De-Anne Kelly (Dawson, National Party, Parliamentary Secretary Trade) Share this | Hansard source

I rise to support the  second reading amendment to the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 moved by the member for Lindsay. This amendment goes to the heart of the question before us, which is effectively about government and ministerial responsibility and accountability versus the Therapeutic Goods Administration, a group of perhaps expert and very well meaning public servants. The Therapeutic Goods Administration is required to look at safety, quality and efficacy. I note that others have said it is a world-class organisation and it may well be, but it is not infallible. We need to recall that it was the TGA that approved Vioxx for Australia, which was withdrawn in 2004 with some estimated 55,000 deaths worldwide. So no organisation no matter how well meaning or expert is ever infallible.

I want to go to the heart and the crux of the differing arguments here. A proponent of the drug, Dr Caroline de Costa, who has put forward RU486 for approval, made the following statement:

The case for medical abortion in Australia should be judged not on political grounds but solely on evidence-based medical criteria.

That is all very well, except that in response there was a great concern that the drug could not be safely used in rural areas given the risks of incomplete termination, prolonged bleeding and infection. In response to these concerns, the Australian Medical Association said that they strongly supported the availability of medical abortion, describing the report raising these concerns about incomplete terminations and so on as ‘narrow and incomplete’ and criticising the report for focusing on the risks to a minority of rural women who do not have adequate medical backup. This gets us to the crux of the argument. It may be all very well to look at safety, quality and efficacy for a great majority of women in Australia—and I think there is an argument for that but I will come to that shortly—but only ministerial overview and an accountable government will look at the situation for every woman, not say that there is a minority of rural women who do not have adequate medical backup and that therefore they constitute a narrow argument that can be overlooked.

Mr Deputy Speaker Somlyay, coming from a rural area  you would appreciate that it is a very real concern that all women should have medical procedures that involve adequate medical backup. But we are not here to discuss the arguments for and against this particular drug; we are here to argue about the process of approval. But the rural argument simply points out that even amongst expert bodies such as the AMA there can be, if I could put it this way, a pushing aside of those who might comprise an uncomfortable minority.

As I have said, this is not a debate about the merits of this drug—it is about the approval process—but I do want to highlight some of the disingenuous arguments being used to support RU486. I want to refer to the manufacturer Pfizer. This is a dual drug process: women take RU486 in order to achieve an abortion and then take Cytotec or misoprostal. The manufacturer of Cytotec, Pfizer, has warned against the use of the drug on pregnant women, not just because of the danger of miscarriage but also because of other effects. In fact, Pfizer’s only clinical tests have been undertaken on its use for stomach ulcers. As I said, we are not here to debate the pros and cons of RU486, but I think it is very significant that, at the same time we are being told that this is a safe drug, in fact the manufacturer is not prepared to guarantee one of the drugs in use.

The other matter that concerns me greatly is that officials from the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases in the United States are presently convening a workshop on what they see as a new threat to public health. This workshop will address the virulence of infection in otherwise healthy young women following an abortion using RU486. As I said, we are not here to debate the merits of this drug, but very significant are the disingenuous arguments being put forward to say that the issue of RU486 is very simple—it is a medical procedure; it is safe—when there are others who are very well credentialed who do not see it that way.

I would like to get back to the issue of the amendment moved by the member for Lindsay. What she has included in her amendment is expert oversight—not infallible, as we have seen, but certainly expert—ministerial responsibility and government accountability on the part of the minister for health of whatever political colour and in whatever government, and then, finally, parliamentary debate on the merits or otherwise of the drug in question. More than that, though, the member for Lindsay has required that all decisions be published—that everything be open, transparent and accountable to the Australian people.

It is not unusual for ministers to make decisions. In fact, that is why governments exist: to be accountable and to require ministers to make decisions. We do not, for instance—and I said this yesterday—allow a group of public servants, no matter how well meaning and expert, to make the decision to go to war. We do not allow the ANAO, the DSD, ASIO, ASPI, the service chiefs, our coalition allies or anybody else to make the decision, although all of their expert input and advice is used by the government and the Minister for Defence of the day, along with cabinet, to make the decision to go to war—and it is properly debated in this House. Why, then, wouldn’t we make the decision as a parliament to allow the Australian people access to such a debate through their elected representatives?

I thought it was very interesting to note the concerns of the member for Lalor about the member for Lindsay’s amendment. She said that the manufacturer of whatever drug is in question would not run the risk of parliament. Why wouldn’t they? If they had confidence in their product, had run all the appropriate trials and believed the product was safe, why wouldn’t they run the risk of parliament? Is it that drug manufacturers will not submit themselves to the democratic process? Is that what we are saying? If they will not and they were using that as an argument against ministerial oversight and parliamentary debate, it is a subtle form of blackmail. If drug manufacturers have a product they are confident about, they should be happy to have that product not only overseen by an accountable minister but brought before the parliament and debated, otherwise you would have the ridiculous situation where drug manufacturers were accountable only to a small group of public servants—and I do not think the Australian public would permit that for very long. I am astonished that the Labor Party, who have been crying for the last few weeks for ministerial responsibility—

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