Thursday, 16 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
At the end of this very extensive debate, I rise to voice my opposition to the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I do so because the system of regulation proposed by this bill is, in my belief, fundamentally inadequate. At present, as honourable members know, final approval for drugs such as RU486 rests with the Minister for Health and Ageing. It is argued by the proponents of this bill that this arrangement—that is, final approval resting with the Minister for Health and Ageing—lacks in transparency and accountability. They seek to resolve this lack of transparency and accountability by replacing the decision made by the Minister for Health and Ageing with a decision made by the Therapeutic Goods Administration, the TGA. If, as many proponents claim, this issue is not about abortion but about the best process of decision making, this bill is flawed for the very same reasons that the proponents claim the current system is—that is, it contains no more transparency and accountability than the current arrangements.
Having spent much of my professional life advising governments—I should say, both Liberal and Labor—and health care institutions on appropriate approaches to the regulation of biotechnology and reproductive technology, it appears to me that both the current arrangements and those proposed in the bill are inadequate. Much has been said about the appropriateness or otherwise of the Minister for Health and Ageing alone having the decision, but little attention has been given to the alternative proposal. There are a number of reasons why I believe that the TGA alone should not have these powers.
First, the TGA’s purview is limited to technical questions of quality, safety and efficacy. It does not consider other criteria. It is not empowered to take into account any ethical or other consideration that may pertain to this issue. Secondly, the TGA’s technical consideration is limited. For example, there is no requirement that doctors or pharmacists report any adverse reaction to the drugs. Yet we know that the use of this drug, in combination perhaps with other drugs, has caused a number of maternal deaths. Indeed, a major investigation into this issue is currently under way in the United States of America. It would be a pity if, out of all of this, the only winners were the drug companies and members of the legal profession.
Thirdly, the work of the TGA is largely funded through the industry that it regulates. Indeed, part of the reason advanced in favour of this bill is that, with the costs of making an application being so high, the CEO of a drug company would not make one, if the decision were to be subject to parliamentary scrutiny. I find this disturbing—not for the reason which was advanced by my friend the member for Moore, but because it may give rise in the community to a perception that the TGA will be a rubber stamp for applications. That would be regrettable, as far as the reputation of the TGA is concerned. This bill proposes that a group of medical experts will decide, on narrow grounds, what pharmaceutical companies in Australia wish to market. As Justice Michael Kirby once observed, the regulation of new technologies is not a matter to be resolved behind closed doors by committees, however expert and sincere they are.
For these reasons, in my view this bill contains a very inadequate system of regulation. Indeed, I find it quite strange that parliamentarians who day in, day out defend the concept of ministerial responsibility and parliamentary scrutiny in other areas would wish to abandon them in this instance. To the contrary, the amendments foreshadowed by both the members for Lindsay and Bowman provide more checks and balances and a higher level of accountability and transparency than the current bill. I prefer the amendment moved by the member for Lindsay, because it involves not only the expert advice of the TGA but also the minister and the parliament. For those who say that this argument should be based on a level of accountability and transparency then obviously both sets of amendments provide more accountability and more transparency than is provided in the bill before the parliament. Accordingly, I will support the amendments.
May I make a few comments about the issue of abortion. I find it disingenuous to say that this debate is not about abortion. That is purely a technical argument. The whole purpose of RU486 is to induce an abortion. If the subject matter were aspirin, we would not have been having this debate in the parliament over the last few days. Indeed, many speakers both here and in the Senate have explicitly stated their stance on the bill and related their stance on the bill in relation to their view about abortion generally.
Two things appear clear to me about abortion in Australia. The first is that there is no desire generally in the community to change the current legal approach to abortion. Contrary to what many have said, abortion is illegal in most Australian states unless certain circumstances are established, which usually relate to a threat to the health and wellbeing of the mother. However, in practice we know we have abortion on demand.
Secondly, there is a growing unease about the high number of abortions. Many Australians are concerned that there are 80,000 to 100,000 abortions performed in this country each and every year. Many believe that we have trivialised a profound issue and many also worry that this bill will compound that view. I believe that this level of abortion in Australia is a blight upon our nation. Many speakers both here and in the Senate have voiced concerns about the high abortion rate. Anecdotal evidence is supported and reinforced by surveys. A national poll conducted by the Sexton Marketing Group found, for example, that 87 per cent of people wanted the number of abortions in Australia reduced and 78 per cent wanted mandatory counselling before the procedure was undertaken.
I note that this bill proposes absolutely nothing that would reduce the incidence of abortion in Australia, something which I think overwhelmingly Australians would like to see. Indeed, the comment by Serena Williams, a young Melbourne woman reflecting on the unwanted loss of a pregnancy, in the Herald Sun last Sunday succinctly summarised the concerns of many people. She said:
I cannot understand why we are fighting so hard to promote less counselling, less help and debilitating bleeding at home without medical supervision, which is what would happen with RU486.
Given the level of concern in the community about the prevalence of abortion, I urge my colleagues in the government to consider what support and counselling can be provided for people facing this choice—and, by counselling, I do not mean services provided by abortion clinics. The reality today is that we have abortion with very little or no support for the women and the men facing these significant decisions. I urge the government—indeed, I urge this parliament—to address the issue. I believe a program that provided counselling and some time for people to consider all their choices would be widely supported in the Australian community.
We need more discussion, not less, about the causes for such a high incidence of abortion. For far too long we have danced around the subject—like the elephant sitting in the middle of the living room that we all know exists but whose existence we do not want to acknowledge. I hope this debate will not be the last word on the subject in this parliament but the beginning of a mature reflection on a matter of concern to so many Australians.
That the amendment (Miss Jackie Kelly’s) be agreed to.