Jan McLucas (Queensland, Australian Labor Party, Shadow Minister for Aged Care, Disabilities and Carers) Share this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 that we are dealing with today, if passed, will remove the effective legislative restrictions on the importation of RU486 and other drugs which facilitate a medical rather than surgical abortion. The effect of the passing of this bill will mean that decisions about the safety, quality and effectiveness of the drug would pass to the Therapeutic Goods Administration, the entity in this country which evaluates all other medicines that are used in our country. It is a bill about the method of approval of a drug. It is not a bill that debates abortion as such.

The Labor Party has determined that it has a predisposition to support an end to what has been an effective ban on RU486, that RU486 be dealt with by the TGA in accordance with its normal procedures and that members of the caucus exercise a conscience vote on the bill. The following is my personal position on the legislation. Strong views are held by many, if not all, senators in this place. I respect that there are many who are vehemently opposed to women accessing abortion by whatever means. Strong views are also held by many, including me, that women, whatever their means or wherever they live, should have the right to terminate a pregnancy within the state and territory legislative systems that are in place. Those strong views on each side must be respected, but in doing so we have to recognise that this is a debate about the method of approval of a set of drugs, not about the legality of abortion.

As we make these important decisions, it is critical that we are in full possession of the facts. I commend those who provided evidence to the inquiry of the Senate Community Affairs Legislation Committee for their advice and commend the committee for their report. It has been unfortunate, but not unpredictable given the sensitivity of the issue, that many of the facts about RU486 have been misrepresented in the lead-up to this debate. The women of Australia—in fact, all Australians—deserve better than that. I believe it is the responsibility of all members of parliament to ensure that the facts are heard and not blurred or muddied.

The current legislative arrangements mean that there are special restrictions on the importation of RU486 that do not apply to any other medicine, including others which can be and are used to assist in abortions. RU486 is defined under the Therapeutic Goods Act 1989 as a restricted good. Under the act, written ministerial approval is required to import restricted goods into Australia. Approval may be given with or without conditions. A written approval must be laid by the minister before each house of the parliament within five days of it being given. However, any application refused is not required to be reported. The Customs (Prohibited Imports) Regulations 1956, made under the customs acts of 1901, prohibit the importation of goods, including substances, that purport to produce abortions, unless the secretary or an authorised officer has by instrument in writing granted permission to import the goods and the instrument is produced to the collector. It is those pieces of legislation that this bill intends to change.

Much has been said about the history of the Harradine amendment made in 1996. There are those who say that there was a deal between the then Senator Harradine and the government in exchange for support for other bills. Others say that that position is untenable as it occurred prior to when the balance of power was held by Senator Harradine. I do not know the truth—I was not here—but what we do know is that in 1996 much less was known about the drug, so more caution would have been expected. Much less clinical evidence was available. But we should also remember that we operate in a political environment where the rewriting of history is an oft-used tactic and the absolute truth of deals will never be known. Frankly, what happened in 1996 is not relevant to today’s debate.

RU486, or mifepristone, is a synthetic steroid that blocks the action of progesterone, the hormone that is essential for pregnancy. The drug has been licensed for use in humans since 1988 and is now available in the United States, Canada, the UK, many countries in Western Europe, Russia, China, Israel, Turkey and New Zealand. RU486 is primarily used in combination with prostaglandin to induce early abortions, up to nine weeks. In all those countries this is done under medical supervision, although in some countries women may be allowed home if they can access medical care in case of emergency. We know that many doctors and women consider that a medically induced abortion is preferable to a surgical abortion for a range of reasons, including that an anaesthetic is not required, that medical termination can be performed much earlier than a surgical abortion and that some women find it more acceptable as it enables greater involvement in the process.

By using RU486 and prostaglandin, between 92 and 97 per cent of women will abort completely. The remainder will require a surgical procedure to complete the abortion. Fewer than one woman in 1,000 will experience severe bleeding. In France, where RU486 is available for use under medical supervision, the drug is used in about 10 per cent of the 200,000 annual abortions done in the country. In more than a decade, researchers there have found that the pill has not replaced surgery as the most common method of abortion. It has also not increased the total number of abortions. The use of RU486 as an abortifacient is supported by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the AMA, the Family Planning Association, the Public Health Association of Australia, the Doctors Reform Society and many other women’s groups.

It is also important that we do not confuse RU486 with the morning-after pill Postinor. The actions of these two drugs are completely different. Postinor acts to prevent the implantation of the embryo in the uterus. However, there has been considerable confusion in the community which needs to be unravelled. Postinor, the morning-after pill, is available without prescription as an S3 medicine. It is kept behind the counter at a pharmacy and a pharmacist must provide advice on its sale. It is not an abortifacient, because it is taken before implantation has occurred. It is prescribed completely differently to the way that RU486 would be prescribed if the TGA found it to be safe.

No drug—either prescribed by a doctor or purchased over the counter—is without risk. That is why appropriate authorities like the TGA exist to evaluate, register and list drugs for use in our community. Further, the TGA establishes the course of therapy for using drugs in consultation with appropriate authorities. In this case, consultation would be expected to include the College of Obstetricians and Gynaecologists, the College of General Practitioners and the Rural Doctors Association, among many others. For example, in New Zealand RU486 can only be taken in a licensed facility, and the procedure occurs within that facility. In Australia, it is expected that the drug may only be prescribed if an ultrasound has been performed, and that facilities will be available if complete evacuation does not occur.

Any death from any drug is a tragedy. The recorded death rate from RU486 is less than one in 100,000. The death rate from a completed pregnancy is 12 in 100,000 in developed countries. From all available evidence, RU486 is in fact a remarkably safe drug. But I reiterate: it is not for us as politicians to assess the safety of RU486. That should be done by appropriately qualified technicians who have at their disposal evidence and the skills to evaluate the evidence. Much has been made of the four women who died from a rare bacterial infection after taking RU486, although a causal link has not been identified. There are some facts around these cases that have not been promulgated by the opponents of RU486 but that need to be known. Firstly, twice as many women have died from this infection following childbirth as from the use of RU486. There have been eight deaths against four. The four deaths referred to all involved the administration of RU486 vaginally, instead of orally. Vaginal administration of the drug is considered off-label use, which is allowed but not recommended by the FDA. No causal link has been established between the taking of RU486 and the deaths of these women.

Opponents of RU486 alternatively state that this bill will mean that women will be taking RU486 irresponsibly to unthinkingly procure an abortion, or that women will be traumatised by the experience of a medical abortion, which they must experience alone. There is no evidence that Australian women have abortions unthinkingly. In fact, such a suggestion is offensive in the extreme. We know that over the past decade the proportion of medically funded abortions done for teenagers has fallen by 12 per cent, while the proportion of abortion patients over 35 rose by 37 per cent. We also know that an abortion patient was 40 per cent more likely to be married or in a de facto relationship in 2002 than in 1992. It seems that the decision to have an abortion is increasingly a family planning decision, usually made by a middle-class woman in a committed relationship. Our health care system is well able to cope with restrictions on use, appropriate medical monitoring, the provision of informed consent, patient information and support, and the reporting of adverse reactions. All of these can be put in place to ensure the safe use of RU486 if—and that is the important word—it is deemed to be safe by the TGA.

Much has been made of the potential problems and benefits of making RU486 available to women living in rural and remote areas. Women in rural and remote areas are entitled to the same level of health care as women living in, say, Sydney. It is true that they do not always get it, but we should not be putting extra barriers in their way. If we think that women in these remote areas have inadequate medical care for the use of RU486, then the logic is that we must also admit that their care is inadequate for managing spontaneous abortion, birth and a whole range of health problems. We are happy to let doctors in these areas deliver Medicare funded services and prescribe PBS medications, many of which must be carefully monitored. So why is RU486 any different in this respect?

Many women seeking abortion seek support and counselling regardless of whether the abortion is done surgically or medically, and that support is currently available. Whether it is sufficient or delivered appropriately is another debate, but can I say that the current move to require women to receive prescribed forms of pretermination counselling is driven by those seeking to limit women’s choice and options rather than to provide support to women coming to a decision. It is very important to note that the evidence shows that where RU486 has been introduced into a country the rate of terminations has not risen. The committee received evidence that the number of terminations in the UK, the USA, Germany and Sweden stayed constant after the introduction of RU486. In fact, there is some evidence that the rate of termination has fallen in some of these countries.

I urge all participants in this debate to be factual with their contributions. I urge the media to challenge incorrect, graphic and emotive language, and I encourage our community to look past the language of fear to the facts. It is really important for us all to note one crucial fact here: this is not a vote about whether or not abortion should be allowed in Australia. Abortion is a legal procedure in Australia. The debate about the legality of abortion and who can access it occurs in the parliaments of the states and territories. This debate is about allowing a drug, which has been around for some time and widely used overseas, into Australia for clinical use, which must be subject to scientific and ethical approvals and not the personal beliefs and biases of any health minister.

Minister Abbott has today been extremely defensive about his position. But I put it to the Senate that, if the minister were of a different disposition, my position would not change. Any politician, in my view, is not equipped to be making decisions about the availability of RU486, which would be legal in Australia after the appropriate assessment of its quality, safety and efficacy were complete. Clearly, the use of RU486 will not come without a whole set of guidelines. Those should be put in place by the experts. That is not precluded by this bill. It is time for RU486 to be treated as any other drug in Australia. That is what this bill does and that is why I will be voting for this bill.

In closing, I wish to commend the four women proponents of this bill. They have worked together extremely well and they have been courageous. The women of Australia will thank them in future if this bill is successful. I also commend Professor Caroline de Costa, a professor of obstetrics and gynaecology from Cairns in North Queensland, who was courageous enough to put an article in the Medical Journal of Australia which has been recognised by many as the catalyst for this debate.