Alby Schultz (Hume, Liberal Party) Share this | Hansard source

I stand here as a human being whose body is not biologically structured to understand problems associated with pregnancy or indeed abortion. I am not going to talk about abortion because this debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not about abortion. I am, however, going to take the opportunity to pick up the point that has been made repeatedly by members on both sides of the House today about ‘qualified persons’. It would appear from comments in this debate that some members of the House have a view that people in the medical profession are the best placed and most responsible people in the community to make drugs such as RU486 available on prescription. Whilst this is generally so, there have been countless occasions on which drugs have been prescribed without follow-up investigation of the long-term negative health effects and, in some cases, death of individual recipients of drugs under prescription. My family has been down that path. My 13-year-old grandson had all of his internal organs destroyed because of the overprescription of drugs that were supposed to help them. Public accountability for these outcomes in most cases is nonexistent and in many cases covered up. So much for the accountability of people who are qualified to make decisions on drugs such as RU486.

In 1994, RU486 was imported into Australia through the backdoor. Abortion drugs, as I understand it, have always been prohibited imports unless exempted by the Department of Health and Ageing. In fact, in 1988 the federal government gave a commitment that it would not allow such an exemption without the Minister for Health and Ageing’s involvement. The point is that the drug RU486 was approved by a nameless, unaccountable bureaucrat without the specific knowledge of or approval by the minister of the day, and a minister of the Crown would have been made publicly accountable for any serious health outcomes or indeed the death of any person from side effects following the use of the drug. Is it any wonder, then, that the drug mifepristone, commonly referred to as RU486, has never been registered for use in Australia?

In 1996 the government passed an amendment to the Therapeutic Goods Act which made the Minister for Health and Ageing responsible for decisions in relation to the importation, trial, registration and listing of RU486 and, indeed, other abortifacients, rather than the Therapeutic Goods Administration, commonly referred to as the TGA, which is the statutory body usually responsible for the approval of medicines in Australia. This was on the grounds that these drugs amounted to a special category of drug requiring an additional layer of public scrutiny. I thought that was a very responsible attitude by the government.

A majority of correspondents and callers to my office and to me personally are opposed to the use of RU486 in Australia or wish the decision regarding its use to remain with the minister. RU486 has been in use in the United Kingdom since 1991 and in the United States since 2000. France was one of the first countries to approve the drug in 1988, and it is also used in New Zealand. In America the deaths of four women from septicaemia within a two-year period after each had used mifepristone have prompted the US government to convene a group of experts to examine the cases. A further woman has also died in Canada, two in the United Kingdom and one in Sweden. My reason for raising this is it is a question of health outcomes from the use of drugs such as RU486. According to the American College of Obstetricians and Gynaecologists, complete abortion will occur in 96 to 97 per cent of cases where both mifepristone and misoprostol are used, and for those for which the drug does not work a surgical abortion is still required. It has been estimated that between five and eight per cent of treated women will require urgent post-abortion care, including in some cases dilation and curettage, fluid resuscitation and/or blood transfusion. The United States FDA’s patient information sheet on mifepristone states that women who use the drug can expect to experience bleeding for an average of nine to 16 days and that bleeding may last for up to 30 days. In French trials one woman bled for 69 days.

The physical elements of a medical abortion are the same as miscarriage: heavy bleeding, including the expulsion of blood clots and tissue, pain and nausea. These physical signs are the same signs associated with septicaemia and have been dangerously overlooked in some cases. In other parts of the world, medical abortion is administered under close supervision due to the risks involved and, according to Australia’s Chief Medical Officer, this would make it unsuitable for use by women in rural and regional areas where limited access to obstetric facilities exists. He also concluded that making mifepristone available as a prescription medicine without appropriate frameworks to ensure its safe use would increase the risks to women undergoing termination.

Decisions about RU486, due to the nature of the drug, cannot be made by the TGA. The TGA cannot ensure that the drug is administered in safe circumstances to women who are fully informed, that proper supervision is provided and that the drug is not going to end up on the black market being sold to desperate young women. I believe decisions about the use of RU486 need to be made by the minister in consultation with his or her cabinet colleagues and, in the final analysis, certainly need to be made by the parliament itself. There needs to be accountability. It would appear from past experiences and history that the only people who appear to be accountable for decisions that they make in this country are members of parliaments and the parliaments themselves and, more specifically, ministers, who have a statutory obligation to be responsible for their roles as ministers of the Crown.

Having said that, I will take this opportunity to talk about the concerns I have as an individual about the health, particularly the mental health, of people who are subjected to the after-effects of a drug that many people in countries across the world are concerned about. In an article published in the current issue of News Weekly of 18 February 2006, Charles Francis AM, RFD, QC has this to say:

When Roussel Uclaf first announced production of the abortifacient RU-486 (Mifeprex) in France, it was hailed by the media as a “Holy Grail”. Despite its many problems, abortion-providers appear still to regard it as a great benefit and argue that politicians have no right to deprive women of it.

He goes on to say:

No reputable pharmaceutical company in America wanted to have anything to do with the production or marketing of Mifeprex. It was left to the Population Council Inc (a powerful pro-abortion group) to obtain the rights from Roussel Uclaf to market the drug through a new shell company, Danco Laboratories Inc.

Danco was incorporated in 1995 —not in the US, but in the Cayman Islands. It does not market any other pharmaceuticals. The shareholders were not interested in setting up a company which would produce a range of medications beneficial to mankind. In some of the proceedings against Danco, the inference is they were simply in it for the “quick buck”.

He further says:

When the original application for approval was made to the US Food and Drug Administration ... it was accompanied by two French tests and one US test only, none of which met FDA’s standards.

The FDA appears to have been reluctant to approve RU-486; but after intense pressure from the Clinton Administration, the drug was approved in September 2000, subject to a number of restrictions.

He goes on to also say:

Despite its high-sounding name, Danco—

the company I referred to—

was unable to manufacture RU-486 itself, nor could it find anyone in the US prepared to do so.

Eventually Danco settled for a Chinese company located near Shanghai, a company cited by the FDA for producing tainted drugs.

This is another reason I have for opposing this drug being out of the control of this parliament. Inevitably, the deaths of young women as a result of problems led to litigation associated with five women in North America. He says:

A prominent Californian products liability law firm is acting for the relatives of Holly Patterson, Chanelle Bryant and Hua Thuy Tran (referred to as “the decedents”).

The complainants’ briefs in these cases make poignant, informative and frightening reading. No intelligent person reading these briefs would want RU-486 available in Australia as an abortifacient.

The essence of the main allegations against Danco and the Population Council is that they marketed the drug with full knowledge of “unacceptable risks of serious injury or death”. By the time the drug was provided to the decedents, it was already associated with such risks.

I want to put those comments on the record and to make a final point in this House in the brief time available to me. The issue that I personally believe is paramount to the introduction of drugs in this country is that the people who are approving and/or administering the drugs have to be made accountable for any outcomes from that drug which cause significant health problems—or indeed create a long-term situation which ultimately results in severe disability or death in some instances—to the person that the drug is being prescribed for.

Whilst I am not going to support the bill in this House, I am going to support the Kelly amendment—as it is commonly referred to—to the bill. The amendment not only allows the Minister for Health and Ageing continue making the decision but allows the parliament itself to either disapprove or not disapprove the minister’s decision. Failing that amendment getting up, the amendment that makes the approval, monitoring and accountability of RU486 a decision of the parliament would be the next alternative that I would support.

I thank you, Mr Deputy Speaker, for the opportunity to make a contribution to this very important debate tonight. Whilst I respect the individual contributions made today by my fellow parliamentarians from both sides of the House, it is a conscience vote. That is the vote that I will be making when the privilege of a conscience vote is extended to me. Whilst I understand that there are many people throughout Australia—and indeed in the electorate of Hume—who may have different views from me and many people who are diametrically, socially and religiously opposed to abortion, this is not an issue of abortion. I believe it is an issue of public health safety and that is the reason I made the contribution that I made in this House here tonight.

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