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

I seek leave to incorporate my second reading speech.

Leave granted.

The speech read as follows—

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

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

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

I note how unusual a practice this is.

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

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

This is a debate about governance and consistency.

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

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

That is essentially why I support this bill.

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

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

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

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

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

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

And that is precisely the debate we are having today.

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

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

And that is precisely right.

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

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

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

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

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

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

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

And I quote from the submission:

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

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

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

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

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

No intervention is without risk. One cannot avoid risk.

And that is true.

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

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

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

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

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

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

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

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

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

Mary Lander suffers from a skull-based brain tumour.

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

The answer was mifepristone or RU486.

To quote from the transcript of the story: -

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

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

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

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

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

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

It’s a ridiculous and unfair situation.

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

The situation must be rectified.

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

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

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

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

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

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

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

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

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

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

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

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

Likewise, as the AMA states in its Committee submission,

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

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

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

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

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

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