Peter Andren (Calare, Independent) Share this | Hansard source

Let me say at the outset that I will abstain from voting on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I know that that may be regarded as a cop-out and as disfranchising my electorate, but I hope that I can explain my dilemma. Let me also state that I support pregnancy termination for medical purposes. I also recognise that abortion is more and more available, not just for medical reasons but as a form of birth control. I am not happy with that trend but acknowledge that it is a fact of life beyond the control of parliament—unless it were to outlaw abortion and return us to the time when abortion was hidden and the outcomes often terribly damaging.

So where does this leave the argument on my position? Logic suggests that the Therapeutic Goods Administration is the only body capable of judging the efficacy of a drug entering the Australian market. It should not be the role of one minister, cabinet or parliament as a whole to impose political judgment on such approvals, for it would be a judgment with little or no medical expertise. The judgment of a drug’s production, side effects, efficacy and administration should rest with a professional organisation such as the TGA but with a rider—as we move into assessing a drug that has so many ethical, as well as medical and scientific, questions about it, surely there needs to be an ethicist on board the TGA process.

I am not convinced that the TGA has the necessary powers to monitor this particular drug, or set of drugs, as this process we are examining really entails, for this involves mifepristone and a prostaglandin taken in tandem to achieve a termination. I do not disagree that where a surgical or medical option is available a woman should have a choice. But it is not the choice but the supervision of the choice that disturbs me. My concern surrounds the protocols for administration and follow-up in the use of these drugs. I am not convinced in my examination of the TGA’s responsibilities that sufficient protocols are currently in place to ensure that doctors prescribing these drugs would be involved sufficiently in the entire process, especially in country areas. I am not satisfied that key bodies such as the AMA have even considered the need for much tighter protocols in the case of these drugs.

What concerns me is that vulnerable women, many of them very young, will, if not required to self-administer these drugs, be alone while the termination process is occurring. In response to concerns about some outcomes from the use of the drugs, a US Food and Drug Administration alert of July 2005 states:

Patients should contact a healthcare professional right away if they have taken these medicines and develop stomach pain or discomfort, or have weakness , nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking misoprostol. These symptoms, even without a fever, may indicate sepsis. Make sure your healthcare practitioner knows that you are undergoing a medical abortion.

To my mind, the American situation leaves the onus very much on the patient, and therein lies some of my concerns about the protocols that may in future be in place here.

If I were convinced that these drugs were administered within a clinic and the woman supervised and cared for in a clinic as with a surgical abortion, I would have no problems. But this drug is being promoted as an answer to isolation, for country women to be able to achieve terminations without the expensive, time-consuming trip to a city or major centre. It may save time on travel to an urban clinic, but I doubt that it will offer emotional security anywhere near as much as a clinical procedure, where at least there is medical and, one would hope, psychological support.

I am conscious of the written advice to the Minister for Health and Ageing from Chief Medical Officer Professor John Horvath that the use of RU486 for abortion ‘carries a significantly higher risk’ than surgical abortion of later adverse events and that the use of medical abortion by GPs in situations where there was not ‘an established relationship with an obstetric service that could deal with emergency complications outside normal clinic hours would substantially increase the risks to women undergoing termination’. The AMA executive, councillor and obstetrician, Dr Andrew Resce, responded to the CMO’s advice by stating that women would only be able to gain access to medical abortion ‘under the supervision and advice of a doctor who would be responsible for managing the entire termination process’.

Therein lies my concern. How is this possible in all circumstances, especially in remote and not so remote rural communities—in Indigenous communities as close to Bathurst, say, as Hill End, an hour and 15 minutes away over a lot of winding gravel road? I do not believe the supervision, the obstetric backup or the management processes are in place. Equally, I do not believe the minister of the day or parliament should be the judge on this. Nor do I believe that women should, as some have suggested, be the judge and that men should butt out. A pregnancy also involves a male.

There is much pressure on many women to take the abortion route, and we must ensure we have in place absolutely every support necessary to enable a woman to also exercise her own choice to continue a pregnancy. For many young people—indeed, for many women in general in our society—the prospect of an unexpected pregnancy is accompanied by financial panic, a lack of child-care options or perhaps pressure from partners to abandon the relationship. The reality is an unexpected pregnancy has financial consequences long before the emotional and medical issues are considered.

The most recent Bureau of Statistics child-care survey shows only one in five children from low-income families in Sydney can access long day care or preschool, and in a society where the extended family is more and more becoming a truncated and disjointed one almost 80 per cent of these families do not have grandparent care. The child-care situation is even more critical in rural areas, including my electorate. Barnardos Australia says there are simply not enough child-care places and that they are too expensive anyway, even with the maximum child-care benefit. The AMA, in its submission to the Senate inquiry, at least in part recognising this crisis suggested child-care costs should be claimed as an expense and paid pre tax. The AMA seems to ignore those many pregnant women who may be below the tax-free threshold. They do not need tax breaks; they just need a break. These are the vulnerable for whom every emotional, financial and medical support must be available in the event of a termination, if indeed it is recommended.

I have carefully studied the Senate Community Affairs Legislation Committee report on the bill. At page 14 it states:

The medical groups emphasised the need for legal terminations to be performed safely and to the highest possible standard to ensure that women who choose this option do not suffer unnecessary harm.

Can those medical groups guarantee that medical abortions offer as many safeguards as clinical termination, especially for women in rural and remote areas? The TGA risk management approach states:

… the healthcare provider (the medical practitioner) evaluates risks for the individual patient …

That may be so, but I ask: how can the risks be assessed on a woman suffering heavy bleeding, monitoring her condition perhaps alone or with inexpert company in the 12 days or so between the taking of the second of the two drugs and the return visit? A phone call to the doctor is an option, but will the GP always be available in a country area? Do we rely on mobile phones? The TGA risk management approach also says it encourages practitioners to report adverse events and that it communicates through peak bodies and forums. I do not think these procedures are sufficient in the case of what could be a largely self-managed medical procedure of such monumental emotional and physical impact.

In New Zealand there is the Abortion Supervisory Committee which oversees the operation of protocols for early medical abortion procedures. That would seem to be the very least we need here. Contrary to statements in the Senate report, I do not have confidence that under the TGA’s current drug oversight women will have the level of medical supervision currently required in a surgical termination. In evidence to the Senate inquiry, Dr Renate Klein, who does not oppose abortion but does oppose this medical option, proposed the establishment of a committee of informed community members, including social scientists, doctors, pharmacists and, importantly, ethicists, to conduct its own investigation into the availability of RU486 and its accompanying drug regime. This would run in parallel to any TGA study.

In the Senate committee report, the Royal Women’s Hospital noted that ‘gynaecologists are suitably trained to supervise medical abortion’. The RWH also says:

Protocols would be established regarding all of the steps required for medical abortion.

‘Would be established’ is a key phrase. Until they are in place, the TGA cannot effectively supervise and regulate the use of those drugs covered in this bill. The parliament’s job is perhaps to put in place those regulations to give the TGA the power to do its job properly. However, while parliament should be responsible for making laws and regulations to ensure the safe administration of drugs, it is not the parliament’s role through cabinet or disallowance instruments to sit in judgment on the efficacy or risks of a drug, even one that is strictly not therapeutic in intent.

That perhaps approximates the Treasurer’s position—I hope I do not misrepresent him; I listened very carefully to his excellent contribution—but I cannot support the TGA option until I am convinced of its preparedness and ability to supervise this type of drug. The Rural Doctors Association of Australia told the inquiry that rural doctors are ‘keenly aware of their duty’. Of course they are; that is not in dispute. The Rural Doctors Association went on to say:

They know the range of treatment they and their nearest hospital can provide …

The fact is quite a few rural hospitals are not near enough. Some do not have sufficient emergency services to cover unexpected procedures. We have single doctors in single communities covering vast areas, on call at all hours of the night, without the availability when the need is there. That is quite a reality in circumstances like this. A country hospital several hours away is little comfort if something goes wrong.

As the Senate committee report noted, there is a climate of review developing around these drugs. The US Congress has the RU-486 Suspension and Review Act before it. On 30 January the Italian government imposed restrictions requiring every individual request for the use of RU486 to be justified on precise clinical and epidemiological grounds. Trials of the drug have been suspended in Canada despite the country’s liberal abortion laws. Some European countries, according to the Senate committee report, require supervised administration of the drug in a hospital setting and appropriate follow-up. This is closer to the position that I would support, but at this point I cannot see anything in the TGA approach to this that encourages me to think that that will be the outcome.

Indeed, consultant psychiatrists Stephen and Dianne Grocott told the Senate inquiry:

There is a need for independent research into the true psychological consequences of RU486, especially the consequences for women who decline to attend for follow-up.

This, however, is not an argument for continued ministerial control and approval; it is an argument for a proper framework within which our drug advisory and administration process can properly work and guarantee absolutely safe treatment.

The question facing all of us was perhaps summed up by Drs Elvis Seman and David van Gend when they told the inquiry:

The debate on RU486 provides an opportunity for the profession to reaffirm the ethical distinction between medically essential termination of pregnancy and abortion for non-medical reasons.

I ask those who would argue for the sanctity of life in all circumstances to be as passionate on the issue of capital punishment—a dilemma we are faced with at this very moment. It should also be recognised that, among the data available on this issue, medical termination has reduced the death toll from crude, non-clinical abortion in some Third World countries.

I thank all of those people and organisations, particularly my own individual constituents, who have made such strong submissions to me on this issue. I congratulate members for the deep thought they have put into this debate. I reach an impasse: I cannot agree to hand over control of this process at this stage to what I see as inadequate TGA protocols, yet I certainly believe the assessment of all drugs should be in the hands of independent medical and ethics professionals. I certainly do not believe such assessment should be subject to the prevailing position of various governments, cabinets and individual MPs at various times. I reject the amendments, for they also risk political and ill-informed judgments and prejudices based on the whims and vagaries of the parliament of the time on what should be strictly medical and ethical decisions. I hope my position on this bill helps highlight the need to closely examine and review the TGA risk management approach, particularly for the drug regime we are debating here. All my votes are in essence a conscience vote. On this occasion I choose, in good conscience, not to cast one.

See this speech in context