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Thursday, 30 June 1994
Page: 2541


Senator HARRADINE (10.40 p.m.) —I apologise for having to rise on the adjournment—I do not normally do that—but this is a very serious matter. It relates to an importation, authorised by the Department of Human Services and Health, of a prohibited import against a policy that was adopted by the Department of Community Services and Health, as it used to be known, and against undertakings given to me and the parliament. The import is the abortion drug RU486, which is a prohibited import under the Customs (Prohibited Imports) Regulations. The department, against the undertakings given to me and the parliament, approved the importation of that drug. That is point number one.

  In the estimates committee I asked questions about the trials that were being done on RU486. The Therapeutic Goods Administration officials said, `These trials are only clinical trial notifications. We do not approve of them; we just accept the word of the ethics committees to which the promoters of the trial have gone to obtain approval.' When I asked what trials they were, they gave me and the committee two clinical trial notifications: one by the Sydney Centre for Reproductive Health Research, which shared the same address as the Family Planning Association of New South Wales, which was endorsed by an ethics committee, namely the Family Planning Association of NSW ethics committee. On that ethics committee was the manager of the Sydney reproductive health centre, the organisation which was undertaking the trial. In my view, that is totally unethical. Yet the Therapeutic Goods Administration accepted that because that is what the law is.

  However, I then asked a specific question about the trial in Victoria being done by Professor Healy at Monash University. I asked for details of that trial and also for details of the ethics committee and what the women subjects of the trial were being told, because I have been informed that they are not being told the truth—they are being deceived. That is pretty clear from the material that we already have from the New South Wales trial.

  This trial is another trial and includes a trial of mifepristone and prostaglandin. They are very dangerous drugs with a whole host of health risks involved and about which the women subjects in Melbourne are not being told. I asked what the women subjects were being told. That information was not given to the estimates committee. If honourable senators have a look at the Hansard of the estimates committee they will see that the officers of the Therapeutic Goods Administration tried to obfuscate it. They said, `You have been given the material.'

  I indicated clearly that I had not. I had been given material about another trial in Victoria about which they had not provided the clinical trial notification to the committee. They gave me the information about that; they did not give me the information about the Monash one. I want to know why this trial was approved by the ethics committee of the Family Planning Association of Victoria and not the Monash University ethics committee. As yet, that has not come forward. The whole of the material has not come forward. It is a disgrace. We are spending money on therapeutic goods administration. Money is being spent indirectly on these trials. We are entitled to know what the trials are; we are entitled to know all of the information. I insist that we have to have it; and we have got to have it urgently. I will be pursuing this matter during the break with the relevant minister.