House debates

Tuesday, 14 February 2006

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

Second Reading

5:30 pm

Photo of Sophie MirabellaSophie Mirabella (Indi, Liberal Party) Share this | Hansard source

I want to thank the Prime Minister for giving members of the House a conscience vote on the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. As we all know, ‘free’ votes are rare in the Australian parliament, and we as parliamentarians are bound not by party votes or practices but by our individual consciences. I welcome this aspect of the debate on the bill.

But before we embark on further debate on what has already been something of a rhetorical minefield of loaded language it is important to put some things on the record in this place. This is not a debate about the religious practices of the Minister for Health and Ageing. This is not a debate about the rights of women. This is not a debate about the rights of embryos. This is not a debate about men telling women what they should do. This is a debate on a clumsy bill, foisted on the parliament by four women with well-meaning but essentially misguided motives.

I want to place on record that I support the current arrangements that exist in state and federal law regarding abortion. We know that, in Australia, the legislation pertaining to abortion and pregnancy termination is not an Australian government matter but the responsibility of state governments. Each jurisdiction has different legislation, adding to the complexity of this matter.

The substance of this bill is simple, but its effects would be far-reaching. In some ways, the bill is nothing more than a ruse, clearly muddying the waters of sophisticated discussion on an important ethical and medical issue. The question must be raised as to why we did not have this debate when Mr Wooldridge was minister for health. Why did we not have this debate when Senator Patterson was minister for health? And, indeed, why did we not have this debate when the member for Fremantle precariously held the health portfolio?

The member for Lalor was at pains last week to say, ‘This debate is not about Tony.’ She and other members of the Labor Party and the feminist sisterhood have done a good job of making the debate about Minister Abbott in a most personal and vindictive way, which has clouded sensible debate on this issue. The member for Lalor seems obsessed with the religious beliefs of the minister for health, as are many others. The female sisterhood of the Labor Party is at it again: they criticise the minister for health for his Catholicism and his views on abortion—which, incidentally, are not exclusively Catholic views—and then wonder why the growing number of the religious right will not vote for them.

One thing I find personally intolerable is revisionist history, and for this reason it is important to look at the legislative background that gives rise to debate on this bill. Back in 1996, the amendment that gave the minister for health discretion in approving the importation and use of RU486 and other abortifacient drugs was supported by every political party. When the 1996 act was amended, abortifacient drugs, of which RU486 is one, were classified as restricted drugs and required the consent of the minister for health before their importation into Australia. There is nothing particularly controversial about that. It was, after all, something that received bipartisan support in this place. Even the Greens, believe it or not, supported the amendment.

The Greens senators in the other chamber might recount the words of one of their own, Senator Chamarette, when she claimed back in 1996 of members of parliament and senators:

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

There were no T-shirts with the words ‘Mr Abbott, get your rosaries off our ovaries’ back then, as one particularly silly and juvenile Greens senator proudly displayed last week.

For those who want to make the point that RU486 should be assessed by the TGA, as is the case with thousands of other drugs, the 1996 legislation gives the answer. RU486 falls into a different category of drug as its purpose does not fit into the legislative proscription of a therapeutic good.

The 1996 debate on ministerial control of RU486 only occurred because in 1994 a very junior official in the department of health ingenuously decided to approve the importation of RU486 without the knowledge or consent of the minister for health, and then proceed with trials of the drug by Family Planning Victoria, which were then suspended by the then minister, Dr Lawrence—a Labor minister—because the organisation had not properly informed women of the drug’s health risks and side effects. Indeed, there are significant health risks that I shall comment on a little later.

The current restrictions are necessary and should remain in place. Regrettably, the bill takes away the power of the executive and gives it to the bureaucrats. Symbolically, this bill represents perhaps the greatest dispersal of power in this country in the last 30 years. What sort of trend does that set for the future decisions of this parliament? Are our ministers and elected representatives bereft of making decisions that affect the Australian people? Why should we as legislators, and the minister for health in particular, let the faceless, unaccountable, undemocratic and unelected cabal at the Therapeutic Goods Administration supplant our role as accountable, elected and responsible representatives of the people?

As the great George Burton Adams said when writing on the 1626 trial of the Duke of Buckingham:

The modern doctrine of ministerial responsibility can hardly be more fully stated ... The minister is responsible and must be held accountable.

I for one have every faith in the minister to do the right thing by the government’s standards. How effective can the Therapeutic Goods Administration be in deciding the merits of a drug that, by the current legislative standards of the 1996 amendment, is clearly not ‘therapeutic’?

The most assiduous promoters of the drug state the overseas experience that the drug is widely available in the US. I wonder whether these advocates have actually read the disclaimers in the US that women have to sign before they clock up treatment for a chemically induced abortion through RU486. I count myself as one of the few Australian parliamentarians—perhaps the only one—to have received comprehensive briefings on the safety and efficacy of RU486 by the pro-life movement, the pro-choice movement and the independent authority, the American Food and Drug Administration. This was an invaluable opportunity in the formation of my own conscience on this matter to hear the pros and cons of both sides of this argument.

The story was not all rosy. The American Food and Drug Administration is aware of the deaths linked to RU486 use—so aware that it is establishing an inquiry into the safety of RU486. Since its approval of RU486 in 2000, significant safety concerns have arisen. In July 2005, the FDA issued a public health advisory on RU486 and said that there had been four documented cases of death from infection in little over 18 months following medical abortion with RU486. I have seen the briefs of the complainants in the cases against Danco Laboratories—which is the US distributor of RU486—that were filed by the families of two young women who recently died in California as a result of using RU486.

The promotional material makes it sound so easy: a ‘safe and effective’, ‘nonsurgical’ method of termination, but the reality is quite different. After the initial dose of RU486, the patient then needs to take a second drug—a prostaglandin Cytotec or misoprostol—which causes the uterine contractions that expel the embryo. Curiously, the experience has been that RU486 has neither significantly increased the number of abortions nor increased its availability in rural and remote areas. Yet, over time, it essentially substitutes surgical terminations with a chemically induced procedure. This raises the prospect of whether we should be encouraging rural women down this path fraught with the possible medical dangers without the likelihood of appropriate medical superintendence.

With rural obstetricians in something of a decline, midwifery units in short supply in rural and regional areas and the difficulties associated with doctor shortages in some areas of rural and regional Australia, replacing a surgical termination with a chemically induced one, and then not having the associated medical expertise to administer it, worries me deeply. The fact is that the level of medical assistance and supervision needed after a chemically induced abortion—for example, via RU486—is even greater than that of a surgical termination.

We know from the research undertaken by the Parliamentary Library that ‘medical abortion, like surgical abortion, requires the availability of an appropriate level of back-up medical care to address possible complications arising from the procedure’. Up to eight per cent of the cases will not result in a successful termination. There have been numerous cases of the foetus failing to expel from the uterus. Rural women will require instant medical assistance in the case of the ensuing internal bleeding, cramping, infection, haemorrhaging, abdominal pain, pelvic pain, septic shock or ruptured ectopic pregnancy that can commonly occur with RU486. In other words, where RU486 is used, the medical practitioner must be able to perform an emergency surgical abortion or have ready access to surgical abortion.

The proponents of RU486 list its ‘safety’ as its redeeming feature. This is seriously misleading as they conveniently omit statistics regarding the incidence of heavy bleeding and pain which is a direct concomitant of this form of chemically induced abortion. For instance, the New England Journal of Medicine reported trials where nine per cent of women reported bleeding after 30 days and one per cent were still bleeding after 60 days. They found:

Excessive bleeding necessitated blood transfusions in four women, and accounted for 25 to 27 hospitalizations ... 56 of 59 surgical interventions, and 22 of 49 administrations of intravenous fluid.

A Columbia University study also found that ‘20 per cent of women bled or spotted for five to six weeks’. So much for the safe alternative to surgical abortion.

The medical disclaimers for RU486 in the US clearly state that if one cannot easily get emergency medical help after taking the pill then it should not be taken. Representing a rural area myself, I am disturbed by this fact. We have also got to be a little sceptical of the fact that most of the medical literature supporting RU486 is sanctioned by the pharmaceutical industry.

This bill raises important moral and ethical issues which I feel are not best left in the hands of laboratory technicians and bureaucrats. Governments are here to govern and ministers are here to be held accountable. Those of us in this place representing rural and regional areas carry a heavy responsibility of a significant medical, ethical and social magnitude when coming to a position on this bill. I am comfortable with my decision to vote against this bill, even though in all likelihood it will pass in its current form. Some of my enthusiastic colleagues have submitted amendments. I know these are well meaning, but essentially for me they miss the point. I feel Australia is best served by retaining the current arrangements which recognise the primacy of the parliament and the role of the executive government of the day.

I will vote against this bill not under the influence of the flurry of email activity from people right across the country or the significant increase in telephone traffic to my electorate office but, rather, because the current situation has served us well and should continue. This drug will not increase access to abortion for country women, it will not make abortion safer but will increasingly substitute surgical abortion—the latter being the safer and more efficient abortion option. I for one do not wish to see my public duty as a representative supplanted on such a serious ethical and social minefield by an unelected, unrepresentative and faceless bureaucracy and will be opposing the bill.

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