Louise Markus (Greenway, Liberal Party) Share this | Hansard source

I rise today to make my contribution to the very important issue of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 that is before the chamber today. I acknowledge from the outset that this is a complex and difficult issue that requires careful consideration. There are several issues that we need to consider today, not only the medical implications of the drug RU486 but also the principle that important decisions affecting the community should be made by those people who are directly accountable to the community.

I want to state from the outset that I support the amendment proposed by the member for Lindsay. The amendment strikes a balance between recommendation from the Therapeutic Goods Administration and parliamentary and ministerial accountability. This is a debate of many discrete parts and is about the process of approving abortifacients. People have offered many reasons as to why this drug should be considered differently from those drugs which ordinarily come before the Therapeutic Goods Administration. RU486 is an abortifacient, provoking reaction from all corners of the debate and ought not to be regarded as ‘ordinary’. It was for this reason that in 1996 the drug was moved into the hands of the health minister.

I would like to quickly examine the facts behind RU486. The drug mifepristone is a synthetic steroid that induces medical abortion and is an alternative to surgical termination. It works by blocking the transmission in the body of progesterone, a drug that is crucial to the progression of pregnancy. The uterine lining breaks down, making it impossible for the uterus to hold the foetus. The administration of the drug occurs in two phases. An initial dosage is administered, followed two days later by a course of prostaglandin. This causes the uterus to contract and expel the foetus within hours.

It is commonly administered during the first nine weeks of pregnancy but also within the second trimester and even then in conjunction with prostaglandin. RU486 can lead to serious side effects for those women who choose to end their pregnancy in this way. Women can experience internal bleeding and infection as a result of the retained parts of the foetus within the uterus. These women require urgent medical attention. In those cases where the use of RU486 has not worked, urgent surgical care and completion is required. In other cases, the mother experiences severe complications that can lead to death.

Currently, RU486 falls under a category of drug known as restricted goods—generally abortifacients—within the Therapeutic Goods Act. These goods must have the written approval of the health minister for evaluation, registration, listing and importation. Restricted goods provisions were introduced in 1996 and supported by both sides of the chamber. The amendments were based on the philosophy that the minister for health ought to be ultimately accountable for decisions in relation to the evaluation, registration, listing and importation of abortifacients because they are a special category of drugs which require additional public scrutiny. More than this, the Senate at the time recognised the health risks of the drug for women, including the damage to the long-term reproductive health of women and the risk of fatality. I agree with the position put forward by others that, in a case such as that of RU486, a sensitive community issue, it is not sufficient to assess only scientific criteria.

So now the situation remains that, should a sponsor wish to introduce RU486 into Australia, they must obtain written consent from the Minister for Health and Ageing before progressing to the Therapeutic Goods Administration. The Nash-Moore-Allison-Troeth bill which was debated and passed in the Senate last week seeks to remove the role of the minister from the approval process. Instead approval for the registration, listing and importation of the drug would rest with the TGA.

Firstly, I believe that this proposition removes ministerial accountability from the equation. I agree with the commitment of the Prime Minister and the Minister for Health and Ageing to ministerial accountability. Australia is an elected democracy based on an amalgam of responsible government and the Westminster system. I believe that we need to respect the office of the minister and the responsibilities and conventions that sit alongside it. Those of us who are privileged to serve our communities through election to parliament bear a grave responsibility. As elected officials, we are charged with making informed decisions on behalf of the nation and we are expected to be accountable for those decisions. In a case such as this, where we are dealing with a procedure inextricably linked to a sensitive community issue, one cannot remove ministerial accountability. We expect ministers to be responsible for making tough and sensitive decisions, and this case should be no different. At the end of the day the Therapeutic Goods Administration, with all its expertise, is not accountable in the same fashion as a minister of the Crown.

One of the reasons given to change the situation is to improve access to such procedures for women in rural and regional Australia. Women in these areas face challenges in gaining access to GPs and medical practitioners. The use of RU486 really does require strict supervision and is administered in many other nations within the context of a clinic. To provide it in any other way would actually present grave risks to any woman who chooses this option in rural Australia.

The amendment of the member for Lindsay strikes a balance between receiving scientific advice from the TGA and honouring the concept of ministerial responsibility. This amendment allows for the provision of RU486 to function as follows. Any sponsor seeking the listing, registration, evaluation or importation of RU486 makes application. The health minister receives written advice from the Therapeutic Goods Administration in relation to the safety and efficacy of the drug. The minister is then required to provide a written statement of reasons as to the approval or refusal to grant the importation. This advice is tabled in each house of parliament by the minister within five sitting days. The approval or refusal is a disallowable legislative instrument, meaning that in the case of grave concern the minister’s advice may be overturned, but only by the parliament. Parliamentary accountability is retained in the final decision.

There are an estimated 73,000 to 91,000 abortions in Australia every year. It seems to me that many feel their only options are to either keep the baby and struggle on—often alone and without support—or seek an abortion. Pregnancy is viewed through a lens, and a number of women feel as though their choices are limited. A third option, to complete the pregnancy and place the child in adoption, is often not encouraged and requires support and services. Last year there were only 70 adoptions across the nation despite the enormous estimated number of abortions. No matter what their age, women need support, advice and assistance for all options.

It is important for me to say that, while abortion is not an option that I would choose for myself, I am not here to judge those women who face enormous challenges. I do believe that women require advice about all options available and that support structures are critical to women being able to make real choices. It is important that we provide women with education on all options open to them, including adoption. In many other debates we focus on the value of humanity and the rights and responsibilities of individuals. I feel it is important to focus for a moment on the potential of the human life within the womb to have a future—a contribution unmeasured and significant, no matter how small or large, to a family, a community, a nation and, potentially, our world. In conclusion, I strongly support the amendment of the member for Lindsay and I do not support the private member’s bill.

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