The following is the first collection of questions asked by Senator Joyce and sudsequent responses during the Senate Inquiry.

Senator JOYCE—This would be a correct state, wouldn’t it? There are people walking around today who, when we bring in RU846, mifepristone and misoprostol, through either clostridium sordellii or whatever, who will be dead after they take this drug.

Dr Pesce—Over a large number of years, it is probably inevitable.

Senator JOYCE—But it is inevitable, is it not? So it is a fact that there are people who will die from this?

Dr Pesce—They will die from complications of the termination of pregnancy.

Senator JOYCE—It will be from this drug though, just like it is in the United States?

Dr Pesce—I think it will be from the abortion. Whether it is due to the drug or not remains to be proven.

Senator JOYCE—But it actually antagonises and enhances the chance of infection through such things—or you do not think that is the case?

Dr Pesce—No, there is no evidence for a link between the actual drug and the type of infection that occurred. There is no doubt that it occurred after an abortion. There is no direct link between the drug and the choice of the medical abortion and this death, although perhaps one day that might be found. But there is no theoretical, clinical or scientific connection that has been established between this particular drug and the deaths.

Senator JOYCE—I have just two more questions.

CHAIR—One more question.

Senator JOYCE—One last question: in your ethics committee, how many people’s lives did you consider in the use of this drug? Do you consider that it just affects one person’s life or two and why did you come to that decision?

Dr Pesce—We particularly made a decision not to enter into whether abortion should be available, the morals of it. We wanted to make a clinical decision based on medical evidence and so very specifically we said where abortion is lawful then options should be made available to the woman. We did not go into the morals of whether abortion should be made available to women. We just made a comment that, if a country and a society have come to a decision that abortion is lawful in certain circumstances, in those circumstances where it is lawful, all of the options should be made available to the doctors and their patients.

Senator JOYCE—So there is a very specific reference as to who it is safe for.


Senator JOYCE—Quality, consistency, safety and efficacy are the standards by which you judge a drug. At what stage in the in utero development of a person do you start considering the effects of a drug on their life?

Ms Halton—It depends on what the drug is. I am sorry, but you will have to be a bit more specific.

Senator JOYCE—Okay. In the development of a child before they are born, at what stage do you consider the effects of a drug on that child’s life?

Ms Halton—In any application for the registration of a drug, the TGA evaluators take the data that is provided in respect of the actions of that drug. They consider it in respect of those particular criteria. We cannot provide you with an answer that goes to a particular point because, unless we are talking about a particular product or a particular circumstance, there is no blanket answer to that question.

Senator JOYCE—So the answer to that question is that you do not in fact consider the effects upon the unborn child?

Ms Halton—No, I did not say that. I said that there has to be a particular example given before we can answer that in a particular way.

Senator JOYCE—So if the question was ‘Is this going to affect the life of this unborn child?’ that would be a consideration that you would then have to take into account?

Ms Halton—It would depend on what the drug is and what the application is in respect of.

Senator JOYCE—RU486—there is a drug.

Ms Halton—We do not have an application for RU486 and the TGA has not put in place any speculative arrangements in that regard.

Senator JOYCE—I will change it around. Are there any other drugs that are currently under your auspices for which you have to consider the effects on the unborn child?

Prof. Horvath—Every drug that is considered—and I will answer this clinically and my colleague from the TGA can give you a technical answer—looks at the effects on the unborn child potentially, because there are some drugs that affect different growth pathways in a teratogenic effect. There are in fact a number of clinical guidelines, with different levels of warnings, depending on the previous evidence, as to the safety of the drug for an unborn child.

Dr Graham—Effects in pregnancy is a standard part of the product information—which is information that companies must supply with their products. In fact, there is a guideline around drugs and their effects on a pregnant woman, and that is guidance to the medical profession.

Senator JOYCE—Thalidomide and RU486, to give you an example: one considers a child and one does not.

Dr Graham—Yes.


Senator JOYCE—Thank you very much, Dr Ross and Dr Sue. I want to run past an issue and I want you to give me an answer about what would happen next. If a person presents to you, you administer Mifepristone and then you do not see her again so she now has either a mummifying or—hopefully not but possibly—a putrefying foetus in her body, tell me what would happen next.

Dr Maxwell—This is where it is very important that you have adequate follow-up mechanisms. It would be very important that you had a clear expectation about when the patient was going to come back to you or check back in with you. It would be vital that before you give this medication you make sure that you have the contact details—that you have the address, the phone number and the mobile phone number. With the patient’s consent, obviously, it may even be worth while having the contact details of someone who she is close to.

Senator JOYCE—But my question was: what is going to happen to that patient next? They have not come back for the Misoprostol.

Dr Maxwell—Sorry, I misread the question. I thought it was: what are we going to do about it?

Senator JOYCE—No, what is going to happen to that person?

Dr Maxwell—If the patient has an incomplete miscarriage then there is a risk of them developing a septic abortion. That is a situation where this medication has some risk. But that appears to be quite rare, looking at the numbers.

Senator JOYCE—I just want to know what happens to that person when it becomes septic.

Dr Page—They would be admitted to the local hospital and treated.

Dr Maxwell—They would