Judith Troeth (Victoria, Liberal Party) Share this | Hansard source

As my colleague Senator Nash has said, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 seeks to remove responsibility for approval for abortion drugs, particularly RU486, from the purview of the Minister for Health and Ageing and return it to the Therapeutic Goods Administration. I am a co-sponsor of this bill in the Senate. I believe strongly in the reasons for this bill and I will be voting for it. As Senator Nash has said, we must separate politics from medical decision making. 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 these amendments restricted goods cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health and Ageing. RU486 is the only medicine that is subject, as far as I know, to the restricted goods condition.

It is interesting to note that the act, as it was amended in 1996, also effectively banned the entry of RU486 into Australia not only for use as an abortifacient but also for a number of other possible uses such as an emergency contraceptive, in the treatment of some breast and brain tumours, and as treatment for endometriosis and irregular bleeding. In any case, prescription of this drug will lead, we hope, to a wider choice of drug for the medical profession and the alleviation of suffering for patients. Medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration and do not require additional approval from the minister.

What does the TGA do in this process? It is charged with identifying, assessing and evaluating the risks posed by therapeutic goods that come into Australia. It applies any measures necessary for treating the risks posed and monitors and reviews the risks over time. The TGA is a responsible professional body and it is regarded by the government, and I would imagine by the entire scientific community within Australia, as being qualified to manage the risks.

It is also necessary for the purposes of this debate to know that there is a group called the Australian Drug Evaluation Committee which, together with the TGA, makes the recommendations on who can prescribe the drug, how it can be used, and under what circumstances it can be used, and it can also apply any measures necessary for treating the risks which are posed. That particular group is made up of clinicians and key medical experts and it is appointed by the Minister for Health and Ageing. Its brief includes: the quality, the risk benefit, the effectiveness and access within a reasonable time of any drug referred to it for evaluation as well as medical and scientific evaluations of applications for registration of prescription drugs. It also provides services to other government departments, committees and community based organisations on a wide variety of regulatory matters related to prescription medicines. This group has particular professional qualifications in clinical medicine, pharmacology, toxicology or general practice. It has six core and 16 associate members and the review process is exhaustive. The group looks at all sides of the issue, examining the conditions of manufacture, the clinical impact and, of course, the safety of the drug.

Against this scenario of objective scientific measurement we have the view that responsibility for approving the drug should lie with an elected member of parliament, who is also the health minister. It is not that I object to the present holder or indeed any holder of that office personally. It is simply that I do not believe that any of my esteemed colleagues in their particular career as members of parliament have the required scientific knowledge to assess any drug in the considered and stringent way that we accept drugs should be assessed in Australia. Even with expert advice, which I have no doubt is offered to the minister within his office, the decision still rests with the minister and I do not agree, and have never agreed, that that is a desirable aspect.

While I would like to confine this particular debate to the removal of power from the minister to the Therapeutic Goods Administration, I accept that inevitably, because of the results of this drug being used, we will enter into the wider abortion debate. There have been claims that approval for this drug—assuming that it is approved—will lead to ‘do-it-yourself’ abortions, as they have been termed, and ‘backyard abortions’, which is another term, and that it will make abortion too easy. There is nothing easy about abortion.

Abortions must comply with state laws, or the procedure thereof, and they must require medical oversight and approval—and that is so, whether the procedure is medical or surgical. A woman will still be required to satisfy the same tests to have a lawful termination using this drug as she would with a surgical termination. It is my belief that the Therapeutic Goods Administration would place caveats around the use of this drug so that it would be used under proper, lawful medical supervision and so that the dreadful scenarios that have been put to us by opponents of this bill are simply fairytale stuff.

If this drug is approved, Australia will join other countries where it has been approved for use: the United Kingdom, the United States, much of western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia. As well, other scientific bodies that are within Australia, such as the Australian Medical Association, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Rural Doctors Association of Australia, all endorse the use of RU486 for medical termination of pregnancy.

I live in Victoria and I subscribe to the Menhennit ruling, made some 35 years ago, that abortion is legal to satisfy concerns about the health of the mother. And, by and large, that particular tenet is subscribed to by most state governments. Most Australians accept that particular status quo. What we are debating here today is the way in which one of the avenues to reach that objective is to be regulated. As my colleague Fiona Nash has said, this is not a debate about abortion; this is a debate about one of the procedures that we would like to offer as a choice to women, should they contemplate that particular choice of dealing with their pregnancy.

So, what are we to do? Are we to have the safety and efficacy of an internationally widely used drug determined by a minister for health who is still a member of parliament, or are we to have the safety and efficacy of an internationally used drug determined by an objective science and evidence based national authority? The choice is to be made by the Senate. I know my choice, and I will be voting for the bill.