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Tuesday, 23 August 1994
Page: 7

Senator WEST —My question is addressed to the Minister for Family Services and Minister representing the Minister for Human Services and Health, Senator Crowley. Can the minister advise the Senate what action the government has taken to safeguard the health and wellbeing of women participating in the RU486 trials?

Senator CROWLEY —I thank the honourable senator for her question. The government is particularly concerned to maintain levels of standards about women's health, and particularly the safety and wellbeing of women and all services provided for them in this country. Three clinical trials of the drug RU486 are being conducted. The drug is being examined as a post-coital contraceptive and as an abortifacient. Those trials have been scrutinised by the ethics committees of Family Planning, New South Wales, and Family Planning, Victoria.

  There have been expressions of concern from the community about the trials and, as a result of their being raised, the government has obtained copies of the informed consent documentation and information on the procedures for clearing the trials with the institutions' ethics committees. The department has also obtained advice about whether the requirements set down in law have been met.

  I am advised that the Attorney-General's Department has confirmed that the legal requirements in all respects have been met in the conduct of these trials. But in examining the material provided to government, it became clear that the patient information for the abortifacient trial could have been clearer to lay readers and contained more information. Secondly, while the ethics committees were properly constituted and behaved entirely within the law, as required, it is true that one member of the Victorian committee, a minister of religion, did not attend meetings when the decisions about RU486 trials were made and had no input in any other way.

  In the light of that information, the government has moved very quickly to act in this matter. It has secured the agreement of Family Planning, Victoria, first of all, to conduct an independent review of the whole consent process; secondly, to contact women who have so far been part of the trial and offer them counselling; and, thirdly, to suspend any further recruitment of women for the trial until the review is completed.

  A letter has been sent to all ethics committees supervising trials, reminding them of the need to ensure that the trials are strictly in accordance with the NHMRC guidelines. The letter emphasises the importance of user-friendly information, particularly in the consent form area, and the requirement that all consent be totally voluntary. There is no evidence that it has not been voluntary, but these are two areas of major concern in relation to consent and the letter highlights both of these points.

  The Minister for Human Services and Health has recently announced a wide-ranging review of the NHMRC guidelines for ethics committees to ensure that they also adequately protect the safety of participants in trials and to ensure that genuinely informed consent is obtained in all cases. We have required that ethics committees be established in all institutions. What is important now is to ensure that the monitoring of the processes and behaviour of those ethics committees is as up to scratch as it can be. In particular, as I say, we need to highlight the area of concern that has been most importantly raised, and that is genuinely informed consent from people involved in any of the trials. As well, that review will look at the Australian Health Ethics Committee's arrangements for monitoring and enforcing those ethics committees' behaviours and performances.

  We are particularly concerned that the health of Australian women, particularly those involved in trials to do with reproductive health, is the best it can be; that they are offered information and assurance to participate in these trials; and that they have an opportunity to give fully informed consent to participate. Secondly, the review is part of our ongoing and continuing concern for the safety and wellbeing of all Australian women. Trials like this have a part in contributing to access to other procedures for further safety. We must be absolutely sure that all processes in trying to find out information as part of these trials also support the safety and wellbeing of Australian women.