services for women who suffer mental anguish and stress post abortion? Will they determine the cost to the health budget for the requirement for increased medical intervention and assistance as a result of RU486? How will they tackle the moral ramifications of RU486?

Let me tell you how they will deal with all of these issues. Put simply, they will not. It is not within their jurisdiction or authority to do so. Again, I ask you today in this chamber: how can we, elected by the people of Australia to represent their views and opinions and to provide unbiased judgment and fair scrutiny, vote for the Therapeutic Goods Administration to allow RU486 to be provided to our daughters? From the thousands of submissions I have read, I note that the absolute majority are against changing the status of RU486. I believe I am reflecting my constituents and the Australian electorate at the moment and for the reasons outlined and, based on the evidence from the hearings and the submissions, I will not be supporting this bill.