House debates

Tuesday, 14 February 2006

Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005

Second Reading

8:41 pm

Photo of Ann CorcoranAnn Corcoran (Isaacs, Australian Labor Party, Shadow Parliamentary Secretary for Immigration) Share this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 is about whether or not the health minister should have the authority to stop the use of a particular group of drugs in this country. Before any drugs can be used in Australia they must be assessed by the Therapeutic Goods Administration. If the TGA is satisfied that the drug meets standards for quality, safety, efficacy and timely availability, it approves the use of the drug within this country. Part of the TGA’s assessment process is an evaluation of the risk associated with the drug—that is, the potential of the drug to do harm to those it is intended to help and to others who may come into contact with it. The assessed risk of the drug then determines whether the drug is registered or listed. Registered drugs must be used under a doctor’s supervision; listed drugs do not require a doctor’s supervision.

At present a certain group of drugs—ones that are intended to induce an abortion—are treated differently from all other drugs in Australia. Drugs in this group, of which RU486 is the one most commonly talked about, may not be evaluated, registered, listed or imported without the specific approval of the health minister of the day. The minister must notify parliament of any decision he or she makes to approve an application for a drug in this category to be evaluated by the TGA. The minister does not have to report any decision he or she makes not to approve an application for evaluation.

It should be noted that under current arrangements there is no technical reason why someone—a doctor or a sponsor—cannot apply for permission for the drug to be used in Australia for circumstances other than abortion. In fact, no-one has applied—until, I understand, very recently. It is thought that the reason for this is that no-one is prepared to go to the significant costs and effort involved in an application to the TGA when the minister can just dismiss the application. The effect of the added step of gaining ministerial approval has effectively been a ban on these drugs since 1996.

The object of this legislation we are debating today is to bring this group of drugs into line with all other drugs in the country in terms of the process for approving or not approving the availability of these drugs within Australia. The discussion within the community about this bill has been broadened beyond the technical object of the bill to include discussion about abortion and whether or not we ought to allow abortion in this country. It is understandable that the debate has broadened because of the nature of these drugs—they are, after all, intended to bring on an abortion, and this is a very controversial issue.

I, and no doubt most other MPs in this place, have been lobbied by a number of people on both sides of the abortion debate. Some people want us to pass this bill; others want us to vote it down. The people who are asking us to vote this bill down do so because of their strong views that abortion is wrong. One argument for voting against this bill is that we—that is, this parliament—should not pass responsibility for decision making about abortion to unelected officials. It is worth noting in passing that abortion is a state issue, but I do not want to get technical about it, because the principle of the thing is what is important.

Let me deal with that side of the discussion right now. It can be dealt with very simply. This bill is just not about whether or not abortion should be allowed. It is important to understand that this bill does not change any current laws about abortion. This bill does not make an abortion easier to get or more difficult to get. This bill does not change the existing laws that govern abortion. It is also important to make the point that passage of this bill does not mean that RU486 will be immediately available or that it will be rammed down the throats of unwilling women, which are some of the things we have heard. What this bill will do, if passed, is simply put the decision about whether or not a group of drugs which are designed to induce an abortion are to be made available to people in Australia.

By passing this bill parliament is not abrogating its responsibility to make decisions about important matters—abortion in this case. The decision about whether or not we as a society approve of abortion is not part of this bill. This bill simply allows the TGA to decide whether or not a drug that brings on an abortion is safe to use. It does not alter how the decision to abort or not to abort is taken.

If this bill is passed by parliament, the question of whether or not people in Australia have access to the drug RU486 and other like drugs will be decided by the TGA. It will be decided by scientists and experts, and the decision will be based on the grounds of safety. Access to the drug will no longer require the approval of the present or indeed any future health minister. If this drug passes the strict tests of the TGA, it will mean that women—with their doctor’s guidance and advice—may be able to choose to have a medical abortion instead of a surgical abortion. I want to stress again that the medical abortion will be available only if the TGA judges that the drug meets Australian standards for quality and safety. The effects of this bill can come into being only when and if a decision to undergo an abortion is taken. Once a decision is taken to undergo an abortion, this bill if passed may broaden the options available to that woman and her doctor.

An argument has been put to me by some people that this bill ought to be rejected on the grounds that the drug is unproven or unsafe. The assessment of the safety of this drug is actually the point of the bill. The bill will allow experts in the field to make knowledgeable and scientifically based assessments of the safety of the drug. The argument that passage of this bill will increase the number of abortions in Australia is hard to counter because by definition we have no Australian data to consider. However, experience in countries where medical abortion is available suggests that the availability of medical abortion does not increase the overall rate of abortion.

I would like to point out another matter which is not often raised. RU486 can be used in the treatment of a range of conditions, including inoperable meningiomas, endometriosis, fibroids, metastatic breast cancers and bipolar disorder. This is a side of the current laws which is not often highlighted. The effective ban on RU486 has denied this drug to people who may want to use it for purposes other than bringing on an abortion. One constituent has contacted me because she has severe endometriosis. Her doctor advises her that RU486 is probably the only option she has available to her now. In her case the disease has progressed beyond the point of being able to be operated on. She is very keen to see this drug made available to her and to others in her situation.

I would like to thank all those people in Isaacs who have contacted me about this bill. I know that by supporting this bill I have not followed the wishes of some of my constituents but that I have followed the wishes of others. I know that there are strong and genuinely held views on both sides of this debate. I have read and responded to all the emails and letters from those in Isaacs. I have had a number of telephone conversations with constituents who hold views on both sides of this debate, and I hope and I am sure that these conversations will continue. No-one has the monopoly on wisdom and we all have to weigh up the arguments and come to a decision. I have tried to make my decision carefully and honestly and after listening to the arguments for and against. I will be rejecting the amendments that have been proposed and moved to this bill, and I will be supporting this bill.

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