Speeches

THERAPEUTIC GOODS AMENDMENT (REPEAL OF MINISTERIAL RESPONSIBILITY FOR APPROVAL OF RU486) BILL 2005 Second Reading

January 01, 2005

Mr HAYES (Werriwa) (8.50 p.m.)—I know there are many and varied views about the issue of abortion, and it would be unrealistic to think these views can be easily quarantined from the considerations in the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 before us today. From the outset, I should indicate that my personal view and strongly held belief is that life begins at conception. Whether growing up in a Catholic family or being the product of a Catholic education has influenced my view in this regard I am not sure, but I know I hold so deeply to that view that for me not to admit it would amount to gross dishonesty on my part. I accept that among my colleagues and the public there are many who hold equally strong views, but views which are opposed to mine. I respect all these views but, as I believe that life begins at conception and I cannot be persuaded otherwise, I concede that there is no prospect of reconciling these contrary views when it comes to such a critical issue of moral belief.

I recognise that the bill before the House is not about the illegality of abortion. I am aware that some have already raised the issues associated with the criminal codes that apply in the various states and territories. I believe there is little point being pedantic on the legal position of abortion. There is broad acceptance that abortion is both legal and indeed readily accessible throughout Australia. It would be wrong to say that this bill is just about changing the approval process of a particular class of drug. This bill is about parliament relinquishing its responsibility to consider all matters associated with the approval of an abortifacient, including ethical and moral issues—that is, relinquishing the responsibility in favour of the TGA, which in general is an unelected administrative board which is partly funded by the pharmaceutical industry. The truth is that this debate is about abortion and, in particular, the type and extent of access women have to terminations. We would not be having this debate if that were not the case.

The reason why RU486 is a restricted drug and subject to section 23AA of the Therapeutic Goods Act is that its primary intended use is as an abortifacient. As such, for any drug of this type, there are always going to be issues in addition to the scientific and technical evaluations to be considered in any approval process. Abortion will always involve questions as to when life begins; therefore, there will always be issues of a moral, ethical and philosophical nature to be considered. This is why the Therapeutic Goods Amendment Bill was passed in its current form in 1996. It provided legislative support to ensure that drugs such as RU486 were not imported into Australia without the express approval of the minister for health, being a person directly responsible to this parliament. At the time, Senator Harradine aptly summarised the position when he said:

People on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents ... should not be left in the hands of bureaucrats and science technologists. There should be ministerial responsibility ...

The legislation established direct ministerial responsibility as a mechanism to ensure that an issue such as the importation of an abortifacient is subject to thorough consideration, not simply a technical evaluation of the effectiveness of the drug to induce a termination but also consideration of the broader range of social policy and ethical issues.

I do not believe anything has materially changed since the passage of the 1996 amendment that would warrant the removal of ministerial or parliamentary responsibility in the approval of a drug of this type. If passed, this bill would make the abortifacient drug RU486 subject to the ordinary approval processes of the Therapeutic Goods Administration under section 25 of the Therapeutic Goods Act. The act provides that, before any pharmaceutical drug can be marketed in Australia, it must first be evaluated and approved by the TGA against the criteria of quality, safety and effectiveness. The passage of this bill would in effect remove RU486 from the class of restricted goods which currently serves to prevent the evaluation, registration or sale of the drug without the approval of the minister. If the debate were simply about the technical evaluation of a drug and a consequential approval process, clearly the TGA would be the appropriate organisation to undertake this role. The technical and scientific competence of the TGA is not in question.

RU486 is not a medicine or a therapeutic drug, because its intended use is not primarily for therapeutic purposes. The proposed purpose of RU486 is to chemically induce terminations. Clearly, we are not debating whether this drug should be made available for a therapeutic application. We know that mifepristone has already been used in Australia to treat brain tumours and the drug was obtained under the Special Access Scheme. This is a debate about whether or not the availability of RU486 for non-therapeutic use for abortions should appropriately remain with the minister, a person responsible to this parliament.

It is not possible to hide from the fact that there are significant ethical and moral issues associated with this class of drug. But leaving that to one side for the moment, there is also a real and genuine concern as to the longer term effects on women, both physically and mentally, as a consequence of medicated abortions. The Commonwealth’s Chief Medical Officer has already expressed the view that, as a procedure, medicated abortions carry a significant higher risk of later adverse effects. That being the case, it adds to the argument that any assessment of a drug of this type should not be left to a single faceted and technical approval system and must be subject to the most rigorous of evaluations, including the consideration of relevant social policy.

Some have argued that RU486 is simply a chemical way of doing what can already be achieved surgically, and that this medical means of termination provides women with a choice that will make abortion easier for them and more readily available. In all honesty, I must admit, that for me, ‘more’ and ‘easier’ does not necessarily mean better. It is inescapable that a drug of this type will always involve ethical considerations, as it raises issues beyond purely health issues. Therefore, I believe that as a parliament we would be abrogating our responsibilities to relegate this consideration to the TGA.

I would like to conclude by agreeing with the views of Senator Neal, expressed in the 1996 debate when she said:

These issues need to be addressed by the Executive of this government and addressed with absolute and direct accountability and absolute and complete transparency.

I oppose the bill.

 

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