Andrew Southcott (Boothby, Liberal Party) Share this | Hansard source

In considering how to vote on the private member’s bill before us, the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005, like all members, I weighed a number of factors. The first consideration was that abortion under some circumstances is lawful in the six states and two internal territories of Australia. In Victoria, Queensland and New South Wales a common-law test is applied. In Tasmania, South Australia, Western Australia and the Northern Territory there is a detailed statutory regime which deals with the termination of pregnancy. For example, in South Australia the termination of a pregnancy is not unlawful where carried out within 28 weeks of conception in a prescribed hospital by a legally qualified medical practitioner, provided he or she is of the opinion, formed in good faith, that either the maternal health or the foetal disability ground is satisfied. Two doctors must certify this in writing and the abortion must be carried out in a hospital. That is the current law in South Australia. Each state and territory is different but has laws relating to the termination of a pregnancy which are based to an extent on common-law tests set down in judgments over 35 years ago. So the first consideration was that abortion is a lawful procedure under certain circumstances under state and territory law.

The last time the federal parliament had an extensive debate on the issue of abortion was in March 1979. The motion moved then by the Country Party member for Hume, Mr Stephen Lusher, requested that the government introduce legislation to provide that medical benefits would not be provided by the Commonwealth for the termination of a pregnancy unless the termination was performed to protect the life of the mother from a physical pathological condition. This motion was amended to read that the Commonwealth should not pay medical benefits for the termination of pregnancy unless performed in accordance with the law of a state or territory.

For almost 27 years that has more or less been the position in the federal parliament, an understanding that any changes to the abortion laws would come from the state and territory parliaments. But the federal parliament clearly does have a role in the approval, listing and monitoring of drugs. So, in considering the issue of RU486 being used as an abortifacient, the issue is who should determine whether it is safe for maternal health for this drug to be listed. My view is that, if listed for a termination of pregnancy in accordance with state or territory law, the Therapeutic Goods Administration is entirely competent to determine the safety, quality and effectiveness of this drug. There has been a lot of discussion about the risk and adverse effects of RU486. That is a matter for the TGA to determine.

The TGA makes evidence based risk assessments. If it determines that RU486 is not safe it will not be listed. If it determines that it is safe, it will be listed. The TGA’s role is to identify, assess and evaluate the risks posed by drugs and medications. RU486 would only be registered as an abortifacient if it is shown to be safe and effective for that purpose. But there are a number of fail-safes before this would occur.

The final decision in registering any therapeutic good for inclusion on the Australian Register of Therapeutic Goods rests with the Secretary of the Department of Health and Ageing or the secretary’s delegate in the TGA. This occurs after the secretary has received a resolution from the Australian Drug Evaluation Committee, an independent group of medical experts—some of them eminent medical experts—appointed by the minister. The secretary of the department then has circumscribed grounds on which refusal of any therapeutic good can be made. These grounds include: the goods are not eligible for listing, or the goods are not safe for the purposes for which they are to be used. Although no refusal to register has ever been made, that power is there for any drug, exercised by the Secretary of the Department of Health and Ageing. After this stage, the National Drugs and Poisons Schedule Committee is able to apply conditions for the prescribing of medicines. The committee consists of state and territory government members and other persons nominated by the minister, including technical experts. So I have satisfied myself that the TGA is quite able to determine if RU486 is safe for listing in Australia.

The last step that would happen is that, if a woman decided to have a medical abortion, this would be done in consultation with a doctor. The professional bodies, such as the Royal Australian College of General Practitioners and the Royal Australia and New Zealand College of Obstetricians and Gynaecologists, have developed protocols and guidelines in the use of this drug and would expect their members to prescribe it in accordance with these protocols. RU486 would only be administered by a qualified medical practitioner who would be responsible for the supervision and monitoring of their patient.

I sincerely appreciate the many representations I have received covering a wide range of views. As I have said in my speech, there are already several layers of accountability here. Firstly, the termination of a pregnancy would have to be in accordance with the law of a state or territory. Secondly, the TGA must have applied an evidence based risk assessment to RU486 using all available information and determined it to be safe and effective for the purpose for which it is intended to be listed before it is registered in Australia. Thirdly, a qualified medical practitioner must prescribe the drug and monitor their patient in accordance with protocols and guidelines developed by the professional colleges. And, lastly, the woman must give an informed consent to a medical abortion after a discussion with her doctor and a consideration of her options.

If all those conditions are met, I see no reason to oppose this private member’s bill. These free votes, and this debate in particular, are never easy but each member brings to it their own experiences and view of the world. Having weighed the issues, considered all the representations and read the report on the bill by the Senate Community Affairs Legislation Committee and other material carefully, I will be voting for the bill.

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