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Thursday, 9 February 2006
Page: 37


Senator PAYNE (11:15 AM) —I want to make some brief remarks in relation to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. It is my strong view that this bill is intended to correct a perceived inconsistency in the approval process of this drug and related drugs in Australia. The highly emotive issue of abortion has dominated headlines and has, in some respects, been the main focus of much of the discussion about the bill both publicly and in the hearing process—and I have had the opportunity to read some of the Hansards of that. Notwithstanding that, I do believe that the bill is about the appropriateness of the current arrangements for the evaluation of RU486 and related drugs. It is about whether the Therapeutic Goods Administration or the Commonwealth health minister, whoever that may be at any point in time, is best placed to assess and monitor the safety and efficacy of the drugs to which this bill pertains.

I do not regard this bill as one about abortion per se. Abortion is legal in Australia in certain circumstances. It is a matter for the states. It is, in my view, not the subject of this discussion; however, I do acknowledge that many of my colleagues hold a different view from that. I respect their view, and I acknowledge and respect the fact that the Prime Minister has provided the opportunity for a conscience vote on this matter. In situations such as this, where senators and members hold particularly passionate personal views of conscience on the issues under discussion, I think that is the most appropriate and best approach to take.

It is my view that RU486 should be referred—as are all other drugs except it—to our standing body for such matters, the Therapeutic Goods Administration, to be assessed by experts based on the weight of scientific and medical evidence. It seems to me that, if the concerns of the opponents of these particular drugs are well founded, the TGA would examine the impact of the drugs very carefully before coming to a decision on them. Indeed, the fact that both sides of this debate have been passionately argued, in many cases by medical practitioners from diametrically opposed positions, confirms to me the need to action the central premise of this bill to ensure that it is the TGA that evaluates and assesses such drugs. I was interested last night to hear part of the speech of, and to read the words of, the former Minister for Health and Ageing, Senator Kay Patterson, on precisely this point. It occurs to me that she is in a particularly unique position in this chamber and in this discussion to proffer her views.

Most importantly, I do not believe that this is a matter for politicians, no matter their political affiliation, their religious affiliation or their gender. It is a matter which I believe should be in the hands of experts in science and medicine. This bill provides an opportunity to ensure that RU486 and drugs of a similar nature are assessed and evaluated correctly, scientifically and medically by the Therapeutic Goods Administration on grounds in which they are well qualified as experts. If an assessment is made that RU486 is efficacious and safe, and if the evaluation supports the assessment, then it does provide an opportunity for Australian women to access these drugs in appropriate circumstances, in consultation with their medical advisers, in what will be an intensely personal process.

I understand that there are a number of amendments before the chamber; I have had the opportunity to read them as circulated. Some of the amendments are quite extensive and others are more minor. Some of them have the effect of effectively wiping out the whole bill. I suspect I will not have a chance to speak in the committee process, so I take the opportunity briefly now.

One of the amendments requires the minister to seek advice from the Australian Health Ethics Committee—which I understand is currently established to advise the NHMRC—before a decision is made to approve or disapprove an application for RU486. My understanding of the effect of that amendment is that the minister would still have the power, on their own, to approve or disapprove any application to evaluate, register, list or import RU486, and the amendment still does not provide any criteria upon which such a decision would be made. I am not sure how the AHEC, the Health Ethics Committee, is better qualified than the TGA to comment on the safety and efficacy of RU486. If it is not, then the process to move the responsibility to the TGA should not, I would have thought, be offensive to the movers of the amendment. I will listen carefully to the debate on the matter.

Amendment (5) seeks to require the minister to provide, as well as the advice of the Health Ethics Committee, a statement of reasons for approving or refusing an application. Again, it seems to me that, without criteria being required as the basis upon which decisions are made, a statement of reasons would effectively be meaningless. Amendments to translate the decision into a disallowable instrument suggest to me that, although there is an argument around parliamentary review being engaged in that process, that will only happen in the case of an approval. In the case of a rejection it will not be a matter for parliamentary review because there is no capacity to force the minister to reverse a decision and to approve the drug. In fact, it is unclear to me what process the parliament would be engaging in after a written refusal had been disallowed. Again, I look forward to hearing some of the discussion on that matter. It seems to me it may be a never-ending story if we go down this road.

Any of the amendments to which I have referred still leave us with the key problem that the people making decisions on a question of evaluation of safety and efficacy of a drug will be politicians, not experts. It is a matter which I fundamentally believe should be left to the skilled decision making of scientific and medical experts. I do not see myself in a position of being able to support the amendments as they are currently proposed. I indicate that I will be supporting the bill.