Senate debates

Thursday, 9 February 2006

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

Second Reading

12:09 pm

Photo of Natasha Stott DespojaNatasha Stott Despoja (SA, Australian Democrats) Share this | Hansard source

I rise to speak in favour of this private member’s bill—the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005. I speak as a proud pro-choice woman and as a member of the only political party that opposed the Harradine amendments in 1996. For 10 years, the Australian Democrats have been keen to see this decision reversed, and I hope that this afternoon this private members bill will be successful. I want to place on record my congratulations to the cross-party co-sponsors of this private member’s bill.

Contrary to comments by some, but in particular the Minister for Health and Ageing, the Australian Democrats did oppose the 1996 amendments. Those amendments gave the health minister the power of veto over the approval of so-called abortion drugs such as RU486. We put on record at the time:

The Democrats cannot support either the specific amendment or the intent of the amendment. The intent of the amendment is to make it as difficult as possible for women to have another choice and to make it as difficult as possible for manufacturers to actually get their product into the country let alone through the process of trial, approval and making it available.

I recall the angst of many in that debate on both sides of parliament and, indeed, many women. I believe today, therefore, it is pretty heartening to see more senators supporting the handing of the authority back to the Therapeutic Goods Administration—the TGA—the body that we charge in this country to make these decisions for every other sort of drug.

The bill is about a simple change. It is not about the availability of abortion, nor is it even about the safety of RU486. Since this particular issue has been raised, I will comment on it later in my remarks. It is about who should be able to decide whether or not to approve drugs such as RU486 for use in Australia—the TGA or the health minister, whoever he or she may be, regardless or their personal views, regardless of whether they are pro- or anti-choice, for that matter. It is about removing the extraordinary and unprecedented ministerial discretionary power. Schedule 1 of this bill effectively repeals that power of the minister. It amends the Therapeutic Goods Act 1989 to ensure that medications such as RU486 are dealt with within the same evidence based assessment that is used for all other medicines.

In his opinion piece in the Australian, the health minister, Minister Abbott, argued:

In 1996, the federal parliament decided that decisions about abortion drugs were too important to be made by unelected, unaccountable officials.

His imputation that the TGA, the authority that we trust with every other important decision about which drugs can be made available in this country, are unfit in some way to make decisions in relation to this particular class of drugs is alarming. Indeed, it is offensive.

I note that yesterday Professor Terry Hull, the JC Caldwell Professor of Population, Health and Development at the National Centre for Epidemiology and Population Health and Professor of Demography at the Research School of Social Sciences at ANU, rebutted Minister Abbott’s argument. He said:

Minister Abbott is neither trained nor qualified to evaluate the safety nor efficacy of drugs. The Therapeutic Goods Administration was set up in 1989 to make such evaluations and to protect the public’s health.

He went on to say that the members of the Australian Drug Evaluation Committee, an expert committee of the TGA:

... are appointed by the minister and are required to have professional qualifications in clinical medicine, pharmacology, toxicology or general practice.

                  …              …              …

Surely the minister is not presuming to know more about the physical, pharmaceutical or medical risks than the committee he appoints and who report to him or his delegate?

There is something unsurprising about this debate. In fact, it is hardly surprising that anything that relates to women’s bodies—including drugs—is treated differently from other types of debates, or drugs in specific terms, in this place. After all, that is why this debate has become so controversial. Some legislators—some conservative and primarily male legislators—are finding it impossible to avoid interfering in women’s reproductive health rights. I have no doubt that this is why we have been granted a conscience vote in relation to this bill—a drug administration bill which in itself does not make RU486 available in this country. I have no doubt that it is because the subject matter relates to women’s bodies, women’s choices and women’s health.

This bill does not make RU486 available. Of course, if this bill passes both houses of parliament, an application for a licence to import RU486 would need to be made, and approved by the TGA. But, in many cases, these details have been conveniently ignored by some opponents of the bill—including, I have to say, by many of the people who have written to, emailed, faxed and lobbied me. Many of the people who have contacted me have added their names to form letters, some of which arrived in matching handwritten or typed envelopes. Some have sent as many as five form letters, all signed with the same name and address. I put that on the record not to undervalue the heartfelt, emotional and personal pleas that have come to my office, or indeed that correspondence, but to make it very clear that, when people are talking about the overwhelming amount of lobbying in this debate, there have been some very clearly orchestrated campaigns.

I might add that those letters and those opinions do not necessarily reflect the overwhelming view in our community in relation to the issue of choice. The Australian Survey of Social Attitudes found that 81.2 per cent of respondents, and 77 per cent of those who held religious views, believed that a woman should have the right to choose whether or not she has an abortion. The Australian Election Study found that only four per cent of respondents felt that abortion should not be allowed under any circumstances. That is a drop from six per cent back in 1987. But these results have not necessarily stopped those who are opposed to this legislation arguing against this bill and attempting to skew the results of some of the research, the surveys and the public opinion that is out there.

I have heard about push polling on this issue. One constituent who rang my office had been contacted and interviewed about RU486 by a research company called Quantum Market Research which was representing Australians Against RU486. She was originally told that the survey would be about contraception. She found that the questions were leading and offensive, so she complained. When she did, the interviewer admitted that other respondents had actually changed their opinions during the course of the survey. She has now made a complaint to the Australian Market and Social Research Society, because, in particular, the research company has refused to provide her with a copy of the survey, as they are entitled to do. I ask that the company make publicly available a copy of that survey. The results have already been bandied about; the results have been made publicly available—I have seen them in the newspapers, in full-page advertisements.

Some opponents of this legislation have used arguably distorted research and surveys to deflect attention away from what this bill is really about. In his opinion piece to the newspapers, the Minister for Health and Ageing, Mr Abbott, warned of ‘backyard miscarriages’ and ‘the development of an internet black market’ if the authority for approving RU486 is handed back to the TGA. Apart from this being a spurious reflection on the TGA, it overlooks the principal role that we have granted the TGA in our country. It is the national body charged with identifying, assessing and evaluating the risks that are associated with any therapeutic good that comes into this country.

Because the subject of risks has been raised in this chamber and elsewhere, let us look at some of the research on RU486. RU486 has been used safely by millions of women around the world—at least two million in Europe and around 500,000 in the United States of America. It is available in more than 30 developed and developing nations around the world, including the UK, the US, New Zealand, Austria, Finland, Denmark, Belgium, Germany, Greece, Luxembourg, the Netherlands, Spain, Norway and Switzerland, not to mention Israel, China, Russia, South Africa, Tunisia, Estonia, Latvia, Moldova, Georgia, Azerbaijan—and the list goes on. We know that.

It is considered by many doctors—including Australian doctors, I might add—to be a safe alternative to surgical abortion. In fact, late last year, a leading professor of obstetrics and gynaecology at James Cook University in Queensland, Caroline de Costa, writing in the Medical Journal of Australia, pointed to ‘overwhelming’ evidence that the drug is ‘safe, effective and acceptable to women’. The Vice-President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists later joined Professor de Costa in calling for RU486 to be made available in this country. I put this on the record not as an argument for necessarily making the drug available in this country, but simply to counter some of the misinformation in this debate in the public sphere.

RU486 is reported to have a number of advantages over surgical abortion, and, in fact—as has been mentioned in this debate—it was never intended to be used solely as an abortion drug. A briefing paper on the drug prepared by Reproductive Choice Australia states that the drug ‘requires no anaesthesia and puts women at no risk of perforation, damage to the cervix or infection from instruments’. The paper also states that RU486 can:

... be administered to a woman as soon as she knows that she is pregnant and wants to have an abortion. By contrast, a woman must wait until the 5th/6th week before she is able to have a vacuum aspiration abortion.

RU486 also has the potential to be used for a number of other medical purposes, and that is something that we should not overlook in this debate. That is another important reason why the TGA should be responsible for doing its job, assessing the risks and determining whether or not this drug should be available. RU486 has been talked about and considered as a possible treatment for breast cancer, ovarian cancer, uterine cancer, uterine fibroids, psychotic and major depression, bipolar depression, endometriosis and Cushing’s syndrome. Thus it does potentially have a therapeutic application, and that should not be overlooked in this debate.

A number of senators have raised the issue of pregnancy counselling in this debate, including the speaker before me, Senator Coonan. This is a totally legitimate issue in the context of a broader debate about pregnancy and abortion. On the surface, it seems quite a reasonable idea and notion. But I do want to put on the record that I am concerned about the lack of federal government support for pro-choice pregnancy counselling services in Australia, and the tendency of the federal government to favour anti-choice pregnancy counselling and the failure of many of these government funded, anti-choice services to declare their bias. We know that this is the case. We know that there have been examples of deceptive and misleading advertising. In fact, the Australian Federation of Pregnancy Support Services, which we know is linked to anti-choice organisations, made a submission to the Senate inquiry opposing RU486. That is their right to do that, but I believe these organisations must be up-front about where they are coming from, especially if they are in receipt of taxpayers’ dollars. I note that in November that organisation was allocated another $100,000 in funding. I am aware that anti-choice groups have released at least two different polls on the issue of abortion, in addition to the expensive full-page advertisements that we saw this week. I certainly hope there is no link between these surveys and advertisements and the hundreds of thousands of taxpayers’ dollars that have been allocated to the Australian Federation of Pregnancy Support Services. That is in stark contrast to the pro-choice pregnancy counselling services, which receive no federal government funding.

In the time remaining, I want to address the amendments that have been circulated. In particular, I have looked at the amendments circulated in the names of Senators Humphries and Barnett, and it is obvious that those amendments will place additional hurdles in the way of assessment and approval of RU486. For that reason, I will certainly vote against them, and I believe my Democrat colleagues will also oppose those amendments. Under the amendments that have been proposed, the minister would retain the power to approve or disapprove any application to evaluate, register, list or import RU486 without referring to any specified criteria. They require the minister to seek advice from the Australian Health Ethics Committee, which of course is currently set up to advise the NHMRC, before making a decision to approve or disapprove an application for RU486, although—and I acknowledge, again, another weak link in that argument—the minister does not have to follow that advice. This is not about the morality of abortion but the safety of a drug. Therefore, the TGA is the appropriate body to be evaluating it.

I note that the amendments also make the minister’s decision disallowable. I realise amendments have been circulated by Senators Scullion and Colbeck as well which might have a similar effect, though I am not entirely sure. However, the ones in the name of Senators Humphries and Barnett seek to make the minister’s decision disallowable, although this would only apply if the minister had approved the application in the first place. If the minister refuses the application, the parliament can disallow the written decision, but they cannot force the minister to reverse the decision and indeed approve the drug.

As I have pointed out, this debate has become a broader debate, perhaps inevitably, as a result of the strongly held views, emotive views and personal views, some of which have been expressed strongly in this debate. I am worried that this debate, like a number of others we have had in recent times—whether it is debating a motion on the millennium development goals or other issues, for that matter—has become yet another excuse for some people to attempt to wind back the clock on women’s rights. While I believe it is time that Australian women were granted access to RU486 and our country caught up with the many nations in which RU486 is licensed, today I am voting in favour of a piece of legislation that repeals ministerial approval and leaves the decision regarding approval or otherwise of drugs such as RU486 with the TGA.

I suspect and hope that most in this chamber will view this issue as a vote about authorisation and ministerial discretion. Just as I know that there are women and men on all sides of politics who want to protect the current state of women’s reproductive rights and stop some conservative politicians turning back the clock on these issues, I know there are many in this place who also want to move the debate forward. I believe that women have fought long and hard to be able to make decisions about their health and wellbeing. I believe women’s reproductive health is women’s business. I will be supporting the legislation.

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