Senate debates

Thursday, 9 February 2006

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

Second Reading

Debate resumed from 8 February, on motion by Senator Nash:

That this bill be now read a second time.

9:58 am

Photo of Sandy MacdonaldSandy Macdonald (NSW, National Party, Parliamentary Secretary to the Minister for Defence) Share this | | Hansard source

The Senate is debating the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Like all senators, for me this private member’s bill has caused a very large amount of soul searching. A Senate committee received thousands of submissions, and there has been a lot of coverage in the media and a great deal of lobbying by those for and against the bill. This issue has generated enormous interest and it has proved, understandably, to be a controversial issue.

In the end, it is that level of public debate that has made the issue one of public policy and that has led me to my position on this bill. I believe it goes to the heart of why we are elected here as representatives. The Senate votes on public policy. The Senate decides, and sometimes, like today, it is a really tough call. But that is why we are here, that is what we do and that is why we put our names forward to be considered by the public at polls—we ask for their trust to make decisions on their behalf. We do not stand at polling booths on election day and say, ‘Vote for me and I will put all the hard decisions in the hands of advisers and bureaucrats,’ however capable and well meaning they may be.

Ministerial discretion is the bread and butter of some of the most serious decisions made by governments. Think of immigration visas, environmental versus development issues, troop deployments, industry restructure packages, compensation negotiations and even black spot road funding decisions. Competing interests are regularly resolved by ministers and governments, not bureaucrats. If we left these sensitive decisions to others, would that be right? How often in this place do we seek out, and sometimes demand, ministerial intervention or discretion in order to advance the rightful causes of needy constituents?

Bureaucrats administer but do not decide policy. This bill asks bureaucrats funded by the industry that they must analyse to become an integral part of policy making. This bill takes the decision on a matter of public policy away from the minister of the Crown and puts it into whose hands? They have no names. Their identities are concealed under the acronym ‘TGA’. Their role will be hidden. Their reasons will never be held up to public scrutiny or accountability. Their whole decision-making process is industry funded. Will they be men or women? We do not know. The public interest in RU486 is such that it would be wrong for any decision on its use to be hidden.

A key question in this debate is whether you believe that RU486 is a drug like any other drug. I was influenced in this matter by a professional drug regulatory affairs associate working for a multinational pharmaceutical company. This is someone who works with the TGA every day to gain approval to market new drugs. These are her words, as they appeared in the Sydney Morning Herald recently:

In my professional experience, RU486 is not like any other drug. 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.

The doctor then goes on to describe some of the health issues that were canvassed by the Senate committee.

Apart from these health issues, RU486 raises serious ethical and social concerns that go far beyond scientific analysis. I concluded that, if RU486 was a drug like any other, it would not have attracted a private member’s bill, a Senate committee inquiry or the enormous level of public interest shown. RU486 is clearly not like any other drug. This public dimension means that it is a creature of public policy and, as such, it is our responsibility as senators to deal with it, no matter how much we wish it was not and no matter how uncomfortable or inadequate we may feel in dealing with these issues.

I am not a doctor; I am not a scientist. I am clearly not a woman. I am not anti-abortionist; I have believed very strongly from the time that I was at law school in the Menhennit ruling, which was new at the time, of the Victorian Supreme Court that abortions should be permitted but be based on the health and psychological wellbeing of the mother. But when we vote in this place we are not asked about our qualifications to assess each and every bill before us. We are qualified by our election to the Senate. We are senators, first and last, with the ultimate responsibility to adjudicate public policy for all. We may not always get it right. We often make mistakes. We may wish we were somewhere else at times. Nevertheless, this is our job; this is what we do. If we do not want the job then we should stand down and leave it to others.

I think it would be wrong to give our elected powers away to those who are not elected and therefore not accountable to the public. That is why the current system was introduced in the first place in 1994. Carmen Lawrence, who was then the health minister, stopped trials of RU486 which had been instigated by a single TGA official without the minister’s knowledge. That state of affairs was felt by both sides of the parliament to be sadly lacking, thus the current system of explicit ministerial oversight was introduced. I do not believe the case has been sufficiently made out to warrant changing the bilateral decision made at that time.

10:04 am

Photo of George BrandisGeorge Brandis (Queensland, Liberal Party) Share this | | Hansard source

I have decided to vote against the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I have not been influenced by the vigorous lobbying which has taken place on both sides of the issue. I have arrived at my decision purely on the basis of my own careful thought and reflection, and I want to take this opportunity to place on the record the considerations which have led me to this position.

Let me begin by dealing with three fallacies which have bedevilled this debate. The first is the suggestion that, because this issue directly affects women, it is an issue on which the point of view of women carries greater weight than the point of view of men. But women are sharply divided on this issue, just as men are. There is no ‘female’ point of view about abortion. More importantly, the moment the question of abortion is raised, it necessarily entails the question of the status of the embryo—I avoid the use of the term ‘unborn child’, which is emotive and tendentious.

There are those who, like me, believe that human life begins at conception. There are others who believe that human life begins at some later time during pregnancy, whether at an arbitrarily defined period of weeks, at the time when—to use the old language of the law—the foetus ‘quickens’, at the time of viability or at some other stage of the pregnancy. And there are those who believe that human life does not begin until actual birth. I do not wish to enter into the argument about which of those propositions is correct, beyond stating my own personal belief. Nor is there any point in doing so, because this is, for most people, a question so fundamental that seldom is it likely that anyone will be swayed by argument from the belief to which they adhere.

I do not for a moment doubt the good faith and reasonableness with which each of the different beliefs about when life begins is held. On this, above all things, I respect the right of others to have a view which is not mine, and I expect them to respect my right to have a view which is not theirs. My point is that, simply because such a multiplicity of views does exist, opinions about the circumstances in which abortion is morally defensible necessarily entail a view about the point at which human life begins. And that is not a women’s issue. It has nothing to do with gender. It is a philosophical issue for women and men alike.

The second fallacy which has bedevilled the debate is the mischaracterisation by some of the legal status of abortion in this country. I have heard several colleagues—some of them, I regret to say, lawyers—assert that abortion is legal in Australia. That statement is careless and misleading. Every Australian state and territory other than the Australian Capital Territory places legal prohibitions of some kind upon the termination of pregnancy and makes it a criminal offence to perform a termination or to be a party to a termination unless the termination takes place in defined circumstances of excusal. For instance, in Queensland the principal provision is section 224 of the Criminal Code, which provides:

Any person who, with intent to procure the miscarriage of a woman, whether she is or is not with child, unlawfully administers to her or causes her to take any poison or other noxious thing, or uses any force of any kind, or uses any other means whatever, is guilty of a crime, and is liable to imprisonment for 14 years.

That is the prima facie position. However the operation of section 224 is qualified by section 282, which creates a defence in the following terms:

A person is not criminally responsible for performing in good faith and with reasonable care and skill a surgical operation upon any person for the patient’s benefit, or upon an unborn child for the preservation of the mother’s life, if the performance of the operation is reasonable, having regard to the patient’s state at the time and to all circumstances of the case.

Both the offence-creating provision and the defence in my state are substantially similar to the law in the other Australian states, notwithstanding that some of them are common-law jurisdictions and in others the law is codified.

The circumstances of excusal were interpreted in the landmark decision of the Supreme Court of Victoria in the Davidson case in 1969, the so-called Menhennit ruling, to mean that a termination is permissible whenever it is necessary to preserve the mother from serious danger to her life or physical or mental health and the circumstances are not out of proportion to the danger to be averted. The language of the Menhennit ruling, which has been followed in other Australian jurisdictions, has itself been liberally interpreted. In Queensland, the law was settled by the decision in R v Bayliss and Cullen in 1988, where Judge McGuire of the Queensland District Court adopted a very liberal interpretation of the Menhennit ruling, in particular of the circumstances in which the continuation of a pregnancy might be dangerous to the mental health of the mother. Since that time, there has not been a prosecution brought in Queensland under section 224 of the Criminal Code. Bayliss was, to the best of my knowledge, the last occasion upon which a prosecution for performing an abortion was brought in Australia.

Those who claim that abortion is legal in Australia are trying, I suppose, to say that, given the liberality of judicial interpretations, for all practical purposes terminations of pregnancy are lawful because the grounds of excusal are so broad and the criminal provisions are no longer enforced. But, as any competent lawyer knows, there is a great deal of difference between saying that conduct is lawful and saying that conduct is unlawful unless justified or excused by law—however liberally the circumstances of excusal may be interpreted.

The third fallacy which besets this debate is the offensive suggestion that those who do not wish to see the circumstances in which abortion is available further extended are seeking to impose their religious prejudices on others. I am very suspicious of politicians who wear their religion on their sleeves, who practise the politics of ostentatious piety. When it comes to liberal democracy, I am a resolute secularist. Liberal democracies are not religious constructs; it is of their essence that they are equally hospitable to people of all religious faiths and of none.

Liberalism and democracy are not religious doctrines, and my own church, the Catholic Church, is neither democratic nor liberal. It is no business of politicians who are adherents of a particular religious faith to impose the tenets of that faith on other citizens who do not share them. But, whether you are the most conservative opponent of abortion or the most vigorous advocate of its ready availability—wherever you stand on the spectrum in this debate—you cannot have a view about the morality of abortion in isolation from a view about when human life begins. It is just not logically possible. A view about when life begins is not necessarily a religious view—although it may be that, for many people, it is informed by the teachings of their church. There are many atheists who believe that life begins at conception, and there are many religious people who, in the exercise of their informed conscience, do not accept their churches’ teachings about the matter. The question of when human life begins is, to me, a philosophical question, not a theological one.

If a person holds the view, as I do, that human life begins at conception, that view may or may not be informed by religious beliefs or teachings. But even if that view is informed by religious beliefs, that does not mean that to act upon that view is to impose one’s religious values on others. It merely means that, from a belief about when life begins, certain conclusions about the consequences of terminating a pregnancy necessarily follow. Are we to say that people are entitled to hold a belief about when life begins if that belief is not based upon religious values but not entitled to hold such a belief if it is? Those who oppose abortion are no more seeking to impose their values on others than are those who support it.

Let me turn to the substance of the bill. It is very simple. If enacted, it would make the abortifacient drug RU486 subject to the ordinary approval processes of the Therapeutic Goods Administration under section 25 of the Therapeutic Goods Act whereby, before any pharmaceutical drug or medicine can be marketed in Australia, it must first be evaluated and approved by the TGA against the criteria of quality, safety and efficacy. The drug would cease to be within the class of ‘restricted goods’, and thus subject to the special regime provided for by section 23AA under which certain drugs may not be evaluated by the TGA, registered or listed for sale without the approval of the minister for health.

The TGA’s processes are technical processes. What the TGA does in evaluating new drugs is an exercise in science. If RU486 were nothing other than a medicine, if the purpose for which it is prescribed were nothing but a medical procedure, if this were only a medical question, there could be no rational reason for excluding it from the ordinary approval processes of the TGA.

I cannot see how any consideration of the availability of abortion can ever be purely a medical question. Since, for the reasons I have explained, the consideration of abortion necessarily entails consideration of the status of the foetus and therefore inevitably opens the question of when a human life begins, it cannot fail to be an ethical question, a philosophical question, as well. And, while no-one should doubt the competency of the TGA to make scientific determinations based upon technical skill and knowledge, equally no-one would be so foolish as to suggest—and to the best of my knowledge no-one has suggested—that the TGA is competent to make determinations on the ethical and philosophical issues which the abortion debate inevitably raises. The RU486 debate raises both types of issues: philosophical, not just scientific; ethical, not just technical. Because the TGA can only deal with the latter, its processes can never be sufficient to determine the appropriateness of this drug entering the Australian market.

I have not, in the course of this contribution, touched on the question of the medical efficacy of RU486. I do not have the professional expertise to assess the medical literature and I question whether anyone other than a professionally qualified doctor or pharmacologist has the capacity to do so. I note that the only senator who has spoken in this long debate who may be considered to have appropriate professional expertise, Senator Eggleston, has been an opponent of the bill. My own inexpert impression of the medical literature is that the overwhelming weight of it supports the view that RU486 is a safe drug, within the acceptable parameters of medical risk, but that a significant minority of medical opinion challenges that view. Having said that, it is clear that much of the medical literature supporting the drug is propounded by the pharmaceutical companies, which might be thought to have a vested interest in its wider use. Be that as it may, once it is accepted that this is more than merely a medical question, the medical literature cannot determine the issue.

I have no doubt at all that, were this drug generally available for prescription by GPs, its use would rapidly become extensive, and the circumstances and occasions upon which abortions occur in this country would significantly increase. It flies in the face of commonsense and the ordinary experience of mankind to imagine that, by providing an apparently easier, chemically induced method of termination, that procedure would not be readily recommended by doctors and resorted to by their patients. At the same time, the degree of medical superintendence of the termination would be lessened.

The desirability of such a development, having regard to the moral and ethical issues to which I have referred, cannot be left merely to a technical approval process, insusceptible to public scrutiny and accountability, which may not have regard to those issues. For that reason, I believe that responsibility for the authorisation of this drug must be taken by a decision maker who is publicly accountable for his decision. It both raises the profound philosophical and ethical issues of which I have spoken and demands a judgment on a matter of social policy of the first magnitude: how readily available do we wish abortion to be in this country?

Because this is inescapably an ethical and a policy question as well as a medical question, I maintain that this is a matter for politicians, not technicians, discharging their high public duty to make serious and grave decisions for which they must take responsibility and for which they are publicly answerable.

10:19 am

Photo of Ursula StephensUrsula Stephens (NSW, Australian Labor Party, Shadow Parliamentary Secretary for Science and Water) Share this | | Hansard source

My approach to every piece of legislation that comes before us in this place is to consider both its effects and its consequences, because we live with the consequences, whether they are intended or unintended. I come to this debate with a very clear understanding that every unborn child is a human being. This is not a matter of belief but a fact. Each unborn child has the potential to contribute enormously to our great nation.

We generally use the term ‘human life’ to refer to a member of the biological human species, someone who has the human genetic code, and that of course would include an unborn child. But some people’s definition of the term ‘human life’ is more restricted. They apply it to a being that possesses certain human characteristics in addition to the human genetic code, such as the ability to think, to imagine or to communicate. Or they restrict it to being a moral person; that is, one that has rights and probably duties too. Of course, once people begin to limit or restrict their sense of what ‘human life’ means, their opinions on the time at which a foetus gets the right to life because it has achieved the relevant list of characteristics can vary—from the moment of conception to the time the baby is born.

The numerous objections to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, which would enable access to the chemical cocktail that will induce an abortion, are by no means confined to people with religious convictions, just as the belief that anti-Semitism breaks moral law is not restricted to Jewish people. It is the responsibility of the parliament and our responsibility as individuals to reflect on the ethical dimensions of all legislation. As much as the proponents of this bill would like to argue that this issue is merely a matter of procedure and good governance, this is a superficial and rationalist argument that serves to actually diminish our role as legislators.

When the Therapeutic Goods Amendment Bill was passed in 1996, the effect of the bill was to ensure that drugs such as RU486 were not imported into Australia without the knowledge and approval of the health minister, who would then be obliged to advise the parliament of any such approval to allow debate on the issue to occur. Senator Harradine said at the time:

People on both sides of the abortion debate agree that the importation, trials, registration and marketing of such agents ... should not be left in the hands of bureaucrats and science technologists. There should be ministerial responsibility ...

Nothing has changed. This bill is designed to have very specific effects. Just as important in my mind are the consequences of this bill. It is more than a debate about maximising so-called choice for women or about which method of abortion is safer. There are still concerns, on both sides, about the use of abortifacients, and the number of submissions to the inquiry on the bill demonstrates that there is grave community concern about the use of this drug.

Many submissions also touched on the governance issues surrounding the bill. The question posed is primarily about who decides. Who should take ultimate responsibility for allowing abortion drugs like RU486 to be evaluated, registered, listed or imported into Australia? The substances that the TGA oversees are drugs that can be lawfully prescribed and administered by medical practitioners throughout Australia. And, of course, we would expect the TGA to have the technical competence to assess the efficacy, safety and quality of RU486. But this bill involves matters beyond the competence of the Therapeutic Goods Administration.

How and why should we—or would we—expect the TGA to consider the political, ethical or philosophical issues around this drug and this procedure? The TGA was never designed to negotiate the myriad of public policy complexities that accompany debate about such a drug. This task lies with our elected and accountable representatives. It is the role of the minister to be accountable to the parliament, and for the parliament to be accountable to the people of Australia for the decisions of government.

It is already accepted practice in legislation to require that major or sensitive decisions be made by the relevant minister. It occurs regularly in the areas of defence, intelligence, foreign affairs and telecommunications. We even had a debate yesterday—or the day before—in this parliament about ministerial accountability and discretion and the provisions that we make for that in legislation. Ministerial approval serves as a safeguard in sensitive situations—and it is an appropriate safeguard for the use of RU486 as an abortifacient. Yet ministerial accountability for this important social policy decision would be removed by this bill. When it comes to a question of such public interest and controversy, with deep distrust and cynicism on both sides of the argument, it is very important that the approval process surrounding RU486 is not merely independent and unbiased but is seen to be so.

This bill has another effect: it delegates decision making about policy to public servants whose role is to implement policy. This bill gives the TGA the ability to determine policy without reference to elected members of parliament, whose responsibility it so rightly is. So, my argument is that the TGA is an unelected body and should not have this responsibility, whilst we as legislators should not wash our hands of it.

Individual health ministers come and go. This debate is trivialised by suggestions that a minister is not able to make objective decisions because of his or her religion. Whoever he or she is, what matters is that he or she is accountable to the electorate for any decision to approve or not approve RU486. The current system ensures accountability, transparency and public confidence in the process, and these are very good reasons for maintaining it.

The inquiry received extensive evidence on therapeutic issues around the uses of RU486. The argument is clouded by misconceptions about the original therapeutic purpose of both mifepristone and prostaglandin and ongoing confusion with the morning-after pill. The morning-after pill acts to prevent an embryo attaching itself to the lining of the womb. RU486 works in a very different way: it changes the composition of the lining of the womb, killing the developing foetus. It is the first step in a chemical abortion that is completed by using a prostaglandin analogue. RU486 was not originally designed to induce abortions—that is why another drug is needed to complete the procedure. RU486 was originally developed for a therapeutic purpose: as a treatment for serious endocrine conditions like Cushing’s syndrome. Its effect of inducing early abortions has been described by one witness to the investigation as an ‘unexpected outcome of the early investigations’.

Supporters of the bill say we should treat the use of RU486 as an abortifacient like any other drug—but of course it is not. Its use in this way is not therapeutic—not designed to prevent, treat or diagnose an illness, or a defect, or an injury. It is intended to cause an abortion that will end a developing human life. The Therapeutic Goods Administration evaluates medications and therapies for their effects on the foetus. The TGA bans the use of some in these circumstances or establishes strict controls for that reason. Why then would this not be the case for the toxic mix that is RU486, which is unlike any other product typically brought before the TGA for approval?

RU486 has considerable toxicity and affects multiple body systems—with many potential side effects. The committee received a quantum of evidence outlining the medical impacts of RU486 when used as an abortifacient. Supporters of the bill argue that RU486 avoids the risks associated with the anaesthetic and the surgery itself involved in surgical termination. Submissions suggest that RU486 provides an attractive option of replacing a ‘humiliating, difficult, invasive and traumatic procedure with a tablet’. But the evidence does not support this rather simplistic view.

In his advice to the minister, the Chief Medical Officer, Professor Howarth, suggests:

... it carries significantly higher risks of later adverse events, such as incomplete termination and prolonged bleeding, and thus a higher proportion of women who undergo medical abortion require subsequent and, at times, urgent intervention.

In 1990, the original manufacturer, Dr Edouard Sakiz, said:

As far as abortifacient procedures go, RU486 is not at all easy to use ... a woman who wants to end her pregnancy has to ‘live’ with her abortion for at least a week, using this technique. ... It is an appalling psychological ordeal.

The submissions and witnesses presented sound arguments and counterarguments to the committee about the health risks. In ensuring that people do understand that this bill is about mifepristone as an abortifacient, the TGA provided the following evidence:

... there have been several instances since June 1996 where mifepristone has been used for the treatment of brain tumours and serious endocrine conditions. In these cases, the drug was obtained under the Special Access Scheme arrangements for supply of unregistered drugs for use in life threatening conditions.

Before we allow the drug to be used as an abortifacient, we need to know more about its effects. When making policy or passing legislation, it is imperative that we take a long view, and we could do well to start from the fact that the long-term health effects of elective abortion are difficult to study and thus poorly understood.

There are a number of causes of this lack of knowledge. First and foremost, researchers of reproductive decision making have to rely on observational studies. These studies take place in different cultural, religious and legal contexts. All research in this realm is prone to an array of different sources of bias that complicate the process of drawing conclusions. That lack of clarity makes it possible for the long-term health consequences of elective abortion to become politicised, as we are seeing now. People who grant a moral status to an embryo or foetus can cite claims of adverse health consequences of abortion to support their point of view, while those who support ease of access to abortion are often unwilling to consider that pregnancy interruption can affect future mental and physical health.

Some might think such a complicated, politically treacherous and difficult to understand issue is a can of worms that parliament would be wiser not to open. To those of my colleagues who take that view, I point to the issue of cigarette smoking and its health consequences. In the 1950s and 1960s, the same criticisms could have been and were applied to the dilemma of studying whether tobacco consumption had adverse health consequences. While no individual clinician or patient could discern the harms of cigarette smoking and all studies had to be observational, with their inherent biases, well-conducted epidemiologic research was able to document adverse consequences and, ultimately, inform public opinion and policy.

Everyone in this chamber would agree that our national wellbeing has been improved by the persistence and diligence of research into the long-term health effects of smoking. Even small negative effects on long-term health can influence people’s lives, and it is part of our responsibility as representatives of the people to ensure that the legislation we enshrine bears that fact in mind. Given the important and prevalent health conditions that some of the published data have linked to elective abortion, such as premature birth, breast cancer and serious mental health problems, elective abortion must be studied in the same fashion and with similar vigour as cigarette smoking so that women can be fully and accurately informed about potential health effects—both mental and physical.

Reputable research to date points to an association between induced abortion and either suicide or suicide attempts, and the association is not seen after spontaneous abortion. This is an objective rather than a subjective outcome. Any woman contemplating an induced abortion should be cautioned about these mental health correlates of an increased risk of suicide or self-harm attempts as well as depression and a possible increased risk of death from all causes. The particular effects of RU486—of self-administering the treatment, of the abortion taking place over time and without attendant medical support, of the conjunction of two drugs—have not been properly assessed. Dr Renate Klein’s submission to the inquiry points to a history of clinical trials of RU486 that were short-circuited, fast- tracked, incomplete, uncontrolled and even paid for by the pharmaceutical company that manufactures the drug. She notes that ‘the potential long-term effects of this procedure are not even being studied’. Even some of objective findings about abortion that are available are not as widely known as they should be. Mr Charles Francis’ submission challenges the widespread belief that abortion is a safe and simple medical procedure, and that significant harm occurs only in an occasional isolated case. He cited compelling evidence of long-term physical health consequences.

The majority of women having an induced abortion are under 30 years of age, and any woman contemplating an induced abortion early in her reproductive life faces two major long-term physical health consequences. First, her risk of subsequent premature birth, particularly of a low birth weight infant, will be elevated. Secondly, she will lose the protective effect of a full-term delivery on her lifetime risk of breast cancer. The loss of protection will be in proportion to the length of time that elapses before she experiences her first delivery. The link between abortion and breast cancer, the ‘ABC link’, is reliably supported by credible statistics over the past 50 years. Increased rates of placenta previa also warrant mention. Evidence was provided to the committee that, when a woman is properly warned of the risks entailed in abortion, she usually elects to proceed with her pregnancy. So there are sound humanitarian reasons for my opposition to the bill.

We also have to be very careful to make sure that any laws we introduce do not break moral law. A very long time ago—about 100 BC—Cicero wrote in The Foundations of Moral Law:

There is in fact a true law—namely right reason—which in accordance with nature, applies to all men and is unchangeable and eternal. By its commands this law summons men to the performance of their duties; by its prohibitions it restrains them from doing wrong. Its commands and prohibitions always influence good men, but are without effect upon the bad.

To invalidate this law by human legislation is never morally right nor is it permissible ever to restrict its operations, and to annul it wholly is impossible. Neither the Senate nor the people can absolve us from our obligation to obey this law ...

Prophetic words, I think.

It worries me that prestigious organisations such as the AMA are prepared to argue in their submissions that this is not a moral issue. I understand the mass resignation of doctors from the AMA after that statement was made, because doctors are right at the front line of this debate. They are confronted by their conscience, the Hippocratic oath and their own values and ethics when providing medical advice to women who choose this path, often in difficult circumstances.

It is very important that we also consider the long-term consequences of this bill. If human life is not protected by law, if people’s responsibility to care for the unwanted is wiped out, what precedents are we setting for future debates about life issues?

Like everyone else who prepared for this debate, I read widely. I read all the submissions to the committee, the transcripts of the hearings and the thousands of letters and emails, and I undertook wider research. The issues occupied my mind over the summer recess. Something that caught my eye and helped to clarify the challenges that confront us as legislators is none other than Pope Benedict’s first encyclical letter, and some people might be surprised. I commend a closer reading by my colleagues of the Holy Father’s words relating to politics and justice. In paragraph 27 he says:

The just ordering of society and the State is a central responsibility of politics.

…            …            …

Justice is both the aim and the intrinsic criterion of all politics. Politics is more than a mere mechanism for defining the rules of public life: its origin and its goal are found in justice, which by its very nature has to do with ethics.

He goes on to explain the problem with adopting a merely rational approach to moral questions:

The problem is one of practical reason ... [Reason] can never be completely free of the danger of a certain ethical blindness caused by the dazzling effect of power and special interests.

…            …            …

Here politics and faith meet.

As legislators it is important that we are never too proud to check again, to question our assumptions, our presumptions and the consequences of our actions. For those who argue there is no place for interference by the churches in this debate, I quote Pope Benedict again:

The Church wishes to help form consciences in political life and to stimulate greater insight into the authentic requirements of justice as well as greater readiness to act accordingly ... Building a just social and civil order, wherein each person receives what is his or her due, is an essential task which every generation must take up anew.

Let us think about the consequences of the legislation we pass in this place. As Cicero said:

Neither the Senate nor the people can absolve us from our obligation.

10:39 am

Photo of Grant ChapmanGrant Chapman (SA, Liberal Party) Share this | | Hansard source

The bill before the Senate today, the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, proposes to repeal ministerial responsibility for approval of RU486, a drug used to induce abortion as an alternative to surgical termination of a pregnancy, in favour of the Therapeutic Goods Administration having that responsibility. I oppose the bill. In short, the accountability for decisions involving such a drug is rightly placed with elected parliamentary representatives. I am not convinced of the veracity of the information attesting to the drug’s safety, and as someone concerned about the current level of abortions in this country I cannot countenance a situation where abortion is made more readily available.

Before addressing these issues, I congratulate the Senate Community Affairs Legislation Committee for its work in conducting the inquiry on the bill and the great number of organisations and individuals who made submissions to the inquiry and who wrote to me directly about their views on this matter. I respect all of those who have expressed their view, although I appreciate that I will not please all of them in taking the position that I do on this matter.

The issue of responsibility is central to this bill. Although the bill under consideration has been designed to look to be merely a matter of the mechanics of procedure, I do not see it this way. Rather, it is a serious issue of ethics and social policy, one that cannot be adequately examined without proper regard for questions regarding values and matters of principle that it throws up. It is only right that Australia’s elected representatives in the parliament retain the accountability for decisions involving the use of abortifacient drugs.

In opposing this bill, I am not reflecting negatively on the skill and diligence of the TGA in discharging their responsibilities and duties; it is rather a matter that is too serious to escape the direct scrutiny of and accountability on the part of elected members of parliament. A key feature of this debate has been a continual drawing of attention to the perceived personal beliefs of the current minister for health. Of course, this parliament needs to, in the course of considering this bill, look into the future to a time when the current incumbent no longer holds the position. However, this begs the question: how then would the situation change depending on the potentially different views of people in this position? I believe that, whatever the views and the persuasion of an incumbent minister for health on this particular issue, they should, collectively with their parliamentary colleagues, be held accountable for decisions on this drug.

I do not accept that RU486 should be lined up alongside all other drugs under consideration or for possible consideration by the Therapeutic Good Administration. It is a drug designed to abort a pregnancy, to end the life of a human embryo, not to treat an existing medical condition, to prevent a possible medical condition or to sustain life.

Another question which this parliament must address involves the examination of the responsibilities which correctly fall within the province of the Therapeutic Goods Administration. As argued persuasively by the Catholic Archdiocese of Sydney in their submission to the Senate inquiry, the TGA is charged with the responsibility of assessing therapeutic drugs—those drugs which treat or cure disease. Drugs such as RU486, however, are classified as restricted goods on the grounds that they are intended for use as abortifacients. This is a clear warning sign that Australians who are potential users of RU486 should have the confidence that the drug they are using has been reinforced by responsible parliamentary scrutiny—scrutiny which extends beyond what is normally entered into for merely therapeutic classes of drugs.

Further, while the TGA is charged with assessing the quality, safety and efficacy of pharmaceutical goods for use in Australia, it is not charged with the responsibility of assessing the social and ethical issues related to drugs under its consideration. In my view, the social and ethical issues relating to RU486 are present to a degree that clearly distinguishes and separates them from the general issues under consideration by the Therapeutic Goods Administration. That is why parliamentary scrutiny and, through that, greater public scrutiny are required in this instance.

To the public eye, the TGA is rather an invisible and unaccountable body to be dealing with such a complex, serious and sensitive issue as abortion, which through the passage of my many years in this parliament has remained a highly controversial and emotional issue. In summary on this issue of accountability, hundreds of years of evolution of our Westminster parliamentary system did not remove the divine right of kings to have it replaced by the divine right of experts.

The arguments surrounding the safety of RU486 also demand consideration. The champions of this bill do so under the auspices that, among other things, the availability of RU486 to women will provide a safe and easier method of abortion for women, particularly those in rural and remote areas without ready access to surgical abortion. This might be all right in a situation where a woman administering RU486 does so without a hitch, including being in a position to attend the three medical appointments required to administer the drug. However, the United States Federal Drugs Administration patient information sheet on mifepristone, another name for RU486, which was updated only last year in July 2005, requires serious consideration. It states that some women will need further medical attention, including in some cases admission to an emergency room, and that in up to eight per cent of cases the attempted abortion will be incomplete and will require surgical intervention to end the pregnancy or to stop considerable bleeding.

The Federal Drugs Administration also notes that it knows of four women in the United States who died from sepsis, described as a severe illness caused by infection of the bloodstream, after medical abortion using mifepristone, marketed as Mifeprex. There have been ten known deaths in the United States and in Europe. One might say that this mortality rate is relatively low when compared with the mortality rate involved with other drugs and what is considered to be a generally accepted standard and a small price for Australians to pay for access to RU486. I disagree: four lives lost is four too many when they are avoidable. We should put no price on the loss of a human life. Furthermore, as I said earlier with regard to occasional unfortunate side effects of other drugs, at least their purpose is to sustain, not destroy life.

Furthermore, the United States Food and Drug Administration have noted over 800 adverse reactions to RU486 since the drug was approved for use in 2000. Such reactions are listed in the Senate committee’s report to include heavy and often prolonged bleeding, including the need for blood transfusions; incomplete abortions necessitating surgical intervention; moderate or severe physical pain; and considerable mental anguish. The Food and Drug Administration further estimate that only 10 per cent of cases of adverse reactions are actually reported. This brings the true number of adverse reactions to an alarmingly high rate.

It is clear that a woman taking RU486 requires close monitoring and for emergency room back-up to be readily available to deal with cases where RU486 leaves an abortion incomplete or where a woman suffers serious further health problems, including haemorrhage and infections possibly leading to unintended side effects such as sterility. We can never be sure that unforseen circumstances will not intervene to prevent a well intending patient from obtaining this medical support or women who live a significant distance from appropriate medical support being able to travel the distance in time. This point has been well made by my colleague Senator Alan Eggleston, who practised as a general practitioner and obstetrician for over 20 years in Port Hedland in Western Australia and experienced the challenges of rural medicine first hand.

In Australia, regulation of abortion is currently a matter for state and territory governments. I appreciate this and also that there is not a widespread push for a change in the current arrangements; however, in my opposition to this bill and in my long-held position as someone who is pro-life, it is important to address what I consider to be an alarmingly high rate of abortion in Australia today. Indeed, official government figures put it at between 80,000 and 100,000 per year.

Recently released research conducted by independent market research providers on behalf of the Australasian Federation of Right to Life Associations found that 51 per cent of Australians oppose abortion performed for financial or social reasons and 53 per cent oppose Medicare funding in these circumstances. Critically for this debate, 79 per cent of Australians believe abortion can harm the physical or mental health of a woman; 96 per cent believe a woman should receive free independent counselling before having an abortion; and 86 per cent believe there should be a cooling-off period of several days between making an appointment and having an abortion.

This demonstrates that, while currently there may not be an appetite from the majority of the Australian public to change a woman’s right to obtain abortion, there is certainly some appetite for changing the processes governing abortion. It also demonstrates that the majority of the Australian public hold concerns for the wellbeing of Australian women obtaining abortions. That is why I commend particularly recommendation 1 of the Senate committee’s report and I emphasise from that recommendation the need for counselling that is independent and does justice to the grave nature of a decision involving the possible termination of a growing foetus.

With this in mind, the issue of relinquishing ministerial responsibility for RU486 is relevant to our responsibility as parliamentarians. It is our responsibility to address Australians’ concerns about the staggering number of abortions performed each year in this country. Just ask this question: will approval of RU486 increase or decrease the number of abortions performed each year? I suggest the logical argument is that the former is more likely to be the case. Also, it is foolhardy for elected representatives to ignore the widely documented adverse psychological effects often associated with abortion. As Dr Stephen Grocott and Dr Dianne Grocott, consultant psychiatrists, noted in their submission to the Senate inquiry:

Many researchers have documented increased rates of depression, suicidal behaviour, substance abuse and relationship dysfunction that have variously been labelled ... “post-abortion syndrome (PAS)”.

…         …         …

There is a great need for public recognition of the psychological consequences of abortion so individuals can be correctly diagnosed and treated.

Given our focus on mental health in this country at the moment, it would be neglectful for us to ignore the many public calls for due consideration of the psychological impact of abortion. This only adds another level of seriousness to the issue.

In closing, I reiterate my opposition to this bill. For the reasons I have outlined, the case in favour of repealing ministerial responsibility for this drug is not a convincing one and, as elected parliamentarians, I believe that it is our responsibility to have decisions on such gravely serious social and ethical issues retained appropriately within the aegis of this parliament.

10:52 am

Photo of Amanda VanstoneAmanda Vanstone (SA, Liberal Party, Minister for Immigration and Multicultural Affairs) Share this | | Hansard source

It would be no surprise to most senators to understand that I am going to vote in favour of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I am going to vote in favour of the bill largely because I see it as being about process. It is about who is the appropriate person or body to make a decision as to whether RU486 should be available to Australian women and who should make the decision vis-a-vis any particular individual woman. There may have been a time when it was appropriate, 10 years ago, for some ministerial oversight of this issue. But a decade has passed and we can see all around the world where RU486 is used. I believe that it is now time to say that whether this should be available in Australia is something that should be decided by the TGA—the Therapeutic Goods Administration.

In my view, the decision as to this matter is not one that should be held by any individual minister. It is one that should be looked at by experts. After that, if the decision is made that RU486 should be available, the decision with respect to any individual woman should be made by her in consultation with her medical practitioner. I want to make it very clear that my view here is just that: one about process and what is appropriate. It is not about abortion and, in particular, it is not about the current minister, who holds the power in the portfolio, being a Catholic. I read in the paper today that, apparently, the minister believes that that is the case; that some people have this view because of his particular religion. Having been caught by the net of people who support this bill, it is appropriate to make it clear that that is not my position.

I am 53 and feeling pretty good, just in case anybody gets any ideas about trying to win my seat. I am not giving that up. I recall that when I was about five my mother remarried—my father having died when I was much younger. That was 48 years ago, when Adelaide was a very sectarian city; when you were either Roman Catholic or Church of England, as it was then called. My first stepfather was a Roman Catholic, whereas we were Church of England. It worked quite well, actually. It meant that when we were at church on Sunday, we could duck out early because we had to pick him up from his church, which was in another suburb. I thought that was pretty good. We did not have to listen to the whole sermon. I mention that story to indicate that I lived in that time 48 years ago when some people did have adverse views about each other’s religion. It was not a one-way street; it was about each other’s religion. I have no time for that. I lived in a family that had two religions. The majority of my friends happen to be Roman Catholics. I hold very strongly to the liberal view that everybody is entitled to have their own view on this matter. I know there are different views amongst Roman Catholics, there are different views amongst Anglicans and there are different views amongst the broad community. Therefore, I need to put on record that my view is one about process.

Of course there are occasions when ministers have to be the final arbiter. In the current portfolio that I hold there is plenty of opportunity for discussion on that issue. In my current portfolio, I do have powers that are non-compellable. What that really means is that I can use them or not use them and I cannot be asked about them. So I have given consideration to the use of those sorts of powers. I have those sorts of powers in my current portfolio and I do not think it is appropriate that that sort of power be one that is held by a minister in this particular case for any longer time than has now been the case.

I do not want to go into all the details of the debate of who said what, but I say this: to those people who choose to list details of adverse reactions that might have been had by someone who has taken RU486, to list off deaths that might be attributed to it, their argument would carry more weight if they equally listed off the adverse reactions and deaths from surgical abortions and, for that matter, from any other medical intervention. Life is a risky business. Yes, things go wrong, but where they go wrong is not necessarily an indicator of what we should do for those for whom it will go right. There is no magic wand to make everything right in every issue everywhere. Let us understand this: someone who is going to use this, if it becomes available, is going to do so in consultation with their doctor. They are not going to just roll up to the supermarket and buy this pill and pop off into the desert where there are no other health facilities available and give it a go. That is a ridiculous proposition. That is the concept being alluded to with regard to the risk that women will face if they do not have the services available to them. This decision will be made by a woman, if it gets to that, if it becomes available, in consultation with her medical practitioner.

I was at a dinner last night where there were men and women of differing views on this issue. One of the men said that he was opposed to abortion and was going to oppose this bill because he thinks that, if the bill passes, RU486 would be available and—wait for it—he does not want abortion to be any easier and a pill would necessarily be easier. Well, hello! Clearly, he has never had the mindset of it ever happening to him. It is not going to happen to him because he is a boy. I encourage people who think that it is easier to listen to some of the people who are opposed to the bill, who in fact argue that it will not be easier; that it will be harder. It just shows you the banal level of some of the debate that some people are prepared to enter into in relation to this matter.

I want to spend some time briefly on the language and nomenclature that has been used in this debate. People refer to themselves as ‘pro life’. I would like the pro-life people to get another name because, frankly, that describes everybody in this place. It certainly does. I do not know anybody who is against life. Equally, some people refer to those who would take the decision from the minister and put it where it belongs—where it is made on every other medical intervention—as being pro abortion. Let me tell you that I do not know anybody who is pro abortion. Nobody thinks it is a good idea. Nobody wants anybody to be in that position. But the people who call themselves pro choice, and that is the position I am in, want people to make that moral decision themselves. That is the difference. So I regard myself as pro life. I equally regard myself as pro choice.

We see this in another way. For example, a party that sits on the other side calls itself ‘The Greens’. That is meant to seduce people into believing that their policies are all about the environment. If you look on the website, you see that that is not the case.

I want to make that clear. Every woman that I have ever spoken to about that matter hopes that they, their daughters and their friends are never in this position. They are not properly described as pro abortion. That is designed simply to aggravate and is used as a pejorative to put people down. It follows that, if some people can claim to be pro life and exclude others from it, the inference is that the others do not care about life. That is not true.

There are some very interesting views about when life really begins. There are differences of opinion about this amongst the churches. Some people say that life begins as soon as an egg is fertilised. Others have a view that it is a few more days. Still others have a more religious, as opposed to scientific, view that it is when something called ensoulment takes place. Those of you who have read anything about this will understand that having a soul is what is meant to distinguish us as humans from animals—even though you sometimes look at the way humans behave and think that that cannot be right. Sometimes we do not behave as higher beings than the other animals that we share the planet with. Some churches have a view that ensoulment does not take place until up to three months. My own view with respect to my job here is that it is not my place to tell somebody through legislation when they ought to think that happens. It is a decision people have to come to themselves.

I note, incidentally, that some of the churches who are opposed to any form of abortion can somehow come to the concept of what is referred to as a ‘just war’. I am at a loss to marry the two. If you can come to a view that there can be a just war, why can there never be a just abortion? I cannot see it, and I have never had it answered.

I understand that there are very different views here. I say this to everybody: whatever their beliefs about the existence of a god or their particular religion, they are entitled to keep their views to themselves and make them private. My personal view is that religion is debased when it is cast around and used as a political football. My strong belief is that any god that I have ever heard about or read about is looking for converts, not conscripts. No god that I have read about or heard about needs this place to do his or her work. Any omnipotent being must be more powerful and stronger than the Senate—shattering though that may be to some. If you have a belief in a more powerful being, you will understand the point I am making. It is not for us to legislate.

I think the simple version of my view in this respect is that God—whatever your belief about a god is—is looking for converts, not conscripts. You cheapen any religion when you conscript people in to a particular moral view. A moral view has its merits because it is held in the heart and held deeply, not because it is legislated for. That is my position: I think God wants converts, not conscripts. I think this decision does belong with the experts, because in that way, if it is then allowed in Australia, it does give a woman the opportunity to make a proper choice for them about what is appropriate for that woman, wherever she may be, in consultation with her medical practitioner, as to the services that are available to her. I can see no place for this chamber to be used to legislate for people’s particular views.

Having said that this is about process and not about abortion, I should at least conclude by saying this. We all have different views about a wide range of things that are very personal. I have a very strong view about the availability of birth control in Third World countries. I cannot understand how some people, in the name of their religion, can argue in Third World countries that birth control should not be available. I would like to take them back there and make them live the life of a family who has more kids than it can feed, more kids than it can get health care for. I would like them to go to the funerals of the kids that die because they were brought up in terrible conditions. I would like them to sit with the people who die of AIDS because, while birth control may have been available, it was not used because it was seen as a sin.

We all have strong views. We can all colour them up. Believe me, I could colour up what I have just said a lot more strongly than I have. But I think what is appropriate is that we simply air our views politely and civilly, as we ought to in this place. I conclude by coming back to what was going to be the final point I made—that is, that your religious and moral views are your own and it is not for this place to legislate on those.

11:07 am

Photo of Carol BrownCarol Brown (Tasmania, Australian Labor Party) Share this | | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Firstly, I would like to put on record my congratulations to the sponsoring senators for articulating the case for change in a clear, reasonable and considered manner. National Party Senator Fiona Nash, Liberal Party Senator Judith Troeth, Democrat leader Senator Lyn Allison and our own Senator Claire Moore should be applauded for carrying much of the burden for tackling an issue which was always going to be controversial and polarise people, regardless of the bill’s intent being about approval processes.

I respect the right to a conscience vote on issues of personal or moral conviction and I respect other members and senators for their position. However, having said that, I do not believe we are the ones to make decisions about the technical arguments surrounding medical drugs. This bill proposes to amend the Therapeutics Goods Act 1989 to make it possible to evaluate, register, list or import abortifacients such as RU486 for use in Australia without the approval of the Minister for Health and Ageing by removing the restricted goods provision from the act. The Senate Community Affairs Legislation Committee reported on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 and described the approval process as follows:

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 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 5 sitting days of being given.

The restricted goods provision of the act applies exclusively to medicines intended to induce abortion. Medicines used for any purpose other than abortion are evaluated and regulated by the Therapeutic Goods Administration, TGA, without any requirement for approval from the Minister for Health and Ageing.

There has been a concerted effort by some to make this debate about abortion, despite the fact that the decision on abortion has already been made in Australia. The fact is that abortion is currently available and regulated tightly by the states and territories in this country. Over 81 per cent of Australians support a woman’s right to choose when it comes to terminations. The right of a woman to have choices at what is a stressful and critical time is essential. Despite my personal conviction that it is the right of the woman to choose on abortion, it should be remembered that terminations, whether obtained medically or surgically, require professional medical oversight and approval and must satisfy all conditions required by law. This would apply equally to surgical or medical terminations. That aside, it is the approval process for medical drugs that this bill is concerned with. I would like to quote in part from a letter I received from the Uniting Church. It said:

It is our view that the current campaign against RU486 confuses medical, moral and political issues. As the Uniting Church understands it, the issue is whether or not this particular drug is safe to be released for use in a country where abortion is legally available. This is a decision that should be made by the Therapeutic Goods Administration using sound medical evidence and advice.

RU486 is the common name for the drug mifepristone, a synthetic steroid that can be used to treat a variety of conditions, such as Cushing’s syndrome, breast and prostate cancer, glaucoma, depression and others. It also can be used, as we have heard, to induce what is known as a medical abortion, an alternative method to a surgical termination of pregnancy. RU486 has been approved for use in 35 countries, including the United States, the United Kingdom, China, Israel and New Zealand. We have a clear choice in this chamber. We can trust the Therapeutic Goods Administration and its expert committee, the Australian Drug Evaluation Committee, ADEC, whose role, as explained on its website, is to provide advice on:

... the quality, risk-benefit, effectiveness and access ... of any drug referred to it for evaluation;

medical and scientific evaluations of applications for registration of prescription drugs ...

The ADEC has a core membership and expertise comprising three eminent medical practitioners with at least two specialists in clinical medicine, and one member must be a pharmacologist or hold a degree in science specialising in pharmaceutical science. The ADEC is an expert committee in an expert body. Its associate members must include at least one pharmaceutical chemist with recent manufacturing experience in therapeutic goods, at least one toxicologist and a medical practitioner in general practice. All associate members have specialist qualifications and experience in fields of medicine complementary to that of the core membership of the ADEC.

As I have said, we can trust this body to assess rigorous science or we can trust the Minister for Health and Ageing, Mr Abbott, who, as far as I am aware, does not have any professional medical training but who, it seems, believes that he should be making technical medical decisions for all Australians for these drugs. Faced with this choice, for me it is a no-brainer. As a parliamentary research paper on this bill states:

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 is neither necessarily informed of these, nor does it have the capacity for any oversight of such decisions.

Aside from being technically flawed, this definition of parliamentary accountability is flawed. It is totally inadequate. We never get to see what passes the minister’s desk. It is the TGA that makes decisions on the safety and effectiveness of all other drugs—as it has on almost 50,000 other drugs in Australia—and it is the TGA that should make the decision based on evidence it assesses on RU486.

This bill only seeks to subject RU486 to the same rigorous assessment that every other medical drug in this country goes through. This expert assessment is based on medical evidence and delivers a considered judgment about the risk/benefit of the drug, free of political interference. Whilst supporting this bill I would also like to support the Community Affairs Legislation Committee’s sole recommendation, which states:

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 increasing the availability and affordability of child care.

That is something that I am sure we can all agree on.

11:15 am

Photo of Marise PayneMarise Payne (NSW, Liberal Party) Share this | | Hansard source

I want to make some brief remarks in relation to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. It is my strong view that this bill is intended to correct a perceived inconsistency in the approval process of this drug and related drugs in Australia. The highly emotive issue of abortion has dominated headlines and has, in some respects, been the main focus of much of the discussion about the bill both publicly and in the hearing process—and I have had the opportunity to read some of the Hansards of that. Notwithstanding that, I do believe that the bill is about the appropriateness of the current arrangements for the evaluation of RU486 and related drugs. It is about whether the Therapeutic Goods Administration or the Commonwealth health minister, whoever that may be at any point in time, is best placed to assess and monitor the safety and efficacy of the drugs to which this bill pertains.

I do not regard this bill as one about abortion per se. Abortion is legal in Australia in certain circumstances. It is a matter for the states. It is, in my view, not the subject of this discussion; however, I do acknowledge that many of my colleagues hold a different view from that. I respect their view, and I acknowledge and respect the fact that the Prime Minister has provided the opportunity for a conscience vote on this matter. In situations such as this, where senators and members hold particularly passionate personal views of conscience on the issues under discussion, I think that is the most appropriate and best approach to take.

It is my view that RU486 should be referred—as are all other drugs except it—to our standing body for such matters, the Therapeutic Goods Administration, to be assessed by experts based on the weight of scientific and medical evidence. It seems to me that, if the concerns of the opponents of these particular drugs are well founded, the TGA would examine the impact of the drugs very carefully before coming to a decision on them. Indeed, the fact that both sides of this debate have been passionately argued, in many cases by medical practitioners from diametrically opposed positions, confirms to me the need to action the central premise of this bill to ensure that it is the TGA that evaluates and assesses such drugs. I was interested last night to hear part of the speech of, and to read the words of, the former Minister for Health and Ageing, Senator Kay Patterson, on precisely this point. It occurs to me that she is in a particularly unique position in this chamber and in this discussion to proffer her views.

Most importantly, I do not believe that this is a matter for politicians, no matter their political affiliation, their religious affiliation or their gender. It is a matter which I believe should be in the hands of experts in science and medicine. This bill provides an opportunity to ensure that RU486 and drugs of a similar nature are assessed and evaluated correctly, scientifically and medically by the Therapeutic Goods Administration on grounds in which they are well qualified as experts. If an assessment is made that RU486 is efficacious and safe, and if the evaluation supports the assessment, then it does provide an opportunity for Australian women to access these drugs in appropriate circumstances, in consultation with their medical advisers, in what will be an intensely personal process.

I understand that there are a number of amendments before the chamber; I have had the opportunity to read them as circulated. Some of the amendments are quite extensive and others are more minor. Some of them have the effect of effectively wiping out the whole bill. I suspect I will not have a chance to speak in the committee process, so I take the opportunity briefly now.

One of the amendments requires the minister to seek advice from the Australian Health Ethics Committee—which I understand is currently established to advise the NHMRC—before a decision is made to approve or disapprove an application for RU486. My understanding of the effect of that amendment is that the minister would still have the power, on their own, to approve or disapprove any application to evaluate, register, list or import RU486, and the amendment still does not provide any criteria upon which such a decision would be made. I am not sure how the AHEC, the Health Ethics Committee, is better qualified than the TGA to comment on the safety and efficacy of RU486. If it is not, then the process to move the responsibility to the TGA should not, I would have thought, be offensive to the movers of the amendment. I will listen carefully to the debate on the matter.

Amendment (5) seeks to require the minister to provide, as well as the advice of the Health Ethics Committee, a statement of reasons for approving or refusing an application. Again, it seems to me that, without criteria being required as the basis upon which decisions are made, a statement of reasons would effectively be meaningless. Amendments to translate the decision into a disallowable instrument suggest to me that, although there is an argument around parliamentary review being engaged in that process, that will only happen in the case of an approval. In the case of a rejection it will not be a matter for parliamentary review because there is no capacity to force the minister to reverse a decision and to approve the drug. In fact, it is unclear to me what process the parliament would be engaging in after a written refusal had been disallowed. Again, I look forward to hearing some of the discussion on that matter. It seems to me it may be a never-ending story if we go down this road.

Any of the amendments to which I have referred still leave us with the key problem that the people making decisions on a question of evaluation of safety and efficacy of a drug will be politicians, not experts. It is a matter which I fundamentally believe should be left to the skilled decision making of scientific and medical experts. I do not see myself in a position of being able to support the amendments as they are currently proposed. I indicate that I will be supporting the bill.

11:24 am

Photo of Ian MacdonaldIan Macdonald (Queensland, Liberal Party) Share this | | Hansard source

I have listened very intently to many of the speakers so far in this debate, arguing both for and against the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. Speaking towards the end of the debate, as I am, means that the technical aspects of the subject and just about every argument for or against the bill have already been discussed. Accordingly, I do not intend to rehash those arguments. But I do thank other senators for their words, which have assisted me to come to my decision on the bill.

My decision on the bill is based upon what I, in all consciousness, believe is the best way to deal with a drug whose properties have been described in this debate as having widely different consequences. The debate is not about the legality or morality of abortion. Those debates have been held in the past, and, whether we agree or not, abortion in certain circumstances is legal in Australia and is widely—perhaps too widely—practised.

In considering the different aspects and issues raised by the existing legislation and this amending bill, I acknowledge the many concerned Australians who have taken the time to write to and phone me with their views. They have come from both sides of the argument. I have read and listened to those views, deeply respecting the personal views of my constituents. I know that it is an issue that troubles many people, as indeed it troubles me and, I know, many of my colleagues here in the Senate. In the end, though, being an elected representative, it is up to me to make my decision on what I believe is best, taking into account all I have read and heard on the bill and its consequences.

I acknowledge the help of the Minister for Health and Ageing, who called me last Sunday and offered me his views—an offer which I readily and gratefully accepted. Mr Abbott is a great health minister and has done a commendable job in a difficult portfolio. He raised three arguments with me, all well and reasonably put. They were, in summary—and I hope my summary faithfully records the substance of his arguments: firstly, that this was an issue of the supremacy of parliament; secondly, that the passing of the bill would be a reflection on the minister and the government; and, thirdly, that the decisions on availability of the drug should not be left to public servants forming an independent Therapeutic Goods Administration answerable to a departmental secretary. He did say that he always took professional advice, although he conceded that he had not always followed that advice.

I address those three broad arguments as follows. I do not agree that the passing of this bill, a decision to be made by this parliament, means that parliamentarians are abrogating their responsibility. I could not help observing to the minister that it was only 4½ years ago, at the time of the republican debate, when a certain minister was quoted as saying ‘you can’t trust politicians’ to choose a president. Perhaps you cannot trust them to choose a president, but apparently politicians can make a decision on a drug which some say is life saving and some say is life destroying. I do, in fairness to Mr Abbott, say that he did suggest that he may have been misquoted or misunderstood on the ‘don’t trust a politician’ comment.

On the second point, the outcome of the debate on this bill in no way reflects on the minister or the government—a minister who, I repeat and emphasise, has done a wonderful job. The debate is not about personalities or the beliefs of an individual who may from time to time hold the position of health minister. It is in my view about who is best to determine the safety and availability of a drug in Australia.

On the third point, my research has shown that the Therapeutic Goods Administration is a professional organisation within the Department of Health and Ageing comprising over 500 people—many scientists, medical, social and ethical experts—supported by, I am told, their own laboratories and investigation systems. The administration is advised by, amongst other specialist committees, the Drug Evaluation Committee, whose membership reads like a who’s who of respected medical specialists, including psychiatrists, gynaecologists, academics and pharmacologists.

I believe the bill is all about who is best to make a decision on the availability of a drug with properties and effects that I, as a politician, do not claim to understand. In the end result, I believe these decisions are best made by a large group of respected health and scientific experts, rather than by one single politician. As a country person, I should, in closing, indicate that I noted with interest the thoughtful speech of Senator Judith Adams, an experienced and qualified health professional who has practised widely in the bush.

I intend to support the bill and leave the scientific decisions to professionals. If they decide, in their collective wisdom, to make the drug more freely available—and I make no comment on whether they should or should not do that—then I have confidence in the medical profession to wisely use the drug, taking into account all of the circumstances and, importantly, the patient’s needs. It is for the doctor to prescribe the drug if that doctor, in consultation with his or her patient, believes it is in the best interests of the patient to do so.

11:30 am

Photo of Kate LundyKate Lundy (ACT, Australian Labor Party, Shadow Minister for Sport and Recreation) Share this | | Hansard source

Opponents of choice and those who think women are not responsible enough to make decisions about themselves and their health and welfare have subverted this debate. The question before the parliament is simply whether a health minister—and not simply the current health minister—should make the decision on the availability of a drug or whether the responsibility of evaluating drugs should belong to the Therapeutic Goods Administration, or TGA. At present, RU486 is the only drug that is evaluated by the health minister and not the TGA.

Imagine the outcry from the same very vocal anti-choice lobby were there to be a new pro-choice health minister exercising this power of decision, based not on specialist medical knowledge but on personal, ethical and religious beliefs. These very same people would be calling for exactly this legislation to remove the decision-making power from a minister who is not required to have medical or pharmaceutical qualifications. Such is the hypocrisy of the situation.

In Australia, under the 1996 Harradine amendments, the power to restrict RU486 and similar drugs rests with the minister. The minister is required to inform parliament of a decision to approve an application for a drug to be evaluated by the TGA, but parliament may not disallow such a decision. The minister is not required to inform parliament of decisions not to approve applications. Current arrangements do not provide for adequate scrutiny by parliament of arbitrary decisions made by a minister for health.

Therefore, I commend the joint sponsors of this bill: Senators Allison, Troeth, Nash and Moore. Senators should note that the bill is thus sponsored by representatives of the Democrats and the Liberal, National and Labor parties. I thank those senators for the opportunity to spotlight this incredibly undemocratic power wielded at the moment by one extraordinarily insensitive man.

Minister Abbott has been widely reported as making what the Australian Medical Association has described as ‘hot-headed, inflammatory and offensive’ statements in an apparent attempt to defend his role in denying any qualified assessment of RU486. Apparently, without Minister Abbott’s intervention—he claims—unscrupulous doctors prescribing the pill indiscriminately would give rise to backyard miscarriages and an internet black market. What a ridiculous and irresponsible proposition. As the shadow minister for health, Ms Gillard, has pointed out, if the minister thinks doctors would be misprescribing and endangering lives in this way, he should be taking action on that.

The Therapeutic Goods Administration is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods. It must also monitor and review any risks over time. Thus it is the TGA that is the appropriate authority to assess and recommend on RU486 and not a biased minister. The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 does not seek to approve or ban RU486. It seeks to have its assessment made by the most qualified body.

Let us be clear: this bill is not about legalising abortion—it is legal. State legislatures have responsibility for those laws, and this parliament and this government have no role in abortion legislation. Yet we are subjected to this same debate on abortion policy with increasing frequency and on every related topic. Why do some men in positions of power and influence get this periodic urge to prescribe for women what they do with their bodies? Last year it was Senator Boswell who led the charge, with his call for a study on abortion statistics.

One year ago, on 31 January, a petition of 12 male religious leaders was given a lot of prominence. Claiming to represent, at least nominally, 70 per cent of the population of Australia—that is, the nominal adherents to the major religions—these men called for, inter alia: mandatory reporting of abortions and publicly available records and statistics; independent medical practitioners to provide, both orally and in writing, descriptions of the abortion method and potential health risks, physical and psychological, of abortion procedures; and a statutory delay of seven days after the provision of this advice—including written advice—so that the woman might properly consider her decision.

Senator Humphries—then a member of the ACT Legislative Assembly—insisted that pictures of foetuses must be shown to women considering abortions. Then, if the woman still went ahead, they wanted to impose on her and her doctor post-abortion follow-up, including counselling and referral. In effect, this largely male lobby group sought to delay as long as possible the woman’s decision to have an abortion through the provision of mandatory tasks to be performed, first, by medical practitioners, and, then, through a mandatory cooling-off period that would be a further delay for the woman. So much for their concern about late-term abortions.

If the genuine concern of the largely right-wing male lobby group was late-term abortions, logically, it would support the early medical provision of RU486 and the availability of the morning-after pill. One statistic this lobby group does not readily acknowledge is that, according to the Australian Survey of Social Attitudes in 2003, 81.2 per cent of Australians, regardless of gender or religion, agree that women should have the right to choose an abortion.

In debating abortion issues, some senators and members appear to promote anti-women and anti-choice views. They will not trust women, or even their medical advisers, to make informed decisions in individual cases. From their positions of lofty ignorance, they seek to make universal rulings to cover individual plights. I believe it is between a woman and her doctor to determine the best procedure relating to termination.

Don’t they realise that they are tackling the problem in the wrong way? Instead of applying penalties to women facing an abortion, this parliament should be working hard to alleviate the problems and concerns that can force women to the point where they have to make a decision about an abortion. It seems that this government does not even now bother paying lip-service to the concepts of family-friendly environments and workplaces or the needs of workers with family responsibilities. Things like child-care provision are woefully inadequate and unaffordable for many. The government’s recent punitive workplace relations and Welfare to Work legislation will prove to be a huge disincentive for those who wish to have children, given the struggles in providing the right balance between work and family.

Bettina Arndt pointed out recently that unintended pregnancies are the real problem and that there are solutions which will lower the abortion rate. She says:

In the slanging match of the abortion debate, we don’t hear enough about prevention—about cutting the costs of contraception, about more accessible contraception advice services, more education for doctors—

and women and families—

on the latest methods.

Last year, a notice of motion in the Senate sought to affirm reproductive health rights as a fundamental human right. I certainly support this call and believe that no minister or parliamentarian should seek to interfere with this right. As a result of that notice of motion, by agreement, we are now debating a private member’s bill, which has the same effect of removing the minister’s role in approving RU486.

I would also like to take this opportunity to correct some comments made by my colleague Senator Humphries through the course of this debate and on ABC radio 666 on Wednesday morning. Senator Humphries has often expressed his personal opposition to women having the right to manage their reproductive health, as is his right. But, in an interview which he chose to give in his capacity as Chair of the Senate Community Affairs Legislation Committee, he failed to accurately reflect a number of important facts; hence, I feel, using the opportunity to support his personal view. Most misleading was his description of the TGA as mere bureaucrats. Used in a pejorative way, Senator Humphries sought to imply that the TGA decision-making body was not equipped with the medical and health expertise to make such a decision. This is not true. Of course the TGA is equipped to make such decisions. That is its purpose. I suspect that Senator Humphries was trying to back up his own view.

As I said earlier, can you imagine the anti-choice group lobbying so passionately for the health minister to retain the decision-making right on RU486 if in fact the health minister was a vocal pro-choice member of this parliament? I do not think the same thing would happen if the tables were turned. Senator Humphries commented that RU486 was available for other therapeutic uses, such as the treatment of brain tumours and cancer, but this is not the whole story. RU486 would only be available in limited supply and at a massive cost to the patient. It would not be readily available to the average person. Surely the economics of drug availability should not be so glibly ignored by opponents of this bill. The real issue here, as I think everyone knows, is that this bill seeks to prevent the personal views on abortion of the federal health minister interfering with best medical practice under state and territory abortion laws.

RU486 does provide for a non-surgical method of termination of unwanted pregnancy. Medical practitioners advising their patients and the TGA are the appropriate authorities to make these judgments about its use and application in Australian society. That is why I support this bill. I believe every woman has the right to make decisions about her reproductive health, including abortion, and will, like many others in this place, always defend this right.

Having said that, on behalf of Senator Moore I would like to advise the Senate that the sponsors of the so-called RU486 legislation are opposed to the amendments that have been circulated by Senator Barnett and Senator Humphries. We believe that the proposed legislation is very straightforward and clear, that it effectively refers the assessment of this group of drugs to the TGA, the body charged with the assessment for all other medications. This involves the full assessment for safety, quality and efficacy. The decision on the actual usage of the drug, if assessed as safe, is then with the medical practitioner. The final decision on abortion is with the woman, taking full advice from her medical practitioner.

The amendments address administrative processes around the ministerial decision, provide a process for written statements of reasons and make the ministerial decision a disallowable legislative instrument. In effect, this could lead to a debate, such as the one we are having today, on each occasion that a decision is made. These amendments still do not acknowledge the expert role of the TGA. The role of the AHEC is not clear and would probably again involve the ethical nature of the process, not the safety or medical issue. The minister has sole power to approve or disapprove. There are no clear guidelines and no need to do more than take advice. This is just another step in the process, which does not apply to any other medicines. For that reason, the proponents will, as I will, be opposing those amendments.

11:42 am

Photo of Bill HeffernanBill Heffernan (NSW, Liberal Party) Share this | | Hansard source

It is not often I get up in this place, but today is the day. I rise to speak to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. We have been debating a lot of the short-term effects, the medical effects, the science, tomorrow’s headlines and the political outcomes. I want to talk about the 50- and 100-year outcomes of the issue we are dealing with today. The world’s greatest vocation without a doubt is parenthood. No-one can understand the greatness of that vocation unless they are a parent. You do not understand what you mean to your own father and mother until you are a parent. I never understood it. Sadly, my father died before I had the opportunity to understand the pleasure he would have got as I walked up the footpath. You do not understand. You always know what mum and dad mean to you but you never understand what you mean to mum and dad until you have your own children. I think this advance in technology is going to turn the world’s greatest vocation into a social convenience over a long period of time. There is no question that with affluence comes the idea of convenience.

As I said, I do not want to get into the science. Simple, short messages send the message. The AMA says this pill is safer for rural women because it is safer than childbirth. Well, that is probably a scientific statement of fact. It is also a bit of a dog whistle out there if you advance for 50 years the idea that somehow childbirth and parenthood were meant to be a matter of convenience. There is great sacrifice in parenting. There is great sacrifice in giving birth. We have gone from a time in the 1700s when 25 per cent of children died at birth or in the first 12 months. We now have technology that allows us in Australia to do away with 40 per cent of our children before they are born. So I do not want to get into that. What I want to talk and remind everyone about is what the long-term effects can be.

Can I move to—and people may think I am straying from the issue here—the one-child policy in China. At the time that was implemented, they thought that was a great way for China to deal with the population issue. But it is going to cause the greatest social disruption to China. They think pollution is a problem? Wait till they start dealing with that. In India, they have gender selection as a policy. That is going to have an enormous effect 50 years down the track. It is as simple as clear-felling a forest: you do not look at tomorrow’s headline or the plantation that goes in; you look at where you are in 50 or 100 years time. If you clear-fell a forest, it takes 300 years to put it back to how Mother Earth wanted it. Then there is global warming. We all drive cars and all drivers know—and I am one of them—that when we drive the car we are destroying the planet, but because of the social convenience we drive the bloody car. The 100-year outcome is that we have now decided that we are almost too far down the track and it is irreversible.

It is cute to say RU486 is a therapeutic good. RU486 is designed to knock babies over, effectively in pregnancies of less than 49 days, or seven weeks, and even up to 12 weeks. Now, I said that to a doctor in Sydney the other day and the mob around me started to go mad because I called it a baby; they said, ‘It’s a foetus.’ I said, ‘Doctor, will you answer that question for me? Because I know the answer.’ He said: ‘I will. I’m a doctor who’s been dealing with pregnancies for 25 years. I have never had a woman come into my surgery and say, “How’s my foetus doing?” They always say, “How’s my baby doing?”’ This drug is designed to knock over babies. I asked him: ‘Do you think the technology will improve? We’ve improved our tractors and headers. Do you think we’ll improve the technology with this pill?’ He said: ‘Sure. We’ll have a pill that will knock ’em over at 28 weeks in due course.’

This debate is a nice attempt at a Trojan Horse about whether it is the government’s decision, the minister’s decision or an independent body’s decision. It is never going to be, while we have our present system, a minister’s decision; it is always the government’s decision and the government has to wear it.

An example of giving away a decision for government, I think, and I am sorry if this seems a long way from the mood of this debate, is film censorship. Last year we had that show, whatever the name of it was, on Channel 10 or whoever it was—I know I rang the bloke up and gave him a bloody earful. There was full-frontal nudity, with a bloke playing with himself on TV. I rang up and said, ‘Don’t you think that’s going over the top?’ Channel 10 said: ‘No. It’s not breaking the law, because the film review mob’—an independent body—‘said it’s all right.’ Give me a bloody break! The 50-year effect of this will be to destroy what we know as family.

It is cute to say that all the other things in the abortion debate have been put to bed. These things are never put to bed. And no-one wants to talk about the mistakes we have made in the past. Oops, we over-allocated the water licences in New South Wales. We are now paying the penalty. But, at the time, everyone thought it was a bloody good idea when they issued the licences. We mined the aquifer deliberately in the Namoi. Now there is a class action against the government because they—oops—made a mistake.

No-one will convince me that, like the one-child policy in China, the RU486 issue will not seriously interfere with global demography, because what will happen for a start is that, as this becomes more convenient—and the National Union of Students have already put it on the record that they think this is a great innovation—it will slowly but surely destroy the vocation, as it were, of parenthood. The long-term effect, with the growth of affluence, will be that in affluent countries there will be more of a temptation to use it. I am not going to get into the merits of it, because I am the least qualified person in this place to talk about the rights of women over their bodies. I do not want to get into that. I just want to let everyone know where it will all finish up. It is a given, it seems to me, that this will happen.

It is a given, to me, that eventually euthanasia will be legalised in Australia. It is legal in the Netherlands now. There are sensible arguments about it: Senator Macdonald and I have just had a discussion about prolonging life with technology and how sometimes that can be very unfortunate. Unfortunately, once you let these genies out of the bottle you cannot confine them to their original purpose. In the Netherlands now, whether you like it or not, 55 per cent of the people who are euthanased are euthanased without their consent or knowledge. It is an administrative tool for hospital administration to clear the beds out. Fifty-five per cent of the people euthanased are euthanased without their consent or knowledge. Don’t give me that other crap! Eventually euthanasia will be legalised in Australia. It is trendy; it is the way it will go. And guess what will happen? There will be a pill, and it will go to the TGA, not to knock over babies but to knock over people. And we will sit there and say: ‘Well, that’s a matter for the TGA. They’re an independent body.’ I rest my case.

11:51 am

Photo of Annette HurleyAnnette Hurley (SA, Australian Labor Party, Shadow Minister for Citizenship and Multicultural Affairs) Share this | | Hansard source

I have a great deal of sympathy for those members of federal parliament who want to reduce the number of abortions in this community. I also have great respect for the members of the community who see the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 as an opportunity to protest about the rate of abortion. I think this particular reference of RU486 to the minister’s discretion is something of an aberration in the parliamentary scheme of things. It was instigated by Senator Brian Harradine, who had a passionate personal view about abortion and he saw this as one way to reduce the number of abortions.

In terms of accountability, accountability in the matter of abortion does not, in fact, lie with federal members of parliament, nor with the federal minister for health; it lies with state administrations. What the federal minister for health could do about the rate of abortions in this country is to put in place and fund programs to educate and counsel to reduce the rate of abortion. This is a subject that I feel very passionately about. I am sure that there are a lot of women in this country who have abortions who should not be having them and who probably should not have conceived in the first place. And I am sure there are a lot of women in this country who have had abortions, who have had terminations, and suffer as a consequence of that. I think if we had proper programs in place to educate and counsel women then we would reduce the number of abortions, and that is certainly within the ability of the federal minister for health and the federal government to put in place.

It is very difficult not to be swayed by the strong community opinions that have come to me about abortion and the rate of abortion in this country and the effects of RU486 that have been described. It is difficult not to respond to the passionate view about killing large numbers of babies. However, I am trained in science, worked in science for a long period of time and have been trained to deal with the facts and outcomes of a particular instance. Clearly, the facts are that abortions do occur in this country and they are conducted legally under certain circumstances. There is no medical procedure that is without risk, and it is prudent to have expert, independent medical opinion on the safest procedure for medical interventions such as abortion.

Also, I have seen no evidence from other countries that the use of RU486 increases the number of abortions, and no evidence that its use in this country would increase the number of abortions. I have seen no evidence that the ban on RU486 has reduced the number of abortions in this country. In fact, people have talked quite passionately about the high rate of abortions in this country. Therefore I will be voting in favour of this bill. I would certainly strongly support, as the Senate committee has recommended, any programs that would reduce the rate of abortion, but I do not believe that voting against this bill will achieve that effect. On the grounds of facts and outcomes, I will be supporting this bill.

11:55 am

Photo of Helen CoonanHelen Coonan (NSW, Liberal Party, Minister for Communications, Information Technology and the Arts) Share this | | Hansard source

In this important debate it is tempting to succumb to the all too familiar battleground of pro-choice versus pro-life arguments. This is well-trodden turf, with powerful arguments and passionate and sincerely held views on both sides of the debate. I think we can only respect the respective views. But since Moses received the 10 commandments I am not aware that any of us have had the answers handed to us on tablets of stone. We must consult our own consciences and be true to our own values and beliefs in arriving at a reasoned and principled decision on the matter before us.

The central issue of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not whether therapeutic abortion is available in Australia, nor is it whether RU486 is a banned abortifacient. Clearly, therapeutic surgical abortion is widely available in Australia. The lawfulness or unlawfulness of procuring a miscarriage lies within the jurisdiction of individual states and not the Australian government.

Many Australians who have contacted me in relation to this debate have mentioned the often quoted line of former US President Bill Clinton that ‘abortion should be safe, available and rare’ as the benchmark by which we should approach this issue before us. I believe that the majority of Australians acknowledge the quite awful choice that faces any woman uncertain about whether she can cope with her pregnancy, be it for medical reasons or any other, and broadly agrees that it is not up to the government to pre-empt these decisions, which are intensely personal and are informed by individual circumstances. I do not think that women undertake that decision lightly and nor should they. It is a matter where politicians cannot know all of the circumstances surrounding every single decision. That ought to be a matter for the woman, her partner and perhaps her broader family, and undertaken on medical advice.

We have an obligation, if terminations are legally available, to ensure that they are safe. The real issue is that there needs to be good information before someone has to make that decision. That is where we can make a real difference as a government—we can make sure that Medicare will pay for someone to get proper counselling about their options, and other assistance that may be available, so that no-one is stampeded into making a decision because they are young or they are frightened or panicked and simply do not know where to turn or what other options may be available. From my perspective, I have a real passion—and have had for many years—for trying to make sure that no-one has to make this decision in the absence of proper and full information about their options, which should also include what financial help is available. This is an initiative that is being considered by government, and I commend the Minister for Health and Ageing, Tony Abbott, for his efforts in this regard. It has my strong support.

Having said that, I acknowledge that there is—quite rightly in my view—general community disquiet about the sheer number of abortions that we have in this country. There are no definitive statistics for senators to rely on, but there have been unofficial estimates that there are as many as 90,000 abortions in Australia each year, compared with about 250,000 live births. This is obviously a very real and pressing concern, whatever the correct number. We need to look at what is causing so many women to seek a termination. We need to improve information so people do not have unwanted pregnancies. We need a balanced approach to address this problem. I think that this is a far more important issue in the long run perhaps than the one we are debating today, and one that will impact far more directly on the number of abortions in Australia—which I am sure is a matter of great interest to us all.

I have not been convinced that, if at the end of the long and rigorous approval process RU486 is made available in Australia, we would see any increase in the actual number of abortions in this country. It is important to remember that this bill is not about whether lawful therapeutic surgical abortion is available in Australia; it clearly is. It is also important to remember that this debate is not even about whether or not RU486 should be available in Australia. There is currently no application from the manufacturer of RU486 to have the drug registered in Australia. Rather, this debate is about the process such an application must undergo if RU486 is to be assessed for registration. In Australia, the TGA is charged with identifying, assessing and evaluating the risk posed by therapeutic goods that come into Australia and assessing applications for registration. It is a long process during which advice is sought from an independent advisory group, the Australian Drug Evaluation Committee. Affected parties are also able to appeal to the minister for health if they dispute the decision of the TGA and seek to have that decision varied or overturned. I will have something to say about that in a minute.

The minister has the power to revoke a decision or substitute a new one, and the minister’s decision may be subject to appeal to the Administrative Appeals Tribunal or the Federal Court. What the debate before us swings on is the special process for abortifacient drugs, which was inserted into the Therapeutic Goods Act in 1996, requiring a separate ministerial approval at the beginning of the process. As a result of these amendments, medicines intended to be used as abortifacients are classified as restricted goods under the Therapeutic Goods Act. This classification applies only to abortifacients and to no other class of drugs. I note that many of the speakers have said that this is like no other drug. They may be right.

The amendment specifies that restricted goods could not be imported, registered or evaluated without the written approval of the minister for health. This approval must be laid on the table of both houses of parliament. If the minister’s consent is granted, the usual procedures for evaluation and registration would be undertaken and the decision taken in the TGA evaluation process would be subject to ministerial appeal and intervention. In other words, there are no short cuts for any drug, including abortifacients, in undergoing the rigorous TGA process for registration and sale in Australia.

One argument in favour of this private member’s bill has been that RU486 is sometimes used in the treatment of a number of cancers and tumours, including breast cancer and Cushing’s syndrome. It should be noted that the restricted goods regime should not and was never intended to limit access to RU486 under special circumstances when it is being used to treat particular cancers and tumours. The 1996 amendments quite specifically addressed in the debate at the time that that amendment did not and should not impact on the Special Access Scheme. The Special Access Scheme provides for the import and/or supply of an unapproved therapeutic good for a single patient on a case-by-case basis. Applications must be made by registered medical practitioners who must provide details of the patient and the clinical justification for the treatment.

As I understand it, there is currently an application before the minister from a Queensland doctor, and possibly others, seeking to become an authorised prescriber of RU486. However, no decision on this application has been made. I understand that the minister has referred this application to the TGA for comment. The critical question remains whether, in the case of drugs intended to be used as abortifacients, a sponsor should first be required to seek ministerial approval before going through the application process with the TGA. Clearly the senators who voted in 1996 thought this additional step was justified in dealing with major issues of public policy and public health. The clear purpose was to impose an additional layer of accountability on the approval process for therapeutic goods when it comes to this particularly controversial class of medicines.

In effect, the amendment requires the responsible minister—a member of the executive—to take public responsibility for a decision to either allow an application for registration or to refuse it. The act does not specify any guidelines at all that a minister must follow in making his or her decision, nor does it require that conditions be met, only that the approval be in writing and tabled in parliament. If an approval were sought, it would be, to my mind, inconceivable that a responsible minister would do anything other than seek independent expert advice about safety and efficacy and broader issues in reaching a decision to allow or reject an application for registration. Where would a minister go for independent, objective advice if it were not to the TGA? Of course, this is an exercise in speculation, because the process has yet to be tested.

On that point, I must say that I find the very personal aspersions that have been cast on the current minister’s integrity, objectivity and ability to apply himself dispassionately in the course of his duties to have been both gratuitous and insulting. I have no doubt at all that he would act properly in the discharge of any ministerial discretion at his disposal. In my view, the personal beliefs of the current minister are a complete red herring in this debate. If those opposing this bill are comforted that the discretionary safeguard will be exercised according to the beliefs of a committed Catholic, this is only good for so long as that minister retains the portfolio. Another minister may see the issue differently. The inescapable point of principle in this debate is that therapeutic surgical abortion is readily available in Australia. The minister himself has unequivocally stated, in an opinion piece in the Australian newspaper on 6 February, that he would not support withdrawing Medicare funding from abortion or attempts to recriminalise it.

Therefore, the critical question remains: would preventing another method of termination from being assessed for its potential safety and efficacy be justified? It is difficult to come to a concluded view about the safety and potential side-effects of RU486. There are a lot of advocates but not a lot of conclusive and objective information coming from either side of the argument. On some reports, it is a highly unsafe drug with dangerous side-effects. On this view, it is difficult to imagine why anyone would want to use it or prescribe it compared to a predominantly safe and available surgical procedure. On the other hand, the drug, when properly prescribed and supervised—and that is a very strong caveat—appears to have been safely used for many years in many countries. Sometimes even though drugs are properly registered, problems develop. One only has to look at the voluntary worldwide recall of the arthritis drug Vioxx, based on a clinical study showing increased risk of heart attack and stroke. Of course, some medications simply do not make it through the assessment process and are refused registration. We simply do not know whether the TGA would approve RU486 if asked.

But there does not seem to me to be a principled basis to exclude the TGA from doing its job in evaluating a potentially dangerous drug. Clearly, there needs to be a rigorous, evidence based assessment so that we all know what we are talking about. We Australians entrust the TGA with the task of assessing many thousands of drugs. All drugs are potentially dangerous, and many can be life threatening if misused or wrongly prescribed. We entrust the TGA to evaluate the risk and appropriately manage the risk of many powerful drugs. We entrust them to evaluate and approve cytotoxic drugs for chemotherapy, and we entrust them to prescribe anticoagulants, such as warfarin, which were originally developed as rat poisons and require very close monitoring by doctors to be used safely.

It should be noted that the TGA’s role in evaluating safety and efficacy does not end once approval is granted. The TGA has a multifaceted program for monitoring approved products that are on the market. There is a problem reporting system and a recall unit, and reporting of adverse drug reactions is encouraged by the Australian Drug Reactions Advisory Committee. The TGA laboratories undertake random and targeted sampling of approved products. Sponsoring companies are required to provide regular post-market reports on approved products and to inform the TGA of any international concerns related to the safety or effectiveness of a product. And, of course, the TGA has the power to revoke registration and recall drugs. If the TGA’s initial decision is questioned, any affected party can appeal to the minister, who has the power to review, overturn or remake a TGA ruling.

This is a legislated safeguard under section 60 of the act that enables the minister to make a decision at the end of the evaluation process rather than a pre-emptive decision before any evaluation can be made. I believe that an amendment to this review power to ensure that the minister receives notice of a TGA decision and can initiate a review on his or her own motion would overcome most of the objections to removing ministerial accountability. I have to say that it is not as if the TGA is infallible, and I support the minister having a power of review. I think it is just a matter of where it is exercised. I think this existing provision should be strengthened.

In conclusion, I am acutely aware that there are deeply polarised views on this matter. I am also aware that we make decisions on behalf of many others. Ultimately, my view is that public health issues are not something that we can approach through our own personal prisms. I have set out what I believe are principled reasons for supporting the bill whilst respecting the existing role of the minister in reviewing a decision of the TGA. I appreciate that currently a review can only be initiated by parties with standing, but it does provide a capacity for ministerial overview and accountability. That is the subject of this bill, and I support ministerial accountability.

12:09 pm

Photo of Natasha Stott DespojaNatasha Stott Despoja (SA, Australian Democrats) Share this | | Hansard source

I rise to speak in favour of this private member’s bill—the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I speak as a proud pro-choice woman and as a member of the only political party that opposed the Harradine amendments in 1996. For 10 years, the Australian Democrats have been keen to see this decision reversed, and I hope that this afternoon this private members bill will be successful. I want to place on record my congratulations to the cross-party co-sponsors of this private member’s bill.

Contrary to comments by some, but in particular the Minister for Health and Ageing, the Australian Democrats did oppose the 1996 amendments. Those amendments gave the health minister the power of veto over the approval of so-called abortion drugs such as RU486. We put on record at the time:

The Democrats cannot support either the specific amendment or the intent of the amendment. The intent of the amendment is to make it as difficult as possible for women to have another choice and to make it as difficult as possible for manufacturers to actually get their product into the country let alone through the process of trial, approval and making it available.

I recall the angst of many in that debate on both sides of parliament and, indeed, many women. I believe today, therefore, it is pretty heartening to see more senators supporting the handing of the authority back to the Therapeutic Goods Administration—the TGA—the body that we charge in this country to make these decisions for every other sort of drug.

The bill is about a simple change. It is not about the availability of abortion, nor is it even about the safety of RU486. Since this particular issue has been raised, I will comment on it later in my remarks. It is about who should be able to decide whether or not to approve drugs such as RU486 for use in Australia—the TGA or the health minister, whoever he or she may be, regardless or their personal views, regardless of whether they are pro- or anti-choice, for that matter. It is about removing the extraordinary and unprecedented ministerial discretionary power. Schedule 1 of this bill effectively repeals that power of the minister. It amends the Therapeutic Goods Act 1989 to ensure that medications such as RU486 are dealt with within the same evidence based assessment that is used for all other medicines.

In his opinion piece in the Australian, the health minister, Minister Abbott, argued:

In 1996, the federal parliament decided that decisions about abortion drugs were too important to be made by unelected, unaccountable officials.

His imputation that the TGA, the authority that we trust with every other important decision about which drugs can be made available in this country, are unfit in some way to make decisions in relation to this particular class of drugs is alarming. Indeed, it is offensive.

I note that yesterday Professor Terry Hull, the JC Caldwell Professor of Population, Health and Development at the National Centre for Epidemiology and Population Health and Professor of Demography at the Research School of Social Sciences at ANU, rebutted Minister Abbott’s argument. He said:

Minister Abbott is neither trained nor qualified to evaluate the safety nor efficacy of drugs. The Therapeutic Goods Administration was set up in 1989 to make such evaluations and to protect the public’s health.

He went on to say that the members of the Australian Drug Evaluation Committee, an expert committee of the TGA:

... are appointed by the minister and are required to have professional qualifications in clinical medicine, pharmacology, toxicology or general practice.

                  …              …              …

Surely the minister is not presuming to know more about the physical, pharmaceutical or medical risks than the committee he appoints and who report to him or his delegate?

There is something unsurprising about this debate. In fact, it is hardly surprising that anything that relates to women’s bodies—including drugs—is treated differently from other types of debates, or drugs in specific terms, in this place. After all, that is why this debate has become so controversial. Some legislators—some conservative and primarily male legislators—are finding it impossible to avoid interfering in women’s reproductive health rights. I have no doubt that this is why we have been granted a conscience vote in relation to this bill—a drug administration bill which in itself does not make RU486 available in this country. I have no doubt that it is because the subject matter relates to women’s bodies, women’s choices and women’s health.

This bill does not make RU486 available. Of course, if this bill passes both houses of parliament, an application for a licence to import RU486 would need to be made, and approved by the TGA. But, in many cases, these details have been conveniently ignored by some opponents of the bill—including, I have to say, by many of the people who have written to, emailed, faxed and lobbied me. Many of the people who have contacted me have added their names to form letters, some of which arrived in matching handwritten or typed envelopes. Some have sent as many as five form letters, all signed with the same name and address. I put that on the record not to undervalue the heartfelt, emotional and personal pleas that have come to my office, or indeed that correspondence, but to make it very clear that, when people are talking about the overwhelming amount of lobbying in this debate, there have been some very clearly orchestrated campaigns.

I might add that those letters and those opinions do not necessarily reflect the overwhelming view in our community in relation to the issue of choice. The Australian Survey of Social Attitudes found that 81.2 per cent of respondents, and 77 per cent of those who held religious views, believed that a woman should have the right to choose whether or not she has an abortion. The Australian Election Study found that only four per cent of respondents felt that abortion should not be allowed under any circumstances. That is a drop from six per cent back in 1987. But these results have not necessarily stopped those who are opposed to this legislation arguing against this bill and attempting to skew the results of some of the research, the surveys and the public opinion that is out there.

I have heard about push polling on this issue. One constituent who rang my office had been contacted and interviewed about RU486 by a research company called Quantum Market Research which was representing Australians Against RU486. She was originally told that the survey would be about contraception. She found that the questions were leading and offensive, so she complained. When she did, the interviewer admitted that other respondents had actually changed their opinions during the course of the survey. She has now made a complaint to the Australian Market and Social Research Society, because, in particular, the research company has refused to provide her with a copy of the survey, as they are entitled to do. I ask that the company make publicly available a copy of that survey. The results have already been bandied about; the results have been made publicly available—I have seen them in the newspapers, in full-page advertisements.

Some opponents of this legislation have used arguably distorted research and surveys to deflect attention away from what this bill is really about. In his opinion piece to the newspapers, the Minister for Health and Ageing, Mr Abbott, warned of ‘backyard miscarriages’ and ‘the development of an internet black market’ if the authority for approving RU486 is handed back to the TGA. Apart from this being a spurious reflection on the TGA, it overlooks the principal role that we have granted the TGA in our country. It is the national body charged with identifying, assessing and evaluating the risks that are associated with any therapeutic good that comes into this country.

Because the subject of risks has been raised in this chamber and elsewhere, let us look at some of the research on RU486. RU486 has been used safely by millions of women around the world—at least two million in Europe and around 500,000 in the United States of America. It is available in more than 30 developed and developing nations around the world, including the UK, the US, New Zealand, Austria, Finland, Denmark, Belgium, Germany, Greece, Luxembourg, the Netherlands, Spain, Norway and Switzerland, not to mention Israel, China, Russia, South Africa, Tunisia, Estonia, Latvia, Moldova, Georgia, Azerbaijan—and the list goes on. We know that.

It is considered by many doctors—including Australian doctors, I might add—to be a safe alternative to surgical abortion. In fact, late last year, a leading professor of obstetrics and gynaecology at James Cook University in Queensland, Caroline de Costa, writing in the Medical Journal of Australia, pointed to ‘overwhelming’ evidence that the drug is ‘safe, effective and acceptable to women’. The Vice-President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists later joined Professor de Costa in calling for RU486 to be made available in this country. I put this on the record not as an argument for necessarily making the drug available in this country, but simply to counter some of the misinformation in this debate in the public sphere.

RU486 is reported to have a number of advantages over surgical abortion, and, in fact—as has been mentioned in this debate—it was never intended to be used solely as an abortion drug. A briefing paper on the drug prepared by Reproductive Choice Australia states that the drug ‘requires no anaesthesia and puts women at no risk of perforation, damage to the cervix or infection from instruments’. The paper also states that RU486 can:

... be administered to a woman as soon as she knows that she is pregnant and wants to have an abortion. By contrast, a woman must wait until the 5th/6th week before she is able to have a vacuum aspiration abortion.

RU486 also has the potential to be used for a number of other medical purposes, and that is something that we should not overlook in this debate. That is another important reason why the TGA should be responsible for doing its job, assessing the risks and determining whether or not this drug should be available. RU486 has been talked about and considered as a possible treatment for breast cancer, ovarian cancer, uterine cancer, uterine fibroids, psychotic and major depression, bipolar depression, endometriosis and Cushing’s syndrome. Thus it does potentially have a therapeutic application, and that should not be overlooked in this debate.

A number of senators have raised the issue of pregnancy counselling in this debate, including the speaker before me, Senator Coonan. This is a totally legitimate issue in the context of a broader debate about pregnancy and abortion. On the surface, it seems quite a reasonable idea and notion. But I do want to put on the record that I am concerned about the lack of federal government support for pro-choice pregnancy counselling services in Australia, and the tendency of the federal government to favour anti-choice pregnancy counselling and the failure of many of these government funded, anti-choice services to declare their bias. We know that this is the case. We know that there have been examples of deceptive and misleading advertising. In fact, the Australian Federation of Pregnancy Support Services, which we know is linked to anti-choice organisations, made a submission to the Senate inquiry opposing RU486. That is their right to do that, but I believe these organisations must be up-front about where they are coming from, especially if they are in receipt of taxpayers’ dollars. I note that in November that organisation was allocated another $100,000 in funding. I am aware that anti-choice groups have released at least two different polls on the issue of abortion, in addition to the expensive full-page advertisements that we saw this week. I certainly hope there is no link between these surveys and advertisements and the hundreds of thousands of taxpayers’ dollars that have been allocated to the Australian Federation of Pregnancy Support Services. That is in stark contrast to the pro-choice pregnancy counselling services, which receive no federal government funding.

In the time remaining, I want to address the amendments that have been circulated. In particular, I have looked at the amendments circulated in the names of Senators Humphries and Barnett, and it is obvious that those amendments will place additional hurdles in the way of assessment and approval of RU486. For that reason, I will certainly vote against them, and I believe my Democrat colleagues will also oppose those amendments. Under the amendments that have been proposed, the minister would retain the power to approve or disapprove any application to evaluate, register, list or import RU486 without referring to any specified criteria. They require the minister to seek advice from the Australian Health Ethics Committee, which of course is currently set up to advise the NHMRC, before making a decision to approve or disapprove an application for RU486, although—and I acknowledge, again, another weak link in that argument—the minister does not have to follow that advice. This is not about the morality of abortion but the safety of a drug. Therefore, the TGA is the appropriate body to be evaluating it.

I note that the amendments also make the minister’s decision disallowable. I realise amendments have been circulated by Senators Scullion and Colbeck as well which might have a similar effect, though I am not entirely sure. However, the ones in the name of Senators Humphries and Barnett seek to make the minister’s decision disallowable, although this would only apply if the minister had approved the application in the first place. If the minister refuses the application, the parliament can disallow the written decision, but they cannot force the minister to reverse the decision and indeed approve the drug.

As I have pointed out, this debate has become a broader debate, perhaps inevitably, as a result of the strongly held views, emotive views and personal views, some of which have been expressed strongly in this debate. I am worried that this debate, like a number of others we have had in recent times—whether it is debating a motion on the millennium development goals or other issues, for that matter—has become yet another excuse for some people to attempt to wind back the clock on women’s rights. While I believe it is time that Australian women were granted access to RU486 and our country caught up with the many nations in which RU486 is licensed, today I am voting in favour of a piece of legislation that repeals ministerial approval and leaves the decision regarding approval or otherwise of drugs such as RU486 with the TGA.

I suspect and hope that most in this chamber will view this issue as a vote about authorisation and ministerial discretion. Just as I know that there are women and men on all sides of politics who want to protect the current state of women’s reproductive rights and stop some conservative politicians turning back the clock on these issues, I know there are many in this place who also want to move the debate forward. I believe that women have fought long and hard to be able to make decisions about their health and wellbeing. I believe women’s reproductive health is women’s business. I will be supporting the legislation.

12:27 pm

Photo of Julian McGauranJulian McGauran (Victoria, National Party) Share this | | Hansard source

I seek leave to incorporate Senator Ian Campbell’s speech.

Leave granted.

Photo of Ian CampbellIan Campbell (WA, Liberal Party, Minister for the Environment and Heritage) Share this | | Hansard source

The incorporated speech read as follows—

I have closely considered the many submissions made to me on this issue and thank all of those citizens who have taken the trouble to write or phone me to discuss the issue.

I have decided to support the legislation because I believe that as a matter of procedure, the approvals process we have for drugs should be in the hands of an independent expert body. This is the generally applicable regime and I don’t believe RU486 should be an exception.

RU486 is an “abortion pill”. This debate does involve issues of life and death.

My view is that politicians and government must tread very cautiously into this space —a space that primarily is the private domain of the pregnant woman and the man, their trusted family and friends and medical professionals. It is a place for their conscience and—if they are people of religious belief—their God.

While I have great respect for those of my colleagues and those in the community who hold different views, I have always believed passionately in maximising individual freedom and limiting the role and size of government to achieve this.

I am therefore cautious and conservative when I contemplate the extent to which a government or politician should be involved in what is a deeply personal issue.

My colleague, Senator the Hon. Rod Kemp, is unable to be in the Senate for this vote as he is overseas on Government business in his capacity as Minister for the Arts and Sport.

Senator Kemp has indicated to me that he would have voted against the bill if the vote was held before his departure overseas. He also asked if anyone of a mind to vote for the legislation was prepared to “pair” his vote so that the true will of the Senate would be represented in the final count.

I informed Senator Kemp yesterday that I would “pair” him and intend to do so.

Photo of Stephen ConroyStephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Opposition in the Senate) Share this | | Hansard source

I would like to make my small contribution to this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I am indebted to many of the speakers, who I have listened to intently. They have assisted me in reaching my decision about this bill. I am particularly indebted to the last speaker, Senator Natasha Stott Despoja, who wanted to make it clear that this should be a debate purely about this process. My colleague Julia Gillard this morning on radio, again, said, ‘All this debate is about is whether politicians will decide the availability of the medication or the experts will.’ I want to reiterate and support that view. It is also not a debate about Tony Abbott, though, to be fair, he has turned himself into an issue in this debate very successfully. You have to admire his political skills. In a debate which is about a process, Tony Abbott has successfully made himself a large part of this issue.

The movers of this bill stress that the intent is to allow the TGA to have sole decision-making status. They argue that the decision should be based on scientific and technical grounds and that they are the experts who should have the final say. This is not a view I can agree with. Left to their own devices, scientists and doctors would advocate cloning, euthanasia and many other things that I do not support. Ethics and philosophical positions enter into the debate in some circumstances. That is why I believe that this drug raises scientific and ethical matters.

I fully accept the critique of the current process by the movers of this bill. I do not believe handing the power to the minister to have the sole prerogative is the way that this debate should be handled. I believe the process should be more open, transparent and accountable. That is why I cannot support a bill that simply says that we should give it over to scientists and doctors. There is no transparency and no accountability. I think that is a fundamental flaw in the bill. With regard to those who want to advocate that Tony Abbott should not have this power, I agree, but the solution is not to hand it over to an unelected group of people who have no accountability and no transparency.

A number of proposed amendments have been circulated. I hope that in the committee stage there will be some debate about these amendments, because I believe that these amendments should address many of the concerns of many of the people who have spoken. I accept the point made by Senator Stott Despoja that there is a potential difficulty that a rejection by the minister may not be covered. I do believe that the intent is to try to cover that circumstance, and I believe that some of the revised amendments—although I have only just seen them myself—may perhaps address that issue. But I do not believe that the parliament should have no role. I do believe that the parliament has a role in this and that we cannot wash our hands of this debate, because it does go beyond pure science.

I will be supporting the amendments. I hope that they address the concerns that I heard Senator Payne and Senator Stott Despoja raise about them. As I said, I fully accept the critique of the existing situation. It is not satisfactory that a minister of any political or personal persuasion should be in a position to make this call. I do believe it is a debate that should be had in this chamber. Euthanasia was debated in this chamber. Stem cell research was debated in this chamber. Some argue that these are just scientific processes and should be left to the doctors, but the parliament believes that it should have a role in this debate, and I also believe the parliament has a role in the debate around this drug.

This has been a difficult decision for me. I voted to support stem cell research. I voted against euthanasia. I would vote to support abortions being available on Medicare. If the amendments were ultimately successful, I would probably vote for the pill to be available. But I do not believe the bill achieves what it sets out to do. I accept that it is an attempt to change the process, and I do believe the process should be changed.

12:33 pm

Photo of Robert HillRobert Hill (SA, Liberal Party) Share this | | Hansard source

I will be very brief. I do, however, want to thank the Senate Community Affairs Legislation Committee for its report into the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 and for its management of quite a difficult task. I particularly commend the committee’s specific recommendation, which 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 increasing the availability and affordability of child care.

I strongly support more and better sex education within schools and the wider community, easier access and increased availability of publicly funded counselling in sexual matters, and ready and confidential access to a range of contraception options from the age of sexual maturity. This, I believe, would be a positive contribution to reducing the number of abortions in Australia, and I believe that to be a desirable social objective.

Where women require an abortion, I believe they should be treated with sensitivity and support at what must be an extraordinarily difficult and emotionally stressful time. I believe they have the right to access whatever procedural options are safe and can be provided by their medical practitioner. It is for the Therapeutic Goods Administration to determine whether a particular drug is medically safe for the purpose for which it might be prescribed. If the TGA determines a specific drug to be a safe alternative to a surgical abortion then I believe it is appropriate for a medical practitioner to present it as an alternative to surgical abortion. I do not therefore see a role for the minister for health in this process.

12:36 pm

Photo of Fiona NashFiona Nash (NSW, National Party) Share this | | Hansard source

In summing up today, firstly I would like to thank all senators for their contribution to this debate. I am very proud to stand here as a senator for Australia, having watched the debate be conducted in the way it has been and certainly having heard such a range of views on what, in a lot of ways, is a very sensitive issue. I am very proud of all the senators in this place for the contributions that they have made and the way in which they have made them. I would also like to thank all the people who made submissions to the committee inquiry. There were very many submissions, as you would all be well aware, and they were of a very high quality and really reflected the amount of thought and time that people had put into thinking about this issue.

I thank all the witnesses who came before the committee. I sat through the three days of the inquiry, although I was not actually a voting member of the committee. The quality of information that those witnesses brought to that process is certainly to be commended, as is Elton Humphery and his team, who did what can only be described as a magnificent job in preparing the report so that we as senators had the ability to look at the arguments, both for and against, in this very important debate. I particularly thank the co-sponsors of this bill—Senator Moore, Senator Troeth and Senator Allison—for their contribution, their work and their belief that this bill was the right thing to do. It certainly has been a privilege to have worked with such intelligent, thoughtful women.

There are some things about this debate that are particularly clear, certainly to our view as proponents of the bill. This bill is not about abortion. While I respect the views of all the people who do have a pro-life stance—and I have respected their views right throughout this whole process—that does not address what the bill has set out to achieve. The bill is not about abortion. That is a debate we had in this nation many years ago. Our society, the people in this nation, decided that they would allow termination to be legal in this nation under the laws of the states and territories. That is a debate that we have had. This bill is specifically about a method of termination.

I am sure we would all agree that we would prefer to see fewer abortions. There is absolutely no doubt about that. We would all prefer to see greater education and greater prevention—and I concur with my colleague Senator Hill in endorsing the recommendation that the report put forward on that. We would all prefer to see fewer abortions, but we do have to deal with the fact that we live in a society where terminations do occur. What we are debating here is whether or not a method of termination can be made available for women, and their partners by association, in Australia.

We would argue that the best way to assess that method of termination is through the Therapeutic Goods Administration. There are those who say that that is purely done on science, that they are purely looking at the facts and that the moral debate does not come into it for them. We would argue that the moral debate does not have to. That has already been put forward by the people of this nation and a decision has already been made. Where we have a society where termination is legal, who are we to say that we will allow a surgical termination process and yet we will not allow a medical termination process to even be assessed? That just seems illogical.

There have certainly been arguments put forward by those who are against the bill about the issue of safety. I recognise that there is a lot of information out there in the ether—we certainly had a lot of it brought forward to the committee—that is both for and against whether or not this drug is safe. But, as I have said, I do not believe that I have the ability to assess the quality, safety and efficacy of that drug. I do not believe that anybody in this place has that ability and I do not believe that anybody in the other place has that ability. The ability to properly assess this drug lies with the Therapeutic Goods Administration.

Those who have concerns about the safety of this drug should not be worried about supporting this bill, because if those concerns are shown to be correct—if those safety concerns are well-founded—then the Therapeutic Goods Administration will not approve the use of this drug. You only have to read through the list of people on the committees of the Therapeutic Goods Administration to see that they are not nameless, faceless bureaucrats. They are people with knowledge, expertise and life experience. When you read through the list—and if you have not read through it I suggest that you do—you will see that their expertise and knowledge is extraordinary. I do not think I have seen a more eminent list of people who are more appropriate to advise on the safety of drugs.

So I say to those who think that those people are not capable of properly assessing this drug that they are absolutely wrong. They are the appropriate people. They are the best people. We do not have the ability to assess this drug, but they do. As I say, underneath the umbrella of this society in which we have agreed that termination should be lawful, those eminently qualified people should be allowed to assess that drug and tell us whether or not it is appropriate for use.

None of us sitting here know what the people from the TGA will say if they are able to assess this drug. They may approve the drug; they may not. But it is not up to us to tell them that they cannot have the opportunity to assess it. That is not our role, and it is certainly not our role in a society which has said that termination is lawful. The ability of the TGA to do that cannot be overstated, and I think it is something that has been missed in this debate. We have continually heard about these nameless, faceless bureaucrats—but they are not. They are real people with real experience who have been put there to do a job for the people of Australia. We trust them to do it with 50,000 other items—including drugs that are often dangerous, drugs that are often potentially harmful. We trust them to do it with every single one of the nearly 50,000 items that are on the register.

Yet here we have a category of restricted goods, containing eight drugs, and we are saying, ‘We do not trust you, the Therapeutic Goods Administration, to assess those eight drugs.’ We are saying, ‘You have the ability to assess the other 49,353 items’—including dangerous drugs, difficult drugs—‘and we have no problem with that at all, but we will not let you assess those eight drugs.’ To me, that is not right. It is not our role, and the proponents of this bill agree that the appropriate place to assess these drugs is the Therapeutic Goods Administration.

I understand and respect the views of all the people who have contributed to this debate. I have my own personal view, and I point out that it is my own personal view. It is not a National Party view; it is my view. We have many various views within The Nationals on this particular issue. It has been a very strong process to see women from different parties—women who have different ideologies and different philosophical backgrounds—come together on this issue because we know that it is the right thing to do. It is the right thing to do, because society has given us a framework which makes the intent of this particular bill the right thing to do.

I would like to make a few comments on the amendments that have been circulated and flag that they will be coming up during the committee process. I have looked at the amendments and I have read through them very carefully. I thank all the senators involved in putting those amendments forward, because it shows the level of contribution, detail and thought that people are putting into this debate. I thank them for that contribution. But I and the other proponents of this bill have all been through those amendments very carefully, and we would say that they are intrinsically different from what we are putting forward with this bill.

The amendment from Senator Humphries and Senator Barnett seeks to address the issue of the minister alone having the power to approve the drug. But it still allows the minister to have that power within a broader framework, which is against the intent of the bill. I know there is another amendment being put forward by Senator Scullion and Senator Colbeck. Again, having read through it very carefully, and appreciating the intent with which they put it forward, I find that it is against the intent of the private senator’s bill. It still allows for a parliamentary moral value judgment to come upon what the TGA would put forward as a recommendation. As I said earlier, that moral value judgment has already been made by this society and this nation. Having flagged that, I will say that the proponents of the bill will be voting no to all those amendments on the basis that they are intrinsically against the intent of the bill.

It has been a real privilege to work with the co-sponsors of this bill. This is a very important moment for Australia. This is a moment when we say that we understand and respect the views of society. We understand and respect the views of those on both sides in this debate. But, overall, we understand and respect that society has provided a framework in which termination is lawful. This bill says that a method of termination under that framework, under that understanding, should be allowed to be assessed.

On behalf of my co-sponsors—Senator Troeth, Senator Moore and Senator Allison—I commend the bill to the Senate.

Photo of Gavin MarshallGavin Marshall (Victoria, Australian Labor Party) Share this | | Hansard source

The question is that the bill be now read a second time.

Question put.

Bill read a second time.