Jason Wood (La Trobe, Liberal Party) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. This bill, which has caused considerable public debate and strong interest from the media, is one that affects this entire country. In my electorate of La Trobe, I have been lobbied strongly by supporters of the bill and by those who strongly oppose any change to the current system, where the federal Minister for Health and Ageing determines whether RU486 should be assessed by the Therapeutic Goods Administration. The Therapeutic Goods Administration, the TGA, identifies, assesses and evaluates the risks posed by therapeutic goods. On the basis of its clinical and medical investigations, the TGA determines whether the goods are safe for use in Australia. If a drug is approved, the TGA subjects the drug to ongoing rigorous monitoring and reviews. It regulates all medicines but currently does not assess those that are deemed to be restricted goods under the Therapeutic Goods Act 1989. As a medicine that induces an abortion, RU486 has been defined as a restricted good under the act since 1996; therefore, currently it cannot be evaluated by the TGA without written approval from the Minister for Health and Ageing.

One step the TGA can currently take under the legislation is to grant approval for RU486 to be imported under its Special Access Scheme; but, unfortunately, it is the practice that this scheme is frustratingly unworkable. This is because, even if an import permit were granted, RU486 would still be deemed restricted and the TGA could not evaluate it without approval from the Minister for Health and Ageing. Without such an evaluation, the TGA cannot provide the normal assurances for drug use on which doctors depend for their indemnity requirements. In my opinion, all drugs proposed for use in Australia should be assessed and evaluated by independent medical experts and not politicians.

There are those who say that any member of parliament who supports this bill is shirking their responsibility and is not prepared to make a decision for which they were elected. A flaw in this argument is that there are very few members elected to parliament who would be regarded as experts in this field, which is why we have a TGA to medically test and evaluate the safety or otherwise of drugs. But, to greater strengthen this argument, I have canvassed those most medically qualified in this House on whether RU486 should be referred to the TGA. I have canvassed Dr Brendan Nelson, Minister for Defence, from New South Wales; Dr Mal Washer, member for Moore in Western Australia; Dr Andrew Southcott, member for Boothby in South Australia; and Dr Andrew Laming, member for Bowman in Queensland—all members from different states and with different medical backgrounds but who, in their expert medical opinion, believe that RU486 should be referred to the TGA.

If the restricted goods provisions were removed from the Therapeutic Goods Act, the TGA could get on with the job of assessing the risks involved for Australian women in using RU486, just as it does in assessing so many other pharmaceuticals. RU486 has been approved in Western countries in Europe and in the United States, the United Kingdom, New Zealand, Russia, China, Turkey, Tunisia and Israel. This drug is a synthetic steroid and is used to induce what we commonly know as a medical abortion.

Supporters of RU486 state that a woman who has made the difficult decision to terminate her pregnancy could use RU486 during the first nine weeks of her pregnancy, although she could also induce in her second trimester. The woman would visit a licensed facility, where she would be given a specified dose by a medical professional and then return two days later to be given a prostaglandin, usually misoprostal. On taking the drug, the woman can expect an experience much like a spontaneous miscarriage, as described by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Supporters also claim that RU486 is effective in 92 to 98 per cent of cases. Where the drug has been unsuccessful, a surgical abortion will be required, along with backup and medical care. Potential side effects can be internal bleeding and infection caused by retention of the products on conception. Supporters of RU486 state that the drug is a great leap forward for women from rural areas for whom medical access is often limited and also a leap forward for women with strong religious or ethnic backgrounds for whom privacy is very important.

I note that Dr Sharman Stone, Minister for Workforce Participation, who is here today from the rural electorate of Murray in Victoria, is a strong advocate of RU486 being referred to the TGA on the basis of complicated issues faced by women in rural electorates like hers of Murray when compared to inner city electorates. An article in the Medical Journal of Australia in 1997 entitled ‘Women’s satisfaction with medical abortion with RU486’ claimed that many women feel much more control over the termination process when using RU486 and that the use of RU486 does not require anaesthesia or, indeed, risk damaging the cervix.

The Australian Medical Association President, Mukesh Haikerwal, argues that RU486 is safe and has been used overseas for many years, with the successful treatment of over one million women. On the other hand, opponents to RU486 such as Chief Medical Officer, Professor John Horvath, say that when a woman uses RU486 there is a significantly higher risk of experiencing adverse effects than when she opts for a surgical abortion. The risk to women is substantially increased where they are not close to doctors or hospitals that can handle emergency complications. As I mentioned earlier, women from rural areas are a particularly good example of the types of women who might benefit from RU486, but unfortunately it is these women who often live further away from doctors and hospitals who may find themselves in these risky situations, Professor John Horvath highlights.

Opponents also claim that a number of women have died when using RU486. Currently there are investigations into these deaths in the United States. Experts will meet in May to discuss this issue. They believe that the deaths occurred because of lethal bacteria caused by toxic shock syndrome in users. Statistics regarding deaths as a result of using RU486 vary, which is why the TGA needs to examine the drug for use in Australia. With so many varying options on the risks and benefits of RU486, it is imperative that we ensure that this drug is rigorously and independently evaluated. The Therapeutic Goods Administration is the leading body to undertake these evaluations and ultimately tell us whether RU486 is safe for Australian women.

I am greatly concerned with the number of abortions in Australia. The Health Insurance Commission estimated that in 2003 there were, tragically, 73,000 abortions, compared with the ABS figures which state that in the same year there were 251,000 births. However, I also point out, as stated in 2004 by the Minister for Health and Ageing, Tony Abbott, there are no reliable figures on the number of abortions in Australia each year.

I urge fellow colleagues to support a call for more funding for education to prevent unplanned pregnancies, and of course any education must also be targeted at the male population. From memory, I have not seen any major media campaigns on trying to prevent unplanned pregnancies, or if there have been they have simply not worked and need to be changed.

Finally, if RU486 is not approved, that is the end of RU486 in Australia. However, if it is approved by the TGA, this will provide a choice for women but it will not reduce the number of unplanned pregnancies in Australia. Again, that is why I call on politicians who have been elected to make decisions on behalf of their electorates to lobby for additional funding for education on preventing unplanned pregnancies; extra funding for the counselling of women to discuss options rather than having an abortion; and extra funding for women who decide to continue with an unplanned pregnancy.

See this speech in context