Senate debates

Thursday, 9 February 2006

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

Second Reading

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.

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