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Thursday, 9 February 2006
Page: 35


Senator CAROL BROWN (11:07 AM) —I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Firstly, I would like to put on record my congratulations to the sponsoring senators for articulating the case for change in a clear, reasonable and considered manner. National Party Senator Fiona Nash, Liberal Party Senator Judith Troeth, Democrat leader Senator Lyn Allison and our own Senator Claire Moore should be applauded for carrying much of the burden for tackling an issue which was always going to be controversial and polarise people, regardless of the bill’s intent being about approval processes.

I respect the right to a conscience vote on issues of personal or moral conviction and I respect other members and senators for their position. However, having said that, I do not believe we are the ones to make decisions about the technical arguments surrounding medical drugs. This bill proposes to amend the Therapeutics Goods Act 1989 to make it possible to evaluate, register, list or import abortifacients such as RU486 for use in Australia without the approval of the Minister for Health and Ageing by removing the restricted goods provision from the act. The Senate Community Affairs Legislation Committee reported on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 and described the approval process as follows:

In 1996 amendments to the Therapeutic Goods Act were passed that placed medications such as RU486 in a special group of drugs known as ‘restricted goods’. According to the 1996 amendments restricted goods cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health and Ageing. In addition, any such written approval must be laid before each House of the Parliament by the Minister within 5 sitting days of being given.

The restricted goods provision of the act applies exclusively to medicines intended to induce abortion. Medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration, TGA, without any requirement for approval from the Minister for Health and Ageing.

There has been a concerted effort by some to make this debate about abortion, despite the fact that the decision on abortion has already been made in Australia. The fact is that abortion is currently available and regulated tightly by the states and territories in this country. Over 81 per cent of Australians support a woman’s right to choose when it comes to terminations. The right of a woman to have choices at what is a stressful and critical time is essential. Despite my personal conviction that it is the right of the woman to choose on abortion, it should be remembered that terminations, whether obtained medically or surgically, require professional medical oversight and approval and must satisfy all conditions required by law. This would apply equally to surgical or medical terminations. That aside, it is the approval process for medical drugs that this bill is concerned with. I would like to quote in part from a letter I received from the Uniting Church. It said:

It is our view that the current campaign against RU486 confuses medical, moral and political issues. As the Uniting Church understands it, the issue is whether or not this particular drug is safe to be released for use in a country where abortion is legally available. This is a decision that should be made by the Therapeutic Goods Administration using sound medical evidence and advice.

RU486 is the common name for the drug mifepristone, a synthetic steroid that can be used to treat a variety of conditions, such as Cushing’s syndrome, breast and prostate cancer, glaucoma, depression and others. It also can be used, as we have heard, to induce what is known as a medical abortion, an alternative method to a surgical termination of pregnancy. RU486 has been approved for use in 35 countries, including the United States, the United Kingdom, China, Israel and New Zealand. We have a clear choice in this chamber. We can trust the Therapeutic Goods Administration and its expert committee, the Australian Drug Evaluation Committee, ADEC, whose role, as explained on its website, is to provide advice on:

... the quality, risk-benefit, effectiveness and access ... of any drug referred to it for evaluation;

medical and scientific evaluations of applications for registration of prescription drugs ...

The ADEC has a core membership and expertise comprising three eminent medical practitioners with at least two specialists in clinical medicine, and one member must be a pharmacologist or hold a degree in science specialising in pharmaceutical science. The ADEC is an expert committee in an expert body. Its associate members must include at least one pharmaceutical chemist with recent manufacturing experience in therapeutic goods, at least one toxicologist and a medical practitioner in general practice. All associate members have specialist qualifications and experience in fields of medicine complementary to that of the core membership of the ADEC.

As I have said, we can trust this body to assess rigorous science or we can trust the Minister for Health and Ageing, Mr Abbott, who, as far as I am aware, does not have any professional medical training but who, it seems, believes that he should be making technical medical decisions for all Australians for these drugs. Faced with this choice, for me it is a no-brainer. As a parliamentary research paper on this bill states:

Under current arrangements, the Minister is simply required to notify the Parliament of a decision to approve an application for evaluation by the TGA. Given the fact that such a decision would not be disallowable by the Parliament, this does not amount to a significant level of parliamentary scrutiny. Further, the Minister is not required to table decisions not to approve such applications, meaning that the Parliament is neither necessarily informed of these, nor does it have the capacity for any oversight of such decisions.

Aside from being technically flawed, this definition of parliamentary accountability is flawed. It is totally inadequate. We never get to see what passes the minister’s desk. It is the TGA that makes decisions on the safety and effectiveness of all other drugs—as it has on almost 50,000 other drugs in Australia—and it is the TGA that should make the decision based on evidence it assesses on RU486.

This bill only seeks to subject RU486 to the same rigorous assessment that every other medical drug in this country goes through. This expert assessment is based on medical evidence and delivers a considered judgment about the risk/benefit of the drug, free of political interference. Whilst supporting this bill I would also like to support the Community Affairs Legislation Committee’s sole recommendation, which states:

The Committee recommends that increased financial support be provided to improve sex education, including better education on responsible human relationships; wider availability of information about and access to contraception and other fertility control techniques; ensure independent professional counselling for women considering a termination of pregnancy, counselling post termination and counselling for relinquishing mothers as required; greater social support for women who choose to continue with their pregnancy; and increasing the availability and affordability of child care.

That is something that I am sure we can all agree on.