ADJOURNMENT: RU486

Senator NASH (New South Wales) (9.47 pm)—I rise tonight to talk about an issue that has been of particular note of late. In 1996, this parliament allowed an amendment to the Therapeutic Goods Act 1989. That amendment made the minister for health ultimately responsible for deci-sions in relation to the importation, trial, registration and listing of RU486 and other abortifacients rather than the Therapeutic Goods Administration, the statutory body usually responsible for the approval of medicines in Australia,. This was on the grounds that these drugs amounted to a special category of drug requiring an additional layer of public scrutiny. That debate occurred some 10 years ago over concerns about the safety of the drug, in the context of what was known about RU486 at that time. It is interesting to note that in 1996 RU486 was approved for use in less than a dozen countries. In 2006, we are some 10 years on and there is much more data available. RU486 is now approved in some 33 countries, including the United States, New Zealand, France, Israel, Sweden, Russia, Turkey, Tunisia and Britain, but not Austra-lia. I remind the Senate that the practice of abortion does legally occur in Australia and is regu-lated through state and territory law. I respect the right of individuals to hold their views on abortion—be it pro-life or pro-choice—but abortion does occur in this country. The Australian community expects that medicines and medical devices in the marketplace to be safe, of high quality and of a standard at least equal to that in comparable countries. Responsibility for that falls on the Therapeutic Goods Administration. The TGA provides a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines, and to ensure the quality, safety and performance of medical devices. According to the TGA’s 2004-05 annual report, 49,343 items were listed on the Australian register of therapeutic goods. In fact, during 2004-05 some 11,455 applications were approved by the TGA for inclusion on the register. These included medicines such as the prescription drugs that a doctor prescribes and are dispensed by a pharmacist in the local chemist as well as the sorts of non-prescription medicines available at the chemist or supermarket. I believe the Therapeutic Goods Administration has the knowledge and expertise to conduct the evaluation of RU486 for quality, safety and efficacy, and I believe that this parliament does not. Let us allow the TGA to evaluate RU486 in the same impartial manner that it has done with the almost 50,000 therapeutic goods that have already come before it. Let us take the politics out of the issue and put the science back. I believe the TGA has the necessary integrity and professional competence to assess whether or not RU486 is suitable for use in Australia. It is always preferable to avoid surgery wherever possible. There are inherent risks with sur-gery. It is invasive and traumatic. RU486 is an alternative to surgical procedure. Some women in Australia, for a whole variety of reasons, may require an abortion. It is not a decision that is taken lightly. The TGA would take into account the efficacy of the treatment for all women, not just women in rural and regional areas. These women should be able to choose between surgical and medical intervention if the medical alternative is deemed to be appropriate. I believe RU486 would give women that choice. If RU486 were to be approved by the TGA for use in Australia, it would be irresponsible of us as legislators not to give women that choice. There is a level of misinformation surrounding the possible introduction of RU486, such as that the treatment will be available over the counter from a chemist. That is just plain wrong. If the TGA were to allow RU486 to become available in this country, it would be reasonable to assume that it would be classified as a schedule 4 drug or higher, which can only be supplied by prescription from a registered doctor, in the same way other schedule 4 drugs—such as penicillin, the contraceptive pill and the hormonal treatment for breast cancer, tamoxifen—or drugs of a higher classification are made available. I want to make it clear: RU486 would not be a pharmacy medicine or a pharmacy only medicine. Women will not be able to walk up to the chemist and buy it. They would only be able to access the drug if it was prescribed to them and them alone. I am aware of reports following several deaths overseas linked to RU486 and that the United States Food and Drug Administration ordered new labelling and medication guides reflecting the higher risks associated with RU486. I would like to draw to the Senate’s attention an update put out by the US Food and Drug Administration on 4 November. This update provides additional information about the four women referred to in the FDA’s alert of 19 July 2005, who died of sepsis following medical abortions in the United States. On 4 November, the FDA posted this update to its website: Since the July alert, FDA has learned that all four women were infected with the same type of bacteria. In addition, FDA has tested batches of Mifeprex and misoprostol and has not found any contamination with this type of bacteria. A range of key international health sector organisations, including the World Health Organisa-tion, the International Federation of Obstetrics and Gynaecology, the UK Royal College of Obste-tricians and Gynaecologists and the American College of Obstetricians and Gynaecologists, now support the use of medical abortion using RU486 as a method for inducing termination of preg-nancy. These international bodies have now been joined by the Australian Medical Association and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. In the current debate, groups such as the AMA have argued that there is now much greater understanding of the level of risk associated with RU486 as a result of clinical trials and widespread use in other countries. For example, according to AMA President Dr Mukesh Haikerwal, the 1996 restrictions were: ... fairly early in the evolution of the drug. Now, nearly 10 years later, there’s a million women years worth of trials on this now and people have used it successfully with very minimal problems. There are three very important points to remember that I will conclude on: one, there is no one person in this parliament who is qualified to make a clinical and/or therapeutic judgment on this drug; two, as responsible legislators we should take the steps necessary to repeal the Harradine amendment and allow the Therapeutic Goods Administration to get on and do the job that it was designed to do; and three, drugs come with a warning label. If RU486 could be given a label now, that label should read, ‘Do not mix this medication with politics.’

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