Julia Gillard (Lalor, Australian Labor Party, Shadow Minister for Health and Manager of Opposition Business in the House) Share this | Hansard source

I second the motion and welcome the opportunity to speak in this debate on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. I congratulate the member for Moore, whom I am following, on the role he has played in this debate, and of course Sharman Stone, now elevated to the Howard government ministry. I also offer my congratulations to Senators Moore, Allison, Troeth and Nash. I note that my Senate colleagues Senators Moore and Webber are in the gallery watching this debate.

I would like to make some comments today on what this debate is about, who this debate is about, the effect of the amendments which are to be moved and which are before the House of Representatives for its consideration, and the role of the Minister for Health and Ageing in this debate. This debate is of course about RU486, which belongs, as the member for Moore has said, to a special category of drugs under the Therapeutic Goods Act 1989 known as restricted goods. These restricted goods are defined under the act as drugs intended for use in women as abortifacients. The special category of drugs cannot be evaluated, registered, listed or imported without the prior written approval of the minister for health. A written approval must be laid before each house of parliament by the minister within five sitting days of it being given.

The regulations that ban the importation, trial, registration or listing of RU486 and similar abortion drugs without the written approval of the minister for health were incorporated into the Therapeutic Goods Act 1989 as a result of the passage of the Therapeutic Goods Amendment Bill 1996. The provisions relating to RU486 and the role of the minister for health were introduced into the 1996 legislation as a result of an amendment introduced by Senator Brian Harradine. This came about because Senator Harradine was concerned that RU486 had been allowed into Australia as part of two World Health Organisation sponsored clinical trials. One was in New South Wales and one was in Victoria. At the time of the amendment, Senator Harradine and those who supported the amendment restricting RU486 argued that the long-term health effects of using RU486 were unknown and therefore additional scrutiny was required. That argument may have had some merit in 1996, but 10 years on, with the drug now having been used by 2.5 million women, these arguments no longer have force.

It has been noted in the course of the public debate about RU486 that Labor members supported this amendment. It was done on the voices. But when one looks at the Hansard record of what motivated Labor members at that time it is clear that they thought there should be some extra scrutiny of RU486 but they did not believe that what they were putting in place at that point would amount to a complete ban on RU486. That is made clear by the words of the then shadow minister for health, Michael Lee, amongst others. It has in effect become a complete ban, for the reasons that the member for Moore has gone to. The manufacturer of RU486 and the people who would seek to import RU486 are not going to do so if they have to face the uncertainties of a political process, whether that be a political process involving ministerial approval or, indeed, a political process involving parliamentary disallowance, as the amendment which is to be moved to this bill suggests.

It has been an effective ban. We know that RU486 has not become available in Australia. Obviously, given that it is now off patent—so that the amount of money paid for the drug and the reward to the manufacturer are therefore necessarily quite low—and considering the time and cost that would be involved in filing an application for TGA approval, it is unsurprising that an entity making a commercial decision in the face of political hurdles has decided not to even enter the race which ultimately would have made RU486 available.

The bill before us would change the system. It would remove the requirement that RU486 and other designated abortifacients obtain the permission of the Minister for Health and Ageing for importation, trial or listing. The permission of the TGA would still be required, as would ethics approval. In my view, this puts RU486 where it belongs: to be treated like any other drug being imported, trialled, prescribed under the Special Access Scheme or submitted for registration in this country.

The bill before us today is about neither whether abortion should be legal in this country—that is not a decision for this parliament under our current political and legal system—nor whether a medical abortion is legal. This bill is about whether the best method to assess RU486 for safety should lie with the Therapeutic Goods Administration or with the minister for health. In my view, it should lie with the Therapeutic Goods Administration, which we trust to assess the safety and effectiveness of tens of thousands of medicines, many of them dangerous—many of them dangerous new cancer medicines, many of them dangerous and addictive pain-killing medicines, many of them medicines which, if misused, can cause real human distress. We trust the Therapeutic Goods Administration to do that for tens of thousands of medications and drugs. I believe that we can trust the Therapeutic Goods Administration to do that for RU486. The impact of this bill is to give the Therapeutic Goods Administration the power to do the work in respect of RU486 that it is empowered to do in respect of other drugs and medicines—work that it has done successfully for tens of thousands of drugs.

If this bill were adopted, the way in which the system would function for RU486 would be as follows—and we need to note that RU486, because it has not been registered in Australia, for the reasons of which I have spoken, has not been approved for use in Australia. If this bill were adopted and the drug were then imported to Australia for use in clinical studies or under the Special Access Scheme for individual patients, all submissions for importation would have to be approved not only by the Therapeutic Goods Administration but also by the relevant ethics committees that would work on this issue. So we would have two layers of checking: the TGA and the relevant ethics committees. If an application were made for registration of the drug for sale in Australia, this application would have to be considered by the Australian Drug Evaluation Committee, the ADEC, which is an expert advisory group appointed by the minister. Given these layers of checking—if the drug remains unregistered, it goes to the TGA and then an ethics committee; if registration is sought, the TGA and the Australian Drug Evaluation Committee are involved—I ask the question: what further work is it that political intervention by any minister for health could do? The system is robust and should be allowed to do the work that has been set for it, and that is what this bill would achieve.

Having addressed the question of what this bill is about, I want to speak briefly about who this bill is about. In some of the public commentary there has been the image that women will be irresponsibly purchasing RU486, if it is available in Australia, to unthinkingly procure an abortion, or that this is a debate about irresponsible young girls or irresponsible young women. The evidence, whether we like it or not, is to the contrary. There is no evidence that Australian women have abortions unthinkingly. We know that over the past decade the proportion of Medicare funded abortions done for teenagers has fallen by 12 per cent—and that is a tremendously good thing—but the proportion for patients over 35 has risen by 37 per cent. We also know that a patient seeking an abortion was 40 per cent more likely to be married or in a de facto relationship in 2002 than in 1992. Any imagery in this debate of irresponsible young girls is false imagery and not imagery that we should allow to cloud our opinion. It seems that abortions are being had by women in committed relationships in the older age range. We do not necessarily know why, but I say that we should respect their decision because we will never know as much about their individual circumstances as they do.

Having addressed what this debate is about and who this debate is about, I want to spend some time talking about the possible amendments to this bill that have been foreshadowed in the House of Representatives. I note that some of the proponents of those amendments are here today, sitting in the House, listening to the debate. I understand that the amendments are put forward in absolute good faith and they will be spoken to at the appropriate point. But I cannot agree with them, and I will outline my reasons for not agreeing with them at this stage.

Two amendments have been foreshadowed. One has been proposed by the member for Lindsay, who is here now. Currently, as we have discussed, the Minister for Health and Ageing has the ability to approve or not approve the importation of RU486. Under the member for Lindsay’s amendment, the minister would still retain this power. However, after the minister had made a determination, whether positive or negative, the determination would become a disallowable instrument.

This is flawed on two counts. Firstly, the very thing that has made the current scheme of arrangements for RU486 an effective ban—the very thing that has driven that result—is the fact that there is a level of political decision making and uncertainty for a manufacturer or importer. The amendment suggested by the member for Lindsay would make this problem worse. A manufacturer or importer would not only need to go to a ministerial level but would also need to submit themselves to the vagaries of a parliamentary debate on a disallowance motion. I believe that would in effect be a continuation of the ban, because the manufacturer or importer would not run those risks. So, whilst I understand that the amendment is put forward in absolute good faith, I cannot agree with it. I think it would mean a continuing effective ban on RU486 and would introduce a new level of uncertainty.

I also note that the amendment would have the capacity to significantly impact on the work of this parliamentary chamber and the other place because one could anticipate that we would face very regular disallowance debates on RU486. I leave members to contemplate whether they think that is a desirable prospect. A disallowance debate could be triggered by any individual decision of the minister. Those decisions could be made on a number of applications for importation—an application for registration, an application to vary that registration and the like.

An amendment has also been proposed by the member for Bowman. This amendment is in some ways comparable to the amendment moved by Senators Colbeck and Scullion in the Senate, which I note was defeated, but it is also slightly different. The key difference between the amendment proposed by the member for Bowman and the amendment proposed by the member for Lindsay is that, under the member for Bowman’s amendment, there is no continuing role for the Minister for Health and Ageing. Under this amendment, a decision by the Therapeutic Goods Administration to register or list RU486—that is, any determination that RU486 is safe and effective—would be a disallowable instrument. It should be noted that once again there may be more than one such determination. For example, the TGA could make separate decisions on different applications for RU486 from different manufacturers. In my view this amendment is different to the amendment proposed by the member for Lindsay in that it is less likely to trigger multiple RU486 debates, but it is still possible that the parliament could find itself debating this matter on more than one occasion.

It should be noted that the definition of ‘restricted goods’ under the member for Bowman’s amendment is wider than RU486 and abortifacients and would include a range of yet to be developed drugs such as those to improve brain performance. My central criticism of the member for Lindsay’s amendment stands in relation to this amendment. Once again, if you inject this level of political intervention in the process and the uncertainties of what would happen in a disallowance debate, it will amount to an effective ban because no manufacturer or importer will take a step down that path. So, in my view, both amendments ought to be opposed because, even though proposed with goodwill, they amount to a continuation of what has been an effective ban. I think the bill in this place should pass, unamended. I know that members are seriously considering how they are going to vote.

I would like to make some comments about what I think should not be part of this debate. Those comments relate to the role of the minister for health. There has been some commentary in the media—and indeed by the minister for health himself—that in some ways this debate relates to his values and his faith; his very publicly known Catholicism. Those things have played no role in how I have made up my mind on how I am going to vote on this private member’s bill. I do not share the minister’s faith, but I respect it. Indeed, I respect very strongly anybody who can cleave so strongly to faith in the modern age. I think that is a very admirable personal quality. This is not about the minister’s faith. It would not matter whether the current minister were minister for health, whether I were minister for health, whether some other person in this parliament were minister for health or indeed whether some person who is yet to enter this parliament were minister for health—the same policy considerations I have outlined would continue to apply.

What I do say to the minister for health is that I have been concerned not by his faith but by how he has dealt with this debate. This is a debate we should deal with in the least inflammatory way, and not in the most inflammatory way. I do not think it is appropriate in that regard to misstate the number of abortions there are in Australia and to do that consistently. The minister for health consistently uses the figure of 100,000 abortions per year.

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