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Therapeutic Goods Administration

CHAIR —Thank you, Senator Adams. Now Senator Nettle has questions for TGA.

Senator NETTLE —Have any studies been done on the social and health consequences of RU486. I do not know if they have or what they say.

Ms Halton —Senator, that is probably not a question explicitly for the TGA. The TGA is the regulatory agency that deals with application. They do not have a broader research role.

Senator NETTLE —That was why I thought it was outcome 1, Population health, when I went to ask it before.

Ms Halton —Sally forth and we will see whether perhaps between Dr McEwen and myself we can answer some questions.

Senator NETTLE —Do you know if any studies have been done?

Ms Halton —Not that I am aware of and certainly not in Australia because it is not permitted in Australia.

Senator NETTLE —I am aware of overseas studies but I am wondering whether the department of health has done any studies, whether or not they are fulsome studies. They might be literature reviews of overseas studies.

Ms Halton —We are obviously aware of issues in respect of RU486. You would be aware this has been a matter of some considerable debate in the past.

Senator NETTLE —Yes.

Ms Halton —Have we done our own de novo study? Obviously not, because it is not available in Australia, but we are certainly aware of the issues around RU486.

Senator NETTLE —Have you produced any material about what those issues are?

Ms Halton —No. We have acquainted ourselves with the material in relation to the use of RU486 internationally. It is worth putting on the record that we have not received any application in relation to RU486 in Australia. I believe the regulator therefore does not have an opinion in relation to this matter but certainly it is an issue that we are conscious of.

Senator NETTLE —You said you are aware of the issues. Have you formulated a position or a view on what might be the health, medical or social implications of RU486?

Ms Halton —Senator, you would be aware that the department does not have a position.

Senator NETTLE —Yes.

Ms Halton —We are a department and we service government. It is fair to say that we are conscious of some of the medical issues in respect of RU486, so in the event that we are asked for advice in relation to these matters we would give a clinical view about the use of such a product. In a sense that question is a little academic because we have not been asked for that view, nor have we been asked to consider such a view in the context of any request in relation to access to the product in Australia.

Senator NETTLE —You have not been asked for that view by the minister?

Ms Halton —No. We have not had any formal request in relation to that matter.

Senator NETTLE —Do you know whether, in 1996 when the legislation went through, there was any material produced by the department on the medical consequences of RU486?

Ms Halton —I cannot comment about what material might have been produced then. I am aware that Dr McEwen has fairly recent knowledge of some of the medical issues in relation to RU486 which he would be more than happy to talk to you about. In terms of the advice that was given to government at the time, short of digging it all out of archives, I have not got that to hand.

Senator NETTLE —Could I put that on notice, if there is any capacity for you to look at what advice there was at that time.

Ms Halton —It may be a little difficult. It is nearly 10 years ago. It is regrettable but it is a reality that dredging up what happened 10 years ago can prove a little difficult.

Senator NETTLE —It is worth asking the question because it is current now.

Ms Halton —Sure, I understand.

Senator NETTLE —The advice may have been different then to what it might be now.

Ms Halton —The reality is, with any sort of product of this kind—in fact any medical product—a 10-year effluxion of time does mean that you know more, by definition. If you take the example of Vioxx, which is very current, we now know a lot more about the impact of Vioxx so it is no longer on the market. As people know more about a product, the decision that you might or might not have taken earlier may be a different one.

Senator NETTLE —Which is why I think it is helpful to the current debate if we are able to get—

Ms Halton —I will see what I can do, Senator. I cannot make promises because I literally do not know what the state of the record-keeping was.

Senator NETTLE —Can I ask Dr McEwen: the tag about the medical information that you have or—

Dr McEwen —We have really focused on what is in the public domain, and that principally is the information that is available in the compendia that describe the product in the various countries. One can access the very detailed product information from the US. There is a compendium entry from France; one needs to read French. It is available in New Zealand and they have a relatively truncated product description. The US one is probably the most useful because it spells out the details of the clinical trials in the US and France, including the percentages who needed to have some form of intervention after an expiration of 10 to 14 days after they had had the product administered. We can access that sort of information and provide it as an attachment to a question on notice.

Senator NETTLE —Does that include the study by, I think, the American College of Obstetricians and Gynaecologists?

Dr McEwen —It is described as US trials. Just who did it I would need to take on notice.

Senator NETTLE —That would be great. Have you also looked at any studies about satisfaction with the product? You mentioned medical trials. Has that included satisfaction with the product?

Dr McEwen —No, I am not aware of any on patient satisfaction.

CHAIR —We have now made up time for the TGA, so thank you to the TGA representatives.

[10.02 pm]