Carmen Lawrence (Fremantle, Australian Labor Party) Share this | Hansard source

I am sure that many members have spoken with such conviction about their view on ministerial and parliamentary approval for RU486 without fully understanding the process by which it was singled out from other drugs normally approved by the TGA. I have been around a little while, and I am aware of what happened in 1996. It is useful to remind members of the history of this decision. It was not the result of careful analysis or an extended parliamentary debate like this one. Rather, it was a deal done when the government did not have control of the Senate to secure Senator Harradine’s vote for the sale of Telstra and other matters. It was never a matter of high principle. Rather, the women of Australia were denied access to what has now been shown to be an effective and medically approved method of terminating pregnancy because of what was effectively a political deal. To my dismay, and contrary to the views of many of our members at the time, it was not opposed by Labor in the Senate either.

During 1994, when I was Minister for Human Services and Health in the Keating Labor government, trials of RU486 were being conducted in Australia as part of a multitrial program sponsored by the World Health Organisation. The trials were conducted at the Sydney Centre for Reproductive Health, which examined the use of RU486 as an emergency post-coital contraceptive, as they described it, and by the Monash University Department of Obstetrics and Gynaecology at the Family Planning Association of Victoria, who were assessing the effectiveness of combined RU486 and prostaglandin as a method of early pregnancy termination.

In May of that year, as part of his continuing campaign—which I respect—to stop abortions in Australia, Senator Harradine raised questions about the TGA approval for the import of the drug and the ethics committee processes which were in place for the trials to get informed consent from the women. Controversy surrounding the trials came to a head in late 1994 following an article in the Canberra Times which expressed concern about whether women in the trials had actually been given sufficient information to give properly informed consent. A number of pro-choice women active in family planning were also concerned that:

Compared with existing methods of abortion ... It has a greater degree of nausea, pain, prolonged bleeding  ...

Women coming to the Family Planning Association in Victoria in particular, as one woman put it, ‘come expecting to get a curette and they’re being coerced into volunteering for a trial’. At the same time, the Catholic bishops—the feminists and the Catholic bishops was an unusual combination of forces which I do not think we have seen for some time—took the opportunity to lobby the Prime Minister, without success as it turns out, to prevent the trials continuing. They said publicly that they regarded me as a lost cause—my views are well known on this matter—although I was in fact concerned that the processes for obtaining informed consent from the women in the Victorian trial may indeed have been inadequate.

After discussions with those conducting the trials in Victoria, the trials were actually suspended to allow an examination of the ethics and consent procedures by a consent review panel consisting of Bryce, Clarke and Funder. I also established a separate review into the operation of institutional ethics committees more broadly to ensure that ‘they are as effective as possible in overseeing and monitoring clinical trials’.

Once the Victorian panel had reported and its recommendations had been incorporated into the trial’s protocols, the trials resumed and concluded. The Committee on Institutional Ethics that I had set up subsequently reported to Dr Wooldridge, the then Minister for Health and Family Services, following the change of government, and many of its recommendations were subsequently incorporated into institutional ethics protocols and do deserve to be reviewed from time to time. The results of the trials, reported in 1997, confirmed international evaluation and indicated that RU486 could be used safely, with many women in fact expressing a preference for such medical termination over surgical procedures.

But in the meantime, in 1996, soon after the current government was installed, Senator Harradine was successful in inserting ministerial approval for RU486 into the Therapeutic Goods Amendment Bill, which was before the House at that time. This of course was not recommended by either of the committees that I referred to that had assessed the question of the conduct of the trials. The matter was never fully canvassed within my own party or, indeed, within the wider community and several members, including me, argued vehemently against supporting the Harradine proposal.

As a result of the deal that I mentioned, a special category of drugs, to include RU486, was created for the first time in 1996. Under the Therapeutic Goods Act, these ‘restricted goods’, as they are described, cannot now be evaluated, registered, listed or imported without the express written approval of the minister for health. In those amendments, restricted goods were defined as medicines ‘intended for use in women as abortifacients’. In other words, the restricted goods provisions apply exclusively to medicines intended to induce an abortion.

As members well know—they will have at least heard the discussion—all other medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration without any requirement for approval from the Minister for Health and Ageing. The TGA provides a scientifically rigorous and comprehensive process of assessment for drugs and other therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and medical devices. Like other government departments, of course, it is answerable through the responsible minister to this parliament.

Under the present act, a sponsor seeking approval to market an abortifacient can apply through the same process as exists for all prescription medicines in Australia—that is, an application would need to be submitted with supporting data to demonstrate the quality, safety and effectiveness of the drug. The key difference as a result of the restricted goods provisions is that, in addition to the supporting data, written ministerial approval is required before a restricted good such as RU486 can even be evaluated by the TGA. I think it is fair to say that there is no guarantee that this Minister for Health and Ageing or any other—it is not personal—would be guided by the same careful and dispassionate assessment of the drug that is required of the TGA. In any case, such a person would be unlikely to have the expertise.

At the time the amendments were agreed, some senators predicted in the debate that potential sponsors might make the judgment that it would not be worth their while to make application because of the likely expense and controversy surrounding the ministerial decision. Whatever else we might say about those who oppose abortion on any grounds, they are very public, persistent and sometimes emotive. Not all drug companies are willing to subject themselves to such opprobrium. Perhaps as a result, and as was predicted at the time, no application has ever been lodged in Australia despite the fact that, strictly speaking, it is possible to apply for approval to market RU486. The fact that RU486 is currently licensed for use in a large number of countries apart from Australia lends credence to the view that the current legislation represents a barrier to potential sponsors seeking approval. That is why this legislation is necessary, and I welcome it, and it is why the amendments should be rejected.

All the evidence suggests that, given the choice, a substantial proportion of women prefer medical methods of abortion and that it is safe to do so. I quote from the International Planned Parenthood Federation:

There is overwhelming evidence, based on numerous studies and clinical trials to support the statement that this drug is safe and efficacious for medical abortion.

Of course, that has to be assessed in Australia by the TGA. After reviewing existing literature and the results of clinical studies and trials on RU486 for medical abortion, they found unanimously that the drug is safe and effective. As members also know, the WHO has declared medical abortions safe, effective and acceptable if the few conditions which warrant control are identified and post-abortion care is available. No procedure, as members know, is without risk—and nor is child birth. We live every day, consent to drugs and are subjected to medical procedures with known and measurable risks and side effects. And we do so after these drugs and procedures have been meticulously evaluated by the TGA and following medical advice. RU486 should be no different.

I want to end on this note. Like most people, I believe it is desirable to reduce the need for terminations by reducing the number of unwanted pregnancies, not by restricting access to terminations. Most women, their partners and their families would prefer not to be in the position of having to decide whether or not to terminate in the first place. Although we have to accept the fact that contraceptive methods are not foolproof, we can do a lot more in Australia to reduce unwanted pregnancies. Other wealthy nations have lower rates of abortion than we do. I would argue that we need more comprehensive and sustained sex education for young people and a greater willingness to talk frankly to young people about responsible relationships and the risks of premature sexual activity.

We need more easily accessible and affordable family planning information and advice. We need more professional counselling for people with psychological problems, who are sometimes at risk of an unwanted pregnancy. We also need more readily available contraceptives, especially for younger people who are sexually active, and serious strategies to reduce violence, especially sexual violence, in relationships. Women subjected to such violence often seek to end their pregnancies—perhaps understandably. If we adopted such an agenda and promoted it with some energy, we would have fewer unwanted pregnancies and fewer abortions in this country—a goal I am sure we all share.

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