Kim Wilkie (Swan, Australian Labor Party) Share this | Hansard source

I would like to start my contribution to the debate on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 with a quote:

I have nothing against politicians, nothing against politics. But politicians and politics need to be in their right place and I think they are breaking the bounds somewhat and intruding into something that should be kept above politics.

Many members will be surprised to learn that this quote is from the Minister for Health and Ageing. But in the interests of accuracy it should be noted that this comment was made by him in the context of the debate on the republic in 1999, when he was arguing that politicians could not be trusted to choose a head of state. In my view, if the minister were consistent he would also be of that same view in the case of the current debate in this House on the processes to be used in the assessment of RU486. The debate on this bill is not about whether abortion should be allowed in Australia. That matter was settled a long time ago by the state and territory governments, who have jurisdiction regarding this procedure. Unfortunately there has been significant confusion and, I believe, deliberate obfuscation by some on this particular point.

Like all other members, I have received a huge number of emails, letters and phone calls regarding this bill. I thank all of those who have written to me from my own electorate and from other parts of Australia for letting me know their views. I have endeavoured to answer all correspondence on this matter. It is clear from some of the correspondence that there has been misinformation supplied by those who wish to turn the debate on this bill into a debate on abortion. Let us be 100 per cent clear about the intent of this bill. The bill before the House is about whether the Therapeutic Goods Administration, the TGA, should evaluate RU486 without the current requirement for approval to do so from the minister for health.

At present, as other members have noted, RU486 is listed in the restricted goods category, which means that, unlike all other drugs, it cannot be evaluated, registered, listed or imported without the written approval of the minister for health. In the case of all drugs other than those deemed restricted goods, the TGA is regarded by the government as the appropriate authority to determine whether or not a drug is safe for use in Australia. Specifically, the TGA identifies, assesses and evaluates the risks posed by drugs and, on the basis of its investigations, decides whether a drug should be approved for use. If a drug is approved, the TGA then monitors and reviews the risks over time. The approach required of the TGA means that decisions about whether drugs are allowed to be used in Australia are entirely based on scientific, clinical and medical evidence.

As I said before, under the Therapeutic Goods Act 1989, RU4686 is defined as a ‘restricted good’. Restricted goods cannot even be evaluated by the TGA without the written approval of the Minister for Health and Ageing. Since RU486 was classified as a restricted good in 1996, there has been an accumulation of information and evidence about the risks and benefits of RU486 when used as an abortifacient and also in its use for treating certain types of cancers and other conditions. While the current legislation allows the TGA, under its Special Access Scheme, to grant approval for RU486 to be imported, in practice this scheme is unworkable.

Let me inform the House about the plight of Canberra resident Ms Mary Lander, who has given me permission to outline her particular circumstances. Ms Lander discovered about 12 months ago that she had a brain tumour called a meningioma, which accounts for 15 per cent of all primary brain tumours and 12 per cent of all spinal cord tumours. Unfortunately, there would be dangers in operating to remove Ms Lander’s tumour, as it is on the brain stem and any such operation could result in significant damage. Accordingly, doctors are reluctant to operate.

On the basis of her own research, Ms Lander found out that RU486 could be used to stop the growth of a tumour. This is because, being a progesterone antagonist, RU486 binds with the progesterone receptors in the tumour and can therefore halt the growth of tumours and, in some cases, has been known to result in the regression of tumours. Ms Lander therefore applied to the TGA to import the drug seven months after first being diagnosed. Within weeks the TGA, under the Special Access Scheme, had issued a permit to her GP. Meanwhile, Ms Lander had found a supplier in France and planned to pay $2,500 for 200 tablets, which would have provided her with a six-month supply of this drug.

Before the drugs could be sent to Ms Lander, she needed her GP to sign off. But the doctor’s insurer advised the GP against supervising her treatment with RU486, because the drug had not been subject to the normal TGA evaluation processes. This is because, although the import permit had been granted, RU486 is still deemed ‘restricted’ and, therefore, without ministerial approval, the TGA could not evaluate it. Without such evaluation, the TGA could not provide the normal assurances about drug use on which doctors depend for their indemnity requirements. Unfortunately for Ms Lander, this means that she still cannot use the drug, because doctors—on the basis of insurance issues—have so far refused to prescribe it. Ms Lander’s situation is a tragedy. It is a direct result of RU486 being in the restricted goods category.

Indeed, in a report in yesterday’s Canberra Times, Ms Lander posed the following questions—and I ask all members to consider these questions when they come to vote on this bill:

How many people have suffered unnecessarily in the past nine years? How many have been left with defects and disabilities? How many have died because they simply do not know about the drug’s uses and/or how to obtain it? Why is it necessary for people to have to overcome such enormous hurdles and restrictions just to access RU486 for a serious medical condition? Why is it necessary for them to suffer and why is it necessary for them to die, when this medication could ease their suffering or even save their lives?

Ms Lander concluded that ‘clearly it is a consequence of abortion politics’. How can any of us allow the situation to continue whereby Ms Lander and others in similar circumstances are denied the treatment that may well save their lives?

According to documented medical evidence, RU486 benefits are not isolated to the treatment of meningioma. RU486 has been found to have beneficial effects in the treatment of uterine fibroids, endometriosis, cervical ripening, breast cancer, ovarian cancer and prostate cancer. The reason it has proven effective in the treatment of these conditions is that some of these cancers are hormone dependent and RU486 is known as a progesterone antagonist. Due to its antiglucocorticoid activity, RU486 may also be effective when used to treat depression, HIV-AIDS and dementia. Indeed, in terms of its effects on HIV-AIDS, RU486 has been demonstrated to blunt the infectivity of HIV. But, unless this bill is passed by this House, those alternative users are also being denied because of the fact that RU486 is deemed a restricted good and the TGA has not been able to assess it. It is worth noting that, in the respective speeches to the House in this debate, neither the Minister for Health and Ageing nor his parliamentary secretary referred once to the other documented benefits of RU486. In their positions, they should know better.

In my opinion, all drugs proposed for use in Australia should be assessed by the independent scientific, clinical and medical experts at the TGA and not be subject to the approval of one individual, the Minister for Health and Ageing. This would ensure that, if RU486 were to be approved for use in Australia by the TGA, it would have been thoroughly evaluated in terms of its potential risks and benefits and it would also be subject to ongoing rigorous monitoring and review. That is why I support this bill.

In terms of accountability, there has been a lot of baseless rhetoric about where accountability should lie concerning the approval process for this drug. Some, including the minister, have argued that we need to continue to have the Minister for Health and Ageing responsible for the process of initiating and approving the evaluation of RU486 because he is accountable to this parliament. As an aside, I am not sure that argument washes when you see the way the government ministers continue to refuse to be accountable to this parliament on a wide range of issues, most notably at present in the case of the AWB scandal. But, in any case, the TGA and the Australian Drug Evaluation Committee are accountable to the parliament through the minister. In fact, the members of the Australian Drug Evaluation Committee are appointed by the minister. Just as the Reserve Bank of Australia is accountable to the Treasurer through this parliament, the TGA and the Australian Drug Evaluation Committee are also responsible to the parliament—and there is nothing unusual or untoward about this. But the claims about the TGA not being accountable are fallacious.

Let me also comment on the two amendments that have been proposed. One has been moved by the member for Lindsay. Under this amendment, the Minister for Health and Ageing would still retain the power to approve or not approve the use or importation of RU486; but, once the minister had made the determination, the determination could become a disallowable instrument. This is flawed. A manufacturer or importer would still need to seek ministerial approval and then would be subject to the vagaries of this parliament for approval. Why would a manufacturer or importer run the risks associated with such a process, given the enormous costs associated with evaluation, which could run from hundreds of thousands to millions of dollars? In my view, the member for Lindsay’s amendment would continue the effective ban on the use of RU486.

An amendment has also been proposed by the member for Bowman, which would eliminate the role of the Minister for Health and Ageing in the approval process for RU486 but, like the amendment moved by the member for Lindsay, would make any determination to register or list RU486 for use a disallowable instrument, meaning that this parliament would decide whether the drug could be used. This amendment, too, would not guarantee that decisions about the use of RU486 in Australia were made only on the scientific and medical evidence available. Again, this amendment would continue the effective ban on the use of RU4686 in this country by requiring parliament to vote on it.

And that is the crux of this matter. Why should any politicians have any role in determining whether a drug should be evaluated and, if approved, used in Australia? I do not believe that is the role of any of us in this parliament. That is why I will support the bill as proposed by the member for Moore and seconded by the member for Lalor. May I say before closing that I would like to applaud the efforts of Senators Allison, Moore, Troeth and Nash and the members for Moore, Lalor and Murray in this debate. They have worked tirelessly to promote the bill to senators and members from the best of motives. We in this place should not be able to decide whether or not drugs should be approved for use in Australia. That is the rightful and appropriate role of the TGA.

I have heard many of the contributions to this debate from other members. Most of those contributions so far have been thoughtful, sensible and based on fact. It just goes to show how truly democratic this place is when we can get away from the whips. We do not often have conscience votes on matters in this House, and I know that this bill has presented difficulties for many in examining the issues in relation to RU486. However, on the basis of the facts presented in this debate, my vote will be to support this bill.

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