Helen Coonan (NSW, Liberal Party, Minister for Communications, Information Technology and the Arts) Share this | Hansard source

In this important debate it is tempting to succumb to the all too familiar battleground of pro-choice versus pro-life arguments. This is well-trodden turf, with powerful arguments and passionate and sincerely held views on both sides of the debate. I think we can only respect the respective views. But since Moses received the 10 commandments I am not aware that any of us have had the answers handed to us on tablets of stone. We must consult our own consciences and be true to our own values and beliefs in arriving at a reasoned and principled decision on the matter before us.

The central issue of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 is not whether therapeutic abortion is available in Australia, nor is it whether RU486 is a banned abortifacient. Clearly, therapeutic surgical abortion is widely available in Australia. The lawfulness or unlawfulness of procuring a miscarriage lies within the jurisdiction of individual states and not the Australian government.

Many Australians who have contacted me in relation to this debate have mentioned the often quoted line of former US President Bill Clinton that ‘abortion should be safe, available and rare’ as the benchmark by which we should approach this issue before us. I believe that the majority of Australians acknowledge the quite awful choice that faces any woman uncertain about whether she can cope with her pregnancy, be it for medical reasons or any other, and broadly agrees that it is not up to the government to pre-empt these decisions, which are intensely personal and are informed by individual circumstances. I do not think that women undertake that decision lightly and nor should they. It is a matter where politicians cannot know all of the circumstances surrounding every single decision. That ought to be a matter for the woman, her partner and perhaps her broader family, and undertaken on medical advice.

We have an obligation, if terminations are legally available, to ensure that they are safe. The real issue is that there needs to be good information before someone has to make that decision. That is where we can make a real difference as a government—we can make sure that Medicare will pay for someone to get proper counselling about their options, and other assistance that may be available, so that no-one is stampeded into making a decision because they are young or they are frightened or panicked and simply do not know where to turn or what other options may be available. From my perspective, I have a real passion—and have had for many years—for trying to make sure that no-one has to make this decision in the absence of proper and full information about their options, which should also include what financial help is available. This is an initiative that is being considered by government, and I commend the Minister for Health and Ageing, Tony Abbott, for his efforts in this regard. It has my strong support.

Having said that, I acknowledge that there is—quite rightly in my view—general community disquiet about the sheer number of abortions that we have in this country. There are no definitive statistics for senators to rely on, but there have been unofficial estimates that there are as many as 90,000 abortions in Australia each year, compared with about 250,000 live births. This is obviously a very real and pressing concern, whatever the correct number. We need to look at what is causing so many women to seek a termination. We need to improve information so people do not have unwanted pregnancies. We need a balanced approach to address this problem. I think that this is a far more important issue in the long run perhaps than the one we are debating today, and one that will impact far more directly on the number of abortions in Australia—which I am sure is a matter of great interest to us all.

I have not been convinced that, if at the end of the long and rigorous approval process RU486 is made available in Australia, we would see any increase in the actual number of abortions in this country. It is important to remember that this bill is not about whether lawful therapeutic surgical abortion is available in Australia; it clearly is. It is also important to remember that this debate is not even about whether or not RU486 should be available in Australia. There is currently no application from the manufacturer of RU486 to have the drug registered in Australia. Rather, this debate is about the process such an application must undergo if RU486 is to be assessed for registration. In Australia, the TGA is charged with identifying, assessing and evaluating the risk posed by therapeutic goods that come into Australia and assessing applications for registration. It is a long process during which advice is sought from an independent advisory group, the Australian Drug Evaluation Committee. Affected parties are also able to appeal to the minister for health if they dispute the decision of the TGA and seek to have that decision varied or overturned. I will have something to say about that in a minute.

The minister has the power to revoke a decision or substitute a new one, and the minister’s decision may be subject to appeal to the Administrative Appeals Tribunal or the Federal Court. What the debate before us swings on is the special process for abortifacient drugs, which was inserted into the Therapeutic Goods Act in 1996, requiring a separate ministerial approval at the beginning of the process. As a result of these amendments, medicines intended to be used as abortifacients are classified as restricted goods under the Therapeutic Goods Act. This classification applies only to abortifacients and to no other class of drugs. I note that many of the speakers have said that this is like no other drug. They may be right.

The amendment specifies that restricted goods could not be imported, registered or evaluated without the written approval of the minister for health. This approval must be laid on the table of both houses of parliament. If the minister’s consent is granted, the usual procedures for evaluation and registration would be undertaken and the decision taken in the TGA evaluation process would be subject to ministerial appeal and intervention. In other words, there are no short cuts for any drug, including abortifacients, in undergoing the rigorous TGA process for registration and sale in Australia.

One argument in favour of this private member’s bill has been that RU486 is sometimes used in the treatment of a number of cancers and tumours, including breast cancer and Cushing’s syndrome. It should be noted that the restricted goods regime should not and was never intended to limit access to RU486 under special circumstances when it is being used to treat particular cancers and tumours. The 1996 amendments quite specifically addressed in the debate at the time that that amendment did not and should not impact on the Special Access Scheme. The Special Access Scheme provides for the import and/or supply of an unapproved therapeutic good for a single patient on a case-by-case basis. Applications must be made by registered medical practitioners who must provide details of the patient and the clinical justification for the treatment.

As I understand it, there is currently an application before the minister from a Queensland doctor, and possibly others, seeking to become an authorised prescriber of RU486. However, no decision on this application has been made. I understand that the minister has referred this application to the TGA for comment. The critical question remains whether, in the case of drugs intended to be used as abortifacients, a sponsor should first be required to seek ministerial approval before going through the application process with the TGA. Clearly the senators who voted in 1996 thought this additional step was justified in dealing with major issues of public policy and public health. The clear purpose was to impose an additional layer of accountability on the approval process for therapeutic goods when it comes to this particularly controversial class of medicines.

In effect, the amendment requires the responsible minister—a member of the executive—to take public responsibility for a decision to either allow an application for registration or to refuse it. The act does not specify any guidelines at all that a minister must follow in making his or her decision, nor does it require that conditions be met, only that the approval be in writing and tabled in parliament. If an approval were sought, it would be, to my mind, inconceivable that a responsible minister would do anything other than seek independent expert advice about safety and efficacy and broader issues in reaching a decision to allow or reject an application for registration. Where would a minister go for independent, objective advice if it were not to the TGA? Of course, this is an exercise in speculation, because the process has yet to be tested.

On that point, I must say that I find the very personal aspersions that have been cast on the current minister’s integrity, objectivity and ability to apply himself dispassionately in the course of his duties to have been both gratuitous and insulting. I have no doubt at all that he would act properly in the discharge of any ministerial discretion at his disposal. In my view, the personal beliefs of the current minister are a complete red herring in this debate. If those opposing this bill are comforted that the discretionary safeguard will be exercised according to the beliefs of a committed Catholic, this is only good for so long as that minister retains the portfolio. Another minister may see the issue differently. The inescapable point of principle in this debate is that therapeutic surgical abortion is readily available in Australia. The minister himself has unequivocally stated, in an opinion piece in the Australian newspaper on 6 February, that he would not support withdrawing Medicare funding from abortion or attempts to recriminalise it.

Therefore, the critical question remains: would preventing another method of termination from being assessed for its potential safety and efficacy be justified? It is difficult to come to a concluded view about the safety and potential side-effects of RU486. There are a lot of advocates but not a lot of conclusive and objective information coming from either side of the argument. On some reports, it is a highly unsafe drug with dangerous side-effects. On this view, it is difficult to imagine why anyone would want to use it or prescribe it compared to a predominantly safe and available surgical procedure. On the other hand, the drug, when properly prescribed and supervised—and that is a very strong caveat—appears to have been safely used for many years in many countries. Sometimes even though drugs are properly registered, problems develop. One only has to look at the voluntary worldwide recall of the arthritis drug Vioxx, based on a clinical study showing increased risk of heart attack and stroke. Of course, some medications simply do not make it through the assessment process and are refused registration. We simply do not know whether the TGA would approve RU486 if asked.

But there does not seem to me to be a principled basis to exclude the TGA from doing its job in evaluating a potentially dangerous drug. Clearly, there needs to be a rigorous, evidence based assessment so that we all know what we are talking about. We Australians entrust the TGA with the task of assessing many thousands of drugs. All drugs are potentially dangerous, and many can be life threatening if misused or wrongly prescribed. We entrust the TGA to evaluate the risk and appropriately manage the risk of many powerful drugs. We entrust them to evaluate and approve cytotoxic drugs for chemotherapy, and we entrust them to prescribe anticoagulants, such as warfarin, which were originally developed as rat poisons and require very close monitoring by doctors to be used safely.

It should be noted that the TGA’s role in evaluating safety and efficacy does not end once approval is granted. The TGA has a multifaceted program for monitoring approved products that are on the market. There is a problem reporting system and a recall unit, and reporting of adverse drug reactions is encouraged by the Australian Drug Reactions Advisory Committee. The TGA laboratories undertake random and targeted sampling of approved products. Sponsoring companies are required to provide regular post-market reports on approved products and to inform the TGA of any international concerns related to the safety or effectiveness of a product. And, of course, the TGA has the power to revoke registration and recall drugs. If the TGA’s initial decision is questioned, any affected party can appeal to the minister, who has the power to review, overturn or remake a TGA ruling.

This is a legislated safeguard under section 60 of the act that enables the minister to make a decision at the end of the evaluation process rather than a pre-emptive decision before any evaluation can be made. I believe that an amendment to this review power to ensure that the minister receives notice of a TGA decision and can initiate a review on his or her own motion would overcome most of the objections to removing ministerial accountability. I have to say that it is not as if the TGA is infallible, and I support the minister having a power of review. I think it is just a matter of where it is exercised. I think this existing provision should be strengthened.

In conclusion, I am acutely aware that there are deeply polarised views on this matter. I am also aware that we make decisions on behalf of many others. Ultimately, my view is that public health issues are not something that we can approach through our own personal prisms. I have set out what I believe are principled reasons for supporting the bill whilst respecting the existing role of the minister in reviewing a decision of the TGA. I appreciate that currently a review can only be initiated by parties with standing, but it does provide a capacity for ministerial overview and accountability. That is the subject of this bill, and I support ministerial accountability.