House debates
Wednesday, 15 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
Second Reading
1:30 pm
Gary Nairn (Eden-Monaro, Liberal Party, Special Minister of State) Share this | Hansard source
The first thing I would like to say in speaking in this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is to generally thank the many people of Eden-Monaro for their emails, letters, faxes and telephone calls offering their view on the bill. It is important for all members to listen to their constituents. However, I say ‘generally thank’ because unfortunately there have been contributions from just a few constituents that, in all honesty, I cannot say thank you to. I hasten to add that the contributions I refer to have come from both sides of the debate—as members would expect, both extremes of the debate. One measured contribution encouraged me to vote on this bill according to my conscience and not on emotional or religious grounds. I can assure all constituents of Eden-Monaro I will not be voting on either emotional or religious grounds.
I have also been reminded that this debate is not about abortion. This is absolutely correct, but unfortunately many of the people encouraging me to oppose this bill have argued strongly against abortion. Also, many people encouraging me to support the bill have done so on the basis of being strongly pro-abortion. Both of these arguments are not appropriate for this bill. If passed, this bill simply takes the responsibility to register a particular drug away from the Minister for Health and Ageing and places it in the hands of the Therapeutic Goods Authority. It has no impact on the legality or otherwise of abortion.
Much has been argued about which of these two should have that responsibility. If it remains with the minister, the minister of the day could take whatever advice he or she believed appropriate before making a decision. The TGA has a process for determining the safety, efficacy and quality of all drugs that are lodged with it seeking registration. What has not been stated very widely is the detail surrounding an application to the TGA and subsequent to the registration if successful. Firstly, an application for registration to the TGA must be submitted in a specified format, which includes the provision of detailed documentation about the conduct and outcomes of clinical trials in humans in order to establish the product’s safety, efficacy and quality. The data submitted are subject to extensive review by the TGA staff and contracted clinical experts. A summary of the TGA’s evaluation of the application is then put to the Australian Drug Evaluation Committee—ADEC—for advice. If registered by the TGA, restriction on the availability of mifepristone, or RU486, can occur on a recommendation by the National Drugs and Poisons Schedule Committee to the states and territories.
Other restrictions on use which might possibly be recommended by ADEC or be a condition of registration imposed by the TGA, such as limitation of prescribing to medical practitioners who have undergone some form of additional training, can be enforced by the state and territory governments, who control medical practices. Therefore, there is substantial opportunity for the many people who have argued abortion specific matters in this debate to have input not only to the TGA but also to the Australian Drug Evaluation Committee, the National Drugs and Poisons Schedule Committee and their respective state and territory governments. My unemotional, considered view of this matter is that the TGA is the appropriately constituted and qualified body to carry out the necessary independent investigations to determine whether RU486 would be registered if such an application was made. I would also add that the TGA would determine the conditions under which such a registration was made if it determined a registration was warranted.
I am well aware my decision will disappoint many constituents—probably anger many as well. Many in that category are close friends and supporters. Equally, my decision will be welcomed by many. To both those disappointed and those pleased, I emphasise that my vote is not a vote in favour of widespread abortions. Irrespective of the circumstances, I remain strongly of the view that the termination of a pregnancy is a matter for the mother and the father and their health professional. Any individual placed in such a traumatic circumstance is under enough personal strain without added political pressure. For that reason as well, I do not support the amendments proposed as they would simply ensure multiple divisive debates in this House in future years that would only further encourage the two extremes of the abortion debate and do nothing for those having to deal with personal trauma. I intend voting in support of the bill as first introduced.
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