John Murphy (Lowe, Australian Labor Party, Parliamentary Secretary to the Leader of the Opposition) Share this | Hansard source

I rise in opposition to this private member’s bill, the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005. Much has been said already in the Senate last week and in this House, but still more needs to be put to every member of this House in order to demonstrate that the bill is fundamentally opposed to reason, fundamentally opposed to good governance and fundamentally opposed to scientific and moral fact.

This bill is bad law. The consequences of this bill are equally bad law. Why is this bill bad law? I rely on the following points. One, the existing legislative scheme introduced as a late amendment to the original 1996 bill, the Therapeutic Goods Amendment Bill (No. 2) 1996, received bipartisan support in 1996. Two, both government and opposition members supported these amendments, which included critically section 23AA—Ministerial approval of evaluation, registration or listing of restricted goods. Three, RU486 is not merely a therapeutic drug because of its purpose to produce a chemical abortion, and it falls within a special category of drug called ‘restricted goods’. Four, because of this special recognition, the Therapeutic Goods Administration is not in my view the proper agency to administer this type of drug without political scrutiny. The nature of restricted goods means that the decision is not merely a clinical or medical one. Equally, the decision carries higher policy impacts involving social costs above and beyond the notions of freedom of the individual to choose. Hence, the public interest is paramount, specifically with respect to the release of restricted goods to the general public. I believe that it is not the responsibility of faceless bureaucrats to make decisions while operating under the influence of the pharmaceutical corporations.

Five, the TGA is a body dominated and influenced in reaching its decisions both intellectually and, most importantly, financially by medical scientists and the sponsors of these drugs, the pharmaceutical corporations that manufacture them—in this case, the manufacturer of RU486, Danco Laboratories. Six, the Therapeutic Goods Administration is by definition incompetent to administer decision making on dangerous drugs such as RU486. It is by definition non-therapeutic and positively harmful, particularly to women. Seven, the TGA was not envisaged to directly administer restricted goods without public scrutiny. The removal of the minister’s powers without an alternative for public accountability defies the Australian National Audit Office’s fivefold recommendations for greater public scrutiny of the TGA following the Pan Pharmaceuticals debacle. In that case, the TGA demonstrated its failure as an administrator. TGA stands for Therapeutic Goods Administration. What is a therapeutic good? The Parliamentary Library Bills Digest Number 40 of 2005-06 states:

A ‘therapeutic good’ can be broadly defined as ‘a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use’.

This definition in itself does not preclude drugs such as RU486.

What is the statutory definition of a restricted good? The 1996 amendment to the Therapeutic Goods Act inserted the definition of restricted good in clause 1A, which states:

‘Restricted goods’ are defined to be drugs within Regulation 2 of the Therapeutic Goods Regulations (including progesterone antagonists and vaccines against human chorionic gonadotrophin) intended for use in women as abortifacients.

RU486 falls within the definition of restricted good found in subsection 3(1) of the act. Why did this bill receive broad bipartisan support in 1996? It is instructive to read the speech of former Senator Brian Harradine in the debate on the Senate committee report. In part, during the debate on 8 May 1996, he said:

The purpose of these amendments is perfectly clear: to ensure that these particular drugs, which are significantly different in nature to other drugs which are termed therapeutic goods, should not be left entirely in the hands of science technologists and the sponsors of the particular drugs.

As I said earlier, at that time both government and opposition members and senators supported this proposition and voted accordingly. What has changed since then? Nothing. Absolutely nothing. The reasoning in 1996 is as valid now as it was then.

Yet, incredibly, this bill intends to repeal the definition of restricted goods entirely. Equally, the ministerial power presently found in section 23AA is intended to be repealed, along with sections 6AA, 6AB and subsection 57(9). The effect of these amendments is to wipe political accountability entirely from the administration of restricted goods, which include RU486. Instead, all drugs and other items are now to be within the exclusive domain of the TGA. In other words, the purpose of this bill is to entirely remove the distinction between what was hitherto the well-founded distinction between a therapeutic good and a restricted good, and administer the registration of both groups of drugs and other items as one and the same thing. In my view, this bill is flawed on every front: ethically, legally, medically and administratively.

Let us look again, in a little more detail, at the TGA’s performance—or, to be more precise, the lack of performance—as a competent administrator of drugs in Australia. Over the last 10 years alone, the TGA has been the subject of several audits by the Australian National Audit Office. There was the ANAO audit of 1996-97 over the conduct of the TGA’s activities. Fourteen recommendations were made by the ANAO concerning the fundamental operation of the TGA, including the efficiency, effectiveness and accountability of the TGA, including shortcomings in several key areas, including timeliness of decision making, effectiveness of drug evaluation, consultation with consumer organisations and public reporting of adverse drug reactions, specifically, recommendation 12 at paragraph 3.27, which deals with its public reporting ‘to better meet the information needs of Parliament and consumers in the interests of enhanced accountability’.

The ANAO conducted a further report in 2000-01, as a follow-up audit, to review the extent to which the TGA had implemented the recommendations from the 1996 report. Significantly, recommendation 3 at paragraph 3.17 states:

ANAO recommends that, to permit Parliament, industry and other stakeholders to understand variations in TGA’s evaluation performance:

• TGA publish performance indicators of the efficiency of its drug evaluation performance.

These recommendations were supposed to be implemented by 2001. Indeed, we hear the mantra from agencies such as the TGA as noted in the ANAO’s 2000-01 report—that by 2000 the TGA had implemented, or partly implemented, 12 of the 14 recommendations through alternative means. This type of response is used often by government agencies and is synonymous with a ‘substantially implemented’ response. We hear this mantra often in other agencies as well; it is nothing more than a smokescreen. Over the last two years we have seen how ‘substantially implemented’ the changes within the TGA were—how efficient and expert the TGA was—with the eruption of the Pan Pharmaceuticals debacle. We are indebted to Pan Pharmaceuticals. The case demonstrated that all the pencil pushing by the TGA—all the box ticking—means absolutely nothing.

In 2005 the TGA was subject to a third audit by the ANAO, this time over the TGA’s failure to administer its statutory responsibilities for non-prescription medicines. In the 2005 audit, a further 26 recommendations on the conduct and culture of the TGA were made by the ANAO. The ANAO painted the picture that there is a serious cultural issue within the TGA with its ‘rubber stamping’ mentality and its proximity to the vested and sectional interest industry stakeholders it is supposed to be regulating.

The final insult to our parliament and the people of Australia came when the ANAO, clearly frustrated by the apparent lack of progress in changing the culture latent within the TGA, established an audit subcommittee in early to mid 2005 and engaged consultants, Deloitte Touche Tohmatsu, to assist in the ANAO’s work of overseeing and reporting to the secretary on the implementation of regulations designed to address these further recommendations. The consultant, Deloitte, was specifically required to ‘review broader aspects of the TGA’s administration, management and governance structure and make recommendations where appropriate’. In June 2005, Deloitte delivered its findings, stating that ‘the TGA requires holistic, behavioural change, including changes to the agency’s structure and transparency, better governance and accountability, and improved IT systems’. Incredibly, this report was only made available in December last year, some two months ago. In light of this report from Deloitte and the massive underperformance of the TGA, who are we to be giving more power to the TGA, at least until the manifest structural, transparency, governance and accountability issues are resolved?

Compounding this fundamental accountability and structural problem is the issue of bias and influence pervading the culture of the TGA. Who funds the TGA? The Commonwealth Department of Health and Ageing’s annual report of 2004-05 states at page 331: ‘In 2004-05, the TGA received $76.083 Million in funding (revenue) from all sources. Of this, $67.338 Million was from industry fees and charges, $6.177 Million was from the Australian Government, and $2.568 Million was from the sale of goods and services.’ In other words, over 88.5 per cent of the TGA’s revenue is derived from pharmaceutical and other industry fees. Where do they think the greatest influence over the TGA lies? Plainly the greatest influence over the TGA lies in the hands of the pharmaceutical industry. Until the endemic cultural problems within the TGA are sorted out, we as a parliament cannot be so irresponsible as to give the TGA sole responsibility for determination powers over the release of restricted goods such as RU486.

I next touch upon the medical issues of RU486. RU486 is an abortion drug. The intended use is to actually kill the unborn child. This drug is more lethal, more dangerous and more harmful to women taking it than surgical abortion. I ask you to look at the facts—the scientific facts—about RU486. (1) The American Food and Drug Administration website states that RU486 is actually a two-drug prescription. The first drug is mifepristone, of which 200 milligrams are taken orally. Next comes 400 micrograms of the drug misoprostol. (2) RU486 causes the death of the baby by blocking the pregnancy-maintaining actions of progesterone, a hormone of the woman’s body. This is why RU486 is presently classified as a restricted good. (3)The function of misoprostol is to cause strong uterine contractions, thereby emptying the uterus of the dead baby.

This event of forced contractions must be a most traumatic experience for a woman. I understand that this view is shared by key pro-abortion feminists, such as Professor Renata Klein, an associate professor in women’s studies at Deakin University, in RU-486; Misconceptions, Myths and Morals by Klein, Raymond and Dumble published by Spinifex Press, Melbourne.

Edouard Sakiz, then president of French pharmaceutical company Roussel-Uclaf, the original developers of the drug RU486, also states in his interview in Le Monde in August 1990, reprinted in the United Kingdom in the Guardian Weekly on 19 August 1990, that the RU486 procedure is:

... an appalling psychological ordeal because the woman ... has  to ‘live’ with her abortion for at least a week using this technique.

That is, she has to have a dead body inside her body before the corpse is extracted.

I now move to the critical issue of harm to women. First, the drug is not foolproof. RU486 has a significant failure rate. Professor Caroline de Costa notes in the article ‘Medical abortion for Australian women: its time’ in the Medical Journal of Australia, 2005, page 183, that misoprostol fails to cause an abortion in two to seven per cent of women. The Canadian Medical Journal in 2005 reported that the RU486 procedure fails in five to eight per cent of cases in women, thus requiring surgical abortion due to ‘incomplete procedure, excessive bleeding or continuing abortion’. Further, the report of Ravn, Rasmussen, Knudsen and Kristiansen in Acta Obstet Gynecol Scand, 2005, at 84(11) cites an eight per cent failure rate.

I now turn to the issue of safety to women, including the risk of death. There are many references to supposedly authoritative texts saying that chemical abortion, including RU486, is as safe as or safer than surgical abortions. In response to these assertions, I bring to the House’s attention the statement of Dr PD Carney, who is on the board of associate editors of the journal Contraception, who states:

... the death rate from medical abortion  [ru486] among Planned Parenthood patients [is] ... roughly 1.5 per 100,000, compared to a U.S. rate of 0.5 for early surgical abortion.

This means that the maternal death rate for chemical abortion is three times higher than the maternal death rate recorded for early surgical abortions.

I wish to remind the Minister for Health and Ageing of my determination to obtain the truth from him and his predecessors on the exact number of medical procedures procured under Medicare for the purpose of procuring an abortion. I asked question on notice No. 1441 on the issue of pregnancy termination statistics on 13 April 2000 to the then Minister for Health and Ageing, the Honourable. Dr Wooldridge. I was stonewalled. On 7 December 2000 I again asked follow-up questions to Dr Wooldridge for further clarification on the question of the number of Medicare funded pregnancy terminations. Again I was stonewalled. Finally, on 16 November 2004, I asked the present Minister for Health and Ageing and member for Warringah, the Hon. Tony Abbott, whether it was still not possible to estimate the number of late-term pregnancy abortions and what legal impediments prevented him from varying the Medicare codes such that it would be possible to determine the number of Medicare funded procedures that procure an abortion. Yes, again I was stonewalled.

It is clear that successive coalition ministers for health and ageing have not got the political will to establish the truth about the number of abortions carried out in Australia compared with other medical procedures that are not abortions but have the same HIC item number. I question tonight the bona fides of the minister for health. On this issue we come from same constituency. Why did the minister raise 100,000 abortions in Australia, conveniently, a few weeks after the last election? Why did the minister support the Bill Clinton position on abortion last week? Why does the minister duck my questions to him about the number of abortions in Australia every year? Why doesn’t the minister confirm that there are a lot less than 100,000 abortions carried out in Australia each year? Why of all people on this issue does the minister not want to establish the truth? Why does the member for Hughes claim that there are 100,000 abortions carried out in Australia every year? Why did the member for Page just say in his contribution that there are 100,000 abortions carried out in Australia every year? Why do they persist with this false claim?

All members that I have spoken to about this issue want to know the truth. The minister knows that he has the power to establish the correct figures on abortion in Australia. All members of this House that I have spoken to, irrespective of their position in relation to how they are going to vote, would like to reduce the number of abortions carried out in Australia.

I conclude, based on the verifiable and reputable data from medical research on failure rates, we can expect that between 5,000 and 8,000 attempted pregnancy terminations from RU486 per year will fail, thus requiring supplementary surgical abortions, with internal bleeding and psychological trauma. We cannot as a parliament entrust this decision to the TGA. We must take responsibility for the drug and maintain the decision made some 10 years ago in this parliament that RU486 is a dangerous drug that must not be permitted into the market.

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