Kelly Hoare (Charlton, Australian Labor Party) Share this | Hansard source

I rise today to support the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 in its unamended form. In doing so, I congratulate the co-sponsors of the bill, Senators Claire Moore, Lyn Allison, Judith Troeth and Fiona Nash. I also congratulate the member for Moore, Mal Washer, for introducing the bill into the House yesterday.

This is a debate about process. It is a debate about whether any application for the drug RU486 to be imported into and registered within Australia should be considered by the TGA or whether we should continue to allow for ministerial responsibility for approval. Currently, the drug RU486 can be imported into Australia only for research and clinical use with the permission of both the TGA and the Minister for Health and Ageing, who is required to notify the parliament of his or her decision. This restriction has imposed an effective ban on the drug. There are many contentious drugs and drug uses for which the government allows and indeed promotes the use of the TGA as the appropriate agent for oversight. The TGA is, after all, charged with risk management connected to pharmaceuticals.

There are a number of drugs that are used in Australia as abortifacients, as well as others that have abortifacient effects, which the TGA has registered and now monitors. Indeed, the TGA currently lists around 55 drugs or categories of drugs that either cause or are suspected to have caused or may be expected to cause an increased incidence of human foetal malformations or irreversible damage or have a high risk of causing permanent damage to the foetus. These include the antimalarial Quinine, several vaccinations, numerous antiepileptics and the mental illness treatment lithium salts.

It is also important to remember that not only is RU486 designed or capable of inducing abortion; its antiprogesterone action may allow it to improve and save the lives of seriously ill Australians. RU486 is indicated as therapy in a variety of serious and, in some cases, life-threatening medical conditions. As the member for Maranoa just indicated, these include inoperable meningiomas, Cushing’s syndrome, breast and prostate cancer, glaucoma, depression, endometriosis and uterine fibroids. In addition, the drug has shown promise in the treatment of HIV-AIDS, dementia and progesterone dependent uterine and ovarian cancer.

We are all entitled to our beliefs and opinions, but medical decisions should be made on the basis of rigorous and up-to-date medical advice. Who better to evaluate the medical evidence than the Therapeutic Goods Administration? A recent research note by the federal Parliamentary Library service says that the current debate over RU486 is essentially over questions of risk management and that management of the risks associated with medicines is an explicit function of the TGA. The government should step back and let the TGA do its job. The TGA is regarded by the government as being qualified to manage the risks associated with any therapeutic good that is used, or is proposed for use, in Australia.  From this, one could reasonably assume that it is also qualified to manage the risks associated with abortifacients such as RU486.

RU486, like every other pharmaceutical, should be dealt with by independent medical experts at the TGA who can be relied on to make decisions about safety in an unbiased and knowledgeable way. Such decisions should not be made on the basis of the personal beliefs of a minister for health or of a parliamentary secretary for health. I agree with the coordinator of Children by Choice, Cait Calcutt, when she stated:

Women have waited nearly a decade for politicians to decide that politics has no place in medicine and that the TGA, not the clearly-biased Health Minister, should decide whether RU 486 is safe and effective. It’s unfair to ask them to wait any longer.

In 1996 this parliament made a decision based on the facts and information before it that the approval process for the drug RU486 be removed from the TGA and be placed solely in the hands of a single politician—the minister for health. If I had been here at that time, I would not have voted for this change. Indeed, if approval for RU486 had remained in the hands of the medical experts, it is quite likely that at that time it might not have been approved. There had not been the research or the experience which would have allowed the approval.

However, as research continues and trials are conducted, many new drugs have their safety and efficacy investigated, tested and proven. This has led to many countries around the world and the World Health Organisation approving RU486 to be used as an abortifacient, widening the choice for women who, for whatever reason and in whatever circumstances, require an abortion. In July 2005 the World Health Organisation placed RU486 on its list of essential medicines and described abortion by either surgical or medical means as ‘one of the safest medical procedures’. Women in over 30 countries including the UK, the United States, much of western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia have access to this drug, but not Australian women.

The so-called Harradine amendments to the Therapeutic Goods Act in 1996, supported by the parliament, have effectively banned the drug in this country for the last 10 years even though, with the research work going on around the world to ascertain its safety and with the WHO listing, the safety and efficacy of RU486 has obviously been confirmed. At that time there was much political sensitivity surrounding abortion in this country. However, now abortion is legal in all Australian states and territories. If abortion is legal, don’t regional, rural and urban Australian women deserve the right to choose the most effective option for themselves—a decision which should be made between a woman and her doctor?

Although this is supposed to be a debate about process, it has also developed as a debate about abortion and the safety of RU486, so I will now turn my remarks to that. The evidence clearly and overwhelmingly shows that RU486 is safe and effective. Indeed, many Australian, international and world health bodies support the availability of RU486 to all women. These organisations include the World Health Organisation, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Public Health Association of Australia, the AMA, the American Association for the Advancement of Science, the US Federal Drug Administration and the Rural Doctors of Australia, just to name a few.

Although some members are concerned about the political sensitivity of the issue of abortion in their electorates, a recent survey conducted in January this year by Newspoll and commissioned by the Australian Reproductive Health Alliance showed that 68 per cent of Australians are in favour of RU486 being made available to qualified medical practitioners in order to terminate a pregnancy. Some in this debate, including the member for Lindsay in moving her amendments to this bill, have emphasised that as elected representatives we have a responsibility to make these decisions on behalf of our constituents. We do have a responsibility to represent our constituents here, and that is what we all do with dedication, passion and commitment and to the best of our ability. But we do not have a right to make these decisions without the medical expertise and without personally knowing what leads a particular woman to choose to have an abortion. As the member for Moore stated, he does not have the expertise to make these decisions, and he is a qualified, experienced and very good doctor. The current minister for health is not, nor could we anticipate that future ministers would be.

We have heard in this debate personal stories. I have received correspondence and phone calls from women relating their own personal experiences. As parliamentarians, we have no right to decide what is best for women who require an abortion. That is a matter between them, their families and their doctors. It is the woman’s choice. We also do not have the right to deny them and their doctor access to the most effective and safe means. We do have the responsibility to ensure that when there is an application to import RU486 for use as an abortifacient there is the most rigorous investigation by the medical experts within the Therapeutic Goods Administration.

Before I conclude, I want to turn to the amendments proposed by the members for Lindsay and Bowman and to encourage members who, in good conscience, were considering supporting this bill because of all the reasons related in this debate to do so—and I include in that the member for Maranoa, who has just spoken. If either amendment is passed by the House of Representatives, the choice for Australian women will effectively remain where it is today. Both amendments allow for further and continuous parliamentary debate on the issue of abortion, because they both indicate a further level of approval by the parliament. This is a debate we had over 30 years ago, which was settled with states allowing women to have an abortion if they so choose. Also, there has been no application for approval of RU486 because of these procedures. The procedures proposed would be too lengthy, costly and uncertain for manufacturers to go through, thus still denying Australian women this choice.

Further, it has been advised that, if the amendments proposed by the member for Lindsay were to succeed, they will negative the second reading of the bill. She understands this and has since laid out her intention. Also, if members are considering either of the amendments, they need to be aware that if the Kelly amendments are carried, it will be the end of the bill and the Laming amendments will not proceed. So I encourage all members considering supporting this bill to do so, because, if they are considering supporting the amendments for a so-called compromise, this bill will fail.

In conclusion, I reiterate that I am pro choice—that is, I respect and agree with a woman’s right to choose an abortion in consultation with her doctor. That is her decision and hers alone. It is not a matter for any politician of any political persuasion or faith—or, indeed, of no faith. Australian women currently have the right to choose an abortion but not the method. They should have that right and will have that right only if the TGA has the responsibility for proving or not proving the safety and efficacy of the use of RU486 as an abortifacient. I reject the amendments and support the bill.

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