Fiona Nash (NSW, National Party) Share this | Link to this | Hansard source

I rise today to speak in continuation on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. In 1996, this parliament allowed an amendment to the Therapeutic Goods Act 1989. That amendment made the minister for health ultimately responsible for decisions in relation to the importation, trial, registration and listing of RU486 and other abortifacients rather than the Therapeutic Goods Administration, the statutory body usually responsible for the approval of medicines in Australia. This was on the grounds that these drugs amounted to a special category of drug requiring an additional layer of public scrutiny. That debate occurred some 10 years ago, over concerns about the safety of the drug in the context of what was known about RU486 at that time. In 2006, we are 10 years on and there is much more data available. RU486 is now approved in 35 countries, including the United States, New Zealand, France, Israel, Sweden, Russia, Turkey, Tunisia and Britain, but not Australia.

As a senator for the people of New South Wales, my role is to strive to ensure that policies are in place for the benefit of the people I represent. My role is to ensure that I remain open-minded, prepared to consider all views and ideas, in order to provide the best possible outcomes for those people. It is often not an easy task to pursue an idea that may be perceived to be difficult. Yet, when there is a sense of purpose, when you know that encouraging debate on an issue of importance is the right thing to do, it is a path that you follow.

I draw to the attention of the Senate the fact that this bill has been co-sponsored by a Liberal senator, a Democrat senator, a Labor Party senator and me, a member of The Nationals. This is not about party policies. This is about four senators in this place as individuals, with enormous support, who believe, regardless of belonging to different parties, that passing this bill is the right thing to do. I am advised that this is the first time in the history of this place that four members of different parties have co-sponsored a private senator’s bill. I think it brings great strength to the bill that, regardless of our individual philosophies and ideologies, we are united in our belief that passing this bill will be of benefit to people in this country.

I want to very clearly outline what this bill is about. There has been much emotive debate surrounding the issue of RU486. It is important that people have a very clear understanding of the intent of this private senator’s bill regarding RU486 being debated here in the Senate this week. This private senator’s bill was introduced as a result of growing concern that the approval process for drugs such as RU486 was inadequate and that there was a need for a debate regarding that process.

This bill is not about abortion. While the issue of abortion is very difficult and very sensitive—and I respect people’s right to hold the views they do regarding that issue—this bill is not about abortion. Let me explain. We live in a society in which termination is lawful. While we would all like to see as few abortions as possible and we would all like to see much greater education and prevention of unwanted and unplanned pregnancies, we have to deal with the fact that terminations do occur. We also have to acknowledge the fact that, in this nation, we have already had the moral debate about abortion, and the outcome was that termination is lawful. It is lawful under state and territory laws across this land and has been so since the 1970s.

This debate is not about being pro choice or pro life. Those who argue on that basis have misunderstood the intent of this bill. This bill is about whether a method of termination should be allowed to be assessed by the Therapeutic Goods Administration to determine if it is suitable for use in Australia. In spite of those who try to make it more complex, it is as simple as that. This bill is about whether the health minister of the day or the Therapeutic Goods Administration should be responsible for deciding the quality, safety and efficacy of this drug and other abortifacients.

There has been some argument that the responsibility should remain with the minister as there is a necessity for parliamentary scrutiny of this drug because it is related to abortion. Can I point out that it is not parliamentary scrutiny; it is the scrutiny of one minister—the health minister of the day. The minister does not have to inform the parliament if he or she rejects an application for approval of a restricted drug, and, if a drug is approved, the only requirement of the minister is that he or she informs the parliament within five sitting days.

The argument has been put during this debate that the use of restricted drugs such as RU486 is a social policy issue and therefore needs the approval of the minister. I would argue that the social policy issue was determined with the changes to the laws in our states and territories that allowed for lawful termination. This is not a social policy issue. This country has had that debate. This is about determining whether or not a particular method of termination is suitable for use in this nation.

The question is: who is best able to assess this drug? In what has become a very emotive debate, the heart of the debate—indeed, the crux of this bill—is who is best able to assess it. I would put to honourable senators and to the people of Australia that it is the Therapeutic Goods Administration. There is no one person in this parliament who is qualified to make clinical and/or therapeutic judgments on this drug. If we take the premise that the debate about abortion has been had and the result was lawful termination then we should be allowed to assess methods for that termination.

I am not going to stand here today and argue as to the safety of this drug. There is a deluge of information on the safety or otherwise of RU486. Depending on what you read, you could be equally convinced that it is either completely safe or completely unsafe. Reading information from the internet does not give us the ability as legislators to determine the safety of this drug—or, indeed, of any drug. I can assure you that I do not have the qualifications or ability to assess the quality, safety and efficacy of this drug. And that is exactly the point of this bill. As I said earlier, I do not believe that any of my colleagues in this place—or indeed in the other place—have the ability to do this either. And I do not believe that any of my colleagues in either place could, in all honesty, disagree with me on that. The ability to assess the quality, safety and efficacy of this drug rests with the Therapeutic Goods Administration.

I have listened very carefully to all sides in this debate. I have read carefully and studied the views of the community. I have listened to those who attended the Senate committee inquiry, and I respect the views of all of those people. However, one of the views of those that are against the bill is that they do not believe that RU486 is safe. There is much varied literature regarding this drug but, as I said before, there is much information supportive of both sides in this debate. As Benjamin Disraeli said, there are three kinds of lies: lies, damned lies and statistics.

Those who are against the use of RU486 because they are concerned about the safety aspects of these types of drugs should not be concerned about supporting this bill. This bill does not say that RU486 should be used in this country. This bill does say that the Therapeutic Goods Administration should be allowed to assess the drugs in this category. Those people who have concerns about safety should welcome the assessment by the TGA if they are so sure that this drug is unsafe. If their concerns about safety are correct then the TGA would not approve the drug for use in Australia.

There have been concerns put forward that RU486 would lead to an increased incidence of abortion. These concerns are unfounded and could not be substantiated by any submission or witness to the recent Senate committee inquiry into this bill. There have also been concerns put forward about the ability to safely administer the drug in rural areas, saying that the circumstances were not appropriate for use in those areas. Quite frankly, I think this is an appalling slight on our rural medical practitioners. If a situation was not suitable for a woman to use RU486, quite simply the practitioner would not prescribe it.

The Therapeutic Goods Administration is trusted by this government to ensure that medicines and medical devices used in this country are of a very high standard and at least equal to, if not better than, that in comparable countries. We have a TGA that is highly regarded the world over. The government turns to the TGA to ensure that the delivery of medicines and medical devices in this country is of the highest possible standard. According to the Therapeutic Goods Administration’s 2004-05 annual report, 49,343 items were listed on the Australian Register of Therapeutic Goods.

Can I just say on that that there has been some argument about RU486 not being therapeutic as it does not treat a disease. I would argue that the Therapeutic Goods Administration assesses many drugs that are not for a disease—for example, the oral contraceptive pill—and it also assesses medical devices such as prosthetic joints, intra-uterine devices, medical gloves, syringes, condoms and disinfectants. Many of those who oppose this bill are letting the words used in the name of the body most able to assess this drug cloud the fact that the Therapeutic Goods Administration is indeed the body most able.

We trust the Therapeutic Goods Administration to evaluate and monitor around 50,000 items for the people of this nation, often dangerous drugs, and we believe they will do it safely and effectively. Yet the opponents of this bill are saying that the TGA does not have the ability to determine the quality, safety and efficacy of eight particular drugs because those eight drugs fall into a restricted category. That is eight drugs out of almost 50,000 items that we entrust the TGA to put on the Australian Register of Therapeutic Goods. Those drugs are alprostadil, carboprost, dinoprost, dinoprostone, gemeprost, mifepristone, misoprostol, prostaglandins and vaccines against human chorionic gonadotrophin. We are saying at the moment that the TGA has the ability to assess and approve 49,343 drugs, items and devices—but not those eight.

There are those that say the TGA does not have the ability to make a moral evaluation of the social issues surrounding the drug RU486 and others like it. The Therapeutic Goods Administration does not need to have that ability. The moral evaluation of the social issues has already been done in the debate in this nation that led to termination being lawful. How can we say that, in a society where termination is lawful, we will allow surgical termination and yet we will not allow medical termination to even be assessed? It is illogical.

There have been, and will be, many speakers on this bill. There will be many different points of view; there will be many different arguments. There will be emotive arguments. What I ask is that we look at this bill for exactly what it is: a bill that would allow a method of termination to be assessed by the Therapeutic Goods Administration, the only body properly qualified to do so in a society where we have agreed that termination is lawful. I urge senators to support the bill.

Judith Troeth (Victoria, Liberal Party) Share this | Link to this | Hansard source

As my colleague Senator Nash has said, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 seeks to remove responsibility for approval for abortion drugs, particularly RU486, from the purview of the Minister for Health and Ageing and return it to the Therapeutic Goods Administration. I am a co-sponsor of this bill in the Senate. I believe strongly in the reasons for this bill and I will be voting for it. As Senator Nash has said, we must separate politics from medical decision making. In 1996, amendments to the Therapeutic Goods Act were passed that placed medications such as RU486 in a special group of drugs known as restricted goods. According to these amendments restricted goods cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health and Ageing. RU486 is the only medicine that is subject, as far as I know, to the restricted goods condition.

It is interesting to note that the act, as it was amended in 1996, also effectively banned the entry of RU486 into Australia not only for use as an abortifacient but also for a number of other possible uses such as an emergency contraceptive, in the treatment of some breast and brain tumours, and as treatment for endometriosis and irregular bleeding. In any case, prescription of this drug will lead, we hope, to a wider choice of drug for the medical profession and the alleviation of suffering for patients. Medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration and do not require additional approval from the minister.

What does the TGA do in this process? It is charged with identifying, assessing and evaluating the risks posed by therapeutic goods that come into Australia. It applies any measures necessary for treating the risks posed and monitors and reviews the risks over time. The TGA is a responsible professional body and it is regarded by the government, and I would imagine by the entire scientific community within Australia, as being qualified to manage the risks.

It is also necessary for the purposes of this debate to know that there is a group called the Australian Drug Evaluation Committee which, together with the TGA, makes the recommendations on who can prescribe the drug, how it can be used, and under what circumstances it can be used, and it can also apply any measures necessary for treating the risks which are posed. That particular group is made up of clinicians and key medical experts and it is appointed by the Minister for Health and Ageing. Its brief includes: the quality, the risk benefit, the effectiveness and access within a reasonable time of any drug referred to it for evaluation as well as medical and scientific evaluations of applications for registration of prescription drugs. It also provides services to other government departments, committees and community based organisations on a wide variety of regulatory matters related to prescription medicines. This group has particular professional qualifications in clinical medicine, pharmacology, toxicology or general practice. It has six core and 16 associate members and the review process is exhaustive. The group looks at all sides of the issue, examining the conditions of manufacture, the clinical impact and, of course, the safety of the drug.

Against this scenario of objective scientific measurement we have the view that responsibility for approving the drug should lie with an elected member of parliament, who is also the health minister. It is not that I object to the present holder or indeed any holder of that office personally. It is simply that I do not believe that any of my esteemed colleagues in their particular career as members of parliament have the required scientific knowledge to assess any drug in the considered and stringent way that we accept drugs should be assessed in Australia. Even with expert advice, which I have no doubt is offered to the minister within his office, the decision still rests with the minister and I do not agree, and have never agreed, that that is a desirable aspect.

While I would like to confine this particular debate to the removal of power from the minister to the Therapeutic Goods Administration, I accept that inevitably, because of the results of this drug being used, we will enter into the wider abortion debate. There have been claims that approval for this drug—assuming that it is approved—will lead to ‘do-it-yourself’ abortions, as they have been termed, and ‘backyard abortions’, which is another term, and that it will make abortion too easy. There is nothing easy about abortion.

Abortions must comply with state laws, or the procedure thereof, and they must require medical oversight and approval—and that is so, whether the procedure is medical or surgical. A woman will still be required to satisfy the same tests to have a lawful termination using this drug as she would with a surgical termination. It is my belief that the Therapeutic Goods Administration would place caveats around the use of this drug so that it would be used under proper, lawful medical supervision and so that the dreadful scenarios that have been put to us by opponents of this bill are simply fairytale stuff.

If this drug is approved, Australia will join other countries where it has been approved for use: the United Kingdom, the United States, much of western Europe, Russia, China, Israel, New Zealand, Turkey and Tunisia. As well, other scientific bodies that are within Australia, such as the Australian Medical Association, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Rural Doctors Association of Australia, all endorse the use of RU486 for medical termination of pregnancy.

I live in Victoria and I subscribe to the Menhennit ruling, made some 35 years ago, that abortion is legal to satisfy concerns about the health of the mother. And, by and large, that particular tenet is subscribed to by most state governments. Most Australians accept that particular status quo. What we are debating here today is the way in which one of the avenues to reach that objective is to be regulated. As my colleague Fiona Nash has said, this is not a debate about abortion; this is a debate about one of the procedures that we would like to offer as a choice to women, should they contemplate that particular choice of dealing with their pregnancy.

So, what are we to do? Are we to have the safety and efficacy of an internationally widely used drug determined by a minister for health who is still a member of parliament, or are we to have the safety and efficacy of an internationally used drug determined by an objective science and evidence based national authority? The choice is to be made by the Senate. I know my choice, and I will be voting for the bill.

Lyn Allison (Victoria, Australian Democrats) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not about whether or not abortion is or should be legal. That issue was resolved decades ago by every state and territory government in the country, and women can terminate unwanted pregnancies provided they meet the criteria set out in those state laws.

This bill is not about the morality, the desirability or otherwise of abortion. It is not about whether women are wilfully having abortions when they should not or just because it is available to them. It is not about feminism or whether the clinics, public and private, are acting out of self-interest—and, believe it or not, some people say so. It is not about whether women can or should be coerced into motherhood or harassed and shamed out of terminating the pregnancy. It is not about the intimidation women experience from protesters outside clinics photographing them and accusing them of murdering children.

Laws and regulations do not change a woman’s determination to terminate an unwanted pregnancy, even if they do not protect her from this kind of intimidation. They just affect the safety and the quality of the experience. It is not about the safety of RU486. If it were, there would be no reason to not rely on the TGA’s assessment of the risk. It is not about the current rate of abortion and how to get it down. The current rate is 75,000 to 80,000 a year, and dropping by all accounts. It is numerically lower than it was 30 years ago in this country, when there were very many fewer women here.

We have the figures for Scotland, Sweden, England, Wales, Switzerland and other countries where overall abortion rates did not increase following the availability of RU486. After the introduction of RU486 in New Zealand, our nearest neighbour, in 2004 there was a very small decrease for the first time in seven years. Of course it would be good to reduce the number of unwanted pregnancies—there is no question about that—and the need for abortion that arises from those unwanted pregnancies. But there is no cause to panic. It has nothing to do with ethics, the absence of values in schools, women’s careers, the rights of the unborn or dodgy anti-abortion government funded pregnancy counselling.

Let us be frank. This debate is taking place because a very small number of determined Australians think that by defending the ministerial veto on RU486 there is a chance that abortions—a dozen, 100, maybe only one—can be stopped. I respect them for their tenacity and their conviction, but they are wrong and they represent the less than 10 per cent of the general population that holds that abortion should not be available to women, regardless of the method. No amount of push polling, or selective, creative interpretations of history, or manipulation of statistics or studies changes the fundamentals. Abortion is legal in this country. Democratically elected men and women in state and territory parliaments made laws with regard to abortion and the criteria that must be met to terminate a pregnancy—and they did this 30 years ago.

Women cannot and should not be coerced into motherhood against their will. Difficult as abortion is, women have terminated unwanted pregnancies throughout history, in all countries and in all cultures. Women have put their lives at risk rather than bear a child that they cannot rear, and there are numerous compelling and often complex reasons for this. Some women only discover when they are pregnant that they have a gynaecological cancer, and can lose not only their pregnancy but also their chance of ever conceiving again.

Parenting is not easy. It is no piece of cake if you are low paid, if you are in insecure work, if your partner is violent, if you have a serious anxiety disorder, depression or a disability, if you are in poor physical health, if you are single with two kids who are already a handful, or if your parents would banish you as an unmarried mother. The risks of having an unwanted pregnancy are high. There are many years between puberty and menopause. For typical women in sexual relationships for most of their 30 or so reproductive years, pregnancy is a possibility every single month, and that adds up to around 400 occasions in a lifetime. Sixty per cent of women seeking terminations were using contraception that failed.

The Reverend Dr Dean Drayton of the Uniting Church said this week:

The decision to have an abortion is not just a moral issue but a social one. While the current debate attempts to pass moral judgement on the act itself, it ignores the many emotional, physical, financial and social issues that often create a situation where a woman is forced to consider an abortion.

The Uniting Church hopes that those engaged in this debate do not lose sight of the complexity of the issues.

This is why it is galling listening to the men—and it is mostly men—who have such contempt for women who terminate unwanted pregnancies, who have neither compassion nor understanding of the huge and, for many, daunting task of taking an embryo the size of a grain of rice to adulthood. It is okay for people to hold particular ethical or religious views that lead them to oppose abortion but it is not okay for them to impose their position on others who do not. Women are fully human. We will act on our own set of values and can be trusted to make reproductive health decisions for ourselves or to share those decisions with those we trust. An estimated one in three women have had an abortion, and I am one of them.

Fortunately, this bill is not about any of these things. The bill is quite simple. It removes the responsibility for approving the use of the abortion pill in Australia from the health minister and moves it to the agency that approves all other pharmaceuticals, the Therapeutic Goods Administration. Opponents of this bill have suggested that the TGA is not capable of correctly assessing the safety of RU486 and, by implication, that the Minister for Health and Ageing is. Both assertions are completely wrong.

The minister says that doctors cannot be trusted to use the drug properly, but doctors in the World Health Organisation, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Australian Medical Association, the Public Health Association of Australia, the Rural Doctors Association of Australia, the UK Royal College of Obstetricians and Gynaecologists, the International Federation of Gynaecology and Obstetrics, the US Food and Drug Administration, the American Medical Association and the American College of Obstetricians and Gynaecologists say that RU486 should be available to women as a safe alternative to surgical abortion, used in accordance with appropriate medical guidelines and supervision.

RU486 enables women to abort very early in pregnancy—indeed, as soon as the pregnancy is confirmed. Surgical procedures cannot be done before six weeks. It is ironic, I think, that opponents of abortion and RU486 also campaign against late term abortions but are silent on this benefit of this abortifacient.

But the key question here is who has the expertise to make a judgment about the safety and efficacy of a drug that is used for legitimate purposes. The current law not only gives the minister for health a veto over the availability of RU486; it specifically prohibits the assessment of safety and efficacy by the TGA before the minister decides. What a ridiculous system we have! How is the minister to make his decision without the input of the agency that has the expertise to do the assessment—particularly a minister who has no training in either science or medicine and who, I point out, is not a woman? The minister is not required to use any particular criteria in making his decision. The only process set out in the legislation is the requirement to inform the parliament if he approves an application, which will then go on to be assessed by the TGA.

The current minister’s opposition to any change has sent a clear message to possible sponsors of the bill: ‘Do not bother.’ So for 10 years none has, until now. Professor Caroline de Costa made an application to use RU486 for her patients, under the practitioners scheme. That process should take two to three weeks, but, six weeks later, she still has not heard back from the TGA. Other doctors have done likewise; they have made similar applications.

We have heard a lot about the importance of the parliament’s role in all of this, but the truth is that it has no role whatsoever. The decision is not disallowable, cannot be amended and is not open to challenge by parliamentarians or sponsors or women affected. There is no debate in this place. In fact, the parliament will not be informed of the reasons for the decision and will not even hear about it if the application is rejected.

RU486 is not a do-it-yourself, home alone option, as some would suggest, although many women choose RU486 because they see privacy and being in control as being advantages over surgical termination under anaesthetic. Supervision by a doctor is a must, as is access to emergency medical services. Everyone agrees with that. This bill does not change existing laws on abortion in Australia. If RU486 were made available, women and doctors would still need to comply with the relevant state criminal codes regulating the procedure.

It is not only women who may want to use the drug to terminate a pregnancy who miss out. RU486’s antiprogesterone action may be a useful therapy for conditions that include inoperable meningioma, Cushing’s syndrome, breast and prostate cancer, glaucoma, depression, endometriosis and uterine fibroids. Unfortunately, because of the current situation, Australians with these conditions miss out on access to this drug or are forced to cope with intolerable delays in trying to get that access. It is not enough to say that the current legislation allows RU486 to be imported under its special access scheme. In practice the scheme is unworkable. Doctors are worried about being involved in supplying a drug that the TGA has not been able to evaluate—and therefore for which it has not provided the normal assurances about drug use on which doctors depend for their indemnity requirements.

RU486 is safe and effective—not 100 per cent. No drug can claim that. Many other drugs are freely available but have many more side effects and pose much greater risks to the users. The opponents of this bill have made much of the small number of adverse effects associated with the drug, but I urge senators to look at the data carefully. At the end of the day, I urge them to make no judgment about the safety. That is the job of the TGA. No-one in this chamber is qualified to make that judgment, and they should not. All safety is relative, and risks are always weighed against benefits. So, for the sake of Australian women, I urge senators to support this bill.

Claire Moore (Queensland, Australian Labor Party) Share this | Link to this | Hansard source

Many speakers in the first part of this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 will make similar comments. There is much that I am going to say that has already been said, so I will try to amend my comments. It is important that, when we have any bill before our parliament, people understand exactly what the terms and nature of the legislation are. I hope people have taken the opportunity over the last several months to read the bill and the explanatory memorandum and to understand exactly what this debate is about. It is not a national referendum on the rights or wrongs, legality or morality of a woman’s right to choose to abort. In fact, it seeks to clearly identify for all our community where the appropriate assessment process for the safety, efficiency and quality of a medication should be.

There has been no attempt to hide the purpose for which this medication would be used. In fact, throughout the evidence we have seen much information, medical and social. It has been from people who have used different forms of abortion treatments and people who are deeply opposed to that form of treatment—but people who wanted to have a say in the debate. My concern is that I am not quite convinced that the bill was the debate.

It is clear that there is an overwhelming interest in the safety of Australian women, and that is something that we all share. One positive aspect to come out of the volume of correspondence that we have all received and the level of interest is that there is an agreement that women in Australia must be safe and they must have safe choices. What we have before us to consider as a voting parliament is the assessment process.

Four women from across party backgrounds have combined to put before the parliament a private member’s bill. We believe that we should reaffirm the right of the Therapeutic Goods Administration, the TGA as it is commonly called, to do the job for which it was established, for this particular group of medications. We talk mainly about RU486 because that is the drug that is most commonly known and that was most spoken about in the previous discussion in this place in 1996 when the amendment was first introduced. It did not refer, and does not refer today, only to RU486 but to a group of medications, as is public information and available on the internet. There is no confusion about that. But in common parlance throughout this debate and the correspondence process people have focused on RU486.

We have heard from previous speakers and no doubt we will hear in the future exactly what the role of the TGA is. Again, I really encourage people in this debate to look at the information and to find out what our TGA does. That would be a positive step. How are medications evaluated in this country and by whom? Exactly what processes are used? What follow-up is done? What roles do the various expert panels, which Senator Troeth described, have? Who takes positions on those panels? The key positions in the TGA are by ministerial appointment, so there is an acknowledgement that there is that link with the parliament. You do not wake up one morning and find yourself on an expert panel for the TGA. There is some expectation that you have gained that position through the community, through your scientific expertise and through your knowledge of the issue.

Our TGA is widely regarded and respected, not just in Australia. After all, about 50,000 medications have been viewed and assessed by this body—and I will not name them all; they are there on the website. You can find exactly what medications Australians are able to access after the TGA has fulfilled its role to ensure that they meet the safety, efficiency and quality expectations of our community.

What we are asking in our bill is that that expectation is extended to the group of medications that are used mainly for abortion. And that is the key difference in the debate. It has been the key difference in all the correspondence we have had. That has been what some people want the debate to be about. As I have said before in this place, if that is what people want to debate, bring it forward and have that debate. Have another debate at this level—I am not quite sure what the methodology would be—in this place about whether Australians want or support the right of women in the country to choose.

One of the things I have found most confronting through the last few months is how many people want to tell me what most Australians want, how many tools they are able to bring forward to tell me what most Australians want and how many tools people are prepared to bring forward in their letters, emails, submissions and evidence that absolutely prove the comments they are making. But when you actually dig deeper, you find that people need more information and they sometimes do not really fully understand the information they are quoting with conviction.

One of the senators on our panel used to ask the people who came before us: ‘This particular amendment was put forward in 1996; we have lived with it for 10 years; what is different now?’ We have moved with, amongst other things, the increase in worldwide knowledge on this form of medication. The evidence that is able to be accessed is of a greater volume and there is a much greater ability to test the drug because of the number of women who have used RU486. But for me, probably what has changed most in that 10 years is people’s ability to access and feed back the information they can find on the internet. Someone commented today that we have been receiving a Google based argument in our inquiry. That has been proved by looking at the various internet links that people have used in preparing their submissions and their evidence. That in itself is a very good thing because it shows that people are interested in the topic.

The clearest message for me out of all of it was that we need to have this large volume of evidence efficiently and independently assessed. As has been said by previous speakers, this parliament is not the place for that form of medical assessment to be done. That kind of decision must be appropriately referred to the government body which has been designed to fulfil that role—and is seemingly quite confidently able to fulfil that role for all other medications in the country.

To the people who raised questions about the efficiency, funding and processes within the TGA, my response is that if they have concerns about how the TGA operates then those concerns are valid for all medications. As some witnesses—not many—have raised concerns in this inquiry about the ability of the TGA to fulfil its role with regard to safety, efficiency and quality, perhaps what we should do is review the funding for and the processes within the TGA. I do not believe that is necessary. Instead of using that particular lever in making those arguments, we should be ensuring that we are absolutely confident with the Therapeutic Goods Administration on all levels. The feedback that we get from international sources and also from the various medical bodies in this country—many of whom felt that it was important that they give evidence to our inquiry—is that they have that faith. They also believe that there has to be effective interaction between the medical practitioners and the TGA accreditation body.

A major concern was raised in the recent inquiry about the group of drugs listed as a result of the amendment passed in this place in 1996. If the major concern about that group of medications identified in this bill is their safety, surely that should be able to be assessed by the body which is qualified to do the assessment for all other medications. A clear message out of the inquiry should be the reinforcement of the role of the TGA. Surely we would be able to agree on that.

However, if the difference goes deeper than that and is specifically about the usage of the medication, there will be no agreement. There cannot be agreement on that issue, because the evidence, the passion and the emotion around the issue of abortion in this country continues to be great. I believe that none of that debate was unexpected by the people putting up this particular private member’s bill. However, that is not reason enough not to put forward the bill. What we need to do is to take up our responsibility as elected members of parliament and see what we can do to ensure the safety of Australian women. The debate must reinforce the role of the TGA to ensure that Australian women have effective and safe choices, and our community must ensure that they are treated with respect and have their judgments respected.

It is not good enough that people are prepared to impose on others their particular views and ideas about what is right. A question that I consistently asked people who came before our committee who were in the medical profession and who were giving evidence about their concerns about the safety of RU486 was whether there was anything in the proposed legislation that would force them to use this particular medication. Where was the compulsion to use this process? There is none. The amendment that we have put before the parliament carries no compulsion. The amendment that we have put before the parliament gives clear responsibility to a group that has been developed for that job.

I do not think it would have been possible to have this full debate without getting into the debate about abortion in Australia. However, when we are considering this particular piece of legislation we must move away from those issues and focus on the safety and medical aspects. I know that is difficult. I know that there are people in the community who have made cases that the particular use of this drug means that there is an extra role for elected politicians. I do not agree with that premise. As has been said before, the legality or otherwise of abortion is determined at the state government level. Various parliaments have passed various rules about that. It is important that our community fully understands that. The issues about the morality of the drug lie with individuals. People must have the freedom and the respect to make up their own minds on those issues. I am hopeful that there is the degree of respect in our community to allow those decisions to be taken with freedom and independence.

I am concerned that so many people who wished to have their say in this debate were unsure about the exact terms of the debate. They are still confused about whether or not we are looking at legalising RU486. They are still concerned about anything that we will be doing in this particular process that would in any way force people to take actions with which they would not be comfortable. I ask that those people who are involved in this debate please read the legislation. Ask the questions. Do not confuse this debate with one that you may wish to have. This is not the time or the legislation.

I want to acknowledge some of the people who are in the gallery who have been working in women’s health for many years and who have been deeply involved in these discussions. It is important that in processes like this their voices are heard.

After this round of debate, we will have more. Regardless of how the vote goes tomorrow afternoon in this place and in the House of Representatives, the discussion will not end. No piece of legislation, no amendment, remains unchanged. There is nothing in our democracy that should be outside the ability to be reviewed by this parliament; by any parliament. In terms of how we do it, however, what I hope is that we can learn through this process that we can discuss difficult issues and are able to have very serious disagreement. All of us would acknowledge that the last few public hearings have not been the easiest things to get through, but we have survived. One of the messages out of this process should be that we can have these debates and that we are mature enough to be able to have different perspectives yet clearly understand what our roles are.

At this time, I seek leave to table a series of petitions on this issue that we received yesterday, which I have passed through the two whips.

Leave granted.

I will read what the topic is—what people were signing. These petitions were clearly on the topic of the legislation. They say:

We, the undersigned, believe medical experts, not the Federal Health Minister, should determine the availability of RU486 in Australia.

My hope and expectation, in terms of our democratic system, is that people who are prepared to put their names to these petitions as well as the letters and statements have fully read the legislation and understood what it was about. My hope is that this debate will ensure that the people of Australia will fully read the legislation and understand the real issues.

The Google aspect of this process should be admired, because it means that people have taken an interest. I think the degree of interest surely reinforces the need for appropriate medical, safety and efficiency assessment so that our goal to ensure that women are safe is obtained and that we in parliament are able to appropriately do our job, not pretend that we know what all Australians want, nor that we know what should happen and that we have any special ability by being elected to this place to have skills beyond our own knowledge—and that includes being able to assess medical safety, regardless of how knowledgeable we are in other ways. I commend the people who made the effort to be part of the process, to contact the senators and to be involved, but I beg that you actually understand and accept what we are debating and do not get confused with some other debate.

Gary Humphries (ACT, Liberal Party) Share this | Link to this | Hansard source

I rise today in this debate to comment both on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 which is before the chamber and on the report into this legislation which was tabled by the Senate Community Affairs Legislation Committee earlier today. Let me say at the outset that this inquiry was very difficult. It, superficially, examined a fairly simple question—and that is whether the decision about the availability of particular abortifacients in Australia should be a decision made by the Minister for Health and Ageing or a decision made by the Therapeutic Goods Administration of Australia. In practice, of course, it was impossible in the course of this inquiry to separate that simple question from the complex political, ethical, religious and moral issues which are associated with abortion. This minefield issue was further complicated by the relatively short reporting period that the committee had to deal with, coinciding with the Christmas-New Year period. Senators made particular efforts to comprehensively cover the issues confronting them in the course of this inquiry, notwithstanding those impediments. I particularly want to take the opportunity to thank senators on the committee for accommodating my personal travel requirements during that period of time.

What we have in front of us with this report is, notwithstanding those limitations, a comprehensive assessment of the evidence that was given to the committee by both sides of this debate about the operation of RU486 and the impact it would have on Australian medicine if it were to be legalised for use as an abortifacient. We have distilled the essence of nearly 2,500 submissions and letters to assist senators in making a decision on this legislation. In accordance with previous issues before Senate committees which were of an ethical or moral character—issues such as human cloning—the committee has made a decision not to make a recommendation about the bill itself. It has not decided to recommend that the Senate should either support or oppose the legislation. What it has done instead has been to give the arguments surrounding this issue clear understanding and articulation so that it is possible for senators unfamiliar with issues surrounding the operation of this particular drug to better understand what it is that they are voting on. Given the ethical and moral overlay relating to abortion that I spoke about before, it would have been quite pointless to have attempted to go beyond that point.

I hope that senators in the short time available will have an opportunity to read this report. Despite the fact that the report makes no finding on the bill, all the participants in the inquiry did form very strong views about the bill itself. My view is that the bill is a mistake and should not be supported. That view is not based on a particular view about the risks associated with RU486. I acknowledge that a very sizeable body of evidence about the risks associated with the use of RU486 in this country and elsewhere was placed before the committee. In many respects there is a need for further and better data about the operation of this drug, and those issues about the effects of the use of this drug on women’s bodies are issues which could be properly placed before the Therapeutic Goods Administration. In that respect I do not subscribe to the view put to the inquiry that the TGA is incompetent or ill-equipped to make an assessment of the physical properties—the medical risks—associated with the use of this drug in Australia.

However, the point is this: if the medical risks—the physical properties—of RU486 were the only issue to be resolved in this debate we would have no reasonable grounds to quibble with this legislation or the referral of this matter pursuant to that to the TGA. But it is not just about the properties of RU486; it is not just about the chemical operation, the clinical operation, of RU486. The issue is much broader than that. The issue is that RU486 is not just another drug. It facilitates a medical procedure that is not just another medical procedure. This drug and the procedure it facilitates are among the most contentious and controversial aspects of modern medicine today. As the group calling itself Doctors Who Respect Human Life put it to the inquiry:

Abortifacient drugs such as RU486 are unique in that no other drugs are designed to end a human life. Therefore their use demands a unique level of public scrutiny and accountability.

And, indeed, it does.

Controversial issues which arouse great passion and great contention in the Australian community are properly issues for this parliament to consider and for this Senate to vote upon. We would not delegate to a statutory body key decisions in Australian public life. We would not ask a statutory body to decide, for example, whether plutonium should be enriched in Australia; we would not ask a statutory body whether we should drill for oil on the Great Barrier Reef; we would not ask a statutory body to modify the rights of Australians in some pertinent way. But I think that if we pass this legislation today we are passing to a statutory body a seminal decision of our age: whether this new development in abortion practices in Australia should be allowed or should not be allowed.

The fact is that this is an important decision for the Australian community and therefore it is an important decision for the Australian parliament. The point has been made in this debate this afternoon that the decision about abortion was made long ago by parliaments at the state and territory level in Australia and that therefore this parliament, the Commonwealth parliament, has no choice but to follow suit, to rubber-stamp the use of chemical abortifacients in Australia to facilitate the existing decision to allow surgical abortion in Australia. It is true that surgical abortion has been allowed in one form or another in Australian states and territories for some time by the decisions of state and territory parliaments, but chemical abortion is a whole new beast. It is a different concept and deserves different consideration.

Chemical abortions essentially occur outside hospitals, clinics and doctors’ surgeries. Of course, the administration of the drug is designed to occur in those places, but the operation of those drugs takes place in women’s homes, in women’s workplaces and in all sorts of other places where access to appropriate medical assistance may not be as fulsome as it is in clinics and hospitals. In any case, I do not think that this parliament can be snookered in its decision-making role by a decision made perhaps decades ago by state and territory parliaments. The question of whether medical abortion, chemical abortion, should occur in Australia is a decision which today falls on the shoulders of the Australian parliament by virtue of this legislation. We therefore need to make that decision and not defer it to somebody else to make.

Incidentally, all the state and territory parliaments which over time considered the question of access to surgical abortion in Australia had their debates. They debated whether women in those particular states or territories should have access to that kind of procedure. In a sense, by passing this legislation today we would not be having that debate here, except marginally; we would be asking a professional body, a body of technocrats—without being disparaging of them—to have that debate and make that decision. I do not doubt that the scientists, the doctors and so forth who make up the professional body which advises the Therapeutic Goods Administration are well placed to be able to assess the technical operational questions surrounding RU486, but they are not equipped to make the ethical, social and political decisions which would surround the use of RU486 in Australia.

Abortion is a profoundly different procedure from other medical procedures. As I said, in all Australian states and territories there is specific legislation governing the circumstances in which an abortion may occur by surgical means in those states or territories, but there is no legislation governing, for example, a hysterectomy, a tracheotomy or a varicose vein procedure. Why? Because abortion is different. Abortion has an overlay which goes beyond the mere properties or the mere possibilities presented by medical science. It is an issue which is uniquely controversial and uniquely difficult and which uniquely demands the attention of Australian law-makers. As, again, Dr van Gend from Doctors Who Respect Human Life put it in the course of the inquiry’s hearings:

... RU486 is uniquely contentious in its action, raising serious moral issues and obviously therefore requiring a special level of scrutiny and accountability by our elected representatives.

That, of course, is the point. We make those decisions. We are paid to make those decisions. They are difficult decisions—absolutely difficult decisions—but they are decisions that the Australian community expects its elected representatives to make and therefore we should not shirk that responsibility.

I want to conclude by making reference to the fact that there has been intense debate in front of the committee about these issues. At times the proceedings of the committee were very difficult. I do not think that on all occasions we covered ourselves in glory in the way in which the proceedings themselves actually occurred. It is fair to say that there were points when witnesses were not treated with the respect that perhaps they should have been because of the passion and intensity with which these issues came before the committee and continue to vex the Australian community. But that merely reaffirms how important it is that we continue to overview this sort of decision and that we are part of that decision, not merely the mailbox that sends that decision to a body which is not elected and not accountable to the Australian community.

I do not tend to quote members of the Greens party in this place, but I will quote Senator Christabel Chamarrette, who was a Green in the Australian Senate. She said when the 1996 amendments to the Therapeutic Goods Act were being debated:

There is not only a health issue in the narrow sense—that is, whether the drug is safe—but also a question of whether the availability should be limited for ethical or policy reasons in the context of social policy. This debate is yet to be heard.

…         …         …

I ... affirm the right of this parliament to have scrutiny over such issues.

If this bill is passed today, we give up that scrutiny; we no longer have a role in scrutinising that process or that decision. That would be a sad development, in my opinion. The Australian community are certainly divided by this issue, but their divisions and passions about this issue—the fact that they do not agree about it—is no excuse for us to overlook that disagreement and pass the decision on to somebody else. It is our responsibility, and for that reason I believe we should reject the legislation before the house today.

Kerry Nettle (NSW, Australian Greens) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is about who is best placed to assess the safety of the drug RU486, about who can determine whether this drug is safe for use in Australia. The Greens and the majority of people in our community believe that the body that has been set up by the government to assess the safety of drugs—that is, the Therapeutic Goods Administration—is best equipped to make this decision about whether this drug is safe for use in Australia. The Greens believe that the Therapeutic Goods Administration has the appropriate experts and is in the best position to decide whether the drug is safe because it was set up for that specific purpose. It is trusted by the whole of the Australian community with the responsibility to determine whether every other drug is safe for use in Australia. The Greens say that that should also be the case in relation to this drug.

It is worth asking the question: what is the point of the government setting up an organisation like the Therapeutic Goods Administration specifically for that purpose, if we want to stop it from doing its job? What is the point, if we want a Minister for Health and Ageing who is able to say to a body he sets up and appoints to carry out this important responsibility, ‘You can’t do your job’? The Greens say: let the Therapeutic Goods Administration get on with doing its job of making decisions about whether the drug is safe for Australian women.

There are others in the community who hold the view that, somehow or other, the minister for health is best placed to decide whether or not this drug is safe. With all respect to current, former and future health ministers, the Greens do not share the view that one individual is better placed in making this decision than the body set up to do this for the whole country. Health ministers are just individuals and do not necessarily have any medical training. They can seek advice from anywhere they choose; they can base their decision on information from anywhere they like. They do not have to base it on medical evidence. They can base it, if they choose, on their own personal views and their ethical, religious or moral perspectives. There is no accountability in the way in which one individual makes any such decision.

It is unfortunate that many people who oppose this view mistakenly believe that having the health minister decide whether this drug is safe or not for use in Australia somehow offers a form of parliamentary scrutiny. This is not correct. A Parliamentary Library research note explains:

Under current arrangements, the Minister is simply required to notify the Parliament of a decision to approve an application for evaluation by the TGA. Given the fact that such a decision would not be disallowable—

by the parliament—

this does not amount to a significant level of parliamentary scrutiny. Further, the Minister is not required to table decisions not to approve such applications, meaning that the Parliament would neither necessarily be informed nor have the capacity for any oversight of such a decision.

And neither does it require the reasoning and the rationale on which the health minister may make such a decision. The better process is to allow the Therapeutic Goods Administration to do its job in the open, transparent and accountable way that government departments are designed to work, and to carry out this very task. This would allow it to gather together the experts and have a fully accountable, independent, transparent and scientific evaluation of this drug. This method of decision making about the safety of this drug is good governance, and this is the manner in which the Therapeutic Goods Administration was set up and designed to operate. It is authorised to evaluate, approve and regulate therapeutic drugs in the public interest.

We all—and governments in particular, having set the body up—know that the Therapeutic Goods Administration operates using robust and thorough risk assessment procedures. That does not mean, of course, that it gets it right 100 per cent of the time. No science is that exact, and no decision-making body like that is that exact. Some people who oppose this bill have pointed to a handful of well-known examples where the Therapeutic Goods Administration has changed its recommendations and advice in relation to particular drugs, and these people have sought to use this to prove that the Therapeutic Goods Administration makes mistakes. But, in fact, these examples do not suggest that the Therapeutic Goods Administration is unreliable. Rather, they show that the Therapeutic Goods Administration is capable—as it should be—of reasonably reacting in the public interest to new information whenever it surfaces. They are evidence of the way in which the Therapeutic Goods Administration has an ongoing role in determining the safety of drugs that are used in the Australian community.

Unlike the decisions of a single unaccountable member of parliament—who, like any individual, may be prone to powerful internal and external influence—the Therapeutic Goods Administration is set up and transparently designed to protect the public from vested interests. When it comes to health care and the pharmaceutical industry, we all acknowledge that there are very powerful interests involved; it does not matter if the pressure comes from profit-chasing pharmaceutical companies or from desperate consumers with chronic and life-threatening illnesses. The Therapeutic Goods Administration has been set up and is relied on in this country to dispassionately protect the public interest through its clear, accountable and transparent standards and via full reporting through the minister to the parliament—unlike that single individual health minister, whomever that may be.

The Greens agree with the submission that came from Sexual Health and Family Planning Australia, which argued that the Therapeutic Goods Administration provides:

... appropriate, objective, apolitical conclusion based on the efficacy, quality and safety of a drug and its suitability for use by Australians.

The Therapeutic Goods Administration is held in high regard by the World Health Organisation. It has the prestigious status of being a World Health Organisation Collaborating Centre. That is not a status that is afforded to all such regulatory bodies in countries around the world. Rather, the TGA, like a number of others, has been singled out for recognition for the work it does.

Unfortunately—and others have mentioned it—during the debate there have been people who have misunderstood what the debate is about and have sought to have a debate about whether or not people should be able to access terminations in this country. Unfortunately for them, we have had that debate. That is not to say that people agreed with it, but it has been settled. It is right for people to express their views, but, unfortunately, this debate we are having now is not around that issue. This is about what is the appropriate body to determine whether a drug is safe or not. As I keep saying, the Greens believe that that is the body we have set up to make such decisions in all cases—the Therapeutic Goods Administration.

As I said, the problem for people pursuing that argument is that, when we have had debates about whether access to termination should be available, we have come to the outcome that nearly every other modern Westernised nation has reached. The World Health Organisation describes terminations, either surgical or medical, as one of the safest medical procedures that people are able to access. In July last year it placed RU486 on its list of essential medicines. There is an inherent weakness in the argument being put forward by opponents of this bill that this drug is unsafe and therefore it should be rejected. If that were the case then one would imagine that people who are concerned about such issues would want to see its safety and efficacy evaluated by the Therapeutic Goods Administration. If there is genuine dispute over the safety of the drug then it is the Therapeutic Goods Administration that is best placed to cut through any disputed evidence.

Unfortunately—and, again, others have mentioned this—as we often see in intensely political debates, statistics are used in a whole variety of different ways. Indeed, the same statistics are used to substantiate very different arguments. There has been inaccurate reporting of statistics. For example, a number of people who oppose not only this bill but also all access to terminations will talk about the figures for people within the community who are concerned as a way of substantiating their argument. Unfortunately, when you then look at the actual questions that were asked and the answers that were provided, what you find is that even those organisations which are seeking to get a different result find again and again that the majority of Australians support the right of women to access terminations in this country.

A lot of the studies that have been done by people opposing this bill unfortunately have not followed the sorts of rigorous processes that we expect of organisations that are doing such studies. There have not been independent polls carried out. They have not been willing to release the questions that they have put forward. One example is a survey that is available on the Australian Federation of Right to Life Associations website. We heard about this today from Professor Terence Hull, a professor of demography at the ANU. He said he would be giving it to his students as an example of the way in which a survey should not be done. It involved ringing up 12,000 people in order to get the 1,200 answers that were used.

Professor Hull today went through the reasons why he would be using this as an example of the way not to carry out surveys. He quoted from their website the preface that was put when people were asked these questions. Prior to being asked questions about their attitudes about this issue, people were read a preface which came from a particular perspective. When we talk about push polling, this is what we are talking about—people being given a particular view and then being asked if they agree with that. It is really sad to see people choosing that method as the way to try to substantiate their views. It is perhaps not surprising when time and time again for decades people in the Australian community have been asked what their view is and the majority of Australians have said that they think women should be able to choose.

A related argument that was pursued by opponents of this drug concerned the claim that the availability of drug RU486 would increase the number of terminations carried out in Australia. But, when pressed about this issue in the Senate inquiry in Melbourne on Friday, certainly one of the doctors who was claiming there would be an increased number of terminations if RU486 was available had to admit that there was no evidence of that. He had to say to me that from nowhere in the world could he provide evidence of where that had been the case. The only evidence like that he had seen related to other drugs but not to RU486. It is unfortunate to have that kind of argument being put forward and not being able to be substantiated. The committee in fact heard evidence that, where RU486 had been available—in places like Sweden—it actually reduced the overall number of terminations that were carried out.

Of course, it is always worth noting that one of the features of this particular drug is that it can be used early in a pregnancy. When we put as a primary concern the issue of women’s health, to be able to carry out a termination earlier rather than later in the pregnancy brings great benefits for the health of the woman involved. That is what this drug enables people to do. Also, women who make the difficult decision to proceed with a termination are able to proceed with that termination at the time that they make that difficult decision rather than wait around for a long time and experience stress and angst because they cannot access the medical procedure that they at that time are requiring to access.

Again, unfortunately there has been some misinformation in relation to RU486 being used in rural and remote settings—and that led to the Chief Medical Officer needing to comment through his spokesperson that the Minister for Health and Ageing had misinterpreted the information that had been provided to him. That is an example for us of the difficulties that occur when a minister for health is put in that position. It is not their fault. They are appointed to that position with no medical training and they have to interpret advice that they seek and they can misinterpret it, which is what happened in this instance. That is all the more reason that that decision should be made by the medical experts, who are used to assessing the safety and efficacy of drugs, rather than by an individual who happens to have been placed in that portfolio and may or may not have any understanding of the issue.

To conclude, the Greens are proudly a pro-choice party—but that is not the issue we are talking about here. The issue we are talking about here is: who should make a decision about the safety and availability of this drug in the community? The Greens say that that is the body set up to do this very job: the Therapeutic Goods Administration. We are pleased to have the opportunity to be able to be supporting this private member’s bill. We want to see the body tasked with this job, the Therapeutic Goods Administration, looking at the evidence—looking at the 35 other countries where this drug is available and looking at the circumstances of the millions of women who have been using this drug for many decades in other countries—and, on the basis of that evidence, making a decision on whether or not this drug should be available in the community. I certainly want the medical experts deciding issues that relate to women’s health in this country, rather than the man or woman who happens to have been assigned to a particular portfolio and who may have no medical training in this area. I want to see the experts do their job. That is the opportunity we have with supporting this bill before the Senate.

I seek leave to table another part of the petition that Senator Moore just tabled, in which people are expressing their views in relation to this particular bill.

Leave granted.

Thank you. I commend this private member’s bill to the Senate.

Nick Minchin (SA, Liberal Party, Minister for Finance and Administration) Share this | Link to this | Hansard source

I begin my remarks on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 by congratulating the members of the Senate Community Affairs Legislation Committee on their report—and I do mean all members on both sides of this issue. I particularly congratulate the chairman, Senator Humphries—and, in doing so, commend him on his contribution to the debate and say that I endorse everything that Senator Humphries has said and I share his view on this matter.

Despite my regard and respect for the proponents of this bill, I am not at all persuaded personally to support the bill—and I do hope that a majority of senators are not persuaded to support this bill. I do not believe that there are convincing arguments available to us to support a change in the current arrangements regarding approval processes for RU486. I do prefer that the authority for the question of approval should remain with the Minister for Health and Ageing. The minister—whether of a Labor or Liberal government or whatever—is, by virtue of the office and by virtue of being a member of a duly elected government, publicly accountable for his or her actions. They are accountable to the public and the parliament for whatever decisions he or she may make. I do think that it is arguable that support for this bill is an abrogation of the role of the executive government and the parliament and its responsibility—and, in the case of this particular drug, I think that that would be a very grave mistake.

I agree with Senator Humphries that this is not just any old drug. The great flaw in the proponents’ case is that we should just treat RU486 like any other drug that the Therapeutic Goods Administration deals with. As a member of the cabinet, as Minister for Finance and Administration, I obviously have much to do with the TGA. I mean no reflection upon the TGA. It is a very worthy body. But the fact is that its daily dealings are with therapeutic pharmaceuticals—medicines that are designed to cure diseases and illnesses. Indeed, part of its charter is to ensure that we do not approve the use of any drugs that may cause harm to unborn children. That is one of its roles and responsibilities. This drug’s purpose, in being used as an abortifacient, is to destroy a foetus—to destroy an unborn child. Thus, quite clearly, its use raises very serious social and ethical issues which, in my view, should be the responsibility of a duly elected and accountable minister in a government—accountable to the public and the parliament—and not be the pure and sole responsibility of a committee of officials.

I must say that I found most persuasive an opinion piece in the Australian of 31 January by Monique Baldwin—who is described as a full-time ‘drug regulatory affairs associate with a pharmaceutical company in Sydney’—who deals with the TGA every day of her working life as a professional in seeking approval for the drugs which her company manufacturers. In my view, she makes a very persuasive case, with her intimate knowledge of the operation of the TGA, that it should not have the sole responsibility for dealing with this drug, because it is not like any other drug which the TGA deals with. So, for those still undecided on their position on this very significant issue, I do commend that article.

It is true to say, as Senator Nettle says, that this is not a debate as such about whether or not we the parliament should be here and now approving RU486. It is, in fact, a debate about the process by which such a decision should or should not be made. I concede that. But I cannot see how you can possibly divorce from even that debate the ethical questions which are therefore raised. This is a conscience vote, yet we are being asked to suspend our consciences by dealing with this as nothing more than a mechanical matter. I think that would be an abrogation of the true responsibility of every member of this Senate to bring to bear their conscience on this very significant issue. I openly say that I bring to this a conservative disposition. I personally uphold the sanctity of innocent life from conception onwards. I am personally alarmed by the number of abortions that occur in this country. I am alarmed by the number of pregnancies that are terminated. I bring to this debate personal experience in that a former girlfriend of mine had an abortion when we were in a monogamous relationship, and I cannot divorce that experience in my life from this consideration. I do not believe that the parliament should be, or should even be seen to be, doing anything that might bring about or encourage a greater number of abortions in this country.

I am also very concerned by the medical risks which this drug does have for mothers. I was quite moved by the views of Senator Alan Eggleston, who, I guess, in the broad church of the coalition would normally be seen on the small ‘l’ liberal side of the argument. But, as a medical professional, he has made clear to his colleagues his very serious concerns about the health risks to women of the use of this particular drug. I really do have great difficulty with, and cannot support, any repeal by virtue of this bill of ministerial responsibility for the approval of this particular drug.

I want to refer briefly to some points made in this debate, in the report and in the Parliamentary Library document—which I commend—in relation to this matter. There is the suggestion that there is not in fact any requirement on the minister, in exercising his or her current role, to have regard to expert advice in determining whether or not to approve this drug—specifically, the licensing, import registration, evaluation and importation of the drug. The fact is that there is not any possibility of any responsible minister in any government not seeking expert advice at any stage in the consideration of a request for the evaluation, registration, listing or importation of this drug. But, to the extent that that is an argument that is made, it may be that in due course a requirement for the TGA to seek such expert advice from the national Health Ethics Committee of the NHMRC could indeed be formalised.

It is also argued that, while the current legislation requires the minister to table any written approval within five sitting days in the parliament, there is no such requirement with regard to any decision not to approve. Again, I would say to the Senate that any responsible minister, in my view, would table a decision not to approve, albeit that the law does not actually require that. But again, I think that is also something that quite properly could be formalised in any subsequent consideration of the way in which the question of the approval or disapproval of this particular drug should be handled.

I will conclude my remarks at this point, but can I just say that I am pleased that the government was able to facilitate debate on this serious issue. I have nothing but high personal regard for the proponents of the legislation, but I profoundly disagree with their perspective on this matter and I urge senators to oppose this bill.

Steve Fielding (Victoria, Family First Party) Share this | Link to this | Hansard source

Everyone has an opinion about abortion. It is one of those controversial issues that sparks great community debate. We have seen that in the last few weeks in relation to the abortion drug RU486. This debate has been prompted by a private member’s bill introduced by a National Party senator, Fiona Nash. The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is designed to shift responsibility for approving the drug from the health minister to the Therapeutic Goods Administration—that is, the TGA—a body which examines the safety of drugs. Put simply, the question is: who decides on RU486? Do we want our elected leaders deciding whether this drug should be approved in Australia or do we want to give that decision-making power to unelected bureaucrats?

Family First believes that this is a unique drug which raises major social policy and ethical issues as well as medical and safety issues. We cannot consider the social policy issues without taking into account community attitudes. That is not the job of the Therapeutic Goods Administration; that is the job of elected politicians. That is, after all, why people elect us. That is why we are paid. The TGA itself told the Senate parliamentary committee inquiry, on 15 December, that it cannot consider social and ethical issues, only the technical questions around the quality and safety of drugs.

Family First strongly believes that policy decisions should never be made by unelected bureaucrats; their job is to advise on policy and implement policy decisions. As I said earlier, in discharging our responsibility, we as elected politicians must consider community attitudes when we make decisions.

So, in the case of RU486, if a doctor sought approval from the health minister to use the drug, you would expect the minister to seek advice from the TGA, as they are the drug safety experts. However, you would also expect the minister to take into account many other issues, including community attitudes. That way the minister would be carrying out his or her duty of gathering all the information and then making a decision.

We know where the community is at on the abortion issue. Regardless of whether Australians support or oppose abortion, we know that the overwhelming majority of them are concerned about it and want the numbers reduced. An editorial in the Sydney Morning Herald on 4 January this year summed it up well. It said:

A substantial majority supports abortion on demand—but at the same time an even greater majority is uneasy with the number of procedures carried out and wants the abortion rate cut somehow.

The latest research from the Southern Cross Bioethics Institute reveals that Australians think that the number of abortions in Australia each year—90,000—is too high and should be reduced. They want their elected leaders to find ways to reduce the number of abortions. We also know from research that many women who have abortions do not feel they have a choice. Many have abortions due to a lack of financial or emotional support and do not feel they will be able to cope if they have their baby. Family First believes that as a community we have an obligation to offer women alternatives to abortion. For example, governments should fund agencies that provide practical support to pregnant women both before and after the birth of the child.

The Southern Cross Bioethics Institute’s research into RU486 is interesting. It found that 75 per cent of Australians had ‘little or no knowledge’ of the drug. Once people were told about the drug, only 17 per cent supported introducing it. The majority, 59 per cent, said they wanted the decision delayed.

We all know that abortion is a subject of national interest. That is why the RU486 issue was referred to the Senate Community Affairs Legislation Committee, of which I am a member. Family First has labelled the inquiry a farce. Given the importance of this issue, it is a joke that the committee reported to the parliament only today, the debate started just a few hours later and the vote will be tomorrow. What a waste of thousands of dollars of taxpayers’ money, flying committee members and staff around the country to public hearings, when politicians will have less than a day to examine the report. Think about this: late last year when the government was ramming through its industrial relations changes and the Telstra bill, members of the Democrats, the Greens and the Labor Party were all howling with rage about the abuse of the Senate process. Family First felt the same. Just a few months later, here we are with another bill that is being rammed through, but, because it is one that most of the Democrats, Greens and Labor senators support, suddenly concern about ramming bills through seems to have disappeared.

Another reason the minister should retain control over approvals of RU486 is because he or she is accountable to the community for what he or she does. The TGA is not. When the TGA originally approved the morning-after pill, the manufacturer said it must be available only with a doctor’s prescription. Just 12 months later, a TGA committee removed this restriction and the morning-after pill became available over the counter at chemists. And no-one batted an eyelid. Within six months of that decision, a newspaper investigation found that only two out of 10 pharmacies it visited were following proper guidelines when selling the pill. The TGA was not called to account for its backflip. Had the minister been responsible for that decision, you can be sure there would have been much greater public accountability.

Family First is pro women, which is why we must also consider the potentially serious medical and psychological effects, and the deaths overseas, associated with RU486. Doctors and pharmacists are not required to report adverse effects of a drug to the TGA. This means the TGA cannot monitor the effects of a drug, which is a serious issue. On the other hand, the health minister could ensure that mandatory monitoring was a condition of approving its use.

Supporters of the bill say that we should trust the doctors. We are told they will devise safeguards and protection. But, in the United States, the Food and Drug Administration—the equivalent of the TGA—admits that doctors ignore its conditions, such as limiting the use of RU486 to the first 49 days of gestation. We also know that the FDA has received reports that more than a dozen women have taken RU486 while having an ectopic pregnancy. In theory, none of this is supposed to happen.

Supporters of the bill also want us to take comfort from the fact that more than 30 countries have approved RU486. But given that it cannot be used effectively without a prostaglandin like misoprostol, you would think they would tell you that no countries have approved use of this drug for abortion. In fact, it is used off-label and against the manufacturer’s advice. The reason the manufacturer of the prostaglandin wants nothing to do with this is that it could cause possible malformation to any surviving unborn child.

Let us look back. It was 10 years ago, back in 1996, that the parliament decided that the health minister should be responsible for approving RU486 by passing the Therapeutic Goods Amendment Bill 1996. At the time, Labor senator Belinda Neal said:

These issues need to be addressed by the executive of this government ... with absolute and direct accountability ...

Greens senator Christabel Chamarette said:

We deserve to have parliamentary scrutiny of decisions. We deserve to have a voice on issues and not simply leave them to boards of experts.

Nothing has changed. The onus is on those who seek to repeal that bill to show there has been sufficient change since 1996 to warrant such action. Not only have they failed to do so, they have not even attempted to do so. We all know RU486 is like no other drug. It is designed to cause an abortion and end the life of an unborn child. Family First believes this is a major policy issue of social, moral and ethical importance. The community elects, and pays, politicians to do their job, and that includes tackling tough issues like abortion and considering the community’s views as well. For Australia’s elected politicians to wash their hands of this, to pass off their decision-making power on a policy issue like RU486 to unelected bureaucrats, would be a gross dereliction of our duty and a real insult to the people who put us here in the first place.

Guy Barnett (Tasmania, Liberal Party) Share this | Link to this | Hansard source

I stand here today to oppose the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 and its repeal of ministerial responsibility for drugs, including abortion drugs, in the category of restricted goods. I believe we are taking a huge backward step in removing ministerial responsibility and accountability from the management of abortion drugs such as RU486, especially when we do not have to in order to get the best of all outcomes from this debate. The best of all outcomes would involve an improvement in the way responsibility for approval or rejection of the use of drugs, such as RU486, is managed. Such an option would pick up the best of technical and ethical advice in dealing with this issue together with the need for accountability to our bosses—the Australian people.

I oppose the bill because we are not dealing with just another prescription. This is not just another drug. RU486 is a killer drug. It is designed to terminate a pregnancy. A therapeutic drug, on the other hand, is designed to cure or treat an illness. Pregnancy is not an illness. Pro-abortionists want the drug for destroying the life of an unborn baby. It is what sets RU486 apart when advocates argue that we are dealing with just another drug. Even the drug company Pfizer—the manufacturer of the drug Cytotec, which must be used in tandem with RU486 to end the pregnancy and expel the foetus—says it cannot vouch for the safe use of Cytotec in an RU486 abortion.

The bill before the Senate is designed to remove the responsibility for approval of RU486 from the minister and substitute responsibility for that drug with the Therapeutic Goods Administration. I oppose this bill, but I do want to flag at the outset what I believe could be a better process in dealing with abortifacient drugs. Under the current process, the minister must table his notification of approval of an abortifacient drug on the restricted goods list in both houses of the parliament. This, in my view, is inadequate. It is inadequate in terms of ensuring parliamentary scrutiny.

The improved process, in my view, would require the minister to seek advice from the Australian Health Ethics Committee as a subcommittee of the National Health and Medical Research Council. The minister would then prepare a written statement of the reasons to support his approval or rejection. Under the current process, he is only required to notify an approval. So he would prepare a written statement of the reasons to support the approval or rejection of the drug and table these in both houses of parliament. This would then be subject to a parliamentary disallowance motion. That is a suggestion in terms of an improvement to the current process.

The inquiry into RU486 explored the concept of expert advice and the committee was advised that a committee of experts could be constituted to advise the minister if the current arrangements prevail. That is one of the options that was put to our committee by Dr Renate Klein. Given, as my colleagues have said, that we are not here to debate the merits and ethics of abortion but instead the administrative arrangements for dealing with abortion drugs, the improved process that I referred to earlier is something that should be considered very seriously.

The committee received 2,496 submissions and 2,292 additional pieces of correspondence—a total of 4,788 public contributions to the inquiry. The committee considered the bill at public hearings on 15 December, 3 February and 6 February. As a committee member, I want to thank the chair, Senator Gary Humphries, for his leadership. I also want to thank Elton Humphery and his team at the secretariat for the work they did under very considerable pressure to get the job done within the time available.

Members of the committee—and, no doubt, other senators and members—received an enormous amount of correspondence from all sides of the debate. We received hundreds and thousands of letters and emails, and that further demonstrated to me why this issue is too important to leave to the hands of technical experts.

Reproductive Choice Australia, the pro-abortion group, said to our committee of inquiry, ‘Politics has no place in medicine.’ What an extraordinary attitude. Every day, politicians have to assess and decide appropriate health policy. If this drug is of such profound consequence as to require a conscience vote of MPs in the federal parliament, then it surely logically follows that ultimate responsibility for management of the drug must reside with the elected government, which is in turn accountable to parliament. The role of the TGA, with its team of experts, would be as an advisory body and not sole arbiter. To date, no state or territory government has acquiesced and devolved its powers relating to abortion to bureaucrats.

It is worth quoting from remarks made by the Prime Minister today at lunchtime when he summed up the principle of accountability. He said,

I think there are a number of issues that have to be considered, not only the medical implications of it but also the principle that important decisions affecting the community should be made by people who are accountable directly to the community.

I’ve never been one, incidentally, who believes it makes much sense to devote an enormous amount of time and energy and commitment of one’s life to win election to parliament, and to the high office of decision-making, and then to spend the next stage of life busily handing over decisions to people who are not accountable.

That quote was sourced from an AAP site.

I am voting against the bill for the above and several other reasons. RU486 poses undue health risks for women. The use of RU486, or medical abortion, carries with it a 10 times higher risk of death than surgical abortion, according to the latest research by Dr Michael Greene from Harvard University in the United States. This is not a just a morning-after pill. In five to eight per cent of cases, women require a follow-up surgical abortion, which is particularly problematic in isolated and rural areas.

There have been eleven fatalities around the world, so far, associated with the use of RU486 as an abortifacient. These are known fatalities based on a voluntary reporting system in most of the countries. One occurred in France, one in Sweden, one in Canada, three in Britain, and five in the United States. Five of the fatalities were due to septic shock following clostridium sordellii infection; two resulted from haemorrhage, one of which was from a ruptured ectopic pregnancy; and one was from coronary thrombosis. The drug has been banned in Canada and, last week, restrictions similar to a ban were imposed in Italy.

In the United States, the congress is considering the RU486 Suspension and Review Act, which would suspend all sales of RU486, subject to an inquiry of the Food and Drug Administration. In addition, there is an investigation into the Food and Drug Administration’s handling of the approval process for RU486 following four deaths in California. For every woman who dies in association with an RU486 abortion, there are 70 women who suffer life-threatening complications, including severe haemorrhage, sepsis and ruptured ectopic pregnancy.

The Therapeutic Goods Administration is empowered by the act to consider the safety, quality and efficacy of a drug. Of course, ‘efficacy’ means that the drug does exactly what is stated on the tin: it achieves the purpose for which it was designed. In this instance, I believe that is not the case. The TGA has no power or competence to consider the broader social and ethical impacts that may follow if a drug is registered for import and use in Australia. It does not have that power.

Under the existing restricted goods provisions, the Minister for Health and Ageing can consider the social and ethical impact of an abortifacient drug. If the bill is passed and these provisions are removed then the social and ethical implications of introducing RU486 into Australia cannot be taken into consideration.

It is also worth considering the appropriateness and applicability of the Therapeutic Goods Administration to approve access to RU486. A number of submissions and correspondence argued, based on common dictionary definitions of ‘therapeutic’, that therapeutic goods are those which remediate or prevent an illness, and that mifepristone, RU486, should not be classed as a therapeutic good and not be monitored or regulated by the TGA. I agree with this view. RU486 is a drug designed to end a life, not to cure it. Pregnancy is not an illness, as I said earlier, and therefore it could be argued that the TGA regime has no legal jurisdiction over abortifacients.

On page 9 of our Senate committee report, it is stated that it needs to be clarified that, in the legislative context, the relevant definition of ‘therapeutic goods’ is that contained in the Therapeutic Goods Act. Section 3 of the act states that the term ‘therapeutic goods’ includes goods ‘for therapeutic use’. ‘Therapeutic use’ is also defined in section 3 of the act. I want to make it clear for everybody by putting on the record the definition of ‘therapeutic use’ according to the act:

(a)

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)

influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)

testing the susceptibility of persons or animals to a disease or ailment; or

(d)

influencing, controlling or preventing conception in persons; or

(e)

testing for pregnancy in persons; or

(f)

the replacement or modification of parts of the anatomy in persons or animals.

I subscribe to the view that the comprehensive list of therapeutic uses in the Therapeutic Goods Act makes no specific reference to causing an abortion.

It is also worth noting that if the TGA assumed responsibility for the evaluation and approval of RU486 it would also assume ultimate responsibility for several other abortion drugs and vaccines on the restricted goods list. Subsection 3(1) of the TGA Act 1989 states the definition of restricted goods. The bill will repeal this definition and remove the requirement for ministerial approval before restricted goods can be imported, evaluated, registered or listed.

Besides RU486, mifepristone, the following medicines are currently listed as restricted goods which cannot be imported without ministerial approval: alprostadil, carboprost, dinoprost, dinoprostone, gemeprost, misoprostol, prostaglandins and vaccines against human chorionic gonadotrophin. Advocates of the drug incorrectly state that RU486 is the only medicine that is subject to the restricted goods condition. This is set out in their explanatory memorandum. However, RU486 is just one of the class of medicines defined as restricted goods.

How can this cocktail of abortion drugs, together with the controversial drug RU486, which is currently under intense scrutiny around the world, be the sole province of a team of unelected officials who would have ultimate arbitrary powers? RU486 can be used in the early to mid stages of pregnancy, up to 20 weeks. What is stopping another drug being designed in the months or years ahead to kill an unborn baby late term? Nothing at all. It would be up to an unelected team of bureaucrats, no matter how expert, in the TGA. What a cop-out for federal members of parliament.

On this score it is worth quoting two senators who spoke in the debate 10 years ago, when the minister for health was given the power of veto over restricted goods under the TGA Act of 1996. Greens senator Christabel Chamarette said:

We deserve to have parliamentary scrutiny of decisions. We deserve to have a voice on issues and not simply leave them to boards of experts.

ALP senator Belinda Neal said:

... we acknowledge that this issue raises large concerns within the community. It raises issues beyond purely health issues. These issues need to be addressed by the executive of this government and addressed with absolute and direct accountability ...

What has changed in the last decade? Nothing. Abortion remains as emotive an issue as it has always been. It costs Medicare more than $11 million a year. Federal funding is provided without any requirement for independent counselling—and by ‘independent’ I mean from a non abortion provider—and without any requirement for informed consent or a cooling-off period. In my view, this is appalling public policy.

The majority of Australians believe that the estimated 91,000 abortions each year in this country are too many. I agree. What are we doing to fix the problem? One in four pregnancies aborted is far too many. What are we doing to help? By passing this bill we will send all the wrong messages to young Australians—that abortion is no big deal and that now there is a pill which somehow sanitises the experience and the trauma.

I wholeheartedly support the recommendation in the report concerning counselling, which I believe should be available in the prenatal period, especially where a woman is contemplating an abortion, and the postnatal period and that these counselling requirements be covered by Medicare. Medicare funding of abortion, as I indicated, costs $11 million a year. I cannot see why, if it is funded at all, counselling should not be included in that publicly funded process.

As noted by the committee chair, Senator Gary Humphries, in his report:

... the Committee is not making any recommendations relating specifically to the Bill. However, it notes that a number of groups and individuals both supporting and opposing the Bill expressed concern over the number—

in my view, the very high number—

of abortions in Australia and the critical need to address wider personal and social problems. They urged the implementation or enhancement of a range of programs and services aimed at reducing unwanted pregnancies and supporting women through pregnancy.

Finally, I would like to quote from the recommendation. It says:

The Committee recommends that increased financial support be provided to improve sex education, including better education on responsible human relationships; wider availability of information about and access to contraception and other fertility control techniques; ensure independent professional counselling for women considering a termination of pregnancy, counselling post termination and counselling for relinquishing mothers as required; greater social support for women who choose to continue with their pregnancy—

and I wish to emphasise the wonderful work of the pregnancy support services around Australia—

and increasing the availability and affordability of child care.

I thank the Senate.

Judith Adams (WA, Liberal Party) Share this | Link to this | Hansard source

I rise this evening to speak to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I wish to preface my remarks by stating that this bill is not a personal attack on the current minister for health or those who have gone before him. I am a member of the committee that did the inquiry and, as a midwife and someone who has worked for a very long time in rural Western Australia and also in New Zealand, I found the inquiry very interesting. I thank all those people who put forward submissions. Over my break—as it was termed; it was not really a break—from Christmas and New Year through until the end of January I did look at most of the submissions. We had over 1,000 presented to us, along with other correspondence, which was put into another category. A number of submissions were put forward that did not address the terms of reference, so they were put into a different category.

In terms of the process, as a committee we looked at the number of submissions and we were all allowed to put forward types of submissions that we would really like to hear about. There were 2,400 submissions in all, and it was a great honour for those who came to present to us, because their submissions were considered to be of such relevance and importance to such an important issue. Those supporting the bill—as I certainly am—were able to invite the people they wished to appear.

As a result of my own area of expertise, I tried to get a very practical debate. The first people I asked to appear were the administrators, including the Therapeutic Goods Administration, the Department of Health and Ageing, the Australian Medical Association and the Rural Doctors Association of Australia. The Association for Australian Rural Nurses, a number of health care people, people who work in the consultancy area and people who have been involved in research appeared later. During the whole program, some excellent people appeared on that side of the debate, as they did on the other side. I would like to put on the record that as a committee we looked very carefully at which people and organisations we asked to appear before us.

I will speak later about rural women and our rural doctors, but I would like to state now, as a woman and as a midwife, that I am absolutely appalled at the number of abortions that occur. I do not think anyone who took part in the inquiry would not be. I agree wholeheartedly with the recommendation at the end of our committee report, which Senator Barnett has just read, and I think that education is really the only way that we will be able to reduce these abortions or terminations of pregnancy.

The purpose of the bill is to move the responsibility for approval of RU486 from the Minister for Health and Ageing to the Therapeutic Goods Administration, known as the TGA. The drug RU486 belongs to a special category of drugs under the Therapeutic Goods Act 1989 known as ‘restricted goods’, which cannot be evaluated, registered, listed or imported without the written approval of the minister for health. Further, any such written approval must be laid before each house of parliament by the minister within five sitting days of being given. Under the act, the minister does not have to report to the parliament the number of applications for RU486.

Restricted goods are defined under the act as:

... medicines ... intended for use in women as abortifacients.

It is important to note that medicines used for any purpose other than abortion are evaluated and regulated by the TGA without any requirement for approval from the minister. The restricted goods provisions were incorporated into the act in 1996 as a result of amendments introduced to the Therapeutic Goods Amendment Bill 1996 by Senator Brian Harradine, known as the Harradine amendments.

The Therapeutic Goods Administration does not comprise faceless and nameless bureaucrats, as has been stated by a number of individuals. That has really annoyed me because, being a health professional, I regard these people as very, very special. They are a team of highly respected experts in their fields of expertise. The TGA has to date overseen the evaluation and approval of over 50,000 therapeutic goods and therapies in Australia, making it the most experienced and qualified entity in the country to evaluate this category of drugs.

The TGA, as a member of the World Health Organisation and the World Health Organisation Collaborating Centre, has access to other countries where RU486 is being used. I know those countries have been put on the record today, so I will not read out the list of those countries. Of interest to me, as a former New Zealander, is that the TGA has a memorandum of understanding with its New Zealand counterpart, Medsafe. It was signed in 1993 and an agreement has since been signed, in 2003, for the establishment of a joint scheme for the regulation of therapeutic products. I believe the TGA and its respective advisory committees are the correct group of people to make the decision as to whether this drug is safe and to provide the relevant guidelines to ensure that Australian women and their medical practitioners have the opportunity to make an informed decision on whether they can have a medical rather than a surgical termination.

I know from listening to some of the speakers before me that there has been sceptical comment about the guidelines. I visited New Zealand in the last few weeks and would like to speak tonight about its guidelines and the way that they are organised. I know it is getting away from the bill, but our whole inquiry has gone to the issue of the termination, how it works, what is safe and what is not and all of the rest. I would like to bring forward the guidelines that are used in New Zealand to give people an understanding of how they work. New Zealand has special GPs who have been trained in termination procedures, in counselling and in how to deal with affected people. If a woman, for her own reasons, presents to her GP and says she wishes to terminate her pregnancy, under law that GP, if they have not done that training, must refer the woman to one of these specialist GPs.

Women do not go to the pharmacy and get RU486 over the counter. It is prescribed to a clinic and the medical termination must be done at a clinic. The women must have access to trained psychologists, counsellors and people like that who form part of the clinic staff as well as the specialist GPs. If the women are approved as being medically fit to undergo this termination, rather than a surgical termination, and it is their wish to have a medical termination, they are then advised and given every piece of information that they need to make the decision. They are then given the drug at the surgery or clinic and allowed to go home for two days. They have 24-hour access to that clinic and they are not allowed to go any further than four hours away from it in case of any problems. On the third day they come back to the clinic and have their misoprostol. Often, within four hours, they will abort or miscarry at the clinic. So with these guidelines the woman’s safety is absolutely paramount and there is no way that that person will be left without support.

When the process is finished, if they are fit enough and healthy, they are allowed to go home, but they must return in two weeks time. I have been told and we heard at the hearing that, women being women, they might forget to come back or they might forget to do this or that. No medical practitioner is going to allow a woman to go through this type of termination if they do not consider that they are suitable candidates for it. That is just not going to happen. I would like people to really think about that. The minister asked the Chief Medical Officer from the department to provide him with information about the drug, and there was a comment included about rural doctors. As a rural person and a midwife, as I said, I have worked everywhere—right out in remote areas. These medical professionals, especially rural doctors, have a terrific lot of knowledge and expertise. They have to do an extra two years of training before they are even allowed to have a Medicare number in a rural area. As far as having a surgical procedure to back this up, that must happen. They are not going to allow anyone to go through this without that.

There was a very good submission to the inquiry from the Broome Regional Aboriginal Medical Service. There have been many comments that Aboriginal women might not be the right people to have this drug if it were approved in Australia. These six doctors from Broome were saying that they are 3,000 kilometres from Perth and that at the present time, because of the elective surgery waiting list in Broome, Kununurra and Derby where they do elective surgery, there is no way that they can do their terminations. They may be able to but it is very difficult. It means that the woman has to go to Perth on an aircraft, stay in Perth to have her termination, if they can get her in somewhere—by herself, usually, because of the expense of an escort going with her—and then go back again. These doctors know their patients very well and they would be very happy to treat them in their own community. In the Kimberley there are about 10 different areas where they have surgical backup. As they said, one in four pregnancies miscarry. They are always dealing with miscarriages so they have to treat these people all the time.

I think rural doctors do have the expertise. I really thank the Rural Doctors Association for putting forward such a good submission to prove just where they feel they can deal with these issues. I feel, as far as our report goes, we have really done very well. There are very good arguments for and against. I recommend the report to anyone who has doubts about what is going on. I commend the bill.

Helen Polley (Tasmania, Australian Labor Party) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Before I proceed much further I want to acknowledge the thousands of submissions received from many individuals and organisations. They are submissions that clearly indicate that this piece of legislation and its potential ramifications lies close to the heart of many Australians—so much so that they felt strongly inclined to put pen to paper to voice their concerns. I also acknowledge that when legislation is presented in this chamber for debate an open mind is required, a mind that pushes personal beliefs aside and listens to the arguments both for and against. I can stand here with a clear conscience, knowing that I have given the legislation my best and fairest judgment. Sometimes one wonders, when legislation such as this is presented, why it has been rushed through, and I refer particularly to the limited time the Senate Community Affairs Legislation Committee had to study submissions, attend hearings and draw conclusions.

Let us get one thing very clear here: RU486 is not a simple drug like paracetamol. This drug will expel human life, and its consequences on the health of women are varied and dependent upon constant medical supervision. The question that springs to my mind is: why are we considering allowing the TGA to make a decision about a drug that kills? The TGA’s role is to assess therapeutic goods. A therapeutic good is a good that is to be taken for therapeutic use. Is RU486 for therapeutic use? It is clear that it is not.

The term ‘therapeutic’ should not be bandied about loosely. It refers specifically to goods that are given to remediate or prevent illness. They provide a cure and promote wellbeing. The following description of ‘therapeutic’ comes directly from the TGA’s website:

... “therapeutic use” means use in or in connection with: preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons ... influencing, inhibiting or modifying a physiological process ...

It may be argued that RU486 fits this category. However, RU486 does not have a positive health benefit for the women who use it. The description of ‘therapeutic’ continues:

... testing the susceptibility of persons ... to a disease or ailment; or influencing, controlling or preventing conception in persons; or testing for pregnancy in persons; or the replacement or modification of parts of the anatomy ...

These are a few of the definitions of therapeutic use, and RU486 does not fall into any of the categories that are used for defining the role of the TGA.

While the TGA regulates all drugs in Australia, its authority specifically only relates to the safety, efficacy and quality of a drug. It is expert at dealing with raw data. However, as an unelected body it is not appropriate for it to make decisions about goods that have a social or a moral dimension. In its regulatory role the TGA only has to consider drugs on a technical basis. It does not have to address the moral and ethical issues associated with RU486. Let us not kid ourselves here: no matter which way you analyse it, no matter what technical terms you apply, whether you call it a foetus or an embryo or, as I do, a baby, at the end of the day this drug is designed to terminate the life of a child—at what cost?

You may be thinking at this point that I am taking the moral high ground and that I am making judgements about pro-abortion or pro-choice. However, at this time I am focused upon the health of Australian women. RU486 requires constant or close medical supervision during its administration and for up to five days after it has been taken. The level of medical supervision is paramount to ensuring that the drug effectively terminates the pregnancy. However—as I have discovered through discussions with medical practitioners and through evidence given during our hearings—while in principle it is a simple process, the reality is that the foetus is not always expelled the way it is supposed to be. This drug has, in some instances, resulted in serious infections in the women who have used it, and the effects could include losing a fallopian tube, endometriosis, and—in some very extreme cases reported in the United States—death. It is as simple as that.

RU486 is not a medicine; it is a drug with potentially serious side effects. The definition of ‘medicine’, from the dictionary, is ‘an agent, such as a drug, used to treat disease or injury’. Pregnancy is not a disease, nor is it an injury. RU486 is designed to disrupt an entirely healthy pregnancy. RU486 is a drug with potentially serious side effects. By allowing the TGA the authority to decide its use we would be effectively allowing them to facilitate the violation of human rights rather than to limit such violations.

The competence of the TGA is restricted to assessing medicines on medical grounds. Leaving out the cruel human rights considerations raised by RU486, the faceless public servants of the TGA should not make the decision. RU486 is not comparable with any other drug that may be considered by the TGA. It is a drug that ends life and has the potential to harm another. Is that safe? Is that effective? Is that quality? This is not merely a medical matter and therefore the decision regarding the use of RU486 should not be left to the TGA. This is a unique drug, a drug that should be in a category all of its own, a drug that cannot be grouped with other drugs or even considered broadly in the same context as any other drug.

Many people have voiced their concerns about this bill, and I am sure I am not the only one who has received correspondence from concerned constituents. Let me read an extract from the submission from the Catholic Women’s League of Tasmania:

Induced abortion using RU486 has features not met in surgical abortion. The apparent simplicity when compared to a surgical abortion is likely to result in those close to the women regarding it as a relatively trivial event. The process has particular psychological risks. Abortions performed using RU486 can be very stressful because time elapses as the baby dies and is then expelled by the actions of prostaglandin misoprostol. The process is prolonged and painful. The expulsion is a traumatic experience. It can occur unexpectedly at home...at work or in a public place...and then...how to dispose of it?

Please let me reiterate that my comments here today are not about condemning those who are pro-choice or pro-abortion. Even with my conservative views I am the first to admit that there are times when a mother’s life needs to be saved and there are some circumstances when an abortion is in the woman’s best interests. My main concern is the health of women. Put the ideological views aside and let us make decisions that are in the best interests of the health of Australian women and our society.

Let us also make a decision based upon the medical services that are required for monitoring the women who use the RU486 pill. Bear in mind that many Australians do not have the privilege of living close to hospitals and medical practitioners. Obviously I am concerned for Tasmanian women and those who live in some of Australia’s remotest communities and/or are disadvantaged in some way. Picture a woman who lives in a rural community who has been offered RU486 and is requested to stay close to, or in regular contact with, her doctor. How practical is this for a woman who has other young children look after, who does not have transport and who is perhaps not used to regularly contacting her doctor? What happens when complications occur and the expulsion of the baby does not quite go to plan? Or alternatively, from the perspective of a busy medical practice, what happens if the doctor who prescribes the drug forgets to remain in contact with the patient? Doctors are only human and it is known to have happened in other circumstances affecting women. And patient workloads are getting increasingly heavier. Is it fair to lumber GPs with the increased responsibility of the close monitoring of a patient to ensure all goes to plan?

Given that scenario, this drug seems a bit hit and miss. There are too many variables, too many risks and not enough guarantees for the safety of women. Many rural and isolated women do not have ready access to emergency facilities and the time delay in getting the appropriate help could be very serious and even fatal. The supposed ‘benefits’ for rural women should be dismissed.

If you think I am dramatising the side effects of RU486, consider this: the US Food and Drug Administration have registered over 600 reported adverse reactions to RU486. Reporting adverse reactions is not mandatory and estimates are that only about 10 per cent are reported. Five women have died as a direct result of RU486 and the use of RU486 in America is now under review. The US Food and Drug Administration have now issued a warning regarding the serious side effects of the drug. Another factor that requires due consideration is that a surgical procedure will be required in up to 23 per cent of cases of women using RU486 to stop excessive bleeding and to totally complete the abortion. That is almost a quarter of all cases. A quarter of all cases will require a surgical procedure to abort a foetus regardless of the use of RU486 but with even more trauma for women.

Former Senator Brian Harradine presented a background paper to Hansard on 9 May 1996, and I will read a section of that which has particular relevance to the point I am making. He said:

Of critical concern are the short and long term ill-effects on women exposed to RU486. Women taking the drug are advised to live within about 40 kilometres of an abortion clinic. RU486 is promoted as a simple do-it-yourself, private, demedicalised abortion. Yet it requires three or four visits to a specialised medical centre, the taking of up to five hazardous drugs, vaginal ultrasound that all may result in serious complications.

As a mother and grandmother, I dread to think of the implications of allowing such a drug free rein within Australia. I dread to think that this chamber might very well be condemning our daughters to a horrible death or complications that may remove the opportunity for them to ever conceive again.

Former Senator Harradine concludes:

... people on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents raise major public health and public policy issues and should not be left in the hands of bureaucrats and science technologists. There should be ministerial responsibility subject to effective parliamentary scrutiny.

In my view, nothing has changed in the last decade. Further thought should be given to the reason this drug was brought into existence in the first place. Potentially its use as an armoury for the control of population growth attracted the necessary research, promotion and funding required. Developing countries were to be the target for the introduction of RU486. Ninety thousand abortions are performed each year in Australia and if this bill is passed that number has the potential to increase to levels we have never seen before or should wish to see. An increase in the number of abortions will also increase the load on our public hospitals and medical practitioners, and with our health system in the mess that it is in the extra load is definitely not needed.

I have presented a number of arguments which clearly are beyond the criteria of the TGA risk management approach. Will the TGA take the social issues into account? Will they determine the ramifications of increasing abortions in Australia due to the introduction of this drug? Will they make recommendations for increased funding to support services for women who suffer mental anguish and stress post abortion? Will they determine the cost to the health budget for the requirement for increased medical intervention and assistance as a result of RU486? How will they tackle the moral ramifications of RU486?

Let me tell you how they will deal with all of these issues. Put simply, they will not. It is not within their jurisdiction or authority to do so. Again, I ask you today in this chamber: how can we, elected by the people of Australia to represent their views and opinions and to provide unbiased judgment and fair scrutiny, vote for the Therapeutic Goods Administration to allow RU486 to be provided to our daughters? From the thousands of submissions I have read, I note that the absolute majority are against changing the status of RU486. I believe I am reflecting my constituents and the Australian electorate at the moment and for the reasons outlined and, based on the evidence from the hearings and the submissions, I will not be supporting this bill.

Santo Santoro (Queensland, Liberal Party, Minister for Ageing) Share this | Link to this | Hansard source

I congratulate and thank Senator Polley for her very thoughtful and even provocative contribution. I share most of her views and I commend her for putting them as sincerely as she has. I am on record in this place, including in June last year, as a supporter of any measures which will encourage a reduction in the rate of abortion in Australia. When I spoke on this issue last June I said that while I have my own private views I do not believe that government has any business regulating the life choices of citizens. And while my views remain unabashedly on the pro-life side of the abortion debate, I do not resile from my position that private views are private and should of necessity remain separate from the public duties of legislators. We are not a theocracy and, at least on this side of the chamber, we are not supporters of interventionist government. But with this private member’s bill, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, we are presented with what is quaintly termed a ‘conscience vote’, which in the Westminster system is a very peculiar beast.

My position on this bill is well known. I have received hundreds of representations against the passage of this bill and, surprisingly, as I think Senator Polley intimated, very few representations in favour of it. I want to stress that. It is something that I have found incredibly surprising. There are very, very few views in favour of it. A number of my colleagues have and will eloquently expound, as Senator Polley just has, on the social impact, safety data, and very strong arguments for continued restriction of abortifacients. Suffice to say, I am far from persuaded by the rather trite argument that, since the TGA gives the sole approval to many pharmaceuticals which are potentially harmful or fatal, there is no case for special treatment of RU486 and its ilk.

We tolerate risk with pharmaceuticals because we balance that risk against the likely impact of unchecked progression of a given disease or injury. Contrary to the bizarre commentary of some pro-abortion doctors in recent weeks, I cannot regard pregnancy as a disease. As both a father and a Christian, I regard pregnancy as a blessing, a gift, an opportunity and a life. I also note with some sense of irony that many of my colleagues who are most strongly in favour of assisted reproduction funding—which I also wholeheartedly support—are equally leaders in the laissez-faire approach to termination. In contrast, I support IVF because it is a miracle for parents, not as some abstract dimension of a values-free concept of choice. As I said, a number of my colleagues will make the detailed case against RU486, and I do not intend to duplicate their comments. Rather, I want to take this opportunity to comment on two aspects of this so-called conscience vote.

My first concern is that, while I recognise the reasoned position taken by some of the proponents of RU486 and this private member’s bill, I cannot help but feel that we are being asked to accept that only one side of the argument represents good conscience. I say this because it is implicit in the request for a conscience vote that we are asked to form a position based on our private views and legislate accordingly. If we were asked simply to reflect on the conscience of the nation, the evidence would be very clear. It is clear in the work done by the Sexton Marketing Group for the Southern Cross Bioethics Institute, which showed that Australians want a reduction in the rate of abortion without a ban. And it is clear in the research carried out by Market Facts and released by the Australian Federation of Right to Life Associations just last weekend, which found that a slight majority of Australians oppose the decision to terminate a pregnancy for social or financial reasons. Those data certainly inform my conscience, but those propagating RU486 tell us that such democratic views are immaterial. We are told only one side reflects good conscience or good faith because, we are assured, there is urgency in this issue. That urgency is presumably to facilitate more abortions, which is against the valued and measured view of the nation. And that urgency is what has been used to rush this bill without time for considered and careful public debate on the merits or morals of chemical abortion. For that reason alone, I will vote to reject the bill.

My second concern about this debate lies with the elevation of abortion choice as an incontestable right, like some golden calf presented in place of a more complete debate over the philosophy and value of life. I am particularly concerned at the occasionally subtle—and in many cases quite open—attacks on my colleagues who hold a particular religious view which values life above casual choice. In particular, those who have claimed there is a greater need for this reform simply because the health minister of the day is a committed Catholic have introduced an ugly note of bigotry and anticlericalism into this place. To those who want unfettered access to RU486 and who may seek change of other legislation which is inimical to Catholic or other Christian views, I give this counsel: if you want a conscience vote then impugning the real conscience of those who grieve for unborn children does you no credit and reduces your arguments to prejudice.

Regardless of the outcome of this debate, I would sound a call to this chamber and to this parliament to never again accept denigration of Christian or any other religious views as biased, baseless or ill-informed. These are views which reflect our deepest history and our core values, and without them our society would be much the poorer. I will be voting against this bill.

John Faulkner (NSW, Australian Labor Party) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 has been the subject of a highly emotionally charged debate since it was introduced last year. It is important in this second reading debate that we understand very clearly what this bill will do and will not do. This is not a bill to import or approve the importation of RU486; that decision can only be made by the Therapeutic Goods Administration. This is not a bill to remove parliamentary scrutiny of any decision by the TGA about RU486; that scrutiny does not currently exist.

This is not a bill to change the laws concerning abortion; those laws are state matters. This bill will remove the Minister for Health and Ageing’s power to veto—alone and without consultation—any application to the TGA to evaluate RU486. It will end the anomalous situation where, amid all the many dangerous and potentially deadly drugs prescribed by Australian doctors and used in Australian hospitals daily, RU486 has been removed from the responsibility and oversight of the Therapeutic Goods Administration. Supporters of this state of affairs say that the potential side effects and risks of RU486 are too great to leave the decision in the hands of the TGA.

No-one has suggested that the TGA ought not to assess the risks and efficacy of chemotherapy drugs—drugs with awful side effects. No-one has suggested that the TGA ought not to assess the risks and efficacy of medications for heart disease, immune system disorders and cholesterol, all of which have side effects and all of which have risks. That is why we have a Therapeutic Goods Administration. That is why the Therapeutic Goods Administration looks carefully at drugs brought before it.

Many pharmaceuticals studied by the TGA have the potential, if prescribed wrongly or carelessly, to cause injury or death. Yet those drugs do not need the health minister’s approval for an application to the TGA. For those drugs, the TGA’s expertise is perfectly acceptable. The reason for the inconsistency is that RU486, among its other possible uses, such as treating fibroid tumours, endometriosis, Cushing’s syndrome, meningiomas and some kinds of breast cancer, can be used to cause a deliberate miscarriage of pregnancy—a non-surgical abortion. That is the reason this drug has been treated so differently. Concern over risks and side effects is an alibi for the real reason: the determination to keep this option closed to Australian women.

Although the majority of Australians consider that a woman’s decision to continue or to end a pregnancy is a private one, there is still a minority who would like to block women who have made the decision to have an abortion from access to safe termination services. In this minority there are those who have treated this bill as an opportunity to raise a question most Australians consider settled. This simple question of process—that experts, not politicians, should decide if a drug is safe and appropriate for import—has become a proxy for a campaign against Australian women’s right to control their own fertility and choose for themselves whether to continue or end a pregnancy.

So while the question of access to safe and legal pregnancy termination is not the question before the Senate today, for complete transparency I will go on the record as saying that if it were the question before us today I would vote in favour. It is not my right or the right of any politician, or indeed any person, to decide for any woman whether she can end a pregnancy. That is her decision. That is her choice. Nor is it the role of any politician to sit in the consulting room and tell a doctor how to treat their patient or to stand over the TGA and tell them which drugs they can or cannot assess. No question of Australian health should be determined solely on the private moral views of the health minister of the day.

Andrew Bartlett (Queensland, Australian Democrats) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is important, and this debate is important. I am one of those who find it desirable that we have an opportunity from time to time to express our views more genuinely and openly, as we are doing in this case via what is a fairly rare occurrence—that is, a conscience vote. It is a reminder of the diversity of views that often gets hidden in parliament beneath the fairly rigid straitjacket of the party line.

Within the Democrats we have what I say is a great privilege, although also an extra challenge, in having the right to a conscience vote on every piece of legislation. I think that presenting the opportunity to do that should be taken up more often. I am not quite sure why issues like this are determined to be a conscience vote when I can think of some other very important debates that we have had in this chamber on issues that affect the lives of all Australians and that could not be seen as anything other than moral or ethical issues but where the party discipline or straitjacket has come down. We all recognise the need for party discipline, but I think that we could all benefit—and our nation could certainly benefit—from more opportunities for a bit of flexibility in that regard and for people to be able to speak and vote according to well-informed, strongly held views from time to time.

I do understand the strong feelings that many people have about the issues that this legislation raises. Sometimes we could all do better in showing respect for opposing or divergent views that others hold, although that difficulty in showing respect is sometimes understandable when those views occasionally are expressed in highly offensive ways. I use by way of example the extraordinarily offensive, inflammatory and, frankly, puerile advertisement placed in a newspaper today by a group calling themselves Australians Against RU-486. It stated:

RU-486 will probably kill only a few Australian women.

Is that okay with you, Senator?

Car accidents kill thousands of Australians every year. We do not hear people calling for the banning of cars. Tobacco and alcohol kill thousands. Almost all drugs have some risks. Crossing the road has some risk. To say that by virtue of this legislation, under which we would allow the risks of this drug to be assessed by a group of health experts rather than by the random choice of the random health minister of the day, we are labelled as killers shows where people’s strongly held views cross the line to become stupid, inflammatory abuse.

That is part of the problem with some of the debate surrounding this matter. It is not the fact that people have strongly held, genuine and informed views that is the problem; it is the way in which they seek to impose those views on other people. To label as murderers people who choose to have an abortion or who assist someone to do that and to label RU486 as a human pesticide or a drug designed to kill babies is an abuse of language and a vilification of women. It is a vilification of women who find themselves in a situation of extreme difficulty. The last thing they need is this sort of abuse.

I see my role as a senator and indeed as a Democrat to stand with those women in their right to choose, and their right to choose in an environment which has real meaning to the word ‘choice’, an environment free from such abuse and an environment where choice means having all of the options both available and affordable. That means that the chances of them making the choice that is right for them is maximised. It is crucial in this policy area, as in any other, to try to retain an approach which is logical and consistent, and to not get diverted by emotive and misleading rhetoric. If you are against abortion, do not have one. But whilst ever it is legal in Australia it should be a choice for each individual woman to make for herself, rather than having a range of hurdles, obstacles, inconsistencies and abuse put in her way.

As is the case with all of us here, there are some activities that some of my fellow Australians engage in which I am not enthusiastic about. Sometimes I might seek to explain or outline why I think such activities are less than desirable. But just because I find something personally ethnically offensive does not mean that I should be able to use my position as a member of parliament to try to outlaw it. If you oppose this legislation because you oppose abortion then, to be consistent, you should also be moving to prevent Medicare funding of abortion; to ban IVF, which involves the production of many surplus embryos as part of the process; and to amend the current situation with regard to RU486 by banning it altogether rather than by leaving it up to the individual, unaccountable choice of the health minister. If you are genuinely concerned about the safety of RU486 it is far more logical and safer to have any potential health risks assessed by medical experts in the Therapeutic Goods Administration, as occurs with every other drug, rather than leave it up to one individual minister.

It was quite possible that the current health minister, Mr Abbott, who as everyone knows is strongly personally opposed to the use of RU486, could have been, in the most recent reshuffle, out of that position. So it is quite feasible that we could have had a Liberal minister in that position today who is strongly in favour of the use of RU486. There are both here and in the House of Representatives Liberal ministers who will, I am sure, vote in favour of this legislation. Frankly, the same problem would arise: we could have a pro RU486 minister deciding to support the drug on philosophical grounds rather than on its health aspects and its proper assessment. Whoever that person might have been, the fact is that the so-called protection that people opposed to RU486 see in the current arrangement is not a real protection at all and is certainly not a protection that is based around this facade and false cloak of concern for the health impacts of the use of RU486 on women.

Since when do politicians—or, as it currently stands, one politician, the health minister—decide on the safety of a drug? Senator Fielding said that that is what people elect us for. It is not what people elect us for. I do not think a single person voted for me—and I suspect for anybody in this chamber—on polling day on the basis of my ability to assess the safety or otherwise of a drug for release in Australia. What they do elect us to this parliament to do is to ensure that there is a coherent and credible regime put in place to ensure that all pharmaceuticals approved for release in Australia have their safety and adequacy properly and competently assessed. They elect us to do all we can to ensure the safety and health of Australians, and to ensure that all Australians have as many affordable and effective choices as possible available to them in deciding on matters that relate to their health. It is an absurd anomaly to have that principle put to one side solely for one category of drug and solely on the basis—as we all know when you strip away everything else—of some people’s individual ethical or moral opposition to the concept and reality of abortion. It is an illogical approach and for that reason it should be removed.

I would also like to note the approach taken with this legislation. Some have suggested that this has been a rushed process. Contrast it with the approach taken last year on a range of crucial and complex bills to do with matters like workplace relations, security laws and welfare. All of these involved complex—very complex in some cases—and far reaching laws which were introduced at short notice and in some cases with a time frame that provided less than two weeks for reading the large amounts of legislation, for the public to put in submissions, for public hearings to be held and for the committee to produce a report.

While this bill is important, it is exceedingly simple and very straightforward. It was tabled in December after being foreshadowed for a long time and having been the subject of debate backwards and forwards for 10 years. There was over a month for submissions, albeit over Christmas, and three public hearings were held in three different cities seeking to get the views of a wide range of people from throughout the community. Last year we had the guillotining of debate on those major pieces of legislation with minimal notice, coupled with piles of new amendments dropped in the Senate. On this occasion all senators have known, and knew before the debate started, how much time is available for debate on the legislation. I only wish we could have a process even close to approximating this for some of those other matters.

I received, as I am sure many of us—probably all of us—did, many hundreds of emails and letters on this legislation and related matters from people who are strongly opposed to RU486. I would in this instance agree with Senator Santoro’s comment, although I was not so much surprised about that but about the volume of those in comparison to the volume in favour of the legislation. That is an interesting fact, and I note that. It is important to take account of what people contact their politicians about. Frankly, I would encourage people to do a lot more of it, even though it means there are more emails for us to read and respond to. We need to be as open as possible to the views of the community. I endeavoured to read all of those that I could tell were from Queensland, even though many had a lot of commonality in theme. As I said at the start, I respect and understand why people hold those views. They basically had the theme of being opposed to abortion, but in our society I believe that that has to be a choice for each individual woman to make.

One aspect I did find frustrating, though, with some of those emails and correspondence was the fact that many people put forward arguments against RU486 on the basis of calling themselves pro-family; that somehow or other this drug is an anti-family thing. Frankly, I just wish those people genuinely concerned about the family had shown the same sense of urgency, outrage and concern at the end of last year when we had welfare legislation being pushed through this place which dramatically reduced the income of many of the poorest Australian families, including sole parents. That will have a far greater impact on the families of Australia than whether or not one more drug is available for them in considering their health options.

It is worth reminding the Senate and the community of the history of the anomaly of RU486 and that group of drugs being the only ones subject to approval via the health minister of the day instead of via the Therapeutic Goods Administration, as are all other pharmaceuticals. It was inserted via an amendment to a Therapeutic Goods Administration legislation amendment bill back in May 1996. That amendment was moved by former Independent senator Senator Harradine. That amendment was opposed by all Democrat senators at the time but was unfortunately supported by the government of the day and the opposition of the day—and by one Greens senator at the time.

There was an endeavour in March 2001 by the Democrats to move an amendment to another Therapeutic Goods Administration amendment bill to reverse that situation. That again did not receive the support on the record of anyone else in the Senate at the time. I think that was because people have always been concerned about this—they recognise that this is a potentially divisive debate. Even those who did not agree with the current situation—people on all sides of the political fence—felt it was better to just let sleeping dogs lie.

It is important to note the contribution of those who last year decided it was time to wake the dog up again, as it were, not to let the sleeping dog continue to lie. They decided to once again push the matter and again looked for a Therapeutic Goods Administration amendment bill in order to move amendments to try and reverse what I believe is an absurd and outdated anomaly. This anomaly came about as much because of the political dynamics of 1996 as because of a well-thought through policy decision of the majority of senators at the time.

I particularly note Senator Lyn Allison from the Democrats, who pushed this more than anyone initially in flagging potential amendments to other TGA bills that were around. But I also note those men and women—women in particular—from other political parties who pushed this issue within their own parties. To some extent, I recognise that for some of them that was more difficult to do internally with their own party than it would have been within a party like the Democrats. I particularly acknowledge the extra courage and determination of all of those senators, and those women in particular, who pushed this issue and who were willing to put their hands up—and to some extent stick their heads up along with it. That is not always easy, and it is important to acknowledge that.

While I am doing that, as Senator Nash said, this is probably the first private senator’s bill since Federation in 1901 that has had four senators, names attached to it from four different parties. That in itself is also something to note and to celebrate. I obviously feel more celebratory about it because I support the bill, but the fact that senators can come together from four separate parties on any matter and put it forward into the arena for political debate is something that should be celebrated. I would do so even if it was a topic matter I did not support, if perhaps not quite so enthusiastically.

It is quite rare for private bills introduced in the Senate to be passed into law. According to the list in the appendix of Odgers, there have only been eight. If this does pass the Senate, as I hope it does, and then passes the House of Representatives, this will be just the ninth private senator’s bill to do so in over 100 years—and a couple of those, I might say, were quite small, almost administrative, matters. So that is something to note; that shows the significance and importance of the efforts of the many people who have pushed this matter forward for debate. I acknowledge their efforts in that regard.

To make it clear, there have been other private member’s bills initiated in the other place that have passed into law. But nonetheless it is fairly rare, not least because of the very tight party discipline that has been a characteristic of Australian parliamentary politics for a long time and which I mentioned earlier on. That is all the more reason why it is admirable and notable that this matter has got this far.

I urge those senators who are still considering their vote on this to vote in favour of it and recognise that it is as much about good public health administration as it is about some of the moral and ethical issues that people have raised through the course of this debate. If it is successfully passed through this Senate on the vote tomorrow afternoon, then I also urge the same of those members of the House of Representatives still considering this matter.

Gavin Marshall (Victoria, Australian Labor Party) Share this | Link to this | Hansard source

I seek leave to incorporate my second reading speech.

Leave granted.

The speech read as follows—

I rise to add some remarks to this important debate on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for approval of RU486) Bill 2005.

At the outset, can I indicate that I am very supportive of the bill before us, co-sponsored by Senators Allison, Moore, Nash, Nettle and Troeth and I will be voting in favour of it.

In fact, I take this opportunity to pay tribute to the five senators who have put their names to this bill by way of co-sponsoring its introduction into the Senate.

I note how unusual a practice this is.

I was not here in the chamber back in 1996 when the original decision was taken to restrict the importation of and access to Mifepristone in this country and it’s a decision that’s review, I believe is long overdue.

That’s why I congratulate the senators who have co-sponsored this bill before us today.

This is a debate about governance and consistency.

It is about who is best to decide what drugs, regardless of their chemical composition and/or supposed-effects, are safe enough to be imported and used in this country – an individual politician who would always inevitably come with a set of ideological and/or ethical standards and who may also not possess any medical intelligence whatsoever (as is the case with the current Minister for Health) or an Administration stripped of ideological and ethical shackles and charged with assessing and monitoring drugs based on rigorous science and medical standards.

For me, the fact that the TGA is currently charged with assessing and managing the risks associated with the other 50-odd thousand medicines and drugs Australians currently rely on for their healthcare proves that this is the body with the expertise to undertake this very same role in relation to RU486 and all other drugs for that matter.

That is essentially why I support this bill.

But this is not the only reason why I support the bill.

Over the past few months, but more particularly over the past few weeks, senators will have been inundated with correspondence, faxes, telephone calls and many form letters at their offices – both back in the electorate office and here in Parliament House.

Most of these have been alarmist, dogmatic, faith-based appeals and even medical assessments with little regard for the facts surrounding the issue we are actually debating today.

Some even go so far as to call those of us who will support this bill, murderers; tell us that we will have blood on our hands; or threaten to withhold electoral support for us at subsequent elections.

That is any elector’s prerogative and right. However, I would just submit to those people that I make decisions in this place based on what I believe are best public policy principles – not threats.

As you know and as the Prime Minister himself has emphasised, this debate is not about the virtues or otherwise of abortion – surgical or medical – it’s about whether a single Member of Parliament or the Therapeutic Goods Administration should decide on the safety of the drug.

And that is precisely the debate we are having today.

Senators may recall receiving one particular email – a very succinct one providing six points about what the vote on this bill is about. The email was from Sexual Health and Family Planning ACT and I will draw on aspects of it throughout my speech. However, I want to make mention of a reference it makes to a quote in an article written by Dr Leslie Cannold, an ethicist and researcher at the University of Melbourne in The Age newspaper on 4 December 2005, and I quote:

The vote was never about abortion, or even the safety or effectiveness of RU486. It was about who should decide if RU486 is safe and effective enough to be marketed in Australia: the Health Minister or the Therapeutic Goods Administration. This no-brainer of a question is essentially about good governance.

And that is precisely right.

Decisions about the health of all Australians need to be made on the basis of medical evidence by the experts charged by government with precisely this risk assessment role.

However one of the main arguments put forth by those opposed to this bill is that the drug – Mifepristone – is far too dangerous and risky to allow into Australia.

But to quote from the submission of Reproductive Choice Australia to the Senate Committee considering this bill, ‘this claim is illogical. The TGA is the body charged to assess the risk of drugs. On what expertise and process have those who claim the drug is too risky for the regulator to assess relied? How can an evidence-based evaluation of the drug’s safety put women at risk? What sense does it make to deem a drug too unsafe to have its risks properly and impartially evaluated? Isn’t the point of such an expert assessment to weigh the medical evidence and deliver a considered judgement about the risk/benefit profile of the drug? If the evidence exists to support claims that the drug is unsafe, shouldn’t those expressing concern about risk welcome the vindication likely to come from a proper evidence-based evaluation by the TGA?

As it happens, the evidence does not support claim that RU486 is a particularly risky pharmaceutical.

• The World Health Organisation;
• The Royal Australian and New Zealand College of Obstetricians and Gynaecologists;
• The Public Health Association of Australia;
• The Royal College of Obstetricians and Gynaecologists (UK);
• The Australian Medical Association;
• The American Medical Association;
• The American Association for Advancement of Science;
• The US Federal Drug Administration;
• The Rural Doctors Association Australia;
• The Federation of International Gynaecology and Obstetrics;
• The American College of Obstetricians and Gynaecologists; and
• Cochrane Collaboration

all support the availability of RU486 and conclude on the basis of the medical evidence that the risks posed by the drug fall well within acceptable limits and are outweighed by the benefits.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists in its submission to the Senate Committee sought to compare the side effects and maternal mortality of medical termination with surgical termination.

And I quote from the submission:

Serious complications are rare and occur in approximately 4/1000 procedures with either method. Mortality and serious morbidity occurs less frequently than if a pregnancy went to term.

A recent Danish study of 50,000 surgical procedures reported a complication rate of 3.4/100 within two weeks of the procedure with bleeding, re-evacuation or infection being the most common.

Maternal mortality rates relating to surgical termination in Australia and North America are of the order of 0.3-0.8/700, 000 and most recent data indicates the commonest cause was related to anaesthesia.

Serious complications with medical terminations are rare with overall rates due to haemorrhage infection of 2.7-3.0/700 and 2.0/100 requiring surgical evacuation of retained tissue.

There have been four maternal deaths recently reported from North America where there has been an association with medical termination of pregnancy. Although mifepristone has not been sited as the causative agent, this gives an estimated mortality rate comparable with that of surgical termination.

No intervention is without risk. One cannot avoid risk.

And that is true.

RU486 has been used by over 21 million women worldwide in more than 30 countries, including the US, UK and New Zealand.

There is such a greater mass of evidence available today about RU486 compared with back in 1996 when the decision we are seeking to reverse today was first made.

In November 2005, the Federal Council of the AMA revised its position on Termination of Pregnancy to include the statement: “Where the law permits termination of pregnancy, non-surgical forms of termination (such as RU486/mifepristone) should be made available as an alternative to surgical abortion in cases where they are medically deemed to be the safest and most appropriate option based on the appropriate clinical assessment.”

The change to the AMA’s position was made because it now believes the necessary research on non-surgical forms of abortion has been done and has reassured it that the risks to a woman of using RU486 is acceptably low.

Perhaps this is why some elements of the community are confusing today’s debate. Perhaps, with all of the evidence available it is glaringly obvious that the risks associated with RU486 are equal to or could be even less than that for surgical abortion.

Some argue that the drug is in a league of its own, but again, as is made clear in the submission by Reproductive Choice Australia – and I quote - “such claims are also incorrect. There are a number of pharmaceuticals that are both registered in Australia by the TGA and used in a broad range of healthcare settings that can end human life, including morphine sulfate. Nor can it be said that RU486 is the only medicine capable of harming an embryo/fetus or causing miscarriage. Currently, the TGA lists around 55 drugs or categories of drugs that either ‘cause, are suspected to have caused or may be expected to cause an increased incidence of human fetal malformations or irreversible damage’ or have ‘a high risk of causing permanent damage to the foetus’. These include the anti-malarial Quinine, several vaccinations, numerous anti-epileptics and the mental illness treatment Lithium salts.”

It’s worth noting that RU486 can be used to treat a variety of illnesses and life-threatening conditions, including: inoperable meningiomas; Cushing’s syndrome; breast and prostate cancer; glaucoma; depression; endometriosis and uterine fibroids. In addition, the drug has shown promise in the treatment of HIV/AIDS, dementia and progesterone-dependant uterine and ovarian cancer.

Indeed, despite claims that RU486 was designed specifically as an abortifacient it was actually designed by its health care company-creator Roussel Uclaf as a treatment for serious endocrine conditions like Cushing’s syndrome. The discovery that the compound could induce very early abortions was an unexpected outcome of this investigation.

It’s worth noting the ridiculous situation people like Mary Lander find themselves in trying to access RU486 in Australia. Many would remember Mary Lander and her situation from a story aired on the 7.30 Report late last month.

Mary Lander suffers from a skull-based brain tumour.

As Reporter Nick Grimm noted, Mary’s tumour itself is not likely to be deadly, but as it grows it’s pressing against her brain, causing damage. Surgery to remove the lump would also be likely to result in brain damage. Faced with the prognosis, Mary Lander looked overseas for other options and she found one in the United States.

The answer was mifepristone or RU486.

To quote from the transcript of the story: -

‘NICK GRIMM: Australia’s drug watchdog, the Therapeutic Goods Administration, can grant approval support for RU-486 to be imported under its special access scheme. It’s meant to accommodate the needs of people like Mary Lander. It took her four weeks to get the TGA’s blessing.

CHRISTINA RICHARDS: It’s a very time-consuming process. It can be very costly. And when you’re very, very sick the last thing that you need to be doing is spending your energy on trying to apply for a drug that is very contentious.

NICK GRIMM: The TGA granted Mary Lander a permit to import RU-486 valid for six months. However, she discovered there was a catch. Spelt out in the approval letter was a warning that the TGA would not provide any assurances or indemnity about the drug because it is unregistered. Mary Lander says that clause has made doctors refuse to prescribe the drug. Four months on, she still can’t get it into the country and the approval will expire in just two months.

MARY LANDER: I guess the bureaucrats will say they have a due diligence responsibility to make sure that the legislation is being administered in such a way they are required to administer it. But I think there’s a human side and human cost to all of that that needs to be brought into that.

NICK GRIMM: How would you describe the process that you’ve had to go through?

MARY LANDER: I think it’s really quit inhumane. I mean to have to subject somebody to something like that, knowing that the drug is a viable treatment option for a particular tumour.’

It’s a ridiculous and unfair situation.

People like Mary Lander are being caught up in the politics that are intertwined with RU486.

The situation must be rectified.

But not only do the current restrictions on the importation and use of Mifepristone cause people like Mary Lander distress, they interfere with the rights of the states in this country.

In Australia, the states regulate abortion. The curtailment of the legitimate regulatory scope of the TGA to assess RU486 by the Commonwealth improperly interferes with State policy and law in this area. And it should be lifted.

To tackle another point, as the AMA stated in its submission to the Senate Committee considering this bill, ‘restricting access to RU486 in the unsupported expectation that this will reduce the number of abortions performed is not reasonable’.

To go back to the email from Sexual Health and Family Planning ACT,

‘Making a non-surgical option available to women will not increase the abortion rate. Medical abortion, like surgical, requires appropriate medical supervision and women in most states will still need to persuade a medical practitioner their abortion is necessary for them to comply with relevant state criminal codes regulating the procedure.

Overseas experience shows that the availability of medical abortion does not increase the overall number of abortions that take place, as was recently acknowledged by the Australian Christian Lobby.

The introduction of RU486 in Germany in 1999 has seen a steady rise in the number of women choosing a medical abortion, but a relatively steady rate of abortion over all.

Increasing numbers of American women are also choosing medical over surgical abortion, but the US recently recorded its lowest overall rate of abortion in 30 years.

In Sweden, abortion rates actually declined after medical abortion was introduced.’

At the end of the day, abortion is a subject for discussion between a woman and her doctor and a decision for the woman. The method a woman chooses to terminate her pregnancy should be her decision and should be supported by the medical profession and the wider community, whatever that decision is.

We had that debate decades ago. It’s over.

And as the email I received states, ‘We are all entitled to our opinions and beliefs. But medical decisions should be made on the basis of rigorous and up-to-date medical evidence. And who better to evaluate the medical evidence than the TGA?’ it asks.

Likewise, as the AMA states in its Committee submission,

‘The AMA believes that the TGA is best placed to decide upon the safety of all medications and therapeutic products including RU486 and should be given the opportunity to judge the safety and efficacy of this medication as it does all others. It is the best qualified authority to decide when and where and with what support services this drug should be made available. They must exert their judgement freely, fairly and away from undue pressure. The AMAs judgement is that the TGA will find the drug to be as safe as many others that are available in Australia and that the safety profile is acceptable.’

Rational consideration suggests that in the same way as the TGA fulfils its mandate with regard to other drugs – ensuring they are of an acceptable standard and that Australian patients have access to them within reasonable time frames – it should be politically unshackled so it can undertake this work with regard to RU486.

However rational consideration of this issue seems simply impossible for some. As the Reproductive Choice Australia Committee submission states and I will conclude with this quote:

‘If arguments in favour of retaining the effective ban on RU486 are not grounded in logic, what is their source? One candidate is faith. Eighty-two per cent of Australians support a woman’s right to choose whether or not she has an abortion. This figure declines only slightly for religiously identified Australians, 77 per cent of whom support a woman’s right to choose. However, the small minority of Australians (9 per cent) who oppose a woman’s right to choose —and presumably favour a retention of the ban —are predominantly people of “faith”.

Yet Australians of all religions and cultural backgrounds have good reason to oppose the influence of faith rather than logic-based arguments in policy decisions that affect all of us. This is because in pluralist democracies the religious and cultural rights and freedoms we enjoy depend on the refusal of government to favour one group’s religious or cultural outlook over another. As has been shown in many countries across the globe, the State’s imposition of the values of one religious or cultural group on the whole can undermine national cohesiveness and sabotage democracy. Australians must hold on to our principles that religion has no place in politics and politics has no place in medicine. Upholding this conviction does not make our democracy values-neutral but a unifying repository for values shared by most of the world’s religions and subscribed to by the people of all successful democracies: justice, equity, respect, tolerance, honesty, integrity, personal responsibility and trust.’

I thank the Senate and call on all senators to support the bill.

Christine Milne (Tasmania, Australian Greens) Share this | Link to this | Hansard source

Contrary to much of the advertising and public discussion, the question before the Senate today is not whether pregnancy terminations should continue to be legal in Australia. That is another debate under the jurisdiction of state parliaments. The question before us is: who should have responsibility for approving the use of the chemical abortion drug RU486 in a country in which it is legal in every state and territory to have a termination if the mental or physical health of the woman is at risk? Should responsibility for approving RU486 lie with a single member of parliament, the Minister for Health and Ageing, or should it lie with the Therapeutic Goods Administration?

What does that responsibility involve if you are the person or organisation making that decision? It involves assessing the safety of taking the drug. One has to ask: who is best informed or equipped to determine if a drug is safe for use by humans—a politician who may have no medical training at all, or the organisation specifically set up and trusted to make that decision about every other drug on the market in Australia today? The Therapeutic Goods Administration is accountable at every stage. Can the same be said of one parliamentarian?

I think it is dangerous for politicians to involve themselves in medical decision making. Parliamentarians should set the policy framework, and the medical experts should assess what is safe within that framework. The policy framework has already been determined. Parliamentarians in state parliaments around Australia have determined that termination is legal in Australia today. Therefore, the decisions about how that procedure is performed safely are a matter for medical experts and for women in discussion with their doctors. If surgical abortion has already been approved by state parliaments, by parliamentarians like ourselves—in other words, if it is legal—why should the alternative option of chemical abortion not be available if it is safe?

To be safe and to comply with state laws, abortions, whether procured medically or surgically, require medical oversight and approval. If a state requires that a woman satisfy physical and mental health tests before qualifying for a surgical abortion, she will be required to satisfy the same tests to have a lawful termination using medical methods. So failing to support this bill will continue to force women into surgical procedures when a chemical option is available. For many women, a drug may be a better option for their physical and mental health than surgical intervention. They may recover their physical and mental health faster if they can access the procedure at an earlier stage and be secure in their own surroundings, supported by those who care for them. How logical is it for politicians to say that it is okay for women to have a surgical termination but not a drug induced one? If you are opposing this bill, that is exactly what you are arguing.

Decisions about the health of Australians need to be made, on the basis of medical evidence, by the experts charged by the government to assess risk—namely, the Therapeutic Goods Administration. This administration assesses and monitors almost 50,000 drugs on which Australians rely for their health. The only drugs in Australia that are not currently permitted to be assessed and monitored by the TGA are those intended for use as an alternative to surgical abortion. This is inappropriate. If we trust the TGA to assess the risks on every other occasion, why not on this one? Would you trust the health minister to determine if the latest cancer drugs were safe? Many of these cancer drugs have horrendous side effects. Many of these drugs could cause death if used in wrong or inappropriate ways, yet we say that the TGA has the responsibility to assess the risk and effectiveness of the drugs. We trust it to do that. Would we trust a health minister to do so?

The World Health Organisation placed RU486 on its list of essential medicines in July 2005. Europe has 15 years of experience of this drug, which is widely available internationally—in Sweden, France and Great Britain, for example. It is endorsed as safe and effective not only by the WHO but by the Public Health Association of Australia, the Royal College of Obstetricians and Gynaecologists, the American College of Obstetricians and Gynaecologists, the Australian Medical Association, the American Medical Association, the American Association for the Advancement of Science and the Federation of International Gynaecology and Obstetrics.

Whilst I respect everyone’s view on the matter of whether abortion should be legal in Australia, I do not think it is appropriate to confuse that issue with the matter before us. The matter before us is simply: who should decide what medical options are available to give effect to a decision the state parliaments of Australia have made—namely, that termination is legal in Australia? I believe that the Therapeutic Goods Administration—medical experts—should make that decision and not one parliamentarian. I support the bill.

Kay Patterson (Victoria, Liberal Party) Share this | Link to this | Hansard source

I wish to make a very short statement on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 to put my position on the public record. I start by thanking the Prime Minister for responding to the suggestion I made, when I was the Minister Assisting the Prime Minister for Women’s Issues, that we be allowed to have a conscience vote on this bill. That was important and it was one of my contributions in this debate.

I know that I will disappoint some people in the way in which I will be responding on this bill. The people who were surprised by my vote on the euthanasia bill, when I voted to oppose euthanasia, most probably would have thought that I would automatically vote on this bill in a similar way, but I have always been an issues person who tries to take each issue on its merits and evaluate it in that way. That does not always mean that I end up with what some people would see as a consistent response. So be it. I have never claimed to be right. In any of the conscience votes, I believe that I have always done my best to evaluate the situation and make a decision using my limited intellectual ability to come to a conclusion. We always anguish over the conscience votes because they are always tough and there is no right answer. It is a matter of degrees and a matter of trying to weigh up all the arguments.

This bill is not about the legality or otherwise of abortion. I regret that that is the way in which some of the debate has proceeded. There has been an avalanche of mail. If you ever want to privatise Australia Post, I would suggest that one way to actually increase its shares would be to raise an issue like this, because I am sure Australia Post has done a lot of business. I want to thank all the people in the sorting room downstairs for the mammoth task they have undertaken in the last few days. But it is good to see that the public are involved and interested. Although the response has been overwhelmingly to vote against the bill, there have been some letters that have thoughtfully—as have the others—put their proposition and point of view. But it is not about abortion, and some of the arguments have muddied the waters in this debate.

We all know that we had this debate 30 years ago. The states and territories have legislated in relation to abortion and currently, in accordance with the relevant state and territory laws, a woman can access abortion legally in this country. I grew up in the inner city suburbs of Sydney. As a young person, I remember leading a patrol of guides and being at a camp site with one of the girls whose mother was a backyard abortionist and hearing the stories that she as a young person related to us, with our ears wide open, about her mother’s activities. I can think of only some of the outcomes of those backyard abortions that that person performed while she sent her kid off with two shillings to buy a milkshake down the street while she ‘fixed the girl up’. Many of those girls ended up in atrocious conditions, with septicaemia and other terrible outcomes.

We have had the debate. The states have legislated on abortion. Personally, I—as I am sure most, if not all, who are voting in this chamber on this bill—would prefer that there were fewer abortions; in fact, none if possible. We would want to see more done to reduce the number of unwanted pregnancies, whether it is teenage pregnancies, pregnancies of people entering into new relationships or pregnancies of people who have been partnered for significant periods of time who do not think they can afford a child. I think every one of us would want to see fewer unwanted pregnancies. However, if we want to face up to the situation, however much we would prefer not to see an unplanned or unwanted child being conceived, I think we are wishing for the nirvana.

I have been interested in the RU486 debate as it has progressed and nobody I have seen has discussed the fact that over time we have moved from one form of surgical abortion to another. One method was used and now medical practitioners prefer another method of surgical abortion. We never had a health minister who had the responsibility of saying, ‘We will not give a Medicare item number for this form of abortion versus another.’ A clinical decision was made by doctors that a different form of surgical procedure was better for patients. The second form is now used more frequently. It is never to be vetoed by a health minister; it is a clinical decision made by medical practitioners undertaking what is legal in each legislation. If it is not legal then the states have a lot to answer for. If they are not enforcing their laws, the states should be looking to enforce their laws. As I said, there has not been a call for the health minister to have the right of provision over a Medicare item number for one form of surgical abortion over another.

People have come in here and said that RU486 has been used by thousands of women, and so on. There have been various arguments. I do not feel competent to stand up and argue for RU486. That is not what I am doing in supporting this bill. I am saying that I do not have the competency to assess RU486. We have a process for assessing the efficacy and safety of drugs used in Australia, and that is the process that should be used. Passing this bill does not guarantee that RU486 will be deemed safe or made available. It may be, but it may not be. Passing this bill will mean that, should a sponsor apply to market the drug, the TGA will evaluate the drug on its merits, as it does for every other drug which is not an abortifacient.

Had a company written to me when I was the health minister and sought to have RU486 evaluated, despite my keen interest in things medical I do not think that I would have had sufficient expertise to make the decision not to allow the TGA to evaluate the drug. I would have sought the advice of the expertise of the TGA. And if the drug to be administered needed a Medicare item number, I would have sought the advice of the Medical Services Advisory Committee. I do not think the decision to allow or prevent the TGA from evaluating this drug should depend on the view of the minister of the day, whether it was me two years ago, Tony Abbott today or somebody else in the future. I believe we have a process and that is the process that ought to be followed.

I believe the best course of action is for the same procedure to be used as is used for every other class of drug which is not an abortifacient, and that is for the TGA to assess whether the drug should be available in Australia. Then it is up to the clinicians to make a decision, knowing their patients, as to which form of abortion is appropriate, whether it be surgical or medical. They will do that, as they have done with changing from one form of surgical abortion to another.

As I indicated, the Medical Services Advisory Committee may be involved if a separate Medicare item is required. I do not know whether it is, but, given the need for RU486 to be delivered in a way in which more supervision is required than for other drugs, it may be. We do have measures for other drugs—for example, some arthritic drugs—where we have special Medicare item numbers and special requirements in the delivery of those drugs. So it may not just be the TGA. But I believe that we have a process. If we do not think the TGA is up to the task then it is up to us to change the TGA. But we have a process. I do not believe it should rest in the hands of the health minister.

One journalist asked me the other day where I was in 1996. I had done a lot of research on RU486 in 1996. I do not actually remember the debate, which surprises me because I had done a lot of research on it. I may have been away in the Antarctic; I do not remember, and I have not had time to go back and see where I was. But in 1996 we did not know enough about this medication. I think there is enough known now for a proper, professional assessment—whatever that may be. I am not arguing for or against RU486. What I am saying is that it should be evaluated appropriately and a decision made, and then doctors should be left to make decisions on a clinical basis. But woe betide doctors who misuse any form—surgical or medical—outside the law. The states ought to be making sure that their legislation is upheld to the letter of the law.

This is a major issue. As I said, I do not claim to be right. All I have done is use my understanding and ability to think an idea through as far as I possibly can. I regret that hundreds of people who have written to me will be upset, but I have been elected here to make a judgment as best I can, given the information I have got. I will not always satisfy everybody, but in this instance I believe it is appropriate for the TGA to make the decision and I will be supporting the private member’s bill.

Nick Sherry (Tasmania, Australian Labor Party, Shadow Minister for Banking and Financial Services) Share this | Link to this | Hansard source

It is relatively rare that I find myself in absolute agreement with the previous speaker, Senator Patterson, and I do about the way she has approached this matter. Like her, I voted to prohibit euthanasia, for reasons that I outlined on that occasion. This is the third time during my almost 16 years in this place that we have been allowed a conscience vote. The bill before the parliament in this case is the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I think the title of the bill aptly outlines the issue and the purpose of the bill. A conscience vote is very rare and is usually allowed on issues that affect human life. I welcome and accept the responsibility that is placed on my personal judgment, and I hope that those who disagree with the conclusion I come to will understand that I have given the matter considerable thought. I have read much—though not all—of the correspondence and I have spoken to a number of people and listened to the views of people on both sides of the issue.

I thank all those who have written and spoken to me and I also thank and commend the members of the Community Affairs Legislation Committee. Although their report was tabled only a few short hours ago, I have had the chance to look at their considerations. It is not easy; these issues are never easy. It is a well-written and thoroughly researched report, so I thank all the members of that committee who participated.

Previously I participated in two other debates with a conscience vote: the prohibition on euthanasia and the restrictions on stem cell research. On those occasions, as I explained, my principal concern was for what is referred to as the sanctity of life and its importance to Western society. Our society is based on a Judaeo-Christian ethic of respect for individual human life. I am an amateur student of history, still reading and learning, and unfortunately throughout history practice has often horribly deviated from the sanctity of human life. But I strongly believe that that central principle is still very important in our society. As I said in my two previous contributions on conscience vote issues, I try to approach each issue with practical questions: will it work, and what will be the adverse human consequences of a particular policy? I found my decision to support the prohibition on euthanasia relatively easy, and I voted to support the prohibition, for the reasons I outlined in my speech on that occasion; similarly, in respect of restrictions on stem cell research, on which I found it more difficult to reach a conclusion. Much of the debate on this bill has been characterised as being for or against abortion. I do not believe the central issue of this bill should be whether one supports or opposes abortion. With respect, I think that is a simplistic approach. It is not the central issue on which I ultimately base my decision.

On the issue of abortion: I do not agree with abortion. To me, it is the destruction of evolving human life and I find it highly disturbing that abortions are carried out in the community. However, abortion is legal in Australia. Frankly, I have to say that reversing that is very unlikely. There are significant indirect human consequences of backyard illegal practice. As a consequence, if I ever were faced with a decision in this place, I would find it difficult and I would be unlikely to vote to outlaw abortion. However, if it is to continue to remain legal, abortion should be a truly last resort after the exercising of reasonable, independent and, I would argue, mandatory counselling in addition to medical advice. It should certainly not be late term. Obviously, there has been a rapid improvement in the life expectancy of premature babies. They are living healthy lives thanks to medical science. Abortion is primarily, but, in my view, not exclusively, a decision for a woman to make. I think the interests of the father should also be considered.

I have to say that I do get somewhat annoyed at the simplistic slogan of ‘choice’ being applied to complex issues. Issues of this type—in fact, issues of most policy types that we deal with in this place—are rarely simple. I note the growing tendency in public policy terms to wrap controversial and complex issues in the simplistic notion and slogan of ‘choice’. Choice has become a mantra. The real world is often more complex than simply being able to say, ‘It is an individual’s choice.’

Whilst the consequences of this bill are closely linked to the issue of abortion, I have not regarded that as the central issue. There may or may not be a greater number of abortions—I simply do not know—as a consequence of the passing of this bill. I would certainly hope that there were fewer abortions in our community. But I am simply not in a position to make that judgment. I respect the views of those who have made the judgment, but I am certainly not in a position to make that judgment.

So the principle on which I have made up my mind relates fundamentally to what is appropriate, independent, expert, arms-length decision making about the use of or prohibition of particular drugs in Australia. I do not believe that the decision making belongs with an individual minister. If we allow such a process to continue—I point this out to those who strongly oppose abortion and, in this case, the use of RU486—what happens when the current Minister for Health and Ageing, Mr Abbott, concludes his position and a new minister with a different point of view is appointed? That seems to me to be a ridiculous approach to the legal use or otherwise of a drug in this country. Presumably, a new minister at some point in time will have a different view and simply reverse the prohibition. I think that is not an appropriate approach to decisions on any form of drug and in this case RU486.

I do not agree with all of the views of the current health minister, Mr Abbott, on abortion. I share many of his concerns. I note that he does claim that he can exercise independent judgment based on expert advice. I do not accept that argument from the minister. I do not believe that anyone on an issue such as this can exercise independent, arms-length judgment. I do not believe that the minister, Mr Abbott, can do so on this issue. If he truly asked himself whether he could, I do not believe he could conclude that. I certainly do not believe I could if ever I were a minister with that decision-making power. Therefore, the decision on the evaluation of a drug and its particular merits should be made by, in this case, the TGA.

As I said earlier, to some extent this issue has turned into a de facto debate on abortion and the parameters on which abortion should be allowed in Australia. I would welcome that debate. In fact, I would welcome a bill before the parliament. I know it is currently a state responsibility but I certainly believe that, in this day and age, a constitutional head of power could be found to ensure national, uniform laws on abortion that are consistent across the country. As I indicated earlier, whilst I have significant concerns about some aspects of abortion and the parameters in Australia, if ever I were in the position I would cast my vote in the way in which I have indicated. Any particular amendment to the parameters for the exercising and use of abortion in this country I would consider on its merits if I ever had the opportunity to consider such a piece of legislation. For the reasons I have outlined, I will be supporting the legislation before the Senate.

Ruth Webber (WA, Australian Labor Party) Share this | Link to this | Hansard source

Before I commence my remarks and thoughts on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, I would like to start by congratulating the proponents of this piece of legislation, including you, Madam Acting Deputy President Troeth. It is no small task to take on what can be such an emotional, divisive and somewhat distracting debate to try to actually bring forward a piece of very straightforward and sensible administration in this country. I would like to congratulate all four of you. I would also like to congratulate the Senate Community Affairs Legislation Committee for the way the inquiry into this bill was conducted, given the divisive nature that the wider debate has. As has been outlined, the debate seems to have become wider rather than focused on the piece of legislation itself.

I think the result of the committee’s deliberations was achieved usually with a great deal of tolerance, respect and harmony, which is no small challenge. To the main committee members I express my congratulations. I would also like to pay tribute and give my thanks to the committee secretariat, which had to work with all of us—we brought to the table our differing ideological views, temper from time to time and even belligerence from time to time. As usual, the secretariat was ably led by Elton Humphery and I think they did a superb job in fairly tight and sometimes adverse and trying circumstances.

I rise to make my contribution in this debate and, in doing so, I need to make a confession. It is actually a little embarrassing to admit this—considering that I apparently stand here at the moment with the power to make medical decisions on behalf of the Australian public, as the legislation currently stands—but I am not a doctor; in fact, I possess no medical qualifications. I have not studied medicine or anything vaguely related to medicine, and I have always been under the apparently mistaken impression that therefore I was not qualified or best suited to make those decisions on behalf of others. So I never expected to be standing here today with the power to do so, but the legislation as it currently stands enables me to do just that.

Fortunately, I do not have to be too hard on myself, because I am actually not the only person here today who has to make that confession. I am not even in the minority. Here in the Senate we do not seem to have too many people with medical qualifications; yet each and every one of us gets to make the decision about how one particular category of drugs is to be treated. As it stands at the moment, each and every one of us individually will determine whether those drugs should be treated as safe for use in Australian circumstances. The dilemma is that, even amongst those of us in this parliament who do hold medical qualifications, the views are divided.

Under the legislation as it currently stands, it would seem that any one of us can give medical advice on this issue—only on this category of medications, not on any other—regardless of our qualifications or what we bring to the table. So we are subjected to a variety of views on these particular medications. And haven’t Australian women been treated to a wide variety of opinion over the last couple of weeks! According to our own Minister for Health and Ageing, giving rural women, in particular, access to the drug known as RU486 would increase their risk of adverse outcomes, largely because of insufficient infrastructure to help them if something went wrong during the termination or the abortion. But, according to the member for Moore—a GP and an advocate for sensible medical treatment—the health minister asked ‘a very warped, stupid question and got an equally stupid answer’. So it would seem that we cannot agree.

So whose advice should we take? Dr Sharman Stone has pointed to medical information that shows that this particular drug is a safe alternative to surgery. She has pointed out that, while rural women often do not have access to surgical procedures—particularly in my home state of Western Australia—country GPs will be able to supervise the drug’s use, providing women with more options. Meanwhile, our health minister has suggested that perhaps cold showers may be an effective solution to the problem of unwanted pregnancy. So whose word should we take—the current minister for health or Dr Sharman Stone, a member of this parliament who represents rural and regional women? Rarely before has the Australian public been blessed with such diversity of opinion.

If we are going to have a debate about medications and their effects on individuals, perhaps we should have a debate on whether or not to allow, say, Viagra, to be sold to unsuspecting Australians. As I understand it, an editorial in the US journal entitled, conveniently, Contraception noted that Viagra has a mortality rate of five deaths per 100,000 prescriptions. The Adverse Drug Reactions Advisory Committee received 20 reports describing heart attacks linked to the use of Viagra which included four fatalities. Clearly, if we allow this to continue, we are taking a risk with the health and safety of Australian men—let alone the health and safety of those who have sex with them! Surely the men of Australia deserve to be protected from such a dangerous drug. No, of course they do not: Viagra has been legitimately assessed by the Therapeutic Goods Administration as safe for use by Australian men under certain circumstances—a luxury that we do not allow drugs like RU486.

Despite my relative lack of medical experience, I have been able to learn some facts about RU486. I will share some of them with you so that you too may become a qualified medical expert. In the United States, RU486 has been available since 2000. Since then, 400,000 medical abortions have been carried out in the USA. The number of deaths occurring in these instances is approximately one in 100,000. Those of us on the committee were given this information in graphic detail. In the same country, the number of women dying during childbirth—a statistic that was not shared with us—is 12 in 100,000. Here in Australia the maternal mortality rate is an average of 8.2 deaths per 100,000. That is better than in the USA—absolutely—but is still much higher than deaths allegedly involving RU486. Indeed, in Australia alone, there were eight deaths in 2003 resulting from childbirth or subsequent complications. As the committee heard, childbirth can be an extremely risky proposition for some women.

Despite my lack of medical qualifications, I am quite competent in the field of counting. These numbers show quite obviously that, rather than banning RU486, the health minister—if he is concerned about deaths—should seriously think about addressing the dangers of childbirth, because it would seem to be far more risky to Australian women than having a look at the use of RU486. I again quote my fellow Western Australian, Dr Washer, the member for Moore, who said: ‘One-third of all pregnancies end in miscarriage. Are you going to ban pregnancy in country towns?’ We have the capacity in country towns to deal with a miscarriage but, according to others, we do not have the capacity to administer this drug in country towns and look after the women.

This is another thing I have learned during my recent crash course in medicine: if someone takes this drug, the risks being talked about—infection, bleeding and death—have nothing to do with mifepristone. It is not the drug that causes them; it is ending the pregnancy. Ending a pregnancy, whether by delivery, spontaneous abortion—a miscarriage—or by election, through a medical or surgical abortion, is associated with certain risks. Both a term delivery and a miscarriage at six weeks bring with them a risk of infection and/or bleeding. So it seems to me that those who are concerned about this drug should stop pointing out to everyone that country women often do not have access to adequate medical care and actually start fixing the problem.

I am going to move away now from the medical story and focus on something that everyone in this chamber knows a lot about—that is, politics. That is why we are here today. It seems to me that this debate has had very little to do with medical facts and women’s health. Certainly, those that have approached me to ask me to vote against the legislation have brought very little to the table on those two counts. I cannot help thinking that if safety were a concern we would not be talking about this today. The decision would be left to the same people who approve heart medication, cancer treatments and other such challenging drugs. This debate is about politics. This is about either putting decisions about the health of Australian women in the hands of one person or deciding that all drugs should be examined by the same professional body and exposed to the same expert assessment. This is about a small minority of people who wish to impose their views on the rest of the country.

Whilst Senator Patterson and those of us that support this legislation say, quite rightly, that this debate should not be about abortion, because it is about the role of the Therapeutic Goods Administration, many have tried to make this debate about abortion. As we all know, and as has been mentioned, the abortion laws—women’s right to abortion—are determined by various state and territory governments. It is not the province of any federal legislator or the federal parliament to determine what should or should not be in the criminal codes of our various states and territories. In my home state of Western Australia we have changed our regime for access to terminations on numerous occasions—most recently when the changes were brought about by Cheryl Davenport, a former Labor member of the legislative council. We have decided in Western Australia that a woman seeking a termination on medical grounds will not be committing a crime. It has at last, some years ago, been removed from the Criminal Code.

This debate should not be an abortion debate. If people want to have an abortion debate they should appeal to their state legislators to change their laws. It is not the province of the federal parliament to dictate that. We should not even be discussing that matter today. This matter is about the TGA being able to make an informed decision, based on evidence, about a certain category of medications. It is not a matter for politicians to decide based on ignorance or a desire to enforce their moral code on the rest of us. Australian women are also capable of considering philosophical problems. We need to let them do just that.

So I stand here today to show my respect for the Therapeutic Goods Administration, a professional body comprised of experts who should never be referred to, cheaply, as faceless, unelected bureaucrats. These are sound, ethical and expert people providing the best advice that anyone in Australia has access to. It is those in the medical profession and at the TGA on whom the Australian public rely for accurate and comprehensive advice about their unique health matters—all of their health matters—and we should not be excluding one category. More importantly, I stand here today to show my respect for the women of Australia. I am going to allow each and every one of them to make their own decision about what is best for them for their health, their lives and their families if and only if the TGA says that these medications are safe for use.

Julian McGauran (Victoria, National Party) Share this | Link to this | Hansard source

I rise to speak on the private member’s bill, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Despite the stated intentions of the bill—that is, to place the decision on the safety and release of RU486 into the hands of the Therapeutic Goods Administration—in essence and in truth this is a vote on pro-abortion and anti-abortion beliefs. This is because RU486 is another aid to the process or act of abortion. If it were not so, we would not be elevating the matter to the level of a conscience vote in this parliament.

A conscience vote in parliament is extremely rare and inevitably arises on matters of pro-life and pro-choice issues. The conscience votes I have been involved with in my term in parliament have been the euthanasia issue of 1996 and the embryo experimentation matter of 2002. Both were clearly embedded in moral stances and life issues, as is the bill before us. So I notify the Senate that my vote will be against this private member’s bill. I respect the fact that this is a conscience vote, where each is free of party disciplines. But the core of the decision we make today ought to be clear. If you believe that life begins at conception—that is, the body grows and the soul exists—then what choice do you have but to reject the act, the aid or the promotion of abortion?

Since the landmark case in 1969 titled the Menhennit ruling, which effectively legalised abortion on demand, the number of abortions in this country has risen until it is now nudging 100,000 per year. It is accepted across the social spectrum and from every point of view that this number is disturbing; this much we agree on. Another consequence of the Menhennit ruling over the past 35 years or so is that what was fundamentally an early-term abortion judgment—in essence, up to about 12 weeks—is now being reasoned to justify late-term abortions. This new dimension to Menhennit has reached the outer limits, with a documented case of an abortion at eight months in Melbourne and even evidence taken in the committee hearing into this bill that an abortion at nine months is acceptable on the grounds of the unfettered rights of women over those of the unborn child.

Whilst this is the point our society has reached since the Menhennit ruling, there has also been a seismic change in the attitude of pro-choicers and society towards that ever-posed question, ‘When does life begin?’ When Menhennit ruled, the common belief of pro-choicers was that the foetus was not ‘life’ at anything less than 12 weeks. Science has been the instigator of this major shift in attitude. Science has proven that all senses and early body forms exist within seven days, and the rate of growth of the embryo between one and seven days is as fast as that in any other term of the whole human growth experience. In other words, the embryo is hurtling towards its human existence and selfhood. I make this point to show that the old debate of whether the foetus is ‘life’ or not is over. Society and even pro-choicers now accept that it is ‘life’. The science is far too compelling.

What today’s abortion debate really centres on is how much weight is given to the rights of the woman over the rights of the unborn child. So it is a rights debate—complete rights, unfettered rights, limited rights, equal rights and so on, but it is a rights debate. And that is exactly what we are debating here today: the rights of women to have abortions by yet another method. Therefore, the bill before the Senate goes beyond a debate on process only and it is absurd to try and convince those of us participating in the debate that it is otherwise.

It follows then that I give my support to the continuation of the 1996 amendments to the Therapeutic Goods Act 1989 that placed substances such as RU486 in a special group of drugs known as ‘restricted goods’, on the basis that they are drugs which are intended to be used to induce abortions in women. ‘Restricted goods’ is the proper term for drugs that induce abortion. A substance is therapeutic if it relates to the treatment or cure of a disease, and drugs that induce abortion are not administered to women with the intention of treating or curing a disease.

Furthermore, the TGA has no reference by which to judge the ethical, moral, social or psychological impact of this drug. Judgments and decisions made about such medicines require a higher level of scrutiny, and that inevitably should lie with the elected federal representatives. No-one should doubt that passing this bill by voting to support it will inevitably see the release of RU486, particularly given the modus operandi of the TGA. In the past, it has been heavily reliant on sourcing its standards and its conclusions from equivalent overseas agencies, in particular the USA Food and Drug Administration.

While it is said that the TGA is in the best position to judge the safety of RU486, that argument fails to look at the issue as a whole or acknowledge that there can be exceptions in the referral of drugs to the TGA. This is one such exception. Therefore, I conclude it is a risk to refer the matter to the TGA, based on its methodology and its inability to consider the moral and ethical aspects of this drug’s use.

Medical evidence given in the committee hearings into this bill, along with individual research based submissions, produced compelling evidence that this drug is not safe. It is certainly not, as it was originally marketed, a convenient do-it-yourself, at-home procedure. In fact, it relies upon three visits to the doctor and a cocktail of other drugs beyond RU486. The possibility of death from the use of RU486 has been recorded in the New England Journal of Medicine, which estimates the rates of maternal mortality related to its use as being about 10 times those of surgical abortions. The possibility of infection, haemorrhaging and the need to return to undergo a surgical procedure is even higher. Furthermore, researchers suggest that this chemical procedure is more psychologically traumatic than the surgical procedure. One of its so-called attractions is privacy—home alone. But this does not justify its release. It is in fact a good reason not to release it.

It is worth noting that, where this drug has been most frequently used, the very body that released the pill onto the market, the US Food and Drug Administration, is currently investigating a number of deaths associated with RU486. It has recently convened a meeting with the Centers for Disease Control and Prevention to investigate these deaths. This ought to be of serious concern to anyone advocating the release of this drug onto the Australian market. That is, deaths, permanent injuries and psychological scars are ever-increasing as this drug is popularised.

Further, in discussing the safety of the drug, not enough attention has been given to the drug misoprostol, which is the second and equally potent drug in the cocktail of drugs required to enact the termination. This drug will not be placed under the scrutiny of the TGA as an abortifacient. This is because it is not labelled for the purpose it is going to be used for. It is a drug used to treat ulcers. Evidence was given before the committee that in trials of misoprostol as an abortifacient in 40 per cent of cases the drug failed in its purpose. The concern over its safety for such use has prompted the manufacturer to issue a statement that it is not involved or in any way endorses the study or the use of misoprostol as an abortifacient either separately or in combination with other medical therapies. In fact labelling for the drug contains prominent warnings and contraindications for its use by pregnant women. In short, the cocktail of drugs used to achieve termination is of unacceptable risk.

In conclusion, Australians in the great majority now believe that there are too many abortions, estimated to be between 90,000 and 100,000 a year. This is common ground for pro-choice and pro-life advocates. Care and counselling services for women before and after any decision are also common ground. I urge the Senate to reject this bill and work on what is common ground.

Bob Brown (Tasmania, Australian Greens) Share this | Link to this | Hansard source

I congratulate the two speakers before me who have put totally different points of view. Indeed, Senator Webber gave some fascinating insights into the statistical analysis, which we need to make a decision on here, but more particularly into the real purpose of reviewing this legislation, which is to remove the Minister for Health and Ageing as the arbiter of a drug which, like so many other thousands of drugs, should go through to the Therapeutic Goods Administration and then its use become a matter for doctors to determine with their clients.

It might not seem like it, but Senator McGauran and I have got some things in common. We both come from the bush and have very conservative backgrounds. I have to tell a little story that I do not find all that comfortable, I suppose. I went knocking on the door of the Liberal Party too many years ago. Senator McGauran has done that just recently. The trouble is, I was late and the door was shut on me. So Senator McGauran has had a bit of better luck there.

At the same time I was at medical school. I went on to practise medicine and if there was one thing that terrified me it was the prospect of having to deal with somebody who wanted an abortion. But I was in family medical practice and very quickly was faced with this dilemma. For a conservative young man, I can tell you it was a horrific dilemma, until I realised that it was not my right to make a decision; it was my right to give information and counsel. So when the woman involved, and very often it was a very young woman, wanted an abortion and spoke to me about that—and we are talking here about the early 1970s, and how the world has changed since then—I would ask her to come back if possible with her partner at night and spend as long as it took to explain the options of becoming a mother, adopting out the child or proceeding to the option which I was being requested to provide, which was an abortion. In those days that required a plane flight from Tasmania to Melbourne. I found it was not only my choice but my responsibility to go through all those options. It became very evident that, if the people involved wanted an abortion and I was to deny them that, they would simply go somewhere else. How I wish that the options had been wider. We are discussing here the ability of doctors to be able to prescribe a drug-induced abortion as against an instrument-delivered abortion to women and, hopefully, their partners who are faced with that dilemma. Of course it is something we should be able to counsel about as medical practitioners but it is not something we as politicians should deny as an option available to women in those circumstances.

I say this to my male colleagues in this place because I would not presume to give this counsel to women: we have to advisedly allow those who have the knowledge and are confronted with the on-the-ground circumstances, which can be extraordinarily complex and outside our own cultural experience, to have all the options available to give to patients, to people—these are human beings, of course—who are in an invidious situation and want help and the best options available. For us to continue to preclude from this option, on Senator McGauran’s own figures, something like 100,000 women each year, is just beyond the pale. How can we politicians say, ‘This option shall not be among the options available to women in that circumstance’? Of course we cannot. If there are senators listening to this who are having difficulty making up their minds, let me as a past medical practitioner ask you not to make this decision as a politician but to allow it to go to the medical practitioners of this nation and the people who come seeking their advice. I support the legislation.

Alan Eggleston (WA, Liberal Party) Share this | Link to this | Hansard source

The debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 has been very interesting both here in the Senate and in the public arena since the matter was first raised towards the end of last year. It seems to me that there have been two streams in this debate, the first arguing that there is a pressing need to have RU486 available to the women of Australia and the second about whether the categorisation of abortifacient drugs in a special reserve category, with their availability subject to ministerial approval, should remain in place.

Presumably everybody here in the Senate knows that I practised as a GP obstetrician in a large regional centre in WA for quite a long time. With that background, my questions about RU486 are: firstly, does RU486 add anything useful to what is already available in Australia for termination of a pregnancy, particularly in rural and regional areas, which is where I worked for some 22 years? Secondly, is RU486 as convenient and safe as methods of termination already available in Australia?

I suppose we have to look a bit at the history of maternal morbidity and mortality, and also look at the history of abortion, perhaps over the last century. Of course, things have come a long way since 100 years ago, when everywhere in the world there were very high death rates associated with having babies, and there had been for centuries past. The fact that women were forever pregnant and had a much shorter life span—largely because of the complications of obstetrics—had much to do with the secondary social position of women in society. Men lived longer; women tended to die in childbirth and were often anaemic and tired from endless pregnancies.

Abortion 100 years ago was a very secret thing. Nobody knew about it, but presumably it occurred and was done by backyard abortionists. And, of course, there was a high incidence of complications from abortions. But, in both obstetrics and the termination of pregnancy, things have changed greatly. In the latest triennium of Australian maternal mortality figures, I think there were only 34 deaths in over 760,000 births. That was for the three years from 1997 to 2000. It is interesting that 20 years before that, in the triennium from 1964 to 1967, there were over 200 deaths in roughly 600,000 deliveries. So, over the century, maternal mortality has fallen steadily. We in Australia now have, in effect, abortion on demand. It is performed in hospitals, under hospital conditions and with a very low complication rate. So it is an interesting observation that we now have a very safe set of figures for both deliveries and terminations of pregnancies.

I have found, in discussions of RU486, that there is a widespread misconception that it is a kind of superior morning-after pill. In fact, as Senator McGauran has said, RU486 is far from being a morning-after pill and is much more complicated to use than the morning-after pill. The morning-after pill is taken as two pills 12 hours apart within 72 hours of unprotected intercourse. It might produce light bleeding, like a period, but that is the end of it. By contrast, RU486 is recommended for six- to seven-week pregnancies and, in some countries, is used to terminate pregnancies of up to 14 weeks.

Furthermore, the use of RU486 is much more complicated than taking the morning-after pill and much more complicated than going to hospital for a surgical termination of pregnancy. It involves at least three separate visits to the doctor over 14 days. On the first visit the woman is given an anti-progesterone pill to kill the baby. At the second visit, two days later, she receives Prostin to induce contractions to expel the foetus, and at 14 days she is reviewed to see if the abortion is complete. If it is not, the woman is admitted to hospital for a surgical procedure to evacuate the contents of the uterus after any infection has been treated. By any measure we would have to agree that the use of RU486 is a much more complicated procedure than a woman just going to a hospital in the morning to have an ultrasound and then having a short surgical procedure carried out to perform a termination of pregnancy. It is a much more complicated procedure, and it is not done in a hospital.

According to the website RU486facts.org, the incidence of adverse after-effects with RU486 is very high and it is said that 23 per cent of the adverse effects have been judged to be severe. For example, there is a seven per cent haemorrhage rate. It is well known that deaths have occurred from haemorrhage from the use of RU486. It is significant that because of the risk of haemorrhage in RU486-induced home abortions it is reported that the People’s Republic of China has banned the use of RU486 in China. I think that is very interesting, given that the Chinese government has long had a policy of limiting its population. One would have thought that if this drug were convenient and simple to use, without any untoward after-effects, then probably the Chinese government would have promoted it among its own population.

Sepsis is the other significant, severe complication of RU486 abortions. According to a World Health Organisation study, 30 per cent of women who had an incomplete RU486 abortion developed pelvic infections. There is growing evidence, in addition, that mifepristone, which is the antiprogesterone drug used to kill the foetus in RU486, actually depresses the immune system, making the woman concerned more susceptible to the infections which cause septic shock. So my conclusion has to be that, far from adding to the range of safe methods for the termination of pregnancy available in Australia, making RU486 available in this country would be a significantly retrograde step, adding avoidable risk to any woman using this drug to terminate a pregnancy.

It seems to me that there is something in common between supporters of home deliveries and those who are calling for RU486 to be made available in Australia to induce abortions in non-hospital settings. In the case of home deliveries, the argument is that, since the incidence of complication in childbirth is low, most home deliveries will be incident free. The catch is that it is not possible to predict in which deliveries unexpected complications like haemorrhage or obstructed labour will occur. The same applies to home abortions induced with RU486. It is impossible to predict beforehand which ladies using this medication will suffer severe and significant complications in the home environment and have adverse effects thereby. It seems to me that there is a certain naivety about those driving this move to have RU486 made available in Australia in failing to recognise that the possibility of serious consequences from the use of the drug, including death, really does exist and that they really do occur.

I came into this debate when I was asked to express a view about Dr Sharman Stone’s rationale for permitting RU486 to be made available in Australia, which was that it would be convenient and useful for women in regional Australia to have access to this drug to induce abortions rather than go to a hospital for a surgical termination of pregnancy. At the time I felt that I had to express my disagreement with Dr Stone. In contrast to Dr Stone, I believe that RU486 would be hazardous for use in regional Australia because quick access to a surgically equipped medical facility is frequently not available to women in country areas and, if it is, they often have to drive a long way to get there.

The view that I expressed was also expressed by the Chief Medical Officer of the Commonwealth when he was specifically asked by the minister about the use of RU486 in country areas. In addition, the same view has been expressed in a letter circulated to members of the federal parliament by Mr David Gawler, a consultant surgeon at the Royal Darwin Hospital. He specifically mentioned that he believed that there would be particular problems in the use of RU486 with Indigenous women in remote communities in the Northern Territory. I am aware that other doctors working in areas with high Indigenous populations, such as Broome, have, as Senator Adams said, expressed a contrary view to the surgeon, Mr Gawler. But I have to say that my own experience in dealing with pregnant Indigenous women in the Pilbara was that it was a common experience that it was difficult to get them to return for follow-up. In view of the requirement for return visits with RU486, I can foresee difficulties with the use of this drug with Indigenous women in remote areas.

So, from my point of view, I cannot see any net gain to the Australian community from permitting RU486 to be made available in Australia as a means of terminating pregnancy instead of using the currently available and safe surgical methods, which are, from my experience, much simpler and certainly, as I said, much safer to implement for the women concerned.

Turning to the second dimension of this debate, concerning ministerial approval for abortifacient drugs, I would like to make some brief remarks. Abortifacients are not the same as other drugs used to treat medical conditions. It seems to me impossible to deny that such drugs as these involve broader social considerations about our society and, in fact, about who we are and what we stand for.

For me, one of the major causes of concern about the use of RU486 is that it would be difficult to collect data on the number of abortions performed in Australia since most of these abortions would go unreported. From a public health, general sociological and general public interest point of view I think it is important to know how many terminations of pregnancy are being performed in our country. It is a commonly held view that there are between 90,000 and 100,000 abortions performed annually in Australia. I think it is a matter of concern that the number of abortions has reached that level, particularly as the figure includes an increasing number of mid- to late-term abortions on what would otherwise be viable foetuses. This is certainly a trend which I think we as a society should be giving deeper consideration to.

The purpose of the private member’s bill before the Senate today is to remove ministerial authority and to include RU486 in the list of restricted goods which are abortifacients and to leave the evaluation of the use of abortifacient drugs to the Therapeutic Goods Administration. Abortifacient drugs are not the same as other medications. They are not there to treat leukaemia, some rare disease or some common disease like bronchitis. Abortifacients are drugs which induce abortion and mean that an abortion occurs. So, quite apart from the safety issues I have mentioned, it seems to me that there are broader public interest issues surrounding the issue of abortion which mean that decisions about the use of such drugs in Australia require ministerial overview, and, accordingly, I will be voting for the status quo.

Penny Wong (SA, Australian Labor Party, Shadow Minister for Corporate Governance and Responsibility) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 before the chamber tonight is clearly a controversial and sensitive matter. Its controversy and its sensitivity lie perhaps less in what the bill seeks to do and more in the broader debate the bill has ignited. It is a broader debate that has its roots in the contrasting and deeply held beliefs within our community. I respect that some of my colleagues and many of my constituents hold views different from those I hold. I hope that we in this chamber and in the community can conduct this debate with respect for each other’s different views and without personalising the discussion of the merits of the issues.

I recognise that many of those opposed to this legislation are so because they are more generally opposed to abortion either because of their faith or ethical framework or for another reason. However, as has been discussed before, and it is a point that has been made by previous speakers, this is not a bill to legalise or outlaw abortion. In this country we have already come to a position where a woman can legally terminate a pregnancy. That is a matter that has been debated, that has been discussed within the Australian community over many years and each state and territory has arrived at what is the status quo. In fact, it is an issue that continues to be debated and discussed. What we are debating here tonight is not whether abortion should be accessible but whether the body that this parliament has determined should assess the safety of therapeutic goods, of drugs and of medicines should be permitted also to assess the safety and appropriateness of this particular drug. I believe it should.

There are two primary arguments against this legislation that I wish to address. The first is the issue of safety and the second, and what I think is a more important argument in many ways, is the ethical considerations associated with this drug, which those who oppose the bill suggest require more than the Therapeutic Goods Administration’s approval. For this reason they suggest it should remain within the purview of elected persons, in this case the minister.

I turn firstly to the issue of safety. I want to emphasise that I believe there must be a scientific and evidence based assessment of whether this drug is safe and, if it is safe, on what basis it can be used. However, I do not believe that this chamber is the place in which such an assessment would be properly undertaken. The need for such assessment to be undertaken by relevant experts is one of the reasons the TGA exists at all—to ensure that the Australian community has the benefit of impartial evaluation and proper assessment in relation to drugs. If we have believed that the TGA is competent to assess and monitor the some 50,000 drugs Australians currently use, then I ask: why not this drug? If this drug is not safe then, as with any other drug, we in this place assume that the TGA will do its job and that this drug will not be available in this country.

Those who support this bill do not argue for RU486; we do not argue for this drug. We argue for its assessment by the TGA. If those who oppose it believe the TGA cannot properly assess the safety of this drug, do they also argue therefore that other drugs should not be assessed by the TGA or do they argue for the abolition or reform of that body? In general, they do not. Generally, the debate in relation to the TGA’s involvement has been the criticism that the TGA will not take into account the ethical considerations associated with the use of this drug rather than the issue of safety.

Turning to this second issue, I agree that ethical questions should not invariably be determined by scientists or experts. That is why we have debates within this parliament and within our community as to the ethical boundaries of things such as medical research. It is also why the availability and accessibility of abortion has been and continues to be debated at length by the Australian community. But I want to make a number of points in relation to this. If the ethical issue at the core of this bill is whether or not we should allow abortions in this country, the community has already discussed that issue—albeit that there are those who vehemently disagree with the status quo. What we are debating here is in fact not that issue; what we are debating here is a method of terminating a pregnancy, not whether or not a woman can do so.

The second point I want to make is this: I fail to see how requiring ministerial approval meets the call for ethical consideration in any event. Ethical consideration of the competing views within the Australian community will not be adequately or comprehensively dealt with simply through ministerial approval. If the health minister happened to be somebody who was avowedly pro-choice, would those opposed to this bill believe that she or he could adequately weigh their views or that ministerial consideration in those circumstances would be sufficient ethical consideration of all the issues associated with the use of this drug?

I also voice my disappointment at the way in which our current health minister has handled this debate. I believe he has demonstrated his inability to objectively consider the arguments for and against this drug. His interventions into the debate, such as his suggestion that unscrupulous doctors would prescribe drugs for desperate women, are misleading and arguably inflammatory and they do nothing to convince me—and, I am sure, many others—that he is in fact the appropriate person to make the assessment as to the availability of this drug.

As I said at the outset, the ethical issue at the core of this debate is really whether or not abortion should be available. That is the way the public debate has occurred, even if—and I emphasise this, as others before me have emphasised—that is not the matter before the chamber in relation to this bill. The passage or failure of this bill does not actually affect the availability or otherwise of abortion in Australia.

It seems to me that the decision to terminate or not terminate a pregnancy is an intensely personal issue and an issue of conscience. I do not believe that anybody benefits from the politicisation of these personal and conscience based decisions. I believe that there should be limits on the extent to which any of us impose our personal moral views upon others, particularly when one is a parliamentarian. That is a difficult issue, because there is an ethical and moral dimension to so much that we consider in this place. But it seems to me that we as parliamentarians should be cognisant of certain boundaries, of the extent to which we as legislators have the right to impose our own moral position onto others. We cannot, nor should we, do so with impunity. Sometimes I fear we do it in this place without articulating it clearly or discussing it.

We should ask ourselves this question: is this something that I as a legislator should be imposing upon my fellow citizens? Is it appropriate to impose one’s own view about the right ethical choice onto others in the context of such an intensely personal and difficult decision as the decision to terminate a pregnancy? I do not believe it is, and for that reason I describe myself as pro-choice. It seems to me there should be in this place a distinction between what our personal choice might be or what our own conscience might tell us and what we as legislators should impose upon others.

I will be supporting this legislation. I am cognisant of the views of many of those who have written to me from my home state of South Australia who obviously feel very strongly about this issue. I want to place on record my thanks to the committee for the way in which they have dealt with this matter and the enormous workload that they have had in presenting the report to the Senate. Perhaps more importantly in this context, I want to place on record my thanks to the women from the cross-party group who are sponsoring this legislation. It is unusual in this place to have such a thing occur, and it is good that there are occasions when our different political beliefs and our membership of different political parties do not prevent us from pressing an issue that we regard as important for the benefit of women in Australia.

Barnaby Joyce (Queensland, National Party) Share this | Link to this | Hansard source

This is a very historic time in our parliament. There are very few times that one has the opportunity to have a responsibility for making a decision about a defining social issue that will permeate through the annals of our nation. It will be acknowledged as a personal position of commitment by the senators in this chamber. As with many other historical debates in other parliaments throughout the world, your position on this shall be written down in history and your role judged by history accordingly. As it is a conscience vote, it does the unusual thing of definitively stating who you are and the ethical issues that drive you.

This is a debate about the role of government and on the question of its determination in the lives of others and on the question of life itself. So many at times brilliant speeches have elucidated on the proficiency of this parliament to deal with a complex issue such as this while obviously reflecting the social inclination of the constituency from which those speakers were elected.

No doubt there are doctors more qualified than a minister without a medical degree, and they would be far more abreast of medical issues; no doubt we could find accountants more qualified to be a minister overseeing the Treasury; no doubt there are natural resources engineers more capable than a minister with oversight over the environment; no doubt there are telecommunication technicians who would be more apt to oversee that role of the government than an elected representative.

Are we to have rule by experts in their field rather than elected representatives? That would be a very disturbing brave new world. If you believe that, then what on earth are you doing here—unless by some outstanding coincidence you are a technical expert on every issue on which you proffer an opinion in this chamber? We could outsource basically every job in this parliament, and maybe that is a debate that would ultimately give greater technical expertise to the management of the nation. But it would, at the very least, assuage the whole role of the democratic process.

The vote tomorrow is about whether parliamentarians believe they have a role on the most crucial social issues or whether we start running away from difficult issues and start diminishing the parliamentary role further. I have always stated that the Senate has been usurped, and this is a further step that moves members and senators to a more honorary position than to one that actually reflects their position in government.

If this is not an argument about abortion but, as stated, an argument about the most appropriate and most qualified body to assess a drug, then those who vote for this motion must, by reason of this, support the further removal of other areas of governance to those who, though not elected, are better qualified. What is the recourse of the voter if the appointed panel of the TGA is a complete affront to their personal views? Will they accept the decision, or will they apply for a political remedy, most likely at the next election? Irregardless, I believe strongly they will try and pursue a political manipulation of the committee to suit their political purpose, even though they put their hand on their heart stating that their key motivation at this stage is to remove the assessment of this drug from the political process.

There is one thing that has definitely been portrayed during this debate, and that is that this is a highly contentious issue by reason of the closely held views of the citizens of Australia. The proponents of this bill believe that this ethos of political representation should not be respected. They believe a direct political remedy, reflected in the ministerial authority, should be subordinate to an unelected bureaucrat. By removing the path of authority on an issue, we allow the progression of unelected bureaucrats to attain the mantle that we believe, and the community believes, we have been elected for. The minister should be responsible for reflecting a hands-on role on contentious issues.

I believe that the contentiousness of this issue is exactly why this decision should be attached to the process and should be immediately answerable to the parliament. I believe that enacting a decision that endorses the disenfranchising of the citizen by the removal of ministerial control is itself an admittance that the parliament is not up to the job and does not have the qualifications to make decisions affecting contentious issues—and I believe that political parties and members of political parties who endorse this position reflect that no-one in their ministerial authority would ever have the competence to be able to deal with these issues.

We cannot after this say that this issue is peculiar when other issues in other areas could be handed to those with better qualifications. This is going to lead to the corporatisation of government—the final frontier—and it will unfortunately be endorsed by many on the opposition benches and on our own. Many have stated that this is not an abortion debate and that they are not driven by strong bias on that issue. I am afraid I do not believe you, as I certainly have a strong view and it drives my motivations. I am sure if you were honest you would acknowledge it is driving yours. Others have launched schools of red herrings to further their cause and assault the primary truth—that they are really driven by pro-abortion motivations. It reminds me of reading about the Hon. TB Van Buren, who said that his role as an abolitionist during the slavery debate in 1865 was to proffer the argument that slavery should be abolished because it ‘banished free white labour’. It was a very noble outcome based on a very ignoble premise. No doubt history would advise that the ownership of one individual against their will totally and absolutely by another is repulsive. But people did not say that at the time, and there was wide and acknowledged acceptance of slavery.

No-one benefits from abortion; all are hurt. Let us make that the starting point, rather than stating that there is nothing unusual about the process or the number of abortions currently being done in Australia. The RU486 process, with the culmination of little hands and legs, glazed eyes and a skull being flushed by the mother down a toilet, is especially psychologically and physically brutal. It is important for the honesty of my motives that I once more put on the record that I believe that a person has the right to proceed through life without another person believing they have the right to kill them. I object to the action, not to the person, and obviously have grown up in association with many friends who have had abortions.

The right to your life is inalienable and commences at conception. The fact that you are not conscious of your right is irrelevant in a just society. Neither a person asleep, a child born or a child unborn should have their right calibrated by consciousness. Furthermore, there is a philosophical morass if rights develop with your own physical development, or inherently it would stand to reason that a person’s right to their life would continue to change between the in utero, childhood, adolescent and geriatric stages of life. Because of this, throughout this chamber there would be varying degrees of a right to life. The value of the lives of the various senators would, because of their age, be different. This is, of course, implausible and repulsive. The argument that one form of abortion is allowed therefore all should be allowed is to state that because there is a train line that takes people to a place of imminent death, there is nothing wrong with building a highway there as well.

Likewise, I am not embarrassed to say that I have a Christian faith—2,000 years of which have inspired the freedoms that our culture here in Australia is based on. It is obvious that the respect of all human life is a fundamental tenet of that faith. I am guided by my faith and make no excuses for that. A vast number of my constituents in Queensland hold similar views.

Finally, there is a strong link between RU486 and the death of women who would have survived had they had a surgical abortion. The argument that this number will be small and therefore is acceptable repulses me, as it will the child who loses their mother or the husband who loses their wife or partner. The deaths of those women, which will happen, must rest on those who decide tomorrow. It will remain as a stigma far greater than all others in the processes that follow or have come before. Because this chamber is the instigator of the act that leads to the deaths, we have to be responsible for those deaths.

If for no other reason than that I do not want to meet the child who lost their mother because of my vote or to meet the father who lost their wife because of my vote or to meet the parent who lost their daughter because of my vote, I will be voting against RU486. I do not believe there is an acceptable level of collateral damage when it comes to human lives when there is an alternative which is far safer. As to RU486 and the safety of the child, it kills virtually all of them, so the argument that is stated about the safety of RU486, while ignoring half the people it affects, is completely disingenuous and dishonest.

However, I acknowledge that this is a parliamentary process, and I acknowledge that people want to come to a just parliamentary outcome. As such, I hope that the belief that we can come to a just outcome can be furthered and that if amendments are suggested they are taken on board. If there is an absolutist position and no amendment is ever contended or changes anybody’s views, it just goes to show and justify that this was purely a pro-abortion, pro-life debate.

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

Russell Trood (Queensland, Liberal Party) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 because this matter is one of immense public interest and it raises an important issue of public policy and the exercise of ministerial discretion. Like many senators, I imagine, my office has been flooded with correspondence on this issue. Much of it, I regret to say, has not focused on the very issue of the bill—the matter of ministerial discretion. Rather, it has assumed that we are taking a decision to extend the right of abortion. Overwhelmingly, the correspondence has been opposed to that assumed extension.

But we have other opinions on this subject. On 19 January this year the Australian published a Newspoll survey in which the question was asked, ‘Would you personally be in favour of or against RU486 being available in Australia for use by qualified medical practitioners?’ In a sample of 1,200, the following percentages responded in the positive: across all categories, 68 per cent; women, 70 per cent; men, 66 per cent; the age category 35 to 49, 71 per cent; and tertiary educated respondents, 76 per cent.

But whether or not we are in favour of RU486 is not the question before us. The question before us is whether the approval or otherwise of medicines should be vested only in the impartial statutory authority established specifically to carry out the task. Before I address the issue, let me record that I am deeply troubled by the estimated 85,000 abortions that apparently take place in Australia each year. I doubt there are any women who undergo the procedure who are not profoundly affected and perhaps even traumatised as a consequence. Nor can we easily dismiss the body of religious and ethical opinion that abortion is a reprehensible action offending their deepest convictions about the nature and sanctity of life. But the reality is that, subject to physical and psychological need, abortion is legal in all Australian states and territories. Whatever we do this evening or tomorrow in the Senate will not change that reality. Notably, this has been recognised by the President of the Uniting Church in Australia, Dr Dean Drayton. In January he said:

We have already had the public debate about abortion. The issue is whether or not this particular drug is safe to be released for use in a country where abortion is legally available.

That, indeed, is our task—to decide on the desirability of the Minister for Health and Ageing retaining the discretion to ban a registered drug. That discretion was secured by the minister in 1996 as a result, some commentators say, of a deal struck between the government and Senator Harradine. Of course, politics is often about deals, compromises and bargains, some good and some otherwise. Perhaps on that occasion the passage of the bill was worth the price. But, in retrospect, from the perspective of good public policy, this may not have been the Senate’s finest hour. The reason is that it removed from the duly accredited Commonwealth agency—the Therapeutic Goods Administration—the responsibility to make a decision about the suitability of a drug for use in Australia. It gave that responsibility to the minister—the only drug in relation to which he has that discretion.

In public policy terms it is a very peculiar discretion. It lacks adequate accountability, offers no transparency and, perversely for a drug said by its opponents to be so dangerous, does not permit scrutiny and examination by the one agency able to do it professionally—the Therapeutic Goods Administration. Considering the level of legislative and regulatory control of therapeutic goods in this country and the expectation that Australians have that such products will be safe, of high quality and comparable to the best available elsewhere in the world, that is an extraordinary situation indeed. I think it is an untenable one. We now have the opportunity to correct this anomaly by placing the power where it belongs.

The Therapeutic Goods Act 1989 vests the power to assess the efficacy, quality and safety of medicines used for therapeutic purposes in the TGA. The 1989 act, in part, defines ‘therapeutic use’ as:

... influencing, inhibiting or modifying a physiological process in persons or animals; or

... influencing, controlling or preventing conception in persons ...

In my view, the act of 1989 is onerous for the TGA. The obligations it imposes are heavy—and so they should be. In 2004-05 the TGA discharged that responsibility by approving more than 11,000 applications for registration and listing, testing over 1,200 products, receiving 421 reported breaches, completing 349 investigations, issuing 161 formal warnings, and it had persons or companies charged with 106 criminal offences.

The administration employs in excess of 500 staff. Its medical and pharmaceutical professionals are specialists in their fields with levels of expertise that are of the highest order. I have heard no suggestion in this debate that the TGA is anything other than a well-run, competent and highly professional agency. It would seem that few, if any, on either side of the debate contend that the TGA does not fulfil the terms of its charter. Indeed, from all reports, it complies with those responsibilities with unquestionable probity, the highest level of relevant scientific expertise and a will to make decisions and present its findings and recommendations in an unbiased manner. As the TGA itself notes:

... the regulatory framework is based on a risk management approach designed to ensure public health and safety while at the same time freeing industry from any unnecessary regulatory burden.

The Senate Community Affairs Legislation Committee received a great number of submissions and heard evidence from witnesses that strongly support the TGA when assessing restricted drugs such as RU486 and contend that the argument should be focused on the nature of the bill and the discretion the minister exercises.

Dr Haikerwal, the President of the Australian Medical Association, told the committee:

Our membership is wide and reflects the same diversity as exists in the community.

In reference to abortifacients he said:

These are the only drugs to require this kind of ministerial approval. This section of the act has effectively banned the entry of RU486 into Australia not only for use as abortifacients but also for the number of other possible uses, such as emergency contraception, treatment of endometriosis and treatment of some breast and brain tumours.

Dr Sally Cockburn said it was nonsensical to claim that RU486 is too unsafe to be evaluated by the TGA, as some appear to be arguing. She also pointed out that normally the minister would seek advice from the TGA as to the safety of a therapeutic good but that, under section 23AA of the act, any request to evaluate a restricted drug must be in writing. The catch-22 for the minister is that he cannot ask the TGA to assess RU486 without signing off on it. This he does not wish to do.

Professor Caroline de Costa, from the Department of Obstetrics and Gynaecology at James Cook University, said in her submission to the Senate committee that she had read every available study on RU486, in English and French. She declared that she is ‘convinced of the usefulness and safety of the drug’ and that ‘the debate should be about removing the very unusual power of the federal minister for health and the opportunity be given to the TGA’. She also confirmed evidence provided by other witnesses that misoprostol and other drugs which have TGA approval for different applications are currently prescribed off label to induce abortion but are not as effective as RU486. Other peak professional bodies to conclude that RU486 should be available in Australia include the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Rural Doctors Association and the National Association of Specialist Obstetricians and Gynaecologists.

I will now return to Dr Haikerwal’s evidence. He expressed the utmost confidence in the TGA’s competency when he said:

We believe that the TGA is best suited to decide upon the safety of all medications and therapeutic products including RU486 and should be given the opportunity to judge the safety and efficacy of this medication as it does for all others. It is the best qualified authority to decide when and where and with what support services this drug should be made available. They must exert their judgment freely, fairly and away from undue pressure.

These views were supported in much evidence to the committee. Dr Leslie Cannold, medical ethicist at the University of Melbourne, offered that a conscience vote misrepresents the bill by asserting it is about a moral or legal stance on abortion whereas, she said, ‘in reality it is about the integrity of Australia’s framework for ensuring the quality, safety and efficacy of the medicines we take, and that’s what the TGA is for’.

To date, the TGA has approved around 50,000 therapeutic products for use in Australia. Given such a volume, there can be little question that the TGA has amassed a high level of expertise and understanding of its obligations. The Parliamentary Library’s research note on the issue says:

The TGA’s risk management role means that it is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods, applying any measures necessary for treating the risks posed, and monitoring and reviewing the risks over time.

The TGA has consistently discharged that duty, and its professionalism is recognised by its listing by the World Health Organisation as a collaborating centre.

I think I have made my position clear. If this bill is defeated, one of the conclusions that we might draw is that today’s Senate agrees with the government’s decision in 1996—a decision which, in my view, corrupted a regulatory regime which enjoys considerable professional integrity and, as far as one can tell, public confidence. The inference could also be drawn that a resolution in the negative declares a lack of confidence in the professionalism and expertise of the very body charged to maintain confidence in all medicines sold in Australia.

If given the power, I do not know whether the TGA will approve RU486 for sale in Australia. I do believe, however, that it will discharge its responsibility for assessing the medicine conscientiously and, if it approves it, it will only do so after comprehensive assessment consistent with the highest standards it has established. If the TGA decides to list RU486, it will have made a decision consistent with policy in many other countries—but I leave that to the TGA. As a matter of sound policy, we should allow the TGA to do the job it was authorised to do and pass the bill.

Eric Abetz (Tasmania, Liberal Party, Minister for Fisheries, Forestry and Conservation) Share this | Link to this | Hansard source

In considering the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 two issues have exercised my mind: firstly, the issue of abortion; and secondly—and in the context of this bill more importantly—the role of the Therapeutic Goods Administration, or TGA.

Firstly, I come into the abortion debate with a commitment to the concept of the sanctity of human life. Every human life is unique and is to be treasured and valued by society. Most people accept this proposition without much hesitation. Unfortunately, equivocation enters the debate when the question is asked: when does human life begin? The only logical, scientific and consistent answer to this question is: at conception. At conception our unique genetic make-up has been determined, and there is no logical, scientific, moral or other consideration which can establish after conception a time certain for the commencement of human life. Interestingly, no-one argues that human life commences before conception. But if human life does not start at conception, it is incumbent on those arguing that proposition to tell us exactly when human life does commence. No-one has done so with a satisfactory and consistent construct.

Secondly, this bill is designed to take away ministerial responsibility for the approval of one drug, and one drug alone: an abortifacient. The responsibility for its approval would instead be given to a group of officials. I have agreed to limit my comments this evening, so I encourage those interested in this issue to read the excellent column in today’s Sydney Morning Herald by Senator Fierravanti-Wells, and the additional comments of Senators Humphries, Barnett, Fielding, Polley and Joyce, as well as the Family First additional comments, to the Senate committee report that was tabled today. Looking across the chamber, I also invite people to read the excellent speech given by Senator Polley. In short, they represent a clear, logical and democratic approach to the issue before us. Their insurmountable advocacy urges a no vote.

I will be voting no for the following reasons. I support the sanctity of human life. The TGA deals with therapeutic goods—goods designed to prevent or treat a disease, illness, defect or injury, to quote Dr Baldwin—whereas RU486 is designed to kill and expel from the mother’s womb the developing child. Therefore it is not therapeutic, unless we describe pregnancy as an ailment. As an aside, I cannot accept that a developing child is just a bundle of cells, as some seek to describe it. Those that have suffered a miscarriage will quickly tell you that it is more than just bumping your knee and losing a few cells. There is not only the physical side but also a deep emotional hurt, suggesting more than simply a few cells being lost. In any event, our humanity is surely not to be determined by the number of cells we may have on any particular day.

RU486 is not therapeutic. The TGA is not designed to deal with the moral, social and ethical issues surrounding any particular drug. It simply deals with technical, not moral, issues. That is why I am attracted to the proposition of referring these issues to an expert ethics committee and that the minister’s decision become a disallowable instrument. Parliamentarians are elected as representatives of the community to make these judgment calls, difficult though they be. No matter what our views on abortion, we fail in our duty if we want to outsource or subcontract our responsibility to, albeit decent, but nevertheless non-elected and unrepresentative, officials.

There are also genuine health concerns based on peer reviewed studies and questions about the usage of RU486, which have been canvassed in this debate. I am willing to accept that the TGA is possibly the best body to determine some of these claims and counterclaims as to the efficacy of RU486. But I do not accept that the TGA is expert to deal with the moral and social issues that have arisen as a result of this matter. Indeed, in all conscience, I cannot outsource the moral and ethical issues arising from this debate to an unelected body when I am elected by the Australian people to make these judgment calls, fraught with difficulty though they be. In short, the case for change by the proponents has not been made out. That is why I believe ministerial responsibility should remain, albeit with the addition of parliamentary oversight. I thank the Senate.

Mitch Fifield (Victoria, Liberal Party) Share this | Link to this | Hansard source

In many respects, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 has become a proxy battle for a debate for which the Australian public and few parliamentarians have an appetite—the rights or wrongs of abortion. State and territory parliaments determine the legality of abortions and the circumstances under which they can occur. This parliament does not. The law in the states has created what might be called a demilitarised zone in this area of social policy. There is a community consensus on state law as it stands. There is no desire in the community to reopen the abortion debate. This is not a concession to moral relativism by our state parliaments or the community; it is merely a recognition that life is sometimes very complex and not as neat as we might like.

But this bill is not about the pros and cons of abortion, although it has been used by some as a vehicle for some shadow-boxing. I very much regret that some aspects of the debate have taken on the characteristics of a referendum campaign. A yes-no referendum style approach, with associated campaign tactics, helps neither to inform nor to edify discussion on a bill of this nature. We all need to recognise, regardless of our views on abortion, that it is an awful thing. No-one rejoices in it. There are no winners. It is a terrible and difficult decision for any woman. But we live in an imperfect world; there is often no ideal way to handle the circumstances in which people find themselves. We must also recognise that people have a god-given free will. The exercise of that may not always please each of us, but people have the right to exercise it.

This bill is not about the whether or the when but rather the how of abortion. In my view, judgements on the safety, efficacy and appropriateness of a drug or a procedure should be a matter for determination by competent authorities, doctors and their informed patients. But I should make it clear that my vote for this bill in no way reflects a lack of confidence in Minister Abbott. He is a man of character and of great intellect and compassion. He is a diligent and competent minister. But these should be matters for determination by medical experts and by informed individuals, not by ministerial discretion.

Although this is a conscience vote, I thank my constituents and the members of my party in Victoria who have taken the time to put their views to me from both sides of this debate. I have many friends who I know will not agree with my decision but whose views and counsel I nevertheless value and respect. I have a deep regard for the rationale of many who want to maintain ministerial discretion. Indeed, I share the world view of many of those who oppose this bill. But that world view leads me, on this occasion, to a different conclusion. I will be supporting this bill in the Senate.

John Hogg (Queensland, Deputy-President) Share this | Link to this | Hansard source

I rise this evening to oppose the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, as it seeks to remove the transparency and accountability of this parliament in a very sensitive area of public policy. This transparency and accountability was put in place in 1996 in response to grave concerns held about the drug RU486. Those concerns remain today. A Parliamentary Library research note on the issue of RU486 says, inter alia:

… RU486 belongs to a special category of drugs under the Therapeutic Goods Act 1989 (the Act), known as ‘restricted goods’, which cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health. Further, any such written approval must ‘be laid before each House of the Parliament by the Minister within 5 sitting days of being given’.

This gives the parliament the right to scrutinise the decision of the minister and to hold the minister accountable for the reasons supporting the minister’s decision. In such a contentious area, this surely has to be seen as good parliamentary practice.

Dr David van Gend, in the Courier-Mail of 1 December 2005, puts quite simply the reason for ministerial accountability:

The Parliament in 1996 aimed to prevent recurrence of the debacle in 1994 where a junior official in the Health Department approved the importation of RU-486 without the minister’s knowledge.

It raises the issue as to why there needs to be ministerial intervention on RU486 when other drugs are approved by the Therapeutic Goods Administration, the TGA. Again, Dr van Gend says in the Courier-Mail of 1 December 2005:

RU486 is a unique drug in that no other drug is designed to end a human life, and so its importation demands a unique level of public accountability.

Monique Baldwin, in an article in the Australian of 31 January 2006, says of RU486:

It is not designed to prevent, treat or diagnose an illness, defect or injury. It is not therapeutic. It is designed to cause an abortion that will end a developing human life. RU486 raises serious ethical and social concerns that go far beyond scientific analysis.

This is a compelling argument in itself for RU486 to be treated differently, even today, as it was clearly embraced by this parliament in 1996.

The bill, whilst not seeking to debate the demerits or merits of RU486, simply seeks to remove the open and transparent accountability process of 1996 and shunt off the approval process to the TGA, which is required to consider not the public policy aspects of the debate but only the clinical aspects. This would be a retrograde step indeed. The public policy debate is important to people such as me as it crosses the line of some of my most personal and fundamental beliefs.

One such belief is the right of every human being to life. When it comes to human life, I do not make exceptions or value judgments on the importance and value of such life. Each human life is important, precious and unique. We are only given one chance at this life; there are no second chances. I subscribe to the view therefore that each human life should be treated with absolute respect and dignity. Each human life has the right to be nurtured, protected and fostered to maturity without external interference of any sort. I maintain that no individual, collective or government has the right to summarily terminate another’s life. Life is so precious. Life is so important. Life is a continuum. It is not a series of disjointed or unrelated stages. I have a consistent approach in supporting the dignity of human life from its conception to death. That is why I am: opposed to abortion; opposed to the death penalty and opposed to euthanasia. I understand that others do not necessarily share my views on one or all of those issues but I like to think that I have a consistent approach. That is, the value of life does not change because of differing circumstances of human life or differing value judgments about the quality of that life. At the end of the day the unborn life, the unborn child, does have rights and, in particular, the right to life. Making RU486 readily available to terminate that life is unconscionable in my view. RU486, as stated earlier, is no therapy for the unborn child.

Evidence received by me clearly suggests that there has been no change in the circumstances that had parliament deem it necessary in 1996 to make the importation of RU486 the subject of ministerial approval and parliamentary scrutiny. The fact that other countries have approved the drug for use does not make it a correct or proper decision in Australia. There have been grave medical concerns expressed about the effects of RU486. The devastating effect still remains for the unborn human life in that it is summarily terminated. As Monique Baldwin, in the Australian on 31 January 2006, said:

The TGA was never designed to negotiate the public policy complexities that accompany debate about such a drug. This task lies with our elected and accountable representatives. And they should not wash their hands of this responsibility:

There is no compelling reason to change the current approval process. Clearly, the bill raises more issues than it resolves. The debate today will not resolve issues such as the abortion-breast cancer link, post abortion psychological issues and pregnancy or abortion counselling. I therefore believe that the bill should be rejected.

In closing my remarks I want to thank those members of the Community Affairs Legislation Committee on both sides of the debate who pursued the issue diligently and brought down an excellent report. I also want to thank those people on both sides of the debate who have contacted me either by fax, email or letter and offered me their views, which I have considered in putting my views together. Having said that, I have noted in the chamber that there have been distributed proposed amendments to the bill in the committee of the whole stage. Whilst I have only had a brief chance to read those, because my speech was prepared obviously well in advance of the circulation of the document or my knowledge of it, my brief reading seems to tell me that it will improve the process and I think that, whilst I may well be opposed to the bill as it currently stands, I would be quite happy to entertain the amendments as circulated and I would listen to the debate when it undoubtedly takes place at the committee of the whole stage. It seems that the outlined proposals indicating that the minister would be required to seek written advice from the Australian Health Ethics Committee, to consider that advice and prepare reasons for approval or refusal to approve the importation, are a vast improvement on what currently exists. I note also the proposal at the committee of the whole stage requiring consideration of a proposition that written approval or refusal to approve in accordance with this section is a disallowable legislative instrument for the purposes of the Legislative Instruments Act 2003, and there is also a proposal in the circulated amendment sheet that the minister must give written notice together with a statement of reasons of approval or of the refusal to approve the evaluation, registration or listing of restricted goods in accordance with the section.

Whilst I have only had a very brief and cursory look at that proposal, it does seem to me to fit in with basic comments that I have put on the record this evening in respect of this bill. I would be opposed to the bill passing in its current form but if these amendments were to see favour in this chamber, I would be quite happy to support them unless I can be persuaded otherwise at the committee of the whole stage. I commend opposition to the bill as it stands and, given that there seems to have been amendments proposed to the bill at the committee stage, I would seek support for those amendments.

Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

In rising to address the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, I would like to clarify what exactly is the question that we senators are being asked to address and ultimately decide on tomorrow. Before I do that, I would like to congratulate the proponents of this bill on having the guts to put it up in the face of a lot of opposition from what I believe is a minority—but a noisy minority—in the community. In doing so, I am mindful that there has been extensive media coverage, public debate and constituent lobbying, much of which I believe has been tangential to the question, if not misleading.

The question we are being asked today and tomorrow to make a decision on is whether the Minister for Health and Ageing is the most appropriate person to decide if the drug RU486 and other abortifacients should be made available in this country or if their availability should be determined by the Therapeutic Goods Administration in the same manner as every other drug in this country. This clear question is being clouded by the same turbulent and emotive debate which has for many years surrounded the issue of abortion.

I fully agree that abortion is a very difficult and sensitive subject, but it is one which has been subject to considerable public debate. The fact is that abortion is legal in Australia, but what is before us is not that debate. The opponents of this bill are using it as an excuse to reopen and sidetrack this debate. The issue in question is who should decide if a pharmaceutical drug will be allowed into this country. When you think about it, it could potentially be the start of a slippery slope if today this parliament decides that the health minister should continue deciding about this type of drug. What other types of drugs do we think the health minister should decide about?

The TGA has a very specific purpose. It is infinitely more qualified than any health minister will ever be to assess the medical appropriateness of drugs for listing in this country and is free from any accusations of real or potential political influence. If there are significant health implications of taking medications then these should be subject to a rigorous scientific assessment that takes into account and balances the full weight of the medical evidence of the benefits, the risks and the unknowns. The ethical question of whether abortion should be available in Australia has already been decided and is not up for debate today. Abortion is currently safely available in Australia, with the regulation of provision varying from state to state. To paraphrase Prime Minister John Howard—not something I do regularly—the vote slated for February 2006 is about whether a single member of parliament or the Therapeutic Goods Administration, the TGA, should decide on the safety of the drug.

I think it is particularly important to separate politics from medical decision making. Decisions about the health of Australians need to be made on the basis of medical evidence presented by the experts to those charged by our government with the risk assessment role: the TGA. As has already been discussed by previous speakers on this bill, pharmaceuticals such as RU486 intended for use by women as abortifacients are the only drugs the TGA does not have the authority to evaluate and regulate. Yet, since its establishment in 1989, the TGA has fulfilled its responsibility to both assess and monitor the almost 50,000 other drugs on which Australians rely for their health. Why is this one class of drug considered to be so bad?

I do not think the opponents of this bill are really serious about their argument of safety. If they are talking about safety, why do they not argue for similar bans on tranquillisers, mood elevators, Valium, Prozac or many other drugs? Many of these have some very serious questionable social and medical consequences, and arguably have many more side effects, adverse consequences and may even lead to deaths. This issue is about the use of abortifacients.

RU486 is a drug that is recommended by the World Health Organisation, particularly in developing countries. It is a drug that provides an alternative to a surgical procedure for the termination of a pregnancy and therefore gives women more choices. This debate is about women’s health and their choices in a country where termination of pregnancy is already frequently performed. It is particularly important for women living in remote and regional communities.

Termination of pregnancy does occur in Australia, and the best health outcomes are where there is ready access to high-quality services in early pregnancy. RU486 should be one of the options in this setting. The family planning debate has been conducted for a long time in the public domain. The issue now appears to be whether individuals should have choice in this sphere of activity or whether the government has a duty to regulate it. I support the idea that contraceptive use by men or women is a personal decision and support the right of women to choose whether or not to have children.

Even if you disagree and support the notion that family planning is an area for regulation, there is still the issue of whether or not abortifacient drugs may be preferable to surgical abortion, which is already legal in this country. Again I state that we are not being asked to debate this issue; we are being asked to debate whether the health minister should make this decision or whether it should be made by the TGA. Some of the opponents of this argument refuse to understand or acknowledge the basic facts of this debate, and that saddens me greatly. This debate is about whether the TGA should be making the decision on this drug—whether they should be making a medical decision based on facts. I, with the other Green members of the Senate, support this bill.

Linda Kirk (SA, Australian Labor Party) Share this | Link to this | Hansard source

I also rise this evening to speak in favour of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 and to outline the reasons why I support the removal of the ministerial power of approval of RU486 and other abortifacients from the Minister for Health and Ageing and its transfer to the Therapeutic Goods Administration, or TGA. As many other speakers have noted, this debate has been clouded by issues which, although they are of considerable social significance, are not the subject of this legislation. We are not, here, being asked to determine whether access to abortion should be legal in Australia. The states and territories have legislative power over the subject matter and the various parliaments have legislated to provide for the circumstances in which a woman may lawfully terminate an unwanted pregnancy.

As many speakers have said, this issue has already been decided and was done so some 30 years ago. Australian women have already won the right to access legal abortion, and there are no moves afoot within the states and territories to change the existing law. Australians continue to be overwhelmingly in favour of a woman’s right to choose. According to the latest Australian Survey of Social Attitudes, in 2003, 81 per cent of Australians said that a woman should have the right to choose whether or not to have an abortion. I am one amongst this overwhelming majority of Australians. Nor are we being asked to determine whether RU486 is safe. This has, however, been the focus of much of this debate and it is therefore a matter that I will briefly address in my remarks today.

What we are being asked to determine is the process by which there may be access by Australian women to a method of abortion that is accessed by thousands of women worldwide. The issue is whether this drug should be dealt with like any other drug. It really is a straightforward question: should the minister for health have the power to determine the safety, efficacy and quality of the drug RU486 or should this decision be given to the TGA?

As we are all aware, today the Senate Community Affairs Legislation Committee released its report summarising the findings of the inquiry into this bill. I have had the chance to read the majority of the report, and I commend both the senators and the committee secretariat for a most comprehensive report that clearly sets out the issues in this debate. According to its website, the committee received over 2,300 submissions, as well as 2,160 of what might be described as anti-choice letters and some nine pro-choice letters. Like most other senators, I have received hundreds of emails and letters on this issue. In fact, just before I came down here tonight I checked my in-box and found some 40 additional emails that I had received in the last hour or so. The majority of those that I have received are from people who oppose abortion full stop. Many others question the safety of the drug RU486, citing serious side effects and the deaths of women overseas.

But this bill is about neither of these issues. With respect to all of the people who wrote to me and to other senators, this bill is not about proposing to change existing laws. As I said before, this bill does not propose to, nor can it, change existing state and territory laws in relation to abortion; nor does it seek to make a determination of the safety or otherwise of RU486. This bill is about the process by which RU486 should or should not be approved for use in Australia. It proposes to give the TGA, rather than the minister for health, the responsibility for approval of the drug.

I support the objective of the bill, as I believe that placing the responsibility for approval of RU486 with the minister is inappropriate for the following reasons. First, the minister for health does not have the capacity for, or specific expertise in, assessing the safety and efficacy of therapeutic agents. I say this in relation to not only the current minister for health, with respect, but all ministers for health, be they past, present or future. In fact, I think it is the case that very few, if any, members of parliament or members of the government have the capacity to make this assessment.

Secondly, singling out drugs such as RU486 for ministerial approval does not improve the safety of drug regulation and prescription in Australia. Much has been made in this debate about the need for there to be political accountability in the making of the decision on whether to approve the drug RU486. The democratic process requires that the government act in the interests of the people it represents, yet here the existing process allows just one person, the minister for health, to make the decision on whether or not to approve the drug for use in Australia.

The present system precludes the role of the TGA from the process of evaluating medications such as RU486 without the written approval of the minister. The act does not require that the minister seek advice or that he or she give any reasons or follow any protocol when making a decision regarding an application in relation to these drugs. Every other drug is evaluated by the TGA solely on its scientific merits, without ministerial involvement, subject to clear standards of accountability and transparency for evaluating clinical evidence. We in Australia are well served, I believe, by the professional competence and integrity of the TGA. That clearly came out during the committee’s inquiry. There is no reason at all to exclude one group of therapeutic agents from the act by having a separate process such as that which exists for the drug RU486.

I said that I would make a few comments in relation to the issue of the safety of the drug. As I said at the outset, I certainly do not profess to have any expertise in this area; I cannot make an assessment of the safety or otherwise of the drug. That really is something that ought to be left to the experts. I would prefer that safety were not part of this debate because, as I said in my introduction, this bill is not about whether RU486 is safe but about who is qualified to decide.

This is what we know about RU486. Two million women in 35 countries have chosen to use the drug. It has been subject to numerous studies and wide scrutiny. The US based Association of Reproductive Health Professionals says it is safer than aspirin, Tylenol and Viagra. RU486 has been judged as safe by the Australian Medical Association, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Rural Doctors Association, the National Association of Specialist Obstetricians and Gynaecologists and many other individual members of the medical profession.

Many medications are unsafe or need monitoring under certain circumstances. GPs are trained to know when to prescribe drugs or treatments. They do not have a one-size-fits-all approach and they are careful to weigh up an individual’s physical and mental health and social situation and to know when to exercise caution or to suggest other options. This is what they are trained to do.

In the time I have remaining I want to make brief mention of the fact, as other speakers have, that RU486 has applications other than the termination of pregnancy, some of which are potentially life saving—or would be if patients were able to access them. Patients with certain brain tumours and endocrine conditions have been told by their doctors that RU486 would be the best possible treatment, but under the current system they are unable to receive this treatment. I am informed that some of the people in this situation have been through the arduous process of getting approval from the TGA to import the drug. However, there is a catch: because by necessity the approval can only be limited, it is not covered by medical indemnity insurance and so they are often unable to find a doctor who is willing to prescribe the drug.

In closing I say that it is time we had this debate and I welcome it. In 1996 the drug RU486 was effectively banned. For 10 years Australian women have been prevented from choosing what, for many, would have been the safest method of abortion. There are 35 countries, including the United States, Britain and New Zealand, which have judged RU486 to be safe. Most Australians support a woman’s right to choose. However, as I said in my opening remarks, this bill is not about the legality of abortion, nor is it about whether RU486 is safe. Whether RU486 is safe is something that should be left to the TGA, an organisation eminently qualified for this decision. In my view this is something that the medical experts ought to decide and for that reason I will be supporting this bill.

Anne McEwen (SA, Australian Labor Party) Share this | Link to this | Hansard source

I will speak briefly on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. At the outset I thank the members of the Senate Community Affairs Legislation Committee and the staff of that committee who conducted the inquiry into this matter under very difficult circumstances. I also wish to record my appreciation for the work of the four women senators from the major parties who jointly sponsored this bill.

I support the proposed amendments to the Therapeutic Goods Act that, if passed by this Senate, will have the effect of giving the Therapeutic Goods Administration the ability to determine whether Australian doctors should be able to prescribe RU486 for Australian women. That is, I am of the view that the TGA, the organisation that the parliament has charged with the responsibility to make determinations about all other medicines that are available in Australia, should also make a determination about medicines such as RU486 that are able to be used to bring about the termination of a woman’s pregnancy.

I support this bill for a number of reasons which I shall briefly outline. Before I do that I acknowledge that some people, including members of this parliament, are vehemently opposed to the concept that a woman should have the right to terminate her pregnancy whether by surgical or medical intervention, whether legally or illegally procured and regardless of any of the many reasons that women may seek to procure a termination. I respect the right of those people to hold that view; I know that for many it is based on strongly held religious or personal beliefs. I appreciate that persons who hold those beliefs will use every opportunity to state their objections to abortion and will do what they can to sway the rest of us to their view.

I have been around long enough to know that the opponents of a woman’s right to choose to legally terminate a pregnancy will not go away and that from time to time we will again have to revisit the issue of whether women should have access to legal abortion. The evidence is clear that most Australians believe a woman should have that right and, as evidence to the Senate Community Affairs Committee has shown, women will continue to seek to terminate their pregnancies regardless of the legal or medical regime in place because, for some women, there is no alternative than to have to make that awful decision.

I note that many opponents of this bill in their communications to me consistently failed to address the reasons why women find themselves in a position to have to even contemplate terminating their pregnancies. Conveniently ignored are the circumstances of rape, incest, paedophilia, ignorance, domestic violence, poverty, lack of education, lack of access to contraception and the numerous other reasons why women and girls find themselves pregnant when they do not want to be pregnant. Also too often ignored are the implications for a woman and her family, including other children, if an unwanted pregnancy continues.

However, this is not a bill about whether a woman should have the right to terminate her pregnancy, and at this time in all states of Australia abortion is legally available to women who want it and who meet certain criteria. Opponents of a woman’s right to choose may not like it but that is the fact of the matter.

This is a bill about whether a minister of the Crown should have the power of veto over availability of a medicine that could, if it is approved by the TGA for use, provide women and their doctors with an alternative method of achieving an outcome that they are going to anyway be seeking to achieve by other means. The reason the minister currently has the power of veto is that 10 years ago a former senator who was vehemently opposed to abortion was able to exploit his privileged position as a member of parliament to gain parliamentary prohibition on giving Australian women an alternative method of managing their reproductive health.

This bill is an opportunity for the parliament to overturn that decision of a decade ago and to restore the decision about the availability of medical treatment for women to where it should rightly always have been—with the TGA. The TGA is the appropriate body to make the decision about whether RU486 is available for prescription by doctors for their patients. Nothing in the submissions to the Senate inquiry demonstrates other than competence by the TGA in its role in evaluating the safety of the many drugs that it assesses, and continually monitors, for use in Australia. As we know, RU486 is approved for use in many other countries and has been in use in some of those countries for many years. The TGA will be able to benefit from the experience of those other countries if and when it makes an assessment about making this drug available for use in Australia.

Much has been said by opponents of this bill about the alleged potential complications and ill effects that may follow the use of RU486. This debate is so full of contradictory evidence that it is even more essential that the independent TGA make the decision about availability. It should not be up to us in this parliament to decide whether or not women should have access to this drug. It should not be up to us to do a risk evaluation of this drug; we are not competent to do so. That is the role of the TGA, and there is no shortage of information about this drug and its effects that the TGA will be able to take into account if and when it makes that determination.

The TGA is the appropriate body to make the determination about the availability of RU486. However, whether or not a woman is prescribed this medical method of termination, should it become available in Australia, will be up to a woman’s doctor and the woman concerned. I have great faith in the ability of Australia’s medical practitioners to take into account the whole circumstances of a woman’s situation when prescribing this drug—just as they take into account the circumstances of their patients when prescribing any other drug.

The occasionally hysterical scaremongering that has accompanied this debate has done a disservice not only to the medical profession but to their patients who find themselves in the regrettable situation of having to contemplate termination of pregnancy. The parliament is not the place to arbitrate on what decision a woman in those circumstances should make. Let us pass this bill and then allow the processes of the TGA to determine whether or not medical abortion via the use of prescribed drugs should be available. And let us leave it to the woman, the people who support her and her doctor to determine the best method of achieving the outcome that the woman determines she wants.

Chris Evans (WA, Australian Labor Party, Leader of the Opposition in the Senate) Share this | Link to this | Hansard source

I join the debate tonight because those on the speaking list who are listed to come before me are not available, so I want to just make a few comments. I first of all want to congratulate the senators on both sides of the argument, who have argued their cases with dignity and with a calmness that is so often missing in some of these debates.

This is a fairly simple question: should decisions regarding access to RU486 be made by the minister for health or by the Therapeutic Goods Administration? I know this debate has reopened the whole abortion debate. In some ways, it has been used by many people as a proxy for that very important, serious, moral debate about abortion, how it should be regulated and how readily it should be available. But the reality is, as Senator Fifield said, that that is a matter for the states; it is not a question that is in the control of the federal parliament and it is not a question that we are considering here today. That is not the issue before the parliament. The issue before the parliament is the question of who should make the decision about this drug. It is also a fact that abortions are legal in Australia and do take place. That is not the issue.

There have been some excellent speeches. But I want to touch on an issue that arose today, and that is the claim by Mr Abbott, the Minister for Health and Ageing, that somehow he has been attacked because of his religious beliefs. This is not about Mr Abbott and it is not about any particular minister for health. I hope one day in a Labor government to be given the opportunity to serve as minister for health, but I would have the same view then that I have now: that it should not be left to me to make decisions about the efficacy of a drug proposed to be introduced into Australia. I do not have any expertise in that matter, and neither does Mr Abbott. The point is that that decision should be made out of a political environment; not by a politician, not by a person who is under the political pressures that we have all come under in recent weeks, but by an independent body, based on the best scientific and medical advice. It seems to me that that is a very clear and easy decision to make.

I do not think this is about Mr Abbott’s personal or religious views. He is entitled to those. I do not call those into question at all. But whatever one’s personal or religious beliefs, the point is that no politician in the role of minister for health is best placed to make that decision. And some of the arguments about accountability have been farcical, because I do not remember ever getting a say about these decisions when the minister for health makes them. There has been no parliamentary accountability since decisions have been taken.

I want to make very clear that in saying that the question of abortion is not before us today I do not wish to hide behind that. A lot of people consider this to be a debate about abortion. It is not, but I am very clearly and publicly expressing my position that I am pro-choice and have been for many years. I want to put that on the record, but it is not the point of this debate and it is not the point of the legislation. I have a fundamental problem with men trying to tell women how to handle issues of their own fertility and health. It seems to me that that is fundamentally wrong and that it ought to be the woman’s decision about what is best for her and any potential child that might come from a pregnancy.

I support a woman’s right to choose, but I want to make it very clear that people have to focus on the fact that that is not the debate before us. I am very aware of that, because we had the debate in Western Australia only some five years ago, when a close friend and colleague, Cheryl Davenport MLC, a member of the upper house in WA, led the charge to reform the abortion laws in Western Australia. That was successful. The WA parliament, which split much like we will—along non-party lines—supported legalising abortion. Abortion had been practised in the state for many years, but when a particular practitioner was arrested and charged for performing an abortion the issue was brought to a head. That matter was resolved in the state jurisdiction by the state parliament, as is our legal arrangement—and, as we know, various regimes apply in each of the states.

I know that there are very strong opinions in the community and the Senate about these issues. Given that the provision that gave the minister the role to make this decision arose out of a fairly murky arrangement without much debate about its merits, it seems to me that the debate today comes down to this: the opponents of the bill have to prove why this drug, and this drug alone, should be treated differently to every other drug that would be made available to Australians. To oppose this bill, the proponents of that view have to establish why this one drug alone should be treated differently to every other medicinal drug brought into this country. For every other drug, we deem that the TGA is the appropriate body to make the decision, but somehow this is special; somehow RU486 is different.

I do not think the case has been made for that. Sure, it involves in some of its uses the question of abortion, but the issues of safety, efficacy et cetera are for the TGA, just as they are for a range of other drugs—thousands of other drugs—that are now available in Australia. It is a decision for the TGA, to be made on scientific and medical grounds, not for politicians in the heat of a political argument. To pick out one drug with multiple uses and say, ‘No, we won’t allow this drug in; we’ll leave the decision about that drug to a particular member of the government,’ does not make sense. There is no consistency of approach. As far as I am concerned, no case has been made out as to why RU486 should be treated any differently to any other drug—and all those considerations that have been raised by some people about efficacy, potential safety issues, side effects et cetera are properly examined in a political-free environment by those with expertise and access to the best evidence. That is the way RU486 should be treated—just as all the other drugs are.

In closing, I make the point that I think that the parliament is growing in maturity. I think over recent years we have handled the euthanasia debate, the stem cell debate and now this debate in a very mature manner. It is not something that I thought would be possible at the start of the euthanasia bill, but we got through that and we got through a very difficult debate about stem cell research a couple of years ago with a maturity that I think has done the parliament a great deal of credit. People have argued their case fiercely, but they have done it with goodwill, maturity and an ability to see other sides of the argument. It is a credit to the parliament, and the fact that people are able to take different positions and the parties are able to relinquish control of those issues and allow a conscience vote has been taken as a very positive sign about the health of our democracy. But, as I said, I think the decision before us is fairly simple. I do not think there is any case as to why this particular drug should be treated differently to any other. I do not think that case has been made out, and I will be supporting the bill.

Concetta Fierravanti-Wells (NSW, Liberal Party) Share this | Link to this | Hansard source

With the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 I am facing the first conscience vote of my parliamentary career. I will be opposing the bill. This is an issue which has generated much controversy and debate. Indeed, I have received as much correspondence regarding RU486 as with the changes to industrial relations, Welfare to Work and voluntary student unionism. They are letters written with passion—mostly handwritten—by ordinary Australians whose concerns have prompted them to put pen to paper about something they feel very strongly about. This is a drug designed to kill, and Australians are entitled to have a strong view about this. It is a drug which raises medical, social and ethical issues. They are all complex in their nature and they require careful scrutiny and accountability.

In June 1996, the Therapeutic Goods Act 1989 was amended so that medicines intended for use as abortifacients—which covers RU486—became restricted goods. They need to have the approval of the minister for health before they can be imported, evaluated by the Therapeutic Goods Administration or registered on the Australian Register of Therapeutic Goods. Written ministerial approvals, including any conditions, must be tabled before parliament within five days of the approval being given. There is no provision for disapproval.

It is important to look at the definition of ‘therapeutic’ in the act. It says:

therapeutic use means use in or in connection with:

(a)

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)

influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)

testing the susceptibility of persons or animals to a disease or ailment; or

(d)

influencing, controlling or preventing conception in persons; or

(e)

testing for pregnancy in persons; or

(f)

the replacement or modification of parts of the anatomy in persons or animals.

In short, this debate is about whether RU486 should remain in its TGA restricted goods category or whether it should be treated like any other drug and assessed by the TGA. RU486 is not a therapeutic drug. It does not fall within the definition I have just quoted. RU486 is like no other drug. It is a drug that is designed to kill.

I believe the current restrictions should remain so that approval of RU486 is something that the elected government of the day, through its health minister, takes responsibility for and not the TGA. Indeed, the concept of ministerial discretion is a longstanding feature of the Westminster system. It means that sometimes governments need to make decisions about difficult and controversial issues, but most importantly they need to be accountable for those decisions. This is one such decision.

The TGA is obliged to look at a drug only on its safety, efficacy and quality. Ethical and social criteria are not considered, nor are the potential psychological aspects of this drug. Whilst recognising that the TGA is an experienced body, whatever one’s view the TGA is not designed to deal with the morality of any drug. It is not an elected body. It is not accountable to the electorate.

The current requirement for ministerial scrutiny can be understood only in light of events which were precipitated by the decision of an unidentified official within the TGA to authorise the importation of RU486 in 1994 for clinical trials in Australia. That action set in train a series of events culminating in the halting of a Victorian trial of the drug and four separate departmental investigations into the trials ordered by the then Minister for Health and Human Services, the Hon. Dr Carmen Lawrence MP. As an abortifacient, RU486 was a prohibited import unless exempted by the Department of Human Services and Health pursuant to the Customs (Prohibited Imports) Regulations. It was understood that no such exemption would be given unless the minister was consulted. Neither the Minister for Human Services and Health nor the Minister for Family Services, who had responsibility for the Therapeutic Goods Authority, were consulted prior to the exemption by the departmental delegate.

Clinical trials of the drug were carried out in Australia by the Sydney Centre for Reproductive Health and by Monash University Department of Obstetrics and Gynaecology at the Family Planning Association of Victoria. The Australian trials were part of worldwide trials by the Special Program of Research Development and Research Training in Human Reproduction. Senator Graham Richardson, the health minister at the time the exemption was granted, acknowledged that official parliamentary undertakings had been breached and said the government would see whether it could rectify the situation. He later retired and, until trial procedure breaches were exposed, the government and relevant departments remained uninvolved.

Despite claims that the TGA had rigorously scrutinised and strictly evaluated the drug prior to authorising approval during Senate estimates hearings on 25 May 1994, Dr Malcolm Wright, head of the drug evaluation branch of the TGA, demonstrated that this was not correct by stating that the TGA had not carried out an assessment of the quality, safety and efficiency of this product. There had been no independent assessment of legality and questions were raised about whether the trials were actually within the law. Trials were suspended on 16 August 1994. This was the background against which the amendment to the TGA Act was introduced and passed, requiring ministerial scrutiny over any application for the importation of RU486 or any other prostaglandin antagonist.

The then ALP senator Belinda Neal said:

... we acknowledge that this issue raises large concerns within the community. It raises issues beyond purely health issues. These issues need to be addressed by the executive of this government and addressed with absolute and direct accountability ...

The then Greens senator Christabel Chamarette said:

We deserve to have parliamentary scrutiny of decisions. We deserve to have a voice on issues and not simply leave them to boards of experts.

Furthermore, the TGA approval process is most often based on research developed by drug companies. Prominent bioethicists, such as Dr Renate Klein, agree that research to date has been less than adequate in its controls and its reach.

Those promoting RU486 advocate the drug as a safe and easy form of abortion which can be administered with a minimum of fuss. That is not the case. At the recent launch of Australians Against RU486, Dr Catherine Lennon, a Sydney GP, raised some important statistics: in the United States RU486 does not work to abort pregnancy for up to 10 per cent of women who use it; the use of RU486 to abort pregnancy increases your chances of dying to one in 100,000 compared to surgical abortion, where the chances of dying are one in one million; in the US, where RU486 is available, up to 10 per cent of women who use it experience severe bleeding and complications that require further medical attention; users of RU486 are required to make three separate trips to the doctor, take two different medications—mifepristone-RU486 and then, 48 hours later, a second drug, misoprostol-Cytotec—and wait 14 days before the result of the treatment is known.

Dr Lennon cited a recent study which showed that 60 per cent of Australian women are opposed to the introduction of RU486 when provided with details, including complications of the RU486 abortion pill, the time frame compared with surgical abortion and the increased risk of death as compared with medical abortion. The polling, conducted in December 2005 by Quantum Market Research, surveyed over 500 Australian women between the ages of 18 and 45 from all states and territories.

Dr Lennon quoted Edouard Sakiz, who was Chief Executive Officer of Roussel Uclaf, the French company which developed and manufactures the RU486 drug in France. In 1989 he stated that ‘RU486 is not at all easy to use. In fact it is much more complex to use than the technique of vacuum extraction. True: no anaesthetic is required, but a woman who wants to end her pregnancy has to live with her abortion for at least a week using this technique. It’s an appalling psychological ordeal.’ It is also interesting to note the recent publications where Pfizer, the maker of misoprostol, warns that it cannot recommend its use in the termination of pregnancies because of potential risks. These timely warnings that the second component of the RU486 regime should not be used for abortions can only lend greater strength to the argument for ministerial oversight. In short, many of the researchers and physicians readily admit that RU486 is not safe enough to administer without close medical supervision.

The RU486 debate should not be a pro-life or pro-choice issue; it should be about responsibility and accountability. This is a drug like no other drug and therefore ought not to be treated like other drugs. I think the Prime Minister put it best today when he said that it does not make much sense to devote an enormous amount of time, energy and commitment of one’s life to win election to parliament and to the high office of decision making, and then to spend the next stage of life busily handing over decisions to people who are not accountable. I note that the amendments that have been circulated by Senators Barnett and Humphries seek to strengthen provisions regarding advice to be sought by the minister, consideration of that advice, tabling before the parliament and disallowance of the decision. While I oppose the bill, I am happy to give consideration to these amendments. In short, as the Prime Minister said today: ‘Important decisions affecting the community should be made by people who are accountable to the community.’

Dana Wortley (SA, Australian Labor Party) Share this | Link to this | Hansard source

Tomorrow we will vote on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. In recent weeks I have received hundreds of letters and emails on this topic from across Australia, including my home state of South Australia. I have considered the information provided by numerous organisations who took the time to present their views; I considered the bill and the report tabled today. It is clear that this is not a bill for or against abortion. That debate has already been had in Australia: abortion is legal in all states and territories. This is a bill that deals with the decision-making process. It is about transparent and accountable practice in the evaluating, registering and listing of drugs in Australia. This bill seeks to remove responsibility for approval from the Minister for Health and Ageing and hand it to the Therapeutic Goods Administration, the TGA.

The real issue we are debating is whether a single member of parliament—the minister—or the Therapeutic Goods Administration should rule on the safety and availability of the drug RU486. It is my view that the current process of having the decision reside with the minister alone is flawed. The minister is simply required to notify parliament if approval is granted under his authority for evaluation by the TGA of a drug. This decision would not be disallowable by the parliament and therefore could not be considered parliamentary scrutiny. The minister is also not required to inform the parliament of his decision not to approve an application. This means that today parliament is not necessarily informed of these decisions; nor does it have the capacity for oversight of any decisions made by the minister.

However, it is the role of the Therapeutic Goods Administration to carry out a range of assessment and monitoring activities and to ensure the Australian public has access to therapeutic advances. The Australian Drug Evaluation Committee, established more than 40 years ago, is an expert committee of the TGA. Members of this committee are appointed by the minister and are required to have professional qualifications in numerous areas, including pharmacology, toxicology, clinical medicine or general practice. Through the TGA, the Australian Drug Evaluation Committee advises the minister for health and the Secretary of the Commonwealth Department of Health and Ageing. They examine the conditions of manufacture, the clinical impact and the safety of drugs.

Since its establishment in 1989, the TGA has monitored and assessed nearly 50,000 drugs on which Australians rely for health reasons. Supporting this bill means that the evaluation of RU486 will follow the same procedures that are used to evaluate other drugs and medical devices in Australia. The TGA is the authority charged with assessing the risk of drugs. We have no reason to doubt that the TGA would weigh the medical evidence and deliver a considered judgment about the risk and benefit profile of the drug.

Research indicates the antiprogesterone RU486 is also capable of improving and saving the lives of seriously ill Australians who for the past decade have been denied ready and affordable access to treatment for serious medical conditions including breast and prostate cancer, glaucoma, depression, endometriosis, Cushing’s syndrome, uterine fibroids and inoperable meningiomas. The current ban appears to have curtailed research into the drug’s uses. Indeed, the Secretary of the Commonwealth Department of Health and Ageing acknowledged that only a small number of cancer patients had gained access to the drug. The Special Access Scheme was designed to allow registered medical practitioners to request approval to import unapproved therapeutic goods into Australia to treat individual patients with case-by-case evaluation of applications; it has been described as stressful, time-consuming and expensive. There are often lengthy delays and some patients, despite being classified as ‘very seriously ill’ have been unable to import the drug.

The Senate is not voting to approve or reject the drug RU486; it is debating who should have the authority to make that decision—the minister or the TGA, which is the accredited Commonwealth agency established to make those decisions on other drugs. As with other drugs, RU486 will require TGA approval for importation and use. This is the case for drugs not currently approved. It is not the role of any politician to determine whether the drug RU486 is safe. That is not the intention of this bill. It is about ensuring that the proper authority—the TGA, which is made up of qualified experts—be given regulatory oversight of RU486.

Chris Ellison (WA, Liberal Party, Minister for Justice and Customs) Share this | Link to this | Hansard source

The importance of the debate on this private member’s bill is demonstrated by the fact that senators are exercising a conscience vote. This is something which is not common in the parliament. The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, as the title suggests, seeks to remove the responsibility for approval of RU486 from the Minister for Health and Ageing and provide it to the Therapeutic Goods Administration. Of course, in the normal course of events, the Therapeutic Goods Administration is an institution tasked with the approval of medication and drugs which are for the treatment of illness and other sicknesses. The current process for approvals is detailed in the bill’s explanatory memorandum.

In 1996, amendments to the Therapeutic Goods Act were passed which placed medications such as RU486 in a special group of drugs known as restricted goods. According to the 1996 amendments, restricted goods cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health and Ageing. In addition, any such written approval must be laid before each house of the parliament by the minister within five days of being given. RU486 is the only medicine that is subject to the restricted goods condition. One would therefore ask why RU486 attracts such attention. Put simply, RU486 acts to terminate a pregnancy. That is where the issue lies.

The consideration of the report by the Senate Community Affairs Legislation Committee—and I compliment the committee on the report and the work they have done over the last two months—reveals that the safety of RU486 remains an issue of concern. In medically induced terminations, RU486 can be used in conjunction with prostaglandin, a drug that stimulates contractions, resulting in the effective termination of pregnancies of less than seven weeks. Reported adverse side effects of RU486 include infection and septic shock. Haemorrhage, ruptured ectopic pregnancies, abdominal pain and nausea are also reported. Clinical trials conducted in the United States identified that surgical abortion was needed after medical abortion with RU486 and that there was a failure rate in six to eight per cent of cases.

One can see when looking at the Senate report that there are indeed concerns in relation to the possible harmful effects of this drug. Looking at the Senate report, I note that some submissions to the Senate inquiry referred to adverse events and deaths associated with the use of the drug and also concerns raised by the United States Food and Drug Administration. Although the United States Food and Drug Administration approved the use of RU486 in 2000, the decision is one of ongoing controversy. There remain grave concerns about the safety of this drug. In November 2004, the FDA reported that it had received reports of 676 adverse events, ranging in severity from minor symptoms such as nausea and dizziness to serious complications such as blood loss, ectopic pregnancy and rare bacterial infections which have been fatal in some cases.

Reference was made to at least 10 deaths having been associated with the use of RU486 in Europe and United States. Particular attention has been paid to the deaths of four young women in California over the past two years. These women all died of the same infection of the uterus within a week of taking RU486. Three of the families are now suing the manufacturer, Danco. The company says it has no answers as to how this occurred. The FDA is investigating recently reported serious adverse events associated with RU486 and has issued a public health advisory highlighting the risk of blood infection when using the American equivalent of RU486 in a manner that is not consistent with approved labelling. The FDA is reportedly convening a high-level meeting with experts from the Centers for Disease Control and Prevention early this year to examine these recent deaths.

There is also a move in the US congress to pass legislation suspending sales of RU486. The Italian government recently restricted imports of RU486 following the suspension of a trial of the drug in Turin. The trial was suspended after one in 20 women given the drug had partial abortions at home followed by excessive bleeding. I note also that a trial of the drug in Canada was suspended after the death of a young woman from toxic shock syndrome. In clinical trials in the United States, surgical abortion was needed after medical abortion using the American equivalent of RU486. As I said earlier, that failed in six to eight per cent of cases. The maternal mortality rate for RU486 abortion is estimated to be 10 times the rate for surgical abortion carried out at the same period of gestation.

The Senate Community Affairs Legislation Committee endorsed the conclusion of one submission that was made—that is, that the jury is still out on the safety of RU486. This is fair enough. But there is mounting evidence that the safety of this drug is an issue of crucial importance. It would seem therefore that there is little contest in relation to the potential harm of this drug to the health of women. I believe that, when you add the other aspects of this debate to it, this issue is one which should be decided only by the minister.

There has been a central question asked as to whether it should be the minister or the Therapeutic Goods Administration who approves. As I said earlier, why is there such a tension to this drug RU486? There are a number of reasons: one, it involves the termination of a pregnancy; two, it involves potentially serious effects which are harmful to women’s health, as I have mentioned; and, three, it is one which has been under the purview of the Minister for Health and Ageing. This is not just another drug. When you look at the social aspects of this and the concern that has been raised in the community about the debate on this particular drug, it is appropriate that a decision rest with the minister concerned. In fact, the Catholic Archbishop of Sydney emphasised the important distinction between therapeutic goods, which relate to the treatment or cure of disease, and a drug which acts to terminate a pregnancy.

People who have a concern with the minister having responsibility for this decision have expressed doubts about the lack of transparency and accountability. I believe that the foreshadowed amendments, which have been referred to by previous speakers, merit close attention. I understand that amendments are proposed in relation to the exercise of approval by the minister. I believe they go a long way to addressing the concerns expressed by many people who support the bill. The amendments require that the minister must seek certain advice before exercising his or her discretion. The decision to approve or not approve must be reported to the parliament. What is more, that decision must be subject, or is subject, as a disallowable instrument to the scrutiny of parliament.

I believe that those amendments really do answer the concerns people have expressed about the minister exercising this sort of control. I think discussions about who is the particular minister of the day or his or her particular beliefs are not appropriate in this debate. I believe that what we have in place has worked well, but I am prepared to support these amendments as being a means of addressing some of the concerns expressed and offering a degree of accountability to not only the people of Australia but also the parliament.

Having regard to those factors that I have outlined, and having considered this matter very carefully, I will not be supporting this bill. I might just add that I certainly agree with other senators who joined in this debate that this matter has been carefully considered by the Senate committee. I again congratulate them on their hard work—albeit that I do not agree with some of the members and their views—and I also congratulate those other senators who have contributed to this debate in a rational and mature fashion. This is, after all, a very important issue. As I said at the beginning, this is a conscience vote—and that demonstrates the importance of the debate. It is not something that we do every day in this parliament.

Ron Boswell (Queensland, National Party) Share this | Link to this | Hansard source

I join this debate not expecting to have to speak tonight, but I will proceed. We are debating the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. The movers of this bill had to prove one thing: they had to show there was a good reason to undo what both sides of parliament had agreed on in 1996. They have failed to do this. They have not put up a convincing argument to justify turning the original approach on its head.

The fact is that Labor and the coalition in 1996 agreed that ministerial oversight of RU486 needed to be present in an explicit way. They decided this after a single TGA official caused flawed trials of RU486 to be undertaken in Australia without ministerial knowledge. The drug evaluation branch of the TGA at the time stated:

TGA has not carried out an assessment as to the quality, safety and efficiency of this product.

The Melbourne trial was stopped when the consent forms were exposed as being totally inadequate. Carmen Lawrence, as health minister, suspended the trials in August 1994. In 1996 the TGA Act was amended with the support of both sides of the parliament. At that time, Labor Senator Belinda Neal noted:

... we acknowledge that this issue raises large concerns within the community. It raises issues beyond purely health issues. These issues need to be addressed by the executive of this government and addressed with absolute and direct accountability ...

Even Greens Senator Chamarette agreed, saying:

We deserve to have a voice on issues and not simply leave them to boards of experts.

What significant event has happened since that time of unity across the board to change the approach to dealing with this abortion drug? If anything, the intervening time has allowed more information to come forward which actually reinforces the wisdom of the parliament’s earlier decision.

Already this year we have seen major international developments that go to the heart of public policy on RU486. The US Food and Drug Administration is revisiting the safety issues of RU486 with a special investigation with the Centre for Disease Control into recent deaths linked to RU486. That inquiry is happening as we speak. It follows public health warnings, new medication guides and warning labels on the use of RU486 issued in 2005. As I told the Senate last year, the new medication guide of the drug manufacturer, Danco, states:

About 5-8 out of 100 women taking Mifeprex will need a surgical procedure to end the pregnancy or to stop too much bleeding ... Some women should not take Mifeprex. Do not take it if:

• you cannot return for the next 2 visits.

…         …         …

• you cannot get emergency medical help in the two weeks after you take Mifeprex.

That is the drug company’s advice. And this drug is supposed to help rural and outback women. In Danco’s patient agreement form, the woman must sign her name to the following statements:

7. My provider gave me advice on what to do if I develop heavy bleeding or need emergency care due to treatment.

…         …         …

9. I know that, in some cases, the treatment will not work. This happens in about 5 to 8 women out of 100 who use this treatment.

This is on the label. It continues:

11. I understand that if the medicines I take do not end my pregnancy and I decide to have a surgical procedure to end my pregnancy, or if I need a surgical procedure to stop bleeding, my provider will do the procedure or refer me to another provider who will. I have that provider’s name, address and phone number.

There is also a congressional subcommittee looking into the original approval process used by the FDA and the FDA’s response to five deaths and hundreds of other adverse events related to RU486 abortions. As well, there is a bill calling for the suspension of RU486 sales until a complete safety review is done. That is in America.

In Italy, last month, the government announced it was restricting imports of RU486 after a trial was suspended following one in 20 women experiencing partial abortions at home with excessive bleeding.

In Canada, a trial was also suspended after a death. RU486 has never been licensed in Canada, despite its liberal abortion laws. There is also a lot more information now in the medical literature pointing to the comparative dangers posed by chemical abortions as opposed to surgical abortions. As the Senate committee pointed out in the body of its report:

... the overall mortality rate associated with medical abortion is 10 times higher than the mortality rate for surgical abortions at 8 weeks’ gestation ...

So when you put it all together, when you add into the equation all these inquiries and their results, the investigations, the suspensions of trials, the restrictions of imports and the medically adverse findings, RU486 is not performing well. In fact, it is performing like a dog. RU486 is doing worse than when parliament decided to put the decision about its use under its ministerial wing. A lot of the focus in this debate has been turned on to the current health minister. We would do well to remember that health ministers come and go. We have had several since Carmen Lawrence first stopped trials of RU486 in Australia. Health ministers come from a range of backgrounds. Who knows who the next health minister will be? Any bill aimed at getting around a particular minister would be a short-sighted affair and could even backfire on the bill’s supporters in times to come. I hope this bill is not aimed at one minister.

A lot of my work over my 23 years in the Senate has been chasing down bureaucratic decisions in estimates committees or approaching ministers with information about how their experts are not so expert after all. I can cite numerous examples—from Biosecurity Australia in the banana debate, which many here will be familiar with; to stem cell research; and to the distribution of various government assistance programs—where the experts have got it totally wrong. Experts do have an important place, but they are limited by the resources available to them and by their sources of funding, which may be based on a user pays approach such as the TGA depends on. They may be experts but they can only be experts within the guidelines they are given. For example, the TGA may rely on outdated international research because to update findings requires a drug company to fork out lots of money, which they will not want to do.

In important cases, where the community is much involved, such as with RU486, I believe it is most important for the portfolio minister to have a role in the final decision. It may be that he or she will accept the experts’ findings. It may be that he or she sees that there are limitations on expert analysis and thinks there should be more information, more studies or a delay in order to await the outcomes of overseas investigations. All these matters are duly weighed by a minister but can have no place in a limited and narrow analysis by a so-called expert.

The community has a stake in this decision. Who will be their expert and their representative? Who will adjudicate their interests, if not the democratically elected representative of a system of parliament and executive government? This bill asks senators to agree that the minister is not a fit and proper person to assess advice from a bureaucratic organisation that is funded by the industry it is set up to regulate. If that is to be the way of good governance in Australia, why do we need ministers at all? Why don’t we all go home and leave it to the experts? We are not elected to leave it to others precisely when issues of great public interest such as this come along. This is when we really earn the Comcars, the first-class seats, the salary and the superannuation. If we duck the tough questions, what are we doing here? Every portfolio issue that comes across our desks is an invitation to use judgment and wisdom in assessing its pros and cons. No one person could possibly be qualified in all these areas on which we are called to cast our vote, so we use advice and we appoint specialists—geniuses in very narrow fields. But we will rue the day when we let those same unelected and unaccountable advisers run this country and weigh up all the issues that a minister must.

I believe the case for a ministerial role in approving RU486 is the same now as it was in 1996. I think it is even more necessary today. The bill’s advocates have not made the case that the current system is so bad that it needs to be changed. What evidence is there to support the prediction that the current system will not work? If the drug had been approved by the TGA with widespread support around the country and the minister failed to recommend the same, then that would be a poor ministerial decision that would have many consequences for both the minister and the government. But has that happened? Are we at such a parlous stage that the only solution is to throw out the process and start all over again—replace an open process with one that is not transparent, not accountable and presided over by unelected specialists? The current system has not failed anyone to date. Let us be clear about that.

The movers of this bill are convinced that a religious based prejudice will prevail. Perhaps this bill is really about the movers’ own prejudices, because there is no basis for thinking that the existing system does not work. It is the same system that has worked under other health ministers, to Australia’s benefit. Does anyone here think that Carmen Lawrence was wrong to stop trials of RU486? Does anyone think that Michael Wooldridge somehow let the side down? What has the current health minister ever said on this issue that would make it urgent to bring in a private member’s bill to redress some terrible failing?

Following the announcement of this bill, the minister for health sought advice from experts, and that advice was promptly rejected out of hand by the movers of this bill. Why? It was expert advice, after all, and directly related to the issues raised by the movers of this bill, who argued that rural women needed access to chemical abortion drugs because surgical abortion services were not too readily available. Here is why: it turned out that access to urgent medical care was an issue with RU486. No-one denies this; it is on the drug manufacturer’s own medication guides. We all know that it is often difficult to access medical services in the bush, particularly for the more remote communities. Yet here is a drug which requires several follow-up visits to a doctor with ultrasound equipment. Plus, if something goes wrong, as it does in five to eight per cent of cases, by the drug manufacturer’s own admission, there has to be emergency medical care on stand-by. What are we going to do—send in the Royal Flying Doctor Service, medivac them out?

These are facts, not fiction. Any health minister who failed to release this information would be grossly negligent. I urge senators to think about whether the current system has failed. If it has not, should we abandon the Westminster principle of ministerial oversight for the tyranny of unelected experts funded by the drug companies they must judge?

Debate interrupted.