House debates

Wednesday, 15 February 2006

Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005

Second Reading

11:24 am

Photo of Arch BevisArch Bevis (Brisbane, Australian Labor Party, Shadow Minister for Aviation and Transport Security) Share this | Hansard source

It is not often that members of this parliament have a free vote on matters that come before it. In fact, this is only the third occasion in a decade on which that opportunity has been presented to the parliament. It is appropriate that members of parliament have a free or, as it is often referred to, conscience vote on matters of this sort. It is a recognition that members of this parliament, as with all fair-minded people, as with all Australians, can in good faith, with a good heart and with a clear conscience, arrive at quite different views and, in those circumstances, the proper course of action is that there should be a free or conscience vote.

Like all members of parliament, I have had many emails, phone calls and letters from constituents and people around Australia who are concerned about pursuing one or other view of the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I am reminded of a conversation I had just a short time ago with one of my constituents from Ashgrove. The simple fact is that in a conscience vote none of us in this place can pretend to represent either the collective conscience of our 90,000-odd constituents or the individual conscience of any one of them. I can represent my own conscience and no other, and I think that is the situation all of us find ourselves in.

RU486 can currently be imported into Australia for research and clinical use but only with the permission of both the Therapeutic Goods Administration, the TGA, and the Minister for Health and Ageing, who is required under the current law to notify the parliament of his or her decision. That restriction has imposed an effective ban on the drug in Australia. These special requirements for RU486, which do not apply to any other drug, were incorporated into the act with the passage of the Therapeutic Goods Amendment Bill in 1996. At the time, that bill was supported by the coalition, by the Labor Party and by all the minor parties. Now, 10 years later, there is a private member’s bill through which we are reconsidering those issues.

There have been a number of arguments raised in this parliament and outside by those who are concerned about the bill and intend to vote against it or move amendments to it, and I want to deal with the concerns that have been raised. One of the principal issues that featured in the advertisements that have run in the public press has been concern about side effects and the potential lethal effects should RU486 be used. It is instructive to look at the evidence presented to the Senate Community Affairs Committee inquiry in relation to the matter. I want to quote from the committee’s report, where it discusses a submission that was given in evidence by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. The report said:

The College noted that there had been few randomised trials comparing early medical and surgical termination but the data they presented was a compilation of the best available evidence.

It goes on to quote the evidence:

Serious complications are rare and occur in approximately 4/1 000 procedures with either method. Mortality and serious morbidity occurs less frequently than if a pregnancy went to term …

That is, the risk of serious injury and death is greater if the pregnancy goes to term and a birth occurs than if there is medical or surgical intervention. That is not to say that there is not a risk when medical or surgical intervention occurs but, as a matter of fact, the threat of death and serious injury is greater in childbirth than in the process of medical or surgical intervention. In fact, a long list of medical experts providing evidence and others providing expert advice to the Senate committee endorsed the use of RU486.

Paragraph 1.72 of the Senate committee’s report notes the groups who had formally expressed their support for the availability of RU486: the World Health Organisation, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the Australian Medical Association, the Rural Doctors Association of Australia, the Public Health Association of Australia, the Royal College of Obstetricians and Gynaecologists in the UK, the American College of Obstetricians and Gynaecologists, the American Medical Association, the American Association for Advancement of Science, the US Federal Drug Administration and the Federation of International Gynaecology and Obstetrics. That is a long and impressive list of major medical authorities who have, as a matter of science, determined that the drug is safe to be used within appropriate parameters.

I believe the decision about the nature of any side-effects, and the risk management associated with the use of the drug having regard to any side-effects, should be made by the TGA, and doctors in consultation with their patients. Deciding whether or not a drug is dangerous for people to take in certain circumstances is not a decision for politicians, unless it can be demonstrated that the TGA has failed in its duties. There is no evidence—no evidence at all—to suggest that that is the case.

Those who have argued that this bill should be defeated because of concern about side-effects have, I think, misplaced their concerns. RU486 has been approved for use in many countries around the world, including the United Kingdom, the United States, New Zealand, France, Sweden, Austria, Belgium, Denmark, Finland, Germany, Greece, Israel, Luxembourg, the Netherlands, Spain, Switzerland and Norway, amongst others. Each one of these countries maintain careful checks to ensure drugs are safe to be used as prescribed. The technical and clinical evidence is in and it demonstrates overwhelmingly that RU486 is a drug which can be used without serious concern for safety, provided it is used under medical supervision. I note also, as has been mentioned by some other speakers, that RU486 is in fact used in a number of countries around the world for treatment of other diseases such as cancer and, I believe, Alzheimer’s.

It has been argued—with, I think, some merit—that politicians and not doctors should decide these issues. Those who have argued against the private member’s bill and who have supported amendments do so. I put it to them and to those who hold that view that that is precisely what we are doing now. This is not an abrogation of parliament’s responsibilities; this is not politicians stepping away; this is not politicians passing to bureaucrats an important decision that the people of Australia rightly expect politicians to have some role in. That is precisely what we are doing now. This is the point—right now, right here—where politicians are exercising their responsibilities and their conscience in determining that issue. I frankly regard it as a smokescreen for those who have argued in support of the amendment that we somehow need to maintain ongoing parliamentary supervision in this question. The clinical evidence around the world is quite overwhelming.

The only argument in relation to this issue seems to me now to be the question of whether or not, for other reasons, the parliament should legislate to override the scientific evidence and prevent the availability of this drug. One of the things that has been said as to why that should happen is that the TGA is not the appropriate body to deal with these things because it deals with medications and remedies for illnesses and, as pregnancy is not an illness, on that basis the TGA should not have a role. In fact, that also misstates the role of the TGA.

The TGA’s responsibilities under the act are to monitor the safety, quality and efficacy of medicines coming into Australia and extend well beyond the definition that those critics have applied to it. Its role is not limited only to medically essential treatments. For example, the TGA has a role in approving such items as breast implants and a range of cosmetic procedures, neither of which is used to prevent or treat diseases. The TGA is the appropriate body to be considering these matters.

I understand that for some this is not simply an issue about side-effects or about safety but a question of belief as to when life is created. Some who oppose RU486 hold very deep concerns associated very often with a religious belief and, in all cases, I suspect, a view of when life commences. I fully respect the sincerity and depth of concern and belief that they hold. Indeed, many of my good and close friends—many of my good and close friends in the Labor Party—hold those views and I respect them deeply. Like many in our community, I have thought about the questions involved in this debate for many years, long before I became a member of parliament. I have to say I do not share the view that life begins with conception.

I think it is also important to note that this is not a debate about whether abortion should be legalised. It is a point that has been made by other speakers. It was also, I think, clearly made in evidence to the Senate committee by Professors Rogers, Ankeny and Dodds, who said:

Induced abortion is a legal, albeit heavily regulated, procedure in Australia; the licensing of RU486 will not alter this situation. What will change if RU486 is licensed is that Australian women and their medical practitioners will have an increased range of options from which to select the safest and most efficacious treatment for any particular patient.

The Royal Women’s Hospital in Melbourne made the same point and I think it is worth recording here in the debate. They expressed the belief that:

... for many women a medical abortion, which can be performed earlier in pregnancy than surgical abortion, would be preferable ... Some women undergoing a termination of pregnancy want a safe alternative to surgery and to avoid being anaesthetised, which can cause a sense of a loss of control ... Nevertheless, some women will continue to want surgery, and both options should be made available. Several other studies have shown that women value choice, have a strong preference for one or other approach, and are more likely to be satisfied with a method they choose.

I think they are all important parts of this debate which, sadly, because of time restrictions we are not able to go into more fully. But it is important to understand that this is not a debate about whether abortion is legal or not legal in this country—as a matter of law, it is. The questions we confront are different from that.

The amendments that have been proposed and moved do nothing to add to the situation that presently prevails. Having listened to the debate in this parliament, having listened to the views of many constituents and having been involved in debates about matters of this kind for some years, it is my strong view that the private member’s bill is the correct course to follow. The parliament is exercising the responsibility that, as politicians, we should. Those who argue that the parliament is abrogating its responsibility misunderstand the process we are involved in at this time. I will be voting in favour of the private member’s bill.

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