Jennie George (Throsby, Australian Labor Party, Shadow Parliamentary Secretary for Environment and Heritage) Share this | Hansard source

We are being asked to revisit the decision made by parliament in 1996 when an amendment to the TGA Act was carried to create a new category of drugs known as restricted goods. As we know, these restrictive goods included RU486, which cannot be evaluated, registered, listed or imported without the written approval of the minister for health. All other medicines used in this country have been evaluated and regulated by the TGA without any requirement for approval by the minister. I believe the TGA has provided independent scientific advice on new medications in a very professional and impartial manner for the last 20 years.

Under the current arrangements, in my view there is not a significant level of parliamentary scrutiny in relation to RU486, despite the claims made by people in this debate. In my reading of the Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of RU486) Bill 2005 as it stands, the minister is simply required to notify the parliament of a decision to approve an application for evaluation by the TGA, but the minister is not required to table decisions to not approve such applications—meaning that the parliament is neither necessarily informed of these, nor does it have the capacity for any oversight of such decisions.

Some 10 years since that amendment was made to the act, we are being asked to revisit the decision. I, like most other politicians, have received numerous submissions from constituents both for and against the private member’s bill. Some views against the bill have been put very forcefully to me. I have taken all the views from my constituents into consideration, and I have read as much as I can to try to come to a decision that, in all conscience, would allow me to vote in a particular way. I do accept that, in arriving at my conclusion, as a local representative I am accountable to my electorate as to how I vote and the reasons for coming to my decision. It is a conscience vote that I have arrived at in good faith, and I trust that my constituents, even those that will not necessarily agree with the position I put, will treat that decision in good faith.

Having read and thought about the issue I think the fundamental question that has to be answered is this: who in my view is the appropriate authority to evaluate the risks associated with RU486 and determine its appropriateness or otherwise for authorised use in Australia? I have come to the conclusion—and I will give you the reasons in a minute—that in my view the appropriate body is the TGA, and accordingly I will be voting in support of this private member’s bill.

In coming to this position on the bill, I have tried to analyse the arguments both for and against. I have posed a number of questions that I have worked through in coming to that position. The first question is: what do we now know about the use of RU486, which has been used over the decade since the amendment was introduced in 1996? The second question is: what does the experience of the use of that drug conclude about the level of risk involved in the use of RU486? The third question is: what is my assessment, as a lay person, of the safety of the drug? The fourth question is: should medical abortion, using RU486, be allowed in Australia? Previous speakers have pointed out that abortion under certain circumstances under state and territory law is legal.

While I can come to some personal conclusions and answers to the questions I have posed, as I have thought through these issues, I believe that no politician should be the ultimate authority on these issues. We will have our personal views, but those views will not necessarily be based on expertise or a scientific basis for making those judgments. Accordingly, I believe, as previous speakers have outlined, that the TGA has been specifically charged with a responsibility that goes beyond that of individual personal views.

The TGA is specifically charged with identifying, assessing and evaluating the risks posed by therapeutic goods; applying any measures necessary for treating the risks posed; and monitoring and reviewing the risks over time. In other words, evidence based evaluation of the merits or otherwise and the risk profile of RU486 can only be undertaken by an independent body relying on scientific and medical expertise. How better to resolve the genuine concerns expressed by my constituents—and many members in the chamber—about the safety of RU486 than by referring it to the TGA for evaluation and assessment?

In my reading for this debate, what are some of the conclusions that I have personally come to and what is the knowledge that has been accumulated in the past decade, since the decision was originally made? We know that RU486 has been used over the past 10 years in about 33 to 35 countries. There is now a much greater understanding of the level of risk, as a result of clinical trials and widespread use. Some two million terminations have now occurred using RU486 in Europe and the United States. It was first licensed in France in 1988, in the UK in 1991 and in the US in 2000. Countries approving its use include France, New Zealand, Britain, Sweden, the USA, Israel, China, countries in western Europe, Turkey and Tunisia.

The International Planned Parenthood Federation’s medical advisory panel concluded that the drug is safe and effective for medical abortion and approved its use in their 151 member associations across the world. Interestingly, RU486 has been included on the World Health Organisation’s essential drug list. The WHO has declared medical abortion ‘safe, effective and acceptable if the few conditions which warrant control are identified and post-abortion care is available’. The use of RU486 is supported by the AMA here in Australia, by the UK and by the American College of Obstetricians and Gynaecologists.

The President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said recently:

One of its uses is in early termination of pregnancy, and there is evidence that it’s sometimes a better and safer option for women than surgical termination.

It is true that, in the submissions that I have received from constituents, concern has been expressed because there have, it appears, been five deaths attributed to RU486 in the United States and in Canada after women developed septicaemia. This occurred over a five-year period during which there were an estimated 530,000 medical abortions using the drug. According to people with more expertise than me—and I quote from Dr Weisberg from the Family Planning Association—‘The death rate in medical abortions of one in 100,000 was the same as for surgical abortions and lower than the rates for childbirth and ectopic pregnancy at seven and 32 per 100,000 women respectively.’

It is worth noting that in European countries, where RU486 has been available for some time, there has been no increase in the overall number or rate of abortions, but the proportion of abortions performed at earlier gestations has risen. It is true that medical abortions, like surgical abortions, can have serious side effects. Complications, though rare, can include excessive vaginal bleeding requiring transfusion, incomplete abortions or ongoing pregnancy requiring a surgical abortion. There is no doubt in my mind, having read the material, that an appropriate level of backup medical care is needed to ensure that there is speedy treatment in the event of possible complications. Despite the arguments of some that somehow this medication will be readily accessible, the drug, as we know, under the protocols developed by the AMA would only ever be administered by a qualified professional in a licensed facility.

I want to conclude by referring to an article which caught my attention recently. There have been many headlines about RU486 being the killer drug. This article, written by Dr Sally Cockburn, was headed ‘RU486 might be a drug for life’. Naturally, I was most intrigued by the heading and I looked further at the article. It talked about the genesis of RU486. I did not know this—and I think many others who want to argue whether RU486 is or is not a therapeutic drug might have a look at this article—but Dr Cockburn pointed out that the genesis of RU486 began in France in the 1980s, when it was first developed as an exciting new drug formulated to treat Cushing’s disease. She stated:

This drug blocked cortisol and reversed health problems like diabetes. By 1992, research indicated this same drug might hold hope for ageing, cancer, viral and stress related diseases, as well as dementia. The drug offered potential treatment for some of mankind’s most devastating diseases: inoperable brain tumours, ovarian cancer and certain breast cancers.

She went on:

But most amazing were the studies showing it also interfered with replication of HIV …

Dr Cockburn asks: could a cure for cancer or HIV-AIDS be caught up by the fact that RU486 research is, as she says ‘mostly gathering dust’? It is an interesting perspective on the drug RU486, and one which we hear little about.

The intent of the bill before us today is, in my view, reasonably straightforward. I believe that those who oppose the use of RU486—and do so in all sincerity—because of safety concerns have a strong argument to also support this bill. If their concerns about safety are correct, the TGA would not approve the drug for use in Australia.

RU486 has now been used by about two million women. It has been endorsed as safe and effective by people more eminent and with greater expertise than I have—by eminent medical bodies including the WHO, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, similar colleges in both the UK and America, the AMA and the American Medical Association.

By supporting this private member’s bill, we will allow the independent TGA to evaluate RU486 in the same impartial manner that it has done with almost 50,000 therapeutic goods that have already come before it. I believe that the TGA has the integrity and competence to assess whether or not RU486 is safe and suitable for use in Australia.

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