Russell Trood (Queensland, Liberal Party) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 because this matter is one of immense public interest and it raises an important issue of public policy and the exercise of ministerial discretion. Like many senators, I imagine, my office has been flooded with correspondence on this issue. Much of it, I regret to say, has not focused on the very issue of the bill—the matter of ministerial discretion. Rather, it has assumed that we are taking a decision to extend the right of abortion. Overwhelmingly, the correspondence has been opposed to that assumed extension.

But we have other opinions on this subject. On 19 January this year the Australian published a Newspoll survey in which the question was asked, ‘Would you personally be in favour of or against RU486 being available in Australia for use by qualified medical practitioners?’ In a sample of 1,200, the following percentages responded in the positive: across all categories, 68 per cent; women, 70 per cent; men, 66 per cent; the age category 35 to 49, 71 per cent; and tertiary educated respondents, 76 per cent.

But whether or not we are in favour of RU486 is not the question before us. The question before us is whether the approval or otherwise of medicines should be vested only in the impartial statutory authority established specifically to carry out the task. Before I address the issue, let me record that I am deeply troubled by the estimated 85,000 abortions that apparently take place in Australia each year. I doubt there are any women who undergo the procedure who are not profoundly affected and perhaps even traumatised as a consequence. Nor can we easily dismiss the body of religious and ethical opinion that abortion is a reprehensible action offending their deepest convictions about the nature and sanctity of life. But the reality is that, subject to physical and psychological need, abortion is legal in all Australian states and territories. Whatever we do this evening or tomorrow in the Senate will not change that reality. Notably, this has been recognised by the President of the Uniting Church in Australia, Dr Dean Drayton. In January he said:

We have already had the public debate about abortion. The issue is whether or not this particular drug is safe to be released for use in a country where abortion is legally available.

That, indeed, is our task—to decide on the desirability of the Minister for Health and Ageing retaining the discretion to ban a registered drug. That discretion was secured by the minister in 1996 as a result, some commentators say, of a deal struck between the government and Senator Harradine. Of course, politics is often about deals, compromises and bargains, some good and some otherwise. Perhaps on that occasion the passage of the bill was worth the price. But, in retrospect, from the perspective of good public policy, this may not have been the Senate’s finest hour. The reason is that it removed from the duly accredited Commonwealth agency—the Therapeutic Goods Administration—the responsibility to make a decision about the suitability of a drug for use in Australia. It gave that responsibility to the minister—the only drug in relation to which he has that discretion.

In public policy terms it is a very peculiar discretion. It lacks adequate accountability, offers no transparency and, perversely for a drug said by its opponents to be so dangerous, does not permit scrutiny and examination by the one agency able to do it professionally—the Therapeutic Goods Administration. Considering the level of legislative and regulatory control of therapeutic goods in this country and the expectation that Australians have that such products will be safe, of high quality and comparable to the best available elsewhere in the world, that is an extraordinary situation indeed. I think it is an untenable one. We now have the opportunity to correct this anomaly by placing the power where it belongs.

The Therapeutic Goods Act 1989 vests the power to assess the efficacy, quality and safety of medicines used for therapeutic purposes in the TGA. The 1989 act, in part, defines ‘therapeutic use’ as:

... influencing, inhibiting or modifying a physiological process in persons or animals; or

... influencing, controlling or preventing conception in persons ...

In my view, the act of 1989 is onerous for the TGA. The obligations it imposes are heavy—and so they should be. In 2004-05 the TGA discharged that responsibility by approving more than 11,000 applications for registration and listing, testing over 1,200 products, receiving 421 reported breaches, completing 349 investigations, issuing 161 formal warnings, and it had persons or companies charged with 106 criminal offences.

The administration employs in excess of 500 staff. Its medical and pharmaceutical professionals are specialists in their fields with levels of expertise that are of the highest order. I have heard no suggestion in this debate that the TGA is anything other than a well-run, competent and highly professional agency. It would seem that few, if any, on either side of the debate contend that the TGA does not fulfil the terms of its charter. Indeed, from all reports, it complies with those responsibilities with unquestionable probity, the highest level of relevant scientific expertise and a will to make decisions and present its findings and recommendations in an unbiased manner. As the TGA itself notes:

... the regulatory framework is based on a risk management approach designed to ensure public health and safety while at the same time freeing industry from any unnecessary regulatory burden.

The Senate Community Affairs Legislation Committee received a great number of submissions and heard evidence from witnesses that strongly support the TGA when assessing restricted drugs such as RU486 and contend that the argument should be focused on the nature of the bill and the discretion the minister exercises.

Dr Haikerwal, the President of the Australian Medical Association, told the committee:

Our membership is wide and reflects the same diversity as exists in the community.

In reference to abortifacients he said:

These are the only drugs to require this kind of ministerial approval. This section of the act has effectively banned the entry of RU486 into Australia not only for use as abortifacients but also for the number of other possible uses, such as emergency contraception, treatment of endometriosis and treatment of some breast and brain tumours.

Dr Sally Cockburn said it was nonsensical to claim that RU486 is too unsafe to be evaluated by the TGA, as some appear to be arguing. She also pointed out that normally the minister would seek advice from the TGA as to the safety of a therapeutic good but that, under section 23AA of the act, any request to evaluate a restricted drug must be in writing. The catch-22 for the minister is that he cannot ask the TGA to assess RU486 without signing off on it. This he does not wish to do.

Professor Caroline de Costa, from the Department of Obstetrics and Gynaecology at James Cook University, said in her submission to the Senate committee that she had read every available study on RU486, in English and French. She declared that she is ‘convinced of the usefulness and safety of the drug’ and that ‘the debate should be about removing the very unusual power of the federal minister for health and the opportunity be given to the TGA’. She also confirmed evidence provided by other witnesses that misoprostol and other drugs which have TGA approval for different applications are currently prescribed off label to induce abortion but are not as effective as RU486. Other peak professional bodies to conclude that RU486 should be available in Australia include the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Rural Doctors Association and the National Association of Specialist Obstetricians and Gynaecologists.

I will now return to Dr Haikerwal’s evidence. He expressed the utmost confidence in the TGA’s competency when he said:

We believe that the TGA is best suited to decide upon the safety of all medications and therapeutic products including RU486 and should be given the opportunity to judge the safety and efficacy of this medication as it does for all others. It is the best qualified authority to decide when and where and with what support services this drug should be made available. They must exert their judgment freely, fairly and away from undue pressure.

These views were supported in much evidence to the committee. Dr Leslie Cannold, medical ethicist at the University of Melbourne, offered that a conscience vote misrepresents the bill by asserting it is about a moral or legal stance on abortion whereas, she said, ‘in reality it is about the integrity of Australia’s framework for ensuring the quality, safety and efficacy of the medicines we take, and that’s what the TGA is for’.

To date, the TGA has approved around 50,000 therapeutic products for use in Australia. Given such a volume, there can be little question that the TGA has amassed a high level of expertise and understanding of its obligations. The Parliamentary Library’s research note on the issue says:

The TGA’s risk management role means that it is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods, applying any measures necessary for treating the risks posed, and monitoring and reviewing the risks over time.

The TGA has consistently discharged that duty, and its professionalism is recognised by its listing by the World Health Organisation as a collaborating centre.

I think I have made my position clear. If this bill is defeated, one of the conclusions that we might draw is that today’s Senate agrees with the government’s decision in 1996—a decision which, in my view, corrupted a regulatory regime which enjoys considerable professional integrity and, as far as one can tell, public confidence. The inference could also be drawn that a resolution in the negative declares a lack of confidence in the professionalism and expertise of the very body charged to maintain confidence in all medicines sold in Australia.

If given the power, I do not know whether the TGA will approve RU486 for sale in Australia. I do believe, however, that it will discharge its responsibility for assessing the medicine conscientiously and, if it approves it, it will only do so after comprehensive assessment consistent with the highest standards it has established. If the TGA decides to list RU486, it will have made a decision consistent with policy in many other countries—but I leave that to the TGA. As a matter of sound policy, we should allow the TGA to do the job it was authorised to do and pass the bill.