Concetta Fierravanti-Wells (NSW, Liberal Party) Share this | Hansard source

With the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 I am facing the first conscience vote of my parliamentary career. I will be opposing the bill. This is an issue which has generated much controversy and debate. Indeed, I have received as much correspondence regarding RU486 as with the changes to industrial relations, Welfare to Work and voluntary student unionism. They are letters written with passion—mostly handwritten—by ordinary Australians whose concerns have prompted them to put pen to paper about something they feel very strongly about. This is a drug designed to kill, and Australians are entitled to have a strong view about this. It is a drug which raises medical, social and ethical issues. They are all complex in their nature and they require careful scrutiny and accountability.

In June 1996, the Therapeutic Goods Act 1989 was amended so that medicines intended for use as abortifacients—which covers RU486—became restricted goods. They need to have the approval of the minister for health before they can be imported, evaluated by the Therapeutic Goods Administration or registered on the Australian Register of Therapeutic Goods. Written ministerial approvals, including any conditions, must be tabled before parliament within five days of the approval being given. There is no provision for disapproval.

It is important to look at the definition of ‘therapeutic’ in the act. It says:

therapeutic use means use in or in connection with:

(a)

preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)

influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)

testing the susceptibility of persons or animals to a disease or ailment; or

(d)

influencing, controlling or preventing conception in persons; or

(e)

testing for pregnancy in persons; or

(f)

the replacement or modification of parts of the anatomy in persons or animals.

In short, this debate is about whether RU486 should remain in its TGA restricted goods category or whether it should be treated like any other drug and assessed by the TGA. RU486 is not a therapeutic drug. It does not fall within the definition I have just quoted. RU486 is like no other drug. It is a drug that is designed to kill.

I believe the current restrictions should remain so that approval of RU486 is something that the elected government of the day, through its health minister, takes responsibility for and not the TGA. Indeed, the concept of ministerial discretion is a longstanding feature of the Westminster system. It means that sometimes governments need to make decisions about difficult and controversial issues, but most importantly they need to be accountable for those decisions. This is one such decision.

The TGA is obliged to look at a drug only on its safety, efficacy and quality. Ethical and social criteria are not considered, nor are the potential psychological aspects of this drug. Whilst recognising that the TGA is an experienced body, whatever one’s view the TGA is not designed to deal with the morality of any drug. It is not an elected body. It is not accountable to the electorate.

The current requirement for ministerial scrutiny can be understood only in light of events which were precipitated by the decision of an unidentified official within the TGA to authorise the importation of RU486 in 1994 for clinical trials in Australia. That action set in train a series of events culminating in the halting of a Victorian trial of the drug and four separate departmental investigations into the trials ordered by the then Minister for Health and Human Services, the Hon. Dr Carmen Lawrence MP. As an abortifacient, RU486 was a prohibited import unless exempted by the Department of Human Services and Health pursuant to the Customs (Prohibited Imports) Regulations. It was understood that no such exemption would be given unless the minister was consulted. Neither the Minister for Human Services and Health nor the Minister for Family Services, who had responsibility for the Therapeutic Goods Authority, were consulted prior to the exemption by the departmental delegate.

Clinical trials of the drug were carried out in Australia by the Sydney Centre for Reproductive Health and by Monash University Department of Obstetrics and Gynaecology at the Family Planning Association of Victoria. The Australian trials were part of worldwide trials by the Special Program of Research Development and Research Training in Human Reproduction. Senator Graham Richardson, the health minister at the time the exemption was granted, acknowledged that official parliamentary undertakings had been breached and said the government would see whether it could rectify the situation. He later retired and, until trial procedure breaches were exposed, the government and relevant departments remained uninvolved.

Despite claims that the TGA had rigorously scrutinised and strictly evaluated the drug prior to authorising approval during Senate estimates hearings on 25 May 1994, Dr Malcolm Wright, head of the drug evaluation branch of the TGA, demonstrated that this was not correct by stating that the TGA had not carried out an assessment of the quality, safety and efficiency of this product. There had been no independent assessment of legality and questions were raised about whether the trials were actually within the law. Trials were suspended on 16 August 1994. This was the background against which the amendment to the TGA Act was introduced and passed, requiring ministerial scrutiny over any application for the importation of RU486 or any other prostaglandin antagonist.

The then ALP senator Belinda Neal said:

... we acknowledge that this issue raises large concerns within the community. It raises issues beyond purely health issues. These issues need to be addressed by the executive of this government and addressed with absolute and direct accountability ...

The then Greens senator Christabel Chamarette said:

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

Furthermore, the TGA approval process is most often based on research developed by drug companies. Prominent bioethicists, such as Dr Renate Klein, agree that research to date has been less than adequate in its controls and its reach.

Those promoting RU486 advocate the drug as a safe and easy form of abortion which can be administered with a minimum of fuss. That is not the case. At the recent launch of Australians Against RU486, Dr Catherine Lennon, a Sydney GP, raised some important statistics: in the United States RU486 does not work to abort pregnancy for up to 10 per cent of women who use it; the use of RU486 to abort pregnancy increases your chances of dying to one in 100,000 compared to surgical abortion, where the chances of dying are one in one million; in the US, where RU486 is available, up to 10 per cent of women who use it experience severe bleeding and complications that require further medical attention; users of RU486 are required to make three separate trips to the doctor, take two different medications—mifepristone-RU486 and then, 48 hours later, a second drug, misoprostol-Cytotec—and wait 14 days before the result of the treatment is known.

Dr Lennon cited a recent study which showed that 60 per cent of Australian women are opposed to the introduction of RU486 when provided with details, including complications of the RU486 abortion pill, the time frame compared with surgical abortion and the increased risk of death as compared with medical abortion. The polling, conducted in December 2005 by Quantum Market Research, surveyed over 500 Australian women between the ages of 18 and 45 from all states and territories.

Dr Lennon quoted Edouard Sakiz, who was Chief Executive Officer of Roussel Uclaf, the French company which developed and manufactures the RU486 drug in France. In 1989 he stated that ‘RU486 is not at all easy to use. In fact it is much more complex to use than the technique of vacuum extraction. True: no anaesthetic is required, but a woman who wants to end her pregnancy has to live with her abortion for at least a week using this technique. It’s an appalling psychological ordeal.’ It is also interesting to note the recent publications where Pfizer, the maker of misoprostol, warns that it cannot recommend its use in the termination of pregnancies because of potential risks. These timely warnings that the second component of the RU486 regime should not be used for abortions can only lend greater strength to the argument for ministerial oversight. In short, many of the researchers and physicians readily admit that RU486 is not safe enough to administer without close medical supervision.

The RU486 debate should not be a pro-life or pro-choice issue; it should be about responsibility and accountability. This is a drug like no other drug and therefore ought not to be treated like other drugs. I think the Prime Minister put it best today when he said that it does not make much sense to devote an enormous amount of time, energy and commitment of one’s life to win election to parliament and to the high office of decision making, and then to spend the next stage of life busily handing over decisions to people who are not accountable. I note that the amendments that have been circulated by Senators Barnett and Humphries seek to strengthen provisions regarding advice to be sought by the minister, consideration of that advice, tabling before the parliament and disallowance of the decision. While I oppose the bill, I am happy to give consideration to these amendments. In short, as the Prime Minister said today: ‘Important decisions affecting the community should be made by people who are accountable to the community.’